DELAWARE
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13-3971809
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(State
or Other Jurisdiction of Incorporation or Organization)
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(I.R.S.
Employer Identification No.)
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41
Grand Avenue
River
Edge, NJ
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07661
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(Address
of Principal Executive Offices)
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(Zip
code)
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Large
accelerated filer
¨
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Accelerated
filer
¨
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Non-accelerated
filer
¨
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Smaller
reporting company
x
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Page No.
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PART I –
FINANCIAL INFORMATION
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Item
1.
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Financial
Statements
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3
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Condensed
Consolidated Balance Sheets – September 30, 2009 (unaudited) and December
31, 2008 (audited)
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3
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Condensed
Consolidated Statements of Operations – Three and nine months ended
September 30, 2009 and 2008 (unaudited)
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4
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Condensed
Consolidated Statements of Cash Flows – Nine months ended September 30,
2009 and 2008 (unaudited)
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5
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Notes
to Unaudited Condensed Consolidated Interim Financial
Statements
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6
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Item
2.
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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13
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Item
4T.
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Controls
and Procedures
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20
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PART
II – OTHER INFORMATION
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Item
1.
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Legal
Proceedings
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21
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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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(Unaudited)
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(Audited)
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|||||||
September 30,
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December 31,
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|||||||
2009
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2008
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|||||||
ASSETS
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||||||||
Current
assets:
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||||||||
Cash
and cash equivalents
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$ | 1,795 | $ | 2,306 | ||||
Short-term
investments
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- | 7 | ||||||
Accounts
receivable, less allowances of $0 and $4, respectively
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525 | 404 | ||||||
Inventory
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607 | 724 | ||||||
Prepaid
expenses and other current assets
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113 | 162 | ||||||
Total
current assets
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3,040 | 3,603 | ||||||
Property
and equipment, net
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218 | 412 | ||||||
Other
assets
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21 | 21 | ||||||
Total
assets
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$ | 3,279 | $ | 4,036 | ||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
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||||||||
Current
liabilities:
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||||||||
Accounts
payable
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$ | 616 | $ | 986 | ||||
Accrued
expenses
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251 | 411 | ||||||
Accrued
severance expense
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- | 105 | ||||||
Total
current liabilities
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867 | 1,502 | ||||||
Stockholders’
equity:
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||||||||
Preferred
stock, $.001 par value; 5,000,000 shares authorized at September 30, 2009
and December 31, 2008; no shares issued and outstanding at September 30,
2009 and December 31, 2008
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- | - | ||||||
Common
stock, $.001 par value; 60,000,000 shares authorized at September 30, 2009
and December 31, 2008; 41,604.798 shares issued and outstanding at
September 30, 2009 and 38,165,380 at December 31, 2008
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42 | 38 | ||||||
Additional
paid-in capital
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91,774 | 90,375 | ||||||
Accumulated
other comprehensive income
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88 | 70 | ||||||
Accumulated
deficit
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(89,492 | ) | (87,949 | ) | ||||
Total
stockholders’ equity
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2,412 | 2,534 | ||||||
Total
liabilities and stockholders’ equity
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$ | 3,279 | $ | 4,036 |
Three
Months Ended
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Nine
Months Ended
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|||||||||||||||
September
30,
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September
30,
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|||||||||||||||
2009
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2008
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2009
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2008
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|||||||||||||
Product
revenues
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$ | 711 | $ | 393 | $ | 1,869 | $ | 1,033 | ||||||||
Cost
of goods sold
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463 | 254 | 1,251 | 654 | ||||||||||||
Gross
margin
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248 | 139 | 618 | 379 | ||||||||||||
Operating
expenses:
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||||||||||||||||
Research
and development
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62 | 191 | 212 | 2,072 | ||||||||||||
Depreciation
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53 | 84 | 190 | 255 | ||||||||||||
Selling,
general and administrative
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676 | 1,242 | 2,093 | 3,830 | ||||||||||||
Total
operating expenses
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791 | 1,517 | 2,495 | 6,157 | ||||||||||||
Loss
from operations
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(543 | ) | (1,378 | ) | (1,877 | ) | (5,778 | ) | ||||||||
Interest
income
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2 | 27 | 8 | 185 | ||||||||||||
