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: financial condition, operating results and liquidity, future cash flow from operations, our ability to achieve profitability, 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, our ability to continue cobalt-60 production, continuously source certain isotopes, 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

Item 1.       BUSINESS

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, provides radiochemicals for clinical research and life sciences, manufactures a wide range of nuclear medicine calibration and reference standards, is in development of medical devices for the nuclear medicine industry, and produces a variety of cobalt-60 products for medical, research, and industrial applications.

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; International Isotopes Transportation Services, Inc., an Idaho corporation; RadQual, LLC, a limited liability company (RadQual); RadVent, LLC, a limited liability company; Radnostix, LLC, a limited liability company; and TI Services, LLC, a limited liability company (TI Services). Our core business consists of five reportable segments which include: Theranostics Products, Cobalt Products, Nuclear Medicine Standards, Medical Devices, and Fluorine Products.

During 2024, we focused our efforts on achieving profitability in each of our core business segments and launching a fifth segment. We reached several significant goals. During 2024, we:

In 2025, we plan to continue investment in these segments including 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.

Theranostics Products

This segment includes the production and distribution of various isotopically pure radiopharmaceuticals, APIs, and radiochemicals for medical, industrial, and research applications. These products are produced by us from radioisotopes supplied by our vendors. We produce and distribute various products in customized volumes, concentrations, chemical formulations, packages, and specifications tailored to meet our FDA specifications or customer and market demands. Our FDA approved generic sodium iodide I-131 drug product is the only generic product of this type manufactured in the U.S. and offers customers an attractive domestic alternative to the single existing foreign commercial drug manufacturer.

Cobalt Products

Our Cobalt Products segment includes the production of various cobalt-60 products and services, including the fabrication of cobalt-60 sealed sources for radiation therapy, various industrial and medical applications, and recycling of expended cobalt-60 sources.

We have explored, and intend to continue to explore, opportunities to further develop cobalt-60 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 a highly experienced staff of technicians, shipping specialists, and supervisors as part of our efforts to comply with the regulations and support cost effective, timely delivery of these products.

We believe both our domestically manufactured product and service provide us with a competitive edge in competing with other manufacturers.

Nuclear Medicine Standards

According to the IAEA, over 140 countries have the availability of SPECT and/or PET cameras, with more than 33,000 installed units in total. These installed cameras use nuclear medicine products on a regular repeat basis, with many of them requiring calibration as part of on-going certification. Most Nuclear Medicine Standards product sales are to U.S. customers. However, in recent years, because of stronger marketing efforts, we have seen an increase in foreign sales. All 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. The various isotopes used in manufacturing these Nuclear Medicine Standards products are from several sources world-wide, and we are continually working to develop multiple sources of each isotope. In addition to the products themselves, we have developed a complete line of specialty packaging for the safe transportation and handling of these products.

Medical Devices

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

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 U.S. Nuclear Regulatory Commission ("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, but we have maintained all licenses and permits for the project.

On February 8, 2024, we entered into a definitive agreement to sell all our assets related to the Fluorine Products segment and the Planned Uranium De-Conversion Facility to American Fuel Resources ("DUF6 Asset Sale"). We expect to close the agreement before the March 2026 milestone. Closing is contingent on various conditions being met, including approvals and agreements by the NRC and other third parties. Upon the closure of the DUF6 Asset Sale, we plan to pay down the related notes and close our fluorine products business segment.

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.

Theranostics Products

In February 2020, our abbreviated new drug application ("ANDA") for a generic radiopharmaceutical sodium iodide I-131 drug product was approved by the U.S. FDA. This product is approved for use in treatment of hyperthyroidism and carcinoma of the thyroid and is the only generic sodium iodide I-131 product approved by the FDA that is manufactured in the U.S. The only other supplier to the U.S. of an FDA approved sodium iodide product comes from a foreign manufacturer.

We sell our generic sodium iodide I-131 to radiopharmacy customers, who manufacture patient-specific capsules and make direct sales in the U.S. to clinicians. We directly ship our generic sodium iodide I-131 to all 50 states and we also periodically supply a GMP equivalent to some overseas locations.

Since the launch of this drug product in 2020, the corresponding sales have had a significant positive impact on our revenues. We expect this growth in sales for this product to continue in 2025 and beyond as we grow our market share in the U.S., expand into new territories, and develop strategic joint-ventures in countries where it is not economical to serve from our existing manufacturing site.

