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Table of Contents

 



UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

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

 

For the quarterly period ended March 31, 2025

 

OR

 

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

 

For the transition period from _____________ to _______________

 

Commission file number:

000-22923

 

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

(Registrants 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. ☒ Yes ☐ No

 

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

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer ☐

Accelerated filer ☐

Non-accelerated filer

Smaller reporting company

  
 

Emerging growth company

 

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

 

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

 

As of May 9, 2025, the number of shares of common stock, $0.01 par value, outstanding was 526,385,637

 

 

1

 

 

INTERNATIONAL ISOTOPES INC.

FORM 10-Q

For The Quarter Ended March 31, 2025

 

TABLE OF CONTENTS

 

   

Page No.

PART I  FINANCIAL INFORMATION

 
     

Item 1.

Financial Statements

 
 

Unaudited Condensed Consolidated Balance Sheets at March 31, 2025 and December 31, 2024

3

 

Unaudited Condensed Consolidated Statements of Operations for the Three Months Ended March 31, 2025 and 2024

4

 

Unaudited Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2025 and 2024

5

 

Unaudited Condensed Consolidated Statement of Stockholders (Deficit) Equity for the Three Ended March 31, 2025 and 2024

6

 

Notes to Unaudited Condensed Consolidated Financial Statements

7

Item 2.

Management's Discussion and Analysis of Financial Condition and Results of Operations

18

Item 4.

Controls and Procedures

24

     

PART II  OTHER INFORMATION

 
     

Item 1.

Legal Proceedings

24

Item 1A.

Risk Factors

24

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

24

Item 5. Other Information 24

Item 6.

Exhibits

25

Signatures

26

 

2

 

 

PART I FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

 

INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(unaudited)

 

  

March 31,

  

December 31,

 
  

2025

  

2024

 

Assets

        

Current assets

        

Cash and cash equivalents

 $1,645,663  $1,945,523 

Accounts receivable

  1,689,627   1,521,380 

Inventories

  723,524   820,893 

Prepaids and other current assets

  503,008   698,030 

Total current assets

  4,561,822   4,985,826 
         

Long-term assets

        

Restricted cash

  1,446,979   1,431,710 

Property, plant and equipment, net

  3,383,049   3,297,769 

Capitalized lease disposal costs, net

  626,992   639,286 

Financing lease right-of-use asset

     826 

Operating lease right-of-use asset

  2,830,201   2,047,733 

Goodwill

  1,384,255   1,384,255 

Patents and other intangibles, net

  3,332,339   3,373,563 

Total long-term assets

  13,003,815   12,175,142 

Total assets

 $17,565,637  $17,160,968 
         

Liabilities and Stockholders' Equity

        

Current liabilities

        

Accounts payable

 $321,855  $861,883 

Accrued liabilities

  1,576,009   1,494,665 

Unearned revenue

  773,423   513,317 

Current portion of operating lease right-of-use liability

  186,613   150,532 

Current portion of related party notes payable

  1,620,000    

Current installments of notes payable

  153,305   308,399 

Total current liabilities

  4,631,205   3,328,796 
         

Long-term liabilities

        

Accrued long-term liabilities

  28,125   37,500 

Related party notes payable, net of current portion

     1,620,000 

Notes payable, net of current portion

  254,506   278,897 

Asset retirement obligation

  1,562,887   1,544,788 

Operating lease right-of-use liability, net of current portion

  2,686,247   1,940,979 

Mandatorily redeemable convertible preferred stock

  4,063,000   4,063,000 

Total long-term liabilities

  8,594,765   9,485,164 

Total liabilities

  13,225,970   12,813,960 
         

Stockholders' equity

        

Common stock, $0.01 par value; 750,000,000 shares authorized; 524,794,326 and 523,553,435 shares issued and outstanding respectively

  5,247,943   5,235,534 

Additional paid in capital

  126,525,703   126,432,759 

Accumulated deficit

  (127,433,979)  (127,321,285)

Total equity

  4,339,667   4,347,008 

Total liabilities and stockholders' equity

 $17,565,637  $17,160,968 

 

See accompanying notes to condensed consolidated financial statements.

 

3

 

 

INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

Unaudited Condensed Consolidated Statements of Operations

 

  

Three months ended March 31,

 
  

2025

  

2024

 
         

Sale of product

 $3,238,900  $2,904,458 

Cost of product

  1,206,863   1,038,347 

Gross profit

  2,032,037   1,866,111 
         

Operating costs and expenses:

        

Salaries and contract labor

  1,119,326   940,503 

General, administrative, and consulting

  871,024   1,003,557 

Research and development

  106,703   188,247 

Total operating expenses

  2,097,053   2,132,307 
         

Net operating loss

  (65,016)  (266,196)
         

Other income (expense):

        

Other income

  14,349   160,720 

Interest income

  21,824   32,728 

Interest expense

  (83,851)  (81,303)

Total other (expense) income

  (47,678)  112,145 

Net Loss

 $(112,694) $(154,051)
         

Net loss per common share - basic:

 $  $ 

Net loss per common share - diluted:

 $  $ 
         

Weighted average common shares outstanding - basic

  524,082,026   520,167,183 

Weighted average common shares outstanding - diluted

  524,082,026   520,167,183 

 

See accompanying notes to condensed consolidated financial statements.

 

4

 

 

INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

Unaudited Condensed Consolidated Statements of Cash Flows

 

  

Three months ended March 31,

 
  

2025

  

2024

 

Cash flows from operating activities

        

Net loss

 $(112,694) $(154,051)

Adjustments to reconcile net loss to net cash provided by operating activities

        

Depreciation and amortization

  97,945   101,447 

Accretion of obligation for lease disposal costs

  18,099   17,275 

Equity based compensation

  70,279   62,650 

Right-of-use asset changes, net

  (1,119)  (1,119)

Changes in operating assets and liabilities:

        

Accounts receivable

  (168,247)  113,936 

Inventories

  97,369   (7,075)

Prepaids and other current assets

  195,022   193,090 

Accounts payable and accrued liabilities

  (461,879)  41,805 

Unearned revenues

  260,106   44,486 

Net cash (used in) provided by operating activities

  (5,119)  412,444 
         

Cash flows from investing activities:

        

Purchase of property, plant and equipment

  (128,881)  (170,921)

Net cash used in investing activities

  (128,881)  (170,921)
         

Cash flows from financing activities:

        

Proceeds from sale of stock and exercise of options and warrants

  3,894   1,479 

Payments on financing lease

     (755)

Proceeds from the issuance of notes payable

  45,515    

Principal payments on notes payable

  (200,000)  (64,365)

