UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON D.C. 20549

 

FORM 10-Q

 

(Mark One)

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

 

For the quarterly period ended: SeptemberJune 30, 20212022

 

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:

 

Title of each class Trading symbol Name of exchange on which registered
Common stock, par value $0.001 per share NEPH The Nasdaq Stock Market LLC

 

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. ☒ 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). ☒ 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 filerSmaller reporting company
 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 ☒ NO


As of November 1, 2021,August 10, 2022, 10,233,08310,318,818 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 INFORMATION3
Item 1. Financial Statements (unaudited).3
CONDENSED CONSOLIDATED BALANCE SHEETS – SeptemberJune 30, 20212022 and December 31, 202020213
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS – Three and ninesix months ended SeptemberJune 30, 20212022 and 202020214
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY – Three and ninesix months ended SeptemberJune 30, 20212022 and 202020215
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS – NineSix months ended SeptemberJune 30, 20212022 and 2020202176
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS87
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.2220
Item 3. Quantitative and Qualitative Disclosures About Market Risk.3432
Item 4. Controls and Procedures.3432
PART II - OTHER INFORMATION3533
Item 1A. Risk Factors3533
Item 5. Other Information35
Item 6. Exhibits3533
SIGNATURES3634

 

2 

 

 

PART I - FINANCIAL INFORMATION

 

Item 1. Financial Statements.

NEPHROS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share amounts)

(Unaudited)

        
 September 30, 2021 December 31, 2020  June 30, 2022 December 31, 2021 
ASSETS                
Current assets:                
Cash and cash equivalents $7,350  $8,249  $4,179  $6,973 
Accounts receivable, net  1,555   1,364   2,128   1,641 
Inventory  4,649   5,304   4,664   4,795 
Prepaid expenses and other current assets  67   237   151   225 
Total current assets  13,621   15,154   11,122   13,634 
Property and equipment, net  382   295   450   366 
Lease right-of-use assets  814   1,037   626   730 
Intangible assets, net  1,573   506   1,460   1,536 
Goodwill  759   759   759   759 
License and supply agreement, net  569   670   469   536 
Other assets  102   89   67   89 
TOTAL ASSETS $17,820  $18,510  $14,953  $17,650 
                
LIABILITIES AND STOCKHOLDERS’ EQUITY                
Current liabilities:                
Current portion of secured note payable $243  $229  $210  $248 
Accounts payable  641   423   1,411   1,334 
Accrued expenses  573   341   185   444 
Current portion of lease liabilities  366   332   305   364 
Total current liabilities  1,823   1,325   2,111   2,390 
Secured note payable, net of current portion  164   364   -   95 
PPP loan  -   482 
Equipment financing, net of current portion  5   7   3   4 
Lease liabilities, net of current portion  498   759   358   412 
TOTAL LIABILITIES  2,490   2,937   2,472   2,901 
                
COMMITMENTS AND CONTINGENCIES (Note 15)        
COMMITMENTS AND CONTINGENCIES (Note 13)  -   - 
                
STOCKHOLDERS’ EQUITY                
                
Preferred stock, $.001 par value; 5,000,000 shares authorized at September 30, 2021 and December 31, 2020; 0 shares issued and outstanding at September 30, 2021 and December 31, 2020.      - 
Common stock, $.001 par value; 40,000,000 shares authorized at September 30, 2021 and December 31, 2020; 10,233,083 and 9,873,006 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively.  10   10 
Preferred stock, $.001 par value; 5,000,000 shares authorized at June 30, 2022 and December 31, 2021; 0 shares issued and outstanding at June 30, 2022 and December 31, 2021.  -   - 
Common stock, $.001 par value; 40,000,000 shares authorized at June 30, 2022 and December 31, 2021; 10,318,818 and 10,258,444 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively.  10   10 
Additional paid-in capital  146,883   144,296   148,040   147,346 
Accumulated other comprehensive income  66   74   -   64 
Accumulated deficit  (134,683)  (131,858)  (138,829)  (135,725)
Subtotal  12,276   12,522   9,221   11,695 
Noncontrolling interest  3,054   3,051   3,260   3,054 
TOTAL STOCKHOLDERS’ EQUITY  15,330   15,573   12,481   14,749 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $17,820  $18,510  $14,953  $17,650 

 

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)

 

 2021 2020 2021 2020                 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
  Three Months Ended June 30, Six Months Ended June 30, 
 2021 2020 2021 2020  2022 2021 2022 2021 
Net revenue:                                
Product revenues $2,595  $2,094  $7,503  $6,133  $2,839  $2,196  $5,016  $4,908 
Royalty and other revenues  42   27   136   94   45   70   55   94 
Total net revenues  2,637   2,121   7,639   6,227   2,884   2,266   5,071   5,002 
Cost of goods sold  1,225   896   3,365   2,616   1,523   991   2,685   2,140 
Gross margin  1,412   1,225   4,274   3,611   1,361   1,275   2,386   2,862 
Operating expenses:                                
Research and development  632   751   1,675   2,150   431   487   1,009   1,043 
Depreciation and amortization  50   49   151   142   64   51   116   101 
Selling, general and administrative  1,892   1,544   5,745   5,104   2,070   1,854   4,418   3,853 
Change in fair value of contingent consideration  -   (187)  -   (229)
Total operating expenses  2,574   2,157   7,571   7,167   2,565   2,392   5,543   4,997 
Loss from operations  (1,162)  (932)  (3,297)  (3,556)  (1,204)  (1,117)  (3,157)  (2,135)
Other (expense) income:                
Other income (expense):                
Interest expense  (10)  (22)  (34)  (95)  (6)  (11)  (13)  (24)
Interest income  2   3   8   8   1   3   3   6 
Extinguishment of PPP loan  -   -   482   -   -   -   -   482 
Other income (expense), net  8   (61)  16   (124)  72   (1)  63   8 
Total other (expense) income:  -   (80)  472   (211)
Total other income (expense):  67   (9)  53   472 
Net loss  (1,162)  (1,012)  (2,825)  (3,767)  (1,137)  (1,126)  (3,104)  (1,663)
Less: Undeclared deemed dividend attributable to noncontrolling interest  (60)  (60)  (179)  (179)  (66)  (60)  (129)  (119)
Net loss attributable to Nephros, Inc. shareholders  (1,222)  (1,072)  (3,004)  (3,946)  (1,203)  (1,186)  (3,233)  (1,782)
                                
Net loss per common share, basic and diluted $(0.12) $(0.12) $(0.30) $(0.44) $(0.12) $(0.12) $(0.31) $(0.18)
Weighted average common shares outstanding, basic and diluted  10,044,745   9,039,673   9,957,528   8,872,624   10,299,148   9,943,026   10,265,267   9,913,196 
                                
Comprehensive loss:                                
Net loss $(1,162) $(1,012) $(2,825) $(3,767) $(1,137) $(1,126) $(3,104) $(1,663)
Other comprehensive income (loss), foreign currency translation adjustments, net of tax  (4)  4   (8)  4   -   2   (3)  (4)
Comprehensive loss  (1,166)  (1,008)  (2,833)  (3,763)  (1,137)  (1,124)  (3,107)  (1,667)
Comprehensive loss attributable to noncontrolling interest  (60)  (60)  (179)  (179)  (66)  (60)  (129)  (119)
Comprehensive loss attributable to Nephros, Inc. shareholders $(1,226) $(1,068) $(3,012) $(3,942) $(1,203) $(1,184) $(3,236) $(1,786)

 

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)

 

  Shares  Amount  Capital  Income  Deficit  Subtotal  Interest  Equity 
  Three and nine months ended September 30, 2021 
  Common Stock  Additional Paid-in  Accumulated Other Comprehensive  Accumulated     Noncontrolling  Total Stockholders’ 
  Shares  Amount  Capital  Income  Deficit  Subtotal  Interest  Equity 
Balance, December 31, 2020  9,873,006  $10  $144,296  $74  $(131,858) $12,522  $3,051  $15,573 
Net loss      -   -   -   (537)  (537)  -   (537)
Net unrealized losses on foreign currency translation, net of tax      -   -   (6)  -   (6)  -   (6)
Exercise of options  14,754   -   62   -   -   62   -   62 
Cashless exercise of options  131   -   -   -   -   -   -   - 
Exercise of warrants                                
Exercise of warrants, shares                                
Cashless exercise of warrants                                
Cashless exercise of warrants, shares                                
Issuance of vested restricted stock                                
Issuance of vested restricted stock, shares                                
Issuance of common stock, net of equity                                
Issuance of common stock, net of equity issuance costs, shares                                
Stock-based compensation      -   443   -   -   443   2   445 
Balance, March 31, 2021  9,887,891  $10  $144,801  $68  $(132,395) $12,484  $3,053  $15,537 
                                 
Net loss     $-  $-  $-  $(1,126) $(1,126) $-  $(1,126)
Net unrealized gains on foreign currency translation, net of tax      -   -   2   -   2   -   2 
Cashless exercise of options  14,616   -   -   -   -   -   -   - 
Exercise of warrants  110,003   -   297   -   -   297   -   297 
Cashless exercise of warrants  10,963   -   -   -   -   -   -   - 
Stock-based compensation      -   280   -   -   280   1   281 
Balance, June 30, 2021  10,023,473  $10  $145,378  $70  $(133,521) $11,937  $3,054  $14,991 
                                 
Net loss     $-  $-  $-  $(1,162) $(1,162) $-  $(1,162)
Net unrealized losses on foreign currency translation, net of tax      -   -   (4)  -   (4)  -   (4)
Issuance of common stock for asset acquisition (see Note 3)  123,981   -   1,124   -   -   1,124   -   1,124 
Exercise of options  21,291   -   114   -   -   114   -   114 
Issuance of vested restricted stock  23,781   -   -   -   -   -   -   - 
Stock-based compensation      -   267   -   -   267       267 
Balance, September 30, 2021  10,192,526  $10  $146,883  $66  $(134,683) $12,276  $3,054  $15,330 

                                 
  Three and six months ended June 30, 2022  
  Common Stock  

Additional

Paid-in

  

Accumulated

Other

Comprehensive

  Accumulated     Noncontrolling  

Total

Stockholders’

 
  Shares  Amount  Capital  Income  Deficit  Subtotal  Interest  Equity 
Balance, December 31, 2021  10,198,712  $10  $147,346  $64  $(135,725) $11,695  $3,054  $14,749 
Net loss  -   -   -   -   (1,967)  (1,967)  -   (1,967)
Change in non-controlling interest  -   -   -   -   -   -   188   188 
Net unrealized losses on foreign currency translation, net of tax  -   -   -   (3)  -   (3)  -   (3)
Exercise of warrants  60,374   -   163   -   -   163   -   163 
Stock-based compensation  -   -   272   -   -   272   -   272 
Balance, March 31, 2022  10,259,086  $10  $147,781  $61  $(137,692) $10,160  $3,242  $13,402 
Net loss  -  $-  $-  $-  $(1,137) $(1,137) $-  $(1,137)
Restricted stock vesting  44,732   -   -   -   -   -   -   - 
Elimination of cumulative translation adjustment, upon closing of wholly owned foreign subsidiary  -   -   -   (61)  -   (61)  -   (61)
Stock-based compensation  -   -   259   -   -   259   18   277 
Balance, June 30, 2022  10,303,818  $10  $148,040  $-  $(138,829) $9,221  $3,260  $12,481 

 

5
  Three and six months ended June 30, 2021 
  Common Stock  Additional Paid-in  Accumulated Other Comprehensive  Accumulated     Noncontrolling  Total Stockholders’ 
  Shares  Amount  Capital  Income  Deficit  Subtotal   Interest   Equity 
Balance, December 31, 2020  9,873,006  $10  $144,296  $74  $(131,858) $12,522  $3,051  $15,573 
Net loss  -   -   -   -   (537)  (537)  -   (537)
Net unrealized losses on foreign currency translation, net of tax  -   -   -   (6)  -   (6)  -   (6)
Exercise of options  14,754   -   62   -   -   62   -   62 
Cashless exercise of options  131   -   -   -   -   -   -   - 
Stock-based compensation  -   -   443   -   -   443   2   445 
Balance, March 31, 2021  9,887,891  $10  $144,801  $68  $(132,395) $12,484  $3,053  $15,537 
                                 
Net loss  -  $-  $-  $-  $(1,126) $(1,126) $-  $(1,126)
Net unrealized gains on foreign currency translation, net of tax  -   -   -   2   -   2   -   2 
Cashless exercise of options  14,616   -   -   -   -   -   -   - 
Exercise of warrants  110,003   -   297   -   -   297   -   297 
Cashless exercise of warrants  10,963   -   -   -   -   -   -   - 
Stock-based compensation  -   -   280   -   -   280   1   281 
Balance, June 30, 2021  10,023,473  $10  $145,378  $      70  $(133,521) $11,937  $3,054  $14,991 

 

  Three and nine months ended September 30, 2020 
  Common Stock  Additional Paid-in  Accumulated Other Comprehensive  Accumulated     Noncontrolling  Total Stockholders’ 
  Shares  Amount  Capital  Income  Deficit  Subtotal  Interest  Equity 
Balance, December 31, 2019  8,003,739  $8  $131,934  $65  $(127,332) $4,675  $3,014  $7,689 
Net loss      -   -   -   (1,098)  (1,098)  -   (1,098)
Net unrealized losses on foreign currency translation, net of tax      -   -   (1)  -   (1)  -   (1)
Issuance of common stock, net of equity issuance costs of $729  937,500   1   6,770   -   -   6,771   -   6,771 
Issuance of common stock  937,500   1   6,770   -   -   6,771   -   6,771 
Exercise of warrants  18,889   -   51   -   -   51       51 
Exercise of options  556   -   2   -   -   2   -   2 
Cashless exercise of options  755   -   -   -   -   -   -   - 
Stock-based compensation      -   196   -   -   196   26   222 
Balance, March 31, 2020  8,961,439  $9  $138,953  $64  $(128,430) $10,596  $3,040  $13,636 
                                 
