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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
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(Mark One)
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934 |
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For the fiscal year ended December 31, 2004 |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934 |
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For the transition period
from to . |
Commission file number: 000-22891
Corixa Corporation
(Exact name of registrant as specified in its charter)
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Delaware
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91-1654387 |
(State or other jurisdiction of
incorporation or organization) |
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(I.R.S. Employer
Identification No.) |
1900 9th Avenue, Suite 1100
Seattle, WA 98101
(Address of principal executive offices, including zip
code)
Registrants telephone number, including area code:
(206) 366-3700
Securities registered pursuant to Section 12(b) of the
Act:
None
Securities registered pursuant to Section 12(g) of the
Act:
Common Stock, $0.001 par value per share
Indicate by check mark whether the Registrant (1) has filed
all reports required to be filed by Section 13 or 15(d) of
the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that the registrant
was required to file such reports), and (2) has been
subject to such filing requirements for the past
90 days. Yes þ No o
Indicate by check mark if disclosure of delinquent filers
pursuant to Item 405 of Regulation S-K is not
contained herein, and will not be contained, to the best of
registrants knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this
Form 10-K or any amendment to this
Form 10-K. þ
Indicate by check mark whether the registrant is an accelerated
filer (as defined in Exchange Act
Rule 12b-2). Yes þ No o
The aggregate market value of the voting stock held by
non-affiliates of the Registrant was approximately
$232 million as of June 30, 2004, based upon the
closing sale price on The Nasdaq National Market reported for
such date. Shares of Common Stock held by each officer and
director and by each person who owns 5% or more of the
outstanding Common Stock have been excluded in that such persons
may be deemed to be affiliates. This determination of affiliate
status is not necessarily a conclusive determination for other
purposes.
There were 59,525,526 shares of the registrants
Common Stock outstanding as of March 9, 2005.
DOCUMENTS INCORPORATED BY REFERENCE:
Part III incorporates information by reference to the
Registrants Proxy Statement for its 2005 Annual Meeting of
Stockholders.
CORIXA CORPORATION
FORM 10-K
FOR THE FISCAL YEAR ENDED DECEMBER 31, 2004
TABLE OF CONTENTS
In this Annual Report Corixa or the
company, we, us and
our refer to Corixa Corporation and our wholly owned
subsidiaries.
CORIXA®, MPL®, POWERED BY CORIXA® and the Corixa
logo are registered trademarks of Corixa Corporation. All other
brand names, trademarks or service marks referred to in this
Annual Report are the property of their respective owners.
1
PART I
Our disclosure and analysis in this Annual Report and the
documents incorporated by reference contain forward-looking
statements, which provide our current expectations or forecasts
of future events. Forward-looking statements include, without
limitation:
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information concerning possible or assumed future results of
operations, trends in financial results and business plans,
including those relating to earnings growth and revenue growth; |
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statements about the level of our costs and operating expenses
relative to our revenue, and about the expected composition of
our revenue; |
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statements about our product development schedule; |
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statements about our expectations for regulatory approval of any
of our product candidates; |
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statements regarding expected payments under collaboration
agreements; |
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statements about our future capital requirements and the
sufficiency of our cash, cash equivalents, investments and
available equity line facilities and bank borrowings to meet
these requirements; |
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statements about our future operational and manufacturing
capabilities; |
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other statements about our plans, objectives, expectations and
intentions; and |
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other statements that are not historical facts. |
Words such as believes, anticipates,
expects and intends may identify
forward-looking statements, but the absence of these words does
not necessarily mean that a statement is not forward-looking.
Forward-looking statements are subject to known and unknown
risks and uncertainties and are based on potentially inaccurate
assumptions that could cause actual results to differ materially
from those expected or implied by the forward-looking
statements. Our actual results could differ materially from
those anticipated in the forward-looking statements for many
reasons, including the factors described in the section entitled
Managements Discussion and Analysis of Financial
Condition and Results of Operations Important
Factors That May Affect Our Business, Our Results of Operations
and Our Stock Price in this Annual Report. Other factors
besides those described in this Annual Report could also affect
actual results. You should carefully consider the factors
described in the section entitled Managements
Discussion and Analysis of Financial Condition and Results of
Operations Important Factors That May Affect Our
Business, Our Results of Operations and Our Stock Price in
evaluating our forward-looking statements.
You should not unduly rely on these forward-looking statements,
which speak only as of the date of this Annual Report. We
undertake no obligation to publicly revise any forward-looking
statement to reflect circumstances or events after the date of
this Annual Report or to reflect the occurrence of unanticipated
events. You should, however, review the factors and risks we
describe in the reports we file from time to time with the SEC
after the date of this Annual Report.
Overview
We are a developer of innovative immunology-based products that
regulate innate immune responses. These products include:
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Vaccine Adjuvants compounds or additives that, when
combined with a vaccine, boost the bodys immune response
to antigens contained in the vaccine; and |
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TLR4 agonists and antagonists compounds that
interact with a type of cell surface receptor that recognizes
distinct molecular signatures presented by invading pathogens
and generates an immune response. These responses may be useful
in the prevention and/or therapy of many conditions, |
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including seasonal allergic rhinitis, broad infection
prevention, chronic obstructive pulmonary disease and
inflammatory conditions. |
We are a product development company with multiple product
candidates in late-stage human clinical trials. We are driven by
an aggressive partnering and manufacturing strategy that we
believe will give us an opportunity for sustained and consistent
commercial success.
We were originally incorporated in Delaware as WWE Corp. on
Sept. 8, 1994. Our headquarters and our primary research,
process development and clinical and regulatory operations are
in Seattle, Washington and our adjuvant manufacturing operations
are in Hamilton, Montana. The internet address of our corporate
website is http://www.corixa.com. We make available on our
website, free of charge, copies of our annual report on
Form 10-K, quarterly reports on Form 10-Q,
current reports on Form 8-K, and amendments to those
reports filed or furnished pursuant to Section 13(a) or
15(d) of the Securities Exchange Act of 1934, as soon as
reasonably practicable after filing or furnishing the
information to the SEC. The internet address for the information
is http://www.shareholder.com/corixa/edgar.cfm.
Product Development
Using two primary immunology-based approaches, we are developing
innovative immunotherapeutic products that address a range of
infectious and inflammatory diseases, allergies and cancers. Our
primary immunology-based approaches include:
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adjuvants designed to increase the effectiveness of our
partners vaccines; and |
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TLR4 agonists and antagonists designed to regulate innate immune
responses. |
Our MPL® adjuvant is the subject of a multi-year guaranteed
supply agreement with GlaxoSmithKline Inc., or GSK, and three of
our partners vaccine products that contain our adjuvants
have been approved for sale:
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GSKs prophylactic vaccine for the prevention of Hepatitis
B in certain high-risk patients contains our MPL adjuvant and
has been approved for sale in Europe; |
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Allergy Therapeutics Ltd.s, or ATLs, allergy
vaccine, contains our MPL adjuvant and has been approved for
sale on a named patient basis in Germany, Spain, Italy and the
United Kingdom; and |
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Berna Biotechs prophylactic vaccine for the prevention of
Hepatitis B infection contains our synthetic RC-529 adjuvant and
has been approved for sale in Argentina. |
In addition, together with our partners, we are conducting
late-stage clinical trials for several product candidates
targeting a range of infectious and inflammatory diseases,
allergies and cancers.
The following table outlines the approved products that contain
our MPL adjuvants and our significant product candidates that
are at the clinical stage. These programs, as well as our
programs in earlier stages of development are described more
fully in the sections following the table below.
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Development Phase |
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Partner |
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Adjuvants
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MPL adjuvant component in GSKs Fendrix vaccine
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Hepatitis B in certain high- risk patients |
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Approved in European Union, or E.U. |
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GSK |
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MPL adjuvant component in GSKs Cervarix vaccine
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Human Papillomavirus, or HPV, infection, cervical cancer |
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Two GSK Phase III trials |
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GSK |
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MPL adjuvant component in GSKs Simplirix vaccine
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Herpes Simplex Virus, or HSV |
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GSK Phase III trial |
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GSK |
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Product |
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Development Phase |
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MPL adjuvant component in GSKs Mosquirix malaria vaccine
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Malaria |
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GSK Phase IIb trial conducted in Mozambique |
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GSK |
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MPL adjuvant component in GSKs tuberculosis vaccine
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Tuberculosis |
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Corixa U.S. Phase I |
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GSK |
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MPL adjuvant component in ATLs Pollinex Quattro vaccine
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Certain allergies caused by grasses, trees, weeds and pollens |
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ATL E.U. Phase III approved on named patient
basis in Germany, Spain, Italy and the U.K. |
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Allergy Therapeutics |
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MPL adjuvant component in Biomiras BLP25 Liposome Vaccine
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Non-small cell lung cancer |
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Biomira expects to initiate a limited human experience trial in
2005 |
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Biomira |
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MPL adjuvant component in GSKs HER-2/neu vaccine
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Breast cancer |
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GSK U.S. Phase I |
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GSK |
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MPL adjuvant component in GSKs prostate cancer vaccine
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Prostate Cancer |
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GSK E.U. Phase I |
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GSK |
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RC-529 adjuvant component in Berna Biotechs SUPERVAX
vaccine
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Hepatitis B |
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Approved in Argentina |
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Berna Biotech |
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TLR4 Agonists and Antagonists
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CRX-675 TLR4 agonist
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Seasonal allergic rhinitis |
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Corixa U.S. Phase I |
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Unpartnered |
CRX-527 TLR4 agonist
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Infection prevention |
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U.S. IND filing expected in 2005 |
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U.S. Army |
In the column entitled Development Phase:
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Phase I means products that are in, or have
completed, Phase I clinical trials, performed to evaluate
safety; |
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Phase II means products that are in, or have
completed, Phase II dose-ranging clinical testing, being
tested to further determine safety and efficacy; |
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Phase III means products that are in, or have
completed, Phase III clinical testing, being tested to
determine efficacy; and |
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IND means an investigative new drug application. |
We are currently in the process of the transitioning previously
developed antibody-based therapeutics and therapeutic vaccines
for cancer and infectious disease to our partners or other
parties. This process is described more fully in Oncology
Business Divestiture on page 10.
Adjuvants
An adjuvant is a formulated compound or additive that, when
combined with a vaccine, boosts the bodys immune response
to antigens contained in the vaccine. Our adjuvant technology is
based on the fact that certain microbial products have long been
recognized as potent immune system regulators and have
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been shown to induce a broad range of known cytokines, a class
of substances that are produced by cells of the immune system
and can affect the immune response. Modifications of these
microbial products and their physical and biological delivery to
the immune system can influence the way cytokines are expressed,
as well as the recipients own physiological responses.
Such responses mimic the normal, protective responses that are
initiated during infection or injury. With our partners, we are
evaluating the incorporation of our adjuvants in vaccines that
are designed to be safer and more effective and to protect
against a broad range of diseases.
MPL Adjuvant. Our flagship adjuvant, MPL adjuvant, is a
derivative of the lipid A molecule found in gram-negative
bacteria, one of the most potent immune system stimulants. We
also own patented technology for extracting MPL adjuvant from
bacterial cell walls. Several of our partners are evaluating MPL
adjuvant in vaccines for development in infectious disease,
allergy and cancer. More than 273,000 doses of MPL adjuvant have
been administered to nearly 50,000 patients.
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Hepatitis B GSK Fendrix®. On
February 8, 2005, we announced that our partner, GSK,
received regulatory approval of Fendrix from the European Agency
for the Evaluation of Medicinal Products. Fendrix is a novel
vaccine designed to prevent infection from Hepatitis B in
high-risk groups such as pre-haemodialysis and haemodialysis
patients and it includes the GSK Hepatitis B antigen with the
addition of our MPL adjuvant. |
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HPV GSK
Cervarixtm.
Cervical cancer is the second most common cause of cancer death
in women worldwide, with approximately 500,000 new cases
occurring annually. According to the World Health Organization
scientists believe that infections with oncogenic genotypes of
HPV are responsible for most, if not all cervical cancers. A
study published in the British medical journal, The Lancet,
reported Cervarix was the first vaccine to be 100% effective
in protecting women against two strains of HPV (HPV 16 and
18) that are linked to more than 70% of all cases of
cervical cancer. GSK has reported that Cervarix has the
potential to prevent more than 70% of cervical cancers. Two
Phase III trials are underway and GSK expects to file for
approval in Europe and countries outside of the United States by
2006. |
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HSV GSK
Simplirixtm.
Genital herpes is an infection caused by the herpes simplex
virus. There are two types of HSV, HSV-1 and HSV-2, and both can
cause genital herpes. According to the Centers for Disease
Control and Prevention, or CDCP, 45 million people in the
United States ages 12 and older, or 1 out of 5 of the total
adolescent and adult population, are infected with HSV-2.
Nationwide, according to the CDCP, since the late 1970s, the
number of people with genital herpes infection has increased
30%.
Thirteen clinical trials with more than 12,000 volunteers have
been completed evaluating Simplirix vaccine containing our MPL
adjuvant. Results from two double-blind, randomized trials
demonstrated that Simplirix vaccine was highly effective in
protecting women against HSV-1 and HSV-2 genital herpes. GSK is
currently conducting another Phase III pivotal trial in
young adult women in collaboration with the National Institutes
of Health, or NIH. |
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Malaria GSK
Mosquirixtm.
In a proof-of-concept study published in the October 16,
2004 issue of The Lancet, researchers reported GSKs
RTS,S/ AS02A malaria vaccine candidate containing our MPL
adjuvant protected a significant percentage of children against
uncomplicated malaria, infection, and even severe forms of the
disease for at least six months. This largest malaria vaccine
efficacy trial ever conducted in Africa also re-confirmed the
vaccines safety in children 1 to 4 years old. Further
efficacy studies will be needed before consideration for
licensure. The double-blind, controlled trial involved 2,022
children in southern Mozambique and was conducted by the Centro
de Investigação em Saude da Manhiça. |
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Tuberculosis Vaccine. On January 14, 2004, we and
GSK announced that the United States Food and Drug
Administration, or FDA, is allowing the initiation of a
Phase I clinical study to evaluate the safety and
immunogenicity of a novel, proprietary prophylactic vaccine
designed to induce protection against tuberculosis. The trial
was conducted in the United States under an IND held by |
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us and was the first study of a recombinant tuberculosis vaccine
to be conducted on human volunteers. Grants awarded in the late
1990s from the National Institute of Allergy and Infectious
Diseases, or NIAID, part of the NIH, supported research that
uncovered the most effective protein-adjuvant combination for
this vaccine. The vaccine combines a proprietary, recombinant
tuberculosis protein antigen and a GSK proprietary adjuvant
formulation that incorporates several adjuvants including our
MPL adjuvant. |
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Allergy ATL Pollinex Quattro. Allergy
Therapeutics Ltd., or ATL, incorporates MPL adjuvant as a
component in ATLs Pollinex Quattro, an allergy vaccine
that is in Phase III clinical trials in Europe. ATL
specifically targets allergies caused by grasses, trees, weeds
and pollens. ATLs allergy vaccine has been approved for
sale on a Named Patient Basis in Germany, Spain, Italy and the
U.K. |
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Non-small cell lung cancer Biomira BLP Liposome
Vaccine. Biomira plans to incorporate MPL adjuvant as a
component in Biomiras BLP25 Liposome Vaccine for the
treatment of non-small cell lung cancer, or NSCLC. Lung cancer
is the leading cause of cancer-related deaths for both men and
women. The American Lung Association estimates that 173,770 new
cases of lung cancer and 160,440 deaths from lung cancer
occurred in 2004 in the United States. NSCLC is the most common
type of lung cancer, comprising approximately 85% of all cases.
NSCLC accounts for approximately 75% to 80% of all primary lung
cancers. In April 2004, Biomira announced results from its
Phase II clinical trial for the BLP25 Liposome Vaccine and
in December 2004, Biomira announced a survival update from that
clinical trial that showed that vaccinated patients had not yet
reached median survival 23 months post-accrual compared to
patients in the control group who had a median survival of
13.3 months. |
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Other Vaccines Containing MPL: Our MPL adjuvant is also a
component of the GSK breast cancer vaccine that is based on
HER-2/neu, a well-established target in the development of tumor
malignancy. This program was initially developed under our
multi-field vaccine discovery agreement with our development
partner, GSK, and following transfer to GSK, is now in
Phase I development. In addition, GSK is also developing a
prostate cancer vaccine containing MPL that was initially
developed under our multi-field vaccine discovery agreement and
is currently in Phase I stage of development. |
RC-529 Adjuvant. On September 8, 2003 we announced
the Argentinean approval of SUPERVAX, Berna Biotechs
prophylactic vaccine containing our synthetic RC-529 adjuvant
for the prevention of Hepatitis B infection. Developed by Berna
Biotech, the vaccine combines Berna Biotechs Hansenula
polymorpha-based recombinant Hepatitis B antigen with our RC-529
adjuvant.
Clinical results for SUPERVAX showed seroprotection of more than
95% of the individuals vaccinated with SUPERVAX containing our
RC-529 adjuvant after only two vaccinations delivered one month
apart.
TLR4 Agonists and Antagonists
The Innate Immune Response. We have developed a class of
synthetic compounds that interact with a type of immune system
cell surface receptor, known as a toll-like receptor, that when
stimulated, initiates the bodys innate immune response.
Innate immunity provides a first line of defense against a
variety of pathogens. Toll-like receptors, or TLRs, recognize
molecular signatures presented by invading pathogens
and are involved in turning on and turning off critical aspects
of the innate immune response. Our synthetic compounds mimic
these molecular signatures and, depending on their structure,
can either turn on or turn off innate immune reactions.
There are ten kinds of TLRs, and each recognizes a different
class of infectious agent. Our synthetic compounds are
recognized by toll-like receptor 4, or TLR4, which can be
found on a range of antigen-presenting cell types, including
hematopoietic, or blood-forming, cells, many epithelial cells,
and cells
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associated with vascular stability. We are exploring the use of
these synthetic compounds as stand alone therapies based on
their recognition by TLR4.
We have discovered that some of our synthetic compounds can act
as agonists, or stimulants of TLR4 based innate immune responses
and some can act as antagonists, or deactivators, of the innate
immune response. The structures of our synthetic compounds are
all slightly different. We have screened several of our TLR4
agonists and antagonists for their ability to protect animals
from viral, bacterial, fungal and parasitic infection or to
function as anti-inflammatory agents in animal models of human
disease.
We intend to pursue several indications using our TLR4 agonists
and antagonists as stand alone immunotherapeutic and
prophylactic agents. Potential applications for the agonists
include their use in treatment of seasonal or perennial
rhinitis, allergies, asthma, upper airway resistance to
biological warfare agents and chronic obstructive pulmonary
disease, which is often triggered by respiratory viral
infections such that treatment with antibiotics is often
ineffective. Potential applications for the antagonists include
their use as novel therapies for inflammatory bowel disease, or
IBD, rheumatoid arthritis and inflammatory lung diseases such as
cystic fibrosis.
In September 2003, the U.S. Army Medical Research and
Materiel Command awarded us a 3-year contract for
$2.7 million to develop biomarkers for exposure to
Corixas synthetic TLR4 agonists that are being tested for
prevention of airway infections.
In December 2003, the NIAID, part of the NIH, awarded us an
$11.6 million,5-year contract to develop our proprietary
synthetic molecules that act on TLR4. Our research focuses on
drug candidates with the potential to generate protective
immunity against a wide variety of infectious agents for the
purpose of treating and preventing infectious disease.
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CRX-675. Seasonal Allergic Rhinitis is characterized by
an overproduction of the cytokines in the nasal mucosa and
associated with atopic or allergic sensitization. Administration
of certain of our TLR4 agonist CRX-675 has been shown in animal
models to significantly decrease allergic rhinitis. We initiated
a Phase I human clinical trial in 2004 and expect the final
report from the study in late 2005. |
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CRX-527. CRX-527 is an additional TLR4 agonist currently
in development, which is capable of stimulating nonspecific
resistance to viral and bacterial pathogens at the mucosal and
systemic level in preclinical models. CRX-527 is biologically
active when administered to mucosal surfaces, where it
stimulates nonspecific protection and has the potential to
activate a mucosal immune response. We intend to file an IND
with the United States FDA in 2005 and expect to begin
Phase I human clinical testing in early 2006. |
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Other. We are currently evaluating other TLR4 agonist
candidates for use in the treatment of seasonal or perennial
rhinitis, allergy, asthma, upper airway resistance to biological
warfare agents and chronic obstructive pulmonary disease. Our
preclinical studies indicate that our TLR4 agonist candidates
are absorbed into the body and are biologically active at
mucosal, or mucous membrane, surfaces. The tolerability and
effectiveness demonstrated by preclinical mucosal delivery
models indicate that aqueous formulations of the agonist may be
useful in treating or preventing atopic diseases of the
respiratory tract. |
TLR4 Antagonists. Our TLR4 antagonist lead candidate has
shown the ability to quantitatively block signaling through TLR4
and therefore has potential use as an anti-inflammatory compound
in IBD and other inflammatory disease indications. Several
formulations of the antagonist, including an aqueous formula and
stable emulsion formula are under development. We are also
exploring whether the antagonist may be formulated and delivered
orally.
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Corporate Partnerships
As a developer of immunology-based products, we remain committed
to existing collaborations and the pursuit of select
partnerships with pharmaceutical, biopharmaceutical and
diagnostic companies. We focus our partnership efforts on
partnering our core technologies at various stages in the
research, development and commercialization processes. We target
partners that have the expertise and capability to develop,
manufacture and commercialize products. In our corporate
partnerships, we seek to fund our research, development and
commercialization expenses through research reimbursement,
milestone payments, collaborative agreements, credit lines and
option, technology or license fees. We also seek to retain
significant downstream participation in product sales through
either profit sharing or product royalties paid on annual net
sales.
Adjuvants
GSK: Manufacture and Supply Agreement. We entered
into a manufacturing and supply agreement, or the MPL Supply
Agreement, with GSK in July 2004 covering the production of our
MPL adjuvant, which is a component in GSKs future vaccines
currently undergoing clinical trials, vaccines awaiting
regulatory approval and Fendrix, which has received regulatory
approval in the European Union.
The MPL Supply Agreement, which runs through 2012, guarantees
payment to us for supplying GSK with increasing annual
quantities of MPL adjuvant, peaking in 2008 at the current
maximum output of our Hamilton, Montana, MPL adjuvant
manufacturing facility (approximately 2 kilograms/year). Under
the terms of the MPL Supply Agreement, we agreed to expand
current good manufacturing practice, or cGMP, compliant MPL
adjuvant production capacity in association with anticipated
approvals of GSK vaccines that contain MPL adjuvant.
In exchange for a multi-million dollar licensing fee, we granted
GSK a co-exclusive license to manufacture MPL adjuvant in
amounts in excess of our maximum annual output. The MPL Supply
Agreement can be renewed at GSKs option for multiple,
3-year periods beyond 2012.
Other elements of the MPL Supply Agreement include:
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increased base pricing and annual price increases for MPL
adjuvant; |
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payment of royalties to Corixa by GSK on all GSK vaccines
containing MPL adjuvant until 10 years after market
introduction of GSKs HPV vaccine; and |
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a provision for Corixa to repay a prior $5 million loan
from GSK with 1,099,000 shares of Corixa common stock
instead of cash at our option. |
Finally, the MPL Supply Agreement provides for GSK and Corixa to
co-fund a multi-year MPL adjuvant development program for a
large-scale production process. Improvements in the process
derived from this work will be co-owned by us and GSK. If the
modified process is implemented and results in increased Corixa
plant production capacity, and if GSK then revises orders of MPL
adjuvant to levels above those currently contemplated, then GSK
will receive a prenegotiated discount on the amount of MPL
adjuvant it orders over and above todays plant capacity of
approximately 2 kg per year.
GSK: Product License Agreements. We have licensed
our MPL adjuvant to GSK under three separate agreements for use
in infectious disease vaccines, under one agreement for use in
cancer vaccines and under one agreement for use in products to
treat and prevent allergic reactions. MPL adjuvant is a
component in GSKs Fendrix vaccine, in late-stage GSK
vaccine candidates Cervarix and Simplirix and in GSKs
Phase II malaria vaccine candidate.
Under the first agreement, entered into in 1991, we granted GSK
exclusive, worldwide rights to use MPL adjuvant in vaccines in
several infectious disease fields, including Hepatitis B and
Plasmodium falciparium, the parasite that causes malaria. Under
the agreement, GSK has agreed to pay us transfer payments for
supplies of MPL adjuvant and royalties upon commercialization of
products developed under the agreement.
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Under the second agreement, entered into in 1992, we granted GSK
the co-exclusive right to develop vaccines that include MPL
adjuvant against several bacterial infections as well as
combination vaccines that contain diphtheria, pertussis,
tetanus, Haemophilus influenza and polio antigens. In addition
to an annual license fee, GSK has agreed to pay us transfer
payments for supplies of MPL adjuvant and royalties upon
commercial sale of the vaccines.
Under the third agreement, effective in 1995, we granted GSK
rights to use MPL adjuvant in cancer vaccines. The license is
nonexclusive, with the option for exclusivity for up to 10
specific cancer antigens. In addition to annual license fees,
GSK has agreed to pay us transfer payments for clinical and
commercial quantities of adjuvant and royalties on any
commercial sales of therapeutic or prophylactic cancer vaccines
incorporating MPL adjuvant.
Under the fourth agreement, effective in 1996, we granted GSK
rights to use MPL adjuvant in an additional group of vaccines
against infectious diseases, including HPV and tuberculosis. The
license is exclusive for HPV vaccines, co-exclusive for
tuberculosis vaccines, and nonexclusive for additional
infectious disease vaccines. In addition to annual license fees,
GSK has agreed to pay us transfer payments for clinical and
commercial quantities of adjuvant and royalties on any
commercial sales of vaccines incorporating MPL adjuvant.
Under the fifth agreement, effective in 1999, we granted GSK
rights to use MPL adjuvant in an additional group of vaccines to
treat and prevent allergic reactions. GSK has agreed to pay us
annual license fees prior to, and minimum annual royalties
subsequent to, regulatory approval of any allergy vaccine
developed under the agreement. GSK has agreed to also purchase
its clinical and commercial quantities of MPL adjuvant from us
and pay royalties on any commercial sales of approved allergy
vaccines.
Allergy Therapeutics Ltd. In 1996, we entered into a
license and supply agreement with ATL under which we licensed
MPL adjuvant to ATL for use in allergy vaccines to treat and
prevent allergic reactions. Under our agreement with ATL, ATL
has agreed to pay us annual license fees prior to, and minimum
annual royalties subsequent to, regulatory approval of any
allergy vaccine developed under the agreement. ATL has agreed to
also purchase its clinical and commercial quantities of MPL
adjuvant from us and pay royalties on any commercial sales of
approved allergy vaccines.
Biomira Inc. In October 2004, we entered into license and
supply agreements with Biomira under which we granted Biomira a
nonexclusive, worldwide, license to our MPL adjuvant for use in
the continued development of Biomiras BLP25 Liposome
Vaccine. Under the agreement, Biomira paid us an up-front fee
and has agreed to pay us milestone payments and earned royalty
payments.
Berna Biotech. In February 2002, we entered into a
license and supply agreement with Berna Biotechs
subsidiary, Rhein Biotech N.V., or Rhein, under which we granted
Rhein a co-exclusive, worldwide, license to our RC-529 adjuvant
for use in developing a Hepatitis B vaccine. Under the
agreement, Rhein paid us an up-front fee and has agreed to pay
us milestone payments, annual license fees until commercial
launch of a product and earned royalty payments or annual
license fees after launch of a product. SUPERVAX, Berna
Biotechs prophylactic vaccine containing Corixas
RC-529 adjuvant, was approved in September 2003 for the
prevention of Hepatitis B infection in Argentina.
Wyeth. We are also a party to a license agreement and
related supply agreement with Wyeth that was amended and
restated effective September 28, 2001. Under the amended
and restated license agreement we granted Wyeth exclusive use of
RC-529 adjuvant and MPL adjuvant for a specific autoimmune
vaccine, co-exclusive use in certain infectious and autoimmune
disease fields and nonexclusive use in one infectious disease
field. Under the supply agreement, we will provide Wyeth
commercial quantities of RC-529 adjuvant and MPL adjuvant for
use in any vaccines that Wyeth may develop under the license
agreement. Under the agreements, Wyeth has agreed to pay us an
annual license fee until a threshold level of earned royalties
is met, transfer payments for supplies of RC-529 adjuvant and
MPL adjuvant and annual minimum and earned royalty payments when
commercial sale of vaccines are made.
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Aventis. In March 2004, we entered into license and
supply agreements with Aventis Pasteur, or Aventis, under which
we granted Aventis co-exclusive and nonexclusive worldwide
rights for our RC-529 adjuvant for use in multiple infectious
disease fields. The agreements include a provision that allows
for Aventis to add additional nonexclusive vaccine fields in the
future, subject to their availability and future payments to us
by Aventis. Under the terms of the license agreement, Aventis
paid us an up-front fee and has agreed to pay us success-based
milestones payments and earned royalty payments. Under the terms
of the supply agreement, Aventis has committed to placing annual
orders for supply of RC-529 adjuvant based on clinical trial and
commercial forecasts.
TLR4 Agonists and Antagonists
U.S. Army. In September 2003, we entered into a
$2.7 million contract with the U.S. Army Medical
Research and Materiel Command to develop biomarkers for exposure
to Corixas synthetic TLR4 agonists that are being used for
potential prevention of airway infections. The contract will
expire in August 2006. The three primary objectives of this
contract are to develop surrogate biomarkers for measuring
efficacy of Corixas TLR4 agonist-mediated protection
against airway infections, to produce a GMP production lot of
one of Corixas synthetic TLR4 agonists, including
completion of initial toxicological studies, and to plan for the
initiation of human clinical trials with an aerosolized TLR4
agonist.
NIAID/NIH. In December 2003, we entered into an
$11.6 million, 5-year contract with the NIAID to develop
drug candidates with the potential to generate protective
immunity to a wide variety of infectious agents. In connection
with the NIAID sponsored program we will be conducting
preclinical testing of our proprietary TLR4 targeted compounds.
