Filed
pursuant to
Rule
424(b)(5)
File
No. 333-140246
PROSPECTUS
SUPPLEMENT
(To
Prospectus dated January 26, 2007)
4,000,000 Shares
800,000
Warrants
Common
Stock
We
are
offering all of the 4,000,000 shares of common stock and warrants to
purchase 800,000 shares of common stock offered by this prospectus supplement.
We
will
sell our common stock and warrants to investors at the negotiated price of
$20.00 per five shares of common stock. Each purchaser of our common stock
will
receive a warrant to purchase one share of our common stock at an exercise
price
of $5.00 per share for each five shares of our common stock they purchase in
the
offering. The warrants are immediately exercisable. For a more detailed
description of our warrants, see the section entitled "Description of Warrants"
beginning on page S-19. For a more detailed description of our common stock,
see
the section entitled "Description of Capital Stock" beginning on page 3 of
the
accompanying prospectus.
The
warrants will not be listed on any securities exchange or market. Our
common stock is traded on the Over the Counter Bulletin Board under the symbol
“ISRY.OB.” On March 19, 2007, the last reported sales price of our common stock
on the Over the Counter Bulletin Board was $4.47 per share.
Investing
in our common stock involves a high degree of risk. Before buying any shares,
you should read the discussion of material risks of investing in our common
stock referred to under the heading “Risk Factors” beginning on page S-7 of
this prospectus supplement.
Neither
the Securities and Exchange Commission nor any state securities commission
has
approved or disapproved of these securities or passed upon the adequacy or
accuracy of this prospectus supplement or the accompanying prospectus. Any
representation to the contrary is a criminal offense.
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Per
share
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Total
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Public
offering price
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$
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4.00
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$
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16,000,000
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Placement
agent fees (1)
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$
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0.24
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$
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960,000
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Proceeds,
before expenses, to us
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$
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3.76
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$
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15,040,000
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(1)
Excludes that portion of the placement agents' fees payable in warrants. See
"Plan of Distribution."
In
connection with this offering, we will pay fees to the placement agents as
set
forth under “Plan of Distribution.” We have entered into an Escrow Agreement
with the placement agents that provides for a minimum offering amount of $15
million in both escrowed funds and direct funding. Because the minimum offering
amount required as a condition to closing in this offering is less than the
full
amount being offered, the placement agent fees and net proceeds to us, if any,
in this offering may be less than the maximum offering amounts set forth above.
Delivery of the shares and warrants will be made on or about March 22,
2007.
Placement
Agents
Punk,
Ziegel & Company
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Maxim
Group LLC
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The
date
of this prospectus supplement is March 21, 2007.
TABLE
OF CONTENTS
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Prospectus
Supplement
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PROSPECTUS
SUPPLEMENT SUMMARY
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S-1
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RISK
FACTORS
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S-7
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USE
OF PROCEEDS
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S-16
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DETERMINATION
OF OFFERING PRICE
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S-17
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DILUTION
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S-18
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DESCRIPTION
OF THE WARRANTS
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S-19
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PLAN
OF DISTRIBUTION
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S-20
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WHERE
YOU CAN FIND MORE INFORMATION
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S-22
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INCORPORATION
OF CERTAIN DOCUMENTS BY REFERENCE
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S-23
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Prospectus
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ABOUT
THIS PROSPECTUS
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1
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ABOUT
ISORAY
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1
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RISK
FACTORS
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2
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NOTE
REGARDING FORWARD-LOOKING STATEMENTS
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2
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USE
OF PROCEEDS
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3
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GENERAL
DESCRIPTION OF SECURITIES
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3
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DESCRIPTION
OF CAPITAL STOCK
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3
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DESCRIPTION
OF THE WARRANTS
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4
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PLAN
OF DISTRIBUTION
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5
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LEGAL
MATTERS
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7
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EXPERTS
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7
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WHERE
YOU CAN FIND ADDITIONAL INFORMATION
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7
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INCORPORATION
BY REFERENCE
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7
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INDEMNIFICATION
OF DIRECTORS AND OFFICERS
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8
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ABOUT
THIS PROSPECTUS
A
registration statement on Form S-3 (File no. 333-140246) utilizing a
shelf registration process relating to the securities described in this
prospectus supplement has been filed with the Securities and Exchange
Commission, or the SEC, and was declared effective on February 15, 2007. Under
this shelf registration process, of which this offering is a part, we may,
from
time to time, sell up to $20,000,000 of common stock and other securities.
This
document is in two parts. The first part is this prospectus supplement, which
describes the terms of this offering of our common stock and warrants and also
adds, updates and changes information contained in the accompanying prospectus
and the documents incorporated by reference. The second part is the accompanying
prospectus, which gives more general information, some of which may not apply
to
this offering of our common stock and warrants. To the extent the information
contained in this prospectus supplement differs or varies from the information
contained in the accompanying prospectus or any document filed prior to the
date
of this prospectus supplement and incorporated by reference, the information
in
this prospectus supplement will control.
You
should rely only on the information contained in or incorporated by reference
into this prospectus supplement and the accompanying prospectus. We have not,
and the placement agents have not, authorized anyone to provide you with
information that is different. This prospectus supplement is not an offer to
sell or solicitation of an offer to buy these shares of common stock and
warrants in any circumstances under which the offer or solicitation is unlawful.
You should not assume that the information we have included in this prospectus
supplement or the accompanying prospectus is accurate as of any date other
than
the date of this prospectus supplement or the accompanying prospectus,
respectively, or that any information we have incorporated by reference is
accurate as of any date other than the date of the document incorporated by
reference, regardless of the time of delivery of this prospectus supplement
or
of any shares of our common stock and warrants. It is important for you to
read
and consider all information contained in this prospectus supplement and the
accompanying prospectus, including the documents incorporated by reference
herein and therein, in making your investment decision. You should also read
and
consider the information in the documents we have referred you to in
“Incorporation of Certain Information by Reference” and “Where You Can Find More
Information” in this prospectus supplement.
In
addition to the other information contained or incorporated by reference in
this
prospectus supplement and accompanying prospectus, you should carefully consider
the risk factors contained in this prospectus supplement when evaluating an
investment in our common stock and warrants. This prospectus supplement and
accompanying prospectus and the documents incorporated by reference into this
prospectus supplement and accompanying prospectus include “forward-looking
statements”, which include all statements other than statements of historical
fact, including but not limited to:
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any
projections of earnings, revenues or other financial items;
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any
statements of the plans and objectives of management for future
operations;
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any
statements concerning proposed new products or services;
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any
statements regarding future operations, plans, regulatory filings
or
approvals;
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any
statements concerning proposed new products or services, any statements
regarding pending or future mergers or acquisitions; and
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any
statements regarding future economic conditions or performance, and
any
statement of assumptions underlying any of the foregoing.
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In
some
cases, forward-looking statements can be identified by the use of terminology
such as “may”, “will”, “expects”, “plans”, “anticipates”, “estimates”,
“potential”, or “continue” or the negative thereof or other comparable
terminology. There can be no assurance that such expectations or any of the
forward-looking statements will prove to be correct, and actual results could
differ materially from these projected or assumed in the forward-looking
statements. Our future financial condition and results of operations, as well
as
any forward-looking statements, are subject to inherent risks and uncertainties,
including, but not limited to, the risk factors set forth in this prospectus
supplement, or incorporated by reference herein. All forward-looking statements
and reasons why results may differ included in this prospectus supplement are
made as of the date hereof, and we assume no obligation to update any such
forward-looking statement or reason why actual results might differ.
This
prospectus supplement and the accompanying prospectus, contains and incorporates
by reference market data, industry statistics and other data that have been
obtained from, or compiled from, information made available by third parties.
We
have not independently verified their data.
PROSPECTUS
SUPPLEMENT SUMMARY
This
summary highlights selected information appearing elsewhere or incorporated
by
reference in this prospectus supplement and accompanying prospectus and may
not
contain all of the information that is important to you. This prospectus
supplement and the accompanying prospectus include or incorporate by reference
information about the shares and warrants we are offering as well as information
regarding our business and detailed financial data. You should read this
prospectus supplement and the accompanying prospectus in their entirety,
including the information incorporated by reference in this prospectus
supplement and the accompanying prospectus.
Unless
the context requires otherwise, the words “IsoRay,” “we,” “company,” “us” and
“our” refer to IsoRay, Inc. and its subsidiaries.
BUSINESS
OVERVIEW
IsoRay
is
utilizing its patented radioisotope technology, experienced chemists and
engineers, and management team to create a major therapeutic medical isotope
and
medical device company with a goal of providing improved patient outcomes in
the
treatment of solid tumor cancers. IsoRay began production and sales of its
Food
and Drug Administration (“FDA”) cleared product, the IsoRay 131Cs
brachytherapy seed, in October 2004 for the treatment of prostate cancer.
Cesium-131 could also enable meaningful penetration in other solid tumor
applications such as breast, lung, liver, brain and pancreatic cancer, expanding
the total available market opportunity. Management believes its technology
will
allow it to capture a leadership position in an expanded brachytherapy market.
The more clinically beneficial characteristics of the Cesium-131 (Cs-131 or
131Cs)
isotope are expected to decrease radiation exposure to the patient and reduce
the severity and duration of side effects, while treating cancer cells as
effectively, if not more so than other isotopes used in seed brachytherapy.
Brachytherapy
seeds are small devices used in an internal radiation therapy procedure. In
recent years the procedure has become one of the primary treatments for prostate
cancer and is now used more often than surgical removal of the prostate. The
brachytherapy procedure places radioactive seeds as close as possible to (in
or
near) the cancer tumor (the word “brachytherapy” means close therapy). The seeds
deliver therapeutic radiation by killing the tumor cells and cells located
in
the immediate vicinity of the tumor while minimizing exposure to adjacent
healthy tissue. This allows doctors to administer a higher dose of radiation
at
one time than is possible with external beam radiation. Each seed contains
a
radioisotope sealed within a welded titanium capsule. Approximately 70 to 120
seeds are permanently implanted in the prostate in a 45-minute outpatient
procedure. The isotope decays over time and the seeds become inert. The seeds
may be used as a primary treatment or, in conjunction with other treatment
modalities such as external beam radiation therapy, chemotherapy, or as
treatment for residual disease after excision of primary tumors.
Management
believes that the IsoRay 131Cs
seed
represents the
first
major advancement in brachytherapy technology in over 18 years with attributes
that could make it the long term “seed of choice” for internal radiation
procedures. The 131Cs
seed
has FDA clearance for treatment of malignant disease (e.g. cancers of the head
and neck, brain, liver, lung, breast, prostate, etc.) and may be used in
surface, interstitial, and intracavity applications for tumors with known
radiosensitivity.
The
131Cs
isotope appears to have specific advantages for treating cancer over Iodine-125
(I-125 or 125I)
and
Palladium-103 (Pd-103 or 103Pd),
the
other isotopes commonly used in brachytherapy procedures. IsoRay believes that
the short half-life and higher dose rate characteristics of 131Cs
will
expand industry applications and facilitate meaningful penetration into the
treatment of other forms of cancer such as breast cancer. The shorter half-life
of 9.7 days for 131Cs
(versus 17 days for 103Pd
and 60
days for 125I)
mitigates negative effects of long radiation periods on healthy tissue and
is
believed to reduce the duration of certain side effects. The higher initial
dose
rate is believed to be more effective on fast growing cancers by aggressively
attacking cancer cells and disrupting cancer cell re-population cycles. The
characteristics of 131Cs may
result in the use of 10-30% fewer seeds per procedure compared to Pd-103,
thereby reducing the total physical radiation dose to the patient and reducing
the costs of the procedure for both third-party payers and the patient.
IsoRay
and its predecessor companies have accomplished the following key milestones:
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Treated
900th
patient (February 2007);
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Raised
over $25.0 M in debt and equity funding (September 2003 - January
2007)
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Opened
a new manufacturing and production facility (October
2005);
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Deployed
a direct sales force to the market (July 2004 - July
2005);
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Developed
a treatment protocol for prostate cancer with a leading oncologist
(January 2005);
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Treated
the first patient (October 2004);
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Commenced
production of the 131Cs
seed (August 2004);
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Filed
five additional patent applications for the 131Cs
process (November 2003 - August
2004);
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Obtained
a Nuclear Regulatory Commission Sealed Source and Device Registration
required by the Washington State Department of Health and the FDA
(September 2004);
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Received
a Radioactive Materials License from the Washington State Department
of
Health (July 2004);
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Implemented
an ISO-9000 Quality Management System and production operating procedures
(under continuing development);
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Signed
a Commercial Work for Others Agreement between Battelle (manager
of the
Pacific Northwest National Laboratory or PNNL) and IsoRay, allowing
initial production of seeds through 2006 at
PNNL (April 2004);
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Obtained
favorable Medicare reimbursement codes for the Cs-131 brachytherapy
seed
(November 2003);
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Obtained
FDA 510(k) clearance to market the first product: the 131Cs
brachytherapy seed (March 2003);
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Completed
initial radioactive seed production, design verification, computer
modeling of the radiation profile, and actual dosimetric data compiled
by
the National Institute of Standards and Technology and PNNL (October
2002); and
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Obtained
initial patent for 131Cs
isotope separation and purification (May
2000).