Net loss     $-  $-  $-  $(1,657) $(1,657) $-  $(1,657)
Net unrealized gains on foreign currency translation, net of tax      -   -   1   -   1   -   1 
Exercise of warrants  21,123   -   112   -   -   112   -   112 
Exercise of options  2,000   -   5   -   -   5   -   5 
Issuance of vested restricted stock  55,111   -   -   -   -   -   -   - 
Stock-based compensation      -   173   -   -   173   6   179 
Balance, June 30, 2020  9,039,673  $9  $139,243  $65  $(130,087) $9,230  $3,046  $12,276 
                                 
Net loss     $-  $-  $-  $(1,012) $(1,012) $-  $(1,012)
Net unrealized gains on foreign currency translation, net of tax      -   -   4       4   -   4 
Stock-based compensation      -   166   -   -   166   6   172 
Balance, September 30, 2020  9,039,673  $9  $139,409  $69  $(131,099) $8,388  $3,052  $11,440 

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

 

65

 

 

NEPHROS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

 

 2021 2020         
 Nine Months Ended September 30,  Six Months Ended June 30, 
 2021 2020  2022 2021 
OPERATING ACTIVITIES:                
Net loss $(2,825) $(3,767) $(3,104) $(1,663)
Adjustments to reconcile net loss to net cash used in operating activities:                
Depreciation of property and equipment  22   18   53   15 
Amortization of intangible assets, license and supply agreement and finance lease right-of-use asset  140   136   143   94 
Stock-based compensation, including stock options and restricted stock  825   573   549   557 
Inventory obsolescence charge  123   4   108   37 
Extinguishment of PPP loan  (482)  -   -   (482)
Change in fair value of contingent consideration  -   (229)
Accretion of contingent consideration  -   14 
(Gain) loss on foreign currency transactions  (4)  7 
Change in lease right-of-use assets  237   233 
Increase (decrease) in operating assets:        
Gain on foreign currency transactions  (60)  (8)
Change in right-of-use assets  174   158 
Decrease (increase) in operating assets:        
Accounts receivable  (191)  144   (487)  (19)
Inventory  532   (2,827)  23   180 
Prepaid expenses and other current assets  170   207   74   144 
Other assets  (14)  (57)  22   (15)
Decrease (increase) in operating liabilities:        
(Decrease) increase in operating liabilities:        
Accounts payable  223   (79)  77   685 
Accrued expenses  402   464   (262)  300 
Lease liabilities  (240)  (218)  (179)  (155)
Net cash used in operating activities  (1,082)  (5,377)  (2,869)  (172)
                
INVESTING ACTIVITIES:                
Purchase of property and equipment  (36)  (239)  (137)  (23)
Payment of direct transaction costs for asset acquisition  (49)  - 
Net cash used in investing activities  (85)  (239)  (137)  (23)
                
FINANCING ACTIVITES:        
Proceeds from issuance of common stock  -   6,771 
Proceeds from Paycheck Protection Program Loan  -   479 
Net payments from secured revolving credit facility  -   (560)
FINANCING ACTIVITIES:        
Proceeds from sale of subsidiary preferred shares to noncontrolling interest  188   - 
Payments on secured note payable  (186)  (172)  (133)  (123)
Principal payments on finance lease liability  (11)  (6)  (3)  (7)
Principal payments on equipment financing  (2)  (2)  (1)  (1)
Proceeds from exercise of warrants  297   163   163   297 
Proceeds from exercise of options  176   7   -   62 
Payment of contingent consideration  -   (79)
Net cash provided by financing activities  274   6,601   214   228 
Effect of foreign exchange rates on cash  (6)  4 
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS  (899)  989 
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD  8,249   4,166 
CASH AND CASH EQUIVALENTS, END OF PERIOD $7,350  $5,155 
Effect of exchange rates on cash and cash equivalents  (2)  (4)
Net (decrease) increase in cash and cash equivalents  (2,794)  29 
Cash and cash equivalents, beginning of period  6,973   8,249 
Cash and cash equivalents, end of period $4,179  $8,278 
                
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION        
Supplemental disclosure of cash flow information        
Cash paid for interest expense $33  $80  $13  $23 
Cash paid for income taxes $42  $21  $-  $35 
                
SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING AND FINANCING INFORMATION        
Supplemental disclosure of noncash investing and financing activities        
Right-of-use asset obtained in exchange for operating lease liability $21  $201  $69  $21 
Right-of-use asset obtained in exchange for finance lease liability $-  $17 
Issuance of common shares for asset acquisition $1,124  $- 

 

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

76

 

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 waterborne 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 water filtration business is a reportable segment, referred to as the Water Filtration segment.

 

The Company’s pathogen detection systems are portable, near real-time systems designed to provide actionable data for infection control teams and other organizations. The pathogen detection systems business is a reportable segment, referred to as the Pathogen Detection segment.

 

In July 2018, the Company formed a new subsidiary, Specialty Renal Products, Inc. (“SRP”), to drive the development of its second-generation hemodiafiltration system and other products focused on improving therapies for patients with renal disease. TheAfter SRP’s formation, the Company transferredassigned to SRP all of the Company’s rights to three patents relating to SRP,the Company’s hemodiafiltration technology, which were carried at zero book value. SRP is a reportable segment, referred to as the Renal Products segment.

 

The Company’s primary U.S. facilities are located at 380 Lackawanna Place, South Orange, New Jersey 07079, 3221 Polaris Avenue, Las Vegas, Nevada 89102 and 1015 Telegraph Street, Unit B, Reno, Nevada 89502. 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 United States and Ireland.States.

 

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 (“GAAP”) 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 as of December 31, 20202021 was derived from the Company’s audited financial statements. Accordingly, they do not include all of the information and footnotes required by GAAP for annual financial statements. Results as of and for the three and ninesix months ended SeptemberJune 30, 20212022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021.2022.

 

The condensed consolidated interim financial statements and notes thereto should be read in conjunction with the consolidated financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020.2021.

 

Consolidation

 

The accompanying condensed consolidated financial statements include the accounts of Nephros, Inc. and its subsidiaries, including the Company’s wholly owned subsidiary Nephros International which was dissolved during the quarter ended June 30, 2022, and SRP, in which the Company maintains a controlling interest is maintained by the Company.interest. Outside stockholders’ 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 condensed consolidated financial statements.

 

Use of Estimates

 

The preparation of consolidated financial statements in conformity with 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, net realizable 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.

87

 

Reclassifications

Certain reclassifications were made to the prior year’s amounts related to the gross up of the changes in lease right-of-use assets and lease liabilities on the condensed consolidated statement of cash flows to conform to the 2021 presentation.

 

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 $134.7138.8 million as of SeptemberJune 30, 2021.2022.

 

On September 5, 2018,In February 2022, pursuant to a First Amendment to Series A Preferred Stock Purchase Agreement (the “Amendment”) among SRP completed a private placement transaction wherebyand the holders of SRP’s outstanding shares of Series A Preferred Stock, SRP issued and sold preferredan additional 100,003 shares equivalent to 37.5% of its outstanding equity interests for aggregateSeries A Preferred Stock at a price of $5.00 per share, resulting in total gross proceeds of $3.0500,015 million. As. See “Note 11 – Stockholders’ Equity – Noncontrolling Interest,” below. In addition to the funds provided by the sale of approximately July 1, 2020, SRP had fully spentthese additional shares of Series A Preferred Stock, the proceeds from this private placement. On October 9, 2020, NephrosCompany and SRP entered intocontinue to maintain a loan agreement under which Nephrosthe Company agreed to lend up to $1.3 million to SRP, including the $1.0 million borrowed during the year ended December 31, 2020. These loaned funds are to bewere used to fund SRP’s operating activities and are expected to be sufficient to fund SRP through the plannedrecent FDA 510(k) clearance process of SRP’s second-generation hemodiafiltration system, which was initially submitted to the FDA for “Special 510(k)” clearance inon February 24, 2021 and resubmitted for “Traditionalwhich received 510(k) clearance in June 2021.on May 13, 2022. As of SeptemberJune 30, 2021,2022, the outstanding balance of this loan, including accrued interest, was $1.31.4 million.

 

Based on cash that is available for the Company’s operations, and projections of future Company operations, and recent expense reduction measures taken by management, the Company believes that its cash balances will be sufficient to fund its current operating plan – including any remaining negative impact of the COVID-19 pandemic – through at least the next 12 months from the date of issuance of the accompanying condensed consolidated financial statements. Additionally,In the event that operations do not meet expectations, the Company may need to further reduce discretionary expenditures such as additional headcount, new R&D projects, and other variable costs to alleviate any substantial doubt as to the Company’s operating plans are designedability to help control operating costs and to increase revenue until such timecontinue as the Company generates sufficient cash flows from operations.a going concern.

 

While significant progress has been made against the COVID-19 pandemic, some uncertainty remains with respect to the Company’s projections regarding the availability of sufficient cash resources, due to the possibility that COVID-19 infections could increase again and cause further disruption to economic conditions. During the pandemic, particularly during calendar year 2020, the Company saw decreased demand for its hospital filtration products, particularly in emergency pathogen outbreak response. In addition, sales to new customers during 2020 – including water filtration and pathogen detection products – were hindered by pandemic-related travel restrictions. Also in 2020, the Company’s commercial filtration products, which are primarily targeted at the hospitality and food service markets, saw a decrease in demand, due to the closure of many hotels and restaurants. The Company believes that broad vaccine distribution and increased population immunity has reduced the probability of further significant negative COVID-19 impacts, but if these decreases in demand return and the Company is unable to achieve its revenue plan, the Company may need to reduce budgeted expenditures as appropriate to preserve its available capital resources, which could slow its revenue growth plans.

 

On April 24, 2020, the Company obtained a loan from the U.S. Small Business Administration’s Paycheck Protection Program (“PPP”) in the amount of $0.5 million (“PPP loan”). Under the terms of the PPP, certain amounts of the loan may be forgiven if they are used for qualifying expenses during the first 24 weeks of the loan. On January 14, 2021, the U.S Small Business Administration notified the Company that, in accordance with the PPP terms, the PPP loan was forgiven in full, including all principal and interest outstanding as of the date of forgiveness. As such, $0.5 million has been recognized as an extinguishment of debt on the Company’s condensed consolidated statement of operations and comprehensive loss.

Recently Adopted Accounting Pronouncements

In December 2019, the FASB issued Accounting Standards Update ("ASU") 2019-12, “Simplifying the Accounting for Income Taxes,” which removes certain exceptions to the general principles of the accounting for income taxes and also improves consistent application of and simplification of other areas when accounting for income taxes. The Company adopted this guidance as of January 1, 2021 and the guidance did not have an impact on its condensed consolidated financial statements.

Recent Accounting Pronouncements, Not Yet Effective

 

In May 2021, the FASB issued ASU 2021-04, “Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options,” which clarifies and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options that remain equity classified after modification or exchange. The guidance is effective for the Company beginning in the first quarter of fiscal year 2022. Early adoption is permitted. The Company is assessing the impact of adoptingadopted this guidance as of January 1, 2022, and the guidance did not have an impact on its condensed consolidated financial statements.

 

Recent Accounting Pronouncements, Not Yet Effective

In October 2021, the FASB issued ASU 2021-08, “Accounting for Contract Assets and Contract Liabilities from Contracts with Customers,” which requires that an entity recognize contract assets and contract liabilities acquired in a business combination in accordance with Accounting Standards Codification (“ASC”) 606. The guidance is effective for the Company beginning in the first quarter of fiscal year 2023 and should be applied prospectively. Early adoption is permitted. The Company will assess the impact, if any, 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.

 

98

 

 

Major Customers

 

For the three months ended SeptemberJune 30, 20212022 and 2020,2021, the following customers, all of which are in the Water Filtration segment, accounted for the following percentages of the Company’s revenues, respectively:

Schedule of Revenues and Accounts Receivable Percentage of Major Customers

        
Customer 2021 2020  2022 2021 
A  26%  17%  17%  14%
B  12%  9%
C  9%  16%  12%  10%
E  11%  6%
D  6%  11%
Total  46%  39%  47%  44%

 

For the ninesix months ended SeptemberJune 30, 20212022 and 2020,2021, the following customers, all of which are in the Water Filtration segment, accounted for the following percentages of the Company’s revenues, respectively:

 

        
Customer 2021 2020  2022 2021 
A  19%  15%  20%  16%
B  10%  3%  12%  13%
C  9%  11%
D  7%  18%
Total  45%  47%  32%  29%

No other customer accounted for 10% or more of the Company’s revenue during the periods presented above.

