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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 September 30, 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)

 

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)

 

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 $0.0005   PRPH   Nasdaq Capital 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 November 10, 2022
Common Stock, $0.0005 par value   16,277,764

 

 

 

 
 

 

ProPhase Labs, Inc. and Subsidiaries

TABLE OF CONTENTS

 

    PAGE
PART I. FINANCIAL INFORMATION  
     
Item 1. Financial Statements (Unaudited) 3
     
  Condensed Consolidated Balance Sheets as of September 30, 2022 and December 31, 2021 3
     
  Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) for the Three and Nine Months Ended September 30, 2022 and 2021 4
     
  Condensed Consolidated Statements of Stockholders’ Equity for the Three and Nine Months Ended September 30, 2022 and 2021 5-6
     
  Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2022 and 2021 7
     
  Notes to Condensed Consolidated Financial Statements 8
     
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 30
     
Item 3. Quantitative and Qualitative Disclosures about Market Risk 39
     
Item 4. Controls and Procedures 40
     
PART II. OTHER INFORMATION  
     
Item 1. Legal Proceedings 41
     
Item 1A. Risk Factors 41
     
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 54
     
Item 3. Defaults Upon Senior Securities 54
     
Item 4. Mine Safety Disclosures 55
     
Item 5. Other Information 55
     
Item 6. Exhibits 55
     
Signatures 56

 

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)

 

   September 30 2022   December 31, 2021 
   (Unaudited)     
ASSETS          
Current assets          
Cash and cash equivalents  $22,799   $8,408 
Restricted cash   -    250 
Marketable debt securities, available for sale   3,678    8,779 
Marketable equity securities, at fair value   -    76 
Accounts receivable, net   37,832    37,708 
Inventory, net   4,912    4,600 
Prepaid expenses and other current assets   1,105    1,496 
Total current assets   70,326    61,317 
           
Property, plant and equipment, net   6,063    5,947 
Prepaid expenses, net of current portion   121    460 
Operating lease right-of-use asset, net   4,148    4,402 
Intangible assets, net   8,889    10,852 
Goodwill   5,709    5,709 
Deferred tax asset   1,339    - 
Other assets   1,282    608 
TOTAL ASSETS  $97,877   $89,295 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities          
Accounts payable  $1,545   $7,026 
Accrued diagnostic services   274    1,890 
Accrued advertising and other allowances   79    104 
Operating lease liabilities   301    663 
Deferred revenue   2,958    2,034 
Income tax payable   8,341    1,312 
Other current liabilities   3,195    2,495 
Total current liabilities   16,693    15,524 
           
Non-current liabilities:          
Deferred revenue, net of current portion   927    905 
Note payable   -    44 
Unsecured convertible promissory notes, net   7,999    9,996 
Operating lease liabilities, net of current portion   4,337    4,198 
Total non-current liabilities   13,263    15,143 
Total liabilities   29,956    30,667 
           
COMMITMENTS AND CONTINGENCIES   -      
           
Stockholders’ equity          
Preferred stock authorized 1,000,000, $0.0005 par value, no shares issued and outstanding   -    - 
Common stock authorized 50,000,000, $0.0005 par value, 16,026,164 and 15,485,900 shares outstanding, respectively   17    16 
Additional paid-in capital   108,131    104,552 
Retained earnings   14,198    2,642 
Treasury stock, at cost, 17,711,582 and 16,818,846 shares, respectively   (54,138)   (48,407)
Accumulated other comprehensive loss   (287)   (175)
Total stockholders’ equity   67,921    58,628 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY  $97,877   $89,295 

 

See accompanying notes to condensed consolidated financial statements

 

3
 

 

ProPhase Labs, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

(in thousands, except per share amounts)

(unaudited)

 

   September 30, 2022   September 30, 2021   September 30, 2022   September 30, 2021 
   For the three months ended   For the nine months ended 
   September 30, 2022   September 30, 2021   September 30, 2022   September 30, 2021 
Revenues, net  $24,200   $9,472   $100,824   $33,885 
Cost of revenues   12,227    5,495    41,453    16,515 
Gross profit   11,973    3,977    59,371    17,370 
                     
Operating expenses:                    
Diagnostic expenses   2,398    1,478    8,869    6,117 
General and administration   7,512    5,938    21,643    14,713 
Research and development   110    208    174    416 
Total operating expenses   10,020    7,624    30,686    21,246 
Income (loss) from operations   1,953    (3,647)   28,685    (3,876)
                     
Interest income, net   25    230    123    531 
Interest expense   (201)   (296)   (635)   (870)
Change in fair value of investment securities   -    (265)   (76)   (101)
Income (loss) from operations before income taxes   1,777    (3,978)   28,097    (4,316)
Income tax expense   (809)   -    (7,190)   - 
Income (loss) from operations after income taxes   968    (3,978)   20,907    (4,316)
Net income (loss)  $968   $(3,978)  $20,907   $(4,316)
                     
Other comprehensive loss:                    
Unrealized loss on marketable debt securities   (51)   (33)   (112)   (111)
Total comprehensive income  $917   $(4,011)  $20,795   $(4,427)
                     
Earnings (loss) per share:                    
Basic  $0.06   $(0.26)  $1.33   $(0.29)
Diluted  $0.06   $(0.26)  $1.10   $(0.29)
                     
Weighted average common shares outstanding:                    
Basic   15,898    15,439    15,712    15,055 
Diluted   20,248    15,439    19,504    15,055 

 

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)

 

                             
   For the Three Months Ended September 30, 2022 
  

Common Stock

Shares
Outstanding

   Par
Value
  

Additional

Paid in
Capital

   Retained
Earnings
  

Treasury

Stock

   Accumulated Other
Comprehensive Loss
   Total 
Balance as of July 1, 2022   15,722,827   $16   $106,162   $13,230   $(51,015)  $(236)  $68,157 
Repurchase of common shares   (5,048)   1    -    -    (51)   -    (50)
Unrealized loss on marketable debt securities, net of realized loss of $7, net of taxes   -    -    -    -    -    (51)   (51)
Issuance of common stock upon stock options cashless exercise   308,385    -    -    -    -    -    - 
Treasury shares repurchased to satisfy tax withholding obligations   -    -    -    -    (3,072)   -    (3,072)
Stock-based compensation   -    -    1,969    -    -    -    1,969 
Net income   -    -    -    968    -    -    968 
Balance as of September 30, 2022   16,026,164   $17   $108,131   $14,198   $(54,138)  $(287)  $67,921 

 

