UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

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

For the quarterly period ended June 30, 2021March 31, 2022

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 000-21617

 

ProPhase Labs, Inc.
(Exact name of registrant as specified in its charter)

ProPhase Labs, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware 23-2577138

(State or other jurisdiction

of incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

711 Stewart Ave, Suite 200  
Garden City, New York 11530
(Address of principal executive office) (Zip Code)

 

(215)345-0919

(Registrant’s telephone number, including area code)

(215) 345-0919
(Registrant’s telephone number, including area code)

 

Securities Registered Pursuant to Section 12(b) of the Exchange Act:

Title of Each Class Trading Symbol Name of Each Exchange on Which Registered
Common Stock, par value $0.0005PRPH PRPHNasdaqCapital Market

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 during the preceding 12 months (or shorter period that the registration 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 filer Smaller 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

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

 

Class Outstanding AugustMay 13, 20212022
Common Stock, $0.0005 par value 15,154,25315,485,900

 

 

 

ProPhase Labs, Inc. and Subsidiaries

TABLE OF CONTENTS

 

 PAGE
PART I. FINANCIAL INFORMATION 
   
Item 1.Financial Statements (Unaudited)
Condensed Consolidated Balance Sheets as of June 30, 2021 and December 31, 20203
   
 Condensed Consolidated Balance Sheets as of March 31, 2022 and December 31, 20213
Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months Ended June 30,March 31, 2022 and 2021 and 20204
   
 Condensed Consolidated Statements of Stockholders’ Equity for the Three and Six Months Ended June 30,March 31, 2022 and 2021 and 20205
   
 Condensed Consolidated Statements of Cash Flows for the SixThree Months Ended June 30,March 31, 2022 and 2021 and 20206
   
 Notes to Condensed Consolidated Financial Statements7
   
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations2633
   
Item 3.Quantitative and Qualitative Disclosures about Market Risk3041
   
Item 4.Controls and Procedures41
30
PART II. OTHER INFORMATION
Item 1.Legal Proceedings42
Item 1A.Risk Factors43
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds43
Item 3.Defaults Upon Senior Securities43
Item 4.Mine Safety Disclosures43
Item 5.Other Information43
Item 6.Exhibits43
   
PART II. OTHER INFORMATIONSignatures
Item 1.Legal Proceedings31
Item 1A.Risk Factors31
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds31
Item 3.Defaults Upon Senior Securities31
Item 4.Mine Safety Disclosures31
Item 5.Other Information31
Item 6.Exhibits31
Signatures3244

 

2

 

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements.

ProPhase Labs, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(in thousands, except share and per share amounts)

  June 30,  December 31, 
  2021  2020 
  (Unaudited)    
ASSETS      
Current assets        
Cash and cash equivalents $17,677  $6,816 
Marketable debt securities, available for sale  18,095   1,639 
Marketable equity securities, available for sale  479   - 
Accounts receivable, net  6,644   3,155 
Inventory, net  15,169   3,039 
Prepaid expenses and other current assets  428   1,238 
Total current assets  58,492   15,887 
         
Property, plant and equipment, net  6,914   3,578 
Secured promissory note receivable  3,727   2,750 
Prepaid expenses, net of current portion  460   2,084 
Right-of-use asset, net  4,564   4,731 
Intangible asset, net  1,017   1,234 
Goodwill  901   901 
Other assets  248   240 
TOTAL ASSETS $76,323  $31,405 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
Current liabilities        
Accounts payable $7,114  $3,771 
Accrued advertising and other allowances  214   463 
Lease liabilities  635   329 
Other current liabilities  6,211   1,731 
Total current liabilities  14,174   6,294 
         
Non-current liabilities:        
Deferred revenue, net of current portion  121   162 
Unsecured convertible promissory notes, net  9,994   9,991 
Lease liabilities, net of current portion  4,301   4,402 
Total non-current liabilities  14,416   14,555 
Total liabilities  28,590   20,849 
         
COMMITMENTS AND CONTINGENCIES  -    -  
         
Stockholders’ equity        
Preferred stock authorized 1,000,000, $.0005 par value, 0 shares issued and outstanding  -   - 
Common stock authorized 50,000,000, $.0005 par value, issued 31,806,275 and 28,256,275 shares, respectively  16   14 
Additional paid-in capital  99,265   61,674 
Accumulated deficit  (3,969)  (3,631)
Treasury stock, at cost, 16,652,022 and 16,652,022 shares, respectively  (47,490)  (47,490)
Accumulated other comprehensive loss  (89)  (11)
Total stockholders’ equity  47,733   10,556 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $76,323  $31,405 

   March 31,   December 31, 
  March 31,  December 31, 
  2022  2021 
  (Unaudited)    
ASSETS        
Current assets        
Cash and cash equivalents $25,807  $8,408 
Restricted cash  -   250 
Marketable debt securities, available for sale  3,543   8,779 
Marketable equity securities, at fair value  -   76 
Accounts receivable, net  36,694   37,708 
Inventory, net  4,680   4,600 
Prepaid expenses and other current assets  1,831   1,496 
Total current assets  72,555   61,317 
         
Property, plant and equipment, net  6,440   5,947 
Prepaid expenses, net of current portion  251   460 
Right-of-use asset, net  4,319   4,402 
Intangible assets, net  10,143   10,852 
Goodwill  5,709   5,709 
Other assets  248   608 
TOTAL ASSETS $99,665  $89,295 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
Current liabilities        
Accounts payable $8,204  $7,026 
Accrued diagnostic services  1,012   1,890 
Accrued advertising and other allowances  95   104 
Lease liabilities  654   663 
Deferred revenue  2,246   2,034 
Income tax payable  

4,285

   

1,312

 
Other current liabilities  3,274   2,495 
Total current liabilities  19,770   15,524 
         
Non-current liabilities:        
Deferred revenue, net of current portion  858   905 
Deferred tax liability  443   - 
Note payable  18   44 
Unsecured convertible promissory notes, net  7,997   9,996 
Lease liabilities, net of current portion  4,134   4,198 
Total non-current liabilities  13,450   15,143 
Total liabilities  33,220   30,667 
         
COMMITMENTS AND CONTINGENCIES  -    -  
         
Stockholders’ equity        
Preferred stock authorized 1,000,000, $0.0005 par value, 0 shares issued and outstanding  -   - 
Common stock authorized 50,000,000, $0.0005 par value, 15,485,900 and 15,485,900 shares outstanding, respectively  16   16 
Additional paid-in capital  105,634   104,552 
Retained earnings  10,490   2,642 
Treasury stock, at cost, 17,018,846 and 16,818,846 shares, respectively  (49,557)  (48,407)
Accumulated other comprehensive loss  (138)  (175)
Total stockholders’ equity  66,445   58,628 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $99,665  $89,295 

See accompanying notes to condensed consolidated financial statements

3

ProPhase Labs, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations

and Other Comprehensive Loss

(in thousands, except per share amounts)

(unaudited)

  June 30, 2021  June 30, 2020  June 30, 2021  June 30, 2020 
  For the three months ended  For the six months ended 
  June 30, 2021  June 30, 2020  June 30, 2021  June 30, 2020 
Revenues, net $9,142  $3,623  $24,413  $5,511 
Cost of revenues  4,676   2,344   11,020   3,817 
Gross profit  4,466   1,279   13,393   1,694 
                 
Operating expenses:                
Diagnostic expenses  830   -   4,639   - 
General and administration  4,993   1,155   8,775   2,323 
Research and development  93   65   208   124 
Total operating expenses  5,916   1,220   13,622   2,447 
Income (loss) from operations  (1,450)  59   (229)  (753)
                 
Interest income, net  214   11   301   14 
Interest expense  (323)  -   (574)  - 
Change in fair value of investment securities  164       164     
Net income (loss) $(1,395) $70  $(338) $(739)
                 
Other comprehensive loss:                
Unrealized gain (loss) on marketable debt securities  (67)  (5)  (78)  6 
Total comprehensive income (loss) $(1,462) $65  $(416) $(733)
                 
Earnings (loss) per share:                
Basic $(0.09) $0.01  $(0.02) $(0.06)
Diluted $(0.09) $0.01  $(0.02) $(0.06)
                 
Weighted average common shares outstanding:                
Basic  15,154   11,592   14,860   11,587 
Diluted  15,154   11,618   14,860   11,587 

   March 31, 2022   March 31, 2021 
  For the three months ended 
  March 31, 2022  March 31, 2021 
Revenues, net $47,531  $15,271 
Cost of revenues  18,854   6,344 
Gross profit  28,677   8,927 
         
Operating expenses:        
Diagnostic expenses  4,672   3,809 
General and administration  7,824   3,782 
Research and development  35   115 
Total operating expenses  12,531   7,706 
Income (loss) from operations  16,146   1,221 
         
Interest income, net  73   87 
Interest expense  (233)  (251)
Change in fair value of investment securities  (76)  - 
Income from operations before income taxes  15,910   1,057 
Income tax expense  (3,416)  - 
Income from operations after income taxes  12,494   1,057 
Net income $12,494  $1,057 
         
Other comprehensive loss:        
Unrealized gain (loss) on marketable debt securities  37   (11)
Total comprehensive income $12,531  $1,046 
         
Earnings per share:        
Basic $0.81  $0.07 
Diluted $0.68  $0.06 
         
Weighted average common shares outstanding:        
Basic  15,486   14,563 
Diluted  18,740   18,200 

See accompanying notes to condensed consolidated financial statements

4

ProPhase Labs, Inc. and Subsidiaries

Condensed Consolidated Statements of Stockholders’ Equity

(in thousands, except share data)

(unaudited)

  Common Stock Shares Outstanding, Net of Shares of  Treasury Stock  Par Value      Additional Paid in Capital  Accumulated Deficit    Accumulated  Comprehensive Income (Loss)      Treasury  Stock        Total 
  For the Three Months Ended June 30, 2021 
  Common Stock Shares Outstanding, Net of Shares of Treasury Stock  Par Value  Additional Paid in Capital  Accumulated Deficit  Accumulated Comprehensive Income (Loss)  Treasury Stock  Total 
Balance as of April 1, 2021  15,154,253  $16  $102,735  $(2,574) $(22) $(47,490) $52,665 
                             
Issuance of common stock and warrants for cash from public offering, net of $2,365 offering cost                            
Issuance of common stock and warrants for cash from public offering, net of $2,365 offering cost, shares                            
Issuance of common stock and warrants for cash from private offering                            
Issuance of common stock and warrants for cash from private offering, shares                            
Cash dividends  -   -   (4,546)  -   -   -   (4,546)
                             
Unrealized loss on marketable debt securities, net of realized gains of $2, net of taxes  -   -   -   -   (67)  -   (67)
                             
Stock-based compensation  -   -   1,076   -                   -   -   1,076 
                             
Net loss  -   -   -   (1,395)  -   -   (1,395)
                             
Balance as of June 30, 2021  15,154,253  $16  $99,265  $(3,969) $(89) $(47,490) $47,733 

  For the Three Months Ended June 30, 2020 
  Common Stock Shares Outstanding, Net of Shares of Treasury Stock  Par Value  Additional Paid in Capital  Retained Earnings  Accumulated Comprehensive Income (Loss)  Treasury Stock  Total 
Balance as of April 1, 2020  11,581,939  $14  $60,413  $(2,315) $             9  $(47,490) $10,631 
                             
Unrealized loss on marketable debt securities, net of realized gains of $3, net of taxes  -   -   -   -   (5)  -   (5)
                             
Stock-based compensation  9,709   -   198   -   -   -   198 
                             
Net income  -   -   -   70   -   -   70 
                             
Balance as of June 30, 2020  11,591,648  $14  $60,611  $(2,245) $4  $(47,490) $10,894 
  Common Stock Shares Outstanding   Par Value   Additional Paid in Capital   Retained Earnings   Comprehensive Loss   Treasury Stock   Total 
  Common Stock Shares Outstanding  Par Value  Additional Paid in Capital  Retained Earnings  Comprehensive Loss  Treasury Stock  Total 
Balance as of January 1, 2022  15,485,900  $16  $104,552  $2,642  $(175) $(48,407) $58,628 
Issuance of common shares for debt conversion  200,000   -   600   -   -   -   600 
Cash dividends  -   -   -   (4,646)  -   -   (4,646)
Repurchases of common shares  (200,000)  -   -   -   -   (1,150)  (1,150)
Unrealized loss on marketable debt securities  -   -   -   -   37   -   37 
Stock-based compensation  -   -   482   -   -   -   482 
Net income  -   -   -   12,494   -   -   12,494 
Balance as of March 31, 2022  15,485,900  $16  $105,634  $10,490  $(138) $(49,557) $66,445 

 

  For the Six Months Ended June 30, 2021 
  Common Stock Shares Outstanding, Net of Shares of Treasury Stock  Par Value  Additional Paid in Capital  Accumulated Deficit  Accumulated Comprehensive Income (loss)  Treasury Stock  Total 
Balance as of January 1, 2021  11,604,253  $14  $61,674  $(3,631) $            (11) $(47,490) $10,556 
                             
Issuance of common stock and warrants for cash from public offering, net of $2,365 offering cost  3,000,000   2   35,133   -   -   -   35,135 
                             
Issuance of common stock and warrants for cash from private offering  550,000   -   5,500   -   -   -   5,500 
                             
Cash dividends  -   -   (4,546)  -   -   -   (4,546)
                             
Unrealized loss on marketable debt securities, net of taxes  -   -   -   -   (78)  -   (78)
                             
Stock-based compensation  -   -   1,504   -   -   -  1,504
                             
Net loss  -   -   -   (338)  -   -   (338)
                             
Balance as of June 30, 2021  15,154,253  $16  $99,265  $(3,969) $(89) $(47,490) $47,733 

  Common Stock Shares Outstanding   Par Value   Additional Paid in Capital   Retained Earnings   Comprehensive Loss   Treasury Stock   Total 
  

Common Stock

Shares Outstanding,

  Par Value  Additional Paid in Capital  Accumulated Deficit  

Accumulated

Comprehensive Income (loss)

  Treasury Stock  Total 
Balance as of January 1, 2021  11,604,253  $14  $61,674  $(3,631) $(11) $(47,490) $10,556 
Issuance of common stock and warrants for cash from public offering, net of $2,365 offering cost  3,000,000   2   35,133   -   -   -   35,135 
Issuance of common stock and warrants for cash from private offering  550,000   -   5,500   -   -   -   5,500 
Unrealized loss on marketable debt securities  -   -   -   -   (11)  -   (11)
Stock-based compensation  -   -   428   -   -   -   428 
Net income  -   -   -   1,057   -   -   1,057 
Balance as of March 31, 2021  15,154,253  $16  $102,735  $(2,574) $(22) $(47,490) $52,665 

  

  For the Six Months Ended June 30, 2020 
  Common Stock Shares Outstanding, Net of Shares of Treasury Stock  Par Value  Additional Paid in Capital  Accumulated Deficit  Accumulated Comprehensive Income (loss)  Treasury Stock  Total 
Balance as of January 1, 2020  11,573,593  $14  $60,215  $(1,506) $         (2) $(47,490) $11,231 
                             
Unrealized loss on marketable debt securities, net of realized losses of $3, net of taxes  -   -   -   -   6   -   6 
Unrealized (gain) loss on marketable debt securities, net of realized losses, net of taxes                  6       6 
                             
Stock-based compensation  18,055   -   396   -   -   -   396 
                             
Net loss  -   -   -   (739)  -   -   (739)
Net income loss              (739)           (739) 
                             
Balance as of June 30, 2020  11,591,648  $14  $60,611  $(2,245) $4  $(47,490) $10,894 

See accompanying notes to condensed consolidated financial statements

 

5

 

ProPhase Labs, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

(in thousands)

(unaudited)

  June 30, 2021  June 30, 2020 
  For the six months ended 
  June 30, 2021  June 30, 2020 
Cash flows from operating activities        
Net loss $(338) $(739)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:        
Realized loss on marketable debt securities  7   - 
Depreciation and amortization  1,118   167 
Amortization of debt discount  3   - 
Amortization on right-of-use assets  167   - 
Lower of cost or net realizable value inventory adjustment  -   32 
Stock-based compensation expense  1,504   396 
Change in fair value of investment securities  (164)  - 
Non-cash interest income on secured promissory note receivable  (315)  - 
Changes in operating assets and liabilities:        
Accounts receivable  (3,466)  80 
Escrow receivable  -   4,812 
Inventory  (12,130)  (620)
Prepaid and other assets  2,434   91 
Other assets  (8)  - 
Accounts payable and accrued expenses  3,343   412 
Lease liabilities  205   - 
Other liabilities  4,190   26 
Net cash (used in) provided by operating activities  (3,450)  4,657 
         
Cash flows from investing activities        
Issuance of secured promissory note receivable  (1,000)  - 
Purchase of marketable securities  (16,841)  (3,436)
Proceeds from sale of marketable debt securities  300   1,029 
Capital expenditures  (4,237)  (147)
Net cash used in investing activities  (21,778)  (2,554)
        
Cash flows from financing activities        
Proceeds from issuance of common stock from public offering, net  35,135   - 
Proceeds from issuance of common stock and warrants from private offering  5,500   - 
Payment of dividends  (4,546)    
Net cash provided by financing activities  36,089   - 
        
Increase in cash and cash equivalents  10,861   2,103 
Cash and cash equivalents, at the beginning of the period  6,816   434 
Cash and cash equivalents, at the end of the period $17,677  $2,537 
        
Supplemental disclosures:        
Cash paid for income taxes $-  $- 
Interest payment on the promissory notes $500  $- 
         
Supplemental disclosure of non-cash investing and financing activities:        
Net unrealized gain (loss), investments in marketable debt securities $(78) $6 

   March 31, 2022   March 31, 2021 
  For the three months ended 
  March 31, 2022  March 31, 2021 
Cash flows from operating activities        
Net income $12,494  $1,057 
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:        
Realized loss on marketable debt securities  179   2 
Depreciation and amortization  1,249   536 
Amortization of debt discount  1   2 
Amortization on right-of-use assets  83   85 
Gain on sale of assets  (23)  - 
Stock-based compensation expense  482   428 
Change in fair value of investment securities  76   - 
Accounts receivable allowances  (924)   - 
Inventory valuation reserve  25   - 
Changes in operating assets and liabilities:        
Accounts receivable  1,938  (11,178)
Inventory  (105)  (12,987)
Prepaid and other assets  (126)  2,243 
Other assets  360   (8)
Accounts payable and accrued expenses  1,178   4,009 
Accrued diagnostic services  (878)  - 
Deferred revenue  165   - 
Deferred tax liability  

443

   - 
Lease liabilities  (73)  101 
Income tax payable  

2,973

   - 
Other liabilities  770   7,818 
Net cash provided by (used in) operating activities  20,287   (7,892)
         
Cash flows from investing activities        
Issuance of secured promissory note receivable  -   (1,000)
Purchase of marketable securities  (206)  (2,005)
Proceeds from sale of marketable debt securities  5,300   100 
Proceeds from dispositions of property and other assets  85   - 
Capital expenditures  (1,095)  (3,927)
Net cash provided by (used in) investing activities  4,084   (6,832)
         
Cash flows from financing activities        
Proceeds from issuance of common stock from public offering, net  -   35,135 
Proceeds from issuance of common stock and warrants from private offering  -   5,500 
Repayment of note payable  (1,426)  - 
Repurchases of common shares  (1,150)  - 
Payment of dividends  (4,646)  - 
Net cash (used in) provided by financing activities  (7,222)  40,635 
         
Increase in cash, cash equivalents and restricted cash  17,149   25,911 
Cash, cash equivalents and restricted cash, at the beginning of the period  8,658   6,816 
Cash, cash equivalents and restricted cash, at the end of the period $25,807  $32,727 
         
Supplemental disclosures:        
Cash paid for income taxes $-  $- 
Interest payment on the promissory notes $241  $250 
         
Supplemental disclosure of non-cash investing and financing activities:        
Issuance of common shares for debt conversion $600  $- 
Net unrealized gain (loss), investments in marketable debt securities $37  $(11)

See accompanying notes to condensed consolidated financial statements

 

6

 

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

Note 1 - Organization and Business

ProPhase Labs, Inc. (“ProPhase”, “we”, “us”, “our” or the “Company”) is a diversified biotechcompany that offers a range of services including diagnostic testing, genomics testing and contract manufacturing. We provide traditional CLIA molecular laboratory services, including SARS-CoV-2 (“COVID-19”) testing and seek to leverage our Clinical Laboratory Improvement Amendments (“CLIA”) accredited laboratory services to provide whole genome sequencing and research direct to consumers, while building a genomics company withdatabase to be used for further research. In addition, we have deep experience with over-the- counterover-the-counter (“OTC”) consumer healthcare products and dietary supplements. We currently conduct our operations through two operating segments: diagnostic services and consumer products. Until late Fiscal 2020, we were engaged primarily in the research, development, manufacture, distribution, marketing and sale of OTC consumer healthcare products and dietary supplements in the United States. However, commencing in December 2020, we also began offering COVID-19 and other Respiratory Pathogen Panel (RPP) molecular tests through our new diagnostic services business.business, and in August 2021 we began offering personal genomics products and services.

