UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

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

For the fiscal year ended December 31, 20202021

or

oTRANSITION 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)

(208)524-5300

(Registrant's telephone number, including area code)

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

Securities registered pursuant to Section 12(g) of the Act:

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COMMON STOCK, $.01 PAR VALUE

(Title of Class)

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES Yes o    NO Nox

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. YES Yes o    NO Nox

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 Yesx    NO No o

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 Yesx    NO No o

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. (Check one):

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. ☐

o

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). YES Yes oNO Nox

The aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the average bid and asked price of such common equity at June 30, 2020,2021, the last business day of the registrant’s second fiscal quarter, was approximately $25$50 million. For purposes of this calculation, all directors and executive officers of the registrant and holders of 10% or more of the registrant’s common stock are assumed to be affiliates. This determination of affiliate status is not necessarily conclusive for any other purpose.

As of March 25, 2021,22, 2022, the number of shares outstanding of the registrant’s common stock, $.01 par value, was 460,386,690503,167,121 shares.

DOCUMENTS INCORPORATED BY REFERENCE

Certain information called for in Part III of this Annual Report on Form 10-K is incorporated by reference from the registrant’s definitive proxy statement for the 20212022 annual meeting of shareholders, which will be filed with the Securities and Exchange Commission not later than 120 days after the registrant’s fiscal year ended December 31, 2020.2021.

INTERNATIONAL ISOTOPES INC.

FORM 10-K

TABLE OF CONTENTS

Cautionary Note Regarding Forward-Looking Statements

This Annual Report on Form 10-K (the “Annual 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 Annual Report are forward-looking. Words such as: “anticipates,” “believes,” “should,” “expects,” “future” and “intends” and similar expressions identify forward-looking statements. In particular, statements regarding: the impact of the COVID-19 pandemic on our business, financial condition, operating results and liquidity, future cash flow from operations, our ability to achieve profitability, the status of our proposed uranium de-conversion facility, the expected growth in business segment revenues, our expansion into new markets, the ability of our products to compete with several larger companies and products, the results of market studies used to support our business model, our anticipated improvement in economic conditions, the expected increased revenue resulting from sales of our U.S. Food and Drug Administration (FDA)-approved sodium iodide product, our ability to continue cobalt-60 production, and the sufficiency of our available cash and revenues from operations to meet our operating needs, are forward-looking. 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 Annual Report. Certain risks and uncertainties that could cause actual results to differ significantly from management’s expectations are described in the section entitled “Risk Factors” in this Annual Report. That section, along with other sections of this Annual Report, describes some, but not all, of the factors that could cause actual results to differ significantly from management’s expectations. We do not intend to publicly release any revisions to these forward-looking statements that may be made 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 other reports that we file from time to time with the Securities and Exchange Commission (the “SEC”).

PART I

General Business and Products Description

International Isotopes Inc. (the “Company”, “we”, “us” and “our”) produces an FDA approved generic sodium iodide I-131 drug product, manufactures a wide range of nuclear medicine calibration and reference standards, and provides radiochemicals for clinical research and life sciences. The Company also produces a variety of cobalt-60 products and providessupports contract manufacturing services ofactivities for clients radiopharmaceutical and radiochemical products for clients.products.

We were formed as a Texas corporation in 1995. Our wholly-owned subsidiaries are International Isotopes Idaho Inc., a Texas corporation; International Isotopes Fluorine Products, Inc., an Idaho corporation; and International Isotopes Transportation Services, Inc., an Idaho corporation.corporation; RadQual, LLC, a [X] limited liability company (RadQual); and TI Services, LLC, a [X] limited liability company (TI Services). Our core business consists of fourfive reportable segments which include: Nuclear Medicine Standards, Cobalt Products, Radiochemical Products, Radiological Services, and Radiological Services.Fluorine Products.

During 2020,2021, we focused our efforts on achieving profitability in each of our core business segments and reached several significant goals. During 2020,2021, we:

Also, in February 2022, we completed the previously announced sale of certain assets (the “Assets”) to Pharmalogic Idaho, LLC for $4.0 million in cash (the “Transaction”) pursuant to the terms of the Asset Purchase Agreement, dated February 10, 2022 (the “Agreement”). The Assets consisted primarily of manufacturing equipment and a sublease acquired by the Company in connection with the previously announced termination of the manufacturing and supply agreement with another company.

In 2021,2022, we plan to continue efforts to further expand and improve upon our operations in our core business segments. We intend to continue to invest in these segments and work to pursue product development, reduce production costs, and expand sales in each of our segments. The following paragraphs provide a brief description of each of our business segments. Certain financial information with respect to each of our business segments, including revenues from external customers, a measure of profit or loss, and total assets, is set forth in Note 15 to our Consolidated Financial Statements which begin on page F-7.

Nuclear Medicine Standards

This segment consists of the manufacture of sources and standards associated with Single Photon Emission Computed Tomography (SPECT) and Positron EmmissionEmission Tomography (PET) imaging, patient positioning, and calibration or operational testing of dose measuring equipment for the nuclear pharmacy industry. Our nuclear medicine standards products include flood sources, dose calibrators, rod sources, flexible and rigid rulers, spot markers, pen point markers, and a host of specialty design items. These products are manufactured through an exclusive manufacturing agreement with RadQual, of whichour wholly-owned subsidiary, RadQual. In July 2021, we own a 24.5% interest. In August 2017, affiliates of the Company purchased the remaining 75.5% interest of RadQual and at that timeRadQual. Prior this purchase we were named as one of two managing members of RadQual. As a result of this ownership change, we gainedRadQual and had significant influence in management decisions with regard to RadQual’s business operations. WeFollowing the July 2021 acquisition, we have a manufacturing agreement withnow fully consolidated the income and expenses from both RadQual that provides that we will manufacture sources exclusively for RadQualLLC and will not manufacture products that would directly compete with RadQual sources.TI Services.

There are over 5,000 nuclear medicine centers in the United States (U.S.) that require nuclear medicine products on a regular repeat basis. We have been manufacturing these products for RadQual since 2001. The majority ofMost nuclear medicine product sales are to U.S. customers. However, in recent years, as a resultbecause of stronger marketing efforts, we have seen an increase in foreign sales, as shown in Note 14 to the accompanying audited financial statements. All of these products contain radioactive isotopes that decay at a predictable rate. Therefore, customers are required to periodically replace most of these products when they reach the end of their useful lives. The useful life of these products varies depending on the isotope used in manufacture, but in most cases averages eighteen months to two years. TheMost of the isotopes used in manufacturing these nuclear medicine products are available from various sources world-wide and we are not dependent on a single supplier. In addition to the products themselves, we have developed a complete line of specialty packaging for the safe transportation and handling of these products.

RadQual has numerous distributors for direct sales of its products. Formerly, the largest distributor was Technology Imaging Services Inc. (TIS). In December 2010, we formed a 50/50 joint venture with RadQual to acquire the assets of TIS, and those assets were used to create TI Services LLC. This joint venture has provided sales opportunities in existing and future RadQual product lines both domestically and internationally as a marketer for RadQual products.

Cobalt Products

Our cobalt products segment includes the production of bulk cobalt (cobalt-60), fabrication of cobalt capsules for radiation therapy as well as various industrial applications, and recycling of expended cobalt sources.

Bulk cobalt sales have historically accounted for a significant amount of the total revenue from this business segment, and during the past several years we have not had any bulk sales because of an interruption inare reliant on cobalt production in the DOE’s Advanced Test Reactor (ATR) located in Idaho. Through continued work with the DOE, a new cobalt target was designed and in October 2014 we entered into a ten-year agreement with the DOE for the irradiation of the new target design. In 2020 and 2021, we received twoshipments of these cobalt targets. Unfortunately, their specific activity was far below expectations. Therefore,As such, we have revised our future cobalt production expectations undercontract with the DOE contract.to purchase the remainder of these cobalt targets at a discounted rate. We expectare again working with the DOE to process additional material from the ATR by about mid-yearschedule future production of 2021. Subsequent toboth high and low specific activity cobalt. After completing the 2014 agreement with the DOE, we entered into contracts with several customers for the sale of this material. In accordance with those agreements, we began receiving pre-payments from customers on future cobalt shipments which we recorded as unearned revenue. To fulfill our supply agreements with these customers, weWe were able to identify afulfill some of these contracts with the cobalt we received in 2020 and 2021 from the ATR and with cobalt we obtained through secondary supplier of cobalt to satisfy the terms of our supply agreements.suppliers. Accordingly, at the time of shipment, customer payments previously recorded as deferred revenue were reclassified as revenue.

The year-over-year demand for cobalt products has remained strong as a result of the introduction of several new types of cobalt therapy units and we have continued to see demand for cobalt-manufactured products for those devices. We have explored, and intend to continue to explore, opportunities to further develop cobalt products and sales on an on-going basis. The production, use, transport, and import/export of these products are all heavily regulated, but we have developed an experienced staff of technicians, drivers,shipping specialists, and supervisors as part of our efforts to comply with the regulations as well asand support cost effective, and timely delivery of these products.

At the present time, we are the sole purchaser of high activity cobalt from any of the DOE reactors in the U.S. There are a few other cobalt source manufacturers in North America. We believe both our product and service provide us with a competitive edge in competing with these other manufacturers.

Radiochemical Products

This segment includes the production and distribution of various isotopically pure radiochemicals for medical, industrial, and research applications. These products are either directly produced by us or are purchased in bulk from other producers and distributed by us in customized packages and chemical forms tailored to meet customer and market demands. In February 2020, we received FDA approval of our ANDA for our generic sodium iodide I-131 drug product. Our generic sodium iodide drug product is the only generic product of this type manufactured in North Americathe U.S. and offers customers an attractive domestic alternative to the single existing foreign commercial drug product being sold in the U.S.manufacturer. We have severaltwo suppliers of sodium iodide I-131 from whom we purchased material during 20202021 to produce this product in the most reliable manner possible.

In April 2019, we entered into a manufacturing and supply agreement with Progenics. Under this agreement, we werea company to provide contract manufacturing services for certain iodine products. We completed a 6,000 square foot expansion to our existing facility and installed the equipment necessary to support this cGMP contract manufacturing opportunity. However, in December 2020, at the request of the other company we entered into an agreement with Progenics pursuant to which, among other things,terminated the Manufacturing Agreement was terminated effective immediately.contract manufacturing relationship through a settlement agreement. As part of the agreement, we received a termination payment consisting of cash and Progenics’sthe other company’s relinquishment on all claims to their improvements in the expansion to our facility and all the equipment purchased by Progenics in connection with the manufacturing agreement, with the exception of a small amount of retained equipment.them. The termination payment resulted in a significant one-time gain of approximately $2,900,000 which waswe recognized under “other income”. We are currently developing a business plan in 2020. In February 2022, we were able to producesell these improvements and equipment in the expansion of our facility for an additional radiopharmaceutical products or explore new contract manufacturing opportunities in this facility using this equipment.gain of approximately $1,800,000.

Radiological Services

The current services included in this segment are floodradioactive source disposal and processing gemstones.

The majority of our revenue in this segment was previously generated by the performance of activities in connection with contractscertain materials for the DOE and the International Atomic Energy Agency (IAEA) to support recovery of disused sources and removal of certain devices. This type of field service work generated 0% and 67% of the revenue within this business segment during 2020 and 2019 respectively. The decrease in the revenue for 2020 is the result of a contamination event which occurred during one of these contract removals, as discussed below.exempt distribution.