 

As of SeptemberJune 30, 20212022 and December 31, 2020,2021, the following customers accounted for the following percentages of the Company’s accounts receivable, respectively:

 

        
Customer 2021 2020  2022 2021 
C  13%  19%
A  16%  18%  11%  8%
C  15%  6%
F  11%  1%
B  10%  11%
E  10%  6%  10%  0%
G  2%  12%
Total  54%  43%  44%  38%

Accounts Receivable

 

The Company providesrecognizes an allowance that reflects a current estimate of credit termslosses expected to be incurred over the life of a financial asset, including trade receivables. The Company continuously monitors collections and payments from its customers in connection with purchasesand maintains a provision for estimated credit losses. The Company determines its allowance for doubtful accounts by considering a number of factors, including the length of time balances are past due, the Company’s previous loss history, the customer’s current ability to pay its obligations to the Company and the expected condition of the Company’s products. Management periodically reviews customer account activity in ordergeneral economy and the industry as a whole. The Company writes off accounts receivable when they are determined 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. be uncollectible. The allowance for doubtful accounts was approximately $4,0001,000 and $11,000 as of SeptemberJune 30, 20212022, and December 31, 2020,2021, respectively. There were 0 write-offs of accounts receivable for the three and nine months ended September 30, 2021. Write-offs of accounts receivable were approximately $25,000 for the nine months ended September 30, 2020 which were reserved for in a prior period.

 

Depreciation Expense

 

Depreciation related to equipment utilized in the manufacturing process is recognized in cost of goods sold on the condensed consolidated statements of operations and comprehensive loss. For the three and ninesix months ended SeptemberJune 30, 2021,2022, depreciation expense was approximately $7,00022,000 and $22,00028,000, respectively. Approximately $3,000 of the approximately $7,000 and approximately $11,000 of the $22,000 of depreciation expense for the three and nine months ended September 30, 2021, respectively, has been recognized in the cost of goods sold. For the three and ninesix months ended SeptemberJune 30, 2020,2021, depreciation expense was approximately $8,000 and $18,00015,000, respectively. Approximately $4,000 of the approximately $8,000 and approximately $12,000 of the approximately $18,000 of depreciation expense for the three and nine months ended September 30, 2020, respectively, has been recognized in the cost of goods sold.

10

Note 3 – Asset Acquisition

On July 9, 2021, the Company acquired 100% of GenArraytion, Inc. (“GenArraytion”). The acquisition did not qualify as a business combination and, as a result, was accounted for as an asset acquisition as the fair value of the gross assets acquired was primarily related to a single asset. The Company issued 123,981 shares of the Company’s common stock to GenArraytion, reflecting an aggregate purchase price of $1.2 million. The purchase price, including direct acquisition costs of approximately $49,000, was allocated among the acquired assets which include intellectual property and equipment, based upon their relative fair values at the date of acquisition.

Fifty percent of the 123,981 common shares issued were subject to a risk of forfeiture which lapsed during the three months ended September 30, 2021. The Company will also make royalty payments to GenArraytion equal to 5% of net sales of certain products over the next five years.

The total consideration of $1.2 million was allocated as follows to the acquired assets:

Schedule of Assets Acquired

  Total Consideration 
  (in thousands) 
Intellectual property $1,098 
Equipment  75 
Total consideration $1,173 

The acquired intellectual property is being amortized over its estimated useful life of 10 years.

 

Note 43Revenue Recognition

 

The Company recognizes revenue related to product sales when product is shipped via external logistics providers and the other criteria of ASC 606 are met. Product revenue is recorded net of returns and allowances. There was no allowance for sales returns for the three and ninesix months ended SeptemberJune 30, 20212022 or 2020.2021. In addition to product revenue, the Company recognizes revenue related to royalty and other agreements in accordance with the five-step model in ASC 606. Royalty and other revenues recognized for the three and ninesix months ended SeptemberJune 30, 2022 and 2021 and 2020 areis comprised of:

Schedule of License, RoyalRoyalty and Other RevenueRevenues

 2021  2020  2021  2020                 
 

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

  

Three Months Ended June 30,

  Six Months Ended June 30, 
 2021  2020  2021  2020  2022 2021 2022 2021 
 (in thousands) (in thousands)  (in thousands) (in thousands) 
Royalty revenue under the Bellco License Agreement $15  $20  $44  $49  $-  $15  $-  $29 
Royalty revenue under the Sublicense Agreement with Camelbak (1)  -   -   20   -   -   20   -   20 
Other revenue  27   7   72   45   45   35   55   45 
Total royalty and other revenues $42  $27  $136  $94 
Revenue $42  $27  $136  $94 
Total royalty and other revenue $45  $70  $55  $94 

 

(1)In May 2015, the Company entered into a Sublicense Agreement (the “Sublicense Agreement”) with CamelBak Products, LLC (“CamelBak”). Under this 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 IWTD. 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 was able to 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.

 

9

Bellco License Agreement

 

With regard to the OLpūr MD190 and MD220, onOn June 27, 2011, the Company entered into a License Agreement (the(as thereafter amended, the “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 subsequently recognized as license revenue over the term of the License Agreement.

TheIn addition, the License Agreement as amended, also provides minimum sales targets which, if not satisfied, will, atprovided for the discretionpayment of certain royalties to 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 $2.10) per unit; thereafter, €1.25 (approximately $1.50) per unit.territory. The License Agreement also provides for a fixed royalty payment payable to the Company for the period beginningexpired in accordance with its terms on January 1, 2015 through and including December 31, 2021 if the minimum sales targets are not met.2021.

 

11

Other Revenue – Other revenues are derived from sales of services to customers, which primarily include installation, training and testing on products and equipment sold to certain customers.

Note 54Fair 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.

 

At SeptemberJune 30, 20212022 and December 31, 2020,2021, the Company’s cash equivalents consisted of money market funds. The Company values its cash equivalents using observable inputs that reflect quoted prices for securities with identical characteristics and classify the valuation techniques that use these inputs as Level 1.

 

10

At SeptemberJune 30, 20212022 and December 31, 2020,2021, the fair value measurements of the Company’s assets and liabilities measured on a recurring basis were as follows:

 

Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis

  Fair Value Measurements at Reporting
Date Using
 
  Quoted Prices
in Active
Markets for
Identical
Assets
(Level 1)
  Significant
Other
Observable
Inputs
(Level 2)
  Significant
Unobservable
Inputs
(Level 3)
 
  (in thousands) 
September 30, 2021            
Cash equivalents:            
Money market funds $4,019  $-  $- 
             
December 31, 2020            
Cash equivalents:            
Money market funds $4,011  $-  $- 

During the three and nine months ended September 30, 2020, the Company recognized a change in the fair value of contingent consideration of approximately $0.2 million on its condensed consolidated statement of operations and comprehensive loss. This was due to the settlement of the contingent consideration liability. In October 2020, the Company entered into a Second Amendment to the Membership Interest Purchase Agreement dated December 31, 2018 related to the acquisition of the Aether business, in which the Company agreed to pay a lump sum of $0.1 million in full consideration for the Company’s obligation to make payments of contingent consideration under the Membership Interest Purchase Agreement. As such, there were no outstanding amounts related to contingent consideration on the Company’s consolidated balance sheets as of September 30, 2021 or December 31, 2020.

12

  Fair Value Measurements at Reporting Date Using 
  Quoted Prices in Active Markets for Identical Assets (Level 1)  Significant Other Observable Inputs (Level 2)  Significant Unobservable Inputs (Level 3) 
  (in thousands) 
June 30, 2022            
Cash $2,155  $                  $            
Money market funds  2,024         
Cash and cash equivalents $4,179  $-  $- 
             
December 31, 2021            
Cash $2,952  $   $   
Money market funds  4,021         
Cash and cash equivalents $6,973  $-  $- 

 

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

 

The carrying amounts of accounts receivable, 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, lease liabilities and equipment financing approximate fair value as of SeptemberJune 30, 20212022 and December 31, 20202021 because those financial instruments bear interest at rates that approximate current market rates for similar agreements with similar maturities and credit.

 

Note 65Inventory

 

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 SeptemberJune 30, 20212022 and December 31, 20202021, were as follows:

 Schedule of Inventory, Net

 September 30, 2021  December 31, 2020  June 30, 2022 December 31, 2021 
 (in thousands)  (in thousands) 
Finished goods $3,644  $4,340  $3,639  $3,760 
Raw materials  1,005   964   1,025   1,035 
Total inventory $4,649  $5,304  $4,664  $4,795 

 

Note 76Intangible Assets and Goodwill

 

Intangible Assets, net

 

Intangible assets at SeptemberJune 30, 20212022 and December 31, 20202021 are set forth in the table below. Gross carrying values and accumulated amortization of the Company’s intangible assets by type are as follows:

Schedule of Intangible Assets

 September 30, 2021 December 31, 2020  June 30, 2022 December 31, 2021 
 Cost Accumulated Amortization Net Cost Accumulated Amortization Net  Cost Accumulated Amortization Net Cost Accumulated Amortization Net 
 (in thousands)  (in thousands) 
Tradenames, service marks and domain names $50  $(28) $22  $50  $(20) $30  $50  $(35) $15  $50  $(30) $20 
Intellectual property  1,098   -   1,098   -   -   -   1,098   (82)  1,016   1,098   (26)  1,072 
Customer relationships  540   (87)  453   540   (64)  476   540   (111)  429   540   (96)  444 
Total intangible assets $1,688   (115) $1,573  $590   (84)  506  $1,688  $(228) $1,460  $1,688  $(152) $1,536 

11

The Company recognized amortization expense of approximately $11,00038,000 for each of the three months ended SeptemberJune 30, 20212022 and 2020 and such amounts are included$11,000 for the three months ended June 30, 2021. Of the approximately $38,000, approximately $11,000 was recognized in selling, general and administrative expenses and approximately $27,000 was recognized in cost of goods sold on the accompanying condensed consolidated statement of operations and comprehensive loss.

The Company recognized amortization expense of approximately $76,000 for the six months ended June 30, 2022 and $21,000 for the six months ended June 30, 2021. Of the approximately $76,000, approximately $21,000 for each of the nine months ended September 30, 2021 and 2020 and such amounts are includedwas recognized in selling, general and administrative expenses and approximately $55,000 was recognized in cost of goods sold on the accompanying condensed statement of operations and comprehensive loss.

 

As of SeptemberJune 30, 2021,2022, future amortization expense for each of the next five years is (in thousands):

 

Schedule of Future Amortization Expense

Fiscal Years   
2021 (excluding the nine months ended September 30, 2021) $11 
2022  42 
2023  42 
2024  32 
2025  32 

13

     
Fiscal Years   
2022 (excluding the six months ended June 30, 2022) $76 
2023  152 
2024  142 
2025  142 
2026  142 

 

The Company did 0t recognize any intangible asset impairment charges during the three and ninesix months ended SeptemberJune 30, 20212022 or 2020.2021.

 

Goodwill

 

Goodwill has a carrying value on the Company’s condensed consolidated balance sheets of approximately $0.8 million at SeptemberJune 30, 20212022 and December 31, 2020.2021. Goodwill has been allocated to the Water Filtration segment. The Company concluded the carrying value of goodwill was not impaired as of September 30, 2021 or December 31, 2020 as the Company determined that it was not more likely than not that the fair value of goodwill was less than its carrying value.

 

Note 87License and Supply Agreement, net

 

On April 23, 2012, the Company entered into a License and Supply Agreement (the(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, as amended, 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.

 

In exchange for the license, the gross value of the intangible asset capitalized was $2.3 million. License and supply agreement, net, on the condensed consolidated balance sheet is $0.60.5 million and $0.7 million as of SeptemberJune 30, 20212022 and December 31, 2020,2021, respectively. Accumulated amortization is $1.71.8 million and $1.6 million, respectively, as of SeptemberJune 30, 20212022 and December 31, 2020.2021, 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 SeptemberJune 30, 20212022 and 2020 on the condensed consolidated statement of operations and comprehensive loss. Amortization expense of approximately $100,000 was recognized in each of the nine months ended September 30, 2021 and 2020 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 0 interest recognized for the three or ninesix months ended SeptemberJune 30, 20212022 or SeptemberJune 30, 2020.2021.

 

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 $70,00073,000 and $60,00056,000 for the three months ended SeptemberJune 30, 20212022 and 2020,2021, 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 $198,000132,000 and $173,000128,000 for the ninesix months ended SeptemberJune 30, 20212022 and 2020,2021, 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 $73,000 and $70,000 in royalties are included in accrued expenses as of September 30, 2021. Approximately $68,000 in royalties arethis royalty expense was included in accounts payable as of June 30, 2022 and December 31, 2020.2021, respectively.

 

Note 9 – Secured Revolving Credit Facility

On August 17, 2017, the Company entered into the Loan and Security Agreement, subsequently amended on December 20, 2019 (the “Loan Agreement”) with Tech Capital, LLC (“Tech Capital”). The Loan Agreement provided for a secured asset-based revolving credit facility (the “Revolver”) of up to $2.5 million, which the Company drew upon and repaid from time to time during the term of the Loan Agreement. The Company used these proceeds for working capital and general corporate purposes.

On May 26, 2020, the Company terminated the Revolver and, as a result, recognized fees of approximately $7,000, which are included in interest expense on the consolidated statement of operations and comprehensive loss for the year ended December 31, 2020. Although the Revolver was terminated, the Loan Agreement, as amended on May 26, 2020 to reflect this termination, remains in place for purposes of specifying obligations related to the Secured Note (see Note 10 – Secured Note Payable).

For the three and nine months ended September 30, 2020, excluding approximately $7,000 related to the termination of the Revolver, approximately $17,000 and $40,000, respectively, was recognized as interest expense on the condensed consolidated statement of operations and comprehensive loss.

