NEPHROS INC - Quarter Report: 2008 June (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: June
30, 2008
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.)
|
|
|
|
|
3960
Broadway
New
York, New York
|
10032
|
|
(Address
of Principal Executive Offices)
|
(Zip
code)
|
(212)
781-5113
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 is a shell company (as defined in Rule
12b-2 of the Exchange Act).
As
of
August 14, 2008, 38,165,380 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.
|
|||
PART I –
FINANCIAL INFORMATION
|
|||
Item
1.
|
Financial
Statements
|
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
|
||
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
11
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk.
|
18
|
|
Item
4T.
|
Controls
and Procedures
|
18
|
|
PART II – OTHER INFORMATION | |||
Item 4. |
20
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||
Item
6.
|
Exhibits
|
20
|
2
NEPHROS,
INC. AND SUBSIDIARY
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands)
(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
|
|||||
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.
|
|||||||
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
|
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
|
Six
Months
Ended
|
|||||||||||||||
June
30,
|
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
|
)
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Net
loss per common share, basic and diluted
|
|
$
|
(0.06
|
)
|
$
|
(0.13
|
)
|
$
|
(0.11
|
)
|
$
|
(0.26
|
)
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Weighted
average common shares outstanding,
basic
and diluted
|
|
|
38,165,380
|
|
|
12,317,992
|
|
|
38,165,380
|
|
|
12,317,992
|
|
The
accompanying notes are an integral part of these unaudited condensed
consolidated interim financial statements
4
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In
thousands)
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
|
The
accompanying notes are an integral part of these unaudited condensed
consolidated interim financial statements
5
1. |
Basis
of Presentation and
Liquidity
|
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
2007 Annual Report on Form 10-KSB filed with the Securities and Exchange
Commission (the “SEC”) on March 31, 2008. The accompanying 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 Rule 8-03 of Regulation
S-X. Accordingly, since they are interim statements, the accompanying 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, 2007 was derived from
the Company’s audited financial statements but does not include all disclosures
required by GAAP. In the opinion of management, the interim 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 inter-company transactions and balances have been
eliminated in consolidation.
The
Company has incurred significant losses in its operations in each quarter since
inception. For the six months ended June 30, 2008 and 2007, the Company has
incurred a net loss of approximately $4,084,000 and $3,201,000, respectively.
In
addition, the Company has not generated positive cash flow from operations
for
the six months ended June 30, 2008 or 2007. The Company expects to continue
to
incur losses for at least the short-term. 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 has sufficient liquid assets between its current cash balance and its
short-term investments which were liquidated at par value subsequent to June
30,
2008 (see Notes 9 and 11) to meet its current obligations.
2. |
Concentration
of Credit Risk
|
For
the
six months ended June 30, 2008 and 2007, the following customers accounted
for
the following percentages of the Company’s sales, respectively.
Customer
|
2008
|
2007
|
|||||
A
|
84%
|
|
94%
|
|
|||
B
|
8%
|
|
0%
|
|
6
As
of
June 30, 2008 and December 31, 2007, the following customers accounted for
the
following percentages of the Company’s accounts receivable,
respectively.
Customer
|
2008
|
2007
|
|||||
A
|
72%
|
|
0%
|
|
|||
B
|
19%
|
|
0%
|
|
3. |
Revenue
Recognition
|
The
Company recognizes revenue in accordance with Securities and Exchange Commission
Staff Accounting Bulletin No. 104 “Revenue
Recognition”
(“SAB
104”). SAB 104 requires that four basic criteria must be met before revenue can
be recognized: (i) persuasive evidence of 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.
The
Company recognizes revenue related to product sales when delivery is confirmed
by its external logistics provider and the other criteria of SAB 104 are met.
All costs and duties relating to delivery are absorbed by the Company. All
shipments are currently received directly by the Company’s customers. Sales made
on a returned basis are recorded net of a provision for estimated returns.
These
estimates are revised as necessary, to reflect actual experience and market
conditions. The returns provision is based on historical unit return levels
and
valued relative to debtors at the end of each quarter. There were no returns
for
the six months ended June 30, 2008 and 2007.
4. |
Stock-Based
Compensation
|
The
Company complies with the accounting and reporting requirements of Statement
of
Financial Accounting Standards (“SFAS”) No. 123 (Revised 2004), “Share-Based
Payment”
(“SFAS
123R”), using a modified prospective transition method. For the three months
ended June 30, 2008 and 2007, stock-based compensation expense was approximately
$32,000 and $108,000, respectively. For the six months ended June 30, 2008
and
2007, stock-based compensation expense was approximately $64,000 and $295,000,
respectively.