We also supply Theranostics Products in API and radiochemical form. The markets for most radiochemicals can be 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 with the aim to further process and include the radioisotope products into pharmaceutical products approved by the U.S. FDA for labeled use in therapy or imaging, or (3) include our radioisotope products into their pharmaceutical products approved outside the U.S. for encapsulated and/or labeled use in therapy or imaging. We can ship to all 50 states and internationally. We are deploying a unique product strategy which we believe will make us the go-to API supplier for 3^rd party radiopharmaceutical products.

We believe that we are uniquely qualified and have a competitive advantage for future opportunities because we have a unique combination of NRC licensing, GMP compliant operating facility, and trained personnel.

Medical Devices

Our Medical Device segment will consist of our own medical devices and the distribution and servicing of third-party products.  We intend to leverage our existing network of distributors for Theranostics Products and Nuclear Medicine Standards products to purchase, use, and distribute our catalog of Medical Device products. We are actively working to launch three products in this segment: EasyFill, RadVent, and third-party products.

Our EasyFill Automated Capsule System will target radiopharmacy partners both in the US and around the world. There are over 400 radiopharmacy locations globally, of which approximately 20% of them prepare sodium iodide I-131 capsules in house. Most of these potential customers currently lease a shielded encapsulation device from the only available foreign supplier, who is also the only other supplier of sodium iodide I-131 into the U.S. We believe the launch of the EasyFill will also improve our market share of our Theranostics Product segment as the two products are used together. We are actively finalizing the development of the industrialized commercial unit for launch in late 2025.

Our RadVent products, which were purchased from AMICI Inc, are used with various lung imaging studies, in conjunction with other approved radiopharmaceuticals, such as Technetium-99m-DTPA and Xenon-133. These products are generally sold through the same distributor type and for resale to the same end-user demographic as our Theranostics Products and Nuclear Medicine Standards products. The AMICI products were long-established market leaders before their shutdown in 2020 during a moratorium on lung imaging due to the COVID pandemic. At the time, AMICI was also white label supplying to other providers and also supplying some components and medical devices to other companies which were being incorporated into competitive devices. We are actively working on establishing new manufacturing channels and expect to launch the first products from the RadVent portfolio by mid-2025.

Our Medical Devices segment also plans to commercialize various nuclear medicine focused devices which target the same core user base as our own devices and could leverage our existing personnel skills, facilities, logistics, and service engineering capabilities. In 2024 we entered an exclusive agreement for U.S. and Canada to distribute, service, and supply consumables for Scintomics ATT’s entire lineup of radiosynthesis equipment.

Nuclear Medicine Standards

We manufacture and distribute sealed sources and devices for various applications, including medical, laboratory, pre-clinical, industrial, and research. Many of our products are registered with the U.S. NRC and U.S. FDA where required, as well as their equivalent regulatory authorities in international jurisdictions. We ship these products directly to all 50 states and many overseas locations. We are certified under ISO-9001:2015 and ISO-13485-2016 quality programs which allow us to sell our products into several foreign countries where these quality certifications are required for manufacturers.

We have varying target markets and distribution tactics and channels, depending on the type of products we are selling. We predominately sell our medical products through distributors who make direct sales in the U.S. and internationally to end-users. Medical calibration and reference standards are used for daily or periodic operational checks and calibration of nuclear medicine devices, such as SPECT and PET cameras and lab equipment, which are routinely used in nuclear medicine clinics and radiopharmacies around the world. As part of licensing and certification requirements in the U.S. and other high-regulatory jurisdictions, calibration and quality assurance testing for equipment accuracy is required to be part of routine operations of this equipment. Over 140 countries have availability of SPECT and/or PET cameras, with more than 33,000 installed units in total. There are also more than 400 radiopharmacy and CDMO sites which use lab equipment that relies on calibration and reference standards. We also commercialize our PhanQual pre-clinical products in partnership with PhanTech; these products are targeted directly to end-users. Our non-medical industrial products are sold direct to end-users or to OEMs who bundle the sealed sources with their equipment. In the U.S., the core target market for industrial sources and calibration standards are utilities, mining operations, the U.S. Department of Energy, and environmental laboratories.