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Our
Strategy
The
key
elements of IsoRay’s strategy include:
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Continue
to introduce the IsoRay 131Cs
seed into the U.S. brachytherapy market.
Utilizing a direct sales organization and selected channel partners,
IsoRay intends to capture a leadership position by expanding overall
use
of the brachytherapy procedure for prostate cancer, capturing much
of the
incremental market growth and taking market share from existing
competitors.
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Create
a state-of-the-art manufacturing process.
IsoRay has constructed a state-of-the-art manufacturing facility
in
Richland, Washington in its leased facility, to implement our proprietary
manufacturing process which is designed to improve profit margins
and
ensure quality control. IsoRay may construct a permanent manufacturing
facility in another state. Working with leading scientists, IsoRay
intends
to design and create a proprietary separation process to manufacture
enriched barium, a key source material for 131Cs,
to ensure adequate supply and greater manufacturing efficiencies.
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Introduce
Cesium-131 therapies for other cancers.
IsoRay intends to partner with other companies to develop the appropriate
delivery technology and therapeutic delivery systems for treatment
of
other solid tumors such as breast, lung, liver, pancreas, neck, and
brain
cancer. IsoRay’s management believes that the first major opportunities
may be for the use of Cesium-131 in adjunct therapy for the treatment
of
residual lung and breast cancers.
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Support
clinical research and sustained product development.
The Company plans to structure and support clinical studies on the
therapeutic benefits of Cs-131 for the treatment of solid tumors
and other
patient benefits. We are and intend to continue to support clinical
studies with several leading radiation oncologists to clinically
document
patient outcomes, provide support for our product claims and compare
the
performance of our seeds to competing seeds. IsoRay plans to sustain
long-term growth by implementing research and development programs
with
leading medical institutions in the U.S. to identify and develop
other
applications for IsoRay’s core radioisotope
technology.
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Cs-131
Manufacturing Process
Cs-131
is
a radioactive isotope that can be produced by the neutron bombardment of
Barium-130. When Ba-130 is put into a nuclear reactor it becomes Ba-131, the
radioactive material that is the parent isotope of Cs-131. The overall process
includes the following:
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Isotope
Generation. The
radioactive isotope Cs-131 is normally produced by placing a quantity
of
stable non-radioactive barium (ideally pure Ba-130) into the neutron
flux
of a nuclear reactor. The irradiation process converts a small fraction
of
this material into a radioactive form of barium (Ba-131). The Ba-131
decays by electron capture to the radioactive isotope of interest
(Cs-131). Due to the short half-life of both the Ba-131 and Cs-131
isotopes, potential suppliers must be capable of removing irradiated
materials from the reactor core on a routine basis for subsequent
processing to produce ultra-pure Cs-131. The Company has identified
more
than five reactors facilities in the U.S., Europe and the former
Soviet
Union that are capable of meeting these requirements. As of November
10,
2006, IsoRay had agreements in place with three suppliers of irradiated
Ba-131 or Cs-131. The Company’s agreement with Russia’s Institute of
Nuclear Materials (which commenced as of August 25, 2005 and ends
August
25, 2012) allows the Company to purchase irradiated Ba-131 for $300.00
per
Curie of the isotope. The projected value of the agreement as indicated
therein over its term is $30,000,000 with $300,000 worth of isotope
projected therein to be delivered in the first full year of production,
although neither of these amounts are obligations to purchase any
given
quantity of the isotopes in a particular time period. Through September
30, 2006, the Company had paid approximately $202,000 to the Institute
of
Nuclear Materials. On October 6, 2006, our operating subsidiary,
IsoRay
Medical, Inc. ("Medical"), entered into a Contract with FSUE “SSE -
Research Institute of Atomic Reactors (“RIAR”) in Russia. The Contract
provides for delivery to Medical of purified Cs-131 isotope, which
is used
by Medical to produce its proprietary Cs-131 brachytherapy seed used
in
the treatment of prostate cancer. The total stated value of the Contract
over its term, which expires on May 1, 2014, is $6,300,000. Delivery
of
the isotope is scheduled to commence in October 2007 and continue
through
December 2013, upon submission of written orders by Medical forty-five
days in advance of the planned date of delivery. Medical also entered
into
an Agreement for Exclusive Rights to Buy on October 6, 2006 with
RIAR.
This Agreement gives Medical the exclusive right to purchase the
Cs-131
isotope produced by RIAR for a period of seven years, or through
October
6, 2013. In addition, the Company is engaged in the development of
a
barium enrichment device that, if successful, should reduce the cost
of
producing Cs-131 while maintaining the purity and consistency required
in
the end product.
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Isotope
Separation and Purification. Upon
irradiation of the barium feedstock, the Ba-131 begins decaying to
Cs-131.
At pre-determined intervals the Cs-131 produced is separated from
the
barium feedstock and purified using a proprietary radiochemical
separations process (patent applied for). Due to the high-energy
decay of
Ba-131, this process is performed under stringent radiological controls
in
a highly shielded isolator or “hot cell” using remote manipulators. After
separating Cs-131 from the energetic Ba-131, subsequent seed processing
may be performed in locally shielded fume hoods or glove boxes. If
enriched barium feedstock is used, the residual barium remaining
after
subsequent Cs-131 separation cycles (“milkings”) will be recycled back to
the reactor facility for re-irradiation. This material will be recycled
as
many times as economically feasible, which should make the process
more
cost effective. As an alternative to performing the Cs-131 separation
in
our own facilities, IsoRay may enter into agreements with other entities
to supply “raw” Cs-131 by performing the initial barium/cesium separation
at their facilities, followed by final purification at IsoRay’s
facility.
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Internal
Seed Core Technology. The
purified Cs-131 isotope is incorporated into an internal assembly
that
contains a binder, spacer and a gold X-ray marker. This internal
core
assembly is subsequently inserted into a titanium case. The dimensional
tolerance for each material is extremely important. Several carrier
materials and placement methods have been evaluated, and through
a process
of elimination, we have developed favored materials and methods during
our
laboratory testing. The equipment necessary to produce the internal
core
includes accurate cutting and gauging devices, isotope incorporation
vessels, reaction condition stabilization and monitoring systems,
and
tools for placing the core into the titanium tubing prior to seed
welding.
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Seed
Welding. Following
production of the internal core and placement into the titanium capsule,
each seed is laser welded to produce a sealed radioactive source
and
biocompatible medical device. This manufacturing technology requires:
accurate placement of seed components with respect to the welding
head,
accurate control of welding parameters to ensure uniform temperature
and
depth control of the weld, quality control assessment of the weld
integrity, and removal of the finished product for downstream processing
or rejection of unacceptable materials to waste. Inspection systems
are
capable of identifying and classifying these variations for quality
control and to ensure low scrap rates. Finally, the rapid placement
and
removal of components from the welding zone affects overall product
throughput.
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Quality
Control. We
have established procedures and controls to meet all FDA and ISO
9001:2000
Quality Standards. Product quality and reliability will be secured
by
utilizing multiple sources of irradiation services, feedstock material,
and other seed manufacturing components. An intensive production
line
preventive maintenance and spare parts program will be implemented.
Also,
an ongoing training program will be established for customer service
to
ensure that all regulatory requirements for the FDA, DOT and applicable
nuclear radiation and health authorities are
fulfilled.
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Additional
Growth Opportunities
The
Cs-131 isotope has the performance characteristics to be a technological
platform for sustained long-term growth. The most immediate opportunities are
introducing Cs-131 to Canada, Europe and other international markets,
introducing Cs-131-based therapies for other forms of solid tumors focusing
first on breast tumors, and through the marketing of other radioactive isotopes.
These growth initiatives are in the early stages of planning and we believe
may
be significant incremental opportunities.
The
Company plans to introduce Cs-131 initially
into Europe and later into other international markets through partnerships
and
strategic alliances with channel partners for manufacturing and distribution.
Another advantage of the Cs-131 isotope is its potential applicability to other
cancers and other diseases. Cs-131 has FDA clearance to be used for treatments
for a broad spectrum of cancers including breast, brain, lung, and liver cancer,
and the Company believes that a major opportunity exists as an adjunct therapy
for the treatment of breast cancer. Preliminary discussions have begun with
prominent physicians regarding the use of Cs-131-based therapies for the
treatment of lung, pancreatic and brain cancer. There is the opportunity to
develop and market other radioactive isotopes to the US market, and to market
the Cs-131 isotope itself, separate from its use in our seeds. The Company
is
also in the preliminary stages of exploring alternate methods of delivering
our
isotopes to various organs of the body, as it may be advantageous to use
delivery methods other than a titanium-encapsulated seed to deliver radiation
to
certain organs.
OUR
CORPORATE INFORMATION
Our
principal executive offices are located at 350 Hills Street, Suite 106,
Richland, Washington 99354, and our telephone number is (509) 375-1202. We
maintain an Internet website at www.isoray.com.
We have
not incorporated by reference into this prospectus supplement or the
accompanying prospectus the information in, or that can be accessed through,
our
website, and you should not consider it to be a part of this prospectus
supplement or the accompanying prospectus.
Our
independent auditors have expressed doubt about our ability to continue as
a
going concern due to ongoing operating losses, which our management expects
to
continue for the foreseeable future. Because our revenues from sales of our
131Cs
seed
are insufficient to fund our operations at this time, we will need financing
or
growth of our revenues to meet our expenses. Management believes that this
offering, if fully sold, will provide sufficient capital to fund operations
for
the next twelve months.
Although
our predecessor operating company was organized in 1998, IsoRay, Inc. was
incorporated in 1983 in Minnesota and operated under the name Century Park
Pictures Corporation until the merger with IsoRay Medical, Inc. on July 28,
2005.
THE
OFFERING
The
following is a brief summary of some of the terms of the offering and is
qualified in its entirety by reference to the more detailed information
appearing elsewhere in this prospectus supplement and the accompanying
prospectus. For a more complete description of the terms of our common stock,
see the “Description of Capital Stock” section in the accompanying prospectus.
For a more complete description of the warrants, see the “Description of
Warrants” section in this prospectus supplement.
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Securities
We Are Offering
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4,000,000 shares
of common stock
Warrants
to purchase 800,000 shares of common stock
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Common
Stock To Be
Outstanding
After This
Offering
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21,059,462
shares
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Description
of Warrants
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Each
purchaser of five shares of our common stock will receive a warrant
to
purchase one share of common stock. The warrants are immediately
exercisable at an exercise price of $5 per share of our common stock
and
have a four year term. See “Description of Warrants” in this prospectus
supplement.
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Use
of Proceeds
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We
estimate that the net proceeds to us from this offering after expenses
will be approximately $14,872,860 million. We intend to use the net
proceeds from the sale of our shares of common stock offered by this
prospectus supplement for general corporate purposes, including without
limitation, capital expenditures and working capital needs. Proceeds
from the exercise of the warrants being sold through this offering
are
estimated to be $4,000,000, and may be received by the Company at
any time
following the offering depending on when the warrants are exercised
by
investors. These proceeds when received will be used for general
corporate
purposes, including without limitation, capital expenditures and
working
capital needs. See
“Use of Proceeds.”
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Market
for the Warrants
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There
is no established public trading market for the warrants, and we
do not
expect a market to develop. In addition, we do not intend to apply
for
listing of the warrants on any securities exchange.
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Risk
Factors
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See
“Risk Factors” and other information included in this prospectus
supplement, or incorporated herein by reference, for a discussion
of
factors you should carefully consider before deciding to invest in
the
common stock, the warrants or our shares of common stock issuable
upon
exercise of the warrants.
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OTC
Bulletin Board Symbol
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ISRY.OB
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Except
as
otherwise provided for herein, the information contained in this prospectus
supplement assumes (i) the sale of all of the shares and warrants offered hereby
and (ii) that none of the warrants sold hereunder have been exercised.