 

Our wholly-ownedwholly owned subsidiary, ProPhase Diagnostics, Inc. (“ProPhase Diagnostics”), which was formed on October 9, 2020, offers a varietybroad array of medical tests,clinical diagnostic and testing services at its CLIA certified laboratories including state-of-the-art polymerase chain reaction (“PCR”) testing for COVID-19. Critical to COVID-19 testing, we provide fast turnaround times for results. We also offer rapid antigen and Respiratory Pathogen Panel (RPP) molecular tests.antibody/immunity testing for COVID-19. On October 23, 2020, we completed the acquisition of all of the issued and outstanding shares ofacquired Confucius Plaza Medical Laboratory Corp. (“CPM”), which operatesincluded a non-operating but certified 4,000 square foot Clinical Laboratory Improvement Amendments (“CLIA”)CLIA accredited laboratory located in Old Bridge, New Jersey, for approximately $2.5 million in cash (see Note 3, Business Acquisition). As a result of the acquisition of CPM in October 2020, we entered into a new business line, diagnostic services.Jersey. In December 2020, we expanded our diagnostic service business with the signing of a lease and build outbuild-out of a second, larger CLIA accredited laboratory in Garden City, New York. Operations at this second facility commenced in FebruaryJanuary 2021.

 

On August 10, 2021, we acquired Nebula Genomics, Inc. (“Nebula”), a privately owned personal genomics company, through our new wholly owned subsidiary, ProPhase Precision Medicine, Inc. (“ProPhase Precision”) (see Note 3, Business Acquisitions). ProPhase Precision focuses on genomics testing technologies, a comprehensive method for analyzing entire genomes, including the genes and chromosomes in DNA. The data obtained from genomic testing can help to identify inherited disorders and tendencies, help predict disease risk, help identify expected drug response, and characterize genetic mutations, including those that drive cancer progression.

Our wholly-ownedwholly owned subsidiary, Pharmaloz Manufacturing, Inc. (“PMI”), is a full-service contract manufacturer and private label developer of a broad range of non- GMO,non-GMO, organic and natural-based cough drops and lozenges and OTC drug and dietary supplement products.

 

On August 10, 2021, we acquired Nebula Genomics, Inc., a privately owned personal genomics company, through our new wholly-owned subsidiary, ProPhase Precision Medicine, Inc. (see Note 15, Subsequent Events).We also develop and market dietary supplements under the TK Supplements® brand.

In addition, we continue to actively pursue acquisition opportunities for other companies, technologies and products within and outside the consumer products industry.

We use a December 31 year-end for financial reporting purposes. References herein to “Fiscal 2020” mean the fiscal year ended December 31, 2020 and references to other “Fiscal” years mean the year that ended on December 31 of the year indicated. The term “we”, “us” or the “Company” as used herein also refer, where appropriate, to the Company, together with its subsidiaries unless the context otherwise requires.

 

Note 2 - Summary of Significant Accounting Policies

Basis of Presentation

The unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial statements and the rules of the Securities and Exchange Commission (“SEC”) applicable to interim financial statements, and therefore do not include all disclosures that might normally be required for financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The accompanying unaudited condensed consolidated financial statements have been prepared by management without audit and should be read in conjunction with our audited consolidated financial statements, including the notes thereto, appearing in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020.2021. In the opinion of management, all adjustments necessary for a fair presentation of the consolidated financial position, consolidated results of operations and other comprehensive loss and consolidated cash flows, for the periods indicated, have been made. The results of operations for the sixthree months ended June 30, 2021March 31, 2022 are not necessarily indicative of operating results that may be achieved over the course of the full year.

 

7

 

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

Segments

 

In accordance with FASB ASC 280, “Segment Reporting” (“ASC 280”), the Company discloses financial and descriptive information about its reportable operating segments.

ASC 280 establishes standards for reporting information about operating segments in annual and interim financial statements and requires that companies report financial and descriptive information about their reportable segments based on a management approach. ASC 280 also establishes standards for related disclosures about products and services, geographic areas and major customers.

Operating segments are defined as components of an enterprise that engage in business activities for which separate financial information is available and is evaluated by the Chief Operating Decision Maker (“CODM”), which for the Company is its Chief Executive Officer, in deciding how to allocate resources and assess performance. For the six months ended June 30, 2021, weWe maintain two operating segments: diagnostic services (which includes our COVID-19 and other diagnostic testing services) and consumer products. For the six months ended June 30, 2020, we only had the consumer products operating segment.(which includes our contract manufacturing, retail customers and personal genomics products and services) (see Note 14,15 Segment Information).

Business and Liquidity Uncertainties

 

For the six months ended June 30, 2021, our net revenues were derived from both our diagnostic servicesBusiness and consumer products segments. For the six months ended June 30, 2020, our net revenues were derived solely from our consumer products segment.Liquidity Risks and Uncertainties

 

TheWe launched our diagnostic service business commenced in December 2020 and expanded in FebruaryJanuary 2021 with the opening of our new Garden City, New York CLIA accredited laboratory. Our diagnostic service business is and will continue to be influenced by the level of demand for COVID-19 and other diagnostic testing, how long this demand persists, the priceprices we are able to receive for performing our testing services, and the length of timeour ability to collect payment or reimbursement for which that demand persists,our testing services, as well as the availability of COVID-19 testing from other laboratories and the period of time for which we are able to serve as an authorized laboratory offering COVID-19 testing under various Emergency Use Authorizations.

 

While our revenues increased significantly for the six monthsyear ended June 30,December 31, 2021 and the first quarter of fiscal 2022 as a result of the launch of our new diagnostic services business, line, we have made and will continue to make substantial investmentsbe dependent on both government agency and insurance company reimbursement as well as the prevalence of COVID-19 associated strains.

In March 2020, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), was enacted, providing for reimbursement to securehealthcare providers for COVID-19 tests provided to uninsured individuals, subject to continued available funding. Approximately 69% and 57% of our diagnostic services revenue for the necessary equipment, suppliesthree months ended March 31, 2022 and personnel2021, respectively was generated from this program for the uninsured. On March 22, 2022, the Health Resources & Services Administration (HRSA) program stopped accepting claims for COVID-19 testing and treatment due to provide theselack of sufficient funds. Despite requests from the Acting Director of the Office of Management and Budget and the White House Coordinator for COVID-19 Response for additional emergency funding for the uninsured program, emergency funding has not been allocated to the HRSA uninsured program as of the financial statement issuance date. We continue to perform testing services.for uninsured persons and are incurring the accompanying costs. However, as a result of the suspension of the HRSA uninsured program, we did not recognize any revenue related to COVID-19 testing that we performed for uninsured individuals from March 23, 2022 through March 31, 2022. If funding for the HRSA program is reinstituted in the future, we will submit eligible claims for reimbursement to HRSA and record the associated revenues. If the HRSA program remains unfunded and we are unable to submit claims for reimbursement, there could be a material adverse effect on our business and financial condition.

8

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

In addition, our diagnostic service business is subject to extensive federal, state, and local laws and regulations, all of which are subject to change, as well as laws and regulations governing the submission of claims for payment for our services, such as those relating to: coverage of our services under Medicare, Medicaid and other federal health care programs; the amounts that we may bill for our services; and the party to which we must submit claims. Also, reimbursement policies and requirements for some payers and procedures are ambiguous, which could lead to billing errors and related disputes. There can be no assurance that our efforts to offer and perform COVID-19 or other diagnostic testing will be successful in the future or that the revenue and operating profits from such business will increase or maintain their current level.

 

There are still numerous uncertainties associated with the COVID-19 pandemic, including the efficacy of the vaccines that have been developedWe acquired and commenced our personal genomics business in August 2021. This business is and will continue to treat the virusbe influenced by demand for our genetic testing products and their ability to protect against new strains of the virus, people’s willingness to receive a vaccine, possible resurgences of the coronavirus and/or new strains of the virus, the extentservices, our marketing and duration of protectiveservice capabilities, and preventative measures that may be adopted by local, state and/or the federal government in the future as a result of future outbreaks, the duration of any future business closures, the ongoing impact of COVID-19 on the U.S. and world economy and consumer confidence, and various other uncertainties.

The COVID-19 pandemic has also had a negative impact on the global capital markets and economies worldwide and could ultimately have a material adverse impact on our ability to raise capital needed to operate our business.comply with applicable regulatory requirements.

 

Our consumer sales are and will continue to be influenced by and subject to (i) the timing of acceptance of our TK Supplements® consumer products in the marketplace, and (ii) fluctuations in the timing of purchase and the ultimate level of demand for the OTC healthcare and cold remedy products that we manufacture, for others, which areis largely a function of the timing, length and severity of each cold season. Generally, a cold season is defined as the period from September to March when the incidence of the common cold rises as a consequenceresult of the change in weather and other factors. We generally experience in the first, third and fourth quarter higher levels of net salesrevenues from our contract manufacturing of OTC healthcare and cold remedy products.business. Revenues are generally at their lowest levels in the second quarter when customer demand generally declines.

 

8

For the three months ended March 31, 2022, $20.3 million was provided by operating activities. The Company had cash, cash equivalents and marketable securities of $29.4 million as of March 31, 2022. Based on management’s current business plans, the Company estimates it will have enough cash and liquidity to finance its operating requirements for at least 12 months from the date of filing these unaudited condensed consolidated financial statements. However, due to the nature of the diagnostic business and the Company’s focus thus far on COVID-19 testing, there are inherent uncertainties associated with managements’ business plan and cash flow projections, particularly if the Company is unable to grow its diagnostic testing business beyond COVID-19 testing services.

 

UseThe Company’s future capital needs and the adequacy of Estimatesits available funds will depend on the Company’s ability to achieve sustained profitability from its diagnostic services, the Company’s ability to successfully diversify its diagnostic services revenue streams and the Company’s ability to market and grow its personal genomics business. The Company may be required to raise additional funds through equity or debt securities offerings or strategic collaboration and/or licensing agreements in order to fund operations until it is able to generate enough revenues. Such financing may not be available on acceptable terms, or at all, and the Company’s failure to raise capital when needed could have a material adverse effect on its strategic objectives, results of operations and financial condition.

Use of Estimates

The preparation of condensed consolidated financial statements and the accompanying notes thereto, in conformity with GAAP, requires management to make estimates and assumptions that affect reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and reported amounts of revenues and expenses during the respective reporting periods. Examples include revenue recognition and the impact of the variable consideration of diagnostic test reimbursement rates, the provision for bad debt, sales returnsuncollectible receivables and billing errors, allowances, diagnostic services reimbursements,slow moving and/or dated inventory obsolescence, useful lives of property and equipment,associated provisions, the potential impairment of goodwill, intangibles and property and equipment,long-lived assets, stock based compensation valuations, income tax asset valuations and assumptions related to accrued advertising. These

Our estimates and assumptions are based on historical experience, current trends and other factors that management believes to be relevant at the time the condensed consolidated financial statements are prepared. Management reviews the accounting policies, assumptions, estimates and judgments on a quarterly basis. Actual results could differ from those estimates.

 

Cash and Cash Equivalents

We consider all highly liquid investments with a maturity of three months or less at the time of purchase to be cash equivalents. Cash equivalents include cash on hand and monies invested in money market funds. The carrying amount approximates the fair market value due to the short-term maturity of these securities.

 

Marketable Debt SecuritiesRestricted Cash

 

Restricted cash as of December 31, 2021 includes approximately $250,000 held in escrow related to a potential purchase of an additional lab facility. The potential purchase was not consummated, and we are pursuing the return of the escrow, which is in dispute. As of March 31, 2022, we recognized an expense for this balance as the recovery of the funds was no longer considered probable.

9

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

Marketable Debt Securities

We have classified our investments in marketable debt securities as available-for-sale and as a current asset. Our investments in marketable debt securities are carried at fair value, with unrealized gains anand as a separate component of stockholders’ equity. Realized gains and losses from our marketable debt securities are recorded as interest income (expense). These investments in marketable debt securities carry maturity dates between one and three years from date of purchase and interest rates of purchase.

0.94

% to 3.35% during the first two quarters of Fiscal 2021. For the three and six months ended June 30, 2021, we reported unrealized losses of $67,000 and $78,000, respectively. Unrealized gains and losses are classified as other comprehensive loss and the cost is determined on a specific identification basis. The following is a summary of the components of our marketable debt securities and the underlying fair value input level tier hierarchy (in thousands) (see fair value of financial instruments) (in thousands):

Summary of Components of Marketable Securities

 As of June 30, 2021  As of March 31, 2022 
 Amortized Unrealized Fair  Amortized Unrealized Unrealized  Fair 
 Cost Losses Value  Cost Gains Losses  Value 
U.S. government obligations $2,556  $(22) $2,534  $667  $123  $(44) $746 
Corporate obligations  15,628   (67)  15,561   2,839   -   (42)  2,797 
 $18,184  $(89) $18,095  $3,506  $123  $(86) $3,543 

 

  As of December 31, 2020
  Amortized  Unrealized  Fair 
  Cost  Losses  Value 
U.S. government obligations $1,021  $(7) $1,014 
Corporate obligations  629   (4)  625 
  $1,650  $(11) $1,639 

9

We believe that the unrealized gains or losses generally are the result of a change in the risk premiums required by market participants rather than an adverse change in cash flows or a fundamental weakness in the credit quality of the issuer or underlying assets.

  As of December 31, 2021 
  Amortized  Unrealized  Unrealized  Fair 
  Cost  Gains  Losses  Value 
U.S. government obligations $650  $17  $-  $667 
Corporate obligations  8,304   -   (192)  8,112 
  $8,954  $17  $(192) $8,779 

 

Marketable Equity Securities

 

Marketable equity securities are recorded at fair value in the consolidated balance sheets. The change in fair value of marketable equity securities is recognized within other non-operating income, net in the consolidated statements of income.

 

On June 25, 2021, we were issued 1,260,619 common shares (the “Investment Shares”) by the consultant as an interest payment under theour note receivable (see Note 13, Consulting Agreement and Secured Promissory Note (see note 13)Receivable) with a fair value of $315,000. Theat the time of issuance and a fair value of the Investment Shares as of June 30, 2021 was based upon the closing stock price of $0.38 76,000 at December 31, 2021.per share. The investment was classified as a Level 1 financial instrument. We recorded a $164,00076,000 increasedecrease in fair value of investment securities within the statement of operations for the sixthree months ended June 30, 2021.March 31, 2022.

 

Inventories,Accounts Receivable, net

Accounts receivable consists primarily of amounts due from government agencies and healthcare insurers. Unbilled accounts receivable relates to the delivery of our diagnostic testing services for which the related billings will occur in a future period, after a patient’s insurance information has been validated, and represent amounts for which we have a right to receive payment. Unbilled accounts receivable is classified as accounts receivable on the consolidated balance sheet. We carry our accounts receivable at the amount of consideration for which we expect to be entitled less allowances. When estimating the allowances for our diagnostics business, the Company pools its receivables based on the following payer types: healthcare insurers and government payers. The Company principally estimates the allowances by pool based on historical collection experience, current economic conditions, government and healthcare insurer payment trends, and the period of time that the receivables have been outstanding. Should a payer’s reimbursement policy change or their credit quality deteriorate, the Company removes the payer from their respective pools and establishes allowances based on the individual risk characteristics of such payer.

10

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

Accounts are written off as uncollectible at the time we determine that collections are unlikely. Accounts receivable, net is comprised of the following (in thousands):

Schedule of Accounts Receivable Net

  March 31, 2022  December 31, 2021 
Trade accounts receivable $24,727  $18,520 
Unbilled accounts receivable  14,944   23,089 
 Accounts receivable, gross  39,671   41,609 
Less allowances  (2,977)  (3,901)
Total accounts receivable $36,694  $37,708 

Inventory, net

Inventory is valued at the lower of cost, determined on a first-in, first-out basis (FIFO)(“FIFO”), or net realizable value. Inventory items are analyzed to determine cost and the net realizable value and appropriate valuation adjustments are then established.

At June 30, 2021March 31, 2022 and December 31, 2020,2021, the financial statements include non-cash adjustments to adjust inventory for excess, obsolete or short-dated shelf-life inventory by $87,000and $167,000, respectively. The components of inventory are as follows (in thousands):

Schedule of Components of Inventory

 June 30, December 31,  March 31, December 31, 
 2021 2020  2022 2021 
Diagnostic services testing material $13,240  $1,028  $3,103  $2,989 
Raw materials  1,249   1,404   1,238   1,514 
Work in process  345   437   476   260 
Finished goods  335   170   322   272 
Inventory $5,139  $5,035 
Inventory valuation reserve  (459)  (435)
Inventory, net $15,169  $3,039  $4,680  $4,600 

 

Property, Plant and Equipment

Property, plant and equipment are recorded at cost. We use the straight-line method in computing depreciation for financial reporting purposes. Depreciation expense is computed in accordance with the following ranges of estimated asset lives: building and improvements - ten to thirty-nine years; machinery and equipment including lab equipment - three to seven years; computer equipment and software - three to five years; and furniture and fixtures - five years.

We did not identify any indicators of our property, plant and equipment for the six months ended June 30, 2021 and 2020 and concluded there were no impairments or changes in useful lives.

Concentration of Risks

 

Future revenues, costs, margins and profits will continue to be influenced by our ability to maintain our manufacturing availability and capacity together with our marketing and distribution capabilities and the regulatory requirements associated with the developmentConcentration of OTC consumer healthcare products, dietary supplements and other remedies in order to compete on a national level and/or international level. Our diagnostic services business will be influenced by demand for our diagnostic testing services, particularly COVID-19, as well as our marketing and service capabilities and regulatory requirements associated with operating under and maintaining our CLIA license.

Our business is subject to federal and state laws and regulations adopted for the health and safety of users of our products. The manufacturing and distribution of OTC healthcare and dietary supplement products are subject to regulations by various federal, state and local agencies, including the Food and Drug Administration (“FDA”) and, as applicable, the Homeopathic Pharmacopoeia of the United States. The FDA is also responsible for the regulation of diagnostic testing instruments, test kits, reagents and other devices used by clinical laboratories.Financial Risks

 

Financial instruments that potentially subject us to significant concentrations of credit risk consist principally of cash investments, marketable debt securities, and trade accounts receivable. Our marketable securities are fixed income investments, which are highly liquid and can be readily purchased or sold through established markets.

