NEPHROS INC - Quarter Report: 2008 March (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: March
31, 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 May
15 , 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.
|
Unaudited
Condensed Consolidated Interim Financial Statements
|
1
|
Unaudited
Condensed Consolidated Balance Sheets
|
1
|
|
Unaudited
Condensed Consolidated Statements of Operations
|
2
|
|
Unaudited
Condensed Consolidated Statements of Cash Flows
|
3
|
|
Notes
to Unaudited Condensed Consolidated Interim Financial
Statements
|
4
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations.
|
11
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk.
|
23
|
Item
4T.
|
Controls
and Procedures
|
23
|
Item
6.
|
Exhibits
|
|
PART
I –FINANCIAL
INFORMATION
Item
1. Unaudited
Condensed Consolidated Interim Financial Statements
NEPHROS,
INC. AND SUBSIDIARY
UNAUDITED
CONDENSED CONSOLIDATED BALANCE SHEETS
(In
thousands, except share amounts)
March
31,
|
December
31,
|
||||||
|
2008
|
2007
|
|||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
2,505
|
$
|
3,449
|
|||
Short-term
investments
|
4,700
|
||||||
Accounts
receivable, less allowances of $3 and $7, respectively
|
405
|
419
|
|||||
Inventory,
less allowances of $32 and $30, respectively
|
355
|
336
|
|||||
Prepaid
expenses and other current assets
|
459
|
392
|
|||||
Total
current assets
|
3,724
|
9,296
|
|||||
|
|||||||
Property
and equipment, net
|
724
|
762
|
|||||
Investments
|
4,286
|
||||||
Other
assets
|
27
|
27
|
|||||
Total
assets
|
$
|
8,761
|
$
|
10,085
|
|||
|
|||||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
610
|
$
|
488
|
|||
Accrued
expenses
|
922
|
841
|
|||||
Total
current liabilities
|
1,532
|
1,329
|
|||||
|
|||||||
Stockholders’
equity :
|
|||||||
|
|||||||
Preferred
stock, $.001 par value; 5,000,000 shares authorized at March 31,
2008 and
December 31, 2007; no shares issued and outstanding at March 31,
2008 and
December 31, 2007.
|
|||||||
|
|||||||
Common
stock, $.001 par value; 60,000,000 and 60,000,000 shares authorized
at
March 31, 2008 and December 31, 2007, respectively; 38,165,380
and
38,165,380 shares issued and outstanding at March 31, 2008 and
December
31, 2007, respectively.
|
38
|
38
|
|||||
|
|||||||
Additional
paid-in capital
|
90,252
|
90,220
|
|||||
Accumulated
other comprehensive income
|
191
|
110
|
|||||
Accumulated
deficit
|
(83,252
|
)
|
(81,612
|
)
|
|||
Total
stockholders’ equity
|
7,229
|
8,756
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
8,761
|
$
|
10,085
|
The
accompanying notes are an integral part of these unaudited condensed
consolidated interim financial statements
NEPHROS,
INC. AND SUBSIDIARY
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In
thousands, except share amounts)
Three
Months Ended
March
31,
|
|||||||
2008
|
2007
|
||||||
Net
product revenues
|
$
|
387
|
$
|
296
|
|||
Cost
of goods sold
|
238
|
205
|
|||||
Gross
margin
|
149
|
91
|
|||||
Operating
expenses:
|
|||||||
Research
and development
|
723
|
388
|
|||||
Depreciation
expense
|
88
|
83
|
|||||
Selling,
general and administrative
|
1,114
|
1,138
|
|||||
Total
operating expenses
|
1,925
|
1,609
|
|||||
Loss
from operations
|
(1,776
|
)
|
(1,518
|
)
|
|||
Interest
income
|
92
|
25
|
|||||
Interest
expense
|
(84
|
)
|
|||||
Impairment
of auction rate securities
|
(114
|
) |
|
||||
Amortization
of debt discount
|
(3
|
)
|
|||||
Other
income
|
158
|
9
|
|||||
Net
loss
|
$
|
(1,640
|
)
|
$
|
(1,571
|
)
|
|
Net
loss per common share, basic and diluted
|
$
|
(0.04
|
)
|
$
|
(0.13
|
)
|
|
Weighted
average common shares outstanding, basic and diluted
|
38,165,380
|
12,317,992
|
The
accompanying notes are an integral part of these unaudited condensed
consolidated interim financial statements
NEPHROS,
INC. AND SUBSIDIARY
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In
thousands)
Three
Months Ended
March
31,
|
|||||||
2008
|
2007
|
||||||
Operating
activities:
|
|||||||
Net
loss
|
$
|
(1,640
|
)
|
$
|
(1,571
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
|
88
|
83
|
|||||
Amortization
of research & development assets
|
4
|
4
|
|||||
Impairment
of auction rate securities
|
114
|
||||||
Amortization
of debt discount
|
3
|
||||||
Change
in valuation of derivative liability
|
(7
|
)
|
|||||