There are some small regional suppliers internationally and only one major producer of a similar catalog of products in the world that competes directly with us for this broad portfolio of products. Most of the products manufactured by our major competitor are similar in design to our products as these products must meet Original Equipment Manufacturer (OEM) dimensional and performance standards. We attempt to differentiate our products through strategic alignment with OEMs, high levels of service, competitive pricing, patent protections, and exclusive arrangements with OEMs.

We continue working to expand the number and types of products that are manufactured in this segment and expand our qualified suppliers for the raw material used for our products. We plan to eventually manufacture some of our medical products in China through our joint-venture, Radnostix China.

Fluorine Products and the Planned Depleted Uranium De-Conversion Facility

Our Fluorine Products segment was developed in conjunction with uranium de-conversion to take advantage of the anticipated need for depleted uranium de-conversion services. During 2013, we curtailed all further work on the de-conversion facility because of a lack of demand for uranium de-conversion services at that time. We have continued to maintain the assets and licenses related to our previously planned de-conversion facility. 

On February 8, 2024, we entered into a definitive agreement to sell all our assets related to the Fluorine Products segment and the Planned Uranium De-Conversion Facility to American Fuel Resources ("DUF6 Asset Sale"). We expect to close the agreement before the March 2026 milestone. Closing is contingent on various conditions being met, including approvals and agreements by the U.S. Nuclear Regulatory Commission and other third parties. Upon the closure of the DUF6 Asset Sale, we plan to pay down the related notes and close our fluorine products business segment.

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-60 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.

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 was planned to be located in Lea County, New Mexico. Further engineering work on the proposed deconversion facility was placed on hold in 2013 due to changes in market conditions. There is no specific timeline required by the NRC for the start of construction on this project. Most of the pre-construction design, licensing and state permitting has already been completed for the project. These licenses for the de-conversion facility are included in the DUF6 Asset Sale as described above.

Regulation of Radioisotope Production Waste

All our manufacturing processes generate some radioactive waste. We must handle this waste pursuant to the Low-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. Actual disposal costs are subject to change at the discretion of the disposal sites. 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 Standards segment’s and Medical Devices segment’s products. 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. 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, and in some cases our customers arrange for deliveries from our manufacturing site.

Dependence on Customers

Combined sales, on which we are dependent, to our three largest customers, accounted for 32% of our total gross revenues in 2024 and accounted for 22% of our total gross revenues in 2023.

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. These patents are included in the DUF6 Asset Sale as noted above.

In 2009, the University of Washington entered an exclusive utility patent license and royalty agreement with RadQual whereby RadQual has the exclusive right to exploit a patent for Calibration method and system for PET scanners.

In 2009 the USPTO granted a utility patent for Simulated dose calibrator source standard for positron emission tomography radionuclides. The patent is assigned to our RadQual subsidiary.

In 2021, we entered into an exclusive licensing agreement with Memorial Sloan-Kettering Cancer Center (MSKCC) for commercial development of a Radioimmuno Assay (RIA) test kit for the detection for SARS COVID-19 virus in the blood. A patent application for this test kit was submitted to the U.S. patent office in March 2021. The useful application and commercial viability of this opportunity will continue to be evaluated; however, at the present time we do not plan the commercial development of this product but may pursue other related commercial opportunities.

In 2023 we filed various utility and design patents in the U.S. and other international jurisdictions for our EasyFill product and its related consumables. These patents are currently pending approval by the USPTO and international authorities.

In 2023, as part of an asset purchase agreement with AMICI, Inc., we acquired the trademarks for the Swirler Radioaerosol System and Tru-Fit mouthpiece products.

In 2024, we received trademarks in China for our RadQual and Radnostix branding.

In 2024, our application to trademark our RadVent branding and logo in the U.S. was accepted. These marks are awaiting final registration by the USPTO.

Employees

As of December 31, 2024, we had 42 total employees, including 41 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.

Item 1A.      RISK FACTORS

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 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. We have incurred net losses for most fiscal periods since our inception. From inception through December 31, 2024, we have an accumulated deficit (including preferred stock dividends and returns) in the amount of $127,321,285. 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. 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 the development and construction of projects, reduce the scope of, abandon or sell some or all 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.  We are subject to potential material liabilities related to the remediation of environmental hazards and to personal injuries or property damage 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.  Our ongoing operations are currently dependent on Shahe Bagerdjian, President and Chief Executive Officer. The loss of Mr. Bagerdjian could have a material adverse effect on our business. We maintain a $4.1 million key man life insurance policy on Mr. Bagerdjian and an employment agreement that extends through June 19, 2028. However, there is no assurance that we will be able to retain Mr. Bagerdjian 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.  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.  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 in Nuclear Medicine Standards, Cobalt Product, and Theranostics Products segments. We also purchase some of our material and products from overseas suppliers and the price of those products could be adversely affected through changes in currency exchange rates.

