IDAHO FALLS, Idaho, Nov. 14, 2025 /PRNewswire/ -- International Isotopes Inc. (OTCQB: INIS) (the "Company" or "INIS") is pleased to announce its financial results for the third quarter and nine months ended September 30, 2025. Revenue from the sale of product for the third quarter of 2025 was $3,277,816, a decrease of $646,628 or 16%, compared to the same period in the prior year, and for the nine months ended September 30, 2025 was $10,172,036, an increase of $173,901 or 2% from the same period in the prior year. Net loss for the third quarter of 2025 was $203,601, a decrease from a net profit of $150,251 in the same period last year, and for the first nine months of 2025 net loss was $477,080, an increase in loss of $237,245 from the same period last year. Non-GAAP EBITDA(1) decreased to $14,985 for the first nine months of 2025 compared to $210,590 for the same period last year.
Decreases for the third quarter and nine months ended September 30, 2025 were driven primarily by outages of Theranostics Product raw materials in March, July, August and outages of Calibration & Reference Products raw material, namely Gd-153, partially offset by growth of sales of Calibration & Reference Products and Medical Devices compared to the same periods in the prior year. The company estimates outages of raw materials reduced revenues for the third quarter of 2025 by more than $400,000 and by more than $750,000 for the nine months ended September 30, 2025, impacting our Theranostics Products and Calibration & Reference Products segments.
(1) See "Non-GAAP Financial Measures" below.
Shahe Bagerdjian, President & CEO of the Company, said, "We saw significant outages of Theranotics raw materials in July and August before we were able to bring on our new FDA approved supplier. Additionally, we continue to have an outage of Gadolinium-153, which is globally sole-sourced from a foreign government, impacting our Calibration & Reference Products. Despite these difficulties, we were able to increase our total Theranostics products customers from the start of the quarter and our Calibration & Reference division continues to see growth.
"We spent a good portion of the quarter on internal improvements. Our operational efficiencies, having driven down our SG&A costs 24% for the quarter and 11% for the year. Our Calibration & Reference Products segment continues to improve legacy products as well as develop new products. We have also increased our corporate governance, adding a Nominating & Corporate Governance Committee and welcoming Dr. Duke Fu to our board of directors."
Segment Results
Theranostics Products
Revenue from the sale of Theranostics Products for the first nine months of 2025 was $5,176,740, compared to $6,257,410 for the same period in the prior year. This is a decrease of $1,080,670 or 17% compared to the same period in the prior year, primarily due to outage of critical I-131 raw material supply in March, July and August partially offset by recovery of some standing order customers which we had previously reported as lost and from new customers. In the third quarter of 2025, the Company received US FDA approval to add an additional raw material supplier. This supplier did not commence supply until September 2025. We continue to see demand for generic sodium iodide I-131 pharmaceutical and I-131 theranostic API products, which are used in radiolabeling third party drug products.
Calibration & Reference Products (formerly Nuclear Medicine Standards)
In Q3 of 2025, we changed the name of the reporting segment from Nuclear Medicine Standards to Calibration & Reference Products to better describe the broad range of products we manufacture and distribute.
Revenue from the sale of Calibration & Reference Products for the first nine months of 2025 was $3,301,673, compared to $2,099,713 for the same period in the prior year. This represents an increase of $1,201,960 or 57%, compared to the same period in the prior year. This increase was primarily due to remedying the global shortage of Cobalt-57 isotope, which lasted from January 2024 to late July 2024. Additionally, our Calibration & Reference Products segment continues to be impacted by an ongoing global outage of Gd-153, which is the raw material in the Company's key products, BM53 line sources. We expect full year 2025 revenues in this segment to reflect historically normal amounts as the supply chain has normalized, and we continue to launch new products under our RadQual and PhanQual brands.
Cobalt Products
Revenue from the sale of Cobalt Products for the first nine months of 2025 was $1,517,147, compared to $1,641,012 for the same period in the prior year. This represents a decrease of $123,865 or 8%, compared to the same period in the prior year, primarily due to timing of sales over the course of the last 12 months. Large value sales of high activity Cobalt-60 sources are seasonal and occur at various times throughout the year. Frequently the timing of these sales can have a significant impact on period comparisons. Fiscal 2024 marked a historical high in Cobalt Product sales for the Company. The Company remains the only domestic United States manufacturer of high activity Cobalt-60 sealed-source products.
Medical Devices
Revenue from the sale of Medical Device products for the first nine months of 2025 was $176,476, compared to no sales for the same period in the prior year. Medical Devices was a new reportable business segment for fiscal year 2024. We have invested in this segment throughout the past three years and anticipate additional investments in the rest of 2025 as we ramp to commercialization of products. This segment includes The Swirler® and Tru-Fit Mouthpiece, Xenon System, and related accessories under the RadVent brand as well as partnering with leading manufacturers for distribution through our network of global distributors. Additionally, the Company invested in a joint venture arrangement for our EasyFill Automated Iodine Capsule System, which recently signed a distribution and servicing agreements for the full line of Scintomics ATT products and Global Sonics products. The Medical Device segment is focused on bringing products to market which help the industry improve safety, efficiency, and patient access to radiopharmaceutical diagnostics and therapeutics.
