UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON D.C. 20549

 

FORM 10-Q

 

(Mark One)

[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended: June 30, 2019

 

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.)

     

380 Lackawanna Place

South Orange, NJ

  07079
(Address of principal executive offices)   (Zip Code)

 

(201) 343-5202

Registrant’s telephone number, including area code

 

N/A

(Former name, former address and former fiscal year, if changed since last report)

 

Securities registered pursuant to Section 12(b) of the Act: None.

 

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 every Interactive Data File required to be submitted 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 such files). [X] YES [  ] NO

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.:

 

Large accelerated filer [  ] Accelerated filer [  ]
Non-accelerated filer [X] Smaller reporting company [X]
  Emerging growth company [  ]

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [  ]

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). [  ] YES  [X] NO

 

As of August 3, 2019, 7,672,816 shares of the registrant’s common stock, $0.001 par value per share, were outstanding.

 

 

 

     

 

 

NEPHROS, INC. AND SUBSIDIARIES

 

TABLE OF CONTENTS

 

PART I - FINANCIAL INFORMATION 3
Item 1. Financial Statements (unaudited) 3
CONDENSED CONSOLIDATED BALANCE SHEETS – June 30, 2019 and December 31, 2018 3
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS – Three and six months ended June 30, 2019 and 2018 4
CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY – Three and six months ended June 30, 2019 and 2018 5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS – Six months ended June 30, 2019 and 2018 6
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS (unaudited) 7
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations. 25
Item 3. Quantitative and Qualitative Disclosures About Market Risk. 36
Item 4. Controls and Procedures. 36
PART II - OTHER INFORMATION 37
Item 6. Exhibits 37
SIGNATURES 38

 

  2  

 

 

PART I - FINANCIAL INFORMATION

 

Item 1. Financial Statements.

 

NEPHROS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share amounts)

(Unaudited)

 

    June 30, 2019     December 31, 2018  
ASSETS                
Current assets:                
Cash   $ 4,318     $ 4,581  
Accounts receivable, net     1,539       1,452  
Inventory, net     2,314       1,864  
Prepaid expenses and other current assets     266       276  
Total current assets     8,437       8,173  
Property and equipment, net     89       91  
Operating lease right-of-use assets     1,250       -  
Intangible assets, net     569       590  
Goodwill     759       748  
License and supply agreement, net     871       938  
Other assets     39       18  
TOTAL ASSETS   $ 12,014     $ 10,558  
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY                
Current liabilities:                
Secured revolving credit facility   $ 1,021     $ 991  
Current portion of secured note payable     203       195  
Accounts payable     915       836  
Accrued expenses     601       396  
Current portion of contingent consideration     329       236  
Current portion of operating lease liabilities     223       -  
Total current liabilities     3,292       2,654  
Secured note payable, net of current portion     730       843  
Contingent consideration, net of current portion     163       263  
Operating lease liabilities, net of current portion     1,023       -  
TOTAL LIABILITIES     5,208       3,760  
                 
COMMITMENTS AND CONTINGENCIES (Note 16)                
                 
STOCKHOLDERS’ EQUITY                
                 
Preferred stock, $.001 par value; 5,000,000 shares authorized at June 30, 2019 and December 31, 2018; no shares issued and outstanding at June 30, 2019 and December 31, 2018.     -       -  
Common stock, $.001 par value; 40,000,000 and 10,000,000 shares authorized at June 30, 2019 and December 31, 2018, respectively; 7,672,816 and 7,179,514 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively.     8       7  
Additional paid-in capital     130,169       127,873  
Accumulated other comprehensive income     70       71  
Accumulated deficit     (126,444 )     (124,153 )
Subtotal     3,803       3,798  
Noncontrolling interest     3,003       3,000  
TOTAL STOCKHOLDERS’ EQUITY     6,806       6,798  
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY   $ 12,014     $ 10,558  

 

The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.

 

  3  

 

 

NEPHROS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share amounts)

(Unaudited)

 

    Three Months Ended
June 30,
    Six Months Ended
June 30,
 
    2019     2018     2019     2018  
Net revenues:                                
Product revenues   $ 2,284     $ 1,216     $ 4,013     $ 2,174  
Royalty and other revenues     25       150       65       177  
Total net revenues     2,309       1,366       4,078       2,351  
Cost of goods sold     942       536       1,713       1,054  
Gross margin     1,367       830       2,365       1,297  
Operating expenses:                                
Research and development     793       352       1,549       641  
Depreciation and amortization     48       40       98       81  
Selling, general and administrative     1,403       1,091       2,906       2,351  
Change in fair value of contingent consideration     (9 )     -       (19 )     -  
Total operating expenses     2,235       1,483       4,534       3,073  
Loss from operations     (868 )     (653 )     (2,169 )     (1,776 )
Other income (expense):                                
Loss on extinguishment of debt     -       -       -       (199 )
Interest expense     (46 )     (28 )     (92 )     (114 )
Interest income     -       1       -       2  
Other expense, net     (28 )     (2 )     (30 )     (24 )
Net loss     (942 )     (682 )     (2,291 )     (2,111 )
Less: Undeclared deemed dividend attributable to
noncontrolling interest
    (61 )     -       (120 )     -  
Net loss attributable to Nephros, Inc. shareholders   $ (1,003 )   $ (682 )   $ (2,411 )   $ (2,111 )
                                 
                                 
Net loss per common share, basic and diluted   $ (0.14 )   $ (0.10 )   $ (0.33 )   $ (0.32 )
Weighted average common shares outstanding, basic and diluted     7,387,930       7,028,410       7,259,491       6,647,856  
                                 
Comprehensive loss:                                
Net loss   $ (942 )   $ (682 )   $ (2,291 )   $ (2,111 )
Other comprehensive (loss) income, foreign currency translation adjustments, net of tax     2       (6 )     (1 )     (3 )
Comprehensive loss     (940 )     (688 )     (2,292 )     (2,114 )
Comprehensive loss attributable to noncontrolling
interest
    (61 )     -       (120 )     -  
Comprehensive loss attributable to Nephros, Inc.
shareholders
  $ (1,001 )   $ (688 )   $ (2,412 )   $ (2,114 )

 

The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.

 

  4  

 

 

 

NEPHROS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY

(In Thousands, Except Share Amounts)

(Unaudited)

 

    Three and six months ended June 30, 2019  
    Common Stock     Additional Paid-in     Accumulated Other Comprehensive     Accumulated           Noncontrolling     Total Stockholders’  
    Shares     Amount     Capital     Income     Deficit     Subtotal     Interest     Equity  
Balance, December 31, 2018     7,134,719     $        7     $ 127,873     $         71     $ (124,153 )   $ 3,798     $ 3,000     $ 6,798  
Net loss                                     (1,349 )     (1,349 )             (1,349 )
Net unrealized losses on foreign currency translation, net of tax                             (3 )             (3 )             (3 )
Noncash stock-based compensation                     158                       158               158  
Balance, March 31, 2019     7,134,719       7       128,031       68       (125,502 )     2,604       3,000       5,604  
Net loss                                     (942 )     (942 )             (942 )
Net unrealized gains on foreign currency translation, net of tax                             2               2               2  
Issuance of common stock, net of equity issuance costs of $8     493,827       1       1,991                       1,992               1,992  
Issuance of vested restricted stock     44,270       -                                                  
Noncash stock-based compensation                     147                       147       3       150  
Balance, June 30, 2019     7,672,816     $ 8       130,169     $ 70     $ (126,444 )   $ 3,803     $ 3,003     $ 6,806  

 

    Three and six months ended June 30, 2018  
    Common Stock     Additional Paid-in     Accumulated Other Comprehensive     Accumulated           Noncontrolling     Total Stockholders’  
    Shares     Amount     Capital     Income     Deficit     Subtotal     Interest     Equity  
Balance, December 31, 2017     6,143,663     $    6     $ 122,973     $             77     $ (121,106 )   $ 1,950     $             -     $ 1,950  
Net loss                                     (1,429 )     (1,429 )             (1,429 )
Cumulative effect of adoption of ASC 606                                     278       278               278  
Net unrealized gains on foreign currency translation, net of tax                             3               3               3  
Issuance of common stock     211,111       -       854                       854               854  
Cashless exercise of stock options     2.471       -                               -               -  
Cancelled restricted stock shares                                             -               -  
Noncash stock-based compensation                     242                       242               242  
Balance, March 31, 2018     6,357,245       6       124,069       80       (122,257 )     1,898       -       1,898  
Net loss                                     (682 )     (682 )             (682 )
Net unrealized losses on foreign currency translation, net of tax                             (6 )             (6 )             (6 )
Issuance of common stock, net of equity issuance costs of $19     726,735       1       2,923                       2,924               2,924  
Exercise of warrants     50,739       -       138                       138               138  
Noncash stock-based compensation                     226                       226               226  
Balance, June 30, 2018     7,134,719     $ 7     $ 127,356     $ 74     $ (122,939 )   $ 4,498     $ -     $ 4,498  

 

The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.

 

  5  

 

 

NEPHROS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands, Except Share Amounts)

(Unaudited)

 

    Six Months Ended June 30,  
    2019     2018  
OPERATING ACTIVITIES:                
Net loss   $ (2,291 )   $ (2,111 )
Adjustments to reconcile net loss to net cash used in operating activities:                
Depreciation of property and equipment     16       14  
Amortization of intangible assets and license and supply agreement     88       67  
Non-cash stock-based compensation, including stock options and restricted stock     308       468  
Loss on extinguishment of debt     -       199  
Amortization of debt discount     -       34  
Inventory reserve     37       50  
Allowance for doubtful accounts reserve     -       2  
Change in fair value of contingent consideration     (19 )     -  
Accretion of contingent consideration     28       -  
Loss on disposal of equipment     -       10  
Loss (gain) on foreign currency transactions     6       (2 )
(Increase) decrease in operating assets:                
Accounts receivable     (87 )     (21 )
Inventory     (487 )     (728 )
Prepaid expenses and other current assets     (5 )     37  
Other assets     (21 )     -  
Increase (decrease) in operating liabilities:                
Accounts payable     73       (191 )
Accrued expenses     328       160  
Net cash used in operating activities     (2,026 )     (2,012 )
INVESTING ACTIVITIES:                
Acquisition of Biocon     (137 )     -  
Net cash used in investing activities     (137 )     -  
FINANCING ACTIVITIES:                
Proceeds from issuance of common stock, net of equity issuance costs of $8 and $19, respectively     1,992       3,778  
Net proceeds (payments) on secured revolving credit facility     30       (558 )
Payments on secured note payable     (105 )     (49 )
Proceeds from exercise of warrants     -       138  
Payment of contingent consideration     (16 )     -  
Proceeds from issuance of secured note     -       1,187  
Repayment of unsecured long term note payable     -       (1,187 )
Net cash provided by financing activities     1,901       3,309  
Effect of exchange rates on cash     (1 )     (7 )
Net increase (decrease) in cash     (263 )     1,290  
Cash, beginning of period     4,581       2,194  
Cash, end of period   $ 4,318     $ 3,484  
Supplemental disclosure of cash flow information                
Cash paid for interest   $ 62     $ 91  
Cash paid for income taxes   $ 4     $ 3  
                 
Supplemental disclosure of noncash investing and financing information                
Right-of-use asset obtained in exchange for lease liability   $ 800     $ -  
Purchase of equipment included in accrued expenses   $ 14     $ -  

 

The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.

 

  6  

 

 

NEPHROS, INC. AND SUBSIDIARIES

 

NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS (unaudited)

 

Note 1 – Organization and Nature of Operations

 

Nephros, Inc. (“Nephros” or the “Company”) was incorporated under the laws of the State of Delaware on April 3, 1997. The Company was founded by health professionals, scientists and engineers affiliated with Columbia University to develop advanced end stage renal disease (“ESRD”) therapy technology and products.

 

Beginning in 2009, Nephros introduced high performance liquid purification filters, to meet the demand for water purification in certain medical markets. The Company’s filters, generally classified as ultrafilters, are primarily used in hospitals for the prevention of infection from water-borne pathogens, such as legionella and pseudomonas, and in dialysis centers for the removal of biological contaminants from water and bicarbonate concentrate. The Company also develops and sells water filtration products for commercial applications, focusing on the hospitality and food service markets. The Company is also exploring water purification applications in other markets, including diagnostics, military field applications, and data center cooling. The water filtration business is a reportable segment, referred to as the Water Filtration segment.

 

In July 2018, the Company formed a new, wholly-owned subsidiary, Specialty Renal Products, Inc. (“SRP”), to drive the development of its second-generation HDF system and other products focused on improving therapies for patients with renal disease. The Company transferred three patents to SRP, which were carried at zero book value. SRP is a reportable segment, referred to as the Renal Products segment.

 

On December 31, 2018, the Company entered into a Membership Interest Purchase Agreement (the “Biocon Agreement”) with Biocon 1, LLC, a Nevada limited liability company (“Biocon”), Aether Water Systems, LLC, a Nevada limited liability company (“Aether”), and Gregory Lucas, the sole member of each of Biocon and Aether. Pursuant to the terms of the Biocon Agreement, the Company acquired 100% of the outstanding membership interests of each of Aether and Biocon (the “Biocon Acquisition”).

 

Primary U.S. facilities are located at 380 Lackawanna Place, South Orange, New Jersey, 07079, and at 3221 Polaris Avenue, Las Vegas, Nevada 89102. These locations house the Company’s corporate headquarters, research, manufacturing, and distribution facilities. In addition, the Company maintains small administrative offices in various locations in the U.S. and Ireland.

 

Note 2 – Basis of Presentation and Liquidity

 

Interim Financial Information

 

The accompanying unaudited condensed consolidated interim financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 8 and Article 10 of Regulation S-X. The condensed consolidated balance sheet at December 31, 2018 was derived from the Company’s audited annual financial statements. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for annual financial statements. Results as of and for the six months ended June 30, 2019 are not necessarily indicative of the results that may be expected for the year ending December 31, 2019.

 

The condensed consolidated interim financial statements and notes thereto should be read in conjunction with the consolidated financial statements and notes for the year ended December 31, 2018 included in the Company’s Annual Report on Form 10-K.

 

Reverse Stock Split

 

On May 22, 2019, the Company’s Board of Directors authorized a 1-for-9 reverse stock split and approved an amendment to the Company’s Certificate of Incorporation (the “Amendment”) to effect the 1-for-9 reverse split of the Company’s common stock, which was effected at 5:30 p.m. ET on July 9, 2019. All of the share and per share amounts discussed in these condensed consolidated interim financial statements included in this Quarterly Report on Form 10-Q have been adjusted to reflect the effect of this reverse split (see Note 18 – Subsequent Event).

 

Consolidation

 

The accompanying consolidated financial statements include the accounts of Nephros, Inc. and its wholly owned subsidiary, Nephros International Limited, and SRP, in which a controlling interest is maintained by the Company. Outside shareholders’ interest in SRP of 37.5% is shown on the condensed consolidated balance sheet as noncontrolling interest. All intercompany accounts and transactions were eliminated in the preparation of the accompanying consolidated financial statements.

 

  7  

 

 

Use of Estimates

 

The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities, at the date of the financial statements, and the reported amount of revenues and expenses, during the reporting period. Actual results could differ materially from those estimates. Included in these estimates are assumptions about the collection of accounts receivable, value of inventories, useful life of fixed assets and intangible assets, the assessment of expected cash flows used in evaluating goodwill and other long-lived assets, value of contingent consideration, the assessment of the ability to continue as a going concern and assumptions used in determining stock compensation such as expected volatility and risk-free interest rate.

 

Liquidity

 

The Company has sustained operating losses and expects such losses to continue over the next several quarters. In addition, net cash from operations has been negative since inception, generating an accumulated deficit of approximately $126,444,000 as of June 30, 2019. Also, the Company has a loan agreement with a lender, which provides a secured asset-based revolving credit facility of up to $1,000,000. This loan agreement will automatically renew on August 17, 2019, although this renewal is not guaranteed.

 

On May 15, 2019, the Company completed a private placement transaction whereby the Company sold 493,827 shares of its common stock for aggregate net proceeds of approximately $1,992,000.

 

In addition, in July 2018, the Company formed a new, wholly-owned subsidiary, SRP, to drive the development of its second-generation HDF system and other products focused on improving therapies for patients with renal disease. On September 5, 2018, SRP completed a private placement transaction whereby SRP sold preferred shares equivalent to 37.5% of its outstanding equity interests for aggregate proceeds of $3,000,000. The proceeds of this private placement are restricted to SRP expenses and may not be used for the benefit of the Company or other affiliated entities, except to reimburse for expenses directly attributable to SRP.

 

Based on cash that is available for Company operations and projections of future Company operations, the Company believes that its cash will be sufficient to fund the Company’s current operating plan through at least the next 12 months from the date of issuance of the accompanying consolidated financial statements. In the event that operations do not meet expectations, the Company will reduce discretionary expenditures such as additional headcount, new R&D projects, and other variable costs to alleviate the substantial doubt as to the Company’s ability to continue as a going concern. The Company may also seek to raise additional capital, however, there can be no assurance that any such actions could be affected 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.

 

Recently Adopted Accounting Pronouncements

 

In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-02, “Leases,” (“ASC 842”) which discusses how an entity should account for lease assets and lease liabilities. The guidance specifies that an entity who is a lessee under lease agreements should recognize lease assets and lease liabilities for those leases classified as operating leases under previous FASB guidance. The Company adopted the guidance on January 1, 2019 using the transition method provided by ASU 2018-11, “Leases (Topic 842): Targeted Improvements”. Under this transition method, the Company applied the new requirements to only those leases that existed as of January 1, 2019, rather than at the earliest comparative period presented in the financial statements. Prior periods will be presented under existing lease guidance. Upon transition, the Company applied the package of practical expedients permitted under the ASC 842 transition guidance. As a result, the Company did not reassess (1) whether expired or existing contracts contain leases under the new definition of a lease, including whether an existing or expired contract contains an embedded lease, (2) lease classification for expired or existing leases and (3) any initial direct costs of existing leases. As a result of the adoption of this guidance on January 1, 2019, the Company recorded right-of-use assets of approximately $613,000, net of approximately $8,000 of deferred rent liability as of January 1, 2019, and lease liabilities of approximately $621,000. Adoption of the guidance did not have any impact on the Company’s consolidated statements of operations and comprehensive loss or cash provided by or used in operating, investing or financing activities on its consolidated statements of cash flows.

 

In June 2016, the FASB issued ASU 2016-13, “Measurement of Credit Losses on Financial Instruments,” which replaces the current incurred loss impairment methodology with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The guidance is effective for the Company beginning in the first quarter of fiscal year 2020. Early adoption is permitted beginning in the first quarter of fiscal year 2019. The Company early adopted this guidance as of January 1, 2019 and the guidance did not have an impact on its consolidated financial statements.