Interest
expense
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- | - | (2 | ) | - | |||||||||||
Impairment
of auction rate securities
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- | - | - | (114 | ) | |||||||||||
Unrealized
holding gain - auction rate securities
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- | (114 | ) | - | - | |||||||||||
Gain
on sale of investments
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- | 114 | - | 114 | ||||||||||||
Other
income
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146 | 5 | 328 | 163 | ||||||||||||
Net
loss
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$ | (395 | ) | $ | (1,346 | ) | $ | (1,543 | ) | $ | (5,430 | ) | ||||
Net
loss per common share, basic and diluted
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$ | (0.01 | ) | $ | (0.04 | ) | $ | (0.04 | ) | $ | (0.14 | ) | ||||
Weighted
average common shares outstanding, basic
and diluted
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40,439,506 | 38,165,380 | 38,961,179 | 38,165,380 |
Nine Months Ended September 30,
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||||||||
2009
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2008
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|||||||
Operating
activities:
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||||||||
Net
loss
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$ | (1,543 | ) | $ | (5,430 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating
activities:
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||||||||
Depreciation
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190 | 255 | ||||||
Amortization
of research & development assets
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- | 12 | ||||||
Loss
on disposal of equipment
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- | 3 | ||||||
Impairment
of auction rate securities
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- | 114 | ||||||
Gain
on sale of investments
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- | (114 | ) | |||||
Stock-based
compensation
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68 | 97 | ||||||
(Increase)
decrease in operating assets:
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||||||||
Accounts
receivable
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(114 | ) | 93 | |||||
Inventory
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118 | (1 | ) | |||||
Prepaid
expenses and other current assets
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49 | 48 | ||||||
Increase
(decrease) in operating liabilities:
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||||||||
Accounts
payable and accrued expenses
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(638 | ) | 594 | |||||
Net
cash used in operating activities
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(1,870 | ) | (4,329 | ) | ||||
Investing
activities:
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||||||||
Purchase
of property and equipment
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- | (63 | ) | |||||
Proceeds
from sale of short-term investments
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- | 4,100 | ||||||
Maturities
of short-term investments
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7 | 593 | ||||||
Net
cash provided by investing activities
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7 | 4,630 | ||||||
Financing
activities:
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||||||||
Proceeds
from private placement
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1,251 | - | ||||||
Exercise
of stock options
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84 | - | ||||||
Net
cash provided by investing activities
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1,335 | - | ||||||
Effect
of exchange rates on cash
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17 | (5 | ) | |||||
Net
increase (decrease) in cash and cash equivalents
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(511 | ) | 296 | |||||
Cash
and cash equivalents, beginning of period
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$ | 2,306 | $ | 3,449 | ||||
Cash
and cash equivalents, end of period
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1,795 | 3,745 | ||||||
Supplemental
disclosure of cash flow information:
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||||||||
Cash
paid for interest
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2 | - | ||||||
Cash
paid for taxes
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6 | 8 |
1.
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Basis
of Presentation and Going Concern
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2.
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Concentration
of Credit Risk
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Customer
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2009
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2008
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||||||
A
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45 | % | 84 | % | ||||
B
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42 | % | 10 | % |
Customer
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2009
|
2008
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||||||
A
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47 | % | 66 | % | ||||
B
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32 | % | 23 | % |
3.
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Revenue
Recognition
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4.
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Stock-Based
Compensation
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5.
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Comprehensive
Income
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6.
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Loss
per Common Share
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7.
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Recent
Accounting Pronouncements
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8.
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Fair
Value of Financial Instruments
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Fair Value Measurements at Reporting
Date Using
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||||||||||||||||
Total Fair Value at
December 31, 2008
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Level 1
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Level 2
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Level 3
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|||||||||||||
Certificate
of deposit
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$ | 7,000 | $ | 7,000 | $ | — | $ | — | ||||||||
Total
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$ | 7,000 | $ | 7,000 | $ | — | $ | — |
9.
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Inventory
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Unaudited
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Audited
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|||||||
September 30, 2009
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December 31, 2008
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|||||||
Raw
Materials
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$ | 109,000 | $ | 382,000 | ||||
Finished
Goods
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498,000 | 342,000 | ||||||
Total
Inventory
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$ | 607,000 | $ | 724,000 |
10.