During the year ending December 31, 2024, there was a global shortage of cobalt-57, a key isotope for our Nuclear Medicine Standards segment. This shortage occurred from January 2024 until the end of July 2024 and resulted in significant lost sales for this business segment. Our supply of cobalt-57 was restored in July 2024, and we have added additional suppliers in 2024. We are continuing to search for additional means to produce and procure certain critical isotopes, including through our Chinese Joint Venture, which we entered into in June 2024.

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, can significantly increase the cost of doing business, which in turn can negatively impact our operations, financial results and cash flow.  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 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. An unexpected or material increase in these costs could have a material adverse effect on our financial condition and results of operations. In 2024, we experience material waste disposal costs totaling $229,540. We anticipate similar waste disposal expenses in 2025.

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. In 2024 we incurred significant expenses related to two violations in 2021 and 2022. These violations resulted in NRC fines of $63,000, additional legal expenses of $47,636, and professional expenses for corrective actions of $123,216.

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. 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, 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, 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.  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.

Our future growth is largely dependent upon our ability to develop new products that achieve market acceptance with acceptable margins.  Our businesses operate in global markets that are characterized by rapidly changing technologies and evolving industry standards. Accordingly, our future growth rate depends upon several 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.  The production of high-specific activity cobalt-60 is dependent upon the U.S. Department of Energy (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-60 material needed for the manufacture of cobalt-60 sources for our Cobalt Products business segment. Loss of this cobalt-60 supply would have a significantly impact on this 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. We are continuing to search for additional means to produce and procure cobalt-60 material. Our radiochemical iodine is supplied to us through two supply sources. Unanticipated contract terminations by these suppliers or suppliers of the key raw materials of our other products or 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. Combined sales to our three top customers accounted for 32% and 22% of our total gross revenue during 2024 and 2023, 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.  Each of our existing business areas has direct competition from other businesses. High-specific activity cobalt-60 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 U.S. for our generic sodium iodide I-131 drug product. 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, 2024, there were approximately 17,982,500 shares of common stock issuable upon the exercise of vested stock options, at a weighted-average exercise price of $.05 per share. An additional 32,529,296 shares were reserved for issuance under our equity plans as of December 31, 2024. 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 business segments. Any such issuance will have the effect of further diluting the interest of the holders of our securities.

Item 1B.      UNRESOLVED STAFF COMMENTS

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

Item 2.       PROPERTIES

In 2024, we leased one property in Idaho ("Building A") which serves as or main corporate headquarters and houses all of our current manufacturing operations for our core business segments. Our TI Services subsidiary leases an office facility in Ohio. In December 2024, we purchased vacant land adjacent to our main corporate headquarters. 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. Beginning in January 2025, we began leasing a second facility across the street from our main headquarters ("Building B").

Building A: 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 facility was new when leased in March 2001 and remains in excellent condition. We have the right of first refusal on this property that allows us to match any offer to purchase this property.

Building B: 1359 Commerce Way, Idaho Falls, Idaho – This facility is located directly across the street from Building A. We began leasing this facility in January 2025; the initial term is until December 2029 and we have the option to extend the lease for two additional terms of 5 years each. We have the right of first refusal on this property that allows us to match any offer to purchase this property.

775 Boardman-Canfield Rd, Unit A-2, Boardman, Ohio – This office facility houses the employees of TI Services who are engaged in sales activities. The facility was leased in November 2017 and is currently under tenancy from month-to-month.

Land Adjacent to Building A, Idaho Falls, Idaho – Land is located directly South of Building A; it was acquired in December 2024 through a mix of cash and seller's financing. The land has no zoning restrictions in regards to building coverage and height.

Item 3.       LEGAL PROCEEDINGS

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.

Item 4.       MINE SAFETY DISCLOSURES

Not applicable.

PART II

Item 5.       MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

Our common stock is traded on the OTCQB under the trading symbol “INIS”. The following table shows the high and low prices of our common stock on the OTCQB. The following quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission and may not necessarily represent actual transactions:

Holders of Record

As of February 2025, there were 458 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.

