NEPHROS INC - Quarter Report: 2009 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,
2009
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.)
|
|
41
Grand Avenue
River
Edge, NJ
|
07661
|
|
(Address
of Principal Executive Offices)
|
(Zip
code)
|
(201)
343-5202
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).
¨ YES x NO
As of
August 14, 2009, 40,225,110 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.
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PART I –
FINANCIAL INFORMATION
|
|||
Item
1.
|
Financial
Statements
|
||
Condensed
Consolidated Balance Sheets – June 30, 2009 (unaudited) and December 31,
2008 (audited)
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3
|
||
Condensed
Consolidated Statements of Operations – Three and six months ended June
30, 2009 and 2008 (unaudited)
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4
|
||
Condensed
Consolidated Statements of Cash Flows – Six months ended June 30, 2009 and
2008 (unaudited)
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5
|
||
Notes
to Unaudited Condensed Consolidated Interim Financial
Statements
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6
|
||
Item
2.
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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12
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|
Item
4T.
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Controls
and Procedures
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19
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PART
II – OTHER INFORMATION
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|||
Item
1.
|
Legal
Proceedings
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20
|
|
Item
4.
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Submission
of Matters to a Vote of Security Holders
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21
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|
Item
6.
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Exhibits
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21
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|
SIGNATURES
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22
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2
PART I – FINANCIAL
INFORMATION
Item 1. Financial
Statements.
NEPHROS,
INC. AND SUBSIDIARY
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands, except share amounts)
(Unaudited)
|
(Audited)
|
|||||||
June 30,
|
December 31,
|
|||||||
2009
|
2008
|
|||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 890 | $ | 2,306 | ||||
Short-term
investments
|
- | 7 | ||||||
Accounts
receivable, less allowances of $0 and $4, respectively
|
320 | 404 | ||||||
Inventory
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767 | 724 | ||||||
Prepaid
expenses and other current assets
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74 | 162 | ||||||
Total
current assets
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2,051 | 3,603 | ||||||
Property
and equipment, net
|
269 | 412 | ||||||
Other
assets
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20 | 21 | ||||||
Total
assets
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$ | 2,340 | $ | 4,036 | ||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 723 | $ | 986 | ||||
Accrued
expenses
|
205 | 411 | ||||||
Accrued
severance expense
|
- | 105 | ||||||
Total
current liabilities
|
928 | 1,502 | ||||||
Stockholders’
equity:
|
||||||||
Preferred
stock, $.001 par value; 5,000,000 shares authorized at June 30, 2009 and
December 31, 2008; no shares issued and outstanding at June 30, 2009 and
December 31, 2008
|
- | - | ||||||
Common
stock, $.001 par value; 60,000,000 shares authorized at June 30, 2009 and
December 31, 2008; 38,759,872 shares issued and outstanding at June 30,
2009 and 38,165,380 at December 31, 2008
|
39 | 38 | ||||||
Additional
paid-in capital
|
90,408 | 90,375 | ||||||
Accumulated
other comprehensive income
|
62 | 70 | ||||||
Accumulated
deficit
|
(89,097 | ) | (87,949 | ) | ||||
Total
stockholders’ equity
|
1,412 | 2,534 | ||||||
Total
liabilities and stockholders’ equity
|
$ | 2,340 | $ | 4,036 |
The
accompanying notes are an integral part of these unaudited condensed
consolidated interim financial statements
3
NEPHROS,
INC. AND SUBSIDIARY
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In
thousands, except share and per share amounts)
Three
Months Ended
|
Six
Months Ended
|
|||||||||||||||
June
30,
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June
30,
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|||||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
Product
revenues
|
$
|
527
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$
|
253
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$
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1,158
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$
|
640
|
||||||||
Cost
of goods sold
|
336
|
162
|
788
|
400
|
||||||||||||
Gross
margin
|
191
|
91
|
370
|
240
|
||||||||||||
Operating
expenses:
|
||||||||||||||||
Research
and development
|
92
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1,149
|
150
|
1,872
|
||||||||||||
Depreciation
|
65
|
92
|
137
|
180
|
||||||||||||
Selling,
general and administrative
|
628
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1,474
|
1,417
|
2,588
|
||||||||||||
Total
operating expenses
|
785
|
2,715
|
1,704
|
4,640
|
||||||||||||
Loss
from operations
|
(594
|
)
|
(2,624
|
)
|
(1,334
|
)
|
(4,400
|
)
|
||||||||
Interest
income
|
1
|
66
|
6
|
158
|
||||||||||||
Interest
expense
|
(2
|
)
|
-
|
(2
|
)
|
-
|
||||||||||
Impairment
of auction rate securities
|
-
|
-
|
-
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(114
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)
|
|||||||||||
Unrealized
holding gain - auction rate securities
|
-
|
114
|
-
|
114
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||||||||||||
Other
income
|
182
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-
|
182
|
158
|
||||||||||||
Net
loss
|
$
|
(413
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)
|
$
|
(2,444
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)
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$
|
(1,148
|
)
|
$
|
(4,084
|
)
|
||||
Net
loss per common share, basic and diluted
|
$
|
(0.01
|
)
|
$
|
(0.06
|
)
|
$
|
(0.03
|
)
|
$
|
(0.11
|
)
|
||||
Weighted
average common shares outstanding, basic
and diluted
|
38,264,462
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38,165,380
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38,214,921
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38,165,380
|
The
accompanying notes are an integral part of these unaudited condensed
consolidated interim financial statements
4
NEPHROS,
INC. AND SUBSIDIARY
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In
thousands)
Six Months Ended June 30,
|
||||||||
2009
|
2008
|
|||||||
Operating
activities:
|
||||||||
Net
loss
|
$ | (1,148 | ) | $ | (4,084 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
Depreciation
|
137 | 172 | ||||||
Amortization
of research & development assets
|
- | 8 | ||||||
Impairment
of auction rate securities
|
- | 114 | ||||||
Unrealized
holding gain –
auction rate securities
|
- | (114 | ) | |||||
Stock-based
compensation
|
35 | 64 | ||||||
(Increase)
decrease in operating assets:
|
||||||||
Accounts
receivable
|
77 | 164 | ||||||
Inventory
|
(48 | ) | (59 | ) | ||||
Prepaid
expenses and other current assets
|
87 | (86 | ) | |||||
Increase
(decrease) in operating liabilities:
|
||||||||
Accounts
payable and accrued expenses
|
(570 | ) | 1,181 | |||||
Net
cash used in operating activities
|
(1,430 | ) | (2,640 | ) | ||||
Investing
activities:
|
||||||||
Purchase
of property and equipment
|
- | (8 | ) | |||||
Purchase
of short-term investments
|
- | (100 | ) | |||||
Maturities
of short-term investments
|
7 | 700 | ||||||
Net
cash provided by investing activities
|
7 | 592 | ||||||
Effect
of exchange rates on cash
|
7 | 3 | ||||||
Net
decrease in cash and cash equivalents
|
(1,416 | ) | (2,045 | ) | ||||
Cash
and cash equivalents, beginning of period
|
2,306 | 3,449 | ||||||
Cash
and cash equivalents, end of period
|
890 | 1,404 | ||||||
Supplemental
disclosure of cash flow information:
|
||||||||
Cash
paid for interest
|
2 | - | ||||||
Cash
paid for taxes
|
3 | 9 |
The
accompanying notes are an integral part of these unaudited condensed
consolidated interim financial statements
5
NEPHROS,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
1. Basis
of Presentation and Going Concern
Interim
Financial Information
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
2008 Annual Report on Forms 10-K and 10K/A filed with the Securities and
Exchange Commission (the “SEC”) on March 31, 2009 and April 30, 2009,
respectively. The accompanying consolidated 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 Article 8 and Article 10 of
Regulation S-X. Accordingly, since they are interim statements, the
accompanying consolidated 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, 2008 was derived from the Company’s audited consolidated financial
statements but does not include all disclosures required by GAAP. In
the opinion of management, the interim consolidated 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 intercompany transactions and balances have been eliminated in
consolidation.
