UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

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

 

For the quarterly period ended June 30, 20192020

 

OR

 

o 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:

0-22923

 

INTERNATIONAL ISOTOPES INC.

(Exact name of registrant as specified in its charter)

 

Texas 74-2763837

(State or other jurisdiction of

incorporation or organization)

 (IRS Employer Identification No.)

  

4137 Commerce Circle

Idaho Falls, Idaho, 83401

(Address of principal executive offices, including zip code)

 

(208) 524-5300

(Registrant’s telephone number, including area code)

 

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

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.ý Yes¨ No

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).ý Yes¨ No

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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 companyý
 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 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).¨ Yesý No

As of August 9, 2019,14, 2020, the number of shares of common stock, $0.01 par value, outstanding was 419,805,440.423,855,991.

 

 

 

 

INTERNATIONAL ISOTOPES INC.

Form 10-Q

For The Quarter Ended June 30, 20192020

 

TABLE OF CONTENTS

 

  Page No.
PART I – FINANCIAL INFORMATION 
   
Item 1.Financial Statements 
 Unaudited Condensed Consolidated Balance Sheets at June 30, 20192020 and December 31, 201820193
 Unaudited Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 20192020 and 201820194
 Unaudited Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 20192020 and 201820195
 Unaudited Statement of Stockholder’s Equity for the Three and Six Months Ended June 30, 20192020 and 201820196
 Notes to Unaudited Condensed Consolidated Financial Statements7
Item 2.Management's Discussion and Analysis of Financial Condition and Results of Operations18
Item 4.Controls and Procedures2530
   
PART II – OTHER INFORMATION 
   
Item 1.Legal Proceedings2630
Item 1A.Risk Factors2631
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds2631
Item 6.Exhibits2731
Signatures2832

 

 

 

 

 

Part I. Financial Information

Item I. Financial Statements

 

INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(unaudited)

  June 30,  December 31, 
  2019  2018 
Assets (unaudited)    
Current assets        
Cash and cash equivalents $443,310  $828,039 
Accounts receivable  1,402,893   820,370 
Inventories  3,219,941   2,765,729 
Prepaids and other current assets  310,620   315,042 
Total current assets  5,376,764   4,729,180 
         
Long-term assets        
Restricted cash  629,446   622,428 
Property, plant and equipment, net  1,876,602   1,906,182 
Operating lease right-of-use asset  758,666   —   
Goodwill  1,384,255   1,384,255 
Patents and other intangibles, net  4,272,043   4,348,031 
Total long-term assets  8,921,012   8,260,896 
Total assets $14,297,776  $12,990,076 
         
Liabilities and Stockholders' Equity (Deficit)        
Current liabilities        
Accounts payable $3,882,312  $2,285,165 
Accrued liabilities  803,210   939,918 
Current portion of unearned revenue  1,561,458   3,783,541 
Current portion of operating lease right-of-use liability  99,236   —   
Current portion of related party notes payable  120,000   180,000 
Current installments of notes payable  1,933,415   7,956 
Total current liabilities  8,399,631   7,196,580 
         
Long-term liabilities        
Obligation for lease disposal costs  526,915   507,968 
Unearned revenue, net of current portion  7,500   7,500 
Related party notes payable, net of current portion and debt discount  459,767   446,356 
Notes payable, net of current portion  16,602   20,786 
Operating lease right-of-use liability, net of current portion  659,430   —   
Mandatorily redeemable convertible preferred stock, net of discount  4,720,919   4,656,752 
Total long-term liabilities  6,391,133   5,639,362 
Total liabilities  14,790,764   12,835,942 
         
Commitments and contingencies (Note 8)  —     —   
         
Stockholders' equity (deficit)        
Common stock, $0.01 par value; 750,000,000 shares authorized; 419,774,105 and 413,168,301 shares issued and outstanding respectively  4,197,741   4,131,683 
Additional paid in capital  121,125,897   120,805,997 
Accumulated deficit  (127,750,572)  (126,541,421)
Deficit attributable to International Isotopes Inc. stockholders  (2,426,934)  (1,603,741)
Equity attributable to noncontrolling interest  1,933,946   1,757,875 
Total equity (deficit)  (492,988)  154,134 
Total liabilities and stockholders' equity (deficit) $14,297,776  $12,990,076 

  June 30,  December 31, 
  2020  2019 
Assets      
Current assets        
Cash and cash equivalents $831,359  $575,422 
Accounts receivable  1,301,248   875,914 
Inventories  1,298,668   3,423,420 
Prepaids and other current assets  787,577   1,444,593 
Total current assets  4,218,852   6,319,349 
         
Long-term assets        
Restricted cash  638,562   635,498 
Property, plant and equipment, net  1,938,332   2,003,887 
Financing lease right-of-use asset  27,647   13,302 
Operating lease right-of-use asset  2,596,983   709,883 
Goodwill  1,384,255   1,384,255 
Patents and other intangibles, net  4,108,951   4,190,621 
Total long-term assets  10,694,730   8,937,446 
Total assets $14,913,582  $15,256,795 
         
Liabilities and Stockholders' Equity (Deficit)        
Current liabilities        
Accounts payable $2,195,665  $4,229,128 
Accrued liabilities  1,007,884   1,096,090 
Unearned revenue  1,375,948   1,240,205 
Current portion of operating lease right-of-use liability  83,098   100,777 
Current portion of financing lease liability  7,434   2,367 
Current installments of notes payable  1,002,260   1,519,496 
Total current liabilities  5,672,289   8,188,063 
         
Long-term liabilities        
Obligation for lease disposal costs  566,957   546,570 
Related party notes payable, net of debt discount  959,221   1,216,874 
Notes payable, net of current portion  7,801   12,276 
Financing lease liability, net of current portion  20,871   10,970 
Operating lease right-of-use liability, net of current portion  2,528,334   609,106 
Mandatorily redeemable convertible preferred stock, net of discount  4,849,254   4,785,086 
Total long-term liabilities  8,932,438   7,180,882 
Total liabilities  14,604,727   15,368,945 
         
Commitments and contingencies (Note 8)        
         
Stockholders' (deficit) equity        
Common stock, $0.01 par value; 750,000,000 shares authorized; 423,794,088 and 419,842,256 shares issued and outstanding respectively  4,237,941   4,198,423 
Additional paid in capital  122,171,489   121,680,163 
Accumulated deficit  (128,257,551)  (128,064,385)
Deficit attributable to International Isotopes Inc. stockholders  (1,848,121)  (2,185,799)
Equity attributable to noncontrolling interest  2,156,976   2,073,649 
Total equity (deficit)  308,855   (112,150)
Total liabilities and stockholders' equity (deficit) $14,913,582  $15,256,795 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

 

 

INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

Unaudited Condensed Consolidated Statements of Operations

 

  Three months ended June 30,  Six months ended June 30, 
  2019  2018  2019  2018 
             
Sale of product $2,135,839  $2,392,306  $4,663,691  $5,193,332 
Cost of product  971,384   1,363,564   2,059,812   2,805,972 
Gross profit  1,164,455   1,028,742   2,603,879   2,387,360 
                 
Operating costs and expenses                
Salaries and contract labor  596,045   561,058   1,219,744   1,130,517 
General, administrative and consulting  600,580   582,614   1,227,443   1,115,748 
Research and development  50,354   84,464   96,658   190,884 
Total operating expenses  1,246,979   1,228,136   2,543,845   2,437,149 
                 
Net operating (loss) income  (82,524)  (199,394)  60,034   (49,789)
                 
Other income (expense):                
Other (expense) income  (867,660)  (381)  (843,028)  52,981 
Interest income  3,611   2,317   7,033   3,624 
Interest expense  (136,842)  (115,882)  (250,919)  (221,916)
Total other expense  (1,000,891)  (113,946)  (1,086,914)  (165,311)
Net loss  (1,083,415)  (313,340)  (1,026,880)  (215,100)
Less income attributable to noncontrolling interest  73,779   18,939   182,271   82,775 
                 
Net loss attributable to International Isotopes Inc. $(1,157,194) $(332,279) $(1,209,151) $(297,875)
                 
Net income (loss) per common share - basic: $—    $—    $—    $—   
                 
Net income (loss) per common share - diluted: $—    $—    $—    $—   
                 
Weighted average common shares outstanding - basic and diluted:  419,230,535   411,232,012   416,568,617   409,327,531 

  Three months ended June 30,  Six months ended June 30, 
  2020  2019  2020  2019 
             
Sale of product $2,159,559  $2,135,839  $4,495,345  $4,663,691 
Cost of product  903,909   971,384   1,872,434   2,059,812 
Gross profit  1,255,650   1,164,455   2,622,911   2,603,879 
                 
Operating costs and expenses                
Salaries and contract labor  736,539   596,045   1,477,744   1,219,744 
General, administrative and consulting  573,747   600,580   1,362,185   1,227,443 
Research and development  41,465   50,354   88,393   96,658 
Total operating expenses  1,351,751   1,246,979   2,928,322   2,543,845 
Net operating (loss) income  (96,101)  (82,524)  (305,411)  60,034 
                 
Other income (expense):                
Other income  559,895   (867,660)  583,713   (843,028)
Interest income  748   3,611   3,083   7,033 
Interest expense  (196,344)  (136,842)  (391,224)  (250,919)
Total other income (expense)  364,299   (1,000,891)  195,572   (1,086,914)
Net (loss) income  268,198   (1,083,415)  (109,839)  (1,026,880)
Less income attributable to noncontrolling interest  38,870   73,779   83,327   182,271 
Net income (loss) attributable to International Isotopes Inc. $229,328  $(1,157,194) $(193,166) $(1,209,151)
                 
Net income (loss) per common share - basic: $—    $—    $—    $—   
Net income (loss) per common share - diluted: $—    $—    $—    $—   
                 
Weighted average common shares outstanding - basic:  423,751,657   419,230,535   422,211,840   416,568,617 
Weighted average common shares outstanding - diluted:  432,629,537   419,230,535   422,211,840   416,568,617 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

 

 

 

 

INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

Unaudited Condensed Consolidated Statements of Cash Flows

 

 Six months ended June 30,  Six months ended June 30, 
 2019  2018  2020  2019 
Cash flows from operating activities                
Net Loss $(1,026,880) $(215,100)
Adjustments to reconcile net loss to net cash used in operating activities        
Net loss $(109,839) $(1,026,880)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities        
Depreciation and amortization  130,445   136,086   150,969   130,445 
Gain on disposal of property, plant and equipment  (1,700)  —   
Accretion of obligation for lease disposal costs  18,947   11,277   20,387   18,947 
Accretion of beneficial conversion feature and discount  77,578   77,579   191,933   77,578 
Equity based compensation  92,540   125,133   68,531   92,540 
Gain on sale of property, plant and equipment  —     (1,700)
Right-of-use asset amortization  14,448   —   
Forgiveness of Paycheck Protection Program Loan  (495,500)    
Changes in operating assets and liabilities:                
Accounts receivable  (582,523)  (269,663)  (425,334)  (582,523)
Inventories  (454,212)  (709,324)  992,742   (454,212)
Prepaids and other current assets  4,422   238,431   657,016   4,422 
Accounts payable and accrued liabilities  1,666,419   320,689   (785,178)  1,666,419 
Unearned revenues  (39,941)  (43,134)  135,743   (39,941)
Net cash used in operating activities  (114,905)  (328,026)
Net cash provided by (used in) operating activities  415,918   (114,905)
                
Cash flows from investing activities:                
Proceeds from sale of property, plant and equipment  1,700   —     —     1,700 
Purchase of property, plant and equipment  (24,877)  (62,976)  (1,565)  (24,877)
Net cash used in investing activities  (23,177)  (62,976)  (1,565)  (23,177)
                
Cash flows from financing activities:                
Proceeds from sale of stock and exercise of stock options  87,438   73,304 
Distribution to non-controlling interest  (6,200)  —   
Proceeds from issuance of related party notes payable  —     120,000 
Proceeds from sale of stock and exercise of options  10,273   87,438 
Payments on financing lease  (1,556)  —   
Distributions to non-controlling interest  —     (6,200)
Proceeds from issuance of notes payable  871,100   —   
Principal payments on notes payable  (320,867)  (3,656)  (1,035,169)  (320,867)
Net cash (used in) provided by financing activities  (239,629)  189,648 
Net cash used in financing activities  (155,352)  (239,629)
                
Net decrease in cash, cash equivalents, and restricted cash  (377,711)  (201,354)
Net increase (decrease) in cash, cash equivalents, and restricted cash  259,001   (377,711)
Cash, cash equivalents, and restricted cash at beginning of period  1,450,467   1,250,368   1,210,920   1,450,467 
Cash, cash equivalents, and restricted cash at end of period $1,072,756  $1,049,014  $1,469,921  $1,072,756 
                
Supplemental disclosure of cash flow activities:                
Cash paid for interest $86,388  $37,749  $65,536  $86,388 
                
Supplemental disclosure of noncash financing and investing transactions:        
Supplemental disclosure of noncash financing and investing transactions        
Decrease in accrued interest and increase in equity for conversion of dividends to stock $205,980  $205,980  $204,480  $205,980 
Decrease in unearned revnue and increase in notes payable for repayment plan $2,182,142  $—   
        
Reconciliation of cash, cash equivalents, and restricted cash as shown in the condensed consolidated statements of cash flows is presented in the table below:        
        
Six months ended June 30,  2019   2018 
Cash and cash equivalents $443,310  $412,385 
Restricted cash included in current assets  —     20,000 
Restricted cash included in long-term assets  629,446   616,629 
Total cash, cash equivalents, and restricted cash shown in statement of cash flows $1,072,756  $1,049,014 
Increase in operating lease right-of-use asset and right-of-use liability for new lease $2,649,070  $—   
Decrease in operating lease right-of-use asset and right-of-use liability for disposal of old lease $697,009  $—   
Increase in financing lease right-of-use asset and right-of-use liability for new lease $16,524  $—   
Decrease in inventory and decrease in accounts payable for cancellation of DOE contract $1,132,010  $—   
Decrease in related party notes payable and increase in equity for amounts allocated to warrants and beneficial conversion feature $247,560  $—   
Decrease in unearned revenue and increase in notes payable for repayment plan $—    $2,182,142 

Reconciliation of cash, cash equivalents, and restricted cash as shown in the condensed consolidated statements of cash flows is presented in the table below:

  June 30,  June 30, 
  2020  2019 
Cash and cash equivalents $831,359  $443,310 
Restricted cash included in long-term assets  638,562   629,446 
Total cash, cash equivalents, and restricted cash shown in statement of cash flows $1,469,921  $1,072,756 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

 

 

INTERNATIONAL ISOTOPES INCINC. AND SUBSIDIARIES

Reconciliation of Stockholders' (Deficit) Equity

Three and Six Months Ended June 30, 2020

(Unaudited)

             Deficit  Equity    
             Attributable  Attributable    
 Common stock        to  to    
       Additional     Internat'l  Non-  Total 
 Shares  Common  Paid-in  Accumulated  Isotopes  controlling  (Deficit) 
 Outstanding  Stock  Capital  Deficit  Shareholders  Interest  Equity 
Balance, January 1, 2020 419,842,256  $4,198,423  $121,680,163  $(128,064,385) $(2,185,799) $2,073,649  $(112,150)
Shares issued under employee stock purchase plan 241,707   2,417   7,856   —     10,273   —     10,273 
Stock grant 302,125   3,021   (3,021)  —     —     —     —   
Stock in lieu of dividends on convertible preferred C 3,408,000   34,080   170,400   —     204,480   —     204,480 
Convertible debentures beneficial conversion feature —     —     102,584   —     102,584   —     102,584 
Warrants issued with convertible debentures —     —     144,976   —     144,976   —     144,976 
Stock based compensation —     —     68,531   —     68,531   —     68,531 
Net (loss) income —     —     —     (193,166)  (193,166)  83,327   (109,839)
Balance, June 30, 2020 423,794,088  $4,237,941  $122,171,489  $(128,257,551) $(1,848,121) $2,156,976  $308,855 

             Deficit  Equity    
             Attributable  Attributable    
 Common stock        to  to    
       Additional     Internat'l  Non-  Total 
 Shares  Common  Paid-in  Accumulated  Isotopes  controlling  (Deficit) 
 Outstanding  Stock  Capital  Deficit  Shareholders  Interest  Equity 
Balance, April 1, 2020 423,709,226  $4,237,092  $122,151,722  $(128,486,879) $(2,098,065) $2,118,106  $20,041 
Shares issued under employee stock purchase plan 84,862   849   2,758   —     3,607   —     3,607 
Stock based compensation —     —     17,009   —     17,009   —     17,009 
Net (loss) income —     —     —     229,328   229,328   38,870   268,198 
Balance, June 30, 2020 423,794,088  $4,237,941  $122,171,489  $(128,257,551) $(1,848,121) $2,156,976  $308,855 

INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

Reconciliation of Stockholders' (Deficit) Equity

Three and Six Months Ended June 30, 2019

(Unaudited)

 

         Deficit Equity    
          Deficit               Attributable Attributable    
          Attributable to Equity    Common stock       to  to    
 Common stock  Additional     Internat'l  Attributable to         Additional     Internat'l Non- Total 
 Shares Common Paid-in Accumulated Isotopes Noncontrolling Total Shares Common Paid-in Accumulated Isotopes controlling (Deficit) 
 Outstanding  Stock  Capital  Deficit  Shareholders  Interest  Equity Outstanding  Stock  Capital  Deficit  Shareholders  Interest  Equity 
Balance, January 1, 2019  413,168,301  $4,131,683  $120,805,997  $(126,541,421) $(1,603,741) $1,757,875  $154,134  413,168,301  $4,131,683  $120,805,997  $(126,541,421) $(1,603,741) $1,757,875  $154,134 
Shares issued under employee stock purchase plan  68,037   680   2,758   —     3,438   —     3,438  68,037   680   2,758   —     3,438   —     3,438 
Stock grant  279,767   2,798   (2,798)  —     —     —     —    279,767   2,798   (2,798)  —     —     —     —   
Stock in lieu of dividends on convertible preferred C  3,433,000   34,330   171,650   —     205,980   —     205,980  3,433,000   34,330   171,650   —     205,980   —     205,980 
Shares issued for exercise of employee stock options  2,825,000   28,250   55,750   —     84,000   —     84,000  2,825,000   28,250   55,750   —     84,000   —     84,000 
Distribution to non-controlling interest —     —     —     —     —     (6,200)  (6,200)
Stock based compensation  —     —     92,540   —     92,540   —     92,540  —     —     92,540   —     92,540   —     92,540 
Distribution to non-controlling interest  —     —     —     —     —     (6,200)  (6,200)
Net (loss) income  —     —     —     (1,209,151)  (1,209,151)  182,271   (1,026,880) —     —     —     (1,209,151)  (1,209,151)  182,271   (1,026,880)
Balance, June 30, 2019  419,774,105  $4,197,741  $121,125,897  $(127,750,572) $(2,426,934) $1,933,946  $(492,988) 419,774,105  $4,197,741  $121,125,897  $(127,750,572) $(2,426,934) $1,933,946  $(492,988)

 