Stock-based
compensation
|
32
|
187
|
|||||
(Increase)
decrease in operating assets:
|
|||||||
Accounts
receivable
|
40
|
(17
|
)
|
||||
Inventory
|
5
|
(138
|
)
|
||||
Prepaid
expenses and other current assets
|
(55
|
)
|
122
|
||||
Increase
(decrease) in operating liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
235
|
(195
|
)
|
||||
Accrued
severance expense
|
(62
|
)
|
(94
|
)
|
|||
Accrued
interest-convertible notes
|
76
|
||||||
Other
liabilities
|
(192
|
)
|
|||||
Net
cash used in operating activities
|
(1,239
|
)
|
(1,739
|
)
|
|||
Investing
activities
|
|||||||
Purchase
of property and equipment
|
(10
|
)
|
(2
|
)
|
|||
Purchase
of short-term investments
|
(100
|
)
|
|||||
Maturities
of short-term investments
|
400
|
1,900
|
|||||
Net
cash provided by investing activities
|
290
|
1,898
|
|||||
Effect
of exchange rates on cash
|
5
|
1
|
|||||
Net
increase (decrease) in cash and cash equivalents
|
(944
|
)
|
160
|
||||
Cash
and cash equivalents, beginning of year
|
3,449
|
253
|
|||||
Cash
and cash equivalents, end of period
|
$
|
2,505
|
$
|
413
|
|||
Supplemental
disclosure of cash flow information
|
|||||||
Cash
paid for interest
|
$
|
|
$
|
5
|
|||
Cash
paid for taxes
|
$
|
9
|
$
|
32
|
The
accompanying notes are an integral part of these unaudited condensed
consolidated interim financial statements
Notes
to Unaudited Condensed Consolidated Interim Financial
Statements
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. 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 three months ended March 31, 2008 and 2007, the Company
has
incurred a net loss of approximately $1,640,000 and $1,571,000, respectively.
In
addition, the Company has not generated positive cash flow from operations
for
the three months ended March 31, 2008 and 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 is currently exploring the possibility of obtaining loans secured by
its
auction rate securities (“ARS”), as an alternative method of gaining some
liquidity from them; however, there can be no assurance that such efforts will
be successful. The Company believes that its financial resources other than
its
ARS will be sufficient to fund its currently planned activities through the
third quarter of 2008. If the Company is unable to obtain liquidity from its
ARS
on reasonable terms and is unable to obtain sufficient financing from other
sources by such time, then the Company may run out of funds with which to
operate its business.
2.
|
Concentration
of Credit Risk
|
For
the
three months ended March 31, 2008 and 2007, the following customers accounted
for the following percentages of the Company’s sales, respectively.
Customer
|
2008
|
2007
|
|||||
A
|
90%
|
|
90%
|
|
|||
B
|
6%
|
|
0%
|
|
|||
As
of
March 31, 2008 and December 31, 2007, the following customers accounted for
the
following percentages of the Company’s accounts receivable,
respectively.
Customer
|
2008
|
2007
|
|||||
A
|
94%
|
|
91%
|
|
|||
B
|
6%
|
|
0%
|
|
|||
3.
|
Revenue
Recognition
|
The
Company recognizes revenue in accordance with Securities and Exchange Commission
Staff Accounting Bulletin No. 104 “Revenue Recognition” (“SAB No. 104”). SAB No.
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) collectibility is reasonably assured.
The
Company recognizes revenue related to product sales when delivery is confirmed
by its external logistics provider and the other criterion of SAB No. 104 were
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 were 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 three months ended March 31, 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 March 31, 2008 and 2007, stock-based compensation expense was
approximately $32,000 and $187,000, respectively.
There
was
no tax benefit related to expense recognized in the three months ended March
31,
2008 and 2007, as the Company is in a net operating loss position. As of March
31, 2008, there was approximately $343,000 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 $323,000 will be
amortized over the weighted-average remaining requisite service period of 2.6
years. Of the total $323,000, the Company expects to recognize approximately
29.8% in the remaining interim periods of 2008, approximately 39.4% in 2009
and
approximately 30.8% in 2010.