   For the Three Months Ended September 30, 2021 
  

Common

Stock

Shares
Outstanding

   Par
Value
  

Additional

Paid in
Capital

   Accumulated
Deficit
   Treasury
Stock
   Accumulated Other Comprehensive Loss   Total 
Balance as of July 1, 2021   15,154,253   $16   $99,265   $(3,969)  $(47,490)  $(89)  $47,733 
Issuance of common shares related to business acquisition   483,685    -    3,608    -    -    -    3,608 
Unrealized loss on marketable debt securities, net of taxes   -    -    -    -    -    (33)   (33)
Cashless warrants exercise   5,986    -                          
Stock-based compensation   8,800    -    934    -    -    -    934 
Net loss   -    -    -    (3,978)   -    -    (3,978)
Balance as of September 30, 2021   15,652,724   $16   $103,807   $(7,947)  $(47,490)  $(122)  $48,264 

 

See accompanying notes to condensed consolidated financial statements

 

5
 

 

ProPhase Labs, Inc. and Subsidiaries

Condensed Consolidated Statements of Stockholders’ Equity

(in thousands, except share data)

(unaudited)

 

   For the Nine Months Ended September 30, 2022 
  

Common Stock

Shares
Outstanding

   Par
Value
  

Additional

Paid in
Capital

   Retained
Earnings
   Treasury
Stock
   Accumulated Other Comprehensive
Loss
   Total 
Balance as of January 1, 2022   15,485,900   $16   $104,552   $2,642   $(48,407)  $(175)  $58,628 
Issuance of common shares for debt conversion   200,000    -    600    -    -    -    600 
Cash dividends   -    -    -    (9,351)   -    -    (9,351)
Repurchases of common shares   (205,048)   1    -    -    (1,200)   -    (1,199)
Issuance of common stock upon stock options cashless exercise   545,312    -    -    -    -    -    - 
Treasury shares repurchased to satisfy tax withholding obligations   -    -    -    -    (4,531)   -    (4,531)
Unrealized loss on marketable debt securities, net of realized loss of $186, net of taxes   -    -    -    -    -    (112)   (112)
Stock-based compensation   -    -    2,979    -    -    -    2,979 
Net income   -    -    -    20,907    -    -    20,907 
Balance as of September 30, 2022   16,026,164   $17   $108,131   $14,198   $(54,138)  $(287)  $67,921 

 

   For the Nine Months Ended September 30, 2021 
  

Common Stock

Shares
Outstanding

   Par
Value
  

Additional

Paid in
Capital

   Accumulated
Deficit
   Treasury
Stock
   Accumulated Other Comprehensive
Loss
   Total 
Balance as of January 1, 2021   11,604,253   $14   $61,674   $(3,631)  $(47,490)  $(11)  $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 
Issuance of common shares related to business acquisition   483,685    -    3,608    -    -    -    3,608 
Cash dividends   -    -    (4,546)   -    -    -    (4,546)
Unrealized loss on marketable debt securities, net of taxes   -    -    -    -    -    (111)   (111)
Cashless warrants exercise   5,986    -    -    -    -    -    - 
Stock-based compensation   8,800    -    2,438    -    -    -    2,438 
Net loss   -    -    -    (4,316)   -    -    (4,316)
Balance as of September 30, 2021   15,652,724   $16   $103,807   $(7,947)  $(47,490)  $(122)  $48,264 

 

See accompanying notes to condensed consolidated financial statements

 

6
 

 

ProPhase Labs, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

(in thousands)

(unaudited)

 

   September 30, 2022   September 30, 2021 
   For the nine months ended 
   September 30, 2022   September 30, 2021 
Cash flows from operating activities          
Net income (loss)  $20,907   $(4,316)
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:          
Realized loss on marketable debt securities   192    40 
Depreciation and amortization   3,792    2,044 
Amortization of debt discount   4    4 
Amortization on operating lease right-of-use assets   254    247 
Loss on sale of assets   14    - 
Stock-based compensation expense   2,979    2,438 
Change in fair value of investment securities   76    101 
Accounts receivable allowances   2,528    - 
Inventory valuation reserve   (179)   - 
Non-cash interest income on secured promissory note receivable   -    (315)
Changes in operating assets and liabilities:          
Accounts receivable   (2,652)   (7,327)
Inventory   (133)   (5,036)
Prepaid expenses and other current assets   643    1,639 
Deferred tax asset   (1,339)   - 
Other assets   (674)   (368)
Accounts payable   (5,483)   (1,749)
Accrued diagnostic services   (1,616)   3,260 
Accrued advertising and other allowances   (25)   - 
Deferred revenue   946    1,461 
Operating lease liabilities   (223)   197 
Income tax payable   7,029    - 
Other current liabilities   700    (1,292)
Net cash provided by (used in) operating activities   27,740    (8,972)
           
Cash flows from investing activities          
Business acquisitions, net of cash acquired   -    (9,066)
Issuance of secured promissory note receivable   -    (1,000)
Purchase of marketable securities   (1,003)   (21,527)
Proceeds from sale of marketable debt securities   5,800    10,701 
Proceeds from dispositions of property and other assets, net   452    - 
Capital expenditures   (2,323)   (4,258)
Net cash provided by (used in) investing activities   2,926    (25,150)
           
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   (1,444)   - 
Repurchases of common shares   (1,200)   - 
Payment of dividends   (9,351)   (4,546)
Repurchase of common stock for payment of statutory taxes due on cashless exercise of stock option   (4,530)   - 
Net cash (used in) provided by financing activities   (16,525)   36,089 
           
Increase in cash, cash equivalents and restricted cash   14,141    1,967 
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  $22,799   $8,783 
           
Supplemental disclosures:        
Cash paid for income taxes  $1,500   $- 
Interest payment on the promissory notes  $631   $750 
           
Supplemental disclosure of non-cash investing and financing activities:          
Issuance of common shares for debt conversion  $600   $3,608 
Net unrealized loss, investments in marketable debt securities  $(113)  $(111)

 

See accompanying notes to condensed consolidated financial statements

 

7
 

 

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 company 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 database to be used for further research. In addition, we have deep experience with over-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 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. However, commencing in December 2020, we also began offering COVID-19 and were prepared to validate other Respiratory Pathogen Panel (RPP) molecular tests through our diagnostic services business, and in August 2021 we began offering personal genomics products and services.