          Deficit               Deficit Equity    
          Attributable to Equity             Attributable Attributable    
 Common stock  Additional     Internat'l  Attributable to    Common stock       to  to    
 Shares Common Paid-in Accumulated Isotopes Noncontrolling Total      Additional     Internat'l Non- Total 
 Outstanding  Stock  Capital  Deficit  Shareholders  Interest  Equity Shares Common Paid-in Accumulated Isotopes controlling (Deficit) 
Balance April 1, 2019  416,912,686  $4,169,127  $121,039,851  $(126,593,378) $(1,384,401) $1,866,367  $481,966 
Outstanding  Stock  Capital  Deficit ��Shareholders  Interest  Equity 
Balance, April 1, 2019 416,912,686  $4,169,127  $121,039,851  $(126,593,378) $(1,384,400) $1,866,367  $481,966 
Shares issued under employee stock purchase plan  36,419   364   1,493   —     1,857   —     1,857  36,419   364   1,493   —     1,857   —     1,857 
Shares issued for exercise of employee stock options  2,825,000   28,250   55,750   —     84,000   —     84,000  2,825,000   28,250   55,750   —     84,000   —     84,000 
Distribution to non-controlling interest —     —     —     —     —     (6,200)  (6,200)
Stock based compensation      —     28,803   —     28,803   —     28,803  —     —     28,803   —     28,803   —     28,803 
Distribution to non-controlling interest  —     —     —     —     —     (6,200)  (6,200)
Net (loss) income  —     —     —     (1,157,194)  (1,157,194)  73,779   (1,083,415) —     —     —     (1,157,194)  (1,157,194)  73,779   (1,083,415)
Balance, June 30, 2019  419,774,105  $4,197,741  $121,125,897  $(127,750,572) $(2,426,934) $1,933,946  $(492,988) 419,774,105  $4,197,741  $121,125,897  $(127,750,572) $(2,426,934) $1,933,946  $(492,989)

 

See accompanying notes to the unaudited condensed consolidated financial statements.

statements

 

6

INTERNATIONAL ISOTOPES INC AND SUBSIDIARIES

Reconciliation of Stockholders' Equity

Three and Six Months Ended June 30, 2018

(Unaudited)

              Deficit       
              Attributable to  Equity    
  Common stock  Additional     Internat'l  Attributable to    
  Shares  Common  Paid-in  Accumulated  Isotopes  Noncontrolling  Total 
  Outstanding  Stock  Capital  Deficit  Shareholders  Interest  Equity 
Balance, January 1, 2018  406,790,703  $4,067,907  $120,398,620  $(125,696,845) $(1,230,318) $1,577,245  $346,927 
Shares issued under employee stock purchase plan  51,439   515   2,789   —     3,304   —     3,304 
Stock grant  209,825   2,098   (2,098)  —     —     —     —   
Stock in lieu of dividends on convertible preferred C  2,288,646   22,886   183,094   —     205,980   —     205,980 
Shares issued for exercise of employee stock options  2,611,111   26,111   43,889   —     70,000   —     70,000 
Stock based compensation  —     —     125,133   —     125,133   —     125,133 
Net (loss) income  —     —     —     (297,875)  (297,875)  82,775   (215,100)
Balance, June 30, 2018  411,951,724  $4,119,517  $120,751,427  $(125,994,720) $(1,123,776) $1,660,020  $536,244 

              Deficit       
              Attributable to  Equity    
  Common stock  Additional     Internat'l  Attributable to    
  Shares  Common  Paid-in  Accumulated  Isotopes  Noncontrolling  Total 
  Outstanding  Stock  Capital  Deficit  Shareholders  Interest  Equity 
Balance April 1, 2018  409,922,096  $4,099,221  $120,648,517  $(125,662,441) $(914,703) $1,641,081  $726,378 
Shares issued under employee stock purchase plan  29,628   296   1,481   —     1,777   —     1,777 
Shares issued for exercise of employee stock options  2,000,000   20,000   50,000   —     70,000   —     70,000 
Stock based compensation  —     —     51,429   —     51,429   —     51,429 
Net (loss) income  —     —     —     (332,279)  (332,279)  18,939   (313,340)
Balance, June 30, 2018  411,951,724  $4,119,517  $120,751,427  $(125,994,720) $(1,123,776) $1,660,020  $536,244 

See accompanying notes to the unaudited condensed consolidated financial statements.

7 

 

 

 

INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

Notes to Unaudited Condensed Consolidated Financial Statements

For the Quarter Ended June 30, 20192020

 

(1)       The Company and Basis of Presentation

 

International Isotopes Inc. (INIS) was incorporated in Texas in November 1995. The accompanying unaudited condensed consolidated financial statements are presented in conformity with accounting principles generally accepted in the United States of America (GAAP) and include all operations and balances of INIS and its wholly owned subsidiaries. The unaudited condensed consolidated financial statements also include the accounts of INIS’s 50% owned joint venture, TI Services, LLC (TI Services), and the accounts of INIS’s 24.5% interest in RadQual, LLC (RadQual). TI Services is headquartered in Youngstown, Ohio and was formed with RadQual in December 2010 to distribute products and services for nuclear medicine, nuclear cardiology and Positron Emission Tomography (PET) imaging. RadQual is a global supplier of molecular imaging quality control and calibration devices, and is headquartered in Idaho Falls, Idaho. In August 2017, affiliates of INIS purchased 75.5% of RadQual and at the time INIS was named as one of the two managing members of RadQual. As a result of this ownership change, INIS has significant influence in management decisions with regard to RadQual’s business operations. INIS, its wholly owned subsidiaries, TI Services, and RadQual are collectively referred to herein as the “Company,” “we,” “our” or “us.”

 

Nature of Operations – INIS and its subsidiaries, TI Services and RadQual, manufacture a full range of nuclear medicine calibration and reference standards, a wide range of products, includinggeneric sodium iodide I-131 drug product, cobalt teletherapy sources, and a varied selection of radioisotopes and radiochemicals for medical research, pharmacy compounding, and clinical applications. The Company also distributes a varied selection of radioisotopes and radiochemicals for medical and clinical research applications and offers contract manufacturing services for certain pharmaceutical products. The Company also provides a host of transportation, recycling, and radiological field services on a contract basis for customers and holds several patents for a fluorine extraction process that it plans to use in conjunction with a proposed commercial depleted uranium de-conversion facility which would be located in Lea County, New Mexico (the “De-Conversion Facility”). The Company’s business consists of five business segments: Nuclear Medicine Standards, Cobalt Products, Radiochemical Products, Fluorine Products, and Radiological Services. The Company’s headquarters and all operations, with the exception of TI Services, are located in Idaho Falls, Idaho.

 

With the exception of certain unique products, the Company’s normal operating cycle is considered to be one year. Due to the time required to produce some cobalt products, the Company’s operating cycle for those products is considered to be two to three years.Accordingly, preliminary payments received on cobalt contracts, where shipment will not take place for greater than one year, have been recorded as unearned revenue and, depending upon estimated ship dates, classified under either current or long-term liabilities on the Company’s condensed consolidated balance sheets.These unearned revenues are being recognized as revenue in the periods during which the cobalt shipments take place. All assets expected to be realized in cash or sold during the normal operating cycle of business are classified as current assets.

 

Principles of Consolidation – The accompanying unaudited condensed consolidated financial statements are presented in conformity with GAAP and include all operations and balances of INIS and its wholly-owned subsidiaries. All significant intercompanyThe Company also consolidates the accounts and transactions have been eliminated in consolidation.of RadQual into the accompanying unaudited condensed consolidated financial statements. See Note 4 “Investment and Business Consolidation” for additional information regarding RadQual. All significant intercompany accounts and transactions have been eliminated in consolidation.

 

Interim Financial Information – The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with GAAP for interim financial information and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (SEC). Accordingly, the accompanying unaudited condensed consolidated financial statements do not include all of the information and notes required by GAAP for complete financial statements. In the opinion of management, all adjustments and reclassifications considered necessary in order to make the financial statements not misleading and for a fair and comparable presentation have been included and are of a normal recurring nature. Operating results for the three andthree- or six-month periodsperiod ended June 30, 20192020 are not necessarily indicative of the results that may be expected for the year ending December 31, 2019.2020 or any future periods. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 20182019 filed with the SEC on March 22, 2019.

Recent Accounting Pronouncements – In February 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Updated ASU 2016-02, “Leases”, which was issued to increase transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements. The amendments in ASU 2016-02 are effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. Results for reporting periods beginning January 1, 2019 are presented in accordance with Topic 842, while prior-period amounts have not been retrospectively adjusted and continue to be reported in accordance with Topic 840, Leases. Based upon the Company’s leases, the Company was not required to make an adjustment to the opening balance of retained earnings as of January 1, 2019. See Note 10, “Leases” for further discussion.

In June 2018, the FASB issued ASU 2018-07, “Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting”, which expands the scope of Topic 718 to include all share-based payment transactions for acquiring goods and services from nonemployees. ASU 2018-07 specifies that Topic 718 applies to all share-based payment transactions in which the grantor acquires goods and services to be used or consumed in its own operations by issuing share-based payment awards. ASU 2018-07 also clarifies that Topic 718 does not apply to share-based payments used to effectively provide (1) financing to the issuer or (2) awards granted in conjunction with selling goods or services to customers as part of a contract accounted for under ASC 606. The amendments in ASU 2018-07 are effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The Company adopted this standard effective January 1, 2019, and there was no material impact on the financial statements.30, 2020.

 

(2)       Current Developments and Liquidity

 

Business Condition – Since inception, the Company has incurred substantial losses. During the six-month periodsix-months ended June 30, 2020, the Company reported a net loss of $193,166, net of non-controlling interest, and net cash provided by operating activities of $415,918. During the six-months ended June 30, 2019, the Company reported a net loss of $1,209,151, net of non-controlling interest, and net cash used in operating activities of $114,905.

During the six-month periodsix-months ended June 30, 2018, the Company reported net loss of $297,875, net of non-controlling interest, and net cash used in operating activities of $328,026.

During the six months ended June 30, 2019,2020, the Company continued its focus on its long-standing core business segmentswhich consist of its radiochemical products, cobalt products, nuclear medicine standards, and radiological services, and in particular, the pursuit of new business opportunities within those segments. During this period the Company received approval from the U.S. Food and Drug Administration (FDA) for a generic sodium iodide I-131 drug product. This product is approved for use in treatment of hyperthyroidism and carcinoma of the thyroid and is the first generic sodium iodide I-131 product approved by the FDA in the US.

 

Additionally, the Company holds a Nuclear Regulatory Commission (NRC) construction and operating license for the depleted uranium facility in, as well as the property agreement with, Lea County, New Mexico, where the plant is intended to be constructed. The NRC license for the de-conversion facility is a forty (40) year operating license and is the first commercial license of this type issued in the United States.  There are no other companies with a similar license application under review by the NRC. Therefore, the NRC license represents a significant competitive barrier and the Company considers it a valuable asset.

 

On April 5, 2019, the Company entered into a manufacturing and supply agreement with Progenics Pharmaceuticals Inc. Under this agreement, the Company will provide contract manufacturing services for AZEDRA® (Ultratrace® Iobenguane I-131) and other iodine products. The Company is expanding its existing facility and installing the equipment necessary to support this contract manufacturing opportunity. The Company expects to complete startup of these additional new manufacturing spaces by the end of 2019.

The Company expects that cash from operations, cash raised through equity or debt financing and its current cash balance will be sufficient to fund operations for the next twelve months. Future liquidity and capital funding requirements will depend on numerous factors, including, contract manufacturing agreements, commercial relationships, technological developments, market factors, available credit, and voluntary warrant redemption by shareholders. There is no assurance that additional capital and financing will be available on acceptable terms to the Company or at all.

 

(3)       Net Income (Loss) Per Common Share - Basic and Diluted

 

For the six monthssix-months ended June 30, 2019,2020, the Company had 23,488,00024,605,000 stock options outstanding, 20,090,00050,090,000 warrants outstanding, 4,213 outstanding shares of Series C redeemable convertible preferred stock (Series C Preferred Stock), and 850 outstanding shares of Series B redeemable convertible preferred stock (Series B Preferred Stock), each of which were not included in the computation of diluted income (loss) per common share because they would be anti-dilutive. The Company used the treasury stock method in calculating weighted average common shares diluted.

 

For the sixthree months ended June 30, 2018,2020, the Company had 30,350,00014,005,000 stock options outstanding, 45,090,00020,090,000 warrants outstanding, 4,213 outstanding shares of Series C redeemable convertible preferred stock, and 850 outstanding shares of Series B redeemable convertible preferred stock, each of which were not included in the computation of diluted income (loss) per common share because they would be anti-dilutive.

The table below shows the calculation of diluted shares:

  3 Months Ended  6 Months Ended 
  June 30,  June 30,  June 30,  June 30, 
  2020  2019  2020  2019 
Weighted average common shares outstanding - basic  423,751,657   419,230,535   422,211,840   416,568,617 
                 
Effects of dilutive shares                
Stock Options  3,177,880   —     —     —   
Warrants  5,700,000   —     —     —   
Series B redeemable convertible preferred stock  —     —     —     —   
Series C redeemable convertible preferred stock  —     —     —     —   
Weighted average common shares outstanding - diluted  432,629,537   419,230,535   422,211,840   416,568,617 

For the six-months ended June 30, 2019, the Company had 23,488,000 stock options outstanding, 20,090,000 warrants outstanding, 4,213 outstanding shares of Series C Preferred Stock, and 850 outstanding shares of Series B Preferred Stock, each of which were not included in the computation of diluted income per common share because they would be anti-dilutive.

 

The table below summarizes common stock equivalents outstanding at June 30, 20192020 and 2018:2019:

 

 June 30, 
 2020  2019 
Stock options  23,488,000   30,350,000   24,605,000   23,488,000 
Warrants  20,090,000   45,090,000   50,090,000   20,090,000 
850 Shares of Series B redeemable convertible preferred stock  425,000   425,000   425,000   425,000 
4,213 Shares of Series C redeemable convertible preferred stock  42,130,000   42,130,000   42,130,000   42,130,000 
  86,133,000   117,995,000   117,250,000   86,133,000 

 

(4)       Investment and Business Consolidation

 

The Company owns a 24.5% interest in RadQual, with which the Company has an exclusive manufacturing agreement for nuclear medicine products. In August 2017, affiliates of the Company, including the Company’s Chairman of the Board and the Chief Executive Officer, acquired the remaining 75.5% interest in RadQual. The Company’s Chairman of the Board and its Chief Executive Officer also each serve as the managing members of RadQual. As a result of this change in ownership, and other factors, the Company determined that it gained the ability to exercise significant management control over the operations of RadQual. Because of this increased management control, and pursuant to GAAP, the Company has consolidated the accounts of RadQual into its financial statements.

 

(5)       Inventories

 

Inventories consisted of the following at June 30, 20192020 and December 31, 2018:2019:

 

 June 30, 2019 December 31, 2018  June 30, 2020  December 31, 2019 
Raw materials $40,648  $42,911  $33,609  $40,648 
Work in process  3,175,017   2,719,786   1,261,839   3,379,943 
Finished goods  4,276   3,032   3,220   2,829 
 $3,219,941  $2,765,729  $1,298,668  $3,423,420 

 

Work in process includes cobalt-60 targets that are located in the U.S. Department of Energy’s (DOE) Advanced Test Reactor (ATR) located outside of Idaho Falls, Idaho. These targets are owned by the Company and contain cobalt-60 material at various stages of irradiation. The carrying value of the targets is based on accumulated irradiation and handling costs which have been allocated to each target based on the length of time the targets have been held and processed at the ATR. At June 30, 2019,2020, and at December 31, 2018,2019, this cobalt target inventory had a carrying value of $403,076$179,625 and $389,293,$201,349, respectively.

 

Work in process also includes costs to irradiate cobalt-60 material under a contract with the DOE. This material has been placed in the ATR and the Company is makingmade progress payments designed to coincidepurchase this material. During the second quarter of 2020, the Company modified its agreement with the completionDOE due to delays in delivery of Cobalt material. As a result, the irradiation period. DOE refunded certain payments made by INIS in relation to this material and INIS stopped paying the scheduled payments for the inventory. During the six months ended June 30, 2020 work in process was reduced by $2,050,100 from a $918,090 cash refund from the DOE and a reduction of accounts payable of $1,132,010.

The Company has contracted with several customers for the sale of some of this product material and has collected advance payments for project management, up-front handling, and other production costs from those customers. The advance payments from customers were recorded as unearned revenue which are recognized in the Company’s condensed consolidated financial statements as cobalt products are completed and shipped. For the six monthssix-months ended June 30, 20192020 and 2018,2019, the Company recognized approximately $102,500$22,000 and $74,500,$102,500, respectively, of revenue in its condensed consolidated statements of operations for customer orders filled during the period under these cobalt contracts. For the three-months ended June 30, 2020 and 2019, the Company recognized approximately $11,500 and $8,000, respectively of revenue in its condensed consolidated statements of operations for customer orders filled during the period under these cobalt contracts.

 

(6)       Stockholders’ Equity, Options, and Warrants

 

Employee Stock Purchase Plan

 

The Company has an employee stock purchase plan pursuant to which employees of the Company may participate to purchase shares of common stock at a discount. During the six monthssix-months ended June 30, 20192020 and 2018,2019, the Company issued 68,037241,707 and 51,43968,037 shares of common stock, respectively, to employees under the employee stock purchase plan for proceeds of $3,438$10,273 and $3,304,$3,438, respectively. As of June 30, 2019, 511,9772020, 233,454 shares of common stock remain available for issuance under the employee stock purchase plan.

 

10 

Stock-Based Compensation Plans

 

2015 Incentive Plan - In April 2015, the Company’s Board of Directors approved the International Isotopes Inc. 2015 Incentive Plan (as amended, the 2015 Plan), which was subsequently approved by the Company’s shareholders in July 2015. The 2015 Plan was amended and restated in July 2018 to increase the number of shares authorized for issuance under the 2015 Plan by an additional 20,000,000 shares. The 2015 Plan provides for the grant of incentive and non-qualified stock options, stock appreciation rights, restricted stock, restricted stock units, performance shares and units, and other stock or cash-based awards.  The 2015 Plan amended and restated the Company’s Amended and Restated 2006 Equity Incentive Plan (2006 Plan). The 2015 Plan authorizes the issuance of up to 80,000,000 shares of common stock, plus 11,089,967 shares authorized, but not issued under the 2006 Plan. At June 30, 2019,2020, there were 34,679,71833,185,593 shares available for issuance under the 2015 Plan.

 

Employee/Director Grants - The Company accounts for issuances of stock-based compensation to employees by recognizing, as compensation expense, the cost of employee services received in exchange for equity awards. The compensation expense is based on the grant date fair value of the award. Stock option compensation expense is recognized over the period during which an employee is required to provide service in exchange for the award (the vesting period).

 

Non-Employee Grants - The Company accounts for its issuances of stock-based compensation to non-employees by measuring the value of any awards that were vested and non-forfeitable at their date of issuance based on the grant date fair value of the award. The non-vested portion of awards that are subject to the future performance of the counterparty are adjusted at each reporting date to their fair values based upon the then current market value of the Company’s stock and other assumptions that management believes are reasonable.