Our existing preclinical research has shown that an experimental
nasal spray can suppress infection with influenza virus and
another common virus, the respiratory syncitial virus, as well
as a number of bacterial organisms that infect the airways. We
have shown that a single intranasal dose can provide a window of
protection in preclinical models that lasts approximately
1 week. We hope to develop a new type of prophylactic
product that provides continuous protection within 12 to
24 hours after the first intranasal dose is delivered
(vaccines can take weeks to months to generate protection).
Oncology Business Divestiture
Through our acquisition of Coulter Pharmaceuticals, or Coulter,
in 2000, we acquired BEXXAR therapeutic regimen, which was
approved by the FDA in June 2003 for the treatment of patients
with CD20 positive, follicular, non-Hodgkins lymphoma, or
NHL, with and without transformation, whose disease is
refractory to Rituximab and has relapsed following chemotherapy.
NHL is a form of cancer that affects the blood, bone marrow and
lymphatic tissues. BEXXAR therapeutic regimen is dual-action
therapy that pairs the tumor-targeting ability of a cytotoxic
(cancer killing) anti-B1monoclonal antibody, or Tositumomab, and
the therapeutic potential of radiation (Iodine-131) with
patient-specific dosing. Combined, these agents form a
radiolabeled monoclonal antibody, Iodine I 131 Tositumomab, that
is able to bind to the target antigen CD20 found on NHL cells,
thereby initiating an immune response against the cancer and
delivering a dose of radiation directly to tumor cells.
On December 31, 2004, we transferred to GSK all of our
rights and responsibilities, costs and certain assets associated
with commercial and clinical development of BEXXAR therapeutic
regimen on a worldwide basis. In return, GSK has agreed to pay
us development and sales milestones and royalties based on sales
of BEXXAR therapeutic regimen in the United States, Canada and
Australasia. We and GSK will continue to equally share royalties
on Zevalin sales according to the terms of the previous patent
litigation settlement with Biogen Idec Inc., or Biogen Idec. As
part of the transfer, we have agreed to provide GSK with
transition services until approximately June of 2005.
Approximately 160 of our employees were terminated in December
2004 in connection with the transfer. Forty-four of these
employees were retained to provide the transition services to
GSK. Upon the transfer, we immediately began restructuring our
operations in South San Francisco and Seattle to focus our
future operations on the adjuvant business and further
development of our TLR4-based compounds.
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We are in the process of exiting oncology product development in
vaccines and antibodies following the sale of our rights to
BEXXAR therapeutic regimen. We intend to focus our future
operations on our growing adjuvant business and the further
development of proprietary TLR4-based compounds. Discussions are
ongoing with current partners and other parties interested in
the purchase or transfer of our cancer vaccine and antibody
target assets, which include the below partnerships.
On January 13, 2005, we announced that we had entered into
a license agreement with Genentech, Inc., or Genentech, under
which we granted Genentech an exclusive worldwide license to a
novel target for the possible development of humanized
antibody-based therapeutics. Under the terms of the agreement,
we received a $1.6 million up-front license fee, and may
receive up to an additional $8.25 million in future
success-based payments upon completion of certain regulatory and
commercial milestones in addition to royalty payments on product
sales. Genentech will be responsible for development and
commercialization costs of any potential therapeutic based on
our antibody target.
On January 5, 2005, we announced that we had entered into a
license agreement with Gen-Probe, Inc., or Gen-Probe, under
which we granted Gen-Probe the rights to develop molecular
diagnostic tests for approximately 50 potential genetic markers
in the areas of prostate, ovarian, cervical, kidney, lung and
colon cancer. Under the terms of the agreement, Gen-Probe has
gained access to specific Corixa intellectual property covering
multiple genetic sequences related to potential markers for
various cancers. These markers include AMACR for prostate and
colon cancers, CA125 for ovarian cancer, and L523S for cervical
and lung cancers. In exchange, Gen-Probe paid us a
$1.6 million initial access fee, and will pay us an
additional $3.2 million in two equal access fees in January
of 2006 and 2007, unless Gen-Probe terminates the agreement.
Gen-Probe has agreed to also pay us up to $2 million on a
product-by-product basis if certain regulatory and commercial
milestones are achieved. In addition, Gen-Probe has agreed to
pay us royalties on sales of any products developed using our
intellectual property.
We have completed our GSK-funded discovery research on prostate
cancer vaccines, Her-2/neu, mammaglobin and other breast cancer
vaccines, and ovarian and colon cancer vaccines that were
exclusively licensed to GSK under our Multi-Field Vaccine
Agreement. In 2003, we obtained from GSK the right to develop
one prostate cancer vaccine, one breast cancer vaccine and all
ovarian cancer vaccines based on our prior efforts under the
Multi-Field Vaccine Agreement. We are now discussing the sale or
out-licensing of our interest in these programs.
We are also discussing with third parties the sale or
out-licensing of our interest in our lung cancer vaccine that is
the subject of a partnership with Zambon Group spa and its
subsidiaries, collectively referred to herein as Zambon, and an
exclusive license in Japan to the pharmaceutical division of
Japan Tobacco, Inc., or JT, as well as and our WT-1 vaccine
program that is the subject of a partnership with Kirin Brewing
Co., or Kirin.
In the area of antibody-based therapeutics, we are discussing
with third parties the sale or out-licensing of our interest in
antibody targets and related antibodies developed under our
partnerships with Medarex, Inc., or Medarex, and Abgenix, Inc.
as well as the prostate, breast, and colon cancer antibody
targets developed but not licensed to GSK under the Multi-Field
Agreement, the ovarian cancer antibody targets developed under
the Multi-Field Agreement and returned to us by GSK in 2003 as
well as lung cancer antibody targets.
Other Relationships
IDRI. In December 2003, we granted to the Infectious
Disease Research Institute, or IDRI, an exclusive worldwide
license to Leish 111-f, our investigational vaccine for the
treatment of various forms of leishmaniasis. Pursuant to a
service agreement between us and IDRI, in 2004 we completed the
Leish 111-f vaccine Phase I clinical trial in the United
States that we initiated in January 2003. IDRI is responsible
for all other development and commercialization activities in
connection with Leish 111-f vaccine.
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Introgen. In July 1999, we entered into a license
agreement with Introgen Therapeutics, Inc., or Introgen, under
which we granted Introgen an exclusive gene therapy license to
the MDA-7 gene that induces apoptosis in a diverse group of
cancer cells. Introgens INGN 241 product candidate, which
includes the MDA-7 gene, is undergoing safety and efficacy
testing in a Phase I/ II clinical trial to evaluate
antitumor activity. This trial has demonstrated that in patients
with various solid tumors, INGN 241 is well tolerated, produces
the desired pharmacologic protein that is in turn biologically
active, displays minimal toxicity and can lead to tumor
regression.
Patents and Proprietary Technology
Our success depends in part on our ability to obtain, protect
and enforce commercially valuable patents. We try to protect our
proprietary positions by filing United States and foreign patent
applications related to our proprietary technology, inventions
and improvements that are important to developing our business.
As of December 31, 2004, we owned, had licensed or had
options to license 154 issued United States patents that expire
at various times between 2005 and 2022, and had 121 patent
applications pending with the United States Patent and Trademark
Office.
Our patent position is generally uncertain and involves complex
legal and factual questions. Legal standards relating to the
validity and scope of claims in the biotechnology and
biopharmaceutical fields are still evolving. Accordingly, the
degree of future protection for our patent rights is uncertain.
The risks and uncertainties that we face with respect to our
patents and the patents licensed to us include the following:
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the pending patent applications that we have filed or to which
we have exclusive rights may not result in issued patents or may
take longer than we expect to result in issued patents; |
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the claims of any patents that are issued may not provide
meaningful protection; |
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we may be unable to develop additional proprietary technologies
that are patentable; |
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the patents licensed or issued to us may not provide a
competitive advantage; |
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other companies may challenge patents licensed or issued to us; |
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disputes may arise regarding the invention and corresponding
ownership rights in inventions and know-how resulting from the
joint creation or use of intellectual property by us, our
licensors, corporate partners and other scientific
collaborators; and |
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other companies may design around our patented technologies. |
We have licensed several patent applications from Southern
Research Institute, or SRI, related to our microsphere
encapsulation technology. One of these patent applications is
currently the subject of opposition proceedings before the
European Patent Office. In the opposition, the European Patent
Office has revoked a previously issued European patent. Although
SRI has appealed this decision, it is uncertain whether SRI will
ultimately prevail in this opposition proceeding.
Under the publication provisions of the American Inventors
Protection Act of 1999, pending United States patent
applications will publish 18 months after the earliest
claimed priority date and the file histories for these
applications will be open for public inspection. Our patent
applications and the related file histories that are subject to
the American Inventors Protection Act will then be available for
review by others, including our competitors. Pre-issuance
publications could allow us to recover damages from pre-issuance
infringers of published claims that ultimately issue as patents.
Pre-issuance damages will be contingent on publication of claims
that are substantially identical to claims that actually issue
and on notifying infringers regarding subject applications. We
may elect not to publish some or all of our pending United
States patent applications if we do not file internationally. If
we elect not to publish, we will not be able to seek
pre-issuance damages.
Patent applications filed in the United States prior to the
effect of the American Inventors Protection Act of 1999, are
presently maintained in secrecy until the patents are issued.
Patent applications in certain foreign countries generally are
not published until many months or years after they are filed.
Scientific and
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patent publications often occur long after the date of the
scientific developments disclosed in those publications.
Accordingly, we cannot be certain that we or one of our
corporate partners was the first to invent the subject matter
covered by any patent application or that we or one of our
corporate partners was the first to file a patent application
for any such invention.
Our success also depends in part on our ability to protect trade
secrets that are not patentable or for which patents are
difficult to enforce. To protect our proprietary rights, we rely
primarily on confidentiality agreements with employees and third
parties, and protective contractual provisions such as those
contained in license agreements and research agreements.
Nevertheless, other companies may inadvertently develop similar
or alternative technologies or duplicate our technologies that
are not protected by patents or otherwise obtain and use
information that we regard as proprietary. Other parties may
breach confidentiality agreements and other protective contracts
we have entered into, and we may not become aware of, or have
adequate remedies in the event of, any breach.
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.
We attempt to protect our trademarks by filing for United States
and foreign registrations for marks that are important to
developing our business. However, the laws of some foreign
countries do not allow for protection of our proprietary rights
to the same extent as do the laws of the United States, and
effective trademark protection may not be available in other
jurisdictions. Our trademark for MPL adjuvant is currently the
subject of opposition proceedings before the Office for the
Harmonization in the Internal Market, which handles initial
prosecution and opposition of European trademarks. We may not
ultimately prevail in this opposition proceeding. As a result,
we may not receive trademark protection for MPL adjuvant in
Europe.
Government Regulation
Any products that we develop are subject to regulation by
federal, state and local governmental authorities in the United
States, including the FDA, and by similar agencies in other
countries. Any product that we develop must receive all relevant
regulatory approvals or clearances before it may be marketed in
a particular country.
The regulatory process, which includes extensive preclinical
studies and clinical trials of each clinical candidate to study
its safety and efficacy, is uncertain, can take many years and
requires the expenditure of substantial resources. We cannot
assure you that the clinical trials of our product candidates
under development will demonstrate the safety and efficacy of
those product candidates to the extent necessary to obtain
regulatory approval.
The nature and extent of the governmental pre-market review
process for our potential products will vary, depending on the
regulatory categorization of particular products. We believe
that the FDA and comparable regulatory bodies in other countries
will regulate our vaccine and other immunotherapeutic products
and related pharmaceutical products as biologics or drugs. The
necessary steps before a new biological product may be marketed
in the United States ordinarily include the following:
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preclinical laboratory and animal studies; |
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submission to the FDA of an IND, which must become effective
before clinical trials may commence; |
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completion of adequate and well-controlled human clinical trials
to establish the safety and efficacy of the proposed drug for
its intended use; |
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submission to the FDA of a Biologics License Application , or
BLA, or New Drug Application, or NDA; and |
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FDA review and approval of the BLA or NDA before the product is
commercially sold or shipped. |
Preclinical tests include evaluating the product in the
laboratory, as well as animal studies to assess the potential
safety and efficacy of the product. Preclinical studies must be
conducted by laboratories that comply with FDA regulations
regarding good laboratory practices. The results of preclinical
studies, together with manufacturing information, analytical
data and proposed clinical trial protocols, are submitted to the
FDA as part of an IND, which must become effective before the
clinical trials can begin. The IND will automatically become
effective 30 days after the FDA receives it, unless the FDA
indicates prior to the end of the 30-day period that the
proposed protocol raises concerns that must be resolved to the
FDAs satisfaction before the trials may proceed. If the
FDA raises concerns, we may be unable to resolve the proposed
protocol to the FDAs approval in a timely fashion, if at
all. In addition, the FDA may impose a clinical hold on an
ongoing clinical trial if, for example, safety concerns arise,
in which case the study cannot recommence without FDA
authorization under terms sanctioned by the agency.
Clinical trials involve administering the product to healthy
volunteers or to patients being supervised by a qualified
principal investigator. Clinical trials must be conducted
according to good clinical practices under protocols that detail
the trials objectives, inclusion and exclusion criteria,
the parameters to be used to monitor safety and the efficacy
criteria to be evaluated. Each protocol must be submitted to the
FDA as part of the IND. Further, each clinical trial must be
reviewed and approved by an independent institutional review
board. The institutional review board will consider, among other
things, ethical factors and the safety of human subjects. The
institutional review board may require changes in a protocol,
which may delay initiation or completion of a study.
Clinical trials generally are conducted in three sequential
phases that may overlap. In Phase I, the product is
introduced into healthy human or patients; the product is tested
to assess safety, metabolism, pharmacokinetics and
pharmacological actions associated with increasing doses.
Phase II usually involves studies in a limited patient
population to assess the following:
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determine the efficacy for specific, targeted indications; |
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determine dosage tolerance and optimum dosage; and |
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further identify possible adverse reactions and safety risks. |
Once a compound is determined to be effective and to have an
acceptable safety profile in Phase II clinical trials,
Phase III trials are undertaken to evaluate further
clinical efficacy in comparison to standard therapies, within a
broader patient population, generally at geographically
dispersed clinical sites. Phase I, Phase II or
Phase III clinical trials may not be completed successfully
within any specific period of time, if at all, with respect to
any of our potential products. Furthermore, we, the FDA or an
institutional review board may suspend a clinical trial at any
time for various reasons, including a finding that the healthy
individuals or the patients are being exposed to an unacceptable
health risk.
The results of pharmaceutical development, preclinical studies
and clinical trials are submitted to the FDA in the form of a
BLA or NDA for approval of the manufacture, marketing and
commercial shipment of the product. The testing and approval
process is likely to require substantial time, effort and
resources, and we may be unable to obtain approval on a timely
basis, if at all. Regarding any BLA or NDA, the FDA may take a
number of actions, including the following:
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deny the BLA or NDA if applicable regulatory criteria are not
satisfied; |
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require additional testing or information; or |
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require post-market testing and surveillance to monitor the
safety or efficacy of the product. |
Delays in obtaining regulatory approvals:
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would adversely affect the marketing of any products we develop; |
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could impose significant additional costs on us; |
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would diminish any competitive advantages that we may
attain; and |
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could adversely affect our ability to receive royalties and
generate revenue and profits. |
In addition, even if marketing approval is granted, the FDA may
require post-marketing clinical trials, which typically entail
extensive patient monitoring and may result in restricted
marketing of an approved product for an extended period of time.
Any diagnostic products developed by us or our corporate
partners are likely to be regulated as medical devices. In the
United States, medical devices are classified into one of three
classes on the basis of the controls deemed by the FDA to be
necessary to reasonably ensure their safety and effectiveness:
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Class I (general controls) e.g.,
labeling, pre-market notification and adherence to GMP and
quality system regulation, or QSR; |
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Class II (general controls and special
controls) e.g., performance standards and
post-market surveillance; and |
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Class III (pre-market approval). |
Before a new device can be marketed, its manufacturer generally
must obtain marketing clearance through either a pre-market
notification under Section 510(k) of the Federal Food, Drug
and Cosmetic Act or approval of a pre-market approval
application, or PMA. A 510(k) clearance typically will be
granted if a company establishes that its device is
substantially equivalent to a legally marketed
Class I or II medical device or to a Class III
device for which the FDA has not yet required the submission of
a PMA. A 510(k) clearance must contain information to support
the claim of substantial equivalence, which may include
laboratory test results or the results of clinical trials.
Commercial distribution of a device subject to the 510(k)
requirement may begin only after the FDA issues an order finding
the device to be substantially equivalent to a predicate device.
It generally takes from 4 to 12 months from the date of
submission to obtain clearance of a 510(k) submission. The FDA
may determine that a proposed device is not substantially
equivalent to a legally marketed device, that additional
information is needed before a substantial equivalence
determination may be made, or that the product must be approved
through the PMA process. An FDA determination of not
substantially equivalent, a request for additional
information, or the requirement of a PMA could delay market
introduction of products that fall into this category.
Furthermore, modifications or enhancements that could
significantly affect safety or effectiveness, or constitute a
major change in the intended use of any device, cleared through
the 510(k) process would require new 510(k) submissions.
If a device does not qualify for the 510(k) pre-market
notification procedure, a company must file a PMA. The PMA
requires more extensive pre-filing testing than required for a
510(k) pre-market notification and usually involves a
significantly longer review process. A PMA must be supported by
valid scientific evidence that typically includes extensive
data, including preclinical and clinical trial data, to
demonstrate the devices safety and efficacy. If clinical
trials are required, and the device presents a significant
risk, an investigational device exemption application must
be filed with the FDA and become effective prior to the
commencement of clinical trials. If the device presents a
nonsignificant risk to trial subjects, clinical
trials may begin on the basis of appropriate institutional
review board approval. Clinical investigation of medical devices
may involve risks similar to those involved in the clinical
investigation of pharmaceutical products.
A PMA may be denied if applicable regulatory criteria are not
satisfied, and the FDA may impose certain conditions upon the
applicant, such as post-market testing and surveillance. The PMA
review and approval process can be expensive, uncertain and
lengthy, and approvals may not be granted on a timely basis, if
at all.
Regulatory approval, if granted, may entail limitations on the
indicated uses for which the approved product may be marketed.
These limitations could reduce the size of the potential market
for the product.
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Product approvals, once granted, may be withdrawn if problems
occur after initial marketing. Further, manufacturers of
approved products are subject to ongoing regulation, including
compliance with detailed FDA regulations governing GMP. Failure
to comply with manufacturing regulations can result in, among
other things, warning letters, fines, injunctions, civil
penalties, recall or seizure of products, total or partial
suspension of production, refusal of the government to renew
marketing applications and criminal prosecution.
For clinical investigation and marketing of products outside the
United States, we and our corporate partners may be subject to
regulation by regulatory authorities in other countries. The
requirements governing the conduct of clinical trials, marketing
authorization and pricing and reimbursement vary widely from
country to country. The regulatory approval process in other
countries entails requirements similar to those associated with
FDA approval.
Our research and development involves the controlled use of
hazardous chemicals, radioactive and biological materials. We
are subject to federal, state and local laws and regulations
governing the use, storage, handling and disposal of these
materials and related waste products including, among others,
the Occupational Safety and Health Act, the Environmental
Protection Act, the Nuclear Energy and Radiation Control Act,
the Toxic Substances Control Act, the Resource Conservation and
Recovery Act, the Comprehensive Environmental Response,
Compensation, and Liability Act, Title III of the Superfund
Amendments and Reauthorization Act (Community Right-to-Know and
Emergency Response Act), national restrictions on technology
transfer, federal regulations on the protection of human
subjects in clinical studies, the protection of animal welfare
in preclinical studies, import, export and customs regulations
and other present or possible future local, state or federal
regulation. From time to time congressional committees and
federal agencies have indicated an interest in implementing
further regulation of biotechnology and its applications.
Although we believe that our safety procedures for handling,
storing and disposing of these materials and related waste
comply with legally prescribed standards, we cannot completely
eliminate the risk of accidental contamination or injury from
these materials. In the event of an accident, we could be held
liable for damages or penalized with fines, and this liability
could exceed our resources.
Competition
The biotechnology and biopharmaceutical industries are intensely
competitive. Many companies and institutions compete with us in
developing alternative therapies to treat or prevent infectious
diseases or inflammatory conditions, including the following:
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pharmaceutical companies; |
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biotechnology companies; |
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academic institutions; and |
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other research organizations. |
Moreover, technology controlled by third parties that may be
advantageous to our business may be acquired or licensed by our
competitors, thereby preventing us from obtaining technology on
commercially reasonable terms, if at all.
Many of the companies developing competing technologies and
products have significantly greater financial resources and
expertise in research and development, manufacturing,
preclinical and clinical development, obtaining regulatory
approvals and marketing than we do. Other smaller companies may
also prove to be significant competitors, particularly through
collaborative arrangements with large and established companies.
Academic institutions, government agencies and other public and
private research organizations may also conduct research, seek
patent protection and establish collaborative arrangements for
research and development, manufacturing, preclinical and
clinical development, obtaining regulatory approval and
marketing of products similar to ours. These companies and
institutions compete with us in recruiting and retaining
qualified scientific and management personnel as well as in
acquiring and
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developing technologies complementary to our programs. We face
competition with respect to the following:
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product efficacy and safety; |
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timing and scope of regulatory approvals; |
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availability of resources; |
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reimbursement coverage; |
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product price; and |
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patent position. |
Our ability to compete effectively and develop products that can
be manufactured cost-effectively and marketed successfully will
depend on our ability to perform the following:
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advance our technology platforms; |
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license additional technology; |
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maintain a proprietary position in our technologies and products; |
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obtain required government and other public and private
approvals on a timely basis; |
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availability of reimbursement from third-party payors; |
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attract and retain key personnel; and |
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enter into corporate partnerships. |
Manufacturing
We manufacture pharmaceutical-grade products to supply our
previous and ongoing clinical trials. In addition, we
manufacture preclinical and clinical supplies of adjuvants for
our corporate partners, government agencies and academic
researchers. Our primary focus is the manufacture of bulk MPL
adjuvant at our Hamilton, MT facility. We have entered into a
long-term supply agreement with GSK for bulk quantities of MPL
adjuvant. In order to meet the minimum requirements of this
contract we are undergoing a facility upgrade and expansion of
our manufacturing capacity. We believe that our existing
facilities will be sufficient to meet the minimum supply
requirements for GSK in addition to our other customer demands.
Should we require additional capacity in the future, we have
space to expand our manufacturing facility in Hamilton, Montana.
We continue to manufacture small quantities of TLR4 agonist
formulations for our preclinical and clinical studies. We also
manufacture small quantities of adjuvant formulations for our
licensees development programs. We manufacture and sell
small quantities of research adjuvants for academic purposes.
We have outsourced the cGMP manufacture of our RC-529 adjuvant
and our TLR4 agonists for preclinical, clinical supply and
commercialization. In addition, we are in the process of
transferring some of our adjuvant formulations and fill/finish
operations to third party contract manufacturers.
Marketing and Distribution
As a result of our sale of BEXXAR therapeutic regimen and
related assets to GSK and a subsequent reduction in headcount,
we no longer have sales or marketing personnel. We have
distribution personnel only for our adjuvants, and we do not
plan to have sales, marketing or further distribution
capabilities in the near future. As a result, we intend to rely
on our corporate partners to commercialize products that
incorporate our adjuvants and will likely rely on corporate
partners to commercialize certain of our potential TLR4 agonist
and antagonist products.
17
Employees
As of December 31, 2004, we had 263 employees, 35 of whom
hold degrees at the doctorate level. Of these employees, 89 are
engaged in, or directly support research and development
activities, 23 are in production, and 67 are in administration
and business positions. Each of our employees has signed a
confidentiality agreement and none are covered by a collective
bargaining agreement. We have never experienced
employment-related work stoppages and consider our employee
relations to be good.
We conduct operations at two sites. Our headquarters are in
Seattle, Washington, where we lease approximately
150,000 square feet of laboratory, discovery, research and
development and general administration space. In addition, we
own a 35-acre complex near Hamilton, Montana which includes a
60,000 square foot building containing laboratory, pilot
plant, commercial manufacturing, marketing and administrative
facilities. The leases for the Seattle facilities expire in
January 2011 and November 2019. We believe our existing
facilities are adequate to meet our immediate needs and that
suitable additional space will be available in the future on
commercially reasonable terms as needed.
We are in the process of closing our South San Francisco
facility where we currently occupy approximately
25,000 square feet of space that is currently used for our
transitional operations related to the sale of BEXXAR
therapeutic regimen to GSK. During 2003 we subleased to third
parties approximately 125,000 square feet of our South
San Francisco facility. The lease for the South
San Francisco facility expires in 2010, with an option to
renew for two additional 5-year periods.
|
|
Item 3. |
Legal Proceedings |
Not applicable.
|
|
Item 4. |
Submission of Matters to a Vote of Security Holders |
No matters were submitted to a vote of securities holders during
the fourth quarter of 2004.
PART II
|
|
Item 5. |
Market for Registrants Common Equity, Related
Stockholder Matters and Issuer Purchases of Equity
Securities |
Price range of common stock
Our common stock has been quoted on Nasdaq under the symbol
CRXA since our initial public offering in October
1997. Prior to this date our common stock did not trade publicly.
18
The following table shows our high and low sales prices of our
common stock as quoted on Nasdaq for each of the quarters
indicated.
|
|
|
|
|
|
|
|
|
|
|
High | |
|
Low | |
|
|
| |
|
| |
2003
|
|
|
|
|
|
|
|
|
First Quarter
|
|
|
6.92 |
|
|
|
5.16 |
|
Second Quarter
|
|
|
8.92 |
|
|
|
6.40 |
|
Third Quarter
|
|
|
9.89 |
|
|
|
6.69 |
|
Fourth Quarter
|
|
|
9.00 |
|
|
|
5.22 |
|
2004
|
|
|
|
|
|
|
|
|
First Quarter
|
|
|
6.95 |
|
|
|
5.76 |
|
Second Quarter
|
|
|
7.23 |
|
|
|
4.15 |
|
Third Quarter
|
|
|
5.32 |
|
|
|
3.26 |
|
Fourth Quarter
|
|
|
4.76 |
|
|
|
3.26 |
|
As of March 9, 2005 we had 1,520 holders of record of our
common stock.
Dividend Policy
We have never paid cash dividends on our common stock and have
no plans to do so in the foreseeable future.
Securities Authorized for Issuance Under Equity Compensation
Plans
Equity Compensation Plan Information
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Securities | |
|
|
|
|
|
|
Remaining Available | |
|
|
|
|
|
|
for Future Issuance | |
|
|
Number of Securities | |
|
|
|
Under Equity | |
|
|
to be Issued Upon | |
|
Weighted-Average | |
|
Compensation Plans | |
|
|
Exercise of | |
|
Exercise Price of | |
|
(Excluding | |
|
|
Outstanding Options, | |
|
Outstanding Options, | |
|
Securities Reflected | |
|
|
Warrants and Rights | |
|
Warrants and Rights | |
|
in Column(a)) | |
|
|
| |
|
| |
|
| |
Plan category |
|
(a) | |
|
(b) | |
|
(c) | |
|
|
| |
|
| |
|
| |
Equity compensation plans approved by security holders
|
|
|
12,791,845 |
|
|
$ |
8.80 |
|
|
|
2,010,869 |
|
Equity compensation plans not approved by security holders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
12,791,845 |
|
|
$ |
8.80 |
|
|
|
2,010,869 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Item 6. |
Selected Consolidated Financial Data |
The following selected consolidated financial data should be
read in conjunction with the consolidated financial statements
and related notes included in this Annual Report, as well as the
section of this report
19
entitled Managements Discussion and Analysis of
Financial Condition and Results of Operations. Historical
results are not necessarily indicative of future results.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
2001 | |
|
2000 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands, except per share amounts) | |
Consolidated Statement of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative agreements
|
|
$ |
16,927 |
|
|
$ |
29,911 |
|
|
$ |
43,587 |
|
|
$ |
54,147 |
|
|
$ |
33,917 |
|
|
Product sales
|
|
|
4,547 |
|
|
|
3,031 |
|
|
|
2,547 |
|
|
|
981 |
|
|
|
726 |
|
|
Government grants
|
|
|
3,482 |
|
|
|
2,403 |
|
|
|
2,604 |
|
|
|
2,937 |
|
|
|
2,331 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
|
24,956 |
|
|
|
35,345 |
|
|
|
48,738 |
|
|
|
58,065 |
|
|
|
36,974 |
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
62,322 |
|
|
|
84,054 |
|
|
|
94,039 |
|
|
|
134,993 |
|
|
|
60,186 |
|
|
Sales, general and administrative and intangible amortization
|
|
|
10,254 |
|
|
|
11,762 |
|
|
|
19,043 |
|
|
|
80,553 |
|
|
|
12,499 |
|
|
Manufacturing
|
|
|
3,246 |
|
|
|
1,380 |
|
|
|
2,043 |
|
|
|
726 |
|
|
|
419 |
|
|
Restructuring
|
|
|
1,906 |
|
|
|
2,452 |
|
|
|
3,436 |
|
|
|
2,335 |
|
|
|
|
|
|
Impairment of lease-related assets(1)
|
|
|
2,572 |
|
|
|
18,491 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquired in-process research and development(2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
629,700 |
|
|
Goodwill impairment(3)
|
|
|
|
|
|
|
|
|
|
|
161,060 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
80,300 |
|
|
|
118,139 |
|
|
|
279,621 |
|
|
|
218,607 |
|
|
|
702,804 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(55,344 |
) |
|
|
(82,794 |
) |
|
|
(230,883 |
) |
|
|
(160,542 |
) |
|
|
(665,830 |
) |
Interest and other income, net
|
|
|
5,926 |
|
|
|
1,554 |
|
|
|
23,484 |
|
|
|
12,505 |
|
|
|
4,999 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before discontinued operations and cumulative effect of
change in accounting principle
|
|
|
(49,418 |
) |
|
|
(81,240 |
) |
|
|
(207,399 |
) |
|
|
(148,037 |
) |
|
|
(660,831 |
) |
Discontinued operations(4)
|
|
|
(26,989 |
) |
|
|
(2,679 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative effect of change in accounting principle(5)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,338 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(76,407 |
) |
|
|
(83,919 |
) |
|
|
(207,399 |
) |
|
|
(148,037 |
) |
|
|
(667,169 |
) |
Preferred stock dividend
|
|
|
(595 |
) |
|
|
(948 |
) |
|
|
(767 |
) |
|
|
(1,730 |
) |
|
|
(9,887 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common stockholders
|
|
$ |
(77,002 |
) |
|
$ |
(84,867 |
) |
|
$ |
(208,166 |
) |
|
$ |
(149,767 |
) |
|
$ |
(677,056 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per common share before discontinued
operations and cumulative effect of change in accounting
principle
|
|
$ |
(0.87 |
) |
|
$ |
(1.53 |
) |
|
$ |
(4.65 |
) |
|
$ |
(3.61 |
) |
|
$ |
(31.53 |
) |
Discontinued operations per share
|
|
$ |
(0.48 |
) |
|
$ |
(0.05 |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Cumulative effect of change in accounting principle per share
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
(0.30 |
) |
Basic and diluted net loss applicable to common stockholders(6)
|
|
$ |
(1.36 |
) |
|
$ |
(1.60 |
) |
|
$ |
(4.67 |
) |
|
$ |
(3.66 |
) |
|
$ |
(32.30 |
) |
Shares used in computation of basic and diluted net loss per
common share
|
|
|
56,569 |
|
|
|
52,981 |
|
|
|
44,611 |
|
|
|
40,961 |
|
|
|
20,961 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20
|
|
(1) |
See Note 1 of Notes to Consolidated Financial Statements
for an explanation of the 2004 and 2003 impairment of lease
related assets. |
|
(2) |
The $629.7 million reflects the amount of allocated
in-process research and development, or IPR&D, that we
acquired in the 2000 Coulter acquisition. |
|
(3) |
See Note 1 of Notes to Consolidated Financial Statements
for an explanation of the 2002 goodwill impairment charge. |
|
(4) |
See Note 11 of Notes to Consolidated Financial Statements
for an explanation of the 2004 discontinued operations. |
|
(5) |
Effective January 1, 2000, we changed our method of
accounting for nonrefundable up-front license fees to recognize
such fees over the period of our continuing involvement,
generally the term of the related research and development
collaboration arrangement on a straight-line basis, as this
method best matches the effort provided. We had previously
recognized nonrefundable up-front license fees as revenue when
the technology was transferred and when all significant
contractual obligations relating to the fees had been fulfilled.