5.
|
Comprehensive
Income
|
The
Company accounts for comprehensive income in accordance with SFAS No. 130,
“Reporting Comprehensive Income,” 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 accounting
principles generally accepted in the United States of America, the transactions
must be converted into U.S. dollars in accordance with SFAS No. 52, “Foreign
Currency Translation”. 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 condensed consolidated balance
sheets.
6.
|
Loss
per Common Share
|
In
accordance with SFAS No. 128, “Earnings Per Share,” net loss per common share
amounts (“basic EPS”) were 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 2,703,473 from the computation of diluted
EPS for the three month periods ended March 31, 2008 and 2007,
respectively.
7.
|
Recently
Adopted Accounting
Pronouncements
|
In
September 2006, the Financial Accounting Standards Board (FASB) issued Statement
of Financial Accounting (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, 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 No. 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.
8.
|
New
Accounting Pronouncements
|
In
December 2007, the FASB issued Statement of Financial Accounting Standards
No.
141 (revised 2007), “Business Combinations” (“FAS 141R”). FAS 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. FAS 141R determines what
information to disclose to enable users of the financial statements to evaluate
the nature and financial effects of the business combination. FAS No. 141R
is
effective for fiscal years beginning after December 15, 2008. The Company is
currently evaluating the impact of adopting FAS 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 160, “Noncontrolling Interests in
Consolidated Financial Statements” (“FAS 160”), an amendment of Accounting
Research Bulletin No. 51, “Consolidated Financial Statements” (“ARB 51”). FAS
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 FAS 160 on its consolidated results of
operations and financial condition and plans to adopt it as required in the
first quarter of fiscal 2009.
In
March
2008, the FASB issued SFAS No. 161, “Disclosures about Derivative Instruments
and Hedging Activities” (“FAS 161”). FAS 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. FAS 161 is effective for fiscal years beginning after November
15,
2008. Management has evaluated FAS 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.
9.
|
Fair
Value of Financial
Instruments
|
As
described in Note 7, the provisions of SFAS No. 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
No.
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 No. 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).
As
of
December 31, 2007 and March 31, 2008 the Company held $4.7 million and $4.3
million (fair value) in ARS. ARS 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, these ARS have experienced multiple failed auctions since
February 2008, and as a result, these affected ARS are currently not liquid.
Accordingly, while the Company had classified its ARS as current assets at
December 31, 2007, the Company has reclassified them as noncurrent assets at
March 31, 2008.
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 reviews
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 charged an impairment loss of approximately $114,000 on the ARS to
its
results of operations for the three months ended March 31, 2008.
Marketable
securities measured at fair value using Level 3 inputs are comprised of auction
rate securities within the Company’s available-for-sale investment portfolio.
Although ARS would typically be measured using Level 2 inputs, the recent
failure of auctions and the lack of market activity and liquidity required
that
these securities be measured using Level 3 inputs. The fair value of the
Company’s ARS was determined using a pricing model that market participants
would use that considered projected cash flows for the issuing trust, underlying
collateral and expected yields. Projected cash flows were estimated based on
the
underlying loan principal, bonds outstanding and payout formulas. The
weighted-average life over which cash flows were projected considered the
collateral composition of the securities and related historical and projected
prepayments. The discount rates that were applied to the pricing model were
based on market conditions for comparable or similar term asset-backed
securities as well as other fixed income securities. The underlying assets
of
the Company’s ARS are comprised primarily of student loans and their fair value
was measured using Level 3 inputs due to the failure of the auction market,
based on the Company’s assessment of the underlying collateral and the
creditworthiness of the issuers of the securities.
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 March 31, 2008 and December 31, 2007 was
approximately as follows:
Unaudited
March 31, 2008
|
Unaudited
December 31, 2007
|
||||||
Raw
Materials
|
$
|
161,000
|
$
|
62,000
|
|||
Finished
Goods
|
226,000
|
304,000
|
|||||
Total
Gross Inventory
|
$
|
387,000
|
$
|
366,000
|
|||
Less:
Inventory reserve
|
32,000
|
30,000
|
|||||
Total
Inventory
|
$
|
355,000
|
$
|
336,000
|
11.
|
Subsequent
Events
|
As
of
April 28, 2008, Mark W. Lerner resigned
as the Company’s Chief Financial Officer,
and the
Board of Directors appointed Gerald J. Kochanski, 54, as the Company’s Chief
Financial Officer.