 

Option awards outstanding as of June 30, 2019,2020, and changes during the six monthssix-months ended June 30, 2019,2020, were as follows:

 

Fixed Options Shares  

Weighted

Average

Exercise Price

  

Weighted

Average

Remaining

Contractual Life

  

Aggregate

Intrinsic Value

  Shares  

Weighted

Average

Exercise Price

  

Weighted

Average

Remaining

Contractual Life

  

Aggregate

Intrinsic Value

 
Outstanding at December 31, 2018  27,805,000  $0.06         
Outstanding at December 31, 2019  23,655,000  $0.05         
Granted  615,000  $0.06           1,200,000  $0.05         
Exercised  (3,700,000) $0.04           —    $—           
Expired  (632,000) $0.10           —    $—           
Forfeited  (600,000) $0.04           (250,000) $0.06         
Outstanding at June 30, 2019  23,488,000  $0.05   6.8  $235,000 
Exerciseable at June 30, 2019  15,101,000  $.05   6.0  $235,000 
Outstanding at June 30, 2020  24,605,000  $0.05   6.0  $246,600 
Exercisable at June 30, 2020  18,086,500  $0.05   5.4  $235,000 

 

The intrinsic value of outstanding and exercisable shares is based on the closing price of the Company’s common stock on the OTCQB of $0.06 per share on June 28, 2019,30, 2020, the last trading day of the quarter.

 

As of June 30, 2019,2020, there was $104,740$62,250 of unrecognized compensation expense related to stock options that will be recognized over a weighted-average period of 1.932.11 years.

 

In April 2019, 1,500,000 qualified stock options were exercised under a cashless exercise. The Company withheld 875,000 shares to satisfy the exercise price and issued 625,000 shares of common stock. The options exercised were granted under the 2015 Plan, and, accordingly, there was not any income tax effect in the condensed consolidated financial statements for the six months ended June 30, 2019. In addition, in April 2019, 2,000,000 non-qualifiedstock options were exercised for a cash payment of $70,000. The options exercised were granted under the 2015 Plan and, accordingly, there was not any income tax effect in the condensed consolidated financial statementsfor the six months ended June 30, 2019. In May 2019, 200,000 non-qualified stock options were exercised for cash payments of $14,000. The options were granted under the 2015 Plan and, accordingly, there will not be any income tax effect in the condensed consolidated financial statementsfor the six months ended June 30, 2019.

During the three months ended June 30, 2019,2020, the Company granted 615,000an aggregate of 1,200,000 qualified stock options to several of its employees. All options vest over a five-year period, with the exception of one award which vests over a four-year period with the first vesting at one year anniversary for all grants and expiration at ten year anniversary for all grants. The weighted average exercise price for these options was $0.06$0.05 per share. The options have a fair value of $21,562$32,582 as estimated on the date of issue using the Black-Scholes options pricing model with the following weighted-average assumptions: risk free interest rate of 1.87%0.36% to 2.49%0.63%, expected dividend yield rate of 0%, expected volatility of 57.62%56.18% to 65.22%58.75% and an expected life between 5.5 and 7.5 years.

 

Total stock-based compensation expense for the six monthssix-months ended June 30, 2020 and 2019 was $68,531 and 2018$92,540 respectively. Total stock-based compensation expense for the three-months ended June 30, 2020 and 2019 was $92,540$17,009 and $125,133$28,803, respectively. At June 30, 2020, the remaining compensation expense was $62,250 and will be recognized over 2.11 years.

 

11 

Pursuant to an employment agreement with its Chief Executive Officer, the Company awarded 466,667500,000 fully vested shares of common stock to its Chief Executive Officer in February 20192020 under the 2015 Plan. The number of shares awarded was based on a $28,000 stock award using a price of $0.06$0.056 per share. The employment agreement provides that the number of shares issued will be based on the average closing price of common stock for the 20 trading days prior to issue date but not less than $0.05 per share. Compensation expense recorded pursuant to this stock grant was $16,786,$18,128, which was determined by multiplying the number of shares awarded by the closing price of the common stock on February 28, 2019,2020, which was $0.06 per share. The Company withheld 186,900197,875 shares of common stock to satisfy the employee’s payroll tax obligations in connection with this issuance. The net shares issued on February 28, 20192020 totaled 279,767.302,125.

 

Warrants

Warrants outstanding at June 30, 2020, included 17,165,000 Class M Warrants which are immediately exercisable at an exercise price of $0.12 per share and expire on February 17, 2022; 2,925,000 Class N Warrants which are immediately exercisable at an exercise price of $0.10 per share and expire on May 12, 2022; and 30,000,000 Class O Warrants which are immediately exercisable at an exercise price of $0.045 per share and expire December 30, 2024.

 

Warrants outstanding at June 30, 2019, included 17,165,000 Class M Warrants which are immediately exercisable at an exercise price of $0.12 per share and expire on February 17, 2022; and, 2,925,000 Class N Warrants which are immediately exercisable at an exercise price of $0.10 per share and expire on May 12, 2022. All 25,000,000 Class L Warrants expired on December 23, 2018.

Warrants outstanding at June 30, 2018, included 25,000,000 Class L Warrants with an exercise price of $0.06 per share and an expiration date of December 23, 2018, 17,165,000, Class M Warrants which are immediately exercisable at an exercise price of $0.12 per share and expire on February 17, 2022;2022 and 2,925,000 Class N Warrants which are immediately exercisable at an exercise price of $0.10 per share and expire on May 12, 2022.

 

10 

Preferred Stock

 

At June 30, 2019,2020, there were 850 shares of the Series B Preferred Stock outstanding with a mandatory redemption date of May 2022 at $1,000 per share or $850,000. The shares of Series B Preferred Stock are also convertible into 425,000 shares of the Company’s common stock at a conversion price of $2.00 per share. These shares of Series B Preferred Stock doesdo not carry any dividend preferences. Due to the mandatory redemption provision, the Series B Preferred Stock has been classified as a liability in the accompanying condensed consolidated balance sheets.

 

At June 30, 2019,2020, there were 4,213 shares of the Series C Preferred Stock outstanding with a mandatory redemption date of February 2022 at $1,000 per share in either cash or shares of common stock, at the option of the holder. Holders of the Series C Preferred Stock do not have any voting rights except as required by law and in connection with certain events as set forth in the Statement of Designation of the Series C Preferred Stock. The Series C Preferred Stock accrues dividends at a rate of 6% per annum, payable annually on February 17th of each year. The Series C Preferred Stock are convertible at the option of the holders at any time into shares of the Company's common stock at an initial conversion price equal to $0.10 per share, subject to adjustment. At any time after February 17, 2019, ifIf the volume-weighted average closing price of the Company’s common stock over a period of 90 consecutive trading days is greater than $0.25 per share, the Company may redeem all or any portion of the outstanding Series C Preferred Stock at the original purchase price per share plus any accrued and unpaid dividends, payable in shares of common stock.

 

During the six-month periodsix-months ended June 30, 20192020 and 20182019 dividends paid to holders of the Series C Preferred Stocktotaled $251,280 and $252,780, and $241,730respectively, respectively.. Some holders of the Series C Preferred Stock elected to settle their dividend payments with shares of the Company’s common stock in lieu of cash. For the six-month period endingsix-months June 30, 2020 and 2019 the Company issued 3,408,000 and 3,433,000 shares of common stock, respectively, in lieu of a dividend payment of $205,980.$204,480 and $205,980, respectively. The remaining $46,800 of dividend payable was settled with cash. For the same period in 2018, the Company issued 2,288,646 shares of common stock in lieu of a dividend payment of $205,980. The remaining $35,750 of dividend payable was settled in cash.

 

(7)       Debt

 

In December 2013, the Companywe entered into a promissory note agreement with its formerour then Chairman of the Board and one of itsour major shareholders, pursuant to which the Companywe borrowed $500,000 (the 2013 Promissory Note). The 2013 Promissory Note is secured and bears interest at 6% per annum and was originally due on June 30, 2014. According to the terms of the 2013 Promissory Note, at any time, the lenders may settle any or all of the principal and accrued interest with shares of the Company’sour common stock. In connection with the 2013 Promissory Note, each of the two lenders was issued 5,000,000 Class L warrants to purchase shares of the Company’sour common stock at an exercise price of $0.06 per share. The warrants were immediately exercisable. In June 2014, the Companywe renegotiated the terms of the 2013 Promissory Note. Pursuant to the modification, the maturity date was extended to December 31, 2017 and each lender was granted an additional 7,500,000 Class L warrants to purchasepurchases shares of the Company’sour common stock at an exercise price of $0.06 per share. The warrants were immediately exercisable. In December 2016,February 2017, the 2013 Promissory Note was further modified to extend the maturity date to December 31, 2022,2020, with all remaining terms unchanged. On December 23, 2018, all 25,000,000 Class L warrants expired. In December 2019, the 2013 Promissory Note was further modified to extend the maturity date to December 31, 2021, with all remaining terms unchanged.

At June 30, 2019,2020, the principal balance of the 2013 Promissory Note was $500,000 and accrued interest payable on the 2013 Promissory Note was $166,734.$196,734. Interest expense recorded for the six-month periodsix-months ended June 30, 2019,2020, was $15,000.

 

12 

In March 2016, the Company entered into a note payable for the purchase of a vehicle. The principal amount financed was $47,513. The term of the note is six yearsApril 2018, we borrowed $120,000 from our Chief Executive Officer and carries an interest rate of 6.66% per annum. Monthly payments are $805 and the note matures in April 2022. The note is secured by the vehicle that was purchased with the note’s proceeds.

In August 2017, the Company entered into a promissory note agreement with its Chairman of the Board pursuant to which the Company borrowed $60,000 (the 2017 Promissory Note). The 2017 Promissory Note accrues interest at 5% per annuum, which is payable upon maturity of the 2017 Promissory Note. The 2017 Promissory Note is unsecured and was scheduled to mature on June 30, 2018. Pursuant to an amendment to the 2017 Promissory Note on June 29, 2018, the maturity date was extended to March 31, 2019 with all other provisions remaining unchanged. Pursuant to a second amendment to the 2017 Promissory Note on February 2019, the maturity date was extended to July 31, 2019 with all other provisions of the 2017 Promissory Note remaining unchanged. On April 30, 2019, the 2017 Promissory Note and accrued interest were repaid in full with a cash payment of $65,117.

In April 2018, the Company borrowed $120,000 from its Chief Executive Officer and its Chairman of the Board pursuant to a short-term promissory note (the 2018 Promissory Note). The 2018 Promissory Note accrues interest at 6% per annum, which is payable upon maturity of the 2018 Promissory Note. The 2018 Promissory Note was originally unsecured and was originally scheduled to maturematured on August 1, 2018. At any time, the holder of the 2018 Promissory Note may elect to have any or all of the principal and accrued interest settled with shares of the Company’sour common stock based on the average price of the shares over the previous 20 trading days. Pursuant to an amendment to the 2018 Promissory Note onin June 29, 2018, the maturity date was extended to March 31, 2019 with all other provisions remaining unchanged. Pursuant to a second amendment to the 2018 Promissory Note onin February 12, 2019, the maturity date was extended to July 31, 2019 with all other provisions remaining unchanged. Pursuant to a third amendment to the 2018 Promissory Note in AugustJuly 2019, the maturity date was extended to January 31, 2020 andwith all other provisions remaining unchanged. Pursuant to a fourth amendment to the 2018 Promissory Note in December 2019, the maturity date was extended to December 31, 2021, the note was modified to bebecome secured by company assets, with all of the Company’s assets. other provisions remaining unchanged.

At June 30, 2019,2020, accrued interest on the 2018 Promissory Note totaled $8,570.$15,770.

 

11 

In FebruaryApril 2019, one of the prepaid revenue customers requested a refund of the amounts paid. The Company entered into a note agreement to repay $2,182,142 over the next 12 months. The modification was necessary to address the delays to cobalt delivery in 2019 caused by changes to the ATR operating schedule and also to accommodate this customer’s request to reduce their cobalt purchase obligations in future years. The modifications require that the Company refund approximately $1,050,000, of payments received for prior year undelivered material, plus interest at 12% per year, payable over a one-year period on a portion of that amount. The Company has also agreed with this customer to refund approximately $1,100,000 paid for material that was to have been delivered in later years. There will be no interest charge on this refund. In December 2019, this agreement was modified further allowing the Company to delay the original payments by 3 months and refund an additional $462,258 with no interest charge.

On December 20, 2019, the Company borrowed $185,474 from RadQual pursuant toentered into a short-term promissory note agreement with a stated interest ratefour of 6% per annum and a maturity date of July 31, 2019the Company’s major shareholders (the 2019 Promissory Note). The 2019 Promissory Note is unsecured.authorizes the Company to borrow up to $1,000,000. As of December 31, 2019, the Company had borrowed $675,000 under the 2019 promissory note. In June 2019,February 2020, the Company borrowed an additional $180,000. Additionally, in June 2019, an amendment to the$325,000. The 2019 Promissory Note extended the maturity date tobears an interest rate of 4% annually and is due December 31, 2019 with all other2022. According to the terms remaining unchanged. At June 30, 2019, the principal balance of the 2019 Promissory Note, at any time, the lenders may settle any or all of the principal and accrued interest with shares of the Company’s common stock based on the average closing price of the Company’s common stock for the 20 days preceding the payment. In connection with the 2019 Promissory Note, the lenders were issued warrants totaling 30,000,000 warrants to purchase shares of the Company’s common stock at $0.045 per share. The fair value of these warrants issued totaled $365,474$446,079 and was recorded as a debt discount and will be amortized over the life of the 2019 Promissory Note. The Company calculated a beneficial conversion feature of $315,643 which will be accreted to interest expense over the life of the 2019 Promissory Note. At June 30, 2020 accrued interest on the 2019 Promissory Note totaled $3,982.$19,131.

On April 23, 2020, the Company, through its wholly-owned subsidiary entered into a Loan Agreement and Promissory Note (collectively the “SBA Loan”) with KeyBank National Association pursuant to the Paycheck Protection Program (the “PPP”) under the recently enacted Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) administered by the U.S. Small Business Administration (the “SBA”). The Company received total proceeds of $495,500 from the SBA Loan. The SBA Loan is scheduled to mature on April 22, 2022 and has a 1.00% interest rate and is subject to the terms and conditions applicable to loans administered by the SBA under the CARES Act. The SBA Loan may be prepaid at any time prior to maturity with no prepayment penalties.

The SBA Loan contains customary events of default relating to, among other things, payment defaults and breaches of representations and warranties. Subject to certain conditions, the SBA Loan may be forgiven in whole or in part by applying for forgiveness pursuant to the CARES Act and the PPP. The amount of loan proceeds eligible for forgiveness is based on a formula based on a number of factors, including the amount of loan proceeds used by the Company during the twenty-four week period after the loan origination for certain purposes, including payroll costs, interest on certain mortgage obligations, rent payments on certain leases, and certain qualified utility payments, provided that, among other things, at least 60% of the loan amount is used for eligible payroll costs, the employer maintaining or rehiring employees and maintaining salaries at certain level.

As of June 30, 2020, the Company has used the entire loan proceeds to fund qualifying expenses. As a result, the Company believes that it has met the PPP eligibility criteria for forgiveness and has concluded that the loan represents, in substance, a government grant that is expected to be forgiven. As such, the Company has recognized the entire loan amount as Other Income at June 30, 2020.

The Company does not anticipate taking any action that would cause any portion of the loan to be ineligible for forgiveness. However, to the extent that any amount is deemed unforgivable, such amount is payable over two to five years at an interest rate of 1%, with a deferral of payments for the first six months.

 

(8)       Commitments and Contingencies

 

Dependence on Third Parties

 

The production of High Specific Activity Cobalt is dependent upon the DOE, and its prime operating contractor, which controls the ATR and laboratory operations at the ATR located outside of Idaho Falls, Idaho. In October 2014, the Company signed a ten-year contract with the DOE for the irradiation of cobalt targets for the production of cobalt-60. The Company will be able to purchase cobalt targets for a fixed price per target with an annual 5% escalation in price. The contract term is October 1, 2014, through September 30, 2024, however, the contract may be extended beyond that date. Also, the DOE may end the contract if it determines termination is necessary for the national defense, security or environmental safety of the United States. If this were to occur, all payments made by the Company, for partially irradiated undelivered cobalt material, would be refunded.

 

12 

Nuclear Medicine Reference and Calibration Standard manufacturing is conducted under an exclusive contract with RadQual, which in turn has an agreement in place with several companies for distributing the products. The radiochemical product sold by the Company is supplied to the Company through agreements with several suppliers. A loss of any of these customers or suppliers could adversely affect operating results by causing a delay in production or a possible loss of sales.

 

Contingencies

 

Because all the Company’s business segments involve the handling or use of radioactive material, the Company is required to have an operating license from the NRC and specially trained staff to handle these materials. The Company has amended this operating license numerous times to increase the amount of material permitted within the Company’s facility. Although this license does not currently restrict the volume of business operations performed or projected to be performed in the upcoming year, additional processing capabilities and license amendments could be implemented that would permit processing of other reactor-produced radioisotopes by the Company. The financial assurance required by the NRC to support this license has been provided for with a surety bond held with North American Specialty Insurance Company which is supported by a restricted money market account held with Merrill Lynch in the amount of $629,446.$638,562.

 

13 

In August 2011, the Company received land from Lea County, New Mexico, pursuant to a Project Participation Agreement (PPA), whereby the land was deeded to the Company for no monetary consideration. In return, the Company committed to construct a uranium de-conversion and Fluorine Extraction Process facility on the land.  In order to retain title to the property, the Company was to begin construction of the de-conversion facility no later than December 31, 2014, and complete Phase I of the project and have hired at least 75 persons to operate the facility no later than December 31, 2015, although commercial operations need not have begun by that date. In 2015, the Company negotiated a modification to the PPA that extended the start of construction date to December 31, 2015, and the hiring milestone to December 31, 2016. Those dates were also not met, andmet. The Company is in discussion with commercial companies possibly interested in purchasing rights to this project. Should those discussions come to fruition the Company is currently in the process of renegotiatingplans to negotiate a second modification to the PPA agreement to further extend thosethe commitment dates. If the Company is not successful in reaching an amendment to extend the performance dates in the PPA. then it may, at its sole option, either purchase or re-convey the property to Lea County, New Mexico.  The purchase price of the property would be $776,078, plus interest at the annual rate of 5.25% from the date of the closing to the date of payment.  The Company has not recorded the value of this property as an asset and will not do so until such time that sufficient progress on the project has been made to meet the Company’s obligations under the agreements for permanent transfer of the title.

 

On May 3,2, 2019, the Company’s radiological services team was involved in a contamination event involving a breached cesium-137 source at an off-site location in the stateState of Washington. This work was being performed under a contract with the DOE. The Company is currently supportingsupported the initial onsite contamination clean-up operations at that location and is supporting ancompleted removal of the cesium source Company equipment. The Company has reviewed the results of the DOE investigation in conjunctioninto this event and has implemented appropriate corrective actions. Since August 2019 the DOE has assumed full control of the ongoing cleanup operations and has assumed all of the financial obligations associated with the contractors hired to carry out all of the facility recovery operations. Under the terms of the contract the Company believes it should be indemnified from financial liability for this event by the DOE under the Price Anderson Amendments Act (PAAA) and the Company has formally requested the DOE to help determineprovide indemnification under the causePAAA. While the DOE’s review of the request is still underway the Company believes that a determination of indemnification under the PAAA is probable. Such indemnification would allow the Company to recoup all its costs associated with this contamination event. TheDuring 2019, the Company has reported this incidentincurred $2,384,255 in expenses related to the contamination and its insurance carrier and a claim is being processed to address the cost of recovery operations.cleanup. During the six months ended June 30, 20192020, the companyCompany incurred $1,522,605an additional $58,208 in expenses related to the contamination which is recorded as “other expense” in the Company’s consolidated Statements of Operations. In Julyand its cleanup. During 2019, the companyCompany received $634,919$964,958 in reimbursements from its insurance company for this ongoing claim which is recorded as “other income”expenses related to the contamination and its cleanup. During the six months ended June 30, 2020, the DOE paid $576,732 on behalf of the Company for expenses related to the contamination and the its cleanup. The Company has determined that an additional $694,320 of its incurred expenses related to the contamination and its cleanup are probable for recovery pursuant to ASC 410-30.

