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INTERNATIONAL ISOTOPES INC - Quarter Report: 2021 June (Form 10-Q)

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, 2021

 

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:

000-22923

 

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 company x
  Emerging growth company ¨

 

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

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ¨ Yes x No

As of August 8, 2021, the number of shares of common stock, $0.01 par value, outstanding was 501,003,705.

 

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INTERNATIONAL ISOTOPES INC.

Form 10-Q

For The Quarter Ended June 30, 2021

 

TABLE OF CONTENTS

 

    Page No.
PART I – FINANCIAL INFORMATION  
     
Item 1. Financial Statements  
  Unaudited Condensed Consolidated Balance Sheets at June 30, 2021 and December 31, 2020 3
  Unaudited Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2021 and 2020 4
  Unaudited Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2021 and 2020 5
  Unaudited Statement of Reconciliation of Stockholder’s (Deficit) Equity for the Three and Six Months Ended June 30, 2021 and 2020 6
  Notes to Unaudited Condensed Consolidated Financial Statements 8
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 18
Item 4. Controls and Procedures 28
     
PART II – OTHER INFORMATION  
     
Item 1. Legal Proceedings 28
Item 1A. Risk Factors 28
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 28
Item 6. Exhibits 29
Signatures 30

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Part I. Financial Information

Item I. Financial Statements

 

INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(unaudited)

 

   June 30,   December 31, 
   2021   2020 
Assets        
Current assets          
Cash and cash equivalents  $517,506   $1,113,032 
Accounts receivable   1,068,550    796,128 
Inventories   668,781    837,787 
Prepaids and other current assets   148,779    1,247,430 
Total current assets   2,403,616    3,994,377 
           
Long-term assets          
Restricted cash   830,725    638,660 
Property, plant and equipment, net   4,346,063    4,489,551 
Capitalized lease disposal costs, net   256,059       
Financing lease right-of-use asset   21,637    24,642 
Operating lease right-of-use asset   2,486,142    2,539,580 
Goodwill   1,384,255    1,384,255 
Patents and other intangibles, net   4,081,249    4,025,684 
Total long-term assets   13,406,130    13,102,372 
Total assets  $15,809,746   $17,096,749 
           
Liabilities and Stockholders' Equity          
Current liabilities          
Accounts payable  $1,225,050   $2,115,348 
Accrued liabilities   923,098    1,204,672 
Unearned revenue   990,886    1,160,274 
Current portion of operating lease right-of-use liability   105,593    86,494 
Current portion of financing lease liability   8,155    7,786 
Current portion of related party notes payable, net of debt discount   613,295    606,589 
Current installments of notes payable   221,317    480,889 
Current portion of mandatorily redeemable preferred stock, net of debt discount   4,778,339       
Total current liabilities   8,865,733    5,662,052 
           
Long-term liabilities          
Related party notes payable, net of current portion and debt discount   865,603    487,470 
Notes payable, net of current portion   88,560    57,202 
Asset retirement obligation   867,956    588,105 
Financing lease liability, net of current portion   12,716    16,888 
Operating lease right-of-use liability, net of current portion   2,426,354    2,484,359 
Mandatorily redeemable convertible preferred stock, net of current portion and discount         4,913,421 
Total long-term liabilities   4,261,189    8,547,445 
Total liabilities   13,126,922    14,209,497 
           
Commitments and contingencies (Note 8)          
           
Stockholders' equity          
Common stock, $0.01 par value; 750,000,000 shares authorized; 460,830,469 and 424,344,298 shares issued and outstanding respectively   4,608,305    4,243,443 
Additional paid in capital   122,292,543    122,191,837 
Accumulated deficit   (126,644,273)   (125,861,734)
Equity attributable to International Isotopes Inc. stockholders   256,575    573,546 
Equity attributable to noncontrolling interest   2,426,249    2,313,706 
Total equity   2,682,824    2,887,252 
Total liabilities and stockholders' equity  $15,809,746   $17,096,749 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

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INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

Unaudited Condensed Consolidated Statements of Operations 

                                 
   Three months ended June 30,   Six months ended June 30, 
   2021   2020   2021   2020 
                 
Sale of product  $2,759,896   $2,159,559   $4,752,408   $4,495,345 
Cost of product   1,171,968    903,909    2,003,322    1,872,434 
Gross profit   1,587,928    1,255,650    2,749,086    2,622,911 
                     
Operating costs and expenses                    
Salaries and contract labor   625,428    736,539    1,293,948    1,477,744 
General, administrative and consulting   875,799    573,747    1,781,728    1,362,185 
Research and development   71,979    41,465    109,216    88,393 
Total operating expenses   1,573,206    1,351,751    3,184,892    2,928,322 
                     
Net operating income (loss)   14,722    (96,101)   (435,806)   (305,411)
                     
Other income (expense):                    
Other income   32,356    559,895    175,476    583,713 
Interest income   46    748    81    3,083 
Interest expense   (211,456)   (196,344)   (409,747)   (391,224)
Total other (expense) income   (179,054)   364,299    (234,190)   195,572 
Net (loss) income   (164,332)   268,198    (669,996)   (109,839)
Less income attributable to noncontrolling interest   17,055    38,870    112,543    83,327 
                     
Net (loss) income attributable to International Isotopes Inc.  $(181,387)  $229,328   $(782,539)  $(193,166)
                     
Net loss per common share - basic:  $     $     $     $   
                     
Net loss per common share - diluted:  $     $     $     $   
                     
Weighted average common shares outstanding - basic:   460,798,173    423,751,657    457,123,946    422,211,840 
                     
Weighted average common shares outstanding - diluted:   460,798,173    432,629,537    457,123,946    422,211,840 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

 

 

 

 

 

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INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

Unaudited Condensed Consolidated Statements of Cash Flows 

                 
   Six months ended June 30, 
   2021   2020 
Cash flows from operating activities          
Net loss  $(669,996)  $(109,839)
Adjustments to reconcile net loss to net Cash (used in) provided by operating activities          
Depreciation and amortization   287,250    150,969 
Accretion of obligation for lease disposal costs   19,136    20,387 
Accretion of beneficial conversion feature and discount   199,757    191,933 
Equity based compensation   49,093    68,531 
Forgiveness of Paycheck Protection Program Loan         (495,500)
Right-of-use asset amortization   14,532    14,448 
Changes in operating assets and liabilities:          
Accounts receivable   (272,422)   (425,334)
Inventories   169,006    992,742 
Prepaids and other current assets   1,098,651    657,016 
Accounts payable and accrued liabilities   (964,392)   (785,178)
Unearned revenues   (169,388)   135,743 
Net cash (used in) provided by operating activities   (238,773)   415,918 
           
Cash flows from investing activities:          
Purchase of property, plant and equipment   (191,666)   (1,565)
Net cash used in investing activities   (191,666)   (1,565)
           
Cash flows from financing activities:          
Proceeds from sale of stock   8,995    10,273 
Payments on financing lease   (3,803)   (1,556)
Proceeds from the issuance of notes payable   351,250    871,100 
Principal payments on notes payable   (329,464)   (1,035,169)
Net cash provided by (used in) financing activities   26,978    (155,352)
           
Net (decrease) increase in cash, cash equivalents, and restricted cash   (403,461)   259,001 
Cash, cash equivalents, and restricted cash at beginning of period   1,751,692    1,210,920 
Cash, cash equivalents, and restricted cash at end of period  $1,348,231   $1,469,921 
           
Supplemental disclosure of cash flow activities:          
Cash paid for interest  $61,320   $65,536 
           
Supplemental disclosure of noncash financing and investing transactions          
Decrease in accrued interest and increase in equity for conversion of dividends to stock  $207,480   $204,480 
Increase in operating lease right-of-use asset and right-of-use liability for new lease  $1,603   $2,649,070 
Increase in equity and decrease in liability for the conversion of preferred stock  $200,000   $   
Non-cash increase of capitalized ARO for increased funding plan  $260,715   $   
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 