Item 6.       RESERVED

Item 7.       MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

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, produces a variety of cobalt-60 products, and is in development to manufacture and sell medical devices for the nuclear medicine industry. 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 2024, we focused our efforts on achieving profitability in each of our core business segments and launching a fifth segment. We reached several significant goals during 2024, which included the following:

Business Strategy and Core Philosophies

Our business strategy is to continue to build our reputation as a leader in radioisotope applications, such as theranostics, radiopharmaceutical, radiochemical, medical device, cobalt-60, and nuclear medicine product industries, and to maximize revenue potential across all our product segments. 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 enter into additional markets for our Theranostics, Nuclear Medicine, and Medical Devices segments. In addition, we will manage costs and cash flow in such a way to support further expansion of our products and services to exploit additional market opportunities.

Our core philosophy is to strive to provide high quality products and services as a profitable 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 2024, which is explained in greater detail below:

Year Ended December 31, 2024 Compared to Year Ended December 31, 2023

The following table presents comparative revenues for the years ended December 31, 2024 and 2023:

Revenues

Total revenues in 2024 were $13,899,760, compared to $12,267,385 in 2023, which represents an increase of $1,632,375, or approximately 13%. The performance of each segment is discussed in the following paragraphs.

Theranostics Products

Sales of Theranostics Products accounted for approximately 58% of our sales revenue in 2024 as compared to 56% of our total sales revenue in 2023. Sales in this segment increased by $1,163,417, or approximately 17% to $8,006,315 in 2024 as compared to $6,842,898 in 2023. The increase is primarily the result of increased sales of our generic sodium iodide I-131 drug product.

Sales of our FDA-approved generic sodium iodide drug product make up the bulk of sales in this segment. We expect continued growth in sales for this product in 2025 and beyond. Within this segment, we also currently distribute sodium iodide (I-131) as a theranostics API product and a radiochemical product. The radiochemical product is used for a variety of applications including industrial use, and the theranostics API product is being used in investigational and clinical trials. We believe that market growth, new customers, and entry into new territories, in addition to any theranostics API that we plan to submit to the FDA, should increase our future sales in this business segment.

Cobalt Products

Cobalt Products sales accounted for approximately 17% of our total revenue in 2024 and approximately 8% in 2023. Sales in this segment increased by $1,328,499, or approximately 128%, in 2024 to $2,365,572, as compared to $1,037,073 in 2023. The increase in revenue within this segment was the result of increased cobalt-60 sales due to increases in supply of cobalt-60 material from the ATR and increased customer activity. Revenue in the Cobalt Products segment is subject to the variability of cobalt-60 material supply and timing of our cobalt-60 customers' various contracts that utilize our products. 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 cobalt-60 material.

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 will continue to have access to cobalt-60 material produced by the DOE and expect to obtain, process, and sell additional cobalt-60 products as a result during 2025.

We have entered into cobalt-60 supply agreements with several customers. The terms of these cobalt-60 contracts required some advance progress payments from each customer. The funding received under these contracts has been recorded as unearned revenue under short-term liabilities in our consolidated financial statements. We recognized some of this revenue in prior years including in 2024 and 2023 when we fulfilled contract performance objectives by supplying sealed sources manufactured with cobalt-60 from the ATR or alternate suppliers.

Nuclear Medicine Standards

Sales in the Nuclear Medicine Standards segment accounted for approximately 25% of our total revenue in 2024 as compared to 36% in 2023. Sales in this segment were $3,519,216 in 2024, as compared to $4,387,414 in 2023, this is a decrease of $868,198, or approximately 20%. The decrease in 2024 was due to a global shortage of cobalt-57 isotope from January 2024 to the end of July 2024. Due to the shortage of this raw material and our inability to deliver many of our products at that time, sales during this shortage period were approximately $1,000,000 below our projections for this segment. These potential lost sales were slightly offset by total sales of $1,419,503 for the three months ended December 31, 2024, which was the largest quarterly revenue for the Nuclear Medicine Standards segment in the Company's history. Our record 4th quarter 2024 sales for this segment are partly due to pent-up market demand because of the worldwide cobalt-57 shortage. We believe this segment will return to normal recurring revenue and profitability in 2025.