The Washington Department of Health (DOH) issued a Notice of Violation to the Company in May 2020 citing two violations of the Company’s reciprocity license in the State of Washington. Also, the U.S. Nuclear Regulatory Commission (NRC) completed an inspection of the Company’s consolidated Statementsradiological safety program and issued a Notice of Operations.Violation in June 2020 citing two different violations of the Company’s NRC materials license. The Company has requested and completed Predecisional Enforcement Conferences with the Washington DOH and the NRC and has provided the agencies with information on all corrective actions completed by the Company to prevent reoccurrence. The Company is actively workingawaiting the results of deliberations by Washington DOH and NRC on these matters and their respective decisions for any further actions or the imposition of a civil penalty against the Company. In addition to the costs and expenses identified above, in the event the Washington DOH Notice of Violation results in the imposition of a civil penalty against the Company, based upon consultation with its insurance company andlegal counsel, the Company reasonably believes it will recover a majoritysuch civil penalty falls within the parameters for indemnification of the external and subcontract costsCompany under the PAAA. It is not possible at this time to predict the timing or outcome of these clean-up operations.matters or to estimate a potential amount of loss, if any.

 

13 

(9)       Revenue Recognition

 

Revenue from Product Sales

 

The following tables present the Company’s revenue disaggregated by business segment and geography, based on management’s assessment of available data:

 

 Three Months Ended June 30, 2019  Three Months Ended June 30, 2018  Three Months Ended June 30, 2020  Three Months Ended June 30, 2019 
 U.S.  Outside U.S.  Total Revenues  % of Total Revenues  U.S.  Outside U.S.  Total Revenues  % of Total Revenues  U.S.  

Outside

U.S.

  

Total

Revenues

  

% of Total

Revenues

  U.S.  

Outside

U.S.

  

Total

Revenues

  

% of Total

Revenues

 
Radiochemical Products $774,107  $—    $774,107   36% $545,344  $57,000  $602,344   25% $988,952  $124,101  $1,113,053   52% $774,107  $—    $774,107   36%
Cobalt Products  213,239   —     213,239   10%  324,768   —     324,768   14%  217,433   7,233   224,666   10%  213,239   —     213,239   10%
Nuclear Medicine Products  744,612   186,084   930,696   44%  961,653   1,021   962,674   40%  592,170   185,703   777,873   36%  744,612   186,084   930,696   44%
Radiological Services  217,797   —     217,797   10%  111,175   391,345   502,520   21%  43,967   —     43,967   2%  217,797   —     217,797   10%
Fluorine Products  —     —     —     0%  —     —     —     0%  —     —     —     0%  —     —     —     0%
 $1,949,755  $186,084  $2,135,839   100% $1,942,940  $449,366  $2,392,306   100% $1,842,522  $317,037  $2,159,559   100% $1,949,755  $186,084  $2,135,839   100%

 

  Six Months Ended June 30, 2019  Six Months Ended June 30, 2018 
  U.S.  Outside U.S.  Total Revenues  % of Total Revenues  U.S.  Outside U.S.  Total Revenues  % of Total Revenues 
Radiochemical Products $1,233,714  $3,625  $1,237,339   27% $1,073,961  $111,924  $1,185,885   23%
Cobalt Products  549,328   40,000   589,328   13%  652,546   —     652,546   13%
Nuclear Medicine Products  1,578,120   453,498   2,031,618   44%  1,959,386   5,401   1,964,787   38%
Radiological Services  805,406   —     805,406   17%  250,347   1,139,767   1,390,114   27%
Fluorine Products  —     —     —     0%  —     —     —     0%
  $4,166,568  $497,123  $4,663,691   100% $3,936,240  $1,257,092  $5,193,332   100%

Under ASC Topic 606, the Company recognizes revenue when it satisfies a performance obligation by transferring control of the promised goods or services to its customers, in an amount that reflects the consideration the Company expects to receive in exchange for the product or service.

14 

Product sales consist of a single performance obligation that the Company satisfies at a point in time.  Most transactions in the radiochemical products and nuclear medicine standards segments fall into this category. Most sales transactions in the cobalt products business segment fall into this category but other cobalt product sales are recorded as deferred income as discussed below. The Company recognizes product revenue when the following events have occurred: (a) the Company has transferred physical possession of the products, (b) the Company has a present right to payment, (c) the customer has legal title to the products, and (d) the customer bears significant risks and rewards of ownership of the products.   Based on the Company’s historical practices and shipping terms specified in the sales agreements and invoices, these criteria are generally met when the products are:

·Invoiced.
·Shipped from the Company’s facilities (“FOB shipping point”, which is the Company’s standard shipping term). For these sales, the Company determined that the customer is able to direct the use of, and obtain substantially all of the benefits from, the products at the time the products are shipped.

In the radiological services segment, the Company performs services under multiple types of contracts. In this segment, the Company processes gemstones and recovers various types of radioactive and/or hazardous materials from third-party facilities. Contracts for gemstone processing include two performance obligations and revenue for these contracts is recognized when each obligation is met. Recovery projects typically have only one performance obligation which is delivery of the final product or service. Under these contracts, the Company recognizes revenue once the work is complete and the customer has obtained substantially all of the benefits from the services, and the performance obligations under the contract have been met. Some recovery contracts have milestones at which point the Company can invoice and receive payments from the customer. With these contracts, the company considers each milestone a performance obligation and records revenue at the time each milestone is completed, and the customer has inspected and accepted the results of the services. The Company’s standard payment terms for its customers are generally 30 days after the Company satisfies the performance obligations.

  Six Months Ended June 30, 2020  Six Months Ended June 30, 2019 
  U.S.  

Outside

U.S.

  

Total

Revenues

  

% of Total

Revenues

  U.S.  

Outside

U.S.

  

Total

Revenues

  

% of Total

Revenues

 
Radiochemical Products $1,657,543  $210,731  $1,868,274   42% $1,233,714  $3,625  $1,237,339   28%
Cobalt Products  522,428   7,858   530,286   12%  549,328   40,000   589,328   13%
Nuclear Medicine Products  1,459,773   360,224   1,819,997   40%  1,578,120   453,498   2,031,618   45%
Radiological Services  116,288   —     116,288   3%  805,406   —     805,406   18%
Fluorine Products  160,500   —     160,500   4%  —     —     —     0%
  $3,916,532  $578,813  $4,495,345   100% $4,166,568  $497,123  $4,663,691   100%

 

The Company’s revenue consists primarily of products manufactured for use in the nuclear medicine industry, distribution of radiochemicals including sodium iodide I-131 drug product, cobalt source manufacturing, and providing radiological services on a contract basismanufacturing of drug products for customers. With the exception of certain unique products, the Company’s normal operating cycle is considered to be one year. Due to the time required to produce some cobalt products, the Company’s operating cycle for those products is considered to be two to three years.Accordingly, preliminary payments received on cobalt contracts, where shipment will not take place for greater than one year, have been recorded as unearned revenue on the Company’s condensed consolidated balance sheets and classified under current or long-term liabilities, depending upon estimated ship dates. For the six monthssix-months ended June 30, 2019, the Company reported current unearned cobalt products revenue of $1,561,458 and non-current unearned revenue of $7,500. For the period ended December 31, 2018,2020, the Company reported current unearned revenue of $3,783,541 and non-current$1,375,948. For the period ended December 31, 2019, the Company reported current unearned revenue of $7,500.$1,240,205. These unearned revenues will be recognized as revenue in the periods during which the cobalt shipments take place.

During the six months ended June 30, 2019, one of the prepaid revenue customers requested a refund of the amounts paid. The Company entered into an agreement to repay $2,182,142 over the next 12 months. The modification was necessary to address the delays to cobalt delivery in 2019 caused by changes to the ATR operating schedule and also to accommodate this customer’s request to reduce their cobalt purchase obligations in future years. The modifications require that the Company refund approximately $1,050,000, of payments received for prior year undelivered material, plus interest at 12% per year, payable over a one-year period on a portion of that amount. The Company has also agreed with this customer to refund approximately $1,100,000 paid for material that was to have been delivered in later years. There will be no interest charge on this refund. The Company has contracted for the sale of this cobalt to a new customer for approximately the same amount. The entire amount was reclassed from unearned revenue to short-term notes payable.

 

Contract Balances

 

The Company records a receivable when it has an unconditional right to receive consideration after the performance obligations are satisfied.  As of June 30, 2019,2020, and December 31, 2018,2019, accounts receivable totaled $1,402,893$1,301,248 and $820,370,$875,914, respectively.  For the six monthssix-months ended June 30, 2019,2020, the Company did not incur material impairment losses with respect to its receivables.

 

Practical Expedients

The Company has elected the practical expedient not to determine whether contracts with customers contain significant financing components.

15 

(10)       Leases

In February 2016, the FASB issued ASU No. 2016-02, Leases (“ASU 2016-02”). ASU 2016-02 replaced most existing lease accounting guidance. In July 2018 the FASB approved an Accounting Standards Update which, among other changes, allowed a company to elect to adopt ASU 2016-02 using the modified retrospective method applying the transition provisions at the beginning of the period of adoption, rather than at the beginning of the earliest comparative period presented in these financial statements. ASU 2016-02 was effective for the Company beginning on January 1, 2019 and required the Company to record a right-of-use asset and a lease liability for its facilities leases that were previously treated as operating leases. The effect of ASU 2016-02 was to record a cumulative-effect adjustment on January 1, 2019 as a right-of-use asset and an operating lease liability totaling $810,367. The Company has made an accounting policy election to not apply the recognition requirements of ASU 2016-02 to its short-term leases, which are leases with a term of one year or less. The Company has also elected certain practical expedients under ASU 2016-02 including not separating lease and non-lease components on its operating leases, not reassessing whether any existing contracts contained leases, not reconsidering lease classification, not reassessing initial direct costs and using hindsight in determining the reasonably certain term of its leases.

 

The Company leases office and warehouse space under operating leases. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments under the lease. Operating lease, right-of-use assets, and liabilities are recognized at the lease commencement date based on the present value of lease payments over the reasonably certain lease term. The implicit rates with the Company’s operating leases are generally not determinable and the Company uses its incremental borrowing rate at the lease commencement date to determine the present value of its lease payments. The determination of the Company’s incremental borrowing rate requires judgement. The company determines its incremental borrowing rate for each lease using its then-current borrowing rate. Certain of the Company’s leases include options to extend or terminate the lease. The Company establishes the number of renewal options periods used in determining the operating lease term based upon its assessment at the inception of the operating lease. The option to renew the lease may be automatic, at the option of the Company, or mutually agreed to between the landlord and the Company. Once the facility lease term has begun, the present value of the aggregate future minimum lease payments is recorded as a right-of-use asset. Lease expense is recognized on a straight-line basis over the term of the lease.

 

  Six Months Ended 
  June 30, 
  2019 
Operating lease costs $73,706 
Short-term operating lease costs $3,039 
Operating cash flows from operating leases $(76,745)
Right-of-use assets obtained in exchange for new operating lease liabilities $810,367 
Weighted-average remaining lease term (years) - operating leases  7 
Weighted-average discount rate - operating leases  6.75%
14 

 

  Six Months Ended June 30, 
  2020  2019 
Operating lease costs $130,378  $73,706 
Short-term operating lease costs  19,928   3,039 
Financing lease expense:        
Amortization of right-of-use assets  2,179   —   
Interest on lease liabilities  579   —   
Total financing lease expense  2,758     
Total lease expense $153,064  $76,745 
         
Right-of-use assets obtained in exchange for new operating lease liabilities $2,649,070  $810,367 
Right-of-use assets obtained in exchange for new financing lease liabilities $16,524  $—   
         
Weighted-average remaining lease term (years) - operating leases  14.6   7.0 
Weighted-average remaining lease term (years) - financing leases  3.6     
Weighted-average discount rate - operating leases  6.75%  6.75%
Weighted-average discount rate - financing leases  8.82%    

 

The future minimum payments under these operating lease agreements are as follows:

 

2019 (excluding the six months ended June 30, 2019) $73,706 
2020  145,563 
 Operating  Financing 
2020 (excluding the six months ended June 30, 2020) $128,127  $4,821 
2021  136,313   257,383   9,641 
2022  136,313   284,631   9,641 
2023  136,313   287,108   5,880 
2024  287,108   2,929 
Thereafter  318,063   2,886,518   —   
Total minimum operating lease obligations  946,271   4,130,875   32,912 
Less-amounts representing interest  (187,605)  (1,519,443)  (4,607)
Present value of minimum operating lease obligations  758,666   2,611,432   28,305 
Current maturities  (99,236)  (83,098)  (7,434)
Lease obligations, net of current maturities $659,430  $2,528,334  $20,871 

 

(11)        Segment Information

 

The Company has five reportable segments which include: Nuclear Medicine Standards, Cobalt Products, Radiochemical Products, Fluorine Products, and Radiological Services. Information regarding the operations and assets of these reportable business segments is contained in the following table:

 

15 

  Three months ended June 30,  Six months ended June 30, 
Sale of Product 2020  2019  2020  2019 
Radiochemical Products $1,113,053  $774,107  $1,868,274  $1,237,339 
Cobalt Products  224,666   213,239   530,286   589,328 
Nuclear Medicine Standards  777,873   930,696   1,819,997   2,031,618 
Radiological Services  43,967   217,797   116,288   805,406 
Fluorine Products  —     —     160,500   —   
Total Segments  2,159,559   2,135,839   4,495,345   4,663,691 
Corporate revenue  —     —     —     —   
Total Consolidated $2,159,559  $2,135,839  $4,495,345  $4,663,691 

  Three months ended June 30,  Six months ended June 30, 
Depreciation and Amortization 2020  2019  2020  2019 
Radiochemical Products $10,354  $9,269  $20,708  $18,086 
Cobalt Products  8,762   1,022   17,523   2,102 
Nuclear Medicine Standards  15,989   15,673   31,978   31,292 
Radiological Services  8,519   8,636   17,155   17,272 
Fluorine Products  30,898   30,807   56,993   56,902 
Total Segments  74,522   65,408   144,357   125,654 
Corporate depreciation and amortization  (349)  53   4,433   4,791 
Total Consolidated $74,173  $65,461  $148,790  $130,445 

  Three months ended June 30,  Six months ended June 30, 
Segment Income (Loss) 2020  2019  2020  2019 
Radiochemical Products $380,728  $252,946  $386,347  $349,002 
Cobalt Products  75,874   122,252   199,670   315,122 
Nuclear Medicine Standards  117,056   111,921   302,357   328,743 
Radiological Services  (13,532)  (901,234)  (28,461)  (589,955)
Fluorine Products  (36,460)  (39,927)  86,410   (77,422)
Total Segments  523,666   (454,042)  946,323   325,490 
Corporate loss  (294,338)  (703,152)  (1,139,489)  (1,534,641)
Net Income (Loss) $229,328  $(1,157,194) $(193,166) $(1,209,151)

  Three months ended June 30,  Six months ended June 30, 
Expenditures for Segment Assets 2020  2019  2020  2019 
Radiochemical Products $—    $14,844  $—    $14,845 
Cobalt Products  —     —     —     3,493 
Nuclear Medicine Standards  —     4,950   —     4,950 
Radiological Services  —     —     —     —   
Fluorine Products  —     —     1,565   1,589 
Total Segments  —     19,794   1,565   24,877 
Corporate purchases  —     —     —     —   
Total Consolidated $—    $19,794  $1,565  $24,877 

  June 30,  December 31, 
Segment Assets 2020  2019 
Radiochemical Products $748,827  $511,381 
Cobalt Products  1,331,242   3,369,828 
Nuclear Medicine Standards  2,113,653   2,111,225 
Radiological Services  84,012   106,374 
Fluorine Products  5,422,380   5,477,808 
Total Segments  9,700,114   11,576,616 
Corporate assets  5,213,468   3,680,179 
Total Consolidated $14,913,582  $15,256,795 

16 

 

 

  Three months ended June 30,  Six months ended June 30, 
Sale of Product 2019  2018  2019  2018 
Radiochemical Products $774,107  $602,344  $1,237,339  $1,185,885 
Cobalt Products  213,239   324,768   589,328   652,546 
Nuclear Medicine Standards  930,696   962,674   2,031,618   1,964,787 
Radiological Services  217,797   502,520   805,406   1,390,114 
Fluorine Products  —     —     —     —   
Total Segments  2,135,839   2,392,306   4,663,691   5,193,332 
Corporate revenue  —     —     —       
Total Consolidated $2,135,839  $2,392,306  $4,663,691  $5,193,332 

  Three months ended June 30,  Six months ended June 30, 
Depreciation and Amortization 2019  2018  2019  2018 
Radiochemical Products $9,269  $6,046  $18,086  $11,060 
Cobalt Products  1,022   753   2,102   4,796 
Nuclear Medicine Standards  15,673   16,530   31,292   34,468 
Radiological Services  8,636   11,918   17,272   23,957 
Fluorine Products  30,807   30,725   56,902   56,820 
Total Segments  65,408   65,971   125,654   131,101 
Corporate depreciation and amortization  53   141   4,791   4,985 
Total Consolidated $65,461  $66,112  $130,445  $136,086 

  Three months ended June 30,  Six months ended June 30, 
Segment Income (Loss) 2019  2018  2019  2018 
Radiochemical Products $252,946  $103,037  $349,002  $143,557 
Cobalt Products  122,252   93,113   315,122   277,905 
Nuclear Medicine Standards  111,921   165,294   328,743   389,236 
Radiological Services  (901,234)  164,441   (589,955)  566,453 
Fluorine Products  (39,927)  (31,613)  (77,422)  (62,912)
Total Segments  (454,042)  494,273   325,490   1,314,239 
Corporate loss  (703,152)  (826,552)  (1,534,641)  (1,612,114)
Net Income (Loss) $(1,157,194) $(332,279) $(1,209,151) $(297,875)

  Three months ended June 30,  Six months ended June 30, 
Expenditures for Segment Assets 2019  2018  2019  2018 
Radiochemical Products $14,844  $—    $14,845  $—   
Cobalt Products  —     —     3,493   —   
Nuclear Medicine Standards  4,950   3,914   4,950   22,062 
Radiological Services  —     39,354   —     39,354 
Fluorine Products  —     —     1,589   1,560 
Total Segments  19,794   43,268   24,877   62,976 
Corporate purchases  —     —     —     —   
Total Consolidated $19,794  $43,268  $24,877  $62,976 

  June 30  December 31, 
Segment Assets 2019  2018 
Radiochemical Products $325,151  $344,994 
Cobalt Products  3,033,304   2,611,939 
Nuclear Medicine Standards  2,102,076   2,113,960 
Radiological Services  800,523   281,077 
Fluorine Products  5,534,739   5,590,053 
Total Segments  11,795,793   10,942,023 
Corporate assets  2,501,983   2,048,053 
Total Consolidated $14,297,776  $12,990,076 

(12)       Subsequent Events

 

In April 2020, the Company’s Board of Directors approved the International Isotopes Inc. Amended and Restated Employee Stock Purchase Plan (the “ESPP”), which was subsequently approved by the Company’s shareholders in July 2020. As discussed in Note 7 above,a result, the 2018 Promissory Notenumber of shares authorized for issuance under the ESPP was modified in August 2019 to extend the maturity date and to secure the note.increased by an additional 3,000,000 shares.

