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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 10-K
FOR ANNUAL AND TRANSITION REPORTS
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
(Mark one)
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended June 30, 2004.
or
[_] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ______ to ________.
Commission file number: 0-12104
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IMMUNOMEDICS, INC.
(Exact name of registrant as specified in its charter)
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Delaware 61-1009366
(State of incorporation) (I.R.S. Employer
Identification No.)
300 American Road, Morris Plains, New Jersey 07950
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (973) 605-8200
Securities registered pursuant to Section 12(b) of the Act:
None
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, $0.01 par value
Series G Junior Participating Preferred Stock, $0.01 par value
(Title of each class)
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 requirement for the past 90 days. Yes [X] No [_]
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 the registrant's 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 whether the registrant is an accelerated filer (as
defined in Exchange Act Rule 12b-2). Yes [X] No [_]
The aggregate market value of the registrant's common stock held by
non-affiliates computed by reference to the price at which the common stock was
last sold as of December 31, 2003 was $216,961,854. The number of shares of the
registrant's common stock outstanding as of September 7, 2004 was 54,073,059.
Documents Incorporated by Reference:
Certain information required in Part III of this Annual Report on Form
10-K will be set forth in, and incorporated from the registrant's Proxy
Statement for the 2004 Annual Meeting of Stockholders, which will be filed by
the registrant with the Securities and Exchange Commission not later than 120
days after the end of the registrant's fiscal year ended June 30, 2004.
PART I
Item 1 - Business
Introduction
Immunomedics, Inc. (the "Company," "we," "our," or "us") is a
biopharmaceutical company focused on the development of monoclonal
antibody-based products for the targeted treatment of cancer, autoimmune and
other serious diseases. We have developed a number of advanced proprietary
technologies that allow us to create humanized antibodies that can be used
either alone in unlabeled, or "naked" form, or conjugated with radioactive
isotopes, chemotherapeutics or toxins, in each case to create highly targeted
agents. Using these technologies, we have built a pipeline of therapeutic
product candidates that utilize several different mechanisms of action. We
believe that our portfolio of intellectual property which includes approximately
90 issued patents in the United States and more than 250 other issued patents
worldwide, protects our product candidates and technologies.
In addition to our potential therapeutic products, our proprietary
technologies have also enabled us to develop highly specific diagnostic imaging
agents, one of which, CEA-Scan(R), has been approved for use in the United
States, Canada and the European Union, where it is currently being marketed for
the detection of colorectal cancers. Our second diagnostic product,
LeukoScan(R), has been approved in Europe and Australia, where it is currently
being marketed for the detection of bone infections. The sale of diagnostic
imaging agents is not a critical part of our business; however, these diagnostic
products provide revenue that offset a portion of our expenditures on our
therapeutic product candidates.
Therapeutic Product Candidates
We believe that each of our antibodies has therapeutic potential either
when administered alone or when conjugated with therapeutic radioisotopes
(radiolabeled), chemotherapeutics or other toxins to create unique and
potentially more effective treatment options. The attachment of various
compounds to antibodies is intended to allow the delivery of these therapeutic
agents to tumor sites with greater precision than conventional radiation therapy
or chemotherapeutic approaches. This treatment method is designed to reduce the
total exposure of the patient to the therapeutic agents, which ideally minimizes
debilitating side effects. We are currently focusing our efforts on unlabeled,
or "naked" antibodies and antibodies conjugated with drugs or toxins, and to
lesser extent on the use of radioisotopes, such as Yttrium-90, sometimes
referred to as Y-90, and Iodine-131, sometimes referred to as I-131. All of our
therapeutic product candidates are "humanized" antibodies, which means that the
portion of the antibody derived from mouse (murine) DNA sequences is generally
less than 10%.
We currently have humanized antibody product candidates in clinical
development targeting B-cell Non-Hodgkins Lymphoma (NHL), autoimmune diseases
and various solid tumors. We also have a number of other product candidates that
target solid tumors and hematologic malignancies and other diseases in various
stages of pre-clinical development, although it is too early to assess which of
these, if any, will merit further evaluation in clinical trials.
2
The table below summarizes the status of our current therapeutic product
candidates in clinical development:
Program and Product Candidate Description/Target Antigen Disease Indication Development Status
- ----------------------------- -------------------------- --------------------------------- -------------------
CD22 Program: Epratuzumab
IMMU-103 Unlabeled CD22 antibody Non-Hodgkin's lymphoma Phase II clinical
trials completed
Autoimmune Disease, Phase II clinical
Systemic lupus erythmatosus (SLE) trial completed
Sjogren's Syndrome Phase II clinical
trial ongoing
IMMU-102 Y-90-labeled CD22 antibody Non-Hodgkin's lymphoma Phase I/II clinical
trials ongoing
CD20 Program
IMMU-106 Unlabeled CD20 antibody Non-Hodgkin's lymphoma Phase I/II clinical
trial ongoing
PAM4 Program
IMMU-107 Y-90-labeled PAM4 antibody Pancreatic cancer Phase I/II clinical
trial open to
enrollment
AFP Program
IMMU-105 Y-90-labeled AFP antibody Hepatocellular carcinoma Phase I/II clinical
trial ongoing
CEA Program: Labetuzumab
IMMU-100 Unlabeled CEA antibody Colorectal and breast cancers Phase I/II clinical
trial completed
IMMU-101 Y-90-labeled CEA antibody Colorectal and pancreatic cancers Phase I clinical
trial completed
IMMU-111 I-131-labeled CEA antibody Metastatic colorectal cancer Phase II clinical
trial completed
CD22 Program: Epratuzumab
Our most advanced therapeutic product candidate, IMMU-103, is an unlabeled
humanized antibody which targets an antigen, known as the CD22 marker, found on
the surface of a certain class of lymphocytes, a type of white blood cell. This
antibody also binds to the malignant forms of these cells that comprise NHL and
acute and chronic lymphocytic leukemias. The clinical trials of IMMU-103, which
involved more than 340 patients, demonstrated good safety, tolerability and
anti-tumor activity.
3
Two multi-center Phase II trials have been completed evaluating
epratuzumab, administered in combination with rituximab, in patients with NHL.
Rituximab is a CD20 antibody product for the treatment of NHL, having annual
sales exceeding $ 1.6 billion. Results from one Phase II trial, presented in
December 2003 at the American Society of Hematology's 45th Annual Meeting,
included 43 patients with chemotherapy relapsed or refractory follicular,
low-grade NHL and six patients with chronic lymphocytic leukemia (CLL) or small
lymphocytic lymphoma (SLL). At the time of this presentation, 25 patients with
follicular low-grade NHL experienced objective responses, including 12 (28%)
complete responses/complete unconfirmed responses and 13 (30%) partial
responses. Three of the six CLL/SLL patients experienced objective responses:
two experienced complete responses and one experienced a partial response. At
the time of the filing of this Annual Report on Form 10-K, 15 patients are in
remission.
Results from the second multi-center Phase II trial evaluating IMMU-103 in
combination with rituximab were presented at the 40th Annual Meeting of the
American Society of Clinical Oncology in June 2004. This study enrolled 65
patients, 45 with low-grade NHL and 20 with aggressive NHL. At the time of such
presentation, 20 of the 35 evaluable patients with low-grade NHL achieved an
objective response, including eight (23%) complete/unconfirmed complete
responses and twelve (34%) partial responses. Thirteen patients with a type of
aggressive NHL, called diffuse large B-cell lymphoma, were evaluable and six of
these thirteen patients achieved an objective response, including three (23%)
each having complete responses/unconfirmed complete responses or partial
responses. Each study concluded that the combination of epratuzumab and
rituximab was feasible, well tolerated and had promising anti-lymphoma activity,
warranting further study in a prospective randomized clinical trial.
Investigators at Mayo Clinic studied epratuxumab in combination with
CHOP-R (chemotherapy plus rituximab) in patients with diffuse large B-cell
lymphoma (DLBCL). Results were presented at the 40th Annual Meeting of the
American Society of Clinical Oncology in June 2004. Fifteen patients were
treated according to the protocol. Investigators concluded that CHOP-ER
(chemotherapy plus epratuzumab plus rituximab) is feasible for newly diagnosed
patients with DLBCL and further studies are needed to fully assess clinical
benefits of this regimen, if any.
We have also begun the evaluation of IMMU-103 in patients with certain
autoimmune diseases. In May 2004, clinical results of epratuzumab in patients
with systemic lupus erythematosus were presented at the 7th International
Congress on Systemic Lupus Erythematosus (SLE). Epratuzumab was administered as
a single agent in patients with SLE. The objective of this single-center study
was to evaluate the safety, tolerability, lack of immunogenicity and early
efficacy of epratuzumab, administered every other week, for a total of four
doses. At the time of such presentation, there were nine evaluable patients who
had completed all four doses of epratuzumab. A scoring system called BILAG
(British Isle Lupus Activity Grade) was used to determine the level of disease
activity in these patients prior to, and at several time points post
administration of, epratuzumab. Patients with mild to moderate SLE activity
(defined by Global BILAG scores of 6-12 prior to treatment) were enrolled. SLE
assessments after treatment demonstrated consistent clinical improvement, with
decreased global BILAG scores for each patient compared to the pre-therapy
scores. The investigators concluded that these preliminary results in SLE
patients with mildly to moderately active disease indicate epratuzumab is well
tolerated and can be infused in approximately one half-hour, without evidence of
reactions or immunogenicity. Early efficacy data suggests clinical improvement
continuing for at least one month after treatment.
While the clinical results to date have been encouraging, we are not able
to determine when, if ever, epratuzumab will be approved for sale in the United
States or anywhere else. Even if it is approved, there can be no assurance that
it will be commercially successful or that we will ever receive revenues equal
to our financial investment in this product candidate.
4
CD22-Y-90 Program
We continue to evaluate IMMU-102 (Y-90-labeled epratuzumab) in a Phase
I/II clinical trial being conducted in Europe. This clinical trial is examining
the safety and efficacy of IMMU-102 in patients with indolent or aggressive NHL
who have had a relapse of disease following standard chemotherapy. Most recent
results of this ongoing multicenter, dose-escalation trial were reported at the
June 2004 meeting of the European Hematology Association. In this
fractionated-dose study, the amount of Y-90 attached to the antibody is
gradually increased weekly, with two or three administrations per patient. Eight
of the 16 patients (50%) had objective responses (five complete
responses/unconfirmed complete responses and three partial responses), which
were continuing at the time of presentation. These responses were obtained in
patients who failed chemotherapy or chemotherapy with prior bone transplant, and
in patients with both indolent and aggressive lymphoma, including mantle-cell
lymphoma. Treatment has been well tolerated and this dose escalation clinical
trial is nearing complete patient enrollement. We are encouraged by these
initial results using a novel dosing schedule that may allow higher accumulation
of radioactivity in the tumors.
CD20 Program
CD20 is an antigen that is expressed similarly to CD22 on B-lymphocytes
and lymphomas. Rituximab, which has been approved for the therapy of indolent
NHL, is a chimeric antibody (comprised of one-third mouse and two-thirds human
protein) and has annual revenues exceeding $1.6 billion. Our CD20 monoclonal
antibody, called IMMU-106, is humanized (90-95% human and the remainder mouse),
and is constructed of binding sites to CD20, which are very similar to
rituximab. We believe our Company is the first to bring a humanized CD20
antibody into clinical testing, initially in NHL patients and in near-future
expansion into autoimmune diseases. We believe that this humanized CD20 antibody
may be more appropriate to use in patients with non-malignant, B-cell diseases,
where repeated dosing could be required, with less immunogenicity at risk than
with forms that have increased levels of mouse protein.
PAM4-Y-90 Program
We have developed a humanized monoclonal antibody, called IMMU-107 (PAM4),
which appears to be highly specific for pancreatic cancer. Our preclinical
studies in mice with transplanted human pancreatic cancer have demonstrated that
the antibody labeled with Y-90 has activity by itself as well as in combination
with gemcitabine, a radiosensitizing chemotherapeutic that is commonly used to
treat this disease. In fact, the combination appeared to be more effective than
either IMMU-107 or gemcitabine alone. A Phase I study has been opened for
enrollment at one cancer center, and we plan to expand this trial to other
institutions. We intend to evaluate IMMU-107 in a dose-escalation study before
evaluating it in combination with gemcitabine.
AFP-Y-90 Program
We have recently begun the clinical evaluation of IMMU-105, a new
humanized antibody labeled with Y-90, for the treatment of primary liver cancer.
IMMU-105 binds to an antigen known as alpha-fetoprotein (AFP), which is commonly
produced by primary liver tumors. Liver cancer is the third most frequent cancer
killer worldwide, and when diagnosed, has a very poor prognosis, a problem that
is similar to pancreatic cancer. The dose-escalation study has commenced at a
single site in the United States, and we plan to expand this trial to other
institutions.
5
CEA Program
In our CEA Program, we are developing a solid tumor therapeutic product
candidate that targets an antigen known as carcinoembryonic antigen, or CEA. The
CEA antigen is abundant at the site of virtually all cancers of the colon and
rectum, and is associated with many other solid tumors, such as breast and lung
cancers. Our humanized CEA antibody (hCEA) is in clinical testing both in
unlabeled (IMMU-100) and radiolabeled (IMMU-101 and IMMU-111) forms.
IMMU-100, the unlabeled form, has completed a Phase I/II dose-escalation
trial in patients with colorectal or breast cancer. This trial was performed to
demonstrate the safety of administering repeated high doses of the unlabeled CEA
antibody, so that future trials could examine unlabeled antibody combined with
chemotherapy in various solid tumors. This is because of preclinical results
suggesting that this antibody is capable of enhancing the effects of certain
cancer drugs.
IMMU-111, our I-131-labeled CEA antibody, has been tested in a
single-center, Phase II trial in Europe in patients with proven metastatic
colorectal cancer after surgical resection of their liver metastases. At the
January 2003 Gastrointestinal Cancer Conference of the American Society of
Clinical Oncology, we reported on 19 assessable patients who had a median
projected survival after liver resection of 46 months; 91% survived more than
one year, 82% more than two years, 54% more than three years, and 46% more than
four years. We believe that these initial results with IMMU-111 are encouraging,
and will need to be confirmed in a randomized trial comparing those receiving
IMMU-111 to standard care.
TheY-90-labeled CEA antibody, termed IMMU-101, has been tested in two
multicenter Phase I trials in patients with advanced colorectal or pancreatic
cancer. These trials have completed accrual. At the 51st Annual Meeting of the
Society of Nuclear Medicine held in June 2004, these studies, involving 15-18
patients each, showed tumor targeting, acceptable normal organ radiation doses,
and defined the maximum tolerated dose for a single administration. The
investigators concluded that future trials at the maximum tolerated dose are
warranted, especially in less heavily pretreated patient population.
CD74 Program
A humanized antibody, IMMU-115 (naked LL1), targeting CD74, which is
expressed on a number of hematological tumors, has been developed by the
Company. At the June 2004 Annual Meeting of the American Society of Clinical
Oncology, it was reported that this antibody has a broad spectrum of activity in
human B-cell lymphoma cell lines and tumors growing in mice, and also targets a
number of lymphoma and myeloma. It was also shown that IMMU-115 may have a
different mechanism of action than the CD20 antibodies, rituximab and IMMU-106.
We are in the process of completing our preclinical testing of this candidate
antibody product.
IMMU-110 is the CD74 antibody conjugated with the cancer drug,
doxorubicin. This antibody was chosen as our first drug immunoconjugate because
of its rapid internalization into CD74-expressing cells. Preclinical results,
published in Clinical Cancer Research in December 2003 and presented at the June
2004 Annual Meeting of the Society of Clinical Oncology, demonstrated that this
drug immunoconjugate was potent in killing human lymphoma and myeloma cells
grafted to mice, curing a large percentage even at very low doses of doxorubicin
that was attached to the antibody.
6
Diagnostic Imaging Products
Many of our proprietary technologies were originally conceived in the
course of our developing improved cancer diagnostics. Today, our diagnostic
imaging products allow the localization of disease-specific antigens within a
patient's body using an antibody fragment bound to technetium-99m, which can
then be visualized using conventional nuclear medicine equipment to reveal the
presence, location and approximate size of the disease sites. We have
transitioned our focus away from the development of diagnostic imaging products
in order to accelerate the development of our therapeutic product candidates. As
a result, as of June 30, 2004, research and development into diagnostic product
candidates was no longer a material portion of our business.
CEA-Scan
The mouse monoclonal anti-CEA antibody fragment in CEA-Scan(R) is the
diagnostic counterpart to IMMU-100, our humanized antibody described above. It
is directed against CEA, which is an antigen associated with virtually all
cancers of the colon and rectum as well as many other cancers.
LeukoScan
LeukoScan(R) uses a mouse monoclonal antibody fragment that first targets
and then binds to a type of white blood cell known as a granulocyte. These cells
are associated with a potentially wide range of infectious and inflammatory
diseases.
Research and Development Programs
We have historically invested heavily in our research and development
programs, spending approximately $21,934,000, $18,175,000 and $14,202,000 on
these programs during our fiscal years ended June 30, 2004, 2003 and 2002,
respectively, and we intend to continue to commit as much or more in the future.
The following is a brief summary of our principal research and development
programs as of August 23, 2004.
Antibody Engineering
We have made significant progress in recent years humanizing certain mouse
antibodies, which involves replacing certain components of a mouse antibody with
human antibody components using both our own expertise as well as certain
technologies licensed from a third party. Recent advances in molecular biology
have enabled our scientists to re-engineer these humanized antibodies with
improved characteristics, such as favorable pharmacokinetic properties and
increased radionuclide and/or drug loading capacities.
During the past year we, in collaboration with other investigators,
continued the successful targeting with our humanized monoclonal antibodies in
patients with the CEA cancer marker and non-Hodgkin's B-cell lymphoma as
compared to the use of murine counterparts. The antibodies are about 90% human
and have shown good uptake in the patients' tumors. We are now focusing on the
study of these humanized monoclonal antibodies, unlabeled and labeled with
Yttrium-90 (or Iodine-131), in patients with the appropriate target tumors.
Other Antibody-Directed Therapy Approaches
Our majority owned subsidiary, IBC Pharmaceuticals, Inc. ("IBC"), has been
working since 1999 on the development of novel cancer radiotherapeutics using
patented pre-targeting technologies with proprietary, bi-specific antibodies.
This pre-targeting technique involves the administration of an unlabeled
antibody to the patient on day one, followed by the administration of a separate
radionuclide or
7
other therapeutic, conjugated to a peptide, a few days later. This delay permits
the patient's body to eliminate antibodies, which have not bound to the disease
site and are therefore superfluous. A second recognition group is then attached,
either to the radionuclide or therapeutic drug, such that the radionuclide or
drug is localized to the antibody pre-targeted to the tumor site. Using such
methods in pre-clinical human tumor models, target-to-blood uptake ratios of
radionuclide have been improved by two-to-three times compared to the use of
antibodies radiolabeled in the conventional manner. While this advantage is
somewhat offset by the greater complexity involved in multiple administration
and timing of reagents, after achieving promising results from animal studies on
this technology, we have decided to continue clinical studies in France using
Iodine-131 as the therapeutic agent and a bi-specific antibody having our
humanized anti-CEA antibody.
A Phase I clinical trial, which has defined the maximum tolerated dose of
the I-131 peptide, and the optimal dose of the bispecific CEA antibody and the
interval between the unlabeled chemically conjugated bispecific antibody and the
labeled peptide, has been completed in France. Evidence of good tolerability and
disease stabilization were reported for this trial at scientific meetings,
including the June 2004 51st Annual Meeting of the Society of Nuclear Medicine.
Based on the positive outcome of the Phase I study, a multicenter Phase II study
in patients with medullary thyroid cancer (MTC) has been initiated. The primary
objective of this study is to confirm feasibility and safety and assess efficacy
in this rare disease with very limited therapeutic alternatives.
Preclinical studies by IBC continue for the development of new bispecific
antibodies (fusion protein) and peptides for improved targeting and treatment
strategies, including multiple binding-arms for the tumor-targeting antibody and
new carrier peptides that allow attachment of different kinds of therapeutic and
diagnostic isotopes. Some of these results have been published in prominent
cancer journals, such as Cancer Research and Clinical Cancer Research, and also
at cancer conferences, such as the 2004 Annual Meeting of the American
Association for Cancer Research. One or more of these new forms of each of the
two reagents are being studied and tested for potential further clinical
development. We believe that this new pre-targeting system may constitute the
next generation of cancer radioimmunotherapy, and may also be applicable for the
more targeted delivery of cancer drugs.
Peptides
During the past year, we continued to refine our proprietary methods for
the radiolabeling of peptides with technetium-99m (Tc-99m) to the point where we
are now capable of producing these peptides at clinical-scale levels using
single-vial kits. These methods will be generally applicable to the preparation
of radioconjugates and will enable rapid evaluation of different
peptide-receptor systems. In related work, similar synthetic methods have also
been used to prepare peptide conjugates that can be radiolabeled with Gallium-68
(Ga-68), Indium-111 and Yttrium-90, which are being applied to the bi-specific
pre-targeting technology that is being developed through IBC. We believe that
these developments may allow for the introduction of a new class of diagnostic
imaging agents using both traditional gamma-emitting isotopes, such as Tc-99m,
and positron-emitting isotopes, such as Ga-68, particularly since pre-targeting
methods being developed with IBC, are showing very high tumor/normal tissue
ratios.
Patents and Proprietary Rights
Our Patents
We have accumulated a sizeable portfolio of patents and patent
applications in the course of our business, which we believe constitutes a very
valuable business asset. Some of these patents relate to our diagnostic imaging
products and product candidates, while others relate to our therapeutic product
8
candidates. Still others relate to our technologies and other discoveries for
which no product candidate has yet been identified. While the issuance of a
patent does not in itself assure us that our intellectual property rights will
remain secure, we believe that we have taken all reasonable steps necessary to
protect our technologies and inventions from misappropriation by others. As of
August 23, 2004, this portfolio included approximately 90 issued U.S. patents.
In addition, as of such date the portfolio included more than 250 issued foreign
patents, with a large number of U.S. and foreign patent applications pending.
We are aware of certain issued patents, as well as other patents pending,
which are owned by competitors of ours and, to the extent they are determined to
contain valid and enforceable claims, could result in a legal determination that
our products or technologies are infringing. This would result in our needing to
obtain a license under such patents, which might not be available on
commercially reasonable terms, if at all. While we do not presently believe that
this will impair in any material respect our ability to operate our business and
commercialize our therapeutic product candidates, we cannot assure you that it
will not adversely affect our business.
Our Licenses
We have obtained licenses from various parties for rights to use
proprietary technologies and compounds. Included in the foregoing discussion of
patents is one U.S. patent and foreign counterparts, to which we have a right
pursuant to an exclusive license granted by Dr. David M. Goldenberg, our
Chairman and Chief Strategic Officer. We also have certain rights with respect
to patents and patent applications owned by the Center for Molecular Medicine
and Immunology, or CMMI, by virtue of a license agreement between CMMI and us.
In addition, we have certain rights with respect to patents and patent
applications assigned solely to the National Institutes of Health ("NIH") or
jointly to NIH and us, as well as with respect to certain patent applications
assigned to the University of Massachusetts. We also acquired rights to patents
and patent applications assigned or licensed to IBC by virtue of our acquisition
of a controlling interest in IBC.
In July 1998, we signed a license agreement with Dako A/B to our worldwide
patents for specific anti-CEA monoclonal antibodies, which Dako markets for in
vitro use. In June 2002, we granted a non-exclusive license to Daiichi Pure
Chemicals Co. under these patents, which included an up-front payment of
$825,300. In addition, we recorded royalty payments of $183,000 and $265,000 for
the years ended June 30, 2004 and 2003, respectively.
It is our policy to vigorously defend our intellectual property rights
where appropriate. Accordingly, at any time, and from time to time, we may be
engaged in licensing discussions with other parties that we believe may be
infringing our patents or other intellectual property rights.
Our Trademarks
The mark "IMMUNOMEDICS" is registered in the United States and 36 foreign
countries and a European Community Trademark has been granted. Our logo is also
registered in the United States and in two foreign countries. The mark
"IMMUSTRIP" is registered in the United States and Canada. The mark "CEA-SCAN"
is registered in the United States and 21 foreign countries, and a European
Community Trademark has been granted. The mark "LEUKOSCAN" is registered in the
United States and 11 foreign countries, and a European Community Trademark has
been granted. The mark "LYMPHOSCAN" is registered in the United States and nine
foreign countries, and a European Community Trademark has been granted. The mark
"CEA-CIDE" is registered in the United States and 14 foreign countries, and a
European Community Trademark has been granted. The mark "LYMPHOCIDE" is
registered in the United States, and a European Community Trademark has been
granted. In addition, we have applied for registration in the United States for
several other trademarks for use on products now in development or
9
testing, and for corresponding foreign and/or European Community Trademarks for
certain of those marks.