Use
of Estimates
The
preparation of financial statements in conformity with U.S. generally accepted
accounting principles requires management to make estimates and assumptions that
affect the amounts reported in the Company’s consolidated financial statements
and accompanying notes. Actual results could differ materially from those
estimates.
Going
Concern and Management’s Response
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. The Company’s recurring losses and
difficulty in generating sufficient cash flow to meet its obligations and
sustain its operations raise substantial doubt about its ability to continue as
a going concern. The consolidated financial statements do not include
any adjustments that might result from the outcome of this
uncertainty.
On July
24, 2009, the Company raised gross proceeds of $1,251,000 through the private
placement to eight accredited investors of an aggregate of 1,345,161 shares of
its common stock and warrants to purchase an aggregate of 672,581 shares of its
common stock, representing 50% of the shares of common stock purchased by each
investor. The Company sold the shares to investors at a price per
share equal to $0.93. The warrants have an exercise price of
$1.12, are exercisable immediately and will terminate on July 24,
2014.
Each
investor agreed that it will not sell, pledge, sell short or otherwise dispose
of any of the purchased shares or warrants during the period commencing on the
date of purchase and ending on January 31, 2010.
The
shares of common stock and the warrants issued to the investors were not
registered under the Securities Act of 1933, as amended, in reliance upon the
exemption from registration provided by Section 4(2) and Regulation D
thereunder.
Based on
the Company’s current cash flow projections, it will need to raise additional
funds through either the licensing or sale of its technologies or additional
public or private offerings of its securities before the end of
2010. The Company continues to investigate strategic funding
opportunities as they are identified. However, there is no guarantee
that the Company will be able to obtain further financing. If it is
unable to raise additional funds on a timely basis or at all, the Company would
not be able to continue its operations.
The
Company has incurred significant losses in its operations in each quarter since
inception. For the six months ended June 30, 2009 and 2008, the
Company has incurred net losses of approximately $1,148,000 and $4,084,000,
respectively. In addition, the Company has not generated positive
cash flow from operations for the six months ended June 30, 2009 and
2008. 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.
6
The
Company’s current operating plans primarily include the continued development
and support of the Company’s business in the European market, organizational
changes necessary to begin the commercialization of the Company’s water
filtration business and the completion of current year milestones which are
included in the Office of Naval Research appropriation. There can be
no assurance that the Company’s future cash flow will be sufficient to meet its
obligations and commitments. If the Company is unable to generate
sufficient cash flow from operations in the future to service its commitments
the Company will be required to adopt alternatives, such as seeking to raise
debt or equity capital, curtailing its planned activities or ceasing its
operations. There can be no assurance that any such actions could be effected on
a timely basis or on satisfactory terms or at all, or that these actions would
enable the Company to continue to satisfy its capital requirements.
2. Concentration
of Credit Risk
For the
six months ended June 30, 2009 and 2008, the following customers accounted for
the following percentages of the Company’s sales, respectively.
Customer
|
2009
|
2008
|
||||||
A
|
41%
|
84%
|
||||||
B
|
49%
|
8%
|
As of
June 30, 2009 and December 31, 2008, the following customers accounted for the
following percentages of the Company’s accounts receivable,
respectively.
Customer
|
2009
|
2008
|
||||||
A
|
44%
|
66%
|
||||||
B
|
24%
|
23%
|
3. Revenue
Recognition
Revenue
is recognized 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 or 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 No. 104 are
met. Product revenue is recorded net of returns and
allowances. All costs and duties relating to delivery are absorbed by
the Company. All shipments are currently received directly by the
Company’s customers.
4. Stock-Based
Compensation
The
Company accounts for stock-based compensation under the provisions of Statement
of Financial Accounting Standards (“SFAS”) No. 123 (Revised 2004) “Share-Based Payment” (“SFAS
123R”). SFAS 123R requires the recognition of the fair value of
stock-based compensation in net income. The fair value of the
Company’s stock option awards are estimated using a Black-Scholes option
valuation model. This model requires the input of highly subjective
assumptions and elections including expected stock price volatility and the
estimated life of each award. In addition, the calculation of compensation costs
requires that the Company estimate the number of awards that will be forfeited
during the vesting period. The fair value of stock-based awards is
amortized over the vesting period of the award. For stock-based
awards that vest based on performance conditions (e.g. achievement of certain
milestones), expense is recognized when it is probable that the condition will
be met.
For the
three months ended June 30, 2009 and 2008, stock-based compensation expense was
approximately $24,000 and $32,000, respectively. For the six months
ended June 30, 2009 and 2008, stock-based compensation expense was approximately
$35,000 and $64,000, respectively.
There was
no tax benefit related to expense recognized in the three and six months ended
June 30, 2009 and 2008, as the Company is in a net operating loss
position. As of June 30, 2009, there was approximately $264,000 of
total unrecognized compensation cost related to unvested share-based
compensation awards granted under the equity compensation
plans. Such amount does not include the effect of future grants of
equity compensation, if any. Of this amount, approximately $264,000
will be amortized over the weighted-average remaining requisite service period
of 3.0 years. Of the total $264,000, the Company expects to recognize
approximately 18% in the remaining interim periods of 2009, approximately 32% in
2010, approximately 32% in 2011 and approximately 18% in 2012.