Net cash used in financing activities

  (150,591)  (63,641)
         

Net (decrease) increase in cash, cash equivalents, and restricted cash

  (284,591)  177,882 

Cash, cash equivalents, and restricted cash at beginning of period

  3,377,233   3,568,893 

Cash, cash equivalents, and restricted cash at end of period

 $3,092,642  $3,746,775 
         

Supplemental disclosure of cash flow activities:

        

Cash paid for interest

 $39,954  $155,168 
         

Supplemental disclosure of noncash financing and investing transactions

        

Decrease in current installments of notes payable for issuance of stock

 $25,000  $ 

Increase in operating lease right-of-use asset and right-of-use liability for new lease

 $830,720  $ 

Decrease in accrued interest and increase in equity for conversion of dividends to stock

 $6,180  $90,420 

 

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

 

  

March 31,

  

March 31,

 
  

2025

  

2024

 

Cash and cash equivalents

 $1,645,663  $2,368,496 

Restricted cash included in long-term assets

  1,446,979   1,378,279 

Total cash, cash equivalents, and restricted cash shown in statement of cash flows

 $3,092,642  $3,746,775 

 

See accompanying notes to condensed consolidated financial statements.

 

5

 

 

INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

Condensed Consolidated Statement of Stockholders' (Deficit) Equity

Three Months Ended March 31, 2025

(Unaudited)

 

  

Common stock

             
          

Additional

         
  

Shares

  

Common

  

Paid-in

  

Accumulated

  

Total

 
  

Outstanding

  

Stock

  

Capital

  

Deficit

  

(Deficit) Equity

 

Balance, January 1, 2025

  523,553,435  $5,235,534  $126,432,759  $(127,321,285) $4,347,008 

Shares issued under employee stock purchase plan

  152,705   1,527   2,367      3,894 

Stock in lieu of dividends on convertible preferred C

  118,846   1,188   4,992      6,180 

Stock for Amici

  312,500   3,125   21,875      25,000 

Shares issued for issuance of RSUs

  250,000   2,500   (2,500)      

Stock based compensation

  406,840   4,069   66,210      70,279 

Net loss

           (112,694)  (112,694)

Balance, March 31, 2025

  524,794,326  $5,247,943  $126,525,703  $(127,433,979) $4,339,667 

 

 

 

INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

Condensed Consolidated Statement of Stockholders' (Deficit) Equity

Three Months Ended March 31, 2024

(Unaudited)

 

  

Common stock

             
          

Additional

         
  

Shares

  

Common

  

Paid-in

  

Accumulated

  

Total

 
  

Outstanding

  

Stock

  

Capital

  

Deficit

  

(Deficit) Equity

 

Balance, January 1, 2024

  519,787,870  $5,197,879  $126,168,605  $(127,329,859) $4,036,625 

Shares issued under employee stock purchase plan

  43,495   435   1,044      1,479 

Stock in lieu of dividends on convertible preferred C

  1,808,400   18,084   72,336      90,420 

Shares issued for issuance of RSUs

  250,000   2,500   (2,500)      

Stock based compensation

        62,650      62,650 

Net loss

           (154,051)  (154,051)

Balance, March 31, 2024

  521,889,765  $5,218,898  $126,302,135  $(127,483,910) $4,037,123 

 

See accompanying notes to the condensed consolidated financial statements

 

6

 

INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

Notes to Unaudited Condensed Consolidated Financial Statements

March 31, 2025

 

 

(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, including International Isotopes Idaho Inc., a Texas corporation; International Isotopes Fluorine Products, Inc., an Idaho corporation; International Isotopes Transportation Services, Inc., an Idaho corporation; RadQual, LLC, a limited liability company (RadQual); RadVent, LLC, a limited liability company; Radnostix, LLC, a limited liability company; and TI Services, LLC, a limited liability company (TI Services). RadQual is a global supplier of molecular imaging quality control and calibration devices, and is based at INIS headquarters in Idaho Falls, Idaho. TI Services is headquartered in Boardman, Ohio and distributes products for nuclear medicine, nuclear cardiology, and Positron Emission Tomography (PET) imaging. INIS, and its wholly-owned subsidiaries are collectively referred to herein as the “Company,” “we,” “our” or “us.”

 

Nature of Operations – The Company manufacture a full range of nuclear medicine calibration and reference standards, a wide range of products, including cobalt teletherapy sources, and an FDA-approved radiopharmaceutical drug product. The Company also holds several patents for a fluorine extraction process that would be used in conjunction with a proposed commercial depleted uranium de-conversion facility which would be located in Lea County, New Mexico (the “De-Conversion Facility”). The Company’s business consists of five major business segments: Theranostics Products, Cobalt Products, Nuclear Medicine Standards, Medical Devices, and Fluorine Products. The Company’s headquarters and all operations, with the exception of TI Services, are located in Idaho Falls, Idaho. For 2025, the Company’s business consists of five business segments: Theranostics Products, Cobalt Products, Nuclear Medicine Standards, Medical Device Products, and Fluorine Products. The Company’s headquarters and all manufacturing operations 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 including RadQual and TI Services. See Note 4 “Investment and Business Consolidation” for additional information. 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 months ended March 31, 2025 are not necessarily indicative of the results that may be expected for the year ending December 31, 2025 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, 2024 filed with the SEC on March 3, 2025.

 

Recent Accounting Pronouncements  In December 2023, FASB issued ASU 2023-09, Income Taxes (Topic 740) - Improvements to Income Tax Disclosures, which enhances the disclosures required for income taxes in the Company’s annual consolidated financial statements. Notably, this ASU requires entities to disclose specific categories in the effective tax rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold. ASU 2023-09 is effective for the Company in its annual reporting for fiscal 2025 on a prospective basis. Early adoption and retrospective reporting are permitted. The Company is currently evaluating the impact of ASU 2023-09 on its consolidated financial statements.

  

7

  
 

(2)       Current Developments and Liquidity

 

Business Condition – Since inception, the Company has incurred substantial losses. During the three months ended March 31, 2025, the Company reported a net loss of $112,694 and net cash used in operating activities of $5,119. During the three months ended March 31, 2024, the Company reported net loss of $154,051 and net cash provided by operating activities of $412,444.

 

During the three months ended March 31, 2025, the Company continued its focus on its strongest long-standing core business segments which consist of its Theranostics Products (previously called Radiochemical Products), Cobalt Products, and Nuclear Medicine Standards, and in particular, the pursuit of new business opportunities within those segments. Additionally, the Company has begun to focus on the start-up of its Medical Device segment which includes assets purchased from AMICI, Inc. (AMICI) in 2023 and investing into an EasyFill Automated Iodine Capsule System.