 

In May 2018, the FASB issued ASU 2018-07, “Improvements to Nonemployee Share-Based Payment Accounting,” which expands the scope of Accounting Standards Codification (“ASC”) 718 to include share-based payment transactions for acquiring goods and services from nonemployees. The Company adopted this guidance as of January 1, 2019 and the guidance did not have an impact on its consolidated financial statements.

 

  8  

 

 

Recent Accounting Pronouncements, Not Yet Effective

 

In January 2017, the FASB issued ASU 2017-04, “Simplifying the Test for Goodwill Impairment,” which simplifies the test for goodwill impairment. The guidance is effective for the Company beginning in the first quarter of fiscal year 2020. Early adoption is permitted for interim or annual goodwill impairments tests after January 1, 2017. The Company is assessing the impact of adopting this guidance on its consolidated financial statements.

 

In August 2018, the FASB issued ASU 2018-13, “Disclosure Framework-Changes to the Disclosure Requirements for the Fair Value Measurement,” which modifies the disclosure requirements on fair value measurements. The guidance is effective for the Company beginning in the first quarter of fiscal year 2020. Early adoption is permitted. The Company is assessing the impact of adopting this guidance on its consolidated financial statements.

 

In August 2018, the FASB issued ASU 2018-15, “Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That is a Service Contract,” which aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. The guidance is effective for the Company beginning in the first quarter of fiscal year 2020. Early adoption is permitted. The Company is assessing the impact of adopting this guidance on its consolidated financial statements.

 

In November 2018, the FASB issued ASU 2018-18, “Collaborative Arrangements: Clarifying the Interaction Between Topic 808 and Topic 606.” The new guidance clarifies that, when the collaborative arrangement participant is a customer in the context of a unit-of-account, revenue from contracts with customers guidance should be applied, adds unit-of-account guidance to collaborative arrangements guidance, and requires, that in a transaction with a collaborative arrangement participant who is not a customer, presenting the transaction together with revenue recognized under contracts with customers is precluded. The guidance is effective for the Company beginning in the first quarter of fiscal year 2020. Early adoption is permitted. The Company is assessing the impact of adopting this guidance on its consolidated financial statements.

 

Concentration of Credit Risk

 

The Company deposits its cash in financial institutions. At times, such deposits may be in excess of insured limits. To date, the Company has not experienced any impairment losses on its cash. The Company also limits its credit risk with respect to accounts receivable by performing credit evaluations when deemed necessary.

 

Major Customers

 

For the three months ended June 30, 2019 and 2018, the following customers accounted for the following percentages of the Company’s revenues, respectively:

 

Customer   2019     2018  
A   12%     5%  
B   12%     3%  
C   10%     - %  
D   7%     13%  
E   6%     13%  
F   2%     11%  
Total   49%     45%  

 

For the six months ended June 30, 2019 and 2018, the following customers accounted for the following percentages of the Company’s revenues, respectively:

 

Customer   2019     2018  
A   14%     4%  
B   12%     9%  
D   7%     14%  
E   6%     13%  
Total   39%     40%  

 

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As of June 30, 2019, and December 31, 2018, the following customers accounted for the following percentages of the Company’s accounts receivable, respectively:

 

Customer   2019     2018  
A   12%     5%  
B   10%     11%  
C   16%     - %  
E   7%     11%  
G   -     15%  
Total   45%     42%  

 

Accounts Receivable

 

The Company provides credit terms to customers in connection with purchases of the Company’s products. Management periodically reviews customer account activity in order to assess the adequacy of the allowances provided for potential collection issues and returns. Factors considered include economic conditions, each customer’s payment and return history and credit worthiness. Adjustments, if any, are made to reserve balances following the completion of these reviews to reflect management’s best estimate of potential losses. The allowance for doubtful accounts was approximately $10,000 and $15,000 as of June 30, 2019 and December 31, 2018, respectively. For the three and six months ended June 30, 2019, there was no provision for bad debt expense. Write-offs of accounts receivable were approximately $5,000 for the six months ended June 30, 2019 which were reserved for in a prior period. There were no write-offs of accounts receivable for the three months ended June 30, 2019. There was no allowance for sales returns at June 30, 2019 or December 31, 2018. During the three and six months ended June 30, 2018, there was no provision for bad debt expense and there were no write-offs of accounts receivable.

 

Depreciation Expense

 

Depreciation related to equipment utilized in the manufacturing process is recognized in cost goods sold on the condensed consolidated statements of operations and comprehensive loss. For the three months ended June 30, 2019 and 2018, depreciation expense was approximately $8,000 and $7,000, respectively. For the six months ended June 30, 2019 and 2018, depreciation expense was approximately $16,000 and $14,000, respectively. Approximately $4,000 and $6,000 of depreciation expense has been recognized in cost of goods sold for the three and six months ended June 30, 2019, respectively. There was no depreciation recognized in cost of goods sold for the three or six months ended June 30, 2018.

 

Leases

 

The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets and operating lease liabilities on the condensed consolidated balance sheet.

 

Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As most of the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term.

 

The Company has elected, as an accounting policy not to apply the recognition requirements in ASC 842 to short-term leases. Short-term leases are leases that have a term of 12 months or less and do not include an option to purchase the underlying asset that the Company is reasonably certain to exercise. The Company recognizes the lease payments for short-term leases on a straight-line basis over the lease term.

 

The Company has also elected, as a practical expedient, by underlying class of asset, not to separate lease components from nonlease components and, instead, account for them as a single component.

 

Note 3 – Biocon Acquisition

 

On December 31, 2018, the Company completed the Biocon Acquisition, which included the acquisition of 100% of the outstanding membership interests of each of Aether and Biocon. The purpose of the Biocon Acquisition was to accelerate growth and to expedite entry into additional markets.

 

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Transaction costs associated with the Biocon Acquisition of approximately $33,000 were recorded in selling, general and administrative costs for the year ended December 31, 2018.

 

The Company has accounted for the Biocon Acquisition as a business combination under the acquisition method of accounting.

 

The following is a summary of total consideration for the Biocon Acquisition, including a final working capital adjustment in the six months ended June 30, 2019 of approximately $11,000:

 

    Total Consideration  
       
Fixed purchase price   $ 1,070,000  
Acquisition date fair value of contingent consideration     562,000  
Total consideration 1   $ 1,632,000  

 

1 Total consideration of $1,632,000 consists of $5,000 in accrued expenses, $137,000 in working capital payments, $499,000 of contingent consideration liabilities, as well as an upfront payment of $991,000, of which $250,000 is held in escrow.

 

The Company has allocated the total consideration for the transaction based upon the fair value of net assets acquired and liabilities assumed at the date of acquisition.

 

The following is a summary of the final purchase price allocation for the Biocon Acquisition. Changes to the purchase price allocation from amounts reported on the Company’s Annual Report on Form 10K for the year ended December 31, 2018 were due to the final working capital adjustment.

 

    Fair Values  
Trade accounts receivable   $ 164,000  
Inventories     179,000  
Equipment     39,000  
Security deposit     7,000  
Goodwill     759,000  
Intangible assets     590,000  
Total assets acquired, net of cash acquired     1,738,000  
Accounts payable     91,000  
Accrued expenses     15,000  
Total liabilities assumed     106,000  
Net assets acquired, net of cash acquired   $ 1,632,000  

 

Intangible Assets

 

The acquired intangible assets are being amortized over their estimated useful lives as follows:

 

    Preliminary Fair
Values
    Weighted Average Useful Life (Years)  
Tradenames, service marks and domain names     50,000       5  
Customer relationships     540,000       17  
Total intangible assets   $ 590,000          

 

The estimated fair value of the identifiable intangible assets was determined using the “income approach,” which is a valuation technique that provides an estimate of the fair value of an asset based on market participant expectations of the cash flows an asset would generate over its remaining useful life. The assumptions, including the expected projected cash flows, utilized in the preliminary purchase price allocation and in determining the purchase price were based on the Company’s best estimates as of December 31, 2018, the closing date of the Biocon Acquisition.

 

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Some of the more significant assumptions inherent in the development of those asset valuations include the estimated net cash flows for each year for each asset or product (including net revenues, cost of goods sold, research and development costs, selling and marketing costs and working capital / contributory asset charges), the appropriate discount rate to select in order to measure the risk inherent in each future cash flow stream, the assessment of each asset’s life cycle, the potential regulatory and commercial success risks, competitive trends impacting the asset and each cash flow stream, as well as other factors. No assurances can be given that the underlying assumptions used to prepare the discounted cash flow analysis will not change. For these and other reasons, actual results may vary significantly from estimated results.

 

Goodwill

 

Goodwill is calculated as the excess of the consideration transferred over the net assets recognized. Factors that contributed to the Company’s recognition of goodwill include the Company’s intent to expand its product portfolio. Goodwill has been allocated to the Water Filtration segment.

 

Unaudited Pro Forma Results of Operations

 

The following table reflects the unaudited pro forma combined results of operations for the three and six months ended June 30, 2018 (assuming the closing of the Biocon Acquisition occurred on January 1, 2017):

 

    Three Months Ended     Six Months Ended  
    June 30, 2018     June 30, 2018  
Total revenues   $ 1,502,000     $ 2,672,000  
Net loss attributable to Nephros, Inc   $ (675,000 )   $ (2,063,000 )

 

The pro forma results have been prepared for comparative purposes only and are not necessarily indicative of the actual results of operations had the closing of the Biocon Acquisition taken place on January 1, 2017. Furthermore, the pro forma results do not purport to project the future results of operations of the Company.

 

The unaudited pro forma information reflects the following adjustments:

 

  Adjustments to amortization expense for the three and six months ended June 30, 2018 of approximately $11,000 and $21,000, respectively related to identifiable intangible assets acquired;
  Eliminate interest expense in the historical Biocon results of operations and eliminate interest income in the Company’s historical results of operations, each of which was approximately $1,000 and $2,000 for the three and six months ended June 30, 2018, respectively, which interest was related to a lease that was terminated as of the acquisition; and
  Eliminate sales, and related cost of goods, for products sold by Biocon to the Company, with a gross margin impact of approximately $1,000 and $2,000 for the three and six months ended June 30, 2018, respectively.

 

Note 4 – Revenue Recognition

 

The Company recognizes revenue related to product sales when product is shipped via external logistics provider and the other criteria of ASC 606, “Revenue from Contracts with Customers,” (“ASC 606”) are met. Product revenue is recorded net of returns and allowances. In addition to product revenue, the Company recognizes revenue related to license, royalty and other agreements in accordance with the five-step model in ASC 606. License, royalty and other revenue recognized for the three months ended June 30, 2019 and 2018 is comprised of:

 

    Three Months Ended
June 30,
    Six Months Ended
June 30,
 
    2019     2018     2019     2018  
Royalty revenue under the Sublicense Agreement with CamelBak (1)   $ -     $ 100,000     $ -     $ 100,000  
Royalty revenue under the License Agreement with Bellco     14,000       31,000       40,000       58,000  
Other revenue     11,000       19,000       25,000       19,000  
Total license, royalty and other revenue   $ 25,000     $ 150,000     $ 65,000     $ 177,000  

 

  (1) In May 2015, the Company entered into a Sublicense Agreement with CamelBak Products, LLC (“CamelBak”). Under the Sublicense Agreement, the Company granted CamelBak an exclusive, non-transferable, worldwide (with the exception of Italy) sublicense and license, in each case solely to market, sell, distribute, import and export the Company’s individual water treatment device. In exchange for the rights granted to CamelBak, CamelBak agreed, through December 31, 2022, to pay the Company a percentage of the gross profit on any sales made to a branch of the U.S. military, subject to certain exceptions, and to pay a fixed per-unit fee for any other sales made. CamelBak was also required to meet or exceed certain minimum annual fees payable to the Company, and if such fees are not met or exceeded, the Company may convert the exclusive sublicense to a non-exclusive sublicense with respect to non-U.S. military sales. In the first quarter of 2019, the Sublicense Agreement was amended to eliminate the minimum fee obligations starting May 6, 2018 and, as such, Camelbak has no further minimum fee obligations.

 

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Bellco License Agreement

 

With regard to the OLpūr MD190 and MD220, on June 27, 2011, the Company entered into a License Agreement (the “Bellco License Agreement”), effective July 1, 2011, with Bellco S.r.l. (“Bellco”), an Italy-based supplier of hemodialysis and intensive care products, for the manufacturing, marketing and sale of the Company’s patented mid-dilution dialysis filters (the “Products”). Under the License Agreement, as amended, the Company granted Bellco a license to manufacture, market and sell the Products under its own name, label, and CE mark in certain countries on an exclusive basis, and to do the same on a non-exclusive basis in certain other countries. Under the License Agreement with Bellco, the Company received upfront payments which were previously deferred and recognized as license revenue over the term of the License Agreement. As of the adoption of ASC 606, the remaining deferred revenue of approximately $278,000 was recognized as a cumulative effect adjusted to accumulated deficit as of January 1, 2018 in accordance with ASC 606.

 

The License Agreement, as amended, also provides minimum sales targets which, if not satisfied, will, at the discretion of the Company, result in conversion of the license to non-exclusive status. Beginning on January 1, 2015 through and including December 31, 2021, Bellco will pay the Company a royalty based on the number of units of Products sold per year in the covered territory as follows: for the first 125,000 units sold in total, €1.75 (approximately $2.15) per unit; thereafter, €1.25 (approximately $1.50) per unit. The License Agreement also provides for a fixed royalty payment payable to the Company for the period beginning on January 1, 2015 through and including December 31, 2021 if the minimum sales targets are not met.

 

The Company recognized royalty income from Bellco pursuant to the License Agreement for the three months ended June 30, 2019 and 2018 of approximately $14,000 and $31,000, respectively. The Company recognized royalty income from Bellco pursuant to the License Agreement for the six months ended June 30, 2019 and 2018 of approximately $40,000 and $58,000, respectively.

 

Note 5 – Fair Value Measurements

 

The Company measures certain financial instruments and other items at fair value.

 

To determine the fair value, the Company uses the fair value hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs market participants would use to value an asset or liability and are developed based on market data obtained from independent sources. Unobservable inputs are inputs based on assumptions about the factors market participants would use to value an asset or liability.

 

To measure fair value, the Company uses the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable:

 

Level 1 - Quoted prices in active markets for identical assets or liabilities.

 

Level 2 - Inputs other than Level 1 that are observable for the asset or liability, either directly or indirectly, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data by correlation or other means.

 

Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Value is determined using pricing models, discounted cash flow methodologies, or similar techniques and also includes instruments for which the determination of fair value requires significant judgment or estimation.

 

Assets and Liabilities Measured at Fair Value on a Recurring Basis

 

The Company evaluates its financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level of classification for each reporting period.

 

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The following table sets forth the Company’s financial assets and liabilities that were measured at fair value on a recurring basis as of June 30, 2019:

 

   

Quoted prices in

active markets

for

identical assets

(Level 1)

   

Significant other

observable

inputs

(Level 2)

   

Significant

unobservable

inputs

(Level 3)

    Total  
At June 30, 2019:                                
Total contingent consideration liability   $        -     $  -     $ 492,000     $ 492,000  

 

The following table sets forth the Company’s financial assets and liabilities that were measured at fair value on a recurring basis as of December 31, 2018:

 

   

Quoted prices in

active markets

for

identical assets

(Level 1)

   

Significant other

observable

inputs

(Level 2)

   

Significant

unobservable

inputs

(Level 3)

    Total  
At December 31, 2018:                                
Total contingent consideration liability   $       -     $ -     $ 499,000     $ 499,000  

 

The following table summarizes the change in fair value, as determined by Level 3 inputs, for the contingent consideration liability using unobservable Level 3 inputs for the six months ended June 30, 2019:

 

    Contingent
Consideration
 
      (Unaudited)  
Balance as of December 31, 2018   $ 499,000  
Payments against contingent consideration     (16,000 )
Change in fair value of contingent consideration liability     (19,000 )
Accretion of contingent consideration liability     28,000  
Balance as of June 30, 2019   $ 492,000  

 

Consideration paid in a business combination may include potential future payments that are contingent upon the acquired business achieving certain levels of earnings in the future (“contingent consideration”). Contingent consideration liabilities are measured at their estimated fair value as of the date of acquisition, with subsequent changes in fair value recorded in the consolidated statements of operations. Fair value as of the date of acquisition is estimated based on projections of expected future cash flows of the acquired business. The Company estimated the contingent consideration liability using the income approach (discounted cash flow method) which requires the Company to make estimates and assumptions regarding the future cash flows and profits. Changes in these estimates and assumptions could have a significant impact on the amounts recognized.

 

There were no transfers between levels in the fair value hierarchy during the three or six months ended June 30, 2019.

 

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Assets and Liabilities Not Measured at Fair Value on a Recurring Basis

 

The carrying amounts of cash, accounts receivable, secured revolving credit facility, accounts payable and accrued expenses approximate fair value due to the short-term maturity of these instruments.

 

The carrying amounts of the secured long-term note payable and operating lease liabilities approximate fair value as of June 30, 2019 and December 31, 2018 because those financial instruments bear interest at rates that approximate current market rates for similar agreements with similar maturities and credit.

 

Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis

 

See Note 3 – Biocon Acquisition for the allocation of the total consideration for the Biocon Acquisition based upon the fair value of net assets acquired and liabilities assumed at the date of acquisition.

 

Note 6 – Inventory, net

 

Inventory is stated at the lower of cost or net realizable value using the first-in, first-out method and consists of raw materials and finished goods. The Company’s inventory components as of June 30, 2019 and December 31, 2018 were as follows:

 

    June, 2019     December 31, 2018  
    (Unaudited)     (Audited)  
Finished goods   $ 2,118,000     $ 1,633,000  
Raw materials     282,000       280,000  
Less: inventory reserve     (86,000 )     (49,000 )
Total inventory, net   $ 2,314,000     $ 1,864,000  

 

Note 7 – Intangible Assets and Goodwill

 

Intangible Assets

 

Intangible assets for the six months ended June 30, 2019 are set forth in the table below. The table shows the gross carrying values and accumulated amortization of the Company’s intangible assets by type as of June 30, 2019:

 

    June 30, 2019  
    Gross Carrying Value     Accumulated Amortization     Intangible Assets, net  
Tradenames, service marks and domain names   $ 50,000     $ (5,000 )   $ 45,000  
Customer relationships     540,000       (16,000 )     524,000  
Total intangible assets   $ 590,000     $ (21,000 )   $ 569,000  

 

The Company recognized amortization expense of approximately $11,000 and $21,000 for the three and six months ended June 30, 2019, respectively in selling, general and administrative expenses on the accompanying condensed consolidated statement of operations and comprehensive loss.

 

Amortization expense for the reminder of the fiscal year 2019 is estimated to be approximately $21,000. Aggregate amortization expense for each of the next five years is estimated to be approximately $42,000.