Fluorine Products

In 2024 and 2023, we had no revenues related to Fluorine Products. Work on our deconversion facility project that is the entirety of this business segment has been on hold since 2013 because of a slowdown in the nuclear industry that specifically impacted fuel cycle facilities. Since that time, we have limited 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. In February 8, 2024, we entered into an asset purchase agreement to sell all our assets related to the Fluorine Products segment and the Planned Uranium De-Conversion Facility to American Fuel Resources ("DUF6 Asset Sale"). We expect to close the agreement in the next 12 months subject to certain closing conditions, including approvals and agreements by the U.S. Nuclear Regulatory Commission and other third parties.

During 2024, we received $50,000 of other income related to the DUF6 Asset Sale and incurred $109,187 of expenses related to maintaining licenses and permits for the proposed de-conversion project, as compared to $7,920 of other income and $113,019 of expenses in 2023. The largest expense in this business segment is $104,379 for the amortization of our NRC license for this project; this amortization is approximately 96% and 92% of the total expenses for 2024 and 2023 respectively. 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. Upon the closure of the DUF6 Asset Sale, we plan to pay down the related notes and dissolve our Fluorine Products segment.

Cost of Revenues and Gross Profit

Cost of revenues for 2024 was $5,251,207 as compared to $4,888,409 in 2023, an increase of $362,798, or 7%. Gross profit percentage increased to 62% for 2024, from 60% in 2023. The following table presents revenues and cost of revenues information:

During 2024, we continued to monitor and control direct costs. Raw materials used in our Theranostics Products and Nuclear Medicine Standards represented the bulk of direct costs for 2024. In each of these business segments, we have purchase agreements in place with suppliers to obtain optimum pricing. Periodically, the cost can increase 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.

The increase in gross profit percentage in 2024 is a result of increased overall sales activity, increased sales prices, and better cost controls. Additionally, we have worked to find more effective cost controls and to increase our overall utilization of our raw materials.

Operating Costs and Expenses

Total operating costs and expenses for 2024 were $8,641,652, as compared to $8,155,275 in 2023. This is an increase of $486,377, or approximately 6%.

The following table presents operating costs and expenses for 2024 as compared to 2023:

Salaries and contract labor expenses decreased by $10,259, which was the result of a decrease in non-cash equity compensation expense and executive salaries due to the conclusion of our CEO transition period. These decreases were partially offset by an increase to the number of our employees and increases to labor rates due to merit raises and cost-of-living adjustments. Non-cash equity compensation expense recorded for the year ended December 31, 2024, was $199,420 as compared to $464,041 for the same period in 2023. This expense is for equity compensation recorded for outstanding stock options and restricted stock units granted to directors, officers, and employees.

General administrative and consulting expenses increased 13% to $4,009,019 in 2024, as compared to $3,545,766 in 2023. Legal and professional expenses increased approximately $285,000 in 2024 as compared to 2023. We had one-time professional expenses of approximately $170,000 in 2024 related to legal consulting and root cause audits for NRC enforcement and settlement for a violation that occurred in 2022. The remaining $115,000 increase in legal and professional expenses is due to increased activity in business development in all business segments and the building out of our Medical Devices segment. General and Administrative expenses also included waste disposal costs of $229,540 in 2024 as compared to $181,804 in 2023. Research and development expense was $610,737 for 2024, compared to $577,354 for 2023. This is an increase of $33,383, or approximately 6%. This increase in research and development expenses was the result of increased costs associated with product development in our Medical Device segment.

Other Income (Expense)

The following table presents other income (expense) for 2024 as compared to 2023:

Other income was $207,966 for 2024 as compared to other income of $160,173 for 2023. This increase of $47,793 was due to an increase in miscellaneous income partially offset by $63,000 of other expense for NRC fines. We have taken extensive internal actions
to mitigate the risk of any similar violations and penalties occurring again. These matters have been finalized with the NRC.

Interest income in 2024 was $122,385 as compared to $78,890 in 2023. This increase of $43,495 was due to increased interest rates and increased cash balances held at banks and other institutions in interest-bearing accounts.

Interest expense decreased during 2024, to $328,678, from $331,780 in 2023. This decrease of $3,102, or approximately 1%, was due to decreased interest for notes payable. Interest expense includes dividends accrued on our Series C Preferred Stock (as defined below) issued in 2017. In 2024 and 2023 we recorded interest expense of $243,030 and $244,530, respectively, for dividends payable on our Series C Preferred Stock.