 

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,  
   2021   2020 
Cash and cash equivalents  $517,506   $831,359 
Restricted cash included in long-term assets   830,725    638,562 
Total cash, cash equivalents, and restricted cash shown in statement of cash flows  $1,348,231   $1,469,921 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

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INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

Reconciliation of Stockholders' (Deficit) Equity

Three and Six Months Ended June 30, 2021

(Unaudited)

 

                  Equity         
                 Attributable   Equity     
                  to   Attributable     
   Common stock   Additional       Internat'l   to   Total 
  Shares  Common   Paid-in   Accumulated   Isotopes   Noncontrolling   (Deficit) 
   Outstanding  Stock   Capital   Deficit   Shareholders   Interest   Equity 
Balance, January 1, 2021  424,344,298  $4,243,443   $122,191,837   $(125,861,734)  $573,546   $2,313,706   $2,887,252 
                                  
Shares issued under employee stock purchase plan  211,640   2,117    6,878          8,995          8,995 
                                  
Stock grant  118,315   1,183    (1,183)                        
                                  
Stock in lieu of dividends on convertible preferred C  1,398,200   13,982    193,498          207,480          207,480 
                                  
Shares issued for exercise of employee stock options  1,799,107   17,991    (17,991)                        
                                  
Warrant exercise  32,621,409   326,214    (326,214)                        
                                  
Conversion of preferred C stock  250,000   2,500    22,500          25,000          25,000 
                                  
Conversion of preferred B stock  87,500   875    174,125          175,000          175,000 
                                  
Stock based compensation  —           49,093          49,093          49,093 
                                  
Net (loss) income  —                 (782,539)   (782,539)   112,543    (669,996)
Balance, June 30, 2021  460,830,469  $4,608,305   $122,292,543   $(126,644,273)  $256,575   $2,426,249   $2,682,824 

 

               Equity         
               Attributable   Equity     
               to   Attributable     
   Common stock   Additional       Internat'l   to   Total 
   Shares  Common   Paid-in   Accumulated   Isotopes   Noncontrolling   (Deficit) 
   Outstanding  Stock   Capital   Deficit   Shareholders   Interest   Equity 
Balance, April 1, 2021  460,636,690  $4,606,367   $122,103,290   $(126,462,886)  $246,771   $2,409,194   $2,655,965 
                                  
Shares issued under employee stock purchase plan  106,279   1,063    3,454          4,517          4,517 
                                  
Conversion of preferred B stock  87,500   875    174,125          175,000          175,000 
                                  
Stock based compensation  —           11,674          11,674          11,674 
                                  
Net (loss) income  —                 (181,387)   (181,387)   17,055    (164,332)
Balance, June 30, 2021  460,830,469  $4,608,305   $122,292,543   $(126,644,273)  $256,575   $2,426,249   $2,682,824 

 

 

 

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INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

Reconciliation of Stockholders' (Deficit) Equity

Three and Six Months Ended June 30, 2020

(Unaudited)

 

                  Deficit         
                  Attributable   Equity     
                  to   Attributable     
   Common stock   Additional       Internat'l   to   Total 
   Shares  Common   Paid-in   Accumulated   Isotopes   Noncontrolling   (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 debenture beneficial conversion feature  —           102,584          102,584          102,584 
                                  
Warrants issued with convertible debenture  —           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         
                  Attributable   Equity     
                  to   Attributable     
   Common stock   Additional       Internat'l   to   Total 
   Shares  Common   Paid-in   Accumulated   Isotopes   Noncontrolling   (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 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 

 

See accompanying notes to the unaudited condensed consolidated financial statements

 

 

 

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INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

Notes to Unaudited Condensed Consolidated Financial Statements

June 30, 2021

 

(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. In July 2021, INIS purchased the remaining interest in RadQual and now owns 100% of RadQual. INIS, its 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, generic sodium iodide I-131 drug product, cobalt teletherapy sources, and a varied selection of radiochemicals for medical research, and clinical applications. The Company also offers contract manufacturing services for certain pharmaceutical products. 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. The Company also consolidates the accounts 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 or six-month period ended June 30, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021 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, 2020 filed with the SEC on March 30, 2021.

 

Recent Accounting Pronouncements – In August 2020, the Financial Accounting Standards Board issued ASU 2020-06 Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40). The update simplifies accounting related to convertible debt instruments. The standard is effective for fiscal years beginning after December 15, 2023 including interim periods within those fiscal years. INIS is currently evaluating the effect this standard will have on its financial statements.

 

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(2)       Current Developments and Liquidity

 

Business Condition – Since inception, the Company has incurred substantial losses. During the six months ended June 30, 2021, the Company reported net loss of $782,539, net of non-controlling interest, and net cash used in operating activities of $238,773. During the six 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, 2021, the Company continued its focus on its strongest long-standing core business segments which consist of its radiochemical products, cobalt products, and nuclear medicine standards, and in particular, the pursuit of new business opportunities within those segments.

 

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.

 

The Company expects that cash from operations, 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 three and six months ended June 30, 2021, the Company had 18,252,500 stock options outstanding, 7,065,000 warrants outstanding, 675 outstanding shares of Series B redeemable convertible preferred stock (Series B Preferred Stock), and 4,188 outstanding shares of Series C redeemable convertible preferred stock (Series C Preferred Stock), each of which were not included in the computation of diluted income (loss) per common share because they would be anti-dilutive.

 

For the six months ended June 30, 2020, the Company had 24,605,000 stock options outstanding, 50,090,000 warrants outstanding, 850 outstanding shares of Series B Preferred Stock, and 4,213 outstanding shares of Series C Preferred Stock, each of which were not included in the computation of diluted income per common share because they would be anti-dilutive.

 

For the three months ended June 30, 2020, the Company had 14,005,000 stock options outstanding, 20,090,000 warrants outstanding, 850 outstanding shares of Series B redeemable convertible preferred stock, and 4,213 outstanding shares of Series C 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 Company used the treasury stock method in calculating weighted average common shares diluted.

 

The table below shows the calculation of diluted shares:

                                 
   3 Months Ended   6 Months Ended 
   June 30,   June 30,   June 30,   June 30, 
   2021   2020   2021   2020 
Weighted average common shares outstanding - basic   460,798,173    423,751,657    457,123,946    422,211,840 
                     
Effects of dilutive shares                    
Stock Options   —      3,177,880    —      —   
Warrants   —      5,700,000    —      —   
Weighted average common shares outstanding - diluted   460,798,173    432,629,537    457,123,946    422,211,840 

 

The table below summarizes common stock equivalents outstanding at June 30, 2021 and 2020:

  

                 
   June 30, 
   2021   2020 
Stock options   18,252,500    24,605,000 
Warrants   7,065,000    50,090,000 
Shares of Series B redeemable convertible preferred stock   337,500    425,000 
Shares of Series C redeemable convertible preferred stock   41,880,000    42,130,000 
    67,535,000    117,250,000 

 

9 

 

 

 

(4)       Investment and Business Consolidation

 

At June 30, 2021, the Company owned 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, 2021 and December 31, 2020:

 

   June 30, 2021   December 31, 2020 
Raw materials  $33,609   $33,609 
Work in process   634,060    803,171 
Finished goods   1,112    1,007 
Total Inventory  $668,781   $837,787 

 

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 made progress payments to purchase this material. During the second quarter and fourth 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. At June 30, 2021, and at December 31, 2020, this cobalt target inventory had a carrying value of $0 and $383,312, respectively.