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 have 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, we were notified by the DOE that we havehad 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 $150,000 in the 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. We used these funds to pay all outstanding subcontractors and reimburse their insurance company for payments they previously paid to us for this matter. We concluded a final settlement with our insurance company and all others regarding this claim in 2021.

The Washington Department of Health (DOH) issued a Notice of Violation to us in May 2020 citing two violations of our reciprocity license in the State of Washington related to the contamination event. On December 22, 2020, the Washington DOH imposed a civil penalty of $11,000 related to the contamination event. The Washington DOH investigation has now been closed.

The U.S. Nuclear Regulatory Commission (NRC) completed an inspection of our radiological safety program and issued a Notice of Violation (NOV) in June 2020 citing two different violations of our NRC materials license also related to the contamination event. The NRC notified us on October 20, 2020 that it had determined the violations were considered a Severity Level II problem. In accordance with their enforcement discretion authority the NRC has decided not to impose any civil penalty against us for these violations in recognition of our significant corrective actions. Our corrective actions for this event included termination of all field service activities and removal of these activities from ourthe Company’s NRC license. The NRC investigation and our actions necessary to address the NOV are now closed.

We believe that the loss in revenue resulting from suspension of radiological field service work will behas been compensated for by increased revenues in our remaining business segments.

In January 2020 we notified our gemstone processing customer that we were terminating their contract for a failure to meet minimum processing volume requirements. The termination activities and wrap up of this service will continue through most ofwas substantially concluded in 2021 and we will seesaw a steady decline in revenue from this service as production is concluded. Wehas been concluding. In the first half of 2022, 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 sales in our nuclear medicine and radiochemical products segments.

Fluorine Products and the Planned Uranium De-Conversion Facility

We established the fluorine products business segment in 2004 to support production and sale of various fluoride gases produced using our Fluorine Extraction Process (FEP). FEP was intended to be completed in conjunction with the operation of a proposed depleted uranium (DUF6) de-conversion facility in Lea County, New Mexico. DUF6 is the waste by-product of uranium enrichment, and any uranium enrichment facility will create very large quantities of DUF6. In October 2012, we received a construction and operating license from the NRC for the planned facility. Changes in the nuclear industry near the end of 2013, however, significantly reduced commercial demand for this type of facility. Therefore, we suspended all further development work on the project. We still anticipate a potential future need for a depleted uranium conversion facility and, therefore, we are keeping all licenses and permits current.

In connection with the proposed de-conversion facility, Lea County, New Mexico transferred property to us under the provisions of the New Mexico Local Economic Development Act, Project Participation Agreement (PPA) as a location for construction of the facility. Under the original agreement, we were obligated to meet certain performance objectives for construction start and staffing levels .levels. Because of the project delay we did not meet those objectives. We willplan to continue to work with Lea County to execute a modification to the agreement at some future point should the project move forward. If we do not extend or modify the commitment

dates in a modified agreement then we may either purchase or re-convey the property to Lea County, New Mexico. If we do not retain title to the property, it could have a material adverse impact on future plans for the project..project.

Industry Overview, Target Markets, and Competition

The industries and markets that require or involve the use of radioactive material are diverse. Our current core business operations involve products that are used in a wide variety of applications and in various markets. The following provides an explanation of the markets and competitive factors affecting our current business segments.

Nuclear Medicine Standards

Calibration and reference standards are required for the daily operational checks and calibration of the measurement of SPECT and PET imaging devices frequently used in nuclear medicine. Calibration and quality assurance testing are required as a routine part of the normal operations of this equipment to ensure its reliability and accuracy. We exclusively manufacture many of these reference standard products for one customer,our wholly-owned subsidiary, RadQual, which in turn has many distributors who make direct sales aroundin the U.S. and internationally. We directly ship these products to all 50 states and many overseas locations. There is only one other major producer of these products in the world that competes directly competes with us for these products. Most of the products manufactured by our competitor are similar in design to our products because all must meet Original Equipment Manufacturer (OEM) dimensional and performance standards. However, we attempt to differentiate our products from our competitor’s products through increased levels of quality control and customer service. We are certified under ISO-9001:2015 and ISO-13485-2016 quality programs that have allowed us to start selling these products into several foreign countries that require this additional quality certification for manufacturers. We use a small number of suppliers for the isotopes and other materials used in manufacturing these nuclear medicine products, but if we were to lose any of these suppliers, others would be available. We are also working to expand the number and types of products that are manufactured in this segment.

Cobalt Products

Historically, we sold high-activity bulk cobalt to one customer that used it to fabricate several models of sealed sources for medical and industrial applications. In 2014, we entered into a new 10-year agreement with the DOE utilizing a new cobalt target design.design for high activity cobalt production. Because of the lengthy irradiation time required we initially anticipated that cobalt shipments to customers would resume in late 2018. However, due to delays in the ATR operating schedule and slower than expected activation rates of cobalt-60 in the new target design, we didwere not able to take our first shipment of these targets until March 2020. Due to lower than desired activity rates in the material, we delayed receipt of additional material untilbought the 2^nd quarter of 2021.remaining targets at a discounted rate and are now working with the DOE on future purchases. Our cobalt products are used in applications such as radiation therapy, security devices, radiography examination and in some commercial applications. While there are other technologies available to provide external radiation therapy, there are several new devices just gaining market approval that still depend on cobalt sources for their specialized applications. There are currently no other producers of high specific activity cobalt in the U.S., however, there is one

producerare producers of high specific activity material in Canada and several other countries. In addition to us, there is only one other company in the U.S. currently licensed to handle large quantities of cobalt.

We manufacture cobalt sources as well as recycle used cobalt sources by recovering the cobalt for re-use in the manufacture of new sealed sources for teletherapy devices, irradiators, and other source applications. We are the only company in the U.S. that provides this unique service. There has been a significant increase in regulation by the NRC in recent years that has created a significant barrier to new entrants to this market. We expect steady demand for cobalt sealed source products over the next several years but are currentlyprimarily dependent upon our contract relationship with the DOE for access to its ATR in Idaho for a large portion of our cobalt production activities.supply. An interruption in the operation of the ATR could have a negative impact on our cobalt products business segment.

Radiochemical Products

In February 2020, our ANDA for a generic radiochemical sodium iodide drug product was approved by the FDA. This product is approved for use in treatment of hyperthyroidism and carcinoma of the thyroid and is the first and only generic sodium iodide I-131 product approved by the FDA in the US. Our product is the only generic product of this type manufactured in North America. Currently,the U.S. The only other supplier in the US there is only one other supplierU.S. of an FDA approved sodium iodide product.product comes from a foreign manufacturer.

We started commercial sales of the drug product in the first quarter of 2020, and these sales had a significant positive impact on our revenues for 2020.2020 and 2021. We expect continued growth in sales for this product in 20212022 and beyond. We are also considering other generic drug opportunities and plan to expand the range of FDA approved products offered within this business segment in the coming years.

We also supply radiochemical products in bulk form. The markets for most radiochemicals are highly competitive. The target markets for these products are customers who (1) incorporate them into finished industrial or medical devices; (2) use radioisotope products in clinical trials for various medical applications; or (3) further process and include the radioisotope products into pharmaceutical products approved by the U.S. FDA for labeled use in therapy or imaging.

In addition,February 2022, we plan to usesold the improvements and equipment in our new facility expansion to provide contract manufacturing of other drug products that are FDA approved or undergoing clinical trials. In April 2019, we had entered into a manufacturing and supply agreement with Progenics. Under this agreement, we were to provide contract manufacturing services for certain iodine products. We completed an expansion to our existing facility and installedmanufacturing facility. Using the equipment necessary to supportcapital from this contract manufacturing opportunity. During 2020 Progenics was acquired by another company and, as a result, revised their contract manufacturing needs. Progenics requested to terminate the contract manufacturing agreement and insale, we entered an agreement with Progenics in December 2020 to terminate the contract manufacturing agreement. As part of the agreement, we received a termination payment consisting of cash and Progenics’s relinquishment of all claims to all improvements made to the expansion of our facility and all the equipment purchased by Progenics in connection with the Manufacturing Agreement with the exception of certain specified equipment. We are currently developing a business plan and exploring other opportunities to produce additional radiopharmaceutical products or explore new contract manufacturing opportunities in this facility using this equipment.opportunities. We believe that we are uniquely qualified and have a competitive advantage to offer this type of contract manufacturing service for future opportunities because we offer a finished facility complete, specialized equipment, andhave a unique combination of NRC licensing, GMP compliant operating facility, and trained personnel.

Fluorine Products and the Planned Depleted Uranium De-Conversion Facility

Our Fluorine Products segment was developed in conjunction with uranium de-conversion in order to take advantage of the anticipated need for depleted uranium de-conversion services. During 2013, we curtailed the all further work on the de-conversion facility because of a lack of demand for uranium de-conversion services at that time. However, we believe that in the future there will be a demand for this service to address still growing stockpiles of depleted UF6. When that demand occurs, we believe the ground-workgroundwork we have completed on the depleted uranium de-conversion and fluorine extraction project should put us in a strong position to take advantage of the NRC license that has already been issued for this facility and should serve to justify the financial investment in this uranium de-conversion project in the future.

Radiological Services

Our radiological services include the support of field services, including therapy unit decommissioning, and gemstone processing.

In the past severalprevious years, we have performed radiological field service activities involving installation or decommissioning of radiation devices in hospitals, research institutions, and various other commercial facilities. In May 2019, while performing a contract for the DOE, our field services team was involved in a contamination event involving a breached cesium-137 source at an off-site location in the state of Washington. Because of the severity of this event, we have suspended these contract activities and have removed this activity from our NRC license. We believe that the loss in revenue resulting from suspension of radiological field service work will be compensated for by increased revenues in our remaining business segments.

In January 2020 we notified our gemstone processing customer that the service contract with them was being terminated because the volume of gemstones sent for processing did not meet contract minimums. The termination activities and wrap up of this service will continue through the remainder ofwere substantially performed in 2021 and we will seesaw a steady decline in revenue from this service as production iswas wrapped up. WeIn the first half of 2022, we plan to convert the spaces in the facility that had beenwere used to perform this contract work into increased 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.

Government Regulation

Licensing

We currently operate under two NRC licenses, one for broad scope operations and another for exempt distribution. Our broad scope license covers calibration and reference standard manufacturing and distribution, radioisotope processing and distribution, large scale cobalt processing and recycle operations, radioactive gemstone processing, environmental sample analysis, certain field service activities, and research and development. The exempt distribution license permits the release and distribution of irradiated gemstones to unlicensed entities in the U.S. All of our existing licenses and permits are adequate to allow current business operations. We do not handle “special nuclear materials” (i.e. nuclear fuels and weapons grade uranium, thorium or plutonium); therefore, our facility is not designated as a “nuclear” facility that would require additional licensing.

As a condition of our NRC licenses in Idaho, we are required to provide financial assurance for decommissioning activities. We fulfill this license requirement with a surety bond which names the NRC as beneficiary and is supported by a restricted cash account held in trust by a third party. Similar financial assurances will be required to fund the decommissioning of the proposed de-conversion facility.

