-- Sale of product for first quarter increased 12% to $3.2 million. 
 
   -- Nuclear Medicine Standards sale of product in the first quarter increased 
      73% to $1.3 million. 
 
   -- Net Income (Loss) improved 27% to a loss of $112,694, with Non-GAAP 
      EBITDA(1)of $7,075, and Non-GAAP Adjusted EBITDA(1)of $91,611. 

IDAHO FALLS, Idaho, May 20, 2025 /PRNewswire/ -- International Isotopes Inc. (OTCQB: INIS) (the "Company" or "INIS") is pleased to announce it's first quarter 2025 results. For the first quarter of 2025, revenue from the sale of products was $3,238,900, an increase of $334,442 or 12%, from the same period in the prior year. Net loss improved to $112,694 from a loss of $154,051 in the same period last year, a 27% increase. Non-GAAP EBITDA(1) increased to $7,075 in the first quarter of 2025, an increase of $26,951 or 136%, from a non-GAAP EBITDA(1) loss of $19,876 in the same period in the prior year. The Company also reported a non-GAAP adjusted EBITDA(1) of $91,611 for the first quarter of 2025, a decrease of 55% compared to the same period in the prior year.

Increases were driven primarily by growth of sales of Nuclear Medicine Standards products and continued improvement in the start-up of the Medical Device segment, partially offset by a decrease in sales of Theranostics products due to a two-week raw material outage in the first quarter of 2025 and a decrease in Cobalt revenue due to seasonality.

(1) See "Non-GAAP Financial Measures" below.

Shahe Bagerdjian, President & CEO of the Company, said, "The first quarter results were as expected and we are happy with a 12% growth of sales. For the rest of 2025, we remain focused on operational improvements and finalizing product launches. We expect to start to realize the fruits of our labor in the 2(nd) half of 2025 due to increased seasonal sales of Cobalt products, and the launch of new RadQual PET products (in first half of 2025) and RadVent products (by the fourth quarter of 2025)."

Segment Results

Theranostics Products

Revenue from the sale of Theranostics Products for the first quarter of 2025 was $1,787,054, compared to $1,905,082 for the same period in 2024. This is a quarterly decrease of $118,028 or 6% compared to the same period in the prior year, primarily due to a two-week raw material outage in the first quarter of 2025. To mitigate any future supply outages, we have applied to the FDA for the approval of additional raw material suppliers and expect FDA approval by the fourth quarter of 2025. For the remainder of 2025, we expect a return to a historical level of sales of Theranostics products. We continue to see demand for generic sodium iodide I-131 pharmaceutical and I-131 theranostic API products, which are used in radiolabeling 3(rd) party drug products.

Nuclear Medicine Standards

Revenue from the sale of Nuclear Medicine Standards products for the first quarter of 2025 was $1,326,766, compared to $765,408 for the same period in 2024. This represents an increase of $561,358, or 73%, compared to the same period in the prior year, primarily due to remedying of the global shortage of Cobalt-57 isotope, which lasted from January 2024 to late July 2024. Additionally, our Nuclear Medicine Standards segment was impacted by an on-going global outage of Gd-153, which is the raw material in the Company's key products, BM53 line sources We expect 2025 revenues to reflect historically normal figures 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 quarter of 2025 was $72,450, compared to $233,968 for the same period in 2024. This represents a decrease of $161,518, or 69%, compared to the same period in the prior year, primarily due to timing of sales in 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 the historical high in Cobalt Product sales. The Company remains the only domestic United States manufacturer of high activity Cobalt-60 sealed-source products. We anticipate sales of Cobalt products for the rest of 2025 to perform similarly to 2024 based on planned production and sales in the next few quarters.

Medical Devices

Revenue from the sale of Medical Device products for the first quarter of 2025 was $52,630, compared to no sales for the same period in 2024. Medical Devices was a new reportable business segment for fiscal year 2024. We have invested in this segment throughout over the last couple years and anticipate additional investments in 2025 as we ramp to commercialization of products. This segment will include The Swirler$(R)$ and Tru-Fit$(TM)$ 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 has investments in a joint venture arrangement for our EasyFill Automated Iodine Capsule System, which recently signed an exclusive distribution and servicing agreement for the full line of Scintomics ATT 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.

 
                               Three Months Ended March 31, 2025 
                            2025          2024       $ Change   % Change 
                        ------------  ------------  ----------  -------- 
Sale of product         $  3,238,900  $  2,904,458  $  334,442      12 % 
Gross profit            $  2,032,037  $  1,866,111  $  165,926       9 % 
Total Operating 
 Expense                $  2,097,053  $  2,132,307  $ (35,254)      -2 % 
Operating Profit 
 (Loss) Before Other 
 Exp.                   $   (65,016)  $  (266,196)  $  201,180      76 % 
Other Income (Expense)  $   (47,678)  $    112,145  $(159,823)    -143 % 
Net Income (Loss)       $  (112,694)  $  (154,051)  $   41,357      27 % 
Weighted avg. shares 
 outstanding - basic     524,082,026   520,167,183 
Weighted avg. shares 
 outstanding - 
 diluted                 524,082,026   520,167,183 
 

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.

 
Non-GAAP Reconciliations 
                                 Three Months Ended March 31, 2025 
                               2025        2024      $ Change   % Change 
                            ----------  ----------  ----------  -------- 
Net income (loss)           $(112,694)  $(154,051)  $   41,357      27 % 
Interest expense, net       $   21,824  $   32,728  $ (10,904)      33 % 
Provision for income taxes  $       --  $       --  $       --        -- 
Depreciation and 
 amortization               $   97,945  $  101,447  $  (3,502)      -3 % 
   EBITDA                   $    7,075  $ (19,876)  $   26,951     136 % 
Non-cash stock-based 
 compensation               $   70,279  $   62,650  $    7,629      12 % 
Gain on disposal of 
property, plant, and 
equipment                   $       --  $       --  $       --        -- 
NRC Enforcement Matters 
 (a)                        $       --  $   76,527  $ (76,527)    -100 % 
Medical Devices Buildout 
 (b)                        $   14,257  $   82,996  $ (68,739)     -83 % 
   Adjusted EBITDA          $   91,611  $  202,297  $(110,686)     -55 % 
 
 
 
(a) Represents costs for an NRC violation that occurred in 2022, including 
legal expenses, costs for corrective actions, and NRC fines. 
(b) Represents legal work for initial buildout of the Medical Devices business 
segment. 
 

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.

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 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 and provides contract manufacturing of various drug products as well as radioisotope API supply for 3rd party theranostics clients. INIS recently launched a manufacturing joint venture with Alpha Nuclides, to bring INIS and RadQual products into China via Radnostix China. The Company is working to launch its RadVent brand of medical devices in 2025, which includes the Swirler(R) and Tru-Fit(TM) product lines. For more information, visit intisoid.com.

 
International Isotopes Contact:  Investor Relations Contact: David Drewitz, 
 admin@intisoid.com              Creative Options Communications Investor and 
 intisoid.com                    Public Relations 
 208.524.5300                    david@creativeoptionscommunications.com 
                                 www.creativeoptionsmarketing.com 
                                 972.814.5723 
-------------------------------  --------------------------------------------- 
 

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SOURCE International Isotopes Inc.

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May 20, 2025 12:52 ET (16:52 GMT)