Viragen, Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 10-K
(Mark One)
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE
ACT OF 1934 |
FOR THE FISCAL YEAR ENDED JUNE 30, 2005
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number 001-15823
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VIRAGEN, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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59-2101668 |
(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer Identification No.) |
865 SW 78th Avenue, Suite 100, Plantation, Florida 33324
(Address of principal executive offices)
(954) 233-8746
(Registrants telephone number, including area code)
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Securities registered pursuant to Section 12(b) of the Act:
Common Stock, $0.01 Par Value
Securities registered pursuant to Section 12(g) of the Act:
None
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Indicate by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has
been subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation
S-K is not contained herein, and will not be contained, to the best of registrants knowledge, in
definitive proxy or information statements incorporated by reference in Part III of this Form 10-K
or any amendment to this Form 10-K. [ ]
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule
12b-2 of the Act).
Yes þ No o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Act).
Yes o No þ
The aggregate market value, as of September 6, 2005, of the registrants common stock held by
non-affiliates based on the closing price on the American Stock Exchange was approximately $26.1
million.
As of September 6, 2005, there were 37,087,677 shares of the issuers common stock
outstanding, par value $0.01.
DOCUMENTS INCORPORATED BY REFERENCE
Risk Factors included in our Prospectus, File No. 333-117338, filed on July 28, 2004, incorporated
by reference into Part II Item 7. Managements Discussion and Analysis of Financial Condition and
Results of Operations.
VIRAGEN, INC. AND SUBSIDIARIES
INDEX TO ANNUAL REPORT ON FORM 10-K
Year Ended June 30, 2005
1
PART I
Item 1. Business
Introduction
Viragen, Inc. (which may be referred to as we, us or our) is a Delaware corporation organized
in 1980. We are a biopharmaceutical company focused on the research, development, manufacture and
commercialization of innovative technologies and products used to treat infectious diseases and
cancers in humans. We are pioneering the science of avian transgenics whereby we intend to produce
high quality proteins and antibodies in the egg whites of transgenic chickens. Through
collaborations with recognized experts, companies and institutions worldwide we are developing
leading-edge science to combat hepatitis, melanoma, ovarian cancer, breast cancer and other
cancers.
We are an international company, with our development and manufacturing operations in Umeå,
Sweden, our research and development activities in Edinburgh, Scotland, and our headquarters in
Plantation, Florida.
Our product and technology portfolio includes,
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Multiferon®, natural leukocyte-derived multi-subtype interferon alpha, used in
the treatment of a number of viral diseases and cancer indications. |
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Avian Transgenics, whereby we intend to develop and use transgenic chickens to
produce therapeutic proteins and antibodies for human use in the whites of eggs. |
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VG101, an antibody to the GD3 antigen, which is over-expressed on malignant
melanoma tumors, thereby preventing the bodys natural immune system from stopping
cancer cell growth and proliferation. |
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VG102, an antibody to the CD55 antigen, which is over-expressed on nearly all
solid cancerous tumors and which prevents the bodys natural immune system from
killing cancer cells. |
We operate through:
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Viragen, Inc. parent company; |
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ViraGenics, Inc. 100% owned by Viragen, Inc.; |
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Viragen International, Inc. 81.2% majority owned by Viragen, Inc.; |
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Viragen (Scotland) Ltd. 100% owned by Viragen International, Inc.; and |
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ViraNative AB 100% owned by Viragen International, Inc. |
You
can learn more about us by visiting our web site at
www.viragen.com. The information on
our website is neither incorporated into, nor a part of, this report. We post links on our website
to the following filings as soon as reasonably practicable after they are electronically filed with
or furnished to the Securities and Exchange Commission (SEC): annual reports on Form 10-K,
quarterly reports on Form 10-Q, statements of beneficial ownership on Forms 3, 4 and 5, current
reports on Form 8-K and any amendment to those reports filed or furnished pursuant to Section 13(a)
or 15(d) of the Securities and Exchange Act of 1934. Our website also includes copies of our press
releases. All of these filings and press releases are available through our website free of charge.
Our filings may also be read and copied at the SECs Public Reference Room at 100 F Street, NE,
Washington, DC 20549. Information on the operation of the Public Reference Room may be obtained by
calling the SEC at 1-800-SEC-0330. The SEC also maintains an Internet site that contains reports,
proxy and information statements, and other information filed electronically with the SEC. The
address of that site is www.sec.gov. Our stock trades on the American Stock Exchange under the
symbol VRA.
2
Recent Developments
Multiferon®
In February 2005, we filed a registration with the Swedish Medical Products Agency for
Multiferon® for first line adjuvant therapy, following resection and short term treatment with
dacarbazine, in patients with high risk malignant melanoma. We expect a decision on this submission
by the end of calendar 2005. If approved by the Swedish authorities, we intend to file for
decentralized European Union approval through the Mutual Recognition Procedure to secure approval
in key European countries.
In June 2005, Pentafarma S.A. (Pentafarma) received notification of registration approval for
Multiferon® from the Chilean authorities. Headquartered in Santiago, Pentafarma is a
wholly-owned subsidiary of Fresenius Medical Care, the worlds largest, integrated provider of
products and services for chronic kidney failure. An initial stocking order has been placed and
Pentafarma is planning a market launch in the fourth quarter of calendar 2005. In November 2003,
we entered into an agreement with Pentafarma to distribute our natural human alpha interferon,
Multiferon®,exclusively in Chile.
Avian Transgenics
In September 2005, we plan to execute an extension to the Roslin/Viragen/ViraGenics Research
Agreement due to expire on December 1, 2005. This extension will continue for a term of twelve
months, and will expire on December 1, 2006. Throughout this extended term, the parties will
continue to cooperate to aim to successfully achieve established objectives on four specific
product candidates, while continuing to develop scientific milestones in support of the technology.
We expect to report progress and milestone achievements on all candidate products during calendar
2006.
In June 2005, ViraGenics and the Roslin Institute reported detection and recovery of an
active, humanized antibody from the egg white of transgenic chickens. The anti-GD3 antibody
expression was detected at far higher levels than ever reported before and has demonstrated
stability in that it is expressed intact in a succession of eggs. At the current time, additional
eggs are being collected and antibody recovery and purification processes are being perfected to
result in pure antibody for further pre-clinical testing by ViraGenics and by Sloan-Kettering
Institute. Antibody recovery and purification methods are being developed by our scientific staff
at Viragen (Scotland), in Edinburgh.
Antibodies
In June 2005, we reported recovery of a version of the anti-GD3 antibody from transgenic eggs,
the antibody being the subject of a collaborative research agreement between Viragen and
Sloan-Kettering Institute. Concurrently, we are developing a manufacturing process for a cell
culture-produced, humanized form of this antibody in addition to completing the avian process. We
intend to submit both forms of the antibody for further preclinical testing and then select the
best candidate to move forward to an Investigational New Drug Application.
In April 2005, we entered into an exclusive global license with Cancer Research Technology UK
in the United Kingdom for the development and commercialization of an anti-CD55 antibody. We are
currently developing a manufacturing process for a humanized form of this antibody in preparation
for final pre-clinical testing.
3
Operations
Multiferon®
We produce a natural human alpha interferon product under the tradename of Multiferon® from
human white blood cells, also known as leukocytes. Multiferon® is currently approved for the
treatment of a broad range of infectious diseases and cancers in ten countries. The product is
approved for sale in Bulgaria, Chile, Mexico, Philippines and Sweden as a second-line therapy for
the treatment of any and all diseases in which patients show an initial response to recombinant
alpha interferon followed by treatment failure. It is also approved for sale in Egypt, Hong Kong,
Indonesia, Myanmar, and South Africa as a second-line therapy for the treatment of Hairy Cell
Leukemia and Chronic Myelogenous Leukemia, and work is ongoing to expand the approved indications
in these countries. Regulatory approval activities are also underway in a number of other
European, South American, Middle East and Far East territories. Our natural human alpha interferon
is not approved for sale in the United States or other European Union countries. We have not yet
sought the approval of Multiferon® from the United States Food and Drug Administration or its
European Union counterparts, except Sweden.
We have completed collection of data from a clinical trial in malignant melanoma conducted in
Germany, including a long-term follow-up of those patients, and we have filed for registration of
this indication in Sweden. In the coming months, and provided we receive approval from Swedish
authorities, we plan to seek approval of Multiferon® for the treatment of malignant melanoma in
parts of the European Union through the Mutual Recognition Procedure. The Mutual Recognition Procedure (MRP) permits a registrant of a new drug or biological product to
use a single registration dossier to gain marketing authorization in a number of EU countries. The
prerequisite requirement is that any new registration must have a sponsor country that has reviewed
and approved the registration dossier. In the case of Multiferon®, and following the expected
Swedish approval of our dossier, Sweden would agree to act as our sponsor country for the MRP
filing. Once the dossier is approved through the MRP process, it is then permissible to go to each
country that has approved the filing and seek reimbursement authorization. All countries are not
required to approve the filing in the MRP process, and there is no guarantee that any country will
agree to reimburse for the product.
During fiscal 2005, we initiated, through our international partners, two clinical trials with
Multiferon®. Arriani Pharmaceuticals, in Greece, has initiated a trial using Multiferon® for the
rescue of patients with Hepatitis C who have failed to respond to treatment with recombinant
interferon alpha. Laboratorios Pisa, in Mexico, has initiated a trial using Multiferon® for the
rescue of patients with Hepatitis C who have failed to respond or who have relapsed from treatment
with recombinant interferon alpha. Both trials are expected to complete dosing of patients during
calendar 2006.
In June 2005, we filed a request with the Swedish Medical Products Agency for the approval of
a new ampoule filler for Multiferon®. The new filler, located in Germany, is expected to be
approved early in the new fiscal year. In June 2005, we completed the production of validation
batches of Multiferon® in a new pre-filled syringe dosage form. This new filling and packaging
operation, also located in Germany, is pending completion of stability studies and is expected to
be filed with the Swedish Medical Products Agency during calendar 2005 and approved in calendar
2006.
We have entered into several agreements for the distribution of Multiferon® in various
countries. To date, we have not recognized significant revenue from many of these agreements. The
majority of these agreements require that the distributor obtain the necessary regulatory
approvals, which may not yet be obtained. Regulatory approval is a mandatory step in the marketing
of a drug, but it is by no means the final challenge in marketing a biopharmaceutical product. In
many countries, a separate process may be required for obtaining reimbursement authorization. In
addition, physicians must be educated about the merits of the product over time and, in some of
these territories, hospital formularies govern the acceptance for use of a new product. Therefore,
we are unable to predict the timing of approvals or sales in these various countries.
There are other challenges associated with international marketing activities including:
language and cultural barriers, poorly organized regulatory infrastructure and/or compliance
procedures in certain countries where Multiferon® may be marketed, performance of our distribution
channels, governments willingness to promote cheaper generic versions of competing products and
the general populations inability to afford private care drug products. It may take significant
time to overcome these challenges with no assurance that a particular market will ever be
effectively penetrated.
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We will require significant additional financing to complete additional clinical trials for
the purpose of obtaining European Union and/or U.S. Food and Drug Administration approvals of any
product. We have initiated a number of clinical trials that are not yet completed and must be
completed in order to provide current evidence in various territories of the utility of our
product. Even if we are able to secure necessary funding, any additional clinical testing that may
be required by authorities for European Union approval will be an expensive and complex process
that could take a number of years to complete, with no assurance that regulatory approvals will
eventually be obtained.
Avian Transgenics
We have an ongoing avian transgenic research and development project in collaboration with the
Roslin Institute of Scotland. We believe that once fully developed, this technology will be used
to create chickens which produce eggs containing therapeutic proteins in the egg white to treat
many serious diseases, including cancer. We believe this technology promises a faster and more cost
effective method of production for many promising biopharmaceutical products. Avian transgenic
production, based upon transgenic chickens, is expected to offer significant economic and
technological advantages over traditional methods of protein production including: ease of
scale-up; low capital risk; deferred capital investment; fast drug evaluation and development; and
competitive costs.
The potential for reduced capital outlay and cost effectiveness of protein production is the
greatest incentive for the use of transgenic hens. Chickens have one of the lowest founder animal
development costs of any transgenic system. The founder hen is bred or cloned to produce a
transgenic flock. We believe that eventually a large number of birds can be produced very quickly
and cheaply compared to other methods. Chickens can lay 250 eggs per year with each egg
conservatively projected to be capable of containing significant quantities of the target drug per
egg. This speed and productivity, on a per egg basis, means that a relatively large amount of
protein could be generated quickly.
Other key advantages include the relative ease of scale-up, time to production and normal
protein modifications such as glycosylation (the sugar structure of a protein which is critical to
its function). It is believed that chickens yield a glycosylation pattern more similar to that
found in humans than other transgenic systems such as with mammals or plants. This is believed to
offer distinct clinical advantages for patients who develop neutralizing and binding antibodies to
foreign sugar antigens on transgenic proteins which, in turn, may negate some or all of the
beneficial effect of the protein drug in the patient.
In June 2005, ViraGenics and the Roslin Institute reported detection and recovery of an
active, humanized antibody from the egg whites of transgenic chickens. The anti-GD3 antibody
expression was detected at far higher levels than ever reported before and was determined to be
expressed active and intact in a succession of eggs. At the present time, additional eggs are being
collected and antibody recovery and purification processes are being perfected to result in pure
antibody for further pre-clinical testing by ViraGenics and by Sloan-Kettering Institute. Antibody
recovery and purification methods have been and are being developed by our scientific staff at
Viragen (Scotland), in Edinburgh.
We have three other protein product candidates in development using the avian transgenics
system that are in progress. We hope to report achievement of key milestones with all of these
candidates during calendar 2006.
5
Antibodies
In collaboration with the Sloan-Kettering Institute, we have initiated research on monoclonal
antibodies targeting the ganglioside GD3 for the treatment of melanoma and possibly certain other
cancers. Monoclonal antibodies are laboratory-produced, highly specialized therapeutic proteins
that can locate and bind to cancer cells wherever they are in the body. Many monoclonal antibodies
are used in cancer detection or therapy. While the particular antibody that we are working on in
cooperation with the Sloan-Kettering Institute has been known for a number of years, it requires
optimization to allow it to be used as an efficient therapeutic. The antibody has been humanized
and further work is ongoing to develop an optimized form for human therapeutic use. While working
with traditional monoclonal antibody manufacturing methods, we are also engaged in working with our
avian transgenics team on this important protein. We expect to have produced sufficient quantities
of humanized antibody by the end of calendar 2005. This antibody material will be tested via
confirmatory in-vitro methods by Viragen and Sloan-Kettering Institute in order to determine
appropriate binding properties in comparison to the former murine (mouse) form. This confirmatory
testing is expected to be completed early in calendar 2006 and if successful, will permit selection
of the most appropriate form of the antibody for toxicological analyses, preceding meetings with
the Food and Drug Administration.
In collaboration with the Cancer Research Technology UK and the University of Nottingham, we
are developing monoclonal antibodies to block the protective effect of the protein CD55 on the
surface of tumor cells. The protein CD55 is one of a number of proteins which protect normal
healthy cells from being destroyed by the complement system in the body. However, cancer cells can
also express this control protein at levels up to 100 fold greater than normal, in order to
camouflage themselves from the immune system. We are developing an antibody to remove this
protection from tumor cells for the treatment of colorectal, breast, ovarian and certain bone
cancers. With this protective effect removed, the bodys natural immune system, the antibody
itself, or other anti-cancer compounds, can then act against the tumor. We expect this product
candidate to be potentially useful in stand-alone applications as well as in combination with other
bio and or chemo-therapeutic agents in a variety of cancers. We are currently engaged in the
development of production processes for this antibody in various applicable forms in order to
conduct further in-vitro and possibly some preliminary in-vivo testing (animals). This is expected
to be completed in calendar 2006. Following review of these data, we expect to select one or more
forms of the antibody to proceed to toxicological analysis in calendar 2006. These data are
required prior to initiating meetings with the UK Health authorities to gain consensus for a
development plan, including clinical trials.
In May 2005, a research and collaboration agreement with the University of Miami and
UM/Sylvester Comprehensive Cancer Center to develop a therapeutic agent based on a compound
developed by University scientists was allowed to expire. As a result, we have stopped all work and
all expense on this project, formerly known as IEP-11, and we have returned all documentation and
rights to this compound to the University.
In April 2004, our Scottish subsidiary, Viragen (Scotland), was awarded a grant from the
Scottish government for approximately $833,000 for the purpose of supporting the research and
development of our anti-CD55 antibody. This grant is being funded over a three year period, with
final funding to occur in calendar 2007.
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Distribution Agreements and Strategic Alliances
Multiferon®
In November 2003, we entered into an agreement with Pentafarma S.A. (Pentafarma) to serve as
our exclusive distributor of our natural human alpha interferon, Multiferon®, exclusively in Chile.
Headquartered in Santiago, Pentafarma is a wholly-owned subsidiary of Fresenius Medical Care, the
worlds largest, integrated provider of products and services for chronic kidney failure. In June
2005, we reported that Pentafarma received notification of registration approval for
Multiferon® from the Chilean authorities. An initial stocking order has been placed and
Pentafarma is planning a market launch in the fourth quarter of calendar 2005.
In May 2003, we entered into an exclusive distribution agreement with Arriani Pharmaceuticals
S.A. to distribute Multiferon® in Greece and designated Balkan countries. The agreement provides
that Arriani Pharmaceuticals, headquartered in Athens, Greece, shall take the measures necessary to
achieve regulatory approvals for Multiferon® in Greece, Cyprus and Slovenia following our receipt
of the Mutual Recognition Procedure (MRP) approval in the European Union (EU), as well as to obtain
and maintain the appropriate regulatory approvals in Bulgaria and Croatia. We have not yet
commenced the MRP registration process. As a result, we are not realizing any financial benefit
from this agreement at this time. MRP approval for Cyprus and Slovenia is subject to their pending
acceptance into the EU. Arriani has received notification of registration approval in Bulgaria,
and reimbursement authorization is pending for that country. A clinical trial with Multiferon® has
been initiated in 2005 in rescue treatment of Hepatitis C. This trial is expected to be completed
in calendar 2006.
In May 2003, we entered into a distribution agreement with CJ Pharma, the U.S. Pharmaceutical
Division of CJ Corporation, and their CJ Hong Kong Ltd. subsidiary, as exclusive distributors of
our natural human alpha interferon in Hong Kong. In April 2004, we terminated this distribution
agreement due to lack of performance. We are currently in the process of identifying potential
partners to license, market, sell and distribute Multiferon® in Hong Kong.
In March 2003, the South African regulatory authorities approved an application filed by
Viragens distribution partner in that country, Key Oncologics Ltd. The South African regulatory
approval allows for the treatment of patients with hairy cell leukemia and chronic myelogenous
leukemia who did not respond to recombinant (synthetic) interferon regimens. Additional
applications have been filed to broaden the products approved indications to include the treatment
of other viral and malignant diseases.
In January 2003, we renewed and extended our agreement with Laboratorios Pisa, a leading
Mexican pharmaceutical company. The new agreement has a term of ten years and provides
Laboratorios Pisa with the exclusive rights to distribute Multiferon® in Mexico. In February 2004,
Multiferon® was approved in Mexico to target the treatment of hairy cell leukemia, chronic
myelogenous leukemia, renal cell carcinoma and malignant melanoma. The product was launched in
Mexico in September 2004 for the treatment of hepatitis B and C. A clinical trial has been
initiated in the rescue of patients with hepatitis C as a Phase IV trial. This trial is expected
to be completed during calendar 2006.
In September 2002, negotiations were finalized to appoint Harvester Trading Co., a leading
healthcare distributor in Taiwan, Republic of China, as our exclusive distributor for Multiferon®
in that country. Due to the lack of activity, in accordance with the agreement, we have notified
Harvester of our intention to terminate the agreement. We will attempt to identify a new potential
partner in Taiwan.
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In September 2002, we entered into an exclusive agreement with Drogsan Healthcare Ltd. to
exclusively distribute Multiferon® in Turkey following the notification from MetDem, our prior
distributor, of their intent to exit the healthcare market. Drogsan Healthcare is a leading
pharmaceutical company in Turkey, with experience in the distribution of pharmaceutical products.
Regulatory documentation in support of the registration approval process have been provided to
Drogsan and we have received questions from the authorities requesting additional
information. This information is being provided to Drogsan in an attempt to secure the
registration. There can be no assurance that approval will be granted or that sales will result
from this arrangement.
In April 2002, we signed an exclusive supply and distribution agreement with AGC, a
Pakistan-based, multinational conglomerate, for a number of middle-eastern countries. In 2003,
this agreement was modified to limit the exclusive territories to Pakistan. The agreement provides
for the purchase and distribution of Multiferon® upon receipt of regulatory approval. AGC has
notified us that regulatory approval was received in late 2004 and that reimbursement was
authorized in 2005. We have not received any orders from AGC and it is not possible to determine
if AGC will comply with its obligation under the agreement. In June 2005, under the provisions of
this agreement, Viragen notified a representative of AGC of its obligation to place orders
following product approval in the region. The notification also provided that absent receipt of an
order, within the terms of the agreement, the agreement would be terminated.
We are considering proposals from other potential business partners for the development,
marketing, sale and distribution of Multiferon® in other territories around the world.
Avian Transgenics
On November 15, 2000, we entered into a development, license and collaboration agreement with
the Roslin Institute (Edinburgh). The agreement provides for joint continued development of
transgenics technology in chickens. The technology will be used to create chickens which produce
eggs containing targeted new drugs in the egg white to treat many serious diseases, including
cancer. We believe this technology promises a much faster and cost effective method of production
for many promising biopharmaceutical products. In March 2004, we extended our agreement with the
Roslin Institute to develop avian transgenic technology. The agreement continues to provide us
with the worldwide exclusive rights to continue development and commercialize Roslins proprietary
avian transgenic biomanufacturing technology. In September 2005, we intend to execute a one-year
extension to this agreement with Roslin to successfully complete the research and development
process and to develop new science for the future of the technology.
In March 2003, we entered into an agreement with Oxford BioMedica plc to obtain rights to a
technology for use in our collaboration with Roslin Institute to develop avian transgenic
technology as a novel platform for the efficient, cost-effective manufacturing of protein drugs.
The agreement provided Viragen with an option to acquire an exclusive worldwide license for
proprietary gene transfer vectors, biotechnology tools designed to transfer genes into cells at
high efficiency. In June 2004, we exercised the option, entering into a license agreement for
Oxford BioMedicas Lentivector gene delivery technology, which provided us with worldwide exclusive
rights to use this technology in the creation of transgenic avians for biopharmaceutical
production. Initial studies evaluating a novel use for these vectors, which transfer genes for
therapeutic proteins into developing chicken embryos, have yielded successful and consistent
results. However, it should be noted that additional work is necessary to be able to express the
targeted proteins in the egg whites of transgenic chickens in sufficient quantities to make the
process commercially viable. This work is currently underway at the Roslin Institute and our own
research and development facility in Scotland.
In March 2004, we entered into an agreement with RMR Technologies and the University of South
Florida to obtain rights to a gene delivery technology to be evaluated in connection with our
collaboration with Roslin Institute. This agreement was terminated in May 2005.
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Antibodies
In July 2000, Viragen entered into a research agreement with Cancer Research Technology UK in
the United Kingdom and the University of Nottingham to evaluate therapeutics based on the CD55
antigen, which we believe may have potential in the treatment of several indications including
breast, ovarian and colorectal cancers. This project is based on the development of monoclonal
antibodies designed to block the protective effect of the protein CD55 on the surface of tumor
cells. The initial development work was carried out in collaboration with the Cancer Research
Technology UK Department of Clinical Oncology at the University of Nottingham in England.
In April 2005 we executed an exclusive global license with Cancer Research Technology UK for
an anti-CD55 antibody to be developed for the treatment of human disease. Rights include the use of
the antibody as a therapeutic and a diagnostic agent in cancers. We have created a humanized form
of this antibody and are currently developing optimized manufacturing processes in preparation for
final pre-clinical testing.
In December 1999, through Viragen (Scotland) Ltd., we entered into a collaborative agreement
with the Sloan-Kettering Institute in New York City. The agreement is for the development of a
human monoclonal antibody targeting the ganglioside GD3, which may be used alone or in combination
with our Multiferon® product as well as other products, for the treatment of melanoma, a
potentially fatal skin cancer. This technology could also prove useful in the treatment of certain
other cancers. In February 2002, the agreement was extended through February 2007. While working
with traditional monoclonal antibody manufacturing methods, we are also engaged in working with our
avian transgenics team on producing this important antibody.
In May 2005, we entered into discussions and negotiations with the Sloan-Kettering Institute
to license on an exclusive basis the anti-GD3 antibody. It is not known if or when a license
agreement will be executed. We are currently continuing the collaborative research agreement and we
have created a humanized form of this antibody and are developing cell culture based manufacturing
methods as well as production in our avian transgenics system.
The Interferon Industry
Prior to 1985, natural interferon was the only type of interferon available. Research
institutions and other biomedical companies, including Viragen, Inc., were working to solve the
problem of the high cost related to the commercial-scale production of natural interferon. In 1985,
Hoffmann-La Roche, Inc. and Schering-Plough Corporation, two major pharmaceutical companies,
successfully developed synthetic interferons using recombinant DNA technology. These companies
subsequently received U.S. Food and Drug Administration approval to produce and market their
recombinant alpha interferon products for numerous indications.
After the emergence of recombinant or synthetic alpha interferon, the medical communitys
interest in natural interferon diminished. This was due primarily to the limited availability and
higher cost of production of natural interferon. Most clinical studies thereafter utilized a
synthetic product.
Hoffmann-La Roche, Inc., which produces Roferon® and PEGASYS®, and
Schering-Plough Corporation, which produces Intron A® and Peg-Intron®,
continue to actively market their products for a wide range of indications and promote the
therapeutic benefits of their synthetic interferon products. In 1993, Schering AG Germany, through
its U.S. owned Berlex Laboratories, received U.S. Food and Drug Administration approval of
BetaSeronTM, its recombinant beta interferon, for the treatment of relapsing/remitting
multiple sclerosis. In 1996, Biogen, Inc. received U.S. Food and Drug Administration approval for
Avonex®, its recombinant beta interferon, for relapsing/remitting multiple sclerosis. In
1997, Teva Pharmaceuticals received U.S. Food and Drug Administration approval of its peptide
chemical compound, Copaxone®, for relapsing/remitting multiple sclerosis.
Infergen®, which is licensed by InterMune from Amgen, is approved by the U.S. Food and
Drug Administration for the treatment of hepatitis C.
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The current worldwide market for interferon alpha, which is dominated by the recombinant
interferons, is estimated to be in excess of $3 billion. Pegylated versions of the drug have been
produced to offer patients the convenience of a weekly dosage, instead of three times a week, thus
providing a more convenient mode of administration. Pegylation is a process which helps prevent the
interferon from being broken down by the immune system. As a result, the interferon persists longer
in the body.
Our Natural Interferon Product
We derive our natural human alpha interferon from human white blood cells also known as
leukocytes. Natural interferon is the bodys first natural defense response to foreign substances
such as viruses, interfering with the viral growth and replication processes. Natural interferons
are naturally-produced proteins that induce anti-viral, anti-tumor and immunomodulatory responses
within the body. Clinical studies indicate that interferons may also inhibit malignant cell and
tumor growth without affecting normal cell activity. Our proprietary interferon product,
Multiferon®, is comprised of multiple subtype alpha interferons and is unique to any other
interferon alpha product in the world.
There are two industrial sources of interferon for medical use. They are differentiated
primarily by their source products, methods of manufacture and resulting composition. The first,
the type we produce, is a natural multi-subtype human leukocyte-derived alpha interferon. This is
produced by incubated human white blood cells, induced by a virus that is not normally pathogenic
in humans, to produce natural interferon as a normal mechanism of defense. Natural interferon is
then purified to produce a highly concentrated and highly pure product for clinical use. The second
type of interferon is recombinant or synthetic interferon (typically alpha or beta). Generally, it
is produced from a single human gene in bacterial cells by recombinant DNA techniques.
The interferon market is dominated by recombinant products. This is mainly due to the high
cost and complexity of producing natural interferon, as well as the marketing expertise of those
companies that offer recombinant products. We believe that the production methods we have
developed, as well as enhanced methods currently under development, will continue to reduce our
costs of production and, ultimately, the market price of natural human leukocyte derived interferon
to patients. However, we cannot assure you that any new manufacturing technology will achieve the
level of manufacturing proficiency, reductions in production costs and product improvement hoped
for.
We believe that there may be certain advantages to the natural interferon products, especially
in terms of tolerability and efficacy. Clinical studies and anecdotal evidence indicate that there
may be therapeutic differences between the use of natural interferon and synthetic interferon. We
believe that treatment with synthetic interferon may cause an immunological response through the
production by the human immune system of neutralizing and/or binding antibodies. These antibodies
could reduce the effectiveness of the treatment or may cause adverse side effects and treatment
failure in some patients. Published clinical literature suggests that the production of
neutralizing and/or binding antibodies may be essentially non-existent in patients treated with
natural interferon. Furthermore, primarily due to biological differences, the side effects of
treatment with natural interferon may be milder than those caused by a recombinant or synthetic
interferon and also those attributed to the newer pegylated formulations. In addition, some
patients who are non-responsive or have experienced adverse side effects to recombinant interferon
have shown a response when treated by natural interferon.
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Applications of Interferon
Interferon is a naturally occurring protein which serves to enhance the bodys immune response
to viral infections. It has been clinically proven that interferons can arrest the progress of many
viral based infections, reducing adverse symptoms and disease related complications. In addition,
it is believed that the multi-subtype nature of natural interferons may provide advantages over
single subtype recombinant forms.
Hepatitis C
The hepatitis C virus is a major worldwide cause of acute and chronic hepatitis. Hepatitis C
affects an estimated 4 million Americans and 5 million Europeans. Approximately 30,000 new cases of
hepatitis C are diagnosed each year in the U.S. and it is responsible for an estimated 8,000 deaths
annually. Hepatitis C is currently a leading cause of liver transplantation in the United States.
The U.S. Food and Drug Administration has approved certain synthetic interferon products for the
treatment of hepatitis C including:
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Hoffmann-La Roches Roferon® and PEGASYS® |
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Hoffmann-La Roches PEGASYS® used in combination with COPEGUS®, Roches ribavirin |
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Schering-Ploughs Intron A® and Peg-Intron ® used in conjunction with Rebetol® |
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Intermunes Infergen®. |
Synthetic interferon has proven to be effective in the treatment of some cases of hepatitis C.
Based on clinical experience in Sweden, our natural interferon product has also proven effective in
the treatment of hepatitis C in a second-line setting. However, prior to approval by the U.S.
Food and Drug Administration, extensive additional clinical trials costing many millions of dollars
will be required. These studies could take several years to complete.
It is not likely that we will be able to initiate clinical trials in hepatitis C in the United
States or the EU without the financial assistance of a third party. Excluding the ongoing studies
mentioned in Greece, Mexico and tentatively in Sweden, and all in
rescue or second-line therapy, we
have no current plans to conduct any additional studies in Hepatitis in any country.
Melanoma
Melanoma is a type of cancer which originates in the melanocytes, the cells responsible for
pigmentation of the skin. Over 30,000 cases per year are diagnosed in the United States alone.
Melanoma has one of the fastest growing occurrence rates, increasing at a rate in excess of 4% per
year. Lifetime risk of developing melanoma in an average American is currently about one in 75 and
it is the most commonly occurring cancer in women between the ages of 25 and 29. Melanoma is second
only to breast cancer in women ages 30 to 34.
We conducted a Phase II/III clinical trial in Germany with our natural interferon product for
the adjuvant treatment of malignant melanoma, which indicated promising results. The study
involved 252 patients with malignant melanoma in 20 centers, who were randomized to receive either
our natural interferon product after dacarbazine or no adjuvant therapy.
The preliminary results obtained in this study showed that adjuvant treatment with low doses
of our product, preceded by dacarbazine, significantly increases long term overall survival in
high-risk resected cutaneous melanoma patients. The results suggest a survival benefit which is at
least comparable to that obtained with a high-dose recombinant interferon regimen, but over a much
shorter, and thus less expensive, treatment period.
The final data collected from our melanoma study has been submitted to the registration
authorities in Sweden for approval. We expect a decision from the authorities by the end of
calendar 2005. If approved, our plan, with the sponsorship of the Swedish authorities, is to
seek European approval with a filing through the Mutual Recognition Procedure. In addition, we are
now contemplating a new malignant melanoma study in a number of European countries to further
assess the utility of Multiferon® in treating this aggressive disease.
11
Chronic Myelogenous Leukemia
Chronic myelogenous leukemia is one of a group of diseases called myeloproliferative
disorders. It is usually recognized by a distinctive cytogenetic abnormality, known as the
Philadelphia chromosome. The current treatment for chronic myelogenous leukemia is high dose
chemotherapy with bone marrow transplantation. Interferon therapy has emerged as a possible
effective initial treatment in this disease. This type of therapy affects both the presence of
leukemia cells and the number of bone marrow cells having the Philadelphia chromosome.
Multiferon®
is approved in a number of countries for the treatment of
patients with chronic myelogenous leukemia who did not respond to
treatment with recombinant interferon. We have no
current plans to conduct any additional studies in this indication in any country.
Hairy Cell Leukemia
Hairy cell leukemia is a disease in which a type of white blood cell called the lymphocyte,
present in the blood and bone marrow, becomes malignant and proliferates. It is called hairy cell
leukemia because the cells have tiny hair-like projections when viewed under the microscope. Hairy
cell leukemia is a rare cancer. There are approximately 600 new cases diagnosed every year in the
United States, making up about 2% of the adult cases of leukemia each year.
Multiferon®
is approved in a number of countries for the treatment of
patients with hairy cell leukemia who did not respond to treatment
with recombinant interferon. We have no current plans to conduct any additional studies in these
indications in any country.
Research and Development
Our research and development projects include the avian transgenics platform, two humanized
antibodies and ongoing studies in support of Multiferon® and next-generation interferon alpha
products.
Avian Transgenics
Our avian transgenic manufacturing program is designed to enable us to produce protein-based
drugs, including monoclonal antibodies, in the whites of eggs laid by transgenic chickens. Our goal
is to develop a technology which will enable us to offer a viable and cost-effective alternative
for the large-scale production requirements of the biopharmaceutical industry and also for our own
therapeutic protein products. Existing protein production technologies are often inefficient and
costly. We believe that this technology will allow us to offer the biopharmaceutical industry an
efficient method of production of their protein-based products. It is envisaged that this
technology will have a higher capacity, lower manufacturing costs and may be able to offer
improvements to the products themselves.
We believe our avian transgenics project could offer a rapid and cost effective way to produce
large volumes of therapeutic proteins. In addition to meeting the current and future alternative
production demands of the biopharmaceutical industry and generating significant revenue for us,
this project could also accelerate the progress of several life-saving drugs to the market at an
affordable cost.
At the current time, we are developing four product candidates using the avian transgenic
technology. The first, a humanized version of the anti-GD3 antibody that is the subject of a
collaborative research agreement between Viragen and Sloan-Kettering Institute, has already
realized key milestones, including our June 2005 announcement of detection and recovery of the
intact and bioactive antibody, from the white of transgenic hen eggs. Of the remaining three
product candidates in development, two are currently approved commercial products. We have not yet
announced the identity of these three product candidates, but expect with continuing successes, to
do so in the coming months. We expect to report successes in developing this technology and
possibly initiating production of some or all of our product candidates in the 2006 calendar year.
Antibodies
There have been a great number of developments in the treatment of cancer in humans over the
years. Monoclonal antibodies have been shown to be able to offer significant advantages over other
therapies, yet even with this success, current products still fall far short of the ideal with
respect to both efficacy and to a lesser extent, safety. Trends in treatment options are tending to
favor multiple agents and therapies in combination or sequential administration as well as targeted
therapeutics. Still, there remains much room for improvement.
We have selected two monoclonal antibodies for our research and development projects based
largely upon 1) novelty, 2) prior pre-clinical information, and 3) prior testing in humans. Both of
our current antibody projects are unique in these respects and both offer the potential to be
developed into a platform based technology.
VG102
In April 2005, we executed a global exclusive license with Cancer Research Technology UK for
the rights to develop and commercialize an anti-CD55 antibody. This specific antibody was developed
through the research of Professor Lindy Durrant of the University of Nottingham, UK. The CD55
antigen is significantly over-expressed on nearly all solid tumors in humans. Early studies at
Nottingham demonstrated that the antibody was able to bind only to tumor antigen and furthermore,
it was shown to bind in a highly novel manner, different from all anti-CD55 antibodies known in the
scientific literature. This novelty underpins the intellectual property surrounding VG102, in
addition to other intellectual property we have created through our development activities. The
CD55 antigen has been shown to block the bodys natural immune system from attacking and killing
cancer cells. Theoretically, if an antibody can be developed that binds selectively to tumor CD55
antigen, this protective mechanism will be removed and the natural immune system, or concomitantly
or sequentially administered anti-tumor agents, would then be able to destroy cancer cells.
Importantly, Professor Durrant has produced the mouse form of this antibody and has
administered it successfully to humans in a scintigraphy procedure (imaging). These studies
demonstrated the specificity of binding only to tumor antigen, and not normal cells, and
demonstrated tolerability in humans, albeit small numbers and dosages, without safety incident. It
is this data, and our own exploratory data in our laboratories, that has led us to license what we
believe may become an important addition to the arsenal for fighting a number of types of cancer.
At the current time we are developing production processes for a humanized version of this
antibody to continue pre-clinical studies, and we hope to be ready to initiate toxicology studies
on the humanized form during calendar 2006, followed by meetings with regulatory authorities to
agree upon clinical development protocols. We have not yet selected a target indication for this
antibody; however, we have identified ovarian cancer, breast cancer and
head and neck cancer as among the possibilities. At this time, we are not able to predict any date
for the start of clinical trials.
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VG101
In 1999, we entered into a collaborative research and development agreement with
Sloan-Kettering Institute (SKI) for the joint development of an antibody to the GD3 antigen, which
is over-expressed on several types of cancer cells, most notably melanoma. This agreement was
extended in February 2002 and goes through February 2007. It is believed that the GD3 antigen
protects melanoma cells from the bodys natural immune system, and anti-cancer therapeutics,
thereby allowing cells to proliferate and grow. By removing this protection, using an antibody that
selectively binds to the GD3 antigen, the natural immune system has a better chance to kill these
tumor cells, as would separately administered anti-cancer agents.
SKI clinicians have previously studied the mouse form of this antibody in a fairly extensive
manner in numerous human clinical trials. However, use of mouse-derived antibodies typically
influences the outcome of testing in humans in that the human body reacts to mouse antibody as if
it was a foreign invader, thereby reducing the overall efficacy, and tolerability, of the product.
SKI was able to demonstrate that this antibody had beneficial effects in patients with Stage IV
melanoma, the most deadly stage of this disease. SKI also found that the antibody had therapeutic
utility when used alone, but greater therapeutic utility when used with other compounds. If the
antibody can be produced in a humanized form, thereby eliminating at least some of the undesirable
effects, whether used alone or in combination with other products, it could offer significant
improvement in this disease setting. Importantly, to date, there are no other products available to
successfully treat Stage IV melanoma.
We are currently engaged in negotiations with SKI, for an exclusive license to this antibody,
as provided for in the earlier agreement. At the current time, we are developing production
processes for various forms of the antibody, including the avian transgenics technology, in an
effort to generate humanized forms. These antibodies be shared with SKI clinicians for
comparability testing, done in parallel with studies at our Viragen (Scotland) laboratories,
following which we will select one humanized form to complete pre-clinical studies in preparation
for meetings with the US Food and Drug Administration. We expect a meeting with the FDA could be
requested in calendar 2006, provided a license agreement is executed. We are not able to predict a
date for the start of clinical trials.
IEP 11
We entered into an agreement with the University of Miami and the UM/Sylvester Comprehensive
Cancer Center to develop an anti-cancer technology with an option to license the technology upon
completion of certain milestones. In May 2005, we decided to allow this option to expire. This
project has thus been terminated and we will no longer have any expenses related to it. We have
returned all documentation and the rights to this technology to the University.
Multiferon®
Our natural, leukocyte-derived multi-subtype interferon alpha product, Multiferon® has been
developed as an alternative to synthetic (recombinant), single-subtype products, and is currently
approved in many countries for any indication where patients fail, relapse from, or fail to
tolerate, synthetic interferon alpha products. Multiferon® is currently approved in 10 countries
around the world and actively marketed in 5 of those countries through local distribution partners,
and our own sales team in Sweden.
Interferon alpha is the human bodys first line of defense against infectious disease. Human
leukocytes, in the blood, secrete a number of different types of interferon alphas when exposed to
attack by viruses and bacteria. Viragen collects human leukocytes, a by-product of blood
collection, and under highly exacting procedures, subjects these to a viral challenge that is known
to be benign to humans, but stimulates the leukocytes to produce a unique mixture of interferon
alpha subtypes. We then collect and purify the resultant interferon alphas using our proprietary
technologies to result in Multiferon®. The mixture of subtypes contained in Multiferon® is unique
among all interferon alpha products.
Multiferon® has been and continues to be studied in clinical trials in humans as rescue
therapy for patients who have been treated with synthetic interferon alpha products but who have
for various reasons not responded to that treatment. At the current time, we have clinical trials
under way in Mexico and Greece in hepatitis C and we are currently contemplating a study in Sweden
in order to investigate a different treatment regimen also in hepatitis C.
Multiferon® is also indicated for use in some types of leukemia and cancers. We have recently
completed a long term follow up of a clinical trial conducted in patients with high-risk malignant
melanoma, and subsequently we have filed with the Swedish MPA for approval for first line adjuvant
therapy in February, 2005. We expect a decision on this by the end of calendar 2005. We are now
contemplating another larger clinical trial in malignant melanoma to study further the effects of
the product on various stages of the disease in what will potentially become a pan-European study.
We will not start this clinical trial until some time in 2006, provided we obtain regulatory
approvals to do so, and provided we have the financial ability to fund this study.
Multiferon® is believed to have other potential uses in other cancer treatment regimens and we
are currently evaluating a number of other possible indications for which clinical trials would be
required in order to gain approvals.
While developing data in support of Multiferon®, we have been gathering information on the
mechanisms of action involved in the interferon alpha response against viral diseases and cancers.
From this information, we envisage that potential next generation interferon products may evolve.