Separation
Agreement
On
May 7,
2008, the Company entered into a separation agreement and release
with Mr. Lerner, pursuant to which, the employment agreement
between the Company and Mr. Lerner, dated as of March 6, 2006, was
terminated. Pursuant to the separation agreement, Mr. Lerner
agreed to remain employed by the Company and to consult with the
Company's officers, directors and agents and otherwise provide assistance
in the Company's transition to a new chief financial officer until a
separation date as late as May 15,
2008. The separation agreement provides that (i)
Mr. Lerner will continue to receive his current base salary for a period of
three months following the separation date, to be paid in accordance with
the Company’s normal payroll practices, and (ii) the Company will reimburse Mr.
Lerner for up to $5,000 of reasonable expenses for professional
outplacement assistance. The separation agreement also contains mutual
releases and other customary provisions.
Employment
Agreement
The
Company entered into an employment agreement with Mr. Kochanski, dated as of
April 1, 2008. Pursuant to such employment agreement, Mr. Kochanski’s initial
annual base salary is $185,000. For the first year of Mr. Kochanski’s
employment, the Company will pay him a non-accountable commuting allowance
of
$10,000. In addition, the Company will pay up to $10,000 of Mr. Kochanski’s
moving costs. Mr. Kochanski may be awarded a bonus based on performance. The
employment agreement also provides that Mr. Kochanski shall be entitled to
receive an option to purchase 250,000 shares of the Company’s common stock under
its 2004 Equity Incentive Plan. The option will vest in four equal annual
installments of 62,500 shares on each of March 31, 2009, March 31, 2010, March
31, 2011 and March 31, 2012, provided that he remains employed by the Company
at
such time, and provided further that all options shall vest and become
exercisable in full immediately upon the occurrence of a Change in Control
(as
defined in the Company’s 2004 Stock Incentive Plan).
Mr.
Kochanski’s employment agreement provides that, upon termination by the Company
for Cause or Disability (as such terms are defined in the agreement) or by
Mr.
Kochanski for any reason other than his exercise of the Change of Control
Termination Option (as defined in the agreement), the Company shall pay him
only
his accrued but unpaid base salary and bonuses for services rendered through
the
date of termination, his unvested options shall immediately be cancelled and
forfeited and his vested options shall remain exercisable for 90 days after
such
termination. If Mr. Kochanski’s employment is terminated by his death or by his
voluntary resignation or retirement other than upon his exercise of the Change
of Control Termination Option, then the Company shall pay him his accrued but
unpaid base salary for services rendered through the date of termination and
any
bonuses due and payable through such date of termination and those that become
due and payable within 90 days after such date. If the Company terminates Mr.
Kochanski’s employment for any other reason, then, provided he continues to
abide by certain confidentiality and non-compete provisions of his agreement
and
executes a release, he shall be entitled to: (1) any accrued but unpaid base
salary for services rendered through the date of termination; and (2) the
continued payment of his base salary, in the amount as of the date of
termination, for a period of either three months or, if he has been employed
under the agreement for at least one year, six months subsequent to the
termination date or until the end of the remaining term of the agreement if
sooner, such payments to be made at the times such base salary would have been
paid had his employment not been terminated.
Upon
any
sale of all or substantially all of the Company’s business or assets, whether
direct or indirect, by purchase, merger, consolidation or otherwise, Mr.
Kochanski shall have a period of time in which to discuss, negotiate and confer
with any successor entity regarding the terms and conditions of his continued
employment. If Mr. Kochanski, acting reasonably, is unable to timely reach
an
agreement through good faith negotiations with such successor, then he may
elect
(the “Change of Control Termination Option”) to terminate his employment with
the Company and receive the payments and bonuses described above with respect
to
such a termination.
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, including
the “Risk Factors” section hereof, 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 Securities and Exchange Commission (“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 SEC’s Staff Accounting Bulletin (“SAB”), No.
101 “Revenue Recognition in Financial Statements,” as amended by SAB No. 104.
SAB No. 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) collectibility 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.
Business
Overview
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.
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
have obtained approval from Western IRB, Inc. which enables us to proceed with
our clinical trial. We began our clinical trials at the beginning of the fourth
quarter of 2007. At year end 2007, 50% of the needed study patients had been
enrolled in the study and were being treated three times per week on the Nephros
devices. The remaining patients were enrolled in the first quarter of 2008.
We
have targeted submitting our data to the FDA with our 510(k) application on
these products by the third quarter
of
2008. We also plan to apply for CE marking in Europe for our OLpūr H2H during
the course of our clinical trial.
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 and is, to our knowledge, the only water filter that allows
the user to sight-verify that the filter is properly performing its cleansing
function. The DSU is designed to remove a broad range of bacteria, viral agents
and toxic substances, including salmonella, hepatitis, cholera, HIV, Ebola
virus, ricin toxin, legionella, fungi and e-coli.