There
was
no tax benefit related to expense recognized in the six months ended June 30,
2008 and 2007, as the Company is in a net operating loss position. As of June
30, 2008, there was approximately $311,000 of total unrecognized compensation
cost related to unvested share-based compensation awards granted under the
equity compensation plans which does not include the effect of future grants
of
equity compensation, if any. Of this amount, approximately $311,000 will be
amortized over the weighted-average remaining requisite service period of 2.3
years. Of the total $311,000, the Company expects to recognize approximately
32.9% in the remaining interim periods of 2008, approximately 43.4% in 2009
and
approximately 23.7% in 2010.
5. |
Comprehensive
Income
|
The
Company accounts for comprehensive income in accordance with SFAS No. 130,
“Reporting
Comprehensive Income”
(“SFAS
130”), which requires comprehensive income (loss) and its components to be
reported when a company has items of other comprehensive income (loss).
Comprehensive income (loss) includes net income plus other comprehensive income
(loss) (i.e., certain revenues, expenses, gains and losses reported as separate
components of stockholder’s equity (deficit) rather than in net income
(loss)).
The
Company accounts for certain transactions with a foreign affiliate in a currency
other than U.S. dollars. For the purposes of presenting the condensed
consolidated interim financial statements in conformity with GAAP, the
transactions must be converted into U.S. dollars in accordance with SFAS No.
52,
“Foreign
Currency Translation” (“SFAS
52”).
Since
these transactions are of a long-term investment nature and settlement is not
planned or anticipated in the foreseeable future, the offsetting foreign
currency adjustment is accounted for as an other comprehensive income item
in
the unaudited condensed consolidated balance sheets.
7
6. |
Loss
Per Common
Share
|
In
accordance with SFAS No. 128, “Earnings
Per Share,”
(“SFAS
128”) 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 13,214,324 and 5,184,768 from
the computation of diluted EPS for the three and six month periods ended June
30, 2008 and 2007, respectively.
7. |
Recently
Adopted Accounting
Pronouncements
|
In
September 2006, the Financial Accounting Standards Board (“FASB”) issued SFAS
No. 157, “Fair
Value Measurements” (“SFAS
157”). This Standard 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, the FASB issued FASB Staff Position (FSP) No. 157-2, “Effective
Date of FASB Statement No.157”
(“FSP
157-2”), which delayed the effective date of SFAS 157 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
SFAS 157 for financial assets and liabilities on January 1, 2008. The
disclosures required under SFAS 157 are set forth in Note 9. The Company is
currently in the process of evaluating the effect, if any, that the adoption
of
FSP 157-2 will have on its results of operations or financial
position.
In
February 2007, the FASB issued SFAS No. 159, “The
Fair Value Option for Financial Assets and Financial Liabilities-Including
an
amendment of FASB Statement No. 155”
(“SFAS
159”). This statement permits entities to choose to measure selected assets and
liabilities at fair value. The Company adopted SFAS 159 on January 1, 2008
resulting in no material impact to the Company’s financial condition, results of
operation or cash flows.
In
December 2007, the FASB issued SFAS No. 141 (revised 2007), “Business
Combinations” (“SFAS 141R”).
SFAS 141R 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. SFAS 141R
determines what information to disclose to enable users of the financial
statements to evaluate the nature and financial effects of the business
combination. SFAS 141R is effective for fiscal years beginning after December
15, 2008. The Company is currently evaluating the impact of adopting SFAS 141R
on its consolidated results of operations and financial condition and plans
to
adopt it as required in the first quarter of fiscal 2009.
In
December 2007, the FASB issued SFAS No. 160, “Noncontrolling
Interests in Consolidated Financial Statements”
(“SFAS
160”), an amendment of Accounting Research Bulletin No. 51, “Consolidated
Financial Statements”
(“ARB
51”). SFAS 160 establishes accounting and reporting standards for the
noncontrolling interest in a subsidiary and for the deconsolidation of a
subsidiary. Minority interests will be recharacterized as noncontrolling
interests and will be reported as a component of equity separate from the
parent’s equity, and purchases or sales of equity interests that do not result
in a change in control will be accounted for as equity transactions. In
addition, net income attributable to the noncontrolling interest will be
included in consolidated net income on the face of the income statement and
upon
a loss of control, the interest sold, as well as any interest retained, will
be
recorded at fair value with any gain or loss recognized in earnings. This
pronouncement is effective for fiscal years beginning after December 15, 2008.
The Company is currently evaluating the impact of adopting SFAS 160 on its
consolidated results of operations and financial condition and plans to adopt
it
as required in the first quarter of fiscal 2009.
8
In
March
2008, the FASB issued SFAS No. 161, “Disclosures
about Derivative Instruments and Hedging Activities”
(“SFAS
161”). SFAS 161 requires enhanced disclosures about an entity’s derivative and
hedging activities and thereby improves the transparency of financial reporting.