1412

 

 

Note 108Secured 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 $1.2 million. The Secured Note was amended and restated on May 26, 2020 to reflect the then-current balance on the Secured Note. There were no other changes to the terms and conditions of the Secured Note. As of SeptemberJune 30, 2021,2022, the principal balance of the Secured Note was $0.40.2 million.

 

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, 20182018.. 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 (see Note 9 – Secured Revolving Credit Facility)entered into on August 17, 2017 and subsequently on December 20, 2019 (the “Loan Agreement”). An event of default under such Loan Agreement is an event of default under the Secured Note and vice versa. In addition, the accounts receivable, inventory, and other assets of Nephros International Limited, a wholly-owned subsidiary of the Company, are available collateral in meeting the Company’s obligations under the Loan Agreement.

 

During each of the three months ended SeptemberJune 30, 20212022 and 2020,2021, the Company made payments under the Secured Note of approximately $72,000 and $73,000, respectively.. Included in the total payments made, approximately $9,0005,000 and $14,00010,000, respectively, was recognized as interest expense on the condensed consolidated statement of operations and comprehensive loss for the threesix months ended SeptemberJune 30, 20212022 and 2020.2021. During each of the ninesix months ended SeptemberJune 30, 20212022 and 2020,2021, the Company made payments under the Secured Note of approximately $216,000144,000 and $217,000, respectively.. Included in the total payments made, approximately $30,00011,000 and $45,00022,000 was recognized as interest expense on the condensed consolidated statements of operations and comprehensive loss for the ninesix months ended SeptemberJune 30, 20212022 and 2020,2021, respectively.

 

As of SeptemberJune 30, 2021,2022, future principal maturities are as follows (in thousands):

Schedule of Future Debt Principal Maturities

    
Fiscal Years      
2021 (excluding the nine months ended September 30, 2021) $43 
2022  269 
2022 (excluding the six months ended June 30, 2022) $115 
2023  95   95 
Total $407  $210 

 

Note 119Leases

 

The Company has operating leases for corporate offices, an automobile and office equipment. The leases have remaining lease terms of 1 year to 43 years.

 

Lease cost, as presented below, includes costs associated with leases for which right-of-use (“ROU”) assets have been recognized as well as short-term leases.

 

The components of total lease costs were as follows:

Schedule of Components of Lease Cost

        
 Three months ended September 30, 2021 Three months ended September 30, 2020  

Three months ended

June 30, 2022

 

Three months ended

June 30, 2021

 
 (in thousands)  (in thousands) 
Operating lease cost $

98

  $105  $102  $99 
Finance lease cost:                
Amortization of right-of-use assets  3   3   1   2 
Interest on lease liabilities  1   -   1   1 
Total finance lease cost  4   3   2   3 
Variable lease cost  

17

   7   10   10 
Total lease cost $119  $115  $114  $112 

 

1513

 

 

        
 Nine months ended September 30, 2021 Nine months ended September 30, 2020  

Six months ended

June 30, 2022

 

Six months ended

June 30, 2021

 
 (in thousands)  (in thousands) 
Operating lease cost $294  $300  $213  $200 
Finance lease cost:                
Amortization of right-of-use assets  9   4   5   5 
Interest on lease liabilities  2   1   3   2 
Total finance lease cost  11   5   8   7 
Variable lease cost  36   30   19   19 
Total lease cost $341  $335  $240  $226 

 

Supplemental cash flow information related to leases was as follows:

Schedule of Supplemental Cash Flow Information Related to Leases

        
 Nine months ended September 30, 2021 Nine months ended September 30, 2020  

Six months ended

June 30, 2022

 

Six months ended

June 30, 2021

 
 (in thousands)  (in thousands) 
Cash paid for amounts included in the measurement of lease liabilities:             
Operating cash flows from operating leases $316  $293  $211  $208 
Financing cash flows from finance leases $9  $5  $3  $7 

 

Supplemental balance sheet information related to leases was as follows:

Schedule of Supplemental Balance Sheet Information Related to Leases

  September 30, 2021  December 31, 2020 
  (in thousands) 
Operating lease right-of-use assets $787  $1,002 
Finance lease right-of-use assets $27  $35 
         
Current portion of operating lease liabilities $354  $321 
Operating lease liabilities, net of current portion  483   735 
Total operating lease liabilities $837  $1,056 
         
Current portion of finance lease liabilities $12  $11 
Finance lease liabilities, net of current portion  15   24 
Total finance lease liabilities $27  $35 
         
Weighted average remaining lease term        
Operating leases  2.5 years   3.1 years 
Finance leases  2.4 years   3.3 years 
         
Weighted average discount rate        
Operating leases  8.0%  8.0%
Finance leases  8.0%  8.0%

         
  June 30, 2022  December 31, 2021 
   (in thousands) 
Operating lease right-of-use assets $608  $867 
Finance lease right-of-use assets $18  $30 
         
Current portion of operating lease liabilities $295  $344 
Operating lease liabilities, net of current portion  350   575 
Total operating lease liabilities $645  $919 
         
Current portion of finance lease liabilities $10  $12 
Finance lease liabilities, net of current portion  8   18 
Total finance lease liabilities $18  $30 
         
Weighted average remaining lease term        
Operating leases   2.1 years    2.7 years 
Finance leases   1.8 years    2.7 years 
         
Weighted average discount rate        
Operating leases  8.0%  8.0%
Finance leases  8.0%  8.0%

 

As of SeptemberJune 30, 2021,2022, maturities of lease liabilities were as follows:

Schedule of Maturities of Lease Liabilities

  Operating Leases  Finance Leases 
  (in thousands) 
2021 (excluding the nine months ended September 30, 2021) $100  $3 
2022  395   14 
2023  269   8 
2024  156   7 
2025  -   4 
Total future minimum lease payments  920   36 
Less imputed interest  (83)  (9)
Total $837  $27 

  Operating Leases    Finance Leases   
  (in thousands) 
2022 (excluding the six months ended June 30, 2022) $196  $7 
2023  276   8 
2024  204   7 
2025  25   4 
2026  -   - 
Total future minimum lease payments  701   26 
Less imputed interest  (56)  (8)
Total $645  $18 

1614

 

Note 1210Stock 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 calculates 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.

 

Stock Options

 

The Company granted stock options to purchase 59,868239,000 and 232,296254,500 shares of common stock, respectively, to employees during the three and ninesix months ended SeptemberJune 30, 2021.2022. 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 ninesix months ended SeptemberJune 30, 2021, respectively,2022, was approximately $0.3 million and $1.2 million.

 

The fair value of each option grant is estimated on the date of grant using the Black-Scholes option pricing model. The below 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 ninesix months ended SeptemberJune 30, 2021.2022.

 Schedule of Fair Value Assumptions

Assumptions for Option Grants   
Stock Price Volatility  71.6075.24%
Risk-Free Interest Rate  0.812.68%
Expected Life (in years)  6.185.59 
Expected Dividend Yield  -%

 

Stock-based compensation expense related to stock options was approximately $212,000242,000 and $166,000215,000 for the three months ended SeptemberJune 30, 20212022 and 2020,2021, respectively. For the three months ended SeptemberJune 30, 2021,2022, approximately $203,000225,000 and $12,00017,000 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 SeptemberJune 30, 2020,2021, approximately $150,000203,000 and $16,00012,000 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 stock options was $661,000473,000 and $483,000448,000 for the ninesix months ended SeptemberJune 30, 20212022 and 2020,2021, respectively. For the ninesix months ended SeptemberJune 30, 2021,2022, approximately $626,000443,000 and $35,00030,000 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 ninesix months ended SeptemberJune 30, 2020,2021, approximately $435,000424,000 and $48,00024,000 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.

 

There was 0 tax benefit related to expense recognized in the three or ninesix months ended SeptemberJune 30, 20212022 and 2020,2021, as the Company is in a net operating loss position. As of SeptemberJune 30, 2021, there was $2.0 million of total unrecognized compensation expense related to unvested stock-based awards granted under the equity compensation plans, which will be amortized over the weighted average remaining requisite service period of 4.5 years.

Restricted Stock

Total stock-based compensation expense for restricted stock on the Company’s condensed consolidated statement of operations and comprehensive loss was approximately $55,000 for the three months ended September 30, 2021 and is included in selling, general and administrative expenses. There was 0 stock-based compensation expense for restricted stock recognized during the three months ended September 30, 2020.

Total stock-based compensation expense for restricted stock was approximately $161,000 and $52,000 for the nine months ended September 30, 2021 and 2020, respectively. For the nine months ended September 30, 2021, approximately $161,000 is included in selling, general and administrative expenses on the accompanying condensed consolidated statement of operations and comprehensive loss. For the nine months ended September 30, 2020, approximately $42,000 and $10,000 are included in selling, general and administrative expenses and research and development expenses, respectively, on the accompanying condensed consolidation statement of operations and comprehensive loss.

Approximately $168,000 of restricted stock was granted to employees during the three and nine months ended September 30, 2021 for services rendered during the year ended December 31, 2020.

As of September 30, 2021,2022, there was approximately $213,0002.1 million of total unrecognized compensation expense related to unvested stock-based awards granted under the equity compensation plans, which will be amortized over the weighted average remaining requisite service period of 2.4 years.

 

Restricted Stock

Total stock-based compensation expense for restricted stock on the Company’s condensed consolidated statement of operations was approximately $17,000 and $65,000 for the three months ended June 30, 2022 and 2021, respectively. For the three months ended June 30, 2022, approximately $17,000 is included in selling, general and administrative expenses on the accompanying condensed consolidated statement of operations and comprehensive loss. For the three months ended June 30, 2021, approximately $65,000 is 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 $58,000 and $106,000 for the six months ended June 30, 2022 and 2021, respectively. For the six months ended June 30, 2022, approximately $58,000 is included in selling, general and administrative expenses and research and development expenses on the accompanying condensed consolidated statement of operations and comprehensive loss. For the six months ended June 30, 2021, approximately $106,000 is included in selling, general and administrative expenses and research and development expenses, on the accompanying condensed consolidation statement of operations and comprehensive loss.

1715

 

As of June 30, 2022, there was approximately $114,000 of unrecognized compensation expense related to 15,000 unvested stock-based awards granted under the equity compensation plans, which will be amortized over the weighted average remaining requisite service period of 2.6 years.

 

The aggregate shares of common stock legally issued and outstanding as of SeptemberJune 30, 20212022 is greater than the aggregate shares of common stock outstanding for accounting purposes by the amount of unvested restricted shares.

 

SRP Equity Incentive Plan

SRP’s 2019 Equity Incentive Plan (the “SRP Plan”) was approved on May 7, 2019 under which 150,000 shares of SRP’s common stock are reserved for the issuance of options, restricted stock and other stock awards.

 

There wereSRP issued 029,880 shares of restricted stock pursuant to the SRP stock options grantedPlan during the three or nineand six months ended SeptemberJune 30, 2021. There was no stock-based2022. Stock-based compensation expense related to the SRP stock optionsgrants was approximately $18,000, for the three and six months ended SeptemberJune 30, 2021. There was approximately $3,000 recognized for stock-based compensation expense for the nine months ended September 30, 2021 which2022 and was included in selling, general and administrative expenses on the accompanying condensed consolidated statement of operations and comprehensive loss.

 

Stock-based compensation expense related to the SRP stock optionsgrants was approximately $6,0001,000 and $38,0003,000, respectively, for the three and ninesix months ended SeptemberJune 30, 2020.2021 and For the three months ended September 30, 2020, approximately $2,000 and $4,000 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 nine months ended September 30, 2020, approximately $16,000 and $22,000are 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 September 30, 2021, all outstanding SRP stock options were vested. SRP stock options weregrants are expensed over the respective vesting period, which was based on a service condition. Stock-based compensation expense related to the SRP stock optionsgrants is presented by the Company as noncontrolling interest on the consolidated balance sheets as of SeptemberJune 30, 20212022 and December 30, 2020.31, 2021.

 

Note 1311Stockholders’ Equity

July 2021 Common Stock Issuance

On July 9, 2021, the Company issued 123,981 shares of common stock to acquire 100% of GenArraytion. The purchase price was $1.2 million, including transaction costs of approximately $49,000, and was allocated among the acquired assets based upon their relative fair values at the date of acquisition. Fifty percent of the 123,981 common shares issued were subject to a risk of forfeiture which lapsed during the three months ended September 30, 2021.

February 2020 Common Stock Issuance

On February 4, 2020, the Company issued 937,500 shares of common stock through a public offering resulting in gross proceeds to the Company of $7.5 million. The purchase price for each share was $8.00. Proceeds, net of equity issuance costs of $0.7 million, recorded as a result of the offering were $6.8 million.