The
number of shares of our common stock outstanding after this offering is based
on
approximately 17,059,462 shares outstanding as of March 6, 2007 and excludes:
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4,157,402 shares
of common stock issuable upon the exercise of warrants outstanding
at
March 6, 2007;
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59,065
shares of common stock issuable upon the conversion of preferred
stock
outstanding at March 6, 2007;
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3,088,439 shares
of common stock issuable upon the exercise of options outstanding
at March
6, 2007;
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85,542
shares of common stock issuable upon the conversion of convertible
debentures outstanding at March 6, 2007;
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911,778 shares
of common stock reserved for future stock option grants as of March
6,
2007 under our equity compensation plans; and
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800,000
shares of common stock issuable upon the exercise of the warrants
included
in this offering at an exercise price of $5.00 per
share.
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RISK
FACTORS
Investing
in our common stock involves a high degree of risk. You should carefully
consider the risks listed below and other information included and incorporated
by reference in this prospectus supplement and accompanying prospectus. There
may also be risks of which we are currently unaware, or that we currently regard
as immaterial based on the information available to us that later prove to
be
material. If any of these risks occur, our business, operating results and
financial condition could be seriously harmed, the trading price of our common
stock could decline, and you could lose some or all of your investment.
Risks
Related to this Offering
There
Is A Limited Market For Our Common Stock. Currently
only a limited trading market exists for our common stock. Our common stock
currently trades on the Over-The-Counter Bulletin Board, a market with limited
liquidity and minimal listing standards, under the symbol “ISRY.OB.” While
management has applied for listing on the American Stock Exchange, the Company
is uncertain as to when its application will be approved, if at all, assuming
it
continues to meet the applicable listing requirements. Any broker-dealer that
makes a market in our stock or other person that buys or sells our stock could
have a significant influence over its price at any given time. Shareholders
may
experience more difficulty in attempting to sell their shares than if the shares
were listed on a national stock exchange or quoted on the NASDAQ Stock Market.
We cannot assure our shareholders that a market for our stock will be sustained.
There is no assurance that our shares will have any greater liquidity than
shares that do not trade on a public market.
Our
Stock Price Is Likely To Be Volatile. There
is
generally significant volatility in the market prices and limited liquidity
of
securities of early stage companies, and particularly of early stage medical
product companies. Contributing to this volatility are various events that
can
affect our stock price in a positive or negative manner. These events include,
but are not limited to: governmental approvals, refusals to approve, regulations
or actions; market acceptance and sales growth of our products; litigation
involving the Company or our industry; developments or disputes concerning
our
patents or other proprietary rights; changes in the structure of healthcare
payment systems; departure of key personnel; future sales of our securities;
fluctuations in our financial results or those of companies that are perceived
to be similar to us; investors’ general perception of us; and general economic,
industry and market conditions. If any of these events occur, it could cause
our
stock price to fall.
Our
Common Stock May be Subject To Penny Stock Regulation. So
long
as our shares’ market price is below $5.00 per share, our shares are subject to
the provisions of Section 15(g) and Rule 15g-9 of the Securities Exchange Act
of
1934, as amended, commonly referred to as the “penny stock” rule. Section 15(g)
sets forth certain requirements for transactions in penny stocks and Rule
15g-9(d)(1) incorporates the definition of penny stock as that used in Rule
3a51-1 of the Exchange Act. The SEC generally defines penny stock to be any
equity security that has a market price less than $5.00 per share, subject
to
certain exceptions. Rule 3a51-1 provides that any equity security is considered
to be penny stock unless that security is: registered and traded on a national
securities exchange meeting specified criteria set by the SEC; authorized for
quotation on The NASDAQ Stock Market; issued by a registered investment company;
excluded from the definition on the basis of price (at least $5.00 per share)
or
the Company’s net tangible assets; or exempted from the definition by the SEC.
As our shares may be deemed to be “penny stocks”, trading in the shares may be
subject to additional sales practice requirements on broker-dealers who sell
penny stocks to persons other than established customers and accredited
investors. This classification also could make our shares ineligible for market
coverage by many established brokerage firms.
There
Is No Public Market For The Warrants To Purchase Common Stock In This Offering.
There
is
no established public trading market for the warrants being offered in this
offering, and we do not expect a market to develop. In addition, we do not
intend to apply for listing the warrants on any securities exchange or for
quotation on the any securities market. Without an active market, the liquidity
of the warrants will be limited.
Since
We Have Broad Discretion In How We Use The Proceeds From This Offering, We
May
Use The Proceeds In Ways In Which You Disagree. Our
management will have significant flexibility in applying the net proceeds of
this offering. You will be relying on the judgment of our management with regard
to the use of these net proceeds, and you will not have the opportunity, as
part
of your investment decision, to assess whether the proceeds are being used
appropriately. It is possible that the net proceeds will be invested in a way
that does not yield a favorable, or any, return for our company. The failure
of
our management to use such funds effectively could have a material adverse
effect on our business, financial condition, operating results and cash flow.
Purchasers
Of The Shares And Purchasers Of The Warrants Who Convert Their Warrants Will
Incur Immediate Dilution. Purchasers
of shares of common stock in this offering and purchasers who convert their
warrants into shares of common stock will experience immediate and substantial
dilution because the purchase price of the common stock and the per share
exercise price of the warrants will be higher than the net tangible book value
per share of the outstanding common stock immediately after this offering.
In
addition, purchasers will experience dilution, which may be substantial, when
we
issue additional shares of common stock that we are permitted or required to
issue under options, warrants, our stock option plans or other employee or
director compensation plans.
Future
Sales By Shareholders, Or The Perception That Such Sales May Occur, May Depress
The Price Of Our Common Stock.
The sale
or availability for sale of substantial amounts of our shares in the public
market, including shares covered by this prospectus and shares issuable upon
exercise or conversion of outstanding preferred stock and derivative securities,
or the perception that such sales could occur, could adversely affect the market
price of our common stock and also could impair our ability to raise capital
through future offerings of our shares. As of March 6, 2007, we had 17,059,462
outstanding shares of common stock, and the following additional shares were
reserved for issuance: 3,088,439 shares upon exercise of outstanding options,
4,157,402 shares upon exercise of outstanding warrants, 59,065 shares upon
conversion of preferred stock, and 85,542 shares upon conversion of convertible
debentures. On the effective date of this prospectus supplement, a total of
23,906,759 shares of common stock (including 800,000 shares issuable upon
exercise of warrants registered hereunder and including not only shares
registered through this prospectus but also the 13,701,990 shares registered
through our Form SB-2 registration statements initially filed on November 10,
2005 and October 16, 2006, the 4,800,000 shares registered through our Form
S-8
registration statements initially filed on August 19, 2005 and August 18, 2006,
and 604,769 shares eligible for resale under Rule 144(k)) will be eligible
for
sale in the public market. As additional shares of our common stock become
available for resale in the public market, the price of our common stock may
decrease due to the additional shares in the market. Any decline in the price
of
our common stock may encourage short sales, which could place further downward
pressure on the price of our common stock and may impair our ability to raise
additional capital through the sale of equity securities.
The
Issuance Of Shares Upon Conversion Or Exercise Of The Preferred Stock And
Derivative Securities May Cause Immediate And Substantial Dilution To Our
Existing Shareholders. The
issuance of shares upon conversion of the preferred stock and convertible
debentures and the exercise of warrants and options may result in substantial
dilution to the interests of other shareholders, including purchasers in this
offering, since the selling shareholders may ultimately convert or exercise
and
sell all or a portion of the full amount issuable upon conversion or exercise.
If all derivative securities being registered through this prospectus and
through our other currently effective registration statements were converted
or
exercised into shares of common stock, there would be an additional 9,102,216
shares of common stock outstanding as a result. The issuance of these shares
will have the effect of further diluting the proportionate equity interest
and
voting power of holders of our common stock, including investors in this
offering.
We
Do
Not Expect To Pay Any Dividends For The Foreseeable Future. We
do not
anticipate paying any dividends to our shareholders for the foreseeable future.
The terms of certain of our and our subsidiary's outstanding indebtedness
substantially restrict the ability of either company to pay dividends.
Accordingly, investors must be prepared to rely on sales of their common stock
after price appreciation to earn an investment return, which may never occur.
Investors seeking cash dividends should not purchase our common stock. Any
determination to pay dividends in the future will be made at the discretion
of
our Board of Directors and will depend on our results of operations, financial
conditions, contractual restrictions, restrictions imposed by applicable law
and
other factors our Board deems relevant.
Certain
Provisions Of Minnesota Law And Our Charter Documents Have An Anti-Takeover
Effect. There
exist certain mechanisms under Minnesota law and our charter documents that
may
delay, defer or prevent a change of control. Anti-takeover provisions of our
articles of incorporation, bylaws and Minnesota law could diminish the
opportunity for shareholders to participate in acquisition proposals at a price
above the then-current market price of our common stock. For example, while
we
have no present plans to issue any preferred stock, our Board of Directors,
without further shareholder approval, may issue shares of undesignated preferred
stock and fix the powers, preferences, rights and limitations of such class
or
series, which could adversely affect the voting power of your shares. In
addition, our bylaws provide for an advance notice procedure for nomination
of
candidates to our Board of Directors that could have the effect of delaying,
deterring or preventing a change in control. Further, as a Minnesota
corporation, we are subject to provisions of the Minnesota Business Corporation
Act, or MBCA, regarding “business combinations,” which can deter attempted
takeovers in certain situations. Pursuant to the terms of a shareholder rights
plan adopted in February 2007, each outstanding share of common stock has one
attached right. The rights will cause substantial dilution of the ownership
of a
person or group that attempts to acquire the Company on terms not approved
by
the Board of Directors and may have the effect of deterring hostile takeover
attempts. The effect of these anti-takeover provisions may be to deter business
combination transactions not approved by our Board of Directors, including
acquisitions that may offer a premium over the market price to some or all
stockholders. We may, in the future, consider adopting additional anti-takeover
measures. The authority of our Board to issue undesignated preferred or other
capital stock and the anti-takeover provisions of the MBCA, as well as other
current and any future anti-takeover measures adopted by us, may, in certain
circumstances, delay, deter or prevent takeover attempts and other changes
in
control of the company not approved by our Board of Directors.
Risks
Related To Our Business
Our
Independent Accountants Have Expressed Doubt About Our Ability To Continue
As A
Going Concern And We Only May Have Sufficient Capital To Fund Our Operations
For
The Next Twelve Months.
IsoRay,
Inc. has generated material operating losses since inception. We expect to
continue to experience net operating losses. Our ability to continue as a going
concern is subject to our ability to obtain necessary funding from outside
sources, including obtaining additional funding from the sale of our securities,
the exercise of our warrants, or obtaining loans and grants from various
financial institutions where possible. The substantial doubt expressed by our
auditors about our ability to continue as a going concern increases the
difficulty in meeting such goals. However, following the sale of this offering,
management believes that we will have sufficient proceeds to fund our operations
for the next twelve months. There can be no assurance that the Company will
attain profitability.
Our
Revenues Depend Upon One Product.
Until
such time as we develop additional products, our revenues depend upon the
successful production, marketing, and sales of the IsoRay 131Cs
seed.
The rate and level of market acceptance of this product may vary depending
on
the perception by physicians and other members of the healthcare community
of
its safety and efficacy as compared to that of competing products, if any;
the
clinical outcomes of the patients treated; the effectiveness of our sales and
marketing efforts in the United States and Europe; any unfavorable publicity
concerning our product or similar products; our product’s price relative to
other products or competing treatments; any decrease in current reimbursement
rates from the Centers for Medicare and Medicaid Services or third-party payers;
regulatory developments related to the manufacture or continued use of the
product; availability of sufficient supplies of enriched barium for 131Cs
seed
production; ability to produce sufficient quantities of this product; and the
ability of physicians to properly utilize the device and avoid excessive levels
of radiation to patients. Because of our reliance on this product as the sole
source of our revenue, any material adverse developments with respect to the
commercialization of this product may cause us to continue to incur losses
rather than profits in the future.
Although
Approved To Treat Any Malignant Tissue, Our Sole Product Is Currently Used
To
Treat One Type Of Cancer. As
of the
date of this prospectus supplement, the IsoRay 131Cs
seed
is used exclusively for the treatment of prostate cancer. We believe the
131Cs
seed
will be used to treat cancers of other sites as well, as is currently the case
with our competitors’ 125I
and
103Pd
seeds.
However, we believe that clinical data gathered by select groups of physicians
under treatment protocols specific to other organs will be needed prior to
widespread acceptance of our product for treating other cancer sites. If our
current and future products do not become accepted in treating cancers of other
sites, our sales will depend solely on treatment of prostate cancer and we
will
require ever increasing market share to increase revenues.
