NEPHROS INC - Quarter Report: 2010 September (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:
September 30, 2010
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 has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files).
¨
YES o 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
November 12, 2010, 41,811,048 shares of issuer’s common stock, with $0.001 par
value per share, were outstanding.
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
the definitions of “large accelerated filer”, “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large
accelerated filer
¨
|
Accelerated
filer
¨
|
Non-accelerated
filer
¨
|
Smaller
reporting company
x
|
(Do not
check if a smaller reporting company)
Table
of Contents
Page No.
|
||
PART I –
FINANCIAL INFORMATION
|
||
Item
1.
|
Financial
Statements
|
3
|
Condensed
Consolidated Balance Sheets – September 30, 2010 (unaudited) and December
31, 2009 (audited)
|
3
|
|
Condensed
Consolidated Statements of Operations – Three and nine months ended
September 30, 2010 and 2009 (unaudited)
|
4
|
|
Condensed
Consolidated Statements of Cash Flows – Nine months ended September 30,
2010 and 2009 (unaudited)
|
5
|
|
Notes
to Unaudited Condensed Consolidated Interim Financial
Statements
|
6
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
11
|
Item
4.
|
Controls
and Procedures
|
17
|
PART
II – OTHER INFORMATION
|
||
Item
1.
|
Legal
Proceedings
|
18
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
18
|
Item
6.
|
Exhibits
|
19
|
SIGNATURES
|
20
|
2
PART I – FINANCIAL
INFORMATION
Item 1. Financial
Statements.
NEPHROS,
INC. AND SUBSIDIARY
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands, except share amounts)
(Unaudited)
|
(Audited)
|
|||||||
September 30,
|
December 31,
|
|||||||
2010
|
2009
|
|||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
|
$
|
421
|
$
|
1,004
|
||||
Accounts
receivable
|
449
|
629
|
||||||
Inventory,
less allowance of $18
|
608
|
653
|
||||||
Prepaid
expenses and other current assets
|
68
|
135
|
||||||
Total
current assets
|
1,546
|
2,421
|
||||||
Property
and equipment, net
|
115
|
210
|
||||||
Other
assets
|
21
|
21
|
||||||
Total
assets
|
$
|
1,682
|
$
|
2,652
|
||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$
|
584
|
$
|
455
|
||||
Accrued
expenses
|
233
|
239
|
||||||
Deferred
revenue
|
67
|
-
|
||||||
Total
current liabilities
|
884
|
694
|
||||||
Commitments
and Contingencies (Note 11)
|
||||||||
Stockholders’
equity:
|
||||||||
Preferred
stock, $.001 par value; 5,000,000 shares authorized at September 30, 2010
and December 31, 2009; no shares issued and outstanding at September 30,
2010 and December 31, 2009.
|
-
|
-
|
||||||
Common
stock, $.001 par value; 90,000,000 shares authorized at September 30, 2010
and December 31, 2009; 41,811,048 and 41,604,798 shares issued and
outstanding at September 30, 2010 and December 31, 2009,
respectively.
|
42
|
42
|
||||||
Additional
paid-in capital
|
91,957
|
91,815
|
||||||
Accumulated
other comprehensive income
|
42
|
76
|
||||||
Accumulated
deficit
|
(91,243)
|
(89,975)
|
||||||
Total
stockholders’ equity
|
798
|
1,958
|
||||||
Total
liabilities and stockholders’ equity
|
$
|
1,682
|
$
|
2,652
|
The
accompanying notes are an integral part of these unaudited condensed
consolidated interim financial statements
3
NEPHROS,
INC. AND SUBSIDIARY
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In
thousands, except share and per share amounts)
(Unaudited)
Three
Months Ended
|
Nine
Months Ended
|
|||||||||||||||
September
30,
|
September
30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Product
revenues
|
$
|
622
|
$
|
711
|
$
|
2,421
|
$
|
1,869
|
||||||||
Cost
of goods sold
|
319
|
463
|
1,446
|
1,251
|
||||||||||||
Gross
margin
|
303
|
248
|
975
|
618
|
||||||||||||
Operating
expenses:
|
||||||||||||||||
Research
and development
|
116
|
62
|
259
|
212
|
||||||||||||
Depreciation
|
30
|
53
|
98
|
190
|
||||||||||||
Selling,
general and administrative
|
550
|
676
|
1,903
|
2,093
|
||||||||||||
Total
operating expenses
|
696
|
791
|
2,260
|
2,495
|
||||||||||||
Loss
from operations
|
(393
|
)
|
(543
|
)
|
(1,285
|
)
|
(1,877
|
)
|
||||||||
Interest
income
|
-
|
2
|
1
|
8
|
||||||||||||
Interest
expense
|
-
|
-
|
-
|
(2
|
)
|
|||||||||||
Other
income
|
18
|
146
|
16
|
328
|
||||||||||||
Net
loss
|
$
|
(375
|
)
|
$
|
(395
|
)
|
$
|
(1,268
|
)
|
$
|
(1,543
|
)
|
||||
Net
loss per common share, basic and diluted
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
$
|
(0.03
|
)
|
$
|
(0.04
|
)
|
||||
Weighted
average common shares outstanding, basic and diluted
|
41,811,048
|
40,439,506
|
41,717,781
|
38,961,179
|
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)
Nine Months Ended September 30,
|
||||||||
2010
|