 

We maintain cash and cash equivalents with certain major financial institutions. As of June 30, 2021,March 31, 2022, our cash and cash equivalents balance were $17.7million and our bankrestricted cash balance was $17.925.8 million. Of the total bank balance, $0.50.9 million was covered by federal depository insurance and $17.4 24.9million was uninsured at June 30, 2021.March 31, 2022.

 

1011

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

Accounts receivable subject us to credit risk concentrations from time-to-time. We extend credit to our consumer healthcare product customers based upon an evaluation of the customer’s financial condition and credit history and generally do not require collateral. Our diagnostic services receivable credit risk is based on payer reimbursement experience, which includes government agencies and healthcare insurers, the period the receivables have been outstanding and the historical collection.collection rates. The collectability of the diagnostic services receivables is also directly linked to the quality of our billing processes, which dependdepends on information provided to the payors and billing services of third parties. These credit concentrations impact our overall exposure to credit risk, which could be further affected by changes in economic, regulatory or other conditions that may impact the timing and collectability of trade receivables and diagnostic test receivables. Additionally, the reimbursement receivables from the diagnostic service business are subject to billing errors and related disputes.meeting their requirements for reimbursement.

 

We also assess the financial condition of the debtor under the Secured Note (see Note 13), balances due to us and other factors, and based on this assessment, we did not offset our note receivable with an allowance at June 30, 2021 and June 30, 2020.Leases

 

Leases

At the inception of an arrangement, we determine whether the arrangement is or contains a lease based on the unique facts and circumstances present in the arrangement. Most leases with a term greater than one year are recognized on the balance sheet as right-of-use assets and short-term and long-term lease liabilities, as applicable. We have elected not to recognize on the balance sheet leases with terms of 12 months or less. We typically only include an initial lease term in its assessment of a lease arrangement. Options to renew a lease are not included in our assessment unless there is reasonable certainty that we will renew.

 

Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. Certain adjustments to the right-of-use asset may be required for items such as incentives received. The interest rate implicit in our leases is typically not readily determinable. As a result, we utilize our incremental borrowing rate, which reflects the fixed rate at which we could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term and in a similar economic environment (see Note 10, Lease)12, Leases).

 

The components of a lease should be allocated between lease components (e.g.(e.g., land, building, etc.) and non-lease components (e.g.(e.g., common area maintenance, consumables, etc.). The fixed and in-substance fixed contract consideration (including any consideration related to non-components) must be allocated based on the respective relative fair values to the lease components and non-lease components.

 

Goodwill and Long-livedIntangible Assets

 

We review ourGoodwill represents the excess of the fair value of the consideration transferred over the fair value of the underlying identifiable assets and liabilities acquired in a business combination. Goodwill and intangible assets deemed to have an indefinite life are not amortized, but instead are assessed for impairment annually. Additionally, if an event or change in circumstances occurs that would more likely than not reduce the fair value of the reporting unit below its carrying value, we would evaluate goodwill at least annually for impairment as well as the carrying value of goodwill and our long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of these assets may not be fully recoverable. When it is determined that the carrying amount of long-lived assets or goodwill is impaired, impairment is measured by comparing an asset’s estimated fair value to its carrying value. The determination of fair value is based on quoted market prices in active markets, if available, or independent appraisals; sales price negotiations; or projected future cash flows discounted at a rate determined by management to be commensurate with our business risk. The estimation of fair value utilizing discounted forecasted cash flows includes significant judgments regarding assumptions of revenue, operating and marketing costs; selling and administrative expenses; interest rates; property and equipment additions and retirements; and industry competition, general economic and business conditions, among other factors.time.

 

Management has determinedIn testing for goodwill impairment, we have the option to first assess qualitative factors to determine whether the existence of events or circumstances lead to a determination that there was no impairment to our long-lived assetsit is more likely than not that the fair value of the reporting unit is less than its carrying amount. If, after assessing the totality of events and goodwill oncircumstances, we conclude that it is not more likely than not that the basisfair value of a review of a discounted cash flow analysis, which forreporting unit is less than its carrying amount, then performing the two-step impairment test is not required. If we conclude otherwise, we are required to perform the two-step impairment test. The goodwill impairment test is performed at the reporting unit level ofby comparing the subsidiaries to which the goodwill relates. There were no events or circumstances that required an assessment to be performed on our long-lived assets with definite lives. If there is a material change in the assumptions used in the determination ofestimated fair value orof a material change inreporting unit with its respective carrying value. If the conditions or circumstances influencingestimated fair value we couldexceeds the carrying value, goodwill at the reporting unit level is not impaired. If the estimated fair value is less than the carrying value, an impairment charge will be requiredrecorded to recognize a material impairment charge.reduce the reporting unit to fair value.

 

1112

 

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

Intangible assets deemed to have finite lives are amortized on a straight-line basis over their estimated useful lives, where the useful life is the period over which the asset is expected to contribute directly, or indirectly, to our future cash flows.

Fair Value of Financial Instruments

We measuresmeasure assets and liabilities at fair value based on expected exit price as defined by the authoritative guidance on fair value measurements, which represents the amount that would be received on the sale date of an asset or paid to transfer a liability, as the case may be, in an orderly transaction between market participants. As such, fair value may be based on assumptions that market participants would use in pricing an asset or liability. The authoritative guidance on fair value measurements establishes a consistent framework for measuring fair value on either a recurring or nonrecurring basis whereby inputs, used in valuation techniques, are assigned a hierarchical level.

 

The following are the hierarchical levels of inputs to measure fair value:

 

Level 1: Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets.
Level 2: Inputs reflect quoted prices for identical assets or liabilities in markets that are not active; quoted prices for similar assets or liabilities in active markets; inputs other than quoted prices that are observable for the assets or liabilities; or inputs that are derived principally from or corroborated by observable market data by correlation or other means.
Level 3: Unobservable inputs reflecting the Company’s assumptions incorporated in valuation techniques used to determine fair value. These assumptions are required to be consistent with market participant assumptions that are reasonably available.

 

The carrying amounts of our financial assets and liabilities, such as cash, accounts receivable, accounts payable, secured note receivable and unsecured note payable, approximate their fair values because of the currentshort-term nature of these instruments.

 

We account for our marketable securities at fair value, with the net unrealized gains or losses of marketable debt securities reported as a component of accumulated other comprehensive income or loss and marketable equity securities change in fair value reported on the condensed consolidated statement of operations (see note 13, Secured Promissory Note Receivable and Consulting Agreement).operations. The components of marketable securities and are as follows (in thousands):

 

Schedule of Fair Value of Financial Instruments

  As of June 30, 2021 
  Level 1  Level 2  Level 3  Total 
Marketable debt securities                
U.S. government obligations $-  $2,534  $-  $2,534 
Corporate obligations  -   15,561   -   15,561 
Marketable equity securities  479   -   -   479 
  $479  $18,095  $-  $18,574 

  As of March 31, 2022 
  Level 1  Level 2  Level 3  Total 
U.S. government obligations $-  $746  $-  $746 
Corporate obligations  -   2,797   -   2,797 
  $-  $3,543  $-  $3,543 

 

  As of December 31, 2020 
  Level 1  Level 2  Level 3  Total 
Marketable debt securities                
U.S. government obligations $-  $1,014  $-  $1,014 
Corporate obligations  -   625   -   625 
  $-  $1,639  $-  $1,639 
13

 

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

  As of December 31, 2021 
  Level 1  Level 2  Level 3  Total 
U.S. government obligations $-  $667  $-  $667 
Corporate obligations  -   8,112   -   8,112 
Marketable equity securities  76   -   -   76 
  $76  $8,779  $-  $8,855 

There were no transfers of marketable debt securities between Levels 1, 2 or 3 for the sixthree months ended June 30,March 31, 2022 and 2021.

 

Revenue Recognition

We recognize revenue that represents the transfer of promised goods or services to customers at an amount that reflects the consideration that is expected to be received in exchange for those goods or services. We recognize revenue when performance obligations with our customers have been satisfied. At contract inception, we evaluate the contract to determine if revenue should be recognized using the following five steps: (1) identify the contract with the customer; (2) identify the performance obligations; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations; and (5) recognize revenue when (or as) the entity satisfies a performance obligation.

 

Contract with Customers and Performance Obligations

A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account. A contract’s transaction price is allocated to each distinct performance obligation and recognized as revenue when, or as, the performance obligation is satisfied. We had historically generated sales principally through two types of customers, contract manufacturing and retail customers for our consumer products. Sales from product shipments to contract manufacturing and retailer customers are recognized at the time ownership is transferred to the customer. As of December 2020, we also began generating revenues through diagnostic services. Revenue from diagnostic services is recognized when the results are made available to the customer. Net revenuesRevenue from consumer products were $1.6 million and $4.1 million forour personal genomics business is recognized when the three and six months ended June 30, 2021, respectively. Net revenue from diagnostic services was $7.5 million and $20.3 million for the three and six months ended June 30, 2021, respectively. Net revenues for consumer products were $3.6 million and $5.5 million and zero sales from diagnostic services for the three and six months ended June 30, 2020, respectively.

The Company’s performance obligation for contract manufacturing and retail customers isgenetic testing results are provided to provide the goods ordered by the customer. For diagnosticsubscription services associated with our genomic testing, we recognize revenue ratably over the Company has one performance obligation, which is to provide the resultsterm of the laboratory test to the customer.subscription.

12

 

Transaction Price

For contract manufacturing and retail customers, the transaction price is fixed based upon either (i) the terms of a combined master agreement and each related purchase order, or (ii) if there is no master agreement, the price per individual purchase order received from each customer. The customers are invoiced at an agreed upon contractual price for each unit ordered and delivered by the Company.

 

Revenue from retail customers is reduced for trade promotions, estimated sales returns and other allowances in the same period as the related sales are recorded. No such allowance is applicable to our contract manufacturing customers. We estimate potential future product returns and other allowances related to current period revenue. We analyze historical returns, current trends, and changes in customer and consumer demand when evaluating the adequacy of the sales returns and other allowances.

 

14

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

We do not accept returns in thefrom our contract manufacturing revenue stream.customers. Our return policy for retail customers accommodates returns for (i) discontinued products, (ii) store closings and (iii) products that have reached or exceeded their designated expiration date. We do not impose a period of time during which product may be returned. All requests for product returns must be submitted to us for pre-approval. We will not accept return requests pertaining to customer inventory “Overstocking” or “Resets”. We will accept return requests only for products in their intended package configuration. We reserve the right to terminate shipment of product to customers who have made unauthorized deductions contrary to our return policy or pursue other methods of reimbursement. We compensate the customer for authorized returns by means of a credit applied to amounts.

Accrued advertising and other allowances operations as of June 30, 2021 included (i) $321,000 for estimated returns and allowances, which is reported as a liability and (ii) $214,000 for cooperative and incentive promotion costs, which is also reported as a liability. As of December 31, 2020, accrued advertising and other allowances included (i) $291,000 for estimated returns, which is reported as a liability and (ii) $463,000 for cooperative and incentive promotion costs, which was also reported as a liability.amounts owed.

 

For our diagnostic services business, a revenue transaction is initiated when we receive a requisition order to perform a diagnostic test. The information provided on the requisition form is used to determine the party that will be billed for the testing performed and the expected reimbursement. We provide diagnostic services to a range of customers, including health plans, government agencies and consumers.customers. In many cases, the customer that orders our services is not responsible for paying for these services. Depending on the billing arrangement and applicable law, the payer may be the patient or a third party, such as a health plan, Medicare or Medicaid program and other government reimbursement programs. We bill the providers at standard price and take into consideration negotiated discounts and anticipated reimbursement remittance adjustments based on the payer portfolio, when revenue is recorded. We use the most expected value method to estimate the transaction price for reimbursements that vary from the listed contract price.

 

For our personal genomics business, a revenue transaction is initiated by a DNA test kit sale direct to the consumer sales via our website or through online retailers. The kit sales and subscriptions are billed at a standard price and take into consideration any discounts when revenue is recorded.

Recognize Revenue When the Company Satisfies a Performance Obligation

Performance obligations related toRecognition for contract manufacturing and retail customers areis satisfied at a point in time when the goods are shipped to the customer as (i) we have transferred control of the assets to the customers upon shipping, and (ii) the customer obtains title and assumes the risks and rewards of ownership after the goods are shipped.

For diagnostic services, the Company satisfies its performance obligationrecognition occurs at the point in time that the results are made available to the customer, which is when the customer benefits from the information contained in the results and obtains control.

 

13

For genomic services, we satisfy our product performance obligation at a point in time when the genetic testing results are provided to the customer. For subscriptions services associated with its genomic testing, we satisfy our performance obligation ratably over the subscription period. If the customer does not return the test kit, services cannot be completed by us, potentially resulting in unexercised rights (“breakage”) revenue, including lifetime subscription services. We estimate breakage for the portion of test kits not expected to be returned using an analysis of historical data and consider other factors that could influence customer test kit return behavior. When breakage revenue is recognized on a kit, we recognize breakage on any associated subscription services ratably over the term of the subscription. The Company recognized breakage revenue from aggregate unreturned test kits and subscriptions of $0.4 million for the three months ended March 31, 2022.

 

Contract Balances

As of June 30, 2021 and December 31, 2020, we have deferred revenue of $233,000 and $331,000, respectively, in relation to R&D stability and release testing programs recognized as contract manufacturing revenue. Deferred revenues primarily consist of amounts that have been billed to or received from customers in advance of revenue recognition and prepayments received from customers in advance of services performed for the R&D work. We recognize As of March 31, 2022 and December 31, 2021, we have deferred revenuesrevenue of $3.1 million and $2.9 million, respectively. Our new personal genomics business comprised $2.9million of the deferred revenue as revenues whenof March 31, 2022. The deferred revenue balance within the personal genomics business is comprised of kits to be sequenced and subscription services, are performed which have an average life between 12 and the corresponding36 months. The remainder of deferred revenue recognition criteria are met. Customer prepayments are generally applied against invoices issuedrelates to customers when services are performedresearch and billed.development (“R&D”) stability and release testing programs recognized as contract manufacturing revenue.

15

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

The following table disaggregates our deferred revenue by recognition period (in thousands):

Schedule of Deferred Revenue

   As of
June 30, 2021
 As of
December 31, 2020
 
Recognition Period        
0-12 Months  $112 $         169 
13-24 Months   74  84 
Over 24 Months   47  78 
Total  $233 $331 

  March 31,  December 31, 
  2022  2021 
Recognition Period        
0-12 Months $2,246  $2,034 
13-24 Months  598   530 
Over 24 Months  260   375 
Total $3,104  $2,939 

 

Disaggregation of Revenue

We disaggregate revenue from contracts with customers into threefour categories: diagnostic services, contract manufacturing, retail customers and diagnosticothers, and genomic products and services. We determined that disaggregating revenue into these categories achieves the disclosure objective to depict how the nature, amount, timing and uncertainty of revenue and cash flows are affected by economic factors.

 

The following table disaggregates ourthe Company’s revenue by revenue source for the three and sixmonths ended June 30,March 31, 2022 and 2021 and 2020 (in thousands):

Schedule of Disaggregation by Revenue

 For the three months ended  For the six months ended  For the three months ended 
Revenue by Customer Type June 30, 2021  June 30, 2020  June 30, 2021  June 30, 2020  March 31, 2022 March 31, 2021 
Diagnostic services $44,913  $12,738 
Contract manufacturing $1,041  $3,472  $2,949  $5,195   1,154   1,908 
Retail and others  565   151   1,190   316   546   625 
Diagnostic services  7,536   -   20,274   - 
Total revenue $9,142  $3,623  $24,413  $5,511 
Genomic products and services  918   - 
Total revenue, net $47,531  $15,271 

 

Customer Consideration

The Company makes payments to certain diagnostic services customers for distinct services that approximate the fair value for those services. Such services include specimen collection, the collection and delivery of insurance and patient information necessary for billing and collection, and logistics services, as well as other information requirements.services. Consideration associated with specimen collection services is classified in cost of revenues and the remaining costs are classified as diagnostic expenses within operating expenses in the accompanying statement of operations. Diagnostic services cost

Sales Tax Exclusion from the Transaction Price

We exclude from the measurement of revenue includes specimen collection payments to customersthe transaction price all taxes assessed by a governmental authority that are both imposed on and other costs incurred in connectionconcurrent with a specific revenue-producing transaction and collected by the company operated laboratories, including reagent and other raw material costs, direct and indirect labor and other laboratory facility overhead (see Note 14, Segment Information).Company from the customer.

 

Shipping and Handling Activities

We account for shipping and handling activities that we perform as activities to fulfill the promise to transfer the goods.good.

 

1416

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

Advertising and Incentive Promotions

Advertising and incentive promotion costs are expensed within the period in which they are utilized. Advertising and incentive promotion expense is comprised of (i) media advertising, presented as part of salesgeneral and marketingadministrative expense, (ii) cooperative incentive promotions and coupon program expenses, which are accounted for as part of net sales,revenue, and (iii) free product, which is accounted for as part of cost of sales.revenues. Advertising and incentive promotion expenses incurred for the three months ended June 30,March 31, 2022 and 2021 and 2020 were $111,000 60,000and $49,000168,000, respectively. Advertising and incentive promotion expenses incurred for the six months ended June 30, 2021 and 2020 were $279,000 and $96,000, respectively.

 

Share-BasedStock-Based Compensation

 

The Company accounts for stock-based compensation in accordance with FASB ASC 718, “Compensation - Stock Compensation.” Under the fair value recognition provision of the ASC, stock-based compensation cost is estimated at the grant date based on the fair value of the award. The Company estimates the fair value of stock options and warrants granted using the Black-Scholes-Merton option pricing model and stock grants at their closing reported market value. We recognize all share-basedstock-based payments to employees and directors, including grants of stock options, as compensation expense in the condensed consolidated financial statements based on their grant date fair values. FairThe grant date fair values of stock options are determined through the use of the Black-Scholes option pricing model. The compensation cost is recognized as an expense over the requisite service period of the award, which usually coincides with the vesting period. We account for forfeitures as they occur.

 

Stock and stock options to purchase our common stock have been granted to employees pursuant to the terms of certain agreements and stock option plans.plans (see Note 7, Stockholders’ Equity). Stock options are exercisable during a period determined by us, but in no event later than seven years from the date granted. For the three months ended June 30, 2021 and 2020, we charged to operations $1,076,000 and $198,000, respectively, for share-based compensation expense associated with vesting of outstanding equity awards. For the six months ended June 30, 2021 and 2020, we charged to operations $1,504,000 and $396,000, respectively, for share-based compensation expense associated with vesting of outstanding equity awards.

Research and Development (“R&D”)

R&D costs are charged to operations in the period incurred. R&D costs incurred for the three months ended June 30,March 31, 2022 and 2021 and 2020 were $93,00035,000 and $65,000115,000, respectively. R&D costs are principally related to personnel expenses and new product development initiatives and costs associated with our OTC health care products, dietary supplements and validation feescosts in association with the diagnostic services business including the validation work of the diagnostic services businessbusiness.

 

Income Taxes

We utilize the asset and liability approach, which requires the recognition of deferred tax assets and liabilities for the future tax consequences of events that have been recognized in our financial statements or tax returns. In estimating future tax consequences, we generally consider all expected future events other than enactments of changes in the tax law or rates. Until sufficient taxable income to offset the temporary timing differences attributable to operations and the tax deductions attributable to option, warrant and stock activities are assured, a valuation allowance equaling the total deferred tax asset is being provided.

 

We utilize a two-step approach to recognizingThe Company recognizes deferred tax liabilities and measuring uncertain tax positions. The first step is to evaluateassets based on the differences between the financial statement carrying amounts and the tax positionbases of assets and liabilities, using enacted tax rates in effect in the years the differences are expected to reverse.