The
Lease On Our Production Facility Ends In October 2007. The
Company’s current production facility lease ends in October 2007. While the
landlord has agreed to work with the Company to minimize production disruptions,
the landlord has indicated that it does not intend to enter into a long-term
leasing agreement with the Company. Management is in the final stages of
negotiation to lease space for a new production facility. Once the new lease
is
signed, the Company will begin to obtain the necessary permits and licenses
and
to make the necessary leasehold improvements. Management believes that the
Company will be able to obtain the necessary permits for the new facility in
a
timely manner that will not cause delays in the leasehold improvements
construction schedule. This new facility is expected to be operational at the
end of calendar year 2007. Management believes that the new production facility
lease currently being negotiated will be able to accommodate the Company’s
anticipated future growth for several years. The Company continues to use PNNL
to provide third-party assay of its products, but has otherwise vacated PNNL
facilities. Management believes that if the Company is unable to obtain the
new
lease, the necessary permits, or finish the leasehold improvements before having
to vacate the present manufacturing facility, that a temporary manufacturing
facility is available and could be used although production capacity and
scheduling flexibility would be limited.
We
Have Limited Data On The Clinical Performance Of 131Cs.
As of
February 15, 2007, the IsoRay 131Cs
seed
had been implanted in over 900 patients.
While this number of patients may prevent us from drawing statistically
significant conclusions, the side effects experienced by these patients were
less severe than side effects observed in seed brachytherapy with 125I
and
103Pd
and in
other forms of treatment such as radical prostatectomy. These early results
indicate that the onset of side effects generally occurs between one and three
weeks post-implant, and the side effects are resolved between five and eight
weeks post-implant, indicating that, at least for these initial patients, side
effects resolved more quickly than the side effects that occur with competing
seeds or with other forms of treatment. These limited findings support
management’s belief that the 131Cs
seed
will result in less severe side effects than competing treatments, but we may
have to gather data on outcomes from additional patients before we can establish
statistically valid conclusions regarding the incidence of side effects from
our
seeds.
We
Will Need To Raise Additional Capital.
The
hiring of upper level executives and increasing production requirements
significantly increased IsoRay’s monthly cash requirements since August 2005.
Monthly operating cash requirements as of February 1, 2007 were approximately
$700,000, excluding capitalized items. Capital expenditures typically include
the purchase or capital lease of equipment, with a life-expectancy of more
than
12 months, costing in excess of $2,500, which would include among other things:
analytical systems, improved packaging for final products and, new production
systems which increase manufacturing throughput. Ongoing requirements to meet
greater payroll obligations coupled with legal and accounting fees associated
with our public reporting status have resulted in greater amounts of short-term
cash demands. We will also need substantial funds to complete the development,
manufacturing, and marketing of our current and future products. If we raise
the
full net approximately $15 million being offered hereunder, management believes
that we will have sufficient capital to fund our operations for the next twelve
months.
We
will
seek to raise any needed additional capital through not only warrant
solicitation, public and private offerings of equity and debt securities, but
also collaborative arrangements, strategic alliances, or from other sources.
We
may be unable to raise additional capital on commercially acceptable terms,
if
at all, and if we raise capital through additional equity financing, existing
shareholders may have their ownership interests diluted. Our failure to be
able
to generate adequate funds from operations or from additional sources would
harm
our business, requiring us to scale back our operations, potentially
significantly, or delay the implementation of our business
strategy.
The
Passage Of Initiative 297 In Washington May Result In The Relocation Of Our
Manufacturing Operations. Washington
voters approved Initiative 297 in late 2004, which may impose restrictions
on
sites at which mixed radioactive and hazardous wastes are generated and stored.
IsoRay has been assured by the Attorney General’s office of the State of
Washington that medical isotopes are not included in Initiative 297 and that
manufacturing in IsoRay’s new production facility would not be interrupted, but
there is no assurance that this interpretation of Initiative 297 by the Attorney
General’s Office will continue to exclude medical isotopes. In June 2006, a U.S.
District Court judge ruled that Initiative 297 was unconstitutional in its
entirety. However, the State of Washington has indicated that it may appeal
the
decision. If this decision is overturned and Initiative 297 is enforced it
could
impact our ability to manufacture our seeds in the State of
Washington.
Management
believes that we will be able to continue our manufacturing operations in the
State of Washington for the foreseeable future. In the event Initiative 297
is
enforced against us, management may consider establishing an alternate
manufacturing facility outside of Washington, and we may consider moving all
or
part of our operations to another state even if Initiative 297 is not enforced
against us.
We
Have Limited Manufacturing Experience And May Not Be Able To Meet
Demand.
The
existing management team and staff of IsoRay have experience primarily in
research and development of products and our experience in commercial-scale
manufacturing is limited. We began commercial production of the 131Cs
seed
in the fourth quarter of 2004. Although our management team has significant
radiochemistry experience, there is a possibility that production demands may
result in challenges that may be too difficult or expensive to overcome. We
have
developed and deployed semi-automated laser welding equipment that can produce
seeds faster than fully-automated equipment the Company has reviewed that would
cost several million dollars to design and fabricate. We believe we will
continually find more efficient means of welding the titanium seeds; however,
there is a possibility that future demand will outstrip our ability to produce
seeds using the semi-automated process. Management believes that the new
production facility lease currently being negotiated will be able to accommodate
the Company’s anticipated future growth for several years. The Company continues
to use PNNL to provide third-party assay of its products, but has otherwise
vacated PNNL facilities.
We
Are Subject To The Risk That Certain Third Parties May Mishandle Our Product.
We
rely
on third parties, such as Federal Express, to deliver our 131Cs
seed,
and on other third parties, including various radiopharmacies, to package our
131Cs
seed
in certain specialized packaging forms that, as of the date of this prospectus
supplement, we do not provide at our own facilities. We are subject to the
risk
that these third parties may mishandle our product, which could result in
adverse effects, particularly given the radioactive nature of our product.
As an
example, on January 5, 2006, we were notified by one of our primary customers,
Chicago Prostate Cancer Center (“CPCC”), that it would no longer accept
131Cs
products from the radiopharmacy exclusively used by us at that time due to
quality control concerns. The role of the radiopharmacy is to provide
third-party assay, preloading, and sterilization of the 131Cs
seeds
which are then shipped directly to customers for use in patient implants. We
immediately began working to bring these functions in house. On March 28, 2006,
CPCC resumed ordering from us.
Our
Operating Results Will Be Subject To Significant Fluctuations. Our
quarterly revenues, expenses, and operating results are likely to fluctuate
significantly in the future. Fluctuation may result from a variety of factors,
which are discussed in detail throughout this “Risk Factors” section,
including:
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our
achievement of product development objectives and
milestones;
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demand
and pricing for the Company’s
products;
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effects
of aggressive competitors;
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hospital,
clinic and physician buying
decisions;
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research
and development and manufacturing
expenses;
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patient
outcomes from our therapy;
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physician
acceptance of our products;
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government
or private healthcare reimbursement
policies;
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our
manufacturing performance and
capacity;
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incidents,
if any, that could cause temporary shutdown of our manufacturing
facilities;
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the
amount and timing of sales orders;
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rate
and success of future product
approvals;
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timing
of FDA clearance, if any, of competitive products and the rate of
market
penetration of competing products;
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seasonality
of purchasing behavior in our
market;
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overall
economic conditions; and
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the
successful introduction or market penetration of alternative
therapies.
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We
Rely Heavily On A Limited Number Of Suppliers. Some
materials used in our products are currently available only from a limited
number of suppliers. For example, virtually all titanium tubing used in
brachytherapy seed manufacture comes from a single source, Accellent
Corporation. We currently obtain a key component of our seed core from a single
supplier. We do not have formal written agreements with either this key supplier
or with Accellent Corporation. Any interruption or delay in the supply of
materials required to produce our products could harm our business if we were
unable to obtain an alternative supplier or substitute equivalent materials
in a
cost-effective and timely manner. Over sixty percent (60%) of our cesium is
now
supplied through the Institute of Nuclear Materials (“INM”) located in the
former Soviet Union. This percentage will continue to increase as demand for
our
products increases. Management expects that we will be able to supplement our
supply of cesium with deliveries under our recent contract with the Russian
Research Institute of Atomic Reactors (“RIAR”), although deliveries have not yet
begun under this contract and are now not expected until October 2007. Failure
to obtain deliveries of cesium from these sources would have a material adverse
effect on seed production and there may be a delay before we could locate
alternative suppliers. Additional factors that could cause interruptions or
delays in our source of materials include limitations on the availability of
raw
materials or manufacturing performance experienced by our suppliers and a
breakdown in our commercial relations with one or more suppliers. Some of these
factors may be completely out of our and our suppliers’ control.
Future
Production Increases Will Depend on Our Ability to Acquire Larger Quantities
of
131Cs
and Hire More Employees. IsoRay
currently obtains 131Cs
through its contract with INM and through reactor irradiation of natural barium
and subsequent separation of cesium from the irradiated barium targets. The
amount of 131Cs
that
can be produced from a given reactor source is limited by the power level and
volume available within the reactor for irradiating targets. This limitation
can
be overcome by utilizing barium feedstock that is enriched in the stable isotope
130Ba.
However, the number of suppliers of enriched barium is limited and they may
be
unable to produce this material in sufficient quantities at a reasonable
price.
IsoRay
has entered into exclusive agreements with the Institute of Nuclear Materials
and the Russian Research Institute of Atomic Reactors in Russia to provide
131Cs
in
quantities sufficient to supply a significant percentage of future demand for
this isotope. Delivery of the isotope from the Institute of Nuclear Materials
began in January 2006 and delivery of initial quantities of the isotope from
RIAR are expected to begin during October 2007. IsoRay believes these suppliers
may also provide access to sufficient quantities of enriched barium that may
be
recycled for use in other reactors to increase the production of 131Cs.
Although the agreements provide for supplying 131Cs
in
significant quantities, there is no assurance that this will result in IsoRay
gaining access to a sufficient supply of enriched barium feedstock and if
sufficient supplies are attained we will need to increase our manufacturing
staff. If we were unable to obtain supplies of isotopes from Russia in the
future, our overall supply of cesium and barium would be reduced significantly.
We
Are Subject To Uncertainties Regarding Reimbursement For Use Of Our Products.
Hospitals
and freestanding clinics may be less likely to purchase our products if they
cannot be assured of receiving favorable reimbursement for treatments using
our
products from third-party payers, such as Medicare, Medicaid and private health
insurance plans. Currently, Medicare reimburses hospitals, clinics and
physicians for the cost of seeds used in brachytherapy procedures on a per
seed
basis. Historically, private insurers have followed Medicare guidelines in
establishing reimbursement rates. However, third-party payers are increasingly
challenging the pricing of certain medical services or devices, and we cannot
be
sure that they will reimburse our customers at levels sufficient for us to
maintain favorable sales and price levels for our products. There is no uniform
policy on reimbursement among third-party payers, and we can provide no
assurance that our products will continue to qualify for reimbursement from
all
third-party payers or that reimbursement rates will not be reduced. A reduction
in or elimination of third-party reimbursement for treatments using our products
would likely have a material adverse effect on our revenues.
In
2003,
we applied to the Centers for Medicare and Medicaid Services (CMS) and received
reimbursement codes for use of our 131Cs
seed
(HCPCS code C2633 and APC code 2633). Reimbursement amounts are reviewed and
revised periodically on an ad hoc basis. Adjustments could be made to these
reimbursement amounts or policies, which could result in reduced reimbursement
for brachytherapy services, which could negatively affect market demand for
our
products.
Furthermore,
any federal and state efforts to reform government and private healthcare
insurance programs could significantly affect the purchase of healthcare
services and products in general and demand for our products in particular.
We
are unable to predict whether potential healthcare reforms will be enacted,
whether other healthcare legislation or regulations affecting the business
may
be proposed or enacted in the future or what effect any such legislation or
regulations would have on our business, financial condition or results of
operations.
It
Is
Possible That Other Treatments May Be Deemed Superior To Brachytherapy.
Our
131Cs
seed
faces competition not only from companies that sell other radiation therapy
products, but also from companies that are developing alternative therapies
for
the treatment of cancers. It is possible that advances in the pharmaceutical,
biomedical, or gene therapy fields could render some or all radiation therapies,
whether conventional or brachytherapy, obsolete. If alternative therapies are
proven or even perceived to offer treatment options that are superior to
brachytherapy, physician adoption of our product could be negatively affected
and our revenues from our product could decline.