It is not possible at this time to predict whether any of these developments or potential new
products will be successful or what costs will be incurred to further determine the therapeutic
value of such products.
The timelines and costs for the completion of biopharmaceutical research and product
development programs are difficult to accurately predict for various reasons, including the
inherent exploratory nature of the work. The achievement of project milestones is dependent on
issues which may impact development timelines and can be unpredictable and beyond Viragens
control. These issues include; availability of capital funding, presence of competing technologies,
unexpected experimental results which may cause the direction of research to change, accumulated
knowledge about the intrinsic properties of the candidate product, the availability of Good
Manufacturing Practices grade material, results from preclinical and clinical studies, potential
changes in prescribing practice and patient profiles and regulatory requirements.
The completion of all of the above research and development projects is dependent upon our
ability to raise significant additional funding or our ability to identify potential collaborative
partners that would share in project costs. Our future capital requirements are dependent upon
many factors, including: revenue generated from the sale of our natural human alpha interferon
product, progress with future clinical trials; the costs associated with obtaining regulatory
approvals; the costs involved in patent applications; competing technologies and market
developments; and our ability to establish collaborative arrangements and effective
commercialization activities.
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Intellectual Property
We believe that our natural human alpha interferon production techniques are unique and are
capable of yielding a superior quality product and will allow us to produce the product at
relatively low costs. We have developed a broad and valuable intellectual property portfolio on
the manufacturing methods used to produce Multiferon® and continue to develop this portfolio
through in-house research and development.
In April 2005, we were notified by the US Patent and Trademark Office that our patent
application (#09/869,269) had been accepted for grant. This patent, entitled Modification of
Interferon Alpha Production, describes a process relating to the manufacture of Multiferon®, our
natural human alpha interferon drug derived from human white blood cells, and relates to the novel
use of an enhancing agent to optimize the yield of interferon from the cell preparation during the
production process. This patent expires in December 2018.
In February 2004, Viragen filed a patent application with the UK Patent Office covering the
use of natural, multi-subtype alpha interferon for human treatment and prevention of avian
influenza virus, commonly known as avian flu. Subsequent applications were filed with the UK Patent
Office in February and May 2005 and an application was filed with the US Patent and Trademark
Office in March 2005. Avian influenza is an infectious viral disease of birds caused by type A
influenza strain. The type A influenza group of viruses has certain characteristics that make them
of particular concern to the human population. They have a tendency to undergo mutation, resulting
in new variants for which no vaccine is available. In addition, such viruses have the potential to
combine with viruses from other species, leading to pandemics due to the resulting difficulties in
developing effective treatments or preventative measures. While no clinical studies are currently
planned or ongoing, we believe that Multiferon® is a prime candidate for evaluation in avian
influenza studies.
As mentioned previously, we continue to develop our knowledge base of the Multiferon® product,
to evaluate new and beneficial ways of manufacturing. As a result of research and development work
performed in house, a provisional application for a modification to the Multiferon® production
process was filed with the UK Patent Office in February 2005.
As a result of research and development work performed in house, Viragen filed a provisional
patent application with the UK Patent Office for an optimal interferon product in April 2005.
Viragen is developing a broad intellectual property portfolio in the area of avian
transgenics. In May 2005 our International application WO04047531 entitled Protein Production in
Transgenic Avians, filed jointly with Oxford Biomedica UK Ltd entered into the National Phase.
This patent application describes the use of specific viral based vectors as gene delivery vehicles
in creating transgenic birds that may be used to produce proteins of interest in their eggs.
In May 2005, our patent application NZ532709 derived from the International application
WO03049537 entitled Methods of Preparing Eggs for Nuclear Transfer and Uses Thereof was accepted
for grant by the Intellectual Property Office of New Zealand. This patent expires in December
2021. Other regional applications for this invention are progressing through the normal
prosecution process. This patent application describes the use of gamma irradiation in the
enucleation of avian cells in preparation for nuclear transfer. This process may be one of the
preparatory steps used in creating transgenic birds.
In September 2004, a provisional patent application was filed with the UK Patent Office
describing a method to optimise gene vector constructs so that expression of the protein is
maximized and may be used as one of the steps in the process of creating transgenic birds which
produce proteins of interest in their eggs.
In September 2004, a provisional patent application was filed with the UK Patent Office
describing a system that allows pre-screening of gene vector constructs to determine their utility
in creation of transgenics and this method may be used as one of the steps in the process of
creating transgenic birds which produce proteins of interest in their eggs.
In May 2005, a provisional patent application was filed with the UK Patent Office describing a
novel promoter construct to be used in creation of transgenics. This promoter may be used in the
creation of transgenic birds which produce proteins of interest in their eggs.
United States and foreign patents have been issued to others for genetically engineered and
human-derived interferons and methods and processes for producing transgenic birds. In the event of
valid claims, we may have to negotiate license agreements with patent holders to use some processes
and products. We believe that we do not infringe upon any current patent. We have not received any
communications or had any conversations with the owners of related patents that may potentially
make claims or who have threatened to make a claim that our patents infringe their patents.
It is possible to challenge the validity and enforceability of a patent by litigation after
its issuance. If the outcome is against the owner of the patent, other parties may be free to use
the subject matter of the patent. Protection provided by foreign patents may be different than in
the United States. The actual protection we receive from a foreign patent may vary from one country
to another. Protection realized may also depend on the type of patent, scope of coverage granted
and the legal remedies available in each country. We cannot guarantee that any future patents will
offer substantial protection or commercial benefit to us.
Regulation
Our activities, products and processes are subject to substantial government regulation within
the United States, the European Union (EU) and other foreign jurisdictions. The U.S. Food and Drug
Administration, foreign jurisdictions and state and local agencies regulate the manufacturing,
advertising, packaging, labeling and sale of biologic substances and pharmaceutical products.
Regulatory authorities have stringent mandatory procedures and standards, which apply to the
clinical testing, manufacture and marketing of any biologic products, including ours. Regulatory
approvals for commercialization of any new product take significant time and capital, since it
involves extensive testing procedures and lengthy clinical trials. These trials involve the
measurement of product safety and efficacy under specific protocols. The process of obtaining
approvals requires extensive prior animal testing to demonstrate product safety. Human tests are
then performed to show and to document findings as to safety and effectiveness. Data is then
gathered and evaluated, followed by the submission of all information and data to the regulatory
authorities. This process takes many years and substantial funding.
14
Extension of the number of licenses held in the EU can be achieved for products like
Multiferon® through the Mutual Recognition Procedure. This process makes it possible to hold
marketing authorizations in all, or some, Member States. Mutual Recognition is administered by and
between the competent authorities of the member states where marketing authorizations are sought.
Subject to the successful completion of clinical trials, we believe this is the regulatory route
that we will use to secure regulatory approval in the EU. Product pricing and reimbursement
guidelines are dictated by the individual EU member states and are
subject to change. The Mutual Recognition Procedure (MRP) permits a registrant of a new drug or biological product to
use a single registration dossier to gain marketing authorization in a number of EU countries. The
prerequisite requirement is that any new registration must have a sponsor country that has reviewed
and approved the registration dossier. In the case of Multiferon®, and following the expected
Swedish approval of our dossier, Sweden would agree to act as our sponsor country for the MRP
filing. Once the dossier is approved through the MRP process, it is then permissible to go to each
country that has approved the filing and seek reimbursement authorization. All countries are not
required to approve the filing in the MRP process, and there is no guarantee that any country will
agree to reimburse for the product.
In Europe and the United States, human clinical trial programs generally involve a three-phase
process. Typically, Phase I trials are conducted in healthy volunteers to determine any early side
effects and the pattern of drug distribution and metabolism. Phase II trials are conducted in
groups of patients afflicted with the target disease to provide preliminary data on the
effectiveness and safety of a new drug product. If Phase II evaluations indicate potential
effectiveness with an acceptable safety profile, Phase III trials are performed. Phase III is
performed to demonstrate clinical effectiveness and safety within an expanded patient population
from multiple clinical study sites. Regulatory authorities may also require Phase IV studies to
track patients after a product is approved for commercial sale.
American pharmaceutical manufacturers who sell outside of the United States are also subject
to U.S. Food and Drug Administration jurisdiction. Semi-finished drugs may be shipped, under
controlled circumstances, for further processing, packaging, labeling and distribution to third
parties in approved foreign countries. This controlled distribution is also subject to the laws
that apply in the importing countries. For Viragen to conduct this type of sale, we must comply
with all U.S. Food and Drug Administration rules and regulations.
It is possible that the U.S. Food and Drug Administration or foreign regulatory authorities
could modify or expand their approval criteria or reporting requirements. These changes could
significantly increase or decrease the time and expense to develop a new product and bring that
product to market.
Competition
Competition in the research, development and production of interferon and other immunological
products is intense and growing. Our competition includes many major, well-established and
well-financed pharmaceutical and commercial entities, as well as major educational and scientific
institutions. Many researchers, some of whom have substantial private and government funding, are
involved with interferon production, including production of interferon through synthetic DNA
technology. A number of large companies, including Hoffmann-La Roche, Inc., Schering-Plough
Corporation, Biogen, Inc., Chiron Corp., Berlex Laboratories and Ares-Serono are producing, selling
and conducting clinical trials with their recombinant interferons (alpha and beta) and other
immunological products in the areas of cancer and viral infections, including hepatitis C.
We believe that competition is also based on production ability, technological superiority,
regulatory expertise in obtaining governmental approvals for testing and manufacturing and the
capabilities of companies in marketing and selling the product.
We are aware of a number of companies that are engaged in research and development of various
transgenic systems and models that are hoped to be used to efficiently and productively manufacture
proteins for human therapeutic use. These include but are not limited to the use of cattle, goats,
plants and avians. Some of these companies are larger, well-funded enterprises and that have been
working in this field for many more years than has Viragen. There can be no assurance that any of
these companies will not complete their research, enlist large, multinational pharmaceutical and
biotech companies to invest in their technology and produce a therapeutic product that comes to
market before Viragen.
There are a large number of companies around the world that have monoclonal antibodies in
their research, development or commercial pipelines. There are large, well-financed multinational
pharmaceutical and biotech companies that have monoclonal antibodies which have been approved for
marketing for a number of years. Competition in the field of antibodies is extensive and intense.
Intellectual property on monoclonal antibodies is equally extensive making it difficult for new
entries to this field to generate new patents. Although we monitor competitive activity in the
field, there can be no assurances that our antibody projects will be competitive, will have secure
intellectual property free of licenses from third parties, or will ever be clinically proven to be
safe and efficacious in comparison to competitive products.
The timing of the entry of a new pharmaceutical product into the market is an important factor
in determining that products eventual success. Early market entry has advantages in gaining
product acceptance and market share. Our ability to develop products, complete clinical studies and
obtain governmental approvals in the past has been hampered by a lack of adequate capital. We are
not presently a competitive factor in the interferons market, nor are any of our distributors.
Employees
As of September 6, 2005, we have 67 employees. Of these, 47 are research and development,
manufacturing and quality assurance/quality control personnel. The remaining 20 employees are
management, regulatory and/or administrative personnel. Our domestic and Scottish-based employees
are not represented by any collective bargaining agreements. The majority of our Swedish-based
employees are members of a Swedish union representing scientific personnel. We have never
experienced a work stoppage. We believe our relations with our employees and the Swedish unions to
be good.
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Item 2. Properties
In November 1996, Viragen entered into a ten year lease for 14,800 square foot facility
located at 865 SW 78th Avenue, Suite 100, Plantation, Florida 33324. This location contains our
domestic administrative, international marketing and executive offices. The lease contains an
option for up to two additional five-year terms. Current monthly rental on the property, including
common area maintenance charges and applicable taxes, is approximately $30,000.
In November 1996, Viragen (Scotland) executed a five year lease, subsequently modified for
additional space, for a newly constructed laboratory and manufacturing facility located in
Pentlands Science Park near Edinburgh, Scotland. The facility consists of approximately 17,000
square feet with base monthly rental payments of approximately $33,000 plus common area and
maintenance charges. The lease further provides for up to four five year extensions at our option.
In October 2001, we exercised our first option to extend the lease through October 2006. In March
2002 and September 2003, we entered into sub-lease agreements, sub-leasing a portion of our space
to third parties, with initial terms of one year, thereafter renewable on a monthly basis. The
area covered in these sub-lease agreements totals approximately 4,000 square feet generating
monthly sub-lease rent of approximately $8,000.
Through ViraNative, we lease approximately 25,500 square feet of laboratory, production and
office facilities in Umeå, Sweden. This space is covered by two separate leases. These leases were
renewed through December 2006 at a total lease cost of approximately $31,000 per month. Our
Multiferon® product is manufactured in this facility. In June, 2005, we initiated modifications at
this facility in order to improve compliance with evolving regulations and to upgrade specific
equipment used in the manufacturing process. These upgrades and subsequent validations are expected
to be completed by the end of calendar 2005. These modifications have been presented to and agreed upon
with the Medical Products Agency in Sweden. We do not expect any significant delays or
interruptions to operations as a result of these modifications.
ViraNative also owns a 21,500 square foot building in Umeå, Sweden, which was recently
renovated at a cost of approximately $1.5 million to accommodate a portion of our Multiferon®
production. This building was purchased prior to our acquisition of ViraNative to provide expanded
production capacity and is intended to potentially house all of ViraNatives research, production
and administrative facilities. This facility carries a 25 year mortgage held by a Swedish bank for
approximately $631,000.
We believe our properties are in good condition, well-maintained and generally suitable and
adequate to carry on our business. We also believe that we maintain sufficient insurance coverage
on all of our real and personal property.
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Item 3. Legal Proceedings
In October 1997, Viragen, the Companys former president and Cytoferon Corp., a former
affiliate of the president, were named as defendants in a civil action brought in the United States
District Court for the Southern District of Florida (Walter L. Smith v Cytoferon Corp. et al; Case
No: 97-3187-CIV-MARCUS). The plaintiff is a former Viragen stockholder and investor in Cytoferon
Corp. The suit alleged the defendants violated federal and state securities laws, federal and state
RICO statutes, fraud, conspiracy, breach of fiduciary duties and breach of contract. The plaintiff
was seeking an unspecified monetary judgment and the delivery of 441,368 shares of common stock.
Viragen filed a motion to dismiss denying the allegations and requesting reimbursement of its
costs.
In November 1997, the plaintiff filed a notice of voluntary dismissal with the federal court
concurrently notifying Viragen of his intent to refile a complaint in circuit court in the state of
Florida. In December 1998, the U.S. District Court awarded us reimbursement of attorneys fees and
expenses under Rule 11 of the Federal Rules of Civil Procedure and the Private Securities
Litigation Reform Act. We recovered $31,000 during fiscal 2000.
In November 1997, the plaintiff filed a complaint in the Circuit Court of the 11th Judicial
Circuit for Miami-Dade County, Florida (Case No: 97-25587 CA30) naming the same defendants. The
suit alleges breach of contract, fraud, violation of Floridas RICO statute and breach of fiduciary
duties. It sought an unspecified monetary judgment and specific performance delivery of 441,368
shares of Viragen common stock. The plaintiff claimed that he was entitled to additional shares of
common stock under a consulting agreement. He also claimed that Viragens former president
breached his fiduciary duty to Cytoferon Corp. by not achieving sufficient financing for Viragen,
which would have entitled Cytoferon Corp. to additional shares. He also claimed misrepresentations
in connection with the previous Cytoferon financings.
In March 1998, the Circuit Court granted Viragens motion to dismiss the complaint.
Subsequently, the plaintiff filed an amended complaint alleging breach of contract, fraud,
violation of Floridas RICO Act and breach of fiduciary duties and seeking an unspecified monetary
judgment and specific performance delivery of 441,368 shares of Viragen common stock. In April
1998, Viragen filed a motion to dismiss plaintiffs amended complaint which was denied by the
court.
In August 2000, counsel for plaintiff indicated that they desired to withdraw as counsel. In
January 2001, the Circuit Court ruled in favor of Viragen on all counts related to the Circuit
Court Case (No.: 97-25587 CA30). No further claims against Viragen are pending in this matter. In
July 2002, the Circuit Court ruled in favor of Mr. Smith and Cytoferon and all counts against these
defendants were dismissed. Following this ruling, we filed for recovery of related litigation costs
in these matters. The court granted us recovery of fees against both the plaintiff in this matter
and his attorneys. In April 2003, we were notified that the plaintiff and their counsel were
appealing the award of approximately $210,000 in legal fees. We are currently vigorously pursuing
the recovery of these fees.
In February 2001, Viragen filed a lawsuit, (Viragen, Inc. v. Walter Larry Smith, W. Richard
Leuck, Roland St. Louis, Jr., Esq., Juan C. Martinez, Esq., St. Louis, Guerra, Auslander, P.A. and
John Does Nos. 1-10, Case No. 01-3842 CA 01) in a malicious prosecution and conspiracy action
against the above mentioned parties in a attempt to recapture the losses incurred by Viragen, Inc.
as a result of having to disclose the lawsuit Walter L. Smith v. Gerald Smith, Cytoferon Corp.,
Viragen, Inc. and John Does Nos. 1-10, Case No. 97-25587 CA (30) (Smith Litigation) as well as
the attorneys fees and costs expended by Viragen, Inc. in defending this action. The Smith
Litigation wrongfully alleged that Viragen, Inc. engaged in, among other things, fraud and RICO
violations during the course of a 1992 stock offering done by Cytoferon, Corp. In the Smith
Litigation, the Court granted final summary judgment in favor of Viragen, Inc., specifically
finding that there was no evidence connecting Viragen, Inc. in any way to the allegations made
against it in the complaint in that action.
Due to the insolvency of one insurance carrier of certain defendants in this case, hearings in
this matter had been repeatedly postponed. In September 2005, a Florida court ruled that one
attorney defendant was covered by a different insurance carrier. We have agreed to a mediation
conference with this defendant to be held in the fourth calendar quarter of 2005. We continue to
vigorously pursue our claims in this matter.
17
Item 4. Submission of Matters to a Vote of Security Holders
No matter was submitted during the fourth quarter of our fiscal year to a vote of security
holders through the solicitation of proxies or otherwise.
18
PART II
Item 5. Market for Registrants Common Equity and Related Stockholder Matters
Our common stock began trading on the American Stock Exchange on April 17, 2000, under the
symbol VRA. The following table sets forth the high and low closing sales prices as reported on
the American Stock Exchange for the periods indicated, as adjusted for Viragens one for ten
reverse stock split effective June 15, 2004.
|
|
|
|
|
|
|
|
|
|
|
High |
|
Low |
2004-2005 Period |
|
|
|
|
|
|
|
|
Fourth Quarter ended 06/30/05 |
|
$ |
0.78 |
|
|
$ |
0.55 |
|
Third Quarter ended 03/31/05 |
|
|
1.00 |
|
|
|
0.64 |
|
Second Quarter ended 12/31/04 |
|
|
1.22 |
|
|
|
0.90 |
|
First Quarter ended 09/30/04 |
|
|
1.40 |
|
|
|
0.87 |
|
|
|
|
|
|
|
|
|
|
2003-2004 Period |
|
|
|
|
|
|
|
|
Fourth Quarter ended 06/30/04 |
|
$ |
2.20 |
|
|
$ |
1.25 |
|
Third Quarter ended 03/31/04 |
|
|
3.20 |
|
|
|
2.00 |
|
Second Quarter ended 12/31/03 |
|
|
2.90 |
|
|
|
2.30 |
|
First Quarter ended 09/30/03 |
|
|
3.50 |
|
|
|
2.00 |
|
The above quotations represent prices between dealers, and do not include retail mark-ups,
markdowns or commissions and do not represent actual transactions.
As of September 6, 2005, we had approximately 920 stockholders of record. On September 6,
2005, the closing price of the common stock was $0.72 per share.
We have never paid any dividends on our common stock. We do not anticipate paying any cash
dividends in the foreseeable future because:
|
|
|
we have experienced losses since inception, |
|
|
|
|
we have significant capital requirements in the future, and |
|
|
|
|
we presently intend to retain future earnings, if any, to finance the expansion of our business. |
Future dividend policy will depend on:
|
|
|
our earnings, if any, |
|
|
|
|
capital requirements, |
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|
|
expansion plans, |
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|
|
|
legal or contractual limitations, |
|
|
|
|
financial condition, and |
|
|
|
|
other relevant factors. |
19
Item 6. Selected Financial Data
The following selected financial data should be read together with Managements Discussion
and Analysis of Financial Condition and Results of Operations, the consolidated financial
statements and notes thereto and other financial information included elsewhere in this Annual
Report on Form 10-K. The consolidated statements of operations data set forth below of Viragen for
the fiscal years ended June 30, 2005, 2004 and 2003 and the consolidated balance sheet data as of
June 30, 2005 and 2004 have been derived from Viragens audited consolidated financial statements
which are included elsewhere in this Annual Report on Form 10-K. The consolidated statement of
operations data set forth below for the fiscal years ended June 30, 2002 and 2001 and the
consolidated balance sheet data as of June 30, 2003, 2002 and 2001 have been derived from Viragens
audited consolidated financial statements which are not included in this Annual Report on Form
10-K.
|
|
|
|
|
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|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June 30, |
|
|
2005 |
|
2004 |
|
2003 |
|
2002 |
|
2001 |
STATEMENTS OF OPERATIONS DATA |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales |
|
$ |
278,784 |
|
|
$ |
266,137 |
|
|
$ |
630,785 |
|
|
$ |
1,275,264 |
|
|
$ |
|
|
Interest and other
income, net |
|
|
1,538,067 |
|
|
|
632,378 |
|
|
|
535,428 |
|
|
|
333,130 |
|
|
|
717,567 |
|
Net
loss(a) |
|
|
(26,207,706 |
) |
|
|
(18,177,164 |
) |
|
|
(17,348,686 |
) |
|
|
(11,088,832 |
) |
|
|
(11,007,809 |
) |
Net loss
attributable to
common
stock |
|
|
(26,209,856 |
) |
|
|
(18,179,714 |
) |
|
|
(17,351,336 |
) |
|
|
(11,091,482 |
) |
|
|
(11,010,459 |
) |
Basic and diluted
net loss per
common
share(b) |
|
|
(0.71 |
) |
|
|
(0.55 |
) |
|
|
(1.21 |
) |
|
|
(1.10 |
) |
|
|
(1.16 |
) |
Weighted average
common
shares
outstanding(b) |
|
|
36,697,852 |
|
|
|
33,183,832 |
|
|
|
14,393,803 |
|
|
|
10,041,571 |
|
|
|
9,511,691 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At June 30, |
|
|
2005 |
|
2004 |
|
2003 |
|
2002 |
|
2001 |
BALANCE SHEET DATA |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Working (deficit) capital |
|
$ |
(7,300,733 |
) |
|
$ |
25,181,900 |
|
|
$ |
4,070,504 |
|
|
$ |
(209,519 |
) |
|
$ |
6,178,436 |
|
Total assets |
|
|
21,984,792 |
|
|
|
48,219,996 |
|
|
|
27,867,417 |
|
|
|
20,796,604 |
|
|
|
12,820,951 |
|
Convertible notes and
debentures, current(c) |
|
|
16,104,994 |
|
|
|
|
|
|
|
2,224,599 |
|
|
|
711,982 |
|
|
|
|
|
Convertible notes and
debentures, long-term (c) |
|
|
|
|
|
|
12,490,919 |
|
|
|
1,827,163 |
|
|
|
|
|
|
|
|
|
Long-term debt |
|
|
598,104 |
|
|
|
1,072,087 |
|
|
|
1,124,335 |
|
|
|
1,023,948 |
|
|
|
25,488 |
|
Stockholders equity |
|
|
2,593,617 |
|
|
|
29,189,581 |
|
|
|
15,720,208 |
|
|
|
11,470,620 |
|
|
|
10,292,409 |
|
|
|
|
(a) |
|
Net loss for the fiscal year ended 2005 includes a goodwill impairment charge of
approximately $6.9 million. |
|
(b) |
|
Outstanding share and per share amounts have been adjusted retroactively to reflect the 1:10
reverse stock split that became effective on June 15, 2004. |
|
(c) |
|
Net of discounts |
20
Item 7. Managements Discussion and Analysis of Financial Condition and Results of Operations
Cautionary Factors That May Affect Future Results
This document and other documents we may file with the Securities and Exchange Commission
contain forward-looking statements. Also, our company management may make forward-looking
statements orally to investors, analysts the media and others. Forward-looking statements express
our expectations or predictions of future events or results. They are not guarantees and are
subject to many risks and uncertainties. There are a number of factorsmany beyond our
controlthat could cause actual events or results to be significantly different from those
described in the forward-looking statement. Any or all of our forward-looking statements in this
report or in any other public statements we make may turn out to be wrong.
Forward-looking statements might include one or more of the following:
|
|
|
projections of future revenue; |
|
|
|
|
anticipated debt or equity fundings; |
|
|
|
|
anticipated clinical trial commencement dates, completion timelines or results; |
|
|
|
|
anticipated receipt of regulatory approvals; |
|
|
|
|
descriptions of plans or objectives of management for future operations, products or services; |
|
|
|
|
forecasts of future economic performance; and |
|
|
|
|
descriptions or assumptions underlying or relating to any of the above items. |
Forward-looking statements can be identified by the fact that they do not relate strictly to
historical or current facts. They use words such as anticipate, estimate, expect, project,
intend, plan, believe or words of similar meaning. They may also use words such as would,
should, could or may.
Factors that may cause actual results to differ materially include the risks and uncertainties
discussed below, as well as in the Risk Factors section included in our Prospectus (File No.
333-117338) filed July 28, 2004 with the Securities and Exchange Commission. You should read them.
You should also read the risk factors identified from time to time in our reports on Form 10-Q or
10-K, and registration statements on Form S-1 or S-3 and amendments, if any, to these documents.
Viragen will provide you with a copy of any or all of these reports at no charge. Copies of these
documents may also be obtained free of charge from our website at
www.viragen.com or the Securities
and Exchange Commission website at www.sec.gov.
Our business, results of operations and financial condition could be adversely affected by a
number of risks and uncertainties, including the following:
|
|
|
whether we are able to secure sufficient funding to maintain our operations,
complete clinical trials and successfully market our product and otherwise continue as
a going concern; |
|
|
|
|
whether our stock price will enable us to conduct future financings; |
|
|
|
|
whether the efficacy, price and timing of our natural human alpha interferon will enable us to compete with other well
established, highly capitalized, biopharmaceutical companies; |
|
|
|
|
whether clinical testing confirms the efficacy of our product, and results in the
receipt of regulatory approvals. We have not sought the approval of our natural human
alpha interferon product from the U.S. Food and Drug Administration or its European
Union counterparts, except Sweden; |
|
|
|
|
whether our patent applications result in the issuance of patents, or whether
patents and other intellectual property rights provide adequate protections in the
event of misappropriation or infringement by third parties; |
|
|
|
|
whether our avian transgenics program succeeds in producing targeted drugs in egg
whites of transgenic chickens in commercially viable quantities; |
|
|
|
|
whether, despite receipt of regulatory approvals, our products are accepted as a
treatment superior to that of our competitors; and |
|
|
|
|
whether we can generate revenue sufficient to offset our historical losses and
achieve profitability. |
21
Our natural human alpha interferon product was developed and is manufactured overseas in our
Swedish facility. Our avian transgenic and oncology programs are also being researched and
developed in Europe. Our dependence on foreign manufacturing and expected international sales
exposes us to a number of risks, including:
|
|
|
unexpected changes in regulatory requirements; |
|
|
|
|
tariffs and other trade barriers, including import and export restrictions; |
|
|
|
|
political or economic instability; |
|
|
|
|
compliance with foreign laws; |
|
|
|
|
transportation delays and interruptions; |
|
|
|
|
difficulties in protecting intellectual property rights in foreign countries; and |
|
|
|
|
currency exchange risks. |
Viragen has incurred operational losses and operated with negative cash flows since its
inception in December 1980. Net losses have totaled approximately $26.2 million, $18.2 million and
$17.3 million, for the fiscal years ended June 30, 2005, 2004 and 2003, respectively.
We believe we have enough cash to support our operations through at least December 31, 2005.
However, we will require substantial additional funding to support our operations subsequent to
that date. As we do not anticipate achieving sufficient cash flows from operations by December 31,
2005, our plans include obtaining additional capital through equity and debt financings. As we can
not provide any assurance that additional capital will be obtainable when required, these
conditions raise substantial doubt as to our ability to continue as a going concern.
Critical Accounting Policies
Our discussion and analysis of our financial condition and results of operations is based upon
our financial statements, which have been prepared in accordance with accounting principles
generally accepted in the United States. The preparation of these financial statements
requires management to make estimates and assumptions that affect the reported amounts of
assets, liabilities, revenue and expenses. On an on-going basis, we evaluate our estimates,
including those related to inventories, depreciation, amortization, asset valuation allowances,
contingencies and litigation. We base our estimates on historical experience and on various
other assumptions that are believed to be reasonable under the circumstances, the results of
which form the basis for making judgments about the carrying values of assets and
liabilities that are not readily apparent from other sources. Actual results may differ from
these estimates under different assumptions or conditions. We believe that the following critical
accounting policies affect our more significant judgments and estimates used in the preparation of
our financial statements.
|
|
|
Inventories. Inventories consist of raw materials and supplies, work in process and
finished product. Finished product consists of purified natural human alpha interferon
that is available for sale. Costs of raw materials and supplies is determined on a
first-in, first-out basis. Costs of work in process and finished product consisting of raw
materials, labor and overhead are recorded at a standard cost (which approximates actual
cost). Excess/idle capacity costs are expensed in the period in which they are incurred
and are recorded in cost of sales. Our inventories are stated at the lower of cost or
market (estimated net realizable value). If the cost of our inventories exceeds their
expected market value, provisions are recorded currently for the difference between the
cost and the market value. These provisions are determined based on estimates. The
valuation of our inventories also requires us to estimate excess inventories and
inventories that are not saleable. The determination of excess or non-saleable inventories
requires us to estimate the future demand for our product and consider the shelf life of
the inventory. If actual demand is less than our estimated demand, we could be required to
record inventory write-downs, which would have an adverse impact on our results of
operations. |
22
|
|
|
Long-lived assets. In accordance with SFAS No. 144, Accounting for the Impairment or
Disposal of Long-Lived Assets, we review our long-lived assets, including intangible assets,
for impairment whenever events or changes in circumstances indicate that the carrying amount
of these assets may not be fully recoverable. The assessment of possible impairment is based
on our ability to recover the carrying value of our asset based on our estimate of its
undiscounted future cash flows. If these estimated future cash flows are less than the
carrying value of the asset, an impairment charge is recognized for the difference between
the assets estimated fair value and its carrying value. As of the date of the financial
statements included in this annual report, we are not aware of any items or events that
would cause us to adjust the recorded value of our long-lived assets, including intangible
assets, for impairment. |
|
|
|
|
Goodwill. In accordance with SFAS No. 142, Goodwill and Other Intangible Assets,
goodwill is not amortized. Goodwill is reviewed for impairment on an annual basis or sooner
if indicators of impairment arise. Management has selected April 1st as the
date of our annual impairment review. All of our goodwill arose from the acquisition of
ViraNative on September 28, 2001 and the subsequent achievement of certain milestones
defined in the acquisition agreement. We periodically evaluate that acquired business for
potential impairment indicators. Our judgments regarding the existence of impairment
indicators are based on legal factors, market conditions, and the operational performance
of the acquired business. During the fourth quarter of fiscal 2005, we completed our annual
impairment review of our goodwill with the assistance of an independent valuation firm. The
impairment review indicated that our goodwill was impaired and an impairment charge of
approximately $6.9 million was recorded. Changes in the estimates used to conduct our
impairment review, including revenue projections or market values, could cause our analysis
to indicate that our goodwill is further impaired in subsequent periods and result in a
write-off of a portion or all of our goodwill. |
|
|
|
|
Stock-based compensation. Our employee stock option plans are currently accounted for
under Accounting Principles Board Opinion No. 25 (APB 25), Accounting for Stock Issued to
Employees, and related interpretations. We grant stock options to employees and directors
to purchase a fixed number of shares of our common stock with an exercise price equal to
the fair market value of the shares at the date of grant. In accordance with APB 25, we
recognize no compensation expense for these stock option grants. We account for our
stock-based compensation arrangements with non-employees in accordance with Statement of
Financial Accounting Standards (SFAS) No. 123, Accounting for Stock-Based Compensation
and related guidance, including Emerging Issues Task Force (EITF) No. 96-18, Accounting for
Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction
with Selling, Goods or Services. Accordingly, we recognize as expense the estimated fair
value of such instruments as calculated using the Black-Scholes valuation model. The
estimated fair value is re-determined each quarter using the methodologies allowable by
SFAS No. 123 and EITF No. 96-18 and the expense is amortized over the vesting period of
each option or the recipients contractual arrangement, if shorter. |
|
|
|
|
Convertible Debt Issued with Stock Purchase Warrants: Viragen accounts for convertible
debt issued with stock purchase warrants in accordance with APB No. 14, Accounting for
Convertible Debt and Debt Issued with Stock Purchase Warrants, EITF No. 98-5, Accounting
for Convertible Securities with Beneficial Conversion Features or Contingently Adjustable
Conversion Ratios, and EITF No. 00-27, Application of Issue No. 98-5 to Certain Convertible
Instruments. The determination of the relative fair value of the components of our
convertible notes and debentures issued with common stock purchase warrants requires the
use of estimates. Changes in those estimates would result in different relative values
being attributed to the components, which could result in more discount on the principal
amount of the debentures. Modifications to the terms of outstanding convertible notes
could also require us to adjust the relative fair value of the components of our
convertible notes, which could result in additional discount on the principal amount of the
debentures. This additional discount would result in additional non-cash interest expense
over the life of the convertible notes. |
23
|
|
|
Revenue recognition. We recognize revenue from sales of our natural human alpha interferon
product when title and risk of loss has been transferred, which is generally upon shipment.
Moreover, recognition requires persuasive evidence that an arrangement exists, the price is
fixed and determinable, and collectibility is reasonably assured. |
|
|
|
|
Litigation and other contingencies. We monitor the status of our litigation and other
contingencies for purposes of loss accrual. If we believed a loss to be probable and
reasonably estimated, as required by SFAS No. 5, Accounting for Contingencies, we would
establish an appropriate accrual. We would base our accruals on information available at
the time of such determination. Information may become available to us after that time, for
which additional accruals may be required. |
Liquidity and Capital Resources
We do not have enough cash or working capital to meet our operating requirements through the
end of fiscal 2006. As of June 30, 2005, we had approximately $6.9 million in cash down from
approximately $22.8 million as of June 30, 2004. As of June 30, 2005, we had a working capital
deficit of approximately $7.3 million, compared to working capital of approximately $25.2 million
as of June 30, 2004. The change in working capital is primarily attributed to the reclassification
of our convertible notes due March 31, 2006 totaling approximately $16.1 million from long-term to
short-term at March 31, 2005. Cash used to fund operations during the fiscal year ended June 30,
2005 totaled approximately $14.2 million, while financing expenditures, including the repayment of
our line of credit and short-term borrowings and long-term debt, totaled approximately $1.6
million.
We have experienced losses and a negative cash flow from operations since inception. During
the fiscal years ended June 30, 2005, 2004 and 2003, we incurred significant losses of
approximately $26.2 million, $18.2 million and $17.3 million, respectively, and had an accumulated
deficit of approximately $146.7 million as of June 30, 2005. We anticipate additional future
losses as we commercialize our natural human alpha interferon product and conduct additional
research activities and clinical trials to obtain additional regulatory approvals. We believe we
have sufficient cash to support operations, including those of our subsidiaries, through at least
December 31, 2005. However, we will require substantial additional funding to support our
operations subsequent to December 31, 2005. As we do not anticipate achieving sufficient cash flows
from operations by December 31, 2005, our plans include seeking additional capital through equity
and debt financings. No assurance can be given that additional capital will be available when
required or upon terms acceptable to us. Our inability to generate substantial revenue or obtain
additional capital through equity or debt financings would have a material adverse effect on our
financial condition and our ability to continue operations. Additionally, while we are currently
in negotiations to extend and otherwise restructure our $20 million June 2004 note financing, we
can not assure you that these negotiations will be successful.
As a result of these financial conditions, the report of our independent registered public
accounting firm on our June 30, 2005 consolidated financial statements includes an explanatory
paragraph indicating that these conditions raise substantial doubt about our ability to continue as
a going concern.
During the fiscal year ended June 30, 2005, we received a contribution in the amount of $0.28
million from a business development agency in Sweden. This contribution was awarded in connection
with our capital investment in our renovated facility in Umeå, Sweden, which was completed during
our fiscal year ended June 30, 2004. This contribution was recorded as a reduction of the cost of
the building improvements. We could be required to repay a portion of this contribution if we do
not meet certain conditions under the award, including, but not limited to, keeping the facility in
operation. The amount we could be required to repay decreases on an annual basis beginning in July
2005. After July 2005, we could only be required to repay 70% of the award. Upon the second,
third and fourth anniversary, the repayment amount decreases to 45%, 25% and 10%, respectively, of
the award. At this time, we do not believe we will be required to repay any portion of the
contribution.
24
June 2004 Convertible Notes
On April 1, 2004, we entered into purchase agreements for the issuance and sale of convertible
notes and common stock purchase warrants in the aggregate amount of $20 million. The notes were
placed with a group of new and returning institutional investors. The $20 million purchase price
for the notes and warrants was placed in escrow pending satisfaction of all conditions precedent to
closing, including receipt of stockholder approval for the sale of the notes and warrants, as well
as a one for ten reverse split of our common stock. On June 11, 2004, our stockholders voted to
approve the sale of the notes, the one for ten reverse split of our common stock and a change in
the number of the authorized shares of our common stock to 100 million shares. On June 18, 2004,
we completed the sale of the notes and warrants. Under the terms of these agreements, we received
approximately $18.96 million, net of finders fees and legal expenses. These agreements also
provided for the issuance to the purchasers of an aggregate of 5,357,051 three-year common stock
purchase warrants exercisable at $1.819 per share.
These convertible notes mature on March 31, 2006. The notes are convertible by the investors,
in whole or in part, into shares of our common stock at a conversion price equal to $1.516. This
conversion price is subject to reductions if we enter into additional financing transactions for
the sale of our stock below the public trading price and below the conversion price.
These notes may be prepaid at 110% of their face amount, plus the issuance to note holders of
additional warrants to purchase the number of shares of our common stock into which the notes would
otherwise have been convertible, at an exercise price equal to the prevailing conversion price of
the notes. If issued on prepayment, the warrants may be exercised for the period that would have
been the remaining life of the notes had they not been prepaid. Commencing one year after issuance,
we also have the right to require note holders to convert their notes, subject to certain
limitations; provided that our common stock has traded at 200% or more of the conversion price of
the notes on each of the 30 trading days ending five days prior to the date fixed for conversion.
As of June 30, 2005, the entire principal amount of these convertible notes of $20 million
remained outstanding. Interest payable on the convertible notes is payable in cash or shares of
our common stock at our option. The value of shares used to satisfy the interest payment equals
the average closing price of our common stock for the 20 trading days prior to the interest payment
date. For the fiscal year ended June 30, 2005 we paid interest on the notes of $1,050,000 in cash
and $350,000 through the issuance of shares of our common stock valued at $0.67 per share.
Line of Credit and Short Term Borrowings
Our Swedish subsidiary maintains an overdraft facility, denominated in Swedish Krona, with a
bank in Sweden. In July 2004, the terms on this overdraft facility were renegotiated to provide
for a reduced interest rate and a reduction in the maximum borrowing capacity. The maximum
borrowing capacity on this overdraft facility was approximately $767,000 as of June 30, 2005
compared to $1.1 million as of June 30, 2004. Borrowings outstanding under this facility are at a
floating rate of interest, which was approximately 5.25% at June 30, 2005 compared to 7.4% at June
30, 2004. This overdraft facility renews annually and was renewed in December 2004. There was no
outstanding balance under this overdraft facility as of June 30, 2005. Outstanding borrowings
under this overdraft facility were approximately $807,000 as of June 30, 2004. The overdraft
facility is secured by certain assets of ViraNative including inventories and accounts receivable.
During June 2005, we obtained short term financing of approximately $224,000 for the purchase
of certain corporate insurance policies. Outstanding borrowings under this arrangement bear
interest at an effective rate of 6.86%. Principal and interest payments of approximately $26,000
are payable in nine equal monthly installments. The outstanding balance on this short term
borrowing was approximately $224,000 as of June 30, 2005.
During June 2004, we obtained short term financing of approximately $270,000 for the purchase
of certain corporate insurance policies. This short term financing had been repaid as of March 31,
2005.
25
Long-Term Debt
Our Swedish subsidiary has a 25-year mortgage with a Swedish bank obtained to purchase one of
our facilities in Sweden. The outstanding principal balance on this loan, which is payable in
Swedish Krona, was approximately $631,000 and $689,000 at June 30, 2005 and 2004, respectively.
This loan carries a floating rate of interest which was approximately 5.25% at June 30, 2005 and
2004. We are required to make quarterly payments of principal and interest of approximately $17,000
under this agreement. This loan matures in September 2024 and is secured by the related land and
building, including improvements, with a carrying value of approximately $2.3 million as of June
30, 2005.
Under the terms of a loan with a Swedish governmental agency that was obtained for the
purposes of conducting clinical trials, we were required to make quarterly payments of principal
and interest of approximately $34,000. The loan carried a floating rate of interest at the
Stockholm interbank offered rate (STIBOR) 90 plus 7%, which was approximately 9.30% as of June 30,
2004. This loan had an outstanding balance, which was payable in Swedish Krona, of approximately
$537,000 at June 30, 2004. On September 30, 2004, we paid the entire outstanding principal,
including accrued interest, on this loan. No amounts are due on this loan as of June 30, 2005.
Our future cash requirements are dependent upon many factors, including:
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restructuring the terms of our $20 million notes due March 31, 2006; |
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|
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|
revenue generated from the sale of our natural human alpha interferon product; |
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|
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market conditions and our ability to service our convertible debt; |
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progress with future clinical trials; |
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the costs associated with obtaining regulatory approvals; |
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the costs involved in patent applications; |
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competing technologies and market developments; and |
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our ability to establish collaborative arrangements and effective commercialization activities. |
We believe that our natural human alpha interferon product can be manufactured in sufficient
quantity and be priced at a level to offer non-responding patients a reasonable attractive
alternative treatment to the synthetic interferons currently being marketed. However, we can not
assure you of the success of our commercialization efforts and other projects. Required regulatory
approvals are subject to the successful completion of lengthy and costly clinical trials. The
successful commercialization of Multiferon(R) and the completion of required clinical trials and
facility expansions depend on our ability to raise significant additional funding.
