10-K: Radnostix Reports 2025 Loss Amid Revenue Dip, Strategic Shifts

Radnostix Inc. reported a 6% revenue decrease and a net loss in 2025, while advancing product development and terminating a major asset sale.

Summary

• Total revenue decreased by 6% to $13.07 million in 2025 from $13.90 million in 2024.
• A net loss of $908,002 was recorded in 2025, a significant decline from a net income of $8,574 in 2024.
• Operating loss for 2025 was $956,187, compared to an operating profit of $6,901 in 2024.
• Theranostics Products revenue decreased by 15% to $6.84 million, partly due to an estimated $500,000 in lost sales from raw material supplier outages.
• Cobalt Products revenue decreased by 26% to $1.75 million, with a Q4 2025 shutdown for hot cell refurbishment delaying approximately $350,000 in revenues to 2026.
• Calibration & Reference Products revenue increased by 21% to $4.25 million, recovering from 2024 supply issues but offset by an ongoing global outage of Gadolinium-153, which resulted in $0 sales in 2025 compared to $210,000 in 2024.
• Medical Devices Products revenue significantly increased to $228,951 in 2025 from $8,657 in 2024, though it remains a small portion of total revenue.
• The asset purchase agreement to sell the Fluorine Products segment and the Planned Uranium De-Conversion Facility to American Fuel Resources (AFR) was mutually terminated on March 11, 2026, due to AFR's inability to secure funding, with Radnostix retaining $170,000 in non-refundable payments.
• A voluntary recall of specific lots of Dibasic Sodium Phosphate Capsules (provided with Generic Sodium Iodide I-131 kits) was initiated on February 19, 2026, due to out-of-specification capsule weight, resulting in a $75,000 inventory write-off in Q4 2025 and estimated $50,000 in customer credits and $25,000-$75,000 per week in lost revenue in Q1 2026.
• Refurbishment of Cobalt-60 Processing Hot Cell windows was completed in Q1 2026, extending their life by 15-20 years and expecting $150,000 in annual radiological waste cost savings.
• Construction of a dedicated Calibration & Reference Products manufacturing facility was completed in Q4 2025, with an NRC license amendment received on January 16, 2026, for equipment installation.

Sentiment

Score: 4

Explanation: StockSavvy.ai views this as a mixed filing with significant financial underperformance (net loss, revenue decline) and operational setbacks (recalls, supply outages) in 2025, offset by strategic advancements in facility development and the potential upside from retaining the DUF6 assets in a booming nuclear energy market. The immediate financial results are concerning, but the long-term strategic positioning has some positive elements.

Positives

• Calibration & Reference Products segment sales increased by 21% in 2025, reaching $4.25 million, nearly matching the record from 2023.
• Medical Devices Products segment saw a significant revenue increase from $8,657 in 2024 to $228,951 in 2025, indicating early growth.
• Completion of Cobalt-60 Processing Hot Cell window refurbishment in Q1 2026 is expected to extend asset life by 15-20 years and save approximately $150,000 annually in radiological waste costs.
• Dedicated Calibration & Reference Products manufacturing facility build-out completed in Q4 2025, with NRC license amendment received in January 2026, expected to greatly expand manufacturing capacity and product portfolio.
• Termination of the DUF6 APA allows Radnostix to regain control of assets believed to have appreciated in value, with plans to re-evaluate options including developing the plant into an operating entity or amending the license for additional uranium-related activities.
• Received $170,000 in non-refundable payments from AFR despite the termination of the DUF6 APA.
• Cash provided by operating activities was $620,163 in 2025.
• The FDA-approved generic sodium iodide I-131 drug product is the only generic product of its type manufactured in the U.S., offering a competitive domestic alternative.
• The company is ISO-9001:2015 and ISO-13485-2016 certified, enabling sales in several foreign countries.
• The company holds a 40-year NRC construction and operating license for the depleted uranium de-conversion facility, representing a significant competitive barrier.