The objective of the guidance is to provide users of financial statements with
an enhanced understanding of how and why an entity uses derivative instruments:
how an entity accounts for derivative instruments and related hedged items
and
how derivative instruments and related hedged items affect an entity’s financial
position, financial performance, and cash flows. SFAS 161 is effective for
fiscal years beginning after November 15, 2008. Management has
evaluated SFAS 161 and has determined that it will have no impact on
the Company’s consolidated financial statements.
In
December 2007, the SEC issued SAB No. 110, “Share-Based
Payment”
(“SAB
110”). SAB 110 establishes the continued use of the simplified method for
estimating the expected term of equity based compensation. The simplified method
was intended to be eliminated for any equity based compensation arrangements
granted after December 31, 2007. SAB 110 is being published to help companies
that may not have adequate exercise history to estimate expected terms for
future grants. The Company does not expect the adoption of SAB 110 to have
a
material effect on its consolidated financial statements.
In
May
2008, the FASB issued SFAS No. 162, “The
Hierarchy of Generally Accepted Accounting Principles” (“SFAS
162”). SFAS 162 identifies the sources of accounting principles and the
framework for selecting the principles to be used in the preparation of
financial statements of nongovernmental entities that are presented in
conformity with GAAP. SFAS 162 is effective 60 days following the SEC’s approval
of the Public Company Accounting Oversight Board amendments to AU Section 411,
“The
Meaning of Present Fairly in Conformity With Generally Accepted Accounting
Principles.”
The
adoption of this statement is not expected to have a material effect on the
Company’s financial statements.
In
May
2008, the FASB issued SFAS No. 163, “Accounting
for Financial Guarantee Insurance Contracts –
An
interpretation of FASB Statement No. 60”
(“SFAS
163”). SFAS 163 requires that an insurance enterprise recognize a claim
liability prior to an event of default when there is evidence that credit
deterioration has occurred in an insured financial obligation. It also clarifies
how SFAS No. 60 “Accounting
and Reporting by Insurance Enterprises”
(“SFAS
60”) applies to financial guarantee insurance contracts, including the
recognition and measurement to be used to account for premium revenue and claim
liabilities, and requires expanded disclosures about financial guarantee
insurance contracts. SFAS 163 is effective for financial statements issued
for
fiscal years beginning after December 15, 2008, except for some disclosures
about the insurance enterprise’s risk-management activities. SFAS 163 requires
that disclosures about the risk-management activities of the insurance
enterprise be effective for the first period beginning after issuance. Except
for the disclosures identified above, earlier application is not permitted.
The
adoption of this statement is not expected to have a material effect on the
Company’s financial statements.
9. |
Fair
Value of Financial
Instruments
|
As
described in Note 7, the provisions of SFAS 157 were adopted by the Company
on
January 1, 2008 for financial assets and liabilities, and will be
adopted by the Company on January 1, 2009 for non-financial assets and
liabilities.
SFAS
157
clarifies that fair value is an exit price, representing the amount that would
be received to sell an asset or paid to transfer a liability in an orderly
transaction between market participants. As such, fair value is a market-based
measurement that should be determined based on assumptions that market
participants would use in pricing an asset or liability. SFAS 157 establishes
a
fair value hierarchy that prioritizes the inputs to valuation techniques used
to
measure fair value. The hierarchy gives the highest priority to unadjusted
quoted prices in active markets for identical assets or liabilities (Level
1
measurements) and the lowest priority to unobservable inputs (Level 3
measurements).
The
Company invested in auction rate securities (“ARS”) which are long-term debt
instruments with interest rates reset through periodic short-term auctions.
If
there are insufficient buyers when such a periodic auction is held, then the
auction “fails” and the holders of the ARS are unable to liquidate their
investment through such auction. With the liquidity issues experienced in global
credit and capital markets, the ARS held by the Company have experienced
multiple failed auctions since February 2008, and as a result, the Company
did
not consider these affected ARS liquid in the first quarter of 2008.
Accordingly, while the Company had classified its ARS as current assets at
December 31, 2007, the Company reclassified them as noncurrent assets at March
31, 2008.
9
Based
upon an analysis of other-than-temporary impairment factors, the Company wrote
down ARS with an original par value of approximately $4.4 million to an
estimated fair value of $4.3 million as of March 31, 2008. The Company reviewed
impairments associated with the above in accordance with Emerging Issues Task
Force (EITF) 03-1 and FSP SFAS 115-1/124-1, “The Meaning of
Other-Than-Temporary-Impairment and Its Application to Certain Investments,” to
determine the classification of the impairment as “temporary” or
“other-than-temporary.”