We believe the change in accounting principle is preferable
based on guidance provided in SEC Staff Accounting
Bulletin No. 101, Revenue Recognition in Financial
Statements. |
|
(6) |
See Note 1 of Notes to Consolidated Financial Statements
for an explanation of the computation of the number of shares
and the method used to calculate basic and diluted net loss per
common share. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
2001 | |
|
2000 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Consolidated Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and securities available-for-sale
|
|
$ |
116,187 |
|
|
$ |
191,985 |
|
|
$ |
116,757 |
|
|
$ |
118,723 |
|
|
$ |
194,738 |
|
Working capital
|
|
|
72,878 |
|
|
|
106,783 |
|
|
|
55,792 |
|
|
|
41,824 |
|
|
|
144,504 |
|
Total assets
|
|
|
191,201 |
|
|
|
250,566 |
|
|
|
196,106 |
|
|
|
367,382 |
|
|
|
504,334 |
|
Long-term obligations, less current portion
|
|
|
119,110 |
|
|
|
108,138 |
|
|
|
6,920 |
|
|
|
27,657 |
|
|
|
33,422 |
|
Redeemable common stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,000 |
|
|
|
2,000 |
|
Accumulated deficit
|
|
|
(1,270,967 |
) |
|
|
(1,194,560 |
) |
|
|
(1,110,641 |
) |
|
|
(903,242 |
) |
|
|
(755,205 |
) |
Total stockholders equity
|
|
|
20,292 |
|
|
|
80,956 |
|
|
|
128,392 |
|
|
|
281,765 |
|
|
|
404,575 |
|
|
|
Item 7. |
Managements Discussion and Analysis of Financial
Condition and Results of Operations |
The following discussion should be read together with our
consolidated financial statements and the accompanying notes
included elsewhere in this Annual Report.
Summary of Critical Accounting Policies
The preparation of financial statements in accordance with
accounting principles generally accepted in the United States
requires that management make a number of assumptions and
estimates that affect the reported amounts of assets,
liabilities, revenue and expenses in our consolidated financial
statements and accompanying notes. Management bases its
estimates on historical information and assumptions believed to
be reasonable. Although these estimates are based on
managements best knowledge of current events and
circumstances that may impact us in the future, actual results
may differ from these estimates. We
21
believe the following critical accounting policies affect the
more significant judgments and estimates used in preparing our
consolidated financial statements:
Revenue associated with up-front license, technology access and
research and development funding payments under collaborative
agreements is recognized ratably over the relevant periods
specified in the agreement, generally the research and
development period. Generally, our collaborative agreements
include a research and development phase that spans a specified
time period. However, in certain cases the collaborative
agreement specifies a research and development phase which
culminates with the completion of a development work plan but
does not have a fixed date and requires us to estimate the time
period over which the work plan will be performed and therefore,
the period over which revenue should be recognized. Our
estimated time periods are based on managements estimate
of the time required to achieve a particular development
milestone considering experience with similar projects, level of
effort and stage of development. If our estimate of the research
and development time period increases the amount of revenue we
recognize related to up-front license and technology access fees
for a given period would decrease.
We performed an impairment test on goodwill on March 13,
2002, due to the presence of impairment indicators as described
in Note 1 of Notes to Consolidated Financial Statements.
This impairment test involved a two-step approach. Step one
required estimating the fair value of the company and comparing
it to the carrying value of recorded net assets. Since the
carrying value of the recorded net assets exceeded the estimated
fair value, we performed the second step that required
allocating the fair value to all of our assets and liabilities,
including unrecorded intangibles, to determine the deemed fair
value, if any, of goodwill. Both steps required us to make
significant assumptions and estimates, including determining our
fair value and the fair value of our assets and liabilities. In
addition, this process required us to estimate future cash flows
from our research and development projects in process and the
applicable discount rates. We engaged an independent third-party
valuation specialist to assist us in our impairment analysis.
The analysis resulted in a $161.1 million goodwill
impairment charge in the first quarter of 2002, which
represented the write-off of all goodwill existing as of the
date of the test. In the event that future acquisitions result
in goodwill, we will be required to perform this test on at
least an annual basis.
As a result of the sublease of approximately 117,000 square
feet of our leased facilities in the second and third quarters
of 2003, we identified an indicator of impairment of our
long-term lease related assets. We determined that the assets
were not recoverable and reduced the carrying value of the
assets to their fair value. The fair value was determined based
on estimated current market rental rates. We recognized a loss
of $18.5 million.
In December 2004, in connection with GSKs acquisition of
our rights to BEXXAR therapeutic regimen and our plans to close
our remaining South San Francisco facilities, we reviewed
the remaining lease related assets for potential impairment. We
determined that the undiscounted cash flows related to a
potential sublease would be less than the carrying value of the
recorded lease intangible and leasehold improvements. Because
the carrying value exceeded the fair value, we recorded an
impairment loss of $2.6 million.
Overview
We are a developer of innovative immunotherapeutic products that
regulate innate immune responses. These products include:
|
|
|
|
|
Vaccine Adjuvants compounds or additives that, when
combined with a vaccine, boost the bodys immune response
to antigens contained in the vaccine; and |
22
|
|
|
|
|
TLR4 agonists and antagonists compounds that
interact with a type of cell surface receptor that recognizes
distinct molecular signatures presented by invading pathogens
and generates an immune response. These responses may be useful
in the prevention and/or therapy of many conditions, including
seasonal allergic rhinitis, broad infection prevention, chronic
obstructive pulmonary disease and inflammatory conditions. |
We are a product development company with multiple product
candidates, many in late-stage human clinical trials. We are
driven by an aggressive partnering and manufacturing strategy
that we believe will give us an opportunity for sustained and
consistent commercial success.
We generate revenue from technology licenses, collaborative
research and development arrangements, cost reimbursement
contracts and adjuvant product sales. Revenue under technology
licenses and collaborative agreements typically consists of
nonrefundable and/or guaranteed technology license fees,
collaborative research funding, technology access fees, and
various milestone and future product royalty or profit-sharing
payments.
Revenue associated with up-front license, technology access and
research and development funding payments under collaborative
agreements is recognized ratably over the relevant periods
specified in the respective agreements, generally the research
and development period. Revenue from substantive at-risk
milestones is recognized upon completion of the milestones and
future product royalties are recognized when earned, as defined
in the respective agreements. Revenue under cost reimbursement
contracts is recognized as the related costs are incurred.
Revenue from adjuvant sales is recognized upon customer
acceptance of the product. Payments received in advance of
recognition as revenue are recorded as deferred revenue.
Revenue from collaborative agreements was 68%, 85% and 89% of
total revenue for the years ended December 31, 2004, 2003
and 2002, respectively. Revenue from product sales was 18%, 9%
and 5% for the years ended December 31, 2004, 2003 and
2000, respectively. Revenue from government grants and contracts
was 14%, 6% and 6% of total revenue for the years ended
December 31, 2004, 2003 and 2002, respectively. As of
December 31, 2004, we had total stockholders equity
of $20.3 million.
We have entered into, and intend to continue to enter into,
collaborative agreements at various stages in the research and
development process. We believe that this active corporate
partnering strategy provides four distinct advantages:
|
|
|
|
|
it focuses on our fundamental strength in immunotherapeutic
product discovery and selected product development; |
|
|
|
it capitalizes on our corporate partners strengths in
product development, manufacturing and commercialization; |
|
|
|
it may enable us to retain significant downstream participation
in product sales; and |
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it reduces our financing requirements. |
Our material collaborative agreements that provided us with
funding during 2004 include the following:
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GSK. Effective September 1998, we entered into a
comprehensive corporate partnership with GSK. Under the
agreement we granted GSK an exclusive worldwide license to
develop, manufacture and sell vaccine products and certain
dendritic cell therapy products that incorporate antigens
discovered or in-licensed under this corporate partnership. We
also granted GSK license rights to develop, manufacture and sell
passive immunotherapy products, such as T cell or antibody
therapeutics, and therapeutic drug monitoring products, in each
case that incorporate these antigens. On August 31, 2002
the funded research and development period of our collaboration
and license agreement with GSK terminated in all of the cancer
fields covered by the agreement. GSK extended the funded
research and development period for an additional 2 years
through August 2004 for the research and development programs
for tuberculosis and chlamydia vaccines. Under |
23
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the terms of the extension, GSK was required to fund one-half of
the actual cost of the tuberculosis program and the cost of the
chlamydia program for a 2-year period. |
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In January 2003, we and GSK entered into new agreements to
further advance the development of multiple solid tumor
vaccines. Following expiration of the funded research period for
the cancer fields under the original agreement, one of the new
agreements extends our and GSKs collaborative efforts into
vaccine development and potential proof-of-principle clinical
trials. Under the terms of this new agreement, GSK granted us a
worldwide, exclusive license to develop a vaccine candidate for
prostate cancer and a vaccine candidate for breast cancer. As a
part of this agreement, GSK retains the option to buy-back
exclusive worldwide rights for either or both vaccine candidates
following the completion of proof-of-principle clinical trials.
If GSK exercises its buy-back rights, we have the option of
participating in further development, up to and including a
sharing of promotion rights in the United States. The buy-back
price will be based on our research costs incurred under this
new agreement, plus a premium of 25% and up to an additional
$3.0 million depending on the stage of development at the
time GSK exercises its buy-back option. In the event GSK does
not exercise its buy-back option, we will be free to develop the
vaccines alone or with other partners and have agreed to pay GSK
success- based milestones and royalties in the event of product
sales. Under these new agreements, we are responsible for
providing resources and development funding of up to
$32 million to complete proof-of-principle clinical studies
over a period of time in excess of 5 years. At
December 31, 2004, we had provided approximately
$10.6 million resource and development funding. This
funding will be used to pay for GMP grade material, production
and clinical trials for prostate and breast cancer vaccine
development efforts. |
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GSK has the right to terminate any of these agreements in the
event of our material default of such agreement, or our
bankruptcy or insolvency. If we materially breach our original
agreement with GSK, GSK may as an alternative to terminating the
agreement, continue its licenses with a reduction in the amounts
owed to us as potential milestones and royalties. Under our
original agreement, GSK also has the right for any reason with
6 months prior notice to terminate its licenses in the
breast, prostate and colon fields and for the HER-2/neu and
mammaglobin antigens, although this termination right does not
apply to the breast cancer vaccine candidate and prostate cancer
vaccine candidate that GSK has licensed to us under one of the
new agreements. Also under the original agreement, GSK has the
right for any reason with 6 months prior notice to
terminate its licenses in the tuberculosis and chlamydia fields
after August 2004. In addition, under our original agreement, if
an acquisition of us results in a material breach of that
agreement, GSK would have the right to terminate that agreement
and we and any of our employees that remain employees of us or
our acquiror would be precluded from working in any of the
disease fields covered by our original agreement with GSK for
2 years after such termination. |
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If we materially breach our new agreement for the development of
a breast cancer vaccine candidate and prostate cancer vaccine
candidate because of our failure to perform the development
program, the rights to those vaccine candidates will revert to
GSK and we will also be deemed to be in material breach of our
new agreement under which we acquired from GSK the ovarian
cancer rights and diagnostic and T cell product rights related
to our cancer antigens that were included in our original
agreement. If GSK terminates our new agreement that covers
ovarian cancer, diagnostics and T cell products because of our
material breach, then all of the rights under that agreement
will revert to GSK with the exception of any rights we may have
granted to any third parties before the termination, and we will
be required to pay GSK twice the amount of revenue we received
from those third parties as would have been paid to GSK had the
agreement not been terminated for our material breach. |
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Prior to December 31, 2004, we had a collaboration
agreement with GSK for the development and commercialization of
BEXXAR therapeutic regimen, which was approved in June, 2003 by
the FDA for the treatment of patients with CD20 positive,
follicular, NHL, with and without transformation, whose disease
is refractory to Rituximab and has relapsed following
chemotherapy. Under the terms of the agreement, both companies
contributed to the commercialization efforts of |
24
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BEXXAR therapeutic regimen in the United States and shared
profits and losses from GSKs sales of BEXXAR therapeutic
regimen equally. We recognized the costs we incurred associated
with BEXXAR therapeutic regimen related activities such as the
cost of co-promotion revenue and sales and promotion costs in
our statement of operations. We and GSK then prepared a
quarterly calculation of the joint profit or loss which
considered all revenue and costs associated with BEXXAR
therapeutic regimen commercial activities incurred by us and GSK
and the equal sharing of the joint profit or loss. The result of
this sharing calculation was either a reimbursement from GSK to
Corixa or a payment from Corixa to GSK and was recorded in our
statement of operations as co-promotion revenue. Prior to
commercialization, we recorded our share of the net
reimbursement or payment from the joint profit or loss
calculation in sales, general and administrative expenses. For
the year ended December 31, 2004, we recorded
$2.2 million of co-promotion revenue which is recorded in
discontinued operations. |
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Under the terms of the agreement, GSK agreed to reimburse us for
certain clinical and manufacturing development costs and pay us
for the achievement of certain defined clinical development,
regulatory and sales milestones. In 2004, we recognized revenue
of $4.3 million for the reimbursement of clinical and other
development costs from GSK which is recorded in discontinued
operations. |
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On December 31, 2004, we transferred to GSK all worldwide
rights and responsibilities related to the manufacturing,
development and commercialization of the BEXXAR therapeutic
regimen. According to the agreement we will continue to receive
development and sales milestones and royalties based on sales of
BEXXAR therapeutic regimen in the United States, Canada and
Australasia. We and GSK will continue to equally share royalties
on Zevalin sales according to the terms of the previous patent
litigation settlement with Biogen Idec. We have recorded our
BEXXAR therapeutic regimen activities as a discontinued
operation in our statement of operations as discussed in
Note 11 of Notes to Consolidated Financial Statements. |
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GSK: Manufacture and Supply Agreement. We entered into a
manufacturing and supply agreement with GSK in July 2004
covering the production of our MPL adjuvant, which is a
component in GSKs future vaccines currently undergoing
clinical trials, vaccines awaiting regulatory approval and
Fendrix, which has received regulatory approval in the European
Union. |
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The agreement, which runs through 2012, guarantees payment to us
for supplying GSK with increasing annual quantities of MPL
peaking in 2008 at the current maximum output of our Hamilton,
Montana, MPL manufacturing facility (approximately 2
kilograms/year). Under the terms of the agreement, we agreed to
expand cGMP compliant MPL production capacity in association
with anticipated approvals of GSK vaccines that contain MPL
adjuvant. |
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We received a multi-million dollar up-front licensing fee and
will grant GSK a co-exclusive license to manufacture MPL
adjuvant at amounts over and above our maximum annual output.
The manufacturing agreement can be renewed at GSKs option
for multiple, three-year periods beyond 2012. Other elements of
the agreement include: increased base pricing and annual price
increases for MPL adjuvant; and payment of royalties to Corixa
by GSK on all GSK vaccines containing MPL adjuvant until
10 years after market introduction of GSKs HPV
vaccine. |
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In connection with the MPL manufacturing and supply agreement,
we amended the terms of an existing $5 million outstanding
loan from GSK whereby they agreed that we may elect to repay
this loan in either cash or 1,099,000 shares of our common
stock. |
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Amounts receivable from GSK at December 31, 2004 and 2003
were $8.2 and $4.1 million, respectively. For the
years ended December 31, 2004, 2003 and 2002,
approximately 23%, 19% and 42% of our revenue resulted from
collaborative agreements with GSK. |
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Genentech. In December 2004, we entered into a license
agreement with Genentech, under which we granted Genentech an
exclusive worldwide license to a novel target for the possible
development of humanized antibody-based therapeutics. Under the
terms of the agreement, we received a |
25
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$1.6 million one-time nonrefundable license fee, and may
receive up to an additional $8.25 million of future
success-based payments upon completion of certain regulatory and
commercial milestones in addition to royalty payments on product
sales. Genentech is responsible for development and
commercialization costs of any potential therapeutic based on
our antibody target. |
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Amersham Health. In October 2001, we entered into an
agreement whereby Amersham Health, a subsidiary of Amersham plc
agreed to market BEXXAR therapeutic regimen in Europe. Under the
terms of a stock purchase agreement with Amersham Health, we
sold $15 million of shares of our common stock to Amersham
Health. Upon execution of the agreement Amersham Health
purchased 271,343 shares of our common stock for
approximately $5 million at a price of $18.43 per
share, which represented a forty percent premium of
approximately $1.4 million to the then current market value
of our common stock. The premium was accounted for as a
nonrefundable up-front license payment and was deferred and
recognized as revenue ratably over the development term of the
agreement. Following our partial option exercises in October
2001 and December 2002, on May 14, 2003, we completed the
exercise of our option to sell up to $15 million of shares
of our common stock to Amersham Health when we sold
721,814 shares of our common stock to Amersham Health at a
price per share of $6.927 for a total purchase price of
approximately $5 million. On December 10, 2004, we and
Amersham Health terminated the development, commercialization
and license agreement. In connection with the termination,
Amersham paid us a $3 million termination fee in accordance
with the terms of the agreement which is recorded in
discontinued operations. |
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Wyeth. We have license and supply agreements with Wyeth,
granting Wyeth licenses to certain adjuvants for use in vaccines
for certain infectious and autoimmune disease fields that Wyeth
is developing. These agreements grant Wyeth exclusive,
co-exclusive and nonexclusive license rights depending on the
disease field. Under the terms of the agreements, Wyeth pays
annual license fees, milestones, transfer payments and future
royalty payments. We recognized revenue related to our
agreements with Wyeth of $1.8 million, $2.5 million
and $2.0 million in 2004, 2003 and 2002, respectively. |
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Zambon Group and JT. During May and June 1999, we entered
into corporate partnerships with Zambon and JT, respectively,
for the research, development and commercialization of vaccine
products aimed at preventing and treating lung cancer. Zambon
has exclusive rights to develop and sell vaccine products in
Europe, the countries of the former Soviet Union, Argentina,
Brazil and Columbia and co-exclusive rights in China. Under the
June 1999 agreement we granted JT exclusive rights to develop
and sell vaccine products outside of the territory licensed to
Zambon, including the United States and Japan, and co-exclusive
rights to develop and sell vaccine products in China. We also
granted Zambon a nonexclusive license and JT an option to
formulate vaccines that may result from the collaboration using
our microsphere delivery system with our proprietary adjuvants.
During 2002, the 3-year research terms of the agreements expired
and the respective research funding obligations ceased. In
November 2002, we and Zambon amended our agreement so that we
jointly fund clinical testing of a non-small cell lung cancer
vaccine. In December 2002, we recorded a milestone payment of
$1.0 million from Zambon in connection with the filing of
our IND for a lung cancer vaccine candidate in the United
States. In January 2003, we amended and restated our agreement
with JT so that we hold exclusive rights to all antigens
discovered in our lung cancer vaccine program, in all countries
previously licensed to JT, with the exception of rights
associated with commercialization of a non-small cell, lung
carcinoma vaccine candidate in Japan. Under the terms of our
amended agreement with JT, JT will continue to hold an exclusive
license to this vaccine candidate for development and
commercialization in Japan, and we will hold all rights in North
America and in those territories not previously licensed to
Zambon. In connection with the restructuring of the JT
agreement, we and JT have agreed to pay each other fees,
milestones and royalties in the event that development
milestones and product sales are achieved. We recognized revenue
of $831,000, $993,000 and $6.9 million in connection with
our agreements in 2004, 2003 and 2002, respectively. |
26
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Kirin. In December 2002, we entered into a multiyear
development and commercialization agreement with Kirin for
potential cancer vaccine for the treatment of multiple forms of
cancer, including leukemia, myelodysplasia and melanoma. Under
the agreement we granted Kirin exclusive rights to develop and
market vaccine products resulting from our WT-1 vaccine
candidate in Asia/ Australasia. We and Kirin have agreed to
share WT-1 vaccine commercialization rights and Kirin has agreed
to fund one-half of the research and development costs in North
America. We will retain marketing rights for the potential
vaccine in Europe. Upon entering into the agreement, Kirin paid
us $3 million in up-front license fees, which is being
recognized as revenue over the estimated research and
development term. Under the terms of the agreement, Kirin has
agreed to co-fund development of WT-1 vaccine candidate and pay
us success-based milestone payments and royalties on future
product sales in Asia/ Australasia. In connection with this
agreement, we recognized revenue of $2.8 million in 2004
and $2.3 million in 2003. |
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Kirin has the right to terminate our agreement in the event of
our material breach. Kirin may also choose not to terminate the
agreement for our material breach, no matter when the breach
occurs, but instead may keep its licenses intact rather than
pursue any other rights and remedies, in which case all of
Kirins payment obligations to us will be reduced. Kirin
has the right to terminate our agreement at any time in North
America, Asia or both territories, and in any of these cases
Kirin must pay us a termination fee. Both we and Kirin have the
right to terminate the agreement before commercial launch of the
first product if together we determine there are no products
worthy of further development or if any product causes
irreversible or development limiting toxicity. However, if Kirin
chooses to terminate the agreement due to toxicity, we have the
right to continue product development ourselves and depending on
further development Kirin may be obligated to pay us a
termination fee. If we choose to terminate the agreement due to
toxicity, Kirin will have the right to continue product
development and pay us royalties in the event of product sales.
Kirin also has the right to terminate our agreement in the event
product development and commercialization is prevented due to
certain third party intellectual property positions. Kirin also
has the right to terminate our agreement if no product has
successfully completed clinical trials by 10 years after
the effective date, if no product has achieved regulatory
approval in the United States or Japan by 12 years after
the effective date, if our performance is delayed by at least
18 months as a result of force majeure or if we terminate
or breach a third party license under which Kirin is a
sublicensee and if, as a result, Kirin is sued or Kirins
rights under our agreement are materially diminished. In
addition, Kirin also has the right to terminate the agreement in
the event of our bankruptcy or insolvency. |
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Medicis. In August 2000, we entered into a multiyear
development, commercialization and license agreement covering
our psoriasis immunotherapeutic product,
PVACtm
treatment, with Medicis Pharmaceutical Corporation, or Medicis.
Under the agreement we provide Medicis exclusive rights to PVAC
treatment in the United States and Canada. Medicis made a
nonrefundable payment of $17 million upon effectiveness of
the agreement. In December 2003 we announced that we had
discontinued development of PVAC treatment due to phase II
trial results that confirmed PVAC therapy failed to provide a
statistically significant benefit versus placebo. We also
terminated our license agreement with Medicis. In connection
with the termination of the license agreement, Medicis has no
additional funding obligations. As a result of discontinuing
development of PVAC treatment, we recognized $5 million of
revenue and $2.5 million of expense that was previously
deferred and was related to the initial Medicis payment received
in 2000. |
As of December 31, 2004, our accumulated deficit was
approximately $1.3 billion, of which $679.4 million is
attributable to the write-off of acquired IPR&D costs
associated with our acquisitions, $221.2 million is
attributable to goodwill related charges and $21.1 million
is attributable to lease-related impairment charges. We may
incur substantial additional operating losses over the next
several years. Such losses have been and may continue to be
principally the result of various costs associated with our
discovery, research and development programs and the purchase of
technology. As noted above, the funded research phase of certain
of our collaborative agreements has expired and we may bear a
larger portion of
27
the related research program costs in the future. Additionally,
as research programs progress from early stages into clinical
development the costs continue to increase. Substantially all of
our revenue to date has resulted from corporate partnerships,
other research, development and licensing arrangements, research
grants and product sales. Our ability to achieve a consistent,
profitable level of operations depends in large part on entering
into corporate partnerships for product discovery, research,
development and commercialization, obtaining regulatory
approvals for our products and successfully manufacturing and
marketing our products once they are approved. Even if we are
successful in the aforementioned activities our operations may
not be profitable. In addition, payments under corporate
partnerships and licensing arrangements are subject to
significant fluctuations in both timing and amount. Therefore,
our operating results for any period may fluctuate significantly
and may not be comparable to the operating results for any other
period.
Results of Operations
We have reclassified amounts related to BEXXAR therapeutic
regimen operations from approval (in June 2003) through
December 31, 2004 to discontinued operations.
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Years Ended December 31, 2004, 2003 and 2002 |
Revenue
Our revenue was $25.0 million for 2004, $35.3 million
in 2003 and $48.7 million in 2002. The 2004 decrease in
revenue compared with 2003 is primarily due to decreased revenue
from our collaborative agreement with Medicis of
$7.9 million due to discontinuing development of PVAC in
December 2003, decreased revenue received from our collaborative
agreement for the development and commercialization of BEXXAR
therapeutic regimen with GSK of $2.9 million prior to
approval of BEXXAR therapeutic regimen, decreased revenue
received from our vaccine development agreements with GSK of
$1.8 million and decreased revenue of $1.3 million
from Zenyaku Kogyo Co., Ltd. related to our PVAC agreement.
These decreases were partially offset by revenue received from
our license agreement with Genentech of $1.6 million,
increased product sales of $1.4 million and increased
revenue from our government grants and contracts of
$1.1 million.
The 2003 decrease in revenue compared with 2002 is primarily due
to the anticipated expiration of the funded research phases of
certain of our collaborative agreements, including decreases of
$6.9 million related to our vaccine development agreement
with GSK, $4.0 million related to our lung cancer vaccine
partnership with JT, $1.9 million related to our lung
cancer vaccine partnership with Zambon and $1.4 million
related to our therapeutic antibody agreement with Purdue Pharma
L.P., or Purdue Pharma. In addition, reimbursement revenue from
our collaborative agreement for BEXXAR therapeutic regimen with
GSK decreased $4.1 million and revenue from our
collaborative agreement with Beaufour Ipsen related to our
proprietary ANERGIX vaccine platform decreased approximately
$1.7 million. These decreases were partially offset by
increases resulting from revenue which had previously been
deferred from our collaboration with Medicis of
$4.7 million as a result of discontinuing development of
PVAC in December 2003 and increased revenue of $2.3 million
related to our WT-1 cancer vaccine agreement with Kirin.
Product sales consist primarily of sales of adjuvants
manufactured in our Montana facility.
Revenue under government grants and contracts was
$3.5 million in 2004, $2.4 million in 2003 and
$2.6 million in 2002.
We expect revenue to fluctuate in the future depending on our
ability to enter into new collaboration agreements, timing and
amounts of payments under our existing collaboration agreements
and our ability to commercialize our potential products.
28
Expenses
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Research and Development Expenses |
Our research and development expenses were $62.3 million
for 2004, $84.1 million in 2003 and $94.0 million in
2002. The 2004 decrease in expense compared with 2003 is due
primarily to reduced early stage research and development
expense of $12.9 million due to our focus in 2004 on
programs that we believe have the highest chance of near-term
commercial success, a reduction in license fees payable to
Genesis Research and Development Corporation, Ltd. of
$4.7 million due to discontinuing development of PVAC in
December 2003, a reduction in South San Francisco
facilities expense of $2.0 million due to buildings that we
subleased in 2003 and reduced cost of production of BEXXAR
therapeutic regimen for clinical development activities prior to
approval of $2.2 million.
The 2003 decrease in expense as compared with 2002 was due
primarily to reduced early stage research and development
expense of $8.0 million as we focused on programs with the
highest chance of near-term commercial success, a reduction in
deferred compensation expense of $1.2 million related to
options assumed in the Coulter acquisition and a reduction in
South San Francisco facilities expense of $2.7 million
due to buildings that we subleased in 2003. These decreases were
partially offset by an increase of $2.3 million resulting
from fees paid to Genesis Research and Development Corporation,
Ltd., or Genesis, that were previously deferred and amortized
over the estimated development period prior to discontinuing
development of PVAC in December 2003 and $1.7 million
resulting from manufacturing development activities associated
with our adjuvants and TLR4 product candidates.