 

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. On February 8, 2024, the Company entered into a definitive agreement to sell all of its assets related to the Fluorine Products segment and the Planned Uranium De-Conversion Facility, including the Lea County land. The Company expects to close the agreement within 24 months of signing. Closing is contingent on various conditions being met, including approvals and agreements by the NRC and other third parties. Proceeds from this sale would be $12.5 million in total.

 

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 commercial relationships, technological developments, market factors, available credit, and management of redeemable convertible preferred stock. There is no assurance that additional capital and financing will be available on acceptable terms to the Company or at all.

   

8

 
 

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

 

For the three months ended March 31, 2025, the Company had 26,512,500 stock options outstanding, 5,000,000 restricted stock units outstanding, and 4,063 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 three months ended March 31, 2024, the Company had 25,812,500 stock options outstanding, 6,750,000 restricted stock units outstanding, and 4,063 outstanding shares of 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.

 

The table below shows the calculation of diluted shares:

 

  

3 Months Ended

 
  

March 31,

  

March 31,

 
  

2025

  

2024

 

Weighted average common shares outstanding - basic

  524,082,026   520,167,183 
         

Effects of dilutive shares

        

Stock Options

      

Series C Preferred Stock

      

Weighted average common shares outstanding - diluted

  524,082,026   520,167,183 

 

The table below summarizes common stock equivalents outstanding at March 31, 2025 and March 31, 2024:

 

  

March 31,

 
  

2025

  

2024

 

Stock options

  26,512,500   25,812,500 

Restricted Stock Units

  5,000,000   6,750,000 

Shares of Series C Preferred Stock

  40,630,000   40,630,000 
   72,142,500   73,192,500 

 

9

 
 

(4)       Investment and Business Consolidation

 

In June 2023, the Company acquired several medical devices with related assets and intellectual property rights from AMICI and has been working on FDA 510k transfers, and start-up of manufacturing. In January 2025, the parties amended the Asset Purchase Agreement whereby the Company received additional product rights and related assets to make up for a shortfall by AMICI in deliverable assets originally contemplated in the Asset Purchase Agreement.

 

On June 3, 2024, the Company entered into a Strategic Development and Distribution Agreement with Alpha Nuclide Inc for the rights to manufacture and distribute the Company’s Theranostics Products and Nuclear Medicine Products in mainland China as part of a 50/50 joint Venture between the Company and Alpha Nuclides. The parties will begin with the distribution of the Company’s Nuclear Medicine Products as part of phase I of the strategic alliance, with further planned milestones for the establishment of a joint venture to register the Company’s Theranostics & Nuclear Medicine Products with the CFDA for local manufacturing and distribution. The parties envision commercializing INIS's radiopharmaceutical Iodine-131, radiochemical API, and theranostics API I-131 for 3rd party therapeutic applications in China. The parties intend to manufacture and distribute the products from Alpha Nuclide's Jiaxing facility, which Alpha Nuclides is responsible for establishing. The parties also intend to enter into a supply agreement for raw material isotopes to be supplied from Alpha Nuclide to the Company to be used in the Company’s manufacturing process at the Company’s Idaho Falls, Idaho facility.

 

On August 6, 2024, the Company entered into a joint venture agreement with Phantech LLC to form PhanQual. PhanQual will leverage INIS’s and Phantech’s technologies, facilities, experience, and global network to design, manufacture, and distribute sealed sources, including adapting Phantech's patented and cutting-edge fillable calibration source technology, into sealed source calibration devices to better serve the R&D and theranostics community. Additionally, RadQual will globally distribute Phantech’s entire portfolio of fillable sources through RadQual’s global network of distributors. PhanQual’s revenues and operations will operate through RadQual and will be included in our Nuclear Medicine Standards segment.

 

 

(5)       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 three months ended March 31, 2025 and 2024, the Company issued 152,705 and 43,495 shares of common stock, respectively, to employees under the employee stock purchase plan for proceeds of $3,894 and $1,479, respectively. As of  March 31, 2025, 1,682,924 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 March 31, 2025, there were 18,342,456 shares available for issuance under the 2015 Plan.

 

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

 

Non-Employee Grants - The Company accounts for its issuances of stock-based compensation to non-employees by 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.

 

10

 

Option awards outstanding as of  March 31, 2025, and changes during the three months ended March 31, 2025, were as follows:

 

          

Weighted

     
      

Weighted

  

Average

     
      

Average

  

Remaining

  

Aggregate

 

Fixed Options

 

Shares

  

Exercise Price

  

Contractual Life

  

Intrinsic Value

 

Outstanding at December 31, 2024

  26,087,500  $0.05   6.1     

Granted

  425,000   0.04         

Exercised

              

Expired

              

Forfeited

              

Outstanding at March 31, 2025

  26,512,500   0.05   5.9  $235,375 

Exercisable at March 31, 2025

  19,967,500  $0.05   4.9  $157,275 

 

The intrinsic value of outstanding and exercisable shares is based on the closing price of the Company’s common stock on the OTCQB of $0.05 per share on March 31, 2025.

 

As of  March 31, 2025, there was $91,286 of unrecognized compensation expense related to stock options that will be recognized over a weighted-average period of 1.71 years.

 

Total stock-based compensation expense for the three months ended March 31, 2025 and 2024 was $70,279 and $62,650, respectively.

 

During the three months ended March 31, 2025, the Company granted an aggregate of 425,000 qualified stock options to 5 of its employees. These options vest over a five-year period with the first vesting on the first anniversary of the date of grant and expiration at ten-year anniversary for all grants. The exercise price for these granted options was $0.04 and $0.05 per share. The options issued during the three months ended March 31, 2025 have a fair value of $12,444, 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 4.36% to 4.47%, expected dividend yield rate of 0%, expected volatility of 75.77% to 81.30% and an expected life between 5 and 7 years.

  

Restricted Stock Units outstanding as of  March 31, 2025, and changes during the three months ended March 31, 2025, were as follows:

 

Non-Vested Restricted Stock Units

 

Number of restricted stock units

  

Weighted average grant-date fair value

 

Outstanding at December 31, 2024

  5,250,000  $0.04 

Granted

       

Vested and Exercised

  (250,000)  0.04 

Forfeited / Cancelled

       

Outstanding at March 31, 2025

  5,000,000  $0.04 

 

As of  March 31, 2025, there was $43,685 of unrecognized compensation expense related to Restricted Stock Units that will be recognized over a weighted-average period of 1.00 years.

 

11

 

Preferred Stock

 

At March 31, 2025, there were 4,063 shares of the Series C Preferred Stock outstanding with a mandatory redemption date of February 28, 2027 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 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.