We
fulfilled two purchase orders for our DSU to a major medical center in New
York
City in 2006. In 2007, this NYC medical center extended the terms of our
joint
evaluation agreement and we are working with their representatives on certain
specifications for a customized DSU to meet their requirements. We are in
discussion with this hospital in connection with its adoption of the DSU as
part of its water filtration system. These initial DSU sales did not result
in material net revenues. We have begun a multi-hospital study to demonstrate
the efficacy of the DSU. Our goal is to publish this study in 2008 in a relevant
publication of substantial distribution. We are planning to pursue additional
sales of our DSU upon completion of planned improvements in product
ergonomics.
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 totaling $1 million, we expect to work with the
U.S.
Marine Corps in developing a personal potable water purification system for
warfighters. Work on this project commenced in January 2008 and billings
of
approximately $23,000 have taken place during the three months ended March
31,
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, such an agreement has not been executed as of March 31,
2008.
Since
our
inception, we have incurred annual net losses. As of March 31, 2008 we had
an
accumulated deficit of approximately $83,252,000, and we expect to incur
additional losses in the foreseeable future. We recognized net losses of
approximately $1,640,000 for the three month period ended March 31, 2008, and
approximately $1,571,000 for the three month period ended March 31,
2007.
Since
our
inception, we have financed our operations primarily through sales of our equity
and debt securities. From inception through March 31, 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 finances 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;
|
(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.
Regaining
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. However, if we are not able to generate revenues
from operations or timely raise equity capital, we are likely to again fail
to
comply with the AMEX rules regarding minimum shareholders’ equity. Should this
occur within 12 months of January 17, 2009, then, in accordance with Section
1009(h) of the AMEX Company Guide, the AMEX may evaluate the relationship
between the two incidents and apply more truncated procedures for compliance
or
immediately initiate delisting proceedings. Furthermore, there can be no
assurance that we will not run afoul of the AMEX’s other continued listing
standards. If we fail to meet such 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 quarter 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.
In
September 2006, the FASB issued Statement of Financial Accounting (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, 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. Please see the discussion entitled “Impairment
Loss of Auction Rate Securities”
in the
Results of Operations section of this document for the impact of SFAS 157 on
the
results of operations for the three months ended March 31, 2007.
New
Accounting Pronouncements
See
Note
8 to our condensed consolidated financial statements set forth in Item 1 of
this
quarterly eeport 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 March 31, 2008 Compared to the Three Months Ended March 31,
2007
Revenues
Total
revenues for the three months ended March 31, 2008 were approximately $387,000
compared to approximately $296,000 for the three months ended March 31, 2007.
Total revenues increased approximately $91,000. The increase of almost 31%
is
due to the following factors: approximately a $23,000
increase in the sales of our OLpūr MDHDF filter series product due to increased
unit sales in our Target European Market; approximately $44,000 from the impact
of favorable currency translation factors; and $23,000 of revenue related to
our
initial contract with the Office of U.S. Naval Research, which we recognized
during the 2008 period. The increased unit sales of our OLpūr MDHDF filter
series product is in our Target European Market where unit sales increased
by 8%
to 12,672 units in the three months
ended
March 31, 2008 from 11,744 units in the three months ended March 31, 2007.
We
expect to recognize additional revenue in future periods from our initial
contract with the Office of U.S. Naval Research, which provides for total
reimbursements to us of up to $866,000.
Cost
of Goods Sold
Cost
of
goods sold was approximately $238,000 for the three months ended March 31,
2008
compared to approximately $205,000 for the three months ended March 31, 2007.
The increase of approximately $33,000 in cost of goods sold is primarily
due to:
(a) a $29,000 increase (measured in constant dollars) due to volume; and
(b) a
$29,000 increase due to foreign currency translation. Such increases were
partially offset by a reduction in actual costs of $18,000 and lower freight-in
expense and inventory adjustments of approximately $5,000.
Research
and Development
Research
and development expenses were approximately $723,000 and $388,000 respectively,
for the three months ended March 31, 2008 and March 31, 2007. This increase
of
approximately $335,000 or 86% is primarily due to an increase in clinical trial
expense of approximately $360,000, an increase in salary expense of
approximately $37,000, an increase in supplies and cartridge development expense
of approximately $25,000 and an increase in subcontractors’ expenses related to
the military development contract of approximately $33,000. These factors are
partially offset by a decrease of approximately $64,000 in deferred compensation
expense and a decrease of approximately $53,000 in machine development expense.