The
Company determined the ARS classification to be “other-than-temporary,” and
charged an impairment loss of approximately $114,000 on the ARS to its results
of operations for the three months ended March 31, 2008.
During
the three months ended June 30, 2008 approximately $300,000 of principal on
the
Company’s ARS had been paid back by the debtor, resulting in the Company’s
investment in ARS having decreased from $4.4 million to $4.1 million (par value)
at June 30, 2008. The net book value of the Company’s ARS at June 30, 2008 was
$3.986 million, due to the approximate $114,000 impairment recorded at March
31,
2008. On July 22, 2008 the Company sold its ARS to a third party at 100% of
par
value, for proceeds of $4.1 million. The Company reclassified the ARS from
Available-for-Sale to Trading Securities due to the sale of the investments
in
July 2008. See Note 11, Subsequent Events, for further discussion of the sale
transaction.
In
accordance with SFAS No. 115, “Accounting
for Certain Investments in Debt and Equity Securities,”
(“SFAS
115”) the ARS, classified as Trading Securities, are valued at their fair value
of $4.1 million at June 30, 2008. The adjustment of the investment’s carrying
value from $3.986 million net book value to $4.1 million fair value resulted
in
an Unrealized Holding Gain of approximately $114,000 which is included in the
Company’s Statement of Operations for the three and six months ended June 30,
2008.
The
underlying assets of the Company’s ARS were comprised primarily of student loans
and their fair value at March 31, 2008 was measured using Level 3 inputs due
to
the failure of the auction market. Due to the subsequent sale of the investments
at par, the fair value of the securities was measured using Level 1 inputs
as the proceeds redeemed in July 2008 were placed in a money market account
with
observable market sources.
10. |
Inventory,
net
|
Inventory
is stated at the lower of cost or market using the first-in first-out method.
The Company’s inventory as of June 30, 2008 and December 31, 2007 was
approximately as follows:
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
|
At
June
30, 2008 the Company held $4.1 million (fair value) in ARS as an investment.
The
Company sold the ARS to a third party on July 22, 2008 for $4.1 million.
The
Company recorded an Unrealized Holding Gain through earnings for the three
months ended June 30, 2008 of approximately $114,000 (the difference between
fair value and book value) when the Company adjusted such investment to fair
value, as a result of the Company’s reclassification of such investment from
Available-for-Sale to Trading Securities. The Company subsequently reversed
the
Unrealized Holding Gain and recorded a Realized Gain in July 2008 when the
sale
transaction was executed.
10
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, and our
Annual Report for the year ended December 31, 2007 on Form 10-KSB, 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 throughout this
Quarterly Report and our Annual Report for the year ended December 31, 2007
on
Form 10-KSB. Our actual results may differ materially.
Overview
The
following discussion and analysis of our condensed consolidated interim
financial condition and results of operations should be read in conjunction
with
our unaudited condensed consolidated interim financial statements and related
notes included in this quarterly report on Form 10-Q (the “Quarterly Report”)
and the audited consolidated financial statements and notes thereto as of and
for the year ended December 31, 2007 included in our Annual Report on Form
10-KSB filed with the SEC on March 31, 2008. Operating results are not
necessarily indicative of results that may occur in future periods.
Financial
Operations Overview
Revenue
Recognition:
Revenue
is recognized in accordance with SAB 101 “Revenue
Recognition in Financial Statements”
(“SAB
101”), as amended by SAB 104. SAB 101 requires that four basic criteria must be
met before revenue can be recognized: (i) persuasive evidence of 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.
Since
our
inception in April 1997, we have been engaged primarily in the development
of
hemodiafiltration, or HDF, products and technologies for treating patients
with
End Stage
Renal
Disease, or ESRD. Our products include the OLpūr MD190 and MD220, which are
dialyzers (our “OLpūr
MDHDF Filter Series”),
OLpūr
H2H, an add-on module designed to enable HDF therapy using the most common
types
of hemodialysis machines, and the OLpūr NS2000 system, a stand-alone HDF machine
with associated filter technology. We began selling our OLpūr MD190 dialyzer in
some parts of our Target European Market (consisting of France, Germany,
Ireland, Italy and the United Kingdom (U.K.), as well as Cyprus, Denmark,
Greece, the Netherlands, Norway, Portugal, Spain, Sweden and Switzerland) in
March 2004, and have developed units suitable for clinical evaluation for our
OLpūr H2H product. We are developing our OLpūr NS2000 product in conjunction
with an established
machine manufacturer in Italy. We are working with this manufacturer to modify
an existing HDF platform they currently offer for sale in parts of our Target
European Market, incorporating our proprietary H2H technology.