7
5. Comprehensive
Income
The
Company complies with the provisions of SFAS No. 130 “Reporting Comprehensive
Income,” which requires companies to report all changes in equity during
a period, except those resulting from investment by owners and distributions to
owners, for the period in which they are recognized. Comprehensive
income is the total of net income and all other non-owner changes in
equity (or other comprehensive income (loss)) such as unrealized gains or losses
on securities classified as available-for-sale and foreign currency translation
adjustments. As of June 30, 2009 and December 31, 2008, accumulated
other comprehensive income was approximately $62,000 and $70,000
respectively.
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 12,399,475 and 13,214,324
from the computation of diluted EPS for the three and six month periods ended
June 30, 2009 and 2008, respectively.
7. Recently
Adopted Accounting Pronouncements
In
September 2006, the FASB issued SFAS No. 157, Fair Value Measurements ("No.
157"). This statement defines fair value, establishes a framework for measuring
fair value in generally accepted accounting principles and expands disclosures
about fair value measurements. SFAS No. 157 does not require any new fair value
measurements but rather eliminates inconsistencies in guidance found in various
prior accounting pronouncements and was effective for fiscal years beginning
after November 15, 2007. In February 2008, the FASB issued FASB Staff Position
No. 157-2 ("FSP No. 157-2"). FSP No. 157-2 delays the effective date of SFAS No.
157 for all nonfinancial assets and nonfinancial liabilities, except those that
are recognized or disclosed at fair value in the financial statements on a
recurring basis (at least annually), until fiscal years beginning after November
15, 2008 and interim periods within those fiscal years. These nonfinancial items
include assets and liabilities such as reporting units measured at a fair value
in a goodwill impairment test and nonfinancial assets acquired and liabilities
assumed in a business combination. Effective January 1, 2008, we adopted SFAS
No. 157 for financial assets and liabilities recognized at fair value on a
recurring basis, and on January 1, 2009, we fully adopted SFAS No. 157. Upon
full adoption, SFAS No. 157 had no effect on our financial position, results of
operations and cash flows.
In
December 2007, the FASB issued SFAS No. 141 (revised 2007), Business
Combinations ("No. 141R"). This statement establishes requirements for (i)
recognizing and measuring in an acquiring company's financial statements the
identifiable assets acquired, the liabilities assumed and any noncontrolling
interest in the acquiree, (ii) recognizing and measuring the goodwill acquired
in the business combination or a gain from a bargain purchase and (iii)
determining what information to disclose to enable users of the financial
statements to evaluate the nature and financial effects of the business
combination. The provisions of SFAS No. 141R are effective for business
combinations for which the acquisition date is on or after the beginning of the
first annual reporting period beginning on or after December 15, 2008. Upon
adoption, SFAS No. 141R had no effect on our financial position, results of
operations and cash flows.
8. New
Accounting Pronouncements
In April
2009, the FASB issued FSP SFAS 141R-1“Accounting for Assets Acquired and
Liabilities Assumed in a Business Combination That Arise from
Contingencies” (“FSP SFAS 141R-1”). FSP SFAS 141R-1 amends the provisions
in SFAS No. 141 (R) for the initial recognition and measurement, subsequent
measurement and accounting, and disclosures for assets and liabilities arising
from contingencies in business combinations. FSP SFAS 141R-1 eliminates the
distinction between contractual and non-contractual contingencies, including the
initial recognition and measurement criteria in Statement 141 (R) and instead
carries forward most of the provisions in SFAS 141 for acquired contingencies.
FSP SFAS 141R-1 is effective for assets or liabilities arising from
contingencies in business combinations for which the acquisition date is on or
after the beginning of the first annual reporting period beginning on or after
December 15, 2008. The Company is currently evaluating the impact of the
adoption of FSP SFAS 141R-1 will have on its consolidated financial
statements
8
On
May 28, 2009, the FASB issued Financial Accounting Standards
No. 165, Subsequent
Events (“SFAS No. 165”), which we adopted on a prospective basis
beginning April 1, 2009. SFAS No. 165 is intended to
establish general standards of accounting and disclosure of events that occur
after the balance sheet date but before financial statements are issued or are
available to be issued. It requires the disclosure of the date
through which an entity has evaluated subsequent events and the basis for
selecting that date. The application of SFAS No. 165 did not
have an impact on our consolidated financial position, results of operations or
cash flows.
In June
2009, the Financial Accounting Standards Board (“FASB”) issued SFAS
No. 168, The FASB
Accounting Standards Codification
TM and the
Hierarchy of Generally Accepted Accounting Principles—a replacement of FASB
Statement No. 162 (“SFAS 168”). The statement confirmed
that the FASB Accounting
Standards Codification (the “Codification”) will become the single
official source of authoritative U.S. GAAP (other than guidance issued by
the SEC), superseding existing FASB, American Institute of Certified Public
Accountants, Emerging Issues Task Force (“EITF”), and related literature. After
that date, only one level of authoritative U.S. GAAP will exist. All other
literature will be considered non-authoritative. The Codification does not
change U.S. GAAP; instead, it introduces a new structure that is organized
in an easily accessible, user-friendly online research system. The Codification,
which changes the referencing of financial standards, becomes effective for
interim and annual periods ending on or after September 15,
2009. We will apply the Codification beginning in the third quarter
of fiscal 2009. The adoption of SFAS 168 is not expected to have any substantive
impact on our condensed consolidated financial statements or related
footnotes.
In
April 2009, the Financial Accounting Standards Board (“FASB”) issued FASB
Staff Position (“FSP”) FAS 157-4, Determining Fair Value
when the Volume and Level of Activity for the Asset or Liability have
Significantly Decreased and Identifying Transactions that are not
Orderly (“FSP 157-4”), which is effective for the Company for
interim and annual reporting periods ending after June 15, 2009, and shall be
applied prospectively. FSP 157-4 affirms that the objective of fair value when
the market for an asset is not active is the price that would be received to
sell an asset or paid to transfer a liability in an orderly transaction between
market participants at the measurement date under current market conditions. The
FSP provides guidance for estimating fair value when the volume and level of
market activity for an asset or liability have significantly decreased and
determining whether a transaction was orderly. This FSP applies to
all fair value measurements when appropriate. The adoption of
FSP 157-4 did not have a significant impact on the Company’s financial
statements or related footnotes.
In
April 2009, the FASB issued FSP FAS 115-2 and FAS 124-2, Recognition and Presentation of
Other-Than-Temporary Impairments (“FSP 115-2”), which is effective for
the Company for interim and annual reporting periods ending after June 15, 2009.
FSP 115-2 amends existing guidance for determining whether an other than
temporary impairment of debt securities has occurred. Among other changes, the
FASB replaced the existing requirement that an entity’s management assert it has
both the intent and ability to hold an impaired security until recovery with a
requirement that management assert (a) it does not have the intent to sell
the security, and (b) it is more likely than not it will not have to sell
the security before recovery of its cost basis. The Company has no debt as of
June 30, 2009 therefore, FSP FAS 115-2 and FAS 124-2, Recognition and Presentation of
Other-Than-Temporary Impairments (“FSP 115-2”) has no impact on its June
30, 2009 financial statements.