 

During the three months ended March 31, 2025 and 2024, dividends paid to holders of the Series C Preferred Stock totaled $37,800 and $243,030 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 three months ended March 31, 2025 and 2024, the Company issued 118,846 shares of common stock in lieu of a dividend payment of $6,180. $37,800 of dividend payable was settled with cash. The remaining balance of $199,800 was outstanding as of March 31, 2025 pending receipt of information from shareholders and will be settled in the second quarter of 2025.

  

12

 

 

 

(6)        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. In January 2022, the 2013 Promissory Note was modified to extend the maturity date to December 31, 2023, with all remaining terms unchanged. In February 2024, the 2013 Promissory Note was modified to extend the maturity date to March 31, 2026, with all remaining terms unchanged. At March 31, 2025, accrued interest payable on the 2013 Promissory Note was $339,234

 

In April 2018, the Company borrowed $120,000 from its then 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. In June 2018, the 2018 Promissory Note was modified to extend the maturity date to March 31, 2019 with all other provisions remaining unchanged. In February 2019, the 2018 Promissory Note was modified to extend the maturity date to July 31, 2019 with all other provisions remaining unchanged. In July 2019, the 2018 Promissory Note was modified to extend the maturity date to January 31, 2020 with all other provisions remaining unchanged. In December 2019, the 2018 Promissory Note was modified to extend the maturity date to December 31, 2021, the note was also modified to become secured by company assets, with all other provisions remaining unchanged. In December 2021, the 2018 Promissory Note was modified to extend the maturity date to December 31, 2023, with all remaining terms unchanged. In December 2023, the 2018 Promissory Note was modified to extend the maturity date to January 31, 2025, with all remaining terms unchanged. In February 2024, the 2018 Promissory Note was modified to extend the maturity date to March 31, 2026, with all remaining terms unchanged. At March 31, 2025, accrued interest on the 2018 Promissory Note totaled $49,970.

 

In December 2019 and February 2020, the Company borrowed an aggregate of $1,000,000 from four of the Company’s major shareholders pursuant to a promissory note (the 2019 Promissory Note). The 2019 Promissory Note bears an interest rate of 4% annually and was originally 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 was amortized over the life of the 2019 Promissory Note. The Company calculated a beneficial conversion feature of $315,643 which was accreted to interest expense over the life of the 2019 Promissory Note. In December 2022, the 2019 Promissory Note was modified to extend the maturity date to December 31, 2024, with all remaining terms unchanged. In February 2024, the 2019 Promissory Note was modified to extend the maturity date to March 31, 2026, with all remaining terms unchanged. At March 31, 2025, the accrued interest on the 2019 Promissory Note totaled $209,131.

 

In June 2023, the Company executed an asset purchase agreement with AMICI for the purchase of medical devices and related assets and intellectual property rights. In Connection with the asset purchase agreement, the Company entered a promissory note agreement for $427,100 with AMICI. According to the terms of the note, the Company is required to pay AMICI a minimum of $10,000 per month for a period of 45 months. The amount due is not subject to interest until the 25th month after the anniversary of the closing of the agreement. At March 31, 2025, the balance of this note was $217,100.

 

13

 
 

(7)       Commitments and Contingencies

 

Dependence on Third Parties

 

Sales to the Company’s top three customers for the three months ended March 31, 2025 were approximately 32% of its total gross revenue. The Company is making efforts to reduce its dependency on a small number of customers by expanding both domestic and foreign. Approximately 17% of the Company's total gross revenue was from sales from a single customer as part of our Theranostics Products segment.

 

The production of Cobalt-60 is dependent upon the U.S. Department of Energy (DOE), and its prime operating contractor, which controls the Advanced Test Reactor (ATR) and laboratory operations at the ATR located outside of Idaho Falls, Idaho. From 2014 to 2024, the Company had a ten-year contract with the DOE for the irradiation of cobalt targets for the production of cobalt-60. The Company was able to purchase cobalt targets as available for a fixed price per target and with an annual 5% escalation in price. The contract term was October 1, 2014, through September 30, 2024. The Company continues to source cobalt-60 from the DOE through amendments to the existing contract.

 

Sales of our most predominant Theranostics 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 Theranostics Products sales until material could be purchased from alternate suppliers including obtaining regulatory approval to use material from alternative suppliers if necessary. In the three-months ended March 31, 2025, we experienced a short supply interruption from our key raw material supplier.  The Company has identified additional suppliers, with anticipated regulatory approvals for those suppliers later this year and continue to search for additional means to produce and procure certain critical isotopes.

 

The Nuclear Medicine Reference and Calibration Standard products sold by the Company are dependent upon certain radioisotopes that are supplied to the Company through agreements with several suppliers. A loss of any of these suppliers could adversely affect operating results by causing a delay in production or a possible loss of sales. Beginning in the three months ended  March 31, 2024, there was a global shortage of Cobalt-57 isotopes, a key isotope for this business segment that resulted in significant lost sales. In the third quarter of 2024 our main supply of Cobalt-57 was restored, and our global isotope supply chain has normalized. In three months ended  March 31, 2025, a global outage of Gadolinium-153 isotopes, a key isotope for this business segment, resulted in significant lost sales. While the Company continues to work with industry to restart supply of this key isotope, we are uncertain of the timeframe to restore supply.

 

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 the 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. At  March 31, 2025, the balance of this account was $1,446,979.

 

On February 8, 2024, the Company entered into a definitive agreement to sell all of its assets related to the Fluorine Products segment and the Planned Uranium De-Conversion Facility, including the Lea County land, for an aggregate purchase price of approximately $12.5 million, subject to conditions. The Company expects to close the agreement within 24 months of signing. Closing is contingent on various conditions being met, including approvals and agreements by the NRC and other third parties. The Company has not recorded the value of this property as an asset and will not do so until such time that material changes to or sufficient progress on the project has been made to meet the Company’s obligations under the agreements for permanent transfer of the title. 

 

14

 
 

(8)      Revenue Recognition

 

Revenue from Product Sales

 

The Company’s revenue consists primarily of distribution of theranostics including sodium iodide I-131 drug product, calibration and reference standards manufactured for use in the nuclear medicine industry, 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 has not taken place 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 three months ended March 31, 2025, the Company reported current unearned revenue of $773,423. For the period ended December 31, 2024, the Company reported current unearned revenue of $513,317. 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  March 31, 2025, and December 31, 2024, accounts receivable totaled $1,689,627 and $1,521,380, respectively.  For the three months ended March 31, 2025, the Company did not incur material impairment losses with respect to its receivables.