Our
Industry Is Intensely Competitive. The
medical products industry is intensely competitive. We compete with both public
and private medical device, biotechnology and pharmaceutical companies that
have
been established longer than we have, have a greater number of products on
the
market, have greater financial and other resources, and have other technological
or competitive advantages. In addition, centers that wish to offer the
131Cs
seed
must comply with licensing requirements specific to the state in which they
do
business and these licensing requirements may take a considerable amount of
time
to comply with. Certain centers may choose to not offer our 131Cs seed
due
to the time required to obtain necessary license amendments. We also compete
with academic institutions, government agencies, and private research
organizations in the development of technologies and processes and in acquiring
key personnel. Although we have patents granted and patents applied for to
protect our isotope separation processes and 131Cs
seed
manufacturing technology, we cannot be certain that one or more of our
competitors will not attempt to obtain patent protection that blocks or
adversely affects our product development efforts. To minimize this potential,
we have entered into exclusive agreements with key suppliers of isotopes and
isotope precursors.
We
May Be Unable To Adequately Protect Or Enforce Our Intellectual Property Rights
Or Secure Rights To Third-Party Patents. Our
ability and the abilities of our partners to obtain and maintain patent and
other protection for our products will affect our success. We are assigned,
have
rights to, or have exclusive licenses to patents and patents pending in the
U.S.
and numerous foreign countries. The patent positions of medical device companies
can be highly uncertain and involve complex legal and factual questions. Our
patent rights may not be upheld in a court of law if challenged. Our patent
rights may not provide competitive advantages for our products and may be
challenged, infringed upon or circumvented by our competitors. We cannot patent
our products in all countries or afford to litigate every potential violation
worldwide.
Because
of the large number of patent filings in the medical device and biotechnology
field, our competitors may have filed applications or been issued patents and
may obtain additional patents and proprietary rights relating to products or
processes competitive with or similar to ours. We cannot be certain that U.S.
or
foreign patents do not exist or will not be issued that would harm our ability
to commercialize our products and product candidates.
One
Of Our Licensed Patents May Be Terminated Under Certain
Conditions.
Our
131Cs
separation patent is essential for the production of Cesium-131. The owner
of
the patent, Lane Bray, a shareholder of the Company and Chief Chemist of
Medical, has the right to terminate the license agreement that allows the
Company to use this patent if we discontinue production for any consecutive
18
month period. The Company has no plans to discontinue production, and management
considers it highly unlikely that production will be discontinued for any
significant period at any time in the future.
Failure
To Comply With Government Regulations Could Harm Our Business.
As a
medical device and medical isotope manufacturer, we are subject to extensive,
complex, costly, and evolving governmental rules, regulations and restrictions
administered by the FDA, by other federal and state agencies, and by
governmental authorities in other countries. Compliance with these laws and
regulations is expensive and time-consuming, and changes to or failure to comply
with these laws and regulations, or adoption of new laws and regulations, could
adversely affect our business.
In
the
United States, as a manufacturer of medical devices and devices utilizing
radioactive by-product material, we are subject to extensive regulation by
federal, state, and local governmental authorities, such as the FDA and the
Washington State Department of Health, to
ensure
such devices are safe and effective. Regulations promulgated by the FDA under
the U.S. Food, Drug and Cosmetic Act, or the FDC Act, govern the design,
development, testing, manufacturing, packaging, labeling, distribution,
marketing and sale, post-market surveillance, repairs, replacements, and recalls
of medical devices. In Washington State, the Department of Health, by agreement
with the federal Nuclear Regulatory Commission ("NRC"), regulates the
possession, use, and disposal of radioactive byproduct material as well as
the
manufacture of radioactive sealed sources to ensure compliance with state and
federal laws and regulations. Our 131Cs
brachytherapy seeds constitute both medical devices and radioactive sealed
sources and are subject to these regulations.
Under
the
FDC Act, medical devices are classified into three different categories, over
which the FDA applies increasing levels of regulation: Class I,
Class II, and Class III. Our 131Cs
seed
has been classified as a Class II device and has received clearance from the
FDA
through the 510(k) pre-market notification process. Although not anticipated,
any modifications to the device that would significantly affect safety or
effectiveness, or constitute a major change in intended use, would require
a new
510(k) submission. As with any submittal to the FDA, there is no assurance
that
a 510(k) clearance would be granted to the Company.
In
addition to FDA-required market clearances and approvals for our products,
our
manufacturing operations are required to comply with the FDA's Quality System
Regulation, or QSR, which addresses requirements for a company's quality program
such as management responsibility, good manufacturing practices, product and
process design controls, and quality controls used in manufacturing. Compliance
with applicable regulatory requirements is monitored through periodic
inspections by the FDA Office of Regulatory Affairs ("ORA"). We anticipate
both
announced and unannounced inspections by the FDA. Such inspections could result
in non-compliance reports (Form 483) which, if not adequately responded to,
could lead to enforcement actions. The FDA can institute a wide variety of
enforcement actions, ranging from public warning letters to more severe
sanctions such as fines, injunctions, civil penalties, recall of our products,
operating restrictions, suspension of production, non-approval or withdrawal
of
pre-market clearances for new products or existing products, and criminal
prosecution. There can be no assurance that we will not incur significant costs
to comply with these regulations in the future or that the regulations will
not
have a material adverse effect on our business, financial condition and results
of operations.
The
marketing of our products in foreign countries will, in general, be regulated
by
foreign governmental agencies similar to the FDA. Foreign regulatory
requirements vary from country to country. The time and cost required to obtain
regulatory approvals could be longer than that required for FDA clearance in
the
United States and the requirements for licensing a product in another country
may differ significantly from FDA requirements. We will rely, in part, on
foreign distributors to assist us in complying with foreign regulatory
requirements. We may not be able to obtain these approvals without incurring
significant expenses or at all, and the failure to obtain these approvals would
prevent us from selling our products in the applicable countries. This could
limit our sales and growth.
Our
Business Exposes Us To Product Liability Claims. Our
design, testing, development, manufacture, and marketing of products involve
an
inherent risk of exposure to product liability claims and related adverse
publicity. Insurance coverage is expensive and difficult to obtain, and,
although we currently have a five million dollar policy, in the future we may
be
unable to obtain or renew coverage on acceptable terms, if at all. If we are
unable to obtain or renew sufficient insurance at an acceptable cost or if
a
successful product liability claim is made against us, whether fully covered
by
insurance or not, our business could be harmed.
Our
Business Involves Environmental Risks. Our
business involves the controlled use of hazardous materials, chemicals,
biologics, and radioactive compounds. Manufacturing is extremely susceptible
to
product loss due to radioactive, microbial, or viral contamination; material
or
equipment failure; vendor or operator error; or due to the very nature of the
product’s short half-life. Although we believe that our safety procedures for
handling and disposing of such materials comply with state and federal standards
there will always be the risk of accidental contamination or injury. In
addition, radioactive, microbial, or viral contamination may cause the closure
of the respective manufacturing facility for an extended period of time. By
law,
radioactive materials may only be disposed of at state-approved facilities.
At
our leased facility we use commercial disposal contractors. We may incur
substantial costs related to the disposal of these materials. If we were to
become liable for an accident, or if we were to suffer an extended facility
shutdown, we could incur significant costs, damages, and penalties that could
harm our business.
We
Rely Upon Key Personnel. Our
success will depend, to a great extent, upon the experience, abilities and
continued services of our executive officers and key scientific personnel.
IsoRay has an employment agreement with Roger Girard, its Chief Executive
Officer, and Lori Woods, its Vice President, and its subsidiary has employment
agreements with most of its executive officers and key scientific personnel.
If
we lose the services of several of these officers or key scientific personnel,
our business could be harmed. Our success also will depend upon our ability
to
attract and retain other highly qualified scientific, managerial, sales, and
manufacturing personnel and their ability to develop and maintain relationships
with key individuals in the industry. Competition for these personnel and
relationships is intense and we compete with numerous pharmaceutical and
biotechnology companies as well as with universities and non-profit research
organizations. We may not be able to continue to attract and retain qualified
personnel.
The
Value Of Our Granted Patent, and Our Patents Pending, Is Uncertain.
Although
our management strongly believes that our patent on the process for producing
131Cs,
our
patent pending on the manufacture of the brachytherapy seed, our patent
applications on additional methods for producing 131Cs
and
other isotopes which have been filed, and anticipated future patent
applications, which have not yet been filed, have significant value, we cannot
be certain that other like-kind processes may not exist or be discovered, that
any of these patents is enforceable, or that any of our patent applications
will
result in issued patents.
Our
Ability To Expand Into Foreign Markets Is Uncertain. Our
future growth will depend in part on our ability to establish, grow and maintain
product sales in foreign markets, particularly in Europe and Asia. However,
we
have limited experience in marketing and distributing products in other
countries. Any foreign operations would subject us to additional risks and
uncertainties, including our customers’ ability to obtain reimbursement for
procedures using our products in foreign markets; the burden of complying with
complex and changing foreign regulatory requirements; language barriers and
other difficulties in providing long-range customer service; potentially longer
accounts receivable collection times; significant currency fluctuations, which
could cause third-party distributors to reduce the number of products they
purchase from us because the cost of our products to them could fluctuate
relative to the price they can charge their customers; reduced protection of
intellectual property rights in some foreign countries; and the possibility
that
contractual provisions governed by foreign laws would be interpreted differently
than intended in the event of a contract dispute. Any future foreign sales
of
our products could also be adversely affected by export license requirements,
the imposition of governmental controls, political and economic instability,
trade restrictions, changes in tariffs and difficulties in staffing and managing
foreign operations. Many of these factors may also affect our ability to import
enriched barium from Russia under our contracts with the INM and
RIAR.
Our
Ability To Initiate Operations And Manage Growth Is Uncertain. Our
efforts to commercialize our medical products will result in new and increased
responsibilities for management personnel and will place a strain upon the
entire company. To compete effectively and to accommodate growth, if any, we
may
be required to continue to implement and to improve our management,
manufacturing, sales and marketing, operating and financial systems, procedures
and controls on a timely basis and to expand, train, motivate and manage our
employees. There can be no assurance that our personnel, systems, procedures,
and controls will be adequate to support our future operations. If the IsoRay
131Cs
seed
were to rapidly become the “seed of choice,” it is unlikely that we could meet
demand. We could experience significant cash flow difficulties and may have
difficulty obtaining the working capital required to manufacture our products
and meet demand. This would cause customer discontent and invite competition.
Our
Reporting Obligations As A Public Company Are Costly. Operating
a public company involves substantial costs to comply with reporting obligations
under federal securities laws that are continuing to increase as provisions
of
the Sarbanes Oxley Act of 2002 are implemented. These reporting obligations
increase our operating costs. We may not reach sufficient business volume to
justify our public reporting status.
USE
OF PROCEEDS
We
estimate that the net proceeds from the sale of the 4,000,000 shares of
common stock and warrants to purchase 800,000 shares of common stock we are
offering will be approximately $14,872,860 million, after deducting
placement agent fees and the estimated offering expenses payable by us and
assuming that we sell all of the shares and warrants offered hereunder but
none
of the warrants are exercised.
We
intend
to use the net proceeds from the sale of our shares of common stock offered
by
this prospectus supplement for general corporate purposes, including without
limitation capital expenditures and working capital needs, as described
below:
Salaries,
fees and expenses
|
|
$
|
1,160,000
|
|
Sales,
marketing and advertising
|
|
|
2,000,000
|
|
Purchase,
rental or leasing and installation of machinery and equipment(1)
|
|
|
2,500,000
|
|
Construction
or leasing of plant and facilities(2)
|
|
|
2,000,000
|
|
Licensing
and acquisitions of new products or business units
|
|
|
1,167,860
|
|
Research
and development
|
|
|
2,172,140
|
|
Repayment
of indebtedness
|
|
|
590,000
|
|
Working
capital and payment of offering expenses
|
|
|
3,450,000
|
|
|
|
|
|
|
Total
|
|
$
|
15,040,000
|
|
(1)
Includes
production equipment such as hot cells, gloveboxes, laser welders, and
automation equipment. No vendors have been selected for these
items.
(2)
Includes
tenant improvements and lease payments for our new production facility.
Although
we have identified some of the potential uses of the proceeds from this
offering, we have and reserve broad discretion in the application of these
proceeds. Accordingly, we reserve the right to use these proceeds for different
purposes or uses which we have not listed above. See "Risk Factors -
Since
We Have Broad Discretion In How We Use The Proceeds From This Offering, We
May
Use The Proceeds In Ways In Which You Disagree."
Pending
any ultimate use of any portion of the proceeds from this offering, we intend
to
invest the proceeds in short-term US governmental securities.
Proceeds
from the exercise of the warrants being sold through this offering are estimated
to be $4,000,000, assuming all warrants are exercised using cash, and may be
received by the Company at any time following the offering depending on when
and
if the warrants are exercised by investors. These proceeds when and if received
are expected to be used for general corporate purposes, including without
limitation, capital expenditures and working capital needs.