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Equity
Transactions
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Title of Warrant
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Date Issued
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Expiry Date
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Exercise Price
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Total Common
Shares Issuable
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||||||||
IPO
Underwriter Warrants
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3/24/2005
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9/20/2009
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$ | 7.50 | 200,000 | |||||||
Lancer
Warrants
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1/18/2006
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1/18/2009
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$ | 1.50 | 21,308 | |||||||
Class
D Warrants
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11/14/2007
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11/14/2012
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$ | 0.706 | 9,112,566 | |||||||
Placement
Agent Warrants
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11/14/2007
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11/14/2012
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$ | 0.90 | 1,756,374 | |||||||
Total
all Outstanding Warrants
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$ | 1.02 |
(1)
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11,090,248 |
(A)
=
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the
VWAP (as defined below) on the Trading Day (as defined below) immediately
preceding the date of such election;
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(B)
=
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the
Per Share Exercise Price of this Warrant, as adjusted;
and
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(C)
=
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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.
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Title of Warrant
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Date Issued
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Expiry Date
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Exercise Price
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Total Common
Shares Issuable
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||||||||
Class
D Warrants
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11/14/2007
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11/14/2012
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$ | 0.90 | 7,389,565 | |||||||
Placement
Agent Warrants
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11/14/2007
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11/14/2012
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$ | 0.706 | 129,681 | |||||||
July
2009 Warrants
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7/24/2009
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7/24/2014
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$ | 1.12 | 672,581 | |||||||
Total
all Outstanding Warrants
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$ | .92 |
(1)
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8,191,827 |
11.
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Contingencies
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12.
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Subsequent
Events
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·
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OLpur
MDHDF filter series (which we sell in various countries in Europe and
currently consists of our MD190 and MD220 diafilters), which is to our
knowledge, the only filter designed expressly for HDF therapy and
employing our proprietary Mid-Dilution Diafiltration
technology;
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·
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OLpur
H2H, our add-on module designed to allow the most common types of
hemodialysis machines to be used for HDF therapy;
and
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·
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OLpur
NS2000 system, our stand-alone HDF machine and associated filter
technology.
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·
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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;
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·
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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
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·
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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.
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·
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During
the 2009 period, our net loss decreased by approximately
$3,887,000;
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·
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During
the 2009 period, our stock-based compensation expense decreased by
approximately $29,000;
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·
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Our
accounts receivable increased by approximately $114,000 during the 2009
period compared to a decrease of approximately $93,000 during the 2008
period;
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·
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Our
inventory decreased by approximately $118,000 during the 2009 period
compared to an increase of approximately $1,000 during the 2008
period;
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·
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Our
prepaid expenses and other assets decreased by approximately $49,000 in
the 2009 period compared to a decrease of approximately $48,000 in the
2008 period; and
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·
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Our
accounts payable and accrued expenses decreased by approximately $638,000
in the aggregate in the 2009 period compared to an increase of
approximately $594,000 in the 2008
period.
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·
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we
may not be able to obtain funding if and when needed or on terms favorable
to us in order to continue
operations;
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·
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we
may not be able to continue as a going
concern;
|
|
·
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we
may not obtain appropriate or necessary regulatory approvals to achieve
our business plan or efeeffectivelyemarket our
products;
|
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effectively
market our products;
|
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·
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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;
|
|
·
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we
may encounter unanticipated internal control deficiencies or weaknesses or
ineffective disclosure controls and
procedures;
|
|
·
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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
|
|
·
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We
may not be able to achieve sales growth in Europe or expand into other key
geographic markets.
|
|
·
|
Developed
procedures to implement a formal quarterly closing calendar and process
and held quarterly meetings to address the quarterly closing
process;
|
|
·
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Established
a detailed timeline for review and completion of financial reports to be
included in our Forms 10-Q and
10-K;
|
|
·
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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
|
|
·
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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.
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31.1
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Certification
by the Chief Executive Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
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31.2
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Certification
by the Chief Financial Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
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32.1
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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.
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NEPHROS,
INC.
|
||
Date:
November 12, 2009
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By:
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/s/
Ernest A. Elgin III
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Name:
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Ernest
A. Elgin III
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Title:
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President
and Chief Executive Officer
(Principal
Executive Officer)
|
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Date:
November 12, 2009
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By:
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/s/
Gerald J. Kochanski
|
Name:
|
Gerald
J. Kochanski
|
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Chief
Financial Officer (Principal Financial
and
Accounting Officer)
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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.
|