In
April 2009, the FASB issued FSP FAS 107-1 and APB 28-1, Interim Disclosures about Fair
Value of Financial Instruments (“FSP 107-1”), which is effective for the
Company for the quarterly period beginning April 1, 2009. FSP 107-1
requires an entity to provide the annual disclosures required by FASB Statement
No. 107, Disclosures
about Fair Value of Financial Instruments, in its interim financial
statements. The Company has provided the disclosures required by FSP
107-1 in its quarterly report on Form 10-Q for the period ended June 30,
2009 in Note 9 - Fair Value of Financial Instruments.
9. Fair
Value of Financial Instruments
The
carrying amounts of cash and cash equivalents, short-term investments, accounts
receivable, accounts payable and accrued expenses approximate fair value due to
the short-term maturity of these instruments.
The
following table details the fair value measurements within the fair value
hierarchy of the Company’s financial assets at December 31,
2008:
Fair Value Measurements at Reporting
Date Using
|
||||||||||||||||
Total Fair Value
at
December 31, 2008
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Certificate
of deposit
|
$
|
7,000
|
$
|
7,000
|
$
|
—
|
$
|
—
|
||||||||
Total
|
$
|
7,000
|
$
|
7,000
|
$
|
—
|
$
|
—
|
9
The
Company had no financial assets held at fair value at June 30,
2009.
10. Inventory
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, 2009 and December 31, 2008 was
approximately as follows:
Unaudited
|
Audited
|
|||||||
June 30, 2009
|
December 31, 2008
|
|||||||
Raw
Materials
|
$ | 276,000 | $ | 382,000 | ||||
Finished
Goods
|
491,000 | 342,000 | ||||||
Total
Inventory
|
$ | 767,000 | $ | 724,000 |
11. Warrants
Issuance
of Common Stock due to Placement Agent Warrants’ Cashless Exercise
Provision
National
Securities Corporation (“NSC”) and Dinosaur Securities, LLC (“Dinosaur” and
together with NSC, the “Placement Agent”) acted as co-placement agents in
connection with the 2007 Financing pursuant to an Engagement Letter, dated June
6, 2007 and a Placement Agent Agreement dated September 18, 2007. The Placement
Agent received (i) an aggregate cash fee equal to 8% of the face amount of the
Lambda Purchased Note and the Enso Purchased Note allocated and paid 6.25% to
NSC and 1.75% to Dinosaur, and (ii) warrants (“Placement Agent Warrant”) with a
term of five years from the date of issuance to purchase 10% of
the aggregate number of shares of the Company’s common stock issued upon
conversion of the Lambda Purchased Note and the Enso Purchased Note with an
exercise price per share of the Company’s common stock equal to
$0.706. The Company issued Placement Agent Warrants to purchase an
aggregate of 1,756,374 shares of the Company’s common stock to the Company’s
placement agents in November 2007 in connection with their roles in the 2007
Financing.
The
Placement Agent Warrants have a Cashless Exercise provision which
states, “ If, and only if, at the time of exercise pursuant to this
Section 1 there is no effective registration statement registering, or no
current prospectus available for, the sale of the Warrant Shares to the Holder
or the resale of the Warrant Shares by the Holder and the VWAP (as defined
below) is greater than the Per Share Exercise Price at the time of exercise,
then this Warrant may also be exercised at such time and with respect to such
exercise by means of a “cashless exercise” in which the Holder shall be entitled
to receive a certificate for the number of Warrant Shares equal to the quotient
obtained by dividing (i) the result of (x) the difference of (A) minus (B),
multiplied by (y) (C), by (ii) (A), where:
(A)
=
|
the
VWAP (as defined below) on the Trading Day (as defined below) immediately
preceding the date of such election;
|
(B)
=
|
the
Per Share Exercise Price of this Warrant, as adjusted;
and
|
(C)
=
|
the
number of Warrant Shares issuable upon exercise of this Warrant in
accordance with the terms of this Warrant by means of a cash exercise
rather than a cashless
exercise.
|
“VWAP” means, for any
date, the price determined by the first of the following clauses that applies:
(a) if the Common Stock is then listed or quoted for trading on the New
York Stock Exchange, American Stock Exchange, NASDAQ Capital Market, NASDAQ
Global Market, NASDAQ Global Select Market or the OTC Bulletin Board, or any
successor to any of the foregoing (a “Trading Market”), the
daily volume weighted average price of the Common Stock on the Trading Market on
which the Common Stock is then listed or quoted for trading as reported by
Bloomberg L.P. for such date if such date is a date on which the Trading Market
on which the Common Stock is then listed or quoted for trading (a “Trading Day”) or the
nearest preceding Trading Date (based on a Trading Day from 9:30 a.m. (New York
City time) to 4:02 p.m. (New York City time); (b) if the Common Stock is
not then listed or quoted for trading on a Trading Market and if prices for the
Common Stock are then reported in the “Pink Sheets” published by Pink Sheets,
LLC (or a similar organization or agency succeeding to its functions of
reporting prices), the most recent bid price per share of the Common Stock so
reported; or (c) in all other cases, the fair market value of a share of
Common Stock as determined by an independent appraiser selected in good faith by
the Holder and reasonably acceptable to the Company.”
10
The
Company did not have an effective registration statement or a current prospectus
available for the sale of the Warrant Shares to the Holder or the resale of the
Warrant Shares by the Holder and the VWAP (as defined above) was greater than
the Per Share Exercise Price during June 2009. Several Placement
Agents elected to exercise the Cashless Exercise provision of their
warrants.
Placement
Agents elected to exercise 1,348,690 of the 1,756,374 Placement Agent Warrants
outstanding in June 2009. All elected the Cashless Exercise provision
of their warrants. As a result, 594,492 shares of common stock were
issued to the Placement Agents in June 2009. The number of shares
outstanding in the June 30, 2009 balance sheet and the number of shares
outstanding used in the earnings per share calculation for the three and six
months ended June 30, 2009 include these shares.
As of
June 30, 2009 there were 407,684 Placement Agent Warrants
outstanding.
12.
Contingencies
A former
employee in the United States filed a claim in March 2009 against the
Company and its CEO alleging breach of the individual’s employment agreement and
fraud. The individual was employed with the Company from April 2008
through January 8, 2009. The Company’s loss is limited to $10,000,
which is the deductible under its Employment Practices Liability
insurance. An accrual of $10,000 has been recorded as of June
30, 2009.