Our Trade Secrets
We also rely upon unpatented trade secrets, and we cannot assure you that
others will not independently develop substantially equivalent proprietary
information and techniques or otherwise gain access to our trade secrets or
disclose such technology, or that we can meaningfully protect such rights. We
require our employees, consultants, outside scientific collaborators, sponsored
researchers and other advisers to execute confidentiality agreements upon the
commencement of employment or consulting relationships with us. These agreements
provide that all confidential information developed or made known to the
individual during the course of the individual's relationship with us is to be
kept confidential and not disclosed to third parties except in specific
circumstances. In the case of our employees, the agreement provides that all
inventions conceived by such employees shall be our exclusive property. There
can be no assurance, however, that these agreements will provide meaningful
protection or adequate remedies for our trade secrets in the event of
unauthorized use or disclosure of such information.
Third Party Rights
Our success also depends in part on our ability to gain access to third
party patent and proprietary rights and to operate our business without
infringing on third party patent rights. We may be required to obtain licenses
to patents or other proprietary rights from third parties to develop,
manufacture and commercialize our product candidates. Licenses required under
third-party patents or proprietary rights may not be available on terms
acceptable to us, if at all. If we do not obtain the required licenses, we could
encounter delays in product development while we attempt to redesign products or
methods or we could be unable to develop, manufacture or sell products requiring
these licenses at all.
Strategic Partnering and Relationships
Amgen Inc.
On December 17, 2000, we entered into a Development and License Agreement
(the "Amgen Agreement") with Amgen Inc. ("Amgen"), whereby Amgen obtained
exclusive rights to continue the clinical development and commercialization in
North America and Australia of our unlabeled, or "naked," CD22 antibody
compound, epratuzumab, for the treatment of patients with non-Hodgkin's
lymphoma. We received an up-front payment of $18,000,000 that was recognized,
beginning February 2001, as revenue of $750,000 per month over a period of 24
months.
On April 8, 2004, pursuant to a termination agreement between Amgen and
us, Amgen returned all rights for epratuzumab, the humanized CD22 monoclonal
antibody therapeutic we licensed to Amgen as part of the Amgen Agreement in
December 2000, including rights to second generation molecules and conjugates.
As part of the transaction, we issued to Amgen a five-year warrant to
purchase 100,000 shares of our common stock at a price equal to $16.00 per share
with an estimated value of $310,000, which was recorded in the fourth quarter as
an expense of 2004. If epratuzumab is approved for commercialization in the
United States for NHL therapy, we will be required to pay Amgen a milestone
payment in the amount of $600,000. There are no other financial obligations
between the parties as a result of the Amgen Agreement.
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Other Collaborations
We conduct research on a number of our programs in collaboration with a
not-for-profit organization called The Center for Molecular Medicine and
Immunology, or CMMI, and its clinical unit, the Garden State Cancer Center. CMMI
performs contracted pilot and pre-clinical trials in scientific areas of
importance to us and also conducts basic research and pre-clinical evaluations
in a number of areas of potential interest to us. Dr. David M. Goldenberg, our
Chairman of the Board and Chief Strategic Officer, is the President and a
Trustee of CMMI.
In 2004, the Company received two Small Business Innovation Research Phase
I Grant Awards from the National Cancer Institute, one for $86,000, and one for
$100,000, each budgeted for a six-month period. The first award, entitled
"Molecular Imaging by Affinity Enhancement PET " will be applied to investigate
the use of bispecific antibodies and gallium-68-radiolabeled bivalent peptides
for specific targeting of disease and possible improved detection using positron
emission tomography, or PET. The combination of bispecific antibodies with
rapidly targeting and systemically clearing low molecular weight
gallium-68-radiolabeled agents, married to the sensitivity of PET detection
techniques, may lead to an entire new class of disease-specific imaging agents.
The second award, entitled "Minimal Disease Radioimmunotherapy of Colorectal
Cancer," will be applied to study the potential treatment of colorectal cancer
using a humanized, high affinity, anti-CEA humanized monoclonal antibody,
hMN-14, and an intracellularly-trapped "residualizing" form of iodine-131
radionuclide. This iodine-131-radiolabeled antibody, produced using our
proprietary radioiodination technology, is designed to solve the problem of in
vivo deiodination associated with directly radioiodinated MAbs, and thereby
deliver an enhanced dose of radiation to targeted tumor cells.
In October 2003, we entered into a research collaboration with Schering AG
of Berlin, Germany, involving bispecific antibody, pretargeting technologies for
cancer therapy being developed by IBC.
We also collaborate with numerous other academic and research centers. Our
academic collaborators have included such institutions as the University of
Nijmegen, The Netherlands; INSERM, Nantes, France; University of Gottingen,
Germany; University of Marburg, Germany; New York Presbyterian Hospital -
Cornell Medical College; University of Massachusetts; Fox Chase Cancer Center;
and Brigham & Women's Hospital-Harvard Medical School. We believe these ongoing
research efforts will identify new and improved products and techniques for
diagnosing and treating various cancers and infectious diseases.
Government Regulation
Regulatory Compliance
Our research and development activities, including testing in laboratory
animals and in humans, our manufacture of antibodies, as well as the handling,
labeling and storage of the product candidates that we are developing, are all
subject to stringent regulation, primarily by the U.S. Food and Drug
Administration (FDA) in the United States and by comparable authorities in other
countries. If for any reason we are unable to comply with applicable
requirements there will likely occur various adverse consequences, including one
or more delays in approval, or even the refusal to approve, product licenses or
other applications, the suspension or termination of clinical investigations,
the revocation of approvals previously granted, as well as fines, criminal
prosecution, recall or seizure of products, injunctions against shipping
products and total or partial suspension of production and/or refusal to allow
us to enter into governmental supply contracts.
11
The process of obtaining requisite FDA approval is costly and time
consuming even in the best of circumstances. For a new human drug or biological
product to be marketed in the United States, current FDA requirements include:
(i) the successful conclusion of pre-clinical tests to gain preliminary
information on the product's safety; (ii) the filing with the FDA of an
Investigational New Drug, or "IND," to conduct human clinical trials for drugs
or biologics; (iii) the successful completion of human clinical investigations
to establish the safety and efficacy of the product candidate for its intended
indication; and (iv) the filing and then acceptance and approval by the FDA of a
New Drug Application, or "NDA," for a drug product, or a Biological License
Application, or "BLA," for a biological product, in either case to allow
commercial distribution of the drug or biologic.
Pre-clinical tests involve the evaluation of the product candidate in both
the laboratory and in animal studies to assess safety as well as potential
efficacy. The results of the pre-clinical tests, if favorable, are then
submitted to the FDA as part of an IND to support the evaluation of the product
in human patients. Historically, the results from pre-clinical testing and early
clinical trials have often not been predictive of results obtained in later
clinical trials. A number of new drugs and biologics have shown promising
results in clinical trials, but subsequently failed to establish sufficient
safety and efficacy data to obtain necessary regulatory approvals. Data obtained
from pre-clinical and clinical activities are susceptible to varying
interpretations, which may delay, limit or prevent regulatory approval. In
addition, we may encounter regulatory delays or rejections as a result or many
factors, including changes in regulatory policy during the period of product
development.
Clinical trials involve administration of the product to patients under
the supervision of a qualified principal investigator. Such trials are typically
conducted in three sequential phases, although the phases may overlap.
Typically, clinical testing involves the following:
o In Phase I trials, the initial introduction of the drug into human
patients, the product candidate is tested for safety, dosage
tolerance, absorption, metabolism, distribution and excretion;
o Phase II trials involve further studies in a limited patient
population afflicted with a specified disease to: (i) determine the
biological or clinical activity of the product for specific,
targeted indications; (ii) determine dosage tolerance and optimal
dosage; and (iii) identify possible adverse effects and safety
risks; and
o In Phase III, large scale, multi-center, comparative clinical trials
are conducted with patients afflicted with a target disease in order
to provide enough data to statistically evaluate the efficacy and
safety of the product, as required by the FDA. Phase IV studies, or
post-marketing studies, may also be required to provide additional
data on safety or efficacy.
The results of the pre-clinical and clinical testing of a chemical
pharmaceutical product are then submitted to the FDA in the form of an NDA, or
for a biological pharmaceutical product in the form of a BLA, for approval to
commence commercial sales. In responding to an NDA or a BLA, the FDA may grant
marketing approval, request additional information or deny the application if it
determines that the application does not provide an adequate basis for approval.
We cannot assure you that any approval required by the FDA will be obtained on a
timely basis, if at all.
Among the conditions for an NDA or a BLA approval is the requirement that
the applicable manufacturing, clinical, pharmacovigilance, quality control and
manufacturing procedures conform on an ongoing basis with current Good Clinical
Practices, or GCP, current Good Manufacturing Practices, or GMP, and computer
information system validation standards. Before approval of a BLA, the FDA will
perform a pre-licensing inspection of clinical sites, manufacturing facilities
and the related quality control
12
records to determine its compliance with these requirements. To assure
compliance, applicants must continue to expend time, money and effort in the
area of training, production and quality control. After the applicant is
licensed for the manufacture of any product, manufacturers are subject to
periodic inspections by the FDA. We will also face similar inspections
coordinated by the European Medicine Agency, or EMEA, by inspectors from
particular European Union member states that conduct inspections on behalf of
the European Union.
The drug approval process is similar in other countries and is also
regulated by specific agencies in each geographic area. Approval by the FDA does
not ensure approval in other countries. In addition, even if we can obtain drug
approval in other countries, it may require considerable more time to obtain
such approval in the United States. In European Union countries, Canada, and
Australia, regulatory requirements and approval processes are similar in
principle to those in the United States and can be as rigorous, costly and
uncertain. Additionally, depending on the type of drug for which an applicant is
requesting approval, there are currently two potential tracks for marketing
approval in European Union countries: mutual recognition and the centralized
procedure. These review mechanisms may ultimately lead to approval in all
European Union countries, but each method grants all participating countries
some decision-making authority in product approval.
Orphan Drug Act
We generally seek to have our product candidates designated as "Orphan
Drugs" by the FDA under the Orphan Drug Act of 1983, when applicable. Under the
Orphan Drug Act, the FDA may grant orphan drug designation to drugs intended to
treat a "rare disease or condition," which generally is a disease or condition
that affects fewer than 200,000 individuals in the United States. Orphan drug
designation must be requested before submitting a BLA. After the FDA grants
orphan drug designation, the generic identity of the therapeutic agent and its
potential orphan use are publicly disclosed by the FDA. Orphan drug designation
does not convey any advantage in, or shorten the duration of, the regulatory
review and approval process. If a product which has an orphan drug designation
subsequently receives the first FDA approval for the indication for which it has
such designation, the product is entitled to orphan exclusivity, i.e., the FDA
may not approve any other applications to market the same drug for the same
indication for a period of seven years, except in certain very limited
circumstances.
To date, we have successfully obtained Orphan Drug designation for
AFP-Scan, LymphoScan, CEA-Scan(R), epratuzumab and labetuzumab. There can be no
assurance, however, that our competitors will not receive approval of other
different drugs or biologics for treatment of the diseases for which our
products and product candidates are targeted.
Other Regulatory Considerations
We are also subject to regulation under the Occupational Safety and Health
Act, the Toxic Substances Control Act, the Resource Conservation and Recovery
Act, The Clean Air Act, and other current and potential future federal, state,
or local regulations. Our research and development activities involve the
controlled use of hazardous materials, chemicals, biological materials and
various radioactive compounds. We believe that our procedures comply with the
standards prescribed by state and federal regulations; however, the risk of
injury or accidental contamination cannot be completely eliminated.
We are subject to the U.S. Foreign Corrupt Practices Act, which prohibits
corporations and individuals from engaging in certain activities to obtain or
retain business or to influence a person working in an official capacity. Under
this act, it is illegal to pay, offer to pay, or authorize the payment of
anything of value to any foreign government official, government staff member,
political party or political candidate in an attempt to obtain or retain
business or to otherwise influence a person working in an
13
official capacity. Our present and future business has been and will continue to
be subject to various other laws and regulations.
Pricing Controls
The levels of revenues and profitability of biopharmaceutical companies
may be affected by the continuing efforts of government and third party payers
to contain or reduce the costs of health care through various means. For
example, in certain foreign markets, pricing reimbursement or profitability of
therapeutic and other pharmaceutical products is subject to governmental
control. In the United States, there have been, and we expect that there will
continue to be, a number of federal and state proposals to implement similar
governmental pricing control. While we cannot predict whether any such
legislative or regulatory proposals will be adopted, the adoption of such
proposals could have a material adverse effect on our business, financial
condition and profitability.
Third Party Reimbursement
In addition, in the United States and elsewhere, sales of therapeutic and
other pharmaceutical products are dependent in part on the availability of
reimbursement to the consumer from third party payers, such as government and
private insurance plans. Third party payers are increasingly challenging the
prices charged for medical products and services. We cannot assure you that any
of our products will be considered cost effective and that reimbursement to the
consumer will be available or will be sufficient to allow us to sell our
products on a competitive and profitable basis.
Competition
Competition in the biopharmaceutical industry is intense and based
significantly on scientific and technological factors such as the availability
of patent and other protection for technology and products, the ability to
commercialize technological developments and the ability to obtain governmental
approval for testing, manufacturing and marketing. We compete with specialized
biopharmaceutical firms in the United States, Europe and elsewhere, as well as a
growing number of large pharmaceutical companies. Many biopharmaceutical
companies have focused their development efforts in the human therapeutics area,
including cancer. Many major pharmaceutical companies have developed or acquired
internal biotechnology capabilities or made commercial arrangements with other
biopharmaceutical companies. Further, such companies have substantially greater
financial resources and greater access to capital markets than we do. These
companies, as well as academic institutions, governmental agencies and private
research organizations, also compete with us in recruiting and retaining highly
qualified scientific, technical and professional personnel and consultants. Our
ability to compete successfully with other companies in the biopharmaceutical
field will also depend to a considerable degree on the continuing availability
of capital to us.
We are aware of certain products under development or manufactured and
commercialized by competitors that are used for the prevention, diagnosis or
treatment of certain diseases that we have targeted for product development. In
addition, we are aware of several companies that have potential antibody or
other product candidates that target the same antigen as our lead product
candidate, epratuzumab, as well as various other biopharmaceutical products that
are likely to compete directly with our product candidates.
We expect that our products under development and in clinical trials will
address major markets within the cancer sector. Our competition will be
determined in part by the potential indications for which drugs are developed
and ultimately approved by regulatory authorities. Additionally, the timing of
market introduction of some of our potential products or of competitors'
products may be an important
14
competitive factor. Accordingly, the relative speed with which we can develop
products, complete pre-clinical testing, clinical trials and approval processes
and supply commercial quantities to market are expected to be important
competitive factors. We expect that competition among products approved for sale
will be based on various factors, including product efficacy, safety,
reliability, availability, price, availability of reimbursement, patent
position, manufacturing capacity and capability, distribution capability and
government action. We cannot assure you that we will be able to compete
successfully in any of these areas, and our inability to compete would
materially and adversely affect our business prospects.
Marketing, Sales and Distribution
At present we have only limited marketing and sale capabilities as we
focus our efforts on developing our therapeutic product candidates. CEA-Scan(R)
is marketed and sold to physicians in the United States directly by our small
internal sales force, which is focused on new customers in major medical
centers. Our nuclear medicine technicians work with our sales force and provide
technical support directly to customers. We also have agreements with third
parties to market CEA-Scan(R) and LeukoScan(R) that provide customer support and
distribution of the products.
Our European operations are headquartered in Darmstadt, Germany. We have
also established sales representation in most major European markets. We service
other markets through the appointment of local organizations that provide sales
and marketing support as well as local product redistribution. In October 2001,
we entered into a Distribution Agreement with Logosys Logistik GmbH. Under this
agreement, Logosys packages and distributes LeukoScan(R) and CEA-Scan(R) in the
European Union since January 2002. We will continue to evaluate future
arrangements and opportunities with respect to other products we may develop in
order to optimize our profits and our distribution, marketing and sales
capabilities.
Manufacturing
We have completed the construction of a large-scale bioreactor facility at
our Morris Plains, New Jersey, location. This facility will be used for the
production of all of our therapeutic product candidates for clinical trials, and
potentially in commercial quantities as well. We are now in the process of
validating the utilities, equipment and systems associated with this facility
and we have begun process validation, involving the production of antibodies for
current and future clinical trials.
We have historically manufactured CEA-Scan(R) and LeukoScan(R) for
commercial sale at our facility in Morris Plains. We also perform antibody
processing and purification of all our therapeutic product candidates at this
facility. We have scaled-up our antibody purification and fragmentation
manufacturing processes for our diagnostic imaging agents to permit us to
produce commercial levels of product. Our purification area consists of four
independent antibody-manufacturing suites, several support areas, and quality
control laboratories. The Committee on Proprietary Medicinal Products of the
European Commission approved the manufacturing facility and product
manufacturing processes in May 1998. The FDA approved the facility and processes
for CEA-Scan(R) in December 1998.
Reliance on Third Parties
Certain end-stage portions of the manufacturing process for CEA-Scan(R)
and LeukoScan(R) were performed under a manufacturing agreement with SP
Pharmaceuticals. This arrangement was terminated in December 2002. We are
currently in the process of validating our end-stage manufacturing processes at
a new manufacturing source.
15
We currently rely on third parties to supply raw materials and to perform
certain end-stage portions of the manufacturing process for our diagnostic
imaging products, CEA-Scan(R) and LeukoScan(R). We do not currently have the
resources necessary to perform these processes, and if our third party suppliers
were to become unwilling or unable to do so for any reason, we would be unable
to deliver these products to customers until we entered into an agreement with
another qualified manufacturer. This could cause substantial delays in customer
deliveries and adversely affect our results of operations.
Other Regulatory Considerations
In addition to regulating and auditing human clinical trials, the FDA
regulates and inspects equipment, facilities and processes used in the
manufacturing of such products prior to providing approval to market a product.
If after receiving clearance from the FDA, a material change is made in
manufacturing equipment, location, or process, additional regulatory review may
be required. We must also adhere to current Good Manufacturing Practice and
product-specific regulations enforced by the FDA through its facilities
inspection program. The FDA also conducts regular, periodic visits to re-inspect
equipment, facilities, and processes following the initial approval. If, as a
result of these inspections, the FDA determines that our equipment, facilities
or processes do not comply with applicable FDA regulations and conditions of
product approval, the FDA may seek civil, criminal or administrative sanctions
and/or remedies against us, including the suspension of our manufacturing
operations.
CEA-Scan(R) and certain of our other imaging agents are derived from the
fluids produced in mice. Regulatory authorities, particularly in Europe, have
expressed concerns about the use of these fluids for the production of
monoclonal antibodies. These regulatory authorities may determine that our
quality control procedures for these products are inadequate. While we are
continuing our development efforts to produce certain of our monoclonal
antibodies using alternative methods, this process constitutes a substantial
production change, which in itself will require additional manufacturing
equipment and new regulatory approvals. In the event we have to discontinue the
use of mouse fluids, we may not have the resources at the time to acquire the
necessary manufacturing equipment and expertise that we will need to make the
changes in our development programs.
Employees
As of August 23, 2004, we employed 119 persons on a full-time basis, of
whom 20 were in research and development departments, 19 of whom were engaged in
clinical research and regulatory affairs, 63 of whom were engaged in operations
and manufacturing and quality control, and 17 of whom were engaged in finance,
administration, sales and marketing. Of these employees, 49 hold M.D., Ph.D. or
other advanced degrees. We believe that while we have been successful to date in
attracting skilled and experienced scientific personnel, competition for such
personnel continues to be intense and there can be no assurance that we will
continue to be able to attract and retain the professionals we will need to grow
our business. Our employees are not covered by a collective bargaining
agreement, and we believe that our relationship with our employees is excellent.
Corporate Information
We were incorporated in Delaware in 1982. Our principal offices are
located at 300 American Road, Morris Plains, New Jersey 07950. Our telephone
number is (973) 605-8200. In addition to our majority-owned subsidiary, IBC, we
also have two foreign subsidiaries, Immunomedics B.V. in The Netherlands and
Immunomedics GmbH in Darmstadt, Germany, to assist us in managing sales and
marketing efforts and coordinating clinical trials in Europe. Our web address is
16
www.immunomedics.com. We have not incorporated by reference into this Annual
Report on Form 10-K the information on our website, and you should not consider
it to be a part of this document.
We have historically not made our reports filed with the Securities and
Exchange Commission ("SEC") available on our website. We now intend to commence
making our annual reports on Form 10-K, quarterly reports on Form 10-Q, current
reports on Form 8-K, Forms 3,4 and 5 filed on behalf of directors and executive
officers and any amendments to such reports filed pursuant to Section 13(a) or
15(d) of the Securities Exchange Act of 1934, as amended (the "Exchange Act"),
available on our website, free of charge, as soon as reasonably practicable
after such material is electronically filed with, or furnished to, the SEC.
Copies of this Annual Report on Form 10-K may also be obtained without charge
electronically or by paper by contacting Investor Relations, Immunomedics, Inc.,
300 American Road, Morris Plains, New Jersey 07950 or by calling (973) 605-8200.
In addition, concurrently with the filing with the SEC of our proxy
materials for our 2004 Annual Meeting of Stockholders, we intend to make
available on our website (i) the charters for the committees of the Company's
Board of Directors, including the Audit Committee, Compensation Committee and
Nominating and Board Governance Committee, and (ii) the Company's Code of
Business Conduct and Ethics (the "Code of Ethics") governing its directors,
officers and employees. Within the time period required by the SEC, the company
will post on its website any modifications to the Code of Ethics, as required by
the Sarbanes-Oxley Act of 2002.
The public may also read and copy the materials we file with the SEC at
its Public Reference Room at 450 Fifth Street NW, Washington, DC 20549. The
public may obtain information on the operation of the Public Reference Room by
calling the SEC at 1-800-SEC-0330. The SEC also maintains a web site at
http://www.sec.gov that contains reports, proxy and information statements and
other information regarding companies that file electronically with the SEC.
17
Factors That May Affect Our Business and Results of Operations
Risks Relating to Our Business and Operations
We have a long history of operating losses and it is likely that our
operating expenses will continue to exceed our revenues for the foreseeable
future.
We have incurred significant operating losses since our formation in 1982,
and have never earned a profit since that time. As of June 30, 2004, we had an
accumulated deficit of approximately $148.3 million. The only significant
revenue we have earned to date has come from the limited sale of our two
diagnostic imaging products in Europe and, to a lesser degree, the United
States, and the licensing of our lead therapeutic product candidate,
epratuzumab, to Amgen in 2001. We have never received revenue from the
commercialization of any therapeutic product. We expect to continue to
experience significant operating losses as we invest further in our research and
development activities while simultaneously attempting to develop and
commercialize our other therapeutic product candidates. If we fail in our
attempts to develop commercially viable therapeutic products, it is likely that
we will never achieve significant revenues or become profitable, either of which
would seriously jeopardize our ability to continue as a going concern.
Our most advanced therapeutic product candidates are still only in the
clinical development stage, and will require us to raise capital in the future
in order to fund further expensive and time-consuming studies before they can
even be submitted for final regulatory approval.
Even our most advanced therapeutic product candidates are still in the
clinical development stage and will not be available for commercial sale any
time soon, if ever. In order to complete the clinical development process for
each of our product candidates, it will be necessary to invest significant
financial resources, and devote a great deal of time and effort, just to reach
the point where an application for final FDA or foreign regulatory approval can
be submitted. In addition, we will need to raise additional capital to finance
the costly process of obtaining approval for any of our current products should
we get to that stage of product development.
Clinical trials involve the administration of a product candidate to
patients who are already extremely ill, making patient enrollment often
difficult and expensive. Moreover, even in ideal circumstances where the
patients can be enrolled and then followed for the several months or more
required to complete the study, the trials can be suspended, terminated or
otherwise fail for any number of reasons, including:
o late-stage clinical trials may raise safety or efficacy concerns not
readily apparent in earlier trials;
o unforeseen difficulties in manufacturing the product candidate in
compliance with all regulatory requirements and in the quantities
needed to complete the trial may be cost-prohibitive;
o during the long trial process, alternative therapies may become
available which make further development of the product candidate
impracticable; and
o if we are unable to obtain the additional capital we need to fund
all of the clinical trials we foresee, we may forced to cancel or
otherwise curtail some important trials.