DETERMINATION
OF OFFERING PRICE
We
will
sell our common stock and warrants in this offering at a negotiated price of
$20
per five shares of common stock. Each purchaser of five shares of our common
stock will receive a warrant to purchase one share of common stock at an
exercise price of $5.00 per share. Prior to this offering, there was no public
market for the warrants. The terms and conditions of the warrants, including
exercise price, were determined by negotiation by us and the purchasers. The
principal factors considered in determining these terms and conditions include:
|
•
|
|
the
market price of our common stock;
|
|
•
|
|
the
recent market prices of, and demand for, publicly traded common stock
and
warrants to purchase publicly traded common stock of generally comparable
companies; and
|
|
•
|
|
other
factors deemed relevant by the purchasers and us.
|
DILUTION
Our
net
tangible book value on December 31, 2006 was approximately $4,056,916, or
approximately $0.25 per share. “Net tangible book value” is total assets minus
the sum of liabilities and intangible assets. “Net tangible book value per
share” is net tangible book value divided by the total number of shares of
common stock outstanding at December 31, 2006.
Net
tangible book value dilution per share to new investors represents the
difference between the amount per share paid by purchasers of shares of common
stock in this offering and the net tangible book value per share of our common
stock immediately after completion of this offering. For purposes of this
calculation, the entire purchase price for the shares and warrants is being
allocated to the shares of common stock and assumes no exercise of the warrants.
After giving effect to the sale of 4,000,000 shares of our common stock in
this
offering and after deducting the placement agent fees and our estimated offering
expenses, at a public offering price of $4.00 per share, our net tangible book
value as of December 31, 2006 would have been $0.92 per share. This amount
represents an immediate increase in net tangible book value of $0.67 per share
to existing shareholders and an immediate dilution of $3.08 per share to
purchasers of common stock in this offering, as illustrated in the following
table:
Public
offering price per share
|
|
$
|
4.00
|
|
Net
tangible book value per share as of December 31, 2006
|
|
$
|
0.25
|
|
Increase
in net tangible book value per share attributable to this
offering
|
|
$
|
0.67
|
|
Pro
forma net tangible book value per share as of December 31, 2006 after
giving
effect to this offering
|
|
$
|
0.92
|
|
Dilution
per share to new investors in this offering
|
|
$
|
3.08
|
|
|
|
|
|
|
The
table
above excludes, as of December 31, 2006, the following securities:
·
|
4,707,131 shares
of common stock issuable upon the exercise of warrants with a weighted
average exercise price of $4.36;
|
|
|
·
|
77,080
shares of common stock issuable upon the conversion of preferred
stock;
|
|
|
·
|
3,184,639 shares
of common stock issuable upon the exercise of options with a weighted
average exercise price of $2.49;
|
|
|
·
|
109,639
shares of common stock issuable upon the conversion of convertible
debentures at $4.15 per share;
|
|
|
·
|
970,578 shares
of common stock reserved for future stock option grants under our
equity
compensation plans; and
|
|
|
·
|
800,000
shares of common stock issuable upon the exercise of the warrants
included
in this offering at an exercise price of $5.00 per share and up to
200,000
shares of common stock issuable upon the exercise of the warrants
to be
issued to the placement agents at an exercise price of $4.40 per
share.
|
|
|
To
the
extent that any of these options, warrants and convertible securities are
exercised or converted, there may be further dilution to new investors.
DESCRIPTION
OF WARRANTS
The
material terms and provisions of the warrants being offered pursuant to this
prospectus supplement and the accompanying prospectus are summarized below.
This
summary is subject to, and qualified in its entirety by, the form of warrant
filed as an exhibit to our current report on Form 8-K, which we will file prior
to the opening of the market on the day following the pricing of the
offering.
Each
warrant entitles the registered holder to purchase the number of shares of
our
common stock set forth on the cover thereof at a price of $5.00 per share,
subject to adjustment, as discussed below, at any time commencing on the closing
date. The warrants will expire on the fourth anniversary of the closing date.
We
will not make an application to list the warrants on the OTC Bulletin Board,
any
national securities exchange or other nationally recognized trading system.
The
common stock underlying the warrants is quoted on the OTC Bulletin
Board.
The
exercise price and number of shares of common stock issuable upon exercise
of
the warrants may be adjusted in certain circumstances, including in the event
of
our reorganization, reclassification, merger, consolidation, sale of
substantially all assets, subdivision or combination of stock, or payment of any
stock dividend.
The
warrants may be exercised upon surrender of the warrant on or prior to the
expiration date at the offices of the Company, with the subscription form set
forth in the warrant completed and executed as indicated, accompanied by full
payment of the exercise price, in certified or other immediately available
funds, for the number of warrants being exercised as provided for in the
warrant. In the event that a registration statement covering the shares issuable
upon the exercise of a warrant is not effective at the time the warrant is
exercised, the holder of the warrant may elect a cashless exercise of the
warrant.
The
warrantholders do not have the rights or privileges of holders of common stock,
including any voting rights, until they exercise their warrants and receive
shares of common stock. After the issuance of shares of common stock upon
exercise of the warrants, each holder will be entitled to one vote for each
share held of record on all matters to be voted on by stockholders.
No
fractional shares will be issued upon exercise of the warrants.
PLAN
OF DISTRIBUTION
We
are
offering the shares and warrants through placement agents. Subject to the terms
and conditions contained in the placement agent agreements, dated March 14,
2007
and February 2, 2006, Punk Ziegel & Company, L.P. and Maxim Group LLC have
agreed to act as the placement agents for the sale of up to 4,000,000 shares
of
common stock and warrants to purchase 800,000 shares of common stock. The
placement agents are not purchasing or selling any shares or warrants by this
prospectus supplement, nor are they required to arrange for the purchase or
sale
of any specific number or dollar amount of shares and warrants, but have agreed
to use their best efforts to arrange for the sale of all shares and
warrants.
The
placement agents propose to arrange for the sale to one or more purchasers
of
the common stock and warrants offered pursuant to this prospectus supplement
and
the accompanying prospectus through direct purchase agreements between the
purchasers and us.
Our
obligation to issue and sell shares of our common stock and warrants to the
purchasers is subject to the conditions set forth in the purchase agreements,
which may be waived by us in our discretion. A purchaser’s obligation to
purchase our common stock and warrants is subject to conditions set forth in
the
purchase agreement as well, which also may be waived.
It
is
expected that the sale of up to 4,000,000 shares of our common stock and
warrants to purchase up to 800,000 shares of our common stock will be completed
on or about March 19, 2007. We have entered into an Escrow Agreement dated
March
14, 2007 with the placements agents and American Stock Transfer & Trust
Company as escrow agent whereby the escrow agent will receive and hold funds
from purchasers and release them to us only if the minimum offering amount
of
$15 million is raised through escrowed funds in combination with any direct
funding. If the minimum offering amount is not raised, the escrow agent will
return the money raised to purchasers without any deduction or
interest.
Because
the minimum offering amount required as a condition to closing in this offering
is $15 million, the actual total offering commissions are not presently
determinable and may be less than the maximum amount set forth above.
We
will
pay the placement agents an aggregate cash commission equal to 6.0% of the
gross
proceeds of the sale of the shares and warrants. We will also reimburse the
placement agents for up to $35,000 in documented expenses in addition to legal
expenses incurred by them in connection with this offering. In no event will
the
total amount of compensation paid to the placement agents and other securities
brokers and dealers upon completion of this offering exceed 8% of the gross
proceeds of this offering. The estimated offering expenses payable by us, in
addition to the placement agents’ fee of $960,000, and not including any expense
reimbursement payable to the placement agents, are approximately $167,140,
which
includes legal, accounting and printing costs and various other fees associated
with registering and listing the common stock. After deducting certain fees
due
to the placement agents and our estimated offering expenses, we expect the
net
proceeds from this offering to be approximately $14.9 million, excluding any
exercise of the warrants.
The
placement agents will receive warrants to purchase 5% of the aggregate shares
of
common stock sold pursuant to this offering. These warrants will have an
exercise price equal to 110% of the price of the shares sold pursuant to this
offering, or $4.40 per share, a four year term, and will provide for cashless
exercise. These warrants are not registered hereunder but the Company has agreed
to grant registration rights for the warrants consisting of a one-time demand
registration right and future piggyback registration rights.
The
securities to be received by Punk, Ziegel & Company, L.P. and Maxim Group
LLC will not be sold, transferred, hypothecated, assigned, pledged or otherwise
subjected to any hedging, short sale, put, derivative or call transaction for
a
period of 180-days from the date of the consummation of this offering as
outlined in Rule 2710(g)(1) of the National Association of Securities Dealers,
Inc.
We
have
agreed to indemnify the placement agents against certain liabilities, including
liabilities under the Securities Act of 1933, as amended, and liabilities
arising from breaches of representations and warranties contained in the
placement agent agreement. We have also agreed to contribute to payments the
placement agents may be required to make in respect of such
liabilities.
The
placement agents have informed us that they will not engage in over-allotment,
stabilizing transactions or syndicate covering transactions in connection with
this offering.
The
placement agent agreements are included as exhibits to our Current Report on
Form 8-K that we will file with the SEC in connection with the consummation
of
this offering.
Our
common stock is traded on the OTC Bulletin Board under the symbol “ISRY.OB.”
The
placement agents and their affiliates have provided and may provide certain
financial advisory and investment banking services for us for which they receive
fees. The placement agents and their affiliates may from time to time in the
future engage in transactions with us and perform services for us in the
ordinary course of their business.
WHERE
YOU CAN FIND MORE INFORMATION
We
file
annual, quarterly and current reports, proxy statements and other information
with the SEC. Our SEC filings are available to the public over the Internet
at
the SEC’s website at http://www.sec.gov.
The
SEC’s website contains reports, proxy and information statements and other
information regarding issuers, such as us, that file electronically with the
SEC. You may also read and copy any document we file with the SEC at the SEC’s
Public Reference Room at 100 F Street, N.E., Room 1580,
Washington, D.C. 20549. You may also obtain copies of these documents at
prescribed rates by writing to the SEC. Please call the SEC at 1-800-SEC-0330
for further information on the operation of its Public Reference Room. We
maintain a website at www.isoray.com.
We have
not incorporated by reference into this prospectus supplement or the
accompanying prospectus the information in, or that can be accessed through,
our
website, and you should not consider it to be a part of this prospectus
supplement or the accompanying prospectus.
INCORPORATION
OF CERTAIN DOCUMENTS BY REFERENCE
The
SEC
allows us to “incorporate by reference” into this prospectus the information we
file with it. This means that we can disclose important information to you
by
referring you to those documents. The information we incorporate by reference
is
considered to be a part of this prospectus, and later information we file with
the SEC will automatically update and supersede this information. The following
documents filed with the SEC (in each case, Commission File No. 000-14247)
are incorporated by reference in this prospectus:
(a) Our
Annual Report on Form 10-KSB for the fiscal year ended June 30, 2006 (filed
September 28, 2006), which contains audited financial statements for our latest
fiscal year for which such statements have been filed.
(b) Our
Quarterly Reports on Form 10-QSB for the fiscal quarters ended September 30,
2006 (filed November 14, 2006) and December 31, 2006 (filed February 14, 2007).
(c) Our
Current Reports on Form 8-K filed on August 10, 2006, August 18, 2006, September
8, 2006, September 11, 2006, November 6, 2006 and February 7, 2007.
(d) The
description of our common stock contained in our Registration Statement on
Form
SB-2, filed with the Commission on October 16, 2006, including any amendments
or
reports filed for the purpose of updating such description.
(e) Our
Proxy
Statement on Schedule 14A filed on January 16, 2007.
We
are
also incorporating by reference any future filings we make with the SEC under
Section 13(a), 13(c), 14 or 15(d) of the Exchange Act until this offering
is completed, except for information furnished under Item 2.02 or
Item 7.01 of our Current Reports on Form 8-K which is not deemed to be
filed and not incorporated by reference herein.
You
may
request a copy of these filings (other than an exhibit to a filing unless that
exhibit is specifically incorporated by reference into that filing), at no
cost,
by writing or calling us at IsoRay, Inc., 350 Hills Street, Suite 106, Richland,
Washington 99354, telephone number (509) 375-1202, Attention: Chief
Financial Officer.
ISORAY,
INC.
$20,000,000
Common
Stock
Warrants
We
may,
from time to time in one or more offerings, sell up to $20,000,000 in the
aggregate, inclusive of any exercise price thereof, of:
|
•
|
|
shares
of our common stock;
|
|
•
|
|
warrants
to purchase shares of our common stock; or
|
|
•
|
|
any
combination of the foregoing.
|
We
will
provide the specific terms of these securities in supplements to this
prospectus. The prospectus supplement may also add, update or change information
in this prospectus. You should read this prospectus and any prospectus
supplement, as well as the documents incorporated by reference or deemed to
be
incorporated by reference into this prospectus, carefully before you invest.