 

Noncontrolling Interest

 

On September 5, 2018,February 1, 2022, SRP entered into a First Amendment to Series A Preferred Stock Purchase Agreement (the “SRP Amendment”) with certainthe holders of SRP’s outstanding shares of Series A Preferred Stock. The SRP Amendment amended the terms of the Series A Preferred Stock Purchase Agreement, dated September 9, 2018, among SRP and the purchasers identified therein (the “SRP Purchase Agreement”), pursuant to which SRP had sold to such purchasers an aggregate of 600,000 shares of its Series A Preferred Stock (“Series A Preferred”) forat a price of $5.00 per share. The aggregate purchase price wasshare resulting in total gross proceeds of $3.0 million. The purpose of the SRP incurred transaction-related expensesAmendment was to permit SRP to sell up to an additional 100,003 shares of approximately $30,000, which were included in selling, generalits Series A Preferred Stock at one or more closings to occur by February 28, 2022, and administrative expenses on the same terms and conditions as otherwise set forth in the SRP Purchase Agreement. Pursuant to the SRP Amendment, on February 4, 2022, SRP conducted a closing in which it sold 100,003 shares of Series A Preferred Stock, resulting in gross proceeds of $500,015. The Company purchased 62,500 shares of SRP’s Series A Preferred at such closing and, as a result, maintained its 62.5% stock ownership position in SRP. The other purchasers at the February 4, 2022 closing included the Company’s consolidated statementChief Executive Officer, who purchased 313 shares, and Lambda Investors LLC (“Lambda”), an affiliate of operationsWexford Capital, which beneficially owns approximately 36% of the Company’s common stock, which purchased 25,938 shares of SRP Series A Preferred Stock. Such purchases were made on the same terms as all other purchasers. In addition to the funds provided by the Series A Purchase Agreement, Nephros and comprehensive loss forSRP continue to maintain a loan agreement under which Nephros agreed to lend up to $1.3 million to SRP, including the $1.0 million borrowed during the year ended December 31, 2018. The net proceeds from2020. These loaned funds were used to fund SRP’s operating activities through the issuancerecent FDA 510(k) clearance process of SRP’s second-generation hemodiafiltration system, which was initially submitted to the Series A Preferred were restricted to SRP expensesFDA on February 24, 2021 and may not be used for the benefitwhich received 510(k) clearance on May 13, 2022. As 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% ofJune 30, 2022, the outstanding common shares, and holdersbalance of Series A Preferred retained a 37.5%this loan, including accrued interest, in SRP on a fully diluted basis, holding was $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 the Company’s largest stockholder amounted to 18,0001.4 and 400,000 shares, respectively.million.


 

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.

18

 

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.

16

 

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 consolidated interim 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 0 warrants exercised duringDuring the three months ended SeptemberJune 30, 2021. During the nine months ended September 30, 2021, the Company issued an aggregate of2022, no warrants were exercised. Warrants to purchase 120,96663,102 shares of itsthe Company’s common stock upon the exercise of outstanding warrants relating to an aggregate of 126,008 shares of common stock. Of such 120,966 shares issued, 110,003 were issued in cash exercises resulting in gross proceeds to the Company of $0.3 million (the “Cash Exercises”) and 10,963 shares were issued in connection with cashless (net) exercises of outstanding warrant relating to 16,005 shares of common stock (the “Cashless Exercises”). Among the shares issued in connection with the Cash Exercises, 66,667 shares were issued to the Company’s largest stockholder, which resulted in proceeds to the Company of $0.2 million. Among the Cashless Exercises, 4,570 shares of common stock were issued to persons affiliated with members of the Company’s management upon the exercise of warrants relating to 6,669 shares.expired unexercised.

 

During the threesix months ended SeptemberJune 30, 2020, there were 0 warrants exercised. During the nine months ended September 30, 2020,2022, warrants to purchase 40,01260,374 shares of the Company’s common stock were exercised, resulting in proceeds of $0.2 million and the issuance of 40,01260,374 shares of the Company’s common stock. Of the warrants exercised during the six months ended June 30, 2022, warrants to purchase 14,815 shares of the Company’s common stock were exercised by members of management, resulting in proceeds of approximately $40,000.

Note 1412Net 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 and unvested restricted stock, 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.

 

19

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

 Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share

 September 30, June 30, 
 2021 2020 2022 2021 
Shares underlying warrants outstanding  123,476   270,597   -   123,476 
Shares underlying options outstanding  1,298,172   1,159,655   1,603,835   1,262,263 
Unvested restricted stock  40,557       15,000   64,338 

17

 

Note 1513Commitments and Contingencies

 

Purchase Commitments

 

In exchange for the rights granted under the License and Supply Agreement with Medica (see Note 87 – 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 ended December 31, 2021,2022, the Company has agreed to make minimum annual aggregate purchases from Medica of €3.33.5 million (approximately $4.03.8 million). As of SeptemberJune 30, 2021,2022, the Company’s aggregate purchase commitments totaled €2.82.1 million (approximately $3.32.3 million).

 

Contractual Obligations

 

See Note 119 – Leases for a discussion of the Company’s contractual obligations.

 

Note 1614Segment Reporting

 

The Company has defined three reportable segments: Water Filtration, Pathogen Detection and Renal Products. The Water Filtration segment primarily develops and sells high performance water purification filters. The Pathogen Detection segment develops and sells portable, real-time water testing systems designed to provide actionable data on waterborne pathogens in approximately one hour. The Renal Products segment is focused on the development of medical device products for patients with renal disease, including a 2ndgeneration 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. Items below loss from operations are not reported by segment, since they are excluded from the measure of segment profitability reviewed by the Company’s chief operating decision maker. The Company does not report balance sheet information by segment since such information is not reviewed by the Company’s chief operating decision maker.

 

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, 2020.2021.

 

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:

Schedule of Segment Information

                
 Three Months Ended June 30, 2022 
 

Three Months Ended September 30, 2021

(in thousands)

  (in thousands) 
  Water Filtration   Pathogen Detection   Renal Products   Nephros, Inc. Consolidated  Water Filtration Pathogen Detection Renal Products Nephros, Inc. Consolidated 
Total net revenues $2,578  $59  $-  $2,637  $2,849  $35  $-  $2,884 
Gross margin  1,360   52   -   1,412 
Gross margin (loss)  1,407   (46)  -   1,361 
Research and development expenses  363   237   32   632   205   159   67   431 
Depreciation and amortization expense  49   1   -   50   63   1   -   64 
Selling, general and administrative expenses  1,703   175   14   1,892   1,804   184   82   2,070 
Change in fair value of contingent consideration               
Total operating expenses  2,115   413   46   2,574   2,072   344   149   2,565 
Loss from operations $(755) $(361) $(46) $(1,162) $(665) $(390) $(149) $(1,204)

 

                 
  Six Months Ended June 30, 2022 
  (in thousands) 
  Water Filtration  Pathogen Detection  Renal Products  Nephros, Inc. Consolidated 
Total net revenues $5,008  $63  $-  $5,071 
Gross margin (loss)  2,460   (74)  -   2,386 
Research and development expenses  460   365   184   1,009 
Depreciation and amortization expense  114   2   -   116 
Selling, general and administrative expenses  3,953   356   109   4,418 
Total operating expenses  4,528   722   293   5,543 
Loss from operations $(2,068) $(796) $(293) $(3,157) 

2018

 

 

                
 Three Months Ended June 30, 2021 
 

Nine Months Ended September 30, 2021

(in thousands)

  (in thousands) 
  Water Filtration   Pathogen Detection   Renal Products   Nephros, Inc. Consolidated  Water Filtration Pathogen Detection 

Renal

Products

 Nephros, Inc. Consolidated 
Total net revenues $7,504  $135  $-  $7,639  $2,190  $76  $-  $2,266 
Gross margin  4,162   112   -   4,274   1,215   60   -   1,275 
Research and development expenses  961   505   209   1,675   305   149   33   487 
Depreciation and amortization expense  150   1   -   151   51   -   -   51 
Selling, general and administrative expenses  5,314   372   59   5,745   1,735   96   23   1,854 
Total operating expenses  6,425   878   268   7,571   2,091   245   56   2,392 
Loss from operations $(2,263) $(766) $(268) $(3,297) $(876) $(185) $(56) $(1,117)

 

                
 Six Months Ended June 30, 2021 
 

Three Months Ended September 30, 2020

(in thousands)

  (in thousands) 
  Water Filtration   Pathogen Detection   Renal Products   Nephros, Inc. Consolidated  Water Filtration Pathogen Detection 

Renal

Products

 Nephros, Inc. Consolidated 
Total net revenues $2,121  $-  $-  $2,121  $4,926  $76  $-  $5,002 
Gross margin  1,227   (2)  -   1,225   2,802   60   -   2,862 
Research and development expenses  359   49   343   751   598   268   177   1,043 
Depreciation and amortization expense  49   -   -   49   101   -   -   101 
Selling, general and administrative expenses  1,317   116   111   1,544   3,612   196   45   3,853 
Change in fair value of contingent consideration  (187)  -   -   (187)
Total operating expenses  1,538   165   454   2,157   4,311   464   222   4,997 
Loss from operations $(311) $(167) $(454) $(932) $(1,509) $(404) $(222) $(2,135)

 

  

Nine Months Ended September 30, 2020

(in thousands)

 
   Water Filtration   Pathogen Detection   Renal Products   Nephros, Inc. Consolidated 
Total net revenues $6,199  $28  $-  $6,227 
Gross margin  3,597   14   -   3,611 
Research and development expenses  1,014   206   930   2,150 
Depreciation and amortization expense  142   -   -   142 
Selling, general and administrative expenses  4,381   377   346   5,104 
Change in fair value of contingent consideration  (229)  -   -   (229)
Total operating expenses  5,308   583   1,276   7,167 
Loss from operations $(1,711) $(569) $(1,276) $(3,556)

2119

 

 

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

 

The following discussion should be read in conjunction with our condensed consolidated financial statements and notes thereto included in Item 1 of Part I of this Quarterly Report on Form 10-Q. This discussion includes forward-looking statements about our business, financial condition and results of operations including discussions about management’s expectations for our business. These statements represent projections, beliefs and expectations based on current circumstances and conditions and in light of recent events and trends, and these statements should not be construed either as assurances of performances or as promises of a given course of action. Instead, various known and unknown factors are likely to cause our actual performance and management’s actions to vary, and the results of these variances may be both material and adverse.

 

Business Overview

 

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

 

In medical markets, we sell water filtration products and waterborne pathogen detection products. Our medical water filters, mostly classified as ultrafilters, are used primarily by hospitals for the prevention of infection from waterborne 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 water 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 marketed primarily to the food service, hospitality, convenience store, and health care markets.

 

Our pathogen detection systems are portable, near real-time systems designed to provide actionable data for testing laboratories, infection control teams, biomedical engineers in dialysis clinics, and water quality teams in building management organizations.

 

We also have a subsidiary, Specialty Renal Products, Inc. (“SRP”), a development-stage medical device company, focused primarily on developing hemodiafiltration (“HDF”) technology. SRP is developing aOn May 13, 2022, the FDA gave 510(k) clearance to SRP’s second-generation model of the Nephros OLpūr H2H Hemodiafiltration System, the FDA 510(k)-cleared medical device thatwhich enables nephrologists to provide HDF treatment to patients with end stage renal disease (“ESRD”).

 

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.

 

COVID-19 Pandemic

 

Most customers and prospects – including healthcare, hospitality, and food and beverage–beverage – have begun to re-openre-opened to our sales activity as the country has progressed through the COVID-19 pandemic. Furthermore,In addition, our filter emergency response business has begun to normalize.normalized. We expect the pandemic to continue its overall trend toward abatement in the coming months, but recent infection increases from new viral variants such as the Delta variant may interrupt that abatement for a period of time.from time to time, as has occurred with the Delta and Omicron variants.

 

During the pandemic, we maintained full operations, supporting our customers and strategic partners, with no significant interruptions in supply chain or service capabilities.

 

We believe that, as the COVID-19 pandemic generally subsides, we may experience a net positive impact on demand for our products, due especially to increased global awareness of infectious pathogens and the serious problems they cause. Specifically, we expect that:

 

Purchase decisions for infection control filtration that had been deferred, both in new and existing customer organizations, may be re-prioritized.
Demand for our pathogen detection products may increase as unoccupied buildings, including office buildings and hotels, are readied for re-occupation. Extended periods of low, or no, water flow through building piping creates opportunities for biofilm propagation – a problem our strategic partners are trained to eradicate.
Demand for our commercial filtration products may increase as business returns to hotels, casinos, and restaurants.

 

2220

 

 

Our Products

 

Water Filtration Products

 

We develop and sell water filtration products used in both medical and commercial applications. Our water filtration products employ multiple filtration technologies, as described below.

 

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 waterborne 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.

 

Our primary sales strategy in medical markets is to sell through value-added resellers (“VARs”). Leveraging VARs has enabled us to expand rapidly our access to target customers without significant sales staff expansion. In addition, while we are currently focused inon 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.

 

In commercial markets, we develop and sell our Nephros- and AETHER-branded filters, for which 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.

 

Our Aether filter offerings have the potential to generate accretive revenue growth in at least three ways. First, we expect the business to continue its organic growth. Second, cross-selling opportunities are generated by offering taste/odor-focused products to the medical markets, as well as pathogen-focused filtration to the commercial markets. Finally, as part of the more substantial Nephros organization, Aether may be able to compete for larger filtration contracts than may have been available to it as a smaller, independent firm. In the year since we acquired the AETHER brand, we have seen some promising results in each of these strategies, but it is still too early to judge the likelihood or magnitude of their long-term success.

 

In commercial markets, our model combines both direct and indirect sales. Our sales staff have sold products directly to a number of convenience stores, hotels, casinos, and restaurants. We are also pursuing large corporate contracts through partnerships.

 

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.hands.
Dialysis Centers:Centers and Home/Portable Dialysis Machines: 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. Nephros filters are a leading tool used to provide proactive protection to patients in high-risk areas (e.g., ice machines, surgical rooms, NICUs) and reactive protection to patients in broader areas during periods of water pathogen outbreaks. Our products are used in hundreds of medical facilities to aid in infection control, both proactively and reactively.