Any failure or substantial delay in successfully completing clinical
trials for our product candidates, particularly the ongoing trials for our most
advanced product candidate, epratuzumab, could severely harm our business and
results of operation.
18
Even once the clinical development process has been successfully
completed, our ability to derive revenues from the sale of therapeutics will
depend upon our first obtaining FDA as well as foreign regulatory approvals, all
of which are subject to a number of unique risks and uncertainties.
Even if we are able to demonstrate the safety and efficacy of our product
candidates in clinical trials, if we fail to gain timely approval to
commercialize our product candidates from the FDA and other foreign regulatory
authorities, we will be unable to generate the revenues we will need to build
our business. These approvals may not be granted on a timely basis, if at all,
and even if and when they are granted they may not cover all the indications for
which we seek approval. For example, while we may develop a product candidate
with the intention of addressing a large, unmet medical need, the FDA may only
approve the use of the drug for indications affecting a relatively small number
of patients, thus greatly reducing the market size and our potential revenues.
The approvals may also contain significant limitations in the form of warnings,
precautions or contraindications with respect to conditions of use, which could
further narrow the size of the market. Finally, even after approval can be
obtained, we may be required to recall or withdraw a product as a result of
newly discovered safety or efficacy concerns, either of which would have a
materially adverse effect on our business and results of operations.
In order to become a truly successful biopharmaceutical company, we will
need to raise significant amounts of additional capital. Because it can be
difficult for a small-cap company like ours to raise equity capital on
acceptable terms, we cannot assure you that we will be able to obtain the
necessary capital when we need it, or on acceptable terms, if at all.
Even if our technologies and product candidates are superior, if we lack
the capital needed to bring our future products to market, we will never be
successful. We have obtained the capital necessary to fund our research and
development programs to date primarily from the following sources:
o Approximately $185.0 million from the public and private sale of our
debt and equity securities through August 3, 2004;
o $18.0 million from Amgen under our epratuzumab licensing agreement;
and
o limited product sales of CEA-Scan(R) and LeukoScan(R), licenses,
grants and interest income from our investments.
We intend to continue expending substantial capital on our research and
development programs, and we will need to raise still additional capital in
order to obtain the necessary regulatory approvals and then commercialize our
future therapeutic products. Our capital requirements are dependent on numerous
factors, including:
o the rate at which we progress our research programs and the number
of product candidates we have in pre-clinical and clinical
development at any one time;
o the cost of conducting clinical trials involving patients in the
United States, Europe and possibly elsewhere;
o our need to establish the manufacturing capabilities necessary to
produce the quantities of our product candidates we project we will
need;
o the time and costs involved in obtaining FDA and foreign regulatory
approvals;
o the cost of first obtaining, and then defending, our patent claims
and other intellectual property rights; and
o our ability to enter into licensing and other collaborative
agreements to help off-set some of these costs.
19
Our existing cash resources are expected to be sufficient to fund our
operations for the next 12 months, but we may need additional cash before such
time for many reasons, including, but not limited to, changes in our research
and development plans, the need for unexpected capital expenditures or costs
associated with any acquisitions of other businesses, assets or technologies
that we may choose to undertake. If we deplete our existing capital resources
sooner than we otherwise anticipate, we will be required to either obtain
additional capital quickly, or else significantly reduce our operating expenses
and capital expenditures, either of which could have a material adverse effect
on us.
Our ability to raise future capital on acceptable terms will depend not
only upon our operating performance, but also on conditions in the public and
private debt and equity markets, as well as the overall performance of other
companies in the biopharmaceutical and biotechnology sectors. Financing may not
be available to us when we need it on terms we find acceptable, if at all.
Furthermore, the terms of any such debt or equity financing may include
covenants which limit our future ability to manage the business, contain
preferences, privileges and rights superior to those enjoyed by holders of our
common stock or cause substantial dilution to our existing stockholders.
Certain potential for conflicts of interest, both real and perceived,
exist which could result in expensive and time-consuming litigation.
Certain members of our senior management and Board of Directors have
relationships and agreements, both with us as well as among themselves and their
respective affiliates, that create the potential for both real, as well as
perceived, conflicts of interest. These include Dr. David M. Goldenberg, our
Chairman and Chief Strategic Officer, Ms. Cynthia L. Sullivan, our President and
Chief Executive Officer, and certain companies with which we do business,
including the Center for Molecular Medicine and Immunology, also known as the
Garden State Cancer Center, or CMMI. For example, Dr. Goldenberg is the
President and a Trustee of CMMI, a not-for-profit cancer research center that we
use to conduct certain research activities. In fiscal year 2004, we reimbursed
CMMI a total of $401,000 for research activities conducted on our behalf.
Further, Dr. Goldenberg's employment agreement with us permits him to devote
more of his time working for CMMI than for us, and other key personnel of our
Company also have responsibilities to both CMMI and us.
As a result of these and other relationships, the potential for both real
and perceived conflicts of interest exists, and disputes could arise over the
allocation of funds, research projects and ownership of intellectual property
rights. In addition, in the event that we become involved in stockholder
litigation regarding these potential conflicts, we might be required to devote
significant resources and management time defending the company from these
claims, which could adversely affect our results of operations.
If we cannot successfully and efficiently manufacture the compounds that
make up our products and product candidates, our ability to sell products and
conduct clinical trials will be impaired.
Our ability to conduct our pre-clinical and clinical research and
development programs depends, in large part, upon our ability to manufacture our
proprietary compounds in accordance with FDA and other regulatory requirements.
While we have completed construction on the major expansion of our manufacturing
facilities in New Jersey in anticipation of our current and future needs, we
have no historical experience in manufacturing these compounds in significant
quantities, and we may not be able to do so in the quantities and with the
degree of purity that is required. As with any new manufacturing facility, it
may be some time before we become aware of any deficiencies in either the design
of the new facility or the in construction itself. Any interruption in
manufacturing at this site, whether by natural acts or otherwise, would
significantly and adversely affect our operations, and delay our research and
development programs.
20
Our future success will depend upon our ability to first obtain and then
adequately protect our patent and other intellectual property rights, as well
avoiding the infringement of the rights of others.
Our future success will be highly dependent upon our ability to first
obtain and then defend the patent and other intellectual property rights
necessary for the commercialization of our product candidates. We have filed
numerous patent applications on the technologies and processes that we use in
the United States and certain foreign countries. Although we have obtained a
number of issued U.S. patents to date, the patent applications owned or licensed
by us may not result in additional patents being issued. Moreover, these patents
may not afford us the protection we need against competitors with similar
technologies or products.
The successful development of therapeutic products frequently requires the
application of multiple technologies that may be subject to the patent or other
intellectual property rights of third parties. Although we believe it is likely
we will need to license technologies and processes from third parties in the
ordinary course of our business, we are not currently aware of any material
conflict involving our technologies and processes with any valid patents or
other intellectual property rights owned or licensed by others. In the event
that a third party were to claim such a conflict existed, they could sue us for
damages as well as seek to prevent us from commercializing our product
candidates. It is possible that a third party could successfully claim that our
products infringe on their intellectual property rights. Uncertainties resulting
from the litigation and continuation of patent litigation or other proceedings
could have a material adverse effect on our ability to compete in the
marketplace. Any patent litigation or other proceeding, even if resolved in our
favor, would require significant financial resources and management time. Some
of our competitors may be able to sustain these costs more effectively than we
can because of their substantially greater financial and managerial resources.
If a patent litigation or other proceeding is resolved unfavorably to us, we may
be enjoined from manufacturing or selling our products without a license from
the other party, in addition to being held liable for significant damages. We
may not be able to obtain any such license on commercially acceptable terms, if
at all.
In addition to our reliance on patents, we attempt to protect our
proprietary technologies and processes by relying on trade secret laws,
nondisclosure and confidentiality agreements and licensing arrangements with our
employees and other persons who have access to our proprietary information.
These agreements and arrangements may not provide meaningful protection for our
proprietary technologies and processes in the event of unauthorized use or
disclosure of such information. In addition, our competitors may independently
develop substantially equivalent technologies and processes or otherwise gain
access to our trade secrets or technology, either of which could materially and
adversely affect our competitive position.
We face substantial competition in the biotechnology industry and may not
be able to compete successfully against one or more of our competitors.
The biotechnology industry is highly competitive, particularly in the area
of diagnostic and therapeutic oncology products. In recent years, there have
been extensive technological innovations achieved in short periods of time, and
it is possible that future technological changes and discoveries by others could
result in our products and product candidates quickly becoming uncompetitive or
obsolete. A number of companies, including IDEC Pharmaceuticals, Genentech,
Glaxo SmithKline, Ligand Pharmaceuticals, Millennium Pharmaceuticals, Amersham
Health, Protein Design Laboratories, Schering AG and Corixa Corporation, are
engaged in the development of diagnostic and therapeutic oncology products. Many
of these companies have significantly greater financial, technical and marketing
resources than we do. In addition, many of these companies have more established
positions in the pharmaceutical industry and are therefore better equipped to
develop, commercialize and market
21
oncology products. Even some smaller competitors may obtain a significant
competitive advantage over us if they are able to discover or otherwise acquire
patentable inventions, form collaborative arrangements or merge with larger
pharmaceutical companies.
We expect to face increasing competition from universities and other
non-profit research organizations. These institutions carry out a significant
amount of research and development in the field of antibody-based technologies,
and they are increasingly aware of the commercial value of their findings. As a
result, they are demanding greater patent and other proprietary rights, as well
as licensing and future royalty revenues.
We may be liable for contamination or other harm caused by hazardous
materials that we use in the operations of our business.
In addition to laws and regulations enforced by the FDA, we are also
subject to regulation under various other foreign, federal, state and local laws
and regulations. Our research and development programs involve the controlled
use of viruses, hazardous materials, chemicals and various radioactive
compounds. The risk of accidental contamination or injury from these materials
can never be completely eliminated, and if an accident occurs we could be held
liable for any damages that result, which could exceed our available resources.
The nature of our business exposes us to significant liability claims, and
our insurance coverage may not be adequate to cover any future claims.
The use of our compounds in clinical trials and any future sale exposes us
to liability claims that could be substantial. These claims might be made
directly by healthcare providers, medical personnel, patients, consumers,
pharmaceutical companies and others selling or distributing our compounds. While
we currently have product liability insurance that we consider adequate for our
current needs, we may not be able to continue to obtain comparable insurance in
the future at an acceptable cost, if at all. If for any reason we cannot
maintain our existing or comparable liability insurance, our ability to
clinically test and market products could be significantly impaired. Moreover,
the amount and scope of our insurance coverage, as well as the indemnification
arrangements with third parties upon which we rely, may be inadequate to protect
us in the event of a successful product liability claim. Any successful claim in
excess of our insurance coverage could materially and adversely affect our
financial condition and operating results.
The loss of any of our key employees could adversely affect our
operations.
We are heavily dependent upon the talents of Dr. Goldenberg, our Chief
Strategic Officer, Ms. Sullivan, our President and Chief Executive Officer, and
Dr. Horak, our Chief Scientific Officer, as well as certain other key personnel.
If Dr. Goldenberg, Ms. Sullivan, Dr. Horak or any of our other key personnel
were to unexpectedly leave our company, our business and results of operations
could be materially and adversely affected. In addition, as our business grows
we will need to continue to attract additional management and scientific
personnel. Competition for qualified personnel in the biotechnology and
pharmaceutical industries is intense, and we may not be successful in our
recruitment efforts. If we are unable to attract, motivate and retain qualified
professionals, our operations could be materially and adversely affected.
Given that cancer therapeutics such as the ones we are developing can cost
upwards of $20,000 per treatment, even if our product candidates become
available for sale it is likely that federal and state governments, insurance
companies and other payers of health care costs will try to first limit the
22
use of these drugs to certain patients, and even then be reluctant to provide a
level of reimbursement that permits us to earn a significant profit on our
investment, if any.
Our ability to successfully commercialize therapeutic products will
depend, in significant part, on the extent to which hospitals can obtain
appropriate reimbursement levels for the cost of our products and related
treatment. Third-party payers are increasingly challenging the prices charged
for diagnostic and therapeutic products and related services. In addition,
legislative proposals to reform health care or reduce government insurance
programs may result in lower prices or the actual inability of prospective
customers to purchase our products. Furthermore, even if reimbursement is
available, it may not be available at price levels sufficient for us to realize
a positive return on our investment.
Risks Related to Our Common Stock
The market price of our common stock has fluctuated widely in the past,
and is likely to continue to fluctuate widely based on a number of factors, many
of which are beyond our control.
The market price of our common stock has been, and is likely to continue
to be, highly volatile. Furthermore, the stock market generally and the market
for stocks of relatively small biopharmaceutical companies like us have from
time to time experienced, and likely will again experience, significant price
and volume fluctuations that are unrelated to actual operating performance.
From time to time, stock market analysts publish research reports or
otherwise comment upon our business and future prospects. In addition, the
emergence of so-called "chat rooms" on the Internet has resulted in many
investors conjecturing about our business and prospects, often times without any
real basis in fact. Due to a number of factors, we may fail to meet the
expectations of securities analysts or investors and our stock price would
likely decline as a result. These factors include:
o announcements by us, our partners or our competitors of clinical
results, technological innovations, product sales, new products or
product candidates and product development timelines;
o the formation or termination of our corporate alliances, such as our
agreement with Amgen;
o developments or disputes concerning our patent or other proprietary
rights, and the issuance of patents in our field of business to
others;
o government regulatory action;
o period-to-period fluctuations in the results of our operations; and
o developments and market conditions for emerging growth companies and
biopharmaceutical companies, in general.
In the past, following periods of volatility in the market prices of the
securities of companies in our industry, securities class action litigation has
often been instituted against those companies. If we face such litigation in the
future, it would result in substantial costs and a diversion of management's
attention and resources, which could negatively impact our business.
23
Our principal stockholder can significantly influence all matters
requiring the approval by our stockholders.
As of June 30, 2004, Dr. Goldenberg, our Chairman and Chief Strategic
Officer, together with certain members of his family including Ms. Cynthia L.
Sullivan, our President and Chief Executive Officer, who is Dr. Goldenberg's
wife, and other affiliates, controlled the right to vote approximately 23.6% of
our common stock. As a result of this voting power, Dr. Goldenberg has the
ability to significantly influence the outcome of substantially all matters that
may be put to a vote of our stockholders, including the election of our
directors.
We have adopted anti-takeover provisions that may frustrate any
unsolicited attempt to acquire our Company or remove or replace our directors
and executive officers.
Provisions of our certificate of incorporation, our by-laws and Delaware
corporate law could make it more difficult for a third party to acquire control
of our Company in a transaction not approved by our Board of Directors. For
example, we have adopted a stockholder rights plan that makes it more difficult
for a third party to acquire control of our Company without the support of our
Board of Directors. In addition, our Board of Directors may issue up to ten
million shares of preferred stock and determine the price, rights, preferences
and privileges, including voting and conversion rights, of these shares without
any further vote or action by our stockholders. The issuance of preferred stock
could have the effect of delaying, deterring or preventing an unsolicited change
in control of our company, or could impose various procedural and other
requirements that could make it more difficult for holders of our common stock
to effect certain corporate actions, including the replacement of incumbent
directors and the completion of transactions opposed by the incumbent Board of
Directors. The rights of the holders of our common stock would be subject to,
and may be adversely affected by, the rights of the holders of any preferred
stock that may be issued in the future.
We are also subject to Section 203 of the Delaware General Corporation Law
("DGCL"), which prohibits us from engaging in a business combination with any
"interested" stockholder (as defined in Section 203 of the DGCL) for a period of
three years from the date the person became an interested stockholder, unless
certain conditions are met.
Item 2 -- Properties
Our headquarters is located at 300 American Road, Morris Plains, New
Jersey 07950, where we lease approximately 74,000 square feet of commercial
office space. In November 2001, we renewed the lease for an additional term of
20 years expiring in October 2021 at a base annual rate of $545,000, which rate
is fixed for the first five years and increases thereafter every five years. The
November 2001 renewal includes an additional 15,000 square feet of space. Our
manufacturing, regulatory, medical, research and development laboratories, and
our finance, marketing and executive offices are currently located in this
facility. We have also completed the construction and equipping of a 7,500
square-foot, commercial-scale manufacturing facility within our Morris Plains
headquarters, which consists of four independent antibody manufacturing suites,
several support areas, and a quality control laboratory. See Item 1,
"Manufacturing." In addition, our European subsidiary, Immunomedics GmbH, leases
executive office space in Darmstadt, Germany.
Item 3 -- Legal Proceedings
F. Hoffmann-LaRoche
In November 1996, we brought suit in The Netherlands against F.
Hoffmann-LaRoche and its Roche Diagnostics subsidiary and European affiliates
("Roche") for infringement of our European patent
24
covering specific anti-CEA antibodies, which Roche is using in its CEA
immunoassay. The suit sought an injunction against the sale of CEA immunoassays
by Roche that infringe our European patents, as well as damages for past
infringement. Roche denied infringement and countered with nullity actions in
The Netherlands and Germany, seeking to invalidate our Dutch and German patents.
A trial was held before the Patent Court in The Hague on August 8, 1997,
resulting in dismissal of the action. We appealed. A trial on the Dutch nullity
action was held before the Patent Court in The Hague on June 5, 1998, resulting
in dismissal of that action and maintenance of all claims of our patent. Roche
appealed. A trial on the German nullity action was held in Munich on December 9,
1998, resulting in maintenance of the patent in amended form that continues to
protect our products and which we believe is still infringed by Roche's
immunoassays. Roche did not appeal. The appeals of the Dutch infringement and
nullity actions were heard concurrently on March 2, 2000. A decision, although
originally set for September 7, 2000, was rendered on February 15, 2001, and
then only a partial decision. The validity of the patent, with claims amended as
they were in the German action, was upheld and the jurisdiction of the Dutch
Court to issue a cross-border injunction was upheld. The Dutch Appeals court's
decision finally was rendered on July 19, 2002, holding that Roche infringed the
patent and that the decision could be enforced in all countries named in the
suit, contingent upon posting of a bond in the amount of Euro 2 million. Roche
appealed the holdings of the Appeals Court to the Dutch Supreme Court.
On December 22, 2003, the Dutch Supreme Court held that Immunomedics'
Dutch part of its European patent for highly specific monoclonal antibodies
against the cancer marker, carcinoembryonic antigen (CEA), was valid. The
Company's claim of infringement was not finally decided by the Dutch Supreme
Court. Among other things, the Supreme Court held that the Court of Appeal which
had ruled that Roche had infringed Immunomedics' European Patent had not given
Roche sufficient opportunity to comment on an expert opinion filed by
Immunomedics in which it was stated that Roche's CEA test kit did satisfy a
criterion that is generally satisfied for specific antibodies that bind to CEA.
The Company is of the opinion that after Roche has had the opportunity to
comment the Court of Appeal will not change its opinion. The Company has argued
that the Dutch court should enforce the European Patent in all European
countries for which the European Patent was validated, since Roche sold the same
product in each country. The Dutch Supreme Court repeated the reasoning of the
Dutch District Court that the Brussels Convention should be interpreted to
permit cross-border enforcement of European patents where a related group of
companies sells the same product in countries where that same patent has been
validated. The Dutch Supreme Court referred this issue to the European Court of
Justice (ECJ) to provide a final interpretation of the Brussels Convention on
this point.
On May 19, 2004 and July 20, 2004, Roche filed nullity actions in German
and United Kingdom courts, respectively, challenging our patents relating to an
improved method of disease therapy with cytotoxic agents, including anticancer,
antimicrobial, anti-autoimmune disease and anti-organ-rejection therapy, wherein
cytokines are used to prevent, mediate or reverse radiation-induced or
drug-induced or antibody-induced toxicity, especially to hematopoietic cells.
We believe that the patents referred to above are valid and those that are
the subject of our infringement action have been infringed, and we believe that
the Company will prevail in the litigation, although no assurances can be given
in this regard. To the extent that Roche contests or challenges our patents, or
files appeals or further nullity actions, there can be no assurance that
significant costs for defending such patents may not be incurred.
Cytogen, Inc. and C.R. Bard Inc.
We have also sued Cytogen, Inc. and C.R. Bard, Inc. for infringement of
our licensed patent by Cytogen's sale of its "Prostascint" prostate
cancer-imaging product. The complaint was filed in New Jersey on February 23,
2000 and served on March 20, 2000 after two unsuccessful attempts at settlement.
The suit
25
was bifurcated and damages were separated. Discovery was completed on the
liability issues. A Markman hearing was held for the purpose of determining the
scope and interpretation of the claims, following which each side submitted
motions for summary judgment, all of which have been denied.
Willow Bay Associates, LLC
In 2000, a now-defunct finance broker filed suit against the Company in
the United States District Court for the District of Delaware. In the case, the
plaintiff claimed that it is entitled to damages in the form of brokerage
commissions for breach of an alleged confidentiality and non-circumvention
contract. The suit against the Company was dismissed on summary judgment, but
subsequently reinstated. Trial was held in late January 2004, and post-trial
submissions were filed in March. A decision by the Court is expected in the near
future. Although it is not possible to forecast the Court's decision, based on
the Court's initial ruling of dismissal and the trial, the Company believes that
judgment will be entered in its favor. The Company further believes that even in
the event of an unfavorable outcome, this lawsuit will not have a material
adverse affect on the Company's financial position and results of operations.
From time to time we are a party to various claims and litigation arising
in the normal course of business. We believe that the outcome of such claims and
litigation will not have a material adverse effect on our financial position and
results of operations.
Item 4 -- Submission of Matters to a Vote of Security Holders
No matter was submitted to a vote of our security holders during the
fourth quarter of fiscal year 2004.
26
PART II
Item 5 -- Market For Registrant's Common Equity and Related Stockholder Matters
and Issuer Purchases of Equity Securities
Our common stock is quoted on the Nasdaq National Market under the symbol
"IMMU." The following table sets forth, for the last two fiscal years, the high
and low sales prices for our common stock, as reported by the Nasdaq National
Market:
Fiscal Quarter Ended High Low
- ---------------------------------------------------------------- ----- -----
September 30, 2002 ............................................. $7.55 $3.65
December 31, 2002 .............................................. 8.40 4.50
March 31, 2003 ................................................. 5.77 2.25
June 30, 2003 .................................................. 7.95 2.64
September 30, 2003 ............................................. $9.70 $5.36
December 31, 2003 .............................................. 8.93 3.23
March 31, 2004 ................................................. 5.50 3.46
June 30, 2004 .................................................. 6.24 3.98
As of September 7, 2004, the closing sales price of the Company's common
stock on the Nasdaq National Market was $2.81. As of September 7, 2004, there
were approximately 675 stockholders of record of the common stock and, according
to our estimates, approximately 16,500 beneficial owners of our common stock. We
have not paid dividends on our common stock since inception and do not plan to
pay cash dividends in the foreseeable future. We currently intend to retain
earnings, if any, to finance our growth.
Sale of Unregistered Securities
None.
Securities Authorized for Issuance Under Equity Compensation Plans
Information regarding our equity compensation plans as of June 30, 2004,
is disclosed in Item 12, "Security Ownership of Certain Beneficial Owners and
Management and Related Stockholder Matters."
Issuer Purchases of Equity Securities
None.
27
Item 6 -- Selected Financial Data
The following table sets forth our consolidated financial data as of and
for each of the five fiscal years ended June 30, 2004. The selected consolidated
financial data as of and for each of the five years ended June 30, 2004, have
been derived from our audited consolidated financial statements. The
consolidated financial statements for the years ended June 30, 2004, 2003 and
2002 are included elsewhere in this Annual Report on Form 10-K. The information
below should be read in conjunction with the consolidated financial statements
(and notes thereon) and "Management's Discussion and Analysis of Financial
Condition and Results of Operations" included in Item 7.