In October 2012, we were granted a 40-year construction and operating license by the NRC for our planned depleted uranium de-conversion and fluorine extraction processing facility (the “de-conversion facility”). The de-conversion facility is planned to be located in Lea County, New Mexico, and is proposed to initially de-convert up to approximately 11 million pounds of depleted uranium hexafluoride (DUF₆) annually into fluoride products and depleted uranium oxides (DUO).Mexico. Further engineering work on the proposed de-conversion facility was placed on hold in 2013 until additional contracts for utilization could be obtained. There is no specific timeline required by the NRC for the start of construction on this project. The majority of the pre-construction design, licensing and state permitting has already been completed for the project and a ground water permit from the state of New Mexico remains to be obtained before the plant could begin operation.

Regulation of Radioisotope Production Waste

All of our manufacturing processes generate some radioactive waste. We must handle this waste pursuant to the Low LevelLow-Level Radioactive Waste (LLRW) Policy Act (LLRW Act), which requires the safe disposal of mildly radioactive materials. The estimated costs for storage and disposal of these materials have been included in the manufacturing and sales price of our products. However, actual disposal costs are subject to change at the discretion of the disposal site and are ultimately applied at the time of disposal. We have obtained all necessary permits and approvals for the disposal of our waste materials, and we do not anticipate any negative changes in capacity or regulatory conditions that would limit or restrict our waste disposal capabilities.

Nuclear Regulatory Commission Oversight

We operate under two NRC licenses and are subject to NRC oversight and periodic inspections of our operations.

Other Regulations

We are registered as a medical device manufacturer through the FDA for several of our nuclear medicine reference and calibration standards. We are registered with the U.S. Department of Transportation (DOT) for the shipment of radioactive materials. We also have an NRC license for the import and export of radioactive materials. Because of increasing security controls and regulations, it is likely that we may encounter additional regulations affecting transportation, storage, sale, and import/export of radioactive materials.

We are also subject to inspection by the FDA to manufacture our sodium iodide I-131 product in compliance with our ANDA for sodium iodide I-131 and all applicable cGMP requirements for this and other contract manufactured products. We are registered with the FDA as a drug manufacturing facility, and we are subject to periodic and random inspections by the FDA for the continued manufacture of drug products.

We are subject to government regulation and intervention both in the U.S. and in all foreign jurisdictions in which we conduct business. Compliance with applicable laws and regulations results in higher capital expenditures and operating costs and changes to current regulations with which we must comply can necessitate further capital expenditures and increases in operating costs to enable continued compliance.

Environmental Compliance

We are subject to various federal, state, local and foreign government requirements regulating the discharge of materials into the environment or otherwise relating to the protection of the environment. These laws and regulations include, but are not limited to the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), the Resource Conservation and Recovery Act (RCRA) and state statutes such as the Idaho Hazardous Waste Management Act, the LLRW Policy Act, NRC regulations concerning various irradiated, radioactive, and depleted uranium materials, and U.S. DOT regulations concerning shipment of radioactive materials. Certain of these laws and regulations can impose substantial fines and criminal sanctions for violations and require installation of costly equipment or operational changes to limit emissions and/or decrease the likelihood of accidental hazardous substance releases. We have incurred, and expect to continue to incur, capital and operating costs to comply with these laws and regulations. For the years ended December 31, 20202021 and 2019,2020, we incurred costs of approximately $190,171$52,000 and $101,633,$190,171, respectively, for licensing and monitoring fees. In addition, changes in laws, regulations and enforcement of policies, or the imposition of new clean-up requirements or remedial techniques, could require us to incur costs in the future that would have a negative effect on our financial condition or results of operations.

Distribution Methods for Products

We sell our products directly to our customers who, in some cases, are both end users and distributors. We use common commercial carriers for delivery of our products. For smaller quantities of material, and overnight and next-day delivery, we utilize other commercial carriers.

Dependence on Customers

Historically, we have been dependent on one customer, RadQual, of which we ownowned 24.5%, for a significant amount of our gross revenue. In August 2017, several affiliates of the CompanyJuly 2021, we purchased the remaining 75.5% and at that time, we were named asof the ownership interest in RadQual, making it a managing member of RadQual.wholly-owned subsidiary. Our sales to RadQual for 20202021 accounted for approximately 28% of our total gross revenue for 2021 and our sales to RadQual for 2020 totaled approximately 26% of our total gross revenue for 2020 and our sales to2020. The change in ownership of RadQual for 2019 totaled approximately 28% of our total gross revenue for 2019.has substantially eliminated any risks associated with having RadQual as a single major customer.

Combined sales, on which we are dependent, to our three largest customers, accounted for 17% of our total gross revenues in 2021 and accounted for 11% of our total gross revenues in 2020 and accounted for 18% of our total gross revenues in 2019. The change in ownership of RadQual and naming us as a managing member of RadQual business operations coupled with TI Services diversification of sales has significantly reduced most risks associated with having RadQual as a single major customer.2020.

Patents, Trademarks, Licenses and Royalty Agreements

In 2004, we obtained certain patents related to the FEP. In 2010, we were granted an additional process patent on the FEP process. During 2012, we were granted additional process patents for the FEP process in the United States.  In 2013, the FEP process patent was granted in Russia and in 2014 the FEP process patent was granted in South Africa.

Employees

As of December 31, 2020,2021, we had 32 total employees, including 30 full-time employees.

Available Information

Our internet website address is www.intisoid.com. We are subject to the reporting requirements under the Securities Exchange Act of 1934, as amended (the Exchange Act). Consequently, we are required to file reports and information with the SEC, including Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act. These reports and other information concerning us are available free of charge through (i) our website as soon as reasonably practicable after they are electronically filed with, or furnished to, the SEC, and (ii) the SEC’s website at www.sec.gov. Information contained on, or accessible through, our website is not incorporated by reference into this Annual Report or other reports filed with the SEC.

A = Risks Related to our Company

B = Risks Related to our Products and Operations

C = Risks Related to the Economy

Readers should carefully consider the following factors that may affect our business, future operating results and financial condition, as well as other information included in this Annual Report. The risks and uncertainties described below are not the only ones the Company faces. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations. If any of the following risks actually occur, our business, financial condition and operating results could be materially adversely affected.

Risks Related To Our Company

We have incurred, and may continue to incur, losses. [A]We have incurred net losses for most fiscal periods since our inception. From inception through December 31, 2020,2021, we have generated $133,337,403$142,999,345 in revenues and an accumulated deficit (including preferred stock dividends and returns) in the amount of $125,861,734.$126,764,081. The negative cash flow we have sustained has materially reduced our working capital, which in turn could materially and negatively impact our ability to fund future operations and continue to operate as a going concern. Management has taken and continues to take, actions to improve our financial condition and results of operations. The availability of necessary working capital, however, is subject to many factors beyond our control, including, among other things, our ability to obtain financing on favorable terms, or at all, economic cycles, market acceptance of our products, competitors' responses to our products, the intensity of competition in our markets, and the level of demand for our products.

We may need additional financing to continue operations. [A]Because we may continue to experience negative cash flow, we may need to obtain additional financing to continue operations. Management will continue to plan and take actions to improve our financial results which could enhance our ability to obtain financing. However, obtaining additional financing is subject to many factors beyond our control and may not be available to us on acceptable terms or at all. If we are unable to raise additional funds when needed, we could be required to delay development and construction of projects, reduce the scope of, abandon or sell some or all of our growth projects or default on our contractual commitments in the future, any of which would have a material adverse effect on our business, financial condition and operating results.

Our operations expose us to the risk of material environmental liabilities. [B] We are subject to potential material liabilities related to the remediation of environmental hazards and to personal injuries or property damages that may be caused by hazardous substance releases and exposures. The materials used in our operations expose us to risks of environmental contamination that could subject us to liability, including remediation obligations that could be very costly. In addition, the discovery of previously unknown contamination could require us to incur costs in the future that would have a negative effect on our financial condition or results of operations. We have a Surety Bond in place supported by funds in a restricted cash account to provide the financial assurance required by the NRC for our Idaho facility license for decommissioning and a similar mechanism will be required to fund the decommissioning of the proposed new depleted uranium facility. However, if a contamination event occurred within, or outside of, our facility, we may be financially responsible to remediate such contamination and could have to borrow money or fund the remediation liability from our future revenue. We may not be able to borrow the funds, or have available revenue, sufficient to meet this potential liability, which could have a significant negative impact on our financial condition and results of operations.

We are dependent upon key personnel. [A]Our ongoing operations are dependent on Steve T. Laflin, President and Chief Executive Officer. The loss of Mr. Laflin could have a material adverse effect on our business. We have a $2 million key man life insurance policy on Mr. Laflin and an employment agreement that extends through February 28, 2022. However, thereThere is no assurance that we will be able to retain Mr. Laflin or our existing personnel or attract additional qualified employees. The loss of any of our key personnel or an inability to attract additional qualified employees could result in a significant decline in revenue.

General economic conditions in markets in which we do business can impact the demand for our goods and services. Decreased demand for our products and services can have a negative impact on our financial performance and cash flow. [C] Demand for our products and services, in part, depends on the general economic conditions affecting the countries and industries in which we do business. A downturn in economic conditions in the U.S. or industry that we serve may negatively impact demand for our products and services, in turn negatively impacting our operations and financial results. Further, changes in demand for our products and services can magnify the impact of economic cycles on our businesses.

Volatility in raw material and energy costs, interruption in ordinary sources of supply and an inability to recover unanticipated increases in energy and raw material costs from customers could result in lost sales or significantly increase the cost of doing business. [B] Market and economic conditions affecting the costs of raw materials, utilities, energy costs, and infrastructure required for the delivery of our goods and services are beyond our control and any disruption or halt in supplies, or rapid escalations in costs could affect our ability to manufacture products or to competitively price our products in the marketplace. For instance, an interruption in the supply of isotopes such as cobalt-57, cobalt-60, or iodine-131 could result in lost sales of nuclear medicine and calibration standards sales, cobalt product sales, and sodium iodide I-131 generic drug product. We also purchase some of our radiochemical products from overseas suppliers and the price of those products could be adversely affected through changes in currency exchange rates.

We are subject to extensive government regulation in jurisdictions around the globe in which we do business. Regulations address, among other things, environmental compliance, import/export restrictions, healthcare services, taxes and financial reporting, and can significantly increase the cost of doing business, which in turn can negatively impact our operations, financial results and cash flow. [B] We are subject to government regulation and intervention both in the United States and in all foreign jurisdictions in which we conduct business. Compliance with applicable laws and regulations results in higher capital expenditures and operating costs and changes to current regulations with which we must comply can necessitate further capital expenditures and increases in operating costs to enable continued compliance. Additionally, from time to time, we may be involved in legal or administrative proceedings under certain of these laws and regulations. Significant areas of regulation and intervention include the following:

Radioactive Waste. All of our manufacturing processes generate some radioactive waste. For waste that cannot be decayed in storage we must handle this waste pursuant to the LLRW Policy Act, which requires the safe disposal of mildly radioactive materials. The estimated costs for storage and disposal of these materials have been included in the manufacturing and sales price of our products. However, actual disposal costs are subject to change at the discretion of the disposal site and are ultimately applied at the time of disposal. An unexpected or material increase in these costs could have a material adverse effect on our financial condition and results of operations.