 

The Company did not recognize any intangible asset impairment charges during the three or six months ended June 30, 2019.

 

Goodwill

 

Goodwill had a carrying value on the Company’s condensed consolidated balance sheets of approximately $759,000 and $748,000 at June 30, 2019 and December 31, 2018, respectively. As a result of a final working capital adjustment, goodwill increased approximately $11,000 during the six months ended June 30, 2019. Goodwill has been allocated to the Water Filtration segment.

 

Note 8 – License and Supply Agreement, net

 

On April 23, 2012, the Company entered into a License and Supply Agreement (as thereafter amended, the “License and Supply Agreement”) with Medica S.p.A. (“Medica”), an Italy-based medical product manufacturing company, for the marketing and sale of certain filtration products based upon Medica’s proprietary Medisulfone ultrafiltration technology in conjunction with the Company’s filtration products, and for an exclusive supply arrangement for the filtration products. Under the License and Supply Agreement Medica granted to the Company an exclusive license, with right of sublicense, to market, promote, distribute, offer for sale and sell the filtration products worldwide, with certain limitations on territory, during the term of the License and Supply Agreement. In addition, the Company granted to Medica an exclusive license under the Company’s intellectual property to make the filtration products during the term of the License and Supply Agreement. The filtration products covered under the License and Supply Agreement includes both certain products based on Medica’s proprietary Versatile microfiber technology and certain filtration products based on Medica’s proprietary Medisulfone ultrafiltration technology. The term of the License Agreement with Medica expires on December 31, 2025, unless earlier terminated by either party in accordance with the terms of the License and Supply Agreement.

 

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In exchange for the license, the gross value of the intangible asset capitalized was approximately $2,250,000. License and supply agreement, net, on the condensed consolidated balance sheet is approximately $871,000 and $938,000 as of June 30, 2019 and December 31, 2018, respectively. Accumulated amortization is approximately $1,379,000 and $1,312,000 as of June 30, 2019 and December 31, 2018, respectively. The intangible asset is being amortized as an expense over the life of the License and Supply Agreement. Amortization expense of approximately $33,000 was recognized in each of the three months ended June 30, 2019 and 2018 on the condensed consolidated statement of operations and comprehensive loss. Amortization expense of approximately $67,000 was recognized in each of the six months ended June 30, 2019 and 2018 on the condensed consolidated statement of operations and comprehensive loss.

 

As of September 2013, the Company has an understanding with Medica whereby the Company has agreed to pay interest to Medica at a 12% annual rate calculated on the principal amount of any outstanding invoices that are not paid pursuant to the original payment terms. There was no interest recognized for the three or six months ended June 30, 2019. For the three and six months ended June 30, 2018, approximately $2,000 and $12,000, respectively, of interest expenses was recognized on the condensed consolidated statement of operations and comprehensive loss.

 

In addition, for the period beginning April 23, 2014 through December 31, 2025, the Company will pay Medica a royalty rate of 3% of net sales of the filtration products sold, subject to reduction as a result of a supply interruption pursuant to the terms of the License and Supply Agreement. Approximately $61,000 and $36,000 for the three months ended June 30, 2019 and 2018, respectively, was recognized as royalty expense and is included in cost of goods sold on the condensed consolidated statement of operations and comprehensive loss. Approximately $108,000 and $65,000 for the six months ended June 30, 2019 and 2018, respectively, was recognized as royalty expense and is included in cost of goods sold on the condensed consolidated statement of operations and comprehensive loss. Approximately $61,000 and $50,000 are included in accounts payable as of June 30, 2019 and December 31, 2018, respectively.

 

Note 9 – Secured Note Payable

 

On March 27, 2018, the Company entered into a Secured Promissory Note Agreement (the “Secured Note”) with Tech Capital, LLC (“Tech Capital”) for a principal amount of $1,187,000. As of June 30, 2019, the principal balance of the Secured Note was approximately $933,000. The Company used the proceeds from the Secured Note to repay the Company’s 11% unsecured promissory notes issued in June 2016 pursuant to the Note and Warrant Agreement (see Note 11 – Unsecured Promissory Notes and Warrants).

 

The Secured Note has a maturity date of April 1, 2023. The unpaid principal balance accrues interest at a rate of 8% per annum. Principal and interest payments are due on the first day of each month commencing on May 1, 2018. The Secured Note is subject to the terms and conditions of and is secured by security interests granted by the Company in favor of Tech Capital under the Loan and Security Agreement between the Company and Tech Capital, dated August 16, 2017 and all of the riders and amendments thereto (the “Loan Agreement”) (see Note 10 – Secured Revolving Credit Facility). An event of default under such Loan Agreement shall be an event of default under the Secured Note and vice versa. In the event the principal balance under the Loan Agreement is due, all amounts due under the Secured Note shall also be due.

 

During the three and six months ended June 30, 2019, the Company made payments under the Secured Note of approximately $72,000 and $144,000, respectively. Included in the total payments made, approximately $19,000 and $39,000 was recognized as interest expense on the condensed consolidated statement of operations and comprehensive loss for the three and six months ended June 30, 2019, respectively. During the three and six months ended June 30, 2018, the Company made payments under the Secured Note of approximately $72,000. Approximately $23,000 of the $72,000 was recognized as interest expense on the condensed consolidated statement of operations and comprehensive loss for the three and six months ended June 30, 2018.

 

Debt issuance costs of approximately $6,000 were recognized as interest expense on the condensed consolidated statement of operations and comprehensive loss for the six months ended June 30, 2018.

 

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As of June 30, 2019, future principal maturities are as follows:

 

2019 (excluding the six months ended June 30, 2019)   $ 109,000  
2020     231,000  
2021     251,000  
2022     271,000  
2023     71,000  
Total   $ 933,000  

 

Note 10 – Secured Revolving Credit Facility

 

On August 17, 2017, the Company entered into the Loan Agreement with Tech Capital. The Loan Agreement provides for a secured asset-based revolving credit facility of up to $1,000,000, which the Company may draw upon and repay from time to time during the term of the Loan Agreement. The outstanding principal balance of the Loan Agreement was approximately $1,021,000 and $991,000 as of June 30, 2019 and December 31, 2018, respectively. The Company is using these proceeds for working capital and general corporate purposes.

 

The Loan Agreement has a term of 12 months, which was automatically renewed on August 17, 2018 and will automatically renew for successive 12-month periods unless cancelled. Availability under the Loan Agreement will be based upon periodic borrowing base certifications valuing certain of the Company’s accounts receivable and inventory. Outstanding borrowings under the Loan Agreement accrue interest, which shall be payable monthly based on the average daily outstanding balance, at a rate equal to 3.5% plus the prime rate per annum, provided that such prime rate shall not be less than 4.25% per annum. As of June 30, 2019, the current interest rate was 9.00% per annum.

 

The Company also granted to Tech Capital a first priority security interest in its assets, including its accounts receivable and inventory, to secure all of its obligations under the Loan Agreement. In addition, Nephros International Limited, the Company’s wholly-owned subsidiary, unconditionally guaranteed the Company’s obligations under the Loan Agreement.

 

For the three months ended June 30, 2019 and 2018, approximately $12,000 and $3,000, respectively, was recognized as interest expense on the condensed consolidated statement of operations and comprehensive loss. For the six months ended June 30, 2019 and 2018, approximately $23,000 and $9,000, respectively, was recognized as interest expense on the condensed consolidated statement of operations and comprehensive loss. As of June 30, 2019, approximately $4,000 of the $23,000 of interest expense incurred for the six months ended June 30, 2019 is included in accrued expenses on the condensed consolidated balance sheet.

 

Note 11 - Unsecured Promissory Notes and Warrants

 

In June 2016, the Company entered into a Note and Warrant Agreement (the “Note and Warrant Agreement”) with new creditors as well as existing stockholders under which the Company issued unsecured promissory notes and warrants resulting in total gross proceeds to the Company of approximately $1,187,000. The outstanding principal under the notes accrued interest at a rate of 11% per annum. The notes required the Company to make interest only payments on a semi-annual basis, with all outstanding principal under the notes being repayable in cash on the third anniversary of the date of issuance. In addition to the notes, the Company issued warrants to purchase approximately 300,000 shares of the Company’s common stock. The portion of the gross proceeds allocated to the warrants, approximately $393,000, was accounted for as additional paid-in capital resulting in a debt discount. The debt discount, which included approximately $9,000 of debt issuance costs in addition to the fair value of the warrants, was being amortized to interest expense using the effective interest method in accordance with ASC 835 over the term of the Note and Warrant Agreement.

 

On March 30, 2018, the principal balance of the notes, along with the remaining accrued interest of approximately $43,000, was repaid in full. The remaining debt discount of approximately $199,000 was recorded as loss on extinguishment of debt in the Company’s consolidated statements of operations and comprehensive loss for the six months ended June 30, 2018.

 

For the six months ended June 30, 2018, approximately $34,000 was recognized as amortization of debt discount and is included in interest expense on the consolidated statement of operations and comprehensive loss. For the six months ended June 30, 2018, approximately $30,000 of interest expense was incurred.

 

For the six months ended June 30, 2018, the amount of interest expense recognized related to related parties comprised of entities controlled by a member of management and by Lambda, the Company’s largest stockholder, was approximately $1,000.

 

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Note 12 – Leases

 

The Company has operating leases for corporate offices, an automobile and office equipment. The leases have remaining lease terms of 1 year to 5 years.

 

The Company entered into an operating lease that began in December 2017 for 380 Lackawanna Place, South Orange, New Jersey 07079, which consists of approximately 7,700 square feet of space. The rental agreement expires in November 2022 with a monthly cost of approximately $11,000. Approximately $11,000 related to a security deposit for this U.S. office facility is classified as other assets on the condensed consolidated balance sheet as of June 30, 2019 and December 31, 2018. The Company uses this facility to house its corporate headquarters and research facilities.

 

The Company also has a rental agreement for 591 East Sunset Road, Henderson, Nevada 89011 (“Henderson”) which consists of approximately 8,000 total square feet of space. The Henderson lease expires in November 2020 with a monthly cost of approximately $6,000. The Company is moving its offices from the Henderson facility to a new location in Las Vegas, as described below and expects to terminate the Henderson lease during the third quarter of 2019, ceasing rent payments after September 2019. As a result, the right-of-use asset and corresponding lease liability relating to the Henderson office lease have been adjusted. Approximately $7,000 related to a security deposit for this office facility is classified as other assets on the condensed consolidated balance sheet as of June 30, 2019 and December 31, 2018.

 

The Company entered into an operating lease that began in February 2019 for 211 Donelson Pike, Nashville, Tennessee 37214, for office space. The rental agreement expires in January 2021 with a monthly cost of approximately $850. Approximately $1,000 related to a security deposit for this office facility is classified as other assets on the condensed consolidated balance sheet as of June 30, 2019.

 

The Company entered into an operating lease in March 2019 for approximately 16,000 total square feet of office space at 3221 Polaris Avenue, Las Vegas, Nevada 89118. The rental agreement commenced in June 2019 with a monthly cost of approximately $15,000. Approximately $20,000 related to a security deposit for this office facility is classified as other assets on the condensed consolidated balance sheet as of June 30, 2019.

 

The lease agreement for the Company’s office space in Ireland was entered into on August 1, 2018 and includes a twelve-month term.

 

The Company also has lease agreements for an automobile and office equipment.

 

Prior to the adoption of ASC 842, operating lease expense of approximately $37,000 and $88,000 was recognized in the Company’s consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2018, respectively.

 

Operating lease expense was approximately $58,000 and $116,000, for the three and six months ended June 30, 2019, respectively, in the Company’s consolidated statements of operations and comprehensive loss and includes costs associated with leases for which ROU assets have been recognized as well as short-term leases.

 

Supplemental cash flow information related to leases was as follows:

 

   

Six months ended

June 30, 2019

 
    (Unaudited)  
Cash paid for amounts included in the measurement of lease liabilities:        
Operating cash flows from operating leases   $ 113,000  
         
ROU assets obtained in exchange for lease obligations        
Operating leases   $ 800,000  

 

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Supplemental balance sheet information related to leases was as follows:

 

    June 30, 2019  
      (Unaudited)  
Operating ROU assets   $ 1,250,000  
         
Other current liabilities   $ 223,000  
Operating lease liabilities     1,023,000  
Total operating lease liabilities   $ 1,246,000  
         
Weighted average remaining lease term, operating leases     4.4 years  
         
Weighted average discount rate, operating leases     8.0 %

 

As of June 30, 2019, maturities of lease liabilities were as follows:

 

2019 (excluding the six months ended June 30, 2019)   $ 141,000  
2020     339,000  
2021     333,000  
2022     329,000  
2023     201,000  
2024     137,000  
Total future minimum lease payments     1,480,000  
Less imputed interest     (234,000 )
Total   $ 1,246,000  

 

Note 13 – Stock Plans and Share-Based Payments

 

The fair value of stock options and restricted stock is recognized as stock-based compensation expense in the Company’s condensed consolidated statement of operations and comprehensive loss. The Company and its consolidated subsidiaries calculate stock-based compensation expense in accordance with ASC 718. The fair value of stock-based awards is amortized over the vesting period of the award. The Company’s consolidated subsidiary, SRP, maintains its own equity incentive compensation plan.

 

Stock Options

 

During the six months ended June 30, 2019, the Company granted stock options to purchase 72,574 shares of common stock to employees, directors and a consultant. These stock options are being expensed over the respective vesting period, which is based on a service condition. The fair value of the stock options granted during the six months ended June 30, 2019 was approximately $313,000.

 

The fair value of each option grant is estimated on the date of grant using the Black-Scholes option pricing model. The below weighted average assumptions for the risk-free interest rates, expected dividend yield, expected lives and expected stock price volatility were utilized for the stock options granted during the six months ended June 30, 2019.

 

Weighted Average Assumptions for Option Grants      
Stock Price Volatility     98.8 %
Risk-Free Interest Rates     2.3 %
Expected Life (in years)     6.12  
Expected Dividend Yield     - %

 

During the six months ended June 30, 2018, stock options to purchase 11,111 shares of the Company’s common stock were exercised in a cashless exercise, resulting in the issuance of 2,471 shares of the Company’s common stock.

 

Stock-based compensation expense related to stock options was approximately $132,000 and $124,000 for the three months ended June 30, 2019 and 2018, respectively. For the three months ended June 30, 2019, approximately $118,000 and $14,000 are included in selling, general and administrative expenses and research and development expenses, respectively, on the accompanying condensed consolidated statement of operations and comprehensive loss. For the three months ended June 30, 2018, approximately $118,000 and $6,000 are included in selling, general and administrative expenses and research and development expenses, respectively, on the accompanying condensed consolidated statement of operations and comprehensive loss.

 

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Stock-based compensation expense related to stock options was approximately $275,000 and $253,000 for the six months ended June 30, 2019 and 2018, respectively. For the six months ended June 30, 2019, approximately $242,000 and $33,000 are included in selling, general and administrative expenses and research and development expenses, respectively, on the accompanying condensed consolidated statement of operations and comprehensive loss. For the three months ended June 30, 2018, approximately $237,000 and $16,000 are included in selling, general and administrative expenses and research and development expenses, respectively, on the accompanying condensed consolidated statement of operations and comprehensive loss. During the six months ended June 30, 2018, previously issued stock options were modified for an employee who is no longer employed with the Company. As a result of this modification, included in the approximately $16,000 of research and development expenses is approximately $12,000 of stock option modification expense on the accompanying condensed consolidated statement of operations and comprehensive loss for the six months ended June 30, 2018.

 

There was no tax benefit related to expense recognized in the three months ended June 30, 2019 and 2018, as the Company is in a net operating loss position. As of June 30, 2019, there was approximately $1,270,000 of total unrecognized compensation expense related to unvested stock-based awards granted under the equity compensation plans. Approximately $231,000 of the $1,270,000 total unrecognized compensation expense will be recognized at the time that certain performance conditions are met. The remaining unrecognized compensation expense of approximately $1,039,000 will be amortized over the weighted average remaining requisite service period of 1.8 years. Such amount does not include the effect of future grants of equity compensation, if any.

 

Restricted Stock

 

Total stock-based compensation expense for restricted stock was approximately $15,000 and $103,000 for the three months ended June 30, 2019 and 2018, respectively. For the three months ended June 30, 2019, approximately $14,000 and $1,000 are included in selling, general and administrative expenses and research and development expenses, respectively, on the accompanying condensed consolidated statement of operations and comprehensive loss. For the three months ended June 30, 2018, approximately $90,000 and $13,000 are included in selling, general and administrative expenses and research and development expenses, respectively, on the accompanying condensed consolidated statement of operations and comprehensive loss.

 

Total stock-based compensation expense for restricted stock was approximately $30,000 and $215,000 for the six months ended June 30, 2019 and 2018, respectively. For the six months ended June 30, 2019, approximately $28,000 and $2,000 are included in selling, general and administrative expenses and research and development expenses, respectively, on the accompanying condensed consolidated statement of operations and comprehensive loss. For the six months ended June 30, 2018, approximately $190,000 and $25,000 are included in selling, general and administrative expenses and research and development expenses, respectively, on the accompanying condensed consolidated statement of operations and comprehensive loss.

 

As of June 30, 2019, all shares of restricted stock have vested.

 

SRP Equity Incentive Plan

 

SRP’s 2019 Equity Incentive Plan was approved on May 7, 2019 under which 150,000 shares of SRP’s common stock is reserved for the issuance of options and awards. During the three and six months ended June 30, 2019, SRP granted stock options to purchase 23,040 shares of common stock to its directors and one employee. These stock options are being expensed over the respective vesting period, which is based on a service condition. The fair value of the stock options granted during the three and six months ended June 30, 2019 was approximately $88,000.

 

The fair value of each option grant is estimated on the date of grant using the Black-Scholes option pricing model. The below weighted average assumptions for the risk-free interest rates, expected dividend yield, expected lives and expected stock price volatility were utilized for the stock options granted by SRP during the six months ended June 30, 2019.

 

Weighted Average Assumptions for Option Grants      
Stock Price Volatility     92.4 %
Risk-Free Interest Rates     2.3 %
Expected Life (in years)     6.10  
Expected Dividend Yield     - %

 

Stock-based compensation expense related to the SRP stock options was approximately $3,000 for the three and six months ended June 30, 2019. For the three and six months ended June 30, 2019, approximately $1,000 and $2,000 are included in selling, general and administrative expenses and research and development expenses, respectively, on the accompanying condensed consolidated statement of operations and comprehensive loss. Stock-based compensation expense related to the SRP stock options is presented by the Company as noncontrolling interest on the condensed consolidated balance sheet as of June 30, 2019.