Our research and development activities can be divided into
research and preclinical programs and clinical development
programs to treat cancer and infectious disease. We estimate the
costs associated with research and preclinical programs and
clinical development programs approximate the following (in
millions):
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2004 | |
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2003 | |
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2002 | |
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| |
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Research and preclinical programs
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$ |
42.1 |
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$ |
35.8 |
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$ |
42.3 |
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Clinical development programs
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20.2 |
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48.3 |
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51.7 |
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Total research and development
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$ |
62.3 |
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$ |
84.1 |
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$ |
94.0 |
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Because of the large number of research projects we have ongoing
at any one time, and the ability to utilize resources across
several projects, our research and development costs are not
directly tied to any individual project and are allocated among
multiple projects. We manage our projects by reviewing
scientific data and by supplementing this data with our cost
allocations. Our cost allocations are based primarily on human
resource time incurred on each project. The costs allocated to a
project as a result do not necessarily reflect the actual costs
of the project. Accordingly, we do not maintain actual cost
incurred information for our projects on a project-by-project
basis. Costs attributed to research and preclinical projects
largely represent our pipeline generating activities. Costs
associated with clinical development programs represent the
advancement of these activities into product candidates.
Most of our product development programs are at an early stage
and may not result in any approved products. Product candidates
that may appear promising at early stages of development may not
reach the market for a number of reasons. Product candidates may
be found ineffective or cause harmful side effects during
clinical trials, may take longer to pass through clinical trials
than had been anticipated, may fail to receive necessary
regulatory approvals and may prove impracticable to manufacture
in commercial quantities at reasonable cost and with acceptable
quality. Furthermore, as part of our business strategy, we may
enter into collaborative arrangements with third parties to
complete the development and commercialization of our product
candidates and it is uncertain which of our product candidates
would be subject to future collaborative arrangements. The
participation of a collaborative partner may accelerate the time
to completion and reduce the cost to us of a product candidate
or it may delay the time and increase the cost to us due to the
alteration of our existing strategy. The risks and uncertainties
associated with our research and development projects are
discussed more fully in the section of this report titled
29
Important Factors That May Affect Our Businesses, Our
Results of Operations and Our Stock Price. Because of
these risks and uncertainties, we cannot predict when or whether
we will successfully complete the development of our product
candidates or the ultimate product development cost.
We recorded deferred compensation of $29.2 million
associated with the Coulter acquisition in 2000, which
represents the intrinsic value of the unearned options of
Coulter employees existing at the date of acquisition. Deferred
compensation was fully amortized during 2004. We amortized
$15,000, $188,000 and $1.3 million of deferred compensation
to research and development expense in 2004, 2003 and 2002,
respectively.
We expect research and development costs to fluctuate as we
continue to develop a pipeline of potential products.
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Sales, General and Administrative Expenses |
Our sales, general and administrative expenses were
$10.3 million for 2004, $11.8 million in 2003 and
$19.0 million in 2002. The 2004 decrease in expense
compared with 2003 is primarily due costs associated with the
commercialization of BEXXAR therapeutic regimen prior to FDA
approval (in June 2003) of $3.4 million, partially offset
by increases in other administrative expenses.
The 2003 decrease in expense as compared with 2002 is primarily
due to workforce reductions in 2002 of $2.3 million, legal
fees related to our patent infringement litigation with Biogen
Idec prior to FDA approval of BEXXAR therapeutic regimen and
pre-commericalization costs related to BEXXAR therapeutic
regimen of $2.1 million.
We expect sales, general and administrative expenses to continue
to fluctuate in the future.
Our manufacturing costs were $3.2 million for 2004,
$1.4 million in 2003 and $2.0 million in 2002.
Manufacturing cost consists primarily of the costs of adjuvant
production in our Montana facility. The increase in 2004
manufacturing cost was primarily due to increased adjuvant
production compared with the prior year. We expect manufacturing
costs to increase in the future as production of MPL adjuvant
increases.
As a result of the transfer of BEXXAR therapeutic regiment to
GSK and discontinuation of oncology product development, we
recorded a restructuring charge in the fourth quarter of 2004, a
portion of which is included in discontinued operations, of
$3.8 million that consisted of employee severance and
benefits. As of December 31, 2004 we had paid $169,000 of
the total restructuring charge. The remaining severance and
benefits will be paid in 2005. We expect to record additional
charges in 2005 of up to $1.5 million related to these
workforce reductions as certain employees involved in the
transition of BEXXAR therapeutic regimen to GSK complete their
transition activities. We expect to incur additional non-cash
charges as we enter into potential sublease arrangements in the
future.
In 2003 and 2002 we incurred restructuring charges of
$2.5 million and $3.4 million, respectively in
connection with workforce reductions.
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Impairment of Lease Related Assets and Goodwill |
In December 2004, in connection with GSKs acquisition of
our rights to BEXXAR therapeutic regimen and our plans to close
our remaining South San Francisco facilities, we reviewed
the remaining lease related assets for potential impairment. We
determined that the undiscounted cash flows related to a
potential sublease would be less than the carrying value of the
recorded lease intangible and leasehold improvements. Because
the carrying value exceeded the fair value, we recorded an
impairment loss of $2.6 million.
30
In 2003 we subleased approximately 117,000 square feet of
our leased facilities in South San Francisco. Upon entering
into the sublease agreements an estimate of the undiscounted
future cash flows attributable to the subleases was performed
and was determined to be less than the carrying amount of the
intangible asset acquired lease, related leasehold improvements
and furniture and fixtures. Because the carrying value exceeded
the fair value, we recognized an impairment charge of
$18.5 million related to these assets.
On March 12, 2002, we received a second complete review
letter from the FDA regarding our BLA for BEXXAR therapeutic
regimen. In the complete review letter, the FDA stated that
additional clinical studies would be required to provide
sufficient evidence of the safety and net clinical benefit of
BEXXAR therapeutic regimen. Upon announcement of the complete
review letter from the FDA, the value of our common stock
declined. In managements opinion, this decline in our
stock price represented an indication of impairment of recorded
goodwill. In accordance with SFAS 142, an interim test of
goodwill impairment was performed as of March 13, 2002. The
impairment test involves a two step approach. Under step one of
the test we compared our estimated fair value based upon the
market price of our common stock to the carrying value of our
equity. Because the carrying value of our equity exceeded our
fair value, we performed step-two of the test which involved
allocating our fair value (the reporting unit) to all of our
assets and liabilities to determine how much, if any, of the
excess value should be allocated to goodwill. The results of the
impairment test indicated that the entire balance of goodwill
was impaired and accordingly we recognized a $161.1 million
goodwill impairment charge in the first quarter of 2002.
Interest Income
Our interest income decreased to $2.9 million for 2004,
from $3.4 million in 2003 and from $4.3 million in
2002. The 2004 decrease in interest income as compared with 2003
is due primarily to lower cash and investment balances in 2004.
Interest Expense
Our interest expense was $6.8 million in 2004 as compared
with $4.4 million in 2003 and $2.3 million in 2002.
The 2004 increase in interest expense as compared with 2003 is
due primarily to higher debt balances as a result of our
convertible subordinated note financing completed in June of
2003.
Other Income, Net
Our other income was $9.8 million for 2004 compared with
$2.5 million in 2003 and $21.5 million in 2002. The
2004 increase in other income as compared to 2003 is due
primarily to a $20 million up-front patent litigation
settlement payment from Biogen Idec to us net of the portion of
the settlement payable to other parties including a
$9.9 million payment by us to GSK for their portion of the
settlement. The settlement provided for Biogen Idec to pay us
and GSK a $20 million up-front settlement payment, as well
as a one-time milestone payment based on future Zevalin sales
performance, and royalty payments on Zevalin sales from
January 1, 2004, until such time as all BEXXAR therapeutic
regimen patents expire. Other income in 2003 includes a
$2.5 million gain from additional consideration received
from our 2002 asset sale to Medarex. Other income in 2002
includes $22.0 million from the sale of specific
preclinical assets and other equipment to Medarex.
Loss from Discontinued operations
Our loss from discontinued operations was $27.0 million for
2004 and $2.7 million for 2003. We have recorded our BEXXAR
therapeutic regimen activities as a discontinued operation in
our statement of operations. Discontinued operations include
BEXXAR therapeutic regimen co-promotion revenue, clinical
reimbursement revenue, clinical development and regulatory
milestone revenue and the cost of all commercial activities with
separately identified cash flows from the date of approval (in
June 2003) through the date of disposition that will no longer
be present in the ongoing entity subsequent to the
31
disposal. We have also recorded the loss on the transfer of raw
material inventory and certain equipment transferred to GSK in
discontinued operations.
Liquidity and Capital Resources
We have financed our operations primarily through funding from
collaborative agreements and the issuance of equity and debt
instruments. For the previous 3 years, we have received
cash of approximately $140.4 million from collaborative
research agreements and grants, approximately $96.3 million
from the sale of convertible subordinated notes, approximately
$71.2 million from the sale of 11 million newly issued
shares of our common stock and 1.9 million five-year
warrants to purchase common stock in private placements to
select institutional and other accredited investors,
$21 million from the sale of preclinical assets to Medarex,
$22.8 million from bank loans, approximately
$10 million from the issuance of common stock under a
collaborative agreement with Amersham Health and
$5.1 million from the issuance of common stock under our
equity line facility with BNY Capital Markets, Inc., or CMI.
During 2004, 2003 and 2002 we received total research and
development funding of $10.0 million under our vaccine
discovery collaboration with GSK.
As of December 31, 2004, we had approximately
$116.2 million in cash, cash equivalents and securities
available-for-sale of which $23.2 million are restricted as
to their use. As of December 31, 2004, future funding
available under terms of our existing agreements is
approximately $144.0 million excluding milestone payments,
which are contingent upon the success of the research.
The following are contractual commitments at December 31,
2004 associated with debt obligations, lease obligations and
credit lines (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period | |
|
|
| |
Contractual Commitment |
|
Total | |
|
1 Year | |
|
2-3 Years | |
|
4-5 Years | |
|
Thereafter | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Long-term obligations
|
|
$ |
127,799 |
|
|
$ |
8,694 |
|
|
$ |
3,089 |
|
|
$ |
101,466 |
|
|
$ |
14,550 |
|
Operating leases
|
|
|
108,685 |
|
|
|
10,690 |
|
|
|
18,439 |
|
|
|
19,421 |
|
|
|
60,135 |
|
Interest on long term obligations
|
|
|
18,064 |
|
|
|
5,840 |
|
|
|
9,387 |
|
|
|
2,468 |
|
|
|
369 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual commitments
|
|
$ |
254,548 |
|
|
$ |
25,224 |
|
|
$ |
30,915 |
|
|
$ |
123,355 |
|
|
$ |
75,054 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We are responsible for providing resources and development
funding of up to $32 million over a period in excess of
5 years related to a collaborative agreement with GSK. At
December 31, 2004, we have provided approximately
$10.6 million of the total $32 million of resource and
development funding. The funding consists of our personnel and
external costs associated with preclinical and clinical
development activities.
We are also required to pay dividends on our preferred stock.
The dividend can be paid in cash or common stock, at our option.
The maximum amount of cash that would be paid in a year would be
$2.5 million and the maximum number of shares of common
stock that would be issued is 146,828.
In June 2003, we sold $100 million of
4.25% convertible subordinated notes due in 2008 to a
qualified institutional buyer pursuant to Rule 144A under
the Securities Act of 1933, as amended. The notes are
convertible into our common stock at a conversion price of
$9.175 subject to adjustment in certain circumstances. We pay
interest on the notes on January 1 and July 1 of each
year, beginning on January 1, 2004. The notes mature on
July 1, 2008.
In March 2004, NDC New Markets Investments IV, L.P., or NDC, of
which Wells Fargo Community Development Corporation is a limited
partner, pursuant to a promissory note and credit agreement,
provided a loan of approximately $14.6 million to us to
support our construction costs at the Ninth and Stewart Life
Sciences Building in Seattle. The term of the loan is
7 years. We pay interest only during the term of the loan,
with a balloon principal payment due on March 1, 2011. The
note bears interest at LIBOR plus 0.8%. NDC will forgive up to
$3.3 million of the loan beginning in 2008 if we are in
compliance with the terms and conditions of the note and the
credit agreement. Pursuant to a security
32
agreement between us and NDC, the loan and the debt service
reserve from NDC is fully secured by securities available for
sale.
During 2004, we used $59.1 million of cash in our
operations, compared with $52.5 million in 2003 and
$45.0 million in 2002. The increase in cash used in
operations in 2004 as compared to 2003 is due primarily to the
cost associated with the commercialization of BEXXAR therapeutic
regimen which is recorded as a discontinued operation. Our
investing activities provided cash of $30.3 million in
2004, compared with cash used of $92.9 million in 2003 and
cash provided of $9.5 million in 2002. The increase in cash
provided by investing activities in 2004 was primarily due to
reduced purchases of available-for-sale-securities partially
offset by purchases of property and equipment associated with
our Seattle facility. Our financing activities provided cash of
$10.5 million in 2004 as compared to $134.9 million in
2003 and $49.5 million in 2002. The decrease in 2004 of
cash received from financing activities was due primarily to the
net proceeds of approximately $96.3 million from our sale
of 4.25% convertible subordinated notes received in 2003
and net proceeds of $28.4,million from the sale of common stock
in a private placement offering.
For 2004, 2003 and 2002, we invested $26.4 million,
$6.7 million and $6.3 million, respectively, in
property and equipment.
We believe that our existing capital resources, together with
committed payments under our existing corporate partnerships,
bank credit agreements, equipment financing and interest income
will be sufficient to fund our current and planned operations
over at least the next 18 months. However, we intend to
seek additional corporate partnerships, and also may seek
additional funding through:
|
|
|
|
|
public or private equity financings, which could result in
significant dilution to our stockholders; |
|
|
|
public or private debt financings; and |
|
|
|
additional capital lease transactions. |
However, additional financing may be unavailable on acceptable
terms, if at all. If sufficient capital is not available, we may
be forced to limit some or all of our research and development
programs and related operations, curtail commercialization of
our product candidates and, ultimately, cease operations.
Our future capital requirements will depend on many factors,
including, among others:
|
|
|
|
|
continued scientific progress in our discovery, research and
product development programs; |
|
|
|
progress with preclinical studies and clinical trials; |
|
|
|
the magnitude and scope of our discovery, research and
development programs; |
|
|
|
our ability to maintain existing, and establish additional,
corporate partnerships and licensing arrangements; |
|
|
|
the time and costs involved in obtaining regulatory approvals; |
|
|
|
the time and costs involved in expanding and maintaining our
manufacturing facilities; |
|
|
|
the costs involved in preparing, filing, prosecuting,
maintaining, defending and enforcing patent claims; |
|
|
|
the potential need to develop, acquire or license new
technologies and products; and |
|
|
|
other factors not within our control. |
New Accounting Pronouncements
On December 16, 2004, the FASB issued FAS 123R,
Share-Based Payment An Amendment of FASB
Statements No. 123 and 95, which is effective for
public companies in periods beginning after June 15, 2005.
We will be required to implement the proposed standard no later
than the quarter that begins July 1, 2005. The cumulative
effect of adoption, if any, applied on a modified prospective
basis,
33
would be measured and recognized on July 1, 2005.
FAS 123R addresses the accounting for transactions in which
an enterprise receives employee services in exchange for
(a) equity instruments of the enterprise or
(b) liabilities that are based on the fair value of the
enterprises equity instruments or that may be settled by
the issuance of such equity instruments. FAS 123R would
eliminate the ability to account for share-based compensation
transactions using APB 25, and generally would require
instead that such transactions be accounted for using a
fair-value based method. Companies will be required to recognize
an expense for compensation cost related to share-based payment
arrangements including stock options and employee stock purchase
plans. We are currently evaluating option valuation
methodologies and assumptions of FAS 123R related to
employee stock options. Current estimates of option values using
the Black-Scholes method may not be indicative of results from
valuation methodologies ultimately adopted in the final rules.
In September 2004, the FASB issued FSP 03-1-1 delaying the
effective date for applying paragraphs 10-20 of
EITF 03-1 The Meaning of Other-than-Temporary
Impairment and its Application to Certain Investments.
Paragraphs 10-20 provide guidance for evaluating whether
impairments of debt and equity holdings are
other-than-temporary and require immediate
recognition in earnings. The effective date for applying the
accounting guidance of EITF 03-1 is currently under review
by the FASB. The disclosure requirements of EITF 03-1
remain unchanged and were effective for fiscal periods ending
after December 15, 2003. We have included the required
disclosures within this report.
|
|
Item 7A. |
Quantitative and Qualitative Disclosure About Market
Risk |
Interest Rate Risk
Our exposure to market risk for changes in interest rates
relates primarily to our investment portfolio and our long-term
debt. All of our cash equivalent and marketable fixed income
securities are designated as available-for-sale and,
accordingly, are presented at fair value on our balance sheets.
We generally invest our excess cash in A-rated or higher short-
to intermediate-term fixed income securities and money market
mutual funds. Fixed rate securities may have their fair market
value adversely affected due to a rise in interest rates, and we
may suffer losses in principal if forced to sell securities that
have declined in market value due to changes in interest rates.
At December 31, 2004, we had long-term obligations
outstanding of approximately $119.1 million. Our payment
commitments associated with these debt instruments are comprised
of interest payments, principal payments, or a combination
thereof. The market value of our fixed rate debt will fluctuate
with movements of interest rates, increasing in periods of
declining rates of interest, and declining in periods of
increasing rates of interest. The carrying value of our variable
rate debt approximates fair value because the interest rate
changes as market rates change. The fair value of our
convertible debt is base on quoted prices.
The table below summarizes the estimated effects on the fair
value of securities available-for-sale and convertible notes and
fixed rate bank loans based on hypothetical increases and
decreases in interest rates. It is assumed the changes occur
immediately and uniformly to each category of instrument
containing interest rate risks. Significant variations in market
interest rates could produce changes in the timing of
34
repayments due to available prepayment options. The fair value
of such instruments could be affected and, therefore, actual
results might differ from those reflected in the following table:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated | |
|
Fair Value | |
|
Hypothetical | |
|
|
|
|
Hypothetical | |
|
After | |
|
Percentage | |
|
|
|
|
Change in | |
|
Hypothetical | |
|
Change in | |
|
|
|
|
Interest Rate | |
|
Change in | |
|
Stockholders | |
|
|
Fair Value at | |
|
(bp = basis points) | |
|
Interest Rate | |
|
Equity | |
|
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands) | |
December 31, 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Securities available-for-sale
|
|
$ |
97,629 |
|
|
|
100 bp decrease |
|
|
$ |
99,162 |
|
|
|
6.7 |
% |
|
|
|
|
|
|
|
100 bp increase |
|
|
|
96,131 |
|
|
|
(6.5 |
)% |
|
|
|
|
|
|
|
200 bp increase |
|
|
|
94,675 |
|
|
|
(12.9 |
)% |
|
|
|
|
|
|
|
300 bp increase |
|
|
|
93,261 |
|
|
|
(19.1 |
)% |
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fixed rate debt
|
|
$ |
88,309 |
|
|
|
100 bp decrease |
|
|
$ |
91,515 |
|
|
|
(14.0 |
)% |
|
|
|
|
|
|
|
100 bp increase |
|
|
|
85,267 |
|
|
|
13.3 |
% |
|
|
|
|
|
|
|
200 bp increase |
|
|
|
82,379 |
|
|
|
26.0 |
% |
|
|
|
|
|
|
|
300 bp increase |
|
|
|
79,635 |
|
|
|
38.0 |
% |
December 31, 2003
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Securities available-for-sale
|
|
$ |
155,095 |
|
|
|
100 bp decrease |
|
|
$ |
157,917 |
|
|
|
3.5 |
% |
|
|
|
|
|
|
|
100 bp increase |
|
|
|
152,354 |
|
|
|
(3.4 |
)% |
|
|
|
|
|
|
|
200 bp increase |
|
|
|
149,691 |
|
|
|
(6.7 |
)% |
|
|
|
|
|
|
|
300 bp increase |
|
|
|
147,117 |
|
|
|
(9.9 |
)% |
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fixed rate debt
|
|
$ |
104,290 |
|
|
|
100 bp decrease |
|
|
$ |
108,094 |
|
|
|
(16.7 |
)% |
|
|
|
|
|
|
|
100 bp increase |
|
|
|
100,681 |
|
|
|
15.8 |
% |
|
|
|
|
|
|
|
200 bp increase |
|
|
|
97,254 |
|
|
|
30.8 |
% |
|
|
|
|
|
|
|
300 bp increase |
|
|
|
94,000 |
|
|
|
45.0 |
% |
Important Factors That May Affect Our Businesses, Our Results
of Operations and Our Stock Price.
|
|
|
We are changing the focus and scale of our manufacturing
efforts and may encounter problems or delays that could result
in lost revenue. |
In connection with our agreement with GSK regarding the supply
of MPL adjuvant that we announced on July 26, 2004, or the
MPL Supply Agreement, we have determined to dedicate our
Hamilton, Montana manufacturing facility to the manufacturing of
MPL, including upgrading the facility and increasing output. If
we are unsuccessful in increasing output, we may not be able to
supply GSK the full guaranteed minimum amounts of MPL adjuvant
in later years, which may result in transfer of manufacturing to
GSK and related decrease in royalties payable to us by GSK on
GSKs vaccines that include our MPL adjuvant.
Our manufacturing facilities must continually adhere to cGMP
regulations enforced by the FDA through its facilities
inspection program. If our existing or expanded facilities
cannot pass a pre-approval plant inspection, FDA approval
or regulatory approval outside of the United States of our
partners vaccine candidates may be delayed or denied. The
consequent lack of supply of MPL adjuvant could delay our
partners clinical programs, limit sales of commercial
products that contain MPL adjuvant or result in the breach
or termination of our agreements to supply MPL adjuvant to third
parties.
35
Dedicating the facility to production of MPL adjuvant will also
require us to out-source all other cGMP manufacturing to third
party contract manufacturing organizations. We intend to rely on
third-party contract manufacturers to produce cGMP grade RC-529
adjuvant and TLR4 agonists and antagonists for clinical trials
and product commercialization. Either we or our contract
manufacturers may be unable to manufacture these products at a
cost or in quantities necessary to make them commercially
viable. Third-party manufacturers also may be unable to meet our
needs with respect to timing, quantity or quality. If we are
unable to contract for a sufficient supply of required products
on acceptable terms, or if we encounter delays or difficulties
in our relationships with these manufacturers, our preclinical
and clinical testing would be delayed, thereby delaying
submission of products for regulatory approval, or the market
introduction and commercial sale of the products. Moreover,
contract manufacturers that we may use must continually adhere
to cGMP regulations enforced by the FDA through its facilities
inspection program. If the facilities of those manufacturers
cannot pass a pre-approval plant inspection, the regulatory
approval of our product candidates may be delayed or denied.
|
|
|
We expect to incur future operating losses and may never
achieve profitability. |
We have experienced significant operating losses in each year
since our inception on September 8, 1994. As of
December 31, 2004, our accumulated deficit was
approximately $1.3 billion, of which $679.4 million is
attributable to the write-off of in-process research and
development costs associated with our acquisitions,
$221.2 million is attributable to goodwill-related charges
and $21.1 million is attributable to lease-related
impairment charges. We may incur substantial additional
operating losses over at least the next several years. Such
losses have been and may continue to be principally the result
of various costs associated with our discovery, research,
development and manufacturing programs and the purchase of
technology. Additionally, as research programs progress from
early stages into clinical development the costs continue to
increase. Substantially all of our revenue to date has resulted
from corporate partnerships, other research, development and
licensing arrangements and research grants. Our ability to
achieve a consistent, profitable level of operations depends in
large part on the manufacture and supply of our
MPL adjuvant to GSK, entering into corporate partnerships
for product discovery, research, development and
commercialization, obtaining regulatory approvals for other
product candidates and successfully manufacturing, marketing and
selling our products once they are approved. Even if we are
successful in the aforementioned activities, our operations may
not be profitable. In addition, payments under corporate
partnerships and licensing arrangements are subject to
significant fluctuations in both timing and amounts, resulting
in quarters of profitability and quarters of losses. We may
never achieve profitability, and our ability to achieve a
consistent, profitable level of operations depends in large part
on our ability to successfully:
|
|
|
|
|
manufacture and supply our proprietary adjuvants to our
commercial partners; |
|
|
|
enter into corporate partnerships for product discovery,
research, development and commercialization; and |
|
|
|
obtain regulatory approvals for our product candidates. |
Even if we are successful in the above activities, our
operations may not be profitable.
|
|
|
We will need additional capital, and our ability to
implement our existing financing plans and secure additional
funding is uncertain. |
We may be unable to raise on acceptable terms, if at all,
additional capital resources necessary to conduct our
operations. If we are unable to raise additional capital as will
be required, we will be forced to limit some or all of our
research and development programs and related operations or
curtail commercialization of our product candidates. Our future
capital requirements will depend on many factors, including:
|
|
|
|
|
the time and costs involved in expanding our MPL adjuvant
manufacturing capabilities; |
|
|
|
continued scientific progress in our discovery, research and
product development programs; |
36
|
|
|
|
|
progress with preclinical studies and clinical trials; |
|
|
|
the ability of our partners to commercialize products containing
technology we developed, including BEXXAR therapeutic regimen
and vaccines containing our MPL and RC-529 adjuvants; |
|
|
|
the magnitude and scope of our discovery, research and product
development programs; |
|
|
|
our ability to maintain existing, and establish additional,
corporate partnerships and licensing arrangements; |
|
|
|
the time and costs involved in obtaining regulatory approvals; |
|
|
|
the costs involved in preparing, filing, prosecuting,
maintaining, defending and enforcing patent claims, and the cost
of any judgment that may be enforced against us for legal fees
or other costs of other parties to such claims; |
|
|
|
the potential need to develop, acquire or license new
technologies and products; and |
|
|
|
other factors beyond our control. |
We believe that our existing capital resources, together with
committed payments under adjuvant supply contracts and existing
corporate partnerships, bank credit arrangements, equipment
financing and interest income, will be sufficient to fund our
current and planned operations over at least the next
18 months. However, we intend to seek additional funding
through corporate partnerships, and also may seek additional
funding through:
|
|
|
|
|
public or private equity financings; |
|
|
|
public or private debt financings; and |
|
|
|
capital lease transactions. |
Additional financing may be unavailable on acceptable terms, if
at all. If we are unable to raise any additional capital as may
be required, we may be forced to limit some or all of our
research and development programs and related operations or
curtail commercialization of our products and product candidates.
|
|
|
Many of our product candidates are at an early stage of
product development and we may not be able to successfully
commercialize our product candidates. |
In December 2004, we transferred BEXXAR therapeutic regimen and
substantially all of our assets related to BEXXAR therapeutic
regimen to GSK in exchange for contingent royalty and milestone
payments. BEXXAR therapeutic regimen was our primary approved
product and after this sale, we are at an early stage in the
development of the majority of our remaining product candidates.
Three of our partners vaccine products that contain our
adjuvants have been approved for sale: Berna Biotechs
prophylactic vaccine for the prevention of Hepatitis
B infection contains our synthetic RC-529 adjuvant and
has been approved for sale in Argentina, ATLs allergy
vaccine contains our MPL adjuvant and has been approved for
sale on a named patient basis only in Germany, Spain, Italy and
the United Kingdom, and GSKs Fendrix prophylactic vaccine
designed to prevent infection from Hepatitis B in high-risk
groups such as pre-haemodialysis and haemodialysis patients
contains our MPL adjuvant and has been approved for sale in
the European Union. Other than these products, we have no
existing approved products, and we may be unable to
commercialize any additional products.
Development of therapeutic and prophylactic immunology-based
products is subject to risks of failure inherent in their
development or commercial viability. Also, physicians, patients
or the medical community generally may not accept or utilize any
products that may be developed by our corporate partners or us.
These risks include the possibility that any such products may:
|
|
|
|
|
be found unsafe or cause harmful side effects during clinical
trials; |
|
|
|
be found to be ineffective; |
37
|
|
|
|
|
take longer to progress through clinical trials than had been
anticipated; |
|
|
|
fail to receive necessary regulatory approvals; |
|
|
|
be difficult or impossible to manufacture in commercial
quantities at reasonable cost and with acceptable quality; |
|
|
|
be uneconomical to market; |
|
|
|
fail to be developed prior to the successful marketing of
similar products by competitors; |
|
|
|
be impossible to market because they infringe on the proprietary
rights of third parties or compete with products marketed by
third parties that are superior; |
|
|
|
not be as effective as alternative treatment methods; |
|
|
|
not qualify for reimbursement from government and third-party
payors; and |
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fail to achieve market acceptance. |
Any products successfully developed by us or our corporate
partners, if approved for marketing, may never achieve market
acceptance. Such products will compete with products
manufactured and marketed by other major pharmaceutical and
other biotechnology companies. If we do not successfully develop
and market our products, either alone or with our corporate
partners, we will not generate revenue and our business will
suffer.
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If we are unable to protect our trade secrets, we may be
unable to protect our interests in proprietary know-how that is
not patentable or for which we have elected not to seek patent
protection. |
Our success depends in part on our ability to protect trade
secrets that are not patentable or for which we have elected not
to seek patent protection. To protect our trade secrets, we rely
primarily on confidentiality agreements with employees and third
parties, and protective contractual provisions such as those
contained in license agreements and research agreements.
Nevertheless, other parties may develop similar or alternative
technologies or duplicate our technologies that are not
protected by patents, or otherwise obtain and use information
that we regard as proprietary. Other parties may breach
confidentiality agreements and other protective contracts we
have entered into, and we may not become aware of, or have
adequate remedies in the event of, any breach. Any material leak
of confidential data into the public domain or to third parties
could harm our competitive position.
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If we are unable to obtain, protect and enforce our patent
rights, we may be unable to effectively protect or exploit our
proprietary technology, inventions and improvements. |
Our success depends in part on our ability to obtain, protect
and enforce commercially valuable patents. We try to protect our
proprietary positions by filing United States and foreign patent
applications related to our proprietary technology, inventions
and improvements that are important to developing our business.
However, if we fail to obtain and maintain patent protection for
our proprietary technology, inventions and improvements, our
competitors could develop and commercialize products that would
otherwise infringe our patents.
Our patent position is generally uncertain and involves complex
legal and factual questions. Legal standards relating to the
validity and scope of claims in the biotechnology and
biopharmaceutical fields are still evolving. Accordingly, the
degree of future protection for our patent rights is uncertain.