2009
|
|||||||
Operating
activities:
|
||||||||
Net
loss
|
$
|
(1,268
|
)
|
$
|
(1,543
|
)
|
||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
Depreciation
|
98
|
190
|
||||||
Noncash
stock-based compensation
|
70
|
68
|
||||||
(Increase)
decrease in operating assets:
|
||||||||
Accounts
receivable
|
168
|
(114
|
)
|
|||||
Inventory
|
28
|
118
|
||||||
Prepaid
expenses and other current assets
|
67
|
49
|
||||||
Increase
(decrease) in operating liabilities:
|
||||||||
Accounts
payable and accrued expenses
|
129
|
(638
|
)
|
|||||
Deferred
revenue
|
67
|
-
|
||||||
Net
cash used in operating activities
|
(641
|
)
|
(1,870
|
)
|
||||
Investing
activities:
|
||||||||
Purchase
of property and equipment
|
(6
|
)
|
-
|
|||||
Maturities
of short-term investments
|
-
|
7
|
||||||
Net
cash provided by (used in) investing activities
|
(6
|
)
|
7
|
|||||
Financing
activities:
|
||||||||
Proceeds
from private placement
|
-
|
1,251
|
||||||
Proceeds
from stock options exercised
|
72
|
84
|
||||||
Net
cash provided by financing activities
|
72
|
1,335
|
||||||
Effect
of exchange rates on cash
|
(8
|
)
|
17
|
|||||
Net
decrease in cash and cash equivalents
|
(583
|
)
|
(511
|
)
|
||||
Cash
and cash equivalents, beginning of period
|
1,004
|
2,306
|
||||||
Cash
and cash equivalents, end of period
|
$
|
421
|
$
|
1,795
|
||||
Supplemental
disclosure of cash flow information:
|
||||||||
Cash
paid for interest
|
$
|
-
|
$
|
2
|
||||
Cash
paid for taxes
|
$
|
2
|
$
|
6
|
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
2009 Annual Report on Form 10-K filed with the Securities and Exchange
Commission (the “SEC”) on April 2, 2010. 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, 2009 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 GAAP 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 condensed consolidated financial statements do not include any
adjustments that might result from the outcome of this uncertainty. 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. 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 nine months ended September 30, 2010 and 2009, the Company
has incurred net losses of approximately $1,268,000 and $1,543,000,
respectively. In addition, the Company has not generated positive
cash flow from operations for the three and nine months ended September 30, 2010
and 2009. 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’s current operating plans primarily include the continued development
and support of the Company’s business in the European and Canadian markets,
organizational changes necessary to expand the commercialization of the
Company’s water filtration business and the completion of current year
milestones that 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.
On
October 1, 2010, the Company issued a senior secured note to Lambda
Investors LLC in the principal amount of $500,000. The Company
expects that the proceeds from the note will allow it to fund its operations
through February 2011.
6
NEPHROS,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
1. Basis
of Presentation and Going Concern (continued)
The note
bears interest at the rate of 12% per annum and matures on April 1, 2011, at
which time all principal and accrued interest will be due. However,
the Company has agreed to prepay amounts due under the note with the cash
proceeds from (a) the planned rights offering, (b) any other equity
or debt financing, or (c) the sale of any assets outside the ordinary
course of business in each case prior to the maturity date. If the
Company does not pay principal and interest under the note when due, the
interest rate increases to 16% per annum. The Company may prepay the
note without penalty at any time.
The note
is secured by a first priority lien on all of the Company’s property, including
its intellectual property.
As long
as indebtedness remains outstanding under the note, the Company will be subject
to certain covenants which, among other things, restrict its ability to merge
with another company, sell a material amount of its assets, incur any additional
indebtedness, repay any existing indebtedness, or declare or pay any dividends
in cash, property or securities.
In
connection with the note, the Company has agreed to pay Lambda Investors an 8%,
or $40,000, sourcing/transaction fee. In addition, the Company will
reimburse Lambda Investors’ legal fees and other out-of-pocket expenses incurred
in connection with the note in the amount of $50,000 as well as Lambda
Investors’ legal fees and other out-of-pocket expenses incurred in connection
with the rights offering in the amount of $50,000. Those payments
will be paid upon the completion of the rights offering or, if earlier, upon the
maturity of the note.