 

Our wholly owned subsidiary, ProPhase Diagnostics, Inc. (“ProPhase Diagnostics”), which was formed on October 9, 2020, offers a broad array of clinical diagnostic and testing services at its CLIA certified laboratories including 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 testing for COVID-19. On October 23, 2020, we acquired Confucius Plaza Medical Laboratory Corp. (“CPM”), which included a non-operating but certified 4,000 square foot CLIA accredited laboratory located in Old Bridge, New Jersey. In December 2020, we expanded our diagnostic service business with the build-out of a second, larger CLIA accredited laboratory in Garden City, New York. Operations at this second facility commenced in January 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 sequencing technologies, a comprehensive method for analyzing entire genomes, including the genes and chromosomes in DNA. The data obtained from genomic sequencing can be used to help 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, ProPhase BioPharma, Inc. (“PBIO”) was formed on June 28, 2022, for the licensing, development and commercialization of novel drugs, dietary supplements and compounds beginning with Equivir and Equivir G. PBIO announced a second licensing agreement for two small molecule PIM kinase inhibitors, Linebacker LB-1 and LB-2, in July 2022, with plans to pursue development and commercialization of LB-1 as a cancer co-therapy.

 

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.

 

We also develop and market dietary supplements under the TK Supplements® brand.

 

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, 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 three and nine months ended September 30, 2022, are not necessarily indicative of operating results that may be achieved over the course of the full year.

 

8
 

 

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. We maintain two operating segments: diagnostic services (which includes our COVID-19 and other diagnostic testing services) and consumer products (which includes our contract manufacturing, retail customers and personal genomics products and services) (see Note 15 Segment Information).

 

Business and Liquidity Risks and Uncertainties

 

Our diagnostic service business is and will continue to be impacted by the level of demand for COVID-19 and other diagnostic testing, how long this demand persists, the prices we are able to receive for performing our testing services, our ability to collect payment or reimbursement for 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 since the launch of our diagnostic services business, we have been 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 healthcare providers for COVID-19 tests provided to uninsured individuals, subject to continued available funding. Approximately 31.5% and 64.7% of our diagnostic services revenue for the nine months ended September 30, 2022 and 2021, 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 lack of sufficient funds. As a result of the suspension of the HRSA uninsured program, we have not recognized any revenue related to COVID-19 testing that we performed for uninsured individuals from March 22, 2022 through September 30, 2022.

 

For the nine months ended September 30, 2022, $27.7 million was provided by operating activities. The Company had cash, cash equivalents and marketable securities of $26.5 million as of September 30, 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 management’s business plan and cash flow projections, particularly if the Company is unable to grow its diagnostic testing business beyond COVID-19 testing services.

 

The Company’s future capital needs and the adequacy of its available funds will depend on its 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.

 

9
 

 

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

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 uncollectible receivables and billing errors, allowances, slow moving and/or dated inventory and associated provisions, the potential impairment of long-lived assets, stock based compensation valuations, income tax asset valuations and assumptions related to accrued advertising.

 

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.

 

Restricted 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 September 30, 2022, we recognized an expense for this balance as the recovery of the funds was no longer considered probable.

 

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 and 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.

 

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):

 Summary of Components of Marketable Securities

   As of September 30, 2022 
   Amortized   Unrealized   Unrealized   Fair 
   Cost   Gains   Losses   Value 
U.S. government obligations  $1,448   $-   $(93)  $1,355 
Corporate obligations   2,342    129    (148)   2,323 
   $3,790   $129   $(241)  $3,678 

 

   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 condensed consolidated balance sheets. The change in fair value of marketable equity securities is recognized within other non-operating income, net in the condensed consolidated statements of operations and comprehensive income (loss).

 

On June 25, 2021, we were issued 1,260,619 common shares (the “Investment Shares”) as an interest payment under our note receivable (see Note 13, Consulting Agreement and Secured Promissory Note Receivable) with a fair value of $315,000 at the time of issuance and a fair value of $76,000 at December 31, 2021. The investment was classified as a Level 1 financial instrument. We recorded a $112,000 decrease in fair value of investment securities within the condensed consolidated statement of operations and comprehensive income (loss) for the nine months ended September 30, 2022.

 

10
 

 

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

Accounts Receivable, net

 

Accounts receivable consists primarily of amounts due from government agencies and healthcare insurers for our diagnostic services. 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 condensed 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.

 

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

   September 30, 2022   December 31, 2021 
Trade accounts receivable  $38,231   $18,520 
Unbilled accounts receivable   6,031    23,089 
Accounts receivable, gross   44,262    41,609 
Less allowances   (6,430)   (3,901)
Total accounts receivable  $37,832   $37,708 

 

Inventory, net

 

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

 

At September 30, 2022 and December 31, 2021, the components of inventory are as follows (in thousands):

 Schedule of Components of Inventory

   September 30, 2022   December 31, 2021 
Diagnostic services testing material  $2,271   $2,989 
Raw materials   1,904    1,514 
Work in process   609    260 
Finished goods   383    272 
Inventory  $5,167   $5,035 
Inventory valuation reserve   (255)   (435)
Inventory, net  $4,912   $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.

 

Concentration of Financial Risks

 

Financial instruments that potentially subject us to significant concentrations of credit risk consist principally of cash investments, marketable debt securities, and 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 September 30, 2022, our cash and cash equivalents was $22.8 million. Of the total bank balance, $1.0 million was covered by federal depository insurance and $21.8 million was uninsured at September 30, 2022.

 

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 rates. The collectability of the diagnostic services receivables is also directly linked to the quality of our billing processes, which depends on information provided to the payors and meeting their requirements for reimbursement.

 

11
 

 

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

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 condensed consolidated 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 condensed consolidated balance sheet leases with terms of 12 months or less. We typically only include an initial lease term in our 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 12, Leases).

 

The components of a lease should be allocated between lease components (e.g., land, building, etc.) and non-lease components (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 Intangible Assets

 

Goodwill 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 that time.

 

In 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 it 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 circumstances, we conclude that it is not more likely than not that the fair value of a reporting 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 by comparing the estimated fair value of a reporting unit with its respective carrying value. If the estimated fair value exceeds 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 recorded to reduce the reporting unit to fair value. There have been no triggering events during the nine months ended September 30, 2022 and thus, there has been no adjustment to goodwill as of September 30, 2022.

 

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 measure 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.

 

12
 

 

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

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, and unsecured note payable, approximate their fair values because of the short-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 statements of operation and comprehensive income (loss). The components of marketable securities are as follows (in thousands):

 Schedule of Fair Value of Financial Instruments

   As of September 30, 2022 
   Level 1   Level 2   Level 3   Total 
U.S. government obligations  $-   $1,355   $-   $1,355 
Corporate obligations   -    2,323    -    2,323 
   $-   $3,678   $-   $3,678 

 

   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 nine months ended September 30, 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. Sales from product shipments to contract manufacturing and retailer customers are recognized at the time ownership is transferred to the customer. Revenue from diagnostic services is recognized when the results are made available to the customer. Revenue from our personal genomics business is recognized when the genetic testing results are provided to the customer. For subscription services associated with our genomic testing, we recognize revenue ratably over the term of the subscription.