Health Compliance. Health regulations dictated by the United States Occupational Safety and Health Administration and NRC are extensive in our business. There is no assurance that our activities will comply with all applicable health regulations at times and, as a result, may expose us to liability under applicable health regulations. Costs and expenses resulting from such liability may materially negatively impact our operations and financial condition. Overall, health laws and regulations will continue to affect our business worldwide.

NRC License Enforcement Actions. The NRC may take enforcement action in the event that we are found to be in violation of NRC regulations or in violation of any of our license requirements. Consequences of violations depend upon the severity of the violations as well as the adequacy and timeliness of corrective actions implemented by the licensee to investigate and correct the cause of the violation and to prevent reoccurrence. The NRC has discretionary authority in the action they choose to take against license violations, but these actions can include civil penalties and restrictions upon licensee operations or license suspension. The imposition of any such penalties and/or restrictions upon our operations or suspension of our license could have a material adverse effect on our financial condition and results of operations.

Environmental Regulation. We are subject to various federal, state, local and foreign government requirements regulating the discharge of materials into the environment or otherwise relating to the protection of the environment. These laws and regulations include, but are not limited to CERCLA, the RCRA and state statutes such as the Idaho Hazardous Waste Management Act, the LLRW Policy Act, NRC regulations concerning various irradiated, radioactive, and depleted uranium materials, and U.S. DOT regulations concerning shipment of radioactive materials. Certain of these laws and regulations can impose substantial fines and criminal sanctions for violations and require installation of costly equipment or operational changes to limit emissions and/or decrease the likelihood of accidental hazardous substance releases. We have incurred, and expect to continue to incur, capital and operating costs to comply with these laws and regulations. In addition, changes in laws, regulations and enforcement of policies, or the imposition of new clean-up requirements or remedial techniques, could require us to incur costs in the future that would have a negative effect on our financial condition or results of operations.

Import/Export Regulation. We are subject to significant regulatory oversight of our import and export operations due to the nature of our product offerings. Penalties for non-compliance can be significant and violations can result in adverse publicity. Because of increasing security controls and regulations, it is likely that we may encounter additional regulations affecting the transportation, storage, sale, and import/export of radioactive materials.

Taxes. We structure our operations to be tax efficient and to make use of tax credits and other incentives. Nevertheless, changes in tax laws, actual results of operations, final audit of tax returns by taxing authorities, and the timing and rate at which tax credits can be utilized can change the rate at which we are taxed, thereby affecting our financial results and cash flow.

We may incur material losses and costs as a result of product liability claims that may be brought against us. [B] We face an inherent business risk of exposure to product liability claims in the event that products supplied by us fail to perform as expected or such failures result, or are alleged to result, in bodily injury. Although we have purchased insurance with coverage and in amounts that we believe to be adequate and reasonable in light of our current and planned operations, including our planned uranium de-conversion and fluoride gas production business, if a successful product liability claim were brought against us in excess of our available insurance coverage, it would have a material adverse effect on our business and financial results.

Catastrophic events such as natural disasters, pandemics, including the COVID-19 pandemic,novel strain of coronavirus (COVID-19), war and acts of terrorism could disrupt our business or the business of our suppliers or customers, and any such disruptions could have a negative impact on our operations, financial results and cash flow. [C]  Our operations are at all times subject to the occurrence of catastrophic events outside our control, ranging from severe weather conditions such as hurricanes, floods, earthquakes and storms, to health epidemics and pandemics, to acts of war and terrorism. Any such event could cause a serious business disruption that could affect our ability to produce and distribute our products and possibly expose us to third-party liability claims. Additionally, such events could impact our suppliers, thereby causing energy and raw materials to become unavailable to us, and our customers, who may be unable to purchase or accept our products and services. Any such occurrence could have a negative impact on our operations and financial condition.

In addition, public health epidemics or outbreaks could adversely impact our business. For example, the COVID-19 pandemic had a significant impact upon our business operations in 2020.2020 and 2021. The future developments of COVID-19, length and continued severity of the pandemic, the impacts of variants, the continued efficacy of vaccines, and the extent of further economic impact are highly uncertain and cannot be predicted with confidence. In particular, the continuation of the pandemic could result in a further negative impact on the global economy and financial markets, resulting in even more significant economic downturn, and could also continue to adversely impact our operations, including among others, our manufacturing and supply chain, sales and marketing and product development operations and could have ana continued adverse impact on our operations, financial results, and cash flow.

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 2020 and 2021.  There was no discernable impact from COVID-19 to our cobalt products business segment during the period.  The decrease in sales for 2020 and 2021 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.

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.  However, if we are unable to obtain alternative sources of raw materials in the future or if we experience other disruptions from the COVID-19 pandemic, we may experience an adverse impact on our operations, financial results, and cash flow.

Global economic and political conditions that affect supply chain fulfillment or create price inflation could have a negative effect on our operations and financial results. The raw materials we use for our products are shipped in from domestic or international suppliers. Global supply chain disruption can affect our ability to get these key raw materials. We ship our products throughout the United States and internationally. As such, increases to shipping costs due to inflated fuel costs or other relevant costs can affect the prices of our materials and shipping. These increased costs could have an adverse effect on our revenues and profit margins for our products.

Our future growth is largely dependent upon our ability to develop new products that achieve market acceptance with acceptable margins. [B] Our businesses operate in global markets that are characterized by rapidly changing technologies and evolving industry standards. Accordingly, our future growth rate depends upon a number ofseveral factors, including, but not limited to, our ability to (i) identify emerging technological trends in our target end-markets, (ii) develop and maintain competitive products, (iii) enhance our products by adding innovative features that differentiate our products from those of our competitors, and (iv) develop, manufacture, and bring products to market quickly and cost-effectively. Our ability to develop new products based on technological innovation or U.S. FDA approval can affect our competitive position and requires the investment of significant resources. These development efforts divert resources from other potential investments in our businesses, and they may not lead to the development of new products on a timely basis or that meet the needs of our customers as fully as competitive offerings. In addition, the markets for our products may not develop or grow as we currently anticipate. The failure of our technologies or products to gain market acceptance due to more attractive offerings by our competitors could significantly reduce our revenues and adversely affect our competitive standing and prospects.

We are dependent on various third parties in connection with our business operations. [B] The production of high-specific activity cobalt is dependent upon the DOE, and its prime-operating contractor, which controls the Idaho reactor. Current activity at the Idaho ATR may continue to affect the supply of cobalt material needed for the manufacture of cobalt sources. Loss of the ability to use, or cost-effectively use, these irradiation services would significantly impact our cobalt products business segment because there is not currently another reactor available in the U.S. that is capable of providing this type of service for us. Our radiochemical iodine is supplied to us through threetwo supply sources. Unanticipated contract terminations by any of these suppliers andor other third parties would have a material adverse impact on our operations, financial results, and cash flow.

We are dependent on a limited number of customers in connection with some of our current business operations. [B]Combined sales to our three top customers accounted for 18%17% and 11% of our total gross revenue during 20202021 and 2019,2020, respectively. Although we are making efforts to reduce our dependency on a small number of customers, the loss of any one of these customers could have a significant impact on our future results of operations and financial condition. Unanticipated contract terminations by any of these current customers could have a material adverse impact on operations, financial results, and cash flow.

We are subject to competition from other companies. [B] Each of our existing business areas has direct competition from other businesses. High-specific activity cobalt is supplied by other reactor facilities around the world. Nuclear medicine calibration and reference standards are being produced by one other major manufacturer in the U.S. We have one major competitor in the US for our sodium iodide I-131 drug product. Most of our radiochemicals are also manufactured by several other companies in the world, and there are other providers of radiological field services. Most of our competitors have significantly greater financial resources that could give them a competitive advantage over us.

Risks Related To Our Common Stock

Trading in our common stock is limited and the price of our common stock may be subject to substantial volatility.  Our common stock is quoted on the OTCQB Marketplace under the U.S. trading symbol “INIS”. The market for our securities is limited, the price of our stock is volatile, and the risk to investors in our common stock is greater than the risk associated with stock trading on other markets. These factors may reduce the potential market for our common stock by reducing the number of potential investors. This may make it more difficult for investors in our common stock to sell shares to third parties or to otherwise dispose of their shares. This could cause our stock price to decline.

We currently do not intend to pay dividends on our common stock.  We do not plan to pay dividends on shares of our common stock in the near future. Consequently, an investor in our common stock can only achieve a return on its investment in us if the market price of our common stock appreciates.

We are contractually obligated to issue shares in the future, which will dilute your interest in us. As of December 31, 2020,2021, there were approximately 17,059,50015,507,500 shares of common stock issuable upon the exercise of vested stock options, at a weighted-average exercise price of $.05 per share. An additional 40,073,83737,239,804 shares were reserved for issuance under our equity plans as of December 31, 2020.2021. Our outstanding preferred stock and certain of our outstanding debt is also convertible into shares of our common stock at the holders’ option. In addition, we expect to issue additional options to purchase shares of our common stock to compensate employees, consultants and directors, and we may issue additional shares to raise capital to expand our manufacturing capability, develop additional products, or fund our planned uranium de-conversion plant. Any such issuances will have the effect of further diluting the interest of the holders of our securities. Also, outstanding as of December 31, 2020,2021, were Class M Warrants (as defined below) for the issuance of 17,165,0004,140,000 shares of common stock, which have since expired, and Class N Warrants (as defined below) for the issuance of 2,925,000 shares of common stock and Class O Warrants (as defined below) for the issuance of 30,000,000 shares of common stock. The weighted average exercise price for all outstanding warrants as of December 31, 20202021, was $0.07$0.11 per share. In February 2022, 515,000 Class M Warrants were exercised at a price of $0.12.

Risks Related to Our Proposed De-Conversion and FEP Produced Fluoride Gas Business

We will need to raise additional funds to complete the construction of our de-conversion and FEP facility. We need to secure more customer contracts and raise additional funds to complete the design and construction of a de-conversion facility with a production-scale FEP operation. We may not be able to raise the additional capital required to complete the facility on acceptable terms, or at all. In addition, the total funds required to complete this project have been based upon early preliminary estimates and, while we believe these estimates are conservative, unforeseen expenses may be incurred and additional funding may be required to complete the project.

We do not have an operating history with respect to our strategy to combine de-conversion services and FEP-produced fluoride gas products and this business may not succeed.  We have no operating results with respect to providing de-conversion services or producing high volumes of fluoride gas products using FEP to date and, therefore, we do not have an operating history upon which you can evaluate this business or our prospects. Our prospects must be considered in light of the risks and uncertainties encountered in entering a new line of business.

Some of these risks relate to our potential inability to:

• construct our planned de-conversion and FEP production plant, including the effective management of the cost of the design and construction of the facility, and obtain the additional financing necessary for such construction;

• maintain the necessary regulatory approvals for the facility and the ongoing operations of the facility;

• obtain the groundwater permit from the state of New Mexico;

• produce commercially economicviable volumes of high-purity fluoride products using FEP;

• effectively manage this new business and its operations;

• successfully establish and maintain our intended low-cost structure; and

• successfully address the other risks described throughout this Annual Report.

If we cannot successfully manage these risks, our business and results of FEP operations and financial condition will suffer.