 

 

(9)      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.

 

Beginning and January 2025, the Company entered into a new operating lease agreement for a second facility across the street for our main headquarters. The initial term of the lease is five years, ending December 2029 and includes the option to extend the lease for two additional terms of five years each. The monthly lease rate increases annually by 3% each year. The Company has the right of first refusal on this property that allows it to match any offer to purchase this property. The Company recorded an operating lease right-of-use asset and corresponding operating lease right-of-use liability of $830,720 for this lease based on a life of 15 years and incremental borrowing rate of 6.75%.

 

15

 
  

Three Months Ended March 31,

 
  

2025

  

2024

 

Operating lease costs

 $93,707  $71,777 

Short-term operating lease costs

  2,850   1,800 

Financing lease expense:

        

Amortization of right-of-use assets

     755 

Interest on lease liabilities

     44 

Total financing lease expense

     799 

Total lease expense

 $96,557  $74,376 
         

Right-of-use assets obtained in exchange for new operating lease liabilities

 $830,720  $ 

Right-of-use assets obtained in exchange for new financing lease liabilities

 $  $ 
         

Weighted-average remaining lease term (years) - operating leases

  11.4   10.8 

Weighted-average remaining lease term (years) - financing leases

     0.7 

Weighted-average discount rate - operating leases

  6.75%  6.75%

Weighted-average discount rate - financing leases

     6.75%

 

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

 

  

Operating Leases

  

Financing Leases

 

2025 (excluding the three-months ended March 31, 2025)

 $281,121    

2026

  374,828    

2027

  374,828    

2028

  374,828    

2029

  374,828    

Thereafter

  2,328,178    

Total minimum lease obligations

  4,108,611    

Less-amounts representing interest

  (1,235,751)   

Present value of minimum lease obligations

  2,872,860    

Current maturities

  (186,613)   

Lease obligations, net of current maturities

 $2,686,247  $ 

 

16

 
 

(10)        Segment Information

 

The Company’s reportable segments are reported in a manner consistent with the way management evaluates the businesses. The results of operations are regularly reviewed by the Company's chief operating decision maker ("CODM"), the Chief Executive Officer. The Company identifies its reportable business segments based on differences in products and services. The accounting policies of the business segments are the same as those described in the summary of significant accounting policies. In order to evaluate each reportable segment's performance, the CODM uses income from operations as a measure of profit and loss. The CODM compares operational performance against management expectations when making decisions regarding allocation of operating and capital resources to each segment.

 

In 2025, the Company has five reportable segments which include: Theranostics Products, Cobalt Products, Nuclear Medicine Standards, Medical Device Products, and Fluorine Products. Information regarding the operations and assets of these reportable business segments is contained in the following table:

 

  

Three months ended March 31,

 

Sale of Product

 

2025

  

2024

 

Theranostics Products

 $1,787,054  $1,905,082 

Cobalt Products

  72,450   233,968 

Nuclear Medicine Standards

  1,326,766   765,408 

Medical Device Products

  52,630    

Fluorine Products

      

Total Segments

  3,238,900   2,904,458 

Corporate revenue

      

Total Consolidated

 $3,238,900  $2,904,458 

 

  

Three months ended March 31,

 

Depreciation and Amortization

 

2025

  

2024

 

Theranostics Products

 $8,209  $9,046 

Cobalt Products

  16,002   23,311 

Nuclear Medicine Standards

  29,880   32,978 

Medical Device Products

      

Fluorine Products

  26,095   26,095 

Total Segments

  80,186   91,430 

Corporate depreciation and amortization

  17,759   10,017 

Total Consolidated

 $97,945  $101,447 

  

  

Three months ended March 31,

 

Segment Income (Loss)

 

2025

  

2024

 

Theranostics Products

 $876,994  $1,013,464 

Cobalt Products

  (148,226)  (66,325)

Nuclear Medicine Standards

  267,563   9,497 

Medical Device Products

  (181,669)  (28,511)

Fluorine Products

  (26,159)  21,249 

Total Segments

  788,503   949,374 

Corporate loss

  (901,197)  (1,103,425)

Net Income

 $(112,694) $(154,051)

  

  

Three months ended March 31,

 

Expenditures for Segment Assets

 

2025

  

2024

 

Theranostics Products

 $46,515  $93,924 

Cobalt Products

  12,835    

Nuclear Medicine Standards

  18,214   49,038 

Medical Device Products

  28,876    

Fluorine Products

      

Total Segments

  106,440   142,962 

Corporate purchases

  22,441   27,959 

Total Consolidated

 $128,881  $170,921 

 

  

March 31,

  

December 31,

 

Segment Assets

 

2025

  

2024

 

Theranostics Products

 $1,214,813  $992,513 

Cobalt Products

  186,076   167,881 

Nuclear Medicine Standards

  2,769,890   2,928,814 

Medical Device Products

  607,523   553,117 

Fluorine Products

  4,849,644   4,875,738 

Total Segments

  9,627,946   9,518,063 

Corporate assets

  7,937,691   7,642,905 

Total Consolidated

 $17,565,637  $17,160,968 

 

17

 
 

ITEM 2. MANAGEMENTS 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. Forward-looking statements reflect managements 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 managements expectations are described in the risk factors set forth in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the Securities and Exchange Commission (SEC) on March 3, 2025 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 managements 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 wholly-owned subsidiaries (including RadQual, LLC, TI Services, LLC, RadVent, LLC, and Radnostix, 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 own 100% of RadQual, LLC (RadQual), a global supplier of molecular imaging quality control and calibration devices. As TI Services, LLC is a 50/50 joint venture between the Company and RadQual, TI Services, LLC is also a wholly-owned subsidiary of the Company.

 

Our business consists of the following five business segments:

 

Theranostics Products. Our Theranostics Products segment (formerly called Radiochemical Products) includes production and distribution of various isotopically pure radiopharmaceuticals, APIs, and radiochemicals for medical, industrial, and research applications. The Company produces these products from radioisotopes supplied by its vendors. The Company produces and distributes various products in customized volumes, concentrations, chemical formulations, packages, and specifications tailored to meet FDA specifications or customer and market demands. The Company's FDA approved generic sodium iodide I-131 drug product is the only generic product of this type manufactured in the U.S. and offers customers an attractive domestic alternative to the single existing foreign commercial drug manufacturer. Additionally, this segment includes the Theranostics Products segment of our Radnostix China Joint Venture.

 

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.