 

13
 

 

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

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.

 

We do not accept returns from our contract manufacturing 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 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. 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 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

 

Recognition for contract manufacturing and retail customers is 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, recognition 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.

 

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 our 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 $0.3 million and $1.0 million for the three and nine months ended September 30, 2022, respectively. The Company recognized breakage revenue from aggregate unreturned test kits and subscriptions of $0.1 million for both the three and nine months ended September 30, 2021.

 

14
 

 

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

Contract Balances

 

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 research and development (“R&D”) work. As of September 30, 2022 and December 31, 2021, we have deferred revenue of $3.9 million and $2.9 million, respectively. Our new personal genomics business comprised $3.7 million and $2.7 million of the deferred revenue as of September 30, 2022 and December 31, 2021, respectively. The deferred revenue balance within the personal genomics business is comprised of kits to be sequenced and subscription services, which have an average life between 12 and 36 months. The remainder of deferred revenue relates to R&D stability and release testing programs recognized as contract manufacturing revenue.

 

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

 Schedule of Deferred Revenue

Recognition Period  September 30, 2022   December 31, 2021 
0-12 Months  $2,958   $2,034 
13-24 Months   626    530 
Over 24 Months   301    375 
Total  $3,885   $2,939 

 

Disaggregation of Revenue

 

We disaggregate revenue from contracts with customers into four categories: diagnostic services, contract manufacturing, retail and others, 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 the Company’s revenue by revenue source for the three and nine months ended September 30, 2022 and 2021 (in thousands):

 Schedule of Disaggregation by Revenue

                     
   For the three months ended   For the nine months ended 
Revenue by Customer Type  September 30, 2022   September 30, 2021   September 30, 2022   September 30, 2021 
Diagnostic services  $20,542   $7,142   $91,613   $27,416 
Contract manufacturing   2,749    1,120    5,662    4,069 
Retail and others   357    1,210    1,369    2,400 
Genomic products and services   552    -    2,180    - 
Total revenue, net  $24,200   $9,472   $100,824   $33,885 

 

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. 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 condensed consolidated statements of operations and comprehensive income (loss).

 

Sales Tax Exclusion from the Transaction Price

 

We exclude from the measurement of the transaction price all taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction and collected by the Company from the customer.

 

15
 

 

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

Shipping and Handling Activities

 

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

 

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 general and administrative expense, (ii) cooperative incentive promotions and coupon program expenses, which are accounted for as part of net revenue, and (iii) free product, which is accounted for as part of cost of revenues. Advertising and incentive promotion expenses incurred for the three months ended September 30, 2022 and 2021 were $161,000 and $136,000, respectively. Advertising and incentive promotion expenses incurred for the nine months ended September 30, 2022 and 2021 were $286,000 and $415,000, respectively.

 

Stock-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 stock-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. The 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 (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.

 

Research and Development

 

R&D costs are charged to operations in the period incurred. R&D costs incurred for the three months ended September 30, 2022 and 2021 were $110,000 and $208,000, respectively. R&D costs incurred for the nine months ended September 30, 2022 and 2021 were $174,000 and $416,000, 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 costs in association with the diagnostic services business.

 

Income Taxes

 

The Company recognizes deferred tax liabilities and assets based on the differences between the financial statement carrying amounts and the tax bases of assets and liabilities, using enacted tax rates in effect in the years the differences are expected to reverse.

 

The provision for, or benefit from, income taxes includes deferred taxes resulting from the temporary 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, it is probable that the deferred income tax assets are realizable. Valuation allowances are established when it is more likely than not that the tax benefit of the deferred tax asset will not be realized. The evaluation, as prescribed by ASC 740- 10, “Income Taxes,” includes the consideration of all 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 tax credit carryforward from expiring unused.

 

The 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 recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The Subtopic provides guidance on the de-recognition, classification, interest and penalties, accounting in interim periods, disclosure and transition.

 

16
 

 

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

Recently Issued Accounting Standards, Adopted

 

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 Company adopted ASU 2020-06 on January 1, 2022. 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 Company adopted ASU 2021-04 on January 1, 2022. 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 condensed consolidated financial statements.

 

In June 2022, the FASB issued ASU 2022-03, ASC Subtopic 820 “Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions”. The FASB is issuing this Update (1) to clarify the guidance in Topic 820, Fair Value Measurement, when measuring the fair value of an equity security subject to contractual restrictions that prohibit the sale of an equity security, (2) to amend a related illustrative example, and (3) to introduce new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value in accordance with Topic 820. For public business entities, the amendments in this Update are effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. Early adoption is permitted for both interim and annual financial statements that have not yet been issued or made available for issuance. We are currently assessing the impact of the adoption of this ASU on our condensed consolidated financial statements.

 

17
 

 

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

Note 3 - Business Acquisition

 

Nebula Acquisition

 

On August 10, 2021 (the “Nebula Effective Date”), the Company 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 common stock of Nebula from the Seller Parties, for an aggregate purchase price of approximately $14.3 million, 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 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 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.

 

In connection with the Nebula Acquisition, ProPhase Precision entered into an employment agreement with Kamal Obbad, the Chief Executive Officer of Nebula, on the Nebula Effective Date, pursuant to which Mr. Obbad serves as Senior Vice President, Director of Sales and Marketing of ProPhase Precision. As a condition to the employment agreement, Mr. Obbad was awarded a stock option to purchase 250,000 shares of Company common stock at an exercise price equal to $7.67 per share, the closing price of the Company common stock on the Nebula Effective Date (see Note 7, Stockholders’ Equity).

 

Based on the valuation, the total consideration of $12.7 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 (in thousands):

 Schedule of Assets Acquired and Liabilities Assumed

Account  Amount 
Short term investments  $1,800 
Accounts receivable   171 
Inventory   133 
Prepaid expenses 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.