 

AccordingAs of 2019, according to the American Hospital Association, there are approximately 6,2006,100 hospitals in the U.S., with approximately 931,000 beds, treated921,000 beds. In 2019, over 36 million patients in the United States in 2017.were admitted to these hospitals. The U.S. Centers for Disease Control and Prevention (“CDC”) estimates that healthcare associated infections (“HAI”) occurredoccur in approximately 1 out of every 31 hospital patients, or about 687,000which calculates to over 1 million patients in 2015.2019. 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.

 

In June 2017,January 2022, the Center for Clinical Standards and Quality at the Centers for Medicare and Medicaid Services (“CMS”) announced the addition ofexpanded its requirements – originally implemented in 2017 – 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,In this 2022 update, CMS requires teams to be assigned to the development of formal water management plans (“WMPs”), as well as detailed documentation regarding the development of the WMPs and their execution. CMS surveyors willregularly 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.

 

2321

 

 

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

 

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.

Dialysis Centers - Water/Bicarbonate. In the dialysis water market, Nephros ultrafiltration products are among the highest performing products on the market. The DSU-D, SSU-D and the SSUmini have become the standard endotoxin filter in many portable reverse osmosis systems. The EndoPur®, our large-format ultrafilter targeted at dialysis clinic water systems, provides the smallest pore size available. Following a long pilot project at a major dialysis provider, we are now seeing growth in the use of this product. In addition, we aim to expand EndoPur’s usage into heat-disinfected water systems, which we anticipate will further open the market for this product.

 

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.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 a cartridge-based, “plug and play” market entry that requires no plumbing at installation or replacement. The EndoPur is available in 10”, 20”, and 30” configurations.configuration.

 

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. In addition, the recently acquired AETHER brand expandsexpanded our product line to include water filtration and purification technologies that are primarily focused on improving odor and taste and on reducing scale and heavy metals from filtered water.

 

We purchased the AETHER brand to expedite our access to commercial markets and to expand our filtration expertise and capabilities. Our commercial market focus is inon the hotel, restaurant, and convenience store markets. In the first yearfirst-year post-acquisition, we upgraded Aether facilities to increase production and logistics capacity, integrated Aether products into the Nephros infection control product portfolio, and initiated sales efforts with a number ofseveral large commercial customers. In March 2022, we closed a contract to provide water filtration systems to an organization of approximately 3,000 Quick Service Restaurants (“QSR”). We have recently addedcontinue to our commercial sales team and, going forward, expect to close on one or more large contracts thatpursue other national accounts, which may result in step-change increases in commercial market revenue.

 

2422

 

 

Over time, we believe that the same water safety management programs currently underway at medical facilities may migrate to commercial markets. As the epidemiology of waterborne pathogens expands, links to contamination sources will become more efficient and the data more readily available. In cases where those sources are linked to restaurants, hotels, office buildings and residential complexes, the corporate owners of those facilities will likely face increasing liability exposure. We expect that building owners will come to understand ASHRAE-188, which outlines risk factors for buildings and their occupants, and provides water safety management guidelines. We believe, in time, most commercial buildings will need to follow the basic requirements of ASHRAE-188: create a water management plan, perform routine testing, and establish a plan to treat the building in the event of a positive test.

 

As demand for water testing and microbiological filtration grows, we will be ready to deploy our expertise and solutions based on years of experience servicing the medical market. We believe that we have an opportunity to offer unique expertise and products to the commercial market, and that our future revenue from the commercial market could even surpass our infection control revenue.

 

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

 

 The NanoGuard set of products are in-line, 0.005-micron ultrafilter that provides dual-stage retention of any organic or inorganic particle larger than 15,000 Daltons. NanoGuard products are designed to fit a variety of existing plumbing configurations, including 10” and 20” standard housings, and AETHER and Everpure® manifolds. Included in the NanoGuard product line are both conventional and flushable filters.filters.

 The AETHER line of commercial filters, which are also sold under the Nephros brand, provide a variety of technology solutions that improve water quality in food service, convenience store, hospitality, and industrial applications. AETHER filters improve water taste and odor, and reduce sediment, dirt, rust particles and other solids, chlorine and heavy minerals, lime scale build-up, and both particulate lead and soluble lead.

 

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.

 

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 were able to 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. Related to this Sublicense Agreement, there was no royalty revenue recognized during the three and six months ended June 30, 2022, and approximately $20,000 of revenue was recognized in the three and ninesix months ended SeptemberJune 30, 2021. There was no royalty revenue recognized during the three or nine months ended September 30, 2020. CamelBak product sales have been slower than originally expected. However, military contracts often take years to close, and we remain optimistic about these products and markets.

 

Pathogen Detection Systems (“PDS”)

 

Pathogen Detection in Infection Control. We recently expanded our portfolio of solutions with the introduction of our PluraPath™ pathogen detection system, which we believe represents a significant growth opportunity for Nephros.

 

We developed the PluraPath pathogen detection system to provide real-time data to infection control teams executing their water management plans. We integrated our ultrafilter technology with emerging, quantitative polymerase chain reaction (qPCR) technology and real-time analytics. We chose a portable, open-source qPCR platform that allows us to parallel-processesparallel-process up to 15 different bacteria and virus assays. We worked with industry experts to select and develop DNA- and RNA-based assays that could meet our goals of providing quantitative precision within one hour. We also developed a mobile application to extract and process the data real-time. Furthermore, we designed the system so that anyone can perform qPCR testing, not just someone with training in microbiological laboratory techniques.

 

2523

 

 

With the PluraPath system, it will be possible to map and track the changes to levels of multiple bacterial and viral pathogens in a building’s water system on a real-time basis, at cost levels equivalent to assays that currently take 24-72 hours or more and typically provide data on only a single pathogen. Using PluraPath, we expect that infection control teams will be able to quickly assess approximate levels of a broad array of pathogens in their water systems, and optimally focus their secondary disinfection efforts and point-of-use filtration; services and products offered by our strategic partners.

 

The PluraPath system does not replace culture-based assays, which are the current regulatory requirements for confirmation in testing for waterborne pathogens. Rather, we believe PluraPath will become a valuable tool in the arsenal of defense, permitting faster decision making about a larger target population of pathogens. Our objective is to provide our customers and strategic partners with a user-friendly system that delivers dependable, actionable data to infection control teams in less than an hour.

Pathogen Detection in Centralized Testing Laboratories. Due to qPCR testing’s accuracy, ability to automate, and its cost efficiencies, we expect that centralized testing laboratories will increasingly migrate their standard testing to qPCR technologies in the coming years. Nephros PDS is well positioned to assist in this strategic transformation. We are pursuing relationships with multiple centralized laboratories and testing service providers.

Pathogen Detection in Dialysis Facilities. We have also been investigating pathogen detection efforts in the dialysis space. The LAL (limulus amebocyte lysate) test is a dialysis industry standard assay that identifies the presence of potential endotoxins, agnostic to the source species. The source of endotoxins are gram-negative bacteria. LAL testing routinely takes 48-72 hours to provide results from the time of shipping the sample to a central laboratory. When dialysis clinics have urgent contamination or severely elevated endotoxin issues, they may have to shut down for extended periods of time creating enormous logistical issues for patients and increasing the cost of care.

 

To provide a real-time solution for this testing paradigm, we announceddeveloped the DialyPath™ pathogen detection and endotoxin estimation system in October 2020.system. The DialyPath system mirrors our PluraPath but includes a gram-negative DNA marker test and test for six different gram-negative bacteria. The DialyPath system is designed to provide data on two test samples in one run in less than one hour. The system will provide an estimate of the overall endotoxin in the sample, as well as estimated levels of six specific endotoxin-generating bacteria known to be frequent invaders of dialysis clinic water systems.

 

Facility-Wide Pathogen Detection. Bacterial contaminants in water systems can originate from thousands of different bacterial families. The technology now exists to map the water system biome in real-time, on-site, using an enhanced form of the portable PluraPath system and a bioinformatics database. The SequaPath system provides the capability to screen water for over 20,000 different bacterial genera (families), including genera of the 40+ pathogenic bacteria listed by the Centers for Disease Control & Prevention (CDC)(“CDC”) in their “Opportunistic Pathogens of Premise Plumbing.” The system incorporates our proprietary filtration technology and a DNA sequencing step that makes it possible to screen rapidly for genera of waterborne pathogens. Like PluraPath, the SequaPath platform is portable, allowing for same-day on-site analysis.

 

The SequaPath technology was used in 2020 to perform an academic study that found far more bacteria in buildings unoccupied during the COVID-19 pandemic than in occupied buildings. The potential for building biome mapping is enormous. We are developing the technology, processes, and procedures to perform as many as 96 tests in a single run. SequaPath is currently available as a service offering.

 

While this service could be of value to the management of any water system in any building in any part of the world, we will first focus on the hospital customers of our strategic partners. Once proven in the hospital space, we believe that SequaPath has the potential to shift the building water testing paradigm across multiple markets and geographies.

Our Pathogen Detection Systems laboratories facility in Reno, Nevada, has matured into a first-class, environmental test development and manufacturing organization. The lab was recently enrolled in the CDC’s ELITE Program, which recognizes approximately 150 U.S. laboratories capable of advanced isolation techniques with respect to Legionella identification. Our focus extends well beyond Legionella. Indeed, we believe our laboratories now offer the most extensive list of CDC-noted, opportunistic waterborne pathogens in a single test on the market today.

Additional Pathogen Detection Markets.On July 9, 2021, we acquired substantially all the Company acquired 100%assets of GenArraytion, Inc. (“GenArraytion”). The acquisition did not qualify as a business combination and, as a result, was accounted for as an asset acquisition. The Company issued 123,981 shares of the Company’s common stock to GenArraytion, reflecting an aggregate purchase price of $1.2 million. This acquisition will givegave us access to GenArraytion’s many proprietary assays, multiplexing technology, and selection methods for detecting waterborne pathogens and other microorganisms using Polymerase Chain Reaction technology. GenArraytion’s assets will beand business have been integrated into our Pathogen Detection Systems segment.

Due primarily to the intellectual property acquired in the GenArraytion acquisition, including proprietary techniques of rapid assay development, we are exploring additional pathogen detection market opportunities, including additional waterborne pathogen detection markets as well as non-waterborne areas, such as mosquito- and tick-borne illness and women’s health panels.

24

 

Hemodiafiltration (HDF) Systems and Specialty Renal Products: HDF SystemProducts, Inc.

 

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.

26

 

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.

 

Nephros and First-Generation HDF Background

 

OverIn the course of our history, we originallyearly 2000’s, Nephros developed a medical device that enabled a standard HD machine to perform HDF. This first-generation device (“HDF1”) was cleared by the U.S. Food and Drug Administration (“FDA”) for the treatment of patients with chronic renal failure in 2012.

We refer to our approach as an on-line mid-dilution hemodiafiltration (“mid-dilution HDF”) system. Our originalHDF1 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, andwhich 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. TheWith the HDF Filter, however, 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 byIn the U.S. Food and Drug Administration (“FDA”) foryears following 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,HDF1 product’s FDA clearance, DaVita Healthcare Partners, the Renal Research Institute (a research division of Fresenius Medical Care), and Vanderbilt University conducted post-market evaluations of our hemodiafiltration systemHDF1 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 goalpurpose of the evaluationsthis feedback was to better understand the potential for HDF in the U.S. clinical setting in ordersettings, 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 flowworkflow 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.

 

25

Specialty Renal Products Inc.and Second-Generation HDF

 

Over the past two years,In 2017 and 2018, we have dramatically simplified and redesigned our HDF device.HDF1 device into a second-generation device (HDF2). Our updates have made the system significantly easier to use. By shifting from a reusable substitution ultrafilter to a disposable substitution ultrafilter, we were able to simplifysimplified the set-up process and substantially reducereduced the time required between patient treatments – two of the key complaints from users of our first-generation system. We used real-time user feedback to aid in the fine-tuning of our changes to the system that impacted usability. We believe our second-generation HDF system will meet the needs of both clinicians and patients.

 

In July 2018, we spun-off the development of the HDF device into a new private entity, Specialty Renal Products, Inc. (“SRP.”) We raised $3 million of outsidenew capital directly into SRP to fund the second-generation development described above. Nephros maintains a 62.5% ownership stake in SRP.

 

We submittedOn May 13, 2022, the second-generationFDA cleared HDF2 for patient use, which enables nephrologists to provide HDF system for FDA clearance in June 2021. Once it istreatment to patients with end stage renal disease (“ESRD”). To date, Nephros’s HDF1 and HDF2 systems are the only HDF systems cleared by the FDA.

In late 2022, we intendplan to launch itthe HDF2 system at 2-31-3 clinics with previous experience with our device.to establish clinical experience. SRP is currently manufacturing devices and supplies for its commercial launch. We have also hired a Director of Operations to lead the commercial launch and select initial clinics.

In 2023, we plan to then expand our efforts on a measured basis, to clinics that wish to provide HDF therapy to their patients. AtWe believe this time, we do not believe makingmeasured launch approach is more likely to be successful than a rapid and broadbroader push into the market would be optimal.market. Nephrologists in the United States are not trained on HDF therapy; however, we believe many nephrologists want to exploreare interested in exploring the option and weoption. We also believe that early adopters will want to perform studies to better understand the technology. We intend to support these investigator-initiated studies.