Negatives

• Total revenue decreased by 6% to $13.07 million in 2025 from $13.90 million in 2024.
• Net loss of $908,002 in 2025, a significant decline from a net income of $8,574 in 2024.
• Operating loss of $956,187 in 2025, compared to an operating profit of $6,901 in 2024.
• Theranostics Products sales decreased by 15% due to periodic supplier outages, resulting in approximately $500,000 in lost revenue.
• Cobalt Products sales decreased by 26%, partly due to a Q4 2025 manufacturing shutdown.
• Ongoing global outage of Gadolinium-153 radioisotope led to $0 sales for related products in 2025, down from $210,000 in 2024.
• Voluntary recall of Dibasic Sodium Phosphate Capsules in February 2026 resulted in a $75,000 inventory write-off in Q4 2025, $50,000 in customer credits, and estimated weekly lost revenue of $25,000-$75,000 in Q1 2026.
• Accumulated deficit of $128,229,287 as of December 31, 2025, and a history of recurring losses.
• Working capital decreased by $1,005,629 from the prior year.
• Reliance on a just-in-time supply chain for radioisotopes poses significant risk, with limited inventory buffer.
• Dependence on three largest customers for 31% of total gross revenues in 2025.
• NRC fines of $63,000, additional legal expenses of $47,636, and professional expenses for corrective actions of $123,216 incurred in 2024 related to 2021 and 2022 NRC violations.

Risks

• Recurring Losses and Need for Financing: The company has incurred net losses for most fiscal periods since inception, with an accumulated deficit of $128,229,287 as of December 31, 2025, and may need additional financing to continue operations and development activities, which may not be available on acceptable terms or at all.
• Environmental Liabilities: Operations expose the company to material liabilities related to environmental hazards, remediation, personal injuries, or property damage from hazardous substance releases and exposures.
• Dependence on Key Personnel: Ongoing operations are dependent on Shahe Bagerdjian, President and CEO; the loss of Mr. Bagerdjian could have a material adverse effect on the business.
• Economic Conditions: General economic conditions in markets served can impact demand for goods and services, negatively affecting financial performance and cash flow.
• Volatility in Raw Material and Energy Costs: Market and economic conditions affecting costs of raw materials, utilities, and energy are beyond control, leading to potential disruptions or rapid escalations.
• Just-in-Time Supply Chain for Radioisotopes: Unique dependence on a just-in-time supply chain for radioisotopes and finished products, with limited inventory buffer, making the business vulnerable to delays from production outages, logistics failures, equipment malfunctions, or regulatory holds.
• Foreign Supplier Risks: Purchase of significant raw material radioisotopes from overseas suppliers (some government agencies) exposes the company to risks from currency exchange rates, tariffs, sanctions, geopolitics, national security classifications, embargos, or regional conflicts.
• Cobalt-57 and Gadolinium-153 Shortages: Experienced a global shortage of cobalt-57 in 2024 and an ongoing global outage of gadolinium-153 since January 2025, leading to lost sales.
• Reliance on Research Reactors: I-131 products are highly reliant on research reactors, which have a higher frequency of downtime compared to traditional power reactors.
• Sole-Sourcing Cobalt-60: Sole-sourcing cobalt-60 from Idaho National Lab (INL) and reliance on the Advanced Test Reactor (ATR) at INL, which has planned maintenance in 2027 and could prioritize U.S. Navy nuclear fleet operations, disrupting supply.