Lambda
Investors is the Company’s largest stockholder and beneficially owns
approximately 44% of the Company’s outstanding common stock, including warrants
to purchase an aggregate of 7,190,811 shares of the Company’s common
stock. The warrants held by Lambda Investors have an exercise
price of $0.90 per share and have full ratchet anti-dilution
protection. The shares beneficially owned by Lambda Investors may be deemed
beneficially owned by Wexford Capital LP, which is the managing member of Lambda
Investors. One of the Company’s directors is a partner and
general counsel of Wexford Capital. Another of the Company’s
directors and Acting Chief Executive Officer is a vice president of Wexford
Capital.
The
Company, on October 1, 2010, withdrew the Form S-1 that was filed with the
Securities and Exchange Commission on May 21, 2010.
On
October 1, 2010, the Company filed with the Securities and Exchange Commission a
Registration Statement on Form S-1 relating to a proposed rights offering to
raise up to $3.5 million from the Company’s existing stockholders.
The
Company continues to investigate additional funding opportunities. However,
there can be no assurance that the Company will be able to obtain further
financing, do so on reasonable terms or do so on terms that would not
substantially dilute the equity interests in the Company. If the Company is
unable to raise additional funds on a timely basis, or at all, the Company will
not be able to continue its operations.
2. Concentration
of Credit Risk
For the
nine months ended September 30, 2010 and 2009, the following customers accounted
for the following percentages of the Company’s sales, respectively.
Customer
|
2010
|
2009
|
||||||
A
|
49
|
%
|
45
|
%
|
||||
B
|
31
|
%
|
42
|
%
|
||||
C
|
6
|
%
|
6
|
%
|
As of
September 30, 2010 and December 31, 2009, the following customers accounted for
the following percentages of the Company’s accounts receivable,
respectively.
Customer
|
2010
|
2009
|
||||||
A
|
64 | % | 44 | % | ||||
B
|
5 | % | 34 | % | ||||
C
|
11 | % | 18 | % |
7
NEPHROS,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
3. Revenue
Recognition
Revenue
is recognized in accordance with Accounting Standards Codification (ASC) Topic
605. 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 ASC Topic 605 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 in accordance with ASC Topic 718
by recognizing the fair value of stock-based compensation in the statement of
operations. 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 September 30, 2010 and 2009, stock-based compensation expense
was approximately $21,000 and $33,000, respectively. For the nine
months ended September 30, 2010 and 2009, stock-based compensation expense was
approximately $70,000 and $68,000, respectively.
There was
no tax benefit related to expense recognized in the three and nine months ended
September 30, 2010 and 2009, as the Company is in a net operating loss
position. As of September 30, 2010, there was approximately $149,000
of total unrecognized compensation cost related to unvested share-based
compensation awards granted under the equity compensation plan which will be
amortized over the weighted average remaining requisite service period of 2.2
years. Such amount does not include the effect of future grants of equity
compensation, if any. Of the total $149,000, the Company expects to recognize
approximately 14% in the remaining interim periods of 2010, approximately 53% in
2011, approximately 20% in 2012 and approximately 13% in 2013.
5. Comprehensive
Income
Comprehensive
income (loss), as defined in ASC Topic 220, is the total of net income (loss)
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 September 30, 2010, accumulated other comprehensive income was approximately
$42,000. As of December 31, 2009, accumulated other comprehensive
income was approximately $76,000.
6. Loss
per Common Share
In
accordance with ASC Topic 260-10, net loss per common share amounts (“basic
EPS”) are computed by dividing net loss attributable to common stockholders 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 9,085,109 and 9,698,539 from
the computation of diluted EPS for the three and nine month periods ended
September 30, 2010 and 2009, respectively.
8
NEPHROS,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
7. Recently
Adopted Accounting Pronouncements
In
December 2009, the Financial Accounting Standards Board (“FASB”) issued an
amendment to ASC Topic 810-Improvements to Financial Reporting By Enterprises
Involved with Variable Interest Entities. This amendment to ASC Topic 810
requires a qualitative approach for determining the primary beneficiary of a
variable interest entity and replaces the quantitative evaluation previously set
forth under FASB Interpretation No. 46 (revised December 2003), Consolidation of
Variable Interest Entities. This approach is focused on identifying the
reporting entity that has the ability to direct the activities of a variable
interest entity that most significantly affects the entity's economic
performance and has the obligation to absorb the entity's losses or has the
right to receive benefits from the entity. The amendment, among other things,
will require enhanced disclosures about a reporting entity's involvement in
variable interest
entities. The guidance under the amendment to ASC Topic 810 will be effective
for the first annual period beginning after November 15, 2009, and interim
periods within that first annual period. The Company adopted the pronouncement
on January 1, 2010 resulting in no impact to the Company’s consolidated
financial statements.
In
February 2010, the FASB issued an amendment which requires that an SEC filer, as
defined, evaluate subsequent events through the date that the financial
statements are issued. The update also removed the requirement for an SEC filer
to disclose the date through which subsequent events have been evaluated. The
adoption of this guidance on January 1, 2010 did not have a material effect on
the Company’s consolidated financial statements.