The provision for, recognition by determining ifor benefit from, income taxes includes deferred taxes resulting from the weighttemporary differences in income for financial and tax purposes using the liability method. Future realization of deferred income tax assets requires sufficient taxable income within the carryback, carryforward period available under tax law. We evaluate, on a quarterly basis whether, based on all available evidence, indicatesit is probable that the deferred income tax assets are realizable. Valuation allowances are established when it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit of the deferred tax asset will not be realized. The evaluation, as prescribed by ASC 740- 10, “Income Taxes,” includes the largest amount that is more than fifty percent likelyconsideration of being realized upon ultimate settlement. Any interestall available evidence, both positive and negative, regarding historical operating results including recent years with reported losses, the estimated timing of future reversals of existing taxable temporary differences, estimated future taxable income exclusive of reversing temporary differences and carryforwards, and potential tax planning strategies which may be employed to prevent an operating loss or penalties related to income taxes will be recorded as interest or administrative expense, respectively.tax credit carryforward from expiring unused.

 

AsThe Company accounts for uncertainties in income taxes under the provisions of FASB ASC 740-10-05 (the “Subtopic”). The Subtopic clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements. The Subtopic prescribes a resultrecognition threshold and measurement attribute for the financial statement recognition and measurement of our historical losses from continuing operations, we have recorded a full valuation allowance againsttax position taken or expected to be taken in a net deferred tax asset. Additionally, we have not recorded a liability for unrecognized tax benefit.return. The Subtopic provides guidance on the de-recognition, classification, interest and penalties, accounting in interim periods, disclosure and transition.

17

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

Recently Issued Accounting Standards, Not Yet Adopted

 

In September 2016, the FASB issued ASU 2016-13,The Financial Instruments - Credit Losses (Topic 326). The ASU sets forth a “current expected credit loss” (CECL) model which requires the Company to measure all expected credit losses for financial instruments held at the reporting date based on historical experience, current conditions, and reasonable supportable forecasts. This replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial assets measured at amortized cost and applies to some off-balance sheet credit exposures. In February 2020, the FASB issued ASU 2020-02, Financial Instruments - Credit Losses (Topic 326), which amends the effective date of the original pronouncement for smaller reporting companies. ASU 2016-13 and its amendments will be effective for the Company for interim and annual periods in fiscal years beginning after December 15, 2022. We are currently assessing the impact of the adoption of this ASU on our financial statements.

15

The FASBAccounting Standards Board (“FASB”) recently issued ASUAccounting Standards Update (“ASU”) 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470- 20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, to reduce complexity in applying GAAP to certain financial instruments with characteristics of liabilities and equity. The guidance in ASU 2020-06 simplifies the accounting for convertible debt instruments and convertible preferred stock by removing the existing guidance that requires entities to account for beneficial conversion features and cash conversion features in equity, separately from the host convertible debt or preferred stock. The guidance in ASC 470-20 applies to convertible instruments for which the embedded conversion features are not required to be bifurcated from the host contract and accounted for as derivatives. In addition, the amendments revise the scope exception from derivative accounting in ASC 815-40 for freestanding financial instruments and embedded features that are both indexed to the issuer’s own stock and classified in stockholders’ equity, by removing certain criteria required for equity classification. These amendments are expected to result in more freestanding financial instruments qualifying for equity classification (and, therefore, not accounted for as derivatives), as well as fewer embedded features requiring separate accounting from the host contract. The amendments in ASU 2020-06 further revise the guidance in ASC 260, Earnings Per Share, to require entities to calculate diluted earnings per share (EPS) for convertible instruments by using the if-converted method. In addition, entities must presume share settlement for purposes of calculating diluted EPS when an instrument may be settled in cash or shares. The amendments in ASU 2020-06 are effective for public entities, excluding smaller reporting companies, for fiscal years beginning after December 15, 2021. For all other entities, the amendments are effective for fiscal years beginning after December 15, 2023. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020. The adoption of ASU 2020-06 did not have a material impact on the Company’s condensed consolidated financial statements or disclosures.

In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40). This ASU reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. This ASU provides guidance for a modification or an exchange of a freestanding equity-classified written call option that is not within the scope of another Topic. It specifically addresses: (1) how an entity should treat a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange; (2) how an entity should measure the effect of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange; and (3) how an entity should recognize the effect of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange. This ASU will be effective for all entities for fiscal years beginning after December 15, 2021. An entity should apply the amendments prospectively to modifications or exchanges occurring on or after the effective date of the amendments. Early adoption is permitted, including adoption in an interim period. The adoption of ASU 2021-04 did not have a material impact on the Company’s condensed consolidated financial statements or disclosures.

Recently Issued Accounting Standards, Not Yet Adopted

In September 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326). The ASU sets forth a “current expected credit loss” (CECL) model which requires the Company to measure all expected credit losses for financial instruments held at the reporting date based on historical experience, current conditions, and reasonable supportable forecasts. This replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial assets measured at amortized cost and applies to some off-balance sheet credit exposures. In February 2020, the FASB issued ASU 2020-02, Financial Instruments - Credit Losses (Topic 326), which amends the effective date of the original pronouncement for smaller reporting companies. ASU 2016-13 and its amendments will be effective for the Company for interim and annual periods in fiscal years beginning after December 15, 2022. We are currently assessing the impact of the adoption of this ASU on our financial statementsstatements.

18

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

Note 3 - Business Acquisition

 

Nebula Acquisition

On October 23, 2020, we completedAugust 10, 2021 (the “Effective Date”), the acquisitionCompany and its wholly owned subsidiary, ProPhase Precision, entered into and closed a Stock Purchase Agreement (the “Nebula Stock Purchase Agreement”) with Nebula, each of the stockholders of Nebula (the “Seller Parties”), and Kamal Obbad, as Seller Party Representative. Pursuant to the terms of the Nebula Stock Purchase Agreement, ProPhase Precision acquired all of the issued and outstanding shares of capitalcommon stock of CPMNebula from the Seller Parties, for an aggregate purchase price of approximately $2.514.3 million, in cash, subject to post-closing adjustments (the “Nebula Acquisition”). A portion of the purchase price equal to $3.6 million was paid in shares of the Company’s common stock to certain adjustments,Seller Parties and noteholders of Nebula, based on their election to receive shares of the Company’s common stock in lieu of cash, which shares were valued at a price per share of $7.46, which is equal to the average closing price of the Company’s common stock on Nasdaq for the five trading days preceding the signing of the Nebula Stock Purchase Agreement. A portion of the purchase price equal to $1,080,000 (the “Escrow Amount”) is being held in escrow by Citibank, N.A. (the “Escrow Agent”) until February 23, 2023(“Escrow Termination Date”), pursuant to the terms and conditions of a Stock Purchase Agreement, by and amongan escrow agreement entered into with the Company, CPM, Pride Diagnostics LLC (“Pride Diagnostics”) andEscrow Agent, as security for the members of Pride Diagnostics (together with Pride Diagnostics, the “Seller Parties”), and Arvind Gurnani, as representativeindemnification obligations of the Seller Parties. CPM (now knownAt the Escrow Termination Date, the remaining amount, if any, of the Escrow Amount, less any amount reasonably necessary to pay any claim with respect to which a notice of claim has been timely and properly given, will be delivered to the Seller Parties, as applicable.

In connection with the Nebula Acquisition, ProPhase Diagnostics NJ, Inc.) owns a 4,000 square foot (CLIA) accredited laboratory located in Old Bridge, New Jersey. On October 23, 2020, wePrecision entered into an employment agreement with Kamal Obbad, the Chief Executive Officer of Nebula, on the Effective Date, pursuant to which Mr. Obbad serves as Senior Vice President, Director of Sales and Marketing of ProPhase Precision. As a Consulting Agreement withcondition to the employment agreement, Mr. Gurnani forObbad was awarded a six-month period forstock option to purchase 250,000 shares of Company common stock at an aggregate totalexercise price equal to $7.67 per share, the closing price of $300,000, which was subsequently terminated after two months of service.the Company common stock on the Effective Date (see Note 7, Stockholders’ Equity).

 

Based on the preliminary valuation, the total consideration of $2.512.7 million, which is net of $1.6 million in cash acquired, has been allocated to assets acquired and liabilities assumed based on their respective fair values as follows (amount in(in thousands):

Schedule of Assets Acquired and Liabilities Assumed

     
Clinical lab material $180 
Lab equipment  112 
Definite-lived intangible asset  1,307 
Total assets acquired  1,599 
Liabilities assumed  - 
Net identifiable assets acquired  1,599 
Goodwill  901 
Total consideration $2,500 
Account Amount 
Short term investments $1,800 
Accounts receivable  171 
Inventory  133 
Prepaid and other current assets  379 
Definite-lived intangible assets  10,990 
Total assets acquired  13,473 
Accounts payable  (805)
Accrued expenses and other current liabilities  (43)
Deferred revenue  (2,391)
Note payable  (81)
Deferred tax liability  (1,925)
Total liabilities assumed  (5,245)
Net identifiable assets acquired  8,228 
Goodwill  4,446 
Total consideration, net of cash acquired (1) $12,674 

(1)Net of $1.6 million cash acquired.

19

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

Goodwill has been measured asrepresents the excess of the total considerationpurchase price over the amounts assigned tonet identifiable tangible and intangible assets acquired. The Company believes the identifiable assets acquired and liabilities assumed in the amount of $901,000, which was primarilygoodwill related to the acquisition was a result of the assembled workforce. Other definite-lived intangible asset of approximate $1.3 million were relatedexpected synergies to the CLIA license, which was determined to have an estimated useful life of three years. The Company recognized $109,000 be realized from combining operations and $207,000 amortization expense during the three and six months June 30, 2021, respectively.

is not deductible for income tax purposes. The preliminary purchase price allocation is adjusted, as necessary, up to one year after the acquisition closing date if management obtains more information regarding asset valuations and liabilities assumed.

 

The intangible assets identified in conjunction with the Nebula Acquisition are as follows (in thousands):

Schedule of Intangible Assets Acquisition

  Gross Carrying Value  Estimated Useful Life (in years) 
Trade names $5,550   15 
Proprietary intellectual property  4,260   5 
Customer relationships  1,180   1 
Total $10,990     

Note 4 – Goodwill and Acquired Intangible Assets

Goodwill

There were no changes in goodwill for the three months ended March 31, 2022.

1620

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

Intangible Assets, Net

Intangible assets as of March 31, 2022 and December 31, 2021 consisted of the following (in thousands):

Schedule of Intangible Assets

  

March 31,

2022

  

December 31,

2021

  

Estimated Useful

Life (in years)

Trade names $5,550  $5,550  15
Proprietary intellectual property  4,260   4,260  5
Customer relationships  1,180   1,180  1
CLIA license  1,307   1,307  3
 Total intangible assets, gross  12,297   12,297   
Less: accumulated amortization  (2,154)  (1,445)  
Total intangible assets, net $10,143  $10,852   

Amortization expense for acquired intangible assets was $709,000 and $109,000 during the three months ended March 31, 2022 and 2021, respectively. The estimated future amortization expense of acquired intangible assets as of March 31, 2022 is as follows (in thousands):

Schedule of Estimated Future Amortization Expense of Acquired Intangible Assets

     
Remaining periods ended December 31, 2022 $1,669 
Year ended December 31, 2023  1,585 
Year ended December 31, 2024  1,222 
Year ended December 31, 2025  1,222 
Year ended December 31, 2026  890 
Thereafter  3,555 
 Total intangible assets, net $10,143 

Note 4 –5 - Property, Plant and Equipment

The components of property, plant and equipment are as follows (in thousands):

Schedule of Property, Plant and Equipment

  

June 30, 2021

  December 31, 2020  Estimated Useful Life
Land $352  $352   
Building improvements  1,859   1,729  10-39 years
Machinery  4,669   4,441  3-7 years
Lab equipment  4,316   1,002  3-7 years
Computer equipment  1,182   881  3-5 years
Furniture and fixtures  457   194  5 years
   12,835   8,599   
Less: accumulated depreciation  (5,921)  (5,021)  
Total property, plant and equipment, net $6,914  $3,578   

  

March 31,

2022

  

December 31,

2021

  Estimated Useful Life
Land $352  $352   
Building improvements  1,729   1,729  10-39 years
Machinery  4,740   4,740  3-7 years
Lab equipment  4,936   4,330  3-7 years
Computer equipment  1,589   1,211  3-5 years
Furniture and fixtures  468   468  5 years
 Property, Plant and Equipment, Gross  13,814   12,830   
Less: accumulated depreciation  (7,374)  (6,883)  
Total property, plant and equipment, net $6,440  $5,947   

 

Depreciation expense incurred for the six months ended June, 2021 and 2020 was $900,000 and $167,000, respectively. Depreciation expense for the three months ended June 30,March 31, 2022 and 2021 and 2020 was $474,000 491,000and $900,000428,000, respectively.

Note 5 –6 -Unsecured Convertible Promissory Notes Payable

On September 15, 2020, we issued two unsecured, partially convertible, promissory notes (the “September 2020 Notes”) for an aggregate principal amount of $10 million to two investors (collectively, the “Lenders”).

 

On February 28, 2022, we entered into a letter agreement (the “Letter Agreement”) with one of the Lenders providing for the payoff of its September 2020 Note in the principal amount of $2,000,000.

Pursuant to the terms of the Letter Agreement, (i) the Lender converted $600,000 of the principal amount due to him under his September 2020 Note into 200,000 shares of Company common stock (the “Conversion Shares”) at a price of $3.00 per share as provided for under the terms of the September 2020 Note (the “Conversion”), (ii) the Company paid to the Lender $1,440,548 in cash, representing $1,400,000 of the remaining principal under the September 2020 Note following the Conversion plus $40,548 in accrued and outstanding interest under the September 2020 Note, and (iii) the Company repurchased the Conversion Shares at a price of $5.75 per share for an aggregate amount of $1,150,000 (for a total aggregate payment to the Lender of $2,590,548).

21

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

The September 2020 Notes areNote that remains outstanding as of March 31, 2022 is due and payable on September 15, 2023 and accrueaccrues interest at a rate of 10% per year from the closing date, payable on a quarterly basis, until the September 2020 Notes areNote is repaid in full. We have the right to prepay the outstanding September 2020 NotesNote at any time after the 13 month13-month anniversary of the closinginitial issuance date after providing written notice to the Lenders,Lender and may prepay the September 2020 NotesNote prior to such time with the consent of the Lenders.Lender. The Lenders haveLender has the right, at any time, and from time to time, on and after the 13-month anniversary of the closinginitial issuance date to convert up to an aggregateof $3.0 million of the September 2020 NotesNote into common stock of the Company at a conversion price of $3.00 per share. Repayment of the September 2020 NotesNote has been guaranteed by our wholly-ownedwholly owned subsidiary, PMI.

 

The September 2020 Notes containNote contains customary events of default. If a default occurs and is not cured within the applicable cure period or is not waived, any outstanding obligations under the September 2020 NotesNote may be accelerated. The September 2020 NotesNote also contain certain restrictive covenants which, among other things, restrict our ability to create, incur, assume or permit to exist, directly or indirectly, any lien (other than certain permitted liens described in the September 2020 Notes)Note) securing any indebtedness of the Company, and prohibits us from distributing or reinvesting the proceeds from any divestment of assets (other than in the ordinary course) without the prior approval of the Lenders.Lender.

 

For the sixthree months ended June 30,March 31, 2022 and 2021, and 2020, we incurred $574,000233,000 and $0251,000, respectively, in interest expense underrelated to the September 2020 Notes and $323,000 and $0 for the three months ended June 30, 2021 and 2020.Notes.

 

Note 6 –7 - Stockholders’ Equity

Our authorized capital stock consists of 50million shares of common stock, $0.0005par value, and one1000000 million shares of preferred stock, $0.0005par value.

 

Preferred Stock

The preferred stock authorized under our certificate of incorporation may be issued from time to time in one or more series. As of June 30, 2021March 31, 2022 and December 31, 2020, 2021, 0 shares of preferred stock have been issued.

 

Common Stock Dividends

 

On May 13, 2021,February 14, 2022, the Boardboard of directors of the Company declared a special cash dividend of $0.30per share on the Company’s common stock, paid on March 10, 2022, in the amount of $4.6 million to holders of record of the Company’s common stock on May 25, 2021, resulting in the payment of $March 1, 2022.

4.5 

22

millionProPhase Labs, Inc. and Subsidiaries

Notes to stockholders on June 3, 2021.Condensed Consolidated Financial Statements

(unaudited)

 

In Fiscal 2020, 0cash dividends were declared.Common Stock

 

Common Stock Repurchase Program

Registered Direct OfferingOn September 8, 2021, the board of directors (the “Board”) approved a stock repurchase program under which the Company was authorized to repurchase up to $6.0 million of its outstanding shares of common stock from time to time, over a six-month period.

During the three months ended March 31, 2022, the Company did not make any common shares repurchase under the stock repurchase program. The stock repurchase program expired on March 30, 2022.

 

On January 5, 2021, we entered into a securities purchase agreement with certain accredited investors and qualified institutional buyers, pursuant to which we issued and sold to the purchasers an aggregate of (i) 550,000 shares of our common stock, and (ii) warrants to purchase up to 275,000 shares of common stock in a registered direct offering.

The shares and warrants were sold at a purchase price of $10.00 per share for net proceeds of $5.5 million. Each Warrant has an exercise price equal to $11.00 per share of common stock, will be exercisable at any time and from time to time, subject to certain conditions described in the Warrant, after the date of issuance, and will expire on the date that is three years from the date of issuance. The Shares and the Warrants are immediately separable and were issued separately.

Public Offering

On January 18, 2021, we entered into an underwriting agreement for the public offering of 3 million shares of common stock, at a price to the public of $12.50 per share. We also issued to the Underwriters warrants to purchase up to an aggregate of 180,000 shares of common stock (6% of the shares of common stock sold in the offering) at an exercise price of $15.625 per share (equal to 125% of the public offering price per share).On January 21, 2021, we completed the offering for net proceeds of $35.1 million, after deducting the underwriting discounts and commissions and estimated offering expenses.

17

The 2010 Directors’ Equity Compensation Plan

 

On May 20, 2021, the stockholders of the Company approved the Amended and Restated 2010 Directors’ Equity Compensation Plan (the “Amended 2010 Directors’ Plan”) at the 2021 Annual Meeting of Stockholders of the Company (the “2021 Annual Meeting”). The Amended 2010 Directors’ Plan had been previously approved byauthorizes the boardissuance of directors of the Company on April 7, 2021, subject to stockholder approval at the 2021 Annual Meeting.

The Amended 2010 Directors’ Plan provides for an increase in the number of shares reserved for issuance under the plan by 100,000 shares, from 675,000 sharesup to 775,000shares.

During the three and six months ended June 30, 2021, no shares of common stock and options were granted to our directors under the 2010 Directors’ Plan.

During the three and six months ended June 30, 2020, 9,709 and 18,055 shares of common stock, respectively were granted to our directors under the 2010 Directors’ Plan. We recorded $35,000 of director fees during the six months ended June 30, 2020 in connection with these grants, which represented the fair value of the shares calculated based on the average closing price of our shares of common stock for the last five trading days of the quarter in which the Board fee was earned.stock.

 

At June 30, 2021,March 31, 2022, there were 200,000 425,126 stock options outstanding and there were 228,126 no shares of common stock available to be issued pursuant tounder the terms of theAmended 2010 Directors’ Plan.No stock options were exercised during the six months ended June 30, 2021.