Net Income or Loss

Our net income was $8,574 in 2024, compared to a net loss of $869,016 in 2023. This is an increase in net income of $877,590. This decrease is the result of increased revenue and profit margin in 2024 as compared to 2023.

EBITDA and Adjusted EBITDA

The following table presents EBITDA⁽¹⁾ and Adjusted EBITDA⁽¹⁾ for 2024 and 2023, as well as reconciliations to net income (loss) for 2024 as compared to 2023:

⁽¹⁾ EBITDA and Adjusted EBITDA are non-GAAP financial measure. See "Non-GAAP Financial Measures" below for more information.

Non-GAAP Financial Measures

This report contains financial measures that do not comply with U.S. generally accepted accounting principles (“GAAP”), such as EBITDA and Adjusted EBITDA. EBITDA is defined as net income plus interest, income taxes, depreciation and amortization. Adjusted EBITDA is defined as EBITDA, adjusted to exclude items that are deemed to be unusual and non-recurring, and that we do not believe are indicative of the companies recurring operating performance, such as non-cash stock-based compensation, gain on disposal of assets, and costs associated with NRC enforcement matters and our medical devices buildout.

These non-GAAP financial measures are supplemental measures to our results of operations as reported under GAAP. Our management uses these measures to better analyze our financial results and business operations.  In management’s opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the ongoing operating performance of the Company and its future outlook. Such measures should not be considered alternatives to net income or any other performance measures derived in accordance with GAAP. The Company's measurement of EBITDA and Adjusted EBITDA may not be comparable to similar measures of other companies as they are not performance measures calculated in accordance with GAAP.

See the tables above for reconciliations of GAAP to non-GAAP measures.

Liquidity and Capital Resources

At December 31, 2024, we had cash and cash equivalents of $1,945,523 compared to $2,688,141 at December 31, 2023. Restricted cash, which is included in long-term assets increased to $1,431,710 at December 31, 2024 compared to $880,752 at December 31, 2023. This increase in Restricted Cash was due to requirements for increased reserved cash requirements as part of revisions to our Decommissioning Funding Plan. Net cash provided by operating activities was $638,783 in 2024, compared to net cash provided by operating activities of $582,589 in 2023. This represents an increase in cash provided by operating activities of $56,194. This increase is due to improved operational performance, an increase in accounts payable and decreased inventory, partially offset by increased accounts receivable and decreased unearned revenues in the year over year comparison.

Accounts receivable at December 31, 2024 were $1,521,380 as compared to $1,469,298 at December 31, 2023.

Inventories at December 31, 2024 were $820,893 as compared to $927,111 at December 31, 2023. 

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 net income of $8,574, for the year ended December 31, 2024, and have an accumulated deficit of $127,321,285 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 $685,215 for 2024 and net cash used in investing activities was $149,058 for 2023. During 2024, we used $551,215 to purchase equipment and leasehold improvements and $170,000 towards our purchase of land. We used $149,058 to purchase equipment in 2023. We had proceeds from sale of equipment of $36,000 in 2024, and we had no proceeds from sale of equipment in 2023.

Financing activities used cash of $145,228 for the year ended December 31, 2024. We received proceeds from the sale of common stock in the amount of $11,969 and made principal payment on loans in the amount of $154,365 in 2024. For the year ended December 31, 2023, financing activities used cash of $80,504. We received proceeds from the sale of common stock in the amount of $8,398 and made principal payment on loans in the amount of $83,389 in 2023.

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 Class M Warrants were exercisable at an exercise price of $0.12 per share, subject to adjustment as set forth in the warrant. In February 2022, 515,000 Class M Warrants were exercised; in February 2022 all remaining Class M Warrants expired.

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. The Class N Warrants were exercisable at an exercise price of $0.12 per share, subject to adjustment as set forth in the warrant, and expired in February 2022.

In total, 4,213 shares of Series C Preferred Stock were issued for gross proceeds of $4,213,000. The Series C Preferred Stock accrues dividends at a rate of 6% per annum, payable annually on February 17^th 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.

In total, 150 shares of Series C Preferred Stock have previously been converted to common stock at the option of the holder At December 31, 2023, 4,063 shares of Series C Preferred Stock were outstanding. All outstanding shares of Series C Preferred Stock were originally required to 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. Since original issuance, the redemption date of the Series C Preferred Stock has been extended to February 28, 2027. 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. 