 

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 months ended June 30, 2021 and 2020, the Company recognized approximately $157,890 and $22,000, 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, 2021 and 2020, the Company recognized approximately $150,090 and $11,500, 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 months ended June 30, 2021 and 2020, the Company issued 211,640 and 241,707 shares of common stock, respectively, to employees under the employee stock purchase plan for proceeds of $8,995 and $10,273, respectively. As of June 30, 2021, 2,888,271 shares of common stock remain available for issuance under the employee stock purchase plan.

 

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. At June 30, 2021, there were 37,204,004 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).

 

10 

 

 

Non-Employee Grants - The Company accounts for its issuances of stock-based compensation to non-employees by recognizing compensation expense based on the grant date fair value of the award. Stock option compensation expense is recognized over the vesting period for the award.

 

Option awards outstanding as of June 30, 2021, and changes during the six months ended June 30, 2021, were as follows:

 

Fixed Options  Shares  

Weighted

Average

Exercise Price

  

Weighted

Average

Remaining

Contractual Life

  

Aggregate

Intrinsic Value

 
Outstanding at December 31, 2020   20,400,000   $0.06           
Granted   125,000   $0.05           
Exercised   (2,062,500)  $0.04           
Expired        $             
Forfeited   (210,000)  $0.07           
Outstanding at June 30, 2021   18,252,500   $0.05    5.3   $1,560,550 
Exercisable at June 30, 2021   15,379,500   $0.05    4.9   $1,324,930 

 

The intrinsic value of outstanding and exercisable shares is based on the closing price of the Company’s common stock on the OTCQB of $0.14 per share on June 30, 2021, the last trading day of the quarter.

 

As of June 30, 2021, there was $29,693 of unrecognized compensation expense related to stock options that will be recognized over a weighted-average period of 1.98 years.

 

Total stock-based compensation expense for the six months ended June 30, 2021 and 2020 was $49,093 and $68,531 respectively. Total stock-based compensation expense for the three-months ended June 30, 2021 and 2020 was $11,674 and $17,009, respectively.

 

During the six months ended June 30, 2021, the Company granted 125,000 qualified stock options to several of its employees. All options vest over a five-year period with the first vesting at one-year anniversary for all grants and expiration at the ten year anniversary for all grants. The weighted average exercise price for these options was $0.05 per share. The options have a fair value of $3,280 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 0.46% to 0.78%, expected dividend yield rate of 0%, expected volatility of 52.52% to 55.63% and an expected life between 5.5 and 7.5 years.

 

In January 2021, 2,062,500 qualified stock options were exercised under a cashless exercise. The company withheld 263,393 shares to satisfy the exercise price and issued 1,799,107 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 year ended December 31, 2021.

 

Pursuant to an employment agreement with its Chief Executive Officer, the Company awarded 195,804 fully vested shares of common stock to its Chief Executive Officer in February 2021 under the 2015 Plan. The number of shares awarded was based on a $28,000 stock award using a price of $0.143 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 $14,198, which was determined by multiplying the number of shares awarded by the closing price of the common stock on February 28, 2021, which was $0.12 per share. The Company withheld 77,489 shares of common stock to satisfy payroll tax obligations in connection with this issuance. The net shares issued on February 28, 2021 totaled 118,315.

 

Warrants

 

In January 2021, all 30,000,000 Class O Warrants and 13,025,000 Class M Warrants were exercised under a cashless exercise. The Company withheld 10,403,591 shares to satisfy the exercise price and issued 32,621,409 shares of common stock.

 

Warrants outstanding at June 30, 2021, included 4,140,000 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.

 

 

11 

 

 

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 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; 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.

 

Preferred Stock

 

At June 30, 2021, there were 675 shares of the Series B Preferred Stock outstanding with a mandatory redemption date of May 2022 at $1,000 per share or $675,000. The shares of Series B Preferred Stock are also convertible into 337,500 shares of the Company’s common stock at a conversion price of $2.00 per share. These shares of Series B Preferred Stock do 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, 2021, there were 4,188 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. If 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.

 

In March 2021, 25 shares of the Series C Preferred Stock were converted to 250,000 shares of common stock at the request of the holder.

 

In April 2021, 175 shares of the Series B Preferred Stock were converted to 87,500 shares of common stock at the request of the holder.

 

During the six months ended June 30, 2021 and 2020 dividends paid to holders of the Series C Preferred Stock totaled $254,280 and $251,280, 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 months ended June 30, 2021 and 2020 the Company issued 1,398,200 and 3,408,000 shares of common stock, respectively, in lieu of a dividend payment of $207,480 and $204,480, respectively. The remaining $46,800 of dividend payable was settled with cash.

 

(7)          Debt

 

In December 2013, the Company entered into a promissory note agreement with its then Chairman of the Board and one of our major shareholders, pursuant to which we borrowed $500,000 (the 2013 Promissory 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 December 2019, the 2013 Promissory Note was modified to extend the maturity date to December 31, 2021, with all remaining terms unchanged.

 

At June 30, 2021, the principal balance of the 2013 Promissory Note was $500,000 and accrued interest payable on the 2013 Promissory Note was $226,734. Interest expense recorded for the six months ended June 30, 2021, was $15,000.

 

In April 2018, the Company borrowed $120,000 from its Chief Executive Officer and Chairman of the Board pursuant to a 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 originally matured 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 in June 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 in February 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 July 2019, the maturity date was extended to January 31, 2020 with 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 become secured by company assets, with all other provisions remaining unchanged. At June 30, 2021, accrued interest on the 2018 Promissory Note totaled $22,970.

 

12 

 

 

In April 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 $1,100,000, 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. At June 30, 2021 balance on this refund is $154,282 and is included in short-term notes payable.

 

On December 20, 2019, the Company entered into a promissory note agreement with four of the Company’s major shareholders (the 2019 Promissory Note). The 2019 Promissory Note 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 February 2020, the Company borrowed an additional $325,000. The 2019 Promissory Note bears an interest rate of 4% annually and is due December 31, 2022. According to the terms 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 Class O Warrants). The fair value of these Class O Warrants issued totaled $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, 2021 accrued interest on the 2019 Promissory Note totaled $59,131.

 

In March 2021, one of the Company’s subsidiaries, RadQual, entered into a promissory note (the March 2021 Promissory Note) for the purchase of equipment. The principal amount under the March 2021 Promissory Note totals $101,250, bears interest at 5%, is secured by equipment, and is due March 2023.

 

In April 2021, the Company borrowed $250,000 from our Chief Executive Officer and Chairman of the Board pursuant to a promissory note (the April 2021 Promissory Note). The April 2021 Promissory Note bears an interest rate of 6% annually and is due December 31, 2022. At any time, the holder of the April 2021 Promissory Note may elect to have any or all of the principal and accrued interest settled with shares of the Company’s common stock based at the price of $0.11 per share. .At June 30, 2021 accrued interest on the April 2021 Promissory Note totaled $3,250.

 

(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.

 

Sales of our most predominant radiochemical products are dependent upon a few key suppliers. An interruption in production by any of these individual suppliers could have an immediate negative impact upon radiochemical sales until material can be purchased from alternate suppliers including obtaining regulatory approval to use material from alternative suppliers if necessary.

 

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 two 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.

 

 

13 

 

 

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 $830,725.

 

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. The Company has been in discussion with commercial companies possibly interested in purchasing rights to this project. Should those discussions come to fruition the Company plans to negotiate a second modification to the PPA agreement to further extend the 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 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 cesium source and Company equipment. The Company has reviewed the results of the DOE investigation into this event and has implemented appropriate corrective actions. Beginning in August 2019, the DOE assumed full control of the cleanup operations and assumed all the financial obligations associated with the contractors hired to carry out all of the facility recovery operations. On January 5, 2021, the Company was notified by the DOE that they have been indemnified from any financial liability for this event under the Price Anderson Act (PAA). As part of this indemnification notification, the Company received payment in full for its claim with the DOE for recovery of certain expenses incurred for this event. The Company recognized Other Income of approximately $112,000 in the six months ended June 30, 2021 for additional cost recoveries for this event. All remaining cost recoveries as part of this settlement with the DOE were recognized in previous financial periods pursuant to ASC 410-30. The Company used these funds to pay all outstanding subcontractors and reimburse their insurance company for payments they previous paid the Company for this matter. The Company is actively pursuing a final settlement with its insurance company regarding this claim as of the date of this filing.