 

Goodwill represents the excess of the purchase price over the net identifiable tangible and intangible assets acquired. The Company believes the goodwill related to the acquisition was a result of the expected synergies to be realized from combining operations and 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      

 

18
 

 

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

Note 4 - Intangible Assets, Net

 

Intangible assets as of September 30, 2022 and December 31, 2021 consisted of the following (in thousands):

 Schedule of Intangible Assets, Net

             
   September 30, 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   (3,408)   (1,445)    
Total intangible assets, net  $8,889   $10,852     

 

Amortization expense for acquired intangible assets was $545,000 and $445,000 during the three months ended September 30, 2022 and 2021, respectively. Amortization expense for acquired intangible assets was $2.0 million and $662,000 during the nine months ended September 30, 2022 and 2021, respectively. The estimated future amortization expense of acquired intangible assets as of September 30, 2022 is as follows (in thousands):

 

 Schedule of Estimated Future Amortization Expense of Acquired Intangible Assets 

      
Remaining periods in the year ended December 31, 2022  $414 
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   3,556 
 Total intangible assets, net  $8,889 

 

Note 5 - Property, Plant and Equipment

 

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

 Schedule of Property, Plant and Equipment

            
   September 30, 2022   December 31, 2021   Estimated Useful Life
Land  $352   $352    
Building improvements   1,729    1,729   10-39 years
Machinery   4,892    4,740   3-7 years
Lab equipment   4,403    4,330   3-7 years
Computer equipment   2,140    1,211   3-5 years
Furniture and fixtures   461    468   5 years
Property, Plant and Equipment, Gross   13,977    12,830    
Less: accumulated depreciation   (7,914)   (6,883)   
Total property, plant and equipment, net  $6,063   $5,947    

 

Depreciation expense incurred for the three months ended September 30, 2022 and 2021 was $540,000 and $481,000, respectively. Depreciation expense incurred for the nine months ended September 30, 2022 and 2021 was $1,637,000 and $1,381,000, respectively.

 

19
 

 

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

Note 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).

 

The September 2020 Note that remains outstanding as of September 30, 2022 is due and payable on September 15, 2023 and accrues interest at a rate of 10% per year from the closing date, payable on a quarterly basis, until the September 2020 Note is repaid in full. We have the right to prepay the outstanding September 2020 Note at any time after the 13-month anniversary of the initial issuance date after providing written notice to the Lender and may prepay the September 2020 Note prior to such time with the consent of the Lender. The Lender has the right, at any time, and from time to time, on and after the 13-month anniversary of the initial issuance date to convert up to an aggregate of $3.0 million of the September 2020 Note into common stock of the Company at a conversion price of $3.00 per share. Repayment of the September 2020 Note has been guaranteed by our wholly owned subsidiary, PMI.

 

The September 2020 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 September 2020 Note may be accelerated. The September 2020 Note 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 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 Lender.

 

For the three months ended September 30, 2022 and 2021, we incurred $200,000 and $251,000, respectively, in interest expense related to the September 2020 Notes. For the nine months ended September 30, 2022 and 2021, we incurred $635,000 and $753,000, respectively, in interest expense related to the September 2020 Notes.

 

Note 7 - Stockholders’ Equity

 

Our authorized capital stock consists of 50 million shares of common stock, $0.0005 par value, and one million shares of preferred stock, $0.0005 par 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 September 30, 2022 and December 31, 2021, no shares of preferred stock have been issued.

 

Common Stock Dividends

 

On February 14, 2022, the board of directors of the Company declared a special cash dividend of $0.30 per 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 March 1, 2022.

 

On May 9, 2022, the board of directors of the Company declared a special cash dividend of $0.30 per share on the Company’s common stock, paid on June 4, 2022, in the amount of $4.7 million to holders of record of the Company’s common stock as of May 25, 2022.

 

20
 

 

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

Note 7 - Stockholders’ Equity (continued)

 

Common Stock

 

Stock Repurchase Program

 

On September 8, 2021, the Company’s board of directors 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 nine months ended September 30, 2022, the Company did not make any common shares repurchases under the stock repurchase program. The stock repurchase program expired on March 30, 2022.

 

On July 24, 2022, the Company’s board of directors authorized a new stock repurchase program of up to $6 million of shares of the Company’s common stock, which became effective August 17, 2022 (the “Commencement Date”). There were 5,048 shares repurchased under this new program during the three and nine months ended September 30, 2022.

 

Following the Commencement Date, and for a period of six months thereafter, repurchases may be made through open market transactions (based on prevailing market prices), privately negotiated transactions, block trades, or any combination thereof, in accordance with applicable federal securities laws, including Rule 10b-18 of the Securities Exchange Act of 1934, as amended. The number of shares to be repurchased and the timing of the repurchases, if any, will depend on a number of factors, including, but not limited to, price, trading volume and general market conditions, along with the Company’s working capital requirements and general business conditions. The board of directors of the Company will re-evaluate the program from time to time, and may authorize adjustments to its terms. The Company expects to utilize its existing funds to fund any repurchases under the repurchase program.

 

The 2022 Directors’ Equity Compensation Plan

 

On May 19, 2022, the stockholders of the Company approved the 2022 Directors’ Equity Compensation Plan (the “2022 Directors’ Plan”) at the 2022 Annual Meeting of Stockholders of the Company (the “2022 Annual Meeting”). The 2022 Directors’ Plan amended and restated the Company’s Amended and Restated 2010 Directors’ Equity Compensation Plan and provides for an increase in the number of shares reserved for issuance under the plan by 300,000 shares and provides for the adjustment of the per share exercise price of stock options granted under the 2022 Plan in the event of any change in the outstanding shares of common stock of the Company as a result of, among other things, any distribution or special dividend to stockholders of shares, cash or other property (other than regular cash dividends).

 

As of September 30, 2022, there were 120,000 stock options outstanding and there were 180,000 shares of common stock available to be issued under the 2022 Directors’ Plan.

 

The 2022 Equity Compensation Plan

 

On May 19, 2022, the stockholders of the Company approved the 2022 Equity Compensation Plan (the “2022 Plan”) at the 2022 Annual Meeting. The 2022 Plan amended and restated the Company’s Amended and Restated 2010 Equity Compensation Plan and provides for an increase in the number of shares reserved for issuance under the plan by 1,000,000 shares and provides for the adjustment of the per share exercise price of stock options granted under the 2022 Plan in the event of any change in the outstanding shares of common stock of the Company as a result of, among other things, any distribution or special dividend to stockholders of shares, cash or other property (other than regular cash dividends).

 

As of September 30, 2022, there were 3,797,000 stock options outstanding and 1,130,785 shares of common stock available to be issued under the 2022 Plan.

 

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 2,300,000 shares have been granted in the form of stock options to Ted Karkus (the “CEO Option”), our Chief Executive Officer. During the nine months ended September 30, 2022, 600,000 stock options were exercised under the 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, has adjusted the exercise price of the CEO Option in connection with each special cash dividend paid by the Company proportionately to the amount of the dividend paid. The current exercise price of the CEO Option is $0.60 per share after the latest special cash dividend paid on June 3, 2022.