11
To
date,
we have devoted most of our efforts to research, clinical development, seeking
regulatory approval for our ESRD products, establishing manufacturing and
marketing relationships and establishing our own marketing and sales support
staff for the development, production and sale of our ESRD therapy products
in
our Target European Market and the United States upon their approval by
appropriate regulatory authorities.
In
the
first quarter of 2007, we received approval from the U.S. Food and Drug
Administration (the “FDA”) for our Investigational Device Exemption
(“IDE”)
application for the clinical evaluation of our OLpūr H2H module and OLpūr MD 220
filter. We have also received the approval from the Institutional Review Board
(“IRB”)
associated with the clinics at which the trials will take place. We obtained
approval from Western IRB, Inc. to conduct a clinical trial. We completed the
patient treatment phase of our clinical trial during the second quarter of
2008.
We have targeted submitting our data to the FDA with our 510(k) application
on
these products by the end of the third quarter of 2008.
We
have
also applied our filtration technologies to water filtration and in 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. The DSU is designed to remove a broad range of bacteria,
viral agents and toxic substances, including salmonella, hepatitis, cholera,
Ebola virus, ricin toxin, legionella, fungi and e-coli.
In
the
current quarter, we fulfilled DSU sales to a major university teaching hospital
and obtained orders from a United States Air Force hospital. We currently have
pilot installations of the DSU at several other hospitals, including a
children’s hospital in the mid-Atlantic region. We are actively qualifying
distributors nationwide to sell the DSU and they are in the process of
completing product evaluations.
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 war fighters. Work on this
project commenced in January 2008 and we have billed approximately $52,000
during the six months ended June 30, 2008. In December 2007, the U.S. Department
of Defense Appropriations Act appropriated an additional $2 million to continue
the development of a dual stage ultra reliable personal water filtration system.
Although it is our intention to execute an agreement with the U.S. Department
of
Defense to utilize this appropriation before it expires in September 2009,
such
an agreement has not been executed as of June 30, 2008.
Since
our
inception, we have financed our operations primarily through sales of our equity
and debt securities. From inception through June 30, 2008, we received net
offering proceeds from private sales of equity and debt securities and from
the
initial public offering of our common stock (after deducting underwriters’
discounts, commissions and expenses, and our offering expenses) of approximately
$52.0 million in the aggregate. An additional source of financing was our
license agreement with Asahi, pursuant to which we received an up front license
fee of $1.75 million in March 2005.
The
following trends, events and uncertainties may have a material impact on our
potential sales, revenue and income from operations:
(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;
|
12
(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.
|
To
the
extent we are unable to succeed in accomplishing (1) through (4), our sales
could be lower than expected and dramatically impair our ability to generate
income from operations. With respect to (5), the impact could either be
positive, in the case where dialysis clinics consolidate into independent
chains, or negative, in the case where competitors acquire these dialysis
clinics and use their own products, as competitors have historically tended
to
use their own products in clinics they have acquired.
Compliance
with American Stock Exchange’s Listing Standards
During
2006, we received notices from AMEX that we were not in compliance with certain
conditions of the continued listing standards of Section 1003 of the AMEX
Company Guide. Specifically, AMEX noted our failure to comply with Section
1003(a)(i) of the AMEX Company Guide relating to shareholders’ equity of less
than $2,000,000 and losses from continuing operations and/or net losses in
two
out of our three most recent fiscal years; Section 1003(a)(ii) of the AMEX
Company Guide relating to shareholders’ equity of less than $4,000,000 and
losses from continuing operations and/or net losses in three out of our four
most recent fiscal years; and Section 1003(a)(iii) of the AMEX Company Guide
relating to shareholders’ equity of less than $6,000,000 and losses from
continuing operations and/or net losses in our five most recent fiscal years.
We
submitted a plan in August 2006 to advise AMEX of the steps we had taken, and
proposed to take, to regain compliance with the applicable listing
standards.
On
November 14, 2006, we received notice that the AMEX staff had reviewed our
plan
of compliance to meet the AMEX’s continued listing standards and that AMEX would
continue our listing while we sought to regain compliance with the continued
listing standards during the period ending January 17, 2008. During the plan
period, we were required to provide the AMEX staff with updates regarding
initiatives set forth in our plan of compliance. On November 14, 2007, all
of
our Series A 10% Secured Convertible Notes Due 2008 and our Series B 10% Secured
Convertible Notes due 2008 (collectively, the "Notes"), representing an
aggregate principal amount of $18 million, were converted into shares of our
common stock and warrants, resulting in an increase in our stockholders’ equity.
As a result, and notwithstanding our loss during the fourth quarter of 2007,
our
stockholders’ equity, at December 31, 2007, was approximately $8,756,000 and in
excess of the $6,000,000 required by the AMEX rules.