 

The Company’s corrective actions for this event included termination of all field service activities and removal of these activities from the Company’s NRC license. The Company believes that the loss in revenue resulting from suspension of radiological field service work will be compensated for by increased revenues in the Company’s remaining business segments.

 

 

14 

 

 

(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, 2021   Three Months Ended June 30, 2020 
   U.S.  

Outside

U.S.

  

Total

Revenues

  

% of Total

Revenues

   U.S.  

Outside

U.S.

  

Total

Revenues

  

% of Total

Revenues

 
Radiochemical Products  $1,091,114   $137,095   $1,228,209    45%  $988,952   $124,101   $1,113,053    40%
Cobalt Products   562,744    14,250    576,994    21%   217,433    7,233    224,666    8%
Nuclear Medicine Products   699,384    186,344    885,728    32%   592,170    185,703    777,873    28%
Radiological Services   68,965          68,965    2%   43,967          43,967    2%
Fluorine Products                     0%                     0%
   $2,422,206   $337,689   $2,759,896    100%  $1,842,522   $317,037   $2,159,559    78%

 

   Six Months Ended June 30, 2021   Six Months Ended June 30, 2020 
   U.S.  

Outside

U.S.

  

Total

Revenues

  

% of Total

Revenues

   U.S.  

Outside

U.S.

  

Total

Revenues

  

% of Total

Revenues

 
Radiochemical Products  $1,637,924   $251,462   $1,889,386    40%  $1,657,543   $210,731   $1,868,274    39%
Cobalt Products   676,023    19,344    695,367    15%   522,428    7,858    530,286    11%
Nuclear Medicine Products   1,581,450    433,437    2,014,887    42%   1,459,773    360,224    1,819,997    38%
Radiological Services   130,755          130,755    3%   116,288          116,288    2%
Fluorine Products   22,013          22,013    0%   160,500          160,500    3%
   $4,048,165   $704,243   $4,752,408    100%  $3,916,532   $578,813   $4,495,345    100%

 

The Company’s revenue consists primarily of calibration and reference standards manufactured for use in the nuclear medicine industry, distribution of radiochemicals including sodium iodide I-131 drug product, and cobalt source manufacturing. 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 months ended June 30, 2021, the Company reported current unearned revenue of $990,886. For the period ended December 31, 2020, the Company reported current unearned revenue of $1,160,274. These unearned revenues will be recognized as revenue in the periods during which the cobalt shipments take place. 

 

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, 2021, and December 31, 2020, accounts receivable totaled $1,068,550 and $796,128, respectively.  For the six months ended June 30, 2021, the Company did not incur material impairment losses with respect to its receivables.

 

(10)         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.

 

15 

 

 

 

                 
   Six Months Ended June 30, 
   2021   2020 
Operating lease costs  $126,904   $130,378 
Short-term operating lease costs   7,670    19,928 
Financing lease expense:          
Amortization of right-of-use assets   3,005    2,179 
Interest on lease liabilities   1,018    579 
Total financing lease expense   4,023    2,758 
Total lease expense  $138,597   $153,064 
           
Right-of-use assets obtained in exchange for new operating lease liabilities  $1,603   $2,649,070 
Right-of-use assets obtained in exchange for new financing lease liabilities  $     $16,524 
           
Weighted-average remaining lease term (years) - operating leases   13.6    14.6 
Weighted-average remaining lease term (years) - financing leases   2.6    3.6 
Weighted-average discount rate - operating leases   6.75%   6.75%
Weighted-average discount rate - financing leases   8.76%   8.82%

 

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

 

   Operating   Financing 
2021 (excluding the six months ended June 30, 2021)  $131,858   $4,821 
2022   285,159    9,641 
2023   287,108    5,881 
2024   287,108    2,929 
2025   287,108       
Thereafter   2,599,409       
Total minimum operating lease obligations   3,877,750    23,272 
Less-amounts representing interest   (1,345,803)   (2,401)
Present value of minimum operating lease obligations   2,531,947    20,871 
Current maturities   (105,593)   (8,155)
Lease obligations, net of current maturities  $2,426,354   $12,716 

 

(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:

 

 

 

 

16 

 

 

 

   Three months ended June 30,   Six months ended June 30, 
Sale of Product  2021   2020   2021   2020 
Radiochemical Products  $1,228,209   $1,113,053   $1,889,386   $1,868,274 
Cobalt Products   576,994    224,666    695,367    530,286 
Nuclear Medicine Standards   885,728    777,873    2,014,887    1,819,997 
Radiological Services   68,965    43,967    130,755    116,288 
Fluorine Products               22,013    160,500 
Total Segments   2,759,896    2,159,559    4,752,408    4,495,345 
Corporate revenue                         
Total Consolidated  $2,759,896   $2,159,559   $4,752,408   $4,495,345 

 

   Three months ended June 30,   Six months ended June 30, 
Depreciation and Amortization  2021   2020   2021   2020 
Radiochemical Products  $78,430   $10,354   $157,977   $20,708 
Cobalt Products   12,399    8,762    26,038    17,523 
Nuclear Medicine Standards   17,868    15,989    34,238    31,978 
Radiological Services   252    8,519    504    17,155 
Fluorine Products   31,158    30,898    57,253    56,993 
Total Segments   140,107    74,522    276,010    144,357 
Corporate depreciation and amortization   6,941    (349)   11,240    4,433 
Total Consolidated  $147,048   $74,173   $287,250   $148,790 

 

   Three months ended June 30,   Six months ended June 30, 
Segment Income (Loss)  2021   2020   2021   2020 
Radiochemical Products  $404,457   $380,728   $408,882   $386,347 
Cobalt Products   208,581    75,874    178,484    199,670 
Nuclear Medicine Standards   51,843    117,056    262,754    302,357 
Radiological Services   58,242    (13,532)   110,649    (28,461)
Fluorine Products   (31,627)   (36,460)   (65,141)   86,410 
Total Segments   691,496    523,666    895,628    946,323 
Corporate loss   (872,883)   (294,338)   (1,678,167)   (1,139,489)
Net Income (Loss)  $(181,387)  $229,328   $(782,539)  $(193,166)

 

   Three months ended June 30,   Six months ended June 30, 
Expenditures for Segment Assets  2021   2020   2021   2020 
Radiochemical Products  $     $     $3,103   $   
Cobalt Products               16,592       
Nuclear Medicine Standards   32,911          167,911       
Radiological Services                        
Fluorine Products               4,060    1,565 
Total Segments   32,911          191,666    1,565 
Corporate purchases                        
Total Consolidated  $32,911   $     $191,666   $1,565 

 

   June 30,   December 31, 
Segment Assets  2021   2020 
Radiochemical Products  $3,067,625   $2,916,442 
Cobalt Products   632,133    743,127 
Nuclear Medicine Standards   2,235,779    2,052,220 
Radiological Services   15,057    60,696 
Fluorine Products   5,312,164    5,371,506 
Total Segments   11,262,758    11,143,991 
Corporate assets   4,546,988    5,952,758 
Total Consolidated  $15,809,746   $17,096,749 

 

(12)         Subsequent Events

 

On July 8, 2021, the Company entered into a Membership Interest Purchase Agreement (the Purchase Agreement) with RadQual and the sellers set forth in the Purchase Agreement, which included the Company’s Chairman of the Board, Chief Executive Officer, former Chairman of the Board, and certain other stockholders of the Company (collectively, the “Sellers”). Pursuant to the Purchase Agreement, the Company acquired all of the outstanding membership interests of RadQual not then owned by the Company for an aggregate purchase price of approximately $4.4 million, payable in shares of the Company’s common stock valued at $0.11 per share (determined by the average trading price of the Company’s common stock on the OTC Markets during the 60 trading day period immediately prior to June 2, 2021) (the “RadQual Acquisition”). The Company issued an aggregate of 40,176,236 shares of its common stock to the Sellers as consideration in the RadQual Acquisition. Prior to the RadQual Acquisition, the Company owned approximately 24.5% of the outstanding membership interests of RadQual, and after acquiring all of the remaining membership interests of RadQual, RadQual became a wholly-owned subsidiary of the Company. The RadQual Acquisition closed on July 8, 2021.