Fluorine Products
For the three months and nine months ended September 30, 2025 and the three months and nine months ended September 30, 2024, we had no sales in our Fluorine Products segment and we incurred $26,095 and $82,330 of expenses related to maintenance of plans, designs, and other assets for a proposed de-conversion facility, as compared to $26,095 and $80,941. On February 8, 2024, we entered into the Fluorine Products Asset Sale. During the three months and the nine months ended September 30, 2025, we received $30,000 and $60,000 respectively in extension payments related to the Fluorine Products Asset Sale. These payments were included in Other Income on our Statement of Operations. On September 30, 2025, we and the buyer jointly submitted to the NRC a consent request to allow us to transfer our license to the buyer, we are currently waiting on NRC's consent. We expect to close the agreement by the March 2026 milestone.
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||
| | 2025 | 2024 | $ Change | % | | 2025 | 2024 | $ Change | % |
| Sale of Product | $3,277,816 | $3,924,444 | $(646,628) | (16 %) | | $10,172,036 | $9,998,135 | $173,901 | 2 % |
| Gross Profit | $1,940,019 | $2,449,428 | $(509,409) | (21 %) | | $6,113,615 | $6,333,050 | $(219,435) | (3 %) |
| Total Operating Expense | $2,121,433 | $2,269,823 | $(148,390) | (7 %) | | $6,494,886 | $6,599,765 | $(104,879) | (2 %) |
| Operating Profit (Loss) Before Other Exp | $(181,414) | $179,605 | $(361,019) | (201 %) | | $(381,271) | $(266,715) | $(114,556) | (43 %) |
| Other Income (Expense) | $(22,187) | $(29,354) | $7,167 | (24 %) | | $(95,809) | $29,470 | $(125,279) | (425 %) |
| Net Income (Loss) | $(203,601) | $150,251 | $(353,852) | (236 %) | | $(477,080) | $(237,245) | $(239,835) | (101 %) |
| Net Income Per Common | - | - | - | | | - | - | - | |
| Net Income Per Common | - | - | - | | | - | - | - | |
| Weighted Avg. Shares | 528,088,472 | 523,138,891 | | | | 526,568,064 | 522,028,572 | | |
| Weighted Avg. Shares | 528,088,472 | 523,138,891 | | | | 526,568,064 | 522,028,572 | | |
Full Earnings Release Available on INIS Website
A full version of this earnings release is available on our Investor Center website at https://intisoid.com/investor-center/.
Non-GAAP Financial Measures
This press release 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.
| | Three months ended September 30, | Nine months ended September 30, | ||||||
| | 2025 | 2024 | $ Change | % Change | 2025 | 2024 | $ Change | % Change |
| Net income (loss) | $(203,601) | $150,251 | $(353,852) | -236 % | $(477,080) | $(237,245) | $(239,835) | 101 % |
| Interest expense, net | 66,300 | 50,072 | $ 16,228 | 32 % | 192,367 | 146,624 | $ 45,743 | 31 % |
| Provision for income taxes | - | - | | | - | - | | |
| Depreciation and amortization | 100,716 | 100,789 | $(73) | 0 % | 299,698 | 301,211 | $(1,513) | -1 % |
| EBITDA | (36,585) | 301,112 | $(337,697) | -112 % | 14,985 | 210,590 | $(195,605) | -93 % |
About International Isotopes Inc.
International Isotopes Inc. (INIS), established in 1995, with its headquarters in Idaho Falls, ID, USA, manufactures a wide range of radioisotope-focused products. INIS manufactures and supplies generic sodium iodide I-131 radio-pharmaceutical drug product for hyperthyroidism and thyroid cancer. INIS provides contract manufacturing of various drug products as well as radioisotope API supply for 3rd party theranostics clients INIS manufactures and distributes a complete line of calibration and reference standards for nuclear pharmacies and SPECT/PET imaging systems as well as industrial calibration standards under its RadQual brand. The Company also manufactures Cobalt-60 sealed source products. For more information, visit intisoid.com.
International Isotopes Inc. Safe Harbor Statement
Certain statements in this press release are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements with respect to the Company's future growth expectations. Information contained in such forward-looking statements is based on current expectations and is subject to change. These statements involve a number of risks, uncertainties and other factors that could cause actual results, performance, or achievements of International Isotopes Inc. to be materially different from any future results, performance or achievements of the Company expressed or implied by these forward-looking statements. Other factors, which could materially affect such forward-looking statements, can be found in the Company's filings with the Securities and Exchange Commission at www.sec.gov, including its Annual Report on Form 10-K for the year ended December 31, 2024. Investors, potential investors, and other readers are urged to consider these factors carefully in evaluating the forward- looking statements and are cautioned not to place undue reliance on such forward-looking statements. The forward-looking statements made herein are only made as of the date of this press release and International Isotopes, Inc. and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
| International Isotopes Contact: [email protected] www.intisoid.com www.radnostix.com 208.524.5300 | Investor Relations Contact: David Drewitz, Creative Options Communications Investor and Public Relations [email protected] www.creativeoptionsmaketing.com 972.814.5723 |
SOURCE International Isotopes Inc.