Off Balance Sheet Arrangements
Under SEC regulations, we are required to disclose our off-balance sheet arrangements that
have or are reasonably likely to have a current or future effect on our financial condition,
changes in financial condition, revenues or expenses, results of operations, liquidity, capital
expenditures or capital resources that are material to investors. An off-balance sheet
arrangement means a transaction, agreement or contractual arrangement to which any entity that is
not consolidated with us is a party, under which we have:
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Any obligation under certain guarantee contracts; |
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Any retained or contingent interest in assets transferred to an unconsolidated entity or
similar arrangement that serves as credit, liquidity or market risk support to that entity
for such assets; |
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Any obligation under a contract that would be accounted for as a derivative instrument,
except that it is both indexed to our stock and classified in stockholders equity in our
statement of financial position; and |
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Any obligation arising out of a material variable interest held by us in an
unconsolidated entity that provides financing, liquidity, market risk or credit risk
support to us, or engages in leasing, hedging or research and development services with us. |
26
As of the date of this annual report, we do not have any off-balance sheet arrangements that
we are required to disclose pursuant to these regulations. In the ordinary course of business, we
enter into operating lease commitments, purchase commitments and other contractual obligations.
These transactions are recognized in our financial statements in accordance with generally accepted
accounting principles in the United States.
Contractual Obligations
Our significant contractual obligations for the next five years and thereafter as of June 30,
2005 are as follow:
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Payments due by period |
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Less Than |
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1-3 |
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3-5 |
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More Than |
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Contractual obligations |
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Total |
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1 Year |
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Years |
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|
Years |
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5 Years |
|
Convertible notes and
debentures, including
interest (1) |
|
$ |
21,050,000 |
|
|
$ |
21,050,000 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Long-term debt (2) |
|
|
631,000 |
|
|
|
33,000 |
|
|
|
99,000 |
|
|
|
99,000 |
|
|
|
400,000 |
|
Operating leases (3) |
|
|
1,779,000 |
|
|
|
1,181,000 |
|
|
|
598,000 |
|
|
|
|
|
|
|
|
|
Research and development
agreements (4) |
|
|
1,104,000 |
|
|
|
680,000 |
|
|
|
424,000 |
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|
|
|
|
|
|
|
|
Officers and key employee
agreements (5) |
|
|
1,100,000 |
|
|
|
875,000 |
|
|
|
225,000 |
|
|
|
|
|
|
|
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Insurance
financing |
|
|
284,000 |
|
|
|
284,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalties (7) |
|
|
35,000 |
|
|
|
35,000 |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Total contractual obligations |
|
$ |
25,983,000 |
|
|
$ |
24,138,000 |
|
|
$ |
1,346,000 |
|
|
$ |
99,000 |
|
|
$ |
400,000 |
|
|
|
|
(1) |
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Consists of outstanding principal balance on the June 2004 convertible notes. These notes
mature on March 31, 2006 and accrue interest at 7% payable quarterly. |
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(2) |
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Long-term debt consists of a mortgage loan with a Swedish bank. |
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(3) |
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Operating leases consist of facility and equipment lease agreements. |
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(4) |
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Research and development agreements include agreements related to our avian transgenic and
antibody projects. |
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(5) |
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Includes agreements entered into with officers and other key employees. |
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(6) |
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Consists of short-term financing agreements for premiums on
various corporate insurance policies. |
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(7) |
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Royalties represent royalties due to Medicore according to settlement reached in July 2003. |
27
Results of Operations
2005 Compared to 2004
Product Sales
For the fiscal year ended June 30, 2005, product sales totaled approximately $279,000 compared
to approximately $266,000 for the fiscal year ended June 30, 2004. This five percent increase in
product sales of approximately $13,000 is attributed to an increase in sales of Multiferon®
in Sweden and South Africa, which was partially offset by decreases in Indonesia and Mexico.
The timing and size of orders placed by our distributors can have a significant impact on our
product sales for a particular period. This is expected for markets in which we have recently
launched Multiferon®. As these markets develop, we can expect a more consistent trend in orders
and thus product sales. Of the $279,000 in total product sales in fiscal 2005, approximately 70%
occurred in the last two fiscal quarters.
We have entered into several agreements for the distribution of our natural human alpha
interferon, Multiferon®, in various countries. To date, we have not recognized significant
revenue from many of these agreements. The majority of these agreements require that the
distributor obtain the necessary regulatory approvals, which may not yet be obtained. Regulatory
approval is a mandatory step in the marketing of a drug, but it is by no means the final challenge
in marketing a biopharmaceutical product. In many countries, a separate process may be required for
obtaining reimbursement authorization, physicians must be educated about the merits of the product
over time, and in some of these territories, hospital formularies govern the acceptance for use of
a new product.
There are other challenges associated with international marketing activities including:
language and cultural barriers, poorly organized regulatory infrastructure and/or compliance
procedures in certain countries where Multiferon® may be marketed, performance of our
distribution channels, governments willingness to promote cheaper generic versions of competing
products and the general populations inability to afford private care drug products. It may take
significant time to overcome these challenges with no assurance that a particular market will ever
be effectively penetrated.
Cost of Sales
Cost of sales, which includes excess/idle production costs, totaled approximately $2.6 million
for the year ended June 30, 2005 compared to approximately $2.0 million for the year ended June 30,
2004. The increases in cost of sales for the year ended June 30, 2005 is primarily attributed to
increased excess/idle capacity. Excess/idle capacity represents fixed production costs incurred at
our Swedish manufacturing facilities, which were not absorbed as a result of the production of
inventory at less than normal operating levels. For the year ended June 30, 2005, excess/idle
capacity costs were due to minimal production activities as a result of low sales demand. For the
year ended June 30, 2004, the excess/idle capacity costs were the result of the suspension of
routine manufacturing as of March 31, 2003. This planned break in routine manufacturing was
dictated by the Swedish regulatory authorities and was necessary to allow for certain steps of our
production process to be segregated and transferred to our owned facility located in Umeå, Sweden.
We will continue to incur excess/idle production costs until we generate higher sales demand and
resume production at normal operating levels that absorb our fixed production costs.
28
Inventory Write-down
During fiscal 2005, we recorded write-downs of approximately $720,000 of our finished product
inventory. Upon evaluating the shelf-life of certain lots of our Multiferon® inventory, near-term
sales forecasts and consideration of alternative uses, write-downs of the value of this inventory
were deemed necessary. The remaining cost of finished goods inventory at June 30, 2005 is
approximately $19,000 and we anticipate the use of this inventory for sales in the near future.
The determination of excess or non-saleable inventories requires us to estimate the future
demand for our product and consider the shelf life of the inventory. If actual demand is less than
our estimated demand, we could be required to record additional inventory write-downs, which would
have an adverse impact on our results of operations.
A significant portion of our inventory is classified as work in process. Included in work in
process is approximately $643,000 of inventory that has been filled in ampoules, but that is
pending final release by regulatory authorities, which is expected in the first or second quarter
of fiscal 2006. We currently anticipate the use of these ampoules prior to their shelf-life
expiration, which is up to three years from June 30, 2005. The remainder of work in process is
approximately $1.4 million of purified Multiferon® that has not yet been filled into ampoules or
syringes. Subsequent to June 30, 2005, a freezer at our facility in Sweden malfunctioned causing
the temperature of a portion of this purified Multiferon® to rise above the approved levels for
frozen product. We will be unable to utilize this particular inventory for commercial use and a
write-down of approximately $560,000, reduced by related insurance recovery, if any, will be
recorded in the first quarter of fiscal 2006. We currently anticipate we will fill the remainder
of our purified Multiferon® into ampoules and/or syringes prior to shelf-life expiration, which
ranges from nine to fifteen months from June 30, 2005.
Research and Development Costs
Research and development costs include scientific salaries and support fees, product used for
clinical trials, laboratory supplies, consulting fees, contracted research and development,
equipment rentals, repairs and maintenance, utilities and research related travel. For the year
ended June 30, 2005, research and development costs totaled approximately $5.0 million compared to
approximately $3.6 million for the year ended June 30, 2004. This increase of approximately $1.4
million was attributed to an increase in costs incurred related to our antibody projects totaling
approximately $0.4 million and an increase in consulting fees, licensing fees and other expenses
related to Multiferon®. These increases were partially offset by the reversal of a long-standing
trade liability of approximately $0.2 million during the quarter ended December 31, 2004.
We will continue incurring research and development costs, including projects associated with
Multiferon® as well as other projects to more fully develop potential commercial applications of
our natural human alpha interferon product, as well as broaden our potential product lines in the
areas of avian transgenics and oncology. We anticipate expenditures to increase over the next
twelve months, particularly in the area of regulatory-related consulting fees and manufacturing of
our development products. Our ability to successfully conclude additional clinical trials, a
prerequisite for expanded commercialization of any biopharmaceutical product, is dependent upon our
ability to raise significant additional funding necessary to conduct and complete these trials or
our ability to secure a partner with whom to conduct these trials.
29
Selling, General and Administrative Expenses
Selling, general and administrative expenses include administrative personnel salaries and
related expenses, office and equipment leases, utilities, repairs and maintenance, insurance,
legal, accounting, consulting, depreciation and amortization expenses. For the year ended June 30,
2005, selling, general and administrative expenses totaled approximately $8.6 million compared to
approximately $7.4 million for the year ended June 30, 2004. This increase of approximately $1.2
million is primarily attributed to increases in personnel-related costs, consulting fees, and
accounting fees, primarily associated to efforts necessary to comply with the requirements of
Section 404 of the Sarbanes-Oxley Act of 2002, at our Florida headquarters of approximately $0.7
million, $0.1 million and $0.4 million, respectively.
We anticipate that selling related expenses will increase in fiscal 2006 compared to fiscal
2005. This increase is expected due to the planned expansion of our Multiferon® sales efforts.
These increases will be incurred in sales personnel related expenses, consulting fees, travel
related expenses, promotional materials and other marketing related costs.
Impairment of Goodwill
Statement of Financial Accounting Standards (SFAS) No. 142, Goodwill and Other Intangible
Assets, requires that purchased goodwill and certain indefinite-lived intangibles be tested for
impairment on at least an annual basis. Due to a lack of significant revenues from our natural
interferon product and a longer than anticipated timeframe to receive regulatory approvals in
certain markets, revenue and cash flows for the ViraNative reporting unit were lower than expected
in fiscal 2005. Primarily based on this trend, the revenue projections for the next several years
were revised downward. As a result of these revised projections, the present value of the future
estimated cash flows from the reporting unit were significantly less than those estimated in prior
periods. The fair value of the ViraNative reporting unit was estimated using a combination of the
present value of estimated future cash flows, quoted market prices and market multiples from
comparable businesses. After evaluating the results of these valuation methods a goodwill
impairment charge of approximately $6.9 million was recognized in April 2005 on the ViraNative
reporting unit.
Amortization of Intangible Assets
Amortization of intangible assets represents the amortization of our acquired developed
technology. This developed technology is being amortized over its estimated useful life of
approximately 14 years. For the year ended June 30, 2005, amortization of intangible assets totaled
approximately $169,000 compared to approximately $158,000 during the year ended June 30, 2004. This
increase in amortization expense of approximately $11,000 is due to foreign exchange fluctuations.
Interest Expense
Interest expense for the year ended June 30, 2005 totaling approximately $5.7 million
primarily represents interest expense on our June 2004 convertible notes consisting of principal
interest totaling $1.1 million in cash and approximately $0.3 million in shares of our common stock
valued at $0.67 per share and non-cash interest expense related to the amortization of the
discounts on these notes and related closing costs totaling approximately $4.2 million.
Interest expense for the year ended June 30, 2004 totaling approximately $7.4 million
primarily represents interest expense on our April and June 2003 convertible debentures of
approximately $6.7 million. Approximately $6.3 million of this amount represent non-cash interest
expense, which is comprised of the amortization of the discounts on the debentures, which arose
from detachable warrants and shares of common stock issued with the debentures, as well as the
debentures beneficial conversion feature.
30
Included in interest expense for the year ended June 30, 2004, was an adjustment to record
non-cash interest expense totaling approximately $1.4 million as a result of the revaluation of the
warrants issued in connection with the April and June 2003 convertible debentures. At the time of
issuance the warrants were valued using their expected lives, which was less than their contractual
lives. Ernst & Young LLP, our independent registered public accounting firm, concurred with this
approach. In January 2004, we were informed by Ernst & Young LLP that they had reevaluated their
interpretation of the accounting literature as it relates to the accounting for common stock
purchase warrants issued in connection with financing transactions. As a result of this subsequent
interpretation, we and Ernst & Young LLP determined that valuing the warrants issued in connection
with our April and June 2003 securities purchase agreements using their expected lives was not
correct. By using the expected lives of the warrants, less value was attributed to them than if we
had used the contractual lives. Thus, an additional discount of approximately $1.4 million would
have been recorded on the convertible debentures issued under the April and June 2003 securities
purchase agreements by using the contractual lives on the warrants. This additional discount
associated with the convertible debentures resulted in an understatement of our non-cash interest
expense of approximately $0.4 million in the quarter ended June 30, 2003 and $0.5 million in the
quarter ended September 30, 2003. After consideration of all of the facts and circumstances, we
recognized the full amount of the prior period non-cash interest expense in the quarter ended
December 31, 2003, as management believes it is not material to any period affected. Also, we
recorded additional non-cash interest expense of approximately $0.5 million in the quarter ended
December 31, 2003 relating to this matter.
Also included in interest expense is interest incurred on the debt facilities maintained by
our Swedish subsidiary. These debt facilities have interest rates of approximately 5.25%. Interest
expense on these debt facilities for the year ended June 30, 2005 and 2004 totaled approximately
$0.1 million and $0.2 million, respectively.
Other Income, net
The primary components of other income, net are interest earned on cash and cash equivalents
and short-term investments, grant income from government agencies in Scotland, sublease income on
certain office space in our facility in Scotland, transaction gains or losses on foreign exchange,
remeasurement gains or losses on assets and liabilities denominated in currencies other than the
functional currency, gains or losses on the disposal of property, plant and equipment, and income
generated from research and development support services provided by our Swedish subsidiary.
Other income, net for the year ended June 30, 2005, totaled approximately $1.5 million
compared to approximately $0.6 million for the year ended June 30, 2004. This increase of
approximately $0.9 million is primarily attributed to an increase in interest earned on cash and
cash equivalents and short-term investments totaling approximately $0.4 million and remeasurement
gains on foreign exchange totaling approximately $0.5 million. These foreign exchange gains arose
from the remeasurement of British Pound denominated bank accounts and short-term investments to
U.S. dollars as well as the remeasurement of a U.S dollar denominated intercompany liability.
During the quarter ended December 31, 2004 we recorded approximately $0.6 million gain on the
remeasurement of a liability to Viragen by Viragen Scotland, which was denominated in U.S. dollars.
In prior periods, this liability had been translated at historical exchange rates since this
liability was determined to be long-term in nature. This determination was based on the fact that
Viragen Scotland did not have the ability or intent to repay the liability to Viragen. In recent
periods, Viragen Scotland has been gradually settling the liability by charging Viragen for
services performed on our behalf. Management anticipates the liability will be settled through
these charges in the near term. Therefore, it was determined that the account should no longer be
considered long-term and thus translation at current exchange rates is appropriate. Since the
liability was denominated in U.S. dollars and the Pound Sterling has been strengthening against the
U.S. dollar over the last few years, the remeasurement of the liability resulted in a gain. Had the
determination been made when Viragen (Scotland) began settling the liability with charges to
Viragen in prior periods and the liability been remeasured at then current exchange rates, the
impact on the statements of operations would not have been material and there would have been no
effect on stockholders equity as such currency gains are reclassifications from accumulated other
comprehensive income.
31
Income Tax Benefit
We are subject to tax in the United States, Sweden, and the United Kingdom. These
jurisdictions have different marginal tax rates. For the year ended June 30, 2005 and 2004, income
tax benefit totaled approximately $44,000 and $44,000, respectively. Income tax benefits for these
periods arose from of the amortization expense on certain intangible assets. Due to the treatment
of the identifiable intangible assets under SFAS No. 109, Accounting for Income Taxes, our balance
sheet reflects a deferred income tax liability of approximately $457,000 as of June 30, 2005, all
of which is related to our developed technology intangible asset acquired on September 28, 2001.
Based on our accumulated losses, a full valuation allowance is provided to reduce deferred
income tax assets to the amount that will more likely than not be realized. As of June 30, 2005, we
had net operating loss carry-forwards of approximately $85.1 million for U.S. federal income tax
purposes. The expiration dates on these net operating loss carry-forwards range from 2005 through
2025. At June 30, 2005, Viragen (Scotland) and ViraNative had net operating loss carry-forwards
totaling approximately $25.8 million and $13.8 million, respectively. The net operating losses at
Viragen (Scotland) and ViraNative do not expire.
2004 Compared to 2003
Product Sales
Product sales for 2004 decreased significantly compared to the previous year. For the fiscal
year ended June 30, 2004 product sales totaled approximately $266,000 compared to approximately
$631,000 for the fiscal year ended June 30, 2003. This decrease is primarily due to the absence of
sales of bulk interferon product to Alfa Wasserman under a contractual arrangement which expired in
December 2002. For the fiscal year ended June 30, 2003, sales to Alfa Wasserman totaled
approximately $288,000.
Cost of Sales
Cost of sales and excess/idle production costs totaled approximately $2.0 million for the
fiscal year ended June 30, 2004. The increase in cost of sales of approximately $0.8 million for
the fiscal year ended June, 2004, and the resulting negative margins are attributed to excess/idle
capacity costs. Excess/idle capacity costs represent fixed production costs incurred at our Swedish
manufacturing facility, which were not absorbed as a result of the suspension of routine
manufacturing as of March 31, 2003. This planned break in routine manufacturing was necessary to
allow for certain steps of our production process to be segregated and transferred to our owned
facility located in Ersboda, Sweden, which is currently being renovated. We will continue to incur
excess/idle production costs until we resume production at normal operating levels that absorb our
fixed production costs.
Research and Development Costs
Research and development costs include scientific salaries and support fees, laboratory
supplies, consulting fees, contracted research and development, equipment rentals, repairs and
maintenance, utilities and research related travel. For the fiscal year ended June 30, 2004,
research and development costs totaled approximately $3.6 million compared to approximately $3.3
million for the fiscal year ended June 30, 2003. This increase of approximately $0.3 million is
mainly attributed to costs incurred in the development of potential commercial applications of our
natural human alpha interferon product at our Scottish facility totaling approximately $0.3
million. Also contributing to the increase in research and development were increases related to
our avian transgenics project and other research and development costs totaling approximately $0.3
million and $0.3 million, respectively. These increases were offset in part by a decrease in
research and development costs incurred in our oncology projects totaling approximately $0.6
million. Our reduction in oncology related research expenditures reflect our decision to focus
limited research funding availability to projects believed to have a greater likelihood of
commercial success within a shorter period of time.
32
Selling, General and Administrative Expenses
Selling, general and administrative expenses include administrative personnel salaries and
related expenses, office and equipment leases, utilities, repairs and maintenance, insurance,
legal, accounting, consulting, depreciation and amortization expenses. Selling, general and
administrative expenses totaled approximately $7.4 million for the fiscal year ended June 30, 2004
compared to approximately $7.2 million for the fiscal year ended June 30, 2003. This increase of
approximately $0.2 million is mainly attributed to increases in personnel-related termination
costs, consulting fees, and patent related legal fees at our Swedish subsidiary totaling
approximately $0.2 million, $0.1 million and $0.1 million, respectively. During the fiscal year
ended June 30, 2004, we also experienced an increase in general corporate legal fees and patent
filing fees related to our avian transgenics project totaling approximately $0.2 million. Also
contributing to the increase were increases in insurance expense and travel related expenses at our
Florida headquarters totaling approximately $0.1 million and $0.1 million, respectively. These
increases were offset in part by a decrease in personnel related expenses at our Florida
headquarters totaling approximately $0.6 million for the fiscal year ended June 30, 2004.
Amortization of Intangible Assets
Amortization of intangible assets includes the amortization of the purchase price allocated to
separately identified intangible assets obtained in the acquisition of ViraNative in September
2001. The separately identified intangible assets consist of developed technology and a customer
contract. The developed technology is being amortized over its estimated useful life of
approximately 14 years. The customer contract was amortized over the term of the contract, which
expired in December 2002. For the fiscal year ended June 30, 2004, amortization of intangible
assets totaled approximately $158,000, compared to approximately $184,000 during the fiscal year
ended June 30, 2003. The decrease of approximately $26,000 for the fiscal year ended June 30, 2004
is primarily the result of the acquired customer contract being fully amortized as of December
2002.
Interest and Other Income
The primary components of interest and other income are interest earned on cash and cash
equivalents, grant income from government agencies in Scotland, sub-lease income on certain office
space in our facility in Scotland, transaction gains or losses on foreign exchange, gains or losses
on the disposal of property, plant and equipment, and income generated from research and
development support services provided by our Swedish subsidiary. Interest and other income for the
fiscal year ended June 30, 2004, totaled approximately $632,000 compared to approximately $535,000
for the previous fiscal year. This increase of approximately $97,000 is primarily attributed to an
increase in income generated from research and development support services provided by our Swedish
subsidiary and interest earned on cash and cash equivalent totaling approximately $49,000 and
$106,000, respectively. Also contributing to this increase in interest and other income is an
increase in sub-lease income at our Scottish facility totaling approximately $53,000. These
increases in interest and other income were offset in part by an increase in the loss of the
disposition of property, plant and equipment totaling approximately $118,000.
Interest Expense
Interest expense in fiscal 2004 totaled approximately $7.4 million and primarily consists of
interest expense on our convertible notes and debentures of approximately $6.7 million.
Approximately $6.3 million of this amount represents non-cash interest expense for the fiscal year
ended June 30, 2004. Interest expense for the fiscal year ended June 30, 2003 totaling
approximately $8.0 million included approximately $7.8 million in non-cash interest expense on
previously outstanding convertible notes and debentures. This non-cash interest expense is
comprised of the amortization of the discounts on the debentures, which arose from the valuation of
detachable warrants and shares of common stock issued with the debentures, as well as the
debentures beneficial conversion feature.
33
Included in interest expense for the fiscal year ended June 30, 2004, is an adjustment to
record non-cash interest expense totaling approximately $1.4 million as a result of the revaluation
of warrants issued in connection with our April and June 2003 convertible debentures. At the
time of issuance the warrants were valued using their expected lives, which was less than their
contractual lives. Ernst & Young LLP, our independent registered accounting firm, concurred with
this approach. In January 2004, we were informed by Ernst & Young LLP that they had revaluated
their interpretation of the accounting literature as it relates to the accounting for common stock
purchase warrants issued in connection with financing transactions. As a result of this subsequent
interpretation, we and Ernst & Young LLP determined that valuing the warrants issued in connection
with our April and June 2003 securities purchase agreements using their expected lives was not
correct. By using the expected lives of the warrants, less value was attributed to them than if we
had used the contractual lives. Thus, by using the contractual lives
on the warrants, an additional discount of approximately $1.4 million would
have been recorded on the convertible debentures issued under the April and June 2003 securities
purchase agreements. This additional discount
associated with the convertible debentures resulted in an understatement of our non-cash interest
expense of approximately $0.4 million in the fiscal year ended June 30, 2003. After consideration
of all of the facts and circumstances, we recognized the full amount of the prior period non-cash
interest expense in the quarter ended December 31, 2003, as management believes it is not material
to any period affected.
Also included in interest expense for the fiscal years ended June 30, 2004 and June 30, 2003
is interest incurred on the debt facilities maintained by our Swedish subsidiary totaling
approximately $165,000 and $194,000, respectively. These credit facilities have interest rates
ranging from 5.25% to 9.90%.
Income Tax Benefit
We are subject to tax in the United States, Sweden, and the United Kingdom. These
jurisdictions have different marginal tax rates. For the year ended June 30, 2004, income tax
benefit totaled approximately $44,000, a decrease of approximately $17,000 when compared to the
same period of the previous fiscal year as a result of the fully amortized customer contract
intangible asset. Income tax benefit for the fiscal year ended June 30, 2004 consists of the
amortization expense on certain intangible assets. Due to the treatment of the identifiable
intangible assets under SFAS No. 109, Accounting for Income Taxes, our balance sheet reflects a
deferred tax income liability of approximately $500,000 as of June 30, 2004, all of which is
related to our developed technology intangible asset acquired on September 28, 2001.
Based on our accumulated losses, a full valuation allowance is provided to reduce deferred
income tax assets to the amount that will more likely than not be realized. As of June 30, 2004,
we had a net operating loss carry forward of approximately $61.4 million for U.S. federal income
tax purposes.
34
Research and Development Programs
Our
research and development programs include the avian transgenics platform, two humanized
antibodies and ongoing studies in support of Multiferon® and next-generation interferon alpha
products. Research and development costs totaled approximately
$5.0 million, $3.6 million and $3.3 million, for the
fiscal years ended June 30, 2005, 2004 and 2003, respectively.
Avian Transgenics
Our avian transgenic manufacturing program is designed to enable us to produce protein-based
drugs, including monoclonal antibodies, in the whites of eggs laid by transgenic chickens. Our goal
is to develop a technology which will enable us to offer a viable and cost-effective alternative
for the large-scale production requirements of the biopharmaceutical industry and also for our own
therapeutic protein products. Existing protein production technologies are often inefficient and
costly. We believe that this technology will allow us to offer the biopharmaceutical industry an
efficient method of production of their protein-based products. It is envisaged that this
technology will have a higher capacity, lower manufacturing costs and may be able to offer
improvements to the products themselves.
We believe our avian transgenics project could offer a rapid and cost effective way to produce
large volumes of therapeutic proteins. In addition to meeting the current and future alternative
production demands of the biopharmaceutical industry and generating significant revenue for us,
this project could also accelerate the progress of several life-saving drugs to the market at an
affordable cost.
At the current time, we are developing four product candidates using the avian transgenic
technology. The first, a humanized version of the anti-GD3 antibody that is the subject of a
collaborative research agreement between Viragen and Sloan-Kettering Institute, has already
realized key milestones, including our June 2005 announcement of detection and recovery of the
intact and bioactive antibody, from the white of transgenic hen eggs. Of the remaining three
product candidates in development, two are currently approved commercial products. We have not yet
announced the identity of these three product candidates, but expect with continuing successes, to
do so in the coming months. We expect to report successes in developing this technology and
possibly initiating production of some or all of our product candidates in the 2006 calendar year.
For the fiscal years ended 2005, 2004 and 2003, we incurred costs related to the avian
transgenics project totaling approximately $1.7 million, $1.9 million and $1.0 million,
respectively. Since the date of inception of this project, we have incurred approximately $5.8
million in related research and development costs.
35
Antibodies
There have been a great number of developments in the treatment of cancer in humans over the
years. Monoclonal antibodies have been shown to be able to offer significant advantages over other
therapies, yet even with this success, current products still fall far short of the ideal with
respect to both efficacy and to a lesser extent, safety. Trends in treatment options are tending to
favor multiple agents and therapies in combination or sequential administration as well as targeted
therapeutics. Still, there remains much room for improvement.
We have selected two monoclonal antibodies for our research and development projects based
largely upon 1) novelty, 2) prior pre-clinical information, and 3) prior testing in humans. Both of
our current antibody projects are unique in these respects and both offer the potential to be
developed into a platform based technology.
VG102
In April 2005, we executed a global exclusive license with Cancer Research Technology UK for
the rights to develop and commercialize an anti-CD55 antibody. This specific antibody was developed
through the research of Professor Lindy Durrant of the University of Nottingham, UK. The CD55
antigen is significantly over-expressed on nearly all solid tumors in humans. Early studies at
Nottingham demonstrated that the antibody was able to bind only to tumor antigen and furthermore,
it was shown to bind in a highly novel manner, different from all anti-CD55 antibodies known in the
scientific literature. This novelty underpins the intellectual property surrounding VG102, in
addition to other intellectual property we have created through our development activities. The
CD55 antigen has been shown to block the bodys natural immune system from attacking and killing
cancer cells. Theoretically, if an antibody can be developed that binds selectively to tumor CD55
antigen, this protective mechanism will be removed and the natural immune system, or concomitantly
or sequentially administered anti-tumor agents, would then be able to destroy cancer cells.
Importantly, Professor Durrant has produced the mouse form of this antibody and has
administered it successfully to humans in a scintigraphy procedure (imaging). These studies
demonstrated the specificity of binding only to tumor antigen, and not normal cells, and
demonstrated tolerability in humans, albeit small numbers and dosages, without safety incident. It
is this data, and our own exploratory data in our laboratories, that has led us to license what we
believe may become an important addition to the arsenal for fighting a number of types of cancer.
At the current time we are developing production processes for a humanized version of this
antibody to continue pre-clinical studies, and we hope to be ready to initiate toxicology studies
on the humanized form during calendar 2006, followed by meetings with regulatory authorities to
agree upon clinical development protocols. We have not yet selected a target indication for this
antibody; however, we have identified ovarian cancer, breast cancer and head and neck cancer as
among the possibilities. At this time, we are not able to predict any date for the start of
clinical trials.
For the fiscal years ended 2005, 2004 and 2003, we incurred costs related to the VG102 project
totaling approximately $575,000, $206,000 and $144,000, respectively. Since the date of inception
of this project, we have incurred approximately $1.5 million in research and development costs.
VG101
In 1999, we entered into a collaborative research and development agreement with
Sloan-Kettering Institute (SKI) for the joint development of an antibody to the GD3 antigen, which
is over-expressed on several types of cancer cells, most notably melanoma. This agreement was
extended in February 2002 and goes through February 2007. It is believed that the GD3 antigen
protects melanoma cells from the bodys natural immune system, and anti-cancer therapeutics,
thereby allowing cells to proliferate and grow. By removing this protection, using an antibody that
selectively binds to the GD3 antigen, the natural immune system has a better chance to kill these
tumor cells, as would separately administered anti-cancer agents.
36
SKI clinicians have previously studied the mouse form of this antibody in a fairly extensive
manner in numerous human clinical trials. However, use of mouse-derived antibodies typically
influences the outcome of testing in humans in that the human body reacts to mouse antibody as if
it was a foreign invader, thereby reducing the overall efficacy, and tolerability, of the product.
SKI was able to demonstrate that this antibody had beneficial effects in patients with Stage IV
melanoma, the most deadly stage of this disease. SKI also found that the antibody had therapeutic
utility when used alone, but greater therapeutic utility when used with other compounds. If the
antibody can be produced in a humanized form, thereby eliminating at least some of the undesirable
effects, whether used alone or in combination with other products, it could offer significant
improvement in this disease setting. Importantly, to date, there are no other products available to
successfully treat Stage IV melanoma.
We are currently engaged in negotiations with SKI, for an exclusive license to this antibody,
as provided for in the earlier agreement. At the current time, we are developing production
processes for various forms of the antibody, including the avian transgenics technology, in an
effort to generate humanized forms. These antibodies be shared with SKI clinicians for
comparability testing, done in parallel with studies at our Viragen (Scotland) laboratories,
following which we will select one humanized form to complete pre-clinical studies in preparation
for meetings with the US Food and Drug Administration. We expect a meeting with the FDA could be
requested in calendar 2006, provided a license agreement is executed. We are not able to predict a
date for the start of clinical trials.
During the fiscal years 2005 and 2004, we have incurred minimal costs associated with our R24
project. For the fiscal year 2003, we incurred costs in connection with this project totaling
approximately $598,000. Since the date of inception of this project, we have incurred
approximately $1.5 million in research and development costs.
IEP 11
We entered into an agreement with the University of Miami and the UM/Sylvester Comprehensive
Cancer Center to develop an anti-cancer technology with an option to license the technology upon
completion of certain milestones. In May 2005, we decided to allow this option to expire. This
project has thus been terminated and we will no longer have any expenses related to it. We have
returned all documentation and the rights to this technology to the University.
For the fiscal years ended 2005, 2004 and 2003 we incurred costs related to the IEP 11 project
totaling approximately $78,000, $95,000 and $85,000, respectively. Since the date of inception of
this project, we have incurred approximately $258,000 in research and development costs.
Multiferon®
Our natural, leukocyte-derived multi-subtype interferon alpha product, Multiferon(R) has been
developed as an alternative to synthetic (recombinant), single-subtype products, and is currently
approved in many countries for any indication where patients fail, relapse from, or fail to
tolerate, synthetic interferon alpha products. Multiferon® is currently approved in 10 countries
around the world and actively marketed in 5 of those countries through local distribution partners,
and our own sales team in Sweden.
Interferon alpha is the human bodys first line of defense against infectious disease. Human
leukocytes, in the blood, secrete a number of different types of interferon alphas when exposed to
attack by viruses and bacteria. Viragen collects human leukocytes, a by-product of blood
collection, and under highly exacting procedures, subjects these to a viral challenge that is known
to be benign to humans, but stimulates the leukocytes to produce a unique mixture of interferon
alpha subtypes. We then collect and purify the resultant interferon alphas using our proprietary
technologies to result in Multiferon®. The mixture of subtypes contained in Multiferon® is
unique among all interferon alpha products.
37
Multiferon® has been and continues to be studied in clinical trials in humans as rescue
therapy for patients who have been treated with synthetic interferon alpha products but who have
for various reasons not responded to that treatment. At the current time, we have clinical trials
under way in Mexico and Greece in hepatitis C and we are currently contemplating a study in Sweden
in order to investigate a different treatment regimen also in hepatitis C.
Multiferon®is also indicated for use in some types of leukemia and cancers. We have
recently completed a long term follow up of a clinical trial conducted in patients with high-risk
malignant melanoma, and subsequently we have filed with the Swedish
Medical Products Agency for approval for first line
adjuvant therapy in February, 2005. We expect a decision on this by the end of calendar 2005. We
are now contemplating another larger clinical trial in malignant melanoma to study further the
effects of the product on various stages of the disease in what will potentially become a
pan-European study. We will not start this clinical trial until some time in 2006, provided we
obtain regulatory approvals to do so, and provided we have the financial ability to fund this
study.
Multiferon®is believed to have other potential uses in other cancer treatment regimens and
we are currently evaluating a number of other possible indications for which clinical trials would
be required in order to gain approvals.
While developing data in support of Multiferon®, we have been gathering information on the
mechanisms of action involved in the interferon alpha response against viral diseases and cancers.
From this information, we envisage that potential next generation interferon products may evolve.
It is not possible at this time to predict whether any of these developments or potential new
products will be successful or what costs will be incurred to further determine the therapeutic
value of such products.
The timelines and costs for the completion of biopharmaceutical research and product
development programs are difficult to accurately predict for various reasons, including the
inherent exploratory nature of the work. The achievement of project milestones is dependent on
issues which may impact development timelines and can be unpredictable and beyond Viragens
control. These issues include; availability of capital funding, presence of competing technologies,
unexpected experimental results which may cause the direction of research to change, accumulated
knowledge about the intrinsic properties of the candidate product, the availability of Good
Manufacturing Practices grade material, results from preclinical and clinical studies, potential
changes in prescribing practice and patient profiles and regulatory requirements.
The completion of all of the above research and development projects is dependent upon our
ability to raise significant additional funding or our ability to identify potential collaborative
partners that would share in project costs. Our future capital requirements are dependent upon
many factors, including: revenue generated from the sale of our natural human alpha interferon
product, progress with future clinical trials; the costs associated with obtaining regulatory
approvals; the costs involved in patent applications; competing technologies and market
developments; and our ability to establish collaborative arrangements and effective
commercialization activities.
38
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Market risk generally represents the risk of loss that may result from the potential change in
value of a financial instrument as a result of fluctuations in interest rates and market prices. We
have not traded or otherwise transacted in derivatives nor do we expect to do so in the future. We
have established policies and internal processes related to the management of market risks which we
use in the normal course of our business operations.
Interest Rate Risk
The fair value of long-term debt is subject to interest rate risk. While changes in market
interest rates may affect the fair value of our fixed-rate long-term debt, we believe a change in
interest rates would not have a material impact on our financial condition, future results of
operations or cash flows.
Foreign Currency Exchange Risk
We conduct operations in several different countries. The balance sheet accounts of our
operations in Scotland and Sweden are translated to U.S. dollars for financial reporting purposes
and resulting adjustments are made to stockholders equity. The value of the respective local
currency may strengthen or weaken against the U.S. dollar, which would impact the value of
stockholders investment in our common stock. Fluctuations in the value of the British Pound and
Swedish Krona against the U.S. dollar have occurred during our history, which have resulted in
unrealized foreign currency translation gains and losses, which are included in accumulated other
comprehensive income and shown in the equity section of our balance sheet.
While most of the transactions of our U.S. and foreign operations are denominated in the
respective local currency, some transactions are denominated in other currencies. Since the
accounting records of our foreign operations are kept in the respective local currency, any
transactions denominated in other currencies are accounted for in the respective local currency at
the time of the transaction. Upon settlement of this type of transaction, any foreign currency gain
or loss results in an adjustment to income.
Our results of operations may be impacted by the fluctuating exchange rates of foreign
currencies, especially the British Pound and Swedish Krona, in relation to the U.S. dollar. Most of
the revenue and expense items of our foreign subsidiaries are denominated in the respective local
currency. An unfavorable change in the exchange rate of the foreign currency against the U.S.
dollar will result in lower revenue when translated into U.S. dollars. Operating expenses would
also be lower in these circumstances.
During the fiscal year ended June 30, 2005, the U.S. dollar has experienced adverse
fluctuations against the British Pound and the Swedish Krona. At one point during the fiscal year,
the U.S. dollar had lost approximately 6.60% and 14.25% of its value against the British Pound and
Swedish Krona, respectively, compared to June 30, 2004. As a result of the weak U.S. dollar during
fiscal 2005, we experienced greater revenues, but, more significantly, greater operating expenses
of our foreign subsidiaries when translated to U.S. dollars.
We do not currently engage in hedging activities with respect to our foreign currency
exposure. However, we continually monitor our exposure to currency fluctuations. We have not
incurred significant realized losses on exchange transactions. If realized losses on foreign
transactions were to become significant, we would evaluate appropriate strategies, including the
possible use of foreign exchange contracts, to reduce such losses.
We were not adversely impacted by the European Unions adoption of the Euro currency. Our
foreign operations to date have been located in Scotland and Sweden, which have not participated in
the adoption of the Euro as of June 30, 2005.
39
Item 8. Financial Statements and Supplementary Data
Our Financial Statements begin on page F-1 of this Annual Report on Form 10-K.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosures
Not applicable.
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We conducted an evaluation of the effectiveness of the design and operation of our disclosure
controls and procedures as of the end of the period covered by this Annual Report on Form 10-K.
This evaluation was done under the supervision and with the participation of management, including
our Chief Executive Officer (CEO) and Chief Financial Officer (CFO) as of the end of the period
covered by this Annual Report on Form 10-K. Based upon this evaluation, our CEO and CFO have
concluded, subject to the limitations noted below, that our disclosure controls and procedures were
effective to ensure that information required to be disclosed in our reports filed under the
Exchange Act, was recorded, processed, summarized and reported within the time periods specified in
the Securities and Exchange Commission rules and forms.
Internal Control over Financial Reporting
Managements report on internal control over financial reporting is included on page F-2 of
this Annual Report on Form 10-K. The report of our independent registered public accounting firm
related to managements assessment of the effectiveness of internal control over financial
reporting is included on page F-3 of this Annual Report on Form 10-K.
Changes in Internal Control
There has been no significant change in our internal control over financial reporting in
connection with the evaluation required by paragraph (d) of Rule13a-15 of the Exchange Act that
occurred during the fourth quarter of our fiscal year ended June 30, 2005 that has materially
affected, or is reasonably likely to materially affect, our internal control over financial
reporting.
Limitations on the Effectiveness of Controls
Our management, including the CEO and CFO, does not expect that our disclosure controls and
procedures or our internal control over financial reporting will prevent all error and all fraud. A
control system, no matter how well designed and operated, can provide only reasonable, not
absolute, assurance that the control systems objectives will be met. Further, the design of a
control system must reflect the fact that there are resource constraints, and the benefits of
controls must be considered relative to their costs. Because of the inherent limitations in all
control systems, no evaluation of controls can provide absolute assurance that all control issues
and instances of fraud, if any, have been detected. These inherent limitations include the
realities that judgments in decision-making can be faulty, and that breakdowns can occur because of
simple error or mistake. The design of any system of controls is based in part upon certain
assumptions about the likelihood of future events, and there can be no assurance that any design
will succeed in achieving its stated goals under all potential future conditions. Over time,
controls may become inadequate because of changes in conditions or deterioration in the degree of
compliance with policies or procedures. Because of the inherent limitations in a cost-effective
control system, misstatements due to error or fraud may occur and not be detected.
40
Certifications
Attached as exhibits 31.1 and 31.2 to this Annual Report on Form 10-K are certifications of
the CEO and the CFO, which are required under the Sarbanes-Oxley Act of 2002. This Controls and
Procedures section includes information concerning the controls evaluation referred to in the
certifications and it should be read in conjunction with the certifications for a more complete
understanding of the topics presented.
Item 9B. Other Information
Not applicable.
41
PART III
Item 10. Directors and Executive Officers of the Registrant
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Served as |
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Officer and/or |
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Name |
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Director Since |
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Charles A. Rice
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54 |
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Chief Executive Officer
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2004 |
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President
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Director
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Dennis W. Healey
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Chief Financial Officer
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1980 |
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Treasurer
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1980 |
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Executive Vice President
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1993 |
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Secretary
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1994 |
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Carl N. Singer
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Chairman of the Board
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1997 |
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Randolph A. Pohlman
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Director
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Robert C. Salisbury
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Director
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1998 |
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Charles J. Simons
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Director
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Nancy A. Speck
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Director
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C. Richard Stafford
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Director
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2003 |
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Nicholas M. Burke
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33 |
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Vice President
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2004 |
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Controller
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On February 28, 1997, we amended our Certificate of Incorporation and established a classified
board of directors commencing with the 1997 annual meeting. Following that meeting, we divided
directors into three subclasses consisting of class A, class B and class C. Each director holds
office for a three-year term expiring at the annual meeting of stockholders held three years
following the annual meeting at which he or she was elected. At each annual meeting of
stockholders, directors of the respective class whose term has expired will stand for election.