 

The 2010 Equity Compensation Plan

On May 20, 2021, the stockholders of the Company approved the Amended and Restated 2010 Equity Compensation Plan (the “Amended 2010 Plan”) at the 2021 Annual Meetings.Meeting. The Amended 2010 Plan had been previously approved byauthorizes the boardissuance of directors of the Company on April 7, 2021, subject to stockholder approval at the 2021 Annual Meeting.

The Amended 2010 Plan provides for an increase in the number of shares reserved for issuance under the plan by 1,000,000 shares, from 3,900,000 sharesup to 4,900,000shares.

There were 675,000 options granted under the 2010 Plan during the six months ended June 30, 2021 for a total fair value shares of $1,973,000.common stock.

 

As of June 30,December 31, 2021 and March 31, 2022, there were 1,890,2502,014,874 stock options outstanding and 340,659295,785 stock options available to be issued pursuant to the terms ofunder the 2010 Plan. We will recognize an aggregate of approximately $1,583,0001,684,000 of remaining share-based compensation expense related to outstanding stock options over a weighted average period of 3.02.8 years.No stock options were exercised during the six months ended June 30, 2021.

 

The 2018 Stock Incentive Plan

On April 12, 2018, our stockholders approved the 2018 Stock Incentive Plan (the “2018 Stock Plan”). The 2018 Stock Plan provides for the grant of incentive stock options to eligible employees of the Company, and for the grant of non-statutory stock options to eligible employees, directors and consultants. The 2018 Stock Plan provides that the total number of shares that may be issued pursuant to the 2018 Stock Plan is 2,300,000 shares. At April 12, 2018, all 2.32,300,000 million shares available for issuance under the 2018 Stock Plan have been granted in the form of a stock option with an initial exercise price of $3.00 per share, which are exercisable in 36 monthly installments,options to Ted Karkus (the “CEO Option”), our Chief Executive Officer. NoTo date, no stock options have been exercised duringunder the six months ended June 30, 2021 and 2020.2018 Stock Plan. No share based compensation expense will be recognized in forward periods related to the 2018 Stock Plan.

 

The 2018 Stock Plan requires certain proportionate adjustments to be made to the stock options granted under the 2018 Stock Plan upon the occurrence of certain events, including a special distribution (whether in the form of cash, shares, other securities, or other property) in order to maintain parity. Accordingly, the Compensation Committee of the board of directors, as required by the terms of the 2018 Stock Plan, adjusted the terms of the CEO Option, such that the exercise price of the CEO Option was reduced from $3.00$3.00 per share to $2.00per share,, effective as of September 5, 2018, the date athe special $1.00special cash dividend was paid to the Company’s stockholders. The exercise price of the CEO Option was further reduced from $2.00to $1.75per share,effective as of January 24, 2019, the date athe $0.25special cash dividend was paid to the Company’s stockholders. The exercise price of the CEO Option was further reduced from $1.75to $1.50per share, effective as of December 12, 2019,the date another $0.25 0.25 special cash dividend was paid to Company’s stockholders. The exercise price of the CEO Option was further reduced from $1.50to $1.20per share, effective as of June 3, 2021,, the date another $0.30 special cash dividend was paid to Company’s stockholders. The exercise price of the CEO Option was further reduced from $1.20 to $0.90 per share, effective as of March 10, 2022, the date another $0.30special cash dividend was paid to Company’s stockholders.

 

1823

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

Inducement Option Award

As part of Nebula Acquisition, the Company issued a non-qualified stock option to Kamal Obbad, the Chief Executive Officer of Nebula, as an inducement to his employment with the Company (the “Inducement Award”). The Inducement Award entitles Mr. Obbad to purchase up to 250,000 shares of the Company’s common stock at an exercise price of $7.67 per share, the closing price of the Company’s common stock on the closing date of the Nebula Acquisition. The Inducement Award was granted to Mr. Obbad on the closing date of the Nebula Acquisition. The Inducement Award vested 25% on the grant date and will vest 25% per year for the next three years subject to Mr. Obbad’s continued employment with the Company. The Inducement Award expires on the seventh anniversary of the grant date. Any portion of the Inducement Award that does not vest and become exercisable will be forfeited for no consideration. The grant date fair value of the Inducement Award was approximately $1,128,000.

During the year ended December 31, 2021, we issued an inducement award to a non-employee to purchase up to 100,000 shares of the Company’s common stock at an exercise price of $5.76, the closing price of the common stock on the date of grant. The award vests in four equal installments from the date of grant. The award expires on the seventh anniversary of the grant date.

All inducement awards have been granted outside of the Company’s equity compensation plans.

 

The following table summarizes stock options activity during the sixthree months ended June 30, 2021March 31, 2022 for the Amended 2010 Plan, the Amended 2010 Directors’ Plan, and the 2018 Stock Plan and the Inducement Awards (in thousands, except per share data).

Schedule of Stock Options Activity

  Number of Shares  Weighted Average Exercise Price  Weighted Average Remaining Contractual Life
(in years)
  Total Intrinsic Value 
Outstanding as of January 1, 2022  5,110  $3.27   3.4  $20,820 
Forfeited  (20)  8.99   -   - 
Outstanding as of March 31, 2022  5,090  $3.11   3.2  $20,767 
Options vested and exercisable  4,069  $2.41   2.4  $19,398 

As of March 31, 2022, there were 5,090,000 stock options outstanding and 295,785 stock options available to be issued. We will recognize an aggregate of approximately $2,746,000 of remaining share-based compensation expense related to outstanding stock options over a weighted average period of 2.8 years.

Stock Warrants

The following table summarizes warrant activity during the three months ended March 31, 2022 (in thousands, except per share data):

Schedule of Stock Options Activity

  Number of Shares  Weighted Average Exercise Price  Weighted Average Remaining Contractual Life
(in years)
  Total Intrinsic Value 
Outstanding as of January 1, 2021  3,795  $2.21   3.4  $26,441 
Granted  675   9.13   5.1   - 
Forfeited  (92)  5.31   -   - 
Outstanding as of June 30, 2021  4,378  $3.06   3.2  $16,182 
Options vested and exercisable  3,573  $2.22   2.7  $15,183 

The following table summarizes weighted average assumptions used in determining the fair value of the options at the date of grant during the six months ended June 30, 2021:

Summary of Weighted Average Assumptions Used In Determining Fair Value of OptionsWarrant Activity

  For the six months ended 
  June 30, 2021 
Exercise price $9.13 
Expected term (years)  3.5 
Expected stock price volatility  83%
Risk-free rate of interest  0.6%
Expected dividend yield (per share)  0%
  Number of Shares  Weighted Average Exercise Price  Weighted Average Remaining Contractual Life
(in years)
 
Outstanding as of January 1, 2022  855  $8.23   1.9 
Warrants granted  -   -   - 
Outstanding as of March 31, 2022  855  $8.23   1.6 
Warrants vested and exercisable  855  $8.23   1.6 

 

We During the six months ended June 30, 2021, we issued warrants to purchase recognized $275,0000 shares of common stock in a registered direct offering and warrants to purchase 180,000 shares of common stock to the underwriters in a public offering. The following table summarizes warrant activities during the six months ended June 30, 2021 (in thousands, except per share data).

Schedule of Warrant Activity

  Number of Shares  Weighted Average Exercise Price  Weighted Average Remaining Contractual Life
(in years)
 
Outstanding as of January 1, 2021  450  $3.22   2.7 
Warrants granted  455   12.83   3.0 
Outstanding as of June 30, 2021  905  $8.05   2.4 
Warrants vested and exercisable  815  $8.61   2.4 

The following table summarizes weighted average assumptions used in determining the fair value of the warrants at the date of grant during the six months ended June 30, 2021:

Summary of Weighted Average Assumptions Used in Determining Fair Value of Warrants

  For the six months ended 
  June 30, 2021 
Exercise price $12.83 
Expected term (years)  3.0 
Expected stock price volatility  81%
Risk-free rate of interest  0.2%
Expected dividend yield (per share)  0%

As of June 30, 2021, there were 905,000 warrants outstanding and we recognized $105,000and $193,000 of share-based compensation expense during the three and six months ended June 30, 2021. We had no compensation expense during the six months ended June 30, 2020.March 31, 2022 and 2021, respectively.

24

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

Note 7 –8 - Defined Contribution Plans

We maintain the ProPhase Labs, Inc. 401(k) Savings and Retirement Plan, a defined contribution plan for our employees. Our contributions to the plan are based on the amount of the employee plan contributions and compensation. Our contributions to the plan in the three and six months ended June 30,March 31, 2022 and 2021 were $23,000 52,000and $35,00013,000, respectively. Our contributions to the plan in the three and six months ended June 30, 2020 were $17,000 and $33,000, respectively.

 

Note 9 – Income Taxes

We recognize tax assets and liabilities for the future tax consequences related to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and for net operating loss carryforwards. Management evaluated the deferred tax assets for recoverability using a consistent approach that considers the relative impact of negative and positive evidence, including historical profitability and projections of future reversals of temporary differences and future taxable income. We are required to establish a valuation allowance for deferred tax assets if management determines, based on available evidence at the time the determination is made, that it is not more likely than not that some portion or all of the deferred tax assets will be realized. As of March 31, 2022 the Company has net deferred tax liabilities for federal and combined states jurisdictions compared to net deferred tax assets with a full valuation allowance as of December 31, 2021. The decrease in deferred tax assets with a corresponding decrease in valuation allowance against those assets as of March 31, 2022 is primarily due to utilization of net operating losses. The Company has net deferred tax assets in other states jurisdictions where we maintain a full valuation allowance. Judgment is required to estimate forecasted future taxable income, which may be impacted by future business developments, actual results, tax initiatives, legislative, and other economic factors. The Company will continue to monitor income levels and potential changes to its operating and tax model, and other legislative or global developments in its determination.

The Company’s effective tax rate for the three months ended March 31, 2022 is 21.47% and it is primarily driven by federal tax at 21%, state taxes at 7.1%, and a decrease in the valuation allowance for federal and combined states jurisdictions. The total tax expense for the three months ended March 31, 2022 is $3.4 million and it mostly relates to current federal and combined state taxes.

1925

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

Note 8 –10 - Other Current Liabilities

The following table sets forth the components of other current liabilities at June 30, 2021March 31, 2022 and December 31, 2020,2021, respectively (in thousands):

Schedule of Other Current Liabilities

 June 30, 2021 December 31, 2020  March 31, December 31, 
Accrued diagnostic services $4,353  $- 
 2022 2021 
Accrued commissions  639   461  $1,294  $1,283 
Accrued payroll  240   464   50   514 
Accrued expenses  467   304   356   300 
Accrued returns  321   291   246   338 
Accrued income tax payable  8   8 
Accrued benefits and vacation  71   34   50   60 
Deferred revenue  112   169 
Accrued insurance reimbursement  

1,278

   

-

 
Total other current liabilities $6,211  $1,731  $3,274  $2,495 

Note 11 - Commitments and Contingencies

 

Note 9– Commitments and Contingencies

Manufacturing Agreement

Manufacturing Agreement

In connection with the asset purchase agreement, theThe Company and its wholly-ownedwholly owned subsidiary, PMI, entered into a manufacturing agreement (the “Manufacturing Agreement”) with Mylan Consumer Healthcare Inc. (formerly known as Meda Consumer Healthcare Inc.) (“MCH”) andin connection with the asset purchase agreement we entered into with Mylan Inc. (together with MCH, “Mylan”.in 2017. Pursuant to the terms of the Manufacturing Agreement, Mylan (or an affiliate or designee) purchased the inventory of the Company’s Cold-EEZE® brand and product line, and PMI agreed to manufacture certain products for Mylan, as described in the Manufacturing Agreement, at prices that reflect current market conditions for such products and include an agreed upon mark-up on our costs. On May 1, 2021, the Manufacturing Agreement was assigned by Mylan to Nurya Brands, Inc. (“Nurya”) in connection with Nurya’s acquisitions of certain assets from Mylan, including the Cold-EEZE® brand and product line. Unless terminated sooner by the parties, the Manufacturing Agreement will remain in effect until March 29, 2022.2023. Thereafter, the Manufacturing Agreement may be renewed by Nurya for up to fivefour successive one-year periods by providing notice of its intent to renew not less than 90 days prior to the expiration of the then-current term.

 

20

Future Obligations

Employment Agreement Obligations:

We have estimated future minimum obligations for an executive’s employment agreement over the next five years including the remainderas of Fiscal 2021,March 31, 2022, as follows (in thousands):

Schedule of Estimated Future Minimum Obligations

  

Employment

Contracts

 
2021 $338 
2022  675 
2023  675 
2024  675 
2025           675 
Total $3,038 

  Employment Contracts 
Remaining periods in 2022 $506 
2023  675 
2024  675 
2025  675 
2026  675 
Total $3,206 

 

LitigationLitigation

In the normal course of our business, we may be named as a defendant in legal proceedings. It is our policy to vigorously defend litigation or to enter into a reasonable settlementssettlement where management deems it appropriate.

 

26

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

Note 10 –12 - Leases

 

On October 23, 2020, we completed the acquisition of CPM. CPM, (which is now known as ProPhase Diagnostics NJ, Inc.) iswhich included the lesseeacquisition of a 4,000square foot CLIA accredited laboratory located in Old Bridge, New Jersey, which was owned by CPM (which is now known as ProPhase Diagnostics acquired as part of the transaction.NJ, Inc.). The lease acquired is for a term of 24 months with a monthly base lease payment of $5,950.

 

On December 8, 2020, wethe Company entered into a Lease Agreement (the “New York“NY Lease”) with BRG Office L.L.C. and Unit 2 Associates L.L.C. (the “Landlord”), pursuant to which the Company has agreed to lease certain premises located on the second floor (the “Leased Premises”) of 711 Stewart Avenue, Garden City, New York (the “Building”). The Leased Premises serve as the Company’s second laboratory location and corporate headquarters, offering a wide range of laboratory testing services for diagnosis, screening and evaluation of diseases, including COVID-19 and Respiratory Pathogen Panel Molecular tests.

 

The New YorkNY Lease was effective as of December 8, 2020, and commenced in December 2020January 2021 (the “Commencement Date”) when the facility was made available to us by the Landlord. Payments on the lease begin upon the date of the Landlord’s substantial completion of certain improvements to the Leased Premises (the “Commencement Date”), as set forth in the New York Lease.landlord. The initial term of the New YorkNY Lease is 10 yearsand seven months (the “Initial Term”), unless sooner terminated as provided in the New YorkNY Lease. We may extend the term of the New YorkNY Lease for one additional option period of five years. We have the option to terminate the New YorkNY Lease on the sixth anniversary of the Commencement Date, provided that we give the Landlordlandlord written notice not less than nine months and not more than 12 months in advance and that we pay the Landlordlandlord a termination fee as more particularly described in the New York Lease.fee.The Landlord provided a construction allowance to the Company in an aggregate amount not to exceed $250,795, to reimburse the Company for the cost of certain improvements to be made by the Company to the Leased Premises.

 

For the first year of the New YorkNY Lease, we will pay a base rent of $56,963per month (subject to a seven monthseven-month abatement period), with a gradual rental rate increase of 2.75% for each 12 month12-month period thereafter in lieu of paying its proportionate share of common area operating expenses, culminating in a monthly base rent of $74,716during the final months of the Initial Term. In addition to the monthly base rent, we are responsible for ourits proportionate share of real estate tax escalations in accordance with the terms of the New YorkNY Lease.

 

We also have a right of first refusal to lease certain additional space located on the ground floor of the Building containing 4,500 square feet and 4,600 square feet, as more particularly described in the New YorkNY Lease. We also have a right of first offer to purchase the Building during the term of the New YorkNY Lease.

21

 

At June 30, 2021,March 31, 2022, we had operating lease liabilities for the New York and New Jersey leases of approximately $4.9 4.8million and right of use assets of approximately $4.6 4.3million, which were included in the condensed consolidated balance sheet.

 

The following summarizes quantitative information about our operating leases (amounts in thousands):

Summary of Quantitative Information About Operating Leases

  

For the Six Months Ended

June 30, 2021

 
Operating leases             
Operating lease cost $408 
Variable lease cost  - 
Operating lease expense  408 
Short-term lease rent expense  - 
Total rent expense $408 

  March 31, 2022  March 31, 2021 
  For the three months ended 
  March 31, 2022  March 31, 2021 
Operating leases        
Operating lease cost $204  $204 
Operating lease expense  204   204 
Total rent expense $204  $204 

  

For the Six Months Ended

June 30, 2021

 
Operating cash flows used in operating leases $(36)
Right-of-use assets obtained in exchange for operating lease liabilities $- 
Weighted-average remaining lease term – operating leases (in years)            9.9 
Weighted-average discount rate – operating leases  10.00%

27

 

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

Maturities of the Company’s operating leases, excluding short-term leases, are as follows (amounts in(in thousands):

Schedule of Maturity of Operating Leases

        
Remaing Months Ended December 31, 2021 $321 
Year Ended December 31, 2022  774 
Remaining Periods Ended December 31, 2022 $580 
Year Ended December 31, 2023  738   738 
Year Ended December 31, 2024  747   747 
Year Ended December 31, 2025  768   768 
Year Ended December 31, 2026  783 
Thereafter  4,659   3,876 
Total  8,007   7,492 
Less present value discount  (3,071)  (2,704)
Operating lease liabilities $4,936  $4,788 

 

Note 11– Significant Customers

Revenue for the three months ended June 30, 2021 and 2020 was $9.1 million and $3.6 million, respectively. Two diagnostic services clients accounted for 24.9% and 16.8% of our revenue for the three months ended June 30, 2021. No contract manufacturing customer accounted for a significant portion of our revenue for the three months ended June 30, 2021. Three third-party contract manufacturing customers accounted for 58.7%, 16.6% and 12.2%, respectively, of our revenue from continuing operations for the three months ended June 30, 2020. The loss of sales to any of these large customers could have a material adverse effect on our business operations and financial condition.

Revenue for the six months ended June 30, 2021 and 2020 was $24.4 million and $5.5 million, respectively. Two diagnostic services clients accounted for 38.5% and 24.0%, respectively, of our revenue for the six months ended June 30, 2021. Two third-party contract manufacturing customers accounted for 55.2% and 17.1%, respectively, of our revenue for the six months ended June 30, 2020. The loss of sales to any of these large customers could have a material adverse effect on our business operations and financial condition.

Three diagnostic services clients generated 38.9%, 21.0% and 10.2% of our total reimbursement receivable balances from government agencies and healthcare issuers at June 30, 2021. Two consumer product customers represented 72.4%, and 12.8% of our total trade receivable balances at June 30, 2020.

22

 

Note 12 –13 - Earnings (Loss) Per ShareConsulting Agreement and Secured Promissory Note Receivable

Basic earnings per share (“EPS”) excludes dilution and is computed by dividing income available to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or otherwise result in the issuance of common stock that shared in the earnings of the entity. Diluted EPS also utilizes the treasury stock method which prescribes a theoretical buy back of shares from the theoretical proceeds of all options outstanding during the period, and the if-converted method for convertible debt. The potentially anti-dilutive effect of stock options, warrants, and convertible debt for the three and six months ended June 30, 2021 was 3,024,000 and 3,393,000 shares, respectively.

 

For the three and six months ended June 30, 2021, dilutive loss per share were the same as basic earnings per share due to the exclusion of Common Stock in the form of stock options (“Common Stock Equivalents”), which in a net loss position would have an anti-dilutive effect on loss per share.

For the three months ended June 30, 2020, there were 2,307,000 Common Stock Equivalents that were in the money that were included in the fully diluted earnings per share computation. For the six months ended June 30, 2020, dilutive loss per share were the same as basic earnings per share due to the exclusion of Common Stock Equivalents, which in a net loss position would have an anti-dilutive effect on loss per share.