On
March
5, 2008, we received a letter from the AMEX acknowledging that we had resolved
the continued listing deficiencies referenced in the AMEX’s letters dated July
17, 2006 and November 14, 2006. At
June
30, 2008, our stockholders' equity was $4,814,000, which is less than the
applicable AMEX continued listing standard. Management is considering
various approaches to regaining compliance, however, there can be no assurance
that we will be successful. In accordance with Section 1009(h) of the
AMEX Company Guide, the AMEX may evaluate the relationship between these
incidents and truncate its evaluation process or immediately initiate delisting
proceedings. Furthermore, there can be no assurance that we will not fail to
comply with the AMEX rules regarding minimum shareholders’ equity or other
continued listing standards in the future. If we fail to meet any of these
standards, then our common stock may be delisted from the AMEX.
Critical
Accounting Policies
The
Company adopted several changes to its critical accounting policies during
the
first six months of 2008 as set forth below. 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, one 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-KSB for the year ended December 31, 2007.
13
In
September 2006, the FASB issued SFAS 157. This Standard 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, the FASB issued FSP 157-2, which
delayed the effective date of SFAS 157 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 SFAS 157 for
financial assets and liabilities on January 1, 2008. The disclosures required
under SFAS 157 are set forth in Note 9 to our condensed financial statements
set
forth in Item 1 of this quarterly report. We are currently in the process of
evaluating the effect, if any, that the adoption of FSP 157-2 will have on
our
results of operations or financial position.
New
Accounting Pronouncements
See
Note
8 to our unaudited 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.
Three
Months Ended June 30, 2008 Compared to the Three Months Ended June 30,
2007
Net
Product Revenues
Net
product revenues were approximately $253,000 for the three months ended June
30,
2008 compared to approximately $348,000 for the three months ended June 30,
2007, a decrease of 27%. The $95,000 decrease in net product revenues represents
a decrease of approximately $124,000 at constant dollars, offset by a favorable
foreign currency effect of approximately $29,000. The decrease is primarily
due
to reduced sales of ESRD therapy products in Europe due to delays in receipt
of
raw materials, resulting production delays and deferred shipments of ordered
product until after quarter end.
Cost
of Goods Sold
Cost
of
goods sold was approximately $162,000 for the three months ended June 30, 2008
compared to approximately $245,000 for the three months ended June 30, 2007,
a
decrease of 34%. The $83,000 decrease in cost of goods sold represents a
decrease in approximately $104,000 at constant dollars, partially offset by
a
currency exchange impact of an increase of $21,000. This decrease is correlated
to our decrease in sales.
14
Research
and Development
Research
and development expenses were approximately $1,149,000 for the three months
ended June 30, 2008 compared to approximately $416,000 for the three months
ended June 30, 2007, an increase of 176%. The increase of $733,000 is primarily
due to the expense of conducting a clinical trial in the U.S. for our ESRD
therapy products. The clinical trial is required to obtain Food and Drug
Administration’s (“FDA”) approval to market such ESRD therapy products in the
United States. Clinical trial fieldwork ended on May 30, 2008.
Depreciation
Expense
Depreciation
expense was approximately $92,000 for the three months ended June 30, 2008
compared to approximately $84,000 for the three months ended June 30, 2007,
an
increase of 10%. The increase of $8,000 in depreciation expense represents
approximately $12,000 positive impact of foreign currency exchange and a
decrease in constant dollar depreciation expense of approximately $4,000.
Selling,
General and Administrative Expenses
Selling,
general and administrative expenses were approximately $1,474,000 for the three
months ended June 30, 2008 compared to approximately $1,152,000 for the three
months ended June 30, 2007, an increase of 28%. The increase of approximately
$322,000 resulted from the following increases during the three months ended
June 30, 2008 over the same period in 2007: $104,000 increased personnel costs
including salaries and fringe benefits; $53,000 increased recruiting expenses
due to hiring of a new CFO, V.P. of Marketing and an Engineer; $11,000 increased
travel expenses; $56,000 increased marketing expenses in order to develop a
market for the DSU product in the U.S.; $26,000 increase in professional fees,
taxes and other expenses; and a $72,000 increase in insurance
expense.
Interest
Income
Interest
income was approximately $66,000 for the three months ended June 30, 2008
compared to approximately $8,000 for the three months ended June 30, 2007.
The
increase of approximately $58,000 is a result of our having in excess of $4
million of investments generating interest income during the three months ended
June 30, 2008, compared to none during the comparable period in
2007.