Terms of our directors expire as follows:
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class A at our 2007 annual meeting of stockholders; |
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class B at our 2005 annual meeting of stockholders; and |
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class C at our 2006 annual meeting of stockholders |
In March 2004, Charles A. Rice was appointed president and chief executive officer and
director of Viragen. In March 2005, Mr. Rice was appointed president and chief executive officer
and director of Viragen International, Inc. From January 2003 to September 2003, Mr. Rice served
as group president of KV Pharmaceutical Company with responsibility for commercial activities.
From August 1992 to November 2002, Mr. Rice served as president and chief executive officer of Dey,
Inc., a division of Germanys Merck KGaA, where he developed and implemented strategies to create a
rapidly growing and profitable business. Mr. Rice has a degree in Biology from Georgia College and
extensive business education and experience through training and coursework at a variety of
domestic and international universities, in addition to continuous participation in industry
organizations.
Dennis W. Healey is a certified public accountant. He has served as chief financial officer
and treasurer since 1980 and was elected to the board in 1984. He was appointed executive vice
president in 1993 and secretary in 1994. Mr. Healey is also executive vice president, treasurer,
secretary and a director of Viragen International, Inc. In December 2003, concurrent with the
appointment of Dr. Pohlman, Mr. Healey resigned from Viragens board of directors.
Carl N. Singer was elected a director in August 1997 and currently serves as chairperson of
the board of directors and chairman of the executive committee. Since 1981, Mr. Singer has served
as chairperson of Fundamental Management Corporation, a Florida-based institutional investment
fund. Mr. Singer has also served as a director, president and CEO of Sealy, Inc., Scripto, Inc. and
the BVD Company. Mr. Singer also serves as chairperson of the board of Viragen International, Inc.
42
Randolph A. Pohlman, PhD., was appointed to the board of directors in December 2003. He
currently serves as a member of the executive and the audit and finance committees. Since 1995, Dr.
Pohlman has served as the Dean of the H. Wayne Huizenga School of Business and Entrepreneurship at
Nova Southeastern University. Prior to his arrival at Nova Southeastern University, Dr. Pohlman
served as a senior executive at Koch Industries, the second-largest privately held company in the
United States from 1990 to 1995. Prior to his tenure at Koch Industries, Dr. Pohlman was associated
with Kansas State University, where he served for fourteen years in a variety of administrative and
faculty positions, including holding the L.L. McAninch Chair of Entrepreneurship and Dean of the
College of Business. Dr. Pohlman also served as a Visiting Research Scholar at the University of
California, Los Angeles in 1983, and was a member of the Executive Education Advisory Board of the
Wharton School of the University of Pennsylvania.
In March 2004, upon the appointment of Mr. Rice as president and chief executive officer,
Robert C. Salisbury resigned his positions as president and chief executive officer of Viragen,
positions he had held since January 2003. Mr. Salisbury has been a director of Viragen since
December 1998 and serves as chairperson of the nominating and governance committee and as a member
of the compensation committee. From 1974 to 1995, Mr. Salisbury was employed by the Upjohn Company
serving in several financial related positions. These positions included manager of cash
management, internal control and corporate finance from 1975 to 1981. He also served as a vice
president from 1985 to 1990, senior vice president from 1991 to 1994, and executive vice president
for finance and chief financial officer from 1994 to 1995. Following the merger of Pharmacia and
Upjohn, Inc. in 1995, Mr. Salisbury served as executive vice president and chief financial officer
until 1998. Mr. Salisbury also serves as president and a director of Fundamental Management
Corporation, a Florida-based institutional investment fund.
Charles J. Simons was elected to the board of directors in July 1998. He currently serves as
chairperson of the audit and finance committee and as a member of the executive and nominating and
governance committees. In addition, he is an independent management and financial consultant. From
1940 to 1981, he was employed by Eastern Airlines, last serving as vice chairman, executive vice
president and as a director. Mr. Simons is the vice-chairman of the board of G.W. Plastics, Inc., a
plastic manufacturer. Mr. Simons is also a director of Diasa Inc. and Preferred Care Partners.
On February 7, 2005, the board of directors of Viragen appointed Professor Nancy A. Speck,
Ph.D. to the board of directors. Dr. Speck also serves as a member of the nominating and
governance committee. Dr. Speck is a distinguished professor and researcher in the field of cancer
at Dartmouth Medical School and holds the James J. Carroll Chair in Oncology. Dr. Speck moved to
Dartmouth Medical School in 1989 as an Assistant Professor. She is currently a Professor of
Biochemistry, the Associate Director for Basic Science at the Norris Cotton Cancer Center at
Dartmouth and holds the prestigious James J. Carroll Chair in Oncology.
C. Richard Stafford was appointed to the board of directors in June 2003. He currently serves
as a member of the audit and finance committee and chairperson of the compensation committee. From
1977 to 2001, Mr. Stafford was vice president responsible for worldwide mergers and acquisitions
for Carter-Wallace, Inc., a former New York Stock Exchange listed international pharmaceutical,
diagnostics, and toiletries company. From 1974 to 1977, Mr. Stafford was president of Caithness
Corporation, an oil, gas and mineral exploration firm. From 1971 to 1974, he served as a vice
president of corporate finance at the global investment banker, Bear Stearns. Mr. Stafford also
served as director of corporate development of the Bristol-Myers Company from 1966 to 1971, and as
an associate at Milbank, Tweed, Hadley & McCloy from 1960 to 1965. He is a cum laude graduate of
Harvard College and a graduate of Harvard Law School.
Nicholas M. Burke is a certified public accountant and joined Viragen as our controller in
October 2001. He was appointed as vice president in March 2004. Prior to joining Viragen, Mr. Burke
served as corporate controller of SmartDisk Corporation a Florida-based computer peripherals
technology company from 1999 to 2001. From 1994 until 1999, Mr. Burke was a senior member of the
audit staff of Ernst & Young LLP, Viragens independent registered public accounting firm,
concentrating his practice in the computer technology and biotechnology industries.
43
There is no family relationship between any of the officers and directors.
Effective June 30, 2005, Per-Erik Persson resigned as a director of Viragen and Viragen
International. Mr. Persson remains chairperson of the board of directors of ViraNative, a
wholly-owned subsidiary of Viragen International, a position he has held since September 2003.
Effective February 1, 2005 Dr. Douglas Lind resigned as a director of Viragen.
During fiscal 2005, Viragens board of directors met on seven occasions.
Committees of the Board of Directors
Our board of directors has established an executive committee, an audit and finance committee,
a compensation committee and a nominating and governance committee. All committees operate under a
written charter adopted by the board of directors. The following table identifies the members of
our board of directors who serve on each of those committees.
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Audit and |
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Nominating and |
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Executive |
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Finance |
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Compensation |
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Governance |
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Name |
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Committee |
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Committee |
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Committee |
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|
Committee |
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Carl N. Singer |
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X |
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Randolph A. Pohlman |
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X |
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X |
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Robert C. Salisbury |
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X |
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X |
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Charles J. Simons |
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X |
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X |
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X |
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Nancy A. Speck |
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X |
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C. Richard Stafford |
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X |
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X |
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|
Executive Committee
The executive committee acts for the full board of directors during intervals between board of
directors meetings, except on matters which by law may not be delegated or have otherwise been
delegated to other committees of the board. The executive committee will meet as necessary. All
actions by the committee are reported at the next board of directors meeting. During fiscal 2005,
the executive committee met on four occasions.
Audit and Finance Committee
The audit and finance committee was organized in February 1998. The role of the audit and
finance committee is to assist the board of directors in monitoring (1) the integrity of our
financial statements, (2) our compliance with legal and regulatory requirements, (3) the
independent registered public accounting firms qualifications, independence, and fees, (4) the
development, implementation and performance of our internal control function and (5) the
performance of our independent registered public accounting firm.
The audit and finance committee reviews our financial reporting process on behalf of the board
of directors. Management has the primary responsibility for the financial statements and the
reporting process, including the system of internal controls. In this context, the committee has
met and held discussions with management and the Companys independent registered public accounting
firm. Management represented to the committee that Viragens consolidated financial statements were
prepared in accordance with generally accepted accounting principles, and the committee has
reviewed and discussed the consolidated financial statements with management and the independent
registered public accounting firm. The committee discussed with the independent registered public
accounting firm matters required to be discussed by Statement on Auditing Standards No. 61
(Communication With Audit Committees). In addition, the committee has discussed with the
independent registered public accounting firm, the firms independence from the Company and its
management, including the matters in the written disclosures required by the Independence Standards
Board Standard No. 1 (Independence Discussions With Audit Committees).
44
The committee discussed with our independent registered public accounting firm the overall
scope and plans for their respective audit. The committee meets with the independent registered
public accounting firm, with and without management present, to discuss the results of their
examinations, the evaluations of Viragens internal controls, and the overall quality of our
financial reporting.
In reliance on the reviews and discussions referred to above, the committee recommended to the
board of directors, and the board of directors has approved, that the audited consolidated
financial statements be included in Viragens annual report on Form 10-K for the year ended June
30, 2005, for filing with the Securities and Exchange Commission.
Each member of our audit and finance committee is independent within the meaning of Rule
10A-3 under the Securities Exchange Act of 1934 and satisfies the independence standards of Section
121A of the Rules of the American Stock Exchange.
During fiscal 2005, the audit and finance committee met on eleven occasions.
Audit Committee Financial Expert
Our board of directors has determined that our audit committee financial expert within the
meaning of Item 401(h) of Regulation S-K is Charles J. Simons. In general, an audit committee
financial expert is an individual member of the audit committee who (a) understands generally
accepted accounting principles and financial statements, (b) is able to assess the general
application of such principles in connection with accounting for estimates, accruals and reserves,
(c) has experience preparing, auditing, analyzing or evaluating financial statements comparable to
the breadth and complexity to the Companys financial statements, (d) understands internal controls
over financial reporting and (e) understands audit committee functions.
Compensation Committee
The
compensation committee was organized in February 2001. Under its
amended charter adopted in 2005,
the compensation committee is to consist of not less than two members. Each member of the
compensation committee satisfies the independence standards of Section 121A of the Rules of the
American Stock Exchange.
The compensation committee was formed to advise and make recommendations to the board of
directors with respect to (1) compensation payable to our executive officers and non-employee
directors, (2) incentive and equity-based compensation plans, including stock option plans in which
officers or employees are eligible to participate and (3) arrangements with executive officers and
other key officers relating to their employment relationship with us.
Nominating and Governance Committee
The nominating and governance committee was organized in November 2003. Under its charter,
the nominating and governance committee is to consist of not less than two members. Each member of
the nominating and governance committee satisfies the independence standards of Section 121A of the
Rules of the American Stock Exchange.
The nominating and governance committee was formed to (1) to assist the board of directors by
identifying individuals qualified to become board members, and to recommend for selection by the
board of directors the director nominees to stand for election for the next annual meeting of the
our shareholders; (2) to recommend to the board of directors director nominees for each committee
of the board of directors; (3) to oversee the evaluation of the board of directors and management,
and (4) to develop and recommend to the board of directors a set of corporate governance guidelines
and code of business conduct and ethics.
45
During fiscal 2005, the nominating and governance committee met on two occasions.
Compensation Committee Interlocks and Insider Participation
No member of our compensation committee during the last completed fiscal year: a) was an
officer or employee of Viragen or any of its subsidiaries, b) was formerly an officer or employee
of Viragen or any of its subsidiaries, or, c) had any relationship requiring disclosure by Viragen
under any paragraph of Item 404 of Regulation S-K.
Director Compensation
In March 2004, the board of directors approved and implemented a modified structure for
director compensation. Compensation received by individual directors may vary depending upon
committee membership and participation and number of meetings attended. The approved fees provide:
|
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Attendance fee per meeting of the board of directors: $1,500 |
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Audit and finance committee: |
|
o |
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Chairperson annual retainer $10,000 |
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o |
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Committee member annual retainer $5,000 |
|
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o |
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Attendance fee per meeting $750 |
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Executive committee, nominating and governance committee and compensation committee: |
|
o |
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Chairperson of the nominating and governance committee and compensation
committee annual retainer $5,000 |
|
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o |
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Committee member annual retainer $2,500 |
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|
o |
|
Attendance fee per meeting $750 |
All attendance fees are reduced by one-half for telephonic attendance.
Commencing in March 2000, Mr. Carl N. Singer receives $100,000 per year for his services as
chairperson of the board of directors and chairperson of the executive committee. He receives no
other director fees.
Code of Ethics
We have adopted a Code of Ethics for Senior Finance Personnel (Code of Ethics) that applies
to our chief executive officer, chief financial officer, controller, and persons performing similar
functions. We have also adopted a Business Ethics and Conflict of Interest Statement (Business
Ethics and Conflict of Interest Statement) that applies to directors, executive officers and
employees of Viragen and its subsidiaries. The Code of Ethics and Business Ethics and Conflict of
Interest Statement are available on our web site, free of charge, at www.viragen.com under the
Corporate Governance section. We will also provide a copy of this document, free of charge, upon
request. Any amendments to, or waivers of, the Code of Ethics will be disclosed on our website or
on Form 8-K promptly following the date of such amendment or waiver.
46
Item 11. Executive Compensation
The following table includes information concerning the compensation of the chief executive
officer of Viragen and its four other most highly compensated executive officers whose salary and
bonus exceeded $100,000 for the year ended June 30, 2005.
Summary Compensation Table
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Long Term Compensation |
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Awards |
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Payouts |
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Securities |
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Restricted |
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Underlying |
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Annual Compensation |
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Stock |
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Options/ |
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Name and |
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Fiscal |
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Other Annual |
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Awards |
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SARs |
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All Other |
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Principal Position |
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Year |
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Salary ($) |
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Bonus ($) |
|
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Compensation ($) |
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($) |
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(#) |
|
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LTIP Payouts ($) |
|
|
Compensation ($) |
|
Charles A. Rice |
|
|
2005 |
|
|
$ |
300,000 |
|
|
$ |
|
|
|
$ |
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|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
CEO, President and |
|
|
2004 |
|
|
|
78,750 |
|
|
|
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|
|
|
|
|
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|
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|
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|
150,000 |
|
|
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|
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|
Director |
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|
2003 |
|
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Carl N. Singer |
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|
2005 |
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$ |
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|
|
|
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|
|
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|
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$ |
100,000 |
|
Chairman of the Board, |
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2004 |
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|
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500 |
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100,000 |
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CEO and President of |
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2003 |
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500 |
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100,000 |
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Viragen International |
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Dennis W. Healey |
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2005 |
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$ |
205,000 |
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Executive V.P., CFO, |
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2004 |
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200,000 |
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35,000 |
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Secretary and Treasurer |
|
|
2003 |
|
|
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252,000 |
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Melvin Rothberg |
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2005 |
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|
$ |
152,896 |
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295,182 |
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Former Executive V.P. |
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|
2004 |
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|
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181,500 |
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Operations |
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2003 |
|
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181,500 |
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Nicholas M. Burke |
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2005 |
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|
$ |
145,000 |
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|
|
20,000 |
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V.P. and Controller |
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2004 |
|
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120,000 |
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20,000 |
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2003 |
|
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|
122,462 |
|
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10,000 |
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Employment Agreements
In March 2004, Charles A. Rice was appointed president and chief executive officer. Mr. Rice
entered into a three year employment agreement with Viragen. Following the initial three-year term,
the agreement is automatically extended for an additional year on each anniversary unless either
party provides at least ninety days notice of their intent not to extend. The agreement provides
for a base salary of $300,000 per year and an incentive bonus. The incentive bonus is based upon
performance and achievement of agreed standards. Commencing in calendar 2005, the board of
directors shall recommend an annual incentive bonus which will not be less than $75,000. Mr. Rice
also was granted options to purchase 150,000 shares of our common stock, exercisable at $2.10 per
share for a five year period from their vest date. These options vest as follows:
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50,000 upon the effective date of the employment agreement; |
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50,000 upon the first anniversary of the effective date; |
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25,000 when, and if, the volume weighted average price of our common stock trades at or
above $5.00 per share for thirty consecutive trading days; |
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25,000 when, and if, the volume weighted average price of our common stock trades at or
above $10.00 per share for thirty consecutive trading days; |
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or with regard to the 50,000 price based vesting, in their entirety upon the tenth
anniversary of the effective date. |
47
Carl N. Singer was elected a director in August 1997 and currently serves as chairman of the
board of directors and chairman of the executive committee. Mr. Singer has served as chairman of
the board of Viragen International since 2000. Commencing in March 2000, Mr. Singer receives
$100,000 per year from Viragen for his services as chairman of the board and chairman of the
executive committee.
Mr. Healey serves as executive vice president, chief financial officer secretary and treasurer
of Viragen. He also serves as executive vice president, chief financial officer, secretary and
director of Viragen International, Inc. On March 1, 2001, Mr. Healey renewed his employment
agreement with Viragen for an additional two years. Following the initial two year term, the
agreement is automatically extended for one additional year on each anniversary unless either party
provides at least ninety days notice of their intent not to renew. Under this agreement, Mr. Healey
received an annual salary of $252,000. On February 14, 2003, Mr. Healey executed an amendment to
his employment agreement which provided for the payment of 20% of his salary in the form of shares
of Viragen common stock. On March 1, 2003, Mr. Healey again executed an amendment to his
employment agreement which provided for the payment of 75% of his salary in the form of shares of
Viragen common stock, which continued through June 30, 2003. Effective July 1, 2003, Mr. Healey
executed an amendment to his employment agreement whereby his annual salary was reduced to
$200,000, which was subsequently increased to $210,000 in lieu of other compensation.
Mr. Healeys employment agreement contains a provision that in the event Viragen were to
spin-off or split-off any present or future subsidiaries, he would be entitled to receive a certain
number of options in the spun-off company. The number of options he would receive would be based on
a formula reflecting his then current option position relative to the fully diluted common stock of
Viragen then outstanding. The pricing of the new options would be based on the relationship of the
exercise price of his existing options with the fair market value of Viragens stock at the date of
the transaction.
Melvin Rothberg served as executive vice president operations. On July 1, 2001, Mr. Rothberg
renewed his two year employment agreement with Viragen. Under this agreement, Mr. Rothberg received
an annual salary of $172,500. He also received an automobile allowance of $600 per month.
Effective February 28, 2002 Mr. Rothbergs annual salary was increased to $181,500 to reflect his
added responsibilities related to the acquisition of ViraNative. On February 14, 2003, Mr.
Rothberg executed an addendum to his employment agreement which provided for the payment of 20% of
his salary in the form of shares of Viragen common stock which continued through June 30, 2003.
On July 1, 2004, Mr. Rothberg entered into a new two year employment agreement. Following the
initial two year term, the agreement was to automatically extend for one additional year on each
anniversary unless either party provided at least ninety days notice of their intent not to renew.
The agreement provided for a base annual salary of $190,000, which was subsequently increased to
$198,500 in lieu of other compensation. On April 22, 2005, Viragen entered into an agreement with
Mr. Rothberg, pursuant to which the parties agreed to an early termination of the employment
agreement dated July 1, 2004. Upon execution of the agreement by the parties, Mr. Rothberg
resigned as executive vice president operations of Viragen and all other positions in which he
served Viragen or its subsidiaries, including Viragen International.
In October 2001, Mr. Burke joined Viragen as Controller. Upon his employment, Mr. Burke
entered into a two year employment agreement. Following the initial two year term, the agreement is
automatically extended for one additional year on each anniversary unless either party provides at
least 90 days notice of their intent not to extend. In January 2002, Mr. Burkes employment
agreement was modified, increasing his salary to $120,000 per year. In March 2004, Mr. Burke was
appointed as vice president of Viragen. On June 21, 2004, his employment agreement was modified,
increasing his an annual salary to $145,000, effective July 1, 2004, and provided for a grant of
20,000 options to purchase shares of Viragen common stock. The options vest one-half upon the grant
date and one-half on the first anniversary of the grant date. These options are exercisable at
$1.57 per share and are exercisable for five years from the vest date.
48
Option/SAR Grants in Last Fiscal Year
The following table includes information as to the grant of options to purchase shares of
common stock during the fiscal year ended June 30, 2005 to each person named in the Summary
Compensation Table.
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Potential |
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Realized Value at |
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Individual Grants |
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Assumed Annual |
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Number of |
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% of Total |
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Rates of Stock |
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Securities |
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Options/SARs |
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Price Appreciation |
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Underlying |
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Granted to |
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Exercise or |
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for Option Term |
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Options/SARs |
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Employees in |
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Base Price |
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Expiration |
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Name |
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Granted (#) |
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Fiscal Year |
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($/Share) |
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Date |
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5% |
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10% |
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Charles A
Rice |
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Carl N.
Singer |
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Dennis W.
Healey |
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Melvin
Rothberg |
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Nicholas M.
Burke |
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Option Exercises and Holdings
The following table includes information as to the exercise of options to purchase shares of
common stock during the fiscal year ended June 30, 2005 by each person named in the Summary
Compensation Table and the unexercised options held as of the end of the 2005 fiscal year.
Aggregated Option/SAR Exercises in Last Fiscal Year
and Fiscal Year End Option Values
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Number of Securities |
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Value of Unexercised |
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Shares |
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Underlying Unexercised |
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In-The-Money |
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Acquired on |
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Value |
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Options at FY End (#) |
|
|
Options at FY End ($) |
|
Name |
|
Exercise (#) |
|
|
Realized ($) |
|
|
Exercisable |
|
|
Unexercisable |
|
|
Exercisable |
|
|
Unexercisable |
|
Charles A. Rice |
|
|
|
|
|
$ |
|
|
|
|
100,000 |
|
|
|
50,000 |
|
|
$ |
|
|
|
$ |
|
|
Carl N. Singer |
|
|
|
|
|
|
|
|
|
|
32,667 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Dennis W. Healey |
|
|
|
|
|
|
|
|
|
|
50,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Melvin Rothberg |
|
|
|
|
|
|
|
|
|
|
5,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Nicholas M. Burke |
|
|
|
|
|
|
|
|
|
|
32,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
EQUITY COMPENSATION PLAN INFORMATION
The following table reflects certain information about our common stock that may be issued
upon the exercise of options, warrants and rights under our existing equity compensation plans as
of June 30, 2005.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
|
(b) |
|
|
(c) |
|
|
|
Number of securities to |
|
|
Weighted-average |
|
|
Number of securities remaining |
|
|
|
be issued upon exercise |
|
|
exerciseice price of |
|
|
avaliable for future issuance under |
|
|
|
of outstanding options, |
|
|
outstanding options, |
|
|
equity compensation plans (excluding |
|
Plan category |
|
warrants, and rights |
|
|
warrants, and rights |
|
|
Securities reflected in column (a)) |
|
Equity compensation
plans approved by
security holders |
|
|
334,467 |
|
|
$ |
5.50 |
|
|
|
123,993 |
|
Equity compensation
plans not approved
by security holders
(1) |
|
|
117,500 |
|
|
|
23.24 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
451,967 |
|
|
|
|
|
|
|
123,993 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Consisting of securities issued in connection with research, supply and consulting
agreements. |
49
1997 Amended Stock Option Plan and 1995 Amended Stock Option Plan
On May 15, 1995 the board of directors adopted, subject to approval by the stockholders, a
stock option plan, called the 1995 Stock Option Plan. The board of directors reserved 400,000
shares of common stock under the 1995 Stock Option Plan. On September 22, 1995, the board of
directors amended the 1995 Stock Option Plan to define certain terms and clarify the minimum
exercise price of the non-qualified options. Viragen stockholders ratified the 1995 Stock Option
Plan at the annual meeting held on December 15, 1995. The 1995 Stock Option Plan expired in May
2005. This expiration did not affect the validity of outstanding stock options previously granted
under the 1995 Stock Option Plan.
On January 27, 1997 the board of directors adopted, subject to approval by the stockholders, a
stock option plan called the 1997 Stock Option Plan. Viragen stockholders ratified the 1997 Stock
Option Plan at the annual meeting held on February 28, 1997. On April 24, 1998 the board of
directors adopted, subject to ratification by the stockholders, an amendment to the 1997 Stock
Option Plan. This amendment reserved an additional 100,000 shares of common stock for issuance
under the plan. On July 31, 1998, the stockholders ratified this amendment to the 1997 Stock Option
Plan. This amendment brought the total shares reserved under the 1997 Stock Option Plan to 400,000
shares. As of September 6, 2005, there were approximately 123,993 shares available under the 1997
Stock Option Plan.
The board of directors may amend, suspend or terminate the 1997 Stock Option Plan at any time.
However, no amendment can be made which changes the minimum purchase price, except in the event of
adjustments due to changes in Viragens capitalization. Unless the 1997 Stock Options Plan has been
suspended or terminated by the board of directors, the plan will expire on January 27, 2007. The
termination or expiration of the plan would not affect the validity of any plan options previously
granted.
The compensation committee of the board of directors and the board of directors currently
administer the 1997 Stock Option Plan. Administration of the plan includes determining:
|
|
|
the persons who will be granted plan options, |
|
|
|
|
the type of plan options to be granted, |
|
|
|
|
the number of shares subject to each plan options, and |
|
|
|
|
the exercise price of plan options. |
Stock options granted under the 1997 Stock Option Plan may qualify as incentive stock options
under Section 422 of the Internal Revenue Code of 1986, as amended. In addition, the plan also
includes a reload option provision. This provision permits an eligible person to pay the exercise
price of the plan option with shares of common stock owned by the eligible person. The person then
receives a new plan option to purchase shares of common stock equal in number to the tendered
shares. Any incentive option, which is granted under the plan must provide for an exercise price of
not less than 100% of the fair market value of the underlying shares, on the date of such grant.
The exercise price of any incentive option granted to an eligible employee owning more than 10% of
our common stock must be at least 110% of the fair market value, as determined on the date of the
grant. The board of directors or the compensation committee determine the term of stock options
granted under the plan and the manner in which they may be exercised. No stock options granted
under the plan may be exercisable more than 10 years after the date of its grant. In the case of an
incentive option granted to an eligible employee owning more than 10% of Viragens common stock, no
plan option may be exercisable more than five years after the date of the grant.
Officers, directors, key employees and consultants of Viragen and its subsidiaries are
eligible to receive non-qualified options under the 1997 Stock Option Plan. Only officers,
directors and employees who are employed by Viragen or by any of its subsidiaries are eligible to
receive incentive options.
50
Incentive options are non-assignable and nontransferable, except by will or by the laws of
descent and distribution during the lifetime of the optionee. Only the optionee may exercise
incentive options. Under an amendment to the 1997 stock option plan, non-qualified options may be
transferable under limited circumstances for estate planning, if authorized by the board of
directors or the compensation committee. If an optionees employment is terminated for any reason,
other than his or her death or disability, or if an optionee is not an employee but is a member of
Viragens board of directors and his or her service as a director is terminated for any reason,
other then death or disability, the plan option granted will lapse to the extent unexercised on the
earlier of the expiration date or 90 days following the date of termination. If the optionee dies
during the term of his or her employment, the plan option granted will lapse to the extent
unexercised on the earlier of the expiration date of the plan option or the date one year following
the date of the optionees death. If the optionee is permanently and totally disabled, the plan
option granted lapses to the extent unexercised on the earlier of the expiration date of the option
or one year following the date of the disability.
Other Option Grants
On February 17, 2005, we granted options to purchase 2,500 shares of our common stock to Dr.
Nancy A. Speck upon her appointment to the board of directors. The options vest one-half on the
grant date and one-half on the first year anniversary of the grant date. The options are
exercisable over five years from the vest dates, at an exercise price of $0.85 per share.
Long-term Incentive Plan Awards
During the most recently completed fiscal year, no long-term incentive plan awards, within the
meaning of paragraph (a)(7)(iii) of Item 402 of Regulation S-K, were awarded to any person named in
the summary compensation table.
Pension Plans
We have no defined benefit or actuarial plans under which benefits are determined primarily by
final compensation (or average final compensation) and year of service.
Repricing of Options/SARs
During the most recently completed fiscal year, we did not adjust or amend the exercise price
of stock options or SARs previously awarded to any person named in the summary compensation table.
51
Item 12. Security Ownership of Certain Beneficial Owners and Management, Related Stockholder
Matters and Issuer Purchases of Equity Securities
The following table shows certain information known to us regarding Viragens common stock
beneficially owned at September 6, 2005, by:
|
|
|
each person who is known by us to own beneficially or exercise voting or dispositive control over 5% or more of
Viragens common stock, |
|
|
|
|
each of Viragens directors, |
|
|
|
|
each of Viragens officers identified in the summary compensation table, and |
|
|
|
|
all officers and directors as a group. |
Under securities law, a person is considered a beneficial owner of any securities that the
person has the right to acquire beneficial ownership of within 60 days.
This table is based upon 37,087,677 shares of common stock outstanding at September 6, 2005,
and does not give effect to:
|
|
|
the issuance of up to 21,858,660 shares that would be issued in the event
outstanding options and warrants are exercised and upon the conversion of convertible
notes or preferred stock, except with respect to beneficial ownership of shares
attributable to the named person in accordance with Securities and Exchange Commission
rules. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Shares |
|
|
|
|
|
|
|
|
|
|
Beneficially Owned |
|
|
Number of |
|
|
|
|
|
|
|
|
|
|
Shares |
|
Percent |
|
|
|
|
|
Acquirable |
|
|
Beneficially |
|
of |
|
|
|
|
|
Within |
Name of Beneficial Owner |
|
Owned |
|
Class |
|
Currently |
|
60 days |
Charles A. Rice |
|
|
250,000 |
|
|
|
* |
|
|
|
100,000 |
|
|
|
150,000 |
|
Randolph A. Pohlman |
|
|
4,112 |
|
|
|
* |
|
|
|
1,112 |
|
|
|
3,000 |
|
Robert C. Salisbury |
|
|
39,000 |
|
|
|
* |
|
|
|
20,500 |
|
|
|
18,500 |
|
Charles J. Simons |
|
|
21,447 |
|
|
|
* |
|
|
|
19,447 |
|
|
|
2,000 |
|
Carl N. Singer |
|
|
479,852 |
|
|
|
1.3 |
% |
|
|
447,185 |
|
|
|
32,667 |
|
Nancy A. Speck |
|
|
1,250 |
|
|
|
* |
|
|
|
|
|
|
|
1,250 |
|
C. Richard Stafford |
|
|
103,000 |
|
|
|
* |
|
|
|
100,000 |
|
|
|
3,000 |
|
Dennis W. Healey |
|
|
152,565 |
|
|
|
* |
|
|
|
102,565 |
|
|
|
50,000 |
|
Nicholas M. Burke |
|
|
32,500 |
|
|
|
* |
|
|
|
|
|
|
|
32,500 |
|
Alexandra Global Master Fund Ltd. |
|
|
3,323,071 |
|
|
|
8.2 |
|
|
|
90,876 |
|
|
|
3,232,195 |
|
Palisades Master Fund L.P |
|
|
3,583,176 |
|
|
|
8.8 |
|
|
|
|
|
|
|
3,583,176 |
|
Satellite Strategic Finance Associates, LLC (1) |
|
|
4,070,000 |
|
|
|
9.9 |
|
|
|
|
|
|
|
4,070,000 |
|
Officers and Directors as a group (9 persons) |
|
|
1,083,726 |
|
|
|
2.9 |
|
|
|
790,809 |
|
|
|
292,917 |
|
|
|
|
* |
|
less than 1% |
|
(1) |
|
Does not include shares issuable upon conversion of notes and/or warrants if
conversion or exercise would increase the holders beneficial ownership to more than 9.9%. |
The beneficial ownership figures include 373,635 shares of common stock held by Fundamental
Management Corporation, a Florida-based institutional investment fund, which have been attributed
to Carl N. Singer. Mr. Singer is the chairperson of Fundamental Management Corporation. Mr.
Salisbury is president and a director of Fundamental Management Corporation. Mr. Salisbury and Mr.
Simons are investors in funds managed by Fundamental Management Corporation.
52
Beneficial Ownership Reporting Compliance
Section 16(a) of the Exchange Act requires our directors and executive officers, and persons
who own ten percent (10%) or more of a registered class of our equity securities, to file with the
Securities and Exchange Commission initial reports of their ownership and reports of changes in
their ownership of common stock and other equity securities of Viragen. Officers, directors and
greater than ten percent (10%) stockholders are required by regulation to furnish us with copies of
all Section 16(a) forms they file.
Based on our records and other information, we believe that during the fiscal year ended June
30, 2005, all Section 16(a) filing requirements applicable to our officers, directors and greater
than ten percent (10%) beneficial owners were completed and timely filed, except as described
below:
|
|
|
In April 2005, C. Richard Stafford, a director of the Company, purchased 21,931 shares
of Viragen common stock. As a consequence of an administrative error, the Form 4 reporting
this purchase was filed late. |
53
Stock Price Performance Graph
The following graph compares the percentage change in the cumulative total stockholder return
on the Companys common stock during the period from June 30, 2000 through June 30, 2005, with the
cumulative total return on the AMEX Market Value Index and the NASDAQ Biotechnology Index.
COMPARISON
OF 5 YEAR CUMULATIVE TOTAL RETURN
AMONG VIRAGE, INC. , THE
AMEX MARKET VALUE (U.S. & FOREIGN) INDEX
AND THE NASDAQ BIOTECHNOLOGY INDEX
* $100
invested on 6/30/00 in stock or index-including reinvestment of
dividends
Fiscal year ending June 30.
54
Item 13. Certain Relationships and Related Transactions
Carl N. Singer, chairperson of the board of directors of Viragen, also serves as chairperson
of the board of directors of Viragen International. Mr. Singer receives $100,000 per year for his
services as Viragen and Viragen Internationals chairperson of the board of directors and
chairperson of Viragens executive committee. He receives no other director fees. Charles A. Rice,
president and chief executive officer of Viragen, serves in the same capacities for Viragen
International. Mr. Rice is also a director of both Viragen and Viragen International, Inc. Dennis
W. Healey, executive vice president and chief financial officer of Viragen, serves in the same
capacities for Viragen International. Mr. Healey is also a
director of Viragen International, Inc. Professor William H. Stimson
is a director of Viragen International and also serves as a
compensated consultant. During the fiscal year ended June 30,
2005, Professor Stimson received approximately $112,000 for his
consulting services.
During the fiscal year ended June 30, 2005 we provided approximately $8.6 million of funding
to Viragen International, our majority-owned subsidiary. As of June 30, 2005, we have a receivable
of approximately $20.3 million from Viragen International. This amount does not show in our balance
sheet because Viragen International is consolidated with Viragen for financial reporting purposes.
Historically, this balance has been settled by the issuance of shares of Viragen International
common stock to Viragen at the then market price.
On August 31, 2004, we contributed to capital $1,000,000 in inter-company balances with
Viragen International. On that date, the closing price of Viragen Internationals common stock was
$0.18 per share as quoted on the over-the-counter bulletin board. We received 5,555,556 shares of
Viragen International common stock for the capital contribution, which increased our ownership in
Viragen International to approximately 81.2%.
During October 1998, Peter Fischbein, a former director, exercised options to purchase 20,000
shares of Viragen common stock at $5.00 per share. These options were exercised through the payment
of $2,000 cash and the issuance of a promissory note payable to Viragen totaling $98,000, and
related pledge and escrow agreements. This promissory note accrued interest at 5.06%, payable
semi-annually, and was secured by the underlying common stock purchased. During February 2000, Mr.
Fischbein exercised options to purchase an additional 2,500 shares of Viragen common stock at $5.00
per share through the issuance of another promissory note payable to Viragen totaling $12,500, and
related pledge and escrow agreements. This promissory note accrued interest at 6.46%, payable
semi-annually. The shares of common stock purchased are being held in escrow, pending payment of
the related notes pursuant to the provisions of the pledge and escrow agreements. On December 31,
2003, we reserved the uncollaterized portion of these notes totaling approximately $64,000, based
on the closing price of our stock on that date. In January 2004, Mr. Fischbein consolidated his
October 1998 and February 2000 notes by issuing a two year promissory note payable to Viragen
totaling approximately $114,000. This promissory note bears interest at 3.5%, payable
semi-annually, and is secured by the underlying common stock purchased. Mr. Fischbein is current
with the semi-annual interest payments on this promissory note.
55
Item 14. Principal Accountant Fees and Services
The following table presents fees for professional services rendered by Ernst & Young LLP for
the fiscal years ended June 30, 2005 and 2004.
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
2005 |
|
|
2004 |
|
Audit fees |
|
$ |
596,000 |
|
|
$ |
296,000 |
|
Audit related fees |
|
|
|
|
|
|
|
|
Tax fees |
|
|
82,000 |
|
|
|
42,000 |
|
All other fees |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
678,000 |
|
|
$ |
338,000 |
|
|
|
|
|
|
|
|
Audit fees includes the audit of our annual financial statements included in our annual report
on Form 10-K, including Sarbanes-Oxley Section 404 attest services in fiscal 2005, review of
interim financial statements included in our quarterly reports on Form 10-Q and services that are
normally provided by our independent registered public accounting firm in connection with statutory
and regulatory filings and consents and other services related to SEC matters. This category also
includes advice on audit and accounting matters that arose during, or as a result of, the audit of
the annual financial statements or the review of interim financial statements.
Audit related fees consist of services provided by Ernst & Young LLP that are reasonably
related to the performance of the audit or review of our financial statements and not included
under audit fees.
Tax fees consist of the aggregate fees billed for professional services rendered by Ernst &
Young LLP for tax compliance, tax advice, and tax planning.
Pre-Approval Policy
In April 2004, we implemented an Audit and Non-Audit Services Pre-Approval Policy. This policy
conforms to guidelines established under the Sarbanes-Oxley Act of 2002 and is administered by the
audit and finance committee and the board of directors. The policy provides that the audit and
finance committee is required to pre-approve the audit and non-audit services performed by our
independent registered public accounting firm in order to assure that they do not impair their
independence. Our policy provides for both general pre-approval and specific pre-approval
guidelines. The policy states that unless a type of service has received general pre-approval, it
will require specific pre-approval by the audit and finance committee if it is to be provided by
our independent registered public accounting firm.
56
PART IV
Item 15. Exhibits and Financial Statement Schedules
(a)(1) Financial Statements
See Item 8. Financial Statements and Supplementary Data for Financial Statements included
with this Annual Report of Form 10-K.
(a)(2) Financial Statement Schedules
All schedules have been omitted because the required information is not applicable or the
information is included in the consolidated financial statements or the notes thereto.
(a)(3) Exhibits
|
|
|
Exhibit |
|
|
Number |
|
Description |
3.
|
|
Articles of Incorporation and By-Laws |
|
|
|
3.1
|
|
Articles of Incorporation and By-Laws (incorporated by reference to
Viragens registration statement on Form S-1 dated June 8, 1981, File No.