 

Nuclear Medicine Standards. Our Nuclear Medicine Standards segment consists of various sealed source calibration and reference products, including our own manufactured products, jointly manufactured products, and third-party products. These products are sold through our RadQual subsidiary for use with Single Photon Emission Computed Tomography (SPECT) and Positron Emission Tomography (PET) imaging equipment, patient positioning, radiopharmacy and radiopharmaceutical CDMO lab equipment, pre-clinical imaging equipment, clinical trial or custom geometry applications, and calibration or operational testing of measuring and/or testing equipment industry. Nuclear Medicine Standards products include flood sources, dose calibrators, cylinder phantoms, rod sources, line sources, flexible and rigid rulers, spot markers, pen point markers, and a host of specialty design items. Pre-clinical products include distribution of fillable sources from Phantech and pre-clinical sealed sources via our PhanQual joint venture with Phantech. Calibration & Reference sources include RadQual products for nuclear pharmacies and related lab equipment; the Company also distributes non-medical sources manufactured by its partner, ORANO LEA. The Nuclear Medicine Standards segment also commercializes bulk isotope sales, medical devices, shielding, and accessories related to the Company's sealed source products.

  

Medical Devices Our Medical Devices segment was started in 2024 from assets previously reported as part of the Nuclear Medicine Standards segment. The products for the Medical Devices segment are currently under development. In 2022 the Company entered a joint venture to develop the EasyFill Automated Capsule System, a robotic lab device to be paired with its Theranostics Products. The EasyFill is still in the developmental stage. In 2023, the Company entered an asset purchase agreement with AMICI, Inc. (AMICI) to purchase manufacturing molds, device registrations, trademarks, and all production rights to several AMICI diagnostic and therapeutic products for lung ventilation; this included the Swirler Radioaerosol System and Tru-Fit mouthpiece products. In January 2025, as part of an amendment to the AMICI asset purchase agreement, the Company received the manufacturing molds, device registrations, trademarks, and all production rights to the AMICI line of Xenon System products. The products that will use these acquired assets from AMICI are currently under development and are expected to be released in the second half of 2025 to be sold through its RadVent subsidiary. In 2024, the Company's Medical Devices segment entered into a distribution and servicing agreement with Scintomics for its complete line of radiosynthesis modules

 

Fluorine Products. We established the Fluorine Products segment in 2004 in conjunction with the development and 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 for this project on hold. On February 8, 2024, we entered into a definitive agreement to sell all of our assets related to the Fluorine Products segment and the Planned Uranium De-Conversion Facility, for an aggregate purchase price of approximately $12.5 million, subject to conditions. We expect to close the agreement within 24 months of signing. Closing is contingent on various conditions being met, including approvals and agreements by the NRC and other third parties.

 

18

 

RESULTS OF OPERATIONS

 

Three Months Ended March 31, 2025, Compared to Three Months Ended March 31, 2024

 

Sale of Product for the three months ended March 31, 2025 was $3,238,900 as compared to $2,904,458 for the same period in 2024, an overall increase of $334,442, or approximately 12%. This increase in sales was the result of increased revenue in our Nuclear Medicine Standards segment partially offset by decreased sales in our Theranostics Products and Cobalt Products, as discussed in more detail below.

 

The following table presents a period-to-period comparison of total revenue by segment for the three months ended March 31, 2025 and 2024: 

 

   

For the three

   

For the three

                 
   

months ended

   

months ended

                 
   

March 31,

   

March 31,

                 

Sale of Product

 

2025

   

2024

   

$ change

   

% change

 

Theranostics Products

  $ 1,787,054     $ 1,905,082     $ (118,028 )     -6 %

Cobalt Products

    72,450       233,968       (161,518 )     -69 %

Nuclear Medicine Standards

    1,326,766       765,408       561,358       73 %

Medical Device Products

    52,630             52,630       %

Fluorine Products

                      %

Total Consolidated

  $ 3,238,900     $ 2,904,458     $ 334,442       12 %

 

Cost of product increased to $1,206,863 for the three months ended March 31, 2025 from $1,038,347 for the same period in 2024. This is an increase of $168,516, or approximately 16%. The increase in cost of product in the three-month comparison was primarily due to the increased sales in the same period. Gross profit for the three months ended March 31, 2025 was $2,032,037, compared to $1,866,111 for the same period in 2024. This represents an increase in gross profit of $165,926, or approximately 9%.

 

The following table presents cost of product and gross profit data for each of our business segments for the three months ended March 31, 2025 and March 31, 2024:

 

   

For the three

           

For the three

         
   

months ended

   

% of

   

months ended

   

% of

 
   

March 31,

   

Total Sales

   

March 31,

   

Total Sales

 
   

2025

   

2025

   

2024

   

2024

 

Total Sales

  $ 3,238,900             $ 2,904,458          

Cost of Sales

                               

Theranostics Products

  $ 505,168       16 %   $ 576,411       20 %

Cobalt Products

    38,872       1 %     109,036       4 %

Nuclear Medicine Standards

    615,470       19 %     352,900       12 %

Medical Device Products

    47,353       1 %                

Fluorine Products

          %           %

Total Segments

  $ 1,206,863       37 %   $ 1,038,347       36 %
                                 

Gross Profit

  $ 2,032,037             $ 1,866,111          

Gross Profit %

    63 %             64 %        

 

19

 

Total operating expenses decreased approximately 2% to $2,097,053 for the three months ended March 31, 2025, from $2,132,307 for the same period in 2024. This decrease of $35,254 is due to decreased General, Administrative, and Consulting expenses due to reduced professional fees and decreased Research and Development expenses due to reduced legal expenses in three months ended March 31, 2025, partially offset by an increase in Salaries and Contract Labor expenses due to increased headcount and increased payrates.

 

The following table presents a comparison of total operating expenses for the three months ended March 31, 2025 and 2024:

 

   

For the three

   

For the three

                 
   

months ended

   

months ended

                 
   

March 31,

   

March 31,

                 

Operating Costs and Expenses:

 

2025

   

2024

   

% change

   

$ change

 

Salaries and Contract Labor

  $ 1,119,326     $ 940,503       19 %   $ 178,823  

General, Administrative and Consulting

    871,024       1,003,557       (13 %)     (132,533 )

Research and Development

    106,703       188,247       (43 )%     (81,544 )

Total operating expenses

  $ 2,097,053     $ 2,132,307       -2 %   $ (35,254 )

 

Other income was $14,349 for the three months ended March 31, 2025 as compared to other income $160,720 for the same period in 2024. This is a decrease of $146,371, or approximately 91% that was due to a decrease in miscellaneous income.