The risks and uncertainties that we face with respect to our
patents include the following:
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the pending patent applications we have filed or to which we
have exclusive rights may not result in issued patents or may
take longer than we expect to result in issued patents; |
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the claims of any patents that issue may not provide meaningful
protection; |
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we may be unable to develop additional proprietary technologies
that are patentable; |
38
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the patents licensed or issued to us may not provide a
competitive advantage; |
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other parties may challenge patents licensed or issued to us; |
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disputes may arise regarding the invention and corresponding
ownership rights in inventions and know-how resulting from the
joint creation or use of intellectual property by us, our
licensors, corporate partners and other scientific
collaborators; and |
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other parties may design around our patented technologies. |
We have licensed several patent applications from SRI related to
our microsphere encapsulation technology. One of these patent
applications is currently the subject of opposition proceedings
before the European Patent Office. The European Patent Office
has revoked the previously issued European patent. Although SRI
has appealed this decision, it is uncertain whether SRI will
prevail in this opposition proceeding. As a result, this patent
may not issue in Europe.
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If we are unable to complete patient enrollment for our
clinical trials on a timely basis, the development and
commercialization of our product candidates will be delayed and,
as a result, our business may be harmed. |
If we are unable to enroll patients in our clinical trials in
sufficient numbers and on a timely basis, completion of these
trials and approval of our product candidates will be delayed.
The timing and completion of current and planned clinical trials
of our product candidates depend on, among other factors, the
rate at which patients are enrolled, which is a function of many
factors, including:
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the size of the patient population; |
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the design of the trial; |
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the proximity of patients to the clinical sites; |
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the number of clinical sites; |
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the eligibility criteria for the study; |
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the availability of investigational agents; |
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the existence of competing clinical trials; and |
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the existence of alternative available products. |
Delays in patient enrollment can result in increased costs and
longer development times. In addition, subjects may drop out of
our clinical trials, and thereby impair the validity or
statistical significance of the trials.
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Our sale of BEXXAR therapeutic regimen and related assets
and the subsequent restructuring of our business may prove
unsuccessful. |
As a result of our sale of BEXXAR therapeutic regimen and
related assets, we have shifted the focus of our business toward
the manufacture and supply of our adjuvant products and toward
research and product development of TLR4 agonists and
antagonists. As a part of the related restructuring, we intend
to eliminate other oncology related product development over the
course of the next several months. After further discussions
with our current partners in our oncology programs, we intend to
transfer our cancer vaccine and antibody target portfolios to
either existing or new partners. If our current partners are not
willing to acquire our interest in these programs or agree to
the transfer of our interest to third parties, then our efforts
to divest our oncology business may be delayed or prevented,
resulting in efforts by our employees on de-prioritized programs
and unbudgeted expenses. In addition, any of our oncology
partners may take the position that our eliminating product
development under the agreement with that partner was a breach
of the agreement, resulting in potential unbudgeted expenses
related to resolving such a dispute. We will not have the
opportunity to capture any future commercial success of BEXXAR
therapeutic
39
regimen and our oncology programs, except to the extent of any
remaining royalty and milestone payments. Our remaining programs
on which we are focusing our resources may not result in any
viable product candidates. We cannot be certain that we have
chosen to focus on the best programs for near-term commercial
success. In addition, we many not realize all of the expected
cost savings associated with the transfer of BEXXAR and the
related restructuring.
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Our restructuring may place additional strain on our
resources and may harm the morale and performance of our
personnel. |
Our restructuring in connection with our sale of BEXXAR
therapeutic regimen and related assets resulted in an
approximate 43% immediate reduction in our workforce, or the
elimination of approximately 160 positions. Following the
workforce reduction, we had approximately 220 employees at
facilities in Seattle, Washington and Hamilton, Montana. Our
restructuring plan may yield unanticipated consequences such as
attrition beyond our planned reduction in workforce. This
workforce reduction could place significant strain on our
administrative, operational and financial resources and result
in increased responsibilities for certain personnel. As a
result, our ability to respond to unexpected challenges may be
impaired and we may be unable to take advantage of new
opportunities. In addition, many of the terminated employees
possess specific knowledge or expertise, and that knowledge or
expertise may prove to have been important to our operations. In
that case, their absence may create significant difficulties. In
addition, this headcount reduction may subject us to the risk of
litigation, which could result in substantial costs to us and
could divert managements time and attention away from
business operations.
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We have a significant amount of debt, which could
adversely affect our financial condition. |
We have outstanding $100 million aggregate principal amount
of convertible notes bearing interest at 4.25% and due in 2008
and as of December 31, 2004, we had outstanding loans to
BNP Paribas, GE Capital and NDC totaling $22.8 million,
which constitute a significant amount of debt and debt service
obligations. If we are unable to generate sufficient cash flow
or otherwise obtain funds necessary to make required payments on
such debt, including from cash and cash equivalents on hand, we
will be in default under the terms of the loan agreements, or
indentures, which could, in turn, cause defaults under our other
existing and future debt obligations. This debt also could have
a negative effect on our earnings per share, depending on the
rate of interest we earn on cash balances.
Even if we are able to meet our debt service obligations, the
amount of debt we have could adversely affect us in a number of
ways, including by:
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limiting our ability to obtain any necessary financing in the
future for working capital, capital expenditures, debt service
requirements, or other purposes; |
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limiting our flexibility in planning for, or reacting to,
changes in our business; |
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placing us at a competitive disadvantage relative to our
competitors who have lower levels of debt; |
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making us more vulnerable to a downturn in our business or the
economy generally; or |
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requiring us to use a substantial portion of our cash to pay
principal and interest on our debt, instead of contributing
those funds to other purposes such as working capital and
capital expenditures. |
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If we are unable to compete effectively in the highly
competitive biotechnology and biopharmaceutical industries, our
business will fail. |
The biotechnology and biopharmaceutical industries are intensely
competitive, and we may be unable to compete effectively in
these industries. Many companies and institutions compete with
us in developing,
40
acquiring or in-licensing alternative therapies to treat or
prevent infectious and inflammatory diseases and cancer,
including:
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pharmaceutical companies; |
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biotechnology companies; |
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academic institutions; and |
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research organizations. |
Moreover, technology controlled by third parties that may be
advantageous to our business may be acquired or licensed by our
competitors, thereby preventing us from obtaining technology on
commercially reasonable terms, if at all.
Many of the companies developing competing technologies and
products have significantly greater financial resources and
expertise in research and development, manufacturing,
preclinical and clinical development, obtaining regulatory
approvals and marketing than we do. Other smaller companies may
also prove to be significant competitors, particularly through
collaborative arrangements with large and established companies.
Academic institutions, government agencies and other public and
private research organizations may also conduct research, seek
patent protection and establish collaborative arrangements for
research and development, manufacturing, and preclinical and
clinical development, and obtain regulatory approval of and
market products similar to ours. These companies and
institutions compete with us in recruiting and retaining
qualified scientific and management personnel, as well as in
acquiring and developing technologies complementary to our
programs. We will face competition with respect to:
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product efficacy and safety; |
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timing and scope of regulatory approvals; |
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availability of resources; |
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reimbursement coverage; |
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product price; and |
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patent position. |
Competitors may develop more effective or more affordable
products, or may achieve earlier patent protection or product
commercialization, than we do. These competitive products may
achieve a greater market share or render our products obsolete.
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Because we have limited sale and distribution
capabilities, we may be unable to successfully commercialize our
product candidates. |
As a result of our sale of BEXXAR therapeutic regimen and
related assets to GSK and a subsequent reduction in headcount,
we no longer have sales or marketing personnel, we have
distribution personnel only for our adjuvants, and do not plan
to have sales, marketing or further distribution capabilities in
the near future. As a result, we intend to rely on our corporate
partners to commercialize products that incorporate our
adjuvants and will likely rely on corporate partners to
commercialize certain of our potential TLR4 agonist and
antagonist products. Our corporate partners may not have
effective sales forces and distribution systems. If we are
unable to maintain or establish relationships and are required
to market any of our products directly, we will need to build a
sales and marketing force with technical expertise and with
supporting distribution capabilities. We may be unable to
maintain or establish relationships with third parties or build
in-house sales and distribution capabilities. Moreover, in light
of our recent reduction in headcount, we may have difficulty
rebuilding our own sales and marketing team if we decide again
to pursue sale and marketing in-house.
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Our product candidates are subject to a government
regulatory approval process that is uncertain, time-consuming
and expensive and may not result in any approved
products. |
Any products that we develop are subject to regulation by
federal, state and local governmental authorities in the United
States, including the FDA, and by similar agencies in other
countries. Any product that we develop must receive all relevant
regulatory approvals or clearances before it may be marketed in
a particular country.
The approval process, which includes extensive preclinical
studies and clinical trials of each product candidate in order
to study its safety and efficacy, is uncertain, can take many
years and requires the expenditure of substantial resources.
Clinical trials of our product candidates may not demonstrate
safety and efficacy to the extent necessary to obtain regulatory
approvals for the indications being studied, if at all.
Companies in the pharmaceutical and biotechnology industries
have suffered significant setbacks in advanced clinical trials,
even after obtaining promising results in earlier trials. The
failure to demonstrate adequately the safety and efficacy of any
of our product candidates could delay or prevent regulatory
approval of the product candidate.
Data obtained from preclinical and clinical activities are
susceptible to varying interpretations, which could delay, limit
or prevent regulatory approval. In addition, we may encounter
delays, or the FDA may reject our product candidates, based on
changes in regulatory policy during the period of product
development, extension of the period of review of any
application for regulatory approval or other factors beyond our
control. Delays in obtaining regulatory approvals could:
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adversely affect the marketing of any products we develop; |
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impose significant additional costs on us; |
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diminish any competitive advantages that we may attain; and |
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adversely affect our ability to receive royalties and generate
revenue and profits. |
We may not be successful in obtaining regulatory approval for
any of our product candidates, or in commercializing any product
candidates for which approval has been or is in the future
obtained.
Regulatory approval, if granted, may entail limitations on the
indicated uses for which the approved product may be marketed.
These limitations could reduce the size of the potential market
for the product. Product approvals, once granted, may be
withdrawn if problems occur after initial marketing. Further,
manufacturers of approved products are subject to ongoing
regulation, including compliance with FDA regulations governing
cGMP. Failure to comply with manufacturing regulations, or other
FDA regulations, can result in, among other things, warning
letters, fines, injunctions, civil penalties, recall or seizure
of products, total or partial suspension of production, refusal
of the government to renew marketing applications and criminal
prosecution.
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Any claims relating to our improper handling, storage or
disposal of hazardous materials could be time-consuming and
costly. |
Our research and development involves the controlled use of
hazardous and radioactive materials and biological waste. We are
subject to federal, state and local laws and regulations
governing the use, manufacture, storage, handling and disposal
of these materials and waste products. Although we believe that
our safety procedures for handling and disposing of these
materials comply with legally prescribed standards, we cannot
completely eliminate the risk of accidental contamination or
injury from these materials. In the event of an accident, we
could be held liable for damages or penalized with fines, and
this liability could exceed our resources. We may have to incur
significant costs to comply with future environmental laws and
regulations.
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We may be required to perform additional clinical trials
or change the labeling of our products if we or others identify
side effects after our products are on the market, which could
harm sales of the affected products. |
If we or others identify side effects after any of our products
are on the market, or if manufacturing problems occur:
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regulatory approval may be withdrawn; |
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reformulation of our products, additional clinical trials,
changes in labeling of our products or changes to or
re-approvals of our manufacturing facilities may be required; |
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sales of the affected products may drop significantly; |
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our reputation in the marketplace may suffer; |
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lawsuits, including class action suits, may be brought against
us; and |
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breach or termination of our agreements to supply product
candidates to third parties may result. |
Any of the above occurrences could harm or prevent sales of the
affected products or could increase the costs and expenses of
commercializing and marketing these products.
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Because we have limited sources of revenue, our results of
operations are uncertain and may fluctuate significantly, which
could cause the market price of our common stock to
decrease. |
To date, almost all of our revenue has resulted from payments
made under agreements with our corporate partners, and we expect
that most of our revenue will result from our adjuvant supply
contracts and corporate partnerships unless and until we are
able to obtain approval for and successfully commercialize our
TLR4 agonist or antagonist candidates. Payments under corporate
partnerships and licensing arrangements are subject to
significant fluctuations in both timing and amount. We may not
receive anticipated revenue under existing corporate
partnerships, and we may be unable to enter into any additional
corporate partnerships.
Since our inception, we have generated only limited revenue from
diagnostic product sales and prophylactic and therapeutic
product sales. We cannot predict when, if ever, our or our
partners research and development programs will result in
any additional commercially available immunotherapy-based
products. We do not know when, if ever, we will receive any
significant revenue from commercial sales of our or our
partners approved products, including from GSKs
sales of BEXXAR therapeutic regimen, or any other of our or our
partners product candidates that may be approved for sale
in the future.
As a result of our limited sources of revenue, our operating
results have varied significantly from quarter to quarter and
year to year in the past and we expect them to continue to
fluctuate. Because of these fluctuations, we believe that
period-to-period comparisons of our operating results are not
meaningful. In addition, our operating results for a particular
quarter or year may fall below the expectations of securities
analysts and investors, which could result in a decrease in our
stock price.
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Our financings and other transactions may result in
dilution and a decline in the price of our common stock. |
Under a terminated collaborative agreement with GSK, we borrowed
$15 million from GSK which we repaid with
3,482,433 shares of our common stock that we are obligated
to register for resale on Form S-3. Under a different
collaborative agreement with GSK, we have an outstanding loan
from GSK in the principal amount of $5 million. In
connection with the MPL Supply Agreement with GSK that we
announced on July 26, 2004, GSK agreed that we may elect to
repay this loan in either cash or 1,099,000 shares of our
common stock. The price of the stock was calculated as the
average per share closing price of our common stock on The
Nasdaq National Market as reported in the Wall Street Journal
for the 30-day trading period immediately preceding but not
including the effective date of the MPL Supply Agreement.
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We have outstanding $100 million aggregate principal amount
of convertible notes due in 2008. The holders of these notes
have the option of converting the principal and unpaid interest
on the notes, at any time prior to the maturity date, into
common stock at a fixed conversion rate of $9.175 per
share. If the notes were converted in full,
10,899,180 shares of our common stock would be issued to
the noteholders; this issuance would have a dilutive effect on
the ownership percentage of our existing stockholders.
In August 2002, as part of a private placement of approximately
7.3 million shares of our common stock, we also issued
warrants to purchase approximately 1.2 million shares of
our common stock at an exercise price of $6.13 per share to
selected institutional and other accredited investors. In
addition, in June 2003, as part of a private placement of
approximately 3.7 million shares of our common stock, we
issued warrants to purchase approximately 670,000 shares of
our common stock at an exercise price of $8.044 per share
to institutional investors. If these warrants are exercised, the
issuance of shares of common stock will have a dilutive effect
on the ownership percentage of our existing stockholders.
We are also required to pay dividends on our outstanding
preferred stock. The dividend can be paid in cash or common
stock, at our option. The maximum amount of cash that would be
paid in a year would be $2.5 million and the maximum number
of shares of common stock that would be issued is 146,828.
The issuance of additional stock as dividends on our preferred
stock or pursuant to other transactions, will have a dilutive
effect on the ownership percentage of our existing stockholders.
From time to time, we expect to enter into new partnerships,
acquisitions and other strategic transactions in which we may
agree to issue additional shares of common stock.
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If our corporate partnerships are unsuccessful or if we
are unable to establish corporate partnerships in the future,
our revenue growth and product development may be
limited. |
The success of our business strategy depends in significant part
on our ability to enter into corporate partnerships and to
manage effectively the relationships that may result from this
strategy. For the years ended December 31, 2004, 2003 and
2002, approximately 68%, 85%, 89% of our revenue resulted from
collaboration agreements, respectively. If our corporate
partnerships are unsuccessful or if we are unable to establish
additional corporate partnerships involving our vaccine
adjuvants, our TLR4 agonists and antagonists, then we may be
prevented from commercializing or recognizing meaningful revenue
from our or our partners products or product candidates.
Our material corporate partnerships include the following:
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we have a material corporate partnership with GSK that includes
a guaranteed MPL supply agreement with GSK under which we have a
collaborative effort to scale-up and increase the efficiency of
our MPL adjuvant production process and an obligation to supply
minimum quantities of our MPL adjuvant to GSK through 2012, and
several related license and supply agreements with GSK, which
grant GSK licenses to MPL adjuvant; and |
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in addition, we have adjuvant license and supply partnerships
with ATL, Biomira, Wyeth and Aventis. |
Further, our oncology business divestiture may result in
multiple transactions involving obligations of our licensees to
develop and commercialize oncology products based on technology
and product candidates previously developed by us, such as our
licenses with Genentech and Gen-Probe.
Management of our relationships with our corporate partners may
require:
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significant time and effort from our management team; |
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effective allocation of our resources to multiple projects; |
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coordination of our research with the research priorities of our
corporate partners; and |
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an ability to attract and retain key management, scientific and
other personnel. |
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Our corporate partners may terminate our current partnerships.
Most of our license agreements may be terminated by our partners
for our material breach or insolvency, or after a specified
termination date.
The process of establishing new corporate partnerships is
difficult and time-consuming. Our discussions with potential
partners may not lead to the establishment of new corporate
partnerships on favorable terms, if at all. If we successfully
establish new corporate partnerships, such partnerships may
never result in the successful development of our product
candidates or the generation of significant revenue.
Because we generally enter into research and development
collaborations with corporate partners at an early stage of
product development, our success largely depends on the
performance of our corporate partners. We do not directly
control the amount or timing of resources devoted by our
corporate partners to collaborative activities. Our corporate
partners may not commit sufficient resources to our research and
development programs or the commercialization of our products
and product candidates. If any corporate partner fails to commit
sufficient resources, our preclinical or clinical development
related to the corporate partnership could be delayed or
terminated. Also, our current corporate partners or future
corporate partners, if any, may pursue existing or other
development-stage products or alternative technologies in
preference to those being developed in collaboration with us.
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If we are unable to gain access to patent and proprietary
rights of others, we may be unable to compete
effectively. |
Our success 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.
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If we are unable to protect our trade secrets, we may be
unable to protect our interests in proprietary know-how that is
not patentable or for which we have elected not to seek patent
protection. |
Our success depends in part on our ability to protect trade
secrets that are not patentable or for which we have elected not
to seek patent protection. To protect our trade secrets, we rely
primarily on confidentiality agreements with employees and third
parties, and protective contractual provisions such as those
contained in license agreements and research agreements.
Nevertheless, other parties may develop similar or alternative
technologies or duplicate our technologies that are not
protected by patents, or otherwise obtain and use information
that we regard as proprietary. Other parties may breach
confidentiality agreements and other protective contracts we
have entered into, and we may not become aware of, or have
adequate remedies in the event of, any breach. Any material leak
of confidential data into the public domain or to third parties
could harm our competitive position.
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If we are unable to protect our trademarks, we may be
unable to compete effectively. |
We try to protect our trademarks by applying for United States
and foreign registrations for marks that are important to
developing our business. However, the laws of some foreign
countries do not protect our proprietary rights to the same
extent as do the laws of the United States, and effective
trademark protection may not be available in other
jurisdictions. If we are unable to protect our trademarks, we
may be unable to establish brand awareness for our products,
which could limit our ability to compete effectively. Of our
trademarks, CORIXA and MPL are currently the subject of
opposition proceedings before the Office for the Harmonization
in the Internal Market, which handles initial prosecution and
opposition of European trademarks. We may not ultimately prevail
in these opposition proceedings. As a result, we may not receive
trademark protection for CORIXA and MPL in Europe.
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Litigation regarding intellectual property rights owned or
used by us may be costly and time-consuming. |
We may incur substantial expenses as a result of litigation,
interferences, opposition proceedings and other administrative
proceedings in which we are or may become involved and the
proceedings may divert the efforts of our technical and
management personnel. An adverse determination in proceedings of
this type could subject us to significant liabilities, allow our
competitors to market competitive products without obtaining a
license from us, or require us to seek licenses from third
parties that may not be available on commercially reasonable
terms, if at all. If we cannot obtain such licenses, we may be
restricted or prevented from developing and commercializing our
product candidates. As a result, an adverse determination could
have a materially adverse effect on our business, financial
condition and operating results.
The enforcement, defense and prosecution of intellectual
property rights, United States Patent and Trademark Office
interference proceedings and related legal and administrative
proceedings in the United States and elsewhere involve complex
legal and factual questions. As a result, these proceedings are
costly and time-consuming, and their outcome is uncertain.
Litigation may be necessary to:
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defend against third-party claims of infringement; |
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enforce our issued and licensed patents; |
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protect our trade secrets or know-how; or |
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determine the enforceability, scope and validity of the
proprietary rights of others. |
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Acceptance of BEXXAR therapeutic regimen in the
marketplace is uncertain and failure to achieve market
acceptance will limit our potential royalty revenue from sales
of BEXXAR therapeutic regimen by GSK. |
In connection with our sale of BEXXAR therapeutic regimen and
related assets to GSK, GSK agreed to pay royalty and milestone
payments to us based on its successful commercialization of
BEXXAR therapeutic regimen. BEXXAR therapeutic regimen requires
the establishment of patient referrals between the physician and
treatment center and involves significant coordination between
the prescribing physician, the treatment center and the
radiopharmacy. In addition, doctors that can potentially refer
NHL patients to treatment centers to receive BEXXAR may prefer
to treat such patients with conventional therapies, such as
chemotherapy and non-radiolabeled biologics. If GSK cannot
identify candidate patients and establish patient referrals to
treatment centers, BEXXAR therapeutic regimen may not be able to
gain market share and we may not realize substantial revenue
from royalty and milestone payments.
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If we do not successfully integrate potential future
acquisitions, we may incur unexpected costs and disruptions to
our business. |
We have completed several acquisitions of complementary
technologies, product candidates and businesses. In the future,
we may acquire additional complementary companies, products and
product candidates or technologies. Managing these acquisitions
has entailed and may in the future entail numerous operational
and financial risks and strains, including:
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exposure to unknown liabilities; |
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higher-than-expected acquisition and integration costs; |
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difficulty and cost in combining the operations and personnel of
acquired businesses with our operations and personnel; |
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disruption of our business and diversion of our
managements time and attention to integrating or
completing the development or commercialization of any acquired
technologies; |
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impairment of relationships with key customers of acquired
businesses due to changes in management and ownership; |
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inability to retain key employees of acquired
businesses; and |
|
|
|
increased amortization expenses if an acquisition results in
significant intangible assets or potential write-downs of
goodwill and other intangible assets due to impairment of the
assets. |
For example, in December 2000 we acquired Coulter, a publicly
held biotechnology company specializing in, among other things,
the development of therapeutic antibodies, including BEXXAR
therapeutic regimen. As a result of our acquisition of Coulter,
we acquired direct sales and marketing personnel in preparation
for the launch of BEXXAR therapeutic regimen. In an effort to
minimize expenses during the delay in the FDA review of BEXXAR
therapeutic regimen, we initiated expense reductions, including
a 15% reduction in total headcount in March 2001. The majority
of these reductions took place in the operations that we
acquired from Coulter. During the first quarter of 2002, we
experienced a decrease in the value of our common stock
subsequent to receiving the complete review letter from the FDA
regarding the BEXXAR therapeutic regimen BLA. As a result,
goodwill and other intangibles were re-evaluated and we
recognized a $161.1 million goodwill impairment charge. In
May 2002, we sold specific preclinical assets and equipment that
we acquired from Coulter to Medarex and, in connection with the
asset sale, initiated a further headcount reduction. In December
2004 we sold BEXXAR therapeutic regimen and related assets,
which constituted substantially all of the remaining assets we
acquired in the Coulter acquisition, to GSK in exchange for
certain royalty and milestone payments.
|
|
|
We depend heavily on the principal members of our
management and scientific staff, the loss of any of whom could
impair our ability to compete. |
The loss of the services of any of the principal members of our
management and scientific staff could significantly delay or
prevent the achievement of our scientific or business
objectives. Competition among biotechnology and
biopharmaceutical companies for qualified employees is intense,
and the ability to retain and attract qualified individuals is
critical to our success. We may be unable to attract and retain
these individuals currently or in the future on acceptable
terms, if at all. In addition, we do not maintain key
person life insurance on any of our officers, employees or
consultants.
We also have relationships with scientific collaborators at
academic and other institutions, some of whom conduct research
at our request or assist us in formulating our research,
development or clinical strategy. These scientific collaborators
are not our employees and may have commitments to, or consulting
or advisory contracts with, other entities that may limit their
availability to us. We have limited control over the activities
of these scientific collaborators and can generally expect these
individuals to devote only limited amounts of time to our
activities. Failure of any of these persons to devote sufficient
time and resources to our programs could harm our business. In
addition, these collaborators may have arrangements with other
companies to assist the companies in developing technologies
that may compete with our products.
|
|
|
Our stock price could be very volatile and shares of our
common stock may suffer a decline in value. |
The market prices for securities of biotechnology companies have
in the past been, and are likely to continue in the future to
be, very volatile. As a result of the fluctuations in the price
of our common stock you may be unable to sell your shares at or
above the price you paid for them. The market price of our
common stock may be subject to substantial volatility depending
on numerous factors, many of which are beyond our control,
including:
|
|
|
|
|
announcements regarding the results of discovery efforts and
preclinical and clinical activities by us or our competitors; |
|
|
|
progress or delay of our or our competitors regulatory
approvals; |
|
|
|
announcements regarding the acquisition of technologies or
companies by us or our competitors; |
|
|
|
changes in our existing corporate partnerships or licensing
arrangements; |
47
|
|
|
|
|
establishment of additional corporate partnerships or licensing
arrangements by us or our competitors; |
|
|
|
technological innovations or new commercial products developed
by us or our competitors; |
|
|
|
changes in our or our competitors intellectual property
portfolio; |
|
|
|
developments or disputes concerning our or our competitors
proprietary rights; |
|
|
|
issuance of new or changed securities analysts reports and
their recommendations regarding us or our competitors; |
|
|
|
changes in government regulations; |
|
|
|
economic and other external factors; |
|
|
|
additions or departures of any of our key personnel; |
|
|
|
operating losses by us; and |
|
|
|
actual or anticipated fluctuations in our quarterly financial
and operating results and degree of trading liquidity in our
common stock. |
Since the beginning of 2002 through March 9, 2005, our
common stock traded as high as $15.84 and as low as $3.26. The
last reported sales price of our common stock on March 9,
2005 was $3.88. If our stock price remains at current levels, we
may be unable to raise additional capital on acceptable terms.
Significant declines in the price of our common stock could also
impede our ability to attract and retain qualified employees and
reduce the liquidity of our common stock.
|
|
|
Product liability claims may damage our reputation and if
insurance proves inadequate, the product liability claims may
harm our financial position. |
Our business exposes us to the risk of product liability claims
inherent in manufacturing, testing and marketing therapies for
treating people with cancer and infectious diseases. A product
liability claim may damage our reputation by raising questions
about a products safety and efficacy and could limit our
ability to sell one or more products by preventing or
interfering with product commercialization. Although we have
product liability and clinical trial liability insurance that we
believe is commercially reasonable, this coverage may be
inadequate or may be unavailable in the future on acceptable
terms, if at all. In addition, defending a suit, regardless of
its merit, could be costly and could divert management attention.
|
|
|
State laws and our certificate of incorporation may
inhibit potential acquisition bids that could be beneficial to
our stockholders. |
Provisions of our amended and restated certificate of
incorporation and bylaws, as well as provisions of Delaware and
Washington law, will make it more difficult for a third party to
acquire us, even if doing so would be beneficial for our
stockholders. This could limit the price that certain investors
might be willing to pay in the future for our shares of common
stock. For example, certain provisions of our certificate of
incorporation or bylaws:
|
|
|
|
|
allow our board to issue preferred stock without any vote or
further action by the stockholders; |
|
|
|
eliminate the right of stockholders to act by written consent
without a meeting; |
|
|
|
eliminate cumulative voting in the election of directors; |
|
|
|
specify a supermajority requirement for stockholders to call a
special meeting; |
|
|
|
specify restrictive procedures for director nominations by
stockholders; and |
|
|
|
specify a supermajority requirement for stockholders to change
the number of directors. |
48
We are subject to certain provisions of Delaware and Washington
law, which could also delay or make more difficult a merger,
tender offer or proxy contest involving us. In particular,
Section 203 of the Delaware General Corporation Law
prohibits a Delaware corporation from engaging in certain
business combinations with an interested stockholder
for a period of 3 years unless specific conditions are met.
Similarly, Chapter 23B.19 of the Washington Business
Corporation Act prohibits corporations based in Washington from
engaging in certain business combinations with an
interested stockholder for a period of 5 years
unless specific conditions are met.
In addition, certain provisions of Delaware and Washington law
could have the effect of delaying, deferring or preventing a
change in control of us, including, without limitation,
discouraging a proxy contest or making more difficult the
acquisition of a substantial block of our common stock. The
provisions could also limit the price that investors might be
willing to pay in the future for shares of our common stock.
49
|
|
Item 8. |
Financial Statements and Supplementary Data |
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Stockholders
Corixa Corporation
We have audited the accompanying consolidated balance sheets of
Corixa Corporation as of December 31, 2004 and 2003, and
the related consolidated statements of operations,
stockholders equity, and cash flows for each of the three
years in the period ended December 31, 2004. These
financial statements are the responsibility of the
Companys management. Our responsibility is to express an
opinion on these financial statements based on our audits.
We conducted our audits in accordance with the 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 Corixa Corporation at December 31,
2004 and 2003, and the consolidated results of its operations
and its cash flows for each of the three years in the period
ended December 31, 2004, in conformity with
U.S. generally accepted accounting principles.
We also have audited, in accordance with the standards of the
Public Company Accounting Oversight Board (United States), the
effectiveness of Corixa Corporations internal control over
financial reporting as of December 31, 2004, based on
criteria established in Internal Control-Integrated Framework
issued by the Committee of Sponsoring Organizations of the
Treadway Commission and our report dated March 15, 2005
expressed an unqualified opinion thereon.
Seattle, Washington
March 15, 2005
50
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Stockholders
Corixa Corporation
We have audited managements assessment, included in the
accompanying Managements Report on Internal Control over
Financial Reporting, that Corixa Corporation maintained
effective internal control over financial reporting as of
December 31, 2004, based on criteria established in
Internal Control Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission
(the COSO criteria). Corixa Corporations management is
responsible for maintaining effective internal control over
financial reporting and for its assessment of the effectiveness
of internal control over financial reporting. Our responsibility
is to express an opinion on managements assessment and an
opinion on the effectiveness of the companys internal
control over financial reporting based on our audit.