• Extensive Government Regulation: Subject to extensive government regulation globally (environmental compliance, import/export restrictions, healthcare services, taxes, and financial reporting), which can significantly increase the cost of doing business.
• Radioactive Waste Disposal Costs: Manufacturing processes generate radioactive waste, with disposal costs subject to change at the discretion of disposal sites, potentially increasing unexpectedly.
• Health and Safety Regulations: Subject to extensive health and safety regulations dictated by the United States Occupational Safety and Health Administration and NRC, with non-compliance potentially leading to liability.
• NRC License Enforcement Actions: The NRC may take enforcement action for violations, including civil penalties, restrictions, or license suspension, which could materially affect financial condition and results of operations.
• Upcoming Cobalt-60 Rules: Long-term proposed NRC rules regarding Financial Assurance Requirements for Category 1 and 2 Byproduct Material Sealed Sources could substantially increase costs for parties with cobalt-60 finished sources in inventory.
• Import/Export Regulatory Oversight: Significant regulatory oversight of import/export operations due to the nature of product offerings, with penalties for non-compliance and potential adverse publicity.
• Type B Package Availability: Limited availability of NRC certified Type B packages for domestic transport of high-activity cobalt-60 products, requiring costly and time-consuming approval.
• Product Liability Claims: Inherent business risk of exposure to product liability claims in the event that products supplied fail to perform as expected or result in bodily injury, potentially exceeding available insurance coverage.
• Catastrophic Events: Operations are subject to catastrophic events outside control, such as natural disasters, pandemics, war, and acts of terrorism, which could disrupt business or the business of suppliers or customers.
• New Product Development: Future growth is largely dependent upon the ability to develop new products that achieve market acceptance with acceptable margins, requiring significant resources and facing risks of market failure or competitive offerings.
• Dependence on Third Parties: Reliance on the U.S. Department of Energy (DOE) for high-specific activity cobalt-60 production and two supply sources for radiochemical iodine; unanticipated contract terminations could have a material adverse impact.
• Customer Concentration: Dependence on a limited number of customers, with combined sales to the three top customers accounting for 31% of total gross revenue during 2025.
• Competition: Direct competition in all existing business areas from other businesses, many of which have significantly greater financial resources.
• Limited Trading and Volatility of Common Stock: Common stock is quoted on the OTCQB Marketplace, with limited market, volatile price, and greater risk to investors.
• No Dividends: The company does not plan to pay dividends on shares of common stock in the near future.
• Future Dilution: Contractually obligated to issue shares in the future (upon exercise of vested stock options, conversion of preferred stock and certain debt), which will dilute existing shareholder interests.
• Cybersecurity Incidents: The operation of the business is dependent on the secure functioning of its computer infrastructure; a cybersecurity incident could have a material adverse effect in the future if it were to cause business disruption or data loss, despite current measures and insurance.