Fiscal year ended June 30,
--------------------------------------------------------
2004 2003 2002 2001 2000
-------- -------- -------- -------- --------
(In thousands, except per share amounts)
Revenues .................................. $4,306 $13,719 $14,287 $8,400 $4,777
Cost and expenses ......................... 27,299 23,533 20,985 16,712 15,652
Interest income - net ..................... 285 1,087 2,069 2,830 1,196
Minority interest ......................... 89 88 -- -- --
Foreign currency transaction gain(loss) ... 30 85 (323) (72) 43
-------- -------- -------- -------- --------
Loss before income tax benefit ............ (22,589) (8,554) (4,952) (5,554) (9,636)
Income tax benefit ........................ 234 680 1,205 803 --
-------- -------- -------- -------- --------
Net loss .................................. (22,355) (7,874) (3,747) (4,751) (9,636)
Preferred stock dividends ................. -- -- -- -- 496
-------- -------- -------- -------- --------
Net loss allocable to common
stockholders ............................. $(22,355) $(7,874) $(3,747) $(4,751) $(10,132)
======== ======== ======== ======== ========
Net loss per common share ................. $(0.45) $(0.16) $(0.08) $(0.10) $(0.23)
======== ======== ======== ======== ========
Weighted average shares
outstanding .............................. 49,886 49,878 49,652 49,498 43,977
Cash, cash equivalents and
marketable securities(1) ................. $13,479 $23,796 $44,788 $53,291 $40,866
Restricted securities ..................... 5,101 6,376 -- -- --
Total assets(1) ........................... 32,089 45,130 54,951 59,657 48,026
Long-term debt ............................ 13,826 5,101 -- -- 70
Stockholders' equity(1)(2) ................ $11,584 $33,667 $41,096 $41,441 $44,096
(1) Subsequent to June 30, 2004 the Company received $14.0 million of net cash
proceeds as a result of the sale of 4,178,116 shares of its common stock.
(2) We have never paid cash dividends on our common stock.
28
Item 7 -- Management's Discussion and Analysis of Financial Condition and
Results of Operations
The SEC encourages companies to disclose forward-looking information so
that investors can better understand a company's future prospects and make
informed investment decisions. This Annual Report on Form 10-K contains such
"forward-looking statements" within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements may be made directly in this
Annual Report, and they may also be made a part of this Annual Report by
reference to other documents filed with the SEC, which is known as
"incorporation by reference."
Words such as "may," "anticipate," "estimate," "expects," "projects,"
"intends," "plans," "believes" and words and terms of similar substance used in
connection with any discussion of future operating or financial performance, are
intended to identify forward-looking statements. All forward-looking statements
are management's present expectations of future events and are subject to a
number of risks and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements. These risks
and uncertainties include, among other things: our inability to further
identify, develop and achieve commercial success for new products and
technologies; the possibility of delays in the research and development
necessary to select drug development candidates and delays in clinical trials;
the risk that clinical trials may not result in marketable products; the risk
that we may be unable to successfully finance and secure regulatory approval of
and market our drug candidates; our dependence upon pharmaceutical and
biotechnology collaborations; the levels and timing of payments under our
collaborative agreements; uncertainties about our ability to obtain new
corporate collaborations and acquire new technologies on satisfactory terms, if
at all; the development of competing products; our ability to protect our
proprietary technologies; patent-infringement claims; and risks of new, changing
and competitive technologies and regulations in the United States and
internationally. Please also see the discussion of risks and uncertainties under
"Factors That May Affect Our Business and Results of Operations" in Item 1 of
this Annual Report.
In light of these assumptions, risks and uncertainties, the results and
events discussed in the forward-looking statements contained in this Annual
Report or in any document incorporated by reference might not occur.
Stockholders are cautioned not to place undue reliance on the forward-looking
statements, which speak only of the date of this Annual Report or the date of
the document incorporated by reference in this Annual Report as applicable. We
are not under any obligation, and we expressly disclaim any obligation, to
update or alter any forward-looking statements, whether as a result of new
information, future events or otherwise except as may be required by applicable
law. All subsequent forward-looking statements attributable to the Company or to
any person acting on our behalf are expressly qualified in their entirety by the
cautionary statements contained or referred to in this section.
Overview
Immunomedics, Inc. is a biopharmaceutical company focused on the
development of monoclonal, antibody-based products for the targeted treatment of
cancer, autoimmune and other serious diseases. We have developed a number of
advanced proprietary technologies that allow us to create humanized antibodies
that can be used either alone in unlabeled, or "naked," form, or conjugated with
radioactive isotopes, chemotherapeutics or toxins, in each case to create highly
targeted agents. Using these technologies, we have built a broad pipeline of
therapeutic product candidates that utilize several different mechanisms of
action. We believe that our portfolio of intellectual property, which includes
approximately 90 issued patents in the United States and approximately 250 other
issued patents worldwide, protects our product candidates and technologies.
29
In addition to our potential therapeutic products, our proprietary
technologies have also enabled us to develop highly specific diagnostic imaging
agents, one of which, CEA-Scan(R), has been approved in the United States,
Canada and the European Union, where it is currently being marketed for the
detection of colorectal cancers. Our second diagnostic product, LeukoScan(R),
has been approved in Europe and Australia, where it is currently being marketed
for the detection of bone infections.
From inception in 1982 until June 30, 2004, we had an accumulated deficit
of approximately $148.3 million and have never earned a profit. In the absence
of increased revenues from the sale of current or future products and licensing
activities (the amount, timing, nature or source of which cannot be predicted),
our losses will continue as we continue to conduct our research and development
activities. These activities are budgeted to expand over time and will require
further resources if we are to be successful. As a result, our operating losses
are likely to be substantial over the next several years.
The development and commercialization of successful therapeutic products
is subject to numerous risks and uncertainties including, without limitation,
the following:
o the type of therapeutic compound under investigation and nature of
the disease in connection with which the compound is being studied;
o our ability, as well as the ability of our partners, to conduct and
complete clinical trials on a timely basis;
o the time required for us to comply with all applicable federal,
state and foreign legal requirements, including, without limitation,
our receipt of the necessary approvals of the U.S. Food and Drug
Administration;
o the financial resources available to us during any particular
period; and
o many other factors associated with the commercial development of
therapeutic products outside of our control.
Research and Development
As of June 30, 2004, we employed 20 professionals in our research and
development departments and 15 professionals in our pre-clinical and clinical
research departments. In addition to salaries and benefits, the other costs
associated with research and development include the costs associated with
producing biopharmaceutical compounds, laboratory equipment and supplies, the
costs of conducting clinical trials, legal fees and expenses associated with
pursuing patent protection, as well as facilities costs. We spent $21.9 million
in the aggregate for the fiscal year ended June 30, 2004, on research and
development expenses.
During fiscal year 2003, we completed the construction of the
manufacturing expansion at a total cost of $6.4 million. This expansion is being
used to support our research and development efforts, as well as prepare for
future commercialization of our product candidates. We believe that our
facilities, as expanded, will be adequate to support our research and
development activities for the next few years without the need for any material
capital expenditures.
At any one time our scientists are engaged in the research and development
of multiple therapeutic compounds. Because we do not track expenses on the basis
of each individual compound under investigation, but rather aggregate research
and development costs for accounting purposes, it is not possible for investors
to analyze and compare the expenses associated with unsuccessful research and
30
development efforts for any particular fiscal period, with those associated with
compounds that are determined to be worthy of further development. This may make
it more difficult for investors to evaluate our business and future prospects.
Therapeutics
We believe that each of our antibodies has therapeutic potential either
when administered alone or when conjugated with therapeutic radioisotopes
(radiolabeled), chemotherapeutics or other toxins to create unique and
potentially more effective treatment options. The attachment of various
compounds to antibodies is intended to allow the delivery of these therapeutic
agents to tumor sites with greater precision than conventional radiation therapy
or chemotherapeutic approaches. This treatment method is designed to reduce the
total exposure of the patient to the therapeutic agents, which ideally minimizes
debilitating side effects. We are currently focusing our efforts on unlabeled,
or "naked," antibodies, and antibodies conjugated with radioisotopes, such as
Yttrium-90, sometimes referred to as Y-90, and Iodine-131, sometimes referred to
as I-131. All of our therapeutic product candidates are "humanized" antibodies,
which means the portion of the antibody derived from mouse (murine) DNA
sequences is generally less than 10%.
Epratuzumab
Our most advanced therapeutic product candidate, epratuzumab (IMMU-103),
is an unlabeled humanized antibody which targets an antigen, known as the CD22
marker, found on the surface of a certain class of lymphocytes, a type of white
blood cell. This antibody also binds to the malignant forms of these cells that
comprise non-Hodgkin's B-cell lymphoma and acute and chronic lymphocytic
leukemias. The clinical trials of IMMU-103, which involved more than 340
patients, demonstrated good safety, tolerability and anti-tumor activity.
In December 2000, we entered into a Development and License Agreement with
Amgen to license IMMU-103 in North America and Australia. Under this agreement,
Amgen was responsible for the final clinical development, manufacture and
commercialization of IMMU-103 for these markets. Amgen had conducted multiple
clinical trials in North America and Australia with IMMU-103 for the treatment
of non-Hodgkin's lymphomas with patients. In some of these trials, IMMU-103 was
administered in combination with Rituxan(R), the first therapeutic antibody
approved for treating cancer in the United States, with reported sales in excess
of $1.5 billion per year.
On April 8, 2004, we entered into a termination agreement with Amgen
whereby Amgen returned to us all rights for epratuzumab. As part of the
transaction, we issued to Amgen a five-year warrant to purchase 100,000 shares
of our common stock at a price equal to $16.00 per share. This warrant has an
estimated value of approximately $310,000. If epratuzumab is approved for
commercialization in the United States for non-Hodgkin's lymphoma therapy, the
Company will be required to pay Amgen a milestone payment in the amount of
$600,000. There are no other financial obligations between the parties as a
result of the termination agreement.
We have recently also begun the evaluation of IMMU-103 in patients with
certain autoimmune diseases. In May 2004, clinical results of epratuzumab in
patients with systemic lupus erythematosus were presented at the 7th
International Congress on Systemic Lupus Erythematosus (SLE). Epratuzumab was
administered as a single agent in patients with SLE. Patients with mild to
moderate SLE activity were enrolled. SLE assessments after treatment
demonstrated consistent clinical improvement compared to the pre-therapy scores.
The investigators concluded that these preliminary results in SLE patients with
mildly to moderately active disease indicate epratuzumab is well tolerated
31
and can be infused in approximately one half-hour, without evidence of reactions
or immunogenicity. Early efficacy data suggests clinical improvement continuing
for at least one month after treatment.
While the clinical results to date have been encouraging, we are not able
to determine when, if ever, epratuzumab will be approved for sale in the United
States or anywhere else. Even if it is approved, there can be no assurance that
it will be commercially successful or that we will ever receive revenues equal
to our financial investment in this product candidate.
We have been evaluating IMMU-102 (Y-90 eMAb) in a Phase I/II clinical
trial being conducted in the United States and Europe. This clinical trial is
examining the safety and efficacy of IMMU-102 in patients with indolent or
aggressive non-Hodgkin's lymphoma who have had a relapse of disease following
standard chemotherapy. We are encouraged by the results of these trials and we
are in the process of expanding these studies.
Other Therapeutic Product Candidates
We also have in development a solid tumor therapeutic product candidate
that targets an antigen known as carcinoembryonic antigen, or CEA. The CEA
antigen is abundant at the site of virtually all cancers of the colon and rectum
and is associated with many other solid tumors, such as breast and lung cancers.
Our humanized CEA antibody (hCEA, IMMU-100) is in clinical testing both in
unlabeled and radiolabeled forms. The unlabeled form is being tested in a Phase
I dose-escalation trial in patients with colorectal or breast cancer. A Phase II
trial has been completed in Europe for IMMU-111 (hCEA-I-131) in patients with
proven or suspected metastatic colorectal cancer who failed chemotherapy. We
believe that the initial results with IMMU-111 are encouraging. This Phase I/II
trial with IMMU-101 (hCEA-Y-90) has completed enrollment in the United States
and in Europe in patients with advanced colorectal and pancreatic cancers.
We have recently begun the clinical evaluation of IMMU-105, a new
humanized antibody labeled with Y-90, for the treatment of primary liver cancer.
IMMU-105 binds to an antigen known as alpha-fetoprotein (AFP), which is commonly
produced by primary liver tumors. We also are commencing clinical trials with
IMMU-106 (anti-CD20) for the treatment of certain autoimmune diseases and
non-Hodgkin's lymphoma, and we have received approval from the U.S. Food and
Drug Administration, or FDA, to begin clinical trials with IMMU-107 (for use in
targeting anti-MUC 1 antibody) for pancreatic cancer therapy. In addition to
these three product candidates, we have several others in pre-clinical
development.
Diagnostics
In 1998, we began to transition our focus away from the development of
diagnostic imaging products in order to accelerate the development of our
therapeutic product candidates. As a result, as of June 30, 2004, research and
development into diagnostic imaging product candidates was no longer a material
portion of our business.
IBC Pharmaceuticals, Inc.
In 1999, we began conducting research involving the selective delivery of
therapeutic agents to fight cancer as part of a collaboration with Beckman
Coulter, Inc. ("Beckman Coulter"). Upon our formation of the joint venture, IBC
Pharmaceuticals, LLC, "IBC LLC", we granted certain intellectual property to the
venture, as did Beckman Coulter. We were then reimbursed for all of the research
activities we conducted on the joint venture's behalf.
32
In the fourth quarter of fiscal year 2002 we were able to acquire all of
the membership interests in IBC LLC held by Beckman Coulter, giving us majority
control of the business. IBC LLC was then reorganized into IBC Pharmaceuticals,
Inc., a Delaware corporation ("IBC"). We currently hold all of the outstanding
shares of IBC Series A Preferred stock, representing approximately 74% of the
total shares of voting stock outstanding. As a result of our majority interest
in IBC, operating results of IBC are consolidated with the Company.
Critical Accounting Policies
The Company's consolidated financial statements are prepared in accordance
with accounting principles generally accepted in the United States, which
require 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 revenue and expenses during the reporting period. Actual
results could differ from these estimates. The following discussion highlights
what we believe to be the critical accounting policies and judgments made in the
preparation of these consolidated financial statements.
Revenue Recognition
Contract revenue from collaborative research agreements is recorded when
earned based on the performance requirements of the contract. Revenue from
non-refundable upfront license fees and certain guaranteed payments where we
continue involvement through collaborative development are deferred and
recognized as revenue over the period of continuing involvement. We estimate the
period of continuing involvement based on the best available evidential matter
available to us at each reporting period. If our estimated time frame for
continuing involvement changes, this change in estimate could impact the amount
of revenue recognized in future periods.
Revenue from product sales is recorded when there is persuasive evidence
that an arrangement exists, delivery has occurred, the price is fixed and
determinable and collectability is reasonably assured. Allowances, if any, are
established for uncollectible amounts, estimated product returns and discounts.
Since allowances are recorded based on management's estimates, actual amounts
may be different in the future.
Foreign Currency Risks
Since Immunomedics operates in countries outside of the United States, it
is exposed to various foreign currency risks. Two specific risks arise from the
nature of the contracts Immunomedics executes with its customers, since from
time to time contracts are denominated in a currency different than the
particular Immunomedics subsidiary's local currency. These risks are generally
applicable only to a portion of the contracts executed by the Company's foreign
subsidiaries providing clinical services. The first risk occurs as revenue
recognized for services rendered is denominated in a currency different from the
currency in which the subsidiary's expenses are incurred. As a result, the
subsidiary's net revenues and resultant earnings can be affected by fluctuations
in exchange rates. Historically, fluctuations in exchange rates from those in
effect at the time contracts were executed have not had a material effect upon
the Company's consolidated financial results.
The second risk results from the passage of time between the invoicing of
customers and affiliates under these contracts and the ultimate collection of
customer payments against such invoices. Because the contract is denominated in
a currency other than the subsidiary's local currency, Immunomedics recognizes a
receivable at the time of invoicing for the local currency equivalent of the
foreign currency invoice amount. Changes in exchange rates from the time the
invoice is prepared and payment from the customer is received will result in
Immunomedics receiving either more or less in local currency than the local
currency equivalent
33
of the invoice amount at the time the invoice was prepared and the receivable
established. This difference is recognized by Immunomedics as a foreign currency
transaction gain or loss, as applicable, and is reported in other expense
(income) in the Company's Consolidated Statements of Operations. In addition,
for intercompany transactions for which settlement is planned or anticipated in
the foreseeable future, the related foreign currency transaction gains or
losses, as applicable, are reported in other expenses (income) in the Company's
Consolidated Statement of Operations.
Finally, the Company's consolidated financial statements are denominated
in U.S. dollars. Accordingly, changes in exchange rates between the applicable
foreign currency and the U.S. dollar will affect the translation of each foreign
subsidiary's financial results into U.S. dollars for purposes of reporting the
Company's consolidated financial results. The process by which each foreign
subsidiary's financial results are translated into U.S. dollars is as follows:
income statement accounts are translated at average exchange rates for the
period; balance sheet asset and liability accounts are translated at end of
period exchange rates; and equity accounts are translated at historical exchange
rates. Translation of the balance sheet in this manner affects the stockholders'
equity account, referred to as the cumulative translation adjustment account.
This account exists only in the foreign subsidiary's U.S. dollar balance sheet
and is necessary to keep the foreign balance sheet stated in U.S. dollars in
balance. To date such cumulative translation adjustments have not been material
to the Company's consolidated financial position.
Stock Based Compensation
Immunomedics grants stock options to its employees at an exercise price
equal to the fair value of the shares at the date of grant and accounts for
these stock option grants in accordance with APB Opinion No. 25, "Accounting for
Stock Issued to Employees" and related interpretations. Under APB Opinion No.
25, when stock options are issued with an exercise price equal to the market
price of the underlying stock on the date of grant, no compensation expense is
recognized in the income statement. However, for purposes of disclosure only, we
estimate the fair value of stock options through the use of option pricing
models. In determining the values to use in our option-pricing model, we make
several subjective estimates about the characteristics of the underlying stock
and the expected timing of option exercise. Changes to these estimates can
change the fair value disclosures in our financial statements.
Impairment of Assets
Immunomedics reviews its long-lived assets for impairment, when events or
changes in circumstances occur that indicate that the carrying value of the
asset may not be recoverable. The assessment of possible impairment is based
upon the Company's judgment of its ability to recover the asset from the
expected future undiscounted cash flows of the related operations. Actual future
cash flows may be greater or less than estimated.
Results of Operations
Fiscal Year 2004 compared to Fiscal Year 2003
Revenues for the fiscal year ended June 30, 2004 were $4,306,000 as
compared to $13,719,000 in the fiscal year ended June 30, 2003, representing a
decrease of $9,413,000, or 69%, primarily due to a decrease in license fees.
License fee and other revenues for fiscal year 2004 decreased to $512,000 from
$10,127,000 for the same period in 2003, primarily due to the complete
recognition of the licensing fees associated with the Development and License
Agreement with Amgen, Inc. ("Amgen Agreement") by February 2003. Revenues
derived from the Amgen Agreement declined from $9,693,000 in 2003 to $275,000 in
2004. Product sales for fiscal year 2004 were about the same as 2003 as a result
of the
34
Company's decision to transition its focus from the sale of diagnostic imaging
products to the development of therapeutic compounds. Revenues from grants for
research and development for fiscal year 2004 increased to $186,000 from $34,000
for the same period of 2003.
Total operating expenses for fiscal year 2004 were $27,299,000 as compared
to $23,533,000 in fiscal year 2003, representing an increase of $3,766,000, or
16%. Research and development expenses for fiscal year 2004 increased by
$3,759,000, from $18,175,000 in fiscal year 2003 to $21,934,000 primarily due to
an increased number of professional staff, as well as increased research and
development efforts including manufacturing expenses such as laboratory supplies
associated with producing compounds to be used in clinical trials. Cost of goods
sold for fiscal year 2004 increased by $170,000 to $713,000 from $543,000 in
fiscal year 2003, primarily due to increased sales of in-vitro diagnostic kits
and other imaging products and establishment of reserves for inventory on hand
for product lines that are being de-emphasized.
Sales and marketing expenses for fiscal year 2004 were $1,331,000 as
compared to $1,313,000 for fiscal year 2003, representing a decrease of $18,000.
General and administrative costs for fiscal year 2004 decreased by $182,000 from
$3,502,000 in fiscal year 2003 to $3,320,000.
Interest and other income for fiscal year 2004 decreased by $586,000 from
$1,096,000 in fiscal year 2003 to $510,000 in 2004, primarily due to lower rates
of return on our invested cash and reduced level of cash available for
investment. Interest expense increased from $9,000 in fiscal year 2003 to
$225,000 in fiscal year 2004. This increase was due to the $6,376,000 bond
financing with the New Jersey Economic Authority, completed in May 2003, and the
issuance of $10,000,000 of convertible senior notes, which was completed in
January 2004.
For fiscal years 2004 and 2003, we recorded a tax benefit of $428,000 and
$745,000, respectively, as a result of our sale of approximately $5,313,000 and
$9,246,000 of New Jersey state net operating losses, respectively. These tax
benefits were partially offset by income tax provisions of $194,000 and $65,000,
primarily from our European subsidiary for 2004 and 2003, respectively.
Net loss allocable to common stockholders for fiscal year 2004 is
$22,355,000, or $0.45 per share, as compared to $7,874,000, or $0.16 per share,
in fiscal year 2003.
Fiscal Year 2003 compared to Fiscal Year 2002
Revenues for the fiscal year ended June 30, 2003 were $13,719,000 as
compared to $14,287,000 in the fiscal year ended June 30, 2002, representing a
decrease of $568,000, or 4%. Product sales for fiscal year 2003 were $3,558,000
as compared to $3,793,000 in fiscal year 2002, representing a decrease of
$235,000, principally reflecting our transition in focus from the sale of
diagnostic imaging products to the development of therapeutic compounds. License
fee and other revenues for fiscal year 2003 decreased to $10,127,000 from
$10,213,000 for the same period in 2002, primarily due to the recognition in
2003 of $265,000 as compared to $1,025,000 in fiscal 2002 of license fee revenue
for a non-exclusive license granted to Daiichi Pure Chemicals Co. partially
offset by recognition in 2003 of $9,693,000 as compared to $9,000,000 in fiscal
2002 of license and supply payments received from Amgen. Revenues from grants
for research and development for fiscal year 2003 decreased to $34,000 from
$281,000 for the same period of 2002.
Total operating expenses for fiscal year 2003 were $23,533,000 as compared
to $20,985,000 in fiscal year 2002, representing an increase of $2,548,000, or
12%. Research and development expenses for fiscal year 2003 increased by
$3,973,000, from $14,202,000 in fiscal year 2002 to $18,175,000, primarily
35
due to an increased number of professional staff, as well as increased research
and development efforts, manufacturing expenses including laboratory supplies
associated with producing compounds to be used in clinical trials and costs
associated with IBC in the amount of $1,002,000, as IBC became a majority-owned
subsidiary of Immunomedics in June 2002. Cost of goods sold for fiscal year 2003
decreased by $132,000 to $543,000 from $675,000 in fiscal year 2002, primarily
due to decreased sales of in-vitro diagnostic kits and other imaging products.
Sales and marketing expenses for fiscal year 2003 were $1,313,000 as
compared to $2,286,000 for fiscal year 2002, representing a decrease of
$973,000. This is primarily due to lower staffing levels in the United States
and Europe and the reduction of other marketing related expenses consistent with
our shift in focus to therapeutics. General and administrative costs for fiscal
year 2003 increased by $617,000 from $2,885,000 in fiscal year 2002 to
$3,502,000. This was primarily due to the recognition of compensation expense of
$360,000 associated with the issuance of a fully vested option to acquire 80,000
shares of our common stock at a purchase price of $4.94 per share to Dr. Morton
Coleman, a non-employee director, in consideration for consulting services to
Immunomedics, as well as an increased number of employees and associated salary
expenses, increased insurance costs, increased regulatory compliance costs for
all public companies and other administrative expenses.
Interest and other income for fiscal year 2003 decreased by $973,000 from
$2,069,000 in fiscal year 2002 to $1,096,000 in 2003, primarily due to lower
rates of return on our invested cash and reduced level of cash available for
investment.
For fiscal years 2003 and 2002, we recorded a tax benefit of $745,000 and
$1,205,000, respectively, as a result of our sale of approximately $9,246,000
and $15,269,000 of New Jersey state net operating losses, respectively. The 2003
tax benefit is partially offset by an income tax provision of $65,000 for our
European subsidiary.
Net loss allocable to common stockholders for fiscal year 2003 is
$7,874,000, or $0.16 per share, as compared to $3,747,000, or $0.08 per share,
in fiscal year 2002.
Liquidity and Capital Resources
Since our inception in 1982, we have financed our operations primarily
through private sales of our equity securities, revenue earned under licensing
agreements and, to a lesser degree, from sales of CEA-Scan(R) and LeukoScan(R),
research grants from various sources and investment income.