 

Interest expense for the three months ended March 31, 2025 was $83,851, compared to $81,303 for the same period in 2024. This is an increase of $2,548, or approximately 3%. Interest expense includes dividends accrued on our Series C Preferred Stock. As discussed below, we issued Series C Preferred Stock in February 2017 and May 2017. For the three months ended March 31, 2025 and 2024, we accrued dividends payable of $60,945 in each period, which have been recorded as interest expense. See Note 7 “Debt” to our unaudited consolidated financial statements in this Quarterly Report for additional information about our indebtedness and the associated interest expense.

 

We had a net loss of $112,694 for the three months ended March 31, 2025 compared to net loss of $154,051 for the same period in 2024. This increase in net income of $41,357 is largely the result of increased sales in our Nuclear Medicine Standards Products segment and increased gross profit percentages partially offset by the decrease in sales in our Theranostics Products and Cobalt Products segments for the three months ended March 31, 2025, as compared to the same period in 2024.

 

Theranostics Products. Sales of Theranostics Products for the three months ended March 31, 2025 was $1,787,054, compared to $1,905,082 for the same period in 2024. This is a decrease of $118,028, or approximately 6% during the three months ended March 31, 2025. The decrease is the result of a two-week temporary supplier outage during the three months ended March 31, 2025. We expect continued sales growth for our Theranostics Products going forward, primarily from the sale of our generic sodium iodide I-131 drug product and new sales of theranostic API product

 

Gross profit of Theranostics Troducts for the three months ended March 31, 2025 was $1,281,886, compared to $1,328,671 for the same period in 2024, and gross profit percentage was approximately 72% for both periods. Cost of product for Theranostics Products decreased to $505,168 for the three months ended March 31, 2025, as compared to $576,411 for the same period in 2024. This is a decrease of $71,243, or approximately 12%, and was the result of the decreased sales. Operating expenses for this segment increased to $404,892 for the three months ended March 31, 2025, compared to $315,207 for the same period in 2024. This in an increase in operating expenses of $89,685, or approximately 28%. This segment reported net income of $876,994 for the three months ended March 31, 2025, as compared to net income of $1,013,464 for the same period in 2024. The decrease in net income of $136,470 is the result of decreases in sales due to a temporary supplier outage and increased operating expenses.

 

20

 

Cobalt Products. Sales of cobalt products for the three months ended March 31, 2025 was $72,450, compared to $233,968 for the same period in 2024. This represents a decrease of $161,518, or approximately 69%. The decrease was primarily due to the timing of cobalt sealed source manufacturing sales. Large value sales of high activity cobalt sources occur at various times throughout the year. Frequently the timing of these sales can have a significant impact on period comparisons.

 

Cost of product for the three months ended  March 31, 2025, was $38,872, as compared to $109,036, for the same period in 2024. Gross profit for cobalt products for the three months ended  March 31, 2025 was  $33,578 compared to  $124,932 for the same period in 2024. This is a  decrease of $91,354, or approximately  73%. Operating expense in this segment were  $181,804 for the three months ended  March 31, 2025, compared to  $191,257 for the same period in 2024. We had a net loss for cobalt products of  $148,226 for the three months ended  March 31, 2025, as compared to a net loss of  $66,325 for the same period in 2024. The decrease in net income of $81,901, or approximately 123%, was attributable timing of cobalt sealed source manufacturing. 

 

Nuclear Medicine Standards. Sales from nuclear medicine products for the three months ended March 31, 2025, was $1,326,766, compared to $765,408 for the same period in 2024. This represents an increase in sales of $561,358, or approximately 73%. The increase was due to a global shortage of Cobalt-57 isotope during the three months ended March 31, 2024 with no such shortage in the three months ended March 31, 2025. The Cobalt-57 shortage began in January of 2024 and was restored in the third quarter of 2024. We added additional suppliers of Cobalt-57 in 2024.

 

Cost of product for our nuclear medicine standards segment for the three months ended March 31, 2025, was $615,470, as compared to $352,900 for the same period in 2024. The increase in cost of sales in the period-to-period comparison of $262,570, or 74%, was due to increased sales during the three-month period ended March 31, 2025, as compared to the same period in 2024. Gross profit for our nuclear medicine standards segment for the three months ended March 31, 2025 was $711,296 compared to $412,508 for the same period in 2024. This is an increase in gross profit of $298,788, or approximately 72%.

 

Operating expenses for this segment for the three months ended March 31, 2025 increased to $443,733, from $403,011 for the same period in 2024. This is an increase of $40,722, or approximately 10%, and is the result of the increased sales activity in the segment. Net income for this segment for the three months ended March 31, 2025 was $267,563, compared to net income of $9,497 for the same period in 2024. This is an increase in net income of $258,066 and is the result of increased sales. 

 

Medical Device Products. For the three months ended March 31, 2025 we had sale of product of $52,630 with no sales in the same period ending March 31, 2024. Sale of product in the first quarter of 2025, included distribution of various third-party products. We plan to commercialize additional third-party medical devices and accessories related to the radiopharmaceutical and theranostics spaces and provide engineering, installation, and preventative maintenance and services related to those medical devices. We are also in development for our Swirler® and Tru-Fit™ Mouthpiece products which will be under the branding of RadVent. These products are based on assets and intellectual property rights we acquired previously from AMICI, Inc. We expect these RadVent products to release later in 2025. We also are under development through a joint venture of our EasyFill Automated Iodine Capsule System.

 

Operating expenses for this segment for the three months ended March 31, 2025 were $181,669 as compared to $28,511 in the same period in 2024. This increase in operating expenses of $153,158 is due to increased activity including labor, professional services, and research and development related to the startup of this new business segment. Net loss for this segment for the three months ended March 31, 2025 was $181,669, compared to net loss of $28,511 for the same period in 2024. This is an increase in net loss of $153,158 due to the increased development activity in the segment. 

 

Fluorine Products. For the three months ended March 31, 2025 and March 31, 2024, we had no revenue for our fluorine products segment.

 

During the three months ended March 31, 2025, we incurred $26,159 of expenses related to maintenance of plans, designs, and other assets for a proposed de-conversion facility, as compared to $28,751 for the same three-month period in 2024. 

 

On February 8, 2024, we entered into a definitive agreement to sell all of our assets related to the Fluorine Products segment and the Planned Uranium De-Conversion Facility. We expect to close the agreement within 24 months of signing. Closing is contingent on various conditions being met, including approvals and agreements by the NRC and other third parties. Upon closing of this agreement, the costs of maintenance for the assets in this segment would not continue. With no assets nor operating activities, this business segment would be phased out. 