 

21
 

 

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

Note 7 – Stockholders’ Equity (continued):

 

Inducement Option Award

 

As part of Nebula Acquisition, the Company issued a non-qualified stock option to the Chief Executive Officer of Nebula (the “Nebula CEO”, as an inducement to his employment with the Company (the “2021 Inducement Award”). The 2021 Inducement Award entitles the Nebula CEO 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 2021 Inducement Award was granted to the Nebula CEO on the closing date of the Nebula Acquisition. The 2021 Inducement Award vested 25% on the grant date and will vest 25% per year for the next three years subject to the Nebula CEO’s continued employment with the Company. The 2021 Inducement Award expires on the seventh anniversary of the grant date. Any portion of the 2021 Inducement Award that does not vest and become exercisable will be forfeited for no consideration. The grant date fair value of the 2021 Inducement Award was approximately $1,128,000.

 

Also, during the year ended December 31, 2021, we issued an inducement award to a prospective 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.

 

On May 9, 2022, the Company issued a non-qualified stock option to the Chief Financial Officer of the Company (the “CFO”), as an inducement to his employment with the Company, effective May 23, 2022 (the “2022 Inducement Award”). The 2022 Inducement Award entitled the CFO of the Company to purchase up to 400,000 shares of the Company’s common stock (the “CFO Option”) at an exercise price of $6.74 per share, the closing price of the Company’s common stock on May 9, 2022. The CFO Option provided for certain proportionate adjustments to be made in the event of any change in the outstanding shares of common stock of the Company as a result of, among other things, any distribution or special dividend to stockholders of shares, cash or other property (other than regular cash dividends) in order to maintain parity. The exercise price of the CFO Option was reduced from $6.74 to $6.44 per share, effective as of June 3, 2022, the date $0.30 special cash dividend was paid to Company’s stockholders. The grant date fair value of the Inducement Award was approximately $1,604,000. In connection with CFO’s separation from service on October 4, 2022, these options were forfeited on October 4, 2022 (see Note 18).

 

During the three and nine months ended September 30, 2022, we also issued an inducement award to a prospective employee to purchase up to 250,000 shares of the Company’s common stock at an exercise price of $13.00, the closing price of the common stock on the date of grant. The award vested 50 shares on the date of grant and the remaining portion will vest 25% per year for the next two years. 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.

 

During the nine months ended September 30, 2022, the Company issued options to purchase 935,000 shares of the Company’s common stock to various employees and consultants. The options were valued at $5,638,000 fair value, using the Black-Scholes option pricing model to calculate the grant-date fair value of the options. The fair value of stock options for employees are expensed over the vesting term in accordance with the terms of the related stock option agreements and are expensed over the terms of the consulting agreement for consultants.

 

The following table summarizes stock option activity during the nine months ended September 30, 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 (1)

 
Outstanding as of January 1, 2022   5,110   $3.27    3.4   $20,820 
Granted   935    9.60    6.6    - 
Cashless exercised   (1,233)   1.91    -    - 
Forfeited   (20)   2.02    -    - 
Outstanding as of September 30, 2022   4,792   $4.55    3.7   $32,899 
Options vested and exercisable   3,280   $3.18    2.6   $26,819 

 

(1)

The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the closing stock price of $11.28 for the Company’s common stock on September 30, 2022.

 

The following table summarizes weighted average assumptions used in determining the fair value of the options at the date of grant during the nine months ended September 30, 2022 and 2021:

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

   For the nine months ended 
   September 30, 
   2022   2021 
Exercise price  $9.73   $7.48 
Expected term (years)   4.5    3.9 
Expected stock price volatility   79%   80%
Risk-free rate of interest   2.3%   0.7%
Expected dividend yield (per share)   0%   0%

 

22
 

 

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

Note 7 – Stockholders’ Equity (continued):

 

During the nine months ended September 30, 2022 certain holders of stock options elected to exercise their stock options pursuant to a cashless exercise provision resulting in the net issuance of 545,312 shares of common stock and the return of 692,736 shares to the Company. The Company also made a cash payment of approximately $4.5 million to repurchase 283,395 shares of treasury stock to satisfy tax withholding obligations related to the cashless exercise of these stock options.

 

Stock Warrants

 

The following table summarizes warrant activity during the nine months ended September 30, 2022 (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, 2022   855   $8.23    1.9 
Warrants granted   -    -    - 
Outstanding as of September 30, 2022   855   $8.23    1.1 
Warrants vested and exercisable   855   $8.23    1.1 

 

We recognized $1,969,000 and $59,000 of share-based compensation expense during the three months ended September 30, 2022 and 2021, respectively. We recognized $2,976,000 and $252,000 of share-based compensation expense during the nine months ended September 30, 2022 and 2021, respectively. We will recognize an aggregate of approximately $5,907,000 of remaining share-based compensation expense related to outstanding stock options over a weighted average period of 3.9 years.

 

Note 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 months ended September 30, 2022 and 2021 were $53,000 and $34,000, respectively. Our contributions to the plan in the nine months ended September 30, 2022 and 2021 were $153,000 and $69,000, respectively.

 

23
 

 

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

Note 9 – Income Taxes

 

We recognize tax assets and liabilities for 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 September 30, 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 September 30, 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 nine months ended September 30, 2022 is 25.57% and it is primarily driven by federal tax at 21%, state taxes at 10.71%, and a decrease in the valuation allowance for federal and combined states jurisdictions. The total tax expense for the nine months ended September 30, 2022 is $7.2 million and it mostly relates to current federal and combined state taxes.

 

Note 10 – Other Current Liabilities

 

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

 Schedule of Other Current Liabilities

   September, 30 2022   December 31, 2021 
Accrued commissions  $2,448   $1,283 
Accrued payroll   59    514 
Accrued expenses   328    300 
Accrued returns   311    338 
Accrued benefits and vacation   49    60 
Total other current liabilities  $3,195   $2,495 

 

Note 11 – Commitments and Contingencies

 

Manufacturing Agreement

 

The Company and its wholly owned subsidiary, PMI, entered into a manufacturing agreement (the “Manufacturing Agreement”) with Mylan Consumer Healthcare Inc. (formerly known as Meda Consumer Healthcare Inc.) (“MCH”) and Mylan Inc. (together with MCH, “Mylan” in connection with the asset purchase agreement we entered into with 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, 2023. Thereafter, the Manufacturing Agreement may be renewed by Nurya for up to four 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.