Note 13 – Secured Promissory Note Receivable and Consulting Agreement

Consulting Agreement

On September 25, 2020 (the “Effective Date”), we entered into a consulting agreement with a consultant (the “Consulting Agreement”). The Consulting Agreement was to be effective through September 1, 2022; provided, however, that we could terminate this agreement at any time on five days’ prior written notice.

The consultant’s duties were to include, among other things, (i) identifying and introducing us to new opportunities in the medical technology and testing fields, (ii) assisting and advising us in acquiring one or more CLIA certified labs suitable for COVID-19 and other testing (“Test Labs”); (iii) assisting us in equipping and staffing any Test Labs acquired by us; (iv) advising and assisting in the operation of such Test Labs; (v) validating and obtaining certification of such Test Labs; and (vi) assisting us in obtaining a flow of business, orders and revenues from multiple sources in the industry, including but not limited to at least one significant, nation-wide manufacturer and distributor of COVID-19 saliva sample collection test kits (“COVID-19 Test Kits”).

All compensation earned by the consultant would first be applied to the acceleration and prepayment of all sums due to us, including but not limited to sums due pursuant to the Amended and Restated Promissory Note (“Secured Note”) described below. Under the terms of the Consulting Agreement, the consultant would not be entitled to receive any payments pursuant to the Consulting Agreement unless and until the Secured Note was paid in full. The total compensation that the consultant would be entitled to earn or to receive under the Consulting Agreement (inclusive of amounts credited against the Secured Note) would be capped at $4.0 million.

23

Promissory Note and Security Agreement

On September 25, 2020 (the “Restatement Effective Date”), we entered into the Secured Note with a company consulting for us (“the consultant,Consultant”), pursuant to which we loaned $3.0 million to the consultant described aboveConsultant (inclusive of $1.0 million in the aggregate previously loaned to the consultant,Consultant, as described below).

 

The Secured Note amended and restated in its entirety (i) that certain Promissory Note and Security Agreement, dated July 21, 2020 (the “Original July 21 Note”), pursuant to which we loaned $750,000to the consultantConsultant and (ii) that certain Promissory Note and Security Agreement, dated July 29, 2020 (the “Original July 29 Note”, and, together with the Original July 21 Note, the “Original Notes”), pursuant to which we loaned $250,000to the consultant.Consultant.

 

The Secured Note bears interest at a rate of 15% per annum from and including the Restatement Effective Date until the principal amount is repaid in full plus any Principal Increases (as defined below) together with any accrued interest that has not been capitalized; provided, however, that upon the occurrence and during an Event of Default (as defined in the Secured Note), the interest rate payable under the Secured Note will automatically increase to 9% above the rate of interest then applicable to the Secured Note.

Interest under the Secured Note will be payable monthly in arrears on the first day of each month for the prior monthly period, as well as at maturity (whether upon demand, by acceleration or otherwise) (each such date, a “Payment Date”); provided, however, that prior to September 1, 2021, interest will be paid and capitalized in kind by increasing the principal amount of the Secured Note (any such increase, a “Principal Increase”) by an amount equal to the interest accrued on the principal amount (as increased by the Principal Increases) during the prior month. On each Payment Date commencingCommencing after September 1, 2021, in addition to payments of interest, described in the preceding sentence, the consultant willConsultant is also required to make payments on the principal amount of the loan equal to 1/36 of the then outstanding principal amount. The amount of the monthly payments will be equal

28

ProPhase Labs, Inc. and Subsidiaries

Notes to the amount required to amortize fully the outstanding principal amount of the loan, together with interest, over a period of Condensed Consolidated Financial Statements

36 months.(unaudited)

 

The entire remaining unpaid principal amount of the Secured Note, together with all accrued and unpaid interest thereon and all other amounts payable under the Secured Note, will be due and payable, if not sooner paid, on September 30, 2022 or an earlier date as a result of a maturity, whether by acceleration or otherwise. The Secured Note may be prepaid in full or in part at any time without penalty or premium.2022.

 

The Secured Note contains customary events of default. If a default occurs and is not cured within the applicable cure period or is not waived, any outstanding obligations under the Secured Note may be accelerated.

The Secured Note contains customary representation and warranties and certain restrictive covenants which, among other things, restrict the consultant’s ability to (i) sell, transfer, finance, lease, license, or dispose of all or substantially all of its property or assets, liquidate, windup, or dissolve, (ii) acquire all or substantially all of the property or assets of, or the equity interests in, any other person, (iii) participate in any merger, consolidation, share exchange, division, conversion, reclassification, or other absorption or reorganization, (iv) except for those existing as of the Restatement Effective Date, create, incur, assume, permit, or suffer to exist any pledges, liens, security interests, and other encumbrances of its property or assets, whether now owned or hereafter owned or acquired, and (v) create, incur or permit to exist any debt that is senior to, or pari passu with the Secured Note.

 

In order to secure the consultant’s obligations under the Secured Note, the consultant granted to the Company a continuing security interest in certain property and assets.

Total interest income recorded in the three and six months ended June 30, 2021 was 0and $233,000 respectively.

Amendment and Termination Agreement

On January 14, 2021, we entered into an Amendment and Termination Agreement (the “Termination Agreement”) with the consultantConsultant pursuant to which the parties amended the Secured Note and terminated the Consulting Agreement.former consulting agreement with the Consultant (the “Consulting Agreement”). Pursuant to the terms of the Termination Agreement, the Company loaned an additional $1 $1 million to the consultantConsultant in consideration for the termination of the Consulting Agreement and termination of the Company’s obligation to pay the consultantany additional consulting fees beyond the $250,000 already earned by the consultant under the Consulting Agreement.fees. As a result, the initial principal amount due under the Secured Note was increased from $2.75 million to $3.75 million plus all accrued and unpaid interest arising under the Secured Note through and including January 14, 2021.

 

Under the terms of the Termination Agreement, the consultantConsultant will continue to sell and process its viral test by RT-PCR (together with other viral and other types of tests). Until the Secured Note is paid in full, each COVID-19 Test Kit sold or processed from and after January 14, 2021, and for which payment of at least the specified amount as defined for the test, is received by the consultant,Consultant, the consultantConsultant will pay us a specified amount (the “Test Fee”). The total payments will not exceed the aggregate amounts due under the Secured Note and shall be applied first to interest and other amounts due under the Secured Note and then to the then-current outstanding principal. Test Fees will be due and payable on the 10th business day after the end of each month commencing in February, 2021, and until the Secured Note is paid in full. We received the first payment in the amount of $95,000with respect to the Test Fees from January 15 through February 2021. On June 25, 2021, we were issued 1,260,619common shares of common stock of the consultantConsultant with a fair value of $315,000as an interest payment with respect tounder the Secured Note in lieu of Test Fees from March through June 2021.

 

On each payment date commencing on or afterEffective September 1, 2021, in addition to paymentsthe payment of the Test Fees described above, the consultant willConsultant is also required to make payments to us in an amount equal to the greater of (x) the Test Fee, or (y) 1/36th of the then outstanding principal amount together with interest thereon and interest accruing onthereon. The Company did not receive any payments from the Secured Note, in accordance with the Secured Note. Accordingly, commencing on September 1, 2021, the minimum number of monthly payments due and payable will be equal to the amount required to amortize fully the outstandingConsultant for either contractual principal amount of the Secured Note, together with interest over a period of 36 monthswith level monthly payments.or interest.

 

2429

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

On October 11, 2021, the Company provided the Consultant with a Notice of Default and demanded the Secured Note be paid in full immediately. On January 25, 2022, the Company filed a complaint with the United States District Court for the District of Delaware for judgment against the Consultant for money damages consisting of principal, interest, default interest and other fees and costs. As a result, the Company considered that it is not probable that it will collect all amounts due under the Secured Note and reduced the carrying value of the Secured Note to $0 as of December 31, 2021 with a corresponding charge-off of $3.75 million during the year ended December 31, 2021.

Note 14 - Significant Customer Concentrations

Revenue for the three months ended March 31, 2022 and 2021 was $47.5 million and $15.3 million, respectively. Three diagnostic services clients accounted for 36.7%, 21.4%, and 11.0% of our revenue for the three months ended March 31, 2022. Two diagnostic services clients accounted for 46.1% and 31.6% of our revenue for the three months ended March 31, 2021. No contract manufacturing customer’s accounted for a significant portion of our revenue for the three month ended March 31, 2022 or 2021. The loss of sales to any of these large customers could have a material adverse effect on our business operations and financial condition.

Two diagnostic services payers comprised 33.6% and 26.5% of our total reimbursement receivable balances from government agencies and healthcare issuers at March 31, 2022. Four diagnostic services payers comprised 43.0%, 11.6%, 10.7% and 10.7% of our total reimbursement receivable balances from government agencies and healthcare issuers at December 31, 2021.

Currently, we rely on a sole supplier to manufacture our saliva collection kits used by customers who purchase our personal genomics services. Change in the supplier or design of certain of the materials that we rely on, in particular the saliva collection kit, could result in a requirement for additional premarket review from the FDA before making such a change.

 

Note 14 –15 - Segment Information

 

The Company has identified 2two operating segments, diagnostic services and consumer products, based on the manner in which the Company’s CEO as CODM assesses performance and allocates resources across the organization. The operating segments are organized in a manner that depicts the difference in revenue generating synergies that include the separate processes, profit generation and growth of each segment. The diagnostic services segment provides COVID-19 diagnostic information services to a broad range of customers in the United States, including health plans, third party payers and government organizations. The consumer products segment is engaged in the research, development, manufacture, distribution, marketing and sale of OTC consumer healthcare products and dietary supplements in the United States.States and also provides personal genomics products and services. The unallocated corporate expenses mainly included professional fees associated with the public company.

 

30

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

The following table is a summary of segment information for three and six months ended June 30,March 31, 2022 and 2021 and 2020 (amounts in thousands):

Schedule of Segment Information

  June 30, 2021  June 30, 2020  June 30, 2021  June 30, 2020 
  For the three months ended  For the six months ended 
  June 30, 2021  June 30, 2020  June 30, 2021  June 30, 2020 
Net revenues                
Diagnostic services $7,537  $-  $20,274  $- 
Consumer products  1,605   3,623   4,139   5,511 
Consolidated net revenue  9,142   3,623   24,413   5,511 
Cost of revenue                
Diagnostic services  3,479   -   7,824   - 
Consumer products  1,197   2,344   3,196   3,817 
Consolidated cost of revenue  4,676   2,344   11,020   3,817 
Depreciation and amortization expense                
Diagnostic services  392   -   737   - 
Consumer products  3   5   6   10 
Total Depreciation and amortization expense  395   5   743   10 
Operating and other expenses  5,466   1,204   12,988   2,423 
Income (loss) from continuing operations, before income taxes                
Diagnostic services  1,164   -   4,004   - 
Consumer products  540   1,274   505   1,684 
Unallocated corporate  (3,099)  (1,204)  (4,847)  (2,423)
Total income (loss) from continuing operations, before income taxes  (1,395)  70   (338)  (739)
Net income (loss) $(1,395) $70  $(338) $(739)

  March 31, 2022  March 31, 2021 
  For the three months ended 
  March 31, 2022  March 31, 2021 
Net revenues        
Diagnostic services $44,913  $12,737 
Consumer products  2,618   2,534 
Consolidated net revenue  47,531   15,271 
Cost of revenue        
Diagnostic services  16,702   4,345 
Consumer products  2,152   1,999 
Consolidated cost of revenue  18,854   6,344 
Depreciation and amortization expense        
Diagnostic services  576   345 
Consumer products  600   3 
Total Depreciation and amortization expense  1,176   348 
Operating and other expenses  11,591   7,522 
Income (loss) from operations, before income taxes        
Diagnostic services  20,026   2,839 
Consumer products  (1,863)  (35)
Unallocated corporate  (2,253)  (1,747)
Total income from operations, before income taxes  15,910   1,057 
Income tax expense  (3,416)  - 
Total income from operations, after income taxes  12,494   1,057 
Net income $12,494  $1,057 

 

The following table is a summary of segment balance sheets information as of June 30, 2021March 31, 2022 and December 31, 20202021 (amounts in thousands):

  

March 31,

2022

  

December 31,

2021

 
       
ASSETS        
Diagnostic services $51,823  $51,150 
Consumer products  23,378   24,139 
Unallocated corporate  24,464   14,006 
Total assets $99,665  $89,295 

Note 16 - Earnings Per Share

Basic earnings per share (“EPS”) excludes dilution and is computed by dividing income available to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or otherwise result in the issuance of common stock that shared in the earnings of the entity. Diluted EPS also utilizes the treasury stock method which prescribes a theoretical buy back of shares from the theoretical proceeds of all options outstanding during the period, and the if-converted method for convertible debt.

31

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

The following is a reconciliation of the weighted average number of common shares outstanding used in calculating basic and diluted net loss per share (in thousands):

Schedule of Basic and Diluted Net Loss Per Share

  June 30,  December 31, 
  2021  2020 
       
ASSETS        
Diagnostic services $32,222  $13,410 
Consumer products  5,294   6,261 
Unallocated corporate  38,807   11,734 
Total assets $76,323  $31,405 
  March 31, 2022  March 31, 2021 
  For the three months ended 
  March 31, 2022  March 31, 2021 
Net income - basic $12,494  $1,057 
Interest on unsecured convertible promissory note  232   - 
Net income - diluted $12,726  $1,057 
         
Weighted average shares outstanding - basic  15,486   14,563 
Diluted shares- Stock Options  2,232   2,895 
Diluted shares- Stock Warrants  222   284 
Unsecured convertible promissory note  800   458 
Weighted average shares outstanding - diluted  18,740   18,200 

The following table represents the number of securities excluded from the income per share computation as a result of their anti-dilutive effect (in thousands):

Schedule of Anti-dilutive Securities Excluded from the Income Per Share Computation

  For the three months ended 
Anti-dilutive securities March 31, 2022  March 31, 2021 
Common stock purchase warrants  455   455 
Stock Options  810   - 
Anti-dilutive securities  1,265   455 

Note 17 - Related Parties

Jason Karkus, Executive Vice President and Co-Chief Operations Officer of ProPhase Diagnostics, is the son of Ted Karkus, the Company’s Chairman and Chief Executive Officer. For the three months ended March 31, 2022 and 2021, Mr. Karkus received compensation of $55,000 and $30,000, respectively.

 

Note 1518Subsequent EventsEvent

Appointment of Chief Financial Officer

On August 10, 2021,May 9, 2022, the Company announced that has appointed Bill White as Chief Financial Officer of the Company, effective May 23, 2022 (the “Effective Date”), replacing Monica Brady, who is currently serving as Chief Financial Officer of the Company. Ms. Brady will remain with the Company and itscontinue to serve as the Company’s Chief Accounting Officer, and Chief Financial Officer of the Company’s wholly-owned subsidiary, ProPhase Precision Medicine, Inc. (“ProPhase Precision”), entered into and closed a Stock Purchase Agreement (the “Nebula Stock Purchase Agreement”) with Nebula Genomics, Inc., a privately owned personal genomics company (“Nebula”), eachDiagnostics, as of the stockholders of Nebula (the “Seller Parties”), and Kamal Obbad,Effective Date.

As an inducement to his employment as Seller Party Representative. Pursuant to the termsChief Financial Officer of the Nebula Stock Purchase Agreement, ProPhase Precision acquired allCompany, the Compensation Committee granted Mr. White a stock option (the “Option Award”) to purchase up to 400,000 shares of the issuedCompany’s common stock. This award was made in accordance with the employment inducement award exemption provided by Nasdaq Rule 5635(c)(4) and outstanding shareswas therefore not awarded under the Company’s stockholder approved equity plan. The option award will vest over a four year period, with 12.5% vesting every six months following the Effective Date, and contingent upon the commencement of common stock of Nebula (the “Nebula Shares”) from the Seller Parties, forhis employment and continued service through each vesting date. The options have an aggregate purchaseexercise price of approximately $14.66.74 million, subject to post-closing adjustments. A portion of the purchase price will be paid in shares to certain Seller Parties and noteholders of Nebula, based on their election to receive shares of Company common stock in lieu of cash, which shares have been valued at a price per share, of $7.46, which is equal to the average closing price of the Company’s common stock on NasdaqMay 9, 2022, and will be exercisable for a period of seven years.

Announcement of Cash Dividend

On May 9, 2022, the five trading days preceding the signingboard of directors of the Nebula Stock Purchase Agreement. A portionCompany declared a special cash dividend of $0.30 per share for stockholders of record as of May 25, 2022, which will approximate $4.6 million. On the same date, the Compensation Committee of the purchaseboard of directors approved an adjustment to the stock option granted to Mr. Karkus on February 23, 2018 (the “CEO Option”), as required under the Company’s 2018 Stock Plan, as a consequence of the special cash dividend. The board of directors has adjusted the terms of the CEO Option, such that the exercise price equalof the CEO Option will be reduced from $0.90 per share to $1,080,0000.60 (the “Escrow Amount”) willper share, effective as of June 3, 2022, the date the special cash dividend is to be held in escrow by Citibank, N.A. (the “Escrow Agent”) until February 23, 2023paid. (“Escrow Termination Date”), pursuant to the terms and conditions of an escrow agreement entered into with the Escrow Agent, as security for the indemnification obligations of the Seller Parties. At the Escrow Termination Date, the remaining amount, if any, of the Escrow Amount, less any amount reasonably necessary to pay any claim with respect to which a notice of claim has been timely and properly given, will be delivered to the Seller Parties, as applicable.

 

2532

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

The following discussion and analysis should be read in conjunction with our interim unaudited condensed consolidated financial statements and related notes included in this Quarterly Report on Form 10-Q (“Quarterly Report”) and the audited condensed financial statements and notes thereto as of and for the year ended December 31, 20202021 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 31, 20212022 (the “2020“2021 Annual Report”). As used in this Quarterly Report, unless the context suggests otherwise, “we,” “us,” “our,” or “ProPhase” refer to ProPhase Labs, Inc. and its subsidiaries, unless the context otherwise requires.

 

Forward-Looking Statements

 

This Quarterly Report contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These forward-looking statements relate to future events or our future financial performance. Forward-looking statements typically are identified by use of terms such as “anticipate”, “believe”, “plan”, “expect”, “intend”, “may”, “will”, “should”, “estimate”, “predict”, “potential”, “continue” and similar words although some forward-looking statements are expressed differently. This Quarterly Report may also contain forward-looking statements attributable to third parties relating to their estimates regarding the growth of our markets.

 

You are cautioned that forward-looking statements are not guarantees of performance and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance, achievements or prospects to be materially different from any future results, levels of activity, performance or achievements expressed or implied by the forward-looking statements. Many of these factors are beyond our ability to predict.

 

Such risks and uncertainties include, but are not limited to:

 

 Our ability to generate revenue and sufficient profits from Respiratory Pathogen Panel (“RPP”) Molecular tests if and when demand for COVID-19 testing decreases or becomes no longer necessary;
Our ability to collect payment for the tests we deliver;
Our ability to manage our growth successfully;
Our ability to compete effectively, including our ability to maintain and increase our markets and/or market share in the markets in which we do business;
Our dependence on our largest manufacturingdiagnostic services customers;
   
 Our ability to successfully offer, perform and generate revenues from our new diagnostic andpersonal genomics sequencing services;
Our ability to generate sufficient profits from Respiratory Pathogen Panel (“ RPP”) Molecular tests if and when demand for COVID-19 testing decreases or becomes no longer necessary;businesses;
   
 Our ability to secure additional capital, when needed to support our diagnostic services business, personal genomics business, manufacturing business and product development and commercialization programs;
   
 Potential disruptions to our supply chain or increases to the price of or adulteration of key raw materials or supplies;
   
 Potential disruptions in our ability to manufacture our products and those of others;
   
 Seasonal fluctuations in demand for the products and services we manufacture at our manufacturing facility;provide;
   
 Our ability to successfully develop and commercialize our existing products and any new products;
Our ability to compete effectively, including our ability to maintain and increase our markets and/or market share in the markets in which we do business;
   
 Our ability to attract, retain and motivate our key employees;
   
 Our ability to protect our proprietary rights;

33

 Our ability to comply with regulatory requirements applicable to our businesses;
The complexity of billing for, and collecting revenue for, testing services;
   
 Our dependence on third parties to provide services critical to our lab diagnostic services business;

26
General economic conditions, including as a result of the ongoing COVID-19 pandemic and the war in Ukraine; and
Our ability to remediate the material weakness in our internal controls over financial reporting and prevent other material weaknesses.