Future Outlook

The company plans to continue investment in its core business segments in 2026, focusing on product development, cost reduction, and sales expansion. It expects continued growth in generic sodium iodide I-131 sales by expanding market share and entering new territories. The EasyFill Automated Capsule System is targeting a Q3 2026 roll out and Q2 2027 commercial ramp up, with RadVent products expected to relaunch before the end of Q2 2026. The company aims to restore Gadolinium-153 supply by 2026 and complete the dedicated Calibration & Reference Products facility in 2026, expecting expanded manufacturing capacity. Following the termination of the DUF6 asset sale, the company will evaluate all options for the DUF6 Plant and related assets, including developing them into an operating entity or amending the NRC license for additional uranium-related activities. The company expects cash from operations and its current cash balance to be sufficient for the next twelve months, but acknowledges the potential need for additional financing for future operations or projects.

Management Comments

• "We believe that our domestically manufactured products and service offerings provide us with a competitive edge over other cobalt-60 manufacturers."
• "We believe we currently are the only U.S. supplier of an FDA approved sodium iodide product that otherwise is only available from a foreign manufacturer."
• "We are deploying a unique product strategy which we believe will make us the go-to API supplier for third party radiopharmaceutical products."
• "We believe that we are well positioned to hold a competitive advantage in the growing theranostics space because of our unique combination of high energy and high activity NRC licensing status that permits handling of high energy and high activity radioisotopes, our compliance with GMP, our FDA licensed operating facility, and experienced and skilled personnel."
• "We believe a launch of EasyFill will allow us to improve our market share of sodium iodide I-131."
• "We decided it was in the best interest of the shareholders to regain control of the assets as we believe they have appreciated in value since we entered the DUF6 APA and we had low confidence that AFR would be able to secure funding to close the deal by the requested extension date."
• "Given the recent boom in nuclear energy and fuel cycle industry and related global investments, the Company will evaluate all possible options for the DUF6 Plant and related assets, including keeping the assets and developing them into an operating entity focused on uranium deconversion."
• "We believe the rehabilitation work to have extended the useful life of our Cobalt-60 process hot cell by 15 to 20 years and estimates saving approximately $150,000 in annual radiological waste costs (management, storage and disposal) by resolving the gasket issues."
• "We expect that cash from operations and our current cash balance will be sufficient to fund operations for the next twelve months."

Industry Context

StockSavvy.ai notes that Radnostix operates within the specialized and highly regulated radioisotope market, which is experiencing growth driven by nuclear medicine, radiopharmaceutical therapies, and increasing clinical applications. The global theranostics market, where Radnostix has a presence with its I-131 product, was valued at $4.3 billion in 2024 and is projected to grow at a 24% CAGR to $12.7 billion by 2029, indicating a strong underlying market trend. The company's focus on domestically manufactured products and its unique NRC licensing status for high-energy isotopes position it to capitalize on supply chain security concerns and regulatory barriers to entry, especially against foreign competitors like Jubilant DraxImage and Nordion. The termination of the DUF6 asset sale and the re-evaluation of the uranium de-conversion facility align with the "recent boom in nuclear energy and fuel cycle industry and related global investments," suggesting a strategic pivot to leverage broader industry tailwinds.

Comparison to Industry Standards

• Radnostix's FDA-approved generic sodium iodide I-131 drug product is noted as the only generic product of its type manufactured in the U.S., offering a domestic alternative to a single existing foreign commercial drug manufacturer (likely Jubilant DraxImage).
• The company believes its domestically manufactured cobalt-60 products and service offerings provide a competitive edge over other cobalt-60 manufacturers, with Nordion identified as a competitor.
• In Calibration & Reference Products, Radnostix competes with Eckert & Ziegler, and in some limited markets, Epsilon Radioactive Sources. The company differentiates through strategic alignment with OEMs, high service levels, competitive pricing, patent protections, and exclusive arrangements.
• The global theranostics market is projected to grow at a 24% CAGR from $4.3 billion in 2024 to $12.7 billion by 2029, providing a benchmark for the growth potential of Radnostix's Theranostics Products segment.
• The company's EasyFill Automated Capsule System, currently under development, aims to compete with a single foreign supplier that currently leases shielded encapsulation devices to radiopharmacies, potentially improving Radnostix's market share for sodium iodide I-131.

Corporate Governance

Legal Proceedings

• Not currently involved in legal proceedings that could reasonably be expected to have a material adverse effect on business, prospects, financial condition, or results of operations.
• In 2024, incurred significant expenses related to two NRC violations in 2021 and 2022, totaling $63,000 in fines, $47,636 in legal expenses, and $123,216 for corrective actions.
• In 2025, entered into a settlement agreement with the NRC related to a 2022 sale and sublease to Pharmalogic, which carried no fines, penalties, or violations, but requires commitment to various non-material administrative tasks as a license condition for a 36-month period.

Related Party Transactions

• The 2013 Promissory Note ($500,000 principal) is with the then Chairman of the Board and a major shareholder, bearing 6% interest, and was extended to March 31, 2028. Accrued interest payable was $361,734 at December 31, 2025.
• The 2018 Promissory Note ($120,000 principal) is with the Chief Executive Officer and current Chairman of the Board, bearing 6% interest, and was extended to March 31, 2028. Accrued interest totaled $55,370 at December 31, 2025.
• The 2019 Promissory Note ($1,000,000 principal) is with the Chief Executive Officer, Chairman, former Chairman, and major shareholders, bearing 4% interest, and was extended to March 31, 2028. Accrued interest totaled $239,131 at December 31, 2025.
• Series C Preferred Stock was issued to certain investors, including two directors, with dividends accruing at 6% per annum, some of which were settled in common stock (1,743,457 shares for $90,660 in 2025 and 1,808,400 shares for $90,420 in 2024).
• On September 11, 2024, 350,000 fully vested Restricted Stock Units were awarded to the CEO as part of an annual bonus, valued at $10,500.