2-72691). |
|
|
|
3.2
|
|
Certificate of Amendment of Certificate of Incorporation dated September
11, 1986 (incorporated by reference to Viragens registration statement
on Form S-2 dated October 24, 1986, File No. 33-9714). |
|
|
|
3.3
|
|
Certificate of Amendment of Certificate of Incorporation dated April 8,
1987 (incorporated by reference to Viragens current report on Form 8-K
dated April 17, 2000, filed on April 13, 2000). |
|
|
|
3.4
|
|
Certificate of Amendment of Certificate of Incorporation dated May 11,
1993 (incorporated by reference to Viragens current report on Form 8-K
dated April 17, 2000, filed on April 13, 2000). |
|
|
|
3.5
|
|
Certificate of Amendment of Certificate of Incorporation dated February
28, 1997 (incorporated by reference to Viragens current report on Form
8-K dated April 17, 2000, filed on April 13, 2000). |
|
|
|
3.6
|
|
Certificate of Amendment of Certificate of Incorporation dated July 2,
1997 (incorporated by reference to Viragens current report on Fort 8-K
dated April 17, 2000, filed on April 13, 2000). |
|
|
|
3.7
|
|
Certificate of Amendment of Certificate of Incorporation dated October 4,
1999 (incorporated by reference to Viragens current report on Form 8-K
dated April 17, 2000, filed on April 13, 2000). |
|
|
|
3.8
|
|
Certificate of Amendment of Certificate of Incorporation dated August 28,
2001, filed on August 28, 2001. |
|
|
|
3.9
|
|
Certificate of Amendment to Certificate of Incorporation dated February
3, 2003 (incorporated by reference to the companys Form 10-Q filed with
the Securities and Exchange Commission on February 14, 2003) |
|
|
|
3.10
|
|
Certificate of Amendment to Certificate of Incorporation dated June 25,
2003 (incorporated by reference to the companys registration statement
on Form S-3 dated June 26, 2003, File No. 333-106536). |
|
|
|
4.
|
|
Instruments defining the rights of security holders, including indentures. |
|
|
|
4.1
|
|
Form of common Stock Certificate (incorporated by reference to Viragens
registration statement on Form S-1 dated June 8, 1981, File No. 2-72691). |
|
|
|
4.2
|
|
Certificate of Designation for Series A Preferred Stock, as amended
(incorporated by reference to 1986 Form S-2, Part II, Item 16, 4.4). |
|
|
|
4.3
|
|
Specimen Certificate for Unit (Series A Preferred Stock and Class A
Warrant) (incorporated by reference to 1986 Form S-2, Part II, Item 15. |
|
|
|
4.4
|
|
1995 Stock Option Plan (incorporated by reference to Viragens
Registration Statement on Form S-8 filed June 9, 1995). |
|
|
|
4.5
|
|
1997 Stock Option Plan (incorporated by reference to Viragens
Registration Statement of Form S-8 filed April 17, 1998). |
57
|
|
|
Exhibit |
|
|
Number |
|
Description |
4.6
|
|
Subscription Agreement between Active Investors Ltd. II and
Viragen, Inc. dated February 18, 2000 (incorporated by reference
to Viragens Registration Statement on Form S-3 filed May 19,
2000). |
|
|
|
4.7
|
|
Loan and Escrow Agreement between AMRO International, S.A. and
Viragen, Inc. dated March 1, 2000 (incorporated by reference to
Viragens Registration Statement on Form S-3 filed May 19, 2000). |
|
|
|
4.8
|
|
Common Stock Purchase Warrant issued to Equitable Equity Lending,
Inc. dated November 1, 1999 (incorporated by reference to
Viragens Registration Statement on Form S-3 filed May 19, 2000). |
|
|
|
4.9
|
|
Common Stock Purchase Warrant granted to Girmon Investment Co.,
Limited dated December 21, 1998 (incorporated by reference to
Viragens Registration Statement on Form S-8 filed May 19, 2000). |
|
|
|
4.10
|
|
Common Stock Purchase Warrant granted to Robert Keller, M.D. dated
November 1, 1999 (incorporated by reference to Viragens
Registration Statement on Form S-8 filed May 19, 2000). |
|
|
|
4.11
|
|
Common Stock Purchase Warrant granted to David W. Kirchembaum
dated November 1, 1999 (incorporated by reference to Viragens
Registration Statement on Form S-8 filed May 19, 2000). |
|
|
|
4.12
|
|
Common Stock Purchase Warrant granted to Bradford J. Beilly dated
November 1, 1999 (incorporated by reference to Viragens
Registration Statement on Form S-8 filed May 19, 2000). |
|
|
|
4.13
|
|
Common Stock Purchase Warrant granted to Catherine Patrick dated
November 1, 1999 (incorporated by reference to Viragens
Registration Statement on Form S-8 filed May 19, 2000). |
|
|
|
4.14
|
|
Form of Common Stock Purchase Warrants granted to Pablo A. Guzman,
M.D. between April 2, 1998 and November 4, 1999 (incorporated by
reference to Viragens Registration Statement on Form S-8 filed
May 19, 2000). |
|
|
|
4.15
|
|
Common Stock Purchase Warrant granted to Dunwoody Brokerage
Services, Inc. dated December 28, 1999 (incorporated by reference
to Viragens Registration Statement on Form S-8 filed May 19,
2000). |
|
|
|
4.16
|
|
Common Stock Purchase Warrant granted to David Squillacote dated
July 1, 1999 (incorporated by reference to Viragens Registration
Statement on Form S-8 filed May 19, 2000). |
|
|
|
4.17
|
|
Common Stock Purchase Warrant granted to Cameron Associates, Inc.
dated January 17, 2000 (incorporated by reference to Viragens
Registration Statement on Form S-8 filed May 19, 2000). |
|
|
|
4.18
|
|
Common Stock Purchase Warrant granted to Nassau Securities, Intl.
dated April 17, 2000 (incorporated by reference to Viragens
Registration Statement on Form S-8 filed May 19, 2000). |
|
|
|
4.19
|
|
Stock Option Agreement between Viragen, Inc. and Gerald Smith
dated February 7, 2000 (incorporated by reference to Viragens
Registration Statement on Form S-8 filed May 19, 2000). |
|
|
|
10.
|
|
Material contracts. |
|
|
|
10.1
|
|
Research Agreement between the Registrant and Viragen Research
Associates Limited Partnership dated December 29, 1983
(incorporated by reference to Medicores S-1, File No. 2-89390,
dated February 10, 1984 (Medicores S-1), Part II, Item
16(a)(10)(xxxiii)). |
|
|
|
10.2
|
|
License Agreement between the Registrant and Viragen Research
Associates Limited Partnership dated December 29, 1983
(incorporated by reference to Medicores S-1, Part II, Item
16(a)(10)(xxxiv)). |
|
|
|
10.3
|
|
Royalty Agreement between the Company and Medicore, Inc. dated
November 7, 1986 (incorporated by reference to the November 1986
Form 8-K, Item 7(c)(i)). |
|
|
|
10.4
|
|
Amendment to Royalty Agreement between the Company and Medicore,
Inc. dated November 21, 1989 (incorporated by reference to the
Companys Current Report on Form 8-K dated December 6, 1989, Item
7(c)(i)). |
|
|
|
10.5
|
|
Agreement for Sale of Stock between the Company and Cytoferon
Corp. dated February 5, 1993 (incorporated by reference to the
Companys Current Report on Form 8-K dated February 11, 1993 Item
7(c)(28)). |
|
|
|
10.6
|
|
Addendum to Agreement for Sale of Stock between the Company and
Cytoferon Corp. dated May 4, 1993 (incorporated by reference to
the Companys Current Report on Form 8-K dated May 5, 1993, Item
7(c)(28)(i)). |
58
|
|
|
Exhibit |
|
|
Number |
|
Description |
10.7
|
|
Amendment No. 2 to the Royalty Agreement between the Company and Medicore, Inc.
dated May 11, 1993 (incorporated by reference to the Companys June 30, 1993
Form 10-K, Part IV, Item 14(a)(10)(xix)). |
|
|
|
10.8
|
|
Marketing and Management Services Agreement between the Company and Cytoferon
Corp. dated August 18, 1993 (incorporated by reference to the Companys June
30, 1993 Form 10-K, Part IV, Item 14(a)(10)(xxiii)). |
|
|
|
10.9
|
|
Agreement for Sale of Stock between Cytoferon and the Company dated November
19, 1993 (incorporated by reference to the Companys June 30, 1994 Form 10-K,
Part IV, Item 14(a)(10)(xxiv)). |
|
|
|
10.10
|
|
Amendment No. 1 to Agreement for Sale of Stock with Cytoferon (incorporated by
reference to the Companys 1995 Form SB-2, Part II, Item 27(10)(xxxii)). |
|
|
|
10.11
|
|
License and Manufacturing Agreement with Common Services Agency (incorporated
by reference to the Companys 1995 Form SB-2, Part II, Item 27(10)(xxxvi)). |
|
|
|
10.12
|
|
Series H Convertible Preferred Stock, Form of Subscription Agreement dated
February 17, 1998 and related Registration Agreement and Common Stock Purchase
Warrants (incorporated By reference to the Companys Registration Statement on
Form S-3 dated April 17, 1998). |
|
|
|
10.13
|
|
Series I Convertible Preferred Stock, Form of Subscription Agreement dated
April 2, 1998 and related Registration Rights Agreement and Common Stock
Purchase Warrants (incorporated by reference to the Companys Registration
Statement on Form S-3 dated April 17, 1998). |
|
|
|
10.14
|
|
Cooperation and Supply Agreement between the Company, Viragen Deutschland GmbH
and German Red Cross dated March 19, 1998 (Certain portions of this exhibit
have been redacted pursuant to a Confidentiality Request submitted to The
Securities and Exchange Commission). |
|
|
|
10.15
|
|
Buffycoat Supply Agreement between Americas Blood Centers and the Company
dated July 15, 1998 (Certain portions of this exhibit have been redacted
pursuant to a Confidentiality Request submitted to the Securities and Exchange
Commission). |
|
|
|
10.16
|
|
Agreement between the Company and the American Red Cross dated August 18, 1998
(Certain portions of this exhibit have been redacted pursuant to a
Confidentiality Request submitted to the Securities and Exchange Commission). |
|
|
|
10.17
|
|
Strategic Alliance Agreement between the Company and Inflammatics, Inc. and
Inflammatics Inc. Series A Convertible Preferred Stock Purchase Agreement
(incorporated By reference to the Companys Annual Report on Form 10-K for The
year ended June 30, 1998). |
|
|
|
10.18
|
|
Gerald Smith Pledge and Escrow Agreement for 200,000 shares dated September 1,
1998 (incorporated by reference to the Companys Annual Report on Form 10-K/A
for the year ended June 30, 1998). |
|
|
|
10.19
|
|
Gerald Smith Pledge and Escrow Agreement for 50,000 shares dated September 1,
1998 (incorporated by reference to the Companys Annual Report on Form 10-K/A
for the year ended June 30, 1998). |
|
|
|
10.20
|
|
Dennis W. Healey Pledge and Escrow Agreement for 200,000 Shares dated September
1, 1998 (incorporated by reference to The Companys Annual Report on Form
10-K/A for the year Ended June 30, 1998). |
|
|
|
10.21
|
|
Dennis W. Healey Pledge and Escrow Agreement for 50,000 Shares dated September
1, 1998 (incorporated by reference to The Companys Annual Report on Form
10-K/A for the year Ended June 30, 1998). |
|
|
|
10.22
|
|
Southern Health SDN. BHD Option to Purchase Master License dated March 23, 1998. |
|
|
|
10.23
|
|
Placement Agreement, Placement Agent Warrant and Investor Warrant dated
September 22, 1998 (incorporated by reference to Viragens Annual Report on
Form 10-K for the year ended June 30, 1998). |
|
|
|
10.24
|
|
Purchase Agreement between the Registrant, the Isosceles Fund and Cefeo
Investments Limited dated March 17, 1999 (incorporated by reference to
Viragens Amendment No. 1 to Registration Statement on Form S-3 filed on June
21, 1999, File No. 333-75749). |
59
|
|
|
Exhibit |
|
|
Number |
|
Description |
10.25
|
|
8% Redeemable Convertible Promissory Note to the Isosceles Fund
dated March 17, 1999 (incorporated by reference to Viragens Form
S-3 registration statement filed April 6, 1999, File No.
333-75749). |
|
|
|
10.26
|
|
8% Redeemable Convertible Promissory Note to Cefeo Investments
Limited dated March 17, 1999 (incorporated by reference to
Viragens Form S-3 registration statement filed April 6, 1999,
File No. 333-75749). |
|
|
|
10.27
|
|
Common Stock Purchase Warrant issued to the Isosceles Fund Dated
March 17, 1999 (incorporated by reference to Viragens Form S-3
registration statement filed April 6, 1999, File No. 333-75749). |
|
|
|
10.28
|
|
Supply and Distribution Agreement between Viragen and the Adamjee
Group of Companies dated November 16, 1998 (incorporated by
reference to the Viragen (Europe) Ltd. Annual Report on Form 10-K
for the year ended June 30, 1999). |
|
|
|
10.29
|
|
Employment Agreement between Viragen and Gerald Smith dated March
1, 1999 (incorporated by reference to Viragens Annual Report on
Form 10-K for the year ended June 30, 1999). |
|
|
|
10.30
|
|
Employment Agreement between Viragen and Dennis W. Healey Dated
March 1, 1999 (incorporated by reference to Viragens Annual
Report on Form 10-K for the year ended June 30, 1999). |
|
|
|
10.31
|
|
Memorandum of Agreement between the Isosceles Fund and the Company
dated March 17, 1999 (incorporated by reference to Viragens
Annual Report on Form 10-K for the year ended June 30, 1999). |
|
|
|
10.32
|
|
Letter of Intent between the Company and Drogsan Healthcare Dated
July 2, 1999 (incorporated by reference to the Viragen (Europe)
Ltd. Annual Report on Form 10-K for the year ended June 30, 1999). |
|
|
|
10.33
|
|
Common stock and Warrants Agreement. Stock Purchase Warrant and
Registration Rights Agreement dated November 24, 1999
(incorporated by reference to Viragens Current Report on Form 8-K
dated December 9, 1999). |
|
|
|
10.34
|
|
Carl N. Singer Promissory Note, Pledge and Escrow Agreement for
50,000 shares dated October 1, 1998 (incorporated by reference to
Viragens Form S-1/A registration statement filed December 22,
1999, File No. 333-75749). |
|
|
|
10.35
|
|
Peter Fischbein Promissory Note, Pledge and Escrow Agreement for
200,000 shares dated October 8, 1998 (incorporated by reference to
Viragens Form S-1/A registration statement filed December 22,
1999, File No. 333-75749). |
|
|
|
10.36
|
|
Employment Agreement, Stock Option Agreement between Viragen and
Melvin Rothberg dated July 1, 1999 (incorporated by reference to
Viragens Form S-1/A registration statement filed December 22,
1999, File No. 333-75749). |
|
|
|
10.37
|
|
Employment Agreement, Stock Option Agreement between Viragen
(Scotland) Ltd. and Dr. D. Magnus Nicolson dated July 1, 1999
(incorporated by reference to Viragens Form S-1/A registration
statement filed December 22, 1999, File No. 333-75749). |
|
|
|
10.38
|
|
Promissory Note and Mortgage and Security Agreement dated August
10, 1999 (incorporated by reference to Viragens Form S-1/A
registration statement filed December 22, 1999, File No.
333-75749). |
|
|
|
10.39
|
|
Mortgage and Security Agreement dated November 3, 1999
(incorporated by reference to Viragens Form S-1/A registration
statement filed December 22, 1999, File No. 333-75749). |
|
|
|
10.40
|
|
Dennis W. Healey Promissory Note,
Pledge and Escrow Agreement for 100,000 shares dated October 3, 2000 (incorporated by reference to
Viragens Annual Report on Form 10-K for the year ended June 30,
2001). |
|
|
|
10.41
|
|
Development, License and Collaborative Agreement between Roslin
Institute (Edinburgh) and Viragen, Inc. dated November 15, 2000
(incorporated by reference to Viragens Form S-3 registration
statement filed December 29, 2000, File No. 333-52996). |
|
|
|
10.42
|
|
Employment Agreement, Stock Option Agreement between Viragen and
Gerald Smith dated March 1, 2001 (incorporated by reference to
Viragens Annual Report on Form 10-K for the year ended June 30,
2001). |
60
|
|
|
Exhibit |
|
|
Number |
|
Description |
10.43
|
|
Employment Agreement, Stock Option Agreement between Viragen and
Dennis W. Healey dated March 1, 2001 (incorporated by reference to
Viragens Annual Report on Form 10-K for the year ended June 30,
2001). |
|
|
|
10.44
|
|
Consulting Agreement, Stock Option Agreement between Viragen and
E. Donald Shapiro dated March 21, 2001 (incorporated by reference
to Viragens Annual Report on Form 10-K for the year ended June
30, 2001). |
|
|
|
10.45
|
|
Consulting Agreement, Stock Option Agreement between Viragen and
Abraham Cohen dated March 21, 2001 (incorporated by reference to
Viragens Annual Report on Form 10-K for the year ended June 30,
2001). |
|
|
|
10.46
|
|
Option Agreement between Geron Corporation and Viragen, Inc. Dated
May 14, 2001 (incorporated by reference to Viragens Form S-3
registration statement filed June 18, 2001, File No. 333-63246). |
|
|
|
10.47
|
|
Consulting Agreement between Viragen and Robert C. Salisbury dated
May 23, 2001 (incorporated by reference to Viragens Annual Report
on Form 10-K for the year ended June 30, 2001). |
|
|
|
10.48
|
|
Agreement for the Acquisition of BioNative AB between Hakan Borg
and others, Viragen (Europe) Limited and Viragen, Inc. dated
September 28, 2001 (incorporated by reference to Viragen (Europe)
Limiteds Annual Report on Form 10-K filed September 28, 2001). |
|
|
|
10.49
|
|
Supply and Distribution agreement between Viragen (Europe) Ltd.,
Viragen (Scotland) Ltd. and Tradeway, Inc. dated October 25, 2001
(incorporated by reference to the Companys quarterly report on
Form 10-Q filed November 19, 2001). |
|
|
|
10.50
|
|
Termination Agreement between Viragen Technology, Inc. and Viragen
(Scotland) Ltd. dated September 28, 2001 (incorporated by
reference to Viragen (Europe) Limiteds quarterly report on Form
10-Q filed November 19, 2001). |
|
|
|
10.51
|
|
Securities Purchase Agreement, Convertible Debentures, Common
Stock Purchase Warrants and Registration Rights Agreement dated
January 11, 2002 (incorporated by reference to Viragens Current
Report on Form 8-K dated January 15, 2002). |
|
|
|
10.52
|
|
Supply and distribution agreement between Viragen International,
Inc. and CJ Pharma dated October 18, 2002 (incorporated by
reference to Viragen Internationals Form 10-Q filed February 14,
2003) |
|
|
|
10.53
|
|
Extension to distribution and supply agreement between Viragen
International, Inc. and Laboratorios Pisa dated January 9, 2003
(incorporated by reference to Viragen Internationals Form 10-Q
filed February 14, 2003) |
|
|
|
10.54
|
|
Securities Purchase Agreement dated November 8, 2002, between
Viragen, Inc., Palisades Equity Fund L.P., Bristol Investment Ltd.
and Alpha Capital AG (incorporated by reference to Viragen, Inc.s
Form S-3 filed on December 5, 2002) |
|
|
|
10.55
|
|
Form of Convertible Debenture (incorporated by reference to
Viragen, Inc.s Form S-3 filed on December 5, 2002) |
|
|
|
10.56
|
|
Form of Common Stock Purchase Warrant (incorporated by reference
to Viragen, Inc.s Form S-3 filed on December 5, 2002) |
|
|
|
10.57
|
|
Registration Rights Agreement dated November 8, 2002, between
Viragen, Inc., Palisades Equity Fund, L.P., Bristol Investment
Ltd. and Alpha Capital AG (incorporated by reference to Viragen,
Inc.s Form S-3 filed on December 5, 2002) |
|
|
|
10.58
|
|
Securities Purchase Agreement dated January 31, 2003, between
Viragen, Inc., Palisades Equity Fund L.P., Crescent
International Ltd., Alpha Capital AG, Brivis Investment, Ltd. and
Castlerigg Master Investments Ltd. (incorporated by reference to
Viragen, Inc.s Form 10-Q filed with the Securities and Exchange
Commission on February 14, 2003) |
|
|
|
10.59
|
|
Form of Secured Convertible Debenture for Securities Purchase
Agreement dated January 31, 2003 (incorporated by reference to
Viragen, Inc.s Form 10-Q filed with the Securities and Exchange
Commission on February 14, 2003) |
|
|
|
10.60
|
|
Form of Stock Purchase Warrant for Securities Purchase Agreement
dated January 31, 2003 (incorporated by reference to
Viragen, Inc.s Form 10-Q filed with the Securities and Exchange
Commission on February 14, 2003) |
61
|
|
|
Exhibit |
|
|
Number |
|
Description |
10.61
|
|
Registration Rights Agreement dated January 31, 2003, between
Viragen, Inc., Palisades Equity Fund, L.P., Crescent International
Ltd., Alpha Capital AG, Brivis Investment, Ltd. and Castlerigg
Master Investments Ltd. (incorporated by reference to Viragen,
Inc.s Form 10-Q filed with the Securities and Exchange Commission
on February 14, 2003) |
|
|
|
10.62
|
|
First Amendment dated February 27, 2003 to the Securities Purchase
Agreement dated January 31, 2003, between Viragen, Inc., Palisades
Equity Fund L.P., Crescent International Ltd., Alpha Capital AG,
Brivis Investment, Ltd. and Castlerigg Master Investments Ltd.
(incorporated by reference to Viragen, Inc.s Form S-3 filed with
the Securities and Exchange Commission on March 4, 2003, File No.
333-103593) |
|
|
|
10.63
|
|
Secured Convertible Debenture between Viragen, Inc. and Palisades
Equity Fund L.P. dated February 28, 2003
(incorporated by reference to Viragen, Inc.s Form S-3 filed with
the Securities and Exchange Commission on March 4, 2003, File No.
333-103593) |
|
|
|
10.64
|
|
Secured Convertible Debenture between Viragen, Inc. and Alpha
Capital AG dated February 28, 2003 (incorporated by reference to
Viragen, Inc.s Form S-3 filed with the Securities and Exchange
Commission on March 4, 2003, File No. 333-103593) |
|
|
|
10.65
|
|
Stock Purchase Warrant between Viragen, Inc. and Palisades Equity
Fund L.P. dated February 28, 2003 (incorporated by reference to
Viragen, Inc.s Form S-3 filed with the Securities and Exchange
Commission on March 4, 2003, File No. 333-103593) |
|
|
|
10.66
|
|
Stock Purchase Warrant between Viragen, Inc. and Alpha Capital AG
dated February 28, 2003 (incorporated by reference to
Viragen, Inc.s Form S-3 filed with the Securities and Exchange
Commission on March 4, 2003, File No. 333-103593) |
|
|
|
10.67
|
|
Consulting Agreement between Viragen, Inc. and Gerald Smith dated
January 31, 2003 (incorporated by reference to Viragen, Inc.s
Form 10-Q filed with the Securities and Exchange Commission on May
14, 2003) |
|
|
|
10.68
|
|
Common Stock Purchase Agreement dated March 31, 2003, between
Viragen, Inc., and Talisman Management Limited. (incorporated by
reference to Viragen, Inc.s Form 10-Q filed with the Securities
and Exchange Commission on May 14, 2003) |
|
|
|
10.69
|
|
Registration Rights Agreement dated March 31, 2003, between
Viragen, Inc., and Talisman Management Limited.
(incorporated by reference to Viragen, Inc.s Form 10-Q filed with
the Securities and Exchange Commission on May 14, 2003) |
|
|
|
10.70
|
|
Form of Common Stock Purchase Warrant dated March 31, 2003,
between Viragen, Inc., and Talisman Management Limited.
(incorporated by reference to Viragen, Inc.s Form 10-Q filed
with the Securities and Exchange Commission on May 14, 2003) |
|
|
|
10.71
|
|
Securities Purchase Agreement dated April 16, 2003, between
Viragen, Inc., Palisades Equity Fund L.P., Crescent
International Ltd. and Alpha Capital AG (incorporated by reference
to Viragen, Inc.s Form 10-Q filed with the Securities
and Exchange Commission on May 14, 2003) |
|
|
|
10.72
|
|
Form of Secured Convertible Debenture for Securities Purchase
Agreement dated April 1, 2003. (incorporated by reference to
Viragen, Inc.s Form 10-Q filed with the Securities and Exchange
Commission on May 14, 2003) |
|
|
|
10.73
|
|
Form of Stock Purchase Warrant for Securities Purchase Agreement
dated April 16, 2003. (incorporated by reference
to Viragen, Inc.s Form 10-Q filed with the Securities and
Exchange Commission on May 14, 2003) |
|
|
|
10.74
|
|
Registration Rights Agreement dated April 16, 2003, between
Viragen, Inc., Palisades Equity Fund, L.P., Crescent
International Ltd. and Alpha Capital AG. (incorporated by
reference to Viragen, Inc.s Form 10-Q filed with the
Securities and Exchange Commission on May 14, 2003) |
|
|
|
10.75
|
|
Additional Funding Agreement dated May 8, 2003, between Viragen,
Inc., Palisades Equity Fund L.P., Crescent International Ltd. and
Alpha Capital AG. (incorporated by reference to
Viragen, Inc.s Form 10-Q filed with the Securities and Exchange
Commission on May 14, 2003) |
62
|
|
|
Exhibit |
|
|
Number |
|
Description |
10.76
|
|
Additional Funding Agreement dated May 13, 2003 between Viragen,
Inc. and Bristol Investment Fund, Ltd. (incorporated by reference
to Viragen, Inc.s Form S-3 filed with the Securities and Exchange
Commission on May 30, 2003, File No. 333-105668) |
|
|
|
10.77
|
|
Secured Promissory Note dated August 6, 2002 between Viragen, Inc.
and Isosceles Fund Limited (incorporated by reference to Viragen,
Inc.s Form S-3 filed with the Securities and
Exchange Commission on June 26, 2003, File No. 333-106536) |
|
|
|
10.78
|
|
Amendment to 8% Secured Promissory Note dated November 22, 2002
between Viragen, Inc. and Isosceles Fund Limited
(incorporated by reference to Viragen, Inc.s Form S-3 filed with
the Securities and Exchange Commission on June 26, 2003, File No.
333-106536) |
|
|
|
10.79
|
|
Form of Stock Purchase Warrant for Amendment to 8% Secured
Promissory Note dated November 22, 2002 between
Viragen, Inc. and Isosceles Fund Limited (incorporated by
reference to Viragen, Inc.s Form S-3 filed with the Securities
and Exchange Commission on June 26, 2003, File No. 333-106536) |
|
|
|
10.80
|
|
Securities Purchase Agreement dated June 27, 2003 between Viragen,
Inc., Palisades Equity Fund LP, Alpha Capital AG, Crescent
International Ltd., Bristol Investment Fund, Ltd. and Gryphon
Master Fund, LP (incorporated by reference to Viragen, Inc.s Form
S-3 filed with the Securities and Exchange Commission on July 18,
2003, File No. 333-107176) |
|
|
|
10.81
|
|
Form of Secured Convertible Debenture for Securities Purchase
Agreement dated June 27, 2003 (incorporated by reference
to Viragen, Inc.s Form S-3 filed with the Securities and Exchange
Commission on July 18, 2003, File No. 333-107176) |
|
|
|
10.82
|
|
Form of Stock Purchase Warrant for Securities Purchase Agreement
dated June 27, 2003 (incorporated by reference to
Viragen, Inc.s Form S-3 filed with the Securities and Exchange
Commission on July 18, 2003, File No. 333-107176) |
|
|
|
10.83
|
|
Registration Rights Agreement dated June 27, 2003 between Viragen,
Inc., Palisades Equity Fund LP, Alpha Capital AG, Crescent
International Ltd., Bristol Investment Fund, Ltd. and Gryphon
Master Fund, LP (incorporated by reference to Viragen, Inc.s Form
S-3 filed with the Securities and Exchange Commission on July 18,
2003, File No. 333-107176) |
|
|
|
10.84
|
|
Letter dated June 1, 2003 between Viragen, Inc., Palisades Equity
Fund LP, Alpha Capital AG, Crescent International Ltd.,
Bristol Investment Fund, Ltd. and Gryphon Master Fund, LP
(incorporated by reference to Viragen, Inc.s Form S-3
filed with the Securities and Exchange Commission on July 18,
2003, File No. 333-107176) |
|
|
|
10.85
|
|
Addendum to employment agreement with Dennis W. Healey dated
February 14, 2003 (incorporated by reference to Viragen, Inc.s
Form S-8 filed with the Securities and Exchange
Commission on August 11, 2003, File No. 333-107852) |
|
|
|
10.86
|
|
Addendum #2 to employment agreement with Dennis W. Healey dated
March 1, 2003 (incorporated by reference to Viragen, Inc.s Form
S-8 filed with the Securities and Exchange
Commission on August 11, 2003, File No. 333-107852) |
|
|
|
10.87
|
|
Addendum to employment agreement with Douglas D. Lind, M.D. dated
February 14, 2003(incorporated by reference to Viragen, Inc.s
Form S-8 filed with the Securities and Exchange Commission on
August 11, 2003, File No. 333-107852) |
|
|
|
10.88
|
|
Addendum to employment agreement with Melvin Rothberg dated
February 14, 2003 (incorporated by reference to Viragen, Inc.s
Form S-8 filed with the Securities and Exchange
Commission on August 11, 2003, File No. 333-107852) |
|
|
|
10.89
|
|
Officers and Directors Alternative Stock Compensation Plan
(incorporated by reference to Viragen, Inc.s Form S-8 filed with
the Securities and Exchange Commission on August 11, 2003, File
No. 333-107852) |
|
|
|
10.90
|
|
Douglas D. Lind, M.D. Common Stock Purchase Warrant agreement
dated June 16, 2003 (incorporated by reference to Viragen, Inc.s
Form S-8 filed with the Securities and Exchange Commission on
August 11, 2003, File No. 333-107852) |
63
|
|
|
Exhibit |
|
|
Number |
|
Description |
10.91
|
|
Toni Vallen Common Stock Purchase Warrant agreement dated August
1, 2003 (incorporated by reference to Viragen, Inc.s Form S-8
filed with the Securities and Exchange Commission on August 11,
2003, File No. 333-107852) |
|
|
|
10.92
|
|
Securities Purchase Agreement dated as of September 29, 2003,
between Viragen, Inc., and Palisades Equity Fund LP, Alpha Capital
AG, Crescent International, Ltd., Bristol Investment Fund Ltd.,
Gryphon Master Fund, LP, Crestview Capital Fund II, LP, PEF
Advisors LLC and PEF Advisors LLP (incorporated by reference to
Exhibit 99.1 of Viragen, Inc.s Form 8-K filed with the Securities
and Exchange Commission on October 2, 2003) |
|
|
|
10.93
|
|
Registration Rights Agreement entered into as of September 29,
2003, between Viragen, Inc., and Palisades Equity Fund LP, Alpha
Capital AG, Crescent International, Ltd., Bristol Investment Fund
Ltd., Gryphon Master Fund, LP, Crestview Capital Fund II, LP, PEF
Advisors LLC and PEF Advisors LLP (incorporated by reference to
Exhibit 99.2 of Viragen, Inc.s Form 8-K filed with the Securities
and Exchange Commission on October 2, 2003) |
|
|
|
10.94
|
|
Form of Common Stock Purchase Warrant for Securities Purchase
Agreement dated September 29, 2003 (incorporated by reference to
Exhibit 99.3 of Viragen, Inc.s Form 8-K filed with the Securities
and Exchange Commission on October 2, 2003) |
|
|
|
10.95
|
|
Securities Purchase Agreement dated as of December 23, 2003,
between Viragen, Inc., and Palisades Master Fund LP, Alpha Capital
AG, Crescent International, Ltd., Bristol Investment Fund Ltd.,
Gryphon Master Fund, LP and Gamma Opportunity Capital Partners, LP
(incorporated by reference to Exhibit 99.2 of Viragen, Inc.s Form
8-K filed with the Securities and Exchange Commission on December
31, 2003) |
|
|
|
10.96
|
|
Registration Rights Agreement entered into as of December 23,
2003, between Viragen, Inc., and Palisades Master Fund LP, Alpha
Capital AG, Crescent International, Ltd., Bristol Investment Fund
Ltd., Gryphon Master Fund, LP and Gamma Opportunity Capital
Partners, LP (incorporated by reference to Exhibit 99.3 of
Viragen, Inc.s Form 8-K filed with the Securities and Exchange
Commission on December 31, 2003) |
|
|
|
10.97
|
|
Form of Common Stock Purchase Warrant for Securities Purchase
Agreement dated December 23, 2003 (incorporated by reference to
Exhibit 99.4 of Viragen, Inc.s Form 8-K filed with the Securities
and Exchange Commission on December 31, 2003) |
|
|
|
10.98
|
|
Development, License and Collaboration Agreement between Roslin
Institute (Edinburgh), ViraGenics, Inc. and Viragen, Inc. executed
March 4, 2004, effective December 1, 2003. (incorporated by
reference to Viragen, Inc.s Form 10-Q filed with the Securities
and Exchange Commission on May 10, 2004) |
|
|
|
10.99
|
|
Employment Agreement, Stock Option Agreements between Viragen,
Inc. and Charles A. Rice dated March 29, 2004. (incorporated by
reference to Viragen, Inc.s Form 10-Q filed with the Securities
and Exchange Commission on May 10, 2004) |
|
|
|
10.100
|
|
Form of Securities Purchase Agreement dated as of April 1, 2004
between Viragen, Inc. and each of eight institutional investors
(incorporated by reference to Exhibit 99.2 of Viragen, Inc.s Form
8-K filed with the Securities and Exchange Commission on April 5,
2004) |
|
|
|
10.101
|
|
Form of convertible promissory note issuable at closing of
Securities Purchase Agreement dated as of April 1, 2004
(incorporated by reference to Exhibit 99.4 of Viragen, Inc.s Form
8-K filed with the Securities and Exchange Commission on April 5,
2004) |
|
|
|
10.102
|
|
Form of common stock purchase warrant accompanying notes issuable
at closing of Securities Purchase Agreement dated as of April 1,
2004 (incorporated by reference to Exhibit 99.5 of Viragen, Inc.s
Form 8-K filed with the Securities and Exchange Commission on
April 5, 2004) |
|
|
|
10.103
|
|
Form of common stock purchase warrant issuable upon prepayment of
notes issuable at closing of Securities Purchase Agreement dated
as of April 1, 2004 (incorporated by reference to Exhibit 99.6 of
Viragen, Inc.s Form 8-K filed with the Securities and Exchange
Commission on April 5, 2004) |
64
|
|
|
Exhibit |
|
|
Number |
|
Description |
10.104
|
|
Form of convertible promissory note issued on June 18, 2004 at
closing of a Securities Purchase Agreement dated as of April 1,
2004 (incorporated by reference to Viragen, Inc.s Form S-3 filed
with the Securities and Exchange Commission on July 13, 2004, File
No. 333-117338) |
|
|
|
10.105
|
|
Form of common stock purchase warrant issued on June 18, 2004 at
closing of a Securities Purchase Agreement dated as of April 1,
2004 (incorporated by reference to Viragen, Inc.s Form S-3 filed
with the Securities and Exchange Commission on July 13, 2004, File
No. 333-117338) |
|
|
|
10.106
|
|
Form of registration rights agreement executed on June 18, 2004 at
closing of a Securities Purchase Agreement dated as of April 1,
2004 (incorporated by reference to Viragen, Inc.s Form S-3 filed
with the Securities and Exchange Commission on July 13, 2004, File
No. 333-117338) |
|
|
|
10.107
|
|
Agreement between Viragen, Inc. and Melvin Rothberg dated April
22, 2005 (incorporated by reference to the Companys current
report on Form 8-K filed April 22, 2005) |
|
|
|
10.108
|
|
General Release by Viragen, Inc. in favor of Melvin Rothberg dated
April 22, 2005 (incorporated by reference to the Companys current
report on Form 8-K filed April 22, 2005) |
|
|
|
10.109
|
|
General Release by Melvin Rothberg in favor of Viragen, Inc. dated
April 22, 2005 (incorporated by reference to the Companys current
report on Form 8-K filed April 22, 2005) |
|
|
|
21.1
|
|
Subsidiaries of the registrant.* |
|
|
|
23.1
|
|
Consent of Independent Registered Public Accounting Firm.* |
|
|
|
31.1
|
|
Certification Pursuant to 18 U.S.C. Section 1350, As Adopted
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002* |
|
|
|
31.2
|
|
Certification Pursuant to 18 U.S.C. Section 1350, As Adopted
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002* |
|
|
|
32.1
|
|
Certification Pursuant to 18 U.S.C. Section 1350, As Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002* |
|
|
|
32.2
|
|
Certification Pursuant to 18 U.S.C. Section 1350, As Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002* |
65
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
|
|
|
|
|
|
|
VIRAGEN, INC. |
|
|
|
|
|
|
|
By:
|
|
/s/ Charles A. Rice |
|
|
|
|
|
|
|
|
|
Charles A. Rice |
|
|
|
|
President and Chief Executive Officer |
Dated: September 12, 2005
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been
signed below by the following persons on behalf of the registrant and in the capacities and on the
dates indicated.
|
|
|
|
|
SIGNATURE |
|
TITLE |
|
DATE |
/s/ Charles A. Rice
Charles A. Rice |
|
President and Chief Executive Officer
|
|
September 12, 2005 |
/s/ Carl N. Singer
Carl N. Singer |
|
Director, Chairman of the Board and Chairman
of the Executive Committee
|
|
September 10, 2005 |
/s/ Dennis W. Healey
Dennis W. Healey |
|
Executive Vice President, Treasurer,
Principal Financial Officer, Director and
Secretary
|
|
September 12, 2005 |
/s/ Randolph A. Pohlman
Randolph A. Pohlman |
|
Director
|
|
September 12, 2005 |
/s/ Robert C. Salisbury
Robert C. Salisbury |
|
Director and Chairman of the Nominating and
Governance Committee
|
|
September 9, 2005 |
/s/ Charles J. Simons
Charles J. Simons |
|
Director and Chairman of the Audit and
Finance Committee
|
|
September 10, 2005 |
Nancy A. Speck |
|
Director
|
|
September ___, 2005 |
/s/ C. Richard Stafford
C. Richard Stafford |
|
Director and Chairman of the Compensation
Committee
|
|
September 10, 2005 |
/s/ Nicholas M. Burke
Nicholas M. Burke |
|
Vice President, Controller and Principal
Accounting Officer
|
|
September 12, 2005 |
66
FORM 10-K ITEM 8
VIRAGEN, INC. AND SUBSIDIARIES
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
|
|
|
|
|
|
|
|
F-2 |
|
|
|
|
F-3 |
|
|
|
|
F-5 |
|
|
|
|
F-6 |
|
|
|
|
F-7 |
|
|
|
|
F-10 |
|
|
|
|
F-12 |
|
All schedules for which provision is made in the applicable accounting regulation of the
Securities and Exchange Commission are not required under the related instructions or are
inapplicable and therefore have been omitted.
F-1
MANAGEMENTS REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING
Our management is responsible for establishing and maintaining adequate internal control over
financial reporting, as such term is defined in Exchange Act Rules 13a-15(f). Under the
supervision and with the participation of our management, including our CEO and CFO, we conducted
an evaluation of the effectiveness of our internal control over financial reporting based on the
framework in Internal ControlIntegrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission. Based on our evaluation, under the Internal
ControlIntegrated Framework, our management concluded that our internal control over financial
reporting was effective as of June 30, 2005. Our managements assessment of the effectiveness of
our internal control over financial reporting as of June 30, 2005 has been audited by Ernst & Young
LLP, an independent registered public accounting firm, as stated in their attestation report which
is included herein.
F-2
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Stockholders of Viragen, Inc.
We have audited the accompanying consolidated balance sheets of Viragen, Inc. and subsidiaries
as of June 30, 2005 and 2004, and the related consolidated statements of operations, stockholders
equity and cash flows for each of the three years in the period ended June 30, 2005. These
financial statements are the responsibility of the Companys management. Our responsibility is to
express an opinion on these financial statements based on our audits.
We conducted our audits in accordance with the auditing standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan and perform the
audit to obtain reasonable assurance about whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements. An audit also includes assessing the accounting principles
used and significant estimates made by management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in all material
respects, the consolidated financial position of Viragen, Inc. and subsidiaries at June 30, 2005
and 2004, and the consolidated results of their operations and their cash flows for each of the
three years in the period ended June 30, 2005, in conformity with U.S. generally accepted
accounting principles.
The accompanying financial statements have been prepared assuming that Viragen, Inc. will
continue as a going concern. As more fully described in Note A, the Company has incurred recurring
operating losses, has an accumulated deficit and has a working capital deficiency. The Companys
ability to continue as a going concern is dependent on its ability to raise adequate capital to
fund necessary product commercialization and development activities. These conditions raise
substantial doubt about the Companys ability to continue as a going concern. Managements plans in
regard to these matters are also described in Note A. The financial statements do not include any
adjustments to reflect the possible future effects on the recoverability and classification of
assets or the amounts and classification of liabilities that may result from the outcome of this
uncertainty.
We also have audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), the effectiveness of Viragen, Inc.s internal control over
financial reporting as of June 30, 2005, based on criteria established in Internal
Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission and our report dated September 7, 2005 expressed an unqualified opinion thereon.
/s/
Ernst & Young LLP
Certified Public Accountants
Fort Lauderdale, Florida
September 7, 2005
F-3
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Stockholders of Viragen, Inc.
We have audited managements assessment, included in the accompanying Managements Report on
Internal Control over Financial Reporting, that Viragen, Inc. maintained effective internal control
over financial reporting as of June 30, 2005, based on criteria established in Internal
ControlIntegrated Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission (the COSO criteria). Viragen, Inc.s management is responsible for maintaining
effective internal control over financial reporting and for its assessment of the effectiveness of
internal control over financial reporting. Our responsibility is to express an opinion on
managements assessment and an opinion on the effectiveness of the Companys internal control over
financial reporting based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether effective internal control over financial reporting was
maintained in all material respects. Our audit included obtaining an understanding of internal
control over financial reporting, evaluating managements assessment, testing and evaluating the
design and operating effectiveness of internal control, and performing such other procedures as we
considered necessary in the circumstances. We believe that our audit provides a reasonable basis
for our opinion.
A companys internal control over financial reporting is a process designed to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally accepted accounting principles. A
companys internal control over financial reporting includes those policies and procedures that (1)
pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the
transactions and dispositions of the assets of the company; (2) provide reasonable assurance that
transactions are recorded as necessary to permit preparation of financial statements in accordance
with generally accepted accounting principles, and that receipts and expenditures of the company
are being made only in accordance with authorizations of management and directors of the company;
and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized
acquisition, use, or disposition of the companys assets that could have a material effect on the
financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or
detect misstatements. Also, projections of any evaluation of effectiveness to future periods are
subject to the risk that controls may become inadequate because of changes in conditions, or that
the degree of compliance with the policies or procedures may deteriorate.
In our opinion, managements assessment that Viragen, Inc. maintained effective internal control
over financial reporting as of June 30, 2005, is fairly stated, in all material respects, based on
the COSO criteria. Also, in our opinion, Viragen, Inc. maintained, in all material respects,
effective internal control over financial reporting as of June 30, 2005, based on the COSO
criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight
Board (United States), the consolidated balance sheets of Viragen, Inc. as of June 30, 2005 and
2004, and the related consolidated statements of operations, shareholders equity, and cash flows
for each of the three years in the period ended June 30, 2005 of Viragen, Inc. and our report dated
September 7, 2005 expressed an unqualified opinion thereon. Our report also includes a fourth
paragraph discussing the Companys recurring operating losses, accumulated deficit and working
capital deficiency which raise substantial doubt about the Companys ability to continue as a going
concern. The financial statements do not include any adjustments to reflect the possible future
effects on the recoverability and classification of assets and the classification of liabilities
that may result from the outcome of this uncertainty.
/s/
Ernst & Young LLP
Certified Public Accountants
Fort Lauderdale, Florida
September 7, 2005
F-4
VIRAGEN, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
2005 |
|
|
2004 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
6,885,537 |
|
|
$ |
22,753,271 |
|
Accounts receivable |
|
|
39,350 |
|
|
|
31,788 |
|
Inventories |
|
|
2,349,513 |
|
|
|
3,477,214 |
|
Prepaid expenses |
|
|
820,922 |
|
|
|
1,353,350 |
|
Other current assets |
|
|
832,610 |
|
|
|
1,022,356 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
10,927,932 |
|
|
|
28,637,979 |
|
Property, plant and equipment |
|
|
|
|
|
|
|
|
Land, building and improvements |
|
|
5,327,018 |
|
|
|
3,805,834 |
|
Equipment and furniture |
|
|
5,670,671 |
|
|
|
5,520,677 |
|
Construction in progress |
|
|
19,630 |
|
|
|
1,861,846 |
|
|
|
|
|
|
|
|
|
|
|
11,017,319 |
|
|
|
11,188,357 |
|
Less accumulated depreciation |
|
|
(5,262,769 |
) |
|
|
(4,362,976 |
) |
|
|
|
|
|
|
|
|
|
|
5,754,550 |
|
|
|
6,825,381 |
|
Goodwill |
|
|
3,653,159 |
|
|
|
10,295,140 |
|
Developed technology, net |
|
|
1,608,585 |
|
|
|
1,828,122 |
|
Deposits and other assets |
|
|
40,566 |
|
|
|
633,374 |
|
|
|
|
|
|
|
|
|
|
$ |
21,984,792 |
|
|
$ |
48,219,996 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
749,561 |
|
|
$ |
814,253 |
|
Accrued expenses and other liabilities |
|
|
1,116,637 |
|
|
|
1,411,458 |
|
Convertible notes |
|
|
16,104,994 |
|
|
|
|
|
Line of credit and short term borrowings |
|
|
224,245 |
|
|
|
1,076,645 |
|
Current portion of long-term debt |
|
|
33,228 |
|
|
|
153,723 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
18,228,665 |
|
|
|
3,456,079 |
|
Convertible notes |
|
|
|
|
|
|
12,490,919 |
|
Long-term debt, less current portion |
|
|
598,104 |
|
|
|
1,072,087 |
|
Deferred income tax liability |
|
|
456,540 |
|
|
|
500,368 |
|
Royalties payable |
|
|
107,866 |
|
|
|
107,866 |
|
Minority interest in subsidiary |
|
|
|
|
|
|
1,403,096 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity |
|
|
|
|
|
|
|
|
Convertible 10% Series A cumulative
preferred stock, $1.00 par value.