This
prospectus may not be used to offer or sell securities unless accompanied by
a
prospectus supplement.
Our
principal executive offices are located at 350 Hills Street, Suite 106,
Richland, Washington 99354, and our telephone number is (509) 375-1202.
Our
common stock is listed on the Over the Counter Bulletin Board under the symbol
“ISRY.” Each prospectus supplement will contain information, where applicable,
as to any listing on the Over the Counter Bulletin Board or any other securities
exchange covered by the prospectus supplement.
Investing
in the securities we may offer involves various risks. See the sections entitled
“Risk
Factors” on page 2 and “Note Regarding Forward-Looking Statements” on page 2.
Additional risks associated with an investment in us as well as with the
particular types of securities will be described in the related prospectus
supplement.
Neither
the Securities and Exchange Commission nor any state securities commission
has
approved or disapproved of these securities or determined if this prospectus
is
truthful or complete. Any representation to the contrary is a criminal offense.
The
date
of this prospectus is January 26, 2007.
TABLE
OF CONTENTS
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Page
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ABOUT
THIS PROSPECTUS
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1
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ABOUT
ISORAY
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1
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RISK
FACTORS
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2
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NOTE
REGARDING FORWARD-LOOKING STATEMENTS
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2
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USE
OF PROCEEDS
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3
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GENERAL
DESCRIPTION OF SECURITIES
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3
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DESCRIPTION
OF CAPITAL STOCK
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3
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DESCRIPTION
OF THE WARRANTS
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4
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PLAN
OF DISTRIBUTION
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5
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LEGAL
MATTERS
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7
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EXPERTS
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7
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WHERE
YOU CAN FIND ADDITIONAL INFORMATION
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7
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INCORPORATION
BY REFERENCE
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7
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INDEMNIFICATION
OF DIRECTORS AND OFFICERS
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8
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ABOUT
THIS PROSPECTUS
This
prospectus is part of a registration statement that we have filed with the
Securities and Exchange Commission, or the SEC, using a “shelf” registration
process. Under this shelf registration process, we may offer from time to time
up to $20,000,000 in the aggregate, inclusive of any exercise price thereof,
of
the following securities:
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shares
of our common stock;
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warrants
to purchase shares of our common stock; or
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any
combination of the foregoing.
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This
prospectus provides you with a general description of the securities we may
offer. Each time we offer securities, we will provide you with a prospectus
supplement that describes the specific amounts, prices and terms of the
securities we may offer. The prospectus supplement also may add, update or
change information contained in this prospectus. You should read carefully
both
this prospectus and any prospectus supplement together with additional
information described below under “Information Incorporated By Reference.”
This
prospectus does not contain all the information provided in the registration
statement we filed with the SEC. For further information about us or the
securities offered hereby, you should refer to that registration statement,
which you can obtain from the SEC as described below under “Where You Can Find
More Information.”
You
should rely only on the information contained or incorporated by reference
in
this prospectus or a prospectus supplement. We have not authorized any other
person to provide you with different information. If anyone provides you with
different or inconsistent information, you should not rely on it. This
prospectus is not an offer to sell these securities and it is not soliciting
an
offer to buy these securities in any jurisdiction where the offer or sale is
not
permitted. You should assume that the information appearing in this prospectus
or any prospectus supplement, as well as information we have previously filed
with the SEC and incorporated by reference, is accurate only as of the date
on
the front of those documents. Our business, financial condition, results of
operations and prospects may have changed since those dates.
We
may
sell the securities to or through placement agents, dealers or agents or
directly to purchasers. We and our agents reserve the sole right to accept
or
reject in whole or in part any proposed purchase of securities. The prospectus
supplement, which we will provide to you each time we offer securities, will
set
forth the names of any placement agents, dealers or agents involved in the
sale
of the securities, and any applicable fee, commission or discount arrangements
with them. See “Plan of Distribution.”
In
this
prospectus, the terms “IsoRay,” the “Company,” “we,” “us,” and “our” refer to
IsoRay, Inc. and its subsidiary IsoRay, Medical, Inc.
We
are a
medical technology company focusing on innovative treatments for prostate cancer
and other solid cancer tumors, with a goal of improved patient outcomes. Our
wholly-owned subsidiary, IsoRay Medical, Inc., a Delaware corporation
("Medical"), began selling its initial product, the Food and Drug Administration
cleared IsoRay Cesium-131 brachytherapy seed, in October 2004 for the treatment
of prostate cancer. Cesium-131 or 131Cs
is an
isotope of the element Cesium that gives off low energy, “soft” x-rays as it
decays killing diseased tissue by irradiating it where it is placed.
Brachytherapy seeds allow physicians to place 131Cs
or
another radioactive isotope within the body to kill cancerous tissue. Our
management believes that the clinical benefits of Cesium-131 will enable us
to
capture market share within the existing brachytherapy market, which uses the
radioactive isotopes Palladium-103 and Iodine-125.
More
comprehensive information about us is available through our Internet website
at
http://www.isoray.com.
The
information on our website is not incorporated by reference into this
prospectus. Our executive offices are located at 350 Hills Street, Suite 106,
Richland, Washington 99354, and our telephone number is (509) 375-1202.
Before
making an investment decision, you should carefully consider the risks described
under “Risk Factors” in the applicable prospectus supplement and in our most
recent Annual Report on Form 10-KSB, or any updates in our Quarterly Reports
on
Form 10-QSB, together with all of the other information appearing in this
prospectus or incorporated by reference into this prospectus and any applicable
prospectus supplement, in light of your particular investment objectives and
financial circumstances. The risks so described are not the only risks facing
our company. Additional risks not presently known to us or that we currently
deem immaterial may also impair our business operations. Our business, financial
condition or results of operations could be materially adversely affected by
any
of these risks. The trading price of our securities could decline due to any
of
these risks, and you may lose all or part of your investment.
This
prospectus, any prospectus supplement and the documents incorporated by
reference herein include “forward-looking statements”. Forward-looking
statements are those that predict or describe future events or trends and that
do not relate solely to historical matters. You can generally identify
forward-looking statements as statements containing the words “believe,”
“expect,” “will,” “anticipate,” “intend,” “estimate,” “project,” “plan,”
“assume” or other similar expressions, or negatives of those expressions,
although not all forward-looking statements contain these identifying words.
All
statements contained or incorporated by reference in this prospectus and any
prospectus supplement other than statements of historical fact are statements
that could be deemed forward-looking statements, including any statements of
the
plans, strategies and objectives of management for future operations; any
statements concerning proposed new products, services, developments or industry
rankings; any statements regarding future economic conditions or performance;
any statements of belief, any statements regarding the validity of our
intellectual property and patent protection; and any statements of assumptions
underlying any of the foregoing.
You
should not place undue reliance on our forward-looking statements because the
matters they describe are subject to known and unknown risks, uncertainties
and
other unpredictable factors, many of which are beyond our control. Our
forward-looking statements are based on the information currently available
to
us and speak only as of the date on the cover of this prospectus, the date
of
any prospectus supplement, or, in the case of forward-looking statements
incorporated by reference, as of the date of the filing that includes the
statement. New risks and uncertainties arise from time to time, and it is
impossible for us to predict these matters or how they may affect us. Over
time,
our actual results, performance or achievements will likely differ from the
anticipated results, performance or achievements that are expressed or implied
by our forward-looking statements, and such difference might be significant
and
materially adverse to our security holders. We do not undertake and specifically
decline any obligation to update any forward-looking statements or to publicly
announce the results of any revisions to any statements to reflect new
information or future events or developments.
We
have
identified some of the important factors that could cause future events to
differ from our current expectations and they are described in this prospectus
and supplements to this prospectus under the caption “Risk Factors” as well as
in our most recent Annual Report on Form 10-KSB, including without limitation
under the captions “Risk Factors” and “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” and in other documents that we
may file with the SEC, all of which you should review carefully. Please consider
our forward-looking statements in light of those risks as you read this
prospectus and any prospectus supplement.
We
will
retain broad discretion over the use of the net proceeds from the sale of our
securities offered by us hereby. Except as described in any prospectus
supplement, we currently intend to use the net proceeds from the sale of
securities offered by us pursuant to this prospectus for working capital,
capital expenditures and other general corporate purposes. We may also use
such
proceeds to fund acquisitions of businesses, technologies or product lines
that
complement our current business. However, we currently have no commitments
or
agreements for any specific acquisitions. Pending application of the net
proceeds, we intend to invest the net proceeds of the offering of securities
by
us in investment-grade, interest-bearing securities.
We,
directly or through agents, dealers or placement agents designated from time
to
time, may offer, issue and sell, together or separately, in one or more
offerings, up to $20,000,000 in the aggregate, inclusive of any exercise price
thereof, of:
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shares
of our common stock, par value $0.001 per share;
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warrants
to purchase shares of our common stock; or
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any
combination of the foregoing, either individually or as units consisting
of one or more of the foregoing, each on terms to be determined at
the
time of sale.
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The
common stock and the warrants are collectively referred to herein as the
securities. This prospectus provides you with a general description of the
securities we may offer. Each time we offer securities, we will provide you
with
a prospectus supplement that describes the specific amounts, prices and terms
of
the securities we offer. The securities involve various risks that we will
describe in the section entitled “Risk Factors” that will be included in each
prospectus supplement.
Common
Stock
The
Company’s Articles of Incorporation provide that the Company has the authority
to issue 200 million shares of capital stock, which are currently divided into
two classes as follows: 194 million shares of common stock, par value of $0.001
per share; and 6 million shares of preferred stock, also with a par value of
$0.001 per share. As of January
5, 2007,
there
were 16,296,045 shares of our common stock issued and outstanding. As of January
5, 2007, the Company also had 77,080 shares of Series B preferred stock, options
to purchase 3,436,176 shares of common stock, warrants to purchase 4,772,068
shares of common stock, warrants to purchase 173,292 shares of preferred stock,
and $455,000 in principal amount of convertible debentures (convertible into
common stock at $4.15 per share) outstanding.
Holders
of shares of our common stock are entitled to one vote per share held of record
on all matters submitted to a vote of stockholders, including the election
of
directors. The holders are entitled to receive dividends when, as and if
declared by our board of directors, in its discretion, out of funds legally
available therefor, subject to preferences that may be applicable to any
outstanding shares of our preferred stock. The Company has not paid any cash
dividends on its common stock and does not plan to pay any cash dividends on
its
common stock for the foreseeable future. In the event of our liquidation,
dissolution or winding up, the holders of our common stock are entitled to
share
ratably in all of our assets remaining after payment of liabilities and after
payment of any preferential amounts to which holders of shares of any series
of
our preferred stock that are or may be outstanding in the future, may be
entitled. The holders of our common stock have no preemptive or other
subscription rights, and there are no conversion rights or redemption or sinking
fund provisions with respect to such shares. All of the outstanding shares
of
our common stock are, and the shares of our common stock when issued will be,
fully paid and nonassessable.
Anti-Takeover
Effects of Provisions of the Articles of Incorporation
The
authorized but unissued shares of our common and preferred stock are available
for future issuance without our shareholders’ approval. These additional shares
may be utilized for a variety of corporate purposes including but not limited
to
future public or direct offerings to raise additional capital, corporate
acquisitions and employee incentive plans. The issuance of such shares may
also
be used to deter a potential takeover of IsoRay that may otherwise be beneficial
to shareholders by diluting the shares held by a potential suitor or issuing
shares to a shareholder that will vote in accordance with IsoRay’s Board of
Directors’ desires. A takeover may be beneficial to shareholders because, among
other reasons, a potential suitor may offer shareholders a premium for their
shares of stock compared to the then-existing market price.
We
may
issue warrants to purchase shares of our common stock, with the stock underlying
the warrants being registered rather than the warrants themselves. The warrants
may be issued independently or together with shares of our common stock and
may
be attached to or separate from the shares of our common stock. The warrants
may
be issued under warrant agreements to be entered into between us and a bank
or
trust company, as warrant agent, all as shall be set forth in the prospectus
supplement relating to warrants being offered pursuant to such prospectus
supplement. The following description of the warrants will apply to the warrants
offered by this prospectus unless we provide otherwise in the applicable
prospectus supplement. The applicable prospectus supplement for a particular
series of warrants may specify different or additional terms.