There is no history of large-scale commercial fluoride gas production utilizing FEP.  We have successfully demonstrated the feasibility of using FEP to produce some fluoride gases and Starmet Corporation (Starmet), which originally developed and patented the technology, also used FEP to produce a fluoride gas. However, FEP has not been used for large-scale commercial production of the size and magnitude envisioned in conjunction with the de-conversion process and there may be technical issues and process challenges related to the utilization of FEP for large-scale commercial production. Unforeseen issues associated with constructing and scaling up these new FEP operations could significantly impact our proposed schedule and our overall ability to produce high-purity fluoride gas in the quantities anticipated.

Prior to the start of operations of the facility, we must obtain a Ground Water Permit from the State of New Mexico, and we cannot guarantee the amount of time required to obtain this permit from the State of New Mexico for operation of these facilities. The operation of the planned depleted uranium de-conversion facility requires a ground water permit from the State of New Mexico. There is no assurance that the ground water permit will be issued to us by the State of New Mexico. We also have no control over the actual time required by the State of New Mexico to review and approve the application for the ground water permit. Failure to obtain the permit, or any delay in obtaining the permit, could delay the start of operations of our planned depleted uranium de-conversion facility, thereby delaying revenue-generating operations at the facility.

The DOE is obligated to take depleted uranium from enrichment companies.  The DOE has constructed two depleted uranium de-conversion facilities. These facilities are obligated to process depleted uranium produced from United States commercial uranium enrichment facilities at a price determined by DOE. We believe our depleted uranium processing facility will offer the better value to enrichment companies, but we cannot assure you that enrichment companies will not select the DOE as their de-conversion service provider.

We may be handling large quantities of DUF₆ and fluoride products, which are radioactive and hazardous materials, respectively, and are subject to intense regulation.  The hazardous nature of DUF₆ and fluoride products affects the actions we are required to take for licensing, air permitting, environmental review, emergency response, liability insurance, personnel training, and generally increases the level of concern by the general public with respect to our handling of these materials. All of these factors complicate the licensing and operations processes and involve a host of additional regulatory factors that could affect the timeline for completing our de-conversion and FEP facility. Additionally, the NRC is revising its regulations on the disposal of depleted uranium waste at LLRW disposal facilities that accept large quantities of depleted uranium. Any changes to the current regulations may result in increased disposal costs that we intend to pass through to our customers, which, depending on the significance of the increased cost, may cause potential customers to continue to store their DUF₆ rather than pay for de-conversion and disposal services.

We will be subject to competition from the DOE and other companies.  While there are no currently operating commercial DUF₆ de-conversion facilities in the U.S., the DOE is operating two de-conversion plants intended to process DUF₆ from the DOE’s existing 1.5 billion-pound stockpile. Additionally, AREVA currently operates a de-conversion plant in France, Urenco is operating a conversion facility in the United Kingdom (U.K.), and the Russian State Atomic Energy Corporation ROSATOM has constructed a facility in Russia. We cannot assure you that the operators of the existing DUF₆ de-conversion facilities will not build additional facilities to expand their operations and compete with us in offering to provide de-conversion services or that commercial enrichment companies will not choose to ship their depleted DUF₆ overseas for processing in France, the U.K., or Russia.

We currently hold conditional title to the property in Lea County, New Mexico where the proposed plant is to be constructed. The property location for our planned facility is located in Lea County, New Mexico. Lea County, New Mexico has transferred the property to us under the provisions of the New Mexico Local Economic Development Act, Project Participation Agreement. Under the original agreement, we were obligated to meet certain performance objectives; namely starting Phase I construction no later than December 31, 2014, completing Phase I and hiring at least 75 employees by December 31, 2015, in order to retain title to the property. We did not meet either of those deadlines. However, in July 2015, we executed an amendment to the PPA that extended the due date of the Phase I construction to December 31, 2016, and Phase I completion and hiring at least 75 employees to December 31, 2016. We did not meet either of those deadlines and we are workingdeadlines. We plan to work with Lea County to execute an additional modification to the agreement to further extend these dates once an estimated restart date for the project is determined. If we do not succeed in extending the commitment dates or in reaching performance dates set forth in a modified agreement then we may, at our sole option, either purchase or re-convey the property to Lea County, New Mexico. In addition, ifIf Lea County does not agree to thata contract modification and we do not retain title to the property, it could have a material adverse impact on our planned de-conversion and FEP project since another location would need to be selected and evaluated for environmental compliance.

We are a smaller reporting company, and therefore, are not required to provide the information required by this item.

We lease one property which serves as or main corporate headquarters and houses all of our current manufacturing operations for our core business segments. We also hold the conditional title to 640 acres of land in Lea County, New Mexico for the proposed de-conversion facility. The following paragraphs provide a brief summary of these properties.

4137 Commerce Circle, Idaho Falls, Idaho – The facility located on this property houses our main corporate headquarters and all of our current manufacturing operations. In January 2020, we entered into a new lease agreement due to new and expanded facilities made available to us. The initial lease term is until January 2030 and provides an option to renew for an additional 5 years. The lease provides for the Company to expand its leased space as needed into additional areas of the building. The facility was new when leased in March 2001 and remains in excellent condition. We have a right of first refusal on this property that allows us to match any offer to purchase this property.

Land - Lea County, New Mexico – In August 2011, we received land from Lea County, New Mexico, pursuant to a PPA, whereby the land was deeded to us for no monetary consideration. In return, we committed to construct a uranium de-conversion and FEP facility on the land. In order to retain title to the property, we were 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. We did not meet the performance milestones set forth in the PPA and we executed a modification to the agreement extending these due dates to December 31, 2016 and 2017, respectively, but did not meet either of those milestones and are working againrespectively. We plan to work with Lea County to execute an additional modification to the agreement to further extend these dates once an estimated restart date for the commitment dates.project is determined. If we do not succeed in extending the commitment dates or in reaching performance dates set forth in a modified agreement then we may, at our 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. We have 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 our obligations under the agreements for permanent transfer of the title.

We are not a party to any legal proceedings that we believe to be material and we are not aware of any pending or threatened litigation against us that we believe could have a material adverse effect on our business, operating results, financial condition, or cash flows.

Not applicable.

PART II

Our common stock is traded on the OTCQB under the trading symbol “INIS”.

Holders of Record

As of March 24,22, 2021, there were 532503 holders of record of our common stock.

Dividends

We have never paid any cash dividends on our common stock. In the future, and based upon our profit performance, our Board of Directors (the “Board”) will evaluate and determine whether to issue dividends, subject to compliance and limitations under any applicable debt or other financing agreements in effect at that time or retain funds for research and development and expansion of our business. We do not anticipate paying any dividends to shareholders of our common stock for the foreseeable future.

Recent Sales of Unregistered Securities; Use of Proceeds from Registered Securities

None.

Purchases of Equity Securities by the Issuer

None.

Performance Graph

We are a smaller reporting company, and therefore, are not required to provide the information required by this item.

We are a smaller reporting company, and therefore, are not required to provide the information required by this item.

The following discussion of our results of operations and financial condition should be read in conjunction with the accompanying financial statements and related notes thereto included in Item 8, “Financial Statements and Supplementary Data,” within this Annual Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report, including information with respect to our plans and strategies for our business, statements regarding the industry outlook, our expectations regarding the future performance of our business and the other non-historical statements contained herein are forward-looking statements. See “Cautionary Note Regarding Forward-Looking Statements.” You should also review the “Risk Factors” in Item 1A. of this Annual Report for a discussion of important factors that could cause actual results to differ materially from the results described herein or implied by such forward-looking statements.

Overview

International Isotopes Inc. (the “Company”, “we”, “us” and “our”) produces an FDA approved generic sodium iodide I-131 drug product, manufactures a wide range of nuclear medicine calibration and reference standards and provides radiochemicals for clinical research and life sciences. The Company also produces a variety of cobalt-60 products and providessupports clients contract manufacturing services of radiopharmaceutical and radiochemical products for clients.products. A more detailed description of each of these product lines and services along with a description of our business segments can be found in Item 1, “Business” within this Annual Report.

During 2020,2021, we focused our efforts on achieving profitability in each of our core business segments and reached several significant goals. During 2020,2021, we:

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 year ended December 31, 2020.2020 and 2021.  There was no discernable impact from COVID-19 to our cobalt products business segment during the period.  Revenue from nuclear medicine products for the year ended December 31, 2020, decreased approximately 6% compared to the same period in 2019. The decrease in sales for the year ended December 31, 2020 and 2021 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. In 2021, our sales recovered somewhat, but we believe there is still some pent-up customer demand that was not realized in 2021 due to continuing factors related to COVID-19. The sale of radiochemical products increased during the year,year; however, we believe the increaseincreases in revenue for 2020 and 2021 would have been greater were it not for the negative impact of COVID-19.

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.

Business Strategy and Core Philosophies

Broadly defined, our business strategy is to continue to build our reputation as a leader in the cobalt, radiochemical, and nuclear medicine product industries, and to maximizing the revenue potential of our new generic sodium iodine I-131 product and our expanded contract manufacturing capabilities. We also intend to continually seek ways to improve our customer service and expand our market share, with the ultimate goal of providing greater return to our shareholders. Specifically, we are continuously working with our customers to improve and develop new products to better serve the needs of the end user which, ultimately, we believe will boost product sales. A key part of our short-term and long-term business strategy is to develop and market additional generic drug products, similar to our sodium iodide I-131 product, thatwhich will offer customers a high quality, reliable, and affordable products as well as increase our revenues. In addition, we will manage cash reserves and pursue additional financial support that will be structured in such a way to support further expansion of our products and services to exploit similaradditional market opportunities.

Our core philosophy is to strive to provide high quality products and services as a profitable and environmentally conscious business, while offering excellent customer service and providing a safe and productive working environment for our employees. We operate in accordance with an ISO Quality Management System and in accordance with all current Good Manufacturing Practices under which we seek to maintain the highest level of quality and continuously improve our product manufacturing processes.

Results of Operations

Following is a summary of results of operations for 2020:2021:

Year Ended December 31, 20202021 Compared to Year Ended December 31, 20192020

The following table presents comparative revenues for the years ended December 31, 20202021 and 2019:2020:

Revenues

Total revenues in 20202021 were $9,364,866,$9,661,942, compared to $8,955,204$9,364,865 in 2019,2020, which represents an increase of $409,692,$297,047, or approximately 5%3%. The performance of each segment is discussed in the following paragraphs.

Radiochemical Products

Sales of radiochemical products accounted for approximately 44% of our total sales revenue in 2020each of 2021 and approximately 32% of total sales revenue in 2019.2020. Sales in this segment increased by $1,219,363,$203,473, or approximately 43%5% to $4,071,571$4,275,044 as compared to $2,852,207$4,071,571 in 2019.2020. The increase is a result of a $1,887,488$354,098 or 93%9% increase in radiochemical product sales year over year that was primarily the result of sales of our new generic sodium iodide I-131 drug product which was launched in March 2020. We expect sales of our new product to continue to trend upward. This increase in sales was partially offset by a reduction in payments received for contract manufacturing services year over year.