The
increased spending for the clinical trials relates to the current US trials
for
the H2H
which
are expected to be completed in the second quarter of 2008. Deferred
compensation expense of approximately $64,000 was recorded in the three months
ended March 31, 2007; no deferred compensation expense was recorded for the
three months ended March 31, 2008. The lower
machine development expense is due to the OLpūr H2H
product’s engineering phase approaching completion with fewer contract hours
required to be logged by our outside developers during the three months ended
March 31, 2008.
Depreciation
Expense
Depreciation
expense was approximately $88,000 for the three months ended March 31, 2008
compared to approximately $83,000 for the three months ended March 31, 2007,
an
increase of 6%. The increase of approximately $5,000 is primarily due to the
effects of currency translation factors.
Selling,
General and Administrative Expenses
Selling,
general and administrative expenses were approximately $1,114,000 for the three
months ended March 31, 2008 compared to approximately $1,138,000 for the three
months ended March 31, 2007, a decrease of $24,000 or 2%. The decrease reflects
reduced selling expenses of approximately $35,000. Selling expenses were
approximately $108,000 for the three months ended March 31, 2008 compared to
approximately $143,000 for the three months ended March 31, 2007, a decrease
of
approximately $35,000 or 24%. The reduction in these expenses is a result of
a
reduction in personnel that took place during the three months ended March
31,
2007. Specifically, compensation expense is $23,000 less and travel and
entertainment expenses are $21,000 less during the three months ended March
31,
2008 than in the corresponding period in 2007. These savings were offset by
currency translation factors which increased marketing expenses in the three
months ended March 31, 2008 by approximately $5,000 and increased expenses
in
other marketing by approximately $4,000.
Interest
Income
Interest
income was approximately $92,000 for the three months ended March 31, 2008
compared to approximately $25,000 for the three months ended March 31, 2007.
The
increase of approximately $67,000 is due to the increase in investments that
we
have had for the three months ended March 31, 2008 compared to the first three
months ended March 31, 2007.
Interest
Expense
We
incurred no interest expense for the three months ended March 31, 2008, because
we had no debt during this period. In the fourth quarter of 2007, all of our
debt securities were converted into equity pursuant to their terms. 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.
We
incurred approximately $84,000 of interest expense for the three months ended
March 31, 2007. The $84,000 of interest expense primarily represents
approximately $76,000 for the accrued interest liability associated with our
6%
Secured Convertible Notes due 2012 (“the Notes”), and approximately $8,000 for
the interest portion of the present value of payments we made to the Receiver
of
the Lancer Offshore, Inc. proceedings pursuant to certain settlement
arrangements. The Notes were converted to equity in November 2007. The final
payment on the Lancer settlement was made in October 2007.
Impairment
loss of Auction Rate Securities
During
the first three months of 2008, our ARS failed to auction due to sell orders
exceeding buy orders. Liquidity for these auction rate securities is typically
provided by an auction process that resets the applicable interest rate at
pre-determined intervals, usually every 7, 28, 35, or 90 days. The funds
associated with our ARS that have experienced failed auctions will not be
accessible to us until a successful auction occurs or a buyer is found outside
of the auction process. Based upon an analysis of other-than-temporary
impairment factors, ARS with an original par value of approximately $4.4 million
were written-down to an estimated fair value of $4.3 million as of
March 31, 2008. We review impairments associated with the above in
accordance with Emerging Issues Task Force (EITF) 03-1 and FSP SFAS 115-1 and
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.”
An
impairment loss of approximately $114,000, on ARS, was charged to our results
of
operations for the three months ended March 31, 2008.
Factors
that may impact our valuation of ARS include changes to credit ratings of the
securities as well as to the underlying assets supporting those securities,
rates of default of the underlying assets, underlying collateral value, discount
rates, counterparty risk and ongoing strength and quality of market credit
and
liquidity.
Amortization
of debt discount
In
the
three months ended March 31, 2007 we recognized approximately $3,000 in expenses
associated with the amortization of debt discounts. We incurred no debt related
amortization expense in the three months ended March 31, 2008.
Other
income and expenses
Other
income in the amount of approximately $158,000 for the three months ended March
31, 2008 resulted from our receipt of New York State Qualified Emerging
Technology Company (“QETC”) tax refunds. Other income of approximately $9,000
for the three months ended March 31, 2007 included the impact of the current
quarter change in valuation of the derivative liability of approximately $7,000
and the recognition of a $2,000 tax refund received by our subsidiary in
Ireland.