Interest
Expense
We
incurred no interest expense for the three months ended June 30, 2008 because
we
had no debt during this period. Interest expense totaled approximately $81,000
for the three months ended June 30, 2007. The prior period interest expense
primarily represents approximately $78,000 for the accrued interest liability
associated with our 6% Secured Convertible Notes due 2012 (the “Old Notes”),
approximately $3,000 of which is associated with the amortization of the debt
discount on the Old Notes. In the fourth quarter of 2007, all of our debt
securities, including securities we issued on September 19, 2007 in exchange
for
the Old Notes, were converted into equity. For further information regarding
the
conversion of these debt securities, please refer to Note 7 to our Consolidated
Financial Statements in our Annual Report on Form 10-KSB for the year ended
December 31, 2007.
Other
Other
expense of approximately $8,000 for the three months ended June 30, 2007
includes the impact of the first quarter 2007 change in valuation of the
derivative liability associated with the conversion feature of the Old Notes
of
approximately $7,000. There was no other expense reported in the three months
ended June 30, 2008.
Six
Months Ended June 30, 2008 Compared to the Six Months Ended June 30,
2007
Revenues
Total
revenues for the six months ended June 30, 2008 were approximately $640,000
compared to approximately $644,000 for the six months ended June 30, 2007.
Total
revenues decreased approximately $4,000 or 1%. Excluding approximately $75,000
of favorable foreign currency exchange impact, the decrease was approximately
$79,000. The decrease is due to lower sales of ESRD therapy products in Europe
being partially offset by revenue earned on military projects in the United
States. The decrease is primarily due to reduced sales of ESRD therapy products
in Europe during the 2008 period due to delays in receipt of raw
materials, resulting production delays and deferred shipments of ordered product
until after quarter end.
15
Cost
of Goods Sold
Cost
of
goods sold was approximately $400,000 for the six months ended June 30, 2008
compared to approximately $450,000 for the six months ended June 30, 2007.
The
decrease of approximately $50,000 or 11% in cost of goods sold represents an
approximately $102,000 decrease (measured in constant dollars) due to volume,
offset by an approximately $52,000 increase due to foreign currency translation.
The decrease in volume was primarily due to lower sales of ESRD therapy products
in Europe. Costs related to the revenue on military projects are included in
R&D expenses.
Research
and Development
Research
and development expenses were approximately $1,872,000 and $804,000,
respectively, for the six months ended June 30, 2008 and June 30, 2007. This
increase of approximately $1,068,000 or 133% is primarily due to the expense
of
conducting a clinical trial in the U.S. for our ESRD therapy products. The
clinical trial is required to obtain FDA approval to market the ESRD therapy
products in the U.S. Clinical trial fieldwork ended on May 30,
2008.
Depreciation
Expense
Depreciation
expense was approximately $180,000 for the six months ended June 30, 2008
compared to approximately $167,000 for the six months ended June 30, 2007,
an
increase of 8%. The increase of $13,000 in depreciation expense represents
approximately $22,000 positive impact of foreign currency exchange and a
decrease in constant dollar depreciation expense of approximately $9,000.
Selling,
General and Administrative Expenses
Selling,
general and administrative expenses were approximately $2,588,000 for the six
months ended June 30, 2008 compared to approximately $2,290,000 for the six
months ended June 30, 2007, an increase of $298,000 or 13%. The increase of
approximately $298,000 resulted from the following increases during the six
months ended June 30, 2008 over the same period in 2007, which were offset
by a
$105,000 reduction in personnel costs including salaries, fringe benefits and
deferred compensation: $131,000 increase in recruiting expenses due to hiring
of
a new CFO, V.P. of Marketing and an Engineer; $56,000 increase in marketing
expenses in order to develop a market for the DSU product in the U.S.; $123,000
increase in professional fees, taxes and other expenses; and a $93,000 increase
in insurance expense.
Interest
Income
Interest
income was approximately $158,000 for the six months ended June 30, 2008
compared to approximately $33,000 for the six months ended June 30, 2007. The
increase of approximately $125,000 or 379% is due to the increase in investments
for the six months ended June 30, 2008 compared to the six months ended June
30,
2007. We had in excess of $4 million of investments generating interest income
during the six months ended June 30, 2008 compared to none in the comparable
period of 2007.
Interest
Expense
We
incurred no interest expense for the six months ended June 30, 2008, because
we
had no debt during this period. The interest expense of approximately $168,000
for the six months ended June 30, 2007 primarily represents approximately
$154,000 for the accrued interest liability associated with our Old Notes,
approximately $8,000 associated with the amortization of the debt discount
on
the Old Notes and approximately $6,000 for the interest portion of the present
value of payments we made to the Receiver for Lancer Offshore, Inc. pursuant
to
certain settlement arrangements. In the fourth quarter of 2007, all of our
debt
securities were converted into equity. Debt securities that we had issued on
September 19, 2007 in exchange for the Old Notes were converted to equity in
November 2007. We made the final payment under our settlement with the Receiver
for Lancer Offshore, Inc. in October 2007.