 

License Agreement

 

On July 19, 2022, the Company through its wholly-owned subsidiary ProPhase BioPharma entered into a License Agreement (the “License Agreement”) with Global BioLife, Inc. (the “Licensor”), with an effective date of July 18, 2022 (the “Linebacker Effective Date”), pursuant to which it acquired from Licensor a worldwide exclusive right and license under certain patents identified in the License Agreement (the “Licensed Patents”) and know-how (collectively, the “Licensed IP”) to exploit any compound covered by the Licensed Patents (the “Licensed Compound”), including Linebacker LB1 and LB2, and any product comprising or containing a Licensed Compound (“Licensed Products”) in the treatment of cancer, inflammatory diseases or symptoms, memory-related syndromes, diseases or symptoms including dementia and Alzheimer’s Disease (the “Field”). Under the terms of the License Agreement, the Licensor reserves the right, solely for itself and for GRDG Sciences, LLC (“GRDG”) to use the Licensed Compound and Licensed IP solely for research purposes inside the Field and for any purpose outside the Field.

 

Subject to certain conditions set forth in the License Agreement, the Company may grant sublicenses (including the right to grant further sublicenses) to its rights under the License Agreement to any of its affiliates or any third party with the prior written consent of Licensor, which consent may not be unreasonably withheld. Either party to the License Agreement may assign its rights under the License Agreement (i) in connection with the sale or transfer of all or substantially all of its assets to a third party, (b) in the event of a merger or consolidation with a third party or (iii) to an affiliate; in each case contingent upon the assignee assuming in writing all of the obligations of its assignor under the License Agreement.

 

24
 

 

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

Under the terms of License Agreement, the Company is required to pay to Licensor a one-time upfront license fee of $50,000 within 10 days of the Linebacker Effective Date and must pay an additional $900,000 following the achievement of a first Phase 3 study which may be required by FDA for the first Licensed Product and an additional $1 million upon the receipt of regulatory approval of a New Drug Application (NDA) for the first Licensed Product.

 

During the term of the License Agreement, the Company is also required to pay to Licensor 3% royalties on Net Revenue (as defined in the License Agreement) of each Licensed Product, but no less than the minimum royalty of $250,000 of Net Revenue per year minus any royalty payments for any required third party licenses.

 

Under the terms of the License Agreement, the development of the Licensed Compound and the first Licensed Product for the United States will be governed by a clinical development plan, including anticipated timeline goals in connection with the clinical trials for the first Licensed Product (the “Development Plan”). The Development Plan may be amended by the mutual written agreement of the parties to the License Agreement based upon results of preclinical studies or clinical trials, including safety and effectiveness, guidance by the FDA, or upon the agreement of the parties.

 

The License Agreement will expire automatically on a country-by-country basis upon the last to occur of the expiration of the last to expire Licensed Patents (the “Term”). Following the expiration of the Term, and on a country-by-country basis, the License will become non-exclusive, perpetual, fully-paid, unrestricted, royalty-free and irrevocable.

 

The License Agreement may be terminated by ProPhase BioPharma for any reason or for convenience in its sole discretion: (i) on a Licensed Product-by-Licensed Product or a country-by-country basis or (ii) in its entirety, in either case ((i) or (ii)) for convenience upon 180 days prior written notice to Lessor. Lessor may terminate the License Agreement solely for a material breach of the License Agreement by ProPhase BioPharma, which is not cured within 60 days’ of written notice to ProPhase BioPharma of such breach.

 

In connection with the License Agreement, the Company has incurred approximately $15,000 in general and administrative expenses that are included in the Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) for the three and nine months ended September 30, 2022. No clinical studies have begun under this agreement.

 

Future Obligations

 

We have estimated future minimum obligations for an executive’s employment agreement over the next five years as of September 30, 2022, as follows (in thousands):

 Schedule of Estimated Future Minimum Obligations

   Employment 
   Contracts 
Remaining periods in 2022  $256 
2023   1,025 
2024   1,025 
2025   1,025 
2026   1,025 
Total  $4,356 

 

Litigation

 

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 settlement where management deems it appropriate.

 

Note 12 – Leases

 

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

 

New York Second Floor Lease

 

On December 8, 2020, the Company entered into a Lease Agreement (the “NY Second Floor Lease”) with BRG Office L.L.C. and Unit 2 Associates L.L.C. (the “Landlord”), pursuant to which the Company leases certain premises located on the second floor (the “Second Floor Leased Premises”) of 711 Stewart Avenue, Garden City, New York (the “Building”). The Second Floor Leased Premises serve as the Company’s second 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.

 

25
 

 

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

New York Second Floor Lease (continued)

 

The NY Second Floor Lease was effective as of December 8, 2020, and commenced in January 2021 (the “Second Floor Commencement Date”) when the facility was made available to us by the landlord. The initial term of the NY Second Floor Lease is 10 years and seven months (the “Second Floor Initial Term”), unless sooner terminated as provided in the NY Second Floor Lease. We may extend the term of the NY Second Floor Lease for one additional option period of five years. We have the option to terminate the NY Second Floor Lease on the sixth anniversary of the Second Floor Commencement Date, provided that we give the landlord advance written notice of not less than nine months and not more than 12 months in advance and that we pay the landlord a termination fee.

 

For the first year of the NY Second Floor Lease, we paid a base rent of $56,963 per month (subject to a seven-month abatement period), with a gradual rental rate increase of 2.75% for each 12-month period thereafter in lieu of paying its proportionate share of common area operating expenses, culminating in a monthly base rent of $74,716 during the final months of the Second Floor Initial Term. In addition to the monthly base rent, we are responsible for our proportionate share of real estate tax escalations in accordance with the terms of the NY Second Floor 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 NY Second Floor Lease. We also have a right of first offer to purchase the Building during the term of the NY Second Floor Lease.

 

On June 10, 2022, we entered into a First Amendment to the NY Second Floor Lease (the “Second Floor Lease Amendment”). The Second Floor Lease Amendment amends the NY Second Floor Lease to provide that any uncured default by the Company or any of its affiliate under the NY First Floor Lease (defined below) will constitute a default by the Company under the NY Second Floor Lease.

 

New York First Floor Lease

 

On June 10, 2022, the Company entered into a second Lease Agreement (the “NY First Floor Lease”) with Landlord, pursuant to which the Company leases approximately 4,516 sq. feet located on the first floor (the “NY First Floor Leased Premises”) of the Building. As described above, the Company currently leases space on the second floor of the Building. The First Floor Leased Premises will be used to expand the Company’s in-house lab capabilities to include traditional clinical testing across multiple specialty areas and Next Generation Sequencing (NGS) to perform Whole Genome Sequencing (WGS) and an array of genetic diagnostic test offerings for both clinical and research purposes.