Liquidity
and Capital Resources
Net
cash
used in operating activities was approximately $1,239,000 for the three months
ended March 31, 2008 compared to approximately $1,739,000 for the three months
ended March 31, 2007. The most significant items contributing to this decrease
during the three months ended March 31, 2008 compared to the three months ended
March 31, 2007 are highlighted below:
·
|
During
the 2008 period, our net loss increased by approximately
$69,000;
|
·
|
During
the 2008 period, our stock-based compensation expense decreased by
approximately $155,000;
|
·
|
During
the 2008 period, we recognized an expense of approximately $114,000
due to
an impairment of ARS, given current market
conditions;
|
·
|
Our
accounts receivable decreased by approximately $40,000 during the
2008
period compared to an increase of approximately $17,000 during the
2007
period;
|
·
|
Our
inventory increased by approximately $5,000 during the 2008 period
compared to an increase of approximately $138,000 during the 2007
period;
|
·
|
Our
prepaid expenses and other assets increased by approximately $55,000
in
the 2008 period compared to a decrease of approximately $122,000
in the
2007 period;
|
·
|
Our
accounts payable and accrued expenses increased by approximately
$235,000
in the aggregate in the 2008 period compared to a decrease of
approximately $195,000 in the 2007
period;
|
·
|
Our
accrued severance expenses decreased by approximately $62,000 in
the
aggregate in the 2008 period compared to a decrease of approximately
$94,000 in the 2007 period;
|
·
|
Our
other liabilities did not change during the 2008 period compared
to a
decrease of approximately $192,000 during the 2007 period (consisting
of
amounts due under settlement
agreements);
|
·
|
We
did not incur any interest expense during the 2008 period compared
to
approximately $76,000 incurred in the 2007 period (consisting of
accrued
interest related to the convertible notes that were issued in June
2006).
|
Net
cash
provided by investing activities was approximately $290,000 for the three months
ended March 31, 2008, compared to net cash provided by investing activities
of
approximately $1,898,000 for the three months ended March 31, 2007. Our net
cash
provided by investing activities for the three months ended March 31, 2008
reflects the maturities of short-term investments in the amount of approximately
$400,000 partially offset by purchases of approximately $100,000 in short-term
investments and approximately $10,000 for purchases of computer equipment at
our
European headquarters. For the three months ended March 31, 2007, our $1,898,000
net cash provided by investing activities reflects the maturities of short-term
investments in the amount of approximately $1,900,000 partially offset by
purchases of $2,000 of fixed assets.
As
of
December 31, 2007 and March 31, 2008 we held $4.7 million and $4.3 million
(fair
value) in ARS. ARS 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, these ARS
have experienced multiple failed auctions since February 2008, and as a result,
these affected ARS are currently not liquid. Accordingly, while we had
classified our ARS as current assets at December 31, 2007, we have reclassified
them as noncurrent assets at March 31, 2008.
All
of
our ARS are secured by student loans, which are backed by the full faith and
credit of the federal government (up to approximately 98% of the value of the
student loan). Additionally, all of our ARS maintain the highest credit rating
of AAA. Although our ARS investments continue to pay interest according to
their
stated terms and we believe that the obligors for our ARS are, in the aggregate,
creditworthy, we have recorded a $114,000 impairment charge during the three
month period ended March 31, 2008, based on our valuation models. If the credit
ratings of the obligors of our ARS deteriorate or if uncertainties in these
markets continue and any such decline in market value is determined to be other
than temporary, then we would be required to further adjust the carrying value
of these investments through an impairment charge, which could negatively affect
our financial condition, cash flow and reported earnings.
At
present, we may not be able to obtain liquidity from our ARS until:
·
|
future
auctions for our ARS are successful;
|
·
|
another
secondary market evolves for our ARS;
|
·
|
our
ARS are redeemed by their issuer;
or
|
·
|
our
ARS mature.
|
To
the
extent that the auctions for our ARS continue to “fail” and no other markets
develop for our ARS, we may be unable to liquidate these assets in a timely
manner, on reasonable terms or at all. Our ARS at March 31, 2008 consist of
two
securities, one of which matures on June 1, 2040 and the other matures on June
1, 2043.
We
are
currently exploring the possibility of obtaining loans secured by our ARS,
as an
alternative method of gaining some liquidity from them; however, there can
be no
assurance that such efforts will be successful. We believe that our financial
resources other than our ARS will be sufficient to fund our currently planned
activities through the third quarter of 2008. If we are unable to obtain
liquidity from our ARS on reasonable terms and we are unable to obtain
sufficient financing from other sources by such time, then we may run out of
funds with which to operate our business.