In
January 2010, the FASB issued an amendment to ASC Topic 820- Improving
Disclosures about Fair Value Measurements, which amends the existing fair value
measurement and disclosure guidance currently included in ASC Topic 820, Fair
Value Measurements and Disclosures, to require additional disclosures regarding
fair value measurements. Specifically, the amendment to ASC Topic 820 requires
entities to disclose the amounts of significant transfers between Level 1 and
Level 2 of the fair value hierarchy and the reasons for these transfers, the
reasons for any transfer in or out of Level 3 and information in the
reconciliation of recurring Level 3 measurements about purchases, sales,
issuances and settlements on a gross basis. In addition, this amendment also
clarifies the requirement
for entities to disclose information about both the valuation techniques and
inputs used in estimating Level 2 and Level 3 fair value measurements. This
amendment is effective for interim and annual reporting periods beginning after
December 15, 2009, except for additional disclosures related to Level 3 fair
value measurements, which are effective for fiscal years beginning after
December 15, 2010. The adoption of this amendment did not impact the Company’s
consolidated financial statements.
8. New
Accounting Pronouncements
In April
2010, the FASB issued an Accounting Standards Update which provides guidance on
defining a milestone and determining when it may be appropriate to apply the
milestone method of revenue recognition for research or development
transactions. Research or development arrangements frequently include payment
provisions whereby a portion or all of the consideration is contingent upon
milestone events such as successful completion of phases in a study or achieving
a specific result from the research or development efforts. The amendments in
this standard provide guidance on the criteria that should be met for
determining whether the milestone method of revenue recognition is appropriate.
This standard is effective for fiscal years and interim periods within those
years beginning on or after June 15, 2010, with early adoption permitted. This
standard is effective for the Company on January 1, 2011. The Company is
currently evaluating the impact that the adoption of this standard will have on
the Company’s consolidated financial statements.
9. Fair
Value of Financial Instruments
The
carrying amounts of cash, short-term investments, accounts receivable, accounts
payable and accrued expenses approximate fair value due to the short-term
maturity of these instruments.
The
Company had no financial assets held at fair value at September 30, 2010 or
December 31, 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 September 30, 2010 and December 31, 2009 was
approximately as follows:
Unaudited
|
Audited
|
|||||||
September 30,
2010
|
December 31,
2009
|
|||||||
Raw
Materials
|
$
|
152,000
|
$
|
257,000
|
||||
Finished
Goods
|
474,000
|
414,000
|
||||||
Total
Gross Inventory
|
626,000
|
671,000
|
||||||
Less:
Inventory reserve
|
(18,000
|
)
|
(18,000
|
)
|
||||
Total
Inventory
|
$
|
608,000
|
$
|
653,000
|
9
NEPHROS,
INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
11. Commitments
and Contingencies
On March
30, 2010, Ernest Elgin, III resigned as the Company’s President and Chief
Executive Officer and also resigned from the Board of Directors. In
connection with Mr. Elgin’s resignation, the Company entered into a separation,
release and consulting agreement with Mr. Elgin, pursuant to which the Company
paid Mr. Elgin his current salary through April 16, 2010, paid his applicable
COBRA premiums through April 30, 2010 and, during any time that his COBRA
coverage is in effect in 2010, will reimburse him for out-of-pocket payments
made in 2010 under his healthcare coverage up to $5,000, which is the deductible
under the healthcare coverage. Mr. Elgin was available to consult
with the Company for up to 15 hours a week until May 31, 2010, for which the
Company paid Mr. Elgin at the rate of 50% of his current salary from April 16 to
May 31, 2010. Mr. Elgin was available to consult with the Company for
up to 7.5 hours a week from June 1 to September 30, 2010 for which the Company
paid Mr. Elgin at the rate of 25% of his current salary. As of
September 30, 2010, the consulting services ceased and there was no
remaining unpaid severance balance.
Gerald
Kochanski, the Company’s Chief Financial Officer, served as the acting Chief
Executive Officer from March 30, 2010 until April 5, 2010. As of April 6, 2010,
Paul A. Mieyal, a member of the Board of Directors, has served as the acting
Chief Executive Officer. Dr. Mieyal is a Vice President of Wexford Capital LP,
the managing member of Lambda Investors LLC, which is the beneficial owner of
approximately 44% of the Company’s outstanding stock based on common stock and
warrants held at September 30, 2010.
Suppliers
The
Company entered into an agreement in December 2003, as amended in June 2005,
with a fiber supplier (“FS”), a manufacturer of medical and technical membranes
for applications such as dialysis, to continue to produce the fiber for the
OLpur MDHDF filter series. Pursuant to the agreement, the FS is the Company’s
exclusive provider of the fiber for the OLpur MDHDF filter series in the
European Union as well as certain other territories. On January 18, 2010 the FS
notified the Company that it is exercising its right to terminate the supply
agreement. Termination of the supply agreement was effective on July 18, 2010.