Stakeholder Impact

• Shareholders: Negative impact from net loss, decreased revenue, and potential future dilution from stock options and convertible debt. Potential positive impact from strategic re-evaluation of DUF6 assets and growth in Calibration & Reference Products.
• Employees: Increased employee headcount and labor rates due to merit raises and cost-of-living adjustments. All employees receive annual information security training. The company's operations are dependent on key personnel, particularly the CEO.
• Customers: Impacted by supplier outages (Theranostics Products), manufacturing shutdowns (Cobalt Products), and a voluntary product recall (I-131 capsules). The company is working to expand product offerings and improve customer service.
• Suppliers: Dependence on a just-in-time supply chain for radioisotopes, with risks from foreign suppliers and specific reactor availability (e.g., INL for Cobalt-60).
• Creditors: Promissory notes with related parties have been extended to March 31, 2028, indicating continued debt obligations.

Next Steps

• Continue to expand sales of FDA approved sodium iodide I-131 generic drug product, including entering new territories.
• Launch theranostics-focused GMP DMF product to serve the emerging theranostics customer base.
• Complete development of and launch an automated I-131 capsule loading system to pharmacies in the U.S. and select overseas customers (targeting Q3 2026 roll out, Q2 2027 commercial ramp up).
• Medical Devices segment to begin offering RadVent products from purchased AMICI, Inc. assets (before end of Q2 2026).
• Complete build-out of dedicated Calibration & Reference Products manufacturing facility and receive final NRC operational license (in FY2026).
• Expand sales of Calibration & Reference Products and increase cash flow by offering new products and further expanding international sales and distributor relationships.
• Explore acquisition opportunities to expand product offerings and increase revenue, cash flow, and profit margin.
• Continue to expand customer base, increase revenues, reduce production and operating costs, and attempt to achieve profitability in core business segment operations.
• Evaluate best value of assets in the Fluorine Products segment, including raising funds to build and operationalize the assets or amending the NRC approved license for additional uranium-related activities.
• Search for additional means to produce and procure certain critical isotopes, including through the joint venture with Alpha Nuclide Inc. for I-131 and Radqual products.
• Work on establishing new suppliers for Gadolinium-153 to restore supply by 2026.
• Submit for shareholder approval in 2026 to reinstate and extend the 2015 incentive plan or adopt a new incentive plan.
• Commit to various non-material administrative tasks as a license condition for a 36-month period related to the NRC settlement agreement from the 2022 sale and sublease to Pharmalogic.
• Address the limited availability of Type B packages authorized for domestic use by working with private and government parties.

Key Dates

Recommendation

Radnostix Inc. faces significant financial headwinds, including a net loss, revenue decline, and ongoing supply chain challenges, exacerbated by a recent product recall. While the company has strategic initiatives underway, such as new product development and the re-evaluation of its valuable DUF6 assets in a growing nuclear energy market, these are long-term plays. The immediate financial performance and operational risks suggest caution. A "hold" recommendation is appropriate for investors to monitor the execution of its strategic pivots and the resolution of current operational issues before considering further investment, given the high risk and uncertainty.

Keywords

Radioisotope, Theranostics, Radiopharmaceuticals, Cobalt-60, Medical Devices, Nuclear Medicine, Calibration Standards, Uranium De-conversion, SEC Filing, 10-K, Radnostix, FDA, NRC, Supply Chain, Cybersecurity, Financial Results