 

Given the risks and uncertainties surrounding forward-looking statements,, you should not place undue reliance on these statements. You should also consider carefully the statements we make under other sections of this Quarterly Report and in our 20202021 Annual Report, as well as in other documents we file from time to time with the SEC that address additional risks that could cause our actual results to differ from those set forth in any forward-looking statements. Our forward-looking statements speak only as the date of this Quarterly Report. We undertake no obligation to publicly update or review any forward-looking statements, whether as a result of new information, future developments or otherwise, except as required by law.

 

General

 

We are a diversified biotechcompany that offers a range of services including diagnostic testing, genomics testing and contract manufacturing. We provide traditional CLIA molecular laboratory services, including SARS-CoV-2 (“COVID-19”) testing and seek to leverage our Clinical Laboratory Improvement Amendments (“CLIA”) accredited laboratory services to provide whole genome sequencing and research direct to consumers, while building a genomics company with data base to be used for further research. In addition, we have deep experience with over-the-counter (“OTC”) consumer healthcare products and dietary supplements. We conduct our operations through two operating segments;segments: diagnostic services and consumer products. Until late fiscal year 2020, we were engaged primarily in the research, development, manufacture, distribution, marketing and sale of OTC consumer healthcare products and dietary supplements in the United States. This includes the development and marketing of dietary supplements under the TK Supplements®Supplements® brand. However, commencing in December 2020, we also began offering COVID- 19 and other RPP Molecular tests through our new diagnostic service business.business, and in August 2021 we began offering personal genomics products and services.

 

Our wholly-owned subsidiary, Pharmaloz Manufacturing, Inc. (“PMI”), is a full-service contract manufacturer and private label developer of a broad range of non- GMO, organic and natural-based cough drops and lozenges and OTC drug and dietary supplement products.

Our wholly-ownedwholly owned subsidiary, ProPhase Diagnostics, Inc., (“ProPhase Diagnostics”), which was formed on October 9, 2020, offers a varietybroad array of medical tests,clinical diagnostic and testing services at its CLIA certified laboratories including state-of-the-art polymerase chain reaction (“PCR”) testing for COVID-19. Critical to COVID-19 testing, we provide fast turnaround times for results. We also offer best-in-class rapid antigen and RPG Molecular tests.antibody/immunity testing for COVID-19. On October 23, 2020, we completed the acquisition of all of the issued and outstanding shares of capital stock of Confucius Plaza Medical Laboratory Corp. (“CPM”), which operatesowned a 4,000 square foot Clinical Laboratory Improvement Amendments (“CLIA”)CLIA accredited laboratory located in Old Bridge, New Jersey for approximately $2.5 million. As a result of the acquisition of CPM in October 2020, we entered into a new business line, diagnostic services. In December 2020, we expanded our diagnostic service business with the signing of a lease and the recent build outbuild-out of a second, larger CLIA accredited laboratory in Garden City, New York. Operations at this second facility commenced in FebruaryJanuary 2021.

 

On August 10, 2021, we acquired Nebula Genomics, Inc. (“Nebula”), a privately owned personal genomics company, through our new wholly-ownedwholly owned subsidiary, ProPhase Precision Medicine, Inc.Medicine. We intend to offer whole genome sequencing and related services through this new subsidiary.ProPhase Precision Medicine, Inc. focuses on genomics testing technologies, a comprehensive method for analyzing entire genomes, including the genes and chromosomes in DNA. The data obtained from genomic testing can help to identify inherited disorders and tendencies, help predict disease risk, help identify expected drug response, and characterize genetic mutations, including those that drive cancer progression.

Our wholly owned subsidiary, Pharmaloz Manufacturing, Inc. (“PMI”), is a full-service contract manufacturer and private label developer of a broad range of non-GMO, organic and natural-based cough drops and lozenges and OTC drug and dietary supplement products.

 

Our diagnostic service business is and will continue to be influenced by the level of demand for COVID-19 and other diagnostic testing, how long this demand persists, the price we are able to receive for performing our testing services, and the length of timeour ability to collect payment or reimbursement for which that demand persists,our testing services, as well as the availability of COVID-19 testing from other laboratories and the period of time for which we are able to serve as an authorized laboratory offering COVID-19 testing under various Emergency Use Authorizations.

 

34

Our personal genomics business is and will continue to be influenced by demand for our genetic testing products and services, our marketing and service capabilities, and our ability to comply with applicable regulatory requirements.

Our consumer sales are and will continue to be influenced by (i) the timing of acceptance of our TK Supplements® consumer products in the marketplace, and (ii) fluctuations in the timing of purchase and the ultimate level of demand for the OTC healthcare and cold remedy products that we manufacture, which is largely a function of the timing, length and severity of each cold season. Generally, a cold season is defined as the period from September to March when the incidence of the common cold rises as a result of the change in weather and other factors. We generally experience in the first, third and fourth quarter higher levels of net revenues from our contract manufacturing business. Revenues are generally at their lowest levels in the second quarter when customer demand generally declines.

In addition, we continue to actively pursue acquisition opportunities for other companies, technologies and products within and outside the consumer products industry.

While our revenues have increased for the six months ended June 30, 2021significantly as a result of our new diagnostic services business, line, we have made and will continue to make substantial investments to securebe dependent on both government agency and insurance company reimbursement as well as the necessary equipment, supplies and personnel to provide these testing services.prevalence of COVID-19 associated strains. There can be no assurance that our efforts to offer and perform COVID-19 or other diagnostic testing will continue to be successful and the revenue and operating profits from such business will increase from or maintain their current level.

 

In addition, we continue to actively pursue acquisition opportunities for other companies, technologies and products within and outside the consumer products industry.Results of Operations

 

27

Financial Condition and Results of Operations Results for the Three Months Ended June 30, 2021March 31, 2022 as Compared to the Three Months Ended June 30, 2020March 31, 2021

For the three months ended June 30, 2021,March 31, 2022, net revenue was $9.1$47.5 million as compared to $3.6$15.3 million for the three months ended June 30, 2020. We experienced higherMarch 31, 2021. The increase in net revenue was the result of a $32.2 million increase in net revenue from diagnostic services and an immaterial increase in consumer products. The increase in net revenue for the three months ended June 30, 2021, primarily as a result of an increase of $7.5 million related to our new diagnostic services business, which was offset by, a decrease of $2.0 million in customer orders from our consumer products businessdue to increased COVID-19 testing volumes performed as a result of the timingOmicron variant, which emerged in early 2022. Overall diagnostic testing volume increased from 113,000 tests in the first quarter of 2021 to 377,000 tests in the first quarter of 2022, of which 60.3% and demand69.0% were reimbursed by the HRSA uninsured program, respectively. The average variable consideration received was $120.14 per adjudicated test in the first quarter of third party contract manufacturing customers. 2022 versus $139.04 per adjudicated test in the first quarter of 2021. See “HRSA Funding” section in the Liquidity and Capital Resources management disclosures below for additional information.

 

Cost of revenues for the three months ended June 30,March 31, 2022 were $18.9 million, comprised of $16.7 million for diagnostic services and $2.2 million for consumer products. Cost of revenues for the three months ended March 31, 2021 were $4.7$6.3 million, as compared to $2.3comprised of $4.3 million for diagnostic services and $2.0 million for consumer products.

We realized a gross profit of $28.7 million for the three months ended June 30, 2020. March 31, 2022 as compared to $8.9 million for the three months ended March 31, 2021. The increase of $19.8 million was comprised of an increase of $19.8 million from diagnostic services offset by an immaterial decrease in consumer products. For the three months ended June 30,March 31, 2022 and 2021 and 2020, we realized aan overall gross margin of 48.9%60.3% and 35.3%58.5%, respectively. Gross margin for diagnostic services was 62.8% and 65.9% in the 2022 and 2021 comparable periods, respectively. The increasedecrease in gross margin from the prior period iswas principally due to increased margins generally associated with our new diagnostic services business.sample collection costs and additional costs for HRSA-related testing for which revenue could not be recognized, partially offset by a decrease in cost of test materials. Gross margins are generallymargin for consumer products was 17.8% and 21.1% in the 2022 and 2021 comparable periods, respectively. Gross margin for consumer products have historically been influenced by fluctuations in quarter-to-quarter diagnostic testing and OTC production volume, fixed operatingproduction costs and related overhead absorption, raw ingredient costs, testing supplies and labor costs and inventory mark to market write-downs.write-downs and timing of shipments to customers.

 

Diagnostic expensesservices costs for the three months ended June 30, 2021March 31, 2022 were $830,000$4.7 million compared to no diagnostics expenses$3.8 million for the three months ended June 30, 2020.March 31, 2021. The $830,000increase of $0.9 million was due to increased COVID-19 testing volumes performed as a result of the Omicron variant, which emerged in diagnostic expenses forearly 2022, partially offset by a greater proportion of costs allocated to cost of revenues as a result of the three months ended June 30, 2021 was comprisednature of agreements with network providers expenses associated with our new diagnostic services business.providers.

 

Sales, generalGeneral and administration expenses for the three months ended June 30, 2021March 31, 2022 were $5.0$7.8 million as compared to $1.2$3.8 million for the three months ended June 30, 2020.March 31, 2021. The increase of $3.8$4.0 million in general and administration expenses was principally related to growthan increase in personnel expenses and professional fees associated with our new diagnostic services business.

 

Research and development costs for the three months ended June 30, 2021March 31, 2022 were $93,000$35,000 as compared to $65,000$115,000 for the three months ended June 30, 2020.March 31, 2021. The increasedecrease in research and development costs for the three months ended June 30, 2021March 31, 2022 as compared to the three months ended June 30, 2020 wereMarch 31, 2021 was principally due to additional professional feesa decrease in personnel expenses associated with our new diagnostics services business.

 

Interest and other income for the three months ended June 30,March 31, 2022 and 2021 was $73,000 and 2020 was $214,000 and $11,000,$87,000, respectively. The increasedecrease in interest income for the three months ended June 30, 2021March 31, 2022 as compared to the three months ended June 30, 2020March 31, 2021 was principally due to the issuancehigher account balance of the new Secured Note receivableour investment account that bears interest at a rate of 15% per annum.interest.

35

 

Interest expense for the three months ended June 30, 2021March 31, 2022 was $323,000$233,000 compared to no interest expense$251,000 for the three months ended June 30, 2020.March 31, 2021. The increasedecrease in interest expense for the three months ended June 30, 2021March 31, 2022 as compared to the three months ended June 30, 2020March 31, 2021 was principally due to the newrepayment during the three months ended March 31, 2022 of one of the two September 2020 unsecured convertible September 2020 Notesnotes payable that accruesaccrued interest at a rate of 10% per year.

 

Gain from change in fair value of investment securities for the three months ended June 30, 2021 was $164,000, which was due to the increase of stock price as of June 30, 2021 compared to stock price on the acquired date on June 25, 2021.

As a consequenceresult of the effects of thedescribed above, net lossincome from operations for the three months ended June 30, 2021March 31, 2022 was $1.4$12.5 million, or ($0.09)$0.81 per share, as compared to the net income$1.1 million, or $0.07 per share, for the three months ended June 30, 2020 of $70,000, or $0.01March 31, 2021. Diluted earnings per share.share for the three months ended March 31, 2022 and 2021 were $0.68 and $0.06, respectively.

 

Non-GAAP Financial ConditionMeasure and Results of Operations Results for the Six Months Ended June 30, 2021 as Compared to the Six Months Ended June 30, 2020

Reconciliation

For the six months ended June 30, 2021, net revenue was $24.4 million as compared to $5.5 million for the six months ended June 30, 2020. We experienced higher net revenue for the six months ended June 30, 2021, primarily as a result of our receipt of $20.3 million from our new diagnostic services business, which was offset by, a decrease of $1.4 million in customer orders from our consumer products business as a result of the timing and demand of third party contract manufacturing customers.

 

CostIn an effort to provide investors with additional information regarding our results of revenues foroperations as determined by accounting principles generally accepted in the six months ended June 30, 2021 were $11.0 million as compared to $3.8 million for the six months ended June 30, 2020. For the six months ended June 30, 2021United States of America (“GAAP”), we disclose certain non-GAAP financial measures. The primary non-GAAP financial measure we disclose are EBITDA and 2020, we realized a gross margin of 54.9% and 30.7%, respectively. The increase in gross margin from the prior period is principally due to increased margins generally associated with our new diagnostic services business. Gross margins are generally influenced by fluctuations in quarter-to-quarter diagnostic testing and OTC production volume, fixed operating costs and related overhead absorption, raw ingredient costs, testing supplies and labor costs and inventory mark to market write-downs.Adjusted EBITDA.

 

Diagnostic expenses forWe define EBITDA as net income (loss) before net interest expense, income taxes, depreciation and amortization. Adjusted EBITDA further adjusts EBITDA by excluding acquisition costs, other non-cash items, and other unusual or non-recurring charges (as described in the six months ended June 30, 2021 were $4.6 million compared to no diagnostics expenses for the six months ended June 30, 2020. The $4.6 million in diagnostic expenses for the six months ended June 30, 2021 was comprised of network providers expenses associated with our new diagnostic services business.table below).

 

Sales, generalWe use EBITDA and administration expenses forAdjusted EBITDA internally to evaluate and manage the six months ended June 30, 2021 were $8.8 million as comparedCompany’s operations because we believe they provide useful supplemental information regarding the Company’s ongoing economic performance. We have chosen to $2.3 million forprovide this information to investors to enable them to perform more meaningful comparisons of operating results. The following table sets forth the six months ended June 30, 2020. The increasereconciliations of $6.5 million in generalEBITDA and administration expenses was principally relatedAdjusted EBITDA excluding other costs to growth in personnel expenses and professional fees associated with our new diagnostic services business.the most comparable GAAP financial measures (in thousands):

 

Research and development costs for the six months ended June 30, 2021 were $208,000 as compared to $124,000 for the six months ended June 30, 2020. The increase in research and development costs for the six months ended June 30, 2021 as compared to the six months ended June 30, 2020 were principally due to additional professional fees associated with our new diagnostics services business.

  For the three months ended 
  March 31, 2022  March 31, 2021 
GAAP net income (1) $12,494  $1,057 
Interest, net  160   164 
Depreciation and amortization  1,250   457 
EBITDA  13,904   1,678 
Share-based compensation expense  482   428 
Non-cash rent expense (2)  10   186 
Bad debt expense (3)  250   - 
Adjusted EBITDA $14,646  $2,292 

 

Interest(1) We believe that net income (loss) is the financial measure calculated and other incomepresented in accordance with GAAP that is most directly comparable to EBITDA and Adjusted EBITDA. EBITDA and Adjusted EBITDA measure the Company’s operating performance without regard to certain expenses. EBITDA and Adjusted EBITDA are not presentations made in accordance with GAAP and the Company’s computation of EBITDA and Adjusted EBITDA may vary from others in the industry. EBITDA and Adjusted EBITDA have important limitations as analytical tools and should not be considered in isolation or as substitutes for the six months ended June 30, 2021 and 2020 was $301,000 and $14,000, respectively. The increase in interest income for the six months ended June 30, 2021 as compared to the six months ended June 30, 2020 was principally due to the issuanceanalysis of the new Secured Note receivable that bears interest at a rate of 15% per annum.

Interest expense for the six months ended June 30, 2021 was $574,000 compared to no interest expense for the six months ended June 30, 2020. The increase in interest expense for the six months ended June 30, 2021Company’s results as compared to the six months ended June 30, 2020 was principally due the new unsecured convertible September 2020 Notes payable that accrues interest at a rate of 10% per year.

Gain from change in fair value of investment securities for the six months ended June 30, 2021 was $164,000, which was due to the increase of stock price as of June 30, 2021 compared to stock price on the acquired date on June 25, 2021.

As a consequence of the effects of the above, net loss from operations for the six months ended June 30, 2021 was $338,000, or ($0.02) per share, as compared to the net loss for the six months ended June 30, 2020 of $739,000, or ($0.06) per share.reported under GAAP.

 

2836

 

(2) The non-cash portion of rent, which reflects the extent to which our GAAP rent expense recognized exceeds (or is less than) our cash rent payments. For newer leases, our rent expense recognized typically exceeds our cash rent payments, while for more mature leases, rent expense recognized is typically less than our cash rent payments.

(3) Full allowance reserved related to restricted cash.

Liquidity and Capital Resources

 

Our aggregate cash, and cash equivalents and marketable debt securitiesrestricted cash as of June 30, 2021 was $35.8March 31, 2022 were $25.8 million as compared to $8.5$8.7 million at December 31, 2020.2021. Our working capital was $44.3$52.8 million and $9.6$45.8 million as of June 30, 2021March 31, 2022 and December 31, 2020,2021, respectively. The increase of $27.3$17.1 million in our cash, and cash equivalents and marketable debt securities balancerestricted cash for the sixthree months ended June 30, 2021March 31, 2022 was principally due to our receipt of aggregate net proceeds of $40.6 million from the issuancesale of common stockmarketable debt securities of $5.3 million and warrants in a registered direct offering and public offering$20.3 million cash provided by operating activities, offset by (i) capital expenditurespurchases of $4.2marketable securities of $0.3 million, (ii) cash dividend payments of $4.5$4.6 million, (iii) issuancerepayment of a promissory note payable of $1.0$1.4 million, (iv) repurchase of common shares for $1.2 million, and (iv) cash used in operations(v) capital expenditures of $3.5$1.1 million.

 

To date the principal sources of capital to fund our operations have been from diagnostic services, product sales, net proceeds from the offering of equity securities, and issuances of promissory notes. Based on management’s current business plans, the Company estimates it will have enough cash and liquidity to finance its operating requirements for at least 12 months from the date of filing these unaudited condensed consolidated financial statements. However, due to the nature of the diagnostic business and the Company’s focus thus far on COVID-19 testing, there are inherent uncertainties associated with managements’ business plan and cash flow projections, particularly if the Company is unable to grow its diagnostic testing business beyond COVID-19 testing services. See “HRSA Funding” below.

COVID-19

The COVID-19 pandemic has not had a material adverse impact on our business to date. We experienced higher than normal net revenue for the last sixyear ended December 31, 2021 and three months ended June 30, 2020,March 31, 2022, primarily as a result of revenue from our new diagnostic services business, which offers COVID-19 testing. There can be no assurance that demand for our COVID-19 testing services will continue to exist in the future due to the widespread and effective vaccination of a majority of Americans against COVID-19 and successful containment efforts. If there is no demand for our COVID-19 testing services, and we are unable to generate sufficient profits from other RPP Molecular tests, our business could be materially adversely affected.

 

There are still numerous uncertainties associated with the COVID-19 pandemic, including the efficacy of the vaccines that have been developed to treat the virus and their ability to protect against new strains of the virus, people’s willingness to receive a vaccine, possible resurgences of the coronavirus and/or new strains of the virus, the extent and duration of protective and preventative measures that may be adopted by local, state and/or the federal government in the future as a result of future outbreaks, including business closures, the ongoing impact of COVID-19 on the U.S. and world economy and consumer confidence, and various other uncertainties.uncertainties all of which could negatively impact our Company as a whole.