We conducted our audit in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether effective internal control
over financial reporting was maintained in all material
respects. Our audit included obtaining an understanding of
internal control over financial reporting, evaluating
managements assessment, testing and evaluating the design
and operating effectiveness of internal control, and performing
such other procedures as we considered necessary in the
circumstances. We believe that our audit provides a reasonable
basis for our opinion.
A companys internal control over financial reporting is a
process designed to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with
generally accepted accounting principles. A companys
internal control over financial reporting includes those
policies and procedures that (1) pertain to the maintenance
of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the
company; (2) provide reasonable assurance that transactions
are recorded as necessary to permit preparation of financial
statements in accordance with generally accepted accounting
principles, and that receipts and expenditures of the company
are being made only in accordance with authorizations of
management and directors of the company; and (3) provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use, or disposition of the
companys assets that could have a material effect on the
financial statements.
Because of its inherent limitations, internal control over
financial reporting may not prevent or detect misstatements.
Also, projections of any evaluation of effectiveness to future
periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree
of compliance with the policies or procedures may deteriorate.
In our opinion, managements assessment that Corixa
Corporation maintained effective internal control over financial
reporting as of December 31, 2004, is fairly stated, in all
material respects, based on the COSO criteria. Also, in our
opinion, Corixa Corporation maintained, in all material
respects, effective internal control over financial reporting as
of December 31, 2004, based on the COSO criteria.
We also have audited, in accordance with the standards of the
Public Company Accounting Oversight Board (United States), the
consolidated balance sheets of Corixa Corporation as of
December 31, 2004 and 2003, and the related consolidated
statements of operations, stockholders equity, and cash
flows for each of the three years in the period ended
December 31, 2004 of Corixa Corporation and our report
dated March 15, 2005 expressed an unqualified opinion
thereon.
Seattle, Washington
March 15, 2005
51
CORIXA CORPORATION
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
|
(In thousands) | |
ASSETS |
Current assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
18,558 |
|
|
$ |
36,890 |
|
|
Securities available-for-sale
|
|
|
76,579 |
|
|
|
107,712 |
|
|
Accounts receivable
|
|
|
13,588 |
|
|
|
7,090 |
|
|
Interest receivable
|
|
|
524 |
|
|
|
1,204 |
|
|
Prepaid expenses and other current assets
|
|
|
4,670 |
|
|
|
8,111 |
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
113,919 |
|
|
|
161,007 |
|
Property and equipment, net
|
|
|
44,237 |
|
|
|
26,337 |
|
Securities available-for-sale, non-current
|
|
|
21,050 |
|
|
|
47,383 |
|
Acquisition-related intangible assets, net
|
|
|
769 |
|
|
|
3,199 |
|
Deferred charges, deposits and other assets
|
|
|
11,226 |
|
|
|
12,640 |
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$ |
191,201 |
|
|
$ |
250,566 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
Current liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
$ |
27,370 |
|
|
$ |
20,534 |
|
|
Dividend payable
|
|
|
201 |
|
|
|
333 |
|
|
Current portion of deferred revenue
|
|
|
4,781 |
|
|
|
7,700 |
|
|
Current portion of long-term obligations
|
|
|
8,689 |
|
|
|
25,657 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
41,041 |
|
|
|
54,224 |
|
Deferred revenue, less current portion
|
|
|
10,758 |
|
|
|
7,248 |
|
Long-term obligations, less current portion
|
|
|
119,110 |
|
|
|
108,138 |
|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
|
Convertible preferred stock, $0.001 par value:
|
|
|
|
|
|
|
|
|
|
|
Authorized 10,000,000
|
|
|
|
|
|
|
|
|
|
|
Designated Series A 12,500 shares; Issued
and outstanding 12,500
|
|
|
|
|
|
|
|
|
|
|
Designated Series B 37,500 shares; Issued
and outstanding 37,500
|
|
|
|
|
|
|
|
|
|
Common stock, $0.001 par value:
|
|
|
|
|
|
|
|
|
|
|
Authorized 100,000,000 shares; Issued and
outstanding 59,515,619 in 2004 and 55,403,506 in 2003
|
|
|
60 |
|
|
|
55 |
|
|
Additional paid-in capital
|
|
|
1,292,385 |
|
|
|
1,276,121 |
|
|
Deferred compensation
|
|
|
|
|
|
|
(404 |
) |
|
Accumulated other comprehensive loss
|
|
|
(1,186 |
) |
|
|
(256 |
) |
|
Accumulated deficit
|
|
|
(1,270,967 |
) |
|
|
(1,194,560 |
) |
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
20,292 |
|
|
|
80,956 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$ |
191,201 |
|
|
$ |
250,566 |
|
|
|
|
|
|
|
|
See accompanying notes
52
CORIXA CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands, except per share amounts) | |
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative agreements
|
|
$ |
16,927 |
|
|
$ |
29,911 |
|
|
$ |
43,587 |
|
|
Product sales
|
|
|
4,547 |
|
|
|
3,031 |
|
|
|
2,547 |
|
|
Government grants
|
|
|
3,482 |
|
|
|
2,403 |
|
|
|
2,604 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
|
24,956 |
|
|
|
35,345 |
|
|
|
48,738 |
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
62,322 |
|
|
|
84,054 |
|
|
|
94,039 |
|
|
Sales, general and administrative
|
|
|
10,254 |
|
|
|
11,762 |
|
|
|
19,043 |
|
|
Manufacturing
|
|
|
3,246 |
|
|
|
1,380 |
|
|
|
2,043 |
|
|
Restructuring
|
|
|
1,906 |
|
|
|
2,452 |
|
|
|
3,436 |
|
|
Impairment of lease-related assets
|
|
|
2,572 |
|
|
|
18,491 |
|
|
|
|
|
|
Goodwill impairment
|
|
|
|
|
|
|
|
|
|
|
161,060 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
80,300 |
|
|
|
118,139 |
|
|
|
279,621 |
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(55,344 |
) |
|
|
(82,794 |
) |
|
|
(230,883 |
) |
Interest income
|
|
|
2,875 |
|
|
|
3,414 |
|
|
|
4,287 |
|
Interest expense
|
|
|
(6,798 |
) |
|
|
(4,378 |
) |
|
|
(2,275 |
) |
Other income
|
|
|
9,849 |
|
|
|
2,518 |
|
|
|
21,472 |
|
|
|
|
|
|
|
|
|
|
|
Net loss from continuing operations
|
|
|
(49,418 |
) |
|
|
(81,240 |
) |
|
|
(207,399 |
) |
Net loss from discontinued operations
|
|
|
(26,989 |
) |
|
|
(2,679 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(76,407 |
) |
|
|
(83,919 |
) |
|
|
(207,399 |
) |
Preferred stock dividend
|
|
|
(595 |
) |
|
|
(948 |
) |
|
|
(767 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common stockholders
|
|
$ |
(77,002 |
) |
|
$ |
(84,867 |
) |
|
$ |
(208,166 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
From continuing operations
|
|
$ |
(0.87 |
) |
|
$ |
(1.53 |
) |
|
$ |
(4.65 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Discontinued operations
|
|
$ |
(0.48 |
) |
|
$ |
(0.05 |
) |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common stockholders
|
|
$ |
(1.36 |
) |
|
$ |
(1.60 |
) |
|
$ |
(4.67 |
) |
|
|
|
|
|
|
|
|
|
|
Shares used in computation of basic and diluted net loss per
common share
|
|
|
56,569 |
|
|
|
52,981 |
|
|
|
44,611 |
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes
53
CORIXA CORPORATION
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other | |
|
|
|
|
|
|
Preferred Stock |
|
Common Stock | |
|
Additional | |
|
|
|
Accumulated | |
|
|
|
Total | |
|
|
|
|
| |
|
Paid-In | |
|
Deferred | |
|
Comprehensive | |
|
Accumulated | |
|
Stockholders | |
|
|
Shares | |
|
Amount |
|
Shares | |
|
Amount | |
|
Capital | |
|
Compensation | |
|
Income (Loss) | |
|
Deficit | |
|
Equity | |
|
|
| |
|
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Balance at December 31, 2001
|
|
|
50 |
|
|
$ |
|
|
|
|
41,573 |
|
|
$ |
41 |
|
|
$ |
1,187,987 |
|
|
$ |
(3,996 |
) |
|
$ |
975 |
|
|
$ |
(903,242 |
) |
|
$ |
281,765 |
|
Preferred stock dividend
|
|
|
|
|
|
|
|
|
|
|
147 |
|
|
|
|
|
|
|
116 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
116 |
|
Stock options exercised
|
|
|
|
|
|
|
|
|
|
|
52 |
|
|
|
|
|
|
|
90 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
90 |
|
Issuance of common stock under the employee stock purchase plan
|
|
|
|
|
|
|
|
|
|
|
138 |
|
|
|
|
|
|
|
736 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
736 |
|
Issuance of common stock, net of offering costs of $2,622
|
|
|
|
|
|
|
|
|
|
|
8,298 |
|
|
|
9 |
|
|
|
50,038 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
50,047 |
|
Remeasurement and issuance of stock options in exchange for
consulting services
|
|
|
|
|
|
|
|
|
|
|
9 |
|
|
|
|
|
|
|
(112 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(112 |
) |
Reclassification of redeemable common stock to equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,000 |
|
Amortization of deferred compensation, net of $1,897 reversal
for terminated employees
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,897 |
) |
|
|
3,329 |
|
|
|
|
|
|
|
|
|
|
|
1,432 |
|
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized loss on securities available-for-sale
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(283 |
) |
|
|
|
|
|
|
(283 |
) |
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(207,399 |
) |
|
|
(207,399 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(207,682 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2002
|
|
|
50 |
|
|
|
|
|
|
|
50,217 |
|
|
|
50 |
|
|
|
1,238,958 |
|
|
|
(667 |
) |
|
|
692 |
|
|
|
(1,110,641 |
) |
|
|
128,392 |
|
Preferred stock dividend
|
|
|
|
|
|
|
|
|
|
|
147 |
|
|
|
|
|
|
|
19 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
19 |
|
Stock options exercised
|
|
|
|
|
|
|
|
|
|
|
115 |
|
|
|
|
|
|
|
359 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
359 |
|
Issuance of common stock under the employee stock purchase plan
|
|
|
|
|
|
|
|
|
|
|
159 |
|
|
|
|
|
|
|
840 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
840 |
|
Issuance of common stock
|
|
|
|
|
|
|
|
|
|
|
4,731 |
|
|
|
5 |
|
|
|
35,670 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
35,675 |
|
Remeasurement of stock options in exchange for consulting
services
|
|
|
|
|
|
|
|
|
|
|
34 |
|
|
|
|
|
|
|
355 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
355 |
|
Amortization of deferred compensation, net of $80 reversal for
terminated employees
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(80 |
) |
|
|
263 |
|
|
|
|
|
|
|
|
|
|
|
183 |
|
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized loss on securities available-for-sale
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(948 |
) |
|
|
|
|
|
|
(948 |
) |
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(83,919 |
) |
|
|
(83,919 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(84,867 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
50 |
|
|
|
|
|
|
|
55,403 |
|
|
|
55 |
|
|
|
1,276,121 |
|
|
|
(404 |
) |
|
|
(256 |
) |
|
|
(1,194,560 |
) |
|
|
80,956 |
|
Preferred stock dividend
|
|
|
|
|
|
|
|
|
|
|
147 |
|
|
|
|
|
|
|
132 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
132 |
|
Stock options exercised
|
|
|
|
|
|
|
|
|
|
|
296 |
|
|
|
|
|
|
|
775 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
775 |
|
Issuance of common stock under the employee stock purchase plan
|
|
|
|
|
|
|
|
|
|
|
187 |
|
|
|
|
|
|
|
736 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
736 |
|
Issuance of common stock
|
|
|
|
|
|
|
|
|
|
|
3,482 |
|
|
|
5 |
|
|
|
14,995 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,000 |
|
Remeasurement of stock options in exchange for consulting
services
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4 |
|
Amortization of deferred compensation, net of $393 reversal for
terminated employees and consultants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(378 |
) |
|
|
404 |
|
|
|
|
|
|
|
|
|
|
|
26 |
|
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized loss on securities available-for-sale
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(930 |
) |
|
|
|
|
|
|
(930 |
) |
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(76,407 |
) |
|
|
(76,407 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(77, 338 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
50 |
|
|
$ |
|
|
|
|
59,515 |
|
|
$ |
60 |
|
|
$ |
1,292,385 |
|
|
$ |
|
|
|
$ |
(1,186 |
) |
|
$ |
(1,270,967 |
) |
|
$ |
20,292 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes
54
CORIXA CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(76,407 |
) |
|
$ |
(83,919 |
) |
|
$ |
(207,399 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Impairment of lease-related assets
|
|
|
2,572 |
|
|
|
18,491 |
|
|
|
|
|
|
Goodwill impairment
|
|
|
|
|
|
|
|
|
|
|
161,060 |
|
|
Amortization of deferred compensation
|
|
|
26 |
|
|
|
183 |
|
|
|
1,432 |
|
|
Depreciation and amortization
|
|
|
8,372 |
|
|
|
10,119 |
|
|
|
12,606 |
|
|
Equity instruments remeasured and issued in exchange for
technology and services
|
|
|
4 |
|
|
|
355 |
|
|
|
(112 |
) |
|
Gain on sale of equipment
|
|
|
|
|
|
|
|
|
|
|
(998 |
) |
|
Gain on sale of securities available-for-sale
|
|
|
(169 |
) |
|
|
(452 |
) |
|
|
|
|
|
Changes in certain assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(6,498 |
) |
|
|
1,829 |
|
|
|
(3,387 |
) |
|
|
Interest receivable
|
|
|
680 |
|
|
|
(415 |
) |
|
|
368 |
|
|
|
Prepaid expenses and other current assets
|
|
|
4,855 |
|
|
|
(2,016 |
) |
|
|
2,166 |
|
|
|
Accounts payable and accrued liabilities
|
|
|
6,836 |
|
|
|
8,551 |
|
|
|
(4,746 |
) |
|
|
Deferred revenue
|
|
|
591 |
|
|
|
(5,242 |
) |
|
|
(5,951 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(59,138 |
) |
|
|
(52,516 |
) |
|
|
(44,961 |
) |
Investing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of securities available-for-sale
|
|
|
(90,635 |
) |
|
|
(200,037 |
) |
|
|
(79,896 |
) |
|
Proceeds from maturities of securities available-for-sale
|
|
|
65,911 |
|
|
|
38,679 |
|
|
|
27,565 |
|
|
Proceeds from sale of securities available-for-sale
|
|
|
81,429 |
|
|
|
75,159 |
|
|
|
68,039 |
|
|
Purchases of property and equipment
|
|
|
(26,414 |
) |
|
|
(6,679 |
) |
|
|
(6,255 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities
|
|
|
30,291 |
|
|
|
(92,878 |
) |
|
|
9,453 |
|
Financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock
|
|
|
1,511 |
|
|
|
36,877 |
|
|
|
50,873 |
|
|
Principal payments made on long-term obligations
|
|
|
(5,546 |
) |
|
|
1,724 |
|
|
|
(6,118 |
) |
|
Proceeds from long-term obligations, net
|
|
|
14,550 |
|
|
|
96,320 |
|
|
|
4,778 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
10,515 |
|
|
|
134,921 |
|
|
|
49,533 |
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents
|
|
|
(18,332 |
) |
|
|
(10,473 |
) |
|
|
14,025 |
|
Cash and cash equivalents at beginning of period
|
|
|
36,890 |
|
|
|
47,363 |
|
|
|
33,338 |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$ |
18,558 |
|
|
$ |
36,890 |
|
|
$ |
47,363 |
|
|
|
|
|
|
|
|
|
|
|
Supplemental Disclosures of Cash Flow Information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest paid
|
|
$ |
6,112 |
|
|
$ |
1,916 |
|
|
$ |
2,667 |
|
Supplemental Schedule of Noncash Investing and Financing
Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock issued for payment of preferred stock dividend
|
|
$ |
727 |
|
|
$ |
967 |
|
|
$ |
880 |
|
|
Common stock issued for payment of long-term obligation
|
|
$ |
15,000 |
|
|
$ |
|
|
|
$ |
|
|
|
Reclassification of redeemable common stock to equity
|
|
$ |
|
|
|
$ |
|
|
|
$ |
2,000 |
|
See accompanying notes
55
CORIXA CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
|
|
1. |
Description of Business and Summary of Significant Accounting
Policies |
|
|
|
Description of Business and Basis of Presentation |
We are a developer of innovative immunotherapeutic products that
regulate innate immune responses. These products include:
|
|
|
|
|
Vaccine Adjuvants compounds or additives that, when
combined with a vaccine, boost the bodys immune response
to antigens contained in the vaccine; and |
|
|
|
TLR4 agonists and antagonists compounds that
interact with a type of cell surface receptor that recognizes
distinct molecular signatures presented by invading pathogens
and generates an immune response. These responses may be useful
in the prevention and/or therapy of many conditions, including
seasonal allergic rhinitis, broad infection prevention, chronic
obstructive pulmonary disease and inflammatory conditions. |
We are a product development company with multiple product
candidates, many in late-stage human clinical trials. We are
driven by an aggressive partnering and manufacturing strategy
that we believe will give us an opportunity for sustained and
consistent commercial success.
We have reclassified amounts related to BEXXAR therapeutic
regimen operations from approval (in June 2003) through
December 31, 2004 to discontinued operation in connection
with the transfer of those operations to GSK in
December 31, 2004.
The consolidated financial statements include our accounts and
those of our wholly owned subsidiary, Coulter. All significant
intercompany account balances and transactions have been
eliminated in consolidation.
Cash and Cash Equivalents
All short-term investments, which consist primarily of
bankers acceptances and certificates of deposit, with
maturities of three months or less at date of purchase are
considered to be cash equivalents. The amounts are recorded at
cost, which approximates fair market value.
|
|
|
Securities Available-for-Sale |
Our investment portfolio is classified as available-for-sale and
is segregated into current and non-current portions based on the
remaining term of the instrument. Investments with outstanding
maturity dates of 2 years or longer are classified as
non-current. Our primary investment objectives are preservation
of principal, a high degree of liquidity and a maximum total
return. We invest primarily in (United States dollar denominated
only): commercial paper; short- and mid-term corporate
notes/bonds, with no more than 10% of the portfolio in any one
corporate issuer; and federal agencies with terms not exceeding
4 years. Such securities are stated at fair value, with the
unrealized gains and losses reflected in stockholders
equity. Interest earned on securities is included in interest
income. The amortized cost of investments is adjusted for
amortization of premiums and accretion of discounts to maturity.
Such amortization and accretions are included in interest
income. The cost of securities sold is calculated using the
specific identification method.
We regularly review the value of our investments. If the value
of any of our investments falls below our cost basis in the
investment, we analyze the decrease to determine whether it is
an other-than-temporary decline in value. To make this
determination for each security, we consider:
|
|
|
|
|
how long and by how much the fair value has been below its cost; |
56
CORIXA CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
|
|
|
the financial condition and near-term prospects of the issuer of
the security, including any specific events that may affect its
operation or earning potential; |
|
|
|
our intent and ability to keep the security long enough for it
to recover its value; |
|
|
|
any downgrades of the security by a rating agency; and |
|
|
|
any reductions or eliminations of dividends, or non-payment of
scheduled interest payments. |
Based on our analysis, we make a judgment as to whether the loss
is other-than-temporary. If the loss is other-than-temporary, we
record an impairment charge within interest income in our
Consolidated Statements of Operations in the period that we make
the determination.
|
|
|
Concentrations of Credit Risk |
We are subject to concentrations of credit risk, primarily from
our investments. Credit risk for investments is managed by the
purchase of investment-grade securities, A1/P1 for money market
instruments and A or better for debt instruments, and
diversification of the investment portfolio among issuers and
maturities.
We sell products to and record collaborative revenue from a
limited number of pharmaceutical and biotechnology companies
without requiring collateral. We periodically assess the
financial strength of these customers and establish allowances
for anticipated losses when necessary. As of December 31,
2004 accounts receivable included two customers that each
accounted for 60% and 12% of gross trade receivables
respectively. As of December 31, 2003, trade accounts
receivable included two customers that each accounted for 58%
and 11% of gross trade accounts receivable, respectively.
Inventories are stated at the lower of cost or market. Cost is
determined using a standard costing approach, which approximates
actual cost. If inventory costs exceed expected market value due
to obsolescence, expected expiration or lack of demand, reserves
are recorded for the difference between the cost and the market
value. Inventories are included on the balance sheet in prepaid
expenses and other current assets.
Property and equipment is stated at cost and is depreciated on
the straight-line method over the assets estimated useful
lives, which range from 3 to 7 years for computers and
equipment and 20 years for buildings. Leasehold
improvements are amortized over the lesser of their estimated
useful lives or the term of the lease.
|
|
|
Impairment of Long-Lived Assets |
Long-lived assets and certain identifiable intangible assets to
be held and used are reviewed for impairment when events or
changes in circumstances indicate that the carrying amount of
such assets may not be recoverable. Determination of
recoverability is based on an estimate of undiscounted cash
flows resulting from the use of the asset and its eventual
disposition. In the event that such cash flows are not expected
to be sufficient to recover the carrying amount of the assets,
the assets are written down to their estimated fair values.
Long-lived assets and certain identifiable intangible assets to
be disposed of are reports at the lower of carrying amount or
fair value less cost to sell.
57
CORIXA CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
|
Acquisition-Related Intangible Assets |
Goodwill is subject to an impairment test at least annually or
more frequently if impairment indicators arise. We amortize
intangible assets with a definite life over their useful lives.
On March 12, 2002, we received a second complete review
letter from the FDA regarding our BLA for BEXXAR therapeutic
regimen. In the complete review letter, the FDA stated that
additional clinical studies would be required to provide
sufficient evidence of the safety and net clinical benefit of
BEXXAR therapeutic regimen. Upon announcement on March 13,
2002 of the receipt of the complete review letter from the FDA,
the value of our common stock declined which, in
managements opinion represented an indication of
impairment of recorded goodwill. In accordance with the
requirements of SFAS 142, an interim test of goodwill
impairment was performed as of March 13, 2002. The
impairment test involves a two-step approach. Under step one of
the test, we compared our estimated fair value (the reporting
unit) based upon the market price of our common stock to the
carrying value of our equity. Because the carrying value of our
equity exceeded our fair value, we performed step two of the
test, which involved allocating our fair value to all of our
assets and liabilities to determine how much, if any, of the
excess value should be allocated to goodwill. The results of the
impairment test indicated that no goodwill was present and
accordingly, we recognized a $161.1 million goodwill
impairment charge in the first quarter of 2002.
Acquisition-related intangible assets at December 31, 2004,
consist of adjuvant know-how with balance of approximately
$769,000. Adjuvant know-how is amortized on the straight-line
method over 7 years.
In the second and third quarters of 2003 we subleased
approximately 117,000 square feet of our leased facilities
in South San Francisco. In accordance with
SFAS No. 144, long-lived assets must be reviewed for
impairment whenever events or changes in circumstances indicate
that the carrying amount of those long-lived assets might not be
recoverable. Upon entering into the sublease agreements an
estimate of the undiscounted future cash flows attributable to
the subleases was performed and was determined to be less than
the carrying amount of the intangible asset acquired lease,
related leasehold improvements and furniture and fixtures.
Because the carrying value exceeded the fair value, we
recognized an impairment charge of $12.6 million and
$5.9 million in the second and third quarters of 2003,
respectively, related to these assets.
In December 2004, in connection with GSKs acquisition of
our rights to BEXXAR therapeutic regimen and our plans to close
our remaining South San Francisco facilities, we reviewed
the remaining lease related assets for potential impairment. We
determined that the undiscounted cash flows related to a
potential sublease would be less than the carrying value of the
recorded lease intangible and leasehold improvements. Because
the carrying value exceeded the fair value, we recorded an
impairment loss of $2.6 million. Fair value of lease
related assets is based on estimated current market rental rates.
58
CORIXA CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The expected future annual amortization expense of our other
acquisition-related intangible assets is as follows (in
thousands):
|
|
|
|
|
|
|
Expected | |
|
|
Amortization | |
Year Ending December 31, |
|
Expense | |
|
|
| |
2005
|
|
$ |
439 |
|
2006
|
|
|
330 |
|
2007
|
|
|
|
|
2008
|
|
|
|
|
2009
|
|
|
|
|
Thereafter
|
|
|
|
|
|
|
|
|
Total expected amortization
|
|
$ |
769 |
|
|
|
|
|
For the years ended December 31, 2004, 2003 and 2002 we had
approximately $727,000, $1.3 million and $4.6 million,
respectively of amortization expense related to intangible
assets.
We have adopted the disclosure-only provisions of
SFAS No. 123, Accounting for Stock-Based
Compensation, (SFAS 123) and apply Accounting
Principles Board Opinion No. 25, Accounting for
Stock issued to Employees, (APB 25) and related
interpretations in accounting for our stock option plans.
Accordingly, our employee stock-based compensation expense is
recognized based on the intrinsic value of the option on the
date of grant.
At December 31, 2004 we had two stock-based employee
compensation plans, which are described more fully in
Note 7. No stock-based employee compensation cost, other
than compensation associated with options assumed in
acquisitions, is reflected in net loss, as all options granted
under those plans had an exercise price equal to the market
value of the underlying common stock on the date of grant. The
following table illustrates the effect on net loss and net loss
per share if we had applied the fair value recognition of
SFAS 123 to stock-based employee compensation.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands, except per share data) | |
Net loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As reported
|
|
$ |
(76,407 |
) |
|
$ |
(83,919 |
) |
|
$ |
(207,399 |
) |
Additional stock-based employee compensation expense determined
under fair value based method for all awards
|
|
|
(7,363 |
) |
|
|
(10,936 |
) |
|
|
(16,822 |
) |
|
|
|
|
|
|
|
|
|
|
|
Pro forma net loss
|
|
|
(83,770 |
) |
|
|
(94,855 |
) |
|
|
(224,221 |
) |
|
Preferred stock dividend
|
|
|
(595 |
) |
|
|
(948 |
) |
|
|
(767 |
) |
|
|
|
|
|
|
|
|
|
|
Pro forma net loss applicable to common stockholders
|
|
$ |
(84,365 |
) |
|
$ |
(95,803 |
) |
|
$ |
(224,988 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss per common share applicable to common stockholders:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As reported
|
|
$ |
(1.36 |
) |
|
$ |
(1.60 |
) |
|
$ |
(4.67 |
) |
|
Pro forma
|
|
|
(1.49 |
) |
|
|
(1.81 |
) |
|
|
(5.04 |
) |
Stock compensation expense for options granted to nonemployees
has been determined in accordance with SFAS 123 and
EITF 96-18, Accounting for Equity Instruments That
Are Issued to Other Than
59
CORIXA CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Employees for Acquiring, or in Conjunction with Selling,
Goods or Services, as the fair value of the
consideration received or the fair value of the equity
instruments issued, whichever is more reliably measured. The
fair value of options granted to nonemployees is periodically
re-measured as the underlying options vest.
The preparation of financial statements in conformity with
accounting principles generally accepted in the United States
requires management to make estimates and assumptions that
affect the amounts reported in the financial statements and
accompanying notes. Actual results could differ from those
estimates.
|
|
|
Other Financial Instruments |
As of December 31, 2004 and December 31, 2003, the
carrying value of financial instruments such as receivables and
payables approximated their fair values, based on the short-term
maturities of these instruments. The fair value of our long-term
convertible debt was based on quoted market prices. The fair
value of securities available-for-sale is based on the current
market value. Additionally, the carrying value of long-term
liabilities with variable interest rates approximated their fair
values because the underlying interest rates approximate market
rates at the balance sheet dates.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2004 | |
|
December 31, 2003 | |
|
|
| |
|
| |
|
|
Carrying Value | |
|
Fair Value | |
|
Carrying Value | |
|
Fair Value | |
|
|
| |
|
| |
|
| |
|
| |
Securities available-for-sale
|
|
$ |
98,815 |
|
|
$ |
97,629 |
|
|
$ |
155,351 |
|
|
$ |
155,095 |
|
Long-term fixed rate debt
|
|
$ |
104,560 |
|
|
$ |
88,309 |
|
|
$ |
105,665 |
|
|
$ |
104,290 |
|
We generate revenue from technology licenses, adjuvant supply
agreements, collaborative research and development arrangements,
cost reimbursement contracts, and sales of research reagents.
Revenue under technology licenses and collaborative agreements
typically consists of nonrefundable and/or guaranteed technology
license fees, collaborative research funding, technology access
fees, and various milestone and future product royalty or
profit-sharing payments. Revenue arrangements with multiple
elements are divided into separate units of accounting if
certain criteria are met, including whether the delivered
element has stand-alone value to the customer and whether there
is objective and reliable evidence of the fair value of the
undelivered items. The consideration received is allocated among
the separate units based on their respective fair values, and
the applicable revenue recognition criteria are applied to each
of the separate units. Payments received in advance of
recognition as revenue are recorded as deferred revenue.
Revenue associated with up-front license, technology access and
research and development funding payments under collaborative
agreements is recognized ratably over the relevant periods
specified in the respective agreements, generally the research
and development period. Revenue from substantive at-risk
milestones and future product royalties is recognized upon
completion of the milestones and adjuvant sales, as defined in
the respective agreements. Revenue under cost reimbursement
contracts is recognized as the related costs are incurred.
Revenue from adjuvant sales is recognized upon customer
acceptance of the product.
|
|
|
Research and Development Expenses |
Pursuant to SFAS No. 2, Accounting for
Research and Development Costs, our research and
development costs are expensed as incurred. The value of
acquired IPR&D is charged to expense on the
60
CORIXA CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
date of acquisition. Research and development expenses include,
but are not limited to, payroll and personnel expense, lab
supplies, preclinical, outside manufacturing, legal fees and
consulting.