 

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Note 14 – Stockholders’ Equity

 

May 2019 Private Placement

 

On May 15, 2019, the Company entered into a Stock Purchase Agreement with certain accredited investors identified therein pursuant to which the Company issued and sold in a private placement 493,827 shares of the Company’s common stock resulting in gross proceeds to the Company of approximately $2,000,000. The purchase price for each share was $4.05. Proceeds, net of equity issuance costs of $8,000, recorded as a result of the private placement were approximately $1,992,000. Of the 493,827 shares of the Company’s common stock issued, 12,346 shares, resulting in proceeds of approximately $50,000, were sold to a member of management.

 

April 2018 Private Placement

 

On April 10, 2018, the Company entered into a Stock Purchase Agreement with certain accredited investors identified therein pursuant to which the Company issued and sold in a private placement 726,735 shares of the Company’s common stock resulting in gross proceeds to the Company of approximately $2,943,000. The purchase price for each share was $4.05. Proceeds, net of equity issuance costs of $19,000, recorded as a result of the private placement were approximately $2,924,000. Of the 726,735 shares of the Company’s common stock issued, 24,331 shares, resulting in proceeds of $98,550, were sold to members of management, including immediate family members.

 

July 2015 Purchase Agreement and Registration Rights Agreement

 

On July 24, 2015, the Company entered into both a securities purchase agreement and registration rights agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”). Under the terms and subject to the conditions of the securities purchase agreement, the Company had the right to sell to Lincoln Park, and Lincoln Park was obligated to purchase, up to $10.0 million in shares of the Company’s common stock, subject to certain limitations, from time to time, over the 36-month period commencing on September 4, 2015. Pursuant to the securities purchase agreement, during the six months ended June 30, 2018, the Company issued and sold approximately 200,000 shares of its common stock to Lincoln Park. The issuance of the common shares to Lincoln Park resulted in gross proceeds of $854,000 for the six months ended June 30, 2018. The securities purchase agreement expired on September 4, 2018.

 

Noncontrolling Interest

 

In July 2018, the Company formed a new, wholly-owned subsidiary, SRP, to drive the development of its second-generation HDF system and other products focused on improving therapies for patients with renal disease.

 

On September 5, 2018, SRP entered into a Series A Preferred Stock Purchase Agreement with certain purchasers pursuant to which SRP sold 600,000 shares of its Series A Preferred Stock (“Series A Preferred”) for $5.00 per share, or aggregate gross proceeds of $3,000,000. SRP incurred transaction-related expenses of approximately $30,000, which were included in selling, general and administrative expenses on the accompanying consolidated statement of operations and comprehensive loss for the three and nine months ended September 30, 2018. The net proceeds from the issuance of the Series A Preferred are restricted to SRP expenses, and may not be used for the benefit of the Company or other affiliated entities, except to reimburse for expenses directly attributable to SRP. Following the Series A Preferred transaction, the Company retained a 62.5% ownership interest in SRP, holding 100% of the outstanding common shares, and holders of Series A Preferred retained a 37.5% interest in SRP on a fully diluted basis, holding 100% of the outstanding preferred shares. Of the 600,000 shares of Series A Preferred issued, the shares purchased by related parties comprised of persons controlled by members of management and by Lambda, the Company’s largest stockholder, amounted to 18,000 and 400,000 shares, respectively.

 

Each share of Series A Preferred is initially convertible into one share of SRP common stock, subject to adjustment for stock splits and recapitalization events. Subject to customary exempt issuances, in the event SRP issues additional shares of its common stock or securities convertible into common stock at a per share price that is less than the original Series A Preferred price, the conversion price of the Series A Preferred will automatically be reduced to such lower price.

 

In the event of any voluntary or involuntary liquidation, dissolution or winding up of SRP, the holders of the Series A Preferred are entitled to be paid out of the assets of SRP available for distribution to its stockholders or, in the case of a deemed liquidation event, out of the consideration payable to stockholders in such deemed liquidation event or the available proceeds, before any payment shall be made to the holders of SRP common stock by reason of their ownership thereof, an amount per share equal to one times (1x) the Series A Preferred original issue price, plus any accruing dividends accrued but unpaid thereon, whether or not declared, together with any other dividends declared but unpaid thereon (the “Series A Liquidation Preference”). If upon any such liquidation, dissolution or winding up of SRP or deemed liquidation event, the assets of SRP available for distribution to its stockholders shall be insufficient to pay the Series A Liquidation Preference in full, the holders of Series A Preferred shall share ratably in any distribution of the assets available for distribution in proportion to the respective amounts which would otherwise be payable in respect of the shares held by them upon such distribution if all amounts payable on or with respect to such shares were paid in full. After the full payment of the Series A Liquidation Preference, the holders of the Series A Preferred and the holders of common stock will share ratably in any remaining proceeds available for distribution on an as-converted to common stock basis.

 

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Each share of Series A Preferred accrues dividends at the rate per annum of $0.40 per share. The accruing dividends shall accrue from day to day, whether or not declared, and shall be cumulative and shall be payable only when, as, and if declared by the Board.

 

Holders of Series A Preferred shall be entitled to cast the number of votes equal to the number of whole shares of common stock into which the shares of Series A Preferred held by such holder are convertible as of the record date for determining stockholders entitled to vote. Except as provided by law or by the other provisions, the holders of Series A Preferred vote together with the holders of common stock as a single class. Notwithstanding the foregoing, for as long as at least 150,000 shares of Series A Preferred are outstanding, SRP is required to obtain the affirmative vote or written consent of a majority of the Series A Preferred in order to effect certain corporate transactions, including without limitation, the issuance of any securities senior to or on parity with the Series A Preferred, a liquidation or deemed liquidation of SRP, amendments to SRP’s charter documents, the issuance of indebtedness in excess of $250,000, any annual budget for the Company’s operations, and the hiring or firing of any executive officers of SRP. In addition, the holders of the Series A Preferred are entitled to elect two members of SRP’s board of directors.

 

The noncontrolling interest in SRP held by holders of the Series A Preferred has been classified as equity on the accompanying condensed consolidated balance sheet, as the noncontrolling interest is redeemable only upon the occurrence of events that are within the control of the Company.

 

Warrants

 

There were no warrants exercised during the six months ended June 30, 2019.

 

During the three and six months ended June 30, 2018, warrants to purchase 50,739 shares of the Company’s common stock were exercised, resulting in proceeds of approximately $138,000 and the issuance of 50,739 shares of the Company’s common stock. Of the warrants exercised during the three and six months ended June 30, 2018, warrants to purchase 8,147 shares of the Company’s common stock were exercised by members of management, resulting in proceeds of approximately $22,000.

 

Note 15 – Net Loss per Common Share

 

Basic loss per common share is calculated by dividing net loss available to common shareholders by the number of weighted average common shares issued and outstanding. Diluted loss per common share is calculated by dividing net loss available to common shareholders by the weighted average number of common shares issued and outstanding for the period, plus amounts representing the dilutive effect from the exercise of stock options and warrants, as applicable. The Company calculates dilutive potential common shares using the treasury stock method, which assumes the Company will use the proceeds from the exercise of stock options and warrants to repurchase shares of common stock to hold in its treasury stock reserves.

 

The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as they would be anti-dilutive:

 

    June 30,  
    2019     2018  
Shares underlying warrants outstanding     738,070       738,070  
Shares underlying options outstanding     880,837       738,338  

 

Note 16 – Commitments and Contingencies

 

Purchase Commitments

 

In exchange for the rights granted under the License and Supply Agreement with Medica (see Note 8 – License and Supply Agreement, net), the Company agreed to make certain minimum annual aggregate purchases from Medica over the term of the License and Supply Agreement. For the year ending December 31, 2019, the Company has agreed to make minimum annual aggregate purchases from Medica of €3,000,000 (approximately $3,700,000). As of June 30, 2019, the Company’s aggregate purchase commitments totaled approximately €2,850,000 (approximately $3,480,000).

 

Contractual Obligations

 

See Note 12 – Leases for a discussion of the Company’s contractual obligations.

 

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Note 17 – Segment Reporting

 

During the three months ended September 30, 2018, the Company began reporting the results of SRP as a new segment as a result of the July 2018 formation of the Company’s new subsidiary, SRP. Prior to the formation of SRP, the Company had only a single operating segment. The Company has reflected these new segment measures beginning in the quarter ended September 30, 2018 and prior periods have been restated for comparability.

 

The Company has defined its two reportable segments as Water Filtration and Renal Products. The Water Filtration segment develops and sells high performance liquid purification filters, known as ultrafilters. The Renal Products segment is focused on the development of medical device products for patients with renal disease, including a 2 nd generation hemodiafiltration system, for the treatment of patients with ESRD.

 

The Company’s chief operating decision maker evaluates the financial performance of the Company’s segments based upon segment revenues, gross margin and operating expenses which include research and development and selling, general and administrative expenses.

 

The accounting policies for the Company’s segments are the same as those described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018.

 

The tables below present segment information reconciled to total Company loss from operations, with segment operating loss including gross profit less direct research and development expenses and direct selling, general and administrative expenses to the extent specifically identified by segment:

 

    Three Months Ended June 30, 2019  
    Water Filtration     Renal
Products
    Nephros, Inc. Consolidated  
Total net revenues   $ 2,309,000     $ -     $ 2,309,000  
Gross margin     1,367,000       -       1,367,000  
Research and development expenses     433,000       360,000       793,000  
Depreciation and amortization expense     48,000       -       48,000  
Selling, general and administrative expenses     1,352,000       51,000       1,403,000  
Change in fair value of contingent consideration     (9,000 )     -       (9,000 )
Total operating expenses     (1,824,000 )     (411,000 )     (2,235,000 )
Loss from operations   $ (457,000 )   $ (411,000 )   $ (868,000 )

 

    Six Months Ended June 30, 2019  
    Water Filtration     Renal
Products
    Nephros, Inc. Consolidated  
Total net revenues   $ 4,078,000     $ -     $ 4,078,000  
Gross margin     2,365,000       -       2,365,000  
Research and development expenses     779,000       770,000       1,549,000  
Depreciation and amortization expense     98,000       -       98,000  
Selling, general and administrative expenses     2,821,000       85,000       2,906,000  
Change in fair value of contingent consideration     (19,000 )     -       (19,000 )
Total operating expenses     (3,679,000 )     (855,000 )     (4,534,000 )
Loss from operations   $ (1,314,000 )   $ (855,000 )   $ (2,169,000 )

 

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    Three Months Ended June 30, 2018  
    Water Filtration     Renal
Products
    Nephros, Inc. Consolidated  
Total net revenues   $ 1,366,000     $ -     $ 1,366,000  
Gross margin     830,000       -       830,000  
Research and development expenses     262,000       90,000       352,000  
Depreciation and amortization expense     40,000       -       40,000  
Selling, general and administrative expenses     1,077,000       14,000       1,091,000  
Total operating expenses     (1,379,000 )     (104,000 )     (1,483,000 )
Loss from operations   $ (549,000 )   $ (104,000 )   $ (653,000 )

 

    Six Months Ended June 30, 2018  
    Water Filtration     Renal
Products
    Nephros, Inc. Consolidated  
Total net revenues   $ 2,351,000     $ -     $ 2,351,000  
Gross margin     1,297,000       -       1,297,000  
Research and development expenses     451,000       190,000       641,000  
Depreciation and amortization expense     81,000       -       81,000  
Selling, general and administrative expenses     2,327,000       24,000       2,351,000  
Total operating expenses     (2,859,000 )     (214,000 )     (3,073,000 )
Loss from operations   $ (1,562,000 )   $ (214,000 )   $ (1,776,000 )

 

As of June 30, 2019, approximately $1,600,000 of total assets are in the Renal Products segment. The $1,600,000 consisted of the remaining cash received of approximately $1,400,000 from the sale of Series A Preferred during the year ended December 31, 2018 and prepaid expenses and other current assets of approximately $200,000.

 

As of December 31, 2018, approximately $2,500,000 of total assets are in the Renal Products segment. The $2,500,000 consisted of the remaining cash received of approximately $2,300,000 from the sale of Series A Preferred during the year ended December 31, 2018 and prepaid expenses and other current assets of approximately $200,000.

 

Note 18 – Subsequent Event

 

The Company effected a reverse stock split, in which every 9 shares of the Company’s common stock issued and outstanding immediately prior to the effective time, which was 5:30 p.m. ET on July 9, 2019, were combined into one share of common stock. Fractional shares were not issued and stockholders who otherwise would have been entitled to receive a fractional share as a result of the reverse stock split received an amount in cash equal to $5.58 per share for such fractional interests. As a result of the reverse split, the number of shares of the Company’s common stock issued and outstanding was reduced from approximately 69,000,000 to approximately 7,700,000.

 

The reverse stock split was approved by the Company’s stockholders on July 30, 2018. The number of shares of common stock subject to outstanding stock warrants and options, and the exercise prices and conversion ratios of those securities, were automatically and proportionately adjusted for the 1-for-9 ratio provided for by the reverse stock split.

 

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

 

This discussion should be read in conjunction with our consolidated financial statements included in this Quarterly Report on Form 10-Q and the notes thereto, as well as the other sections of this Quarterly Report on Form 10-Q, including the “Forward-Looking Statements” section hereof, and our Annual Report on Form 10-K for the year ended December 31, 2018, including the “Risk Factors” and “Business” sections thereof. This discussion contains a number of forward-looking statements, all of which are based on our current expectations and could be affected by the uncertainties and risk factors described in this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K for the year ended December 31, 2018. Our actual results may differ materially.

 

Business Overview

 

We are a commercial-stage company that develops and sells high performance water purification products to the medical device and commercial markets.

 

In medical device markets, our filters, generally classified as ultrafilters, are used primarily by hospitals for the prevention of infection from water-borne pathogens, such as legionella and pseudomonas, and in dialysis centers for the removal of biological contaminants from water and bicarbonate concentrate. Because our ultrafilters capture contaminants as small as 0.005 microns in size, they minimize exposure to a wide variety of bacteria, viruses, fungi, parasites, and endotoxins.

 

In commercial markets, we manufacture and sell filters that improve the taste and odor of water and reduce biofilm, bacteria, and scale build-up in downstream equipment. Marketed under both the Nephros and AETHER™ brands, our products are used in the health care, food service, hospitality, and convenience store markets.

 

Our subsidiary, Specialty Renal Products, Inc. (“SRP”), is a development-stage medical device company focused primarily on developing hemodiafiltration (“HDF”) technology. SRP is developing a second generation of the OLpūr H2H Hemodiafiltration System, the only U.S. Food and Drug Administration (“FDA”) 510(k)-cleared medical device that enables nephrologists to provide HDF treatment to patients with end stage renal disease (“ESRD”).

 

On December 31, 2018, we entered into a Membership Interest Purchase Agreement (the “Agreement”) with Biocon1, LLC, a Nevada limited liability company (“Biocon”), Aether Water Systems, LLC, a Nevada limited liability company (“Aether”), and Gregory Lucas, the sole member of each of Biocon and Aether. Pursuant to the terms of the Agreement, we acquired 100% of the outstanding membership interests of each of Biocon and Aether (the “Biocon Acquisition”).

 

We were founded in 1997 by healthcare professionals affiliated with Columbia University Medical Center/New York-Presbyterian Hospital to develop and commercialize an alternative method to hemodialysis. We have extended our filtration technologies to meet the demand for liquid purification in other areas, in particular water purification.

 

Reverse Stock Split

 

On July 9, 2019, we effected a reverse stock split, in which every 9 shares of our common stock issued and outstanding immediately prior to the effective time, which was 5:30 p.m. ET on July 9, 2019, were combined into one share of common stock. Fractional shares were not issued and stockholders who otherwise would have been entitled to receive a fractional share as a result of the reverse stock split received an amount in cash equal to $5.58 per share for such fractional interests. The number of shares of our common stock issued and outstanding was reduced from approximately 69,000,000 to approximately 7,700,000.

 

All of the share and per share amounts discussed in this Quarterly Report on Form 10-Q have been adjusted to reflect the effect of this reverse split.

 

Our Products

 

Water Filtration Products

 

We develop and sell liquid filtration products used in both medical and commercial applications, employing multiple filtration technologies.

 

In medical markets, our primary filtration mechanism is to pass liquids through the pores of polysulfone hollow fiber. Our filters’ pores are significantly smaller than those of competing products, resulting in highly effective elimination of water-borne pathogens, including legionella bacteria (the cause of Legionnaires disease) and viruses, which are not eliminated by most other microbiological filters on the market. Additionally, the fiber structure and pore density in our hollow fiber enables significantly higher flow rates than in other polysulfone hollow fiber.

 

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In commercial markets, with our recent addition of the Aether product line, carbon-based absorption is the primary filtration mechanism. Aether products allow us to improve water’s odor and taste, to reduce scale and heavy metals, and to reduce other water contaminants for customers who are primarily in the food service, convenience store, and hospitality industries.

 

The Biocon business acquisition has the potential to generate accretive revenue growth in at least three potential ways. First, we expect the business to continue its rapid organic growth, which it was experiencing before being acquired. Second, cross-selling opportunities are generated by offering taste/odor-focused products to the medical device markets, as well as pathogen-focused filtration to the commercial markets. Finally, as part of our larger Nephros organization, Aether may be able to compete for larger filtration contracts than may have been available to it as a smaller, independent firm. With only six months of results thus far, it is still too early to judge each of these strategies.

 

Our sales strategy is a combination of direct selling to end customers and indirect selling through value-added resellers (“VARs”). Leveraging VARs has enabled us to expand rapidly our access to target customers in the medical market without significant sales staff expansion. In addition, while we are currently focused in medical markets, the VARs that support these customers also support a wide variety of commercial and industrial customers. We believe that our VAR relationships will facilitate growth in filter sales outside of the medical industry.

 

Target Markets

 

Our ultrafiltration products currently target the following markets:

 

  Hospitals and Other Healthcare Facilities: Filtration of water for washing and drinking as an aid in infection control. The filters produce water that is suitable for wound cleansing, cleaning of equipment used in medical procedures, and washing of surgeons’ hands. In addition, we have recently begun development of a broad-spectrum diagnostic tool for our hospital and other health care customers to provide them with the ability to assess water safety risks on a real-time basis.
  Dialysis Centers: Filtration of water or bicarbonate concentrate used in hemodialysis.
  Commercial Facilities: Filtration and purification of water for consumption, including for use in ice machines and soft drink dispensers.
  Military and Outdoor Recreation: Individual water purification devices used by soldiers and backpackers to produce drinking water in the field, as well as filters customized to remote water processing systems.