A third
party has brought a claim against the Company alleging they incurred damages as
a result of its cancellation of a transaction in 2008 involving the sale of
Auction Rate Securities. The claim has been referred to a Financial
Industry Regulatory Authority (FINRA) binding arbitration panel and is scheduled
to be heard in March 2010. There are no specific amount of damages
identified in the claim. The Company denies that a transaction
agreement had been reached and denies any liability involving this
claim. No contingent loss accrual has been recorded by the Company as
of June 30, 2009.
13. Subsequent
Events
Sale
of Common Stock
On July
24, 2009, the Company raised gross proceeds of $1,251,000 through the private
placement to eight accredited investors of an aggregate of 1,345,161 shares of
its common stock and warrants to purchase an aggregate of 672,581 shares of its
common stock, representing 50% of the shares of common stock purchased by each
investor. The Company sold the shares to investors at a price per
share equal to $0.93. The warrants have an exercise price of
$1.12, are exercisable immediately and will terminate on July 24, 2014.
Each
investor agreed that it will not sell, pledge, sell short or otherwise dispose
of any of the purchased shares or warrants during the period commencing on the
date of purchase and ending on January 31, 2010.
Issuance
of Common Stock due to Placement Agent Warrants’ Cashless Exercise
Provision
As
described in Note 11 – Warrants, there were 407,684 outstanding Placement Agent
Warrants as of July 1, 2009.
Placement
Agents elected to exercise 240,512 of the Placement Agent Warrants in July
2009. All elected the Cashless Exercise provision of their
warrants. As a result, 120,077 shares of common stock were issued to
the Placement Agents in July 2009. The number of shares outstanding
in the June 30, 2009 balance sheet and the number of shares outstanding used in
the earnings per share calculation for the three and six months ended June 30,
2009 do not include these additional shares since they were issued
after June 30, 2009. There are 167,172 Placement Agent Warrant Shares
outstanding as of the date of this report.
Tax
Refund
A cash
receipt of approximately $146,000 was received in July 2009. The
amount represents a 2008 New York State Qualified Emerging Technology Company
(“QETC”) tax refund. This amount is not recorded in the June 30, 2009
financial statements.
The
Company has evaluated subsequent events through August 14, 2009, the date of
issuance of these financial statements, as required by SFAS 165 for a public
entity.
11
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, 2008 on
Form 10-K, 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 in this Quarterly
Report and our Annual Report for the year ended December 31, 2008 on Form
10-K. Our actual results may differ materially.
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.
Business
Overview
Founded
in 1997, we are a Delaware corporation that has been engaged primarily in the
development of hemodiafiltration, or HDF, products and technologies for treating
patients with End Stage Renal Disease, or ESRD. In January 2006, we
introduced our new Dual Stage Ultrafilter (the “DSU”) water filtration system,
which represents a new and complementary product line to our existing ESRD
therapy business.
We
currently have three products in various stages of development in the HDF
modality to deliver improved therapy to ESRD patients:
·
|
OLpur
MDHDF filter series (which we sell in various countries in Europe and
currently consists of our MD190 and MD220 diafilters); to our knowledge,
the only filter designed expressly for HDF therapy and employing our
proprietary Mid-Dilution Diafiltration
technology;
|
·
|
OLpur
H2H, our add-on module designed to allow the most common types of
hemodialysis machines to be used for HDF therapy;
and
|
·
|
OLpur
NS2000 system, our stand-alone HDF machine and associated filter
technology.
|
We have
also developed our OLpur HD 190 high-flux dialyzer cartridge, which incorporates
the same materials as our OLpur MD series but does not employ our proprietary
Mid-Dilution Diafiltration technology. Our OLpur HD190 was designed for use with
either hemodialysis or hemodiafiltration machines, and received its approval
from the U.S. Food and Drug Administration, or FDA, under Section 510(k) of the
Food, Drug and Cosmetic Act, or the FDC Act, in June 2005.
OLpur and H2H are among
our trademarks for which U.S. registrations are pending. H2H is a registered
European Union trademark. We have assumed that the reader understands that these
terms are source-indicating. Accordingly, such terms appear throughout the
remainder of this Quarterly Report without trademark notices for convenience
only and should not be construed as being used in a descriptive or generic
sense.
12
We
believe that products in our OLpur MDHDF filter series are more effective than
any products currently available for ESRD therapy because they are better at
removing certain larger toxins (known in the industry as “middle molecules”
because of their heavier molecular weight) from blood. The accumulation of
middle molecules in the blood has been related to such conditions as
malnutrition, impaired cardiac function, carpal tunnel syndrome, and
degenerative bone disease in the ESRD patient. We also believe that OLpur H2H
will, upon introduction, expand the use of HDF as a cost-effective and
attractive alternative for ESRD therapy, and that, if approved by the FDA in
2009, our OLpur H2H and MDHDF filters will be the first, and only, HDF therapy,
approved by the FDA, available in the United States at that time.
We
believe that our products will reduce hospitalization, medication and care costs
as well as improve patient health (including reduced drug requirements and
improved blood pressure profiles), and therefore, quality of life, by removing a
broad range of toxins through a more patient-friendly, better-tolerated process.
In addition, independent studies in Europe have indicated that, when compared
with dialysis as it is currently offered in the United States, HDF can reduce
the patient’s mortality risk by up to 35%. We believe that the OLpur MDHDF
filter series and the OLpur H2H will provide these benefits to ESRD patients at
competitive costs and without the need for ESRD treatment providers to make
significant capital expenditures in order to use our products. We also believe
that the OLpur NS2000 system, if successfully developed, will be the most
cost-effective stand-alone hemodiafiltration system available.
In
January 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. Our research and development work on the
OLpur H2H and MD Mid-Dilution filter technologies for ESRD therapy provided the
foundations for a proprietary multi-stage water filter that we believe is cost
effective, extremely reliable, and long-lasting. We believe our DSU can offer a
robust solution to a broad range of contaminated water and disease prevention
issues. Hospitals are particularly stringent in their water quality
requirements. Transplant patients and other individuals whose immune systems are
compromised can face a substantial infection risk in drinking or bathing with
standard tap water that would generally not present a danger to individuals with
normal immune 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. With over 5,000
registered hospitals in the United States (as reported by the
American Hospital Association in Fast Facts of October 20, 2006), we believe the
hospital shower and faucet market can offer us a valuable opportunity as a first
step in water filtration.
Due to
the ongoing concerns of maintaining water quality, on October 7, 2008, we filed
a 510(k) application for approval to market our DSU to dialysis clinics for
in-line purification of dialysate water. Following its review of the
application, the FDA requested additional information from us. On
February 24, 2009, we provided a formal response to the FDA. On July 1,
2009, we received FDA approval of the DSU
to be used to filter biological contaminants from water and bicarbonate
concentrate used in hemodialysis procedures.