The
applicable prospectus supplement will describe the following terms of warrants
offered:
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the
title of the warrants;
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the
securities for which the warrants are exercisable;
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the
price or prices at which the warrants will be issued;
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the
provisions, if any, for changes to or adjustments in the exercise
price;
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the
provisions, if any, for call rights or put rights relating to the
warrants
or the underlying securities;
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the
date on which the right to exercise the warrants shall commence and
the
date on which the right will expire;
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if
applicable, the number of warrants issued with each share of our
common
stock;
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if
applicable, the date on and after which the warrants and the related
common stock will be separately transferable;
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a
discussion of any material federal income tax consequences of holding
or
exercising the warrants; and
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any
other terms of the warrants, including terms, procedures and limitations
relating to the exchange and exercise of the warrants.
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Holders
of warrants will not be entitled, by virtue of being such holders, to vote,
consent, receive dividends, receive notice as stockholders with respect to
any
meeting of stockholders for the election of our directors or any other matter,
or to exercise any rights whatsoever as our stockholders.
The
exercise price payable and the number of shares of our common stock purchasable
upon the exercise of each warrant will be subject to adjustment in certain
events, including the issuance of a stock dividend to holders of our common
stock and/or our preferred stock or a stock split, reverse stock split,
combination, subdivision or reclassification of our common stock. In lieu of
adjusting the number of shares of our common stock purchasable upon exercise
of
each warrant, we may elect to adjust the number of warrants. No fractional
shares will be issued upon exercise of the warrants, but we will pay the cash
value of any fractional shares otherwise issuable. Notwithstanding the
foregoing, in case of any consolidation, merger, or sale or conveyance of our
property as an entirety or substantially as an entirety, the holder of each
outstanding warrant shall have the right to the kind and amount of shares of
stock and other securities and property, including cash, receivable by a holder
of the number of shares of our common stock into which the warrant was
exercisable immediately prior to such transaction.
Each
warrant will entitle the holder to purchase for cash such shares of our common
stock at such exercise price as shall in each case be set forth in, or be
determinable as set forth in, the prospectus supplement relating to the warrants
offered thereby. Warrants may be exercised at any time up to the close of
business on the expiration date set forth in the prospectus supplement relating
to the warrants offered thereby. After the close of business on the expiration
date, unexercised warrants will become void.
The
warrants may be exercised as set forth in the prospectus supplement relating
to
the warrants offered. Upon receipt of payment and the warrant certificate
properly completed and duly executed at the corporate trust office of the
warrant agent or any other office indicated in the prospectus supplement, we
will, as soon as practicable, forward the shares of our common stock purchasable
upon such exercise. If less than all of the warrants represented by such warrant
certificate are exercised, a new warrant certificate will be issued for the
remaining warrants.
We
may
sell the securities through placement agents or dealers, through agents, or
directly to one or more purchasers or through a combination of these methods.
The applicable prospectus supplement will describe the terms of the offering
of
the securities, including:
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the
name or names of any placement agents, if any, and if required, any
dealers or agents;
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the
purchase price of the securities and the proceeds we will receive
from the
sale;
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any
underwriting discounts and other items constituting placement agents’
compensation;
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any
discounts or concessions allowed or reallowed or paid to dealers;
and
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any
securities exchange or market on which the securities may be listed.
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We
may
distribute the securities from time to time in one or more transactions at:
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fixed
price or prices, which may be changed from time to time;
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market
prices prevailing at the time of sale;
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prices
related to such prevailing market prices; or
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Only
placement agents named in the prospectus supplement are placement agents of
the
securities offered by the prospectus supplement.
If
we use
placement agents in the sale of securities, they will acquire the securities
for
their own account and may resell them from time to time in one or more
transactions at a fixed public offering price or at varying prices determined
at
the time of sale. We may offer the securities to the public through underwriting
syndicates represented by managing placement agents or by placement agents
without a syndicate. Any public offering price and any discounts or concessions
allowed or reallowed or paid to dealers may change from time to time.
If
we use
a dealer in the sale of the securities being offered pursuant to this
prospectus, we or such selling stockholders will sell the securities to the
dealer, as principal. The dealer may then resell the securities to the public
at
varying prices to be determined by the dealer at the time of resale.
We
may
sell securities directly or through agents we designate from time to time.
We
will name any agent involved in the offering and sale of securities and we
will
describe any commissions we will pay the agent in the prospectus supplement.
Unless the prospectus supplement states otherwise, our agent will act on a
best-efforts basis for the period of its appointment.
We
may
authorize agents or placement agents to solicit offers by institutional
investors to purchase securities from us at the public offering price set forth
in the prospectus supplement pursuant to delayed delivery contracts providing
for payment and delivery on a specified date in the future. We will describe
the
conditions to these contracts and the commissions we must pay for solicitation
of these contracts in the prospectus supplement.
In
connection with the sale of the securities, placement agents, dealers or agents
may receive compensation from us, or from purchasers of the securities for
whom
they act as agents, in the form of discounts, concessions or commissions.
Placement agents may sell the securities to or through dealers, and those
dealers may receive compensation in the form of discounts, concessions or
commissions from the placement agents or commissions from the purchasers for
whom they may act as agents. Placement agents, dealers and agents that
participate in the distribution of the securities, and any institutional
investors or others that purchase securities directly and then resell the
securities, may be deemed to be placement agents, and any discounts or
commissions received by them from us and any profit on the resale of the
securities by them may be deemed to be placement agent fees under the Securities
Act.
We
may
provide agents and placement agents with indemnification against particular
civil liabilities, including liabilities under the Securities Act, or
contribution with respect to payments that the agents or placement agents may
make with respect to such liabilities. Agents and placement agents may engage
in
transactions with, or perform services for, us in the ordinary course of
business.
In
addition, we may enter into derivative transactions with third parties
(including the writing of options), or sell securities not covered by this
prospectus to third parties in privately negotiated transactions. If the
applicable prospectus supplement indicates, in connection with such a
transaction, the third parties may, pursuant to this prospectus and the
applicable prospectus supplement, sell securities covered by this prospectus
and
the applicable prospectus supplement. If so, the third party may use securities
borrowed from us or others to settle such sales and may use securities received
from us to close out any related short positions. We may also loan or pledge
securities covered by this prospectus and the applicable prospectus supplement
to third parties, who may sell the loaned securities or, in an event of default
in the case of a pledge, sell the pledged securities pursuant to this prospectus
and the applicable prospectus supplement. The third party in such sale
transactions will be an underwriter and will be identified in the applicable
prospectus supplement or in a post-effective amendment.
All
securities we offer other than common stock will be new issues of securities
with no established trading market. Any placement agents may make a market
in
these securities, but will not be obligated to do so and may discontinue any
market making at any time without notice. We cannot guarantee the liquidity
of
the trading markets for any securities.
Placement
agents may engage in stabilizing and syndicate covering transactions in
accordance with Rule 104 under the Exchange Act. Rule 104 permits
stabilizing bids to purchase the securities being offered as long as the
stabilizing bids do not exceed a specified maximum. Placement agents may
over-allot the offered securities in connection with the offering, thus creating
a short position in their account. Syndicate covering transactions involve
purchases of the offered securities by placement agents in the open market
after
the distribution has been completed in order to cover syndicate short positions.
Placement agents may also cover an over-allotment or short position by
exercising their over-allotment option, if any. Stabilizing and syndicate
covering transactions may cause the price of the offered securities to be higher
than it would otherwise be in the absence of these transactions. These
transactions, if commenced, may be discontinued at any time.
LEGAL
MATTERS
The
validity of the securities being offered hereby will be passed on by Keller
Rohrback, PLC, Phoenix, Arizona. Mr. Boatwright, a member of Keller Rohrback,
PLC, is a director of the Company. Mr. Boatwright beneficially owned options
to
purchase 210,000 shares of our common stock as of the date of the opinion.
DeCoria,
Maichel & Teague, P.S., independent registered public accounting firm, has
audited our consolidated balance sheets as of June 30, 2006 and June 30, 2005,
and related consolidated statements of operations, stockholders’ equity
(deficit) and cash flows for the years ended June 30, 2006 and 2005, included
in
our Annual Report on Form 10-KSB for the fiscal year ended June 30, 2006, as
set
forth in their report, which is incorporated by reference in this prospectus
and
elsewhere in the registration statement. Our financial statements are
incorporated by reference in reliance on DeCoria, Maichel & Teague, P.S.’s
report, given on the authority of said firm as experts in accounting and
auditing.
We
have
filed a registration statement on Form S-3 with the SEC relating to the common
stock, and the warrants offered by this prospectus. This prospectus does not
contain all of the information set forth in the registration statement and
the
exhibits and schedules thereto. We have omitted parts of the registration
statement, as permitted by the rules and regulations of the SEC. Statements
contained in this prospectus as to the contents of any contract or other
document referred to are not necessarily complete and in each instance reference
is made to the copy of such contract or other document filed as an exhibit
to
the registration statement, each such statement being qualified in all respects
by such reference. For further information with respect to us and the common
stock, and the warrants offered hereby, reference is made to such registration
statement, exhibits and schedules.
We
are
subject to the information and periodic reporting requirements of the Exchange
Act, and in accordance therewith file periodic reports, current reports, proxy
statements and other information with the SEC. Such periodic reports, current
reports, proxy statements, other information and a copy of the registration
statement on Form S-3 may be inspected by anyone without charge and copies
of
these materials may be obtained upon the payment of the fees prescribed by
the
SEC, at the Public Reference Room maintained by the SEC at 100 F Street, N.E.,
Washington, D.C. 20549. The public may obtain information on the operation
of
the Public Reference Room by calling the SEC at 1-800-SEC-0330. The registration
statement on Form S-3 and the periodic reports, current reports, proxy
statements and other information filed by us are also available through the
Internet web site maintained by the SEC at the following address:
http://www.sec.gov.
The
SEC
allows us to “incorporate by reference” into this prospectus the information we
file with it. This means that we can disclose important information to you
by
referring you to those documents. The information we incorporate by reference
is
considered to be a part of this prospectus, and later information we file with
the SEC will automatically update and supersede this information. The following
documents filed with the SEC (in each case, Commission File No. 000-14247)
are incorporated by reference in this prospectus:
(a) Our
Annual Report on Form 10-KSB for the fiscal year ended June 30, 2006 (filed
September 28, 2006), which contains audited financial statements for our latest
fiscal year for which such statements have been filed.
(b) Our
Quarterly Report on Form 10-QSB for the fiscal quarter ended September 30,
2006
(filed November 14, 2006).
(c) Our
Current Reports on Form 8-K filed on August 10, 2006, August 18, 2006, September
8, 2006, September 11, 2006 and November 6, 2006.
(d) The
description of our common stock contained in our Registration Statement on
Form
SB-2, filed with the Commission on October 16, 2006, including any amendments
or
reports filed for the purpose of updating such description.
(e) Our
Proxy
Statement on Schedule 14A filed on January 16, 2007.
(f) The
prospectus contained as part of our Registration Statements on Form SB-2, filed
with the Commission on December 1, 2006, and November 17, 2006, including any
amendments filed to such Registration Statements.
We
are
also incorporating by reference any future filings we make with the SEC under
Section 13(a), 13(c), 14 or 15(d) of the Exchange Act until this offering
is completed, including those made between the date of filing of the initial
registration statement and prior to effectiveness of the registration statement,
except for information furnished under Item 2.02 or Item 7.01 of our
Current Reports on Form 8-K which is not deemed to be filed and not incorporated
by reference herein.
You
may
request a copy of these filings (other than an exhibit to a filing unless that
exhibit is specifically incorporated by reference into that filing), at no
cost,
by writing or calling us at IsoRay, Inc., 350 Hills Street, Suite 106, Richland,
Washington 99354, telephone number (509) 375-1202, Attention: Chief
Financial Officer.
INDEMNIFICATION
OF DIRECTORS AND OFFICERS
The
Company’s Articles of Incorporation provide to directors and officers
indemnification to the full extent provided by law, and provide that, to the
extent permitted by Minnesota law, a director will not be personally liable
for
monetary damages to the Company or its shareholders for breach of his or her
fiduciary duty as a director, except for liability for certain actions that
may
not be limited under Minnesota law. On July 1, 2006, the Company entered into
Indemnification Agreements with each of its directors and executive officers,
and the Company intends to enter into substantially identical agreements with
any officers and directors who take office in the future. The purpose of the
Indemnification Agreements is to provide all officers and directors with
indemnification to the fullest extent permitted under the Minnesota Business
Corporations Act.
Insofar
as indemnification for liabilities arising under the Securities Act of 1933
may
be permitted to directors, officers and controlling persons pursuant to the
foregoing provisions, or otherwise, in the opinion of the Securities and
Exchange Commission such indemnification is against public policy as expressed
in the Act and is, therefore, unenforceable.