 

21

 

LIQUIDITY AND CAPITAL RESOURCES

 

At March 31, 2025, we had cash and cash equivalents of $1,645,663 as compared to $1,945,523 at December 31, 2024. This is a decrease of $299,860 or approximately 15% was largely due to a decrease in accounts payable and principal payments on notes payable. For the three months ended March 31, 2025, net cash used in operating activities was $5,119 and for the three months ended March 31, 2024, net cash provided in operating activities was $412,444. The decrease in cash provided by operating activities was a result of a decrease of $540,028 in accounts payable in the three months ended March 31, 2025.

 

Inventories at March 31, 2025 totaled $723,524, and inventories at December 31, 2024 totaled $820,893. Our inventory consists of work in process material for our Theranostics Products, Cobalt Products, Nuclear Medicine Products, and Medical Device Products segments.

 

Cash used in investing activities was $128,881 for the three months ended March 31, 2025, and cash used in investing activities was $170,921 for the same period in 2024. The cash used in both periods was for the purchase of equipment. 

 

Cash used in financing activities was $150,591 during the three months ended March 31, 2025, and cash used in financing activities for the same period in 2024 was $63,641. During the three months ended March 31, 2025, cash paid for interest was $39,954 as compared to cash paid for interest of $155,168. the for the same three-month period in 2024. Additionally, during the three months ended March 31, 2025, we received $3,894 in proceeds from the sale of our common stock through our Employee Stock Purchase Plan, as compared to $1,479 in proceeds from the sale of our common stock through our Employee Stock Purchase Plan in the three months ended March 31, 2024. During the three months ended March 31, 2025, principal payments on notes payable were $200,000, as compared to $64,365 for the same period in 2024.

 

In February 2025, we declared our annual dividend on the Series C Preferred Stock. Dividends payable totaled $243,780 at that time. 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 118,846 shares of common stock in lieu of a dividend payment of $6,180. $37,800 of dividend payable was settled with cash. The remaining balance of $199,800 was outstanding as of March 31, 2025 pending receipt of information from shareholders and will be settled in the second quarter of 2025.

 

Total decrease in cash for the three months ended March 31, 2025, was $284,591 compared to a cash increase of $177,882 for the same period in 2024.

 

We expect that cash from operations, cash raised via equity financing, and our current cash balance will be sufficient to fund operations for the next twelve months. Our future liquidity and capital funding requirements will depend on numerous factors, including commercial relationships, technological developments, market factors, available credit, and preferred stock shareholders. There is no assurance that additional capital and financing will be available on acceptable terms to the Company or at all.

 

22

 

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. Pursuit to four modifications in the time period between June 2014 and January 2022, the 2013 Promissory Note was modified to extend the maturity date to December 31, 2023, with all remaining terms unchanged. In February 2024, the 2013 Promissory Note was modified again to extend the maturity date to March 31, 2026, with all remaining terms unchanged. At March 31, 2025, accrued interest payable on the 2013 Promissory Note was $339,234.

 

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 is secured and accrues interest at 6% per annum, which is payable upon maturity of the 2018 Promissory Note. At any time, the holders 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. The 2018 Promissory Note was originally due August 1, 2018. Pursuit to six modifications within the period of June 2018 and December 2023, the 2018 Promissory Note was modified to extend the maturity date to January 31, 2025, with all remaining terms unchanged. In February 2024, the 2018 Promissory Note was modified to extend the maturity date to March 31, 2026, with all remaining terms unchanged. At March 31, 2025, accrued interest on the 2018 Promissory Note totaled $49,970.

 

In December 2019 and February 2020, we borrowed an aggregate of $1,000,000 from our Chief Executive Officer, Chairman of the Board, former Chairman of the Board, and one of our major shareholders pursuant to a promissory note (the 2019 Promissory Note). The 2019 Promissory Note bears an interest rate of 4% annually and was originally 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 December 2022, the 2019 Promissory Note was modified to extend the maturity date to December 31, 2024, with all remaining terms unchanged. In February 2024, the 2019 Promissory Note was modified to extend the maturity date to March 31, 2026, with all remaining terms unchanged. At March 31, 2025, the accrued interest on the 2019 Promissory Note totaled $209,131.

 

In June 2023, we executed an asset purchase agreement with AMICI for the purchase of medical devices and related assets and intellectual property rights. In connection with the asset purchase agreement, we entered a promissory note for $427,100 to AMICI. According to the terms of the note, we are required to pay the seller a minimum of $10,000 per month for a period of 45 months. The amount due is not subject to interest until the 25th month after the anniversary of the closing of the agreement. At March 31, 2025, the balance of this promissory note was $217,100.

 

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, 2024, filed with the SEC on March 3, 2025.

 

23

 

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 March 31, 2025, 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 March 31, 2025.

 

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 March 31, 2025 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 7, “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, 2024.

 

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

 

None.

 

ITEM 5. OTHER INFORMATION

 

During the quarter ended March 31, 2025, no director or officer of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.

 

24

  
 

ITEM 6. EXHIBITS

 

Exhibit No.

Description

 

3.1

Restated 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).

 

3.2

Statement 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).

 

3.3

Certificate of Amendment to Statement of Designation of the Series C Convertible Redeemable Preferred Stock International Isotopes Inc., dated February 16, 2022 (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed on February 22, 2022).

 

3.4

Certificate of Amendment to Statement of Designation of the Series C Convertible Redeemable Preferred Stock International Isotopes Inc., dated December 28, 2022 (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed December 28, 2022).

   

3.5

Certificate of Amendment to Statement of Designation of the Series C Convertible Redeemable Preferred Stock International Isotopes Inc., dated September 26, 2024 (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed on October 2, 2024).

   

3.6

Bylaws (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)).

 

31.1*

Certification by the Chief Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002.

 

31.2*

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

 

32.1**

Certification 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.

 

32.2**

Certification 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.

 

101.INS*

Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

 

101.SCH*

Inline XBRL Taxonomy Extension Schema Document

 

101.CAL*

Inline XBRL Taxonomy Extension Calculation Linkbase Document

 

101.DEF*

Inline XBRL Taxonomy Extension Definition Linkbase Document

 

101.LAB*

Inline XBRL Taxonomy Extension Label Linkbase Document

 

101.PRE*

Inline XBRL Taxonomy Extension Presentation Linkbase Document

 

104

Cover Page Interactive Data File (embedded within the Inline XBRL document and contained in Exhibit 101).

 


* Filed herewith.

** Furnished herewith.

 

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SIGNATURES

 

 

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

 

Date: May 15, 2025

International Isotopes Inc.

   
     
 

By:

/s/ Shahe Bagerdjian

   

Shahe Bagerdjian

   

Chief Executive Officer

     
     
 

By:

/s/ W. Matthew Cox

   

W. Matthew Cox

   

Chief Financial Officer

 

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