In February 2020, we received approval of an ANDA to the FDA for a sodium iodide radiopharmaceutical product for use in treatment of hyperthyroidism and carcinoma of the thyroid. We began sales of this product in March 2020, and these sales have had a significant positive impact on our revenues for 2020.2020 and 2021. We expect continued growth in sales for this product in 20212022 and beyond. This is the first of several potential generic drug products we plan to submit to the FDA in the coming years. Within this segment, we also currently distribute sodium iodide (I-131) as a radiochemical product. ThisThe radiochemical product is being used for a variety of applications including industrial use and use in investigational and clinical trials for the treatment of breast, lung, prostate, and ovarian cancers.trials. We believe that the product enhancements we have made, in addition to the generic drug products we plan to submit to the FDA, should increase future sales in this business segment.

Additionally, we providehave provided contract manufacturing of radiochemical products for our customers. In 2019, we entered into a manufacturing and supply agreement with Progenicsa company and completed an expansion of our existing facility to support that and other contract manufacturing activities. During 2020, Progenics was acquired by anotherBecause of changing market conditions that company and, asrequested a result, revised theirtermination of that contract manufacturing needs. Progenics requested to terminate the contract manufacturing agreementarrangement, and in we entered into a settlement agreement was reached with Progenicsthat company in December 2020. In December 2020, we entered into an agreement with Progenics to which, among other things, the manufacturing agreement was terminated effective immediately. As part of the settlement agreement, we received a termination payment consisting of cash and Progenics’sthe other company’s relinquishment on all claims to expansion of our facility and all the equipment purchased by Progenics in connection with the Manufacturing Agreement with the exception of certain specified equipment.them. The settlement resulted in a significant one-time gain for us in 2020 as detailed under Other Income (Expense) below. In February 2022, we were able to sell these assets we received in the settlement agreement for another significant one-time gain. We are currently developing a business plan to produce additional radiopharmaceutical products or explore new contract manufacturing opportunities in this facility using this equipment.utilizing the cash from that sale.

Cobalt Products

Cobalt products sales accounted for approximately 13%14% of our total sales revenue in 20202021 and approximately 9%13% in 2019.2020. Sales in this segment increased by $379,177,$128,937, or approximately 45%11%, in 2020 to $1,225,580,$1,354,517, as compared to $846,404$1,225,580 in 2019.2020. The increase in revenue within this segment iswas the result of increase Cobalt Sealed Source Manufacturing partially due to receipt of additional cobalt material from the ATR in March 2020.2021. Our sealed source manufacturing generates the majority of our revenue within this segment and sealed source sales depend on our ability to produce or procure this cobalt material.

In October 2014, we entered into a ten-year agreement with the DOE for the irradiation of cobalt targets. It takes many years to irradiate these cobalt targets to the desired level of activity and we anticipated having high specific activity cobalt available for our customers in 2020. However, the material had lower than expected activity and further receipt of material has beenwas delayed until about June 2021. At that point the material still had lower than expected activity, and we reached an agreement with the DOE to purchase the material at a discounted rate. Periodically we have been able to acquire recycled material that can be used to manufacture sealed sources for customers, and in some instances, our customers have supplied their own cobalt material for source fabrication. We also have access to additional low specific activity material produced by the DOE and expect to obtain, process, and sell additional cobalt products as a result during 2022.

We have entered into cobalt supply agreements with several customers. Pursuant to these contracts, we will supply bulk cobalt-60 and, in some cases, provide source manufacturing and installation services for the customer. The terms of these cobalt contracts require some advance progress payments from each customer. The funding received under these contracts has been recorded as unearned revenue under short- and long-term liabilities in our consolidated financial statements. We recognized some of this revenue in 2019prior years including in 2021 and 20182020 when we fulfilled contract performance objectives by supplying sealed sources manufactured with cobalt from ourthe ATR or alternate supplier.suppliers.

As of December 2020, we continued to hold in inventory many old design cobalt targets at the ATR that had undergone some irradiation. In 2020, we performed year-end analytical review of these targets and no longer believe these older design targets to be economically viable. Accordingly, we have written off the entire carrying value from our inventory of these older design targets. We will periodically continue to review any residual value of this cobalt material for any future potential economic opportunity

Nuclear Medicine Standards

Sales of nuclear medicine standards accounted for approximately 39%40% and 44%39%, of our total sales revenue in 20202021 and 2019,2020, respectively. Sales in this segment decreasedincreased by $252,047,$169,192, or approximately 6%5%, to $3,673,256$3,842,447 in 2020,2021, as compared to $3,925,303$3,673,255 in 2019.2020. This decreaseincrease in sales is due partially to the result of the temporary closurereopening of many imaging clinics and suspension of elective or non-essential imaging procedures as a resultthat were closed at certain times during 2020 because of the COVID-19 pandemic. Additionally, the COVID-19 pandemic causedincrease is due partially to easing of some interruption to distribution of our products due to temporary worldwide shipping restrictions.restrictions the COVID-19 pandemic caused.

In 2017, affiliates of the Company purchased 75.5% of the member units of RadQual and at that time, we were named as one of the managing members of RadQual. Because of this change in member ownership and management, we have consolidated RadQual’s operations within the nuclear medicine segment for financial reporting.reporting since that time. For purposes of consolidation, all significant intercompany activity has been eliminated in the reporting process.

We formed In July 2021, we acquired the remaining 75.5% of the member units of RadQual. As a 50/50 joint venture,result of the acquisition, RadQual and TI Services with RadQual in 2010, to distribute productsare now our wholly-owned subsidiaries and promote services for nuclear medicine, nuclear cardiology and PET imaging. Again, due to our affiliate members and management, we have also consolidated TI Services into our financial statements and have eliminated all intercompany transactions.are fully consolidated.

We anticipate that our sales of RadQual products will remain strong and that our managementownership of RadQual will create significant future opportunities through new product development.development and expanding markets. Additionally, we will continue to work closely with TI Services using their expertise in marketing and distribution strategies to strengthen nuclear medicine product sales through TI Services.sales.

Radiological Services

Revenues from our Radiological Services segment accounted for approximately 2% of our total sales revenue in 2020each of 2021 and approximately 13% in 2019.2020. Sales in this segment decreased by $954,651,$55,980, or approximately 82%26%, from $1,170,790 in 2019, to $216,139 in 2020.2020, to $160,159 in 2021. The decrease in revenue is attributable to our termination of radiological field service contract work for the DOE and termination of our contract for gemstone processing.processing and field service activities.

Revenue from gemstone processing for the year ended December 31, 2021, was $131,650 compared to $172,555 for the same period in 2020. This was a decrease of $40,905, or approximately 24%. This decrease in revenue from gemstone processing is the result of termination of our gemstone processing activities. 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 substantially occurred in 2021 and the Company saw a steady decline in revenue from this service as production was wrapped up. In the first half of 2022, we plan to convert the spaces in the facility that had been used to perform this contract work into expanded Nuclear Medicine new 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.

Revenue from field service work for the DOE had accounted for the majority of revenue in this segment. However, Radiological Field Services accounted for 0% of thedid not generate any Radiological Services segment sales in 2020 and approximately 67% in 2019. Revenue from radiological field services was $0 for the year ended December 31, 2020, and $787,940 for the same period in 2019.2021 or 2020. This decrease of $787,940 was the result of our termination of all radiological field service contract work, andthe removal of this activity from our NRC license following the May 2019 contamination event discussed below.

event. 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 have reviewed the results of the DOE investigation into this event and have implemented appropriate corrective actions. On January 5, 2021, we were notified by the DOE that we had been indemnified from any financial liability for this event under the Price Anderson Act (PAA).

The Washington Department of Health (DOH) issued a Notice of Violation to us in May 2020 citing two violations of our reciprocity license in the State of Washington related to the contamination event. On December 22, 2020, the Washington DOH imposed a civil penalty of $11,000 related to the contamination event. The Washington DOH investigation has now been closed.

The U.S. Nuclear Regulatory Commission (NRC) completed an inspection of our radiological safety program and issued a Notice of Violation in June 2020 citing two different violations of our NRC materials license also related to the contamination event. The NRC notified us on October 20, 2020 that it had determined the violations were considered a Severity Level II problem. In accordance with their enforcement discretion authority the NRC has decided not to impose any civil penalty against us for these violations in recognition of our significant corrective actions. Our corrective actions included termination of all field service activities and removal of these activities from our NRC license. The NRC investigation and our actions necessary to address the NOV are now closed.

Revenue from gemstone processing for the year ended December 31, 2020, was $172,555 compared to $382,850 for the same period in 2019. This was a decrease of $210,295, or approximately 55%. This decrease in revenue from gemstone processing is the result of termination of our gemstone processing activities as described below.Fluorine Products

In January 2020, we notified our gemstone processing customer that the service contract with them was being terminated because the volume of gemstones sent for processing did not meet contract minimums. The termination activities and wrap up of this service will continue through the remainder of 2021, and the Company will see a steady decline in revenue from this service as production is wrapped up. We plan to convert the spaces in the facility that had been used to perform this contract work into expanded Nuclear Medicine new 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.

Fluorine Products

In 2020, we had revenues related to Fluorine Products of $178,350$29,775 as compared to $160,500$178,350 in 2019.2020. These revenues were related to an agreement to provide engineering and technical assistance services related to our fluorine products intellectual property. We expectmay have additional revenue amounts in 20212022 as this agreement continues. We developed our fluorine products in conjunction with the uranium de-conversion project, in order to take advantage of the anticipated need for depleted uranium de-conversion services. We established the Fluorine Products segment in 2004 to support production and sale of the gases produced using our FEP. In 2013, we made the decision to place continued formal design work on the proposed de-conversion facility on hold until such time that we are able to secure additional de-conversion services contracts. Until such time that work resumes on the project, we will 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. We continue to explore opportunities for government or commercial contracting for depleted uranium deconversion services that could still utilize FEP.

During 2020,2021, we incurred $142,896$150,196 of planning and other expenses related to the de-conversion project, as compared to $151,035$142,896 in 2019.2020. This is a decreasean increase of $8,139,$7,300, or approximately 5%, and is the result of decreased licenses and permit expenseincreased professional services allocated to this project in 2020.2021. We expect that our costs in the future will be limited to essential items such as continued interactions with our customers, the state of New Mexico, and Lea County, New Mexico.

Cost of Revenues and Gross Profit

Cost of revenues for 20202021 was $3,904,869$3,924,142 as compared to $4,289,490$3,904,869 in 2019, a decrease2020, an increase of $384,621,$19,273, or approximately 9%less than 1%. Gross profit percentage increased to 59% for 2021, from 58% for 2020, from 52% in 2019.2020. The following table presents revenues and cost of revenues information:

During 2020,2021, we continued to monitor and control direct costs. Raw materials used in our radiochemical products and nuclear medicine standards represented the bulk of direct costs for 2020.2021. In each of these business segments, we have purchase agreements in place with suppliers to obtain optimum pricing. Periodically, the cost increases for these raw materials or we may also use alternate supply sources for our material which might not carry pricing as favorable as our contracted suppliers.

In 2020,2021, we were able increase gross profit percentage in our radiochemical segment with continued growth of sales of our new generic sodium iodide I-131 drug product. Throughout 2020,In 2021, our gross profit percentage in our nuclear medicine product segment we maintained a low cost of scrapped material as a result of adjustments madedecreased due to an increase in the manufacturing processes in this segment. With the exception of the cost of cobalt material, we are not aware of any significant future price increases that may potentially affect our cost of revenues.material.