At June 30, 2004, we had working capital of $10,335,000, representing a
decrease of $11,441,000 from $21,776,000 at June 30, 2003. At June 30, 2004, we
had long-term debt of $5,100,800 through the New Jersey Economic Development
Authority and $10,000,000 aggregate principal amount of convertible senior notes
for a total of $15,100,800. The net decrease in working capital resulted
principally from the net loss allocable to common stockholders during fiscal
year 2004 of $22,355,000 partially offset by the $10,000,000 proceeds received
from the January 2004 sale of convertible senior notes.
On January 20, 2004, we completed a $10,000,000 financing of Convertible
Senior Notes, which are due January 12, 2006. The notes bear interest at a fixed
annual rate of 3.25% to be paid semiannually. The holder of the notes may
convert the notes at any time prior to the maturity date into shares of the
Company's common stock at a conversion price of $6.09 per share. Immunomedics
has registered the notes and the shares of common stock issuable upon conversion
of the notes with the SEC for potential sale. Proceeds from the financing have
been and will be used to continue the Company's development of
36
its cancer and autoimmune disease therapeutics and for working capital and other
general corporate purposes.
In August 2004, the Company sold 4,178,116 shares of its common stock,
resulting in net proceeds to the Company of approximately $14.0 million. The
shares were sold to institutional investors at a price of $3.61 per share. The
Company also agreed to grant these investors rights to purchase an additional
4,178,116 shares of its common stock at a price of $3.97 per share, by a date no
later than November 24, 2004. The shares of common stock were sold pursuant to
an effective shelf registration statement filed with the SEC.
Our cash, cash equivalents and marketable securities amounted to
$13,479,000 at June 30, 2004, representing a decrease of $10,317,000 from
$23,796,000 at June 30, 2003. This decrease was primarily attributable to the
funding of operating expenses. It is anticipated that working capital and cash,
cash equivalents and marketable securities will decrease during fiscal year 2005
as a result of planned operating expenses and capital expenditures, offset by
the additional cash proceeds received from the sale of common stock in August
2004 and by projected revenues from sales of our diagnostic imaging products in
the United States and Europe. However, there can be no assurance as to the
amount of revenues, if any, these imaging products will provide.
To date, we have not generated positive cash flow from operations,
excluding the effects of the up-front payment received from Amgen in fiscal year
2001. We believe that based on the rate of our current and anticipated cash
outlay, our existing working capital and the funds received in connection with
our August 2004 sale of common stock should be sufficient to meet our capital
and liquidity requirements for the next twelve months.
Actual results could differ materially from our expectations as a result
of a number of risks and uncertainties, including the risks described in Item 1,
"Factors That May Affect Our Business and Results of Operations," and elsewhere
in this Annual Report on Form 10-K. Our working capital and working capital
requirements are affected by numerous factors and such factors may have a
negative impact on our liquidity. Principal among these are the success of
product commercialization and marketing products, the technological advantages
and pricing of our products, the impact of the regulatory requirements
applicable to us and access to capital markets that can provide us with the
resources when necessary to fund our strategic priorities.
We expect to utilize our cash equivalents and short-term investments to
fund our operations at levels similar to those used in fiscal year 2004.
However, we do not believe that we will have adequate cash at this spending
level to complete our research and development programs. As a result, we will
require additional financial resources after we utilize our current liquid
assets in order for us to continue our research and development programs,
clinical trials of our product candidates and regulatory filings. Additional
financing may not be available to us on terms we find acceptable, if at all, and
the terms of such financing may cause substantial dilution to existing
stockholders. If adequate funds are not available, we may be required to curtail
significantly one or more of our research and development programs. If we obtain
funds through collaborative partnerships, we may be required to relinquish
rights to certain of our technologies or product candidates.
We continue to evaluate various programs to raise additional capital and
to seek additional revenues from the licensing of our proprietary technologies.
At the present time, we are unable to determine whether any of these future
activities will be successful and, if so, the terms and timing of any definitive
agreements.
37
Contractual Commitments
Our major contractual obligations relate to an operating lease for our
facility, a loan from the New Jersey Economic Development Authority used to fund
the expansion of our facility and the issuance of convertible senior notes. We
have identified and quantified the significant commitments in the following
table for the fiscal years ending June 30:
Payments Due by Period
(in thousands)
Contractual Obligation 2005 2006 2007 2008 2009 Thereafter Total
- --------------------------- -------- -------- -------- -------- -------- ---------- --------
Operating Lease(1) $ 545 $ 545 $ 552 $ 556 $ 556 $ 9,098 $ 11,852
NJEDA Loan(2) $ 1,334 $ 1,317 $ 1,301 $ 1,284 $ -- $ 5,236
Convertible Senior Notes(3) $ 325 $ 10,325 -- -- -- $ 10,650
-------- -------- -------- -------- -------- ---------- --------
TOTAL $ 2,204 $ 12,187 $ 1,853 $ 1,840 $ 556 $ 9,098 $ 27,738
(1) In November 2001, we renewed our operating lease for our Morris
Plains, New Jersey facility for an additional term of 20 years expiring in
October 2021 at a base annual rate of $545,000, which included an additional
15,000 square feet. The rent is fixed for the first five years and increases
every five years thereafter.
(2) In May 2003, we obtained a loan for $6,376,000 at a variable interest
rate through the New Jersey Economic Development Authority, repayable monthly in
60 equal installments.
(3) In January 2004, we completed a $10,000,000 financing through the
issuance of convertible senior notes due January 12, 2006. The notes bear
interest at a fixed annual rate of 3.25%, to be paid semiannually. The holders
of the notes may convert the notes at any time prior to January 12, 2006 at a
conversion price of $6.09 per share.
Recently Issued Accounting Pronouncements
In May 2003, the FASB issued Statement of Financial Accounting Standards
No. 150 (SFAS 150), "Accounting for Certain Financial Instruments with
Characteristics of Both Liabilities and Equity," which addresses how an issuer
classifies and measures financial instruments within characteristics of both
liabilities and equity. It requires that an issuer classify a financial
instrument that is within its scope as a liability because that financial
instrument embodies an obligation of the issuers. SFAS 150 is effective for
financial instruments entered into or modified after May 31, 2003, and otherwise
is effective at the beginning of the interim period beginning after June 15,
2003. For financial instruments created before the issuance date of SFAS 150 and
still existing at the beginning of the interim period of adoption, transition
shall be achieved by reporting the cumulative effect of a change in an
accounting principle by initially measuring the financial instruments at fair
value or other measurement attribute required by SFAS 150. The adoption of SFAS
150 did not have any impact on our consolidated financial statements.
In January 2003, the FASB issued FASB Interpretation No. 46 ("FIN 46"),
"Consolidation of Variable Interest Entities". FIN 46 addresses the requirements
for business enterprises to consolidate related entities, for which they do not
have controlling interests through voting or other rights, if they are
determined to be the primary beneficiary as a result of variable economic
interests. FIN 46 provides guidance for determining the primary beneficiary for
entities with multiple economic interests. FIN 46 is effective at the time of
investment for interests obtained in a variable economic entity after January
31, 2003. Beginning in the third quarter of our fiscal year 2004, FIN 46 applies
to interests in variable interest entities (VIEs) acquired prior to February 1,
2003. The adoption of FIN 46 did not have any
38
impact on our consolidated financial statements.
Item 7A -- Quantitative and Qualitative Disclosures About Market Risk
The following discussion about our exposure to market risk of financial
instruments contains forward-looking statements under the Private Securities
Litigation Reform Act of 1995. Actual results may differ materially from those
described due to a number of factors, including uncertainties associated with
general economic conditions and conditions impacting our industry.
Our holdings of financial instruments are comprised primarily of corporate
debt securities and municipal bonds. All such instruments are classified as
securities available for sale. We do not invest in portfolio equity securities
or commodities or use financial derivatives for trading purposes. Our debt
security portfolio represents funds held temporarily pending use in our business
and operations. We manage these funds accordingly. We seek reasonable
assuredness of the safety of principal and market liquidity by investing in
rated fixed income securities while at the same time seeking to achieve a
favorable rate of return. Our market risk exposure consists principally of
exposure to changes in interest rates. Our holdings also are exposed to the
risks of changes in the credit quality of issuers. We typically invest in highly
liquid debt instruments with fixed interest rates.
The table below presents the amounts and related weighted average interest
rates by fiscal year of maturity for our investment portfolio in marketable and
restricted securities as of June 30, 2004:
Fair
2005 2006 2007 2008 2009 Total Value
------ ------ ------ ------ ------ ------ ------
(in thousands)
Fixed rate $2,952 $3,344 $3,170 -- -- $9,466 $9,447
Average interest rate 1.94% 3.19% 1.72% -- -- 2.31% --
39
Item 8 -- Financial Statements and Supplementary Data
IMMUNOMEDICS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
June 30, June 30,
2004 2003
------------- -------------
ASSETS
Current Assets:
Cash and cash equivalents ............................................... $ 9,133,297 $ 13,601,627
Marketable securities ................................................... 4,345,891 10,194,813
Accounts receivable, net of allowance for doubtful accounts of $343,724
and $381,681 at June 30, 2004 and June 30, 2003,
respectively ......................................................... 788,647 930,134
Inventory, net of reserve ............................................... 340,133 839,480
Other current assets .................................................... 748,921 825,372
Restricted securities - current portion ................................. 1,275,200 1,275,200
------------- -------------
Total current assets ....................................... 16,632,089 27,666,626
Property and equipment, net .................................................. 11,532,646 12,298,971
Restricted securities ........................................................ 3,825,600 5,100,800
Other long-term assets ....................................................... 98,243 63,157
------------- -------------
$ 32,088,578 $ 45,129,554
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Current portion of long-term debt ....................................... $ 1,275,200 $ 1,275,200
Accounts payable and accrued expenses ................................... 5,021,513 4,615,746
------------- -------------
Total current liabilities .................................. 6,296,713 5,890,946
------------- -------------
Long-term debt ............................................................... 13,825,600 5,100,800
Minority interest ............................................................ 382,121 471,044
Commitments and Contingencies
Stockholders' equity:
Preferred stock, $.01 par value; authorized 10,000,000 shares; no
shares issued and outstanding at June 30, 2004 and June 30, 2003 .... -- --
Common stock, $.01 par value; authorized 70,000,000 shares; issued and
outstanding, 49,893,693 and 49,878,193 shares at June 30, 2004 and
June 30, 2003, respectively ......................................... 498,937 498,782
Capital contributed in excess of par .................................... 159,493,859 159,037,244
Treasury stock, at cost, 34,725 shares .................................. (458,370) (458,370)
Accumulated deficit ..................................................... (148,257,745) (125,902,490)
Accumulated other comprehensive income .................................. 307,463 491,598
------------- -------------
Total stockholders' equity ................................. 11,584,144 33,666,764
------------- -------------
$ 32,088,578 $ 45,129,554
============= =============
See accompanying notes to consolidated financial statements.
40
IMMUNOMEDICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE INCOME (LOSS)
Years ended June 30,
--------------------------------------------
2004 2003 2002
------------ ------------ ------------
Revenues:
Product sales ............................................. $ 3,607,413 $ 3,558,435 $ 3,792,841
License fee and other revenues ............................ 512,256 10,127,327 10,212,720
Research and development .................................. 186,171 33,710 281,200
------------ ------------ ------------
Total revenues ....................................... 4,305,840 13,719,472 14,286,761
------------ ------------ ------------
Costs and Expenses:
Costs of goods sold ....................................... 713,332 543,400 675,240
Research and development .................................. 21,934,287 18,174,806 14,202,275
Sales and marketing ....................................... 1,331,235 1,312,863 2,286,054
General and administrative ................................ 3,320,220 3,501,855 2,885,500
Acquired in-process research and development .............. -- -- 935,889
------------ ------------ ------------
Total costs and expenses ............................. 27,299,074 23,532,924 20,984,958
------------ ------------ ------------
Operating loss ................................................. (22,993,234) (9,813,452) (6,698,197)
Interest and other income ................................. 509,608 1,095,714 2,069,214
Interest expense .......................................... (224,743) (9,064) --
Minority interest ......................................... 88,923 88,178 --
Foreign currency transaction gain (loss) .................. 30,055 84,864 (323,452)
------------ ------------ ------------
Loss before income tax benefit ................................. (22,589,391) (8,553,760) (4,952,435)
Income tax benefit ............................................. 234,136 679,454 1,205,530
------------ ------------ ------------
Net loss ...................................................... $(22,355,255) $ (7,874,306) $ (3,746,905)
============ ============ ============
Per Share Data (basic and diluted):
Net loss ....................................................... $ (0.45) $ (0.16) $ (0.08)
============ ============ ============
Weighted average number of common shares outstanding ........... 49,886,484 49,877,889 49,651,547
============ ============ ============
Comprehensive income (loss):
Net loss .................................................. $(22,355,255) $ (7,874,306) $ (3,746,905)
Other comprehensive income (loss), net of tax:
Foreign currency translation adjustments .............. 85,737 68,297 393,619
Unrealized gain (loss) on securities available for sale (269,872) (90,903) 10,223
------------ ------------ ------------
Other comprehensive income (loss) ......................... (184,135) (22,606) 403,842
------------ ------------ ------------
Comprehensive loss ............................................. $(22,539,390) $ (7,896,912) $ (3,343,063)
============ ============ ============
See accompanying notes to consolidated financial statements.
41
IMMUNOMEDICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY
Convertible
Preferred Stock Common Stock Capital
--------------- --------------------- Contributed
Shares Amount Shares Amount in Excess of Par
------ ------ ---------- -------- ----------------
Balance, at June 30, 2001 ............................. -- -- 49,533,871 495,339 155,116,973
Exercise of option to purchase common stock ...... -- -- 100,250 1,002 371,370
Exercise of warrants to purchase common stock .... -- -- 104,422 1,044 375,831
Retirement of Shareholder Rights Plan ............ -- -- -- -- (49,739)
Common Stock and warrant issued in connection with
the purchase of additional interest in IBC ... -- -- 138,900 1,389 2,648,601
Compensation expense associates with issuance of
stock options to employees ................... -- -- -- -- 106,440
Other comprehensive income ....................... -- -- -- -- --
Net loss ......................................... -- -- -- -- --
------ ------ ---------- -------- ----------------
Balance, at June 30, 2002 ............................. -- -- 49,877,443 498,774 158,569,476
Exercise of options to purchase common stock ..... -- -- 750 8 1,328
Compensation expense associated with issuance of
stock options to non-employee ................ -- -- -- -- 360,000
Compensation expense associated with issuance of
stock options to employees ................... -- -- -- -- 106,440
Other comprehensive loss ......................... -- -- -- -- --
Net loss ......................................... -- -- -- -- --
------ ------ ---------- -------- ----------------
Balance, at June 30, 2003 ............................. -- $ -- 49,878,193 $498,782 $159,037,244
Exercise of options to purchase common stock ..... -- -- 15,500 155 49,045
Issuance of warrants to purchase common stock .... -- -- -- -- 310,000
Compensation expense associated with issuance of
stock options to employees ................... -- -- -- -- 97,570
Other comprehensive loss ......................... -- -- -- -- --
Net loss ......................................... -- -- -- -- --
------ ------ ---------- -------- ----------------
Balance, at June 30, 2004 ............................. -- $ -- 49,893,693 $498,937 $159,493,859
====== ====== ========== ======== ================
Accumulated
Other
Treasury Accumulated Comprehensive
Stock Deficit Income/(Loss) Total
--------- ------------- ------------- ------------
Balance, at June 30, 2001 ............................. -- (114,281,279) 110,362 41,441,395
Exercise of option to purchase common stock ...... -- -- -- 372,372
Exercise of warrants to purchase common stock .... -- -- -- 376,875
Retirement of Shareholder Rights Plan ............ -- -- -- (49,739)
Common Stock and warrant issued in connection with
the purchase of additional interest in IBC ... (458,370) -- -- 2,191,620
Compensation expense associates with issuance of
stock options to employees ................... -- -- -- 106,440
Other comprehensive income ....................... -- -- 403,842 403,842
Net loss ......................................... -- (3,746,905) -- (3,746,905)
--------- ------------- ------------- ------------
Balance, at June 30, 2002 ............................. (458,370) (118,028,184) 514,204 41,095,900
Exercise of options to purchase common stock ..... -- -- -- 1,336
Compensation expense associated with issuance of
stock options to non-employee ................ -- -- -- 360,000
Compensation expense associated with issuance of
stock options to employees ................... -- -- -- 106,440
Other comprehensive loss ......................... -- -- (22,606) (22,606)
Net loss ......................................... -- (7,874,306) -- (7,874,306)
--------- ------------- ------------- ------------
Balance, at June 30, 2003 ............................. $(458,370) $(125,902,490) $491,598 $33,666,764
Exercise of options to purchase common stock ..... -- -- -- 49,200
Issuance of warrants to purchase common stock .... -- -- -- 310,000
Compensation expense associated with issuance of
stock options to employees ................... -- -- -- 97,570
Other comprehensive loss ......................... -- -- (184,135) (184,135)
Net loss ......................................... -- (22,355,255) -- (22,355,255)
--------- ------------- ------------- ------------
Balance, at June 30, 2004 ............................. $(458,370) $(148,257,745) $307,463 $11,584,144
========= ============= ============= ============
See accompanying notes to consolidated financial statements.
42
IMMUNOMEDICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
Years ended June 30,
--------------------------------------------
2004 2003 2002
------------ ------------ ------------
Cash flows from operating activities:
Net loss ....................................................... $(22,355,255) $ (7,874,306) $ (3,746,905)
Adjustments to reconcile net loss to net cash provided by
(used in) operating activities:
Depreciation ............................................. 1,947,683 1,558,940 977,517
Minority interest ........................................ (88,923) (88,178) --
Provision for allowance for doubtful accounts ............ (37,957) 91,815 164,426
Inventory reserve ........................................ 139,000 -- --
Amortization of bond premium ............................. 216,871 255,162 246,147
Non-cash expense relating to issuance of warrants ........ 310,000 -- --
Non-employee stock based compensation .................... -- 360,000 --
Employee stock based compensation ........................ 97,570 106,440 106,440
Other .................................................... 85,737 68,297 393,619
Changes in operating assets and liabilities:
Accounts receivable ...................................... 179,444 84,767 (476,958)
Inventories .............................................. 360,347 (197,794) 109,083
Other current assets ..................................... 76,451 976,607 (648,193)
Other long-term assets ................................... (35,086) (12,000) --
Accounts payable and accrued expenses .................... 405,767 (1,204,586) 2,090,629
Deferred revenue ......................................... -- (7,475,728) (6,774,272)
------------ ------------ ------------
Net cash used in operating activities .................... (18,698,351) (13,350,564) (7,558,467)
------------ ------------ ------------
Cash flows from investing activities:
Purchase of marketable securities .............................. (849,977) (10,229,667) (13,877,725)
Proceeds from maturities of marketable securities .............. 7,487,356 25,037,578 26,824,966
Purchase of additional interest in IBC ......................... -- -- 2,542,344
Additions to property and equipment ............................ (1,181,358) (7,296,010) (4,105,161)
------------ ------------ ------------
Net cash from investing activities ............................. 5,456,021 7,511,901 11,384,424
------------ ------------ ------------
Cash flows from financing activities:
Issuance of convertible senior notes ........................... 10,000,000 -- --
Facility expansion financing ................................... -- 6,376,000 --
Payments of debt ............................................... (1,275,200) -- (70,412)
Retirement of 1998 Shareholder Rights Plan ..................... -- -- (49,739)
Exercise of warrants ........................................... -- -- 376,875
Exercise of stock options ...................................... 49,200 1,336 372,372
------------ ------------ ------------
Net cash provided by financing activities ................. 8,774,000 6,377,336 629,096
------------ ------------ ------------
Increase (decrease) in cash and cash equivalents .................... (4,468,330) 538,673 4,455,053
Cash and cash equivalents at beginning of period .................... 13,601,627 13,062,954 8,607,901
------------ ------------ ------------
Cash and cash equivalents at end of period .......................... $ 9,133,297 $ 13,601,627 $ 13,062,954
============ ============ ============
Supplemental disclosure of noncash financing activities:
Common stock and warrant issued in connection with the purchase
of additional interest in IBC .............................. $ -- $ -- $ 2,649,990
Cash paid for interest .............................................. $ 76,766 $ -- $ 1,683
Cash paid for income taxes .......................................... $ 4,232 $ 1,490 $ --
See accompanying notes to consolidated financial statements.
43
IMMUNOMEDICS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
1. Business Overview
Immunomedics, Inc., a Delaware corporation ("Immunomedics" or the
"Company") is a biopharmaceutical company focused on the development of
monoclonal antibody-based products for the targeted treatment of cancer,
autoimmune and other serious diseases. Immunomedics currently markets and sells
CEA-Scan(R) in the United States, and CEA-Scan(R) and LeukoScan(R) throughout
Europe and in certain other markets outside the U.S.
Immunomedics is subject to significant risks and uncertainties, including,
without limitation, our inability to further identify, develop and achieve
commercial success for new products and technologies; the possibility of delays
in the research and development necessary to select drug development candidates
and delays in clinical trials; the risk that clinical trials may not result in
marketable products; the risk that we may be unable to successfully finance and
secure regulatory approval of and market our drug candidates; our dependence
upon pharmaceutical and biotechnology collaborations; the levels and timing of
payments under our collaborative agreements; uncertainties about our ability to
obtain new corporate collaborations and acquire new technologies on satisfactory
terms, if at all; the development of competing products; our ability to protect
our proprietary technologies; patent-infringement claims; and risks of new,
changing and competitive technologies and regulations in the United States and
internationally.
Immunomedics expects to utilize its cash equivalents and short-term
investments including the net proceeds of approximately $14.0 million from the
sale of common stock in August 2004, to fund its operations at levels similar to
those used in fiscal year 2004. However, the Company does not believe that it
will have adequate cash at this spending level to complete its research and
development programs. As a result, Immunomedics will require additional
financial resources after it utilizes its current liquid assets in order to
continue its research and development programs, clinical trials of product
candidates and regulatory filing. Immunomedics has never achieved profitable
operations, and there is no assurance that profitable operations, even if
achieved, could be sustained on any continuing basis. The Company's future
operations are dependent on, among other things, the success of its
commercialization efforts and market acceptance of any future therapeutic
products. Since its inception in 1982, Immunomedics' principal source of funds
has been the private and public sale of debt and equity securities and, to a
lesser extent, revenues from licensing. There can be no assurance that
Immunomedics will be able to raise the additional capital it will need on
commercially acceptable terms if at all. If it is unable to raise capital on
acceptable terms, its ability to continue its business would be materially and
adversely affected.
2. Summary of Significant Accounting Policies
Principles of Consolidation and Presentation
The consolidated financial statements include the accounts of Immunomedics
and its majority-owned subsidiaries. All significant intercompany balances and
transactions have been eliminated in consolidation. Minority interest is
recorded for a majority-owned subsidiary (see Note 9).
Use of Estimates
The preparation of financial statements in conformity with U.S. generally
accepted accounting principles requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial
44
statements and the reported amounts of revenues and expenses during the reported
period. Actual results could differ from those estimates.
Foreign Currencies
For subsidiaries outside of the United States that operate in a local
currency environment, income and expense items are translated to United States
dollars at the monthly average rates of exchange prevailing during the year,
assets and liabilities are translated at year-end exchange rates and equity
accounts are translated at historical exchange rates. Translation adjustments
are accumulated in a separate component of stockholders' equity in the
Consolidated Balance Sheets and are included in the determination of
comprehensive income in the Consolidated Statements of Stockholders' Equity.
Transaction gains and losses are included in the determination of net income in
the Consolidated Statements of Operations.
Cash Equivalents and Marketable Securities
Immunomedics considers all highly liquid investments with original
maturities of three months or less, at the time of purchase, to be cash
equivalents.
Immunomedics' investments in cash equivalents and marketable securities
are available for sale to fund operations. The portfolio at June 30, 2004
primarily consists of corporate debt securities and municipal bonds.
Concentration of Credit Risk
Cash, cash equivalents and marketable securities are financial instruments
that potentially subject the Company to concentration of credit risk.
Immunomedics invests its cash in debt instruments of financial institutions and
corporations with strong credit ratings. Immunomedics has established guidelines
relative to diversification and maturities that are designed to help ensure
safety and liquidity. These guidelines are periodically reviewed to take
advantage of trends in yields and interest rates. Immunomedics has historically
held the investments to maturity. However, the Company has the ability to sell
these investments before maturity and has therefore classified the investments
as available for sale. Immunomedics has never experienced any significant losses
on its investments.