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.” The information presented below updates and should be read in
conjunction with the risk factors and information disclosed in such Form
10-KSB.
Our
auction rate securities do not provide us with the liquidity that we intended
them to provide. If we are unable to liquidate such auction rate securities
in a
timely manner and on reasonable terms, then we may run out of funds with which
to operate our business.
As
of
March 31, 2008, we held $4.3 million (fair value) in auction rate securities
(“ARS”) which we reclassified as long-term investments on our balance sheet. ARS
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. Starting in February 2008,
the auctions for our ARS have “failed,” preventing us from liquidating our ARS
holdings. As a result, we could be required to hold our ARS until their
maturity, which is June 1, 2040 and June 1, 2043. To the extent that the
auctions for our ARS continue to “fail” and no other markets develop for our
ARS, we may be unable to liquidate these assets in a timely manner, on
reasonable terms or at all. If we are unable to liquidate our ARS in a timely
manner and on reasonable terms, then we may run out of funds with which to
operate our business as soon as the third quarter of 2008. If the current lack
of liquidity relating to our ARS investments continues, it may have a material
adverse effect on our ability to fund our ongoing operations and growth
initiatives.
As
of
March 31, 2008, we took an impairment charge reducing the carrying value of
our
ARS by $114,000, reflecting an estimated change in fair market value due solely
to a lack of liquidity. If the credit ratings of the obligors of our ARS
deteriorate or if uncertainties in these markets continue, then we may be
required to further adjust the carrying value of these investments through
impairment charges, which could negatively affect our financial condition,
cash
flow and reported earnings.
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:
·
|
we
may not be able to obtain funding if and when needed or on terms
favorable
to us in order to continue operations or fund our clinical trials;
|
·
|
we
may not be able to continue as a going concern;
|
·
|
we
may not be able to liquidate our ARS investments when needed to fund
our
operations;
|
·
|
we
may be unable to maintain compliance with the American Stock Exchange's
continued listing standards;
|
·
|
products
that appeared promising to us in research or clinical trials may
not
demonstrate anticipated efficacy, safety or cost savings in subsequent
pre-clinical or clinical trials;
|
·
|
we
may not obtain appropriate or necessary governmental approvals to
achieve
our business plan or effectively market our products;
|
·
|
we
may encounter unanticipated internal control deficiencies or weaknesses
or
ineffective disclosure controls and procedures;
|
·
|
HDF
therapy may not be accepted in the United States and/or our technology
and
products may not be accepted in current or future target markets,
which
could lead to failure to achieve market penetration of our products;
|
·
|
we
may not be able to sell its ESRD therapy or water filtration products
at
competitive prices or profitably;
|
·
|
we
may not be able to secure or enforce adequate legal protection, including
patent protection, for our products; and
|
·
|
we
may not be able to achieve sales growth in Europe or expand into
other key
geographic markets.
|
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 month periods
ended March 31, 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.
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
|
23
• |
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 March 31, 2008 that have materially affected, or are reasonably
likely to materially affect, our internal control over financial
reporting.
PART
II – OTHER
INFORMATION
Item
6. Exhibits
EXHIBIT
INDEX
10.1
|
Executive
Employment Agreement, dated as of April 1, 2008, between Nephros,
Inc. and
Gerald J. Kochanski
|
10.2
|
Separation
Agreement, dated as of April 28, 2008, between Nephros, Inc. and
Mark W.
Lerner
|
31.1
|
Certification
by the Chief Executive Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
31.2
|
Certification
by the Chief Financial Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
32.1
|
Certifications
by the Chief Executive Officer and Chief Financial Officer Pursuant
to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|
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:
May 15, 2008
|
By:
|
/s/
Norman J. Barta
|
Name:
|
Norman
J. Barta
|
|
Title:
|
President
and Chief Executive Officer (Principal
Executive Officer)
|
|
Date:
May 15, 2008
|
By:
|
/s/
Gerald J. Kochanski
|
Name:
|
Gerald
J. Kochanski
|
|
Chief
Financial Officer (Principal Financial and Accounting
Officer)
|
Exhibit
Index
10.1
|
Executive
Employment Agreement, dated as of April 1, 2008, between Nephros,
Inc. and
Gerald J. Kochanski
|
10.2
|
Separation
Agreement, dated as of April 28, 2008, between Nephros, Inc. and
Mark W.
Lerner
|
31.1
|
Certification
by the Chief Executive Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
31.2
|
Certification
by the Chief Financial Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
32.1
|
Certifications
by the Chief Executive Officer and Chief Financial Officer Pursuant
to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|