Authorized 375,000 shares; 2,150 and
2,250 issued and outstanding at June
30, 2005 and 2004, respectively.
Liquidation preference value: $10 per
share, aggregating $21,500 at June 30,
2005 and $22,500 at June 30, 2004 |
|
|
2,150 |
|
|
|
2,250 |
|
Common stock, $.01 par value.
Authorized 100,000,000 shares;
37,087,677 issued and outstanding at
June 30, 2005; 36,568,385 issued and
outstanding at June 30, 2004 |
|
|
370,877 |
|
|
|
365,685 |
|
Capital in excess of par value |
|
|
146,580,467 |
|
|
|
146,337,835 |
|
Accumulated deficit |
|
|
(146,680,119 |
) |
|
|
(120,470,263 |
) |
Accumulated other comprehensive income |
|
|
2,320,242 |
|
|
|
2,954,074 |
|
|
|
|
|
|
|
|
Total stockholders equity |
|
|
2,593,617 |
|
|
|
29,189,581 |
|
|
|
|
|
|
|
|
|
|
$ |
21,984,792 |
|
|
$ |
48,219,996 |
|
|
|
|
|
|
|
|
See notes to consolidated financial statements which are an integral part of these statements.
F-5
VIRAGEN, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June 30, |
|
|
|
2005 |
|
|
2004 |
|
|
2003 |
|
Product sales |
|
$ |
278,784 |
|
|
$ |
266,137 |
|
|
$ |
630,785 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
2,611,406 |
|
|
|
2,046,799 |
|
|
|
1,296,691 |
|
Inventory write-down |
|
|
720,450 |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
4,958,105 |
|
|
|
3,592,173 |
|
|
|
3,318,768 |
|
Selling, general and administrative |
|
|
8,638,529 |
|
|
|
7,367,950 |
|
|
|
7,231,189 |
|
Impairment of goodwill |
|
|
6,936,215 |
|
|
|
|
|
|
|
|
|
Amortization of intangible assets |
|
|
168,944 |
|
|
|
158,270 |
|
|
|
183,534 |
|
Interest and other income, net |
|
|
(1,538,067 |
) |
|
|
(632,378 |
) |
|
|
(535,428 |
) |
Interest expense |
|
|
5,654,975 |
|
|
|
7,393,239 |
|
|
|
8,007,097 |
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes and minority interest |
|
|
(27,871,773 |
) |
|
|
(19,659,916 |
) |
|
|
(18,871,066 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax benefit |
|
|
43,828 |
|
|
|
43,828 |
|
|
|
60,686 |
|
Minority interest in net loss of subsidiary |
|
|
1,620,239 |
|
|
|
1,438,924 |
|
|
|
1,461,694 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS |
|
|
(26,207,706 |
) |
|
|
(18,177,164 |
) |
|
|
(17,348,686 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Deduct required dividends on convertible
preferred stock, Series A |
|
|
2,150 |
|
|
|
2,550 |
|
|
|
2,650 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS ATTRIBUTABLE TO COMMON STOCK |
|
$ |
(26,209,856 |
) |
|
$ |
(18,179,714 |
) |
|
$ |
(17,351,336 |
) |
|
|
|
|
|
|
|
|
|
|
BASIC AND DILUTED NET LOSS PER COMMON SHARE,
after deduction for required dividends on
convertible preferred stock |
|
$ |
(0.71 |
) |
|
$ |
(0.55 |
) |
|
$ |
(1.21 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE COMMON SHARES BASIC AND
DILUTED |
|
|
36,697,852 |
|
|
|
33,183,832 |
|
|
|
14,393,803 |
|
|
|
|
|
|
|
|
|
|
|
See notes to consolidated financial statements which are an integral part of these statements.
F-6
VIRAGEN, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Preferred |
|
|
|
|
|
|
|
|
|
Capital |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other |
|
Notes |
|
|
|
|
Stock, |
|
Common Stock |
|
in Excess |
|
Treasury Stock |
|
Accumulated |
|
Comprehensive |
|
Due From |
|
|
|
|
Series A |
|
Shares |
|
Amount |
|
of Par Value |
|
Shares |
|
Amount |
|
Deficit |
|
Income |
|
Directors |
|
Total |
|
|
|
Balance at June 30, 2002 |
|
$ |
2,650 |
|
|
|
10,398,658 |
|
|
$ |
104,832 |
|
|
$ |
97,141,424 |
|
|
|
84,528 |
|
|
$ |
(1,277,613 |
) |
|
$ |
(84,939,213 |
) |
|
$ |
656,237 |
|
|
$ |
(217,697 |
) |
|
$ |
11,470,620 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(17,348,686 |
) |
|
|
|
|
|
|
|
|
|
|
(17,348,686 |
) |
Foreign currency translation
adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,843,383 |
|
|
|
|
|
|
|
1,843,383 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(15,505,303 |
) |
Retirement of treasury shares at
cost |
|
|
|
|
|
|
|
|
|
|
(845 |
) |
|
|
(1,276,768 |
) |
|
|
(84,528 |
) |
|
|
1,277,613 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Private placement of common stock,
net |
|
|
|
|
|
|
1,060,978 |
|
|
|
10,610 |
|
|
|
2,724,914 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,735,524 |
|
Beneficial conversion on convertible
debentures |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,539,622 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,539,622 |
|
Value of detachable warrants issued
with convertible debentures |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,086,026 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,086,026 |
|
Conversion of convertible debentures
into common stock |
|
|
|
|
|
|
8,977,223 |
|
|
|
89,772 |
|
|
|
7,501,472 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,591,244 |
|
Exercise of debt and equity offering
warrants |
|
|
|
|
|
|
4,498,253 |
|
|
|
44,983 |
|
|
|
2,239,768 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,284,751 |
|
Shares of common stock issued upon
closing of convertible debentures |
|
|
|
|
|
|
745,210 |
|
|
|
7,452 |
|
|
|
291,330 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
298,782 |
|
Compensation expense on stock options
and warrants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
170 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
170 |
|
Consulting fees paid with common stock |
|
|
|
|
|
|
80,000 |
|
|
|
800 |
|
|
|
109,198 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
109,998 |
|
Change in minority interest ownership in
Viragen International |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,212,348 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,212,348 |
) |
Shares of common stock issued to
certain officers and directors in lieu
of salaries and fees |
|
|
|
|
|
|
98,344 |
|
|
|
983 |
|
|
|
105,092 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
106,075 |
|
Collections on promissory notes for
common stock exercises |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
108,299 |
|
|
|
108,299 |
|
Accrued interest income on directors
notes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,993 |
) |
|
|
(3,993 |
) |
Reclassification of note from former
director |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
113,391 |
|
|
|
113,391 |
|
Dividend on Series A preferred
stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,650 |
) |
|
|
|
|
|
|
|
|
|
|
(2,650 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2003 |
|
$ |
2,650 |
|
|
|
25,858,666 |
|
|
$ |
258,587 |
|
|
$ |
115,249,900 |
|
|
|
|
|
|
$ |
|
|
|
$ |
(102,290,549 |
) |
|
$ |
2,499,620 |
|
|
$ |
|
|
|
$ |
15,720,208 |
|
|
|
|
See notes to consolidated financial statements which are an integral part of these statements.
F-7
VIRAGEN, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Preferred |
|
|
|
|
|
|
|
|
|
Capital |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other |
|
Notes |
|
|
|
|
Stock, |
|
Common Stock |
|
in Excess |
|
Treasury Stock |
|
Accumulated |
|
Comprehensive |
|
Due From |
|
|
|
|
Series A |
|
Shares |
|
Amount |
|
of Par Value |
|
Shares |
|
Amount |
|
Deficit |
|
Income |
|
Directors |
|
Total |
|
|
|
Balance at June 30, 2003 |
|
$ |
2,650 |
|
|
|
25,858,666 |
|
|
$ |
258,587 |
|
|
$ |
115,249,900 |
|
|
|
|
|
|
$ |
|
|
|
$ |
(102,290,549 |
) |
|
$ |
2,499,620 |
|
|
$ |
|
|
|
$ |
15,720,208 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(18,177,164 |
) |
|
|
|
|
|
|
|
|
|
|
(18,177,164 |
) |
Foreign currency translation
adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,208,506 |
|
|
|
|
|
|
|
1,208,506 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(16,968,658 |
) |
Repurchase of Series A preferred
stock |
|
|
(400 |
) |
|
|
|
|
|
|
|
|
|
|
(2,100 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,500 |
) |
Private placement of common stock,
net |
|
|
|
|
|
|
4,546,696 |
|
|
|
45,467 |
|
|
|
8,869,683 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,915,150 |
|
Beneficial conversion on convertible
notes and debentures |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,362,420 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,362,420 |
|
Value of detachable warrants issued
with convertible notes and
debentures |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,246,916 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,246,916 |
|
Conversion of convertible debentures
into common stock |
|
|
|
|
|
|
3,667,055 |
|
|
|
36,671 |
|
|
|
7,227,365 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,264,036 |
|
Exercise of debt and equity offering
warrants |
|
|
|
|
|
|
2,439,308 |
|
|
|
24,393 |
|
|
|
3,758,639 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,783,032 |
|
Exercise of compensatory common stock
options and warrants |
|
|
|
|
|
|
18,000 |
|
|
|
180 |
|
|
|
19,620 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
19,800 |
|
Compensation expense on stock options
and warrants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,338 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,338 |
|
Consulting fees paid with common stock |
|
|
|
|
|
|
49,670 |
|
|
|
497 |
|
|
|
126,043 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
126,540 |
|
Change in minority interest ownership in
Viragen International |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
508,301 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(754,052 |
) |
|
|
|
|
|
|
(245,751 |
) |
Shares of common stock issued to
certain officers and directors in lieu
of salaries and fees |
|
|
|
|
|
|
18,429 |
|
|
|
184 |
|
|
|
38,016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
38,200 |
|
Cancellation of shares in partial
settlement of notes
receivable |
|
|
|
|
|
|
(31,000 |
) |
|
|
(310 |
) |
|
|
(80,290 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(80,600 |
) |
Shares issued for fractional interests
in connection with reverse stock
split |
|
|
|
|
|
|
1,561 |
|
|
|
16 |
|
|
|
(16 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividend on Series A preferred
stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,550 |
) |
|
|
|
|
|
|
|
|
|
|
(2,550 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2004 |
|
$ |
2,250 |
|
|
|
36,568,385 |
|
|
$ |
365,685 |
|
|
$ |
146,337,835 |
|
|
|
|
|
|
$ |
|
|
|
$ |
(120,470,263 |
) |
|
$ |
2,954,074 |
|
|
$ |
|
|
|
$ |
29,189,581 |
|
|
|
|
See notes to consolidated financial statements which are an integral part of these statements.
F-8
VIRAGEN, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Preferred |
|
|
|
|
|
|
|
|
|
Capital |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other |
|
Notes |
|
|
|
|
Stock, |
|
Common Stock |
|
in Excess |
|
Treasury Stock |
|
Accumulated |
|
Comprehensive |
|
Due From |
|
|
|
|
Series A |
|
Shares |
|
Amount |
|
of Par Value |
|
Shares |
|
Amount |
|
Deficit |
|
Income |
|
Directors |
|
Total |
|
|
|
Balance at June 30, 2004 |
|
$ |
2,250 |
|
|
|
36,568,385 |
|
|
$ |
365,685 |
|
|
$ |
146,337,835 |
|
|
|
|
|
|
$ |
|
|
|
$ |
(120,470,263 |
) |
|
$ |
2,954,074 |
|
|
$ |
|
|
|
$ |
29,189,581 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(26,207,706 |
) |
|
|
|
|
|
|
|
|
|
|
(26,207,706 |
) |
Foreign currency translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(518,364 |
) |
|
|
|
|
|
|
(518,364 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(26,726,070 |
) |
Repurchase of Series A preferred stock |
|
|
(100 |
) |
|
|
|
|
|
|
|
|
|
|
(500 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(600 |
) |
Shares issued as payment of interest on
convertible notes |
|
|
|
|
|
|
519,292 |
|
|
|
5,192 |
|
|
|
344,808 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
350,000 |
|
Change in minority interest ownership in
Viragen International |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(101,676 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(115,468 |
) |
|
|
|
|
|
|
(217,144 |
) |
Dividend on Series A preferred stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,150 |
) |
|
|
|
|
|
|
|
|
|
|
(2,150 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2005 |
|
$ |
2,150 |
|
|
|
37,087,677 |
|
|
$ |
370,877 |
|
|
$ |
146,580,467 |
|
|
|
|
|
|
$ |
|
|
|
$ |
(146,680,119 |
) |
|
$ |
2,320,242 |
|
|
$ |
|
|
|
$ |
2,593,617 |
|
|
|
|
See notes to consolidated financial statements which are an integral part of these statements.
F-9
VIRAGEN, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June 30, |
|
|
2005 |
|
2004 |
|
2003 |
|
|
|
OPERATING ACTIVITIES |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(26,207,706 |
) |
|
$ |
(18,177,164 |
) |
|
$ |
(17,348,686 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
970,492 |
|
|
|
867,824 |
|
|
|
843,883 |
|
Amortization of intangible assets |
|
|
168,944 |
|
|
|
158,270 |
|
|
|
183,534 |
|
Inventory write-down |
|
|
720,450 |
|
|
|
|
|
|
|
|
|
Impairment of goodwill |
|
|
6,936,215 |
|
|
|
|
|
|
|
|
|
Loss on disposition of property, plant and equipment |
|
|
|
|
|
|
126,165 |
|
|
|
8,578 |
|
Net unrealized gain on foreign exchange remeasurement |
|
|
(9,177 |
) |
|
|
|
|
|
|
|
|
Gain on remeasurement of subsidiary intercompany liability |
|
|
(595,776 |
) |
|
|
|
|
|
|
|
|
Fees paid with shares of common stock |
|
|
60,000 |
|
|
|
98,200 |
|
|
|
193,369 |
|
Compensation expense on common stock options and warrants |
|
|
|
|
|
|
13,338 |
|
|
|
170 |
|
Minority interest in loss of subsidiary |
|
|
(1,620,239 |
) |
|
|
(1,438,924 |
) |
|
|
(1,461,694 |
) |
Amortization of discounts on convertible notes and debentures |
|
|
3,614,075 |
|
|
|
6,268,192 |
|
|
|
7,070,072 |
|
Amortization of deferred financing costs |
|
|
549,604 |
|
|
|
474,033 |
|
|
|
627,485 |
|
Interest paid with shares of common stock |
|
|
350,000 |
|
|
|
|
|
|
|
|
|
Deferred income tax benefit |
|
|
(43,828 |
) |
|
|
(43,828 |
) |
|
|
(60,686 |
) |
Reserve for notes receivable |
|
|
|
|
|
|
57,923 |
|
|
|
47,000 |
|
Increase (decrease) relating to operating activities from: |
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(7,562 |
) |
|
|
73,546 |
|
|
|
244,631 |
|
Inventories |
|
|
407,251 |
|
|
|
(165,631 |
) |
|
|
(1,445,015 |
) |
Prepaid expenses |
|
|
946,673 |
|
|
|
(474,716 |
) |
|
|
196,438 |
|
Other current assets |
|
|
(42,592 |
) |
|
|
(139,375 |
) |
|
|
886,901 |
|
Accounts payable |
|
|
(62,935 |
) |
|
|
(852,516 |
) |
|
|
81,955 |
|
Accrued expenses and other liabilities |
|
|
(296,571 |
) |
|
|
172,369 |
|
|
|
(87,330 |
) |
Other |
|
|
(953 |
) |
|
|
70,400 |
|
|
|
2,786 |
|
|
|
|
Net cash used in operating activities |
|
|
(14,163,635 |
) |
|
|
(12,911,894 |
) |
|
|
(10,016,609 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of short-term investments |
|
|
(5,519,700 |
) |
|
|
|
|
|
|
|
|
Maturities of short-term investments |
|
|
5,593,350 |
|
|
|
|
|
|
|
|
|
Additions to property, plant and equipment |
|
|
(234,677 |
) |
|
|
(1,453,366 |
) |
|
|
(359,418 |
) |
Proceeds from sale of property, plant and equipment |
|
|
24,738 |
|
|
|
35,783 |
|
|
|
|
|
Contribution received for capital investment in Sweden |
|
|
278,005 |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
141,716 |
|
|
|
(1,417,583 |
) |
|
|
(359,418 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
FINANCING ACTIVITIES |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of convertible notes and debentures, net |
|
|
|
|
|
|
18,956,611 |
|
|
|
11,895,187 |
|
Proceeds from private placements of common stock, net |
|
|
|
|
|
|
8,915,150 |
|
|
|
2,735,524 |
|
Proceeds from exercise of debt and equity offering warrants |
|
|
|
|
|
|
3,783,032 |
|
|
|
2,284,751 |
|
Net payments on lines of credit and short term borrowings |
|
|
(1,048,689 |
) |
|
|
(554,572 |
) |
|
|
(449,998 |
) |
Payments on convertible debentures |
|
|
|
|
|
|
(65,316 |
) |
|
|
(1,111,113 |
) |
Payments on long-term debt |
|
|
(587,791 |
) |
|
|
(35,032 |
) |
|
|
(36,369 |
) |
Collections on promissory notes received upon exercise of compensatory
common stock options |
|
|
|
|
|
|
|
|
|
|
100,000 |
|
Repurchase of preferred stock shares, Series A |
|
|
(1,000 |
) |
|
|
(4,000 |
) |
|
|
|
|
Repurchase of shares by subsidiary |
|
|
|
|
|
|
(48,400 |
) |
|
|
|
|
Proceeds from exercise of compensatory common stock options and warrants |
|
|
|
|
|
|
19,800 |
|
|
|
|
|
|
|
|
Net cash (used in) provided by financing activities |
|
|
(1,637,480 |
) |
|
|
30,967,273 |
|
|
|
15,417,982 |
|
Effect of exchange rate fluctuations on cash |
|
|
(208,335 |
) |
|
|
172,974 |
|
|
|
134,685 |
|
|
|
|
(Decrease) increase in cash and cash equivalents |
|
|
(15,867,734 |
) |
|
|
16,810,770 |
|
|
|
5,176,640 |
|
Cash and cash equivalents at beginning of year |
|
|
22,753,271 |
|
|
|
5,942,501 |
|
|
|
765,861 |
|
|
|
|
Cash and cash equivalents at end of year |
|
$ |
6,885,537 |
|
|
$ |
22,753,271 |
|
|
$ |
5,942,501 |
|
|
|
|
See notes to consolidated financial statements which are an integral part of these statements.
F-10
VIRAGEN, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS (Continued)
Supplemental Cash Flow Information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June 30, |
|
|
2005 |
|
2004 |
|
2003 |
|
|
|
Interest paid |
|
$ |
1,141,296 |
|
|
$ |
643,995 |
|
|
$ |
265,408 |
|
During the years ended June 30, 2005, 2004 and 2003, Viragen had the following non-cash
investing and financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June 30, |
|
|
2005 |
|
2004 |
|
2003 |
|
|
|
Purchase of insurance with notes payable |
|
$ |
224,245 |
|
|
$ |
571,316 |
|
|
$ |
30,886 |
|
Contribution of intercompany balances as capital to Viragen International |
|
|
(101,676 |
) |
|
|
|
|
|
|
(692,528 |
) |
Prepaid expense paid with common stock |
|
|
|
|
|
|
120,000 |
|
|
|
25,998 |
|
Conversion of convertible debentures and accrued interest into common
stock |
|
|
350,000 |
|
|
|
7,264,036 |
|
|
|
7,591,244 |
|
See notes to consolidated financial statements which are an integral part of these statements.
F-11
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE A
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Business and Organization: We are a biopharmaceutical company engaged in the research,
development, manufacture and commercialization of pharmaceutical proteins for the treatment of
viral and malignant diseases. Our product portfolio includes: Multiferon® (multiple-subtype,
natural human alpha interferon) targeting a broad range of infectious and malignant diseases; and
humanized monoclonal antibodies targeting specific antigens over-expressed on many types of cancers
in humans. We are also pioneering the development of Avian Transgenic Technology, with the Roslin
Institute, as a revolutionary manufacturing platform for the large-scale, efficient and economical
production of therapeutic proteins and antibodies.
We own approximately 81.2% of Viragen International, Inc. We operate primarily through
Viragen International Inc., and its wholly owned subsidiaries, ViraNative AB (ViraNative), a
company located in Umea, Sweden, and Viragen (Scotland) Limited (Viragen (Scotland)), a company
located near Edinburgh, Scotland. ViraNative and Viragen (Scotland) house our manufacturing and
research laboratory facilities.
On June 15, 2004, Viragen effected a one for ten reverse split of our common stock. All share
and per share information herein has been restated to retroactively reflect this reverse stock
split.
Consolidation and Basis of Presentation: The consolidated financial statements include
Viragen, Inc., Viragen International, Inc. and all subsidiaries, including those operating outside
the United States of America. All significant intercompany balances and transactions have been
eliminated. The consolidated financial statements have been prepared in conformity with accounting
principles generally accepted in the United States of America, which contemplate continuation of
the Company as a going concern.
Minority
interest in net loss of subsidiary, which is shown in our consolidated statement of operations,
represents the minority stockholders share of the net loss of Viragen International. During fiscal
2005, stockholders equity of Viragen International decreased to a deficit position. Because the
minority stockholders are not required to fund the deficit, we ceased attributing a portion of
Viragen Internationals losses to the minority stockholders at that time. Since then, Viragen has
absorbed 100% of Viragen Internationals losses and will continue to do so until Viragen
International has positive stockholders equity.
During the years ended June 30, 2005, 2004 and 2003, we incurred significant losses of
approximately $26.2 million, $18.2 million and $17.3 million, respectively, and had an accumulated
deficit of approximately $146.7 million as of June 30, 2005. Additionally, we had a cash balance of
approximately $6.9 million and a working capital deficit of approximately $7.3 million at June 30,
2005. We anticipate additional future losses as we commercialize our natural human alpha interferon
product and conduct additional research activities and clinical trials to obtain additional
regulatory approvals. We believe we have enough cash to support operations through at least
December 31, 2005. However, we will require substantial additional funding to support our
operations subsequent to December 31, 2005. As we do not anticipate achieving sufficient cash flows
from operations by December 31, 2005, our plans include obtaining additional capital through equity
and debt financings. No assurance can be given that additional capital will be available when
required or upon terms acceptable to us. Our inability to generate substantial revenue or obtain
additional capital through equity or debt financings, would have a material adverse effect on our
financial condition and our ability to continue operations.
These factors, among others, raise substantial doubt about the Companys ability to continue
as a going concern. The accompanying consolidated financial statements do not include any
adjustments relating to the recoverability and classification of asset carrying amounts or the
amount and classification of liabilities that might result from the outcome of these uncertainties.
F-12
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE A
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
Use of Estimates: The preparation of financial statements in accordance with accounting
principles generally accepted in the United States requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities at the date of the financial
statements and the reported amounts of income and expenses during the reporting periods. The
accounting estimates that require managements most difficult and subjective judgments include: the
assessment of recoverability of goodwill and long-lived assets; and the valuation of inventories.
Actual results could differ from those estimates.
Concentrations of Credit Risk: We are subject to a concentration of credit risk with respect
to our accounts receivable. We sell our natural interferon product to manufacturers and
distributors located outside the United States. Credit terms to our customers generally range from
30 to 180 days. We evaluate and monitor the credit worthiness of each customer on a case-by-case
basis. Allowances are maintained, if necessary, for potential credit losses.
Foreign Currency Translation and Transactions: For our operations in Scotland and Sweden,
local currencies are considered their functional currencies. For financial reporting purposes, we
translate the assets and liabilities of these operations to their U.S. dollar equivalents at rates
in effect at the balance sheet date. Intercompany accounts that are considered long-term in
nature are translated to U.S. dollars at historical rates. We translate statement of operations
accounts at average rates for the period. The resulting unrealized foreign currency translation
gains and losses are included in accumulated other comprehensive income in the equity section of
our balance sheet. Intercompany trading accounts, which are short-term in nature, are remeasured
at current exchange rates as of the balance sheet date and any gains or losses are recorded in
interest and other income. During the fiscal year ended June 30, 2005, we recorded a $596,000 gain
on the remeasurement of a liability to Viragen, Inc. by Viragen (Scotland), which was denominated
in U.S. dollars. See Note H for further discussion. This liability, which is now denominated in UK
Pound Sterling is considered short-term in nature. Subsequent to the recording of the gain, we
recognized a net remeasurement loss on this liability of approximately $34,000 during the fiscal
year ended June 30, 2005.
While most of the transactions of our U.S. and foreign operations are denominated in the
respective local currency, some transactions are denominated in other currencies. Transactions
denominated in other currencies are accounted for in the respective local currency at the time of
the transaction. Upon settlement of this type of transaction, any foreign currency gains or losses
are recorded in interest and other income. For fiscal years 2005, 2004 and 2003, foreign currency
transaction gains and losses were immaterial to our results of operations.
Fair Value of Financial Instruments: The carrying value of financial instruments, including
cash and cash equivalents, accounts receivable, and accounts payable approximate fair value as of
June 30, 2005, due to their short-term nature. The carrying value of long-term debt approximates
fair value as of June 30, 2005, due to the variable interest rates on those instruments.
Cash and Cash Equivalents: Cash equivalents include demand deposits, money market funds,
certificates of deposit and time deposits with maturity periods of three months or less when
purchased.
Short-Term Investments: We invest excess cash in highly liquid instruments with maturities of
less than twelve months as of the date of purchase. During fiscal 2005, we invested a portion of
our cash in UK Pound Sterling denominated certificates of deposit, which matured prior to June 30,
2005. For the year ended June 30, 2005, we recognized a net foreign currency remeasurement gain of
approximately $74,000 related to our short-term investments.
Accounts Receivable: Accounts receivable primarily consists of amounts due from the sale of
our natural human alpha interferon product by our Swedish subsidiary. As of June 30, 2005 and
2004, there was no allowance for doubtful accounts and no allowance for returns.
F-13
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE A
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
Inventories: Inventories consist of raw materials and supplies, work in process, and finished
product. Finished product consists of purified natural human alpha interferon that is available
for sale. Included in work in process is approximately $643,000 of inventory that has been filled
in ampoules, but that is pending final release by regulatory authorities, which is expected in the
first quarter of fiscal 2006. Costs of raw materials and supplies are determined on a first-in,
first-out basis. Costs of work in process and finished product, consisting of raw materials, labor
and overhead are recorded at a standard cost (which approximates actual cost). Excess/idle capacity
costs represent fixed production costs incurred at our Swedish manufacturing facilities, which were
not absorbed as a result of the production of inventory at less than normal operating levels.
Excess/idle capacity costs are expensed in the period in which they are incurred and are included
in cost of sales.
Our inventories are stated at the lower of cost or market (estimated net realizable value). If
the cost of the inventories exceeds their expected market value, provisions are recorded currently
for the difference between the cost and the market value. These provisions are determined based on
estimates. The valuation of our inventories also requires us to estimate excess inventories and
inventories that are not saleable. The determination of excess or non-saleable inventories
requires us to estimate the future demand for our product and consider the shelf life of the
inventory. If actual demand is less than our estimated demand, we could be required to record
inventory write-downs, which would have an adverse impact on our results of operations. During the
year ended June 30, 2005 we recorded write-downs of our finished product inventory totaling
approximately $720,000. Subsequent to June 30, 2005 a freezer at our facility in Sweden
malfunctioned causing the temperature of certain work in process to rise above the approved levels
for frozen product. We will be unable to utilize this inventory for commercial use and a
write-down of approximately $560,000, net of insurance recovery, if any, will be recorded in the
first quarter of fiscal 2006.
Inventories consisted of the following at June 30, 2005 and 2004:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
2005 |
|
|
2004 |
|
Finished product |
|
$ |
19,234 |
|
|
$ |
1,038,944 |
|
Work in process |
|
|
2,031,981 |
|
|
|
2,176,116 |
|
Raw materials and supplies |
|
|
298,298 |
|
|
|
262,154 |
|
|
|
|
|
|
|
|
Total inventories |
|
$ |
2,349,513 |
|
|
$ |
3,477,214 |
|
|
|
|
|
|
|
|
Certain raw materials used in the manufacture of our natural human alpha interferon product,
including human white blood cells, are only available from a limited number of suppliers. We are
dependent on our suppliers to allocate a sufficient portion of their capacity to meet our needs.
Other Current Assets: Other current assets consisted of the following at June 30, 2005 and 2004:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
2005 |
|
|
2004 |
|
Deferred financing costs |
|
$ |
591,780 |
|
|
$ |
549,380 |
|
VAT tax refund receivable |
|
|
114,506 |
|
|
|
197,384 |
|
Grant receivable |
|
|
121,824 |
|
|
|
|
|
Licensing fee |
|
|
|
|
|
|
250,000 |
|
Other current assets |
|
|
4,500 |
|
|
|
25,592 |
|
|
|
|
|
|
|
|
|
|
$ |
832,610 |
|
|
$ |
1,022,356 |
|
|
|
|
|
|
|
|
F-14
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE A
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
Property, Plant and Equipment: Property, plant and equipment is stated at the lower of cost
or net realizable value. Depreciation and amortization is computed using the straight-line method
over the estimated useful life of the assets for financial reporting purposes and using accelerated
methods for income tax purposes. Maintenance and repair costs are charged to operations as
incurred. The estimated useful lives used for financial reporting purposes are:
|
|
|
Building and leasehold improvement
|
|
Shorter of lease term or 25 years |
Equipment and furniture
|
|
3-10 years |
Goodwill: In accordance with Statement of Financial Accounting Standards (SFAS) No. 142,
Goodwill and Other Intangible Assets, goodwill is not amortized but is reviewed for impairment on
an annual basis or sooner if indicators of impairment arise. Management has selected April
1st as the date of our annual impairment review. All of our goodwill arose from the
acquisition of ViraNative on September 28, 2001 and the subsequent achievement of certain
milestones defined in the acquisition agreement. We periodically evaluate that acquired business
for potential impairment indicators. Our judgments regarding the existence of impairment indicators
are based on legal factors, market conditions, and the operational performance of the acquired
business. See Note B for goodwill impairment discussion. Changes in the estimates used to conduct
the impairment review, including revenue projections or market values, could cause our analysis to
indicate that our goodwill is further impaired in subsequent periods and result in a write-off of a
portion or all of our goodwill.
Intangible Assets: Intangible assets consist of separately identified intangible assets
recognized in connection with the acquisition of ViraNative on September 28, 2001. In accordance
with SFAS No. 142, intangible assets with definite useful lives are amortized over their useful
lives. Amortization of intangible assets is computed using the straight-line method over the
estimated useful life of the asset.
Impairment of Long-Lived Assets: In accordance with SFAS No. 144, Accounting for the
Impairment or Disposal of Long-Lived Assets, we review our long-lived assets, including intangible
assets, for impairment whenever events or changes in circumstances indicate that the carrying
amount of these assets may not be fully recoverable. The assessment of possible impairment is based
on our ability to recover the carrying value of our asset based on our estimate of its undiscounted
future cash flows. If these estimated future cash flows are less than the carrying value of the
asset, an impairment charge is recognized for the difference between the assets estimated fair
value and its carrying value. As of the date of these financial statements, we are not aware of
any items or events that would cause us to adjust the recorded value of our long-lived assets,
including intangible assets, for impairment.
Accrued Expenses and Other Liabilities: Accrued expenses and other liabilities consisted of
the following at June 30, 2005 and 2004:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
2005 |
|
|
2004 |
|
Accrued payroll and related expenses |
|
$ |
459,786 |
|
|
$ |
537,433 |
|
Accrued professional service fees |
|
|
364,750 |
|
|
|
228,483 |
|
Accrued rent expense |
|
|
64,736 |
|
|
|
103,016 |
|
Accrued royalties |
|
|
31,501 |
|
|
|
66,426 |
|
Licensing fee |
|
|
|
|
|
|
250,000 |
|
Other accrued expenses |
|
|
195,864 |
|
|
|
226,100 |
|
|
|
|
|
|
|
|
|
|
$ |
1,116,637 |
|
|
$ |
1,411,458 |
|
|
|
|
|
|
|
|
F-15
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE A
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
Convertible Debt Issued with Stock Purchase Warrants: Viragen accounts for convertible debt
issued with stock purchase warrants in accordance with APB No. 14, Accounting for Convertible Debt
and Debt Issued with Stock Purchase Warrants, EITF No. 98-5, Accounting for Convertible Securities
with Beneficial Conversion Features or Contingently Adjustable Conversion Ratios, and EITF No.
00-27, Application of Issue No. 98-5 to Certain Convertible Instruments.
Sale of Stock by Subsidiaries: Viragen accounts for sales of stock by its subsidiaries as
capital transactions for financial reporting purposes.
Revenue: We recognize revenue from sales of our natural human alpha interferon product when
title and risk of loss has been transferred, which is generally upon shipment. Moreover,
recognition requires persuasive evidence that an arrangement exists, the price is fixed and
determinable, and collectibility is reasonably assured.
Advertising: Advertising costs are charged to expense as incurred. Advertising expenses for
fiscal years 2005, 2004 and 2003 were immaterial to our results of operations.
Research and Development Costs: We account for research and development costs in accordance
with SFAS No. 2, Accounting for Research and Development Costs. Accordingly, all research and
development costs are expensed as incurred.
Stock-Based Compensation: As currently permitted under Statement of Financial Accounting
Standards (SFAS) No. 148, Accounting for Stock-Based CompensationTransition and Disclosure, which
amended SFAS No. 123, Accounting for Stock-Based Compensation, we account for our employee
stock-based compensation arrangements under the provisions of Accounting Principles Board Opinion
No. 25 (APB No. 25), Accounting for Stock Issued to Employees, and related interpretations. Under
APB No. 25, compensation expense for stock option grants is currently recognized if the exercise
price is less than the fair value of our common stock on the grant date. Since the exercise price
of the Companys employee and director stock options granted during fiscal 2003 through 2005 were
equal to the market price of the underlying stock on the date of grant, no compensation expense was
recognized. See Note M for recent accounting pronouncement.
Pro forma information regarding net loss and loss per share is required by SFAS No. 123 and
SFAS No. 148, and has been determined as if we had accounted for our employee and director
stock-based compensation under the fair value method of those statements. The fair value for
employee and director stock-based compensation, which consists of stock options, was estimated at
the date of grant using a Black-Scholes option pricing model with the following weighted-average
assumptions: dividend yield of zero percent for all periods; expected life of the stock option
within a range of 3 to 10 years; risk-free interest rates within a range of 2.04% to 3.50%; and a
volatility factor of the expected market price of Viragens common stock of 1.15, 1.07 and 0.90 for
fiscal 2005, 2004 and 2003, respectively. The weighted average grant date fair value of stock
options granted in fiscal 2005, 2004 and 2003 was $ 0.59, $1.38 and $1.20, respectively. For stock
options subject to vesting, pro forma expense is recognized on a straight-line basis over the
vesting period.
Viragen International currently accounts for their stock options in the same manner in which
Viragen does. The pro forma information regarding net loss and loss per share includes Viragen
Internationals stock-based compensation and has been determined as if Viragen International had
accounted for its employee and director stock-based compensation under the fair value method of
those statements. Viragen International has granted stock options to its employees and directors.
The fair value of Viragen Internationals stock options was estimated at the date of grant using a
Black-Scholes option pricing model with the following weighted-average assumptions: dividend yield
of zero percent for 2004 and 2003; risk-free interest rates of 2.00% for 2004 and 2.17% for 2003;
volatility factor of the expected market price of their common stock of 1.02 for 2004 and 0.90 for
2003; and an expected life of the stock option of three years. The weighted average grant date fair
value of stock options granted in fiscal 2004 and 2003 was $0.22 and $0.14, respectively. There
were no stock option grants during fiscal 2005.
F-16
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE A
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
The following table illustrates the effect on net loss and net loss per common share if we had
applied the fair value method to measure stock-based compensation:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year Ended June 30, |
|
|
|
2005 |
|
|
2004 |
|
|
2003 |
|
Net loss as reported |
|
$ |
(26,207,706 |
) |
|
$ |
(18,177,164 |
) |
|
$ |
(17,348,686 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation
determined under the fair
value method |
|
|
(88,654 |
) |
|
|
(151,225 |
) |
|
|
(397,172 |
) |
|
|
|
|
|
|
|
|
|
|
Pro forma net loss |
|
|
(26,296,360 |
) |
|
|
(18,328,389 |
) |
|
|
(17,745,858 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred dividends, Series A |
|
|
(2,150 |
) |
|
|
(2,550 |
) |
|
|
(2,650 |
) |
|
|
|
|
|
|
|
|
|
|
Pro forma net loss
attributable to common stock |
|
$ |
(26,298,510 |
) |
|
$ |
(18,330,939 |
) |
|
$ |
(17,748,508 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per common share after
deduction of required
dividends on convertible
preferred stock: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted as reported |
|
$ |
(0.71 |
) |
|
$ |
(0.55 |
) |
|
$ |
(1.21 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted pro forma |
|
$ |
(0.72 |
) |
|
$ |
(0.55 |
) |
|
$ |
(1.23 |
) |
The effects of applying SFAS No. 123 and SFAS No. 148 on pro forma disclosures of net
loss and net loss per common share for fiscal years 2005, 2004 and 2003, are not likely to be
representative of the net loss and net loss per common share in future years. Specifically, the
amount of stock-based compensation, including the number of stock options that may be issued under
our stock option plans, and the terms of future stock-based compensation, are not known at this
time. In addition, the assumptions used to determine the fair value of stock options can vary
significantly.
We account for our stock-based compensation arrangements with consultants under the provisions
of SFAS No. 123 and related guidance, including EITF No. 96-18, Accounting for Equity Instruments
That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling Goods or
Services.
Income Taxes: Deferred income taxes at the end of each period are determined by applying
enacted tax rates applicable to future periods in which the taxes are expected to be paid or
recovered to differences between financial accounting and tax basis of assets and liabilities.
Loss Per Common Share: Loss per common share has been computed based on the weighted average
number of shares outstanding during each period, in accordance with SFAS No. 128, Earnings per
Share. The effect of outstanding stock options, stock purchase warrants and convertible debt and
equity securities totaling 21,883,804, 22,048,523 and 7,836,653 shares of common stock at June 30,
2005, 2004 and 2003, respectively, is antidilutive. As a result, diluted loss per share data does
not include the assumed exercise of outstanding stock options, stock purchase warrants or
conversion of convertible debt and equity securities and has been presented jointly with basic loss
per share. Loss attributable to common stock reflects adjustments for preferred dividends.
Comprehensive Loss: SFAS No. 130, Reporting Comprehensive Income, establishes standards for
reporting and display of comprehensive income or loss and its components in financial statements.
As reflected in our consolidated statements of stockholders equity, our comprehensive loss is a
measure of net loss and all other changes in equity that result from transactions other than with
stockholders. Our comprehensive loss consists of net loss and foreign currency translation
adjustments.
F-17
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE B
GOODWILL AND OTHER INTANGIBLE ASSETS
On September 28, 2001, Viragen International, Inc., our majority owned subsidiary, acquired
all of the outstanding shares of BioNative AB (BioNative), a privately held biotechnology company
located in Umeå, Sweden. Subsequent to the acquisition, BioNative was renamed ViraNative. The
initial purchase consideration consisted of 2,933,190 shares of Viragen International common stock.
In January 2002, ViraNative achieved two milestones defined in the acquisition agreement. As a
result, the former shareholders of ViraNative were issued an additional 8,799,570 shares of Viragen
International common stock.
The goodwill reported in our balance sheets as of June 30, 2005 and 2004 arose from Viragen
Internationals acquisition of ViraNative on September 28, 2001 and the subsequent achievement of
certain milestones. Subsequent to the initial recording of goodwill at an aggregate amount of
approximately $7.6 million, the carrying amount has increased as a result of foreign currency
fluctuations between the U.S. dollar and the Swedish Krona. The following table reflects the
changes in the carrying amount of goodwill for the fiscal years ended June 30, 2005 and 2004:
|
|
|
|
|
Balance as of June 30, 2003 |
|
$ |
9,678,302 |
|
Foreign exchange adjustment |
|
|
616,838 |
|
|
|
|
|
Balance as of June 30, 2004 |
|
|
10,295,140 |
|
Foreign exchange adjustment |
|
|
294,234 |
|
Impairment charge |
|
|
(6,936,215 |
) |
|
|
|
|
Balance as of June 30, 2005 |
|
$ |
3,653,159 |
|
|
|
|
|
Due to a lack of significant revenues from our natural interferon product and a longer than
anticipated timeframe to receive regulatory approvals in certain markets, revenue and cash flows
for the ViraNative reporting unit were lower than expected in fiscal 2005. Primarily based on this
trend, the revenue projections for the next several years were revised downward. As a result of
these revised projections, the present value of the future estimated cash flows from the reporting
unit were significantly less than those estimated in prior periods. The fair value of the
ViraNative reporting unit was estimated using a combination of the present value of estimated
future cash flows, quoted market prices and market multiples from comparable businesses. After
evaluating the results of these valuation methods a goodwill impairment charge of approximately
$6.9 million was recognized in April 2005 on the ViraNative reporting unit.