During
the three months ended June 30, 2009, Nephros was granted four new
patents. In the U.S., the company was issued patent #7,534,349 for a
Dual Stage Ultrafilter with pump mechanism and/or shower feature. In Canada, the
company was issued patent #2,430,575 for a valve mechanism used in Infusion
Fluid systems which is a feature used on our H2HTM module
and patent #2,396,852 for an Ionic Enhanced Dialysis/Diafiltration system which
is related to
mid-dilution HDF. In China, the company was issued patent #200510092067.3 for a
Dual Stage Hemodiafiltration cartridge used in its OLpūrTM MD HDF
Filter.
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 use by warfighters.
Work on this project commenced in January 2008 and we have billed approximately
$761,000 during the eighteen months ended June 30, 2009. 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, 2009. We have defined the project scope and objectives in connection with
this appropriation and submitted a proposal to the Office of Naval Research in
February 2009. We have also introduced the DSU to various government agencies as
a solution to providing potable water in certain emergency response situations.
We have also begun investigating a range of commercial, industrial and retail
opportunities for our DSU technology.
NYSE
Alternext US LLC (formerly, the American Stock Exchange or “AMEX”)
Issues
On
January 8, 2009, we received a letter from the AMEX notifying us that it
was rejecting our plan of compliance regarding the following listing standards
to which we were in noncompliance of:
·
|
Section
1003(a)(iii), which states AMEX will normally consider suspending dealings
in, or removing from the list, securities of an issuer which has
stockholders’ equity of less than $6,000,000 if such issuer has sustained
net losses in its five most recent fiscal
years;
|
13
·
|
Section
1003(a)(ii), which states AMEX will normally consider suspending dealings
in, or removing from the list, securities of an issuer which has
stockholders’ equity of less than $4,000,000 if such issuer has sustained
net losses in its three of its four most recent fiscal years;
and
|
·
|
Section
1003(f)(v), which states AMEX will normally consider suspending dealings
in, or removing from the list, common stock that sells for a substantial
period of time at a low price per
share.
|
The AMEX
further stated that the AMEX intended to strike our common stock from the AMEX
by filing a delisting application with the SEC pursuant to Rule 1009(d) of the
AMEX Company Guide. Given the turmoil in the capital markets,
we decided not to seek an appeal of the AMEX’s intention to delist our
common stock.
On
January 22, 2009, we were informed by the AMEX that the AMEX had suspended
trading in our common stock effective immediately. Immediately
following the notification, our common stock was no longer traded on the
AMEX.
Effective
February 4, 2009, our common stock was quoted on the Over the Counter Bulletin
Board under the symbol “NEPH.OB”.
In a
letter dated April 13, 2009, we received a copy of the AMEX’s application to
strike our common stock from the AMEX.
Critical
Accounting Policies
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-K for the year ended December 31, 2008. There have been no
material changes to our critical accounting policies and estimates from the
information provided in our Form 10-K for the year ended December 31,
2008.
New
Accounting Pronouncements
See Note
8 to our 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, 2009 Compared to the Three Months Ended June 30,
2008
Net
Product Revenues
Net
product revenues were approximately $527,000 for the three months ended June 30,
2009 compared to approximately $253,000 for the three months ended June 30,
2008, an increase of 108%. The $274,000 increase in net product
revenues is due to revenue of approximately $231,000 during the three months
ended June 30, 2009 compared to approximately $30,000 during the same period in
2008, with the Office of U.S. Naval Research. We had revenue of approximately
$67,000 from sales of our DSU in the United States for the three months ended
June 30, 2009 whereas we had no DSU revenue in the same period in
2008. Sales of our MD filters in our Target European Market were
$6,000 higher in the three months ended June 30, 2009 compared to the same
period in 2008. Sales in Europe were flat due to production delays
with a contract manufacturer. Customer orders in Europe have not
materially decreased from previous year’s levels resulting in a
backlog.
14
Cost
of Goods Sold
Cost of
goods sold was approximately $336,000 for the three months ended June 30, 2009
compared to approximately $162,000 for the three months ended June 30, 2008, an
increase of 107%. The increase of approximately $174,000, or
90%, in cost of goods sold is primarily due to increased costs of approximately
$155,000 during the three months ended June 30, 2009 over the same period in
2008 related to our contract with the Office of U.S. Naval Research and $3,000
in costs related to sales of our DSU in the United States for the three months
ended June 30, 2009 whereas we had no DSU revenue in the same period in
2008. Costs related to Sales of our MD filters in our Target European
Market were $16,000 higher in the three months ended June 30, 2009 compared to
the same period in 2008. Approximately $3,000 of the European revenue
reduction was due to higher units sold and the remaining $13,000 was due to
foreign currency exchange rate fluctuation.
15
Research
and Development
Research
and development expenses were approximately $92,000 for the three months ended
June 30, 2009 compared to approximately $1,149,000 for the three months ended
June 30, 2008, a decrease of 92%. This decrease of $1,057,000 is
primarily due to the fact that there was no clinical trial being
conducted in the three months ended June 30, 2009 compared to the same
period in 2008. The decreased spending related to the clinical trial,
approximated $784,000 for the three months ended June 30, 2009 compared to the
same period in 2008. In addition, salaries, bonus and related fringe
benefit expenses were approximately $241,000 lower for the three months ended
June 30, 2009 compared to the same period in 2008 resulting from the reduction
in headcount made in November 2008. Machine development expenditures
were approximately $25,000 lower; travel expenses were approximately $13,000;
supplies and testing expenses were approximately $15,000 lower for the three
months ended June 30, 2009 compared to the same period in
2008. Spending for research on the water filter increased by
approximately $21,000 the three months ended June 30, 2009 compared to the same
period in 2009.
Depreciation
Expense
Depreciation
expense was approximately $65,000 for the three months ended June 30, 2009
compared to approximately $92,000 for the three months ended June 30, 2008, a
decrease of 29%. The decrease of approximately $27,000 is primarily due to
several assets having been fully depreciated as of year end 2008 resulting in no
depreciation expense for those assets during the three months ended June 30,
2009. There was not a significant disposition of assets during the
three months ended June 30, 2009 compared to the same period in
2008.
Selling,
General and Administrative Expenses
Selling,
general and administrative expenses were approximately $628,000 for the three
months ended June 30, 2009 compared to approximately $1,474,000 for the three
months ended June 30, 2008, a decrease of $846,000 or 57%. The
decrease reflects a reduction in: salaries, fringe benefits and deferred
compensation of approximately $355,000; legal fees of approximately $137,000;
facility rent of approximately $75,000; outside professional service fees of
approximately $90,000; insurance premiums of approximately $24,000; travel
expenses of approximately $23,000; office expense of approximately $12,000 and
recruiting expenses of approximately $130,000 for the three months ended June
30, 2009 compared to the same period in 2008.