 

Hospitals and Other Healthcare Facilities. According to the American Hospital Association, approximately 6,200 hospitals, with approximately 931,000 beds, treated over 36 million patients in the United States in 2017. The U.S. Centers for Disease Control and Prevention estimates that healthcare associated infections (“HAI”) occurred in approximately 1 out of every 31 hospital patients, or about 687,000 patients in 2015. HAIs affect patients in hospitals or other healthcare facilities and are not present or incubating at the time of admission. They also include infections acquired by patients in the hospital or facility, but appearing after discharge, and occupational infections among staff. Many HAIs are caused by waterborne bacteria and viruses that can thrive in aging or complex plumbing systems often found in healthcare facilities.

 

The Affordable Care Act, passed in March 2010, puts in place comprehensive health insurance reforms that aim to lower costs and enhance quality of care. With its implementation, healthcare providers have substantial incentives to deliver better care or be forced to absorb the expenses associated with repeat medical procedures or complications like HAIs. As a consequence, hospitals and other healthcare facilities are proactively implementing strategies to reduce HAI potential. Our ultrafilters are designed to aid in infection control in the hospital and healthcare setting by treating facility water at the points of delivery, such as ice machines, sinks and showers.

 

In June 2017, the Center for Clinical Standards and Quality at the Centers for Medicare and Medicaid Services (“CMS”) announced the addition of requirements for facilities to develop policies and procedures that inhibit the growth and spread of legionella and other opportunistic pathogens in building water systems. Going forward, CMS surveyors will review policies, procedures, and reports documenting water management implementation results to verify that facilities are compliant with these requirements. We believe that these CMS regulations may have a positive impact on the sale of our HAI-inhibiting ultrafilters.

 

We currently have FDA 510(k) clearance on the following portfolio of medical device products for use in the hospital setting to aid in infection control:

 

  The DSU H is an in-line, 0.005-micron ultrafilter that provides dual-stage protection from water borne pathogens. The DSU H is primarily used to filter potable water feeding ice machines, sinks, and medical equipment, such as endoscope washers and surgical room humidifiers. The DSU H has an up to 6-month product life when used in a hospital setting.
  The SSU H is an in-line, 0.005-micron ultrafilter that provides single-stage protection from water borne pathogens. The SSU H is primarily used to filter potable water feeding sinks, showers and medical equipment. The SSU H has an up to 3-month product life when used in a hospital setting.
  The S100 is a point-of-use, 0.01-micron microfilter that provides protection from water borne pathogens. The S100 is primarily used to filter potable water feeding sinks and showers. The S100 has an up to 3-month product life when used in a hospital setting.
  The HydraGuard TM and HydraGuard TM - Flush are 0.005-micron cartridge ultrafilters that provide single-stage protection from water borne pathogens. The HydraGuard TM ultrafilters are primarily used to filter potable water feeding ice machines and medical equipment, such as endoscope washers and surgical room humidifiers. The HydraGuard TM has an up-to 6-month product life and the HydraGuard TM - Flush has an up to 12-month product life when used in a hospital setting.

 

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We received FDA 510(k) clearance to market the HydraGuard TM in December 2016 and began shipping it in July 2017. We began shipping the HydraGuard TM - Flush in September 2017. The DSU H, SSU H, and S100 products received FDA 510(k) clearance in prior years.

 

Our complete hospital infection control product line, including in-line, point-of-use, and cartridge filters, can be viewed on our website at http://www.nephros.com/infection-control/ . We are not including the information on our website as a part of, nor incorporating it by reference into, this Quarterly Report on Form 10-Q.

 

In addition, we are currently developing a diagnostic product designed to enable real-time diagnoses of water borne pathogens, which we expect will complement our medical water filtration products. We plan to offer the product initially to customers and prospective customers that focus on infection control, including hospitals, dialysis centers, and other health care facilities. Following initial launch, we plan to market the product to other markets as well, including those addressed by our AETHER product lines.

 

Based on discussions with potential partners and customers, we expect the water pathogen diagnostics tool to lead to significantly increased sales, as well as to position ourselves as a strategic vendor in the water quality market, providing diagnostics expertise as well as filtration products. We expect to launch this product line in late 2019 and to provide additional product details in the coming quarters.

 

Dialysis Centers - Water/Bicarbonate . To perform hemodialysis, all dialysis clinics have dedicated water purification systems to produce water and bicarbonate concentrate, two essential ingredients for making dialysate, the liquid that removes waste material from the blood. According to the American Journal of Kidney Diseases, there are approximately 6,500 dialysis clinics in the United States servicing approximately 468,000 patients annually. We estimate that there are over 100,000 hemodialysis machines in operation in the United States.

 

Medicare is the main payer for dialysis treatment in the United States. To be eligible for Medicare reimbursement, dialysis centers must meet the minimum standards for water and bicarbonate concentrate quality set by the Association for the Advancement of Medical Instrumentation (“AAMI”), the American National Standards Institute (“ANSI”) and the International Standards Organization (“ISO”). We anticipate that the stricter standards approved by these organizations in 2009 will be adopted by Medicare in the near future.

 

We currently have FDA 510(k) clearance on the following portfolio of medical device products for use in the dialysis setting to aid in bacteria, virus, and endotoxin retention:

 

  The DSU D, SSU D and SSUmini are in-line, 0.005-micron ultrafilters that provide protection from bacteria, viruses, and endotoxins. All of these products have an up to 12-month product life in the dialysis setting and are used to filter water following treatment with a reverse osmosis (“RO”) system, and to filter bicarbonate concentrate. These ultrafilters are primarily used in the water lines and bicarbonate concentrate lines leading into dialysis machines, and as a polish filter for portable RO machines.
  The EndoPur is a 0.005-micron cartridge ultrafilter that provides single-stage protection from bacteria, viruses, and endotoxins. The EndoPur has an up to 12-month product life in the dialysis setting, and is used to filter water following treatment with an RO system. More specifically, the EndoPur is used primarily to filter water in large RO systems designed to provide ultrapure water to an entire dialysis clinic. The EndoPur is available in 10”, 20”, and 30” configurations.

 

The EndoPur is a cartridge-based, “plug and play” market entry that requires no plumbing at installation or replacement. In March 2017, we received FDA 510(k) clearance to market the EndoPur filter. We began shipping the EndoPur 10” filter in July 2017 and the 20” and 30” versions in September 2017.

 

Commercial and Industrial Facilities . Our commercial NanoGuard® product line accomplishes ultrafiltration via small pore size (0.005 micron) technology, filtering bacteria and viruses from water. Our recent acquisition of Biocon and Aether - marketed under the AETHER® brand - expands our product line to include additional water filtration and purification technologies, primarily focused on improving odor and taste and on reducing scale and heavy metals from filtered water.

 

We currently market the following portfolio of proprietary products for use in the commercial, industrial, and food service settings:

 

  The NanoGuard®-D is an in-line, 0.005-micron ultrafilter that provides dual-stage retention of any organic or inorganic particle larger than 15,000 Daltons.
  The NanoGuard®-S is an in-line, 0.005-micron ultrafilter that provides single-stage retention of any organic or inorganic particle larger than 15,000 Daltons.
  The NanoGuard®-E is a 0.005-micron ultrafilter cartridge that plugs into an Everpure® filter manifold and provides single-stage retention of any organic or inorganic particle larger than 15,000 Daltons.

 

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  The NanoGuard®-C is a 0.005-micron cartridge ultrafilter that fits with most 10”, 20”, 30” and 40” cartridge housings and provides single-stage retention of any organic or inorganic particle larger than 15,000 Daltons.
  The NanoGuard®-F is a 0.005-micron flushable cartridge ultrafilter, available in 10” or 20” sizes and provides single-stage retention of any organic or inorganic particle larger than 15,000 Daltons.
  The AETHER® Sediment filter provides a 1-micron barrier to retain sediment, dirt, rust particles and other solids in potable water.
  The AETHER® Carbon Block filter is a carbon-based filter to improve and taste and odor and reduce levels of chlorine and heavy minerals.
  The AETHER® Scale filter uses proprietary technology to reduce the development of lime scale build-up in downstream equipment and surfaces.
  The AETHER® Carbon + Scale filter combines a carbon-based filter with the AETHER® Scale technology in a single filter.
  The Nephros Lead Filter System filters both particulate lead and soluble lead, tested to reduce 99% of 150ppb soluble lead in potable water.

 

AETHER® products combine effectively with NanoGuard® ultrafiltration technologies to offer full-featured solutions to the commercial water market, including to existing users of Everpure® filter manifolds. AETHER® and NanoGuard® products are targeted primarily at the food service, hospitality, convenience store and industrial markets.

 

Military and Outdoor Recreation . We developed our individual water treatment device (“IWTD”) in both in-line and point-of-use configurations. Our IWTD allows a soldier in the field to derive drinking water from any freshwater source. This enables the soldier to remain hydrated, to help maintain mission effectiveness and unit readiness, and to extend mission reach. Our IWTD has been validated by the military to meet the NSF Protocol P248 standard. It has also been approved by the U.S. Army Public Health Command and the U.S. Army Test and Evaluation Command for deployment.

 

In May 2015, we entered into a Sublicense Agreement (the “Sublicense Agreement”) with CamelBak Products, LLC (“CamelBak”). Under this Sublicense Agreement, we granted CamelBak an exclusive, non-transferable, worldwide (with the exception of Italy) sublicense and license, in each case solely to market, sell, distribute, import and export the IWTD. In exchange for the rights granted to CamelBak, CamelBak agreed, through December 31, 2022, to pay us a percentage of the gross profit on any sales made to a branch of the U.S. military, subject to certain exceptions, and to pay us a fixed per-unit fee for any other sales made. CamelBak was also required to meet or exceed certain minimum annual fees payable to us, and, if such fees are not met or exceeded, we may convert the exclusive sublicense to a non-exclusive sublicense with respect to non-U.S. military sales. In the first quarter of 2019, the Sublicense Agreement was amended to eliminate the minimum fee obligations starting May 6, 2018 and, as such, Camelbak has no further minimum fee obligations. Camelbak product sales have been slower than originally hoped. However, military contracts often take years to close, and we remain optimistic about these products and markets.

 

Specialty Renal Products: HDF System

 

Introduction to HDF

 

The current standard of care in the United States for patients with chronic renal failure is hemodialysis (“HD”), a process in which toxins are cleared via diffusion. Patients typically receive HD treatments at least 3 times weekly for 3-4 hours per treatment. HD is most effective in removing smaller, easily diffusible toxins. For patients with acute renal failure, the current standard of care in the United States is hemofiltration (“HF”), a process where toxins are cleared via convection. HF offers a much better removal of larger sized toxins when compared to HD; however, HF treatment is more challenging for patients, as it is performed on a daily basis, and typically takes 12-24 hours per treatment.

 

Hemodiafiltration (“HDF”) is an alternative dialysis modality that combines the benefits of HD and HF into a single therapy by clearing toxins using both diffusion and convection. Though not widely used in the United States, HDF is prevalent in Europe and is performed for a growing number of patients. Clinical experience and literature show the following clinical and patient benefits of HDF:

 

  Enhanced clearance of middle and large molecular weight toxins
  Improved survival - up to a 35% reduction in mortality risk
  Reduction in the occurrence of dialysis-related amyloidosis
  Reduction in inflammation
  Reduction in medication such as EPO and phosphate binders
  Improved patient quality of life
  Reduction in number of hospitalizations and overall length of stay

 

However, like HD, HDF can be resource-intensive and can require a significant amount of time to deliver one course of treatment.

 

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Nephros HDF Background

 

Over the course of our history, we originally developed a medical device that enabled a standard HD machine to perform HDF. We refer to our approach as an on-line mid-dilution hemodiafiltration (“mid-dilution HDF”) system. Our original solution included an OLpūr H2H Hemodiafiltration Module (“H2H Module”), an OLpūr MD 220 Hemodiafilter (“HDF Filter”) and an H2H Substitution Filter (“Dialysate Filter”).

 

Our H2H Module attaches to a standard HD machine to perform on-line HDF therapy. The HD machine controls and monitors the basic treatment functions, as it would normally when providing HD therapy. The H2H Module is a free-standing, movable device that is placed next to either side of an HD machine. The H2H Module connects to the clinic’s water supply, drain, and electricity.

 

The H2H Module utilizes the HDF Filter, and is very similar to a typical hollow fiber dialyzer assembled with a single hollow fiber bundle made with a high-flux (or high-permeability) membrane. The fiber bundle is separated into two discrete, but serially connected, blood paths. Dialysate flows in one direction that is counter-current to blood flow in Stage 1 and co-current to blood flow in Stage 2.

 

In addition to the HDF Filter, the H2H Module also utilizes a Dialysate Filter during patient treatment. The Dialysate Filter is a hollow fiber, ultrafilter device that consists of two sequential (redundant) ultrafiltration stages in a single housing. During on-line HDF with the H2H Module, fresh dialysate is redirected by the H2H Module’s hydraulic (substitution) pump and passed through this dual-stage ultrafilter before being infused as substitution fluid into the extracorporeal circuit. Providing ultrapure dialysate is crucial for the success of on-line HDF treatment.

 

Our original HDF system conformed with current ANSI/AAMI/ISO standards and was cleared by the FDA for the treatment of patients with chronic renal failure in 2012. To date, our HDF System is the only HDF system cleared by the FDA.

 

Over the last four years, DaVita Healthcare Partners, the Renal Research Institute (a research division of Fresenius Medical Care), and Vanderbilt University conducted post-market evaluations of our hemodiafiltration system in their clinics. We gathered direct feedback from these evaluations to develop a better understanding of how our system best fits into the current clinical and economic ESRD treatment paradigm. The ultimate goal of the evaluations was to better understand the potential for HDF, in the U.S. clinical setting in order to (a) improve the quality of life for the patient, (b) reduce overall expenditure compared to other dialysis modalities, (c) minimize the impact on nurse work flow at the clinic, and (d) demonstrate the pharmacoeconomic benefit of the HDF technology to the U.S. healthcare system, as has been done in Europe with other HDF systems. The last evaluation was concluded at Vanderbilt in the first quarter of 2018.

 

Specialty Renal Products, Inc.

 

Leveraging the results of our evaluations, we recently completed development of a second-generation HDF machine prototype. We believe that the design changes will enable our HDF machine to better align with clinical work-flow practices, to be highly reliable, to simplify the training required for proficiency, and to have a dramatically lower cost of goods. We have filed for patent protection on key features of our updated design.

 

In July 2018, we formed a new subsidiary, Specialty Renal Products, Inc. (“SRP”), to drive the development of this second-generation HDF system. A prototype of the new second-generation HDF system has been constructed. We intend to fund the HDF program primarily with funds directly raised into SRP, including a $3 million Series A Preferred Stock financing round completed in September 2018. Pending FDA clearance, we believe we can return to the market with our HDF system in the first half of 2020.

 

Critical Accounting Policies

 

For the six month period ended June 30, 2019, other than the adoption of Accounting Standards Codification 842, “Leases” (see Note 2, “Basis of Presentation and Liquidity,” of the Notes to our Unaudited Condensed Consolidated Interim Financial Statements contained in Item 1 of Part I of this Quarterly Report on Form 10-Q, which is incorporated herein by reference), there were no significant changes to our critical accounting policies as identified in our Annual Report on Form 10-K for the year ended December 31, 2018.

 

Recent Accounting Pronouncements

 

We are subject to recently issued accounting standards, accounting guidance and disclosure requirements. For a description of these new accounting standards, Note 2, “Basis of Presentation and Liquidity,” of the Notes to our Unaudited Condensed Consolidated Interim Financial Statements contained in Item 1 of Part I of this Quarterly Report on Form 10-Q, which is incorporated herein by reference.

 

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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 annual 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, marketing expenses related to product launches, timing of regulatory approval of our various products and market acceptance of our products. Due to these fluctuations, we believe that the period-to-period comparisons of our operating results are not a reliable indication of our future performance.

 

The following table sets forth our summarized, consolidated results of operations for the three months ended June 30, 2019 and 2018:

 

    Three Months Ended June 30,  
    2019     2018    

$

Increase

(Decrease)

   

%

Increase

(Decrease)

 
Total net revenues   $ 2,309,000     $ 1,366,000     $ 943,000       69 %
Cost of goods sold     942,000       536,000       406,000       76 %
Gross margin     1,367,000       830,000       537,000       65 %
Gross margin %     59 %     61 %     -       (2 )%
Research and development expenses     793,000       352,000       441,000       125 %
Depreciation and amortization expense     48,000       40,000       8,000       20 %
Selling, general and administrative expenses     1,403,000       1,091,000       312,000       29 %
Change in fair value of contingent consideration     (9,000 )     -       9,000       100 %
Loss from operations     (868,000 )     (653,000 )     215,000       33 %
Interest expense     (46,000 )     (28,000 )     18,000       64 %
Interest income     -       1,000       (1,000 )     (100 )%
Other expense, net     (28,000 )     (2,000 )     26,000       1,300 %
Net loss     (942,000 )     (682,000 )     260,000       38 %
Less: Undeclared deemed dividend attributable to noncontrolling interest     (61,000 )     -       61,000       100 %
Net loss attributable to Nephros, Inc.   $ (1,003,000 )   $ (682,000 )   $ 321,000       47 %

 

Water Filtration

 

The following table sets forth results of operations for the Water Filtration segment for the three months ended June 30, 2019 and 2018:

 

   

Three Months Ended

June 30,

 
    2019     2018    

$

Increase (Decrease)

   

%

Increase

(Decrease)

 
Total net revenues   $ 2,309,000     $ 1,366,000     $ 943,000       69 %
Cost of goods sold     942,000       536,000       406,000       76 %
Gross margin     1,367,000       830,000       537,000       65 %
Gross margin     59 %     61 %     -       (2 )%
Research and development expenses     433,000       262,000       171,000       65 %
Depreciation and amortization expense     48,000       40,000       8,000       20 %
Selling, general and administrative expenses     1,352,000       1,077,000       275,000       26 %
Change in fair value of contingent consideration     (9,000 )     -       9,000       100 %
Loss from operations   $ (457,000 )   $ (549,000 )   $ (92,000 )     (17 )%

 

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Net Revenues

 

Total net revenues for the three months ended June 30, 2019 were approximately $2,309,000 compared to approximately $1,366,000 for the three months ended June 30, 2018. The increase of approximately $943,000, or 69%, was driven by significant increased medical device sales, to both new and existing customer accounts, as well as our expansion into commercial markets.

 

Cost of Goods Sold

 

Cost of goods sold was approximately $942,000 for the three months ended June 30, 2019 compared to approximately $536,000 for the three months ended June 30, 2018. The increase of approximately $406,000, or 76%, was due to approximately $490,000 in increased direct product costs in support of increased revenue, offset by a decrease of approximately $84,000 in expenses related to adjustments for inventory reserves for expiring items and physical count inventory adjustments.

 

Gross Margin

 

Gross margin was approximately 59% for the three months ended June 30, 2019 compared to approximately 61% for the three months ended June 30, 2018. The decrease of approximately 2% is primarily due to a decrease in royalty revenue related to the Camelbak Sublicense Agreement for which there was no royalty recognized in the three months ended June 30, 2019.