The developed technology intangible asset reported in our balance sheets as of June 30, 2005
and 2004 arose from our acquisition of ViraNative on September 28, 2001. A detail of our developed
technology intangible asset as of June 30, 2005 and 2004 is as follows:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
2005 |
|
|
2004 |
|
Developed technology |
|
$ |
2,187,675 |
|
|
$ |
2,268,472 |
|
Accumulated amortization |
|
|
(579,090 |
) |
|
|
(440,350 |
) |
|
|
|
|
|
|
|
Developed technology, net |
|
$ |
1,608,585 |
|
|
$ |
1,828,122 |
|
|
|
|
|
|
|
|
Our developed technology consists of the production and purification methods developed by
ViraNative prior to the acquisition by Viragen International. This technology was complete and
ViraNative had been selling the resultant natural interferon product prior to the acquisition by
Viragen International. Developed technology was recorded at its estimated fair value at the date of
acquisition. Subsequent to the initial recording of this intangible asset at $1,650,000, the gross
carrying amount has increased as a result of foreign currency fluctuations between the U.S. dollar
and the Swedish Krona.
F-18
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE B
GOODWILL AND OTHER INTANGIBLE ASSETS (Continued)
Developed technology is being amortized over its estimated useful life of approximately 14
years. The 14-year life assigned to this asset was determined using a weighted average of the
remaining lives of the patents on the various components of the production and purification
processes.
Amortization expense recognized for the fiscal year ended June 30, 2005 was approximately
$169,000. Estimated amortization expense for the five succeeding fiscal years is as follows:
|
|
|
|
|
2006 |
|
$ |
159,000 |
|
2007 |
|
|
159,000 |
|
2008 |
|
|
159,000 |
|
2009 |
|
|
159,000 |
|
2010 |
|
|
159,000 |
|
NOTE C CONVERTIBLE NOTES AND DEBENTURES
A detail of our convertible notes and debentures at June 30, 2005 and 2004 is as follows:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
2005 |
|
|
2004 |
|
Outstanding principal |
|
$ |
20,000,000 |
|
|
$ |
20,000,000 |
|
Less discounts |
|
|
(3,895,006 |
) |
|
|
(7,509,081 |
) |
|
|
|
|
|
|
|
|
|
$ |
16,104,994 |
|
|
$ |
12,490,919 |
|
|
|
|
|
|
|
|
At June 30, 2005 and 2004, our convertible notes and debentures represent the outstanding
principal of the convertible notes issued on June 18, 2004 totaling $20 million.
June 2004 Convertible Notes
On April 1, 2004, we entered into purchase agreements for the issuance and sale of convertible
notes and common stock purchase warrants in the aggregate amount of $20 million. The notes were
placed with a group of new and returning institutional investors. The $20 million purchase price
for the notes and warrants was placed in escrow pending satisfaction of all conditions precedent to
closing, including receipt of stockholder approval for the sale of the notes and warrants, as well
as a one for ten reverse split of our common stock. On June 11, 2004 our stockholders voted to
approve the sale of the notes and a one for ten reverse split of our common stock. On June 18,
2004, we completed the sale of the notes and warrants. Under the terms of these agreements, we
received approximately $18.96 million, net of finders fees and legal expenses. These agreements
also provided for the issuance to the purchasers of an aggregate of 5,357,051 three-year common
stock purchase warrants initially exercisable at $1.819 per share. In connection with the April 1,
2004 purchase agreements, we paid a finders fee of 5% or $1 million and issued the finder 80,000
three-year common stock purchase warrants initially exercisable at a price of $1.516 per share.
F-19
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE C
CONVERTIBLE NOTES AND DEBENTURES (Continued)
The purchase agreements provided that we pay interest on the escrowed purchase price at the
rate of 10% per annum until the closing date. From April 1, 2004 through June 18, 2004, the total
amount of interest paid on the escrowed purchase price totaled approximately $428,000. Interest
payable on the convertible notes is payable in cash or shares of our common stock at our option.
The value of shares used to satisfy the interest payment equals the average closing price of our
common stock for the 20 trading days prior to the interest payment date. The amount of interest
paid in cash on the notes following the closing of this transaction through June 30, 2004 totaled
approximately $51,000. For the fiscal year ended June 30, 2005 we paid interest on the notes of
$1,050,000 in cash and $350,000 through the issuance of shares of our common stock valued at $0.67
per share.
These convertible notes mature on March 31, 2006. The notes are convertible immediately by the
investors, in whole or in part, into shares of our common stock at an initial conversion price
equal to $1.516. This conversion price is subject to reductions if we enter into additional
financing transactions for the sale of our stock below the public trading price and below the
conversion price. Resale of the shares issuable upon conversion or payment of the notes and upon
exercise of warrants are registered under our Form S-3 registration statement (File No. 333-117338)
filed with the Securities and Exchange Commission, which was declared effective on July 28, 2004.
These notes may be prepaid at 110% of their face amount, plus the issuance to note holders of
additional warrants to purchase the number of shares of our common stock into which the notes would
otherwise have been convertible, at an exercise price equal to the prevailing conversion price of
the notes. If issued on prepayment, the warrants may be exercised for the period that would have
been the remaining life of the notes had they not been prepaid. Commencing one year after issuance,
we also have the right to require note holders to convert their notes, subject to certain
limitations; provided that our common stock has traded at 200% or more of the conversion price of
the notes on each of the 30 trading days ending five days prior to the date fixed for conversion.
The warrants issued in connection with the notes are exercisable during the three year period
terminating June 18, 2007 and can be exercised on a cashless basis whereby the holder may surrender
a number of warrants equal to the exercise price of the warrants being exercised. The relative
fair value of these warrants was calculated to be approximately $3,264,000 using a Black-Scholes
valuation model. The relative fair value of these warrants was recorded as a discount on the
principal amount of the notes and is amortized to interest expense using the effective interest
rate method over the life of the notes. For the years ended June 30, 2005 and 2004, we recognized
approximately $1,545,000 and $54,000, respectively, as non-cash interest expense from the
amortization of the discount that arose from the issuance of the warrants.
As a result of the common stock purchase warrants issued in connection with the June 2004
notes and the calculated effective conversion price of the notes, a beneficial conversion amount of
approximately $4,372,000 was calculated and recorded as a discount on the principal amount of the
notes at the date of issuance. For the years ended June 30, 2005 and 2004, we recognized
approximately $2,069,000 and $73,000, respectively, as non-cash interest expense from the
amortization of the discount that arose from the beneficial conversion feature.
We incurred costs of approximately $1,161,000 in connection with the sale and issuance of
these notes and warrants, which primarily consisted of the finders fees, the fair value of
warrants issued to the finder, and legal and accounting expenses. These costs will be amortized to
interest expense over the life of the notes using the effective interest rate method. For the
years ended June 30, 2005 and 2004, we recognized approximately $550,000 and $19,000, respectively,
as interest expense from the amortization of these debt issuance costs.
As of June 30, 2005, the entire principal amount of these convertible notes of $20 million
remained outstanding.
F-20
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE C
CONVERTIBLE NOTES AND DEBENTURES (Continued)
June 2003 Convertible Debentures
On June 27, 2003, we entered into a securities purchase agreement with five unrelated
institutional investors. The securities purchase agreement provided for the purchase and sale of
our convertible debentures in the aggregate amount of approximately $5.55 million. Under the terms
of the agreement, Viragen received approximately $4.55 million, net of original issue discounts of
$661,333, and a 6.5% finders fee and legal expenses. This agreement also provided for the issuance
to the purchasers of an aggregate of 1,354,664 five-year common stock purchase warrants exercisable
at a price of $1.722 per share. In connection with the June 2003 securities purchase agreement, we
also issued the finder 19,571 five-year common stock purchase warrants exercisable at a price of
$1.722 per share.
These convertible debentures were to mature on September 1, 2005, and were payable, without
interest, in 24 equal payments of principal commencing September 1, 2003. In lieu of interest, the
debentures provided for an original issue discount equal to $661,333, the equivalent of 10%
interest over the two year life of the debenture. For the fiscal year ended June 30, 2004, we
recognized approximately $659,000 as interest expense from the amortization of the original issue
discount. As of December 31, 2003, this original issue discount had been fully amortized to
interest expense.
The warrants issued in connection with the June 2003 debentures are exercisable during the
five year period ending June 1, 2008 and can be exercised on a cashless basis whereby the holder
may surrender a number of warrants equal to the exercise price of the warrants being exercised.
The relative fair value of these warrants was initially calculated to be approximately $1,381,000
using a Black-Scholes valuation model. The relative fair value of these warrants was recorded as a
discount on the principal amount of the debentures and was amortized to interest expense using the
effective interest rate method over the life of the debentures. As a result of the revaluation of
these warrants (see Warrant Revaluation below), we recorded an additional discount on the principal
amount of the debentures totaling approximately $405,000. For the fiscal year ended June 30, 2004,
we recognized approximately $1,780,000 as non-cash interest expense from the amortization of the
discount that arose from the issuance of the warrants. As of December 31, 2003, the entire
discount resulting from the issuance of the warrants had been fully amortized to interest expense.
As a result of the common stock purchase warrants issued in connection with these debentures
and the calculated effective conversion price of the debentures, a beneficial conversion amount of
approximately $689,000 was initially calculated and recorded as a discount on the principal amount
of the debentures at the date of issuance. As a result of a subsequent financing transaction
entered into in September 2003, the conversion price of these debentures was reduced from $3.17 to
$2.24. Due to this reduction in the conversion price of these debentures, additional beneficial
conversion amount of approximately $1,382,000 was calculated and recorded as a discount on the
principal amount of the debentures. As a result of a subsequent financing transaction entered into
in December 2003, the conversion price of the outstanding debentures from $2.24 to $2.00. Due to
this reduction in the conversion price of the outstanding debentures, an additional beneficial
conversion amount of approximately $96,000 was calculated and recorded as a discount on the
principal amount of the debentures. As a result of the revaluation of the warrants issued in
connection with these debentures (see Warrant Revaluation below), an additional beneficial
conversion amount of $405,000 was calculated and recorded as a discount on the principal amount of
the debentures. For the fiscal year ended June 30, 2004, we recognized approximately $2,569,000 as
non-cash interest expense from the amortization of the discount that arose from the beneficial
conversion feature amount associated with these debentures. As of December 31, 2003, the entire
discount resulting from the beneficial conversion feature had been fully amortized to interest
expense.
We incurred costs of approximately $369,000 in connection with the sale and issuance of these
debentures and warrants, which primarily consisted of the finders fees, the fair value of warrants
issued to the finder, and legal and accounting expenses. These costs were amortized to interest
expense over the life of the debentures using the effective interest rate method. For the fiscal
year ended June 30, 2004, we recognized approximately $367,000 as interest expense from the
amortization of these debt issuance costs. As of December 31, 2003, these debt issuance costs had
been fully amortized to interest expense.
F-21
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE C
CONVERTIBLE NOTES AND DEBENTURES (Continued)
As of December 31, 2003, these convertible debentures had been satisfied and no further
amounts were due as the purchasers had converted approximately $5.5 million of principal resulting
in the issuance of approximately 2.34 million shares of our common stock and we repaid
approximately $65,000 of principal in cash. Warrants to purchase 315,305 shares of our common stock
issued in connection with this transaction remain unexercised as of June 30, 2005. On April 1,
2005 the exercise price of these warrants was reduced to $0.67 per share as a result of the
issuance of our common stock on April 1, 2005 in settlement of interest due on our June 2004
convertible notes.
Resale of the shares issuable upon conversion or payment of the debentures and upon exercise
of the warrants are registered under our Form S-3 registration statement (File No. 333-107176)
filed with the Securities and Exchange Commission, which was declared effective on August 1, 2003.
April 2003 Convertible Debentures, as Amended
On April 16, 2003, we entered into a securities purchase agreement with three unrelated
institutional investors. This agreement was amended on May 8, 2003 and May 16, 2003, to among other
things, include an additional unrelated institutional investor. The securities purchase agreement,
as amended, provided for the purchase and sale of our convertible debentures in the aggregate
amount of approximately $3.8 million. Under the terms of the agreement, we received approximately
$3.1 million, net of original issue discounts of $453,395, a 6.5% finders fee, and legal expenses.
This agreement also provided for the issuance to the purchasers of an aggregate of 3,171,200
three-year common stock purchase warrants exercisable at a price of $0.625 per share. In
connection with the April 2003 securities purchase agreement, we also issued the finder 13,408
three-year common stock purchase warrants exercisable at a price of $0.625 per share.
These convertible debentures were to mature on July 1, 2005, and were payable, without
interest, in 24 equal payments of principal commencing August 1, 2003. The debentures were
convertible immediately, in whole or in part, by the purchasers into shares of our common stock at
a conversion price equal to $2.00 per share. In lieu of interest, the debentures provided for an
original issue discount equal to $453,395, the equivalent of 10% interest over the two year life of
the debentures. For the fiscal year ended June 30, 2004, we recognized approximately $135,000 as
interest expense from the amortization of the original issue discount. As of September 30, 2003,
the entire original issue discount had been fully amortized to interest expense.
The warrants issued in connection with the April 16, 2003 securities purchase agreement and
the amendments dated May 8, 2003 and May 16, 2003, were exercisable during the three year period
ending April 2006. The relative fair value of these warrants was calculated to be approximately
$800,000 using a Black-Scholes valuation model. The relative fair value of the warrants was
recorded as a discount on the principal amount of the debentures and was amortized to interest
expense using the effective interest rate method over the life of the debentures. For the fiscal
year ended June 30, 2004, we recognized approximately $268,000 as non-cash interest expense from
the amortization of the discount that arose from the issuance of these warrants. As of September
30, 2003, the entire initial discount resulting from the issuance of the warrants had been fully
amortized to interest expense. As a result of the revaluation of these warrants (see Warrant
Revaluation below), we recorded additional non-cash interest expense of approximately $505,000
during the fiscal year ended June 30, 2004.
F-22
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE C
CONVERTIBLE NOTES AND DEBENTURES (Continued)
As a result of the common stock purchase warrants issued along with the April 2003 debentures
and the calculated effective conversion price of the debentures, a beneficial conversion amount of
approximately $335,000 was initially calculated and recorded as a discount on the principal amount
of the debentures at the date of issuance. This discount was amortized to interest expense using
the effective interest rate method over the life of the debentures. For the fiscal year ended June
30, 2004, we recognized approximately $120,000 as non-cash interest expense from the amortization
of the discount that arose from the beneficial conversion. As of September 30, 2003, the entire
initial discount resulting from the beneficial conversion feature had been fully amortized to
interest expense. As a result of the revaluation of these warrants (see Warrant Revaluation below),
we recorded additional non-cash interest expense of approximately $108,000 during the fiscal year
ended June 30, 2004.
We incurred costs of approximately $301,000 in connection with the sale and issuance of these
debentures and warrants, which primarily consisted of the finders fees, the fair value of warrants
issued to the finder, and legal and accounting expenses. These costs were amortized to interest
expense over the life of the debentures using the effective interest rate method. For the fiscal
year ended June 30, 2004, we amortized approximately $88,000 to interest expense. As of September
30, 2003, these debt issuance costs have been fully amortized to interest expense.
As of September 30, 2003, the purchasers had converted the entire principal balance on the
April 2003 debentures resulting in the issuance of approximately 1.9 million shares of our common
stock. In addition, all common stock purchase warrants issued in connection with this transaction
have been exercised.
Resale of the shares issued upon conversion or payment of the debentures and upon exercise of
warrants are registered under our Form S-3 registration statement (File No. 333-105668) filed with
the Securities and Exchange Commission, which was declared effective on June 9, 2003.
Warrant Revaluation
We issued common stock purchase warrants in connection with the sale of convertible debentures
under our April and June 2003 securities purchase agreements. At the time of issuance the warrants
were valued using their expected lives, which was less than their contractual lives. Ernst & Young
LLP, our independent registered public accounting firm, concurred with this approach. In January
2004, we were informed by Ernst & Young LLP that they had reevaluated their interpretation of the
accounting literature as it relates to the accounting for common stock purchase warrants issued in
connection with financing transactions. As a result of this subsequent interpretation, we and
Ernst & Young LLP determined that valuing the warrants issued in connection with our April and June
2003 securities purchase agreements using their expected lives was not correct. By using the
expected lives of the warrants, less value was attributed to them than if we had used the
contractual lives. Thus, an additional discount of approximately $1,423,000 would have been
recorded on the convertible debentures issued under the April and June 2003 securities purchase
agreements by using the contractual lives on the warrants.
As a result of the initial valuation of these warrants, the carrying value of the convertible
debentures was overstated and stockholders equity was correspondingly understated by approximately
$986,000 as of June 30, 2003. After consideration of all of the facts and circumstances, we
recognized the additional discounts resulting from the revaluation of these warrants as well as the
related amortization of prior period non-cash interest expense in the quarter ended December 31,
2003, as management believes it is not material to any period affected. Since the amortization of
the additional discount resulted in non-cash interest expense, there was no impact on the cash
flows of the Company for the fiscal years ended June 30, 2003 and 2004.
F-23
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE C
CONVERTIBLE NOTES AND DEBENTURES (Continued)
January 2003 Convertible Debentures, as Amended
On January 31, 2003, we entered into a securities purchase agreement with five unrelated
institutional investors for financing in the aggregate amount of approximately $2.1 million. Under
the terms of the Agreement, we received approximately $1.7 million net of discounts, a 6.5%
finders fee and legal expenses.
In connection with the January 2003 debentures, we paid a finders fee of 6.5% and issued the
finder 7,308 five-year common stock purchase warrants exercisable at a price of $0.625 per share.
As a result of subsequent financings, the exercise price of these warrants was reduced to $0.10 per
share.
On February 27, 2003, we executed an amendment to the January 31, 2003 securities purchase
agreement, which provided for an additional purchase of convertible debentures by two of the
investors in the aggregate amount of $375,000. Under the terms of the amendment, we received
approximately $305,000 net of discounts and a 6.5% finders fee.
These convertible debentures had a two-year term and did not accrue interest during the first
year but would have accrued interest at the rate of 6% per annum payable semi-annually during the
second year. The debentures were convertible immediately into shares of our common stock at a
conversion price equal to $0.85. Resale of the shares issued upon conversion of the debentures,
shares issued at closing and shares issued upon exercise of warrants are registered under our Form
S-3 registration statement (File No. 333-103593) filed with the Securities and Exchange Commission,
which was declared effective on March 28, 2003.
The securities purchase agreement entered into on January 31, 2003 and the amendment dated
February 27, 2003 provided for the issuance to the purchasers of an aggregate of 495,210 shares of
our common stock and a total of 990,420 common stock purchase warrants exercisable at $0.625 per
share. In conjunction with the February 27, 2003 amendment, we also executed agreements with
Palisades Equity Fund LP, Alpha Capital AG and HPC Capital Management to reduce the exercise price
of an aggregate of 830,374 common stock purchase warrants held by them to $0.10 per share.
The relative fair value of the 495,210 shares of our common stock issued in connection with
the January 31, 2003 agreement and the amendment dated February 27, 2003 was calculated to be
approximately $299,000. The relative fair value of the shares issued was recorded as a discount on
the principal amount of the debentures and was amortized to interest expense using the effective
interest rate method over the life of the debentures.
The warrants issued in connection with the January 31, 2003 agreement and the amendment dated
February 27, 2003 were exercisable during the three year period terminating February 2006 and could
be exercised on a cashless basis whereby the holder may surrender a number of warrants equal to the
exercise price of the warrants being exercised. The relative fair value of these warrants was
calculated to be approximately $437,000 using a Black-Scholes valuation model. The relative fair
value of the warrants was recorded as a discount on the principal amount of the debentures and was
amortized to interest expense using the effective interest rate method over the life of the
debentures.
F-24
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE C
CONVERTIBLE NOTES AND DEBENTURES (Continued)
As a result of the shares of common stock and the common stock purchase warrants issued along
with the debentures and the calculated effective conversion price of the debentures, a beneficial
conversion amount of approximately $1,310,000 was calculated and recorded as a discount on the
principal amount of the debentures at the date of issuance. This discount was amortized to
interest expense using the effective interest rate method over the life of the debentures. Due to
subsequent reductions in the conversion price on the debentures from $0.85 to as low as $0.41,
additional beneficial conversion of approximately $107,000 was calculated and charged to interest
expense during the three months ended March 31, 2003.
We incurred costs of approximately $179,000 in connection with the debentures issued in the
January 31, 2003 securities purchase agreement and the amendment to this agreement on February 27,
2003, which primarily consisted of the finders fees, the fair value of warrants issued to the
finder, and legal and accounting expenses. These costs were amortized to interest expense over the
life of the debentures using the effective interest rate method.
As of June 30, 2003, the purchasers had converted the entire $2,475,000 of principal on the
debentures resulting in the issuance of approximately 5.15 million shares of our common stock.
November 2002 Convertible Debentures
On November 8, 2002, we entered into a securities purchase agreement with three unrelated
institutional investors for financing in the aggregate amount of $1,950,000. Under the terms of
the agreement, we received $896,000, net of a 6.5% finders fee and legal expenses on November 15,
2002, representing the first half of the financing. Subsequent to our related registration
statement being declared effective by the SEC, we received an additional $911,625, net of a 6.5%
finders fee and miscellaneous expenses on December 13, 2002, representing the remaining half of
the financing.
The convertible debentures issued on November 8, 2002 accrued interest at the rate of 5% per
annum payable semi-annually and had a two-year term. The debentures were convertible immediately
into shares of our common stock. The conversion price was initially equal to $1.75, subject to
reduction if certain events occurred with a floor of $1.25. In connection with the January 31, 2003
securities purchase agreement for additional financing in the form of convertible debentures,
$300,000 of the remaining principal on the debentures issued in November and December became
convertible into shares of our common stock at a conversion price equal to $0.85 and $675,000 of
the remaining principal on the debentures issued in November and December became convertible into
shares of our common stock at a conversion price equal to $0.625. Resale of the shares issued upon
conversion of the debentures and those issuable upon exercise of warrants are registered under our
Form S-3 registration statement (File No. 333-101480) filed with the Securities and Exchange
Commission, which was declared effective on December 5, 2002.
The securities purchase agreement also provided for the issuance of 60,450 common stock
purchase warrants exercisable at a price of $2.00 per share, 74,450 common stock purchase warrants
exercisable at a price of $2.50 per share, 60,450 common stock purchase warrants exercisable at a
price of $3.00 per share, 162,500 common stock purchase warrants exercisable at a price of $4.00
per share and 130,000 common stock purchase warrants exercisable at a price of $6.00 per share.
These warrants were exercisable during the three year period terminating November 14, 2005. The
relative fair value of the warrants was calculated to be $326,260 using a Black-Scholes valuation
model. The relative fair value of the warrants was recorded as a discount on the principal amount
of the debentures and was amortized to interest expense using the effective interest rate method
over the life of the debentures. Through March 31, 2003, we recognized all $326,260 as interest
expense since the debentures were fully converted by March 31, 2003. Subsequent to the issuance of
these warrants, and as a result of the securities purchase agreement for additional financing
entered into on January 31, 2003, and the subsequent amendment on February 27, 2003, the exercise
price of these warrants was reduced to $0.10.
F-25
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE C
CONVERTIBLE NOTES AND DEBENTURES (Continued)
As a result of the stock purchase warrants issued along with the debentures and the calculated
effective conversion price of the debentures, a beneficial conversion amount of approximately
$661,000 was calculated and charged to interest expense upon the issuance of the debentures. Due
to the subsequent reductions in the conversion price on the debentures from $1.75 to $0.625,
additional beneficial conversion of approximately $427,000 was calculated and charged to interest
expense during the three months ended December 31, 2002. The conversion price on the debentures
was further reduced during January 2003 resulting in the recognition of additional interest expense
totaling approximately $536,000 during the three months ended March 31, 2003. All of these items
charged to interest expense were non-cash items.
We incurred costs of approximately $153,000 in connection with the debentures issued during
November and December 2002, which consisted of the finders fees, legal fees and the fair value of
warrants issued to the finder. These costs were amortized to interest expense over the life of the
debentures using the effective interest rate method. Through March 31, 2003, we recognized all
$153,000 as interest expense from the amortization of these issuance costs since the debentures
were fully converted by March 31, 2003.
As of March 31, 2003, the purchasers had converted the entire $1,950,000 of principal and
related accrued interest on the debentures resulting in the issuance of approximately 2.22 million
shares of our common stock.
August 2002 Note, as Amended
During August 2002, we executed a $500,000, 90 day Note with Isosceles Fund Limited. The Note
bore interest at 8% and was secured by 250,000 shares of our common stock. In connection with this
transaction, we issued 5,387 common stock purchase warrants exercisable at $5.30 per share for a
period of three years. In November 2002, the Note was amended to eliminate the fixed maturity date
and make the Note payable within three business days following demand. The Note was also amended
to provide for conversion of outstanding principal and interest into shares of our common stock at
a price of $1.75 per share in lieu of cash at Isosceles option. As a result of our subsequent
financing transactions, this conversion price was reduced to $0.56. Since Isosceles did not elect
to convert the Note within 90 days of the amendment, we issued Isosceles 11,650 warrants at $2.50
per share, 11,650 warrants at $3.00 per share, 11,650 warrants at $3.50 per share, 40,625 warrants
at $5.0 per share and 37,500 warrants at $6.00 per share. The warrants were exercisable for a
three-year period. The fair value of the warrants, which was calculated to be $67,845, was charged
to interest expense at the time of issuance. As a result of subsequent financing transactions, the
exercise price of these warrants was reduced to $0.56. As a result of the stock purchase warrants
issued and the calculated effective conversion price of the Note, a beneficial conversion amount of
approximately $485,000 was calculated and charged to interest expense. All of these items charged
to interest expense were non-cash items.
During the three months ended September 30, 2003, we issued 960,000 shares upon conversion of
the principal of the August 2002 Note and accrued interest totaling approximately $536,000. No
further amounts are due on this Note. In addition, Isosceles converted all 118,462 warrants issued
in connection with this Note resulting in net proceeds to us of approximately $66,300. Resale of
the shares issued upon conversion of the Isosceles Note and exercise of warrants issued in
connection with this Note as amended are registered under our Form S-3 registration statement (File
No. 333-106536) filed with the Securities and Exchange Commission, which was declared effective on
July 11, 2003.
January 2002 Convertible Debentures
On January 15, 2002, we entered into a securities purchase agreement with Elliott
International, L.P. and Elliott Associates, L.P. (Elliott). Under the terms of this agreement,
we issued two convertible debentures for a total principal amount of $2,500,000. The debentures
carried an interest rate of 6% per annum. The principal and interest were payable commencing April
1, 2002 over nine equal monthly installments. We paid $176,000 for placement fees and expenses on
the transaction. Resale of the shares issued upon conversion of the debentures and those issuable
upon exercise of warrants or purchase option under this agreement are registered under the Form S-3
registration statement (File No. 333-82452) filed with the Securities and Exchange Commission,
which was declared effective on February 26, 2002.
F-26
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE C
CONVERTIBLE NOTES AND DEBENTURES (Continued)
The monthly installments were payable in shares of our common stock or cash (with a 5%
premium) at our option. The debentures were convertible into shares of common stock at a price
equal to the Conversion Price ($12.95 per share) or, with respect to monthly installments which we
elected to pay in stock, the lesser of the Conversion Price or 90% of the arithmetic mean of the
ten lowest volume weighted average prices during the twenty days preceding conversion, but not less
than $7.50 per share. The agreement provided that if we requested to make a monthly payment with
stock valued at less than $7.50 per share, Elliott could, at their option, waive the $7.50 per
share minimum.
Under the securities purchase agreement, Elliott also received warrants to purchase a total of
40,552 shares of our common stock. The warrants were exercisable at $14.80 per share through
January 11, 2007. The warrants can be exercised on a cashless basis whereby the holder may
surrender a number of warrants equal to the exercise price of the warrants being exercised. The
relative fair value of the warrants was calculated to be $230,000 using a Black-Scholes valuation
model. The value of the warrants was recorded as a discount on the principal amount of the
debentures. The exercise price of these warrants is subject to adjustment in the event of stock
dividends, mergers, certain distributions of common stock or issuance of common stock at less than
the exercise price of the warrants on the date of issuance and less than the fair value of common
stock at date of issuance, based on a mathematical calculation. We have sold stock to
institutional investors at prices below the $14.80 exercise price of these warrants and below the
fair value of our common stock at the date of those sales, thus the exercise price on the warrants
has been reduced to $5.60, and can continue to decrease.
Under the securities purchase agreement, Elliott had the option to purchase an additional
136,364 shares at a purchase price of $11.00 per share from May 11, 2002 through November 11, 2003,
which expired unexercised. The relative fair value of this option was calculated to be $505,000
using a Black-Scholes valuation model. The value of the option was recorded as a discount on the
principal amount of the debentures. The purchase price per share was subject to adjustment in the
event of stock dividends, mergers, certain distributions of common stock or issuance of common
stock at less than the Purchase Price of the option on the date of issuance and less than the fair
value of common stock at date of issuance, based on a mathematical calculation.
As a result of the warrants, option to purchase additional shares and the effective conversion
price of the debentures, a beneficial conversion rate was calculated, which resulted in additional
discount on the debentures of approximately $1.34 million. The total discount on the debentures at
the date of issuance was approximately $2.08 million and was composed of the value attributed to
the warrants, the additional purchase option and the beneficial conversion feature on the
convertible debentures. The discount was amortized to interest expense using the effective interest
rate method over the life of the debentures. In addition, deferred finance costs of $176,000, were
amortized to interest expense over the life of the debentures using the effective interest rate
method. We recorded non-cash interest expense for the three months ended September 30, 2002 of
approximately $688,000 on these convertible debentures.
On April 1, 2002, we issued 38,801 shares of our common stock as payment of the first monthly
principal installment on the debentures plus interest accrued to date. The number of shares was
based on a conversion price of approximately $8.00, which represented ninety percent of the average
of the ten lowest volume weighted average prices of our common stock during the twenty trading days
immediately preceding the conversion date. Subsequent to the April 1, 2002 installment, we made
six cash payments totaling approximately $1.7 million, which represented the May through October
monthly principal installments, plus interest accrued including a five percent premium. In
November and December 2002, we issued 147,826 and 182,960 shares of our common stock representing
payment of the November and December installments due on the convertible debentures, respectively.
As of June 30, 2003, these debentures have been paid in full and no further amounts are due on
these debentures.
F-27
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE D
DEBT
Line of Credit and Short Term Borrowings
Our Swedish subsidiary maintains an overdraft facility, denominated in Swedish Krona, with a
bank in Sweden. In July 2004, the terms on this overdraft facility were renegotiated to provide
for a reduced interest rate and a reduction in the maximum borrowing capacity. The maximum
borrowing capacity on this overdraft facility was approximately $767,000 as of June 30, 2005
compared to $1.1 million as of June 30, 2004. Borrowings outstanding under this facility are at a
floating rate of interest, which was approximately 5.25% at June 30, 2005 compared to 7.4% at June
30, 2004. This overdraft facility renews annually and was renewed in December 2004. There was no
outstanding balance under this overdraft facility as of June 30, 2005. Outstanding borrowings
under this overdraft facility were approximately $807,000 as of June 30, 2004. The overdraft
facility is secured by certain assets of ViraNative including inventories and accounts receivable.
During June 2005, we obtained short term financing of approximately $224,000 for the purchase
of certain corporate insurance policies. Outstanding borrowings under this arrangement bear
interest at an effective rate of 6.86%. Principal and interest payments of approximately $26,000
are payable in nine equal monthly installments. The outstanding balance on this short term
borrowing was approximately $224,000 as of June 30, 2005.
During June 2004, we obtained short term financing of approximately $270,000 for the purchase
of certain corporate insurance policies. Outstanding borrowings under this arrangement bore
interest at an effective rate of 5.19%. Principal and interest payments of approximately $31,000
were payable in nine equal monthly installments. This short term financing had been repaid as of
March 31, 2005. The outstanding balance on this short term borrowing was approximately $270,000 as
of June 30, 2004.
Long-Term Debt
Long term debt is comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
2005 |
|
|
2004 |
|
Mortgage loan secured by land and
building in Sweden. Quarterly payments
of principal and interest as described
below. |
|
$ |
631,332 |
|
|
$ |
689,104 |
|
Credit facility in Sweden. Quarterly
payments of principal and interest
as described below. |
|
|
|
|
|
|
536,706 |
|
|
|
|
|
|
|
|
|
|
|
631,332 |
|
|
|
1,225,810 |
|
Less current portion |
|
|
(33,228 |
) |
|
|
(153,723 |
) |
|
|
|
|
|
|
|
|
|
$ |
598,104 |
|
|
$ |
1,072,087 |
|
|
|
|
|
|
|
|
Our Swedish subsidiary has a 25-year mortgage with a Swedish bank obtained to purchase one of
our facilities in Sweden. The outstanding principal balance on this loan, which is payable in
Swedish Krona, was approximately $631,000 and $689,000 at June 30, 2005 and 2004, respectively.
This loan carries a floating rate of interest which was approximately 5.25% at June 30, 2005 and
2004. We are required to make quarterly payments of principal and interest of approximately $17,000
under this agreement. This loan matures in September 2024 and is secured by the related land and
building, including improvements, with a carrying value of approximately $2.3 million as of June
30, 2005.
Under the terms of a loan with a Swedish governmental agency that was obtained for the
purposes of conducting clinical trials, we were required to make quarterly payments of principal
and interest of approximately $34,000. The loan carried a floating rate of interest at the
Stockholm interbank offered rate (STIBOR) 90 plus 7%, which was approximately 9.30% as of June 30,
2004. This loan had an outstanding balance, which was payable in Swedish Krona, of approximately
$537,000 at June 30, 2004. On September 30, 2004, we paid the entire outstanding principal,
including accrued interest, on this loan. No amounts are due on this loan as of June 30, 2005.
F-28
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE D
DEBT (Continued)
Long-term debt outstanding at June 30, 2005 matures as follows:
|
|
|
|
|
2006 |
|
$ |
33,000 |
|
2007 |
|
|
33,000 |
|
2008 |
|
|
33,000 |
|
2009 |
|
|
33,000 |
|
2010 |
|
|
33,000 |
|
Thereafter |
|
|
466,000 |
|
NOTE E
ROYALTY AGREEMENT
In November 1986, we entered into a royalty agreement with Medicore, Inc. with respect to
interferon, transfer factor and products using interferon and transfer factor. The agreement was
subsequently amended in November 1989 and May 1993. The amended agreement provides for a maximum
cap on royalties to be paid to Medicore of $2,400,000. It includes a schedule of royalty payments
of:
|
|
|
5% of the first $7,000,000 of sales, |
|
|
|
|
4% of the next $10,000,000, and |
|
|
|
|
3% of the next $55,000,000 |
These royalties are to be paid until the total of $2,400,000 is achieved. The amended
agreement also states that royalties of approximately $108,000 previously accrued prior to May 1993
under the agreement are payable to Medicore as the final payment. From May 1993 through September
2001, we paid royalties under the amended agreement totaling approximately $70,000.
Royalties owed to Medicore of approximately $90,000, based on our natural human alpha
interferon sales from October 1, 2001 through June 30, 2003, were payable in three installments:
$30,000 was payable by August 1, 2003; $30,000 was payable by August 1, 2004; and $30,000 was
payable by August 1, 2005. These three installments, plus approximately $4,500 in interest, have
been paid. Subsequent to June 30, 2003, in accordance with the terms of the amended agreement,
royalties are paid to Medicore based on sales of natural human alpha interferon on a quarterly
basis. For the fiscal years ended June 30, 2005 and 2004, royalties due under the agreement totaled
approximately $14,000 and $13,000, respectively.
NOTE F
CAPITAL STOCK
Preferred Stock, Series A
The series A preferred stock provides for a 10% cumulative dividend, payable at the option of
Viragen, in either cash or common stock and is convertible into 0.426 shares of common stock. The
holders of the series A preferred stock are not entitled to vote unless dividends are in arrears
for five annual dividend periods. Management has the right to call the preferred stock for
redemption, in whole or in part, if the closing bid for our common stock is $60.00 per share or
higher for a period of ten consecutive business days, at $110.00 per share for a period of five
years from that date, and then at $100.00 per share. During fiscal 2004, we repurchased 400
outstanding shares of our series A preferred stock at a total cost of $4,000. During fiscal 2005,
we repurchased 100 outstanding shares of our series A preferred stock at a total cost of $1,000.
These repurchases included the settlement of dividends payable to the holders.
F-29
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE F
CAPITAL STOCK (Continued)
Common Stock
On June 11, 2004, our stockholders approved an amendment to our Articles of Incorporation to
effect a 1-for-10 reverse split of our outstanding common stock and change the number of shares of
common stock that Viragen is authorized to issue to 100 million. The split became effective on
June 15, 2004.
On June 25, 2003, our stockholders approved an amendment to our Articles of Incorporation to
increase the number of authorized shares of our common stock from 25 million to 70 million.
On March 31, 2003, we retired all 84,528 shares of our common stock held in treasury.
On January 31, 2003, our stockholders approved an amendment to our Articles of Incorporation
to increase the number of authorized shares of our common stock from 15 million to 25 million.
During the fiscal year ended June 30, 2004, we sold approximately 4.5 million shares of our
common stock to institutional investors at prices ranging from $2.00 to $2.24 per share for an
aggregate amount of approximately $8.9 million, net of finders fees and related expenses. In
connection with these transactions, we also issued approximately 1.1 million common stock purchase
warrants with exercise prices ranging from $2.00 to $2.80 per share. The exercise price of these
warrants was subsequently reduced to $0.67 per share as a result of the issuance of shares in April
2005 as payment of interest on our June 2004 convertible notes.
During the fiscal year ended June 30, 2004, we issued approximately 3.7 million shares of
common stock upon conversion of outstanding convertible debentures. These shares were issued at
prices ranging from $2.00 to $3.17 per share.
During the fiscal year ended June 30, 2004, we issued approximately 2.4 million shares of our
common stock upon the exercise of common stock purchase warrants at prices ranging from $0.56 to
$2.24 per share resulting in net proceeds to us of approximately $3.8 million.
During the fiscal year ended June 30, 2003, we issued approximately 8.98 million shares of our
common stock upon conversion of outstanding convertible debentures. These shares were issued at
prices ranging from $0.41 to $2.00 per share.
During the fiscal year ended June 30, 2003, we issued approximately 4.5 million shares of our
common stock upon the exercise of common stock purchase warrants at prices ranging from $0.10 to
$2.00 per share resulting in net proceeds to us of approximately $2.4 million. Approximately
400,000 of these warrants were exercised on a cashless basis.
In December 1999, we retained the investment banking firm of Ladenburg Thalmann & Co., Inc.
for a period of two years to aid us in raising up to $60 million in investment capital, on a best
efforts basis. On March 21, 2000, the Securities and Exchange Commission declared our shelf
registration on Form S-3 (File No. 333-32306) effective. During fiscal 2003, we raised
approximately $2.74 million, net of finders fees and other issuance costs, under this shelf
registration. We issued an aggregate of 1.06 million shares of our common stock at prices ranging
from $1.50 to $6.63 per share. In connection with these transactions, we also issued 31,443 common
stock purchase warrants exercisable at prices ranging from $1.73 to $7.60 per share.
F-30
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE F
CAPITAL STOCK (Continued)
Options and Warrants
Our 1995 Stock Option Plan, which was adopted in May 1995 and amended in September 1995,
authorized the grant of stock options to officers, directors, employees and consultants for up to
400,000 shares of Viragen common stock. Stock options granted under the 1995 Stock Option Plan have
various vest dates and all stock options granted have five-year terms from the vest dates. The 1995
Stock Option Plan expired in May 2005. This expiration did not affect the validity of outstanding
stock options previously granted under the plan.
Our 1997 Stock Option Plan, adopted in February 1997 with a 10-year life, authorized the grant
of stock options to officers, directors, employees and consultants for up to 300,000 shares of
common stock. In April 1998, the 1997 Stock Option Plan was amended increasing the number of shares
of common stock authorized to 400,000 shares. Stock options granted under the plan have various
vest dates and all stock options granted have five-year terms from the vest dates. At June 30,
2005, approximately 124,000 shares were available for issuance under the 1997 Stock Option Plan.
A summary of Viragens stock option activity and related information for the years ended
June 30, follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Number of |
|
|
Weighted |
|
|
|
Number of |
|
|
Average |
|
|
Options |
|
|
Average |
|
|
|
Options |
|
|
Exercise Price |
|
|
Exercisable |
|
|
Exercise Price |
|
Outstanding at June 30, 2002 |
|
|
575,263 |
|
|
$ |
12.00 |
|
|
|
497,163 |
|
|
$ |
12.20 |
|
Granted |
|
|
64,300 |
|
|
|
2.10 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Canceled/Expired |
|
|
(95,813 |
) |
|
|
11.20 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2003 |
|
|
543,750 |
|
|
|
10.90 |
|
|
|
514,350 |
|
|
|
11.50 |
|
Granted |
|
|
201,000 |
|
|
|
2.00 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(18,000 |
) |
|
|
1.10 |
|
|
|
|
|
|
|
|
|
Canceled/Expired |
|
|
(340,050 |
) |
|
|
10.99 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2004 |
|
|
386,700 |
|
|
|
6.71 |
|
|
|
311,200 |
|
|
|
7.86 |
|
Granted |
|
|
2,500 |
|
|
|
0.85 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Canceled/Expired |
|
|
(54,733 |
) |
|
|
13.86 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2005 |
|
|
334,467 |
|
|
$ |
5.50 |
|
|
|
333,217 |
|
|
$ |
5.51 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes information about stock options outstanding at June 30, 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock Options Outstanding |
|
|
Stock Options Exercisable |
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Weighted |
|
|
Number of |
|
|
Weighted |
|
Range of |
|
Number of |
|
|
Remaining |
|
|
Average |
|
|
Options |
|
|
Average |
|
Exercise Prices |
|
Options |
|
|
Contractual Life |
|
|
Exercise Price |
|
|
Exercisable |
|
|
Exercise Price |
|
$0.80 - $1.10 |
|
|
28,000 |
|
|
3.62 years |
|
$ |
1.01 |
|
|
|
26,750 |
|
|
$ |
1.01 |
|
$1.57 - $2.70 |
|
|
195,500 |
|
|
5.34 years |
|
|
2.04 |
|
|
|
195,500 |
|
|
|
2.04 |
|
$5.00 - $7.50 |
|
|
15,800 |
|
|
2.29 years |
|
|
5.46 |
|
|
|
15,800 |
|
|
|
5.46 |
|
$10.40 - $14.50 |
|
|
88,300 |
|
|
1.52 years |
|
|
12.13 |
|
|
|
88,300 |
|
|
|
12.13 |
|
$17.50 - $37.50 |
|
|
6,867 |
|
|
1.17 years |
|
|
36.92 |
|
|
|
6,867 |
|
|
|
36.92 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$0.80 - $37.50 |
|
|
334,467 |
|
|
3.96 years |
|
$ |
5.50 |
|
|
|
333,217 |
|
|
$ |
5.51 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-31
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE F
CAPITAL STOCK (Continued)
We account for our stock-based compensation arrangements with consultants under the provisions
of SFAS No. 123 and related guidance, including EITF No. 96-18. During fiscal 2004 and 2003, we
recognized net stock-based compensation expense of approximately $13,000 and $200, respectively.