16
Other
income and expenses
Other
income in the amount of approximately $158,000 for the six months ended June
30,
2008 resulted from our receipt of New York State Qualified Emerging Technology
Company (“QETC”) tax refunds. Other income for the six months ended June 30,
2007 was approximately $1,000.
Liquidity
and Capital Resources
Net
cash
used in operating activities was approximately $2,640,000 for the six months
ended June 30, 2008 compared to approximately $2,531,000 for the six months
ended June 30, 2007. Approximately $109,000 more cash was used in operating
activities during the six months ended June 30, 2008 than in the six months
ended June 30, 2007. This was primarily due to:
|
·
|
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.
|
Net
cash
provided by investing activities was approximately $592,000 for the six months
ended June 30, 2008, compared to net cash provided by investing activities
of
approximately $2,798,000 for the six months ended June 30, 2007. Our net cash
provided by investing activities for the six months ended June 30, 2008 reflects
the maturities of short-term investments net of purchases in the amount of
approximately $600,000 partially offset by purchases of approximately $8,000
for
purchases of computer equipment. For the six months ended June 30, 2007, our
$2,798,000 net cash provided by investing activities reflects the maturities
of
short-term investments in the amount of approximately $2,800,000 partially
offset by purchases of $2,000 of equipment.
At
June
30, 2008 we held $4.1 million in ARS as a short term investment. We sold our
ARS
to a third party on July 22, 2008 for $4.1 million. We recorded an Unrealized
Holding Gain through earnings for the three months ended June 30, 2008 of
approximately $114,000 (the difference between fair value and book value) 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
in July 2008 when the sale transaction was executed.
Certain
Risks and Uncertainties
Our
Annual Report on Form 10-KSB for the year ended December 31, 2007 includes
a detailed discussion of our risk factors under the heading “Certain Risks and
Uncertainties.”
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:
17
|
·
|
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.
|
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-KSB for the fiscal year ended December
31, 2007 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.
Off-Balance
Sheet Arrangements.
We
did
not engage in any off-balance sheet arrangements during the three and six month
periods ended June 30, 2008 and 2007.
Item
3. Quantitative and Qualitative Disclosures About Market
Risk.
Due
to
our status as a smaller reporting company, this Item is not
required.
Item
4T. Controls and Procedures.
Under
the
supervision and with the participation of management, including our Chief
Executive Officer and Chief Financial Officer, we conducted an evaluation of
the
effectiveness of our disclosure controls and procedures (as defined in Rule
13a-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange
Act”)) as of the end of the period covered by this Quarterly Report on Form
10-Q. Based on that evaluation, our Chief Executive Officer and Chief Financial
Officer concluded that our disclosure controls and procedures have not been
operating effectively as of the end of the period covered by this
report.
18
In
connection with the preparation of our Annual Report of Form 10-KSB, 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. Due to the pervasive effect of the lack of resources, including
a
lack of resources that are appropriately qualified in the areas of U.S. GAAP
and
SEC reporting, and the potential impact on the financial statements and
disclosures and the importance of the annual and interim financial closing
and
reporting process, in the aggregate, there is more than a remote likelihood
that
a material misstatement of the annual financial statements would not have been
prevented or detected.
Remediation
Plans
Management
is in the process of remediating the above-mentioned weakness in our internal
control over financial reporting and is implementing the following
steps:
•
|
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.
|
The
implementation of these remediation plans has been initiated and will continue
during the remainder of fiscal 2008. The material weakness will not be
considered remediated until the applicable remedial procedures are tested and
management has concluded that the procedures are operating effectively.
Management recognizes that use of our financial resources will be required
not
only for implementation of these measures, but also for testing their
effectiveness.
Changes
in Internal Control over Financial Reporting
There
were no changes in our internal control over financial reporting during the
quarter ended June 30, 2008 that have materially affected, or are reasonably
likely to materially affect, our internal control over financial
reporting.
19
PART
II – OTHER
INFORMATION
Item
4. Submission of Matters to a Vote of Security Holders.
2008
Annual Meeting
On
June
25, 2008, we held our 2008 Annual Meeting of Stockholders (the “Annual
Meeting”). The holders of 29,022,229 shares of common stock were present in
person or represented by proxy at the Annual Meeting. At the Annual Meeting,
our
stockholders took the following actions:
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
|
Mr.
Amron
and Mr. Scibetta continue to be members of our Board of Directors along with
our
other directors whose respective terms of office continued beyond the Annual
Meeting, namely, Norman J. Barta, Lawrence J. Centella, Paul A. Mieyal and
Eric
A. Rose, M.D.
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
|
Item
6. Exhibits.
EXHIBIT
INDEX
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.
|
20
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.
|
|
|
|
|
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) |
21
Exhibit
Index
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.
|
22