The FS has continued to sell fiber to the Company while negotiations on terms of
a new supply agreement have continued.
12. Subsequent
Events
On
October 1, 2010, the Company issued a senior secured note to Lambda
Investors LLC in the principal amount of $500,000. It is anticipated
that the proceeds from the note will fund the Company’s operations
through February 2011.
The note
bears interest at the rate of 12% per annum and matures on April 1, 2011, at
which time all principal and accrued interest will be due. However,
the Company has agreed to prepay amounts due under the note with the cash
proceeds from (a) the planned rights offering, (b) any other equity or debt
financing, or (c) the sale of any assets outside the ordinary course of
business in each case prior to the maturity date. If the principal
and interest under the note is not paid when due, the interest rate increases to
16% per annum. The note may be prepaid without penalty at any
time.
The note
is secured by a first priority lien on all of the Company’s property, including
its intellectual property.
As long
as indebtedness remains outstanding under the note, the Company will be subject
to certain covenants which, among other things, restrict its ability to merge
with another company, sell a material amount of its assets, incur any additional
indebtedness, repay any existing indebtedness, or declare or pay any dividends
in cash, property or securities.
In
connection with the note, the Company has agreed to pay Lambda Investors an 8%,
or $40,000, sourcing/transaction fee. In addition, the Company will
reimburse Lambda Investors’ legal fees and other out-of-pocket expenses incurred
in connection with the note in the amount of $50,000 as well as Lambda
Investors’ legal fees and other out-of-pocket expenses incurred in connection
with a proposed rights offering in the amount of $50,000. Those
payments will be paid upon the completion of the rights offering or, if earlier,
upon the maturity of the note.
Lambda
Investors is the Company’s largest stockholder and beneficially owns
approximately 44% of its outstanding common stock, including warrants to
purchase an aggregate of 7,190,811 shares of its common
stock. The warrants held by Lambda Investors have an exercise
price of $0.90 per share and have full ratchet anti-dilution
protection. The shares beneficially owned by Lambda Investors may be deemed
beneficially owned by Wexford Capital LP, which is the managing member of Lambda
Investors. One of the Company’s directors is a partner and
general counsel of Wexford Capital. Another of the Company’s
directors and Acting Chief Executive Officer is a vice president of Wexford
Capital.
The
Company, on October 1, 2010, withdrew the Form S-1 that was filed with the
Securities and Exchange Commission on May 21, 2010.
On
October 1, 2010, the Company filed with the Securities and Exchange Commission a
Registration Statement on Form S-1 relating to the proposed rights offering to
raise up to $3.5 million from its existing stockholders.
10
Item 2. Management’s Discussion and Analysis
of Financial Condition and Results of Operations.
This discussion should be read in
conjunction with our consolidated financial statements included in this
Quarterly Report on Form 10-Q and the notes thereto, as well as the other
sections of this Quarterly Report on Form 10-Q, and our Annual Report for the
year ended December 31, 2009 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 our Annual Report on Form 10-K for the year ended December 31,
2009. Our actual results may differ materially.
Immediate
Need for Capital
We have
incurred significant losses in our operations in each quarter since
inception. In addition, we have not generated positive cash flow from
operations for the year ended December 31, 2008 or 2009 or for the three or nine
months ended September 30, 2010. Our recurring losses and difficulty
in generating sufficient cash flow to meet our obligations and sustain our
operations raise substantial doubt about our ability to continue as a going
concern.
For a
description of the actions taken to raise additional capital, please read
Footnote 12 – Subsequent Events in the Notes to Unaudited Condensed Consolidated
Interim Financial Statements in this document.
Financial
Operations Overview
Revenue Recognition: Revenue
is recognized in accordance with ASC Topic 605. 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,
it is the only filter designed expressly for HDF therapy and employs 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.
11
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 Annual Report without trademark notices for
convenience only and should not be construed as being used in a descriptive or
generic sense.
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.
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 the
first quarter of 2007, we received approval from the FDA for our Investigational
Device Exemption (“IDE”) application for the clinical evaluation of our
OLpūr H2H module and OLpūr MD 220 filter. We completed the patient treatment
phase of our clinical trial during the second quarter of 2008. We submitted our
data to the FDA with our 510(k) application on these products in November
2008. Following its review of the application, the FDA requested
additional information from us. We replied to the FDA inquiries on March 13,
2009.
On June
30, 2010, we received a final decision letter from the FDA for our 510(k)
submission which stated that the FDA could not reach a substantial equivalence
determination for our hemodiafiltration (HDF) system. An in-person meeting with
the FDA took place on September 10, 2010 to discuss the issues raised in the FDA
letter. Based upon the meeting with the FDA reviewers and ongoing
communication, we are evaluating the appropriate course of future
action. The current decision by the U.S. FDA with regard to our HDF
system does not impact our ability to market and sell our mid-dilution (MD)
filters for hemodiafiltration procedures outside of the U.S.