Operating Costs and Expenses

Total operating costs and expenses for 20202021 were $5,875,700,$6,418,592, as compared to $5,224,011$5,875,700 in 2019.2020. This is an increase of $651,689,$542,892, or approximately 12%9%.

The following table presents operating costs and expenses for 20192021 as compared to 2018:2020:

Salaries and contract labor expense increaseddecreased by $267,449,$140,007, or approximately 10%5%, which was the result of the additionreduced number of new personnel and annual salary and wage increases and periodic performance awards made during the year.personnel. In addition, non-cash equity compensation expense recorded for the year ended December 31, 20202021, was $88,180$86,988 as compared to $129,850$88,180 for the same period in 2019.2020. This is a decrease of $41,670,$1,192, or approximately 32%1%, and is the result of equity compensation recorded for outstanding stock options granted to employees and non-employees.

General administrative and consulting expenses increased to $3,459,143 in 2021, as compared to $2,828,460 in 2020, as compared to $2,400,343 in 2019, an increase of $428,117,$630,683, or approximately 18%22%. This increase is a result of increased rent expenselicenses related to our FDA approved product, increased depreciation related to the expansion of our existing facility, increased cost of production supplies, increased professional services expense, and increased insurance expense.

Research and development expense was $271,714 for 2021, compared to $219,498 for 2020, compared to $263,375 for 2019.2020. This is a decreasean increase of $43,877,$52,216, or approximately 17%24%. The majority of this decreaseThis increase in research and development expense was the result of decreasedincreased costs associated with our ANDA submission to the FDA for our new drug product development in our Radiochemical ProductsNuclear Medicine business segment.

During both 20202021 and 2019,2020, we limited further investment in the planned de-conversion facility and limited further spending on the project only for expenses necessary to maintain licensing and continued interactions with New Mexico and Lea County. We will continue to delay further engineering work on the de-conversion project until we are able to secure additional contracts for de-conversion services.

Other Income (Expense)

The following table presents other income (expense) for 20192021 as compared to 2018:2020:

Other income was $3,637,026$683,253 for 20202021 as compared to other expenseincome of ($114,509)3,637,026 for 2019.2020. This is an increaseda decrease in other income of $3,751,535.$2,953,773. The increasedecrease is due to income recognized as part of our termination of our manufacturing and supply agreement with Progenics.in 2020. As part of the termination agreement, we received $500,000 cash of which $128,125 was for payment of outstanding invoices. The remaining $371,875 was recorded as “other income”. Additionally, we receivedand title ofto improvements and equipment that was installed in our facility. These improvements and equipment are valued at approximately $2,500,000; this was also recorded as “other income.” Additionally in 2020, we had income from PPP SBA Loans converted to grant income of $546,100 which was recorded as “other income”. In 2019 we had income and expenses related to the costs resulting from the contamination event that occurred at an offsite location in the state of Washington in May 2019. During 2019, net expense for this cleanup was $206,454. On January 5, 2021 we were notified byrecognized “other income” an anticipated tax refund of approximately $440,000 for the DOE that we had been indemnified from any financial liability for this event under the Price Anderson Act (PAA).Employer Retention Credit.

Interest income in 20202021 was $3,192$111 as compared to $13,090$3,192 in 2019.2020. This decrease of $9,898$3,081 was due to decreased interest rates earned cash balances held at banks and other institutions in interest-bearing accounts.

Interest expense increased during 2020,2021, to $791,532, from $781,837 from $541,274 in 2019.2020. This is an increase of $240,563,$9,695, or approximately 44%1%. This increased interest expense was due to an increase in non-cash interest expensepaid for issuance of warrants related to notes payable and preferred stock issuances.for refunds of cobalt contracts. In 2020, this2021, non-cash interest expense was $390,938$401,077 as compared to $155,157$390,938 in 2019.2020. This is an increase of $235,781.$10,139. Interest expense includes dividends accrued on our Series C Preferred Stock (as defined below) issued in 2017. In 2020,2021, we recorded interest expense of $252,780$244,955 for dividends payable on our Series C Preferred Stock.

In connection with the 2013 Promissory Note (as defined below), we recorded $30,000 of interest expense for each of 20202021 and 2019,2020, and approximately $13,000 and $27,000 of non-cash interest expense related to a debt discount feature on the 2013 Promissory Note for 2020each of 2021 and 2019 respectively.2020.

In connection with the 2019 Promissory Note (as defined below), we recorded $39,000$40,000 and $500$39,000 of interest expense for 20202021 and 20192020 respectively, and approximately $256,000 and $249,000 of non-cash interest expense related to a debt discount feature and issuance of warrants related to the 2019 Promissory Note for 2021 and 2020 with no such expense in 2019.respectively.

In connection with our 2017 issuance of Series C Preferred Stock, we issued Class M Warrants and Class N Warrants. We recorded approximately $131,000 and $128,000 of non-cash interest expense for each of2021 and 2020 and 2019respectively in relation to these warrants.

Net Income or Loss

Our net incomeloss was $2,202,651$902,347 in 2020,2021, compared to a net lossincome of ($1,522,964)$2,202,651 in 2019.2020. This is an increasea decrease in net income of $3,725,615.$3,104,998. Our increasedecrease in net income was the result of $2,916,837 of other income recognized in 2020 as part of our termination agreement of our manufacturing and supply agreement with Progenics couples with income from PPP SBA Loans convertedand increased operating expenses in 2021 as compared to grant income of $546,100.2020.

Liquidity and Capital Resources

On December 31, 2020,2021, we had cash and cash equivalents of $1,113,032$474,851 compared to $575,422$1,113,032 at December 31, 2019.2020. Net cash providedused in operating activities was $1,149,625$161,914 in 2020,2021, compared to net cash usedprovided by operating activities of $53,557$1,149,625 in 2019.2020. This represents an increasea decrease in cash provided in operating activities of approximately $1,203,182.

Accounts receivable at December 31, 2020 were $796,128 as compared to $875,914 at December 31, 2019. Historically, we have not written off any accounts receivable, and there were no accounts written off during 2020 or 2019.$1,311,539.

Accounts receivable at December 31, 2021 were $853,675 as compared to $796,128 at December 31, 2020. Our allowance for bad debt at December 31, 2021 was $18,910 as compared to $0 at December 31, 2020.

Inventories at December 31, 20202021 were $837,787$924,775 as compared to $3,423,420$837,787 at December 31, 2019. The majority2020. A large portion of our inventory consists of irradiated material held at the siteCobalt target inventory. For 2021, our target inventory accounted for approximately 48% of the DOE’s prime-operating contractor, which controls the ATR located outside of Idaho Falls, Idaho.our work in process inventory. For 2020, our target inventory accounted for approximately 88%61% of our work in process inventory and includes cobalt targets of an older design as well as irradiated cobalt material under a new contract with the DOE. During 2019, our target inventory accounted for approximately 89% of our work in process inventory. In 2020 and 2019, as part of our year-end procedures, we evaluated our older target inventory for impairment and concluded that these older design targets have varying but significant degrees of market value depending on any additional costs we may have to incur to transport them to our facility for processing.

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. In April 2020, we modified our 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. Due to this modification in April 2020 work in process was reduced by $2,050,100 from a $918,090 cash refund from the DOE and a reduction of accounts payable of $1,132,010. In October 2020 we made an additional modification to our agreement with DOE, as a result we received a cash refund of $304,000 of our previous progress payments; and work in process was reduced by $304,000. For 2020, our cobalt target inventory accounted for approximately 89% of our work in process inventory as compared to 88% in 2019. In 2020, as part of our year-end procedures, we evaluated our older target inventory held at the DOE ATR for impairment and concluded that these older design targets were fully impaired due to cumulative decay of the radioactive material. This impairment resulted in a $201,249 inventory impairment expense in 2020.

Included in our raw material inventory are raw cobalt, strontium, and other raw elements. RawIn 2021, we determined that our raw material inventory is regularly reviewed for obsolescence.was obsolete and fully impaired. This impairment resulted in a $33,609 inventory impairment expense in 2021.

Included in our work in process inventory are in-process and completed nuclear medicine products, irradiated cobalt and nuclear medicine-related materials and products.

We recognized a net incomeloss of $2,202,651,$902,347, for the year ended December 31, 2020,2021, and have an accumulated deficit of $125,861,734$126,764,081 since inception. To date, our operations and plant and equipment expenditures have been funded principally from proceeds from public and private sales of debt and equity as well as through asset sales.

Net cash used in investing activities was $205,474 for 2021 and net cash provided in investing activities was $28,256 for 20202020. During 2021, we used $205,474 to purchase equipment, and net cash used in investing activities for 2019 was $206,402. During 2020, we used $7,744 to purchase equipment and we used $208,102 to purchase equipment in 2019.2020. We had proceeds from sale of equipment of $36,000 in 2020, and we had no proceeds from sale of equipment in 2019.2021.

Financing activities used cash of $637,109$78,699 for the year ended December 31, 2020.2021. We received proceeds from the sale of common stock in the amount of $18,890 and issued debt for proceeds of $351,255. We made principal payment on loans in the amount of $437,627 in 2021. For the year ended December 31, 2020, financing activities used cash of $637,109. We received proceeds from the sale of common stock in the amount of $16,475 and issued debt for proceeds of $871,100. WeIn addition, we made principal payment on loans in the amount of $1,519,920 in 2020. For the year ended December 31, 2019, financing activities provided cash of $20,412. We received proceeds from the sale of common stock in the amount of $90,913 and issued debt for proceeds of $675,000. In addition, we made principal payment on loans in the amount of $739,111 in 2019.

In February 2017, we entered into subscription agreements with certain investors, including two of our directors, for the sale of (i) an aggregate of 3,433 shares of Series C Preferred Stock, and (ii) Class M warrants to purchase an aggregate of 17,165,000 shares of our common stock (Class M Warrants), for gross proceeds of $3,433,000. The Series C Preferred Stock accrues dividends at a rate of 6% per annum, payable annually on February 17th of each year, commencing on February 17, 2018.  Shares of Series C Preferred Stock are convertible at the option of the holder at any time into shares of our common stock at an initial conversion price equal to $0.10 per share, subject to adjustment.  At any time after February 17, 2019, if the volume-weighted average closing price of our common stock over a period of 90 consecutive trading days is greater than $0.25 per share, we may redeem all or any portion of the outstanding Series C Preferred Stock at the original purchase price per share plus any accrued and unpaid dividends, payable in shares of common stock.  All outstanding shares of Series C Preferred Stock must be redeemed by us on February 17, 2022 at the original purchase price per share, payable in cash or shares of common stock, at the option of the holder. In February 2022, based on approval of majority of the Preferred C Holders, we extended the redemption date of the Series C Preferred Stock to February 17, 2023. Holders of Series C Preferred Stock do not have any voting rights, except as required by law and in connection with certain events as set forth in the Statement of Designation of the Series C Preferred Stock. The Class M Warrants arewere exercisable at an exercise price of $0.12 per share, subject to adjustment as set forth in the warrant, and haveexpired in February 2022. In February 2022, 515,000 Class M Warrants were exercised at a termprice of five years.$0.12. The Company received $61,800 for the exercise.