These amount arose as a result of the variable accounting treatment of certain unearned stock
warrants that were granted to consultants from fiscal 1999 through 2004. The weighted-average fair
values of the stock warrants granted in fiscal 2004 and 2003 were $1.60 and $1.70, respectively.
No stock warrants were granted to consultants in fiscal 2005 and no expense were recognized on
warrants granted prior to fiscal 2005.
A summary of Viragens warrant activity, excluding warrants issued in conjunction with debt
and equity offerings, and related information for the years ended June 30, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Number of |
|
|
Weighted |
|
|
|
Number of |
|
|
Average |
|
|
Warrants |
|
|
Average |
|
|
|
Warrants |
|
|
Exercise Price |
|
|
Exercisable |
|
|
Exercise Price |
|
Outstanding at June 30, 2002 |
|
|
202,550 |
|
|
$ |
29.00 |
|
|
|
126,300 |
|
|
$ |
13.90 |
|
Granted |
|
|
40,000 |
|
|
|
4.20 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Canceled/Expired |
|
|
(6,200 |
) |
|
|
73.90 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2003 |
|
|
236,350 |
|
|
|
23.60 |
|
|
|
213,850 |
|
|
|
15.80 |
|
Granted |
|
|
10,000 |
|
|
|
2.40 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Canceled/Expired |
|
|
(38,375 |
) |
|
|
30.23 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2004 |
|
|
207,975 |
|
|
|
21.38 |
|
|
|
187,975 |
|
|
|
11.95 |
|
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Canceled/Expired |
|
|
(90,475 |
) |
|
|
18.96 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2005 |
|
|
117,500 |
|
|
$ |
23.24 |
|
|
|
117,500 |
|
|
$ |
23.24 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes information about stock warrants, excluding warrants issued in
conjunction with debt and equity offerings, outstanding at June 30, 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock Warrants Outstanding |
|
|
Stock Warrants Exercisable |
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Weighted |
|
|
Number of |
|
|
Weighted |
|
Range of |
|
Number of |
|
|
Remaining |
|
|
Average |
|
|
Warrants |
|
|
Average |
|
Exercise Prices |
|
Warrants |
|
|
Contractual Life |
|
|
Exercise Price |
|
|
Exercisable |
|
|
Exercise Price |
|
$1.10 |
|
|
2,500 |
|
|
3.14 years |
|
$ |
1.10 |
|
|
|
2,500 |
|
|
$ |
1.10 |
|
$2.40 |
|
|
10,000 |
|
|
0.09 years |
|
|
2.40 |
|
|
|
10,000 |
|
|
|
2.40 |
|
$5.00 |
|
|
2,500 |
|
|
2.63 years |
|
|
5.00 |
|
|
|
2,500 |
|
|
|
5.00 |
|
$14.63 |
|
|
90,000 |
|
|
0.87 years |
|
|
14.63 |
|
|
|
90,000 |
|
|
|
14.63 |
|
$110.00 |
|
|
12,500 |
|
|
3.12 years |
|
|
110.00 |
|
|
|
12,500 |
|
|
|
110.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$1.10 - $110.00 |
|
|
117,500 |
|
|
1.13 years |
|
$ |
23.24 |
|
|
|
117,500 |
|
|
$ |
23.24 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-32
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE F
CAPITAL STOCK (Continued)
Our majority owned subsidiary, Viragen International, Inc., also maintains a stock option plan
for the purchase of up to 600,000 shares of its common stock, of which 272,300 remained available
as of June 30, 2005. Stock options granted under the plan have various vesting dates and all stock
options granted have 5 year terms from the vesting dates.
A summary of Viragen Internationals stock option activity and related information for the
years ended June 30, follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Number of |
|
|
Weighted |
|
|
|
Number of |
|
|
Average |
|
|
Options |
|
|
Average |
|
|
|
Options |
|
|
Exercise Price |
|
|
Exercisable |
|
|
Exercise Price |
|
Outstanding at June 30, 2002 |
|
|
471,300 |
|
|
$ |
1.66 |
|
|
|
353,800 |
|
|
$ |
1.93 |
|
Granted |
|
|
102,500 |
|
|
|
0.23 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Canceled/Expired |
|
|
(201,300 |
) |
|
|
2.72 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2003 |
|
|
372,500 |
|
|
|
0.69 |
|
|
|
333,750 |
|
|
|
0.75 |
|
Granted |
|
|
50,000 |
|
|
|
0.35 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Canceled/Expired |
|
|
(44,500 |
) |
|
|
0.77 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2004 |
|
|
378,000 |
|
|
|
0.64 |
|
|
|
353,000 |
|
|
|
0.66 |
|
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Canceled/Expired |
|
|
(52,500 |
) |
|
|
0.99 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2005 |
|
|
325,500 |
|
|
$ |
0.58 |
|
|
|
325,500 |
|
|
$ |
0.58 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes information about Viragen Internationals stock options
outstanding at June 30, 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding Options |
|
|
Exercisable Options |
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Weighted |
|
|
Number of |
|
|
Weighted |
|
Range of |
|
Number of |
|
|
Remaining |
|
|
Average |
|
|
Options |
|
|
Average |
|
Exercise Prices |
|
Options |
|
|
Contractual Life |
|
|
Exercise Price |
|
|
Exercisable |
|
|
Exercise Price |
|
$0.07 - $0.13 |
|
|
52,500 |
|
|
3.15 years |
|
$ |
0.10 |
|
|
|
52,500 |
|
|
$ |
0.10 |
|
$0.35 - $0.37 |
|
|
75,000 |
|
|
1.04 years |
|
|
0.36 |
|
|
|
75,000 |
|
|
|
0.36 |
|
$0.70 - $0.95 |
|
|
198,000 |
|
|
1.61 years |
|
|
0.79 |
|
|
|
198,000 |
|
|
|
0.79 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$0.07 - $0.95 |
|
|
325,500 |
|
|
1.73 years |
|
$ |
0.58 |
|
|
|
325,500 |
|
|
$ |
0.58 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Shares Reserved
Shares of our common stock reserved at June 30, 2005 for possible future issuance are as
follows:
|
|
|
|
|
Convertible preferred stock, Series A |
|
|
916 |
|
Officers, employees, and directors options (exercisable through March 2014) |
|
|
334,467 |
|
Consultant warrants (exercisable through February 2009) |
|
|
117,500 |
|
Debt and equity offering warrants (exercisable through June 2008) |
|
|
8,238,304 |
|
Convertible notes (convertible through March 2006) |
|
|
13,192,617 |
|
|
|
|
|
|
|
|
|
21,883,804 |
|
|
|
|
|
|
F-33
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE G
INCOME TAXES
Viragen, Inc. and its majority-owned subsidiaries, as defined by the Internal Revenue Code,
file consolidated federal and state income tax returns, except for Viragen International, Inc.,
which files its own separate US income tax return.
For financial reporting purposes, net loss before income taxes and minority interest includes
the following components:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June 30, |
|
|
|
2005 |
|
|
2004 |
|
|
2003 |
|
U.S. |
|
$ |
(21,262,050 |
) |
|
$ |
(14,048,621 |
) |
|
$ |
(15,039,427 |
) |
Foreign |
|
|
(6,609,723 |
) |
|
|
(5,611,295 |
) |
|
|
(3,831,639 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(27,871,773 |
) |
|
$ |
(19,659,916 |
) |
|
$ |
(18,871,066 |
) |
|
|
|
|
|
|
|
|
|
|
The components of Viragens income tax benefit are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
2005 |
|
|
2004 |
|
|
2003 |
|
Current: |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
U.S. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred: |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
|
43,828 |
|
|
|
43,828 |
|
|
|
60,686 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
43,828 |
|
|
|
43,828 |
|
|
|
60,686 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total income tax benefit |
|
$ |
43,828 |
|
|
$ |
43,828 |
|
|
$ |
60,686 |
|
|
|
|
|
|
|
|
|
|
|
F-34
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE G
INCOME TAXES (Continued)
Deferred income taxes reflect the net tax effects of temporary differences between the
carrying amount of assets and liabilities for financial reporting purposes and the amounts used for
income tax purposes. Significant components of Viragens deferred income tax liabilities and assets
as of June 30, 2005 and 2004 are as follows:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
2005 |
|
|
2004 |
|
Deferred tax assets: |
|
|
|
|
|
|
|
|
Net operating loss carry-forwards |
|
$ |
43,633,000 |
|
|
$ |
35,068,000 |
|
Research and development credits |
|
|
947,000 |
|
|
|
869,000 |
|
Deferred compensation |
|
|
209,000 |
|
|
|
1,275,000 |
|
Accrued liabilities |
|
|
132,000 |
|
|
|
63,000 |
|
Other |
|
|
86,000 |
|
|
|
88,000 |
|
|
|
|
|
|
|
|
Total deferred tax assets |
|
|
45,007,000 |
|
|
|
37,363,000 |
|
Valuation allowance for deferred tax assets |
|
|
(44,576,000 |
) |
|
|
(36,690,000 |
) |
|
|
|
|
|
|
|
Net deferred tax assets |
|
|
431,000 |
|
|
|
673,000 |
|
|
|
|
|
|
|
|
|
|
Deferred tax liabilities: |
|
|
|
|
|
|
|
|
Fixed assets |
|
|
(431,000 |
) |
|
|
(673,000 |
) |
Identifiable intangibles |
|
|
(457,000 |
) |
|
|
(500,000 |
) |
|
|
|
|
|
|
|
Total deferred tax liabilities |
|
|
(888,000 |
) |
|
|
(1,173,000 |
) |
|
|
|
|
|
|
|
Net deferred tax liability |
|
$ |
(457,000 |
) |
|
$ |
(500,000 |
) |
|
|
|
|
|
|
|
The change in the valuation allowance was a net increase of $7,886,000, $5,477,000 and
$5,214,000 for the years ended June 30, 2005, 2004 and 2003, respectively.
Viragen has undergone two ownership changes, as defined by Internal Revenue Code Section 382,
which may cause the utilization of the net operating losses and tax credits to be limited. The
effects of these limitations have not been calculated at this time.
Viragen has net operating loss and tax credit carry-forwards for US income tax purposes, with
expiration dates, as follows:
|
|
|
|
|
|
|
|
|
|
|
Net Operating |
|
|
|
|
|
|
|
Losses |
|
|
Tax Credits |
|
|
Expiration |
|
$ |
3,145,000 |
|
|
$ |
|
|
|
|
20062008 |
|
|
9,384,000 |
|
|
|
|
|
|
|
20092011 |
|
|
72,596,000 |
|
|
|
947,000 |
|
|
|
20122025 |
|
|
|
|
|
|
|
|
|
|
$ |
85,125,000 |
|
|
$ |
947,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At June 30, 2005, Viragen International has U.S. net operating loss carry-forwards totaling
approximately $7.5 million expiring between 2006 and 2025, which are included in the table above.
At June 30, 2005, Viragen (Scotland) had approximately $25.8 million in net operating loss
carry-forwards that do not expire, which are available to offset future taxable income in Scotland.
At June 30, 2005, ViraNative has approximately $13.8 million in net operating loss carry-forwards
that do not expire, which are available to offset future taxable income in Sweden.
For financial reporting purposes, a valuation allowance has been recognized to offset the
deferred income tax assets related to these carry-forwards.
F-35
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE G
INCOME TAXES (Continued)
The reconciliation of income tax benefit computed at the U.S. federal statutory rate applied
to our consolidated net loss before income taxes and minority interest is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June 30, |
|
|
2005 |
|
2004 |
|
2003 |
Tax at U.S. statutory rate |
|
|
(34.00 |
)% |
|
|
(34.00 |
)% |
|
|
(34.00 |
)% |
State taxes, net of federal
benefit |
|
|
(1.85 |
) |
|
|
(3.63 |
) |
|
|
(3.63 |
) |
Benefit of lower foreign tax
rates |
|
|
1.38 |
|
|
|
1.54 |
|
|
|
1.06 |
|
Goodwill impairment |
|
|
8.46 |
|
|
|
|
|
|
|
|
|
Non-deductible items |
|
|
0.13 |
|
|
|
0.20 |
|
|
|
0.15 |
|
Change in valuation allowance |
|
|
28.29 |
|
|
|
27.86 |
|
|
|
27.63 |
|
Tax return true-up |
|
|
(3.83 |
) |
|
|
|
|
|
|
|
|
Other |
|
|
1.26 |
|
|
|
7.81 |
|
|
|
8.47 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(0.16 |
)% |
|
|
(0.22 |
)% |
|
|
(0.32 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Viragen International files separate U.S. income tax returns. ViraNative, a wholly-owned
subsidiary of Viragen International, files separate income tax returns in Sweden. Viragen
(Scotland) Ltd., a wholly-owned subsidiary of Viragen International, files separate income tax
returns in the United Kingdom. Viragen (Germany) GmbH, also a wholly-owned subsidiary of Viragen
International that has been dormant since inception and was dissolved in June 2005, files separate
income tax returns in Germany.
NOTE H
TRANSACTIONS WITH RELATED PARTIES
As of June 30, 2005, we have a receivable of approximately $20.3 million from our
majority-owned subsidiary, Viragen International. This amount does not show in our balance sheet
because Viragen International is consolidated with Viragen for financial reporting purposes.
Historically, this balance has been settled by the issuance of shares of Viragen International
common stock to Viragen.
On August 31, 2004, we contributed to capital $1,000,000 in inter-company balances with
Viragen International. On that date, the closing price of Viragen Internationals common stock was
$0.18 per share as quoted on the over-the-counter bulletin board. We received 5,555,556 shares of
Viragen International common stock for the capital contribution, which increased our ownership in
Viragen International to approximately 81.2%.
On June 30, 2003, we contributed to capital $6,000,000 in inter-company balances with Viragen
International. On that date, the closing price of Viragen Internationals common stock was $0.35
per share as quoted on the over-the-counter bulletin board. We received 17,142,857 shares of
Viragen Internationals common stock for the capital contribution.
On December 31, 2002, we received 4,479,167 shares of Viragen International common stock to
settle $500,000 in licensing fees receivable from Viragen International, plus accrued interest
totaling $37,500. On that date, the closing price of Viragen Internationals common stock was $0.12
per share as quoted on the over-the-counter bulletin board.
On April 22, 2005, we entered into an agreement with Melvin Rothberg, pursuant to which the
parties agreed to an early termination of the employment agreement dated July 1, 2004 between
Viragen, Inc. and Mr. Rothberg. Upon execution of the agreement by the parties, Mr. Rothberg
resigned as Executive Vice President Operations of Viragen, Inc. and in all other capacities in
which he served Viragen, Inc. and its subsidiaries and affiliates. Mr. Rothberg received the
balance of his salary due to him over the remaining term of the employment agreement, which was due
to expire on June 30, 2006, as well as certain employee benefits. Mr. Rothbergs responsibilities
have been assumed by Charles A. Rice.
F-36
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE H
TRANSACTIONS WITH RELATED PARTIES (Continued)
During the year ended June 30, 2005 we recorded a $596,000 gain on the remeasurement of a
liability to us by Viragen (Scotland), which was denominated in U.S. dollars. This amount has been
recorded in the interest and other income line item of our statement of operations. In prior
periods, this liability had been translated at historical exchange rates since this liability was
determined to be long-term in nature. This determination was based on the fact that Viragen
(Scotland) did not have the ability or intent to repay the amounts owed to us. Beginning in fiscal
2002, Viragen (Scotland) began gradually settling the liability by charging us for services
performed on our behalf. Management anticipates the liability will be settled through these
charges in the near term. Therefore, it was determined that the account should no longer be
considered long-term and thus translation at current exchange rates is appropriate. Since the
liability was denominated in U.S. dollars and the UK Pound Sterling has been strengthening against
the U.S. dollar over the last few years, the remeasurement of the liability resulted in a gain. Had
the determination been made when Viragen (Scotland) began settling the liability with charges to
Viragen in prior periods and the liability been remeasured at then current exchange rates, the
impact on the statements of operations would not have been material and there would have been no
effect on total stockholders equity as such currency gains are reclassifications from accumulated
other comprehensive income.
In May 2004, Viragen USA, Inc., our majority-owned subsidiary, repurchased the shares of its
outstanding common stock not held by Viragen. The shares were held by an officer, two former
officers and a former director. These shares were independently valued at $0.22 per share,
resulting in a total cost of $70,400. Viragen USA, Inc. is now wholly-owned by Viragen.
In March 2004, Robert C. Salisbury resigned his positions as president and chief executive
officer of Viragen, positions he had held since January 2003. Mr. Salisbury received no salary for
serving in these positions. On February 7, 2003, Mr. Salisbury was granted an option to purchase
35,000 shares of Viragen common stock at $1.10 per share. The options vest one-half upon the grant
date and one-half upon the first anniversary of the grant date and are exercisable for five years
from the vest dates. In January 2004, Mr. Salisbury exercised half of these options through the
payment of $19,250 cash.
In June 2003, we entered into a consulting agreement with Dr. Douglas Lind upon the expiration
of his employment agreement. This agreement provided for annual compensation of $60,000. The
agreement did not contain a fixed term. However, either Viragen or Dr. Lind had the option to
terminate the agreement for any reason upon 90 days written notice. Under the agreement, Dr. Lind
was engaged to consult with management on a variety of scientific and biopharmaceutical market
issues. For his consulting services, we issued Dr. Lind 25,000 common stock purchase warrants
exercisable at $2.60 per share for a period of five years. We recognized non-cash compensation
expense of $52,000 in connection with the grant of these warrants. In August 2004, the consulting
agreement was terminated and the warrants expired unexercised in May 2005.
In January 2003, Mr. Gerald Smith resigned his positions as chairman, president and chief
executive officer of Viragen, Inc. and Viragen International. Upon his resignation, Mr. Smith
received a one time payment of $170,000. Mr. Smith also entered into a one-year consulting
agreement related to our avian transgenics program. This agreement, which expired on January 31,
2004, provided for annual compensation of $155,000, health insurance and automobile related
expenses. In October 2003, Mr. Smith resigned as a director of Viragen, Inc. and Viragen
International, Inc.
From February 2003 through June 2003, Dennis W. Healey, chief financial officer, Melvin
Rothberg, executive vice president of operations, and Dr. Douglas Lind consented to modify their
employment agreements so as to receive 20% of their compensation in the form of restricted shares
of common stock, valued at market on each pay date. In March 2003, Mr. Healey increased the amount
of his compensation paid in restricted shares of common stock to 75%. These agreement modifications
ran through June 30, 2003. As of June 30, 2003, we had issued 61,065 shares to Mr. Healey, 14,070
shares to Mr. Rothberg and 18,512 shares to Dr. Lind based upon these agreement modifications. In
July 2003, Mr. Healey modified his employment agreement reducing his salary from $252,000 to
$200,000 per year, which was increased in January 2005 to $210,000 in lieu of other compensation.
F-37
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE H
TRANSACTIONS WITH RELATED PARTIES (Continued)
During October 2000, Mr. Healey exercised 10,000 options to purchase common stock through the
issuance of a $50,000 recourse promissory note payable to Viragen secured by the underlying common
stock purchased, which was held in escrow. In October 2002, Mr. Healey paid the principal and
related interest on his note. The escrowed shares were released upon payment.
On September 1, 1998, Gerald Smith, then president, chief executive officer and chairman,
exercised 25,000 options to purchase Viragen common stock. He exercised the options through the
issuance of promissory notes payable to Viragen totaling $150,000. Mr. Smith also entered into
related pledge and escrow agreements. The promissory note carried an interest rate of 5.47%,
payable semi-annually, and was secured by the underlying common stock purchased. The purchased
shares were being held in escrow, pending payment of the related note pursuant to the provisions of
the pledge and escrow agreements. Mr. Smith paid $100,000 of the principal on his promissory note,
plus related interest, during January 2000. Viragen released the collateral on the promissory note.
In January 2003, Mr. Smith, paid his remaining $50,000 recourse promissory note payable to Viragen,
plus accrued interest.
Mr. Carl Singer receives $100,000 per year for his services as chairman of the board of
Viragen and chairman of Viragens executive committee. Mr. Singer serves as chairman of the board
of Fundamental Management Corporation, a Florida-based institutional investment fund. Mr. Robert
Salisbury, a director of Viragen, serves as president and director of Fundamental Management
Corporation, a Florida-based institutional investment fund, which manages the Active Investors Ltd.
II fund. Active Investors Ltd. II owns approximately 1.0% of our outstanding common stock. Mr.
Salisbury and Mr. Charles Simons, a director of Viragen, are investors in the Active Investors Ltd.
II fund.
Peter Fischbein, a former director, exercised options to purchase 20,000 shares of Viragen
common stock at $5.00 per share during October 1998. These options were exercised through the
payment of $2,000 cash and the issuance of a promissory note payable to Viragen totaling $98,000,
and related pledge and escrow agreements. This promissory note accrued interest at 5.06%, payable
semi-annually, and was secured by the underlying shares of common stock purchased. During February
2000, Mr. Fischbein exercised options to purchase an additional 2,500 shares of Viragen common
stock at $5.00 per share through the issuance of another promissory note payable to Viragen
totaling $12,500 and related pledge and escrow agreements. This promissory note accrued interest at
6.46% payable semi-annually. The shares of common stock purchased are being held in escrow, pending
payment of the related notes pursuant to the provisions of the pledge and escrow agreements. On
December 31, 2003, we reserved the uncollaterized portion of these notes totaling approximately
$64,000, based on the closing price of our stock on that date. In January 2004, Mr. Fischbein
consolidated his October 1998 and February 2000 notes by issuing a two year promissory note payable
to Viragen totaling approximately $114,000. This promissory note bears interest at 3.5%, payable
semi-annually, and is secured by the underlying common stock purchased. Mr. Fischbein is current
with the semi-annual interest payments on this promissory note.
During May 1999, Charles F. Fistel, a former officer, exercised options totaling 41,000
shares. These options were all exercised through the issuance of promissory notes payable to
Viragen totaling $145,000, and related pledge and escrow agreements. The promissory notes bear
interest at 5.15%, payable semi-annually, and were secured by the
underlying shares of common stock
purchased. The shares of common stock purchased were held in escrow, pending payment of the related
notes pursuant to the provisions of the pledge and escrow agreements. Mr. Fistel paid $30,000 of
the principal on his promissory notes, plus related interest, during March 2000. A pro-rated number
of escrowed shares of common stock were released to Mr. Fistel upon receipt of his payment. On
June 30, 2003, we reserved the uncollaterized portion of these notes totaling approximately
$47,000, based on the closing price of our stock on that date. In February 2004, following default
on these promissory notes, we reclaimed the 31,000 shares of common stock held in escrow. These
shares of common stock were valued at $2.60 per share, the then market price. This resulted in an
$80,600 reduction of the outstanding principal on the notes. In May 2004, Mr. Fistels outstanding
principal was further reduced by $22,000 as a result of his surrendering to Viragen 100,000 shares
of Viragen USA valued at $0.22 per share. The outstanding balance on this note is fully reserved as
of June 30, 2005.
F-38
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE I
LICENSE AND MANUFACTURING AGREEMENTS
On July 12, 1995 Viragen (Scotland), a wholly owned subsidiary of Viragen International, Inc.,
entered into a technology license agreement (License Agreement) with Viragen Technology, Inc., a
wholly owned subsidiary of Viragen. The License Agreement granted Viragen (Scotland) rights to
certain proprietary technology, including the right to manufacture and distribute Omniferon.
On September 28, 2001, following Viragen Internationals acquisition of ViraNative, Viragen
(Scotland) and Viragen executed a Termination Agreement, terminating the License Agreement between
the parties. The License Agreement was terminated as Viragen International intends to
commercialize its Multiferon® technology following the ViraNative acquisition. This technology
does not utilize the technology obtained through the License Agreement and accordingly, no
additional royalties due under that agreement will be recognized after September 28, 2001. The
Termination Agreement also provides for mutual ongoing obligations with regard to confidentiality
and required that the $500,000 licensing fee that accrued from July 1, 2001 through September 28,
2001 would bear interest at 6% per annum and be paid in cash or stock within 12 months of the
agreement date, unless extended by mutual agreement of the parties. The parties agreed to extend
the date to December 31, 2002. On December 31, 2002, Viragen International settled the $500,000
licensing fee payable to Viragen, plus accrued interest totaling $37,500, through the issuance to
Viragen of 4,479,167 common shares of their common stock at $0.12 per share, the then current
market price.
NOTE J
COMMITMENTS
Lease agreements
In November 1996, Viragen entered into a ten year lease for 14,800 square feet of office space
in Plantation, Florida, which began on April 1, 1997. This facility contains our U.S.-based
executive and administrative offices. Current monthly rental on the property, including common area
maintenance charges and applicable taxes, is approximately $30,000. The lease contains provisions
for two additional five-year periods at the Companys option.
In November 1996, Viragen (Scotland) executed a five year lease, subsequently modified for
additional space, for a newly constructed laboratory and manufacturing facility located in
Pentlands Science Park near Edinburgh, Scotland. The facility consists of approximately 17,000
square feet with base monthly rental payments of approximately $33,000 plus common area and
maintenance charges. The lease further provides for up to four five year extensions at our option.
In October 2001, we exercised our first option to extend the lease through October 2006. In March
2002 and September 2003, we signed sub-lease agreements, sub-leasing a portion of our space to
third parties, with initial terms of one year, thereafter renewable on a monthly basis. The area
covered in these sub-lease agreements totals approximately 4,000 square feet generating monthly
sub-lease rent of approximately $8,000.
Through ViraNative, we lease approximately 25,500 square feet of laboratory, production and
office facilities in Umeå, Sweden. This space is covered by two separate leases. These leases were
renewed through December 2006 at a total lease cost of approximately $31,000 per month. Our
Multiferon® product is manufactured in this facility.
During the years ended June 30, 2005, 2004, and 2003, Viragen recognized rent expense and
related charges on facilities of approximately $1,169,000, $1,121,000 and $1,057,000, respectively.
We have entered into various lease agreements for miscellaneous office equipment. The
duration of these agreements ranges from twelve to sixty months from origination. The aggregate
base quarterly rental payment on these leases is approximately $14,000.
F-39
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE J COMMITMENTS (Continued)
The approximate minimum rental payments required under our facility and equipment lease
agreements with remaining terms of at lease one year as of June 30, 2005 are as follow:
|
|
|
|
|
Year ended June 30, |
|
Amount |
|
2006 |
|
$ |
1,181,000 |
|
2007 |
|
|
549,000 |
|
2008 |
|
|
39,000 |
|
2009 |
|
|
10,000 |
|
2010 |
|
|
|
|
Employment Contracts
Viragen has entered into employment agreements with certain officers and employees. These
agreements represent a commitment to pay an aggregate amount of approximately $875,000, per year in
salaries to these individuals. Viragen considers Mr. Charles A. Rice, president and chief executive
officer, and Mr. Dennis W. Healey, chief financial officer, to be key employees.
Viragen International
In connection with the acquisition of ViraNative by Viragen International, the former
shareholders of ViraNative are entitled to additional shares of Viragen International common stock
contingent upon the attainment of certain milestones related to regulatory approvals:
|
|
|
8,799,570 additional shares when and if a Mutual Recognition Procedures application is
filed and receives approval from the requisite national and EU regulatory authorities for
the use, sale and marketing of Multiferon® in certain countries, which must include
Germany; and |
|
|
|
|
2,933,190 additional shares when and if Multiferon® has been approved by the requisite
regulatory bodies in the EU for the treatment of Melanoma or when Multiferon® has been
approved by the requisite regulatory bodies for sale in the USA. |
If and as each of these milestones is met, additional shares of Viragen International will be
issued.
NOTE K CONTRIBUTION
During the fiscal year ended June 30, 2005 we received a contribution in the amount of
$278,000 from a business development agency in Sweden. This contribution was awarded in connection
with our capital investment in our renovated facility in Umeå, Sweden, which was completed during
our fiscal year ended June 30, 2004. This contribution was recorded as a reduction of the cost of
the building improvements. We could be required to repay a portion of this contribution if we do
not meet certain conditions under the award, including, but not limited to, keeping the facility in
operation. The amount we could be required to repay decreases on an annual basis beginning in July
2005. After July 2005, we could only be required to repay 70% of the award. Upon the second,
third and fourth anniversary, the repayment amount decreases to 45%, 25% and 10%, respectively, of
the award. At this time, we have no reason to believe we will be required to repay any portion of
the contribution.
F-40
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE L LEGAL PROCEEDINGS
In October 1997, Viragen, the Companys former president and Cytoferon Corp., a former
affiliate of the president, were named as defendants in a civil action brought in the United States
District Court for the Southern District of Florida (Walter L. Smith v Cytoferon Corp. et al; Case
No: 97-3187-CIV-MARCUS). The plaintiff is a former Viragen stockholder and investor in Cytoferon
Corp. The suit alleged the defendants violated federal and state securities laws, federal and state
RICO statutes, fraud, conspiracy, breach of fiduciary duties and breach of contract. The plaintiff
was seeking an unspecified monetary judgement and the delivery of 441,368 shares of common stock.
Viragen filed a motion to dismiss denying the allegations and requesting reimbursement of its
costs.
In November 1997, the plaintiff filed a notice of voluntary dismissal with the federal court
concurrently notifying Viragen of his intent to refile a complaint in circuit court in the state of
Florida. In December 1998, the U.S. District Court awarded us reimbursement of attorneys fees and
expenses under Rule 11 of the Federal Rules of Civil Procedure and the Private Securities
Litigation Reform Act. We recovered $31,000 during fiscal 2000.
In November 1997, the plaintiff filed a complaint in the Circuit Court of the 11th Judicial
Circuit for Miami-Dade County, Florida (Case No: 97-25587 CA30) naming the same defendants. The
suit alleges breach of contract, fraud, and violation of Floridas RICO statute and breach of
fiduciary duties. It sought an unspecified monetary judgment and specific performance delivery of
441,368 shares of Viragen common stock. The plaintiff claimed that he was entitled to additional
shares of common stock under a consulting agreement. He also claimed that Viragens former
president breached his fiduciary duty to Cytoferon by not achieving sufficient financing for
Viragen, which would have entitled Cytoferon to additional shares. He also claimed
misrepresentations in connection with the previous Cytoferon financings.
In March 1998, the Circuit Court granted Viragens motion to dismiss the complaint.
Subsequently, the plaintiff filed an amended complaint alleging breach of contract, fraud,
violation of Floridas RICO Act and breach of fiduciary duties and seeking an unspecified monetary
judgment and specific performance delivery of 441,368 shares of common stock. In April 1998,
Viragen filed a motion to dismiss plaintiffs amended complaint which was denied by the court.
In August 2000, counsel for plaintiff indicated that they intended to withdraw as counsel. In
January 2001, the Circuit Court ruled in favor of Viragen on all counts related to the Circuit
Court Case (No.: 97-25587 CA30). No further claims against Viragen are pending in this matter.
Viragen has submitted to the Circuit Court a request for reimbursement of related litigation costs.
In July 2002, the Circuit Court ruled in favor of Mr. Smith and Cytoferon and all counts against
these defendants were dismissed. Following this ruling, we filed for recovery of related litigation
costs in these matters. In April 2003, we were notified that the plaintiff and their counsel were
appealing the award of approximately $210,000 in legal fees. We are currently vigorously pursuing
the recovery of these fees.
In February 2001, Viragen filed a lawsuit, (Viragen, Inc. v. Walter Larry Smith, W. Richard
Leuck, Roland St. Louis, Jr., Esq., Juan C. Martinez, Esq., St. Louis, Guerra, Auslander, P.A. and
John Does Nos. 1-10, Case No. 01-3842 CA 01) in a malicious prosecution and conspiracy action
against the above mentioned parties in a attempt to recapture the losses incurred by Viragen, Inc.
as a result of having to disclose the lawsuit Walter L. Smith v. Gerald Smith, Cytoferon Corp.,
Viragen, Inc. and John Does Nos. 1-10, Case No. 97-25587 CA (30) (Smith Litigation) as well as
the attorneys fees and costs expended by Viragen, Inc. in defending this action. The Smith
Litigation wrongfully alleged that Viragen, Inc. engaged in, among other things, fraud and RICO
violations during the course of a 1992 stock offering done by Cytoferon, Corp. In the Smith
Litigation, the Court granted final summary judgment in favor of Viragen, Inc., specifically
finding that there was no evidence connecting Viragen, Inc. in any way to the allegations made
against it in the complaint in that action.
Due to the insolvency of one insurance carrier of certain defendants in this case, hearings in
this matter had been repeatedly postponed. In September 2005, a Florida court ruled that one
attorney defendant was covered by a different insurance carrier. We have agreed to a mediation
conference with this defendant to be held in the fourth calendar quarter of 2005. We continue to
vigorously pursue our claims in this matter.
F-41
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE M
- RECENT ACCOUNTING PRONOUNCEMENTS
In December 2004, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standards (SFAS) No. 123R, Share-Based Payment, which is a revision of SFAS
No. 123, Accounting for Stock-Based Compensation. SFAS No. 123R requires all share-based payments
to employees, including grants of employee stock options, to be recognized in the income statement
based on their fair values. This new standard was to be effective for public companies in the
first interim or annual reporting period beginning after June 15, 2005. In April 2005, the
Securities and Exchange Commission (SEC) adopted a new rule, which changed the compliance date of
SFAS No. 123R to the first interim or annual reporting period of the first fiscal year beginning
after June 15, 2005. Since our fiscal year end is June 30, this new rule will not change our
scheduled adoption date of July 1, 2005. SFAS No. 123R permits public companies to adopt its
requirements using one of two methods:
|
1. |
|
A modified prospective method in which compensation cost is recognized beginning with
the effective date (a) based on the requirements of SFAS No. 123R for all share-based
payments granted after the effective date and (b) based on the requirements of SFAS No. 123
for all awards granted to employees prior to the effective date of SFAS No. 123R that
remain unvested on the effective date. |
|
|
2. |
|
A modified retrospective method which includes the requirements of the modified
prospective method described above, but also permits entities to restate based on the
amounts previously recognized under SFAS No. 123 for purposes of pro forma disclosures
either (a) all prior periods presented or (b) prior interim periods of the year of
adoption. |
We plan to use the modified prospective method adopt the requirements of SFAS 123R. We continue
to evaluate technical implementation issues relating to the adoption of SFAS No. 123R, including
the selection and use of an appropriate valuation model.
We are unable to determine the future impact of the adoption of SFAS No. 123R on our results
of operations because the amount and terms of future share-based payments are not known at this
time. However, using the Black-Scholes model for valuating stock-based compensation under SFAS No.
148 would result in expense for options granted in prior years of approximately $17,000 for each of
the years ending June 30, 2006, 2007 and 2008. Had we adopted SFAS No. 123R in prior periods, the
impact of that standard would have approximated the impact of SFAS No. 123 as described in the
disclosure of pro forma net loss and loss per common share in Note A.
In
November 2004, the FASB issued SFAS No. 151, Inventory Costs - an Amendment of ARB No. 43,
Chapter 4. SFAS No. 151 amends ARB 43, Chapter 4, to clarify that abnormal amounts of idle facility
expense, freight, handling costs, and wasted materials (spoilage) should be recognized as
current-period charges. Historically, we have expensed such costs as incurred. In addition, this
Statement requires that allocation of fixed production overheads to the costs of conversion be
based on the normal capacity of the production facilities. The provisions of this Statement are
effective for inventory costs incurred during fiscal years beginning after June 15, 2005. The
adoption of the provisions of SFAS No. 151 is not expected to have a material impact on our
financial position or results of operations.
F-42
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE N GEOGRAPHIC AND SEGMENT INFORMATION
We define geographical regions as countries in which we operate. We operate extensively
through our majority owned subsidiary, Viragen International, Inc., and its wholly owned
subsidiaries, ViraNative AB, a Swedish company located in Umeå, Sweden and Viragen (Scotland) Ltd.,
a Scottish company located in Edinburgh, Scotland. ViraNative and Viragen (Scotland) house our
manufacturing and research laboratory facilities. Our corporate headquarters located in
Plantation, Florida conducts only administrative activities.
The following table reconciles long-lived assets by geographic region to the consolidated total:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
Region |
|
2005 |
|
|
2004 |
|
United Kingdom |
|
$ |
2,753,551 |
|
|
$ |
3,165,472 |
|
Sweden |
|
|
8,100,801 |
|
|
|
15,501,720 |
|
United States |
|
|
202,508 |
|
|
|
281,451 |
|
|
|
|
|
|
|
|
|
|
$ |
11,056,860 |
|
|
$ |
18,948,643 |
|
|
|
|
|
|
|
|
Our product sales are currently derived from the sale of natural human alpha interferon. All
of our product sales for 2005, 2004 and 2003 have been to external customers located outside of the
United States. Product sales are attributed to external customers in individual countries based on
the location of the customer.
The following table illustrates product sales by country:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended June 30, |
|
Country |
|
2005 |
|
|
% |
|
|
2004 |
|
|
% |
|
|
2003 |
|
|
% |
|
Sweden |
|
$ |
156,489 |
|
|
|
56.1 |
|
|
$ |
140,320 |
|
|
|
52.7 |
|
|
$ |
193,785 |
|
|
|
30.7 |
|
Germany |
|
|
43,946 |
|
|
|
15.8 |
|
|
|
44,906 |
|
|
|
16.9 |
|
|
|
44,753 |
|
|
|
7.1 |
|
Indonesia |
|
|
32,094 |
|
|
|
11.5 |
|
|
|
45,188 |
|
|
|
17.0 |
|
|
|
68,374 |
|
|
|
10.8 |
|
Mexico |
|
|
24,661 |
|
|
|
8.9 |
|
|
|
35,723 |
|
|
|
13.4 |
|
|
|
|
|
|
|
|
|
Italy |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
287,769 |
|
|
|
45.6 |
|
Other |
|
|
21,594 |
|
|
|
7.7 |
|
|
|
|
|
|
|
|
|
|
|
36,104 |
|
|
|
5.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
278,784 |
|
|
|
|
|
|
$ |
266,137 |
|
|
|
|
|
|
$ |
630,785 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During fiscal 2003, a significant portion of our product sales and related costs were for the
sale of bulk product (semi-purified) to Alfa Wassermann under a contractual arrangement that
expired in December 2002.
F-43
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
NOTE O UNAUDITED QUARTERLY FINANCIAL INFORMATION
The following table presents selected quarterly financial information for the periods
indicated. This information has been derived from the Companys unaudited quarterly consolidated
financial statements, which in the opinion of management includes all adjustments (consisting only
of normal recurring adjustments) necessary for a fair presentation of such information. The
quarterly per share data presented below was calculated separately and may not sum to the annual
figures presented in the consolidated financial statements. These operating results are also not
necessarily indicative of results for any future period. On June 15, 2004, Viragen effected a one
for ten reverse stock split. All share and per share information herein has been retroactively
restated to reflect this reverse stock split.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
September 30 |
|
|
December 31 |
|
|
March 31 |
|
|
June 30 |
|
Fiscal 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
30,417 |
|
|
$ |
52,548 |
|
|
$ |
80,078 |
|
|
$ |
115,741 |
|
Cost of sales |
|
|
476,260 |
|
|
|
754,352 |
|
|
|
604,944 |
|
|
|
775,850 |
|
Net loss |
|
|
(4,320,890 |
) |
|
|
(3,587,432 |
) |
|
|
(4,844,756 |
) |
|
|
(13,454,628 |
) |
Net loss
attributable to
common stock |
|
|
(4,321,427 |
) |
|
|
(3,587,970 |
) |
|
|
(4,845,293 |
) |
|
|
(13,455,166 |
) |
Basic and diluted
net loss per common
share |
|
$ |
(0.12 |
) |
|
$ |
(0.10 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.36 |
) |
Weighted average
common shares
outstanding |
|
|
36,568,385 |
|
|
|
36,568,385 |
|
|
|
36,568,385 |
|
|
|
37,087,677 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal 2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
51,606 |
|
|
$ |
60,041 |
|
|
$ |
76,678 |
|
|
$ |
77,812 |
|
Cost of sales |
|
|
369,007 |
|
|
|
532,023 |
|
|
|
619,847 |
|
|
|
525,922 |
|
Net loss |
|
|
(3,903,253 |
) |
|
|
(7,337,796 |
) |
|
|
(3,047,550 |
) |
|
|
(3,888,565 |
) |
Net loss
attributable to
common stock |
|
|
(3,903,915 |
) |
|
|
(7,338,459 |
) |
|
|
(3,048,213 |
) |
|
|
(3,889,127 |
) |
Basic and diluted
net loss per common
share |
|
$ |
(0.14 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.11 |
) |
Weighted average
common shares
outstanding |
|
|
27,336,080 |
|
|
|
32,531,422 |
|
|
|
36,373,036 |
|
|
|
36,566,219 |
|
During the quarter ended December 31, 2004, we recorded a write-down of our finished
goods inventory in the amount of $539,900. During the quarter ended June 30, 2005, we recorded an
additional write-down of our finished goods inventory in the amount of $180,550 as well as an
impairment of our goodwill of $6,936,215.
F-44
INDEX OF EXHIBITS
As required under Item 15. Exhibits and Financial Statements Schedules, the exhibits filed as
part of this report are provided in this separate section. The exhibits included in this section
are as follows:
|
|
|
Exhibit No. |
|
Description |
21.1
|
|
Subsidiaries of the Registrant |
|
|
|
23.1
|
|
Consent of Independent Registered Public Accounting Firm |
|
|
|
31.1
|
|
Certification Pursuant to 18 U.S.C. Section 1350, As Adopted
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
31.2
|
|
Certification Pursuant to 18 U.S.C. Section 1350, As Adopted
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
32.1
|
|
Certification Pursuant to 18 U.S.C. Section 1350, As Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
32.2
|
|
Certification Pursuant to 18 U.S.C. Section 1350, As Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |