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UNITED STATES
SECURITIES EXCHANGE COMMISSION
Washington, D. C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
DATE OF REPORT July 19, 1999
Commission file number:
0-22923
INTERNATIONAL ISOTOPES INC.
(Exact name of registrant as specified in its charter)
Texas 74-2763837
(State of incorporation) (IRS Employer Identification Number)
3100 Jim Christal Rd 76207
Denton, Texas (Zip Code)
(Address of principal executive offices)
940-484-9492
(Registrant's telephone number, including area code)
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Item 5. Other Events - Investor Update
International Isotopes Inc., (the "Company") updated its investors on the
Company's progress, and adjusted expectations for financial performance for
fiscal year 1999. The Company issued a press release dated July 15, 1999 in
which the Company revised its financial projections for the fiscal year 1999 as
well as outlined a six-part action plan, which will be immediately implemented.
A copy of the July 15, 1999 press release is attached hereto as Exhibit 99.1 and
incorporated herein by reference.
Item 7. Financial Statements and Exhibits
(c) Exhibits
99.1 Press Release dated July 15, 1999
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
International Isotopes Inc.
(Registrant)
By: /s/ Joan Gillett
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Joan Gillett, CPA
Chief Financial Officer
By: /s/ Ira Lon Morgan, Ph.D.
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Ira Lon Morgan, Ph.D.
Chairman of the Board
Date: July 19, 1999
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EXHIBIT INDEX
EXHIBIT
NUMBER DESCRIPTION
- ------- ---------------------------------
99.1 Press Release dated July 15, 1999
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Exhibit 99.1
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I(3) CONTACT: MEDIA CONTACTS:
Dr. Ira Lon Morgan, Chairman & CEO or Douglas MacDougall or
Carl W Seidel, President Kari Lampka
International Isotopes Inc Feinstein Kean Partners Inc.
(940) 484-9492 (617) 577-8110
www.radio-isotopes.com www.fkpi.com
www.nuclear-medicine.com
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(a) For Immediate Release
INTERNATIONAL ISOTOPES UPDATES INVESTORS ON 1999 FINANCIAL EXPECTATIONS AND
CORPORATE STRATEGY
DENTON, TX, JULY 15, 1999 - INTERNATIONAL ISOTOPES INC. (NASDAQ: INIS, BSE: ITL)
(I(3)), today updated investors on the Company's progress, and adjusted
expectations for financial performance for fiscal year 1999. The Company expects
that 1999 revenues will ramp up more slowly than initially anticipated. This is
due primarily to modifications to customer product specifications and the
underestimation of the time, cost and complexity of validation to meet cGMP and
FDA requirements for gaining simultaneous state and federal regulatory approval
for the multiple manufacturing facilities. As a result of the substantial
revisions to 1999 projections, revenues are expected to increase, but the
Company will continue to report operating losses this fiscal year.
Dr. Lon Morgan, Chairman and CEO of I(3), stated: "I(3)'s objective is to become
the premier worldwide supplier of high quality radioisotope products for the
diagnosis and treatment of cancer and other diseases. Toward that end, we have
invested more than $50 million in the construction and acquisition of multiple
manufacturing facilities and have made substantial progress by completing
construction of several of our key facilities. In order to produce, sell and
distribute products from these facilities, we must go through a series of cGMP
and FDA required steps to test and validate all equipment and procedures as well
as receive state and federal regulatory licensure and customer product
validation."
Dr. Morgan continued: "The steps needed to move from development to
commercialization have proven to be more costly and complex than expected,
causing delays from our original timetable. For example, we experienced
construction delays due to vendors and weather; we have identified the need to
automate several of our labor-intensive operations to control cost of goods; and
we have had to address multiple challenges in the installation and validation of
equipment."
"Nonetheless, the market opportunity for radioisotope products for the nuclear
medicine industry remains strong and continues to grow for both diagnostics and
therapeutics. Moreover, the demand for our specific products is intense, with
multiple potential customers awaiting product samples for validation and
subsequent regulatory submissions. We are therefore adhering to our current
business strategy, including the development of three discrete product lines in
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radioisotopes and pharmaceutical grade radiochemicals, brachytherapy sources,
and contract manufacturing of finished radiopharmaceuticals," he said. "In order
to achieve our revised timetable for product shipments, we will be immediately
implementing a six-part action plan:
o First, we have realigned management responsibilities to concentrate on
those products and efforts that will produce near-term revenues. The Board
of Directors elected me to be Chairman, CEO and acting COO and has
initiated a search for a permanent COO. This new position will be filled
with an individual capable of leading the company through the transition
from the development stage into the manufacturing stage of operations.
o Second, the Company is actively recruiting a senior regulatory professional
to supervise regulatory and product validation processes.
o Third, we are aligning our senior staff into matrix management to make sure
that we can achieve our new objectives in a timely fashion. President, Carl
W. Seidel will concentrate his talents on brachytherapy medical device
manufacturing, marketing, customer service, distribution and joint
ventures; Executive Vice President, Tommy Thompson will focus his efforts
on manufacturing radioisotopes and the automation of production processes;
Vice President Gaylord King will be responsible for finished
radiopharmaceutcals; and Vice President Homer Hupf, Ph.D. will concentrate
on manufacturing finished radioisotopes, radiochemicals and pharmaceutical
grade radiochemicals.
o Fourth, we have shifted our line management to a product-centered focus to
deliver high quality products on a timely basis to our customers and
potential customers. There are now seven (7) task groups, each of which is
responsible for all key aspects of advancing particular products to the
marketplace, including finished radiopharmaceuticals that utilize Thallium
201 and Iodine 125 (brachytherapy seeds), and radioisotopes which include
Fluorine 18, Iodine 123, Thallium 201, Strontium 89, Indium 111, Nickel 63,
Iridium 192 and other standard products currently scheduled for production.
o Fifth, we have implemented a cost control initiative, lead by CFO, Joan
Gillett, that will review and carefully eliminate all manufacturing costs,
inventory costs and current and future capital expenditures that are not
directly related to the near-term production of products.
o Sixth, we are exploring the use of separate financing vehicles, including
joint venture financing, to support any expanded operations and new product
development required by our customers."
Dr. Morgan continued: "It is important to recognize that each of our three
product groups has its own dynamics, its own regulatory pathway and its own
timelines. Furthermore, until we obtain sufficient production to support
operations, there will inevitably be quarter to quarter fluctuations in
financial performance and forecasting will be extremely difficult. We, the
management team, the Board of Directors and employees of I3, are confident and
strongly believe in the promising future for International Isotopes. We
appreciate your support in continuing to share that vision with us."
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International Isotopes Inc., headquartered in Denton, Texas, is initiating
operations to be the premier supplier of finished radiopharmaceuticals,
pharmaceutical grade radiochemicals, radioisotopes and brachytherapy devices
used in nuclear medicine for diagnostics and therapeutic treatment of cancer and
other diseases.
I(3) Safe Harbor Statement
Statements in this press release may constitute forward-looking statements and
are subject to numerous risks and uncertainties, including the ability to meet
time schedules, the need to raise additional capital, the development of
competitive products by others and other risks detailed from time to time in the
Company's filings with the Securities and Exchange Commission. The Company
disclaims any obligation to update statements in this press release.
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