 

17 

 

 

 

ITEM 2. 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 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, 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, 2020 filed with the Securities and Exchange Commission (SEC) on March 30, 2021 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, manufacture a range of cobalt products, and distribute sodium iodide I-131 as a generic drug. 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.

 

RADQUAL ACQUISTION

 

On July 8, 2021, the Company entered into a Membership Interest Purchase Agreement (the Purchase Agreement) with RadQual and the sellers set forth in the Purchase Agreement, which included the Company’s Chairman of the Board, Chief Executive Officer, former Chairman of the Board, and certain other stockholders of the Company (collectively, the Sellers). Pursuant to the Purchase Agreement, the Company acquired all of the outstanding membership interests of RadQual not then-owned by the Company for an aggregate purchase price of approximately $4.4 million, payable in shares of the Company’s common stock valued at $0.11 per share (determined by the average trading price of the Company’s common stock on the OTC Markets during the 60 trading day period immediately prior to June 2, 2021) (the RadQual Acquisition). The Company issued an aggregate of 40,176,236 shares of its common stock to the Sellers as consideration in the RadQual Acquisition. Prior to the RadQual Acquisition, the Company owned approximately 24.5% of the outstanding membership interests of RadQual, and after acquiring all of the remaining membership interests of RadQual, RadQual became a wholly-owned subsidiary of the Company. The RadQual Acquisition closed on July 8, 2021.

 

Our business consists of the following five 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 and PET camera operational testing, and calibration of dose measurement equipment commonly used in the practice of nuclear pharmacy. 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

 

18 

 

 

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. The Company has a contract in place with the U.S. Department of Energy (DOE) for the production of high specific activity cobalt in the Advanced Test Reactor (ATR) in Idaho. This agreement will be in effect until October 2024.

 

Radiochemical Products. Our Radiochemical Products segment includes production and distribution and FDA approved generic sodium iodide I-131 drug product for the treatment of hyperthyroidism and carcinoma of the thyroid. We are the only U.S. Company distributing this generic drug product. This segment also includes distribution of certain other radiochemical products and contract manufacturing of radiopharmaceutical products for our customers.

 

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 consisted 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. The Company has suspended all of its field service activities and is in the process of terminating most gemstone processing. The Company will continue to perform some limited testing services of various gemstones for exempt distribution. 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 will be more than offset by increased revenues in our remaining business segments.

 

COVID-19 UPDATE

 

As a result of the COVID-19 pandemic, we experienced a reduction of sales within our nuclear medicine calibration standards segment and radiochemicals segment during the six months ended June 30, 2020.  There was no discernable impact from COVID-19 to our cobalt products business segment during the period.  The decrease in sales for the six 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. The sale of radiochemical products increased during the six month period, however, we believe the increase in revenue would have been greater were it not for the negative impact of COVID-19. 

 

Starting in June 2020, we saw our sales through RadQual substantially recover from the impact of the COVID-19 pandemic. We have seen little impact on our 2021 sales due to COVID-19. We believe that many of the medical procedures had been delayed, not canceled, and there was a pent-up demand for these products. Revenue within our nuclear medicine calibration standards segment for the six months ended June 30, 2021 increased approximately 11% compared to the same period in 2020. 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 types of PPE.  Alternative sources of raw materials have been obtained without any interruption to production.  With the heightened concern about corporate liquidity during the COVID-19 pandemic, the Company believes that it has adequate cash to support continuing operations.

 

 

19 

 

 

RESULTS OF OPERATIONS

 

Three Months Ended June 30, 2021 Compared to Three Months Ended June 30, 2020

 

Revenue for the three months ended June 30, 2021 was $2,759,896 as compared to $2,159,559 for the same period in 2020, an overall increase of $600,337, or approximately 28%. This increase in revenue was largely the result of increased revenue in our Cobalt Products and Nuclear Medicine Standards segments, 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, 2021 and 2020:

 

  

For the three-

months ended

June 30,

  

For the three-

months ended

June 30,

         
Sale of Product  2021   2020   $ change   % change 
Radiochemical Products  $1,228,209   $1,113,053   $115,156   10%
Cobalt Products   576,994    224,666    352,328   157%
Nuclear Medicine Standards   885,728    777,873    107,855   14%
Radiological Services   68,965    43,967    24,998   57%
Fluorine Products   —      —      —     0%
Total Consolidated  $2,759,896   $2,159,559   $600,337   28%

 

Cost of sales increased to $1,171,968 for the three months ended June 30, 2021 from $903,909 for the same period in 2020. This is an increase of $268,059, or approximately 30%. The increase in cost of sales in the three-month comparison was primarily due to the increased sales activity in our Radiochemical, Cobalt, and Nuclear Medicine segments, as discussed in detail below. Gross profit for the three months ended June 30, 2021 was $1,587,928, compared to $1,255,650 for the same period in 2020. This represents an increase in gross profit of $332,278, or approximately 26%.

 

The following table presents cost of sales and gross profit data for each of our business segments for the three months ended June 30, 2021 and 2020:

 

  

For the three-

months ended

June 30,

  

% of

Total Sales

  

For the three-

months ended

June 30,

  

% of

Total Sales

 
   2021   2021   2020   2020 
Total Sales  $2,759,896       $2,159,559     
Cost of Sales                  
Radiochemical Products  $487,126   18%  $480,816   22%
Cobalt Products   263,948   10%   79,091   4%
Nuclear Medicine Standards   420,894   15%   332,380   15%
Radiological Services   —     0%   11,622   1%
Fluorine Products   —     0%   —     0%
Total Segments   1,171,968   42%   903,909   42%
                   
Gross Profit  $1,587,928       $1,255,650     
Gross Profit %   58%       58%    

 

Operating expense increased approximately 16% to $1,573,206 for the three months ended June 30, 2021, from $1,351,751 for the same period in 2020. This increase of $221,455, is primarily due to an approximate 53% increase in General, Administrative and Consulting Costs. This increase in mainly due to increased costs for licenses and depreciation.

 

The following table presents a comparison of total operating expense for the three months ended June 30, 2021 and 2020:

 

  

For the three-

months ended

June 30,

  

For the three-

months ended

June 30,

         
Operating Costs and Expenses:  2021   2020   % change   $ change 
Salaries and Contract Labor  $625,428   $736,539    -15%  $(111,111)
General, Administrative and Consulting   875,799    573,747    53%   302,052 
Research and Development   71,979    41,465    74%   30,514 
Total operating expenses  $1,573,206   $1,351,751    16%  $221,455 

 

20 

 

 

Other income was $32,356 for the three months ended June 30, 2021, as compared to Other Income of $559,895 for the same period in 2020. This is a decrease of $527,539. The decrease is due to income from the SBA Loan (as defined below) of $495,500 converted to grant income during the three months ended June 30, 2020. Interest expense for the three months ended June 30, 2021 was $211,456, compared to $196,344 for the same period in 2020. This is an increase of $15,112, or approximately 8%. Interest expense includes dividends accrued on our Series C Redeemable Convertible Preferred Stock (Series C Preferred Stock). For the three months ended June 30, 2021, we accrued dividends payable of $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. 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 loss for the three months ended June 30, 2021, was ($181,387), compared to net income of $229,328, for the same period in 2020. This is a decrease of income of $410,715 is the result of $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 three months ended June 30, 2021 was $1,228,209, compared to $1,113,053 for the same period in 2020. This is an increase of $115,156, or approximately 10%. The increase is the result of increased sales of our new generic sodium iodide I-131 drug product.