Basic net loss per share is calculated by dividing net loss
applicable to common stockholders by the weighted average number
of common shares outstanding. Diluted net loss per share is
calculated by dividing the net loss applicable to common
stockholders by the weighted average common shares outstanding
plus the dilutive effect of outstanding stock options, stock
warrants, preferred stock and convertible debt. Because we
report a net loss, diluted net loss per share is the same as
basic net loss per share because the effect of outstanding stock
options, stock warrants, preferred stock and convertible debt
being added to weighted average shares outstanding would reduce
the loss per share. Therefore, outstanding stock options, stock
warrants, preferred stock and convertible debt are not included
in the calculation.
We currently operate as a single segment under
SFAS No. 131, Disclosures About Segments of
an Enterprise and Related Information based on the
information that our chief operating decision maker reviews in
assessing performance and allocating resources.
|
|
|
New Accounting Pronouncements |
On December 16, 2004, the FASB issued FAS 123R,
Share-Based Payment An Amendment of FASB
Statements No. 123 and 95, (FAS 123R) which
is effective for public companies in periods beginning after
June 15, 2005. We will be required to implement the
proposed standard no later than the quarter that begins
July 1, 2005. The cumulative effect of adoption, if any,
applied on a modified prospective basis, would be measured and
recognized on July 1, 2005. FAS 123R addresses the
accounting for transactions in which an enterprise receives
employee services in exchange for (a) equity instruments of
the enterprise or (b) liabilities that are based on the
fair value of the enterprises equity instruments or that
may be settled by the issuance of such equity instruments.
FAS 123R would eliminate the ability to account for
share-based compensation transactions using APB 25, and
generally would require instead that such transactions be
accounted for using a fair-value based method. Companies will be
required to recognize an expense for compensation cost related
to share-based payment arrangements including stock options and
employee stock purchase plans. We are currently evaluating
option valuation methodologies and assumptions of FAS 123R
related to employee stock options. Current estimates of option
values using the Black-Scholes method may not be indicative of
results from valuation methodologies ultimately adopted in the
final rules.
In September 2004, the FASB issued FSP 03-1-1 delaying the
effective date for applying paragraphs 10-20 of
EITF 03-1 The Meaning of Other-than-Temporary
Impairment and its Application to Certain Investments.
Paragraphs 10-20 provide guidance for evaluating whether
impairments of debt and equity holdings are
other-than-temporary and require immediate
recognition in earnings. The effective date for applying the
accounting guidance of EITF 03-1 is currently under review
by the FASB. The disclosure requirements of EITF 03-1
remain unchanged and were effective for fiscal periods ending
after December 15, 2003. We have included the required
disclosures within this report.
Certain reclassifications have been made to the prior
years financial statements to conform to the 2004
presentation. Certain administrative costs have been
reclassified from research and development to sales, general and
administrative. Product sales, restructuring and manufacturing
cost have been reclassified
61
CORIXA CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
on the statement of operations as separate line items. Certain
debt issuance costs have been reclassified from current to
non-current assets.
|
|
2. |
Scientific Collaborative and License Agreements |
GSK. In October 1998, we entered into a collaboration and
license agreement effective September 1, 1998 with GSK for
multiple discovery programs. In August 2002 the funded research
and development period of our collaboration and license
agreement with GSK terminated in all of the cancer fields
covered by the agreement. In October 2002, GSK extended the
funded research and development period for the programs for
tuberculosis and chlamydia vaccines through August 2004. We
recognized revenue of $3.0 million, $4.8 million and
$11.7 million in 2004, 2003 and 2002, respectively, from
this agreement.
In January 2003, we and GSK entered into a new agreement which
extends our and GSKs collaborative efforts into vaccine
development and potential proof-of-principle clinical trials.
Under the terms of the new agreement, GSK granted us a
worldwide, exclusive license to develop a vaccine candidate for
prostate cancer and a vaccine candidate for breast cancer. As a
part of the agreement, GSK retains the option to buy-back
exclusive worldwide rights for either or both vaccine candidates
following the completion of proof-of-principle clinical trials.
If GSK exercises its buy-back rights, we have the option of
participating in further development, up to and including a
sharing of promotion rights in the United States. The buy-back
price will be based on our research costs incurred under this
new agreement plus a premium of 25% and up to an additional
$3.0 million depending on the stage of development at the
time GSK exercises its buy-back option. In the event GSK does
not exercise its buy-back option, we will be free to develop the
vaccines alone or with other partners and have agreed to pay GSK
success-based milestones and royalties in the event of product
sales. Under our new agreement, we are responsible for providing
resources and development funding of up to $32 million to
complete proof-of-principle clinical studies over a period of
time in excess of 5 years. At December 31, 2004, we
had provided approximately $10.6 million of resources and
development funding. This funding will be used to pay for GMP
grade material, production and clinical trials for prostate and
breast vaccine development efforts.
We have an outstanding loan in the principal amount of
$5 million. In connection with the MPL Supply Agreement
with GSK that we announced in July 2004, GSK agreed that we may
elect to repay this loan in either cash or 1,099,000 shares
of our common stock. See Note 6.
Prior to December 31, 2004, we had a collaborative
agreement with GSK for the development and commercialization of
BEXXAR therapeutic regimen, which was approved by the FDA in
June 2003 for the treatment of patients with CD20 positive,
follicular, NHL with and without transformation, whose disease
is refractory to Rituximab and has relapsed following
chemotherapy. Under the terms of the agreement, both companies
contributed to the commercialization efforts of BEXXAR
therapeutic regimen in the United States and shared profits and
losses from GSKs sales of BEXXAR therapeutic regimen
equally. Under the terms of the agreement, GSK maintained the
BEXXAR Service Center which received all orders for BEXXAR
therapeutic regimen and product inquiries and Corixa was
responsible for the manufacture and distribution of the product.
GSK held the sales agreements with the pharmaceutical
wholesalers and all but one of the radiopharmacies, which both
GSK and Corixa signed.
We considered the guidance in EITF 99-19,
Recording Revenue Gross as a Principal versus Net as an
Agent and concluded that GSK is the primary obligor in
a BEXXAR therapeutic regimen sales transaction. Accordingly, GSK
records the revenue associated with the sale of BEXXAR
therapeutic regimen and their sales and promotion cost. We
recognized the costs we incur associated with BEXXAR therapeutic
regimen related activities such as the cost of manufacture and
distribution and sales and promotion costs in our statement of
operations. We and GSK then prepared a quarterly calculation of
the joint profit or loss which considered all revenue and costs
associated with BEXXAR therapeutic regimen commercial activities
incurred by us and GSK and the equal sharing of the joint profit
or loss. The result
62
CORIXA CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
of this sharing calculation was either a reimbursement from GSK
to us or a payment from us to GSK and was recorded in our
statement of operations as co-promotion revenue. Prior to
commercialization, we recorded our share of the net
reimbursement or payment from the joint profit or loss
calculation in sales, general and administrative expenses. For
the year ended December 31, 2004, we recorded
$2.2 million of co-promotion revenue resulting from the
joint profit or loss calculation in discontinued operations.
Additionally, the agreement provided that we and GSK shared
certain costs related to clinical and manufacturing development
activities and that we will receive additional payments from the
achievement of certain clinical development and regulatory
milestones. Development expenses are included in research and
development expenses, and reimbursement revenue is included in
revenue from collaborative agreements. In the second quarter of
2003 we recognized milestone revenue from our collaborative
agreement with GSK for the FDA approval of BEXXAR therapeutic
regimen. We recognized reimbursement revenue of
$4.3 million and $2.3 million in 2004 and 2003,
respectively as discontinued operations and $2.8 million
and $7.0 million in 2003 and 2002, respectively prior to
approval of BEXXAR therapeutic regimen.
On December 31, 2004, we transferred to GSK all of our
rights and responsibilities and costs associated with commercial
and clinical development of BEXXAR therapeutic regimen on a
worldwide basis. See Note 11.
GSK: Manufacture and Supply Agreement. We entered into
the MPL Supply Agreement with GSK in July 2004 covering the
production of our MPL adjuvant, which is a component in
GSKs future vaccines currently undergoing clinical trials,
vaccines awaiting regulatory approval and Fendrix, which has
received regulatory approval in the European Union. The MPL
Supply Agreement, which runs through 2012, guarantees payment to
us for supplying GSK with increasing annual quantities of MPL
adjuvant, peaking in 2008 at the current maximum output of our
Hamilton, Montana, MPL adjuvant manufacturing facility
(approximately 2 kilograms/year). Under the terms of the MPL
Supply Agreement, we agreed to expand cGMP compliant MPL
adjuvant production capacity in association with anticipated
approvals of GSK vaccines that contain MPL adjuvant. In 2004 we
recognized revenue of $2.3 million under this agreement.
We received a multi-million dollar up-front licensing fee and
granted GSK a co-exclusive license to manufacture MPL adjuvant
at amounts over and above our maximum annual output. The MPL
Supply Agreement can be renewed at GSKs option for
multiple, three-year periods beyond 2012. GSK will pay royalties
to Corixa on sales of all GSK vaccines containing MPL adjuvant
until 10 years after market introduction of GSKs HPV
vaccine. GSK and Corixa further agreed to co-fund a multi-year
MPL adjuvant development program for a large scale production
process. If the modified process is implemented and results in
increased Corixa plant production capacity, and if GSK then
revises orders of MPL adjuvant to levels above those currently
contemplated, then GSK will receive a pre-negotiated discount on
the amount of MPL adjuvant it orders over and above todays
plant capacity.
Amersham Health. In October 2001, we entered into an
agreement whereby Amersham Health has agreed to market BEXXAR
therapeutic regimen in Europe. Under the terms of a stock
purchase agreement with Amersham Health we had the option to
sell up to a total of $15 million of shares of our common
stock to Amersham Health. Upon execution of the agreement
Amersham Health purchased 271,343 shares of our common
stock for a total of $5 million, or $18.43 per share,
which represented a premium to the then current market value of
our common stock of approximately forty percent or
$1.4 million. The premium was accounted for as a
nonrefundable license payment and was deferred and recognized as
revenue ratably over the development term of the agreement.
Following our partial option exercises in October 2001 and
December 2002, on May 14, 2003, we completed the exercise
of our option to sell up to $15 million of shares of our
common stock to Amersham Health when we sold 721,814 shares
63
CORIXA CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
of our common stock to Amersham Health at a price per share of
$6.927 for a total purchase price of approximately
$5 million. We recognized revenue from this agreement of
approximately $0 and $195,000 in 2004 and 2003, respectively in
discontinued operations. On December 10, 2004, we and
Amersham Health terminated our development, commercialization
and license agreement, dated October 26, 2001. In
connection with the termination, Amersham paid us a
$3.0 million termination fee in accordance with the terms
of the agreement which is recorded as discontinued operations.
Wyeth. We have several license and supply agreements with
Wyeth, granting Wyeth licenses to certain adjuvants for use in
vaccines for certain infectious and autoimmune disease fields
that Wyeth is developing. These agreements grant Wyeth
exclusive, co-exclusive and nonexclusive license rights
depending on the disease field. Under the terms of the
agreements, Wyeth pays annual license fees, milestones, transfer
payments and future royalty payments. We recognized revenue of
$1.8 million, $2.5 million and $2.0 million in
2004, 2003 and 2002, respectively.
Zambon Group and JT. During May and June 1999, we entered
into corporate partnerships with Zambon and JT, respectively,
for the research, development and commercialization of vaccine
products aimed at preventing and treating lung cancer. Zambon
has exclusive rights to develop and sell vaccine products in
Europe, the countries of the former Soviet Union, Argentina,
Brazil and Columbia and co-exclusive rights in China. Under the
June 1999 agreement, we granted JT exclusive rights to develop
and sell vaccine products outside of the territory licensed to
Zambon, including the United States and Japan, and co-exclusive
rights to develop and sell vaccine products in China. We also
granted Zambon a nonexclusive license and JT an option to
formulate vaccines that may result from the collaboration using
our microsphere delivery system with our proprietary adjuvants.
During 2002, the three-year research terms of the agreements
expired and the respective research funding obligations ceased.
In November 2002, we and Zambon amended our agreement so that we
jointly fund clinical testing of a non-small cell lung cancer
vaccine. In December 2002, we recorded a milestone payment of
$1.0 million from Zambon in connection with the filing of
our IND for a lung cancer vaccine candidate in the United
States. In January 2003, we amended and restated our agreement
with JT so that we hold exclusive rights to all antigens
discovered in our lung cancer vaccine program in all countries
previously licensed to JT, with the exception of rights
associated with commercialization of a non- small cell, lung
carcinoma vaccine candidate in Japan. Under the terms of our
amended agreement with JT, JT will continue to hold an exclusive
license to this vaccine candidate for development and
commercialization in Japan, and we will hold all rights in North
America and in those territories not previously licensed to
Zambon. In connection with the restructuring of the JT
agreement, we and JT have agreed to pay each other fees,
milestones and royalties in the event that development
milestones and product sales are achieved. We recognized revenue
of $831,000, $993,000 and $6.8 million in connection with
the Zambon and JT agreements in 2004, 2003 and 2002,
respectively.
Kirin. In December 2002, we entered into a multiyear
development and commercialization agreement with Kirin for
potential cancer vaccine for the treatment of multiple forms of
cancer, including leukemia, myelodysplasia and melanoma. Under
the agreement we granted Kirin exclusive rights to develop and
market vaccine products resulting from our WT-1 antigen vaccine
program in Asia/ Australasia. We and Kirin have agreed to share
WT-1 vaccine commercialization rights and Kirin will fund
one-half of the research and development cost in North America.
We will retain marketing rights for the potential vaccine in
Europe. Upon entering into the agreement, Kirin paid us
$3 million in up-front license fees which will be recorded
as revenue over the estimated research and development term of
the agreement of approximately 9 years. Under the terms of
the agreement, Kirin will co-fund development of WT-1 vaccine
products and has agreed to pay us success-based milestone
payments and royalties on future product sales in Asia/
Australasia. We recognized revenue related to this agreement of
approximately $2.8 million and $2.3 million in 2004
and 2003, respectively.
64
CORIXA CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Medicis. In August 2000, we entered into a multiyear
development, commercialization and license agreement with
Medicis covering our psoriasis immunotherapeutic product, PVAC
treatment. Under the agreement we granted Medicis exclusive
rights to PVAC treatment in the United States and Canada.
Medicis made a nonrefundable payment of $17 million upon
entering into the agreement. We recognized revenue from this
agreement of $0, $7.9 million and $3.1 million in
2004, 2003 and 2002, respectively. In December 2003 we announced
that we have discontinued development of PVAC treatment due to
phase II trial results that confirmed PVAC therapy failed
to provide a statistically significant benefit versus placebo.
We also terminated our license agreement with Medicis. As a
result of discontinuing development of PVAC treatment, we
recognized $5 million of revenue and $2.5 million of
expense that was previously deferred and was related to the
initial Medicis payment received in 2000.
We developed PVAC treatment in collaboration with New
Zealand-based Genesis. We paid Genesis $8.1 million in
2000, as a result of payments received from Medicis. We also
paid $900,000 to SR Pharma, our licensor for certain
intellectual property related to PVAC treatment. These payments
were being amortized over the period the related Medicis revenue
were being recognized.
Genentech. On December 21, 2004, we entered into a
license agreement with Genentech, under which we granted
Genentech an exclusive worldwide license to a novel target for
the possible development of humanized antibody-based
therapeutics. Under the terms of the agreement, we received a
$1.6 million one-time nonrefundable license fee, and may
receive up to an additional $8.25 million in future
success-based payments upon completion of certain regulatory and
commercial milestones in addition to royalty payments on product
sales. Genentech will be responsible for development and
commercialization costs of any potential therapeutic based on
our antibody target. We recognized revenue of $1.6 million
in 2004 as we have no future obligations under this agreement.
Because of the large number of research projects we have ongoing
at any one time, and the ability to utilize resources across
several projects, the majority of our research and development
costs are not directly tied to any individual project and are
allocated among multiple projects. Our project management is
based primarily on scientific data and supplemented by these
cost allocations, which are based primarily on human resource
time incurred on each project. The costs allocated to a project
as a result do not necessarily reflect the actual costs of the
project. Accordingly, we do not maintain actual cost incurred
information for our projects on a project-by-project basis.
Costs attributed to research and preclinical projects largely
represent our pipeline generating activities. Costs associated
with clinical development programs represent the advancement of
these activities into product candidates.
65
CORIXA CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
3. |
Securities Available-For-Sale |
Securities available-for-sale consists of the following (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross | |
|
Gross | |
|
Fair | |
|
|
Amortized | |
|
Unrealized | |
|
Unrealized | |
|
Market | |
|
|
Cost | |
|
Gain | |
|
Loss | |
|
Value | |
|
|
| |
|
| |
|
| |
|
| |
December 31, 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government agencies
|
|
$ |
69,467 |
|
|
$ |
6 |
|
|
$ |
(824 |
) |
|
$ |
68,649 |
|
|
State and municipal
|
|
|
7,424 |
|
|
|
1 |
|
|
|
(120 |
) |
|
|
7,305 |
|
|
U.S. corporate obligations
|
|
|
20,518 |
|
|
|
19 |
|
|
|
(268 |
) |
|
|
20,269 |
|
|
Other
|
|
|
1,406 |
|
|
|
|
|
|
|
|
|
|
|
1,406 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
98,815 |
|
|
$ |
26 |
|
|
$ |
(1,212 |
) |
|
$ |
97,629 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2003
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government agencies
|
|
$ |
91,306 |
|
|
$ |
117 |
|
|
$ |
(520 |
) |
|
$ |
90,903 |
|
|
State and municipal
|
|
|
24,098 |
|
|
|
62 |
|
|
|
(119 |
) |
|
|
24,041 |
|
|
U.S. corporate obligations
|
|
|
35,916 |
|
|
|
231 |
|
|
|
(27 |
) |
|
|
36,120 |
|
|
Other
|
|
|
4,031 |
|
|
|
|
|
|
|
|
|
|
|
4,031 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
155,351 |
|
|
$ |
410 |
|
|
$ |
(666 |
) |
|
$ |
155,095 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our gross realized gains or losses were immaterial on sales of
available-for-sale securities for fiscal 2004, 2003 and 2002 and
are therefore not shown. The contractual maturities of our
available-for-sale securities are shown below (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair | |
|
|
Amortized | |
|
Market | |
|
|
Cost | |
|
Value | |
|
|
| |
|
| |
December 31, 2004
|
|
|
|
|
|
|
|
|
|
Due in one year or less
|
|
$ |
52,170 |
|
|
$ |
51,728 |
|
|
Due in 1 year through 4 years
|
|
|
46,645 |
|
|
|
45,901 |
|
|
|
|
|
|
|
|
|
|
$ |
98,815 |
|
|
$ |
97,629 |
|
|
|
|
|
|
|
|
The following table shows our investments gross unrealized
losses and fair values, aggregated by investment category and
length of time that individual securities have been in a
continuous unrealized position at December 31, 2004;
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less than 12 Months | |
|
12 Months or More | |
|
Total | |
|
|
| |
|
| |
|
| |
|
|
Fair | |
|
Unrealized | |
|
Fair | |
|
Unrealized | |
|
Fair | |
|
Unrealized | |
Description of Security |
|
Value | |
|
Losses | |
|
Value | |
|
Losses | |
|
Value | |
|
Losses | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Fixed Maturities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government agencies
|
|
$ |
21,090 |
|
|
$ |
(136 |
) |
|
$ |
41,025 |
|
|
$ |
(688 |
) |
|
$ |
62,115 |
|
|
$ |
(824 |
) |
|
State and municipal
|
|
|
4,413 |
|
|
|
(90 |
) |
|
|
2,445 |
|
|
|
(30 |
) |
|
|
6,858 |
|
|
|
(120 |
) |
|
U.S. corporate obligations
|
|
|
18,964 |
|
|
|
(268 |
) |
|
|
|
|
|
|
|
|
|
|
18,964 |
|
|
|
(268 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
44,467 |
|
|
$ |
(494 |
) |
|
$ |
43,470 |
|
|
$ |
(718 |
) |
|
$ |
87,937 |
|
|
$ |
(1,212 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The unrealized losses of these investments represented
approximately 0.01% of the cost of the investment portfolio at
December 31, 2004.
66
CORIXA CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
We reviewed all of our investments with unrealized losses at
December 31, 2004 in accordance with our impairment policy
described in Note 1. Our evaluation concluded that these
declines in fair value were temporary after considering:
|
|
|
|
|
That the majority of such losses for securities in an unrealized
loss position for less than 12 months were interest rate
related |
|
|
|
For securities in an unrealized loss position for 12 months
or more, the financial condition and near-term prospects of the
issuer of the security including any specific events that may
affect its operations or earning potential |
|
|
|
Our intent and ability is to hold the security long enough to
recover its value |
Securities available-for-sale includes $23.2 million that
are restricted under certain debt and lease agreements. See
Note 6.
|
|
4. |
Property and Equipment |
Property and equipment consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Laboratory equipment
|
|
$ |
16,469 |
|
|
$ |
18,399 |
|
Land and buildings
|
|
|
9,794 |
|
|
|
8,723 |
|
Leasehold improvements
|
|
|
31,909 |
|
|
|
12,632 |
|
Construction in progress
|
|
|
5,731 |
|
|
|
4,726 |
|
Computers and office equipment
|
|
|
10,272 |
|
|
|
14,182 |
|
|
|
|
|
|
|
|
|
|
|
74,175 |
|
|
|
58,662 |
|
Accumulated depreciation and amortization
|
|
|
(29,938 |
) |
|
|
(32,325 |
) |
|
|
|
|
|
|
|
|
|
$ |
44,237 |
|
|
$ |
26,337 |
|
|
|
|
|
|
|
|
Interest cost of $338,000, $0 and $0 was capitalized during
2004, 2003 and 2002, respectively related to construction
projects in progress. Depreciation expense was
$7.6 million, $8.8 million and $10.6 million for
2004, 2003 and 2002, respectively.
|
|
5. |
Accounts Payable and Accrued Liabilities |
Accounts payable and accrued liabilities consist of the
following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Trade accounts payable
|
|
$ |
6,312 |
|
|
$ |
5,469 |
|
Severance
|
|
|
3,620 |
|
|
|
1,161 |
|
Employee compensation and related expenses
|
|
|
3,501 |
|
|
|
3,447 |
|
Deferred rent
|
|
|
2,662 |
|
|
|
949 |
|
Accrued research and development expenses
|
|
|
1,961 |
|
|
|
1,106 |
|
Accrued interest
|
|
|
2,558 |
|
|
|
2,383 |
|
Other accrued liabilities
|
|
|
6,756 |
|
|
|
6,019 |
|
|
|
|
|
|
|
|
|
|
$ |
27,370 |
|
|
$ |
20,534 |
|
|
|
|
|
|
|
|
67
CORIXA CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
6. |
Long-term Obligations and Lease Obligations |
Long-term obligations consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Convertible notes
|
|
$ |
100,000 |
|
|
$ |
100,000 |
|
Credit line and loan from corporate partner
|
|
|
5,000 |
|
|
|
20,000 |
|
Bank loans
|
|
|
22,799 |
|
|
|
13,795 |
|
|
|
|
|
|
|
|
|
|
|
127,799 |
|
|
|
133,795 |
|
Less current portion of obligations
|
|
|
8,689 |
|
|
|
25,657 |
|
|
|
|
|
|
|
|
|
Total long-term obligations
|
|
$ |
119,110 |
|
|
$ |
108,138 |
|
|
|
|
|
|
|
|
The loan from a corporate partner consists of a $5 million
loan received in exchange for options to license two of our
early-stage cancer vaccines under a prior collaboration
agreement. In connection with the MPL Supply Agreement with GSK
that we announced on July 26, 2004, GSK agreed that we may
elect to repay the $5 million loan in either cash or
1,099,000 shares of our common stock, which price was
determined by averaging the per share closing price of our
common stock on The Nasdaq National Market as reported in the
Wall Street Journal for the 30 day trading period
immediately preceding but not including the effective date of
the MPL Supply Agreement.
The credit line from a corporate partner consists of a
$15 million credit line related to our collaboration
agreement for BEXXAR therapeutic regimen. In October 2004, we
issued 3,482,433 shares of our common stock to GSK in
connection with the repayment of $15 million credit line.
As of December 31, 2004, we had outstanding bank loans of
$22.8 million. This amount is composed of loans with three
financial institutions (BNP Paribas, NDC and GE Capital).
The BNP loan requires quarterly interest and principal payments
and matures in August 2005. The loan bears a rate of interest of
3.7%, which is a function of either the London InterBank
Offering Rate, or LIBOR, or the prime rate of a major bank or
federal fund. Under the terms of the note, we are required to
maintain a minimum net cash balance equal to the principal
balance plus the interest under the note plus a multiple of our
actual cash burn or $37,500,000, whichever is greater. As of
December 31, 2004, we were in compliance with the covenant.
At December 31, 2004, securities available-for-sale
included a certificate of deposit of $1.4 million that
secures this note.
In March 2004, NDC pursuant to a promissory note and credit
agreement provided a loan of approximately $14.6 million to
us to support our construction costs at the Ninth and Stewart
Life Sciences Building in Seattle. The term of the loan is
7 years. We pay interest only during the term of the loan,
with a balloon principal payment due on March 1, 2011. The
note bears interest at LIBOR plus 0.8%. NDC will forgive a
portion of the loan beginning in 2008 if we are in compliance
with the terms and conditions of the note and the credit
agreement. Pursuant to a security agreement between us and NDC,
the loan and the debt service reserve from NDC is fully secured
by securities available for sale. We received net proceeds of
approximately $14.4 million after deducting debt issuance
cost associated with the loan.
The GE Capital loans require monthly interest and principal
payments and expire beginning in February 2005 through November
2008. The loans bear interest at an average rate of 4.5%.
Deferred charges, deposits and other assets include
$3.5 million that secures our obligations under the GE
Capital loans.
In June 2003, we sold $100 million of
4.25% convertible subordinated notes due in 2008 to a
qualified institutional buyer pursuant to Rule 144A under
the Securities Act of 1933, as amended. The notes are
68
CORIXA CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
convertible into our common stock at a conversion price of
$9.175, subject to adjustment in certain circumstances. At the
initial conversion price, each $1,000 in principal amount of
notes will be convertible into approximately
108.9918 shares of our common stock. The initial conversion
price represents a 25% premium over the last reported sale of
our common stock on June 9, 2003. The notes will be
subordinate to our existing and future senior indebtedness. We
pay interest on the notes on January 1 and July 1 of each
year, beginning on January 1, 2004. The notes mature on
July 1, 2008. We received net proceeds of approximately
$96.3 million after deducting underwriting commissions and
offering expenses. Debt issuance costs of $3.7 million are
being amortized to interest expense over the term of the notes
using the effective interest method. To date, no convertible
debt has been converted to shares.
On or after July 5, 2005, we may redeem the notes, in whole
or in part, at the redemption price, which is 100% of the
principal amount, plus accrued and unpaid interest, if any, to
the date of redemption; provided, however, that if the
redemption date is before July 1, 2007, we may redeem the
notes only if the closing price of our common stock exceeds 140%
of the conversion price for at least 20 trading days in any
consecutive 30-day trading period and if certain other
conditions are met. In certain circumstances, the holders of the
notes may require us to repurchase the notes upon a change
in control, as defined in the agreement.
Minimum future debt payments under all long-term obligations at
December 31, 2004 are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible | |
|
Loan from | |
|
|
Year Ending December 31, |
|
Notes | |
|
Corporate Partner | |
|
Bank Loans | |
|
|
| |
|
| |
|
| |
2005
|
|
$ |
|
|
|
$ |
5,000 |
|
|
$ |
3,694 |
|
2006
|
|
|
|
|
|
|
|
|
|
|
1,650 |
|
2007
|
|
|
|
|
|
|
|
|
|
|
1,439 |
|
2008
|
|
|
100,000 |
|
|
|
|
|
|
|
1,466 |
|
2009
|
|
|
|
|
|
|
|
|
|
|
|
|
Thereafter
|
|
|
|
|
|
|
|
|
|
|
14,550 |
|
|
|
|
|
|
|
|
|
|
|
|
Total minimum payments
|
|
$ |
100,000 |
|
|
$ |
5,000 |
|
|
$ |
22,799 |
|
|
|
|
|
|
|
|
|
|
|
We rent office and research facilities for our Seattle
operations under noncancelable-operating leases that expire in
January 2011 and November 2019, with an option to renew for two
additional five-year periods. We guaranteed a portion of our
obligations under the lease in the form of a letter of credit in
the amount of approximately $5.3 million. We rent office
and research facilities for our South San Francisco
operations under an operating lease that expires in November
2010, with an option to renew for two additional five-year
periods. We have issued a standby letter of credit in the amount
of $2.0 million and have a security deposit of $225,000 in
connection with this lease. At December 31, 2004,
non-current securities available-for-sale includes
$2.0 million that secures the letter of credit for our
South San Francisco leased properties.
69
CORIXA CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Minimum future rental payments under all lease agreements at
December 31, 2004 are as follows (in thousands):
|
|
|
|
|
|
|
|
Operating | |
Year Ending December 31, |
|
Leases | |
|
|
| |
2005
|
|
$ |
10,690 |
|
2006
|
|
|
9,122 |
|
2007
|
|
|
9,317 |
|
2008
|
|
|
9,514 |
|
2009
|
|
|
9,907 |
|
Thereafter
|
|
|
60,135 |
|
|
|
|
|
|
Total minimum payments
|
|
$ |
108,685 |
|
|
|
|
|
We have entered into subleases for a portion of our leased
facilities in South San Francisco with terms expiring
between 2006 and 2010. Aggregate rental receipts under these
subleases are approximately $15.0 million.
Rent expense under operating leases, net of subleases was
$7.4 million in 2004, $7.4 million in 2003 and
$10.6 million in 2002.
We have issued a total of 50,000 shares of preferred stock
to Castle Gate, L.L.C., an investment partnership focused
primarily on health-care and biomedical companies for gross
proceeds of $50 million. We have designated
12,500 shares as Series A and 37,500 shares as
Series B. The Series A shares are convertible into
1,470,588 shares of common stock at a conversion price of
$8.50. The Series B shares are convertible into
1,465,989 shares of common stock at a conversion price of
$25.58. In connection with the preferred stock we issued
warrants which expire between 2005 and 2010 to purchase common
stock as follows:
|
|
|
|
|
Number of Warrants |
|
Exercise Price | |
|
|
| |
312,500
|
|
$ |
8.50 |
|
130,028
|
|
$ |
7.69 |
|
30,540
|
|
$ |
36.84 |
|
237,500
|
|
$ |
18.22 |
|
The preferred stock has an annual cumulative dividend rate of 5%
and may be paid, at our option, in cash or in shares of our
common stock. If we elect to pay in common stock the number of
shares issued is calculated as the cash dividend amount divided
by the stated conversion price of the respective preferred
stock. The Preferred Stock may be converted into common stock at
the option of Castle Gate at any time following issuance.