Reclassification
Certain 2003 and 2002 balances have been reclassified to conform with the
2004 presentation.
Inventory
Inventory is stated at the lower of average cost (which approximates
first-in, first-out) or market, and includes materials, labor and manufacturing
overhead.
Property and Equipment
Property and equipment are stated at cost and are depreciated on a
straight-line basis over the estimated useful lives (5-10 years) of the
respective assets. Leasehold improvements are capitalized and amortized over the
lesser of the life of the lease or the estimated useful life of the asset.
Immunomedics reviews long-lived assets for impairment whenever events or changes
in business circumstances occur that indicate that the carrying amount of the
assets may not be recoverable. Immunomedics assesses the
45
recoverability of long-lived assets held and to be used based on undiscounted
cash flows, and measures the impairment, if any, using discounted cash flows.
Revenue Recognition
Payments received under contracts to fund certain research activities are
recognized as revenue in the period in which the research activities are
performed. Payments received in advance that are related to future performance
are deferred and recognized as revenue when the research projects are performed.
Upfront nonrefundable fees associated with license and development agreements
where the Company has continuing involvement in the agreement are recorded as
deferred revenue and recognized over the estimated service period. If the
estimated service period is subsequently modified, the period over which the
upfront fee is recognized is modified accordingly on a prospective basis.
Revenues from the achievement of research and development milestones are
recognized when the milestones are achieved.
Revenue from the sale of diagnostic products is recorded when there is
persuasive evidence that an arrangement exists, delivery has occurred, the price
is fixed and determinable and collectability is reasonably assured. Allowances,
if any, are established for uncollectible amounts, estimated product returns and
discounts.
Research and Development Costs
Research and development costs are expensed as incurred.
Income Taxes
Income taxes are accounted for under the asset and liability method.
Deferred tax assets and liabilities relate to the expected future tax
consequences of events that have been recognized in the Company's consolidated
financial statements and tax returns. During fiscal years 2004, 2003 and 2002,
the Company recognized tax benefits as a result of the sale of New Jersey net
operating loss carry forwards (see Note 8).
Net Loss Per Share Allocable to Common Stockholders
Net loss per basic and diluted common share allocable to common
stockholders is based on the net loss for the relevant period, divided by the
weighted-average number of common shares outstanding during the period. For the
purposes of the diluted net loss per common share calculations, the exercise or
conversion of all potential common shares is not included because their effect
would have been anti-dilutive, due to the net loss recorded for the years ended
June 30, 2004, 2003 and 2002. The common stock equivalents excluded from the
diluted per share calculation are 5,095,250, 4,325,750, and 3,378,250 for the
fiscal years ended June 30, 2004, 2003 and 2002, respectively.
Comprehensive Loss
Comprehensive loss consists of net loss, net unrealized gains (losses) on
securities available for sale and certain foreign exchange changes and is
presented in the consolidated statements of operations and comprehensive loss.
46
Employee Stock Options
Immunomedics applies the intrinsic value-based method of accounting
prescribed by Accounting Principles Board ("APB") Opinion No. 25, Accounting for
Stock Issued to Employees, and related interpretations, in accounting for its
fixed plan stock options. As such, compensation expense would be recorded on the
date of grant only if the then-current market price of the underlying stock
exceeded the exercise price. SFAS No. 123, Accounting for Stock-Based
Compensation, established accounting and disclosure requirements using a fair
value-based method of accounting for stock-based employee compensation plans. As
allowed by SFAS No. 123, the Company has elected to continue to apply the
intrinsic value-based method of accounting described above, and has adopted the
disclosure requirements of SFAS No. 123.
Had the Company determined compensation cost based on the fair value at
the grant date consistent with the provisions of SFAS No. 123, the Company's net
loss allocable to common shareholders and related per share amounts would have
been the pro forma amounts indicated below:
2004 2003 2002
------------ ------------ ------------
Net (loss), as reported ........................ $(22,355,255) $ (7,874,306) $ (3,746,905)
Add: Stock-based employee compensation
expense ........................................ 97,570 106,440 106,440
Deduct: Total stock-based employee compensation
expense determined under fair value based method
for all awards ................................. (8,251,069) (7,332,028) (6,247,547)
------------ ------------ ------------
Pro forma net (loss) ........................... $(30,508,754) $(15,099,894) $ (9,888,012)
============ ============ ============
Earnings per share:
as reported ........................... $ (0.45) $ (0.16) $ (.08)
pro forma ............................. $ (0.61) $ (0.30) $ (.20)
The fair value of each option granted during the three years ended June
30, 2004 is estimated on the date of grant using the Black-Scholes
option-pricing model with the following weighted-average assumptions: (i)
dividend yield of 0%, (ii) expected term of 8 years for June 30, 2004, 2003 and
2002, (iii) expected volatility of 117% at June 30, 2004, 89% at June 30, 2003
and 129% at June 30, 2002 and (iv) a risk-free interest rate of 4.51%, 3.53% and
4.70% for the years ended June 30, 2004, 2003 and 2002, respectively. The
weighted average fair value at the date of grant for options granted during the
years ended June 30, 2004, 2003 and 2002 was $5.04, $9.91 and $11.60 per share,
respectively.
When the exercise price of employee or director stock options is less than
the fair value of the underlying stock on the grant date, the Company records
compensation expense for the difference over the vesting period of the options.
Options or stock awards issued to non-employees and consultants are recorded at
their fair value as determined in accordance with SFAS No. 123 and 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, and recognized
over the related vesting period and may be subject to remeasurement if
performance commitments exist.
Financial Instruments
The carrying amounts of cash and cash equivalents, other current assets
and current liabilities and restricted securities approximate fair value due to
the short-term maturity of these instruments. The fair
47
value, which equals carrying value, of marketable securities available for sale
is based on quoted market prices.
Recently Issued Accounting Pronouncements
In May 2003, the FASB issued Statement of Financial Accounting Standards
No. 150 (SFAS 150), "Accounting for Certain Financial Instruments with
Characteristics of Both Liabilities and Equity," which addresses how an issuer
classifies and measures financial instruments within characteristics of both
liabilities and equity. It requires that an issuer classify a financial
instrument that is within its scope as a liability because that financial
instrument embodies an obligation of the issuers. This Statement shall be
effective for financial instruments entered into or modified after May 31, 2003,
and otherwise shall be effective at the beginning of the interim period
beginning after June 15, 2003. For financial instruments created before the
issuance date of this Statement and still existing at the beginning of the
interim period of adoption, transition shall be achieved by reporting the
cumulative effect of a change in an accounting principle by initially measuring
the financial instruments at fair value or other measurement attribute required
by this Statement. The adoption of SFAS 150 did not have any impact on our
consolidated financial statements.
In January 2003, the FASB issued FASB Interpretation No. (FIN) 46,
"Consolidation of Variable Interest Entities". FIN 46 addresses the requirements
for business enterprises to consolidate related entities, for which they do not
have controlling interests through voting or other rights, if they are
determined to be the primary beneficiary as a result of variable economic
interests. FIN 46 provides guidance for determining the primary beneficiary for
entities with multiple economic interests. FIN 46 is effective at the time of
investment for interests obtained in a variable economic entity after January
31, 2003. Beginning in the third quarter of our fiscal year 2004, FIN 46 applies
to interests in variable interest Entities (VIE's) acquired prior to February 1,
2003. The adoption of FIN 46 did not have any impact on our consolidated
financial statements.
3. Marketable Securities and Restricted Securities
Immunomedics utilizes SFAS No. 115, Accounting for Certain Investments in
Debt and Equity Securities, to account for investments in marketable securities.
Under this accounting standard, securities for which there is not the positive
intent and ability to hold to maturity are classified as available-for-sale and
are carried at fair value. Unrealized holding gains and losses, which are deemed
to be temporary, on securities classified as available-for-sale are carried as a
separate component of accumulated other comprehensive income (loss).
Immunomedics considers all of its current investments to be available-for-sale.
Marketable securities and restricted securities at June 30, 2004 and 2003
consist of the following (in thousands):
Gross Gross Estimated
Amortized Unrealized Unrealized Fair
Cost Gain Loss Value
---------- ---------- ---------- ----------
June 30, 2004
Agency/NJ Municipal Bonds $7,365 $ -- $(73) $7,292
Corporate Debt Securities 2,101 56 (2) 2,155
---------- ---------- ---------- ----------
$9,466 $56 $(75) $9,447
========== ========== ========== ==========
June 30, 2003
Municipal Bonds - New Jersey $7,017 $14 $(9) $7,022
Corporate Debt Securities 9,293 256 -- 9,549
---------- ---------- ---------- ----------
$16,310 $270 $(9) $16,571
========== ========== ========== ==========
48
Maturities of debt securities classified as available-for-sale were as follows
at June 30, 2004 (in thousands):
Amortized Estimated
Cost Fair Value
---------- ----------
Due within one year $2,951 $2,941
Due after one year through five years 6,515 6,506
---------- ----------
$9,466 $9,447
========== ==========
Restricted securities at 2004 and 2003 of $5,100,800 and $6,376,360,
respectively, are included in the tables above.
Cash and cash equivalents as of June 30, 2004 and 2003 include $1,212,000
and $4,176,000 of mutual funds securities. These securities have less than 90
days maturities from the date of purchase. Included in other comprehensive
income for the years ended June 30, 2004, 2003 and 2002 are approximately
$10,000, ($22,000), and $9,000 of unrealized gains and (losses) related to cash
equivalents with maturities of 90 days or less.
4. Inventory
Inventory consisted of the following at June 30 (in thousands):
2004 2003
---------- ----------
Finished goods $479 $839
Reserve for obsolescence (139) --
---------- ----------
$340 $839
========== ==========
5. Property and Equipment
Property and equipment consisted of the following at June 30 (in
thousands):
2004 2003
---------- ----------
Machinery and equipment $5,314 $4,613
Leasehold improvements 17,336 16,951
Furniture and fixtures 781 766
Computer equipment 1,297 1,217
---------- ----------
24,728 23,547
Accumulated depreciation and amortization (13,195) (11,248)
---------- ----------
$11,533 $12,299
========== ==========
Depreciation expense $1,948 $1,559
========== ==========
49
6. Other Current Balance Sheet Detail
Other current assets consisted of the following at June 30 (in thousands):
2004 2003
---------- ----------
Prepaid insurance $310 $161
Accrued interest receivable 119 197
Customer receivable - material costs -- 170
Prepaid rent 53 58
Prepaid medical/dental insurance 66 53
Miscellaneous other current assets 201 186
---------- ----------
$749 $825
========== ==========
Accounts payable and accrued expenses consisted of the following at June
30 (in thousands):
2004 2003
---------- ----------
Trade accounts payable $1,251 $470
Medical institutions- clinical trial programs 823 788
Various legal counsel 1,487 2,148
Deferred rent expense 314 196
Foreign income taxes payable 383 374
Miscellaneous other current liabilities 764 640
---------- ----------
$5,022 $4,616
========== ==========
7. Stockholders' Equity
The Certificate of Incorporation of the Company authorizes 10,000,000
shares of preferred stock, $.01 par value per share. The preferred stock may be
issued from time to time in one or more series, with such distinctive serial
designations, rights and preferences as shall be determined by the Board of
Directors.
As part of an April 2004 agreement between Amgen, Inc. ("Amgen") and the
Company (see Note 10), the Company issued to Amgen a five-year warrant to
purchase 100,000 shares of our common stock at a price equal to $16.00 per
share, with an estimated value of $310,000. This was expensed in the fourth
quarter of 2004.
In February 2002, the Company's Board of Directors made the decision to
concurrently redeem all outstanding stockholder rights under its 1998
Stockholder Rights Plan, and declare a dividend of one new right per share
pursuant to our 2002 Stockholder Rights Plan (the "2002 Rights Plan") adopted by
the Board of Directors. The 2002 Rights Plan involved the distribution of one
"Right" as a dividend on each outstanding share of the Company's common stock to
each holder of record on March 15, 2002. The
50
redemption cost amounted to $49,739. Each Right entitles the registered holder
to purchase from the Company one one-thousandth of a share of Series G Junior
Participating Preferred Stock, par value $0.01 per share (the "Preferred
Shares"), of the Company, at a price of $150.00 per one one-thousandth of a
Preferred Share (the "Purchase Price"), subject to adjustment. The 2002 Rights
Plan provides that if a third party acquires more than 15% of the Company's
common stock without prior approval of the Board of Directors, all of the
stockholders of the Company (other than the acquiring party) will be entitled to
buy either shares of a special series of our Preferred Shares, or shares of the
Company's common stock with a market value equal to double the Exercise Price
for each Right they hold. Under these circumstances, the Board of Directors may
instead allow each such Right (other than those held by the acquiring party) to
be exchanged for one share of the Company's common stock. The exercise or
exchange of these Rights would have a substantial dilutive effect on the
acquiring party. The Company's Board of Directors retains the right at all times
to discontinue the 2002 Rights Plan through redemption of all rights or amend
the 2002 Rights Plan in any respect. The Rights will expire on March 1, 2012
(the "Final Expiration Date"), unless the Final Expiration Date is extended or
unless the Rights are earlier redeemed by the Company, in each case, as
described in the 2002 Rights Plan. No shareholder has exercised this right as of
June 30, 2004.
Under the terms of the Company's 1983 Stock Option Plan, as amended (the
"1983 Plan"), stock options are granted to employees and members of the Board of
Directors, as determined by the Compensation Committee of the Board of
Directors, at fair market value, become exercisable at 25% per year on each of
the first through fourth anniversaries of the date of grant, and terminate if
not exercised within ten years. In June 1993, the 1983 Plan expired, although
options granted under the 1983 plan that have not terminated may continue to be
exercised. On November 5, 1992, at the Company's Annual Meeting of Stockholders,
adoption of the Company's 1992 Stock Option Plan (the "1992 Plan" and, together
with the 1983 Plan, the "Plans") was ratified. In September 2002, the 1992 Plan
expired, although options granted under the 1992 plan that have not terminated
may continue to be exercised. On December 5, 2001, at the Company's 2001 Annual
Meeting of Stockholders, adoption of our 2002 Stock Option Plan (the "2002 Plan"
and, together with the 1992 Plan, the "Plans") was ratified. The terms of the
2002 Plan are substantially similar to those under the Company's 1992 Plan.
Under the 2002 Plan, 8,000,000 shares were reserved for possible future issuance
upon exercise of stock options. At June 30, 2004, 1,946,875 stock options were
still available for future grant and 6,792,125 shares of common stock were
reserved for possible future issuance upon exercise of stock options both
currently outstanding and which may be issued in the future.
Pursuant to the terms of the 2002 Plan, each of the Company's outside
Directors who had been a Director prior to July 1st of each year is granted, on
the first business day of July of each year, an option to purchase shares of the
Company's common stock at fair market value on the grant date, the amount of
which is determined at the discretion of the Company's Board of Directors. On
July 1, 2004, 2003 and 2002 stock options to purchase 50,000, 40,000 and 160,000
shares of common stock respectively, were granted to these Directors.
Information concerning options for the years ended June 30, 2004, 2003 and
2002 is summarized as follows:
Fiscal 2004
--------------------------------
Shares Option Price Range
---------- ------------------
Outstanding, July 1, 2003 ................... 4,175,750 $1.44 - $24.56
Granted ..................................... 795,000 4.11 - 9.50
Exercised ................................... (15,500) 1.78 - 4.63
Terminated .................................. (110,000) 2.25 - 19.80
---------- ------------------
Outstanding, June 30, 2004 .................. 4,845,250 1.44 - 24.56
---------- ------------------
Exercisable, June 30, 2004 .................. 2,770,875 1.44 - 24.56
---------- ------------------
51
Fiscal 2003
--------------------------------
Shares Option Price Range
---------- ------------------
Outstanding, July 1, 2002 ................... 3,174,250 $1.44 - $24.56
Granted ..................................... 1,126,000 3.34 - 7.71
Exercised ................................... (750) 1.78 - 1.78
Terminated .................................. (123,750) 3.25 - 19.14
---------- ------------------
Outstanding, June 30, 2003 .................. 4,175,750 1.44 - 24.56
---------- ------------------
Fiscal 2002
--------------------------------
Shares Option Price Range
---------- ------------------
Outstanding, July 1, 2001 ................... 2,277,750 $1.44 - $24.56
Granted ..................................... 1,024,000 6.05 - 20.49
Exercised ................................... (100,250) 1.78 - 7.25
Terminated .................................. (27,250) 1.78 - 21.68
---------- ------------------
Outstanding, June 30, 2002 .................. 3,174,250 1.44 - 24.56
---------- ------------------
The following table summarizes information concerning options outstanding
under the Plans at June 30, 2004:
Number Weighted Weighted Number Weighted
outstanding average average exercisable average
Range of at June 30, exercise remaining at June 30, exercise
exercise price 2004 price term (yrs.) 2004 price
- ---------------- ----------- -------- ----------- ----------- --------
$ 1.44 - 3.00 264,500 $1.75 4.8 264,500 $1.75
3.01 - 5.00 1,171,750 4.18 4.5 882,000 3.98
5.01 - 8.00 1,841,500 6.54 8.6 471,250 6.97
8.01-12.00 205,500 9.92 7.3 126,875 9.61
12.01-18.00 710,000 16.82 6.2 640,250 17.09
$ 18.01-24.56 652,000 20.56 6.8 386,000 20.62
----------- -------- ----------- ----------- --------
4,845,250 $9.24 6.8 2,770,875 $9.88
=========== ======== =========== =========== ========
On May 18, 2000, the Board of Directors approved granting an aggregate of
325,000 stock options to Dr. David M. Goldenberg and Cynthia L. Sullivan that
were subject to stockholder approval. Such approval was obtained from the
stockholders during December 2000. The stock options were granted with an
exercise price of $17.75, representing the stock price on the day of the Board
of Directors' approval. The difference in the stock price on that date as
compared to the stock price of $19.06 on the date on which the stockholders'
approval was obtained resulted in compensation cost of $425,750 that is being
expensed by the Company over the vesting period of four years. During fiscal
years 2004, 2003 and 2002, the Company recorded compensation expense of $97,570,
$106,440, and $106,440 respectively, as a component of general and
administrative expense.
52
8. Income Taxes
The provision (benefit) for income taxes is as follows:
Year Ended June 30,
--------------------------------
2004 2003 2002
-------- -------- --------
Federal
Current $ -- $ -- --
Deferred -- -- --
-------- -------- --------
Total Federal -- -- --
State
Current (440) (745) (1,206)
Deferred -- -- --
-------- -------- --------
Total State (440) (745) (1,206)
Foreign
Current 206 66 --
Deferred -- -- --
-------- -------- --------
Total Foreign 206 66
-------- -------- --------
Total (benefit) $(234) $(679) $(1,206)
======== ======== ========
A reconciliation of the statutory tax rates and the effective tax rates for each
of the years ended June 30 is as follows:
2004 2003 2002
------ ------ ------
Statutory rate (34.0%) (34.0%) (34.0%)
State income taxes (net of Federal tax benefit) (5.9%) (5.3%) (24.3%)
Foreign income tax 0.0% (2.4%) 0.0%
Change in valuation allowance 34.2% 34.3% 34.0%
Other 4.7% (0.5%) 0.0%
------ ------ ------
(1.0%) (7.9%) (24.3%)
====== ====== ======
Immunomedics utilizes SFAS No. 109, Accounting for Income Taxes, to
account for income taxes. For fiscal years 2004, 2003 and 2002, the Company
recorded a net tax benefit of $440,000, $745,000 and $1,206,000, respectively,
as a result of its sale of approximately $5,313,000, $9,246,000 and $15,269,000
of New Jersey state net operating losses, respectively.
The tax effects of temporary differences that give rise to significant
portions of the Company's deferred tax assets as of June 30, 2004 and 2003 are
presented below (in thousands):
2004 2003
-------- --------
Deferred tax assets:
Net operating loss carry forwards $57,243 $49,062
Research and development credits 6,377 6,352
Property and equipment 2,173 1,726
Other 611 1,529
-------- --------
Total 66,404 58,669
Valuation allowance (66,404) (58,669)
-------- --------
Net deferred taxes $ -- $ --
======== ========
53
A valuation allowance is provided when it is more likely than not that
some portion or all of the deferred tax assets will not be realized. The
valuation allowances for fiscal years 2005 and 2004 have been applied to offset
the deferred tax assets in recognition of the uncertainty that such tax benefits
will be realized as the Company continues to incur losses. The differences
between book income and tax income primarily relates to depreciation.
At June 30, 2004, the Company has available net operating loss carry
forwards for federal income tax reporting purposes of approximately $153,000,000
and for state income tax reporting purposes of approximately $90,000,000, which
expire at various dates between fiscal 2005 and 2024. Pursuant to Section 382 of
the Internal Revenue Code of 1986, as amended, the annual utilization of a
company's net operating loss and research credit carry forwards may be limited
if the Company experiences a change in ownership of more than 50 percentage
points within a three-year period. As a result of certain financing
arrangements, the Company may have experienced such ownership changes.
Accordingly, the Company's net operating loss carry forwards available to offset
future federal taxable income arising before such ownership changes may be
limited. Similarly, the Company may be restricted in using its research credit
carry forwards arising before such ownership changes to offset future federal
income tax expense. Of the deferred tax asset valuation allowance related to the
net operating loss carry forwards, approximately $24,400,000 relates to a tax
deduction for non-qualified stock options. Immunomedics will increase capital
contributed in excess of par when these benefits are deemed to be more likely
than not to be realized for tax purposes. The net operating loss carry forwards
for Federal income tax reporting purposes referred to above excludes certain
losses from the Company's operations in The Netherlands, which may also be
limited.
9. Related Party Transactions
Certain of the Company's affiliates, including members of its senior
management and Board of Directors, as well as their respective family members
and other affiliates, have relationships and agreements among themselves as well
as with the Company and its affiliates, that create the potential for both real,
as well as perceived, conflicts of interest. These include Dr. David M.
Goldenberg, the Company's Chairman and Chief Strategic Officer, Ms. Cynthia L.
Sullivan, the President and Chief Executive Officer, who is the wife of Dr.
David M. Goldenberg, and certain companies with which the Company does business,
including the Center for Molecular Medicine and Immunology and IBC
Pharmaceuticals, Inc. In addition, the Company's executive vice president, Dr.
Ivan D. Horak, is married to one of our other employees.
Dr. David M. Goldenberg
Dr. David M. Goldenberg was an original founder of Immunomedics over 20
years ago and continues to play a critical role in its business. He currently
serves as Chairman of the Board of Directors and Chief Strategic Officer, and is
married to our President and Chief Executive Officer, Cynthia L. Sullivan. Dr.
Goldenberg is a party to a number of agreements with us involving not only his
services, but intellectual property owned by him. In addition Dr. Goldenberg
performs services for The Center for Molecular Medicine and Immunology ("CMMI"),
a not-for-profit specialized cancer research center.
License Agreement. Pursuant to a License Agreement between Immunomedics
and Dr. Goldenberg, certain patent applications owned by Dr. Goldenberg were
licensed to Immunomedics at the time of Immunomedics' formation in exchange for
a royalty in the amount of 0.5% of the first
54
$20,000,000 of annual net sales of all products covered by any of such patents
and 0.25% of annual net sales of such products in excess of $20,000,000. Five of
the licensed U.S. patents have since expired. In November 1993 the ownership
rights of Immunomedics were extended as part of Dr. Goldenberg's employment
agreement, with Immunomedics agreeing to diligently pursue all ideas,
discoveries, developments and products, into the entire medical field, which, at
any time during his past or continuing employment by Immunomedics (but not when
performing services for CMMI - see below), Dr. Goldenberg has made or conceived
or hereafter makes or conceives, or the making or conception of which he has
materially contributed to or hereafter contributes to, all as defined in the
Employment Agreement.
Employment Agreement. Pursuant to the terms of his employment agreement as
currently in effect, Dr. Goldenberg is entitled to receive incentive
compensation equal to one-half of one percent (0.5%) on the first $75.0 million
of all Annual Net Revenue (as defined therein) of Immunomedics, and one-quarter
of one percent (0.25%) on all such Annual Net Revenue in excess thereof. Annual
Net Revenue is defined to include the proceeds of certain dispositions of assets
or interests therein, including royalties, certain equivalents thereof and, to
the extent approved by the Board of Directors, non-royalty license fees.