Interest
Income
Interest
income was approximately $1,000 for the three months ended June 30, 2009
compared to approximately $66,000 for the three months ended June 30,
2008. The decrease of approximately $65,000 is due to the
decreased investments held during the three months ended June 30, 2009
compared to the three months ended June 30, 2008.
Interest
Expense
We
incurred approximately $2,000 of interest expense for the three months ended
June 30, 2009. This interest relates primarily to financing of
premiums for product liability insurance. There was no interest
expense for the three months ended June 30, 2008.
Other
income and expenses
Other
income in the amount of approximately $182,000 for the three months ended June
30, 2009 resulted primarily from receipt of 2007 New York State Qualified
Emerging Technology Company (“QETC”) tax refunds. There was no other
income for the three months ended June 30, 2008.
Six
Months Ended June 30, 2009 Compared to the Six Months Ended June 30,
2008
Revenues
Total
revenues for the six months ended June 30, 2009 were approximately $1,158,000
compared to approximately $640,000 for the six months ended June 30,
2008. Total revenues increased approximately $518,000 or
81%. The increase in net product revenues is due to revenues of
approximately $565,000 during the six months ended June 30, 2009 compared to
approximately $53,000 during the same period in 2008, with the Office of U.S.
Naval Research. We had revenue of approximately $91,000 from sales of our DSU in
the United States for the six months ended June 30, 2009 whereas we had no DSU
revenue in the same period in 2008. Sales of our MD filters in our
Target European Market were approximately $85,000 lower in the six months ended
June 30, 2009 compared to the same period in 2008. Sales in Europe
were lower due to production delays with a contract
manufacturer. Customer orders in Europe have not materially decreased
from previous year’s levels resulting in a backlog.
16
Cost
of Goods Sold
Cost of
goods sold was approximately $788,000 for the six months ended June 30, 2009
compared to approximately $400,000 for the six months ended June 30,
2008. The increase of approximately $388,000, or 97%, in cost of
goods sold is primarily due to the increase of approximately $391,000 during the
six months ended June 30, 2009 over the same period in 2008 related to our
contract with the Office of U.S. Naval Research and $11,000 in costs related to
sales of our DSU in the United States for the six months ended June 30, 2009
whereas we had no DSU revenue in the same period in 2008. Costs
related to Sales of our MD filters in our Target European Market were
approximately $14,000 lower in the six months ended June 30, 2009 compared to
the same period in 2008 due to a reduction in revenue.
Research
and Development
Research
and development expenses were approximately $150,000 for the six months ended
June 30, 2009 compared to approximately $1,872,000 for the six months ended June
30, 2008, a decrease of 92%. This decrease of $1,722,000 is primarily
due to the fact that there was no clinical trial being conducted in the six
months ended June 30, 2009 compared to the same period in 2008. The
decreased spending related to the clinical trial, approximated $1,167,000 for
the six months ended June 30, 2009 compared to the same period in
2008. In addition, salaries, bonus and related fringe benefit
expenses were approximately $466,000 lower for the six months ended June 30,
2009 compared to the same period in 2008 resulting from the reduction in
headcount made in November 2008. Machine development expenditures
were approximately $58,000 lower; travel expenses were approximately $23,000;
supplies and testing expenses were approximately $24,000 lower for the six
months ended June 30, 2009 compared to the same period in
2008. Spending for research on the water filter increased by
approximately $16,000 the six months ended June 30, 2009 compared to the same
period in 2009.
Depreciation
Expense
Depreciation
expense was approximately $137,000 for the six months ended June 30, 2009
compared to approximately $180,000 for the six months ended June 30, 2008, a
decrease of 24%. The decrease of approximately $43,000 is primarily due to
several assets having been fully depreciated as of year end 2008 resulting in no
depreciation expense for those assets during the six months ended June 30,
2009.
Selling,
General and Administrative Expenses
Selling,
general and administrative expenses were approximately $1,417,000 for the six
months ended June 30, 2009 compared to approximately $2,588,000 for the six
months ended June 30, 2008, a decrease of $1,171,000 or 45%. The
decrease reflects a reduction in: salaries, fringe benefits and deferred
compensation of approximately $407,000; legal fees of approximately $266,000;
facility rent of approximately $120,000; outside professional service fees of
approximately $125,000; insurance premiums of approximately $47,000; travel
expenses of approximately $29,000; office expense of approximately $33,000;
stock exchange fees of approximately $14,000 and recruiting expenses of
approximately $130,000 for the three months ended June 30, 2009 compared to the
same period in 2008.
Interest
Income
Interest
income was approximately $6,000 for the six months ended June 30, 2009 compared
to approximately $158,000 for the six months ended June 30, 2008. The
decrease of approximately $152,000 or 96% is due to the decrease in investments
held during the six months ended June 30, 2009 compared to the six months ended
June 30, 2008. 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 2009.
Interest
Expense
We
incurred approximately $2,000 of interest expense for the six months ended June
30, 2009. This interest relates primarily to financing of premiums
for product liability insurance. There was no interest expense for
the six months ended June 30, 2008.
Impairment
loss of Auction Rate Securities
Effective
January 1, 2008, we adopted fair value measurements under SFAS
No. 157 which applied to our financial assets such as
available-for-sale marketable securities (included as part of investments in the
Unaudited Condensed Consolidated Balance Sheet). These items were to be
marked-to-market at each reporting period; however, the definition of fair value
used for these mark-to-markets is now applied using SFAS
No. 157. Our available-for-sale marketable securities consisted
of auction rate securities (ARS) at June 30, 2008.
17
During
the first three months of 2008, our ARS failed at auction due to sell orders
exceeding buy orders. 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 reviewed 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 six months ended June 30, 2008. Approximately
$300,000 of ARS were redeemed at par during the three months ended June 30, 2008
thereby reducing the total par value from $4.4 million to $4.1 million as of
June 30, 2008.
We sold,
at par value, our remaining ARS to a third party on July 22, 2008 for $4.1
million. We recorded an Unrealized Holding Gain in the second quarter
of 2008 of approximately $114,000 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 on Sale of Investments
of approximately $114,000 in the third quarter of 2008 when the sale transaction
was executed.
There was
no impact on our operations for the six month period ended June 30, 2009 because
the ARS investment was sold in 2008.
Other income and
expenses
Other
income in the amount of approximately $182,000 and $158,000 for the six months
ended June 30, 2009 and June 30, 2008, respectively, resulted primarily from
receipt of New York State Qualified Emerging Technology Company (“QETC”) tax
refunds in each of these periods.
