International Isotopes Inc. Announces 2019 Year End Financial Results

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Mar 31, 2020, 10:05 ET

IDAHO FALLS, Idaho, March 31, 2020 /PRNewswire/ -- International Isotopes Inc. (OTCQB: INIS) (the "Company") announces its financial results for the fiscal year ended December 31, 2019. The Company reported total revenues in 2019 of $8,955,204, compared to $10,368,823 in 2018, which represents a decrease of approximately 14%. The details of the performance of the Company's significant business segments are discussed below.

Sales of radiochemical products accounted for approximately 32% of the Company's total sales revenue in 2019 and approximately 21% of total sales revenue in 2018. Sales in this segment increased by approximately 26% as compared to 2018. The increase was primarily the result of the addition of contract manufacturing operations to this business segment.

Within this segment, the Company had been distributing sodium iodide (I-131) as a radiochemical product. In February 2020, the Company received U.S. Food and Drug Administration (FDA) approval of its generic sodium iodide for use in treatment of hyperthyroidism and carcinoma of the thyroid and the Company launched commercial sales of that product during the first quarter of 2020. Sodium Iodide is also used in variety of relatively new applications including investigational and clinical trials for the treatment of breast, lung, prostate, and ovarian cancers. The Company expects the sales of this product should have a significant and long term positive impact on Company revenues. This is the first of several potential generic drug products the Company plans to submit to the FDA in the coming years.

In addition, the Company has started to provide certain contract manufacturing services within this segment. The Company completed a contract manufacturing agreement with Progenics Pharmaceuticals Inc. in 2019 and began work on a new facility expansion to accommodate this and potentially other contract manufacturing opportunities. Revenue from the new contract manufacturing services is expected to help the Company further increase revenue within this business segment in coming years.

Cobalt products sales accounted for approximately 9% of the Company's total sales revenue in 2019 and approximately 20% in 2018. Sales in this segment decreased by approximately 59% in 2019 as compared to 2018. The decline in revenue within this segment is the result of the continued delays in cobalt production from the Department of Energy's (DOE) Advanced Test Reactor (ATR). The Company's sealed source manufacturing generates the majority of revenue within this segment and those sales depend on the availability of cobalt produced in the ATR. The Company was able to receive its first cobalt delivery from the ATR during the first quarter of 2020 and should be able to generate additional revenue within this business segment during 2020.

Sales of nuclear medicine standards accounted for approximately 44% and 37%, of the Company's total sales revenue in 2019 and 2018, respectively. Sales in this segment increased by approximately 4% in 2019 as compared to 2018. This increase in sales was due to increases in the Company's customer base, the addition of new products, and increases in pricing. The Company is taking steps to increase the rate of new product development and to work closely with distributors to strengthen nuclear medicine product sales both domestically and internationally.

Revenue from the Company's radiological services segment accounted for approximately 13% of the Company's total sales revenue in 2019 and approximately 22% in 2018. The majority of revenue within this segment is from field service work performed for the DOE and revenue from that type of work decreased by approximately 58% in 2019 compared to 2018. This decrease in revenue was due to a contamination event involving a breached cesium-137 source at an off-site location in the state of Washington and the subsequent freeze of all DOE contracts for this type of work. Regardless of the DOE's future plans for field service contracts, it is unlikely that the Company will seek this type of contract work in future years. However, the Company anticipates that the revenue lost by not completing field service activities can be compensated for by increased sales in the other business segments.

The Company's cost of revenue for 2019 decreased approximately 24% as compared to 2018 and gross profit percentage increased to 52% for 2019 from 45% in 2018. Total operating costs and expenses for 2019 increased approximately 5% compared to 2018. The increase was primarily attributable to the addition of new personnel to support contract manufacturing. General administrative and consulting expenses increased approximately 9% in 2019 compared to 2018 due to increases in professional services, insurance, and repair costs.

The Company's other expense increased by $201,305 in 2019 compared to 2018. The increase was due to expenses related to the costs resulting from the contamination event that occurred at an offsite location in the state of Washington in May 2019. This increased expense was the net expense for this cleanup and the Company has assumed that a large amount of that incurred expense is probable for recovery.

Net loss was $1,522,964 in 2019, compared to a net loss of $844,576 in 2018, an increase in loss of approximately 80%. Our increase in net loss was the result of increased operating cost, our other expense related to the previously described contamination event and the resultant loss of additional field service contract work following that event.

Steve Laflin, Chief Executive Officer of the Company, stated, "While the Company has faced some significant challenges in 2019, we have still been able to complete important steps that should contribute towards profitability in the future. Most significant in this regard is the work completed during 2019 that has led to the FDA approval of our generic sodium iodide I-131 product. We have been working for a number of years to gain this approval and with our commercial launch of this product the Company expects to begin seeing significant improvement in our revenue generation in 2020. During 2019 the Company entered into a manufacturing and supply agreement with Progenics Pharmaceuticals Inc. to provide contract manufacturing services for AZEDRA® (Ultratrace® Iobenguane I-131) and other iodine products and we are completing an expansion of our existing facility to support this contract manufacturing opportunity. Also, we have been able to once again begin receiving some cobalt under our agreement with the DOE and will resume source manufacturing activities this year. We believe that these achievements and the continued strong performance by our nuclear medicine standards segment should advance the Company towards achieving profitability."

"We are all aware of the recent outbreak a novel strain of coronavirus (COVID-19) and the disruption this pandemic is causing to global economies. The extent to which the coronavirus will impact our Company operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence at the present time. We will continue to monitor events and may pursue financial relief under some of the newly enacted small business assistance measures recently passed by Congress."

International Isotopes Inc.
Year Ended December 31,

			$	%
	2019	2018	Change	Change
Sale of Product	$ 8,955,204	$ 10,368,823	$ (1,413,619)	-14%
Gross Profit	$ 4,665,714	$ 4,690,530	$ (24,816)	-1%
Total Operating Expense	$ 5,224,011	$ 4,980,357	$ 243,654	5%
Operating Loss Before Other Expense	$ (558,297)	$ (290,064)	$ (268,233)	92%
Other Expense	$ (642,693)	$ (373,882)	$ (268,811)	72%

Net Loss	$ (1,522,964)	$ (844,576)	$ (678,388)	80%

Net Loss Per Common Share	$0.00	$0.00

Weighted Average Shares Outstanding	418,077,055	411,071,598

About International Isotopes Inc.
International Isotopes Inc. manufactures a full range of nuclear medicine calibration and reference standards, a variety of Cobalt-60 products, and provides a wide selection of radioisotopes and radiochemical for medical applications, calibration, and clinical research. The Company also provides contract manufacturing services of radiochemical and radiopharmaceutical products.

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, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements with respect to revenue expectations for the future within our business segments, our ability to launch new products, the timing for the start of commercial sales of new products, increased contract opportunities for services, our long term revenue outlook, expectations for achieving profitability, and the impact of the novel coronavirus (COVID-19) on our business. Information contained in such forward-looking statements is based on current expectations and is subject to change. These statements involve several 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, 2019. 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.

FOR MORE INFORMATION, CONTACT:
David Drewitz
Creative Options Communications
Investor and Public Relations
[email protected]
www.creativeoptionsmarketing.com
Phone: 972-814-5723

SOURCE International Isotopes Inc.