In March 2017, we amended our 8% unsecured debentures issued that were scheduled to mature in July 2017 (the Notes) and gave the noteholders certain additional rights (the Amendment). Pursuant to the Amendment, the Notes were modified to provide each holder the right, at the holder’s option and exercisable prior to May 12, 2017, to convert all or any portion of the principal amount of the Notes, plus accrued but unpaid interest, into shares of our Series C Preferred Stock at a conversion price of $1,000 per share. Holders that elected to convert their Notes into Series C Preferred Stock received a warrant to purchase up to 3,750 shares of our common stock for each share of Series C Preferred Stock received upon conversion of the Notes, with each warrant having a five-year term, a cashless exercise feature, and an exercise price of $0.10 per share of common stock. As a result of this modification, an aggregate of $780,000 of the Notes was converted to 780 shares of Series C Preferred Stock and 2,925,000 Class N Warrants (as defined below). Residual interest was also paid to Note holders who converted of $1,515. The Notes matured in July 2017 and were repaid in full.

As discussed above, in May 2017, we issued 780 shares of Series C Preferred Stock, and Class N warrants to purchase an aggregate of 2,925,000 shares of our common stock (Class N Warrants) upon conversion of $780,000 of the Notes. The Series C Preferred Stock accrues dividends at a rate of 6% per annum, payable annually on February 17th of each year, commencing on February 17, 2018.  Shares of Series C Preferred Stock are convertible at the option of the holder at any time into shares of our common stock at an initial conversion price equal to $0.12 per share, subject to adjustment. At any time after February 17, 2019, if the volume-weighted average closing price of our common stock over a period of 90 consecutive trading days is greater than $0.25 per share, we may redeem all or any portion of the outstanding Series C Preferred Stock at the original purchase price per share plus any accrued and unpaid dividends, payable in shares of common stock. All outstanding shares of Series C Preferred Stock must be redeemed by us on February 17, 2022 at the original purchase price per share, payable in cash or shares of common stock, at the option of the holder. In February 2022, based on approval of majority of the Preferred C Holders, we extended the redemption date of the Series C Preferred Stock to February 17, 2023. Holders of Series C Preferred Stock do not have any voting rights, except as required by law and in connection with certain events as set forth in the Statement of Designation of the Series C Preferred Stock. The Class N Warrants are exercisable at an exercise price of $0.12 per share, subject to adjustment as set forth in the warrant, and have a term of five years.

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. In January 2022, the 2013 Promissory Note was further modified to extend the maturity date to December 31, 2023, with all remaining terms unchanged.

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.In December 2021, the 2018 Promissory Note was further modified to extend the maturity date to December 31, 2023, with all remaining terms unchanged.

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 borrowed $675,000 under the 2019 promissory note; the remaining $325,000 was borrowed in February 2020. 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 are required to issue up to 30,000,000 Class O Warrants to purchase shares of our common stock at $0.045 per share (the Class O Warrants). The warrants are exercisable at an exercise price of $0.045 per share and have a term of five years.

On April 23, 2020, through our wholly-owned subsidiary entered into a Loan Agreement and Promissory Note (collectively the “SBA Loan”) with KeyBank National Association pursuant to the Paycheck Protection Program (the “PPP”) under the recently enacted Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) administered by the U.S. Small Business Administration (the “SBA”). The Company received total proceeds of $546,100 from the SBA Loan. The SBA Loan is scheduled to mature on April 22, 2022 and has a 1.00% interest rate and is subject to the terms and conditions applicable to loans administered by

In July 2021, we received notification from the SBA under the CARES Act. The SBA Loan may be prepaid at any time prior to maturity with no prepayment penalties.

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

As of September 30, 2020, we have used the entire loan proceeds to fund qualifying expenses. As a result, we believe that it has met the PPP eligibility criteria for forgiveness and has concluded that the loan represents, in substance, a government grant that is expected to be forgiven. As such, we have recognized the entire loan amount as ‘Other Income’ in the period ending December 31, 2020.

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

We expect that cash from operations, cash obtained through securities offerings, and our current cash balance will be sufficient to fund operations for the next twelve months. Although we may seek additional debt financing for our projects and operations in the future, there is no assurance that we will be able to secure additional debt financing on acceptable terms to us, or at all.

Off-Balance Sheet Arrangements

As of December 31, 2020, we had no material off-balance sheet arrangements or obligations.

Goals for 20212022

Based upon the investments we have made in our facilities and investments we anticipate making, and based on projects, and products developed thus far in 2021,2022, we have the following goals for the rest of 2020:2022:

Critical Accounting Policies

Revenue recognition - We recognize revenue when products ship or services are performed according to predetermined amounts per customer contract obligations or milestones. We have contracted with several customers for the purchase of cobalt-60 material which is currently undergoing irradiation. We have collected advance payments from these customers for project management and up-front handling and irradiation charges and these prepayments have been recorded as unearned revenue. Our estimated future recognition of this unearned revenue is based on an irradiation completion and shipment schedule and on product shipment dates and service performance dates.

Patents and other intangibles - We amortize our patents and intangibles using the straight-line method over their estimated useful lives. Patents and other intangibles are evaluated for impairment annually or when events or circumstances arise that indicate the existence of impairment. We evaluate the recoverability of intangible assets whenever events or changes in circumstances indicate that an intangible asset’s carrying amount may not be recoverable. Such circumstances could include, but are not limited to, (1) a significant decrease in the market value of an asset, (2) a significant adverse change in the extent or manner in which an asset is used, or (3) an accumulation of costs significantly in excess of the amount originally expected for the acquisition of an asset. If impairment indicators exist, we measure the carrying amount of the asset against the estimated undiscounted future cash flows associated with it. Should the sum of the expected future cash flows be less than the carrying value of the asset being evaluated, an impairment loss would be recognized. The impairment loss would be calculated as the amount by which the carrying value of the asset exceeds its fair value.

Impairment of long-lived assets - As part of our year-end procedures we test our long-lived assets for signs of impairment when indicators of impairment exist. If impairment indicators exist, we measure the carrying value of the asset against its estimated future cash flows. If the expected future value is less than the carrying value of the asset an impairment loss would be recognized.

Critical Accounting Estimates

Asset retirement obligation – The asset retirement obligation is based on the expected future cash flows of the decommissioning funding plan.   The decommissioning funding plan is based on the estimated number of hours of specific personnel, estimated wages and disposal costs.  Once the decommissioning funding plan has been developed, we use a discount rate to determine the estimated current value of the liability.

New Accounting Standards

In February 2016, the FASB issued ASU 2016-02, “Leases” which was issued to increase transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements.  The amendments in ASU 2016-02 are effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years.  We recorded an adjustment in January 2019, to both the assets and liabilities to recognize a lease related to real estate.

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

We are a smaller reporting company, and therefore, are not required to provide the information required by this item.

The following financial statements are included herewith and are hereby incorporated by reference:

Index to Consolidated Financial Statements

FINANCIAL DISCLOSURE

None.

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 Exchange Act) that are designed to ensure information required to be disclosed in our reports that are filed or submitted under the Exchange Act, is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed 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 (CEO) and Chief Financial Officer (CFO), has conducted an evaluation (pursuant to Rule 13a-15(b) of the Exchange Act) of the effectiveness of our disclosure controls and procedures as of December 31, 2020.2021. Based on that evaluation, our CEO and CFO concluded that our disclosure controls and procedures were effective as of December 31, 2020.2021.

Management’s Annual Report on Internal Control over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15(d)-15(f) under the Exchange Act). Internal control over financial reporting is a process to provide reasonable assurance regarding the reliability of our financial reporting for external purposes in accordance with accounting principles generally accepted in the U.S. Internal control over financial reporting includes maintaining records that in reasonable detail accurately and fairly reflect our transactions; providing reasonable assurance that transactions are recorded as necessary for preparation of our financial statements; providing reasonable assurance that receipts and expenditures are made in accordance with management authorization; and providing reasonable assurance that unauthorized acquisition, use or disposition of company assets that could have a material effect on our financial statements would be prevented or detected on a timely basis. Because of its inherent limitations, internal control over financial reporting is not intended to provide absolute assurance that a misstatement of our financial statements would be prevented or detected.

Management conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework and criteria established in Internal Control — Integrated Framework (2013), issued by the Committee of Sponsoring Organizations of the Treadway Commission. This evaluation included review of the documentation of controls, evaluation of the design effectiveness of controls, testing of the operating effectiveness of controls and a conclusion on this evaluation. Based on this evaluation, management concluded that our internal control over financial reporting was effective as of December 31, 2020.2021.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting during the quarteryear ended December 31, 2020,2021, that have materially affected, or are reasonable likely to materially affect, our internal control over financial reporting.

None.

None.

PART III.

We have adopted a Code of Ethics that applies to our principal executive officer, principal financial officer, principal accounting officer and controller, or persons performing similar functions. Our Code of Ethics is posted on our website and can be accessed, free of charge, at http://www.intisoid.com. If we waive, or implicitly waive, any material provision of the Code of Ethics that apply to our executive officers, or substantively amend the Code of Ethics, in each case that is required to be disclosed, we will disclose that fact on our website.

The other information required by this item is incorporated by reference from our definitive proxy statement for our 20212022 annual meeting of shareholders, which will be filed with the SEC within 120 days after December 31, 2020.2021.

The information required by this item is incorporated by reference from our definitive proxy statement for our 2021 annual meeting of shareholders, which will be filed with the SEC within 120 days after December 31, 2020.

The information required by this item is incorporated by reference from our definitive proxy statement for our 20212022 annual meeting of shareholders, which will be filed with the SEC within 120 days after December 31, 2020.2021.

The information required by this item is incorporated by reference from our definitive proxy statement for our 2022 annual meeting of shareholders, which will be filed with the SEC within 120 days after December 31, 2021.

The information required by this item is incorporated by reference from our definitive proxy statement for our 20212022 annual meeting of shareholders, which will be filed with the SEC within 120 days after December 31, 2020.2021.

The information required by this item is incorporated by reference to our definitive proxy statement for our 20212022 annual meeting of shareholders, which will be filed with the SEC within 120 days after December 31, 2020.2021.

(a)(1) and (a)(2) Financial Statements

See the index to and the financial statements beginning on page 28, which financial statements are incorporated herein by reference.

(a)(3) Exhibits

The following documents are filed or incorporated herein by reference as exhibits to this report:

† This exhibit constitutes a management contract or compensatory plan or arrangement.

** Confidential treatment has been granted as to certain portions, which portions were omitted and filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request.

++ Schedules have been omitted pursuant to Item 601(b)(2) of Regulation S-K. The Company hereby undertakes to supplementally furnish copies of any omitted schedules to the Securities and Exchange Commission upon request.

+ Filed herewith.

* Furnished herewith.

None.

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) 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.

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

CONSOLIDATED FINANCIAL STATEMENTS

TABLE OF CONTENTS

Haynie & Company

Salt Lake City, Utah

INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

Consolidated Balance Sheets

See accompanying notes to consolidated financial statements.

INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

Consolidated Statements of Operations

See accompanying notes to consolidated financial statements.

INTERNATIONAL ISOTOPES INC AND SUBSIDIARIES

Consolidated Statement of Stockholders' Equity

Years ended December 31, 20202021 and 20192020