Liquidity
and Capital Resources
Net cash
used in operating activities was approximately $1,430,000 for the six months
ended June 30, 2009 compared to approximately $2,640,000 for the six months
ended June 30, 2008. The $1,210,000 decrease in cash used in
operating activities was primarily due to:
·
|
During
the 2009 period, our net loss decreased by approximately
$2,936,000;
|
·
|
During
the 2009 period, our stock-based compensation expense decreased by
approximately $29,000;
|
·
|
Our
accounts receivable decreased by approximately $77,000 during the 2009
period compared to a decrease of approximately $164,000 during the 2008
period;
|
·
|
Our
inventory increased by approximately $48,000 during the 2009 period
compared to an increase of approximately $59,000 during the 2008
period;
|
·
|
Our
prepaid expenses and other assets decreased by approximately $87,000 in
the 2009 period compared to an increase of approximately $86,000 in the
2008 period; and
|
·
|
Our
accounts payable and accrued expenses decreased by approximately $570,000
in the aggregate in the 2009 period compared to an increase of
approximately $1,181,000 in the 2008
period.
|
Net cash
provided by investing activities was approximately $7,000 for the six months
ended June 30, 2009, compared to net cash provided by investing activities of
approximately $592,000 for the six months ended June 30, 2008. Our
net cash provided by investing activities for the six months ended June 30, 2008
reflects the maturities of short-term investments in the amount of approximately
$700,000 partially offset by purchases of approximately $100,000 in short-term
investments and approximately $8,000 for purchases of computer equipment at our
office in Ireland.
18
Certain
Risks and Uncertainties
Our
Annual Report on Form 10-K for the year ended December 31, 2008 includes a
detailed discussion of our risk factors under the heading “Certain Risks and
Uncertainties.” The information presented below should be read in conjunction
with the risk factors and information disclosed in such Form 10-K.
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;
|
·
|
we
may not be able to continue as a going
concern;
|
·
|
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 regulatory 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-K for the fiscal year ended December 31,
2008 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, unless required by law.
Off-Balance
Sheet Arrangements
We did
not engage in any off-balance sheet arrangements during the six month periods
ended June 30, 2009 and 2008.
Item
4T. Controls and Procedures.
Evaluation
of Disclosure Controls and Procedures
We
maintain a system of disclosure controls and procedures, as defined in
Securities and Exchange Act Rule 13a-15(e),which is designed to provide
reasonable assurance that information, which is required to be disclosed in our
reports filed pursuant to the Securities and Exchange Act of 1934, as amended ,
is accumulated and communicated to management in a timely manner. At the end of
the period covered by this Quarterly Report on Form 10-Q, we carried out an
evaluation, under the supervision and with the participation of our management,
including our Chief Executive Officer and Chief Financial Officer, of the
effectiveness of the design and operation of our disclosure controls and
procedures pursuant to Securities and Exchange Act Rule
13a-15(b). Based upon that evaluation, our Chief Executive Officer
and Chief Financial Officer concluded that our disclosure controls and
procedures as of the end of the period covered by this report were
effective.
19
Changes
in Internal Control over Financial Reporting
In
connection with the preparation of our Annual Report of Form 10-KSB for the year
ended December 31, 2007, 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. Throughout fiscal year
2008 and as reported in our Form 10-Qs filed during the year, we initiated and
implemented the following measures:
·
|
Developed
procedures to implement a formal quarterly closing calendar and process
and held quarterly meetings to address the quarterly closing
process;
|
·
|
Established
a detailed timeline for review and completion of financial reports to be
included in our Forms 10-Q and
10-K;
|
·
|
Enhanced
the level of service provided by outside accounting service providers to
further support and provide additional resources for internal preparation
and review of financial reports and supplemented our internal staff in
accounting and related areas; and
|
·
|
Employed
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.
|
As a
result of the implementation of the above items, the material weakness was
remediated in the fourth quarter of 2008.
In the
quarter ended June 30, 2009, there were no significant changes in our
internal control over financial reporting or in other factors that have
materially affected, or are reasonably likely to materially affect, our internal
control over financial reporting. Through the evaluation of the Sarbanes-Oxley
internal control assessment, a more structured approach, including checklists,
reconciliations and analytical reviews, has been implemented to reduce risk in
the financial reporting process.
PART
II – OTHER INFORMATION
Item
1. Legal Proceedings
A former
employee in France filed a claim in October 2008 stating that the
individual is due 30,000 Euro or approximately $42,000 in back
wages. The individual left our employment four years ago and signed a
Separation Agreement which stated we had no further liability to the
individual. Our attorney has advised us that the Separation Agreement
is valid and should preclude us from having any liability. A
preliminary hearing was held before a French magistrate on June 18, 2009 and the
case was scheduled to be heard before a French court in October
2009. No contingent loss accrual has been recorded by the Company as
of June 30, 2009.
A former
employee in the United States filed a claim in March 2009 against us and
our CEO alleging breach of the individual’s employment agreement and
fraud. The individual was employed with us from April 2008 through
January 8, 2009. Our loss is limited to $10,000, which is the
deductible under our Employment Practices Liability
insurance. An accrual of $10,000 has been recorded as of June
30, 2009.
20
A third
party has brought a claim against us alleging they incurred damages as a result
of our cancellation of a transaction in 2008 involving the sale of Auction Rate
Securities. The claim has been referred to a Financial Industry
Regulatory Authority (FINRA) binding arbitration panel and is scheduled to be
heard in March 2010. There is no specific amount of damages
identified in the claim. We deny that a transaction agreement had
been reached and deny any liability involving this claim. No
contingent loss accrual has been recorded by the Company as of June 30,
2009.
There are
no other currently pending legal proceedings and, as far as we are aware, no
governmental authority is contemplating any proceeding to which we are a party
or to which any of our properties is subject.
Item
4. Submission of Matters to a Vote of Security Holders
There
were no matters submitted to a vote of security holders during the three months
ended June 30, 2009.
Item 6. Exhibits
EXHIBIT
INDEX
4.8
|
Form
of warrant issued to investors in July 2009 private
placement.
|
10.52
|
Form
of Subscription Agreement between Nephros, Inc. and the investors
signatory thereto, dated July 24, 2009.
|
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.
|
21
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, 2009
|
By:
|
/s/
Ernest A. Elgin III
|
Name:
|
Ernest
A. Elgin III
|
|
Title:
|
President
and Chief Executive Officer (Principal Executive
Officer)
|
|
Date:
August 14, 2009
|
By:
|
/s/
Gerald J. Kochanski
|
Name:
|
Gerald
J. Kochanski
|
|
Chief
Financial Officer (Principal Financial and Accounting
Officer)
|
22
Exhibit
Index
4.8
|
Form
of warrant issued to investors in July 2009 private
placement.
|
10.52
|
Form
of Subscription Agreement between Nephros, Inc. and the investors
signatory thereto, dated July 24, 2009.
|
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.
|
23