 

Research and Development Expenses

 

Research and development expenses were approximately $433,000 and $262,000 for the three months ended June 30, 2019 and 2018, respectively. This increase of approximately $171,000, or 65%, reflects a net increase in expenditures on product development for our new water pathogen diagnostic tool.

 

Depreciation and Amortization Expense

 

Depreciation and amortization expenses were approximately $48,000 for the three months ended June 30, 2019 compared to approximately $40,000 for the three months ended June 30, 2018. The increase of approximately $8,000, or 20%, is primarily due to amortization of intangible assets recognized in the Biocon Acquisition.

 

Selling, General and Administrative Expenses

 

Selling, general and administrative expenses were approximately $1,352,000 for the three months ended June 30, 2019 compared to approximately $1,077,000 for the three months ended June 30, 2018, representing an increase of $275,000, or 26%. The increase was primarily due to increased headcount-related expenses of approximately $97,000, increased professional services expenses of approximately $84,000, increased investor relations expenses of approximately $20,000, and increased other expenses of approximately $42,000, primarily related to rent and warehouse expenses associated with Las Vegas and New Jersey facility expansions.

 

Change in Fair Value of Contingent Consideration

 

Change in fair value of contingent consideration was approximately $9,000 for the three months ended June 30, 2019.

 

Interest Expense

 

Interest expense increased approximately $18,000 primarily due to an increase in interest expense related to the secured revolving credit facility of approximately $9,000 during the three months ended June 30, 2019 and accretion expense of approximately $14,000 related to contingent consideration.

 

Interest Income

 

There was no interest income for the three months ended June 30, 2019. Interest income of approximately $1,000 for the three months ended June 30, 2018 was a result of interest income recognized on an equipment lease. As a result of the Biocon Acquisition on December 31, 2018, the equipment lease was terminated.

 

Other Expense

 

Other expense was approximately $28,000 and $2,000 for the three months ended June 30, 2019 and 2018, respectively, was a result of losses on foreign currency transactions.

 

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Renal Products

 

The following table sets forth results of operations for the Renal Products segment for the three months ended June 30, 2019 and 2018:

 

   

Three Months Ended

June 30,

 
    2019     2018    

$

Increase

(Decrease)

   

%

Increase

(Decrease)

 
Research and development expenses   $ 360,000     $ 90,000     $ 270,000       300 %
Selling, general and administrative expenses     51,000       14,000       37,000       264 %
Loss from operations   $ (411,000 )   $ (104,000 )   $ 307,000       295 %

 

Research and Development Expenses

 

Research and development expenses were approximately $360,000 and $90,000 for the three months ended June 30, 2019 and 2018, respectively, an increase of approximately $270,000 due to increased investment in the development of our second-generation HDF product.

 

Selling, General and Administrative Expenses

 

Selling, general and administrative expenses were approximately $51,000 and $14,000 for the three months ended June 30, 2019 and 2018, respectively, an increase of approximately $37,000 due to increased investment in the development of our second-generation HDF product.

 

Six Months Ended June 30, 2019 Compared to the Six Months Ended June 30, 2018

 

The following table sets forth our summarized, consolidated results of operations for the six months ended June 30, 2019 and 2018:

 

    Six Months Ended June 30,  
    2019     2018    

$

Increase

(Decrease)

   

%

Increase

(Decrease)

 
Total net revenues   $ 4,078,000     $ 2,351,000     $ 1,727,000       73 %
Cost of goods sold     1,713,000       1,054,000       659,000       63 %
Gross margin     2,365,000       1,297,000       1,068,000       82 %
Gross margin     58 %     55 %     -       3 %
Research and development expenses     1,549,000       641,000       908,000       42 %
Depreciation and amortization expense     98,000       81,000       17,000       21 %
Selling, general and administrative expenses     2,906,000       2,351,000       555,000       24 %
Change in fair value of contingent consideration     (19,000 )     -       19,000       100 %
Loss from operations     (2,169,000 )     (1,776,000 )     393,000       22 %
Loss on extinguishment of debt     -       (199,000 )     (199,000 )     (100 )%
Interest expense     (92,000 )     (114,000 )     (22,000 )     (19 )%
Interest income     -       2,000       (2,000 )     (100 )%
Other expense, net     (30,000 )     (24,000 )     6,000       25 %
Net loss     (2,291,000 )     (2,111,000 )     180,000       9 %
Less: Undeclared deemed dividend attributable to noncontrolling interest     (120,000 )     -       120,000       100 %
Net loss attributable to Nephros, Inc.   $ (2,411,000 )   $ (2,111,000 )   $ 300,000       14 %

 

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Water Filtration

 

The following table sets forth results of operations for the Water Filtration segment for the six months ended June 30, 2019 and 2018:

 

   

Six Months Ended

June 30,

 
    2019     2018    

$

Increase

(Decrease)

   

%

Increase

(Decrease)

 
Total net revenues   $ 4,078,000     $ 2,351,000     $ 1,727,000       73 %
Cost of goods sold     1,713,000       1,054,000       659,000       63 %
Gross margin     2,365,000       1,297,000       1,068,000       82 %
Gross margin     58 %     55 %     -       3 %
Research and development expenses     779,000       451,000       328,000       73 %
Depreciation and amortization expense     98,000       81,000       17,000       21 %
Selling, general and administrative expenses     2,821,000       2,327,000       494,000       21 %
Change in fair value of contingent consideration     (19,000 )     -       (19,000 )     100 %
Loss from operations   $ (1,314,000 )   $ (1,562,000 )   $ (248,000 )     (16 )%

 

Net Revenues

 

Total net revenues for the six months ended June 30, 2019 were approximately $4,078,000 compared to approximately $2,351,000 for the six months ended June 30, 2018. The increase of approximately $1,727,000, or 73%, was driven by significant increased medical device sales, to both new and existing customer accounts, as well as our expansion into commercial markets.

 

Cost of Goods Sold

 

Cost of goods sold was approximately $1,713,000 for the six months ended June 30, 2019 compared to approximately $1,054,000 for the six months ended June 30, 2018. The increase of approximately $659,000, or 63%, was due to approximately $754,000 in increased direct product costs in support of increased revenue, offset by a decrease of approximately $95,000 in expenses related to adjustments for inventory reserves for expiring items and physical count inventory adjustments.

 

Gross Margin

 

Gross margin was approximately 58% for the six months ended June 30, 2019 compared to approximately 55% for the six months ended June 30, 2018. The increase of approximately 3% is primarily due to a decrease in inventory reserves for expiring items and physical count inventory adjustments, partially offset by a decrease in royalty revenue related to the Camelbak Sublicense Agreement for which there was no royalty recognized in the six months ended June 30, 2019.

 

Research and Development Expenses

 

Research and development expenses were approximately $779,000 and $451,000 for the six months ended June 30, 2019 and 2018, respectively. This increase of approximately $328,000, or 73%, reflects a net increase in expenditures on product development for our new water pathogen diagnostic tool.

 

Depreciation and Amortization Expense

 

Depreciation and amortization expense was approximately $98,000 for the six months ended June 30, 2019 compared to approximately $81,000 for the six months ended June 30, 2018. The increase of approximately $17,000, or 21%, is due to amortization of intangible assets recognized in the Biocon Acquisition.

 

Selling, General and Administrative Expenses

 

Selling, general and administrative expenses were approximately $2,821,000 for the six months ended June 30, 2019 compared to approximately $2,327,000 for the six months ended June 30, 2018, representing an increase of $494,000, or 21%. The increase was primarily due to increased headcount-related expenses of approximately $151,000, increased professional services expenses of approximately $213,000, increased investor relations expenses of approximately $17,000, and increased other expenses of approximately $71,000, primarily related to rent and warehouse expenses associated with Las Vegas and New Jersey facility expansions.

 

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Change in Fair Value of Contingent Consideration

 

Change in fair value of contingent consideration was approximately $19,000 for the six months ended June 30, 2019.

 

Interest Expense

 

Interest expense decreased approximately $22,000 primarily due to interest and related debt discount on the unsecured long-term note payable of approximately $64,000 that was paid off during the six months ended June 30, 2018 and a decrease in interest paid to a vendor of approximately $13,000 offset partially by an increase of approximately $25,000 on interest expense on the secured note payable and secured revolving credit facility during the six months ended June 30, 2019 and an increase in accretion expense of approximately $28,000 related to contingent consideration during the six months ended June 30, 2019.

 

Interest Income

 

There was no interest income for the six months ended June 30, 2019. Interest income of approximately $2,000 for the six months ended June 30, 2018 was a result of interest income recognized on an equipment lease. As a result of the Biocon Acquisition on December 31, 2018, the equipment lease was terminated.

 

Other Expense

 

Other expense was approximately $30,000 and $24,000 for the six months ended June 30, 2019 and 2018, respectively. Other expense for the six months ended June 30, 2019 includes approximately $35,000 related foreign currency exchange losses partially offset by other income of approximately $5,000. Other expense for the six months ended June 30, 2018 is a result of losses on foreign currency transactions.

 

Renal Products

 

The following table sets forth results of operations for the Renal Products segment for the six months ended June 30, 2019 and 2018:

 

   

Six Months Ended

June 30,

 
    2019     2018    

$

Increase

(Decrease)

   

%

Increase

(Decrease)

 
Research and development expenses   $ 770,000     $ 190,000     $ 580,000       305 %
Selling, general and administrative expenses     85,000       24,000       61,000       254 %
Loss from operations   $ (855,000 )   $ (214,000 )   $ 641,000       299 %

 

Research and Development Expenses

 

Research and development expenses were approximately $770,000 and $190,000 for the six months ended June 30, 2019 and 2018, respectively, an increase of approximately $580,000 due to increased investment in the development of our second-generation HDF product.

 

Selling, General and Administrative Expenses

 

Selling, general and administrative expenses were approximately $85,000 and $24,000 for the six months ended June 30, 2019 and 2018, respectively, an increase of approximately $61,000 due to increased investment in the development of our second-generation HDF product.

 

  34  

 

 

Liquidity and Capital Resources

 

The following table summarizes our liquidity and capital resources as of June 30, 2019 and December 31, 2018 and is intended to supplement the more detailed discussion that follows. The amounts stated are expressed in thousands.

 

    June 30,     December 31,  
Liquidity and Capital Resources   2019     2018  
Cash   $ 4,318     $ 4,581  
Other current assets     4,119       3,592  
Working capital     5,145       5,519  
Stockholders’ equity     6,806       6,798  

 

At June 30, 2019, we had an accumulated deficit of approximately $126,444,000 and we expect to incur additional operating losses from operations until such time, if ever, that we are able to increase product sales and/or licensing revenue to achieve profitability.

 

Our cash flow from operations currently is not, and historically has not been, sufficient to meet our obligations and commitments. Based on cash that is available for our operations and projections of our future operations, we believe that our cash will be sufficient to fund our current operating plan through at least the next 12 months from the date of filing of this Quarterly Report on Form 10-Q. In the event that operations do not meet expectations, we will reduce discretionary expenditures such as additional headcount, new R&D projects, and other variable costs to alleviate the substantial doubt as to our ability to continue as a going concern. We may also seek to raise additional capital, however, there can be no assurance that any such actions could be affected on a timely basis or on satisfactory terms or at all, or that these actions would enable us to continue to satisfy our capital requirements.

 

Our future liquidity sources and requirements will depend on many factors, including:

 

  the market acceptance of our products and our ability to effectively and efficiently produce and market our products;
  the continued progress in, and the costs of, clinical studies and other research and development programs;
  the costs involved in filing and enforcing patent claims and the status of competitive products; and
  the cost of litigation, including potential patent litigation and any other actual or threatened litigation.

 

We expect to put our current capital resources to the following uses:

 

  for the development, marketing, and sales of our water-filtration and water diagnostics products;
  for the development of our second-generation HDF product; and
  for working capital purposes.

 

At June 30, 2019, we had cash totaling approximately $4,318,000 and total assets of approximately $11,143,000, excluding other intangible assets (related to the License and Supply Agreement with Medica) of approximately $871,000.

 

Net cash used in operating activities was approximately $2,026,000 for the six months ended June 30, 2019 compared to approximately $2,012,000 for the six months ended June 30, 2018, an increase of approximately $14,000 which is due to a combination of factors, including increased research and development expenses offset by improvements in gross margins, lower stock-based compensation expense and a loss on extinguishment of debt recorded in the six months ended June 30, 2018 related to the unsecured long-term note payable.

 

Net cash used in investing activities was approximately $137,000 for the six months ended June 30, 2019 due to a working capital adjustment related to the Biocon Acquisition. There was no cash used in investing activities for the six months ended June 30, 2018.

 

Net cash provided by financing activities of approximately $1,901,000 for the six months ended June 30, 2019 resulted from net proceeds from the issuance of common stock of approximately $1,992,000, payments on our secured note payable of approximately $105,000, payment of contingent consideration of approximately $16,000 partially offset by net proceeds on our secured revolving credit facility of approximately $30,000.

 

Net cash provided by financing activities of approximately $3,309,000 for the six months ended June 30, 2018 resulted from net proceeds from the issuance of our common stock of approximately $3,778,000, proceeds from the issuance of a secured note payable of approximately $1,187,000 and proceeds from the exercise of warrants of approximately $138,000, offset partially by net payments on our secured revolving credit facility of approximately $558,000, payments on our secured note payable of approximately $49,000 and payments of approximately $1,187,000 on our unsecured long-term note payable.

 

Off-Balance Sheet Arrangements

 

We did not have any off-balance sheet arrangements as of June 30, 2019 or December 31, 2018.

 

  35  

 

 

Forward-Looking Statements

 

Certain statements in this Quarterly Report on Form 10-Q constitute “forward-looking statements”. Such statements include statements regarding the efficacy and intended use of our technologies under development, the timelines and strategy for bringing such products to market, the timeline for regulatory review and approval of our products, 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. 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, but are not limited to, the risks that:

 

  we face significant challenges in obtaining market acceptance of our products, which could adversely affect our potential sales and revenues;
  product-related deaths or serious injuries or product malfunctions could trigger recalls, class action lawsuits and other events that could cause us to incur expenses and may also limit our ability to generate revenues from such products;
  we face potential liability associated with the production, marketing and sale of our products, and the expense of defending against claims of product liability could materially deplete our assets and generate negative publicity, which could impair our reputation;
  to the extent our products or marketing materials are found to violate any provisions of the U.S. Food, Drug and Cosmetic Act or any other statutes or regulations, we could be subject to enforcement actions by the FDA or other governmental agencies;
  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 have sufficient capital to successfully implement our business plan;
  we may not be able to effectively market our products;
  we may not be able to sell our water filtration products or chronic renal failure therapy products at competitive prices or profitably;
  we may encounter problems with our suppliers, manufacturers and distributors;
  we may encounter unanticipated internal control deficiencies or weaknesses or ineffective disclosure controls and procedures;
  we may not obtain appropriate or necessary regulatory approvals to achieve our business plan;
  products that appeared promising to us in research or clinical trials may not demonstrate anticipated efficacy, safety or cost savings in subsequent pre-clinical or clinical trials;
  we may not 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 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 on Form 10-Q, is set forth in our filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and our other reports filed with the SEC. 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, except as required by law.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

 

Not required for smaller reporting companies.

 

Item 4. Controls and Procedures.

 

Evaluation of Disclosure Controls and Procedures

 

We maintain a system of disclosure controls and procedures, as defined in Rule 13a-15(e) or Rule 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which is designed to provide reasonable assurance that information required to be disclosed in our reports filed pursuant to the Exchange Act is accumulated and communicated to management in a timely manner. Management recognizes that any disclosure controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives. Because there are inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud have been or will be detected.

 

At the end of the period covered by this Quarterly Report on Form 10-Q, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, regarding the effectiveness of our disclosure controls and procedures pursuant to Exchange Act Rule 13a-15(b). Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered by this report were effective.

 

Changes in Internal Control Over Financial Reporting

 

There were no changes in our internal control over financial reporting that occurred during our most recent fiscal quarter that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

  36  

 

 

PART II - OTHER INFORMATION

 

Item 6. Exhibits

 

EXHIBIT INDEX

 

Exhibit No.   Description of Exhibit
     
3.1   Conformed Copy of the Fourth Amended and Restated Certificate of Incorporation, incorporating those Certificates of Amendment dated June 4, 2007; June 29, 2007; November 13, 2007; October 23, 2009; March 10, 2011; March 11, 2011; and July 8, 2019.*
     
10.1   Stock Purchase Agreement dated May 15, 2019, among Nephros, Inc. and the purchasers identified therein (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on May 16, 2019).
     
10.2   First Amendment to Employment Agreement between Nephros, Inc. and Daron Evans, effective April 15, 2019 (incorporated by reference to Exhibit 10.1 of the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2019, as filed with the SEC on May 8, 2019).
     
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   Certification by the Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. **
     
32.2   Certification by the Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. **
     
101   Interactive Data File. *
     
*   Filed herewith
**   Furnished herewith.

 

  37  

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

  NEPHROS, INC.
     
Date: August 7, 2019 By: /s/ Daron Evans         
  Name:   Daron Evans
  Title: President, Chief Executive Officer (Principal Executive Officer)
     
Date: August 7, 2019 By: /s/ Andrew Astor
  Name: Andrew Astor
  Title: Chief Financial Officer (Principal Financial and Accounting Officer)

 

  38  

 

 

 

EXHIBIT 3.1

 

CERTIFICATE OF AMENDMENT

OF THE

FOURTH AMENDED AND RESTATED

CERTIFICATE OF INCORPORATION

OF

NEPHROS, INC.

 

Pursuant to Section 242 of the General

Corporation Law of the State of Delaware

 

It is hereby certified that:

 

FIRST: The original Certificate of Incorporation of Nephros, Inc. was filed with the Secretary of State of the State of Delaware on April 3, 1997, and was amended and restated on June 24, 2005 (the “Certificate of Incorporation”).

 

SECOND: The Certificate of Incorporation is hereby amended by deleting the text of Article IV, Section 2 in its entirety and replacing it with the following:

 

Section 2. Capital Stock. The total number of shares of all classes of stock that the Corporation shall have authority to issue is Forty-Five Million (45,000,000) shares consisting of: Forty Million (40,000,000) shares of common stock, $0.001 par value per share (“Common Stock”); and Five Million (5,000,000) shares of preferred stock, $0.001 par value per share (“Undesignated Preferred Stock”).