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 5,800
registered hospitals in the United States alone (as reported by the American
Hospital Association in Fast Facts of November 11, 2009), we believe the
hospital shower and faucet market can offer us a valuable opportunity as a first
step in water filtration.
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. 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.
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 worked on the
development of a personal potable water purification system for use by
warfighters. Work on this project was completed in August 2009 and we billed
approximately $900,000 during the twenty months ended August 2009. In August
2009, we were awarded a new $1.8 million research contract from the Office of
Naval Research (ONR) for continued development of a potable dual-stage military
water purifying filter. The research contract is an expansion of our former ONR
contract and is being performed as part of the Marine Corps Advanced Technology
Demonstration (ATD) project. The primary objective of this expanded research
program is to select concepts and functional prototype filter/pump units that
were developed during the first phase of the project, and further develop them
into smaller field-testable devices that can be used for military evaluation
purposes. An advantage of our ultrafilter is the removal of viruses, which are
not removed with commercially available off-the-shelf microfilter devices. Such
devices generally rely on a secondary chemical disinfection step to make the
water safe to drink. The expanded contract also includes research geared toward
improving membrane performance, improving device durability, developing larger
squad-level water purifier devices, and investigating desalination filter/pump
devices for emergency-use purposes. Approximately $1,178,000 of revenue has been
recognized on this new project since September 2009 of
which approximately $755,000 was recognized on this project during the
nine months ended September 30, 2010.
12
We
have also introduced the DSU to various government agencies as a solution to
providing potable water in emergency response situations. We have also begun
investigating a range of commercial, industrial and retail opportunities for our
DSU technology.
On March
23, 2010, we announced that Nephros signed a development agreement with STERIS
Corporation to jointly develop filtration-based products for medical device
applications. Under the terms of the contract Nephros received a
$100,000 payment from STERIS Corporation during the second quarter of
2010. Of this $100,000, approximately $67,000 is accounted for as
Deferred Revenue on the Balance Sheet at September 30, 2010. The contract has
several milestones identified that, if reached, will result in additional
$100,000 in payments to Nephros. One of the milestones was achieved
resulting in a $40,000 payment during the three months ended September 30, 2010.
We expect we will achieve the remaining milestones during the remainder of 2010
and in early 2011.
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, you 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, 2009.
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, 2009.
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 September 30, 2010 Compared to the Three Months Ended September 30,
2009
Product
Revenues
Net
product revenues were approximately $622,000 for the three months ended
September 30, 2010 compared to approximately $711,000 for the three months ended
September 30, 2009, a decrease of 13%. The $89,000 decrease in net
product revenues is primarily due to a decrease of approximately $136,000 in
billings related to our contract with the Office of U.S. Naval Research during
the three months ended September 30, 2010 compared to the three months ended
September 30, 2009. Revenue from sales of our MD filters in our Target European
Market was approximately $54,000 lower in the three months ended September 30,
2010 compared to the same period in 2009. Approximately $20,000 of the European
revenue decrease was due to less units sold plus an additional decrease of
approximately $34,000 due to foreign currency exchange rate fluctuation. Unit
sales in Europe decreased approximately 6% for the three months ended September
30, 2010 compared to the same period in 2009. These decreases were
partially offset by increased revenue of approximately $101,000 in sales of our
DSU in the United States for the three months ended September 30, 2010 compared
to the same period in 2009. Approximately $73,000 of the increased
DSU sales was related to the development agreement with STERIS Corporation, of
which approximately $33,000 is related to the recognition of revenue previously
deferred and the remaining $40,000 is related to the achievement of a milestone
during the three months ended September 30, 2010.
Cost
of Goods Sold
Cost of
goods sold was approximately $319,000 for the three months ended September 30,
2010 compared to approximately $463,000 for the three months ended September 30,
2009. The decrease of approximately $144,000, or 31%, in cost
of goods sold is primarily due to reduced costs related to the contract with the
Office of U.S. Naval Research which were approximately $87,000 lower for the
three months ended September 30, 2010 compared to the same period in
2009. Approximately $57,000 of lower costs were due to reduced sales
of our MD filters in our Target European Market for the three months ended
September 30, 2010 compared to the same period in 2009.
13
Research
and Development
Research
and development expenses were approximately $116,000 for the three months ended
September 30, 2010 compared to approximately $62,000 for the three months ended
September 30, 2009, an increase of approximately $54,000 or
87%. Approximately $44,000 of the increase was wages primarily due to
personnel working on research projects other than the contract with the
Office of U.S. Naval Research. The remaining $10,000 increase is due
to increased spending on testing materials during the three months
ended September 30, 2010 compared to the same period in 2009.
