IDAHO FALLS, Idaho, April 20, 2015 /PRNewswire/ -- International Isotopes Inc. (OTCQB: INIS, or the "Company") is pleased to provide shareholders with the following update on its business segments.
Historically, INIS has produced and sold high-activity cobalt which is used to fabricate several models of sealed sources for medical and industrial applications. These products include applications such as radiation therapy, security examination, and radiography. Due to technical issues at the Department of Energy's (DOE) Advanced Test Reactor (ATR) during 2012, that were unrelated to INIS, we were forced to discontinue irradiation of cobalt targets. Since that time, INIS has been working closely with the DOE to resolve those issues. We are pleased to report that in October 2014, we were able to sign a new ten-year cobalt production agreement with the DOE utilizing a new cobalt target design. This agreement gives INIS access to all currently available cobalt production positions in the ATR, thereby making INIS the exclusive cobalt supplier from this or any other DOE reactor in the U.S. Globally, there are only a few reactors capable of producing high activity cobalt.
Since the October 2014 agreement was completed with the DOE, we have been in contract negotiations with several customers that were expected to commit to purchasing most of the cobalt that the ATR reactor will produce under our DOE agreement. We are pleased to report that INIS has entered into contracts for the sale of most of the bulk cobalt the ATR will produce. INIS has also reserved an adequate amount of the ATR cobalt for its own use for sealed source manufacture. Although each of the Company's cobalt contracts are slightly different, the terms of all contracts stipulate quarterly progress payments to INIS during the cobalt irradiation cycle, each of which will run two to three years. INIS has received initial down payments from each customer which in the aggregate exceed one million dollars.
Pharmaceuticals and Radiopharmaceuticals
For the past few years, INIS has been developing several new generic radiopharmaceutical products that we plan to submit to the U.S. Food and Drug Administration (FDA) for approval. These products are in various stages of manufacturing development or of the FDA application process. Although these products are generics, we believe each will serve an important niche in the market that we feel is currently underserved. The first of these products is nearing completion of its preparation for an Abbreviated New Drug Application (ANDA) which should be submitted to the FDA around year-end or in early 2016. We believe that the other ANDAs will follow later in 2016. We would like to stress that there can be no assurances that the Company will successfully complete all the development, testing, and submittals required by the FDA. The FDA review process is rigorous and is likely to last fifteen to twenty four months or longer with no guarantee of approval.
Hobbs, NM De-conversion Project
The build-out of the Hobbs, NM uranium hexafluoride de-conversion plant remains contingent upon securing contracts for the throughput of the plant. The 2011 tsunami that struck Japan and low natural gas prices, together, have slowed the progress of nuclear projects globally, including the various enrichment plants that were planned to be built in the US. Those plants were expected to be sources of feed for our facility in NM. We are still in active negotiations regarding the plant, but while we remain optimistic, at the present time we cannot predict if or when the plant will be built. The 40 year operating license that we have secured from the NRC is not impacted by our delayed start of construction. Further, we have continued to meet with the various government entities in Lea County, NM, who put the incentive package together for us to locate there. We continue to work with them to negotiate an extension to that incentive package, including the 660 acres of land where the facility is planned to be sited.
Steve Laflin, President and CEO commented, "While the Hobbs de-conversion project remains on hold, we are continuing to diligently build a solid growth platform for our core business in Idaho Falls. We have a unique foundation of capabilities and a long history of working with the NRC in obtaining many amendments to our NRC license in order to support that business development and growth. Although our business is heavily regulated, which at times makes the progress slow, we are very excited by the products and businesses that we have been working on, some of which we have outlined here, and others which we will update shareholders on when they are a little further advanced . We believe there are significant opportunities in front of us and that we can continue to build a dynamic company in our core business segments. We greatly appreciate shareholders' patience as we methodically work to bring these products and new business opportunities to fruition."
About International Isotopes Inc.
International Isotopes Inc. manufactures a full range of nuclear medicine calibration and reference standards, a variety of cobalt-60 products, provides a wide selection of radioisotopes and radiochemicals for medical devices, calibration, clinical research, and industrial applications, and provides radiological services including source installation/removal, and decommissioning various radiation units on a contract basis to clients.
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 our ability to build additional business, the likelihood of success of future projects, the ability to collect payments under contracts for our products, the Company's ability to apply for and gain regulatory approval of new products, and the Company's ability to bring new business opportunities to fruition. 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 expressed or implied by these forward-looking statements. Other factors, which could materially affect such forward-looking statements, can be found in International Isotopes Inc.'s filings with the Securities and Exchange Commission at www.sec.gov, including our Annual Report on Form 10-K for the year ended December 31, 2014. 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. undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
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