Dr. Goldenberg is also entitled to receive Revenue Incentive Compensation
during the period of his actual employment with us, and for a period of three
years thereafter, unless he unilaterally terminates his employment without cause
or is terminated for cause. With respect to the period that Dr. Goldenberg is
entitled to receive Revenue Incentive Compensation on any given products, it
will be in lieu of any other percentage compensation based on sales or revenue
due him with respect to such products under his employment agreement or the
license agreement. With respect to any periods that Dr. Goldenberg is not
receiving such Revenue Incentive Compensation, he is entitled to receive
one-half of one percent (0.5%) on cumulative annual net sales of, royalties on,
certain equivalents thereof, and, to the extent approved by the Board of
Directors, other consideration received by Immunomedics for such products, up to
a cumulative annual aggregate of $75,000,000, and one-quarter of one percent
(0.25%) on any cumulative Annual Net Revenue in excess of $75,000,000. A
$100,000 annual minimum payment must be paid in the aggregate against all
Revenue Incentive Compensation and Royalty Payments and the License Agreement.
No payments were made in addition to the annual minimum payments.
The terms of his employment agreement also provide that Dr. Goldenberg is
entitled to receive a percent, not less than 20 percent (20%), as determined in
good faith by the Board of Directors, of net consideration (including, without
limitation, license fees) which Immunomedics receives in connection with any
disposition by sale, license or otherwise, of any Undeveloped Assets (as defined
therein) which are not budgeted as part of Immunomedics' strategic plan.
Pursuant to this provision, Dr. Goldenberg received a 20% profit interest in the
membership interests originally acquired by Immunomedics in connection with the
formation of the IBC Pharmaceuticals joint venture with Beckman Coulter in March
1999. Dr. Goldenberg also is compensated by IBC Pharmaceuticals as discussed in
greater detail in these notes to the financial statements.
Dr. Goldenberg is not entitled to any incentive compensation with respect
to any products, technologies or businesses acquired from third parties for a
total consideration in excess of $5,000,000, unless Immunomedics had made a
material contribution to the invention or development of such products,
technologies or businesses prior to the time of acquisition. Except as affected
by a Change in Control (as defined therein) or otherwise approved by the Board
of Directors, Dr. Goldenberg will also not be entitled to any Revenue Incentive
Compensation or Royalty Payments other than the Annual Minimum Payment with
respect to any time during the period of his employment (plus three years,
unless employment is terminated by mutual agreement or by Dr.
55
Goldenberg's death or permanent disability) that he is not the direct or
beneficial owner of shares of Immunomedics' voting stock with an aggregate
market value of at least twenty times his defined annual cash compensation.
Finally, it is a condition to his employment agreement that Dr. Goldenberg
be permitted to continue his involvement with CMMI, as discussed in greater
detail below.
In 2001, Dr. Goldenberg's employment agreement was extended for an
additional five-year period, expiring on June 30, 2006.
Life Insurance. The Company has also agreed with Dr. Goldenberg to
maintain in effect for his benefit a $2,000,000 whole life insurance policy. If
Dr. Goldenberg retires from Immunomedics on or after his agreed retirement, or
if his employment ends because of permanent disability, the Company must pay all
then outstanding loans, if any, made under such policy, and assign such policy
to Dr. Goldenberg in consideration of the services previously rendered by Dr.
Goldenberg to us. There are no outstanding loans as of June 30, 2004. If the
employment of Dr. Goldenberg ends for any other reason, except for cause, Dr.
Goldenberg has the option to purchase such policy for a price mutually agreed
upon by him and the Board of Directors, but not to exceed the cash value thereof
less any outstanding policy loans, or he may purchase such policy at its full
cash value, less any outstanding loans, with the purchase price to the paid out
of the proceeds of the policy or any earlier payment or withdrawal of all or any
portion of its net cash value. The Company also currently maintains $4,000,000
of key man life insurance on Dr. Goldenberg for the benefit of the Company.
Additionally, a trust created by Dr. Goldenberg has purchased a
$10,000,000 whole life policy on his life. The policy provides funds, which may
be used to assist Dr. Goldenberg's estate in settling estate tax obligations and
thus potentially reducing the number of shares of the Common Stock the estate
may be required to sell over a short period of time to raise funds to satisfy
such tax obligations. During what is estimated to be a 15-year period, the
Company is obligated to pay $143,000 per year towards premiums, compared to an
equivalent $250,000 commitment under the previous policies, in addition to
amounts required to be paid by Dr. Goldenberg. The Company has an interest in
this new policy up to the cumulative amount of premium payments made by it under
the old and new policies, which, through June 30, 2004, amounted to $2,123,000.
If Dr. Goldenberg's employment terminates, and the policy is not maintained, the
Company would receive payment of only its invested cumulative premiums, up to
the amount of cash surrender value in the policy.
Severance Agreement. In June 2002, the Board of Directors approved (with
Dr. Goldenberg and Ms. Sullivan abstaining) a severance agreement for Dr.
Goldenberg pursuant to which the Company is required, under certain
circumstances upon his termination for any reason, including as a result of his
disability or a change in control of the Company, to sell to Dr. Goldenberg's
family partnership a $10.0 million life insurance policy the Company has
purchased insuring his life. In addition, if Dr. Goldenberg is terminated upon
his disability or a change in control of the Company within six years of the
date of the severance agreement, the Company will reimburse him for the total
purchase price of the life insurance policy. If he is terminated for any other
reason, whether voluntarily or involuntarily, the Company will reimburse him for
50% of the purchase price, so long he has remained employed by the Company for
three years after the agreement, plus an additional amount for each month of
service in excess of three years.
Cynthia L. Sullivan
Employment Agreement. On March 20, 2001, the Company entered into an
employment agreement with Cynthia L. Sullivan that sets forth the terms of her
employment with the Company through March 9, 2006. During the term of her
employment, the Company will pay Ms. Sullivan an
56
annual minimum base salary of $275,000 and an annual bonus as determined by the
Compensation Committee of the Company's Board of Directors, which in no event
shall be less than 20% of the base salary. Ms. Sullivan shall be awarded a
minimum of 150,000 stock options annually on the anniversary of the employment
agreement. Under her employment agreement, Ms. Sullivan may participate in all
benefit plans and programs to the extent she is eligible including medical and
life insurance.
Under the employment agreement, if Ms. Sullivan is terminated for Cause
(as defined in the employment agreement), by reason of death, unavailability (as
defined in the employment agreement), or by reason of voluntary resignation,
then the Company shall pay Ms. Sullivan the base salary through such date of
termination. If Ms. Sullivan is terminated for any other reason, then the
Company shall continue for a period of four years Ms. Sullivan's medical and
life insurance and shall pay Ms. Sullivan the sum of (i) the highest base salary
paid to Ms. Sullivan during any of the prior three years, (ii) the highest bonus
paid to Ms. Sullivan during the prior three years and (iii) the stock options
that Ms. Sullivan would have otherwise received during the period commencing on
the termination date and ending on the later of 24 months from the termination
date and March 9, 2006 (such sum, collectively with the extension of benefits is
referred to hereinafter as the "Severance Payment").
In the event of a Change of Control (as defined in the employment
agreement), all previous stock option grants made to Ms. Sullivan shall
immediately vest. If, following the Change of Control, the Company does not
agree to allow Ms. Sullivan to remain in her current capacity for a one year
period before either consummating a new contract, or the election by Ms.
Sullivan to be paid the Severance Payment, then her employment shall be
terminated and the Company shall pay Ms. Sullivan the Severance Payment.
Relationships with The Center for Molecular Medicine and Immunology
The Company's product development has involved, to varying degrees, The
Center for Molecular Medicine and Immunology (CMMI), a not-for-profit
specialized cancer research center, for the performance of certain basic
research and patient evaluations, the results of which are made available to the
Company pursuant to a collaborative research and license agreement. CMMI, which
is funded primarily by grants from the National Cancer Institute (NCI), is
located in Belleville, New Jersey. Dr. Goldenberg is the founder, current
President and a member of the Board of Trustees of CMMI. Dr. Goldenberg's
employment agreement permits him to devote more of his time working for CMMI
than for the Company. Certain of the Company's consultants have employment
relationships with CMMI, and Dr. Hans Hansen, the Company's emeritus executive
officer, is an adjunct member of CMMI. Despite these relationships, the Company
believes CMMI is independent of Immunomedics, and CMMI's management and fiscal
operations are the responsibility of CMMI's Board of Trustees.
The Company has reimbursed CMMI for expenses incurred on behalf of the
Company, including amounts incurred pursuant to research contracts, in the
amount of approximately $109,000, $90,000 and $205,000 during the years ended
June 30, 2004, 2003 and 2002, respectively. We also provide, at no cost to CMMI,
laboratory materials and supplies. However, any inventions made independently of
the Company at CMMI are the property of CMMI.
During the fiscal years 2004, 2003 and 2002, the Company's Board of
Directors authorized grants to CMMI of $401,000, $349,000, and $214,000,
respectively, to support research and clinical work being performed at CMMI,
such grants to be expended in a manner deemed appropriate by the Board of
Trustees of CMMI.
57
IBC Pharmaceuticals
In March 1999, IBC Pharmaceuticals, LLC ("IBC LLC"), was formed as a joint
venture between Immunomedics and Beckman Coulter, Inc. ("Beckman Coulter") to
pursue the development of novel cancer radiotherapeutics using pre-targeting
with bi-specific antibodies. The initial Immunomedics investment in IBC LLC
consisted solely of intellectual property and was effected through the means of
a second limited liability company, IMG Technology, LLC ("IMG"), which was
formed together with Dr. Goldenberg. Pursuant to the terms of his employment
agreement as discussed above, Dr. Goldenberg is entitled to a twenty percent
(20%) interest any time Immunomedics contributes "unimproved assets" (as defined
in his employment agreement) to other ventures such as the joint venture with
Beckman Coulter. As a result, Dr. Goldenberg obtained a 20% profit interest in
IMG, which in turn owned approximately 48.79% of the membership interests in IBC
LLC, while Beckman Coulter owned 42.79% of the IBC membership interests. In
connection with Dr. Goldenberg's receipt of an interest in IMG, Immunomedics
recognized $182,000 of compensation expense in fiscal year 1999, based on the
fair value of technology transferred. Shortly after its formation, additional
investors contributed approximately $3.3 million in cash to the IBC LLC joint
venture in exchange for Class B membership interests representing approximately
8.42% of the total membership interests outstanding. These investors included
members of Dr. Goldenberg's family as well as persons affiliated with the
original Coulter Corporation, a predecessor to Beckman Coulter.
In May 2002, Immunomedics acquired all of the Class A membership interests
in IBC LLC owned by Beckman Coulter in exchange for (i) 138,900 shares of
Immunomedics common stock which were valued at approximately $1,800,000 and (ii)
a warrant to purchase an additional 150,000 shares of Immunomedics common stock
at an exercise price of $65.00 per share, exercisable until the earlier of May
2007 or a change in control of Immunomedics, which was valued at approximately
$850,000. This transaction was accounted for as a step acquisition. In
connection with this acquisition, the Company recorded a charge during 2002
related to acquired in-process research and development of approximately
$936,000, which was immediately expensed. At the date of acquisition none of the
products under development by IBC LLC had achieved technological feasibility and
none were being sold in the market. As a result of this acquisition,
Immunomedics controlled, directly and indirectly, all of the Class A membership
interests in IBC LLC and reorganized IBC into a Delaware "C" corporation under
the Internal Revenue Code. Other holders of IBC membership interests approved
the reorganization. As a result of this acquisition, the financial statements of
IBC Pharmaceuticals, Inc. ("IBC") are consolidated with Immunomedics since June
2002.
The IBC reorganization was completed in June 2002, when IBC LLC
contributed all of its assets, and assigned all of its liabilities, to a newly
formed Delaware corporation, in exchange for shares of Series A Preferred Stock
and Series B Preferred Stock. These shares of preferred stock were then
distributed and IBC Pharmaceuticals, LLC is in the process of being dissolved.
IMG has been dissolved. Dr. Goldenberg also contributed 34,725 shares of
Immunomedics common stock to IBC. Such shares were valued at $458,370 and have
been recorded as treasury stock. This treasury stock will be carried at cost as
IBC is controlled by Immunomedics.
IBC reimbursed Immunomedics for $271,000 of its research activities in
2004 which were conducted on the joint venture's behalf. The unreimbursed
research activities ($774,000) is an outstanding receivable at June 30, 2004.
For the fiscal years ended June 30, 2003 and 2002, the Company received
reimbursements of $1,147,000, and $634,000 respectively, from IBC with respect
58
to these research activities. The reimbursements for the fiscal years June 30,
2004 and 2003 were eliminated in consolidation.
As of June 30, 2004, the shares of IBC Pharmaceuticals, Inc. were held as
follows:
Stockholder Holdings Percentage of Total
- --------------------- -------------------------------------------- -------------------
Immunomedics, Inc. 5,599,705 shares of Series A Preferred Stock 73.26%
Third Party Investors 643,701 shares of Series B Preferred Stock 8.42%
David M. Goldenberg 1,399,926 shares of Series C Preferred Stock 18.32%
-------------------
100.00%
In the event of a liquidation, dissolution or winding up of IBC, the
Series A, B and C Preferred Stockholders would be entitled to $0.6902, $5.17 and
$0.325 per share (subject to adjustment), respectively. The Series A and B
stockholders would be paid ratably until fully satisfied. The Series C
stockholders would be paid only after the Series A and B stockholders have been
fully repaid. These liquidation payments would be made only to the extent the
assets of IBC are sufficient to make such payments. A majority of the preferred
stockholders, voting together as a single class, also have the right to require
IBC to redeem their shares under certain circumstances beginning on June 30,
2007. Immunomedics, as the holder of a majority of the preferred shares, has the
ability to control whether or not this right is exercised.
In each of the fiscal years 2004, 2003 and 2002, Dr. Goldenberg received
$55,000 in compensation for his services to IBC. At July 1, 2004, Dr. Goldenberg
was a director of IBC, while Cynthia L. Sullivan, Gerard G. Gorman and Phyllis
Parker served as the President, Treasurer and Secretary, respectively, of IBC.
Other
In fiscal year 2003, compensation expense of $360,000 was recorded which
was associated with the issuance of a fully vested option to acquire 80,000
shares of common stock at a purchase price of $4.94 per share to Dr. Morton
Coleman, a non-employee director, in consideration for consulting services to
the Company.
10. License and Distribution Agreements
In October 2001, the Company entered into a Distribution Agreement with
Logosys Logistik GmbH, pursuant to which Logosys packages and distributes the
Company's diagnostic imaging products, LeukoScan(R) and CEA-Scan(R), within the
countries comprising the European Union and certain other countries.
On December 17, 2000, the Company entered into a Development and License
Agreement (the "Amgen Agreement") with Amgen Inc. ("Amgen"), whereby Amgen
obtained exclusive rights to continue the clinical development and
commercialization in North America and Australia of the Company's unlabeled, or
"naked," CD22 antibody compound, epratuzumab, for the treatment of patients with
non-Hodgkin's lymphoma.
59
Pursuant to the Amgen Agreement, the Company received an up-front payment
of $18,000,000 that was recognized, beginning February 2001, as revenue of
$750,000 per month over a period of 24 months. As of February 2003, this
up-front payment was fully recognized as "License fee and other revenues."
Accordingly, the Company recognized $0, $5,250,000 and $9,000,000 as "License
fee and other revenues" for the fiscal years ended June 30, 2004, 2003 and 2002,
respectively. Costs incurred relating to the manufacture of the materials
supplied to Amgen were recorded as research and development expense as incurred.
For the years ended June 30, 2004, 2003 and 2002, the Company incurred $275,000,
$1,245,000 and $2,036,000, respectively, of costs associated with supplying
materials to Amgen.
On April 8, 2004, pursuant to a termination agreement between Amgen and
the Company, Amgen returned all rights for epratuzumab, the humanized CD22
monoclonal antibody therapeutic the Company licensed to Amgen as part of the
Amgen Agreement, including rights to second generation molecules and conjugates.
As part of the April 2004 transaction, the Company issued to Amgen a
five-year warrant to purchase 100,000 shares of our common stock at a price
equal to $16.00 per share with an estimated value of $310,000 which was expensed
as research and development cost in 2004. If epratuzumab is approved for
commercialization in the United States for non-Hodgkin's lymphoma therapy, the
Company will be required to pay Amgen a milestone payment in the amount of
$600,000. There are no other financial obligations between the parties as a
result of the termination agreement.
In June 2002, the Company granted a non-exclusive license to Daiichi Pure
Chemicals Co. under Immunomedics' carcinoembryonic antigen (CEA) patents. In
addition, the Company recorded a royalty of $183,000, $265,000 and $200,000 for
the years ended June 30, 2004, 2003 and 2002, respectively, as "License fee and
other revenues" under that license.
In October 2003, the Company entered into a research collaboration with
Schering AG of Berlin, Germany, involving bispecific antibody, pretargeting
technologies for cancer therapy being developed by IBC. The Company has received
$29,000 under this agreement through June 30, 2004.
11. Commitments and Contingencies
On November 1, 1993, Immunomedics and Dr. Goldenberg entered into a
five-year employment agreement (the "Agreement") with an additional one-year
assured renewal and thereafter automatically renewable for additional one-year
periods unless terminated by either party as provided in the Agreement. This
Agreement was amended on July 1, 2001, pursuant to which Dr. Goldenberg will
receive an annual minimum base salary of $275,000, an annual bonus to be
determined by the Board of Directors but in no event less than 20% of the base
salary, annual stock option grants to purchase at least 150,000 shares of common
stock, other benefits and certain change of control protections. Under the
Agreement as amended, the Company has agreed to extend Dr. Goldenberg's
employment agreement for a five-year period which expires on June 30, 2006.
Further, the Company acknowledged and approved Dr. Goldenberg's continuing
involvement with CMMI and IBC.
Pursuant to the Agreement, Dr. Goldenberg may engage in other business and
general investment and scientific activities, provided such activities do not
materially interfere with the performance of any of his obligations under the
Agreement, allowing for those activities he presently performs for CMMI and IBC
(see Note 10). The Agreement extends the ownership rights of the Company, with
an obligation to diligently pursue all ideas, discoveries, developments and
products, in the entire medical field, which, at any time during his past or
continuing employment by the Company (but not when performing services for
CMMI), Dr. Goldenberg has made or conceived or hereafter
60
makes or conceives, or the making or conception of which he has materially
contributed to or hereafter contributes to, all as defined in the Agreement
(collectively, "Goldenberg Discoveries").
Further, pursuant to the Agreement, Dr. Goldenberg will receive, subject
to certain restrictions, incentive compensation of 0.5% on the first $75,000,000
of all defined annual net revenue of Immunomedics and 0.25% on all such annual
net revenue in excess thereof (collectively, "Revenue Incentive Compensation").
With respect to the period that Dr. Goldenberg is entitled to receive Revenue
Incentive Compensation on any given products, it will be in lieu of any other
percentage compensation based on sales or revenue due him with respect to such
products under this Agreement or the existing License Agreement between the
Company and Dr. Goldenberg. With respect to any periods that Dr. Goldenberg is
not receiving such Revenue Incentive Compensation for any products covered by
patented Goldenberg Discoveries or by certain defined prior inventions of Dr.
Goldenberg, he will receive 0.5% on cumulative annual net sales of, royalties,
certain equivalents thereof, and, to the extent approved by the Board, other
consideration received by us for such products, up to a cumulative annual
aggregate of $75,000,000 and 0.25% on any cumulative annual aggregate in excess
of $75,000,000 (collectively "Royalty Payments"). A $100,000 annual minimum
payment will be paid in the aggregate against all Revenue Incentive Compensation
and Royalty Payments. For each of the years ended June 30, 2004, 2003 and 2002,
the Company paid Dr. Goldenberg the minimum required payment of $100,000. Dr.
Goldenberg will also receive a percent, not less than 20%, to be determined by
the Board, of net consideration (including license fees) which the Company
receives for any disposition, by sale, license or otherwise (discussions
directed to which commence during the term of his employment plus three years)
of any of defined Undeveloped Assets of the Company which are not budgeted as
part of the Company's strategic plan. Pursuant thereto, Dr. Goldenberg received
his interest in IMG (See Note 9).
On March 20, 2001, Cynthia L. Sullivan entered into a five-year employment
agreement with the Company. Pursuant to this agreement, Ms. Sullivan will
receive an annual minimum base salary of $275,000, an annual bonus in an amount
to be determined by the Board of Directors but in no event less than 20% of the
base salary, an annual grant of stock options covering not less than 150,000
shares of common stock per year and certain other benefits and change of control
protections.
Immunomedics is obligated under an operating lease for facilities used for
research and development, manufacturing and office space. In November 2001, the
Company renewed for an additional term of 20 years expiring in October 2021 at a
base annual rate of $545,000, which is fixed for the first five years and
increases thereafter every five years. The renewal includes an additional 15,000
square feet of space. Rental expense related to this lease was approximately
$663,000, $663,000 and $589,000 in fiscal years 2004, 2003 and 2002,
respectively.
Including the extension of the facility lease as described above, the
minimum lease commitments for facilities are as follows for fiscal years (in
thousands):
2005 ............. $ 545
2006 ............. $ 545
2007 ............. $ 552
2008 ............. $ 556
2009 ............. $ 556
Thereafter ....... $9,098
Immunomedics is a party to various claims and litigation arising in the
normal course of business, which includes some or all of certain of our patents.
Management believes that the outcome
61
of such claims and litigation will not have a material adverse effect on the
Company's consolidated financial position and results of operations. The
following is a summary of certain claims that are outstanding.
F. Hoffmann-La Roche
The Company has brought suit in The Netherlands against F. Hoffmann-La
Roche and its Roche Diagnostics subsidiary and European affiliates ("Roche") for
infringement of the Company's patent covering specific anti-CEA antibodies. The
suit sought an injunction against the sale of CEA immunoassays by Roche that
infringe our European patents, as well as damages for past infringement. Roche
has denied infringement and countered with nullity actions in The Netherlands
and Germany, seeking to invalidate our Dutch and German patents.
We believe that the patents referred to are valid and those that are the
subject of our infringement action have been infringed, and we believe that the
Company will prevail in the litigation, although no assurances can be given in
this regard. To the extent that Roche contests or challenges our patents, or
files appeals or further nullity actions, there can be no assurance that
significant costs for defending such patents may not be incurred.
Cytogen, Inc. and C.R. Bard Inc.
In 2000, the Company sued Cytogen, Inc. and C.R. Bard, Inc. for
infringement of our licensed patent by Cytogen's sale of its "Prostascint"
prostate cancer-imaging product. A hearing was held for the purpose of
determining the scope and interpretation of the claims, following which each
side submitted motions for summary judgment, all of which have been denied.
Willow Bay Associates, LLC
In 2000, a now-defunct finance broker filed suit against the Company in
the United States District Court for the District of Delaware. In the case, the
plaintiff claimed that it is entitled to damages in the form of brokerage
commissions for breach of an alleged confidentiality and non-circumvention
contract. The suit against the Company was dismissed on summary judgment, but
subsequently reinstated. Although it is not possible to forecast the Court's
decision, based on the Court's initial ruling of dismissal and the trial, the
Company believes that judgment will be entered in its favor. The Company further
believes that even in the event of an unfavorable outcome, this lawsuit will not
have a material adverse affect on the Company's financial position and results
of operations.
12. Debt
In January 2004, the Company completed a $10,000,000 financing of
Convertible Senior Notes, which are due January 12, 2006. The notes bear
interest at a fixed annual rate of 3.25% to be paid semiannually in arrears
beginning in July 2004. The holder of the notes may convert the notes at any
time prior to the maturity date into shares of the Company's common stock at a
conversion price of $6.09 per share. Immunomedics has filed a registration
statement under the Securities Act of 1933, as amended, with the SEC for
registration of the notes and the shares of common stock issuable upon
conversion of the notes. Proceeds from the financing will be used to continue
the Company's development of its cancer and autoimmune disease therapeutics and
for working capital and other general corporate purposes. At June 30, 2004, the
Company's indebtedness under this financing was $10,000,000, which will mature
on January 12, 2006, unless earlier converted or repurchased. For the year ended
June 30, 2004, the Company incurred interest expense of approximately $152,000.