 

 

17 

 

 

ITEM2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

This Quarterly Report on Form 10-Q (the “Quarterly Report”) contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including statements regarding industry prospects and future results of operations or financial position, made in this Quarterly Report are forward-looking statements. Words such as “anticipates,” “believes,” “should,” “expects,” “future,” “intends” and similar expressions identify forward-looking statements.  In particular, statements regarding impact of the novel coronavirus (COVID-19) outbreak on our business, financial condition, operating results and liquidity, the future prospects of our business segments, future cash flow from operations, the Company’s ability to achieve profitability, the business prospects and growth projection for our business segments, the U.S. Food and Drug Administration (FDA) approval for certain of our products, and the status of our proposed uranium de-conversion facility, are forward-looking statements. Forward-looking statements reflect management’s current expectations, plans or projections, and are inherently uncertain. Actual results could differ materially from management's expectations, plans or projections.  Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this Quarterly Report. Certain risks and uncertainties that could cause our actual results to differ significantly from management’s expectations are described in the risk factors set forth in our Annual Report on Form 10-K for the fiscal year ended December 31, 20182019 filed with the Securities and Exchange Commission (SEC) on March 22, 201930, 2020 and in the other reports we file with the SEC. These factors describe some but not all of the factors that could cause actual results to differ significantly from management’s expectations. We undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Readers are urged, however, to review the risks and other factors set forth in the reports that we file from time to time with the SEC.

 

BUSINESS OVERVIEW

 

International Isotopes Inc., its subsidiaries and joint venture, TI Services, LLC, and RadQual, LLC (collectively, the Company, we, our, or us) manufacture a full range of nuclear medicine calibration and reference standards, a wide range of cobalt products, including cobalt teletherapy sources,manufacture and distribute sodium iodide I-131 as a varied selection of radioisotopes and radiochemicals for medical research and clinical applications,generic drug, and provide contract manufacturing of radiochemicalradiopharmaceutical products. We also hold several patents for a fluorine extraction process that we intend to use in conjunction with a planned commercial depleted uranium de-conversion facility, and provide a host of transportation, recycling, and processing services on a contract basis for clients. We also own a 24.5% interest in, and have management control of, RadQual, LLC (RadQual), a global supplier of molecular imaging quality control and calibration devices, with which we have an exclusive manufacturing agreement.

 

In August 2017, affiliates of the Company, including the Company’s Chairman of the Board and the Chief Executive Officer, acquired the remaining 75.5% interest in RadQual. The Company’s Chairman of the Board and its Chief Executive Officer also serve as the managing members of RadQual. As a result of this change in ownership, and other factors, the Company determined that it had gained the ability to exercise significant management control over the operations of RadQual. Because of this increased management ability and pursuant to GAAP, the Company has consolidated the accounts of RadQual into its financial statements beginning as of August 2017. See Note 4 “Investment and Business Consolidation” to our unaudited condensed consolidated financial statements in this report for additional information.

 

Our business consists of the following five major business segments:

 

Nuclear Medicine Standards. Our Nuclear Medicine Standards segment consists of the manufacture of sources and standards associated with Single Photon Emission Computed Tomography (SPECT) and Positron Emission Tomography (PET) imaging. These sources are used for indication of patient positioning for SPECT imaging, SPECT camera operational testing, and calibration of dose measurement equipment. Revenue from nuclear medicine products includes consolidated sales from TI Services, LLC (TI Services), a 50/50 joint venture that we formed with RadQual in December 2010 to distribute our products, as well as consolidated sales from RadQual, pursuant to the change in RadQual’s ownership in August 2017, as discussed above. Our nuclear medicine standards products include a host of specially designed items used in the nuclear medicine industry. In addition to the manufacture of these products, we have developed a complete line of specialty packaging for the safe transport and handling of these products.

 

Cobalt Products. Our Cobalt Products segment includes the production of bulk cobalt (cobalt-60), fabrication of cobalt capsules for radiation therapy and various industrial applications, and recycling of expended cobalt sources. We are the only company in the U.S. that can provide all these unique services. There has been a significant increase in regulation by the Nuclear Regulatory Commission (NRC) in recent years that has created a significant barrier to new entrants into this market.

 

18 

Radiochemical Products. Our Radiochemical Products segment includes production and distribution and FDA approved generic sodium iodide I-131 drug product for the treatment of various isotopically pure radiochemicals for medical, industrial, or research applications. Thesehyperthyroidism and carcinoma of the thyroid. We are the only U.S. Company distributing this generic drug product. This segment also distribution of certain radiochemical products are either directly produced by us or are purchased in bulk form from other producers and distributed by us in customized packages and chemical forms tailored to meet customer requirements. In addition, we provide contract manufacturing of radiochemicalradiopharmaceutical products for our customers, discussed below. This segment will also include our generic radiopharmaceutical and pharmaceutical products we plan to begin producing and selling pending FDA approval.customers.

  

We have submitted an abbreviated New Drug Application (aNDA) to the FDA for a radiochemical product. The FDA has granted the Company’s request for an expedited review of the application which could accelerate the approval of the product. Once approved we anticipate a quick start-up of commercial sales of the drug product which should have a significant positive impact on our revenues. We are also considering other generic drug opportunities and plan to expand the range of products offered within this business segment in the coming years.

18 

 

Fluorine Products. We established the Fluorine Products segment in 2004 to support production and sale of the gases that we expected to produce using our Fluorine Extraction Process (FEP) in conjunction with the operation of the proposed depleted uranium de-conversion facility in Lea County, New Mexico. Near the end of 2013, due to changes in the nuclear industry, we placed further engineering work on this project on hold. We continue to hold discussions with potential future customers seeking this type of service, however, further development activity within this segment will be deferred until market and industry conditions change to justify resuming design and construction of the facility. In the meantime, the Company expects to continue to incur some costs associated with the maintenance of licenses and other necessary project investments, and to continue to keep certain agreements in place that will support resumption of project activities at the appropriate time.

 

Radiological Services. Our Radiological Services segment consists of a wide variety of miscellaneous services such as decommissioning disused irradiation units, performing sealed source exchanges in irradiation and therapy units, and gemstone processing. We are licensed through the NRC to perform certainThe Company has suspended all of its field service activities in connection with the U.S. Department of Energy’s (DOE) Orphan Source Recovery Program (OSRP).  These activities include services to support recovery of disused sources under the DOE’s OSRP and installation or removal of certain cobalt therapy units. We designed and built a mobile hot cell unit to useis in the performanceprocess of OSRP field service jobs. This typeterminating gemstone processing. The Company believes that eliminating work in the Radiological Services segment will allow the Company to better focus upon our core business segments and our new products pipeline. We believe that the loss in revenue resulting from wrapping up of radiological field service work is expected to generate the majority of revenue within thiswill be more than compensated for by increased revenues in our remaining business segment in the coming years and has expanded to include similar international contract opportunities through the International Atomic Energy Agency (IAEA).segments.

 

CRITICAL ACCOUNTING POLICIESCOVID-19 UPDATE

 

From time-to-time, management reviewsAs a result of the COVID-19 pandemic, we experienced a reduction of sales within our nuclear medicine calibration standards segment during the six-months ended June 30, 2020.  There was no discernable impact from COVID-19 to our other business segments during the period.  Revenue from nuclear medicine products for the six months ended June 30, 2020, decreased approximately 10% compared to the same period in 2019.  Revenue from nuclear medicine products for the three months ended June 30, 2020, decreased approximately 16% compared to the same period in 2019.  The decrease in sales for the six months and evaluatesthree months ended June 30, 2020, for our nuclear medicine calibration standards segment was the result of the temporary closure of many imaging clinics and suspension of elective or non-essential imaging procedures.  Beginning in June 2020, we saw a substantial recovery of sales of our nuclear medicine products due to a pent-up demand for these products. We are hopeful that sales will remain at normal levels as the year continues.

Starting in June 2020, we have seen our sales through RadQual substantially recover from the impact of the COVID-19 pandemic. We believe that many of the medical procedures have been delayed, not canceled, and there is a pent-up demand for these products. We will also continue to work towards development of several new products and to further expand our international sales. In addition, we will continue to work with TI Services on marketing strategies to boost customer service and sales of some nuclear medicine imaging and pharmacy products.

To-date we have not furloughed or terminated any employees as a result of the financial impact of COVID-19.  The Company has only seen a limited impact in our raw material supply chain related to the COVID-19, primarily some plastics which have been in strong demand for certain accounting policies thattypes of PPE.  Alternative sources of raw materials have been obtained without any interruption to production.  Travel restrictions related to COVID-19 have also delayed vendor installations of some specialized equipment in our new contract manufacturing facility. Due to these delays, we are considerednow targeting the new facility to be significant in determining our results of operationsup and financial position.

A description of the Company’s critical accounting policies that affect the preparation of the Company’s financial statements is set forthrunning in the Company’s Annual Report on Form 10-K forfirst quarter of 2021. With the year ended December 31, 2018, filed withheightened concern about corporate liquidity during the SEC on March 22, 2019.COVID-19 pandemic, the Company believes that it has adequate cash to support continuing operations.

 

RESULTS OF OPERATIONS

 

Three Months Ended June 30, 20192020 Compared to Three Months Ended June 30, 20182019

 

Revenue for the three months ended June 30, 20192020 was $2,135,839$2,159,559 as compared to $2,392,306$2,135,839 for the same period in 2018,2019, an overall decreaseincrease of $256,467,$23,720, or approximately 11%1%. This decreaseincrease in revenue was largely the result of decreasedincreased revenue in our cobalt products and radiological services segments,Radiochemical Products segment, as discussed in detail below.

 

The following table presents a period-to-period comparison of total revenue by segment for the three months ended June 30, 20192020 and 2018:2019:

 

  

For the three-

months ended

June 30,

  

For the three-

months ended

June 30,

       
Sale of Product 2020  2019  $ change  % change 
Radiochemical Products $1,113,053  $774,107  $338,946   44%
Cobalt Products  224,666   213,239   11,427   5%
Nuclear Medicine Standards  777,873   930,696   (152,823)  -16%
Radiological Services  43,967   217,797   (173,830)  -80%
Fluorine Products  —     —     —     0%
Total Consolidated $2,159,559  $2,135,839  $23,720   1%

 

19 

 

 

  

For the three-months

ended June 30,

  

For the three-months

ended June 30,

       
Sale of Product 2019  2018  $ change  % change 
Radiochemical Products $774,107  $602,344  $171,763   29%
Cobalt Products  213,239   324,768   (111,529)  -34%
Nuclear Medicine Standards  930,696   962,674   (31,978)  -3%
Radiological Services  217,797   502,520   (284,723)  -57%
Fluorine Products  —     —     —     0%
Total Consolidated $2,135,839  $2,392,306  $(256,467)  -11%

Cost of sales decreased to $971,384$903,909 for the three months ended June 30, 20192020 from $1,363,564$971,384 for the same period in 2018.2019. This is a decrease of $392,180,$67,475, or approximately 29%7%. The decrease in cost of sales in the three-month comparison was primarily due to the decreased sales activity in two of our five business segments, particularly the cobalt productsNuclear Medicine and radiological services segments, as discussed in detail below. Gross profit for the three months ended June 30, 20192020 was $1,164,455,$1,255,650, compared to $1,028,742$1,164,455 for the same period in 2018.2019. This represents an increase in gross profit of $135,713,$91,195, or approximately 13%, and is primarily due to the decrease in cost of sales in the cobalt products and radiological services segments as a result of the decreased revenue in these segments.8%.

 

The following table presents cost of sales and gross profit data for each of our business segments for the three months ended June 30, 20192020 and 2018:2019:

 

 

For the three-

months ended

June 30,

 

% of

Total Sales

 

For the three-

months ended

June 30,

 

% of

Total Sales

  

For the three-

months ended

June 30,

 

% of

Total Sales

 

For the three-

months ended

June 30,

 

% of

Total Sales

 
 2019  2019  2018  2018  2020  2020  2019  2019 
Total Sales $2,135,839      $2,392,306      $2,159,559      $2,135,839     
Cost of Sales                            
Radiochemical Products $338,487   16% $439,600   18% $480,816   22% $338,487   16%
Cobalt Products  51,494   2%  182,729   8%  79,091   4%  51,494   2%
Nuclear Medicine Standards  446,699   21%  457,058   19%  332,380   15%  446,699   21%
Radiological Services  134,704   6%  284,177   12%  11,622   1%  134,704   6%
Fluorine Products  —     —     —     —     —    0%  —    0%
Total Segments  971,384   45%  1,363,564   57%  903,909   42%  971,384   45%
                                
Gross Profit $1,164,455      $1,028,742      $1,255,650      $1,164,455     
Gross Profit %  55%      43%      58%      55%    

 

Operating expense increased approximately 2%8% to $1,246,979$1,351,751 for the three months ended June 30, 2019,2020, from $1,228,136$1,246,979 for the same period in 2018.2019. This increase of $18,843,$104,772, is primarily due to an approximate 3% increase in General, Administrative and Consulting costs combined with an approximate 6%24% increase in Salaries and Contract Labor costs. The increase in General, Administrative and Consulting costs is a result of increased legal and general operating supply costs incurred during the three months ended June 30, 2019, as compared to the same period in 2018. TheThis increase in Salaries and Contract Labor was a result of adding staff to our payroll. Researchpayroll to support contract manufacturing and Development costs decreased to $50,354, for the three months ended June 30, 2019, as compared to $84,464, for the same period in 2018. This is a decrease of $34,110, or approximately 40% and is primarily the result of a decrease in expenditures fornew product development in several of our business segments for the three months ended June 30, 2019, as compared to the same period in 2018.development.

 

The following table presents a comparison of total operating expense for the three months ended June 30, 20192020 and 2018:2019:

 

 

For the three-

months ended

June 30,

 

For the three-

months ended

June 30,

       

For the three-

months ended

June 30,

 

For the three-

months ended

June 30,

      
Operating Costs and Expenses: 2019  2018  % change  $ change  2020  2019  % change  $ change 
Salaries and Contract Labor $596,045  $561,058   6% $34,987  $736,539  $596,045   24% $140,494 
General, Administrative and Consulting  600,580   582,614   3%  17,966   573,747   600,580   -4%  (26,833)
Research and Development  50,354   84,464   -40%  (34,110)  41,465   50,354   -18%  (8,889)
Total operating expenses $1,246,979  $1,228,136   2% $18,843  $1,351,751  $1,246,979   8% $104,772 

 

20 

Other expenseincome was $867,660$559,895 for the three months ended June 30, 2019,2020, as compared to other expenseOther Expense of $381($867,660) for the same period in 2018.2019. This is an increase of $867,279.$1,427,555. The increase is due to a combination of income and expenses related to the costs resulting from the contamination event that occurred at an offsite location in the stateSBA Loan (as defined below) of Washington in May 2019. For$495,500 converted to grant income during the three months ended June 30, 2019, net expenses for this cleanup were $887,686. This is a combination of2020 and expenses related to the cleanupcontamination event in the state of $1,522,605, offset by income from insurance proceeds forWashington that occurred in the claim of $634,919 for payments received in Julythree months ended June 30, 2019.

Interest expense for the three months ended June 30, 20192020 was $136,842,$196,344, compared to $115,882$136,842 for the same period in 2018.2019. This is an increase of $20,960,$59,502, or approximately 18%43%. Interest expense includes dividends accrued on our Series C Redeemable Convertible Preferred Stock (Series C Preferred Stock). As discussed below, we issued Series C Preferred Stock in February 2017 and May 2017. For the three months ended June 30, 2019,2020, we accrued dividends payable of $63,646,$63,195, which have been recorded as interest expense. Additionally, non-cash interest expense in the amount of $32,084 was recorded for this same period for the issuance of warrants related to the preferred stock issuances. In AprilAs discussed below, in December 2019, we agreed to modifyentered into a promissory note agreement with our cobalt supply agreement withChief Executive Officer, Chairman of the Board, former Chairman of the Board, and one of our cobalt customers. The modification was necessary to address the delays to cobalt delivery inmajor shareholders (the 2019 caused by changes to the ATR operating schedule and also to accommodate this customer’s request to reduce their cobalt purchase obligations in future years. The modifications require that we refund $2,182,142 for prior year undelivered material. The Company has been able to contract for the sale of this cobalt to a separate new customer for approximately the same amount. Approximately $1,050,000 of this refund will include interest at 12% per year, payable over a one-year period on a portion of that amount.Promissory Note). Interest for this refundrecorded for the three months ended June 30, 2020 for the 2019 Promissory Note was $18,153$10,000 whereas there was no similar interest expense for the same period in 2018. Interest2019. Additionally, non-cash interest expense in the amount of $60,259 for the issuance of warrants in conjunction with the 2019 Promissory Note was also paid on a loanrecorded for a vehicle purchased in May 2016.the three months ended June 30, 2020. See Note 7 “Debt” to our unaudited condensed consolidated financial statements in this Quarterly Report for additional information about our indebtedness and the associated interest expense.

 

Our net lossincome for the three months ended June 30, 2019,2020, was $1,157,194,$229,328, compared to a net loss of $332,279,($1,157,194), for the same period in 2018.2019. This is an increase in loss of $824,915income of $1,386,522 and is athe result of increased sales of our radiochemical product sodium iodide, a reduction in net expenses of $887,686 related to the cleanup of the contamination event that occurred at an offsite location in the state of Washington. These expenses are includedWashington in an ongoing insurance claim.the second quarter of 2019, and $495,500 of income from the SBA Loan converted to grant income during the second quarter of 2020.

 

20 

Radiochemical Products. Revenue from the sale of radiochemical products for the three months ended June 30, 20192020 was $774,107,$1,113,053, compared to $602,344$774,107 for the same period in 2018.2019. This is an increase of $171,763,$338,946, or approximately 29%44%. The increase is a result of a $588,946 or 112% increase in radiochemical product sales year over year that was primarily the result of sales of our new generic sodium iodide I-131 drug product which was launched in March 2020. This increase in sales was partially offset by a reduction in payments related to ourreceived for contract manufacturing and supply agreement with Progenics Pharmaceuticals, Inc. (Progenics), as discussed below.services in the three-month period compared to 2019.

 

Gross profit of radiochemical products for the three months ended June 30, 20192020 was $435,620,$632,237, compared to $162,745,$435,620, for the same period in 2018,2019, and gross profit percentages were approximately 57% and 56% for the three months ended March 31, 2020 and 27%2019, respectively. This increased gross profit percentage is a result of sales of our new generic sodium iodine I-131 drug product and continued improvements of utilization of raw materials. Cost of sales for radiochemical products increased to $480,816 for the three months ended June 30, 20192020, as compared to $338,487 for the same period in 2019. This is an increase of $142,329, or approximately 42%, and 2018, respectively. Costwas primarily the result of increased sales of product. Operating expense for radiochemical products decreasedthis segment increased to $338,487$251,509 for the three months ended June 30, 2019, as2020, compared to $439,600$182,674 for the same period in 2018.2019. This is a decreaseincrease in operating expense of $101,112,$68,835, or approximately 23%38%, and wasis primarily the result of improvements in the utilization of raw material purchased in this segment, in the three-month comparison. Our decrease in material costs is due to a reduction in freight charges as a resultincreased costs for support labor for contract manufacturing startup operations, increased support labor related to increased radiochemical sales activity, and increased support labor related to sales of purchasing our material within the U.S. thus eliminating international shipping and customs fees. We expect this cost savings in shipping to continue with future shipments from this domestic supplier. Operating expense for thisnew generic sodium iodine I-131 drug product. This segment increased to $182,674reported net income of $380,728 for the three months ended June 30, 2019,2020, as compared to $59,707 for the same period in 2018. This increase in operating expense of $122,967, or approximately 206%, is primarily due to costs related to the aNDA repairs to equipment, and costs incurred for contract manufacturing. This segment reported net income of $252,946 for the three months ended June 30, 2019, as compared to net income of $103,038 for the same period in 2018.2019. The increase in net income of $149,908$127,782 or approximately 145%51%, is primarily the result of the 112% increase radiochemical product sales but somewhat offset by a $250,000 paymentreduction in payments received related to our contract manufacturing and supply agreement with Progenics. Other changes wereduring the decrease in cost of goods sold as discussed above, and, increase in operating expenses as discussed above.

In April 2019, we entered into a contract manufacturing and supply agreement with Progenics. Under the agreement, we will provide contract manufacturing services for AZEDRA® (Ultratrace® Iobenguane I-131) and other iodine products. We believe that this contract manufacturing for Progenics helps further broaden our customer base and technical experience and positions us for future additional agreements under which we can use our license qualifications and experience in handling iodine-131.three months ended June 30, 2020.

 

Cobalt Products. Revenue from the sale of cobalt products for the three months ended June 30, 20192020 was $213,239,$224,666, compared to $324,768,$213,239, for the same period in 2018.2019. This represents a decreasean increase of $111,529,$11,427, or approximately 34%5%. Our cobalt sealed source manufacturing is largely dependent on our ability to procure cobalt material from the DOE’s Advanced Test Reactor (ATR). Although we have not been able to obtain cobalthigh specific activity material from the ATR reactor since late 2013, periodically we have beenare able to contract with another supplieracquire recycled material or material from alternative suppliers that can be used to manufacture sealed sources for the purchase ofcustomers, and in some instances, our customers have supplied their own cobalt material and during the three months ended June 30, 2019, we were able to manufacture products for customers using this material.source fabrication. In addition, we have begun to supply cobalt to periodically supply material to customers who previously paid for the material under supply agreements entered into with us in 2015. As we have supplied this material to our customers, we have recognized the sales on our statement of operations.

 

21 

We have experienced delays in the delivery of cobalt material from the DOE’s ATR. Because of these delays, we have been forced to purchase cobalt material, at lower activity levels, from alternate suppliers in order to meet contract obligations. Deliveries of cobalt from the ATR are expected to begin in the beginning of 2020.

In October 2014, we entered into a ten-year agreement with the DOE for the irradiation of cobalt targets. The agreement gives us the ability to purchase the current full capacity of the DOE’s ATR throughout the ten-year period. It takes approximately four to fivemany years to irradiate thethese cobalt targets to the desired level of activity andactivity. Our production calculations indicated we anticipateshould have anticipated having high specific activity cobalt available tofor our customers earlyin late 2019. However, extended reactor shutdowns and lower than expected production rates of cobalt-60 in the new design cobalt targets have delayed delivery of high specific activity cobalt until much later in 2020 and every year thereafter through at least 2024.the start of 2021.

 

As of June 30, 2019,March 31, 2020, we continued to hold many in-progress, old design cobalt targets at the ATR. We believe that many of the older design targets we hold at the ATR, and that we report as inventory, still hold significant market value in excess of their current carrying values and we have concluded that no impairment existed at that time. We will periodically continue to review the residual value of this cobalt material for potential impairment and make adjustments as deemed appropriate.

 

During 2015, we entered into cobalt-60 supply agreements with several customers. The terms of the agreements required pre-payments to secure cobalt material in future years. Those prepayments were recorded as unearned revenue on our condensed consolidated balance sheet. During the three months ended June 30, 2019, we began supplying material to some customers and have accordingly recognized approximately $8,000 of revenue as a result of these deliveries.

 

In April 2019, because of our inability to supply high specific activity cobalt material produced by the DOE’s ATR, in 2018, we modified ourwere forced to modify a supply agreement with one of our cobalt customers. The modification included our agreement to reduce the customers cobalt purchase obligations in future years andmodifications require that we agreed to refund approximately $2,182,142. Approximately $1,050,000$1,100,000, of this refund is for payments received from this customer for prior year undelivered material, and will includeplus interest at 12% per year, payable over a one-year period on a portion of the payments.period. We have also agreed with this customer to refund approximately $1,100,000 paid for material that was to have been delivered in later years. There will be no interest charge on this portion ofrefund. In December 2019, this agreement was modified further allowing the refund.Company to delay the original payments by 3 months and refund an additional $462,258 with no interest charge. In addition, we have identified another customer ready to purchase this material. The Company does not anticipate any significant net negative effect of this change as sales under the new agreement are expected to completely offset most of the refunds made under the old agreement. Accordingly, we will classify refund payments due within one year as a short-term liability and payments due beyond one year as a long-term liability, rather than as short-term deferred revenue on our condensed consolidated balance sheets.

 

21 

Cost of sales for the three months ended June 30, 2019,2020, was $51,494,$79,091, as compared to $182,729,$51,494, for the same period in 2018.2019. Gross profit for cobalt products for the three months ended June 30, 20192020 was $161,745$145,575 compared to $142,040$161,745 for the same period in 2018.2019. This is an increasea decrease of $19,705,$16,170, or approximately 14%10% and is primarily attributable to our increasecost of the material sold in source manufacturing for the three months ended June 30, 2019,2020, as compared to the same period in 2018. Our gross profit percentages were approximately 76% and 44% for the three-month periods ended June 30, 2019 and 2018, respectively. The increase2019. Operating expense in the gross profit percentagethis segment increased to $69,701 for the three months ended June 30, 20192020, from $39,493 for the same period in 2019. This is primarily due to decreased costsan increase of raw material used$30,208, or approximately 77%. This increase in the manufacture of sealed sources. Operating expense in this segment decreased to $39,493operating expenses for the three months ended June 30, 2019, from $48,927 for the same period in 2018. This is a decrease of $9,434, or approximately 19%. This2020 is due to a decrease inincreased labor costs for the period.expenses. Our net income for cobalt products was $122,252$75,874 for the three months ended June 30, 2019,2020, as compared to a net income of $93,112$122,252 for the same period in 2018.2019. The increasedecrease in net income of $29,140,$46,378, or approximately 31%38%, was attributable to the decreased cost of sales for cobalt products during the quarter.increased operating expenses.

 

Nuclear Medicine Standards. Revenue from nuclear medicine products for the three months ended June 30, 2019,2020, was $930,696,$777,873, compared to $962,674$930,696 for the same period in 2018.2020. This represents a decrease in revenue of $31,978,$152,823, or approximately 3%16%. As discussed above, due to a change in the member ownership of RadQual, in August 2017 we began reporting our investment in RadQual on a consolidated basis. Therefore, revenue in this segment includes all sales of RadQual and TI Services with all intercompany sales for the consolidated period eliminated. The decrease in sales for the period ended June 30, 2020 was due to slowing sales activity attributed to the COVID-19 global outbreak which resulted in the temporary closure of many imaging clinics and suspension of elective or non-essential imaging procedures.

 

We anticipate thatStarting in June 2020, we have seen our sales through RadQual substantially recover from the impact of the COVID-19 pandemic. We believe that many of the medical procedures have been delayed, not canceled, and there is a pent-up demand for these products. We will remain strong and that, because of our RadQual ownership, we willalso continue to have significant future opportunities to work ontowards development of several new product developmentproducts and to further expand our international sales. Additionally,In addition, we have continuedwill continue to work with TI Services on marketing strategies to boost customer service and sales of some unique nuclear medicine imaging and pharmacy products.

 

22 

Cost of sales for our nuclear medicine standards segment for the three months ended June 30, 2019,2020, was $446,699,$332,380, as compared to $457,058$446,699 for the same period in 2018.2019. The decrease in cost of sales in the period-to-period comparison of $10,359,$114,319, or approximately 2%26%, wasis due to slight decreasesdecrease in material purchased for flood source manufacturingsales for the three-month period ended June, 30, 2019,2020, as compared to the same period in 2018.2019. Gross profit for our nuclear medicine standards segment for the three months ended June 30, 20192020 was $483,997$445,493 compared to $505,616$483,997 for the same period in 2018.2019. This is a decrease in gross profit of $21,619,38,504, or approximately 4%8%. The decrease in gross profit in the period-to-period comparison is primarily the result of the decreased sales. Our gross profit percentages were approximately 57% and 52% for the three-month periods ended June 30, 2020 and 2019, respectively. The increase in the gross profit percentage for the three months ended June 30, 2020 is primarily due to increased profit margins in our sales through TI Services.

 

Operating expense for this segment for the three months ended June 30, 2019 increased2020 decreased to $378,539,$328,437, from $306,728$378,539 for the same period in 2018.2019. This is an increasea decrease of $71,811,$50,102, or approximately 23%13%, and is the result of increased wagedecreased non-controlling member interest expense for the three months ended June 30, 2019, as compared to the same period in 2018.2019. Operating expense also includes consolidated net operating expense reported for RadQual of $137,187$126,367 and non-controlling member interest expense of $76,204,$39,789, for the three months ended June 30, 2019,2020, as compared to $139,524$124,348 of net operating expense and non-controlling member interest expense of $19,965$76,204 for the same period in 2018.2019. Net operating expense included for TI Services was $29,393$23,381 for the three months ended June 30, 2019,2020, and $27,810$29,393 for the same period in 2018.2019. TI Services non-controlling interest included was ($2,425)919) for the three-month period ended June 30, 2019,2020, as compared to ($1,026)2,425) for the same period in 2018.2019. Net income for this segment for the three months ended June 30, 20192020 was $111,921,$117,056, compared to $165,295$111,921 for the same period in 2018.2019. This is a decreasean increase in net income of $53,374,$5,136, or approximately 32%5% and is primarily the result of the increase indecreased operating expense reported for the three months ended June 30, 2019, as compared to the same period in 2018.expenses partially offset by decreased gross profit.

 

Radiological Services.Revenue from all radiological services for the three months ended June 30, 20192020 was $217,797,$43,967, compared to $502,520,$217,797, for the same period in 2018,2019, a decrease of $284,723$173,830 or approximately 57%80%. The majority of our revenue in this segment ishas been generated by the performance of activities in connection with contracts for the DOE and the IAEA.International Atomic Energy Agency (IAEA) to support recovery of disused sources and removal of certain devices. The decrease in the revenue for the period comparison is the result of the random timingDOE cancelling and putting on hold all contracts related to this type of work. The Company plans to suspend these activities going forward.

22 

On May 2, 2019, the Company’s radiological services team was involved in a contamination event involving a breached cesium-137 source at an off-site location in the state of Washington. This work was being performed under a contract with the DOE. The Company supported the initial onsite contamination clean-up operations at that location and completed removal of the work performedcesium source Company equipment. The Company has reviewed the results of the DOE investigation into this event and has implemented appropriate corrective actions. Since August 2019 the DOE has assumed full control of the ongoing cleanup operations and has assumed all of the financial obligations associated with the contractors hired to carry out all of the facility recovery operations. Under the terms of the contract the Company believes it should be indemnified from financial liability for this event by usthe DOE under the Price Anderson Amendments Act (PAAA) and the Company has formally requested the DOE to provide indemnification under the PAAA.

The Washington Department of Health (DOH) issued a Notice of Violation to the Company in May 2020 citing two violations of the Company’s reciprocity license in the State of Washington. Also, the U.S. Nuclear Regulatory Commission (NRC) completed an inspection of the Company’s radiological safety program and issued a Notice of Violation in June 2020 citing two different violations of the Company’s NRC materials license. The Company has requested and completed Predecisional Enforcement Conferences with the Washington DOH and the NRC and has provided the agencies with information on all corrective actions completed by the Company to prevent reoccurrence. The Company is awaiting the results of deliberations by Washington DOH and NRC on these matters and their respective decisions for any further actions or the imposition of a civil penalty against the Company. In addition to the costs and expenses identified above, in the event the Washington DOH Notice of Violation results in the imposition of a civil penalty against the Company, based upon consultation with legal counsel, the Company reasonably believes such civil penalty falls within the parameters for indemnification of the Company under the PAAA. It is not possible at this time to predict the timing or outcome of these agencies. These contracts are historically awarded sporadically over timematters or to estimate a potential amount of loss, if any.

In January 2020, we notified our gemstone processing customer that the service contract with them was being terminated because the volume of gemstones sent for processing did not meet contract minimums. The termination activities and thuswrap up of this service will continue through the remainder of 2020 and the Company will see a steady decline in revenue from this service as production is wrapped up. We plan to create fluctuationsconvert the spaces in the period-to-period comparisonsfacility that had been used to perform this contract work into expanded Nuclear Medicine product manufacturing. The loss in radiological services revenue. The work performedrevenue expected from termination of the gemstone processing agreement is expected to be more than compensated for by the DOE and the IAEA includes services to support recoveryexpansion of disused sources and installation or removal of certain devices.new nuclear medicine source products.

 

Cost of sales for the three months ended June 30, 2019,2020, was $134,704,$11,622, as compared to $284,178,$134,704, for the same period in 2018.2019. Gross profit for this segment for the three months ended June 30, 20192020 was $83,093,$32,345, compared to $218,342,$83,093, reported for the same period in 2018.2019. The decrease in gross profit of $135,249,$50,748, or approximately 62%61%, is the result of the decrease in service contracts completed and reported in this segment for the three months ended June 30, 2019,2020, as compared to the same period in 2018.2019. Operating expense for the three months ended June 30, 20192020 was $96,641,$45,877 as compared to $53,901,$96,641, reported for the same period in 2018.2019. This increasedecrease of $42,740,$50,764, or approximately 79%53%, is the result of an increase in costs in equipment repairsdecreased sales and professional fees.

On May 3, 2019,activity within the Company’s radiological services team was involved in a contamination event at an off-site location in the state of Washington. The Company is currently supporting clean-up operations at that location and is supporting an investigation into the possible causes of the event. The Company has reported this incident to its insurance carrier and a claim is being processed to address the cost of recovery operations. During the three months ended June 30, 2019 the company incurred $1,522,605 in expenses related to the event which is included in “other expense” on the Company’s P&L statements. The company has received $634,919 to-date in reimbursements from its insurance company for this ongoing claim which is included in “other income”. The Company is actively working with its insurance company and believes it will recover a majority of the external contract cost of these clean-up operations.business segment.

 

Net loss for this segment for the three months ended June 30, 20192020 was ($901,234),$13,532, compared to net incomeloss of $164,441,$901,234, for the same period in 2018.2019. This is a decrease in net incomeloss of $1,065,675$887,702, or approximately 99% and is the result of costsnet other expenses incurred in the three months ended June 30, 2019 of $887,686 associated with clean-up operations related to the contamination event as noted above. Additionally, the decrease in revenue reported for the three months ended June 30, 2019, as compared to the same period in 2018 contributes to the decrease in net income.

 

Fluorine Products.There was no revenue to report from the fluorine products segment for the three months ended June 30, 2019,2020, or for the same period in 2018.2019. During the three months ended June 30, 2019,2020, we incurred $39,927$36,460 of expense related to items in support of future planning and design for the proposed de-conversion facility, as compared to $31,613$39,927 for the same three-month period in 2018. The2019. This is an increase of $8,314, or approximately 26% is the result of increased costs for professional services recorded9% in the period-to-period comparison.

 

We established the Fluorine Products segment in 2004 to support production and sale of the gases produced using our Fluorine Extraction Process (“FEP”). WeFEP. The project has been placed on hold since 2013 and we will continue to limit our expenditures to essential items such as maintenance of the NRC license, land use agreements, communication with our prospective FEP product customers, and interface with the State of New Mexico and Lea County officials.officials until such time that we decide to resume the project.

23 

 

Six Months Ended June 30, 20192020 Compared to Six Months Ended June 30, 20182019

 

Revenue for the six-month period ended June 30, 20192020 was $4,663,691,$4,495,345, as compared to $5,193,332$4,663,691 for the same period in 2018,2019, a decrease of $529,641,$168,346, or approximately 10%4%. The performance of all our business segments for the six-month period is discussed in further detail below.

 

23 

The following table presents a period-to-period comparison of total revenue by segment for the six months ended June 30, 20192020 and June 30, 2018:2019:

 

 

For the six-

months ended

June 30,

 

For the six-

months ended

June 30,

       

For the six-

months ended

June 30,

 

For the six-

months ended

June 30,

      
Sale of Product 2019  2018  $ change  % change  2020  2019  $ change  % change 
Radiochemical Products $1,237,339  $1,185,885  $51,454   4% $1,868,274  $1,237,339  $630,935   51%
Cobalt Products  589,328   652,546   (63,218)  -10%  530,286   589,328   (59,042)  -10%
Nuclear Medicine Standards  2,031,618   1,964,787   66,831   3%  1,819,997   2,031,618   (211,621)  -10%
Radiological Services  805,406   1,390,114   (584,708)  -42%  116,288   805,406   (689,118)  -86%
Fluorine Products  —     —     —     0%  160,500   —     160,500   0%
Total Consolidated $4,663,691  $5,193,332  $(529,641)  -10% $4,495,345  $4,663,691  $(168,346)  -4%

 

Gross profit for the six-month period ended June 30, 20192020 was $2,603,878,$2,622,911, compared to $2,387,361,$2,603,879, for the same period in 2018.2019. This represents a decrease of $216,517$19,032 or approximately 9%1%.

 

The following table presents cost of sales and gross profit data for each of our business segments for the six months ended June 30, 20192020 and 2018:2019:

 

 

For the six-

months ended

June 30,

 

% of

Total Sales

 

For the six-

months ended

June 30,

 

% of

Total Sales

  

For the six-

months ended

June 30,

 

% of

Total Sales

 

For the six-

months ended

June 30,

 

% of

Total Sales

 
 2019  2019  2018  2018  2020  2020  2019  2019 
Total Sales $4,663,691      $5,193,332      $4,495,345      $4,663,691     
Cost of Sales                            
Radiochemical Products $618,137   13% $931,053   18% $890,411   20% $618,137   13%
Cobalt Products  171,638   4%  263,243   5%  143,530   3%  171,638   4%
Nuclear Medicine Standards  917,842   20%  930,109   18%  805,154   18%  917,842   20%
Radiological Services  352,195   7%  681,567   13%  33,339   1%  352,196   8%
Fluorine Products  —     0%  —     0%  —     0%  —     0%
Total Segments  2,059,812   44%  2,805,972   54%  1,872,434   42%  2,059,812   45%
                                
Gross Profit $2,603,878      $2,387,360      $2,622,911      $2,603,879     
Gross Profit %  56%      46%      58%      56%    

 

Operating expenses were $2,543,845$2,928,322 for the six-month period ended June 30, 2019, compared to $2,437,149$2,543,845 for the same period in 2018.2019. This represents an increase of $106,696,$384,477, or approximately 4%15%. This increase is primarily due to an approximate 10%11% increase in General, Administrative and Consulting costs combined with an approximate 8%21% increase in Salaries and Contract Labor costs. The increase in General, Administrative and Consulting costs is a result of increased legalrent expense related to the expansion of our existing facility and general operating supply costs incurredincreased professional services expense during the six months ended June 30, 2019,2020, as compared to the same period in 2018.2019. The increase in Salaries and Contract Labor was a result of adding staff to our payroll. Research and Development costs decreased to $96,658,$88,393, for the six months ended June 30, 2019,2020, as compared to $190,884,$96,658, for the same period in 2018.2019. This is a decrease of $94,226,$8,265, or approximately 49%9% and is primarily the result of a decrease in expenditures for product development in several of our business segments for the six months ended June 30, 2019,2020, as compared to the same period in 2018.2019.

 

24 

The following table shows total operating expenses for the six-month period ended June 30, 20192020 and 2018:2019:

 

 

For the six-

months ended

June 30,

 

For the six-

months ended

June 30,

       

For the six-

months ended

June 30,

 

For the six-

months ended

June 30,

      
Operating Costs and Expenses: 2019  2018  % change  $ change  2020  2019  % change  $ change 
Salaries and Contract Labor $1,219,744  $1,130,517   8% $89,227  $1,477,744  $1,219,744   21% $258,000 
General, Administrative and Consulting  1,227,443   1,115,748   10%  111,695   1,362,185   1,227,443   11%  134,742 
Research and Development  96,658   190,884   -49%  (94,226)  88,393   96,658   -9%  (8,265)
Total operating expenses $2,543,845  $2,437,149   4% $106,696  $2,928,322  $2,543,845   15% $384,477 

 

24 

Interest expense for the six months ended June 30, 20192020 was $250,919,$391,224, compared to $221,916$250,919 for the same period in 2018.2019. This is an increase of $29,003,$140,305, or approximately 13%56%. Interest expense includes dividends accrued on our Series C Preferred Stock. As discussed below, we issued Series C Preferred Stock in February and May 2017. For the six months ended June 30, 2019,2020, we accrued dividends payable of $115,538$126,390 which have been recorded as interest expense. Additionally, non-cash interest expense in the amount of $64,167 was recorded for this same period for the issuance of warrants related to the preferred stock issuances. InterestAdditionally, non-cash interest expense in the amount of $123,544 for the issuance of warrants in conjunction with the 2019 Promissory Note was also paid on a loanrecorded for a vehicle purchased in May 2016.the six months ended June 30, 2020.

 

Our net loss for the six-month period ended June 30, 2019,2020, was $1,209,151$193,166 as compared to $297,875$1,209,151 for the same period in 2018.2019. This is an increasea decrease in loss of $911,276$1,015,985 or approximately 306%84%. This increasedecrease in net loss is athe result of increased sales of our radiochemical product sodium iodide, a reduction in net expenses of $887,686 related to the cleanup resulting fromof the contamination event occurring at an offsite locationthat occurred in the state of Washington in May 2019. These expenses are included in an ongoing insurance claim.the second quarter of 2019, and $495,500 of income from the SBA Loan converted to grant income during the second quarter of 2020.

 

Radiochemical Products. Revenue from the sale of radiochemical products for the six-month period ended June 30, 20192020 was $1,237,339$1,868,274 compared to $1,185,885$1,237,339 for the same period in 2018.2019. This is an increase of $51,454,$630,935, or approximately 4%51%. This increase was primarily the result of sales of our new generic sodium iodide I-131 drug product which was launched in March 2020. This increase in sales was partially offset by a reduction in payments received for contract manufacturing services in the six-month period compared to 2019.

 

Cost of sales was $618,137$890,411 for the six-month period ended June 30, 2019,2020, and $931,053$618,137 for the same period in 2018.2019. This is a decreasean increase of $312,916,$272,274, or approximately 34%44%. This decreaseincrease is primarily the result of decreasedour increase in sales, of product and improvements in the utilization of raw material purchased in this segment, in the six-month comparison. Our decrease in material costs is due to a reduction in freight charges as a result of purchasing our material within the U.S. thus eliminating international shipping and customs fees. We expect this cost savings in shipping to continue with future shipments from this domestic supplier.discussed above.

 

Gross profit percentages for our radiochemical products for the six months ended June 30, 20192020 and 20182019 were approximately 50%52% and 21%50%, respectively. Operating expense for this segment for the six-month period ended June 30, 20192020 was $270,200,$597,951, compared to $111,276$270,200 for the same period in 2018.2019. This is an increase of $158,924,$327,751, or approximately 143%121%, and is primarily due primarily due to increased salaries and wages, costs for support labor for contract manufacturing startup operations, increased rent expense directly related to the aNDA, repairs to equipment, and costs incurredour facility expansion for contract manufacturing.manufacturing operations, increased support labor related to increased radiochemical sales activity, and increased support labor related to rollout and sales of our new generic sodium iodine I-131 drug product. Net income for this segment increased to $349,002$386,347 for the six-month period ended June 30, 2019,2020, from $143,557$349,002 for the same period in 2018.2019. This increase of $205,445,$37,345, or approximately 143%11%, is primarily the result of the 87% increase radiochemical product sales but somewhat offset by a $250,000 payment related toreduction in payments received for our contract manufacturing and supply agreement with Progenics. Other changes wereduring the decrease in cost of goods sold as discussed above and increase in operating expenses as discussed above.three months ended June 30, 2020.

 

Cobalt Products. Revenues from the sale of cobalt products for the six-month period ended June 30, 20192020 were $589,328,$530,286, compared to $652,546$589,328 for the same period in 2018.2019. This is a decrease of $63,218,$59,042, or approximately 10%, and is the result of decreased Cobalt Recycling.sealed source manufacturing and Cobalt recycling. Our cobalt sealed source manufacturing is largely dependent on our ability to procure cobalt material from the DOE’s ATR.Advanced Test Reactor (ATR). Although we have not been able to obtain cobalthigh specific activity material from the ATR reactor since late 2013, periodically we are able to acquire recycled material or material from alternative suppliers that can be used to manufacture sealed sources for customers, and in some instances, our customers have supplied their own cobalt material for source fabrication. In addition, we have been ablebegun to contract with another suppliersupply cobalt to periodically supply material to customers who previously paid for the purchasematerial under supply agreements entered into with us in 2015. As we have supplied this material to our customers, we have recognized the sales on our statement of cobalt material and during the six months ended June 30, 2018, we were able to resume manufacturing products for customers using this material.operations.

 

In November 2018, we entered into a supply agreement with an additional customer under which we will begin delivering cobalt material in late 2019 or early 2020. During the six months ended June 30, 2019, we began fulfilling contract milestones of this agreement. All pre-payments for material have been recorded as unearned revenue on our consolidated balance sheets.

We have experienced delays in the delivery of cobalt material from the DOE’s ATR. Because of these delays, we have been forced to purchase cobalt material, at lower activity levels, from alternate suppliers in order to meet contract obligations.

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In October 2014, we entered into a ten-year agreement with the DOE for the irradiation of cobalt targets. The agreement gives us the ability to purchase the current full capacity of the DOE’s ATR throughout the ten-year period. It takes approximately three to fourmany years to irradiate thethese cobalt targets to the desired level of activity and we anticipateanticipated having high specific activity cobalt available tofor our customers earlyin late 2019. However, extended reactor shutdowns and lower than expected production rates of cobalt-60 in the new design cobalt targets have delayed delivery of high specific activity cobalt until much later in 2020 and every year thereafter throughstart of 2021.

As of March 31, 2020, we continued to hold many in-progress, old design cobalt targets at least 2024. As mentioned above, we are continuing to purchase some bulk cobalt from another supplier, which will allow us to complete some additional source manufacturing sales during 2019 in advancethe ATR. We believe that many of the older design targets we hold at the ATR, and that we report as inventory, still hold significant market value in excess of their current carrying values and we have concluded that no impairment existed at that time. We will periodically continue to review the residual value of this cobalt that is being produced in the ATR.material for potential impairment and make adjustments as deemed appropriate.

 

During 2015, we entered into cobalt-60 supply agreements with several customers. The terms of the agreements required pre-payments to secure cobalt material in future years. Those prepayments were recorded as unearned revenue on our condensed consolidated balance sheet. Beginning in 2019, we began supplying material to some customers and have accordingly recognized approximately $102,360 of revenue as a result of these deliveries.

 

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In April 2019, because of our inability to supply high specific activity cobalt material produced by the DOE’s ATR in 2018, we modified our supply agreement with one of our cobalt customers. The modification included our agreement to reduce the customers cobalt purchase obligations in future years and we agreed to refund approximately $1,100,000, of payments received from this customer for prior year undelivered material, plus interest at 12% per year, payable over a one-year period. We have also agreed with this customer to refund approximately $1,100,000 paid for material that was to have been delivered in later years. There will be no interest charge on this refund. In addition, we have identified another customer ready to purchase this material. The Company does not anticipate any significant net negative effect of this change as sales under the new agreement are expected to completely offset refunds made under the old agreement. Accordingly, we will classify refund payments due within one year as a short-term liability and payments due beyond one year as a long-term liability, rather than as short-term deferred revenue on our condensed consolidated balance sheet.

 

Cost of sales for the six months ended June 30, 2019,2020, was $171,638,$143,530, as compared to $263,243,$171,638, for the same period in 2018.2019. Gross profit for cobalt products for the six months ended June 30, 20192020 was $417,689$386,756 compared to $389,304$417,689 for the same period in 2018.2019. This is an increasea decrease of $28,385,$30,933, or approximately 7% and is primarily attributable to our increase inthe result of decreased Cobalt sealed source manufacturing and decrease in cost of sales for the six months ended June 30, 2019, as compared to the same period in 2018.Cobalt recycling. Our gross profit percentages were approximately 71%73% and 60%71% for the six-month periods ended June 30, 20192020 and 2018,2019, respectively. The increase in the gross profit percentage for the six months ended June 30, 20192020 is primarily due to decreased costs of raw material used in the manufacture of sealed sources. Operating expense in this segment decreasedincreased to $102,567$187,086 for the six months ended June 30, 2019,2020, from $111,399$102,567 for the same period in 2018.2019. This is a decreasean increase of $8,832,$84,519, or approximately 8%.82% is a result of increased support labor expenses and equipment expenses in the six months ended June 30, 2020 as compared to the same period in 2019. Our net income for cobalt products was $315,122$199,670 for the six months ended June 30, 2019,2020, as compared to a net income of $277,905$315,122 for the same period in 2018.2019. The increasedecrease in net income of $37,217$115,452 or approximately 13%37%, was attributable to the significantincrease in operating expenses and decrease in cost of sales as well as the decrease in operating expense in this segment for the six months ended June 30, 2019,2020, as compared to the same period in 2018.2019.

 

Nuclear Medicine Standards. Revenue from nuclear medicine products for the six-month period ended June 30, 20192020 was $2,031,618$1,819,997 compared to $1,964,787$2,031,618 for the same period in 2018.2019. This represents an increasea decrease in revenue attributable to this segment of $66,831,$211,621, or approximately 3%10%. The decrease in sales for the period ended June 30, 2020 was due to slowing sales activity attributed to the COVID-19 global outbreak which resulted in the temporary closure of many imaging clinics and suspension of elective or non-essential imaging procedures.

 

As discussed above, due to a change in the member ownership of RadQual, during 2017, we began reporting our investment in RadQual on a consolidated basis. Therefore, revenue in this segment includes all sales of RadQual and sales of TI Services, a 50/50 joint venture that we formed with RadQual in December 2010, to distribute products and services for nuclear medicine, nuclear cardiology, and PET imaging. All intercompany sales for the consolidated period have been eliminated. The decrease in sales for the six months ended June 30, 2020 was due to slowing sales activity attributed to the COVID-19 global outbreak which resulted in the closure of many imaging clinics and suspension of elective or non-essential imaging procedures.

Starting in June 2020, we have seen our sales through RadQual substantially recover from the impact of the COVID-19 pandemic. We believe that many of the medical procedures have been delayed, not canceled, and there is a pent-up demand for these products. We will also continue to work towards development of several new products and to further expand our international sales. In addition, we will continue to work with TI Services on marketing strategies to boost customer service and sales of some nuclear medicine imaging and pharmacy products.

 

Gross profit for the six-month period ended June 30, 20192020 was $1,113,776,$1,014,843, as compared to $1,034,678$1,113,776 for the same period in 2018, an increase2019, a decrease of $79,098,$98,933, or approximately 8%9%. Operating expense for this segment for the six-month period ended June 30, 2019 increased2020 decreased to $800,601,$748,086, from $651,152$785,033 for the same period in 2018.2019. This is an increasea decrease of $149,449$52,515 or approximately 23%9% and includes consolidated net operating expense reported for RadQual of $304,430 and non-controlling member interest expense of $82,223, for the six months ended June 30, 2020, compared to consolidated net operating expense of $277,081 and non-controlling member interest expense of $179,593, for the six months ended June 30, 2019, compared to consolidated net operating expense of $263,377 and non-controlling member interest expense of $84,328, for the six months ended June 30, 2018.2020. Net income for this segment for the six-month period ended June 30, 2019,2020, decreased to $328,743,$302,357, approximately 16%8%, from $389,236$328,743 for the same six-month period in 2018.2019.

 

Radiological Services. TheRevenue from all radiological services segment reported revenue of $805,406 for the six-month periodsix months ended June 30, 20192020 was $116,288, compared to $1,390,114$805,406, for the same period in 2018. This is2019, a decrease of $584,708,$689,118 or approximately 42%86%. The majority of our revenue in this segment ishas been generated by the performance of activities in connection with contracts for the DOE and the IAEA.International Atomic Energy Agency (IAEA) to support recovery of disused sources and removal of certain devices. The decrease in the revenue for the period comparison is the result of the random timingDOE cancelling and putting on hold all contracts related to this type of the work performed by us forwork. The Company plans to suspend these agencies. These contracts are historically awarded sporadically over time and thus will continue to create fluctuations in the period-to-period comparisons in radiological services revenue.activities going forward.

 

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Gross profit was $453,211 for this segment for the six months ended June 30, 2019, and $708,547 for the same period in 2018. This is a decrease in gross profit of $255,336, or approximately 36% and is the result of decreased revenue reported in this business segment. Operating costs were $155,480 and $142,093 for the six months ended June 30, 2019 and 2018, respectively. The increase in operating expense of $13,387, or approximately 9%, is due to increased professional services.

On May 3,2, 2019, the Company’s radiological services team was involved in a contamination event involving a breached cesium-137 source at an off-site location in the state of Washington. This work was being performed under a contract with the DOE. The Company is currently supportingsupported the initial onsite contamination clean-up operations at that location and is supporting an investigation into the possible causescompleted removal of the event.cesium source Company equipment. The Company has reportedreviewed the results of the DOE investigation into this incidentevent and has implemented appropriate corrective actions. Since August 2019 the DOE has assumed full control of the ongoing cleanup operations and has assumed all of the financial obligations associated with the contractors hired to its insurance carrier and a claim is being processed to addresscarry out all of the cost offacility recovery operations. DuringUnder the threeterms of the contract the Company believes it should be indemnified from financial liability for this event by the DOE under the Price Anderson Amendments Act (PAAA) and the Company has formally requested the DOE to provide indemnification under the PAAA.

The Washington Department of Health (DOH) issued a Notice of Violation to the Company in May 2020 citing two violations of the Company’s reciprocity license in the State of Washington. Also, the U.S. Nuclear Regulatory Commission (NRC) completed an inspection of the Company’s radiological safety program and issued a Notice of Violation in June 2020 citing two different violations of the Company’s NRC materials license. The Company has requested and completed Predecisional Enforcement Conferences with the Washington DOH and the NRC and has provided the agencies with information on all corrective actions completed by the Company to prevent reoccurrence. The Company is awaiting the results of deliberations by Washington DOH and NRC on these matters and their respective decisions for any further actions or the imposition of a civil penalty against the Company. In addition to the costs and expenses identified above, in the event the Washington DOH Notice of Violation results in the imposition of a civil penalty against the Company, based upon consultation with legal counsel, the Company reasonably believes such civil penalty falls within the parameters for indemnification of the Company under the PAAA. It is not possible at this time to predict the timing or outcome of these matters or to estimate a potential amount of loss, if any.

In January 2020, we notified our gemstone processing customer that the service contract with them was being terminated because the volume of gemstones sent for processing did not meet contract minimums. The termination activities and wrap up of this service will continue through the remainder of 2020 and the Company will see a steady decline in revenue from this service as production is wrapped up. We plan to convert the spaces in the facility that had been used to perform this contract work into expanded Nuclear Medicine product manufacturing. The loss in revenue expected from termination of the gemstone processing agreement is expected to be more than compensated for by the expansion of new nuclear medicine source products.

Cost of sales for the six months ended June 30, 2020, was $33,339, as compared to $352,196, for the same period in 2019. Gross profit for this segment for the six months ended June 30, 2020 was $82,949, compared to $453,211, reported for the same period in 2019. The decrease in gross profit of $370,262, or approximately 82%, is the result of the decrease in service contracts completed and reported in this segment for the six months ended June 30, 2020, as compared to the same period in 2019. Operating expense for the six months ended June 30, 2020 was $111,410 as compared to $155,480, reported for the same period in 2019. This decrease of $44,070, or approximately 28%, is the result of decreased sales and activity within the business segment.

Net loss for this segment for the six months ended June 30, 2020 was $28,461, compared to net loss of $589,955, for the same period in 2019. This is a decrease in net loss of $561,494, or approximately 95% and is the result of net other expenses incurred in the six months ended June 30, 2019 the company incurred $1,522,605 in expensesof $887,686 associated with clean-up operations related to the May 2, 2019 contamination event which is included in “other expense” on the Company’s P&L statements. The company has received $634,919 to-date in reimbursements from its insurance company for this ongoing claim which is included in “other income”. The Company is actively working with its insurance company and believes it will recover a majority of the external contract cost of these clean-up operations.

Net loss for the six-month period ending June 30, 2019, was $589,956, as compared to net income $566,453 for the same period in 2018.noted above.

 

Fluorine Products.For the six months ended June 30, 2020, we had revenues related to Fluorine Products of $160,500. These revenues were related to an agreement to provide engineering and technical assistance services related to our fluorine products intellectual property. There was no revenue to report from the fluorine products segment for the six months ended June 30, 2019 or for the same period in 2018.2019. During the six months ended June 30, 2019,2020, we incurred $77,422$74,090 of expense related to essential items in support of future planning and design for the proposed de-conversion facility, as compared to $62,912$77,422 for the same six-month period in 2018. The increase2019. This is a decrease of $14,510, or approximately 23% is the result of increased travel and professional services expenses4% in the period-to-period comparison.

 

We established the Fluorine Products segment in 2004 to support production and sale of the gases produced using our Fluorine Extraction Process (“FEP”). We will continue to limit our expenditures to essential items such as maintenance of the NRC license, land use agreements, communication with our prospective FEP product customers, and interface with the State of New Mexico and Lea County officials.

 

LIQUIDITY AND CAPITAL RESOURCES

 

At June 30, 2019,2020, we had cash and cash equivalents of $443,310$831,359 as compared to $828,039$575,422 at December 31, 2018.2019. This is a decreasean increase of $384,729$255,937 or approximately 46%44%. For the six months ended June 30, 2020, net cash provided by operating activities was $415,918 and for the six months ended June 30, 2019, net cash used in operating activities was $114,905 and for the six months ended June 30, 2018, net cash used in operating activities was $328,026.$114,905. The decreaseincrease in cash used inprovided by operating activities and decreaseincrease in cash and cash equivalents at period end in the period-to-period comparison is the result of increaseddecreases in changes to inventory, reportedaccount payable, and cash as wella result of the our modification of our Cobalt supply agreement with DOE as an increase in accounts receivable.discussed below.

 

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Inventories at June 30, 20192020 totaled $3,219,941,$1,298,668, and inventories at December 31, 20182019 totaled $2,765,729.$3,423,420. A significant amount of our inventory consists of work-in-process cobalt raw material held at the ATR located outside of Idaho Falls, Idaho. Work in process includes costs to irradiate cobalt-60 material under a contract with the DOE. This material has been placed in the ATR and the Company made progress payments to purchase this material. During the second quarter of 2020, the Company modified its agreement with the DOE due to delays in delivery of Cobalt material. As a result, the DOE refunded certain payments made by INIS in relation to this material and INIS stopped paying the scheduled payments for the inventory. During the six months ended June 30, 2020 work in process was reduced by $2,050,100 from a $918,090 cash refund from the DOE and a reduction of accounts payable of $1,132,010.

At June 30, 2019,2020, this raw cobalt material inventory accounted for approximately 93%78% of our work-in-process inventory. At December 31, 2018,2019, this in-process raw material inventory accounted for approximately 89% of our work in process inventory. We periodically evaluate the carrying value of our raw materials to determine their future market value to the Company. As ofIn the six months ended June 30, 2019,2020 we determined that norecorded an impairment of this$18,583 for raw cobalt material inventory was necessary.due to activity loss.

 

Cash used in investing activities was $23,177$1,565 for the six months ended June 30, 2019,2020, and cash used in investing activities was $62,976$23,177 for the same period in 2018.2019. The cash used for the six months ended June 30, 2019,2020, and for the same period in 2018,2019, was for the purchase of equipment.

 

Financing activities used cash of $239,629,$155,352, during the six months ended June 30, 2019,2020, and cash providedused by financing activities for the same period in 20182019 was $189,648.$239,629. During the six months ended June 30, 2019,2020, cash paid for interest was $86,388$65,536 and during the same six-month period in 2018,2019, cash paid for interest was $37,749.$86,388. Additionally, during the six months ended June 30, 2019,2020, we received $3,438$10,273 in proceeds from the sale of our common stock through our Employee Stock Purchase Plan, as compared to $3,304$3,438 for the same period in 2018.

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In February 2017, we entered into subscription agreements with certain investors, including two of our directors, for the sale of (i) an aggregate of 3,433 shares of Series C Preferred Stock, and (ii) Class M warrants to purchase an aggregate of 17,165,000 shares of our common stock (Class M Warrants), for gross proceeds of $3,433,000. The Series C Preferred Stock accrues dividends at a rate of 6% per annum, payable annually on February 17th of each year.  Shares of Series C Preferred Stock are convertible at the option of the holder at any time into shares of our common stock at an initial conversion price equal to $0.10 per share, subject to adjustment.  At any time after February 17, 2019, if the volume-weighted average closing price of our common stock over a period of 90 consecutive trading days is greater than $0.25 per share, we may redeem all or any portion of the outstanding Series C Preferred Stock at the original purchase price per share plus any accrued and unpaid dividends, payable in shares of common stock.  All outstanding shares of Series C Preferred Stock must be redeemed by us on February 17, 2022 at the original purchase price per share, payable in cash or shares of common stock, at the option of the holder. Holders of Series C Preferred Stock do not have any voting rights, except as required by law and in connection with certain events as set forth in the Statement of Designation of the Series C Preferred Stock. The Class M Warrants are immediately exercisable at an exercise price of $0.12 per share, subject to adjustment as set forth in the warrant, and have a term of five years.2019.

 

In February 2019,2020, the Company paid its second annual dividend on the Series C Preferred Stock. Dividends payable totaled $252,780.$251,280. Some holders of the Series C Preferred Stock elected to settle their dividend payments with shares of the Company’s common stock in lieu of cash. The Company issued 3,433,0003,408,000 shares of common stock in lieu of a dividend payment of $205,980.$204,480. The remaining $46,800 of dividend payable was settled with cash.

 

Total decreaseincrease in cash for the six-month period ended June 30, 2019,2020, was $377,711$259,001 compared to a cash decrease of $201,354$377,711 for the same period in 2018.2019.

 

We expect that cash from operations, cash raised via equity financing, and our current cash balance will be sufficient to fund operations for the next twelve months. Our future liquidity and capital funding requirements will depend on numerous factors, including, contract manufacturing agreements, commercial relationships, technological developments, market factors, available credit, and voluntary warrant redemption by shareholders. There is no assurance that additional capital and financing will be available on acceptable terms to the Company or at all.all, especially in light of the market volatility and uncertainty as a result of the COVID-19 outbreak.

 

At June 30, 2019,2020, there were 20,090,00050,090,000 outstanding warrants to purchase our common stock. Included in this number are 17,165,000 Class M Warrants issued February 17, 2017, with an exercise price of $0.12 per share and an expiration date of February 17, 2022; and, 2,925,000 Class N Warrants issued May 12, 2017, with an exercise price of $0.10 per share and an expiration date of May 12, 2022.2022; and, 30,000,000 Class O Warrants issued December 30, 2019, with an exercise price of $0.045 and an expiration date of December 30, 2024.

 

Debt

 

In December 2013, we entered into a promissory note agreement with our then Chairman of the Board and one of our major shareholders, pursuant to which we borrowed $500,000 (the “20132013 Promissory Note”)Note). The 2013 Promissory Note is secured and bears interest at 6% per annum and was originally due June 30, 2014. According to the terms of the 2013 Promissory Note, at any time, the lenders may settle any or all of the principal and accrued interest with shares of our common stock. In connection with the 2013 Promissory Note, each of the two lenders was issued 5,000,000 Class L warrants to purchase shares of our common stock at an exercise price of $0.06 per share. The warrants were immediately exercisable. In June 2014, we renegotiated the terms of the 2013 Promissory Note. Pursuant to the modification, the maturity date was extended to December 31, 2017 and each lender was granted an additional 7,500,000 Class L warrants to purchases shares of our common stock at an exercise price of $0.06 per share. The warrants were immediately exercisable. In December 2016,February 2017, the 2013 Promissory Note was further modified to extend the maturity date to December 31, 2022,2020, with all remaining terms unchanged. On December 23, 2018, all 25,000,000 Class L warrants expired. At June 30,In December 2019, the principal balance of the 2013 Promissory Note was $500,000 and accrued interest payable onfurther modified to extend the 2013 Promissory Note was $166,734. Interest expense recorded for the six-month period ended June 30, 2019, was $15,000.

In March 2016, we entered into a note payable for the purchase of a vehicle. The principal amount financed was $47,513. The term of the note is six years and the note carries an interest rate of 6.66%. Monthly payments are $805 and the note matures April 2022. The note is secured by the vehicle that was purchasedmaturity date to December 31, 2021, with the note’s proceeds.all remaining terms unchanged.

 

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In August 2017, we entered into a short-term promissory note agreement with our Chairman ofAt June 30, 2020, accrued interest payable on the Board, pursuant to which we borrowed $60,000 (the “2017 Promissory Note”). The 20172013 Promissory Note accrues interest at 5% per annum, which is payable upon maturity of the 2017 Promissory Note. The 2017 Promissory Note is unsecured and was scheduled to mature on June 30, 2018. Pursuant to an amendment to the 2017 Promissory Note on June 29, 2018, the maturity date was extended to March 31, 2019, with all other provisions remaining unchanged. Pursuant to a second amendment to the 2017 Promissory Note on February 12, 2019, the maturity date was extended to July 31, 2019 with all other provisions of the 2017 Promissory Note remaining unchanged. On April 30, 2019, the 2017 Promissory Note and accrued interest were repaid in full with a cash payment of $65,117.totaled $196,734.

 

In April 2018, we borrowed $120,000 from our Chief Executive Officer and Chairman of the Board pursuant to a short-term promissory note (the “20182018 Promissory Note”)Note). The2018 Promissory Noteaccrues interest at 6% per annum, which is payable upon maturity of the2018 Promissory Note.Note. The 2018 Promissory Note iswas originally unsecured and was originally scheduled to maturematured on August 1, 2018. At any time, the holder of the 2018 Promissory Note may elect to have any or all of the principal and accrued interest settled with shares of our common stock based on the average price of the shares over the previous 20 trading days. Pursuant to an amendment to the 2018 Promissory Note onin June 29, 2018, the maturity date was extended to March 31, 2019 with all other provisions remaining unchanged. Pursuant to a second amendment to the 2018 Promissory Note onin February 12, 2019, the maturity date was extended to July 31, 2019 with all other termsprovisions remaining unchanged. Pursuant to a third amendment to the 2018 Promissory Note in AugustJuly 2019, the maturity date was extended to January 31, 2020 andwith all other provisions remaining unchanged. Pursuant to a fourth amendment to the 2018 Promissory Note in December 2019, the maturity date was extended to December 31, 2021, the note was modified to be secured. become secured by company assets, with all other provisions remaining unchanged.

At June 30, 2019,2020, accrued interest on the 2018 Promissory Note totaled $8,570.$15,770.

 

In December 2019, we entered into a promissory note agreement with our Chief Executive Officer, Chairman of the Board, former Chairman of the Board, and one of our major shareholders (the 2019 Promissory Note). The 2019 Promissory Note authorizes us to borrow up to $1,000,000. As of December 31, 2019, we had borrowed $675,000 under the 2019 promissory note. In February 2019,2020, we borrowed $185,474 from RadQual pursuant to a short-term promissory note with a statedan additional $325,000. The 2019 Promissory Note is secured and bears interest rate of 6%at 4% per annum and has a maturity date of JulyDecember 31, 2019 (the “2019 Promissory Note”)2022. . The2019 Promissory Noteis unsecured.In June 2019, we borrowed an additional $180,000. Additionally, in June 2019, an amendmentAccording to the 2019 Promissory Note extended the maturity date to December 31, 2019 with all other terms remaining unchanged. At June 30, 2019, the principal balance of the 2019 Promissory Note, totaled $365,474at any time, a holder of the 2019 Promissory Note may elect to have any or all of the principal and accrued interest settled with shares of our common stock based on the average price of the shares over the previous 20 trading days. In connection with the 2019 Promissory Note, we issued 30,000,000 Class O Warrants to purchase shares of our common stock at $0.045 per share (the Class O Warrants). The warrants are exercisable at an exercise price of $0.045 per share and have a term of five years. At March 31, 2020, accrued interest on the 2019 Promissory Note totaled $3,982.$19,131.

On April 23, 2020, we, through our wholly-owned subsidiary entered into a Loan Agreement and Promissory Note (collectively the “SBA Loan”) with KeyBank National Association pursuant to the Paycheck Protection Program (the “PPP”) under the recently enacted Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) administered by the U.S. Small Business Administration (the “SBA”). We received total proceeds of $495,500 from the SBA Loan. The SBA Loan is scheduled to mature on April 22, 2022 and has a 1.00% interest rate and is subject to the terms and conditions applicable to loans administered by the SBA under the CARES Act. The SBA Loan may be prepaid at any time prior to maturity with no prepayment penalties.

The SBA Loan contains customary events of default relating to, among other things, payment defaults and breaches of representations and warranties. Subject to certain conditions, the SBA Loan may be forgiven in whole or in part by applying for forgiveness pursuant to the CARES Act and the PPP. The amount of loan proceeds eligible for forgiveness is based on a formula based on a number of factors, including the amount of loan proceeds used by the Company during the twenty-four week period after the loan origination for certain purposes, including payroll costs, interest on certain mortgage obligations, rent payments on certain leases, and certain qualified utility payments, provided that, among other things, at least 60% of the loan amount is used for eligible payroll costs, the employer maintaining or rehiring employees and maintaining salaries at certain level.

As of June 30, 2020, we have used the entire loan proceeds to fund qualifying expenses. As a result, we believe that we have met the PPP eligibility criteria for forgiveness and have concluded that the loan represents, in substance, a government grant that is expected to be forgiven. As such, in accordance with IAS 20 “Accounting for Government Grants and Disclosure of Government Assistance”, we have recognized the entire loan amount as Other Income at June 30, 2020.

We do not anticipate taking any action that would cause any portion of the loan to be ineligible for forgiveness. However, to the extent that any amount is deemed unforgivable, such amount is payable over two to five years at an interest rate of 1%, with a deferral of payments for the first six months.

 

OFF-BALANCE SHEET ARRANGEMENTS

 

As of June 30, 2019,2020, we had no off-balance sheet arrangements or obligations.

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CRITICAL ACCOUNTING POLICIES

From time-to-time, management reviews and evaluates certain accounting policies that are considered to be significant in determining our results of operations and financial position.

A description of the Company’s critical accounting policies that affect the preparation of the Company’s financial statements is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on March 30, 2020.

 

ITEM 4. CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the Exchange Act), that are designed to ensure that material information relating to us is made known to the officers who certify our financial reports and to other members of senior management and the Board of Directors. These disclosure controls and procedures are designed to ensure that information required to be disclosed in our reports that are filed or submitted under the Exchange Act are recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuerus in the reports that it fileswe file or submitssubmit under the Exchange Act is accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate, to allow timely decisions regarding required disclosure.

 

Management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness, as of June 30, 2019,2020, of our disclosure controls and procedures. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of June 30, 2019.2020.

 

Changes in Internal Control over Financial Reporting

 

There have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended June 30, 2019March 31, 2020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

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PART IIOTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

We wereFrom time to time, the Company has been and may again become involved in legal proceedings arising in the ordinary course of business. Except as set forth below, the Company is not a party to any legal proceedings that we believeit believes to be material and we arethe Company is not aware of any pending or threatened litigation against us that we believeit believes could have a material adverse effect on ourits business, operating results, financial condition, or cash flows.

As previously disclosed, on May 2, 2019, the Company’s radiological services team was involved in a contamination event involving a breached cesium-137 source at an off-site location in the State of Washington. This work was being performed under a contract with the U.S. Department of Energy (DOE). The Company supported the initial onsite contamination clean-up operations at that location and completed removal of the cesium source Company equipment. The Company has reviewed the results of the DOE investigation into this event and has implemented appropriate corrective actions. Since August 2019, the DOE has assumed full control of the ongoing cleanup operations and has assumed all of the financial obligations associated with the contractors hired to carry out all of the facility recovery operations. Under the terms of the contract, the Company believes it should be indemnified from financial liability for this event by the DOE under the Price Anderson Amendments Act (PAAA) and the Company has formally requested the DOE to provide indemnification under the PAAA. While the DOE’s review of the request is still underway, the Company believes that a determination of indemnification under the PAAA is probable. Such indemnification would allow the Company to recoup all its costs associated with this contamination event.

In connection with the contamination event, on May 14, 2020, the Washington Department of Health (DOH) issued a Notice of Violation to the Company citing two violations of the Company’s reciprocity license in the State of Washington. Also, the U.S. Nuclear Regulatory Commission (NRC) completed an inspection of the Company’s radiological safety program, and on June 22, 2020, the NRC issued a Notice of Violation to the Company citing two different violations of the Company’s NRC materials license. The Company has requested and completed Predecisional Enforcement Conferences with the Washington DOH and the NRC, and has provided the agencies with information on all corrective actions completed by the Company to prevent reoccurrence. The Company is awaiting the results of deliberations by the Washington DOH and NRC on these matters and their respective decisions for any further actions or the imposition of a civil penalty against the Company. It is not possible at this time to predict the timing or outcome of these matters or to estimate a potential amount of loss, if any. In addition, in the event the Washington DOH Notice of Violation

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results in the imposition of a civil penalty against the Company, based upon consultation with legal counsel, the Company reasonably believes such civil penalty falls within the parameters for indemnification of the Company under the PAAA.

 

ITEM 1A. RISK FACTORS

 

There have been no material changes or updates to the risk factors previously disclosed in Item 1A. “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2018.2019.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

None.

 

ITEM 6. EXHIBITS

 

Exhibit No.Description

3.1Restated Certificate of Formation, as amended (incorporated by reference to Exhibit 3.1 of the Company’s Quarterly Report on Form 10-Q for quarter ended June 30, 2010).

3.2Statement of Designation of the Series C Convertible Redeemable Preferred Stock of International Isotopes Inc. (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed on February 24, 2017).

3.3Bylaws (incorporated by reference to Exhibit 3.2 of the Company's Registration Statement on Form SB-2 filed on May 1, 1997 (Registration No. 333-26269)).

10.1†10.1ManufacturingLoan Agreement and Supply Agreement, datedPromissory Note, effective April 5, 2019,22, 2020, between International Isotopes Idaho Inc. and Progenics Pharmaceuticals, Inc.KeyBank National Association (incorporated by reference to Exhibit 10.1 of the Company’s QuarterlyCurrent Report on Form 10-Q for the quarter ended March 31, 2019,8-K filed on May 15, 2019)April 20, 2020)).+

31.1Certification by the Chief Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002.2002.*

31.2Certification by the Chief Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002.*

32.1Certification by the Chief Executive Officer furnished pursuant to 18 U.S.C. Section 1350 adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.**

32.2Certification by the Chief Financial Officer furnished pursuant to 18 U.S.C. Section 1350 adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.**

101The following financial statements, formatted in XBRL: (i) Unaudited Condensed Consolidated Balance Sheets as of June 30, 20192020 and December 31, 2018,2019, (ii) Unaudited Condensed Consolidated Statements of Operations for the three months and six months ended June 30, 20192020 and 2018,2019, (iii) Unaudited Condensed Consolidated Statements of Cash Flows for the three months and six months ended June 30, 20192020 and 20182019 and (iv) Notes to Unaudited Condensed Consolidated Financial Statements.*

_______________________________

* Filed herewith.

 

** Furnished herewith.

 

† Certain portions of the exhibit have been omitted pursuant to Rule 601(b)(10) of Regulation S-K. The omitted information is (i) not material and (ii) would likely cause competitive harm to the Company if publicly disclosed.

+ Certain schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K under the Securities Exchange Act of 1934, as amended. The Company hereby undertakes to supplementally furnish copies of any omitted schedules to the Securities and Exchange Commission upon request.

 

 

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SIGNATURES

 

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

 

Date:  August 14, 20192020International Isotopes Inc.
  
   
 By:/s/ Steve T. Laflin
  Steve T. Laflin
  President and Chief Executive Officer
   
   
 By:/s/ Laurie McKenzie-CarterW. Matthew Cox
  Laurie McKenzie-CarterW. Matthew Cox
  Chief Financial Officer

 

 

 

 

 

 

 

 

 

 

 

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