 

27

While a number ofseveral studies have been performed in Europe, the body of evidence for optimal use of HDF needs to be built in the U.S. treatment setting. According to European data from Fresenius, over 15% of dialysis treatments are HDF. That could translate to over 10 million individual treatments if HDF achieved that level of penetration in the United States. We do not believe that the United States will instantaneously mirror Europe. However, we do believe that HDF therapy has a place in the treatment landscape for patients with ESRD in the United States, and we look forward to enabling this pathway.

 

Critical Accounting Policies

 

For the nine-monthsix-month period ended SeptemberJune 30, 2021,2022, 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, 2020.2021.

 

Recent Accounting Pronouncements

 

We are subject to recently issued accounting standards, accounting guidance and disclosure requirements. For a description of these new accounting standards, 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.

 

Results of Operations

 

Fluctuations in Operating Results

 

Our results of operations have fluctuated significantly from period to period in the past, including recently, 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.products, expense management, and progress in achieving positive operating cash flow. Due to these fluctuations, we believe that the period-to-period comparisons of our operating results are not a good indication of our future performance.

 

26

Three Months Ended SeptemberJune 30, 20212022 Compared to the Three Months Ended SeptemberJune 30, 20202021

 

The following table sets forth our summarized, consolidated results of operations for the three months ended SeptemberJune 30, 20212022 and 20202021 (in thousands, except percentages):

 

 2021  2020  

$

Increase

(Decrease)

 

%

Increase

(Decrease)

  2022 2021 

$

Increase

(Decrease)

  

%

Increase

(Decrease)

 
Total net revenues $2,637  $2,121  $516   24% $2,884  $2,266  $618   27%
Cost of goods sold  1,225   896   329   37%  1,523   991   532   54%
Gross margin  1,412   1,225   187   15%  1,361   1,275   86   7%
Gross margin %  54%  58%  -   (4)%  47%  56%  -   (9)%
Research and development expenses  632   751   (119)  (16)%  431   487   (56)  (11)%
Depreciation and amortization expense  50   49   1   2%  64   51   13   25%
Selling, general and administrative expenses  1,892   1,544   348   23%  2,070   1,854   216   12%
Change in fair value of contingent consideration  -   (187)  (187)  (100)%
Loss from operations  (1,162)  (932)  230   25%  (1,204)  (1,117)  (87)  (8)%
Interest expense  (10)  (22)  (12)  (55)%  (6)  (11)  5   45%
Interest income  2   3   (1)  (33)%  1   3   (2)  (67)%
Other income (expense), net  8   (61)  69   113%  72   (1)  73   7300%
Net loss  (1,162)  (1,012)  150   15%  (1,137)  (1,126)  (11)  (1)%
Less: Undeclared deemed dividend attributable to noncontrolling interest  (60)  (60)  -   -   (66)  (60)  (6)  (10)%
Net loss attributable to Nephros, Inc. $(1,222) $(1,072) $150   14% $(1,203) $(1,186) $(17)  (1)%

Net Revenues. Our business is reported in three reportable segments: Water Filtration, Pathogen Detection and Renal Products. Our net revenues in each of these segments for the three months ended June 30, 2022 and 2021 (in thousands, except percentages) were as follows:

  2022  2021  

$

Increase

(Decrease)

  

%

Increase

(Decrease)

 
Water Filtration $2,849  $2,190  $659   30%
Pathogen Detection  35   76   (41)  (54)%
Renal Products  -   -   -   -%
Total $2,884  $2,266  $618   27%

Total net revenues in the Water Filtration segment increased 30% due to increased sales in all 3 of our filtration target markets: Hospitals, Dialysis, and Commercial. We believe these sales increases reflect growing market acceptance of our products.

Total net revenues in the Pathogen Detection segment decreased 54% due to lower-than-expected service and testing revenues.

Gross Profit Margin

  2022  2021  

%

Increase

(Decrease)

 
Water Filtration  49%  55%  (6)%
Pathogen Detection  (131)%  79%  (210)%
Renal Products  -%  -%  -%
Total  47%  56%  (9)%

Consolidated gross margin was approximately 47% for the three months ended June 30, 2022 compared to approximately 56% for the three months ended June 30, 2021. The decrease of approximately 9% was driven by increased shipping costs as well as inventory expirations, certain product obsolescence, and adjustments to inventory counts. The negative gross profit margin in the Pathogen Detection segment was primarily caused by the expiration of product inventory that we acquired in connection with our 2021 acquisition of GenArraytion, Inc. Responding to supply chain cost increases, we implemented a broad price increase beginning on June 1, 2022.

Research and Development Expenses

Research and development expenses by segment for the three months ended June 30, 2022 and 2021 (in thousands, except percentages) were as follows:

  2022  2021  

$

Increase

(Decrease)

  

%

Increase

(Decrease)

 
Water Filtration $205  $305  $(100)  (33)%
Pathogen Detection  159   149   10   7%
Renal Products  67   33   34   103%
Total $431  $487  $(56)  (11)%

 

27

Consolidated research and development expenses decreased $56,000 primarily due to decreased investment across product lines as products matured.

Selling, General and Administrative Expenses

Selling, general and administrative expenses by segment for the three months ended June 30, 2022 and 2021 (in thousands, except percentages) were as follows:

  2022  2021  

$

Increase

(Decrease)

  

%

Increase

(Decrease)

 
Water Filtration $1,804  $1,735  $69   4%
Pathogen Detection  184   96   88   92%
Renal Products  82   23   59   257%
Total $2,070  $1,854  $216   12%

Consolidated selling, general and administrative expenses increased $0.2 million primarily due initially to increased headcount expenditures, followed by severance expenses resulting from a reduction-in-force of approximately 15% of company staff in an effort to reduce operating expenses to align with current and projected revenue.

Interest Expense

Interest expense was approximately $6,000 for the three months ended June 30, 2022. It is comprised primarily of interest on our secured note payable. Interest expense was approximately $11,000 for the three months ended June 30, 2021, comprised primarily of interest on our secured note payable.

Other Income (Expense), net

Other income of approximately $72,000 for the three months ended June 30, 2022 is primarily related to the release of the cumulative translation adjustment, from accumulated other comprehensive income (loss) on the liquidation of a foreign entity. Other expense of approximately $1,000 for the three months ended June 30, 2021 is related to foreign currency exchange losses.

Six Months Ended June 30, 2022 Compared to the Six Months Ended June 30, 2021

The following table sets forth our summarized, consolidated results of operations for the six months ended June 30, 2022 and 2021 (in thousands, except percentages):

  2022  2021  

$

Increase

(Decrease)

  

%

Increase

(Decrease)

 
Total net revenues $5,071  $5,002  $69   1%
Cost of goods sold  2,685   2,140   545   25%
Gross margin  2,386   2,862   (476)  (17)%
Gross margin %  47%  57%  -   (10)%
Research and development expenses  1,009   1,043   (34)  (3)%
Depreciation and amortization expense  116   101   15   15%
Selling, general and administrative expenses  4,418   3,853   565   15%
Loss from operations  (3,157)  (2,135)  (1,022)  (48)%
Interest expense  (13)  (24)  11   (46)%
Interest income  3   6   (3)  (50)%
Forgiveness of PPP Loan  -   482   (482)  (100)%
Other income (expense), net  63   8   55   688%
Net loss  (3,104)  (1,663)  (1,441)  (87)%
Less: Undeclared deemed dividend attributable to noncontrolling interest  (129)  (119)  (10)  (8)%
Net loss attributable to Nephros, Inc. $(3,233) $(1,782) $(1,451)  (81)%

28

 

 

Net Revenues. Our business is reported in three reportable segments: Water Filtration, Pathogen Detection and Renal Products. Our net revenues in each of these segments for the threesix months ended SeptemberJune 30, 20212022 and 20202021 (in thousands, except percentages) were as follows:

 

 2021  2020  

$

Increase

(Decrease)

 

%

Increase

(Decrease)

  2022 2021 

$

Increase

(Decrease)

  

%

Increase

(Decrease)

 
Water Filtration $2,578  $2,121  $457   22% $5,008  $4,926  $82   2%
Pathogen Detection  59   -   59   100%  63   76   (13)  (17)%
Renal Products  -   -   -   -   -   -   -   -%
Total $2,637  $2,121  $516   24% $5,071  $5,002  $69   1%

 

Total net revenues in the Water Filtration segment increased 22% as a result of increased medical device filter sales.2%.

 

Total net revenues in the Pathogen Detection segment decreased 17% in the six months ended June 30, 2022, due to lower-than-expected service and testing revenues. By comparison, net revenues increased 100% reflecting early receptivityin the first three months of the market to our pathogen detection products.year. Pathogen Detection is still an early-stage business, and significant revenue fluctuations are expected.

Gross Profit Margin

 

 2021  2020  

%

Increase

(Decrease)

  2022 2021  

%

Increase

(Decrease)

 
Water Filtration  53%  58%  (5)%  49%  57%  (8)%
Pathogen Detection  88%  -%  88%  (118)%  79%  (197)%
Renal Products  -%  -%  -%   -%  -%  -%
Total  54%  58%  (4)%  47%  57%  (10)%

 

Consolidated gross margin was approximately 54%47% for the threesix months ended SeptemberJune 30, 20212022, compared to approximately 58%57% for the threesix months ended SeptemberJune 30, 2020.2021. The decrease of approximately 4%10% was driven by the Water Filtration segment primarily as a result of increased shipping costs, 4.2%, lower product margins, 2.9%, as well as inventory reserve increases for, expirations, certain product obsolescence, and adjustments to inventory adjustments.counts, 2.6%. The negative gross profit margin in the Pathogen Detection segment was primarily caused by the expiration of product inventory that was purchased in the 2021 acquisition of GenArraytion, Inc. Responding to supply chain cost increases, we implemented a broad price increase beginning on June 1, 2022.

 

Research and Development Expenses

 

Research and development expenses by segment for the threesix months ended SeptemberJune 30, 20212022 and 20202021 (in thousands, except percentages) were as follows:

 

 2021  2020  

$

Increase

(Decrease)

 

%

Increase

(Decrease)

  2022 2021 

$

Increase

(Decrease)

  

%

Increase

(Decrease)

 
Water Filtration $363  $359  $4   1% $460  $598  $(138)  (23)%
Pathogen Detection  237   49   188   384%  365   268   97   36%
Renal Products  32   343   (311)  (91)%  184   177   7   4%
Total $632  $751  $(119)  (16)% $1,009  $1,043  $(34)  (3)%

 

Consolidated research and development expenses decreased $0.1 million$34,000 primarily due to decreasingdecreased investment in the second-generation HDF product in the Renal ProductsWater Filtration segment, partially offset by increased R&D investmentsinvestment in our Pathogen Detection products.

29

 

 

Selling, General and Administrative Expenses

 

Selling, general and administrative expenses by segment for the threesix months ended SeptemberJune 30, 20212022 and 20202021 (in thousands, except percentages) were as follows:

 

 2021 2020  

$

Increase

(Decrease)

 

%

Increase

(Decrease)

  2022 2021 

$

Increase

(Decrease)

  

%

Increase

(Decrease)

 
Water Filtration $1,703  $1,317  $386   29% $3,953  $3,612  $341   9%
Pathogen Detection  175   116   59   51%  356   196   160   82%
Renal Products  14   111   (97)  (87)%  109   45   64   142%
Total $1,892  $1,544  $348   23% $4,418  $3,853  $565   15%

 

Consolidated selling, general and administrative expenses increased $0.3$0.6 million or 15% primarily due to increased headcountemployee related expenditures ofcosts, $0.3 million, in the Water Filtration segment.increased travel costs, $0.1 million and increased costs for marketing, $0.1 million.

 

Interest Expense

 

Interest expense was approximately $10,000$13,000 for the threesix months ended SeptemberJune 30, 20212022 compared to $22,000$24,000 for the threesix months ended SeptemberJune 30, 2020. Both expenses included our secured note payable. The $12,0002021. This reduction is primarily due to elimination of our contingent consideration accretion expense.

Other Income (Expense), net

Other income of approximately $8,000 for the three months ended September 30, 2021 is related to foreign currency exchange gains. Other expense of approximately $61,000 for the three months ended September 30, 2020 is related to foreign currency exchange losses.

Nine Months Ended September 30, 2021 Compared to the Nine Months Ended September 30, 2020

The following table sets forth our summarized, consolidated results of operations for the nine months ended September 30, 2021 and 2020 (in thousands, except percentages):

  2021  2020  $
Increase (Decrease)
  

%

Increase

(Decrease)

 
Total net revenues $7,639  $6,227  $1,412   23%
Cost of goods sold  3,365   2,616   749   29%
Gross margin  4,274   3,611   663   18%
Gross margin %  56%  58%  -   (2)%
Research and development expenses  1,675   2,150   (475)  (22)%
Depreciation and amortization expense  151   142   9   6%
Selling, general and administrative expenses  5,745   5,104   641   13%
Change in fair value of contingent consideration  -   (229)  (229)  (100)%
Loss from operations  (3,297)  (3,556)  (259)  (7)%
Interest expense  (34)  (95)  (61)  (64)%
Interest income  8   8   -   - 
Forgiveness of PPP Loan  482   -   482   100%
Other income (expense), net  16   (124)  140   113%
Net loss  (2,825)  (3,767)  (942)  (25)%
Less: Undeclared deemed dividend attributable to noncontrolling interest  (179)  (179)  -   - 
Net loss attributable to Nephros, Inc. $(3,004) $(3,946) $(942)  (24)%

30

Net Revenues. Our business is reported in three reportable segments: Water Filtration, Pathogen Detection and Renal Products. Our net revenues in each of these segments for the nine months ended September 30, 2021 and 2020 (in thousands, except percentages) were as follows:

  2021  2020  

$

Increase

(Decrease)

  

%

Increase

(Decrease)

 
Water Filtration $7,504  $6,199  $1,305   21%
Pathogen Detection  135   28   107   382%
Renal Products  -   -   -   - 
Total $7,639  $6,227  $1,412   23%

Total net revenues in the Water Filtration segment increased 21% as a result of increased medical device filter sales.