Depreciation
Expense
Depreciation
expense was approximately $30,000 for the three months ended September 30, 2010
compared to approximately $53,000 for the three months ended September 30, 2009,
a decrease of 43%. The decrease of approximately $23,000 is primarily due to
several assets having been fully depreciated as of year end 2009 resulting in no
depreciation expense for those assets during the three months ended September
30, 2010. There were no disposals of assets during the three months ended
September 30, 2010.
Selling,
General and Administrative Expenses
Selling,
general and administrative expenses were approximately $550,000 for the three
months ended September 30, 2010 compared to approximately $676,000 for the three
months ended September 30, 2009, a decrease of $126,000 or 19%. The
decrease is primarily due to a decrease in personnel related expenses of
approximately $146,000 during the three months ended September 30, 2010 compared
to the three months ended September 30, 2009. This decrease was
partially offset by increased legal costs of approximately $20,000 during the
three months ended September 30, 2010 compared to the three months ended
September 30, 2009.
Interest
Income
There was
no interest income for the three months ended September 30, 2010 compared to
approximately $2,000 for the three months ended September 30,
2009. The decrease is due to the decreased investments held
during the three months ended September 30, 2010 compared to the three months
ended September 30, 2009.
Interest
Expense
There was
no interest expense for the three months ended September 30, 2010 or September
30, 2009.
Other
income and expenses
Other income for the three months ended
September 30, 2010 was approximately $18,000. Other income for the
three months ended September 30, 2009 was approximately $146,000 which resulted
primarily from receipt of 2007 New York State Qualified Emerging Technology
Company (“QETC”) tax refunds.
Nine
Months Ended September 30, 2010 Compared to the Nine Months Ended September 30,
2009
Revenues
Total
revenues for the nine months ended September 30, 2010 were approximately
$2,421,000 compared to approximately $1,869,000 for the nine months ended
September 30, 2009. Total revenues increased approximately $552,000.
The increase of approximately 30% is due to increased revenue of
approximately $260,000 in sales of our DSU in the United States for the nine
months ended September 30, 2010 over the same period in 2009. Approximately
$73,000 of the increased DSU sales was related to the development agreement with
STERIS Corporation, of which approximately $33,000 is related to the recognition
of revenue previously deferred and the remaining $40,000 is related to the
achievement of a milestone during the three months ended September 30, 2010.
Revenue from sales of our MD filters in our Target European Market was
approximately $324,000 higher for the nine months ended September 30, 2010
compared to the same period in 2009. Approximately $369,000 of the European
revenue increase was due to more units sold, offset partially by $45,000 in
losses due to foreign currency exchange rate fluctuation. Unit sales in Europe
increased approximately 42% for the nine months ended September 30, 2010
compared to the same period in 2009. Partially offsetting the increases above
was a decrease in net product billings of approximately $32,000 related to our
contract with the Office of U.S. Naval Research during the nine months ended
September 30, 2010 compared to the nine months ended September 30,
2009.
Cost of Goods
Sold
Cost of
goods sold was approximately $1,446,000 for the nine months ended September 30,
2010 compared to approximately $1,251,000 for the nine months ended September
30, 2009. The increase of $195,000 or 16% is due to increased
costs of approximately $110,000 related to increased sales of our DSU in the
United States for the nine months ended September 30, 2010 over the same period
in 2009. Costs related to revenue from sales of our MD filters in our Target
European Market was approximately $208,000 higher for the nine months ended
September 30, 2010 compared to the same period in 2009. Costs related
to the contract with the Office of U.S. Naval Research were approximately
$123,000 lower for the nine months ended September 30, 2010 compared to the same
period in 2009 due to the use of a subcontractor rather than
personnel.
14
Research
and Development
Research
and development expenses were approximately $259,000 for the nine months ended
September 30, 2010 compared to approximately $212,000 for the nine months ended
September 30, 2009, an increase of $47,000 or 22%. Approximately
$44,000 of the increase was wages primarily due to personnel working on research
projects other than the contract with the Office of U.S. Naval
Research. The remaining $3,000 increase is due to increased spending
on testing materials during the nine months ended September 30, 2010 compared to
the same period in 2009.
Depreciation
Expense
Depreciation
expense was approximately $98,000 for the nine months ended September 30, 2010
compared to approximately $190,000 for the nine months ended September 30, 2009,
a decrease of 48%. The decrease of approximately $92,000 is primarily due to
several assets having been fully depreciated as of year end 2009 resulting in no
depreciation expense for those assets during the nine months ended September 30,
2010. There were no disposals of assets during the nine months ended September
30, 2010.
Selling,
General and Administrative Expenses
Selling,
general and administrative expenses were approximately $1,903,000 for the nine
months ended September 30, 2010 compared to approximately $2,093,000 for the
nine months ended September 30, 2009, a decrease of $190,000 or
9%. The decrease is primarily due to a decrease in personnel
related expenses of approximately $224,000 during the nine months ended
September 30, 2010 compared to the nine months ended September 30,
2009. This decrease was partially offset by increased legal costs of
approximately $34,000 during the nine months ended September 30, 2010 compared
to the nine months ended September 30, 2009.