 

The NY First Floor Lease became effective as of June 10, 2022 and will commence upon the date of the Landlord’s substantial completion of certain improvements to the NY First Floor Leased Premises  (the “First Floor Commencement Date”), as set forth in the NY First Floor Lease, targeted to be approximately five months from the execution of the NY First Floor Lease. The initial term of the NY First Floor Lease will expire on July 15, 2031, unless sooner terminated as provided in the NY First Floor Lease. The Company may extend the term of the NY First Floor Lease for one additional option period of five years pursuant to the terms described in the NY First Floor Lease. The Company has the option to terminate the NY First Floor Lease effective July 31, 2027 (the “Early Termination Date”), provided the Company gives the Landlord written notice not less than nine months and not more than 12 months prior to the Early Termination Date and pays the Landlord a termination fee as more particularly described in the Lease.

 

For the first year of the NY First Floor Lease, the Company will pay   a base rent of $11,290 per month (subject to an eight month abatement period), with a gradual rental rate increase of approximately 2.75% for each 12 month period thereafter, culminating in a monthly base rent of $14,026 during the final months of the initial term of the NY First Floor Lease. In addition to the monthly base rent, the Company is responsible for its proportionate share of real estate tax escalations in accordance with the terms of the NY First Floor Lease. The Landlord will provide a construction allowance to the Company in an aggregate amount not to exceed $203,220, to reimburse the Company for the cost of certain improvements to be made by the Company to the First Floor Leased Premises.

 

At September 30, 2022, we had operating lease liabilities for the New York and New Jersey leases of approximately $4.6 million and right of use assets of approximately $4.1 million, 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 three months ended   For the nine months ended 
   September 30, 2022   September 30, 2021   September 30, 2022   September 30, 2021 
Operating leases                    
Operating lease cost  $204   $204   $612   $611 
Operating lease expense   204    204    612    611 
Total rent expense  $204   $204   $612   $611 

 

           
   For the nine months ended 
   September 30, 2022   September 30, 2021 
Operating cash flows used in operating leases  $(580)  $(168)
Weighted-average remaining lease term – operating leases (in years)   8.8    9.7 
Weighted-average discount rate – operating leases   10.00%   10.00%

 

26
 

 

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 (in thousands):

Schedule of Maturity of Operating Leases 

      
Remaining periods in the year ended December 31, 2022  $193 
Year Ended December 31, 2023   739 
Year Ended December 31, 2024   747 
Year Ended December 31, 2025   768 
Year Ended December 31, 2026   783 
Thereafter   3,876 
Total   7,106 
Less present value discount   (2,468)
Operating lease liabilities  $4,638 

 

Note 13 – Consulting Agreement and Secured Promissory Note Receivable

 

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”), pursuant to which we loaned $3.0 million to the Consultant (inclusive of $1.0 million in the aggregate previously loaned to the 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 $750,000 to the Consultant 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 $250,000 to the Consultant.

 

Commencing after September 1, 2021, in addition to payments of interest, the Consultant is also required to make payments on the principal amount of the loan equal to 1/36 of the then outstanding principal amount.

 

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, was due and payable on September 30, 2022. As discussed in Amendment and Termination Agreement below, the Company issued a Notice of Default to the Consultant on October 11, 2021.

 

Amendment and Termination Agreement

 

On January 14, 2021, we entered into an Amendment and Termination Agreement (the “Termination Agreement”) with the Consultant pursuant to which the parties amended the Secured Note and terminated the former consulting agreement with the Consultant (the “Consulting Agreement”). Pursuant to the terms of the Termination Agreement, the Company loaned an additional $1 million to the Consultant in consideration for the termination of the Consulting Agreement and termination of the Company’s obligation to pay any additional consulting 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 Consultant 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, the Consultant will pay us a specified amount (the “Test Fee”). We received the first payment in the amount of $95,000 with respect to the Test Fees from January 15 through February 2021. On June 25, 2021, we were issued 1,260,619 shares of common stock of the Consultant with a fair value of $315,000 as an interest payment under the Secured Note in lieu of Test Fees from March through June 2021.

 

Effective September 1, 2021, in addition to the payment of the Test Fees described above, the Consultant 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. The Company did not receive any payments from the Consultant for either contractual principal or interest.

 

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.

 

27
 

 

ProPhase Labs, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

Note 14 - Significant Customer Concentrations

 

Revenue for the three months ended September 30, 2022 and 2021 was $24.2 million and $9.5 million, respectively. One diagnostic services client accounted for 73.8% of our revenue for the three months ended September 30, 2022. Three diagnostic services clients accounted for 19.6%, 12.0% and 10.4% of our revenue for the three months ended September 30, 2021. No contract manufacturing customer’s accounted for a significant portion of our revenue for the three months ended September 30, 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.

 

Revenue for the nine months ended September 30, 2022 and 2021 was $100.8 million and $33.9 million, respectively. Two diagnostic services clients accounted for 54.8%, and 13.0% of our revenue for the nine months ended September 30, 2022. Two diagnostic services clients accounted for 28.4% and 20.7% of our revenue for the nine months ended September 30, 2021. No contract manufacturing customer’s accounted for a significant portion of our revenue for the nine months ended September 30, 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.

 

One diagnostic services payer comprised 70.3% of our total reimbursement receivable balances from government agencies and healthcare issuers at September 30, 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 15 - Segment Information

 

The Company has identified two 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 and also provides personal genomics products and services. The unallocated corporate expenses mainly included professional fees associated with the public company.

 

The following table is a summary of segment information for three and nine months ended September 30, 2022 and 2021 (amounts in thousands):

 Schedule of Segment Information

                     
   For the three months ended   For the nine months ended 
   September 30, 2022   September 30, 2021   September 30, 2022   September 30, 2021 
Net revenues                    
Diagnostic services  $20,541   $7,142   $91,613   $27,416 
Consumer products   3,659    2,330    9,211    6,469 
Consolidated net revenue   24,200    9,472    100,824    33,885 
Cost of revenue                    
Diagnostic services   8,452    4,009    33,558    11,833 
Consumer products   3,775    1,486    7,895    4,682 
Consolidated cost of revenue   12,227    5,495    41,453    16,515 
Depreciation and amortization expense                    
Diagnostic services   584    401    1,755    1,138 
Consumer products   435    -    1,637    6 
Total Depreciation and amortization expense   1,019    401    3,392    1,144 
Operating and other expenses   9,176    13,020    27,882    20,542 
Income (loss) from operations, before income taxes                    
Diagnostic services   6,776    (1,145)   39,671    2,859 
Consumer products   (3,214)   (958)   (5,390)   (