 

(a) Upon the effectiveness (the “Effective Time”) of this Certificate of Amendment pursuant to Section 242 of the General Corporation Law of the State of Delaware, every nine (9) shares of Common Stock of the Corporation issued and outstanding immediately prior to the Effective Time (“Old Common Stock”) shall automatically be combined, without any action on the part of the holder thereof, into one (1) share of fully paid and nonassessable Common Stock of the Corporation (“New Common Stock”), subject to the treatment of fractional shares interests described as follows. No fractional shares of Common Stock shall be issued. No stockholder of the Corporation shall transfer any fractional shares of Common Stock. The Corporation shall not recognize on its stock record books any purported transfer of any fractional share of Common Stock. A holder of Old Common Stock at the Effective Time who would otherwise be entitled to a fraction of a share of New Common Stock shall, in lieu thereof, be entitled to receive a cash payment in an amount equal to the fraction to which the holder would otherwise be entitled multiplied by the last reported per share sale price of the Old Common Stock on the day immediately prior to the Effective Time, as reported on an over-the-counter market quotation system (or if such price is not available, then such other price as determined by the Board of Directors) and as appropriately adjusted for such combination.

 

1

 

 

(b) Subject to any limitations set forth elsewhere in this Certificate of Incorporation, the shares of Undesignated Preferred Stock may be issued from time to time in one or more series. Subject to any limitations set forth elsewhere in this Certificate of Incorporation, the Board of Directors is hereby authorized, by adopting appropriate resolutions and causing one or more certificates of amendment to be signed, verified and delivered in accordance with the DGCL, to establish from time to time the number of shares to be included in such series, and to fix the powers, preferences and rights of, and the qualifications, limitations and restrictions granted to and imposed upon such Undesignated Preferred Stock. Such powers, preferences and rights of, and the qualifications, limitations and restrictions granted to and imposed upon such Undesignated Preferred Stock may include, but are not limited to, the fixing or alteration of the dividend rights, dividend rate, conversion rights, exchange rights, voting rights, rights and terms of redemption (including sinking fund provisions), the redemption price or prices, and the liquidation preferences of any wholly unissued series of shares of Undesignated Preferred Stock, or any of them. In accordance with the authority hereby granted, the Board may increase or decrease the number of shares of any series of preferred stock, whether or not such preferred stock then constitutes Undesignated Preferred Stock, subsequent to the issuance of shares of that series; provided that any such increase shall be no greater than the total number of authorized shares of Undesignated Preferred Stock at such time, and no such decrease shall result in the number of authorized shares of such series being fewer than the number then outstanding. In case the number of shares of any series of preferred stock, other than Undesignated Preferred Stock, shall be so decreased, the shares constituting such decrease shall become Additional Undesignated Preferred Stock. Any shares of a series of preferred stock, which is designated pursuant to this clause (ii), that were issued but, thereafter, are no longer outstanding shall not resume the status of authorized and unissued shares of such series, but shall instead become authorized and unissued shares of Additional Undesignated Preferred Stock. Except as may otherwise be required by law or this Certificate of Incorporation, the terms of any series of Undesignated Preferred Stock may be amended without the consent of the holders of any other series of the Corporation’s preferred stock, or Common Stock.

 

THIRD : That this amendment to the Certificate of Incorporation shall be effective as of 5:30 p.m. ET on July 9, 2019.

 

FOURTH: This amendment to the Certificate of Incorporation has been duly adopted in accordance with Section 242 of the General Corporation Law of the State of Delaware.

 

[Signature on following page.]

 

2

 

 

IN WITNESS WHEREOF, the Corporation has caused this Certificate of Amendment to be signed by its President, as of July 8, 2019.

 

  NEPHROS, INC.
   
  By: /s/ Daron Evans
  Name: Daron Evans
  Title: President

 

3

 

 

CERTIFICATE OF AMENDMENT

OF

FOURTH AMENDED AND RESTATED

CERTIFICATE OF INCORPORATION

OF

 

NEPHROS, INC.

 

The undersigned corporation, a corporation duly organized and existing under the General Corporation Law of the State of Delaware (the “Corporation”), does hereby certify that:

 

1. The name of the Corporation is Nephros, Inc.
   
2. The amendment to the Corporation’s Fourth Amended and Restated Certificate of Incorporation set forth below was duly adopted in accordance with the provisions of Section 242 of the General Corporation Law of the State of Delaware, and has been approved by the stockholders of the Corporation in accordance with Section 242 of the General Corporation Law of the State of Delaware.

 

The Corporation’s Fourth Amended and Restated Certificate of Incorporation is hereby amended by deleting the text of Article IV, Section 2 in its entirety and replacing it with the following:

 

“Section 2. Capital Stock. The total authorized capital stock of the Corporation shall be: 95,000,000 shares, consisting of:

 

(i) 90,000,000 shares of Common Stock, $.001 par value per share (the “Common Stock”);

 

4

 

 

(ii) 5,000,000 shares of preferred stock, $.001 par value per share (collectively, the “Undesignated Preferred Stock”). Subject to any limitations set forth elsewhere in this Certificate of Incorporation, the shares of Undesignated Preferred Stock may be issued from time to time in one or more series. Subject to any limitations set forth elsewhere in this Certificate of Incorporation, the Board of Directors is hereby authorized, by adopting appropriate resolutions and causing one or more certificates of amendment to be signed, verified and delivered in accordance with the DGCL, to establish from time to time the number of shares to be included in such series, and to fix the powers, preferences and rights of, and the qualifications, limitations and restrictions granted to and imposed upon such Undesignated Preferred Stock. Such powers, preferences and rights of, and the qualifications, limitations and restrictions granted to and imposed upon such Undesignated Preferred Stock may include, but are not limited to, the fixing or alteration of the dividend rights, dividend rate, conversion rights, exchange rights, voting rights, rights and terms of redemption (including sinking fund provisions), the redemption price or prices, and the liquidation preferences of any wholly unissued series of shares of Undesignated Preferred Stock, or any of them. In accordance with the authority hereby granted, the Board may increase or decrease the number of shares of any series of preferred stock, whether or not such preferred stock then constitutes Undesignated Preferred Stock, subsequent to the issuance of shares of that series; provided that any such increase shall be no greater than the total number of authorized shares of Undesignated Preferred Stock at such time, and no such decrease shall result in the number of authorized shares of such series being fewer than the number then outstanding. In case the number of shares of any series of preferred stock, other than Undesignated Preferred Stock, shall be so decreased, the shares constituting such decrease shall become Additional Undesignated Preferred Stock. Any shares of a series of preferred stock, which is designated pursuant to this clause (ii), that were issued but, thereafter, are no longer outstanding shall not resume the status of authorized and unissued shares of such series, but shall instead become authorized and unissued shares of Additional Undesignated Preferred Stock. Except as may otherwise be required by law or this Certificate of Incorporation, the terms of any series of Undesignated Preferred Stock may be amended without the consent of the holders of any other series of the Corporation’s preferred stock, or Common Stock. Each twenty (20) of the issued and outstanding shares of Common Stock as of the time the certificate containing this amendment becomes effective (the ``Split Effective Time”), shall be combined and converted (the “Reverse Split”) automatically, without further action, into one (1) fully paid and non-assessable share of Common Stock. In lieu of any fractional shares to which a holder would otherwise be entitled, the Corporation shall cause its transfer agent to disburse to such holders a cash payment in an amount equal to the product obtained by multiplying (i) a price equal to the average closing sales price of the Corporation’s Common Stock for the ten (10) trading days immediately prior to the Split Effective Time, or if no such sale takes place on such days, the average of the closing bid and ask prices for such days, as reported on the OTC Bulletin Board, by (ii) the number of shares of the Corporation’s Common Stock held by a holder that otherwise would have been exchanged for a fractional share interest, as determined by the Corporation’s Board of Directors. Each holder of record of a certificate which immediately prior to the Split Effective Time represents outstanding shares of Common Stock (an ``Old Certificate”) shall be entitled to receive upon surrender of such Old Certificate to the Corporation’s transfer agent for cancellation, a certificate (a “New Certificate”) representing the number of whole shares of Common Stock into and for which the shares formerly represented by such Old Certificate so surrendered are combined and converted. From and after the Split Effective Time, Old Certificates shall represent only the right to receive New Certificates as aforesaid and, to the extent the Corporation so elects, cash pursuant to the provisions hereof.”

 

3. This Certificate of Amendment shall be effective at 5:00 p.m. on the 11th day of March 2011.

 

5

 

 

IN WITNESS WHEREOF, Nephros, Inc. has caused this Certificate of Amendment to be executed by the undersigned officer, on this the 11th day of March 2011.

 

  NEPHROS, INC.
   
  /s/ Gerald J. Kochanski
  Gerald J. Kochanski, Chief Financial Officer

 

6

 

 

CERTIFICATE OF AMENDMENT

OF

FOURTH AMENDED AND RESTATED

CERTIFICATE OF INCORPORATION

OF

NEPHROS, INC.

 

The undersigned corporation, a corporation duly organized and existing under the General Corporation Law of the State of Delaware (the “Corporation”), does hereby certify that:

 

1. The name of the Corporation is Nephros, Inc.
   
2. The amendment to the Corporation’s Fourth Amended and Restated Certificate of Incorporation set forth below was duly adopted in accordance with the provisions of Section 242 of the General Corporation Law of the State of Delaware, and has been approved by the stockholders of the Corporation in accordance with Section 242 of the General Corporation Law of the State of Delaware.

 

The Corporation’s Fourth Amended and Restated Certificate of Incorporation is hereby amended by deleting the text of Article IV, Section 2 in its entirety and replacing it with the following:

 

“Section 2. Capital Stock. The total authorized capital stock of the Corporation shall be: 905,000,000 shares, consisting of:

 

(i) 900,000,000 shares of Common Stock, $.001 par value per share (the “Common Stock”);

 

7

 

 

(ii) 5,000,000 shares of preferred stock, $.001 par value per share (collectively, the “Undesignated Preferred Stock”). Subject to any limitations set forth elsewhere in this Certificate of Incorporation, the shares of Undesignated Preferred Stock may be issued from time to time in one or more series. Subject to any limitations set forth elsewhere in this Certificate of Incorporation, the Board of Directors is hereby authorized, by adopting appropriate resolutions and causing one or more certificates of amendment to be signed, verified and delivered in accordance with the DGCL, to establish from time to time the number of shares to be included in such series, and to fix the powers, preferences and rights of, and the qualifications, limitations and restrictions granted to and imposed upon such Undesignated Preferred Stock. Such powers, preferences and rights of, and the qualifications, limitations and restrictions granted to and imposed upon such Undesignated Preferred Stock may include, but are not limited to, the fixing or alteration of the dividend rights, dividend rate, conversion rights, exchange rights, voting rights, rights and terms of redemption (including sinking fund provisions), the redemption price or prices, and the liquidation preferences of any wholly unissued series of shares of Undesignated Preferred Stock, or any of them. In accordance with the authority hereby granted, the Board may increase or decrease the number of shares of any series of preferred stock, whether or not such preferred stock then constitutes Undesignated Preferred Stock, subsequent to the issuance of shares of that series; provided that any such increase shall be no greater than the total number of authorized shares of Undesignated Preferred Stock at such time, and no such decrease shall result in the number of authorized shares of such series being fewer than the number then outstanding. In case the number of shares of any series of preferred stock, other than Undesignated Preferred Stock, shall be so decreased, the shares constituting such decrease shall become Additional Undesignated Preferred Stock. Any shares of a series of preferred stock, which is designated pursuant to this clause (ii), that were issued but, thereafter, are no longer outstanding shall not resume the status of authorized and unissued shares of such series, but shall instead become authorized and unissued shares of Additional Undesignated Preferred Stock. Except as may otherwise be required by law or this Certificate of Incorporation, the terms of any series of Undesignated Preferred Stock may be amended without the consent of the holders of any other series of the Corporation’s preferred stock, or Common Stock.”

 

3. This Certificate of Amendment shall be effective upon filing.

 

8

 

 

IN WITNESS WHEREOF, Nephros, Inc. has caused this Certificate of Amendment to be executed by the undersigned officer, on this the 10th day of March 2011.

 

  NEPHROS, INC.
   
  /s/ Gerald J. Kochanski
  Gerald J. Kochanski, Chief Financial Officer

 

9

 

 

CERTIFICATE OF AMENDMENT

OF

FOURTH AMENDED AND RESTATED

CERTIFICATE OF INCORPORATION

OF

NEPHROS, INC.

 

Pursuant to Section 242 of the General Corporation Law of the State of Delaware.

 

Nephros, Inc., a corporation organized and existing under the General Corporation Law of the State of Delaware, does hereby certify and set forth as follows:

 

  1. The name of the Corporation is: Nephros, Inc. (the “Corporation”).
     
  2. The Corporation’s original Certificate of Incorporation was filed with the Secretary of State of Delaware on April 3, 1997. The Fourth Amended and Restated Certificate of Incorporation, as filed with the Secretary of State of the State of Delaware on June 24, 2005 (the “Certificate”), is hereby amended by Deleting the existing Section 2 of Article IV and replacing it in its entirety with the following:

 

“Section 2. Capital Stock. The total authorized capital stock of the Corporation shall be: 95,000,000 shares, consisting of:

 

(i) 90,000,000 shares of Common Stock, $.001 par value per share (the “Common Stock”);

 

10

 

 

(ii) 5,000,000 shares of preferred stock, $.001 par value per share (collectively, the “Undesignated Preferred Stock”). Subject to any limitations set forth elsewhere in this Certificate of Incorporation, the shares of Undesignated Preferred Stock may be issued from time to time in one or more series. Subject to any limitations set forth elsewhere in this Certificate of Incorporation, the Board of Directors is hereby authorized, by adopting appropriate resolutions and causing one or more certificates of amendment to be signed, verified and delivered in accordance with the DGCL, to establish from time to time the number of shares to be included in such series, and to fix the powers, preferences and rights of, and the qualifications, limitations and restrictions granted to and imposed upon such Undesignated Preferred Stock. Such powers, preferences and rights of, and the qualifications, limitations and restrictions granted to and imposed upon such Undesignated Preferred Stock may include, but are not limited to, the fixing or alteration of the dividend rights, dividend rate, conversion rights, exchange rights, voting rights, rights and terms of redemption (including sinking fund provisions), the redemption price or prices, and the liquidation preferences of any wholly unissued series of shares of Undesignated Preferred Stock, or any of them. In accordance with the authority hereby granted, the Board may increase or decrease the number of shares of any series of preferred stock, whether or not such preferred stock then constitutes Undesignated Preferred Stock, subsequent to the issuance of shares of that series; provided that any such increase shall be no greater than the total number of authorized shares of Undesignated Preferred Stock at such time, and no such decrease shall result in the number of authorized shares of such series being fewer than the number then outstanding. In case the number of shares of any series of preferred stock, other than Undesignated Preferred Stock, shall be so decreased, the shares constituting such decrease shall become Additional Undesignated Preferred Stock. Any shares of a series of preferred stock, which is designated pursuant to this clause (ii), that were issued but, thereafter, are no longer outstanding shall not resume the status of authorized and unissued shares of such series, but shall instead become authorized and unissued shares of Additional Undesignated Preferred Stock. Except as may otherwise be required by law or this Certificate of Incorporation, the terms of any series of Undesignated Preferred Stock may be amended without the consent of the holders of any other series of the Corporation’s preferred stock, or Common Stock.”

 

  3. The amendment of the Certificate herein certified has been duly adopted in accordance with the provisions of Section 242 of the General Corporation Law of the State of Delaware.
     
  4. This Certificate of Amendment will be effective upon filing.

 

11

 

 

IN WITNESS WHEREOF, Nephros, Inc. has caused this Certificate of Amendment to be signed by its President this 23 rd day of October 2009.

 

  Nephros, Inc.
     
  By: /s/ Ernest A. Elgin III
    Ernest A. Elgin III
    President and Chief Executive Officer

 

12

 

 

CERTIFICATE OF AMENDMENT

TO THE

FOURTH AMENDED AND RESTATED

CERTIFICATE OF INCORPORATION

OF

NEPHROS, INC.

 

It is hereby certified that:

 

1. The name of the Corporation is: Nephros, Inc. (the “Corporation”).
   
2. The Corporation’s Fourth Amended and Restated Certificate of Incorporation, as filed with the Secretary of State of the State of Delaware on June 24, 2005 (the “Certificate”), is hereby amended by deleting the existing Section 2 of Article IV and replacing it in its entirety with the following:

 

“Section 2. Capital Stock. The total authorized capital stock of the Corporation shall be: 65,000,000 shares, consisting of:

 

  (i) 60,000,000 shares of Common Stock, $.001 par value per share (the “Common Stock”);
     
  (ii) 5,000,000 shares of preferred stock, $.001 par value per share (collectively, the “Undesignated Preferred Stock”). Subject to any limitations set forth elsewhere in this Certificate of Incorporation, the shares of Undesignated Preferred Stock may be issued from time to time in one or more series. Subject to any limitations set forth elsewhere in this Certificate of Incorporation, the Board of Directors is hereby authorized, by adopting appropriate resolutions and causing one or more certificates of amendment to be signed, verified and delivered in accordance with the DGCL, to establish from time to time the number of shares to be included in such series, and to fix the powers, preferences and rights of, and the qualifications, limitations and restrictions granted to and imposed upon such Undesignated Preferred Stock. Such powers, preferences and rights of, and the qualifications, limitations and restrictions granted to and imposed upon such Undesignated Preferred Stock may include, but are not limited to, the fixing or alteration of the dividend rights, dividend rate, conversion rights, exchange rights, voting rights, rights and terms of redemption (including sinking fund provisions), the redemption price or prices, and the liquidation preferences of any wholly unissued series of shares of Undesignated Preferred Stock, or any of them. In accordance with the authority hereby granted, the Board may increase or decrease the number of shares of any series of preferred stock, whether or not such preferred stock then constitutes Undesignated Preferred Stock, subsequent to the issuance of shares of that series; provided that any such increase shall be no greater than the total number of authorized shares of Undesignated Preferred Stock at such time, and no such decrease shall result in the number of authorized shares of such series being fewer than the number then outstanding. In case the number of shares of any series of preferred stock, other than Undesignated Preferred Stock, shall be so decreased, the shares constituting such decrease shall become Additional Undesignated Preferred Stock. Any shares of a series of preferred stock, which is designated pursuant to this clause (ii), that were issued but, thereafter, are no longer outstanding shall not resume the status of authorized and unissued shares of such series, but shall instead become authorized and unissued shares of Additional Undesignated Preferred Stock. Except as may otherwise be required by law or this Certificate of Incorporation, the terms of any series of Undesignated Preferred Stock may be amended without the consent of the holders of any other series of the Corporation’s preferred stock, or Common Stock.”

 

3. The amendment of the Certificate herein certified has been duly adopted in accordance with the provisions of Sections 228 and 242 of the General Corporation Law of the State of Delaware.

 

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13

 

 

IN WITNESS WHEREOF , the undersigned has executed this Certificate as of the 13 th day of November, 2007.