Interest
Income
Interest
income was approximately $1,000 for the nine months ended September 30, 2010
compared to approximately $8,000 for the nine months ended September 30,
2009. The decrease of approximately $7,000 or 88% is due to the
decrease in investments held during the nine months ended September 30, 2010
compared to the nine months ended September 30, 2009.
Interest
Expense
There was
no interest expense for the nine months ended September 30,
2010. We incurred approximately $2,000 of interest expense for
the nine months ended September 30, 2009. This interest relates
primarily to financing of premiums for product liability insurance.
Other income
(expense)
Other
income in the amount of approximately $16,000 for the nine months ended
September 30, 2010 resulted from the reversal of a prior year’s accrual
determined to no longer be necessary. Other income in the amount of
approximately $328,000 for the nine months ended September 30, 2009 resulted
primarily from receipt of New York State Qualified Emerging Technology
Company tax refunds for years 2006 and 2007.
15
Liquidity
and Capital Resources
Net cash
used in operating activities was approximately $641,000 for the nine months
ended September 30, 2010 compared to approximately $1,870,000 for the nine
months ended September 30, 2009. The most significant items contributing to this
decrease of approximately $1,229,000 cash used in operating activities during
the nine months ended September 30, 2010 compared to the nine months ended
September 30, 2009 are highlighted below:
|
·
|
during
the 2010 period, our net loss decreased by approximately
$275,000;
|
|
·
|
during
the 2010 period, we recorded deferred revenue of $67,000, whereas there
was no deferred revenue in the 2009
period;
|
|
·
|
during
the 2010 period, depreciation expense decreased by approximately
$92,000;
|
|
·
|
our
accounts receivable decreased by approximately $168,000 during the 2010
period compared to an increase of approximately $114,000 during the 2009
period;
|
|
·
|
our
prepaid expenses and other assets decreased by approximately $67,000 in
the 2010 period compared to a decrease of approximately $49,000 in the
2009 period; and
|
|
·
|
our
accounts payable and accrued expenses increased by approximately $129,000
in the aggregate in the 2010 period compared to a decrease of
approximately $638,000 in the 2009
period.
|
Offsetting
the above changes are the following items:
|
·
|
during
the 2010 period, our stock-based compensation expense increased by
approximately $2,000; and
|
|
·
|
our
inventory decreased by approximately $28,000 during the 2010 period
compared to a decrease of approximately $118,000 during the 2009
period.
|
Net cash
used in investing activities was approximately $6,000 for the nine months ended
September 30, 2010, compared to net cash provided by investing activities of
approximately $7,000 for the nine months ended September 30, 2009. Net cash
used in investing activities for the nine months ended September 30, 2010 was
for the purchase of tooling equipment. Net cash provided by
investing activities was approximately $7,000 for the nine months ended
September 30, 2009 and resulted from the maturities of short-term
investments.
Financing
activities provided net cash of approximately $72,000 for the nine months ended
September 30, 2010 resulting from the issuance of common stock due to the
exercise of stock options.
On July
24, 2009, we raised gross proceeds of $1,251,000 through the private placement
to eight accredited investors of an aggregate of 1,345,161 shares of our common
stock and warrants to purchase an aggregate of 672,581 shares of our common
stock, representing 50% of the shares of common stock purchased by each
investor. We 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. For the
nine months ended September 30, 2009, $84,000 of cash was also provided by the
exercise of stock options.
For a
description of the actions taken to raise additional capital, please read
Footnote 12 – Subsequent Events in the Notes to Unaudited Condensed Consolidated
Interim Financial Statements in this document.
Certain
Risks and Uncertainties
Our
Annual Report on Form 10-K for the year ended December 31, 2009 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:
16
|
·
|
we
may not be able to complete the rights
offering;
|
|
·
|
we
may not be able to continue as a going
concern;
|
|
·
|
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 obtain appropriate or necessary regulatory approvals to achieve
our business plan or effectively market our
products;
|
|
·
|
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 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 and Canada 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,
2009 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 nine month periods
ended September 30, 2010 and 2009.
Item
4. 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 acting 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 acting 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.
17
Changes
in Internal Control over Financial Reporting
There
were no 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
There are
no 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 September 30, 2010.
18
Item 6. Exhibits
EXHIBIT
INDEX
31.1
|
Certification
by the Acting 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 Acting 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.
|
19
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:
November 12, 2010
|
By:
|
/s/ Paul A. Mieyal
|
Name:
|
Paul
A. Mieyal
|
|
Title:
|
Acting
Chief Executive Officer
(Principal
Executive Officer)
|
|
Date:
November 12, 2010
|
By:
|
/s/ Gerald J. Kochanski
|
Name:
|
Gerald
J. Kochanski
|
|
Chief
Financial Officer (Principal Financial
and
Accounting Officer)
|
20