The increase in total net revenues in the Pathogen Detection segment reflects early receptivitylower principal balance of the market to our pathogen detection products.

Gross Profit Margin

  2021  2020  

%

Increase

(Decrease)

 
Water Filtration  55%  58%  (3)%
Pathogen Detection  83%  51%  33%
Renal Products  -%  -%  % 
Total  56%  58%  (2)%

Consolidated gross margin was approximately 56% for the nine months ended September 30, 2021 compared to approximately 58% for the nine months ended September 30, 2020. The decrease of approximately 2% was driven by inventory adjustments.

Research and Development Expenses

Research and development expenses by segment for the nine months ended September 30, 2021 and 2020 (in thousands, except percentages) were as follows:

  2021  2020  

$

Increase

(Decrease)

  

%

Increase

(Decrease)

 
Water Filtration $961  $1,014  $(53)  (5)%
Pathogen Detection  505   206   299   145%
Renal Products  209   930   (721)  (78)%
Total $1,675  $2,150  $(475)  (22)%

Consolidated research and development expenses decreased $0.5 million primarily due to decreasing investment in the second-generation HDF product in the Renal Products segment, partially offset by increased R&D investments in our Pathogen Detection products.

Selling, General and Administrative Expenses

Selling, general and administrative expenses by segment for the nine months ended September 30, 2021 and 2020 (in thousands, except percentages) were as follows:

  2021  2020  

$

Increase

(Decrease)

  

%

Increase

(Decrease)

 
Water Filtration $5,314  $4,381  $933   21%
Pathogen Detection  372   377   (5)  (1)%
Renal Products  59   346   (287)  (83)%
Total $5,745  $5,104  $641   13%

31

Consolidated selling, general and administrative expenses increased $0.6 million primarily due to increased headcount related expenditures of $0.9 million in the Water Filtration segment, which were partially offset by a decrease in headcount related expenditures of $0.3 million in the Renal Products segment as a result decreasing investment in the second-generation HDF product, which was submitted for 510(k) FDA clearance in June 2021.

Interest Expense

Interest expense was approximately $34,000 for the nine months ended September 30, 2021 compared to $95,000 for the nine months ended September 30, 2020. Both expenses included ourcompany’s secured note payable. The $61,000 reduction is primarily due to elimination of both our secured revolving credit facility and contingent consideration accretion expense.

 

Extinguishment of PPP loan

 

Our outstanding PPP loan was forgiven in January of 2021 resulting in an extinguishment of approximately $482,000.

 

Other Income (Expense), net

 

Other income was approximately $16,000$63,000 for the ninesix months ended SeptemberJune 30, 2022, and is primarily related to the release of the cumulative translation adjustment from accumulated other comprehensive income (loss) on the liquidation of a foreign entity. Other income was approximately $8,000 for the six months ended June 30, 2021 as a result of gains on foreign currency transactions. Other expense was approximately $124,000 for the nine months ended September 30, 2020 as a result of losses on foreign currency transactions.

 

Liquidity and Capital Resources

 

The following table summarizes our liquidity and capital resources as of SeptemberJune 30, 20212022 and December 31, 20202021 and is intended to supplement the more detailed discussion that follows. The amounts stated are expressed in thousands.

 

 September 30, December 31,  June 30, December 31, 
Liquidity and Capital Resources 2021  2020  2022 2021 
Cash and cash equivalents $7,350  $8,249  $4,179  $6,973 
Other current assets  6,271   6,905   6,943   6,661 
Working capital  11,798   13,829   9,011   11,244 
Stockholders’ equity  15,330   15,573   12,481   14,749 

 

At SeptemberJune 30, 2021,2022, we had an accumulated deficit of $134.7$138.8 million 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.

 

Based on cash that is available for our operations and projections of our future operations, we believe that our existing cash resources together with our anticipated revenue, will be sufficient to fund our current operating plan through at least the next 12 months from the date of issuance of the condensed consolidated financial statements in this Quarterly Report on Form 10-Q. Additionally, our operating plans are designed to help control operating costs, to increase revenue and to raise additional capital until such time as we generate sufficient cash flows to fund operations. If there were a decrease in the demand for our products due to either economic or competitive conditions, or if we are otherwise unable to achieve our plan or achieve our anticipated operating results, there could be a significant reduction in liquidity due to our possible inability to cut costs sufficiently. In such event, the Company may need to take further actions to reduce its discretionary expenditures, including further reducing headcount, reducing spending on R&D projects and reducing other variable costs.

 

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

 

 the market acceptance of our products, and our ability to effectively and efficiently produce, market and marketsell 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:

 

 the development, marketing, and sales of our water-filtrationwater filtration and water diagnosticspathogen detection products;
the commercial roll-out of our second-generation HDF product; and
 working capital purposes.

 

At September 30, 2021, we had cash and cash equivalents totaling $7.4 million and total assets of $17.2 million excluding the asset related to the License and Supply Agreement with Medica of $0.6 million.

Net cash used in operating activities was $1.1 million for the nine months ended September 30, 2021 compared to $5.4 million for the nine months ended September 30, 2020, a decrease of $4.3 million due primarily to a decrease of $0.5 million in inventory for the nine months ended September 30, 2021, compared to an increase in inventory of $2.8 million for the nine months ended September 30, 2020. Excess inventory was purchased during the nine months ended September 30, 2020 to reduce the risk of pandemic-related supply chain disruptions. Since no such disruption took place, the excess inventory is being sold through in 2021, thus reducing inventory levels.

3230

 

 

Net cash used in operating activities was $2.9 million for the six months ended June 30, 2022, compared to $0.2 for the six months ended June 30, 2021. This increase of $2.7 million is due primarily to an increase in the net loss incurred of $1.4 million, an increase in accounts receivable of $0.5 million offset by a decrease in accounts payable of $0.6 million.

Net cash used in investing activities was approximately $0.1 million$137,000 in the six months ended June 30, 2022 compared to approximately $23,000 for the ninesix months ended September 30, 2021 compared to $0.2 million for the nine months ended SeptemberJune 30, 2021. The change is due primarily due to decreasedincreased purchases of property and equipment.

 

Net cash provided by financing activities of $0.3was approximately $0.2 million for the ninesix months ended SeptemberJune 30, 2021 resulted2022. This was primarily from proceeds from the exercise of warrants of $0.2 million and optionsfrom the sale to Nephros of $0.5SRP preferred shares of $0.2 million, offset partially by payments of $0.2$0.1 million on our secured note.note, principal payments of approximately $3,000 on our finance lease obligation and principal payments of approximately $1,000 on our equipment financing debt.

 

Net cash provided by financing activities of $6.6$0.2 million for the ninesix months ended SeptemberJune 30, 20202021 resulted from net proceeds from the issuance of common stock of $6.8 million, proceeds from the PPP loan of $0.5 million and proceeds from the exercise of warrants and options of $0.2$0.4 million offset partially by net payments on our secured revolving credit facility of $0.6 million, payments of $0.2$0.1 million on our secured note, and paymentprincipal payments of approximately $79,000$7,000 on our contingent consideration.finance lease obligation

Off-Balance Sheet Arrangements

We did not have any off-balance sheet arrangements as and principal payments of September 30, 2021.approximately $1,000 on our equipment financing debt.

 

Forward-Looking Statements

 

Certain statements in thisThe Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. This Quarterly Report on Form 10-Q constitute “forward-looking statements”. Suchcontains such “forward-looking” information, which includes all 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 statementsherein that are not historical facts, includingbased on future expectations. In some cases, you can identify forward-looking statements which may be preceded by the words “intends,following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “plans,“would,“expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similarthe negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are only predictions and are not guarantiesguarantees of future performance,performance. These statements are based on certainour management’s beliefs and assumptions, andwhich in turn are subjectbased on their interpretation of currently available information. The forward-looking statements contained in this report include, but are not limited to, variousstatements regarding the following:

our expectations regarding the impact of the COVID-19 pandemic on our results of operations and financial condition;
our expectation that demand for our water filtration products will increase as business returns to the hospitality industry and commercial buildings return to full occupancy;
the adoption of our second generation HDF system by physicians and clinics;
anticipated future revenues from the sale of our products;
our expectations regarding the use of our current capital resources;
the expected future volatility of our results of operations;
the progress and timing of our research and development efforts;
our expectation that we will reduce our selling, general and administrative expenses in future periods;
our belief that our existing cash resources will be sufficient to fund our current operating plan through at least the next 12 months;
our plans to further reduce cash expenditures in the event we do not achieve our anticipated results from operations; and
the anticipated impact of adoption of recent accounting pronouncements on our financial statements.

These statements involve known and unknown risks, uncertainties and uncertainties, manyother factors that may cause our results, levels of which are beyond our control. Actual results may differactivity, performance or achievements to be materially different from the expectations contained in theinformation expressed or implied by these 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, if not obtained, could adversely affect our potential sales and revenues;
product-related deaths or serious injuries or product malfunctionsinflationary pressures and supply chain challenges across most industries could trigger recalls, class action lawsuitsnegatively impact our revenues, margins, and other events that could cause us to incur expenses and may also limit our ability to generate revenues from such products;customer satisfaction;
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 (the “FDC Act”) or any other statutes or regulations, we could be subject to enforcement actions by the FDAU.S. Food and Drug Administration (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, pathogen detection systemssystem 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;

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we may not be able to 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-clinicalpreclinical or clinical trials;
we may not be able to secure or enforce adequate legal protection, including patent protection, for our products;
we may not be able to achieve sales growth in key geographic markets; and
the effectsongoing COVID-19 pandemic, including the effect that future waves of the Covid-19 pandemicCOVID-19 infections may be more severe than we currently anticipate.cause disruptions to our business, including reduced product sales and supply chain disruptions.

More detailed information about usThese and the risk factors that may affect the realization of forward-looking statements, including the forward-looking statementsadditional risks and uncertainties are described more fully 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, 20202021, and in our other reportsQuarterly Report on Form 10-Q for the period ended March 31, 2022, which we have filed with the SEC. We urge investorsSEC and security holders to read those documents free of charge atwhich are available through the SEC’s web siteEDGAR system at www.sec.gov.www.sec.gov. You should read these risk factors and the other cautionary statements made in this report as being applicable to all related forward-looking statements wherever they appear in this report. We do not undertakecannot assure you that the forward-looking statements in this report will prove to publicly update or revisebe accurate. Furthermore, if our forward-looking statements as a result of new information, future events or otherwise, exceptprove to be inaccurate, the inaccuracy may be material. You should read this report completely. Other than as required by law.law, we undertake no obligation to update these forward-looking statements, even though our situation may change in the future.

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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.

 

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PART II - OTHER INFORMATION

 

Item 1A. Risk Factors

 

As a smaller reporting company, we are not required to provide disclosure pursuant to this item. However, in addition to other information set forth in this Quarterly Report on Form 10-Q, including the important information in the section entitled “Forward Looking Statements,” you should carefully consider the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 20202021 and in Item 1A of our Quarterly Report on Form 10-Q for the period ended March 31, 2022 for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in this Quarterly Report on Form 10-Q. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial might materially adversely affect our actual business, financial condition and/or operating results.

Item 5. Other Information.

On October 29, 2021, Daron Evans resigned from his position as President and Chief Executive Officer of Specialty Renal Products, Inc. (“SRP”), a majority-owned subsidiary of the Company. Mr. Evans will remain a member of the board of directors of SRP and was appointed chairman of the SRP board of directors upon his resignation as its president and chief executive officer. Andrew Astor, our President, Chief Executive Officer and Chief Financial Officer, was also appointed President and Chief Executive Officer of SRP upon Mr. Evans’ resignation. Mr. Astor, who will continue serving as a member of the SRP board of directors, will not receive any additional compensation from SRP or from us for his role with SRP.

 

Item 6. Exhibits

 

EXHIBIT INDEX

Exhibit No.Description of Exhibit
10.1Asset Purchase Agreement between Nephros, Inc. and GenArraytion, Inc. dated July 9, 2021. *
31.1

Certification by the Chief Executive Officer and Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. *

   
32.1

Certification by the Chief Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. **

   
101Interactive Data File. *
101.INS* Inline XBRL Instance Document
101.SCH*Inline XBRL Taxonomy Extension Schema
101.CAL*Inline XBRL Taxonomy Extension Calculation Linkbase
101.LAB*Inline XBRL Taxonomy Extension Labels Linkbase
101.PRE*Inline XBRL Taxonomy Extension Presentation Linkbase
101.DEF*Inline XBRL Taxonomy Extension Definition Linkbase
104Cover Page Interactive Data File (embedded within the Inline XBRL document)
 
*Filed herewith
**Furnished herewith.

 

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SIGNATURES

 

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

 

 NEPHROS, INC.
   
Date: November 4, 2021August 15, 2022By:/s/ Andrew Astor
 Name:Andrew Astor
 Title:President, Chief Executive Officer and Chief Financial Officer (Principal Executive and Financial Officer)

 

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