 

  By: /s/ Norman J. Barta
  Name: Norman J. Barta
  Title: Chief Executive Officer

 

14

 

 

CERTIFICATE OF AMENDMENT

TO THE

FOURTH AMENDED AND RESTATED

CERTIFICATE OF INCORPORATION

OF

NEPHROS, INC.

 

It is hereby certified that:

 

1. The name of the Corporation is: Nephros, Inc. (the “Corporation”).
   
2. The Corporation’s Fourth Amended and Restated Certificate of Incorporation, as filed with the Secretary of State of the State of Delaware on June 24, 2005 (the “Certificate”), as amended, is hereby amended by deleting the existing Section 5 of Article VII and renumbering the remaining sections in Article VII as follows:

 

“Section 5. Special meetings of the stockholders may be called exclusively by the Board, the Chairman of the Board, the Corporation’s President or any Vice President or the Secretary, upon not less than 10 days written notice to the stockholders. Such notice shall state the purpose or purposes of the proposed special meeting. The business transacted at any special meeting shall be limited to the purposes stated when the meeting is called or in the notice of such meeting.

 

Section 6. Notwithstanding any other provisions of this Certificate of Incorporation or the By-laws of the Corporation (and notwithstanding the fact that some lesser percentage may be specified by law, this Certificate of Incorporation or By-laws of the Corporation), the affirmative vote of the holders of 80% or more of the voting power represented by the outstanding shares of capital stock of the Corporation entitled to vote generally in the election of directors (considered for this purpose as one class) shall be required to amend, alter, change or repeal this Article VII or any portion thereof.”

 

3. The amendment of the Certificate herein certified has been duly adopted in accordance with the provisions of Section 242 of the General Corporation Law of the State of Delaware.

 

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15

 

 

IN WITNESS WHEREOF , the undersigned has executed this Certificate as of the 29th of June, 2007.

 

  By: /s/ Norman J. Barta
  Name: Norman J. Barta
  Title: Chief Executive Officer

 

16

 

 

CERTIFICATE OF AMENDMENT

TO THE

FOURTH AMENDED AND RESTATED

CERTIFICATE OF INCORPORATION

OF

NEPHROS, INC.

 

It is hereby certified that:

 

1. The name of the Corporation is: Nephros, Inc. (the “Corporation”).
   
2. The Corporation’s Fourth Amended and Restated Certificate of Incorporation, as filed with the Secretary of State of the State of Delaware on June 24, 2005 (the “Certificate”), is hereby amended by deleting the existing Section 2 of Article IV and replacing it in its entirety with the following:

 

“Section 2. Capital Stock. The total authorized capital stock of the Corporation shall be: 45,000,000 shares, consisting of:

 

  (i) 40,000,000 shares of Common Stock, $.001 par value per share (the “Common Stock”);
     
  (ii) 5,000,000 shares of preferred stock, $.001 par value per share (collectively, the “Undesignated Preferred Stock”). Subject to any limitations set forth elsewhere in this Certificate of Incorporation, the shares of Undesignated Preferred Stock may be issued from time to time in one or more series. Subject to any limitations set forth elsewhere in this Certificate of Incorporation, the Board of Directors is hereby authorized, by adopting appropriate resolutions and causing one or more certificates of amendment to be signed, verified and delivered in accordance with the DGCL, to establish from time to time the number of shares to be included in such series, and to fix the powers, preferences and rights of, and the qualifications, limitations and restrictions granted to and imposed upon such Undesignated Preferred Stock. Such powers, preferences and rights of, and the qualifications, limitations and restrictions granted to and imposed upon such Undesignated Preferred Stock may include, but are not limited to, the fixing or alteration of the dividend rights, dividend rate, conversion rights, exchange rights, voting rights, rights and terms of redemption (including sinking fund provisions), the redemption price or prices, and the liquidation preferences of any wholly unissued series of shares of Undesignated Preferred Stock, or any of them. In accordance with the authority hereby granted, the Board may increase or decrease the number of shares of any series of preferred stock, whether or not such preferred stock then constitutes Undesignated Preferred Stock, subsequent to the issuance of shares of that series; provided that any such increase shall be no greater than the total number of authorized shares of Undesignated Preferred Stock at such time, and no such decrease shall result in the number of authorized shares of such series being fewer than the number then outstanding. In case the number of shares of any series of preferred stock, other than Undesignated Preferred Stock, shall be so decreased, the shares constituting such decrease shall become Additional Undesignated Preferred Stock. Any shares of a series of preferred stock, which is designated pursuant to this clause (ii), that were issued but, thereafter, are no longer outstanding shall not resume the status of authorized and unissued shares of such series, but shall instead become authorized and unissued shares of Additional Undesignated Preferred Stock. Except as may otherwise be required by law or this Certificate of Incorporation, the terms of any series of Undesignated Preferred Stock may be amended without the consent of the holders of any other series of the Corporation’s preferred stock, or Common Stock.”

 

3. The amendment of the Certificate herein certified has been duly adopted in accordance with the provisions of Section 242 of the General Corporation Law of the State of Delaware.

 

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17

 

 

IN WITNESS WHEREOF , the undersigned has executed this Certificate as of the 4th day of June, 2007.

 

  By: /s/ Norman J. Barta
  Name: Norman J. Barta
  Title: Chief Executive Officer

 

18

 

 

FOURTH AMENDED AND RESTATED

CERTIFICATE OF INCORPORATION

OF

NEPHROS, INC.

 

(Pursuant to Sections 242 and 245 of the

General Corporation Law of the State of Delaware)

 

NEPHROS, INC., a corporation organized and existing under and by virtue of the provisions of the General Corporation Law of the State of Delaware,

 

DOES HEREBY CERTIFY:

 

FIRST: That the name of the corporation is NEPHROS, INC. and that this corporation was originally incorporated pursuant to the General Corporation Law on April 3, 1997.

 

SECOND: That the Board of this corporation duly adopted resolutions proposing to amend and restate the Certificate of Incorporation of this corporation, declaring said amendment and restatement to be advisable, and authorizing the appropriate officers of this corporation to submit said amendment and restatement to the stockholders of the corporation for their approval. The resolution setting forth the proposed amendment and restatement is as follows:

 

RESOLVED, that the Certificate of Incorporation of this corporation be amended and restated in its entirety to read as follows:

 

ARTICLE I

 

The name of this corporation is Nephros, Inc. (referred to herein as the “Corporation”).

 

ARTICLE II

 

The address of the Corporation’s registered office in the State of Delaware is 2711 Centerville Road, Suite 400 in the City of Wilmington, 19808, County of New Castle. The name of the Corporation’s registered agent at such address is Corporation Service Company.

 

ARTICLE III

 

The nature of the business or purposes to be conducted or promoted by the Corporation is to engage in any lawful act or activity for which corporations may be organized under the General Corporation Law of the State of Delaware.

 

ARTICLE IV

 

Section 1. Certain Definitions. As used in this Amended and Restated Certificate of Incorporation (the “Certificate of Incorporation”), the following terms shall have the following meanings:

 

“Board” means the Board of Directors of the Corporation.

 

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“DGCL” means the Delaware General Corporation Law, as the same may be amended or supplemented from time to time.

 

Section 2. Capital Stock. The total authorized capital stock of the Corporation shall be: 30,000,000 shares, consisting of:

 

  (i) 25,000,000 shares of Common Stock, $.001 par value per share (the “Common Stock”);
     
  (ii) 5,000,000 shares of preferred stock, $.001 par value per share (collectively, the “Undesignated Preferred Stock”). Subject to any limitations set forth elsewhere in this Certificate of Incorporation, the shares of Undesignated Preferred Stock may be issued from time to time in one or more series. Subject to any limitations set forth elsewhere in this Certificate of Incorporation, the Board of Directors is hereby authorized, by adopting appropriate resolutions and causing one or more certificates of amendment to be signed, verified and delivered in accordance with the DGCL, to establish from time to time the number of shares to be included in such series, and to fix the powers, preferences and rights of, and the qualifications, limitations and restrictions granted to and imposed upon such Undesignated Preferred Stock. Such powers, preferences and rights of, and the qualifications, limitations and restrictions granted to and imposed upon such Undesignated Preferred Stock may include, but are not limited to, the fixing or alteration of the dividend rights, dividend rate, conversion rights, exchange rights, voting rights, rights and terms of redemption (including sinking fund provisions), the redemption price or prices, and the liquidation preferences of any wholly unissued series of shares of Undesignated Preferred Stock, or any of them. In accordance with the authority hereby granted, the Board may increase or decrease the number of shares of any series of preferred stock, whether or not such preferred stock then constitutes Undesignated Preferred Stock, subsequent to the issuance of shares of that series; provided that any such increase shall be no greater than the total number of authorized shares of Undesignated Preferred Stock at such time, and no such decrease shall result in the number of authorized shares of such series being fewer than the number then outstanding. In case the number of shares of any series of preferred stock, other than Undesignated Preferred Stock, shall be so decreased, the shares constituting such decrease shall become Additional Undesignated Preferred Stock. Any shares of a series of preferred stock, which is designated pursuant to this clause (ii), that were issued but, thereafter, are no longer outstanding shall not resume the status of authorized and unissued shares of such series, but shall instead become authorized and unissued shares of Additional Undesignated Preferred Stock. Except as may otherwise be required by law or this Certificate of Incorporation, the terms of any series of Undesignated Preferred Stock may be amended without the consent of the holders of any other series of the Corporation’s preferred stock, or Common Stock.

 

20

 

 

ARTICLE V

 

Whenever a compromise or arrangement is proposed between this Corporation and its creditors or any class of them and/or between this Corporation and its stockholders or any class of them, any court of equitable jurisdiction within the State of Delaware may, on the application in a summary way of this Corporation or of any creditor or stockholder thereof or on the application of any receiver or receivers appointed for this Corporation under ss. 291 the DGCL (or any successor section) or on the application of trustees in dissolution or of any receiver or receivers appointed for this Corporation under ss. 279 of the DGCL (or any successor section) order a meeting of the creditors or class of creditors, and/or of the stockholders or class of stockholders of this Corporation, as the case may be, to be summoned in such manner as the said court directs. If a majority in number representing three fourths in value of the creditors or class of creditors, and/or of the stockholders or class of stockholders of this Corporation, as the case may be, agree to any compromise or arrangement and to any reorganization of this Corporation as consequence of such compromise or arrangement, the said compromise or arrangement and the said reorganization shall, if sanctioned by the court to which the said application has been made, be binding on all the creditors or class of creditors, and/or on all the stockholders or class of stockholders, of this Corporation, as the case may be, and also on this Corporation.

 

ARTICLE VI

 

The Board of this Corporation shall have the power to adopt, amend or repeal By-laws of this Corporation, subject to the power of the stockholders of this Corporation to adopt By-laws and to amend or repeal By-laws adopted by the Board.

 

ARTICLE VII

 

For the management of the business and for the conduct of the affairs of the Corporation, and in further definition, limitation, and regulation of the powers of the Corporation and of its directors and of its stockholders or any class thereof, as the case may be, it is further provided:

 

Section 1. The management of the business and the conduct of the affairs of the Corporation shall be vested in its Board of Directors. The number of directors which shall constitute the whole Board of Directors shall be fixed by, or in the manner provided in, the By-laws. The phrase “whole Board” and the phrase “total number of directors” shall be deemed to have the same meaning, to wit, the total number of directors which the Corporation would have if there were no vacancies. No election of directors need be by written ballot.

 

Section 2. The Board shall be divided into three classes, as nearly equal in number as the then total number of directors constituting the entire Board permits, with the term of office of one or another of the three classes expiring each year. The Board shall by resolution initially divide the Board into three classes, with the term of office of the first class to expire at the Annual Meeting of Stockholders to be held during 2005, the term of office of the second class to expire at the Annual Meeting of Stockholders to be held during 2006 and the term of office of the third class to expire at the Annual Meeting of Stockholders to be held during 2007.

 

21

 

 

Section 3. Commencing with the first Annual Meeting of Stockholders following September 24, 2004, the directors elected at an annual meeting of stockholders to succeed those whose terms then expire shall be identified as being directors of the same class as the directors whom they succeed, and each of them shall hold office until the third succeeding annual meeting of stockholders and until such director’s successor is elected and has been qualified. Any vacancies in the Board for any reason, and any created directorships resulting from any increase in the number of directors, may be filled by the vote of not less than a majority of the members of the Board then in office, although less than a quorum, and any directors so chosen shall hold office until the next election of the class for which such directors shall have been chosen and until their successors shall be elected and qualified. Notwithstanding the foregoing, and except as otherwise required by law, whenever the holders of any one or more series of preferred stock shall have the right, voting separately as a class, to elect one or more directors of the Corporation, the then authorized number of directors shall be increased by the number of directors so to be elected, and the terms of the director or directors elected by such holders shall expire at the next succeeding annual meeting of stockholders.

 

Section 4. Notwithstanding any other provisions of this Certificate of Incorporation or the By-laws of the Corporation, any director or the entire Board of the Corporation may be removed at any time, but only for cause and only by the affirmative vote of the holders of a majority of the outstanding shares of capital stock of the Corporation entitled to vote generally in the election of directors (considered for this purpose as one class, with preferred stock, the terms of which provide for voting as to such matters, voting on an as-converted basis, unless otherwise provided in the amendment to this Certificate of Incorporation defining the rights of the holders of such preferred stock) cast at a meeting of the stockholders called for that purpose. Notwithstanding the foregoing, and except as otherwise required by law, whenever the holders of any one or more series of preferred stock shall have the right, voting separately as a class, to elect one or more directors of the Corporation, the provisions of this Section 4 shall not apply with respect to the election of the director or directors elected by such holders of preferred stock.

 

Section 5. Notwithstanding any other provisions of this Certificate of Incorporation or the By-laws of the Corporation, any action by the Corporation’s stockholders may only be effected at an annual or special meeting of the Corporation’s stockholders called in compliance with Section 6 below, or pursuant to an unanimous written consent of the Corporation’s stockholders in compliance with § 228 of the DGCL (or any successor section of the DGCL).

 

Section 6. Special meetings of the stockholders may be called exclusively by the Board, the Chairman of the Board, the Corporation’s President or any Vice President or the Secretary, upon not less than 10 days written notice to the stockholders. Such notice shall state the purpose or purposes of the proposed special meeting. The business transacted at any special meeting shall be limited to the purposes stated when the meeting is called or in the notice of such meeting.

 

22

 

 

Section 7. Notwithstanding any other provisions of this Certificate of Incorporation or the By-laws of the Corporation (and notwithstanding the fact that some lesser percentage may be specified by law, this Certificate of Incorporation or the By-laws of the Corporation), the affirmative vote of the holders of 80% or more of the voting power represented by the outstanding shares of capital stock of the Corporation entitled to vote generally in the election of directors (considered for this purpose as one class) shall be required to amend, alter, change or repeal this Article VII or any portion hereof.

 

ARTICLE VIII

 

The personal liability of the directors of the Corporation is hereby eliminated to the fullest extent permitted by the provisions of paragraph (7) of subsection (b) of § 102 of the DGCL, (or any successor section of the DGCL).

 

ARTICLE IX

 

The Corporation shall, to the fullest extent permitted by the provisions of § 145 of the DGCL, (or any successor section of the DGCL), indemnify any and all persons whom it shall have power to indemnify under said section from and against any and all of the expenses, liabilities, or other matters referred to in or covered by said section, and the indemnification provided for herein shall not be deemed exclusive of any other rights to which those indemnified may be entitled under any By-law, agreement, vote of stockholders or disinterested directors or otherwise, both as to action in his official capacity and as to action in another capacity while holding such office, and shall continue as to a person who has ceased to be a director, officer, employee, or agent and shall inure to the benefit of the heirs, executors, and administrators of such a person.

 

ARTICLE X

 

Except as may be otherwise provided in this Certificate of Incorporation, from time to time any of the provisions of this Certificate of Incorporation may be amended, altered, or repealed, and other provisions authorized by the laws of the State of Delaware at the time in force may be added or inserted in the manner and at the time prescribed by said laws, and all rights at any time conferred upon the stockholders of the Corporation by this Certificate of Incorporation are granted subject to the provisions of this Article X.

 

THIRD: That the foregoing amendment and restatement was approved by the holders of the requisite number of shares of said Corporation at a meeting called and held upon notice in accordance with § 222 of the DGCL.

 

FOURTH: That said amendment and restatement was duly adopted in accordance with the provisions of §§ 242 and 245 of the DGCL.

 

IN WITNESS WHEREOF, said Corporation has caused this Fourth Amended and Restated Certificate of Incorporation to be signed by its Chief Executive Officer this 24th day of June, 2005.

 

  NEPHROS, INC.
     
  By: /s/ Norman Barta
  Name: Norman Barta
  Title: Chief Executive Officer

 

23

 

 

 

 

Exhibit 31.1

 

CERTIFICATION OF CHIEF EXECUTIVE OFFICER

UNDER SECTION 302 OF THE SARBANES-OXLEY ACT

 

I, Daron Evans, certify that:

 

1. I have reviewed this Quarterly Report on Form 10-Q of Nephros, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under my supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to me by others within those entities, particularly during the period in which this report is being prepared;

 

b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under my supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report my conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. I have disclosed, based on my most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: August 7, 2019 By: /s/ Daron Evans
  Name:   Daron Evans
  Title: President, Chief Executive Officer (Principal Executive Officer)

 

     

 

 

 

Exhibit 31.2

 

CERTIFICATION OF CHIEF FINANCIAL OFFICER

UNDER SECTION 302 OF THE SARBANES-OXLEY ACT

 

I, Andrew Astor, certify that:

 

1. I have reviewed this Quarterly Report on Form 10-Q of Nephros, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under my supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to me by others within those entities, particularly during the period in which this report is being prepared;

 

b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under my supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report my conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. I have disclosed, based on my most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: August 7, 2019 By: /s/ Andrew Astor
  Name:  Andrew Astor
  Title: Chief Financial Officer (Principal Financial and Accounting Officer)

 

     

 

 

 

Exhibit 32.1

 

Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

In connection with the Quarterly Report on Form 10-Q of Nephros, Inc. (the “Company”) for the period ended June 30, 2019 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, Daron Evans, President, Chief Executive Officer of the Company, certifies that:

 

1. the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
   
2. the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

By: /s/ Daron Evans  
Name:  Daron Evans  
Title: President, Chief Executive Officer (Principal Executive Officer)  
     
Dated: August 7, 2019    

 

     

 

 

 

Exhibit 32.2

 

Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

In connection with the Quarterly Report on Form 10-Q of Nephros, Inc. (the “Company”) for the period ended June 30, 2019 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, Andrew Astor, Chief Financial Officer of the Company, certifies that:

 

1. the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
   
2. the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

By: /s/ Andrew Astor  
Name:  Andrew Astor  
Title:

Chief Financial Officer

(Principal Financial and Accounting Officer)

 
     
Dated: August 7, 2019