62
In May 2003, Immunomedics completed a $6,376,000 bond financing with the
New Jersey Economic Development Authority, pursuant to which Immunomedics was
able to refinance its capital investment in a new manufacturing facility at a
rate of interest below that which would have otherwise been available. The
interest rate on the bonds was approximately 1.3% at June 30, 2004. In
connection with this financing, Immunomedics granted certain security interests
to the New Jersey Economic Development Authority with respect to its properties
and assets, and agreed to become subject to certain customary affirmative as
well as restrictive covenants, none of which it believes will affect its
business or operations in any material respect. In addition, the bonds are
subject to mandatory redemption, if the fair value of the Company's
collateralized assets falls below the outstanding loan balance. The Company's
collateral is recorded as restricted securities in the balance sheet. At June
30, 2004, the Company's indebtedness under this financing was approximately
$5,100,800 due in equal monthly installments over the next 48 months. For the
years ended June 30, 2004 and 2003, the Company incurred interest expense of
approximately $73,000 and $9,000, respectively. Interest and principal payments
are due monthly.
The following table summarized the Company's principal payments for the
next five years (in thousands):
2005 ............. $ 1,275
2006 ............. $11,275
2007 ............. $ 1,275
2008 ............. $ 1,276
2009 ............. $ 0
13. Geographic Segments
Immunomedics manages its operations as one line of business of
researching, developing, manufacturing and marketing biopharmaceutical products,
particularly antibody-based diagnostics and therapeutics for cancer and
infectious diseases, and it currently reports as a single industry segment.
Immunomedics markets and sells its products in the United States and throughout
Europe. During fiscal years 2004, 2003 and 2002, no product sales from a single
customer exceeded 10% of consolidated product sales.
The following table presents financial information based on the geographic
location of the facilities of Immunomedics as of and for the years ended (in
thousands):
June 30, 2004
United States Europe Total
------------- -------- --------
Total assets $30,142 $1,946 $32,088
Property and equipment, net 11,528 5 11,533
Revenues 1,131 3,175 4,306
Income (loss) before tax benefits (23,292) 703 (22,589)
June 30, 2003
United States Europe Total
------------- -------- --------
Total assets $40,045 $5,085 $45,130
Property and equipment, net 12,293 6 12,299
Revenues 10,754 2,965 13,719
Income (loss) before tax benefits (9,351) 797 (8,554)
63
June 30, 2002
United States Europe Total
------------- -------- --------
Total assets $51,894 $3,057 $54,951
Property and equipment, net 6,558 4 6,562
Revenues 11,594 2,693 14,287
Income (loss) before tax benefits (4,734) (218) (4,952)
14. Defined Contribution Plans
U.S. employees are eligible to participate in the Company's 401(k) plan,
while employees in international locations are eligible to participate in other
defined contribution plans. Aggregate Company contributions to its benefit plans
totaled approximately $72,000, $55,000, and $52,000 for June 30, 2004, 2003 and
2002, respectively.
15. Quarterly Results of Operations (Unaudited)
Three Months Ended
-------------------------------------------------------------------------------------------
June 30 March 31 Dec. 31 Sept. 30 June 30 March 31 Dec. 31 Sept. 30
2004 2004 2003 2003 2003 2003 2002 2002
-------- -------- -------- -------- -------- -------- -------- --------
(In thousands, except for per share amounts)
Consolidated Statements of Operations Data:
Revenues $912 $1,151 $1,057 $1,186 $1,748 $5,615 $3,124 $3,232
Gross profit (1) 490 940 789 675 801 929 608 677
Income tax
benefit/(provision) (37) (58) 358 (29) (65) 745 -- --
Net income (loss) (6,825) (5,489) (4,858) (5,183) (3,656) 453 (1,785) (2,886)
Net income (loss) per
common share allocable to
common stockholders $(0.14) $(0.11) $(0.10) $(0.10) $(0.07) $0.01 $(0.04) $(0.06)
Weighted average number
of common shares
outstanding 49,886 49,888 49,883 49,882 49,878 49,878 49,878 49,877
(1) Gross profit is calculated as product sales less cost of goods sold.
16. Subsequent Event
In August 2004, the Company sold 4,178,116 shares of its common stock,
resulting in net proceeds to the Company of approximately $14.0 million. The
shares were sold to institutional investors
64
at a price of $3.61 per share. The Company also agreed to grant these investors
rights to purchase an additional 4,178,116 shares of its common stock at a price
of $3.97 per share, by a date no later than November 24, 2004. The shares of
common stock were sold pursuant to an effective shelf registration statement
filed with the Securities and Exchange Commission.
65
Report of Independent Registered Public Accounting Firm
The Board of Directors and Stockholders
Immunomedics, Inc.
We have audited the accompanying consolidated balance sheets of Immunomedics,
Inc. and subsidiaries as of June 30, 2004 and 2003, and the related consolidated
statements of operations, stockholders' equity and cash flows for the two years
in the period ended June 30, 2004. Our audits also included the financial
statement schedule listed in the Index at Item 15(a). These financial statements
and schedules are the responsibility of the Company's management. Our
responsibility is to express an opinion on these financial statements and
schedule based on our audits.
We conducted our audits 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 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 Immunomedics, Inc.
and subsidiaries at June 30, 2004 and June 30, 2003 and the consolidated results
of their operations and their cash flows for each of the two years in the period
ended June 30, 2004 in conformity with U.S. generally accepted accounting
principles. Also, in our opinion, the related consolidated financial statement
schedule, when considered in relation to the basic consolidated financial
statements taken as a whole, present fairly in all material respects the
information set forth therein.
/s/ Ernst & Young LLP
MetroPark, New Jersey
August 12, 2004
66
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders
Immunomedics, Inc.:
We have audited the accompanying consolidated statements of operations and
comprehensive income (loss), changes in stockholders' equity, and cash flows of
Immunomedics, Inc. and subsidiaries for the year ended June 30, 2002. In
connection with our audit of the consolidated financial statements, we also have
audited the consolidated financial statement schedule for the year ended June
30, 2002 as listed in the Index at Item 15(a). These consolidated financial
statements and consolidated financial statement schedule are the responsibility
of the Company's management. Our responsibility is to express an opinion on
these consolidated financial statements and consolidated financial statement
schedule 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 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 audit provides a
reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present
fairly, in all material respects, the results of operations and the cash flows
of Immunomedics, Inc. and subsidiaries for the year ended June 30, 2002, in
conformity with U.S. generally accepted accounting principles. Also in our
opinion, the related consolidated financial statement schedule, when considered
in relation to the basic consolidated financial statements taken as a whole,
presents fairly, in all material respects, the information set forth therein.
/s/ KPMG LLP
Princeton, New Jersey
August 9, 2002
67
Immunomedics, Inc. and Subsidiaries
Schedule II - Valuation and Qualifying Reserves
For the Years Ended June 30, 2004, 2003 and 2002
Allowance for Doubtful Accounts
Balance at Balance
Beginning of Charges to Charges to Other at End
Year ended: Period Reserve(1) Expense Charges of Period
------------ ---------- ---------- ------- ---------
June 30, 2002 $ (125,440) $ -- $ (164,426) $ -- $(289,866)
June 30, 2003 $ (289,866) $ 15,899 $ (107,714) $ -- $(381,681)
June 30, 2004 $ (381,681) $ 37,957 $ -- $ -- $(343,724)
(1) Uncollectible accounts written off, net of reserves
Reserve for Inventory Obsolescence
Balance at Balance
Beginning of Charges to Charges to Other at End
Year ended: Period Reserve Expense Charges of Period
------------ ---------- ---------- ------- ---------
June 30, 2003 $ -- $ -- $ -- $ -- $ --
June 30, 2004 $ -- $ -- $ (139,000) $ -- $(139,000)
68
Item 9 -- Changes in and Disagreements with Accountants on Accounting and
Financial Disclosure
As of October 22, 2002, the Company's Board of Directors, terminated KPMG
LLP ("KPMG") as the Company's independent accountants, and approved the
engagement of Ernst & Young LLP ("Ernst & Young") as the Company's independent
accountants commencing with the fiscal year ended June 30, 2003. Consistent with
the policy of the Company's Board of Directors to consider a change in
accounting firms from time to time, after ten years with KPMG serving as the
Company's independent accountants, the Company's Audit Committee determined it
was an appropriate time to make a change. Following a review of the available
alternatives with the Company's senior management, the Audit Committee resolved
to recommend to the entire Board of Directors that the Company engage Ernst &
Young. The Board of Directors then unanimously approved the recommendation.
The audit reports of KPMG on the Company's consolidated financial
statements as of and for the fiscal years ended June 30, 2002 and 2001 did not
contain an adverse opinion or a disclaimer of opinion, and were not qualified or
modified as to uncertainty, audit scope or accounting principles.
During the Company's fiscal year ended June 30, 2002, and the subsequent
interim period through October 22, 2002, there were no disagreements between the
Company and KPMG concerning any matter of accounting principles or practices,
financial statement disclosure, or auditing scope or procedure, which
disagreements, if not resolved to the satisfaction of KPMG, would have caused it
to make reference to the subject matter of the disagreements in connection with
its reports.
The Company did not consult with Ernst & Young during its fiscal year
ended June 30, 2002 on the application of accounting principles to a specified
transaction, the type of opinion that might be rendered on the Company's
financial statements, any accounting, auditing or financial reporting issue, or
any item that was either the subject of a disagreement or a reportable event as
defined in Item 304 of Regulation S-K.
The Company has provided KPMG with a copy of the foregoing disclosures
which were originally contained in the Form 8-K filed October 25, 2002, which
disclosed the termination of KPMG as the Company's independent accountants.
Item 9A - Controls and Procedures
(a) Evaluation of Disclosure Controls and Procedures. Our principal
executive and principal financial officers, after evaluating the effectiveness
of our disclosure controls and procedures (as defined in Exchange Act Rules
13a-15(e) and 15d-15(e)) as of the end of the period covered by this Annual
Report on Form 10-K, have concluded that, based on such evaluation, our
disclosure controls and procedures were adequate and effective to ensure that
material information relating to us, including our consolidated subsidiaries,
was made known to them by others within those entities, particularly during the
period in which this Annual Report on Form 10-K was being prepared.
(b) Changes in Internal Controls. There were no changes in our internal
control over financial reporting that occurred during our last fiscal quarter,
that has materially affected, or is reasonably likely to materially affect, our
internal control over financial reporting.
69
Limitations on the Effectiveness of Controls: Our management, including
the chief executive officer and chief financial officer, does not expect that
our disclosure controls and procedures or our internal controls will prevent all
error and all fraud. A control system, no matter how well conceived and
operated, can provide only reasonable, not absolute, assurance that the
objectives of the control system are 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, within the company 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. Additionally, controls
can be circumvented by the individual acts of some persons, by collusion of two
or more people, or by management override of the control. The design of any
system of controls also 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, control may become inadequate because of changes in conditions, or
the degree of compliance with the policies or procedures may deteriorate.
Because of the inherent limitations in a cost-effective control system,
misstatements due to error or fraud may occur and not be detected.
Item 9B - Other Information
None.
70
PART III
Item 10 -- Directors and Executive Officers of the Registrant
The response to this item will be set forth in the Proxy Statement for our
2004 Annual Meeting of Stockholders expected to be held on December 1, 2004 (the
"Proxy Statement") and is incorporated by reference herein.
Item 11 -- Executive Compensation
The response to this item will be set forth in the Proxy Statement and is
incorporated by reference herein.
Item 12 -- Security Ownership of Certain Beneficial Owners and Management and
Related Stockholder Matters
Except as set forth below, the response to this item will be set forth in
the Proxy Statement and is incorporated by reference herein.
Equity Compensation Plan Information
The following table provides information as of June 30, 2004 about our
Common Stock that may be issued upon the exercise of options under our existing
equity compensation plans, including the 1992 Stock Option Plan and the 2002
Stock Option Plan.
Number of Securities
Number of Remaining Available for
Securities to be Future Issuance Under
Issued Upon Weighted Average Equity Compensation
Exercise of Exercise Price of Plans (excluding
Outstanding Outstanding securities reflected in
Plan Category Options Options first column) (a)
- ------------------ ---------------- ------------------ -----------------------
(a) (b) (c)
Equity
Compensation Plans
Approved by
Security holders 4,845,250 $9.24 1,946,875
Equity
Compensation Plans
not Approved by
Security holders 0(1) -- 0
- ------------------ ---------------- ------------------ -----------------------
Total 4,845,250 $9.24 1,946,875
(1) We do not have any compensation plans under which equity securities are
authorized for issuance which have not been approved by our stockholders.
Item 13 -- Certain Relationships and Related Transactions
The response to this item will be set forth in the Proxy Statement and is
incorporated by reference herein.
71
Item 14 -- Principal Accounting Fees and Services
The response to this item will be set forth in the Proxy Statement and is
incorporated by reference herein.
72
PART IV
Item 15 -- Exhibits, Financial Statement Schedules
(a) Documents filed as part of this Report:
1. Consolidated Financial Statements:
Consolidated Balance Sheets - June 30, 2004 and 2003
Consolidated Statements of Operations and Comprehensive Income (Loss)
for the years ended June 30, 2004, 2003 and 2002
Consolidated Statements of Changes in Stockholders' Equity for the
years ended June 30, 20043, 2003 and 2002
Consolidated Statements of Cash Flows for the years ended June 30,
2004, 2003 and 2002
Notes to Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm - Ernst & Young
LLP
Report of Independent Registered Public Accounting Firm - KPMG LLP
2. Financial Statement Schedules:
Schedule II - Valuation and Qualifying Reserves
3.1(a) Certificate of Incorporation of the Company, as filed with the
Secretary of State of the State of Delaware on July 6, 1982(c)
3.1(b) Certificate of Amendment of the Certificate of Incorporation of the
Company as filed with the Secretary of State of the State of Delaware
on April 4, 1983(c)
3.1(c) Certificate of Amendment of the Certificate of Incorporation of the
Company as filed with the Secretary of State of the State of Delaware
on December 14, 1984(c)
3.1(d) Certificate of Amendment of the Certificate of Incorporation of the
Company as filed with the Secretary of State of the State of Delaware
on March 19, 1986(c)
3.1(e) Certificate of Amendment of the Certificate of Incorporation of the
Company as filed with the Secretary of State of the State of Delaware
on November 17, 1986(c)
3.1(f) Certificate of Amendment of the Certificate of Incorporation of the
Company as filed with the Secretary of State of the State of Delaware
on November 21, 1990(d)
3.1(g) Certificate of Amendment of the Certificate of Incorporation of the
Company, as filed with the Secretary of State of the State of Delaware
on November 12, 1992(g)
3.1(h) Certification of Amendment of the Certificate of Incorporation of the
Company as filed with the Secretary of State of the State of Delaware
on November 7, 1996(k).
3.1(i) Amended and Restated Certificate of Designations, Preferences and
Rights of Series F Convertible Preferred Stock of Immunomedics, Inc.(p)
3.1(j) Certificate of Designation of Series G Junior Participating Preferred
Stock of the Company, as filed with the Secretary of State of the State
of Delaware on March 15, 2002(w)
3.2 Amended and Restated By-Laws of the Company (w)
4.1 Specimen Certificate for Common Stock(w)
4.2 Common Stock Purchase Warrant issued to Cripple Creek Securities,
LLC(m)
4.3 Form of additional Common Stock Purchase Warrant issuable to Cripple
Creek Securities, LLC(m)
4.4 Rights Agreement, dated as of March 4, 2002, between the Company and
American Stock Transfer and Trust Company, as rights agent, and form of
Rights Certificate(u)
4.5 Warrant For the Purchase of Shares of Common Stock of the Company,
dated as of May 23, 2002 (v)
73
4.6 Indenture dated as of January 20, 2004, between the Company and The
Bank of New York, as trustee, for 3.25% Convertible Senior Notes due
January 12, 2006(x)
4.7 Form of 3.25% Convertible Senior Note due January 12, 2006 (included in
Exhibit 4.6)(x)
4.8 Registration Rights Agreement dated as of January 20, 2004, by and
between the Company and Bear, Stearns & Co. Inc. for 3.25% Convertible
Senior Notes due January 12, 2006(x)
4.9 Purchase Agreement dated as of January 12, 2004, by and between the
Company and Bear, Stearns & Co. Inc. for 3.25% Convertible Senior Notes
due January 12, 2006(x)
10.1# Immunomedics, Inc. 1992 Stock Option Plan (k)
10.2# Immunomedics, Inc. 2002 Stock Option Plan, as amended.(w)
10.3# Executive Supplemental Benefits Agreement with David M. Goldenberg,
dated as of July 18, 1986 (b)
10.4# Amended and Restated Employment Agreement, dated November 1, 1993,
between the Company and Dr. David M. Goldenberg (h)
10.5# Amendment No. 2 to the Amended and Restated Employment Agreement, dated
as of July 1, 2001 between the Company and Dr. David M. Goldenberg (t)
10.6# David M. Goldenberg Severance Agreement, dated as of June 18, 2002,
between David M. Goldenberg and the Company
10.7# Employment Agreement, dated March 10, 2001, between the Company and
Cynthia L. Sullivan (s)
10.8 Exclusive License Agreement with David M. Goldenberg, dated as of July
14, 1982 (a)
10.9 Amended and Restated License Agreement among the Company, CMMI and
David M. Goldenberg, dated December 11, 1990 (e)
10.10 Amendment, dated March 11, 1995, to the Amended and Restated License
Agreement among the Company, CMMI, and David M. Goldenberg, dated
December 11, 1990 (i)
10.11 License Agreement, dated as of January 21, 1997, between the Company
and Center for Molecular Medicine and Immunology, Inc. (l)
10.12 License Agreement, dated March 5, 1999, by and between the Company and
IBC Pharmaceuticals (q)
10.13 Development and License Agreement, dated December 17, 2001, between the
Company and Amgen, Inc. (Confidentiality treatment has been granted for
certain portions of the Agreement) (r)
10.14 Agreement among the Company, David M. Goldenberg and the Center for
Molecular Medicine and Immunology, Inc., dated May, 1983 (a)
10.15 Lease Agreement with Baker Properties Limited Partnership, dated
January 16, 1992 (f)
10.16 Manufacturing Agreement, dated as of April 4, 1996, between the Company
and SP Pharmaceuticals, formerly the Oncology Division of Pharmacia &
Upjohn (Confidential treatment has been granted for certain portions of
the Agreement) (j)
10.17 Distribution Agreement, dated as of November 24, 1997, between the
Company and Eli Lilly Deutschland GmbH (Confidential treatment has been
granted for certain portions of the Agreement) (n)
10.18 Distribution and Product Services Agreement, dated as of May 15, 1998,
between the Company and Integrated Commercialization Solutions, Inc.
(Confidentiality treatment has been granted for certain portions of the
Agreement) (o)
10.19 Contract for Services dated effective as of January 1, 2002 between the
Company and Logosys Logistik GmbH (t)
10.20 Registration Rights Agreement, dated as of May 21, 2002, between the
Company and Beckman Coulter, Inc. (v)
10.21 Contribution and Assignment Agreement, dated as of June 30, 2002,
between IBC Pharmaceuticals, LLC and IBC Pharmaceuticals, Inc.(w)
74
10.22* Bond Financing Agreement, dated May 27, 2003, between the New Jersey
Economic Development Authority, the Company as Borrower, Fleet National
Bank as Agent and as Purchaser
21.1* Subsidiaries of the Company
23.1* Consent of Independent Registered Public Accounting Firm -- Ernst &
Young LLP
23.2* Consent of Independent Registered Public Accounting Firm -- KPMG LLP
31.1* Certification of the Chief Executive Officer pursuant to Section 302(a)
of the Sarbanes-Oxley Act of 2002.
31.2* Certification of the Chief Financial Officer pursuant to Section 302(a)
of the Sarbanes-Oxley Act of 2002.
32.1* Certification pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
32.2* Certification pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
(a) Incorporated by reference from the Exhibits to the Company's
Registration Statement on Form S-1 effective October 6, 1983
(Commission File No. 2-84940)
(b) Incorporated by reference from the Exhibits to the Company's Annual
Report on Form 10-K for the fiscal year ended June 30, 1986
(c) Incorporated by reference from the Exhibits to the Company's Annual
Report on Form 10-K for the fiscal year ended June 30, 1990
(d) Incorporated by reference from the Exhibits to the Company's Quarterly
Report on Form 10-Q for the fiscal quarter ended December 31, 1990
(e) Incorporated by reference from the Exhibits to the Company Registration
Statement on Form S-2 effective July 24, 1991 (Commission File No.
33-41053)
(f) Incorporated by reference from the Exhibits to the Company "s
Registration Statement on Form S-2 effective January 30, 1992
(Commission File No. 33-44750).
(g) Incorporated by reference from the Exhibits to the Company's Annual
Report on Form 10-K for the fiscal year ended June 30, 1993
(h) Incorporated by reference from the Exhibits to the Company's Quarterly
Report on Form 10-Q for the fiscal quarter ended September 30, 1993
(i) Incorporated by reference from the Exhibits to the Company's Annual
Report on Form 10-K for the fiscal year ended June 30, 1995
(j) Incorporated by reference from the Exhibits to the Company's Annual
Report on Form 10-K for the fiscal year ended June 30, 1996
(k) Incorporated by reference from the Exhibits to the Company's Quarterly
Report on Form 10-Q for the fiscal quarter ended September 30, 1996
(l) Incorporated by reference from the Exhibits to the Company's Quarterly
Report on Form 10-Q for the fiscal quarter ended December 31, 1996
(m) Incorporated by reference from the Exhibits to the Company's
Registration Statement on Form S-3, as filed with the Commission on
January 29, 1998
(n) Incorporated by reference from the Exhibits to the Company's Quarterly
Report on Form 10-Q for the fiscal quarter ended December 31, 1997
(o) Incorporated by reference from the Exhibits to the Company's Annual
Report on Form 10-K for the fiscal year ended June 30, 1998
(p) Incorporated by reference from the Exhibits to the Company's Current
Report on Form 8-K, dated December 15, 1998
(q) Incorporated by reference from the Exhibits to the Company's Current
Report on Form 8-K, dated March 23, 1999
(r) Incorporated by reference from the Exhibits to the Company's Quarterly
Report on Form 10-Q (as amended) for the fiscal quarter ended March 31,
2001
(s) Incorporated by reference from the Exhibits to the Company's Annual
Report on Form 10-K for the fiscal year ended June 30, 2001
75
(t) Incorporated by reference from the Exhibits to the Company's Quarterly
Report on Form 10-Q for the fiscal quarter ended September 30, 2001
(u) Incorporated by reference from the Exhibits to the Company's Current
Report on Form 8-K, dated March 8, 2002
(v) Incorporated by reference from the Exhibits to the Company's
Registration Statement on Form S-3, as filed with the Commission on
June 12, 2002
(w) Incorporated by reference from the Exhibits to the Company's Annual
Report on Form 10-K for the fiscal year ended June 30, 2002
(x) Incorporated by reference from the Exhibits to the Company's
Registration Statement on Form S-3, as filed with the Commission on
April 23, 2004
* Filed herewith
# Management contract or compensatory plan or arrangement required to be
filed as an exhibit to this Form 10-K pursuant to Item 14(c) of this
report
76
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.
IMMUNOMEDICS, INC.
Date: September 9, 2004 By: /s/ CYNTHIA L. SULLIVAN
-------------------------------------
Cynthia L. Sullivan
President and Chief Executive Officer
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/ DAVID M. GOLDENBERG Chairman of the Board September 9, 2004
.............................
David M. Goldenberg
/s/ CYNTHIA L. SULLIVAN President, Chief September 9, 2004
............................. Executive Officer
Cynthia L. Sullivan and Director
(Principal Executive Officer)
/s/ MARVIN E. JAFFE Director September 9, 2004
.............................
Marvin E. Jaffe
/s/ RICHARD R. PIVIROTTO Director September 9, 2004
.............................
Richard R. Pivirotto
/s/ MORTON COLEMAN Director September 9, 2004
.............................
Morton Coleman
/s/ MARY PAETZOLD Director September 9, 2004
.............................
Mary Paetzold
/s/ GERARD G. GORMAN Vice President Finance and September 9, 2004
............................. Chief Financial Officer
Gerard G. Gorman (Principal Financial
and Accounting Officer)
77
EXHIBIT LIST
(excludes documents incorporated by reference)
21.1 Subsidiaries of the Company.
23.1 Consent of Independent Registered Public Accounting Firm -- Ernst & Young
LLP.
23.2 Consent of Independent Registered Public Accounting Firm -- KPMG LLP.
31.1 Certification of the Chief Executive Officer pursuant to Section 302(a) of
the Sarbanes-Oxley Act of 2002.
31.2 Certification of the Chief Financial Officer pursuant to Section 302(a) of
the Sarbanes-Oxley Act of 2002.
32.1 Certification of the Chief Executive Officer pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002.
32.2 Certification of the Chief Financial Officer pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002.
(Exhibits available upon request)