 

Gross profit of radiochemical products for the three months ended June 30, 2021 was $741,083, compared to $632,237, for the same period in 2020, and gross profit percentages were approximately 60% and 57% for the three months ended June 30, 2021 and 2020, 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 $487,126 for the three months ended June 30, 2021, as compared to $480,816 for the same period in 2020. This is an increase of $6,310, or approximately 1%, and was the result of increased sales of product. Operating expense for this segment increased to $336,627 for the three months ended June 30, 2021, compared to $251,509 for the same period in 2020. This increase in operating expense of $85,118, or approximately 34%, is primarily due to increased costs for license and depreciation expenses. This segment reported net income of $404,457 for the three months ended June 30, 2021, as compared to net income of $380,728 for the same period in 2020. The increase in net income of $23,728 or approximately 6%, is primarily the result of increased radiochemical product sales but somewhat offset by increased operating expenses during the three months ended June 30, 2020.

 

Cobalt Products. Revenue from the sale of cobalt products for the three months ended June 30, 2021 was $576,994, compared to $224,666, for the same period in 2020. This represents an increase of $352,328, or approximately 157%. Our cobalt sealed source manufacturing is largely dependent on our ability to procure cobalt material from the DOE’s Advanced Test Reactor (ATR). The increased sales in the three months ended June 30, 2021 is due to sales of material received from the ATR during the period.

 

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 many years to irradiate these cobalt targets to the desired level of activity. Our production calculations indicated we should have anticipated having high specific activity cobalt available for our customers in late 2019. However, extended reactor shutdowns and lower than expected production rates of cobalt-60 in the new design cobalt targets delayed delivery of high specific activity cobalt until May 2021.

 

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.

 

Cost of sales for the three months ended June 30, 2021, was $263,948, as compared to $79,091, for the same period in 2020. Gross profit for cobalt products for the three months ended June 30, 2021 was $313,046 compared to $145,575 for the same period in 2020. This is an increase of $167,471, or approximately 115% and is primarily attributable to increased sales for the three months ended June 30, 2021, as compared to the same period in 2020. Operating expense in this segment increased to $104,465 for the three months ended June 30, 2021, from $69,701 for the same period in 2020. This is an increase of $34,764, or approximately 50%. This increase in operating expenses for the three months ended June 30, 2021 is due to increased support labor from increased shipment activity. Our net income for cobalt products was $208,581 for the three months ended June 30, 2021, as compared to a net income of $75,874 for the same period in 2020. The increase in net income of $132,707, or approximately 175%, was attributable to increased sales.

 

Nuclear Medicine Standards. Revenue from nuclear medicine products for the three months ended June 30, 2021, was $885,728, compared to $777,873 for the same period in 2020. This represents an increase in revenue of $107,855, or approximately 14%. 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 increase in sales for the period ended June 30, 2021 was due to increased order activity as recovery from the Covid-19 pandemic continues.

 

21 

 

 

Cost of sales for our nuclear medicine standards segment for the three months ended June 30, 2021, was $420,894, as compared to $332,380 for the same period in 2020. The increase in cost of sales in the period-to-period comparison of $88,514, or 27%, is due to increased sales for the three-month period ended June, 2021, as compared to the same period in 2020. Gross profit for our nuclear medicine standards segment for the three months ended June 30, 2021 was $464,834 compared to $445,493 for the same period in 2020. This is an increase in gross profit of $19,341, or approximately 4%. The increase in gross profit in the period-to-period comparison is primarily the result of the increased sales. Our gross profit percentages were approximately 52% and 57% for the three-month periods ended June 30, 2021 and 2020, respectively. The decrease in the gross profit percentage for the three months ended June 30, 2021 is primarily due to increased raw material cost.

 

Operating expense for this segment for the three months ended June 30, 2021 increased to $412,992, from $328,437 for the same period in 2020. This is an increase of $84,555, or approximately 26%, and is the result of increased expenses for production supplies, support labor expenses, and operating expenses related to RadQual as compared to the same period in 2020. Operating expense includes consolidated net operating expense reported for RadQual of $174,113 and non-controlling member interest expense of $20,121, for the three months ended June 30, 2021, as compared to $126,367 of net operating expense and non-controlling member interest expense of $39,789 for the same period in 2020. Net operating expense included for TI Services was $29,522 for the three months ended June 30, 2021, and $23,381 for the same period in 2020. TI Services non-controlling interest included was ($3,066) for the three-month period ended June 30, 2021, as compared to ($919) for the same period in 2020. Net income for this segment for the three months ended June 30, 2021 was $51,843, compared to $117,056 for the same period in 2020. This is a decrease in net income of $65,213, or approximately 56% and is primarily the result of increased operating expenses partially offset by increased gross profit.

 

Radiological Services. Revenue from all radiological services for the three months ended June 30, 2021 was $68,964, compared to $43,967, for the same period in 2020, an increase of $24,997 or approximately 57%. The increase in the revenue for the period comparison is the result of increased gemstone processing activity from the wrapping up of this contract work.

 

On May 2, 2019, our 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. We supported the initial onsite contamination clean-up operations at that location and completed removal of the cesium source and Company equipment. We have reviewed the results of the DOE investigation into this event and has implemented appropriate corrective actions. Beginning in August 2019, the DOE assumed full control of the cleanup operations and assumed all the financial obligations associated with the contractors hired to carry out all remaining facility recovery operations. On January 5, 2021, we were notified by the DOE that we have been indemnified from any financial liability for this event under the Price Anderson Act (PAA). We are actively pursuing a final settlement with its insurance company regarding this claim as of the date of this filing. 

 

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 throughout 2021 and the Company expects to 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 three months ended June 30, 2021, was $0, as compared to $11,622, for the same period in 2020. Gross profit for this segment for the three months ended June 30, 2021 was $68,965, compared to $32,345, reported for the same period in 2020. The increase in gross profit of $36,619, or approximately 113%, is the result of decreased costs for gemstone processing for the three months ended June 30, 2021, as compared to the same period in 2020. We expect our costs of sales to continue to be very low going forward. Operating expense for the three months ended June 30, 2021 was $10,723 as compared to $45,877, reported for the same period in 2020. This decrease of $35,154, or approximately 77%, is the result of decreased sales and activity within the business segment.

 

Net income for this segment for the three months ended June 30, 2021 was $58,242, compared to net loss of $13,532, for the same period in 2020. This is an increase in net income of $71,774 is the result increase in gross profit and decreased operating expenses for the same period in 2020.

 

Fluorine Products. There was no revenue to report from the fluorine products segment for the three months ended June 30, 2021, or for the same period in 2020. During the three months ended June 30, 2021, we incurred $31,626 of expense related to items in support of future planning and design for the proposed de-conversion facility, as compared to $36,460 for the same three-month period in 2020. This is a decrease of 13% in the period-to-period comparison.

 

22 

 

 

We established the Fluorine Products segment in 2004 to support production and sale of the gases produced using our FEP. 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 until such time that we decide to resume the project.

 

Six Months Ended June 30, 2020 Compared to Six Months Ended June 30, 2019

 

Revenue for the six-month period ended June 30, 2021 was $4,752,408, as compared to $4,495,345 for the same period in 2020, an increase of $257,063, or approximately 6%. The performance of all our business segments for the six-month period is discussed in further detail below.

 

The following table presents a period-to-period comparison of total revenue by segment for the six months ended June 30, 2021 and June 30, 2020:

 

  

For the six-

months ended

June 30,

  

For the six-

months ended

June 30,

         
Sale of Product  2021   2020   $ change   % change 
Radiochemical Products  $1,889,386   $1,868,274   $21,112   1%
Cobalt Products   695,367    530,286    165,081   31%
Nuclear Medicine Standards   2,014,887    1,819,997    194,890   11%
Radiological Services   130,755    116,288    14,467   12%
Fluorine Products   22,013    160,500    (138,487)  -86%
Total Consolidated  $4,752,408   $4,495,345   $257,063   6%

 

Gross profit for the six-month period ended June 30, 2021 was $2,749,086, compared to $2,622,911, for the same period in 2020. This represents an increase of $126,175 or approximately 5%.

 

The following table presents cost of sales and gross profit data for each of our business segments for the six months ended June 30, 2021 and 2020:

 

  

For the six-

months ended

June 30,

  

% of

Total Sales

  

For the six-

months ended

June 30,

  

% of

Total Sales

 
   2021   2021   2020   2020 
Total Sales  $4,752,408        $4,495,345      
Cost of Sales                    
Radiochemical Products  $792,609    17%  $890,411    20%
Cobalt Products   307,201    6%   143,530    3%
Nuclear Medicine Standards   903,166    19%   805,154    18%
Radiological Services   346    0%   33,339    1%
Fluorine Products   —      0%   —      0%
Total Segments   2,003,322    42%   1,872,434    42%
                     
Gross Profit  $2,749,086        $2,622,911      
Gross Profit %   58%        58%     

 

Operating expenses were $3,184,892 for the six-month period ended June 30, 2021, compared to $2,928,322 for the same period in 2020. This represents an increase of $256,570, or approximately 9%. This increase is primarily due to an approximate 31% increase in General, Administrative and Consulting costs that is a result of increased license and permits costs incurred during the six months ended June 30, 2021, as compared to the same period in 2020. Research and Development costs increased to $109,216, for the six months ended June 30, 2021, as compared to $88,393, for the same period in 2020. This is an increase of $20,823, or approximately 24% and is primarily the result of an increase in expenditures for product development in several of our business segments for the six months ended June 30, 2021, as compared to the same period in 2020.

 

23 

 

 

The following table shows total operating expenses for the six-month period ended June 30, 2021 and 2020:

 

  

For the six-

months ended

June 30,

  

For the six-

months ended

June 30,

         
Operating Costs and Expenses:  2021   2020   % change   $ change 
Salaries and Contract Labor  $1,293,948   $1,477,744   -12%  $(183,796)
General, Administrative and Consulting   1,781,728    1,362,185   31%   419,543 
Research and Development   109,216    88,393   24%   20,823 
Total operating expenses  $3,184,892   $2,928,322   9%  $256,570 

 

Interest expense for the six months ended June 30, 2021 was $409,747, compared to $391,224 for the same period in 2020. This is an increase of $18,523, or approximately 5%. Interest expense includes dividends accrued on our Series C Preferred Stock. For the six months ended June 30, 2021, we accrued dividends payable of $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. Additionally, non-cash interest expense in the amount of $128,133 for the issuance of warrants in conjunction with the 2019 Promissory Note was recorded for the six months ended June 30, 2021.

 

Our net loss for the six-month period ended June 30, 2021, was $782,539 as compared to $193,166 for the same period in 2020. This is an increase in loss of 589,373 or approximately 305%. This increase in net loss is the result $495,500 of income from the SBA Loan converted to grant income during the second quarter of 2020 and increased operating expenses in the six months ended June 30, 2021.

 

Radiochemical Products. Revenue from the sale of radiochemical products for the six-month period ended June 30, 2021 was $1,889,386 compared to $1,868,274 for the same period in 2020. This is an increase of $21,112, or approximately 1%. This increase was primarily the result of sales of our new generic sodium iodide I-131 drug product. We expect continued sales growth for our radiochemical products going forward.

 

Cost of sales was $792,609 for the six-month period ended June 30, 2021, and $890,411 for the same period in 2020. This is a decrease of $97,802, or approximately 11%. This decrease is primarily the result of shift of sales activity to our new generic sodium iodide I-131 drug product which has a higher profit margin.

 

Gross profit percentages for our radiochemical products for the six months ended June 30, 2021 and 2020 were approximately 58% and 52%, respectively. Operating expense for this segment for the six-month period ended June 30, 2021 was $687,895, compared to $597,951 for the same period in 2020. This is an increase of $89,944, or approximately 15%, and is primarily due to increased costs for licenses and depreciation partially offset by decreased expenses for support labor. Net income for this segment increased to $408,882 for the six-month period ended June 30, 2021, from $386,347 for the same period in 2020. This increase of $22,535, or approximately 6%, is primarily the result of increased profit margin for radiochemical product during the three months ended June 30, 2021.

 

Cobalt Products. Revenues from the sale of cobalt products for the six-month period ended June 30, 2021 were $695,367, compared to $530,286 for the same period in 2020. This is an increase of $165,081, or approximately 31%, and is the result of decreased Cobalt 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 Advanced Test Reactor (ATR). The increased sales in the six months ended June 30, 2021 is due to sales of material received from the ATR during the period.

 

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.

 

Cost of sales for the six months ended June 30, 2021, was $307,201, as compared to $143,530, for the same period in 2020. Gross profit for cobalt products for the six months ended June 30, 2021 was $388,166 compared to $386,756 for the same period in 2020. This is a increase of $1,410, or less than 1%. Our gross profit percentages were approximately 56% and 73% for the six-month periods ended June 30, 2021 and 2020, respectively. The decrease in the gross profit percentage for the six months ended June 30, 2021 is primarily due to increased costs of raw material used in the manufacture of sealed sources. Operating expense in this segment increased to $209,683 for the six months ended June 30, 2021, from $187,086 for the same period in 2020. This is an increase of $22,597, or approximately 12% is a result of increased equipment expenses in the six months ended June 30, 2021 as compared to the same period in 2020. Our net income for cobalt products was $178,484 for the six months ended June 30, 2021, as compared to a net income of $199,670 for the same period in 2020. The decrease in net income of $21,186 or approximately 11%, was attributable to the increase in operating expenses for the six months ended June 30, 2021, as compared to the same period in 2020.

 

24 

 

 

Nuclear Medicine Standards. Revenue from nuclear medicine products for the six-month period ended June 30, 2021 was $2,014,887 compared to $1,819,997 for the same period in 2020. This represents an increase in revenue attributable to this segment of $194,890, or approximately 11%. The increase in sales for the period ended June 30, 2021 was due to increased order activity as recovery from the Covid-19 pandemic continues.

 

Gross profit for the six-month period ended June 30, 2021 was $1,111,722, as compared to $1,014,843 for the same period in 2020, a increase of $96,879, or approximately 10%. Operating expense for this segment for the six-month period ended June 30, 2021 increased to $893,747, from $748,086 for the same period in 2020. This is an increase of $145,661 or approximately 19% and includes consolidated net operating expense reported for RadQual of $331,144 and non-controlling member interest expense of $108,953, for the six months ended June 30, 2021, compared to consolidated net operating expense of $304,430 and non-controlling member interest expense of $82,223, for the six months ended June 30, 2020. Net income for this segment for the six-month period ended June 30, 2021, decreased to $262,754, approximately 13%, from $302,357 for the same six-month period in 2020.

 

Radiological Services. Revenue from all radiological services for the six months ended June 30, 2021 was $130,755, compared to $116,288, for the same period in 2020, an increase of $14,467 or approximately 12%. The decrease in the revenue for the period comparison is the result of decreased gemstone processing activity.