 

The COVID-19 pandemic has had a negative impact on the global capital markets and economies worldwide and could ultimately have a material adverse impact on our ability to raise capital needed to develop and commercialize products.

 

GeneralHRSA Funding

In March 2020, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was enacted, providing for reimbursement to healthcare providers for COVID-19 tests provided to uninsured individuals, subject to continued available funding. Approximately 69% and 57% of our diagnostic services revenue for the three months ended March 31, 2022 and 2021, respectively was generated from this program for the uninsured. On March 22, 2022, the Health Resources & Services Administration (“HRSA”) uninsured program stopped accepting claims for COVID-19 testing and treatment due to lack of sufficient funds. Despite requests from the Acting Director of the Office of Management and Budget and the White House Coordinator for COVID-19 Response for additional emergency funding for the uninsured program, emergency funding has not been allocated to the HRSA uninsured program. We continue to perform testing for uninsured persons and are incurring the accompanying costs. However, as a result of the suspension of the HRSA uninsured program, we did not recognize $4.3 million in revenues related to COVID-19 testing that we performed for uninsured individuals from March 23, 2022 through March 31, 2022. If funding for the HRSA program is not aware of any other trends, events or uncertainties that have had orreinstituted, we will submit eligible claims for reimbursement to HRSA and record the associated revenues. If the HRSA program remains unfunded and we are reasonably likelyunable to have a material negative impact upon our (i) short-term or long-term liquidity, or (ii) net revenue or income from operations. Any challenge to our patent or trademark rightssubmit claims for reimbursement, there could havebe a material adverse effect on our future; however, we are not aware of any condition that would make such an event probable. Our business is generally subject to seasonal variations thereby impacting our liquidity and working capital during the course of our fiscal year.financial condition.

37

At-the-Market Facility

 

During the six months ended June,On December 28, 2021, we used $3.5 million in cash from operations. To the extent that we do not generate sufficient cash from operations, our cash balances will decline. We may also use our cashentered into a Sales Agreement (the “Sales Agreement”) with ThinkEquity LLC (the “Sales Agent”), pursuant to explore and/or acquire new product technologies, applications, product line extensions, new contract manufacturing applications and other new product opportunities. In the event that our available cash is insufficient to support such initiatives,which we may needoffer and sell, from time to incur indebtedness or issuetime through the Sales Agent, shares of our common stock having an aggregate offering price of up to finance our plans for growth. Volatility in$100,000,000, subject to the credit marketsterms and the liquidity of major financial institutions, including as a resultconditions of the COVID-19 pandemic, may have an adverse impact on our abilitySales Agreement. We are not obligated to fund our business strategy through future borrowings,make any sales of shares under either existing or newly created instruments in the public or private markets on terms that we believe to be reasonable, if at all.Sales Agreement.

 

Off-Balance Sheet Arrangements

It is not our usual business practiceWe will pay the Sales Agent a fixed commission rate of 2.0% of the aggregate gross proceeds from the sale of any shares pursuant to enter into off-balance sheet arrangements such as guaranteesthe Sales Agreement and have agreed to provide the Sales Agent with customary indemnification and contribution rights. We also agreed to reimburse the actual out-of-pocket accountable expenses of the Sales Agent up to $60,000 (of which a $25,000 advance was paid on loans and financial commitments and retained interests in assets transferred to an unconsolidated entity for securitization purposes. We have no off-balance sheet arrangements that have, or are reasonably likely to have, a material current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.December 7, 2021).

 

Additionally, we will pay to H.C. Wainwright & Co. (“Wainwright”), a fee equal to 1.0% of the gross proceeds of the sales price of all the shares sold under the Sales Agreement, pursuant to a separate financial services agreement with Wainwright. Wainwright is not a sales agent under the Sales Agreement.

As of March 31, 2022, we have not sold any shares under the Sales Agreement.

Impact of Inflation

We are subject to normal inflationary trends and anticipate that any increased costs for our contract manufacturing and retail operations would be passed on to our customers.customers; however, any increased costs related to diagnostic services would be absorbed by the Company. Inflation has not had a material effect on our business.

Critical Accounting Policies and Estimates

Our significant accounting policies are described in Note 2 of the Notes to Condensed Consolidated Financial Statements included under Item 8 of this Part II. However, certain accounting policies are deemed “critical”, as they require management’s highest degree of judgment, estimates and assumptions. These accounting policies, estimates and disclosures have been discussed with the Audit Committee of our Board of Directors. A discussion of our critical accounting policies and estimates, the judgments and uncertainties affecting their application and the likelihood that materially different amounts would be reported under different conditions or using different assumptions are as follows:

Use of Estimates

The preparation of condensed consolidated financial statements are preparedand the accompanying notes thereto, in conformity with accounting principles generally accepted in the United States of America (“GAAP”), which require the use ofGAAP requires management to make estimates judgments and assumptions that affect the reported amounts of assets and liabilities theand disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses induring the periods presented. We believerespective reporting periods. Examples include revenue recognition and the estimation of the variable consideration associated with the diagnostic reimbursement rates, the provision for bad debt and billing discrepancies, sales returns and allowances, inventory obsolescence, useful lives of property and equipment, impairment of goodwill, intangibles and property and equipment, income tax valuations and assumptions related to accrued advertising. The estimates and assumptions are based on historical experience, current trends and other factors that management believes to be relevant at the time the condensed consolidated financial statements are prepared. Management reviews the accounting policies, assumptions, estimates employed are appropriate and resulting balances are reasonable; however, due to inherent uncertainties in making estimates, actualjudgments on a quarterly basis. Actual results could differ from the original estimates, requiring adjustments to these balances in future periods. The critical accounting estimates that affect the consolidated financial statements and the judgments and assumptions used are consistent with those described under Part II, Item 7 of the 2020 Annual Report.estimates.

 

2938

Revenue Recognition and Accounts Receivables

We generate revenue principally through four types of revenue streams: diagnostic services, contract manufacturing, genomic products and services, and retail and other. The process for estimating revenues and the ultimate collection of receivables involves assumptions and judgments.

Revenue from our diagnostic services is recognized when the lab test is complete, and the diagnostic test result is provided to the customer. Revenue from our genomics services is recognized when the sequencing report is provided to the customer. Revenue from our consumer products is recognized when the shipments to contract manufacturing and retailer customers are recognized at the time ownership is transferred to the customer. We bill the providers at standard price and take into consideration for negotiated discounts and an anticipated reimbursement remittance adjustments based on the payer portfolio, when revenue is recorded. We use the most expected value method to estimate the transaction price for reimbursements that may vary from the standard price.

We carry our accounts receivable at cost less an allowance for doubtful accounts. Allowances for doubtful accounts are based upon our judgment regarding collectability. On a periodic basis, we evaluate our receivables and establish an allowance for doubtful accounts, based on a history of past write-offs, collections, current credit conditions or generally accepted future trends in the industry and/or local economy. Accounts are written off as uncollectible at the time we determine that collections are unlikely. The reserve is not intended to address return activity or disputed balances with ongoing customers, as this should be addressed in a reserve for credit memos with a corresponding charge to revenue.

Goodwill and Long-lived Assets

We review our goodwill at least annually for impairment as well as the carrying value of goodwill and our long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of these assets may not be fully recoverable. When it is determined that the carrying amount of long-lived assets or goodwill is impaired, impairment is measured by comparing an asset’s estimated fair value to its carrying value. The determination of fair value is based on quoted market prices in active markets, if available, or independent appraisals; sales price negotiations; or projected future cash flows discounted at a rate determined by management to be commensurate with our business risk. The estimation of fair value utilizing discounted forecasted cash flows includes significant judgments regarding assumptions of revenue, operating and marketing costs; selling and administrative expenses; interest rates; property and equipment additions and retirements; and industry competition, general economic and business conditions, among other factors.

Income Taxes

Accounting for income taxes requires recognition of deferred tax liabilities and assets for the expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities. These deferred taxes are measured by applying the provisions of tax laws in effect at the balance sheet date, including the impact of the Tax Cuts and Jobs Act (“TCJA”) enacted on December 22, 2017. The TCJA made broad and significant changes to the U.S. tax code that affects the year ended December 31, 2017, including, but not limited to, a change in the federal rate from 35% to 21% effective January 1, 2018.

We recognize in income the effect of a change in tax rates on deferred tax assets and liabilities in the period that includes the TCJA enactment date. We utilize the asset and liability approach which requires the recognition of deferred tax assets and liabilities for the future tax consequences of events that have been recognized in our financial statements or tax returns. In estimating future tax consequences, we generally consider all expected future events other than enactments of changes in the tax law or rates. Until sufficient taxable income to offset the temporary timing differences attributable to operations and the tax deductions attributable to option, warrant and stock activities are assured, a valuation allowance equaling the total net current and non-current deferred tax asset is being provided.

39

Inventories

Inventory is valued at the lower of cost, determined on a first-in, first-out basis (“FIFO”), or net realizable value. We regularly review inventory quantities on hand and record a provision for excess and obsolete inventory based primarily on current and anticipated customer demand, production and laboratory requirements.

Recently Adopted Accounting Standards

The Financial Accounting Standards Board (“FASB”) recently issued Accounting Standards Update (“ASU”) 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470- 20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, to reduce complexity in applying GAAP to certain financial instruments with characteristics of liabilities and equity. The guidance in ASU 2020-06 simplifies the accounting for convertible debt instruments and convertible preferred stock by removing the existing guidance that requires entities to account for beneficial conversion features and cash conversion features in equity, separately from the host convertible debt or preferred stock. The guidance in ASC 470-20 applies to convertible instruments for which the embedded conversion features are not required to be bifurcated from the host contract and accounted for as derivatives. In addition, the amendments revise the scope exception from derivative accounting in ASC 815-40 for freestanding financial instruments and embedded features that are both indexed to the issuer’s own stock and classified in stockholders’ equity, by removing certain criteria required for equity classification. These amendments are expected to result in more freestanding financial instruments qualifying for equity classification (and, therefore, not accounted for as derivatives), as well as fewer embedded features requiring separate accounting from the host contract. The amendments in ASU 2020-06 further revise the guidance in ASC 260, Earnings Per Share, to require entities to calculate diluted earnings per share (EPS) for convertible instruments by using the if-converted method. In addition, entities must presume share settlement for purposes of calculating diluted EPS when an instrument may be settled in cash or shares. The amendments in ASU 2020-06 are effective for public entities, excluding smaller reporting companies, for fiscal years beginning after December 15, 2021. For all other entities, the amendments are effective for fiscal years beginning after December 15, 2023. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020. The adoption of ASU 2020-06 did not have a material impact on our condensed consolidated financial statements or disclosures.

In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40). This ASU reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. This ASU provides guidance for a modification or an exchange of a freestanding equity-classified written call option that is not within the scope of another Topic. It specifically addresses: (1) how an entity should treat a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange; (2) how an entity should measure the effect of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange; and (3) how an entity should recognize the effect of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange. This ASU will be effective for all entities for fiscal years beginning after December 15, 2021. An entity should apply the amendments prospectively to modifications or exchanges occurring on or after the effective date of the amendments. Early adoption is permitted, including adoption in an interim period. The adoption of ASU 2021-04 did not have a material impact on our condensed consolidated financial statements or disclosures.

Recently Issued Accounting Standards, Not Yet Adopted

In September 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326). The ASU sets forth a “current expected credit loss” (CECL) model which requires the Company to measure all expected credit losses for financial instruments held at the reporting date based on historical experience, current conditions, and reasonable supportable forecasts. This replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial assets measured at amortized cost and applies to some off-balance sheet credit exposures. In February 2020, the FASB issued ASU 2020-02, Financial Instruments - Credit Losses (Topic 326), which amends the effective date of the original pronouncement for smaller reporting companies. ASU 2016-13 and its amendments will be effective for us for interim and annual periods in fiscal years beginning after December 15, 2022. We are currently assessing the impact of the adoption of this ASU on our financial statements.

40

 

Item 3. Quantitative and Qualitative Disclosures about Market Risk.

 

Like virtually all commercial enterprises, we can be exposed to the risk (“market risk”) that the cash flows to be received or paid relating to certain financial instruments could change as a result of changes in interest rate, exchange rates, commodity prices, equity prices and other market changes.

 

Our operations are not subject to risks of material foreign currency fluctuations, nor do we use derivative financial instruments in our investment practices. We place our marketable investments in instruments that meet high credit quality standards. We do not expect material losses with respect to our investment portfolio or excessive exposure to market risks associated with interest rates. The impact on our results of one percentage point change in short-term interest rates would not have a material impact on our future earnings, fair value, or cash flows related to investments in cash equivalents or interest-earning marketable securities.

 

Current economic conditions may cause a decline in business and consumer spending which could adversely affect our business and financial performance including the collection of accounts receivables, notes receivable, realization of inventory and recoverability of assets. In addition, our business and financial performance may be adversely affected by current and future economic conditions, including a reduction in the availability of credit, financial market volatility and recession.

 

Except for the broad effects of COVID-19 including its negative impact on the global economy and major financial markets, there have been no material changes to our market risk exposures since December 31, 2020.2021.

 

Item 4. Controls and Procedures.

Disclosure Controls and Procedures

We carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of June 30, 2021. This evaluation was carried out under the supervision and with the participation of our Principal Executive Officer and Principal Financial and Accounting Officer. Based upon that evaluation, our Principal Executive Officer and Principal Financial and Accounting Officer concluded that our disclosure controls and procedures were effective as of June 30, 2021.

Disclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed with or submitted to the SEC under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports filed under the Exchange Act is accumulated and communicated to management, including our Principal Executive Officerprincipal executive officer and Principal Financialprincipal financial and Accounting Officer,accounting officer, to allow timely decisions regarding required disclosure.

 

We carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of March 31, 2022. This evaluation was carried out under the supervision and with the participation of our principal executive officer and principal financial and accounting officer. Based on that review, our management, including our principal executive officer and principal financial and accounting officer, concluded that due to the material weakness described below, our disclosure controls and procedures were not effective at the reasonable assurance level as of March 31, 2022.

41

Material Weakness

In connection with our 2021 Annual Report, our management conducted an evaluation of the effectiveness of our system of internal control over financial reporting based on the framework in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 Framework). Based upon that review, our management, including our principal executive officer and principal financial and accounting officer, concluded that the Company’s internal controls over financial reporting were not effective as of March 31, 2022, as a material weakness exists. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our financial statements could occur but will not be prevented or detected on a timely basis.

The material weakness that was identified relates to the lack of appropriate standard operating procedures and billing system controls associated with the diagnostic billing and revenue process, as well as the lack of contemporaneous assessments and associated documentation of the reimbursement receivables leading to additional allowance requirements.

Management is committed to remediating the material weakness. We have begun the process of implementing changes to our internal control over financial reporting to remediate the control deficiencies that gave rise to the material weakness, including further improvements in our processes, the current billing system and analyses that support the estimates associated with the allowances. Further, we expect to perform a comprehensive review of our billing standard operating procedures, training and resources in our billing and accounting functions.

We will not consider the material weakness remediated until the remedial controls operate for a sufficient period of time and we have concluded, through testing, that these controls are effectively designed and operating effectively. We will continue to assess throughout 2022.

Changes in Internal Control Over Financial Reporting

 

NoExcept as described above, no change in internal control over financial reporting occurred during the most recent quarter with respect to our operations, which materially affected, or is reasonable likely to materially affect, our internal controls over financial reporting.

 

30

Part II. Other Information

 

Item 1. Legal Proceedings.

From time to time, we have been and may again become involved in legal proceedings arising in the ordinary course of business. We are not presently a party to any material litigation.

42

 

Item 1A. Risk Factors.

There

Factors that could cause our actual results to differ materially from those in this Quarterly Report are any of the risks described in our Annual Report on Form 10-K filed with the SEC on March 31, 2022. Any of these factors could result in a significant or material adverse effect on our results of operations or financial condition. Additional risk factors not presently known to us or that we currently deem immaterial may also impair our business or results of operations. 

As of the date of this Quarterly Report on Form 10-Q, except as described below, there have been no material changes to the risks describedrisk factors disclosed in Item 1A. Risk Factorsour Annual Report on Form 10-K filed with the SEC on March 31, 2022. However, we may disclose changes to such factors or disclose additional factors from time to time in our future filings with the SEC. 

Our ability to achieve or sustain profitability depends on our collection of payment for the tests we deliver, which we may not be able to do successfully.

Our customer base for our COVID-19 tests is principally comprised of governmental bodies, municipalities, and large corporations who pay us directly or through third-party payors. In March 2020, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was enacted, providing for reimbursement to healthcare providers for COVID-19 tests provided to uninsured individuals, subject to continued available funding. Approximately 60 and 57% of our diagnostic services revenue for the three months ended March 31, 2022 and 2021, respectively was generated from this program for the uninsured. On March 22, 2022, the Health Resources & Services Administrations (“HRSA”) uninsured program stopped accepting claims for COVID-19 testing and treatment due to the lack of sufficient funds. Despite requests from the Acting Director of the 2020 Annual Report.Office of Management and Budget and the White House Coordinator for COVID-19 Response for additional emergency funding for the uninsured program, emergency funding has not been allocated to the HRSA uninsured program. We continue to perform testing for uninsured persons and are incurring the accompanying costs. However, as a result of the suspension of the HRSA uninsured program, we did not recognize $4.3 million of revenues related to COVID-19 testing which was performed for uninsured individuals from March 23, 2022 through March 31, 2022. If funding for the HRSA program is reinstituted, we will submit eligible claims for reimbursement to HRSA and record the associated revenues. If the HRSA program remains unfunded and we are unable to submit claims for reimbursement, there could be a material adverse effect on our business and financial condition.

Further, healthcare policy changes that influence the way healthcare is financed or other changes in the market that impact payment rates by institutional or non-institutional customers could also affect our collection rates. If we are unable to convince customers of the value and benefit provided by our tests, these customers may slow, or stop altogether, their purchases of these tests. Our collection risks also include the potential for default or bankruptcy by the party responsible for payment and other risks associated with payment collection generally. Any inability to maintain our past payment collection levels could cause our revenue and ability to achieve profitability to decline and adversely affect our business, prospects and financial condition.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

 

None.

 

Item 3. Defaults Upon Senior Securities.

None

 

Item 4. Mine Safety Disclosures.

 

Not applicable

 

Item 5. Other Information.

 

None

 

Item 6. Exhibits

Exhibit No. Description
10.1Amended and Restated 2010 Equity Compensation Plan (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K (File No. 000-21617) filed on May 21, 2021)
10.2Amended and Restated 2010 Directors’ Equity Compensation Plan (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K (File No. 000-21617) filed on May 21, 2021)
31.1 Certification by the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
   
31.2 Certification by the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
   
32.1 Certification by the Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
   
32.2 Certification by the Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
   
101. INS# Inline XBRL Instance Document
   
101.SCH# Inline XBRL Taxonomy Extension Schema Document
   
101.CAL# Inline XBRL Taxonomy Extension Calculation Linkbase Document
   
101.DEF# Inline XBRL Taxonomy Extension Definition Linkbase Document
   
101.LAB# Inline XBRL Taxonomy Extension Label Linkbase Document
   
101.PRE# Inline XBRL Taxonomy Extension Presentation Linkbase Document
104Cover Page Interactive Data File (embedded within the Inline XBRL document)

3143
 

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.

 

 ProPhase Labs, Inc.
   
 By:/s/ Ted Karkus
  Ted Karkus
  

Chairman of the Board and Chief Executive Officer (Principal Executive Officer)

Date: August 13, 2021

Date: May 13, 2022
 By:/s/ Monica Brady
  Monica Brady
  

Chief Financial Officer

(Principal Financial Officer)

Date: May 13, 2022

Date: August 13, 2021

3244