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 based on the average price of the shares over the previous 20 trading days. 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 purchase 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 February 2024, the 2013 Promissory Note was further modified to extend the maturity date to March 31, 2026.

In April 2018, we borrowed $120,000 from our then Chief Executive Officer and Chairman of the Board pursuant to a promissory note (the 2018 Promissory Note). The 2018 Promissory Note accrues interest at 6% per annum, which is payable upon maturity of the 2018 Promissory Note. The 2018 Promissory Note was originally unsecured and originally matured on August 1, 2018. At any time, the holder of the 2018 Promissory Note may elect to have any or all 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, and 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 2023, the 2018 Promissory Note was further modified to extend the maturity date to January 31, 2025. In February 2024, the 2018 Promissory Note was further modified to extend the maturity date to March 31, 2026.

In December 2019, we entered into a promissory note agreement with our then 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 issued 30,000,000 Class O Warrants with a term of five years to purchase shares of our common stock at $0.045 per share (the Class O Warrants). All the Class O Warrants were exercised in January 2021. In December 2022, the 2019 Promissory Note was modified to extend the maturity date to December 31, 2024, with all remaining terms unchanged. In February 2024, the 2019 Promissory Note was further modified to extend the maturity date to March 31, 2026.

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.

Goals for 2025

Based upon the investments we have made in our facilities and investments we anticipate making, and based on projects, and products developed in 2024, we have the following goals for 2025:

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.

Item 7A.     QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

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

Item 8.       FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

The following financial statements are included herewith:

Index to Consolidated Financial Statements

Item 9.       CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

None.

Item 9A.    CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures (as defined in Rules 13a-15I 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, 2024. Based on that evaluation, our CEO and CFO concluded that our disclosure controls and procedures were effective as of December 31, 2024.

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, 2024.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting during the three months ended December 31, 2024, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Item 9C.      DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

None.

PART III.

Item 10.      DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE

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 are incorporated by reference from our definitive proxy statement for our 2025 annual meeting of shareholders, which will be filed with the SEC within 120 days after December 31, 2024.

Item 11.      EXECUTIVE COMPENSATION

The information required by this item is incorporated by reference from our definitive proxy statement for our 2025 annual meeting of shareholders, which will be filed with the SEC within 120 days after December 31, 2024.

Item 12.      SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

The information required by this item is incorporated by reference from our definitive proxy statement for our 2025 annual meeting of shareholders, which will be filed with the SEC within 120 days after December 31, 2024.

Item 13.      CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

The information required by this item is incorporated by reference from our definitive proxy statement for our 2025 annual meeting of shareholders, which will be filed with the SEC within 120 days after December 31, 2024.

Item 14.      PRINCIPAL ACCOUNTANT FEES AND SERVICES

The information required by this item is incorporated by reference to our definitive proxy statement for our 2025 annual meeting of shareholders, which will be filed with the SEC within 120 days after December 31, 2024.

Item 15.      EXHIBITS, FINANCIAL STATEMENT SCHEDULES

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

See the index to and the financial statements beginning on page [31].

(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.

++ 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.

#  Certain portions of the exhibit have been omitted pursuant to Rule 601(b)(10) of Regulation S-K. The omitted information is not material and is the type of information that the registrant treats as private or confidential.

+ Filed herewith.

* Furnished herewith.

Item 16.      FORM 10-K SUMMARY

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

 

	Page No.
Report of Independent Registered Public Accounting Firm (Haynie & Company, Salt Lake City, UT, PCAOB ID No. 457)	F-1
Financial Statements:
Consolidated Balance Sheets as of December 31, 2024 and 2023	F-3
Consolidated Statements of Operations for the years ended December 31, 2024 and 2023	F-4
Consolidated Statement of Stockholders’ Equity for the years ended December 31, 2024 and 2023	F-5
Consolidated Statements of Cash Flows for the years ended December 31, 2024 and 2023	F-6
Notes to Consolidated Financial Statements	F-7

 

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Table of Contents

 

 

 

 

 

F-1

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Table of Contents

 

 

F-2

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Table of Contents

 

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, 2024 and 2023

See accompanying notes to consolidated financial statements.

INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

Consolidated Statements of Cash Flows

See accompanying notes to consolidated financial statements.

INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

FOR THE YEARS ENDED December 31, 2024 AND 2023