 

On May 2, 2019, our 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. On January 5, 2021, we were notified by the DOE that we have been indemnified from any financial liability for this event under the Price Anderson Act (PAA). As part of this indemnification notification, we received payment in full for our claim with the DOE for recovery of certain expenses incurred for this event. We recognized Other Income of approximately $112,000 in the six months ended June 30, 2021 for additional cost recoveries for this event. All remaining cost recoveries as part of this settlement with the DOE were recognized in previous financial periods pursuant to ASC 410-30. These funds were used to pay all outstanding subcontractors and reimburse our insurance company for payments they previous paid us for this matter. We are actively pursuing a final settlement with its insurance company regarding this claim as of the date of this filing.

 

Cost of sales for the six months ended June 30, 2021, was $346, as compared to $33,339, for the same period in 2020. Gross profit for this segment for the six months ended June 30, 2021 was $130,408, compared to $82,949, reported for the same period in 2020. The increase in gross profit of $47,459, or approximately 57%, is the result of decreased costs for gemstone processing for the three months ended June 30, 2021, as compared to the same period in 2020. Operating expense for the six months ended June 30, 2021 was $19,760 as compared to $111,410, reported for the same period in 2020. This decrease of $91,650, or approximately 82%, is the result of decreased sales and activity within the business segment.

 

Net income for this segment for the six months ended June 30, 2021 was $110,649, compared to net loss of $28,461, for the same period in 2020. This is an increase in net income of $139,110 and is the result in the increase in gross profit and decreased operating expenses for the same period in 2020.

 

Fluorine Products. For the six months ended June 30, 2021, we had revenues related to Fluorine Products of $22,013 compared to $160,500, for the same period in 2020, a decrease of $138,487 or approximately 86%. These revenues were related to an agreement to provide engineering and technical assistance services related to our fluorine products intellectual property. During the six months ended June 30, 2021, we incurred $87,153 of expense related to items in support of future planning and design for the proposed de-conversion facility, as compared to $74,090 for the same six-month period in 2020. This is an increase of 18% 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, 2021, we had cash and cash equivalents of $517,506 as compared to $1,113,032 at December 31, 2020. This is a decrease of $595,526 or approximately 54%. For the six months ended June 30, 2021, net cash used in operating activities was $238,773 and net cash provided for the six months ended June 30, 2020 in operating activities was $415,918. The increase in cash used in operating activities and decrease in cash and cash equivalents at period end in the period-to-period comparison is the result of increased net loss and decreased accounts payable.

 

25 

 

 

 

Inventories at June 30, 2021 totaled $668,781, and inventories at December 31, 2020 totaled $837,787. Previously, a significant amount of our inventory consisted 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. At June 30, 2021, this raw cobalt material inventory at the ATR accounted for approximately 0% of our work-in-process inventory. At December 31, 2020, this in-process raw material inventory accounted for approximately 46% of our work in process inventory.

 

Cash used in investing activities was $191,666 for the six months ended June 30, 2021, and cash used in investing activities was $1,565 for the same period in 2020. The cash used in the six months ended June 30, 2021 was for the purchase of equipment.

 

Financing activities provided cash of $26,978, during the six months ended June 30, 2021, and cash used by financing activities for the same period in 2020 was $155,352. During the six months ended June 30, 2021, cash paid for interest was $61,320 and during the same six-month period in 2020, cash paid for interest was $65,536. Additionally, during the six months ended June 30, 2021, we received $8,995 in proceeds from the sale of our common stock through our Employee Stock Purchase Plan, as compared to $10,273 for the same period in 2020.

 

In February 2021, the Company paid its third annual dividend on the Series C Preferred Stock. Dividends payable totaled $254,280. 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 1,398,200 shares of common stock in lieu of a dividend payment of $207,480. The remaining $46,800 of dividend payable was settled with cash.

 

Total decrease in cash for the six-month period ended June 30, 2021, was $403,461 compared to a cash increase of $259,001 for the same period in 2020.

 

We expect that cash from operations, cash raised via equity or debt financings, 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, our ability to raise additional capital 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, especially in light of the market volatility and uncertainty as a result of the COVID-19 pandemic.

 

At June 30, 2021, there were 7,065,000 outstanding warrants to purchase our common stock. Included in this number are 4,140,000 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.

 

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 2013 Promissory 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 February 2017, the 2013 Promissory Note was further modified to extend the maturity date to December 31, 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, 2021, accrued interest payable on the 2013 Promissory Note totaled $226,734.

 

 

26 

 

 

In April 2018, we borrowed $120,000 from our Chief Executive Officer and Chairman of the Board pursuant to a 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 originally matured 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 in June 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 in February 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 July 2019, the maturity date was extended to January 31, 2020 with 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 become secured by company assets, with all other provisions remaining unchanged. At June 30, 2021, accrued interest on the 2018 Promissory Note totaled $22,970.

 

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 2020, we borrowed an additional $325,000. The 2019 Promissory Note is secured and bears interest at 4% per annum and has a maturity date of December 31, 2022. According to the terms of the 2019 Promissory Note, at 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 Class O Warrants were exercisable at an exercise price of $0.045 per share and had a term of five years. In January 2021, all 30,000,000 Class O Warrants were exercised. At June 30, 2021, accrued interest on the 2019 Promissory Note totaled $59,131.

 

In March 2021, one of the Company’s subsidiaries, RadQual, entered into a promissory note (the March 2021 Promissory Note) for the purchase of equipment. The principal amount under the March 2021 Promissory Note totals $101,250, bears interest at 5%, is secured by equipment, and is due March 2023.

 

In April 2021, we borrowed $250,000 from our Chief Executive Officer and Chairman of the Board pursuant to a promissory note (the April 2021 Promissory Note). The April 2021 Promissory Note bears an interest rate of 6% annually and is due December 31, 2022. At any time, the holder of the April 2021 Promissory Note may elect to have any or all of the principal and accrued interest settled with shares of our common stock based at the price of $0.11 per share. At June 30, 2021 accrued interest on the April 2021 Promissory Note totaled $3,250.

 

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 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 was scheduled to mature on April 22, 2022 and had a 1.00% interest rate and was subject to the terms and conditions applicable to loans administered by the SBA under the CARES Act.

 

In July 2021, we received notification from the SBA that we received approval of forgiveness of the entire loan.

 

OFF-BALANCE SHEET ARRANGEMENTS

 

As of June 30, 2021, we had no off-balance sheet arrangements or obligations.

 

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, 2020, filed with the SEC on March 30, 2021.

 

27 

 

 

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 us in the reports that we file or submit 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, 2021, 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, 2021.

 

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, 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

PART II OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

A discussion of legal matters is found in Note 8, “Commitments and Contingencies”, in the accompanying notes to the unaudited condensed consolidated financial statements included in Part I - Item 1. Financial Statements of this Quarterly Report.

 

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, 2020.

 

 

 

 

 

 

 

 

 

 

 

 

 

28 

 

 

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)).

 

31.1Certification by the Chief Executive Officer under Section 302 of the Sarbanes-Oxley Act of 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, 2021 and December 31, 2020, (ii) Unaudited Condensed Consolidated Statements of Operations for the three months and six months ended June 30, 2021 and 2020, (iii) Unaudited Condensed Consolidated Statements of Cash Flows for the three months and six ended June 30, 2021 and 2020 and (iv) Notes to Unaudited Condensed Consolidated Financial Statements.*
  
104Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)*

______________

*    Filed herewith.

 

**  Furnished herewith.

 

 

 

 

 

 

29 

 

 

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 16, 2021 International Isotopes Inc.
   
     
  By: /s/ Steve T. Laflin
    Steve T. Laflin
    President and Chief Executive Officer
     
     
  By: /s/ W. Matthew Cox
    W. Matthew Cox
    Chief Financial Officer

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

30