Beginning on the fourth anniversary of issuance, shares of
outstanding preferred stock will be converted into common stock
if the price of our common stock exceeds the preferred stock
conversion price by at least 30%, as specified in the agreement.
Additionally, any shares of Preferred Stock that have not been
converted previously will be converted automatically on the
seventh anniversary of issuance. Series A and Series B
preferred shares have voting rights based on the number of
common shares into which the preferred shares are convertible.
In the event of liquidation, the preferred stockholders share
pro rata with common stockholders. To date no preferred stock
has been converted to common stock.
70
CORIXA CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
We elected to pay the annual dividends in 2004, 2003 and 2002 in
shares of our common stock as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A | |
|
Series B | |
|
|
| |
|
| |
|
|
Shares | |
|
Value | |
|
Cash value | |
|
Shares | |
|
Value | |
|
Cash value | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
April 2004
|
|
|
73,529 |
|
|
$ |
456,000 |
|
|
$ |
625,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
December 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
73,299 |
|
|
$ |
271,000 |
|
|
$ |
1,900,000 |
|
April 2003
|
|
|
73,529 |
|
|
$ |
529,000 |
|
|
$ |
625,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
December 2003
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
73,299 |
|
|
$ |
438,000 |
|
|
$ |
1,900,000 |
|
April 2002
|
|
|
73,529 |
|
|
$ |
415,000 |
|
|
$ |
625,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
December 2002
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
73,299 |
|
|
$ |
465,000 |
|
|
$ |
1,900,000 |
|
The dividends have been recorded based on the fair value of the
common stock issued. We accrue the dividend at the lower of the
cash dividend amount or the current fair value of the shares to
be issued.
In October 2004, we issued 3,482,433 shares of our common
stock to GSK in connection with the repayment of
$15 million outstanding under a loan agreement between our
wholly-owned subsidiary Coulter and SmithKline Beecham
Corporation, a wholly-owned subsidiary of GSK. The loan
agreement, as amended, permitted us to repay the outstanding
balance either in cash or registered shares of our common stock,
at our discretion.
In September 2003, we delivered a draw down notice to CMI, in
accordance with the terms of the equity line financing agreement
between us and CMI and, as a result, a draw down period
commenced on September 15, 2003 and terminated on
October 10, 2003. Pursuant to the equity line financing
agreement, CMI purchased an aggregate of 291,334 shares of
our common stock at an average price per share of $8.58 for a
total purchase price of approximately $2,500,000. The price at
which CMI purchased these shares from us was established under
the equity line financing agreement by reference to prices of
our common stock on the Nasdaq National Market for the period
beginning on September 15, 2003 and ending on
October 10, 2003, net of a discount of 2%.
In June 2003, we completed the sale of 3,719,085 shares of
newly issued common stock and issued five-year warrants to
purchase 669,435 shares of our common stock at an
exercise price of $8.044 per share, in a private placement
to a single institutional investor. We sold the newly issued
common stock for $8.044 per share and we issued the
warrants at a purchase price of $0.125 per share. We
received net proceeds of approximately $28.4 million, after
deducting underwriting fees and offering expenses.
In April 2003, we exercised our option to sell
721,814 shares of common stock to Amersham Health at a
price per share of $6.927, for a total purchase price of
$5 million. We sold the shares of common stock pursuant to
our October 2001 collaboration agreement with Amersham Health.
In August 2002, we completed the sale of 7,322,562 shares
of newly issued common stock and issued five-year warrants to
purchase 1,244,836 shares of our common stock at an
exercise price of $6.13 per share, in a private placement
to select institutional and other accredited investors. We sold
the newly issued common stock for $6.13 per share and we
issued the warrants at a purchase price of $.125 per share.
We received net proceeds of approximately $42.8 million,
after deducting underwriting discounts and commissions and
before deducting expenses payable by us.
71
CORIXA CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
In June 2001, we amended and restated the Amended and Restated
1994 Stock Option Plan, and redesignated it the 2001 Stock
Incentive Plan, or 2001 Plan. The amendment provides for an
increase in the shares available for issuance by
924,950 shares to 7,500,000 shares subject to an
annual increase equal to three percent of the outstanding common
stock as of the last trading day of the prior fiscal year, up to
a maximum annual increase of 2,000,000 shares. In addition,
under the merger agreement with Coulter, we assumed their stock
option plans. As a result, we assumed options to purchase
approximately 5,614,535 shares. The amendment also provides
that we may grant stock awards and stock appreciation rights, or
SARs, under the 2001 plan. Options granted under the 2001 Plan
may be designated as incentive or nonqualified at the discretion
of the plan administrator.
Generally, options become exercisable over a two and four-year
period with 25% vesting on the first year anniversary of the
date of grant and the remainder vesting monthly thereafter. All
options expire no later than 10 years from the date of
grant. Incentive stock options are exercisable at not less than
the fair market value of the stock at the date of grant, and
nonqualified stock options are exercisable at prices determined
at the discretion of the plan administrator, but not less than
85% of the fair market value of the stock at the date of grant.
The plan administrator has the discretion to grant options that
are exercisable for unvested shares of common stock and, to the
extent that an optionee holds options for such unvested shares
upon termination, we have the right to repurchase any or all of
the unvested shares at the per-share exercise price paid by the
optionee for the unvested shares.
We adopted the 1997 Directors Stock Option Plan, or
the Directors Plan, on July 25, 1997. As of
December 31, 2004, 422,084 shares of common stock were
reserved for issuance under the Directors Plan.
The Directors Plan provides that each person who first
became a nonemployee director shall be granted nonqualified
stock options to purchase 15,000 shares of common
stock, or the First Option. Thereafter, on the first day of each
fiscal year, commencing in fiscal 1998, each nonemployee
director shall be automatically granted an additional option to
purchase 5,000 shares of common stock, or a Subsequent
Option, if, on such date, he or she shall have served on our
board of directors for at least six months. The First Options
and Subsequent Options generally vest over 36 and
12 months, respectively, and have 10-year terms. The
exercise price of such options shall be equal to the fair market
value of our common stock on the date of grant. The
Directors Plan has a 10-year term, unless terminated
earlier.
As of December 31, 2004, the 2001 Plan and Directors Plan
had 12,791,845 shares of common stock reserved for issuance
to employees, directors and consultants.
72
CORIXA CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
A summary of our stock option activity and related information
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted | |
|
|
Shares Available | |
|
Number of | |
|
Average | |
|
|
for Grant | |
|
Options | |
|
Exercise Price | |
|
|
| |
|
| |
|
| |
Balance at December 31, 2001
|
|
|
1,659,660 |
|
|
|
9,373,447 |
|
|
$ |
16.88 |
|
|
Authorized for grant
|
|
|
1,321,020 |
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
(3,038,900 |
) |
|
|
3,038,900 |
|
|
|
6.05 |
|
|
Exercised
|
|
|
|
|
|
|
(52,225 |
) |
|
|
9.85 |
|
|
Cancelled
|
|
|
2,703,901 |
|
|
|
(2,703,901 |
) |
|
|
22.21 |
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2002
|
|
|
2,645,681 |
|
|
|
9,656,221 |
|
|
|
12.06 |
|
|
Authorized for grant
|
|
|
1,506,501 |
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
(1,893,950 |
) |
|
|
1,893,950 |
|
|
|
6.50 |
|
|
Exercised
|
|
|
|
|
|
|
(114,734 |
) |
|
|
3.11 |
|
|
Cancelled
|
|
|
967,685 |
|
|
|
(967,685 |
) |
|
|
11.59 |
|
|
Shares granted
|
|
|
(33,500 |
) |
|
|
|
|
|
|
|
|
|
Expired
|
|
|
(224,807 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
2,967,610 |
|
|
|
10,467,752 |
|
|
|
11.19 |
|
|
Authorized for grant
|
|
|
1,663,110 |
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
(4,628,700 |
) |
|
|
4,628,700 |
|
|
|
4.19 |
|
|
Exercised
|
|
|
|
|
|
|
(295,758 |
) |
|
|
2.49 |
|
|
Cancelled
|
|
|
2,008,849 |
|
|
|
(2,008,849 |
) |
|
|
11.60 |
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
2,010,869 |
|
|
|
12,791,845 |
|
|
$ |
8.80 |
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes information about the stock
options outstanding at December 31, 2004:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding | |
|
Options Exercisable | |
|
|
| |
|
| |
|
|
Number | |
|
Weighted | |
|
Weighted | |
|
|
|
Weighted | |
|
|
Outstanding on | |
|
Average | |
|
Average | |
|
|
|
Average | |
|
|
December 31, | |
|
Remaining | |
|
Exercise | |
|
|
|
Exercise | |
Range of Exercise Prices |
|
2004 | |
|
Contractual Life | |
|
Price | |
|
Shares | |
|
Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
$0.33 $0.99
|
|
|
209,555 |
|
|
|
2.28 |
|
|
$ |
0.98 |
|
|
|
209,555 |
|
|
$ |
0.98 |
|
$1.20 $3.95
|
|
|
3,960,317 |
|
|
|
9.94 |
|
|
|
3.95 |
|
|
|
6,317 |
|
|
|
1.75 |
|
$3.98 $6.04
|
|
|
2,911,941 |
|
|
|
7.99 |
|
|
|
5.75 |
|
|
|
1,563,330 |
|
|
|
5.73 |
|
$6.09 $13.45
|
|
|
3,763,218 |
|
|
|
6.37 |
|
|
|
10.48 |
|
|
|
3,302,072 |
|
|
|
10.88 |
|
$13.50 $71.53
|
|
|
1,946,814 |
|
|
|
5.41 |
|
|
|
20.81 |
|
|
|
1,823,620 |
|
|
|
21.04 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$0.33 $71.53
|
|
|
12,791,845 |
|
|
|
7.63 |
|
|
|
8.80 |
|
|
|
6,904,894 |
|
|
|
12.09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At December 31, 2003 and 2002, we had 6,749,224 and
5,512,155 options exercisable, respectively.
In 2003 we issued 33,500 shares of common stock previously
granted to certain former Coulter employees upon the FDA
approval of BEXXAR therapeutic regimen. We recorded expense of
$247,000 as a result of the stock issuance.
Deferred compensation of approximately $29.2 million was
recorded at December 31, 2000, as a result of the merger
with Coulter, which represented the difference between the
exercise prices of options assumed from Coulter and their fair
market values. Deferred compensation was fully amortized during
73
CORIXA CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
2004. Deferred compensation expense of approximately $15,000,
$188,000 and $1.5 million was recognized for the years
ended December 31, 2004, 2003 and 2002, respectively. In
2004, 2003 and 2002, approximately $393,000, $80,000 and
$1.9 million, respectively of deferred compensation was
reversed related to employees that terminated employment during
the year.
Included in options outstanding at December 31, 2004 are
approximately 182,000 options granted to consultants for
services. Expense of approximately $14,000 and $101,000 was
recorded in 2004 and 2003, respectively, related to options
granted to consultants. A reduction to expense of $168,000 was
recorded in 2002 related to options granted to consultants due
to the decline in our stock price.
|
|
|
Employee Stock Purchase Plan |
On July 25, 1997, we adopted the 1997 Employee Stock
Purchase Plan, or the Purchase Plan. Effective June 1,
2001, we amended and restated the Purchase Plan and redesignated
it the 2001 Employee Stock Purchase Plan, or the 2001 ESPP. The
amendment provided for an immediate increase in the shares
available for issuance by 375,000 shares to
500,000 shares subject to an annual increase of not more
than 500,000 shares in any calendar year. As of
December 31, 2004, 312,906 shares of common stock were
reserved for issuance under the 2001 ESPP. The 2001 ESPP permits
eligible employees to enroll in a two year offering period with
eight three-month purchase periods and to purchase shares of our
common stock through payroll deductions at a price equal to 85%
of the fair market value of our common stock on the first day of
the applicable two year offering period or the last day of the
date of applicable purchase six-month offering period, whichever
is lower.
The number of authorized shares is subject to automatic increase
on the first trading day of each of the 20 calendar years
beginning in 1998 and ending in 2017. If the number of shares
reserved for issuance is less than 1% of the outstanding common
stock, the number of shares reserved for issuance shall be
increased until it equals 1% of the outstanding common stock (up
to a maximum of 500,000 shares in any calendar year), or
such lower amount as determined by the board of directors. The
board of directors has the power to amend or terminate the 2001
ESPP as long as such action does not adversely affect any
outstanding rights to purchase stock under the 2001 ESPP. The
2001 ESPP has a 20-year term, unless terminated earlier.
In 2004, 187,094 shares were issued under the 2001 ESPP at
$3.93 per share. In 2003, 159,153 shares were issued
under the 2001 ESPP at a price of $5.28 per share. In 2002,
137,663 shares were issued under the 2001 ESPP at price of
$5.24 per share.
Pro forma information regarding net loss and loss per share
required by SFAS 123 as disclosed in Note 1 has been
determined as if we had accounted for our employee stock options
under the fair value method of SFAS 123. The fair value for
these options was estimated at the date of grant using a
Black-Scholes option pricing model with the following
weighted-average assumptions on the option grant date.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee Stock | |
|
Employee Stock | |
|
|
Option | |
|
Purchase Plan | |
|
|
| |
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Expected life (years)
|
|
|
4 |
|
|
|
4 |
|
|
|
4 |
|
|
|
1 |
|
|
|
1 |
|
|
|
1 |
|
Expected volatility
|
|
|
90 |
% |
|
|
90 |
% |
|
|
90 |
% |
|
|
90 |
% |
|
|
90 |
% |
|
|
90 |
% |
Risk-free interest rate
|
|
|
3.6 |
% |
|
|
4.0 |
% |
|
|
4.0 |
% |
|
|
4.0 |
% |
|
|
4.0 |
% |
|
|
4.0 |
% |
Expected dividend yield
|
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
74
CORIXA CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The weighted average fair value of options granted during 2004,
2003 and 2002 was $3.06, $4.98 and $4.66, respectively.
We had common stock warrants outstanding to
purchase 2,794,263 shares of common stock as of
December 31, 2004 at a weighted average exercise price of
approximately $8.32 per share, which warrants expire
between 2005 and 2010. Included in the total common stock
warrants outstanding at December 31, 2004, are warrants to
purchase 100,000 shares of common stock issued in
connection with a line of credit with a weighted average
exercise price of $11.06 per share and
1,244,836 shares of common stock issued in connection with
a private placement to select institutional and other accredited
investors with an exercise price of $6.13 per share.
Included in the total common stock warrants outstanding at
December 31, 2004, are 69,424 warrants issued prior to
1997, in connection with certain collaborative agreements with
exercise prices ranging from $0.0033 to $6.60 per share.
Vesting of 68,182 warrants is contingent upon the achievement of
certain scientific milestones.
Common stock was reserved for the following purposes at
December 31, 2004:
|
|
|
|
|
|
Stock options outstanding
|
|
|
12,791,845 |
|
Warrants to purchase common stock
|
|
|
2,794,263 |
|
Employee stock purchase plan
|
|
|
312,906 |
|
Stock options available for grant
|
|
|
2,010,869 |
|
Conversion of preferred stock
|
|
|
2,936,577 |
|
|
|
|
|
|
Total
|
|
|
20,846,460 |
|
|
|
|
|
At December 31, 2004 and 2003, we had net operating loss
carryforwards of approximately $577.6 million and
$511.8 million, respectively, and research and
experimentation credit carryforwards of approximately
$24.2 million and $22.4 million, respectively, which
begin to expire in 2005. Utilization of net operating loss and
research and development tax credit carryforwards is subject to
certain limitations under Section 382 of the Internal
Revenue Code, or the Code. During the period 1995 through 2003,
we experienced ownership changes as defined by the Code.
Accordingly, our use of losses incurred through the date of any
ownership changes will be limited on an annual basis during the
carryforward period, therefore some of the carryforwards will
expire without being fully utilized.
Deferred income taxes reflect the net tax effects of temporary
differences between the carrying amounts of assets and
liabilities for financial reporting purposes and the amounts
used for income tax purposes. We have recognized a valuation
allowance equal to the net deferred tax assets due to the
uncertainty of realizing the benefits of the assets. The
valuation allowance for deferred tax assets increased
$26.8 million during 2004, $23.2 million during 2003
and $18.5 million during 2002. The effects of
75
CORIXA CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
temporary differences and carryforwards that give rise to
deferred tax assets and liabilities are as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Deferred tax assets:
|
|
|
|
|
|
|
|
|
|
Net operating loss carryforwards
|
|
$ |
197,767 |
|
|
$ |
174,028 |
|
|
Research and experimentation credit and foreign tax credit
carryforwards
|
|
|
24,813 |
|
|
|
22,951 |
|
|
Deferred revenue
|
|
|
5,283 |
|
|
|
5,082 |
|
|
Financial statement expenses not deducted on tax return
|
|
|
5,526 |
|
|
|
4,610 |
|
|
|
|
|
|
|
|
|
|
|
233,389 |
|
|
|
206,671 |
|
Deferred tax liabilities:
|
|
|
|
|
|
|
|
|
|
Tax return expenses not charged against financial statements
|
|
|
(419 |
) |
|
|
(514 |
) |
|
|
|
|
|
|
|
|
|
|
(419 |
) |
|
|
(514 |
) |
|
|
|
|
|
|
|
|
Net deferred tax assets
|
|
|
232,970 |
|
|
|
206,157 |
|
|
Less valuation allowance
|
|
|
(232,970 |
) |
|
|
(206,157 |
) |
|
|
|
|
|
|
|
Net deferred tax assets
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
We have a tax-qualified employee savings and retirement plan, or
the 401(k) Plan, covering all of our employees. Pursuant to the
401(k) Plan, employees may elect to reduce their current
compensation by up to the statutorily prescribed annual limit
($13,000 in 2004) and to have the amount of such reduction
contributed to the 401(k) Plan. We have a 401(k) matching
program whereby we contribute twenty-five cents for each dollar
a participant contributes, with a maximum contribution of 25% of
the first 8% of a participants earnings not to exceed 25%
of the prescribed annual limit. The 401(k) Plan is intended to
qualify under Section 401 of the Code so that contributions
by employees or by us to the 401(k) Plan, and income earned on
401(k) Plan contributions, are not taxable to employees until
withdrawn from the 401(k) Plan, and so that contributions by us,
if any, will be deductible by us when made. At the direction of
each participant, we invest the assets of the 401(k) Plan in any
of eleven investment options. Our contributions under the 401(k)
Plan were approximately $497,000 in 2004, $486,000 in 2003 and
$500,000 in 2002.
We received a $20 million up-front patent litigation
settlement payment from Biogen Idec net of the portion of the
settlement payable to other parties including a
$9.9 million payment by us to GSK for their portion of the
settlement. The settlement provided for Biogen Idec to pay us
and GSK a $20 million up-front settlement payment, as well
as a one-time milestone payment based on future Zevalin sales
performance, and royalty payments on Zevalin sales from
January 1, 2004, until such time as all BEXXAR therapeutic
regimen patents expire.
76
CORIXA CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
In May 2002, Medarex purchased our proprietary UPT technology
for creating antibody-toxin conjugates and certain preclinical
product development programs in the field of oncology and other
disease indications. In return, we received $21 million,
which was paid in six equal monthly payments. These payments are
included in other income in the accompanying statement of
operations. Medarex also purchased certain equipment to support
Medarexs continuing research efforts from Corixa for an
additional $2.5 million. We recorded a gain on the sale of
fixed assets to Medarex of approximately $1 million in the
second quarter of 2002. In 2003 we received an additional
$2.5 million contingent consideration related to the
preclinical asset sale.
|
|
11. |
Discontinued Operations and Restructuring |
|
|
|
Discontinued BEXXAR Therapeutic Regimen Operations |
On December 31, 2004, we transferred to GSK all of our
rights and responsibilities, costs and certain assets associated
with commercial and clinical development of BEXXAR therapeutic
regimen on a worldwide basis. In return, we will continue to
receive development and sales milestones and royalties based on
sales of BEXXAR therapeutic regimen in the United States, Canada
and Australasia. We and GSK will continue to equally share
royalties on Zevalin sales according to the terms of the
previous patent litigation settlement with Biogen Idec. As part
of the sale we transferred raw material inventory and certain
equipment to GSK.
We have reclassified amounts related to BEXXAR therapeutic
regimen operations from approval (in June 2003) through
December 31, 2004 to discontinued operation in our
statement of operations because:
|
|
|
|
|
we will not continue any of the revenue-producing or
cost-generating activities related to BEXXAR therapeutic regimen
after the sale. The cash flows related to the development and
sales milestones and royalties are indirect cash flows as they
are not part of the operating activities related to BEXXAR
therapeutic regimen; and. |
|
|
|
we will have no involvement in BEXXAR therapeutic regimen
operations and no ability to influence operating policies or
decisions. |
Discontinued operations include BEXXAR therapeutic regimen
co-promotion revenue, clinical reimbursement revenue, clinical
development and regulatory milestone revenue, the cost of all
commercial and development activities with separately
identifiable cash flows from the date of approval (in June 2003)
through the date of disposition that will no longer be present
in the ongoing entity subsequent to the disposal. We have also
recorded the loss on the transfer of raw material inventory and
certain equipment transferred to GSK in discontinued operations.
The following table includes the amounts classified as
discontinued operations:
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Revenue
|
|
$ |
13,306 |
|
|
$ |
15,365 |
|
Expenses
|
|
|
(37,549 |
) |
|
|
(18,044 |
) |
Loss on transfer of assets
|
|
|
(2,746 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss from discontinued operations
|
|
$ |
26,989 |
|
|
$ |
2,679 |
|
|
|
|
|
|
|
|
77
CORIXA CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
In connection with the sale of BEXXAR therapeutic regimen to
GSK, we restructured our operations in South San Francisco
and Seattle including a workforce reduction of approximately 160
employees. Approximately 44 of these employees have been
retained to provide transitional services to GSK through
approximately June 30, 2005. We recorded a restructuring
charge in the fourth quarter of 2004 of $3.8 million that
consisted of employee severance and benefits. A portion of the
charge is included in restructuring and a portion is included in
discontinued operations. As of December 31, 2004 we had
paid $169,000 of the total restructuring charge. The remaining
severance and benefits will be paid in 2005. We expect to record
additional charges in 2005 related to workforce reductions as
certain employees involved in the transition of BEXXAR
therapeutic regimen to GSK complete their transition activities.
We also expect to incur additional non-cash charges as we vacate
our South San Francisco facilities.
In November 2003, we restructured our operations including a
workforce reduction of approximately 18 percent, which
includes the elimination of unfilled open positions, as well as
select existing positions. The restructuring charge for the
fourth quarter of 2003 was $2.3 million and consisted of
employee severance, benefits and outplacement services. We paid
$1.4 million of the total restructuring charge in 2003 and
the remaining $900,000 in 2004.
|
|
12. |
Commitments and Contingencies |
We are party to routine claims and litigation incidental to our
business. We believe the ultimate resolution of these routine
matters will not have a material adverse effect on our financial
position and results of operations or cash flows. See
Footnote 6 for a description of our commitments.
|
|
13. |
Geographic Information |
Revenue by country were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
North America
|
|
|
10,594 |
|
|
|
18,815 |
|
|
|
18,940 |
|
Europe:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
UK
|
|
|
4,068 |
|
|
|
6,010 |
|
|
|
12,958 |
|
|
Belgium
|
|
|
5,185 |
|
|
|
3,148 |
|
|
|
3,616 |
|
|
Others
|
|
|
2,315 |
|
|
|
3,690 |
|
|
|
7,066 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,568 |
|
|
|
12,848 |
|
|
|
23,640 |
|
Asia
|
|
|
2,794 |
|
|
|
3,682 |
|
|
|
6,158 |
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
24,956 |
|
|
|
35,345 |
|
|
|
48,738 |
|
|
|
|
|
|
|
|
|
|
|
We recognized 23% of our collaborative revenue in 2004 from one
collaborative partner, 41% from two collaborative partners in
2003 and 42% from one collaborative partner in 2002.
78
CORIXA CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
14. |
Quarterly Financial Data (Unaudited) |
The following table contains selected unaudited statement of
operations information for each quarter of 2004 and 2003. We
believe that the following information reflects all adjustments,
consisting of only normal recurring adjustments, necessary for a
fair presentation of the information for the periods presented.
The operating results for any quarter are not necessarily
indicative of results of any future period.
|
|
|
Quarterly Financial Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q1 | |
|
Q2 | |
|
Q3 | |
|
Q4 | |
|
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands, except per share data) | |
2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$ |
5,957 |
|
|
$ |
4,522 |
|
|
$ |
6,185 |
|
|
$ |
8,292 |
|
|
Net loss from continuing operations
|
|
|
(14,515 |
) |
|
|
(3,682 |
) |
|
|
(12,380 |
) |
|
|
(18,841 |
) |
|
Net loss from discontinued operations
|
|
|
(6,396 |
) |
|
|
(6,760 |
) |
|
|
(8,000 |
) |
|
|
(5,833 |
) |
|
Net loss
|
|
|
(20,911 |
) |
|
|
(10,442 |
) |
|
|
(20,380 |
) |
|
|
(24,674 |
) |
|
Basic and diluted net loss per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing operations
|
|
|
(0.26 |
) |
|
|
(0.07 |
) |
|
|
(0.22 |
) |
|
|
(0.32 |
) |
|
Discontinued operations
|
|
|
(0.12 |
) |
|
|
(0.12 |
) |
|
|
(0.14 |
) |
|
|
(0.10 |
) |
|
Net loss
|
|
|
(0.38 |
) |
|
|
(0.19 |
) |
|
|
(0.37 |
) |
|
|
(0.42 |
) |
2003
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$ |
9,125 |
|
|
$ |
7,559 |
|
|
$ |
5,989 |
|
|
$ |
12,472 |
|
|
Net loss from continuing operations
|
|
|
(18,696 |
) |
|
|
(32,873 |
) |
|
|
(19,530 |
) |
|
|
(10,141 |
) |
|
Net gain (loss from discontinued operations)
|
|
|
|
|
|
|
12,250 |
|
|
|
(8,229 |
) |
|
|
(6,700 |
) |
|
Net loss
|
|
|
(18,696 |
) |
|
|
(20,623 |
) |
|
|
(27,759 |
) |
|
|
(16,841 |
) |
|
Basic and diluted net loss per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing operations
|
|
|
(0.37 |
) |
|
|
(0.64 |
) |
|
|
(0.36 |
) |
|
|
(0.18 |
) |
|
Discontinued operations
|
|
|
|
|
|
|
0.24 |
|
|
|
(0.15 |
) |
|
|
(0.12 |
) |
|
Net loss
|
|
|
(0.37 |
) |
|
|
(0.40 |
) |
|
|
(0.51 |
) |
|
|
(0.31 |
) |
79
|
|
Item 9. |
Changes in and Disagreements with Accountants and
Financial Disclosure |
Not applicable.
|
|
Item 9A. |
Controls and Procedures |
(a) Evaluation of disclosure controls and
procedures. Our chief executive officer and our chief
financial officer, after evaluating the effectiveness of our
disclosure controls and procedures (as defined in
Rules 13a-15(e) and 15d-15(e) of the Securities Exchange
Act of 1934) as of the end of the period covered by this annual
report, have concluded that as of that date, our disclosure
controls and procedures were effective in ensuring that
information required to be disclosed by us in this annual report
is accumulated and communicated by our management, to allow
timely decisions regarding required disclosure.
(b) Managements report on internal control over
financial reporting. Our management is responsible for
establishing and maintaining adequate internal control over
financial reporting, as such term is defined in Exchange Act
Rules 13a-15(f). Management assessed the effectiveness of
our internal control over financial reporting using the criteria
set forth by the Committee of Sponsoring Organizations of the
Treadway Commission (COSO) in Internal
Control Intergrated Framework. Based on our evaluation
using those criteria, our management concluded that our internal
control over financial reporting was effective as of
December 31, 2004. Our managements assessment of the
effectiveness of our internal control over financial reporting
as of December 31, 2004 has been audited by
Ernst & Young LLP, an independent registered public
accounting firm, as stated in their report which is included in
this annual report on Form 10-K in Item 8.
(c) Changes in internal controls. There were no
significant changes in our internal controls during the fourth
quarter of 2004 that have materially affected, or are reasonably
likely to materially affect, our internal controls.
PART III
|
|
Item 10. |
Directors and Executive Officers of the Registrant |
The information required by this item, including, without
limitation, disclosure regarding our Code of Ethics, is
incorporated by reference to the information set forth under the
caption Directors and Executive Officers in our 2005
Proxy Statement to be filed within 120 days after the end
of our fiscal year ended December 31, 2004.
|
|
Item 11. |
Executive Compensation |
The information required by this item is incorporated by
reference to the information set forth under the caption
Compensation of Executive Officers in our 2005 Proxy
Statement to be filed within 120 days after the end of our
fiscal year ended December 31, 2004.
|
|
Item 12. |
Security Ownership of Certain Beneficial Owners and
Management |
The information required by this item is incorporated by
reference to the information set forth under the caption
Common Stock Ownership of Certain Beneficial Owners and
Management in our 2005 Proxy Statement to be filed within
120 days after the end of our fiscal year ended
December 31, 2004.
|
|
Item 13. |
Certain Relationships and Related Transactions |
The information required by this item is incorporated by
reference to the information set forth under the caption
Certain Relationships and Related Transactions in
our 2005 Proxy Statement to be filed within 120 days after
the end of our fiscal year ended December 31, 2004.
80
|
|
Item 14. |
Principal Accounting Fees and Services |
The information required by this item is incorporated by
reference to the information set forth under the caption
Independent Auditors in our 2005 Proxy Statement to
be filed within 120 days after the end of our fiscal year
ended December 31, 2004.
PART IV
|
|
Item 15. |
Exhibits and Financial Statement Schedules. |
The following documents are filed as part of this report:
|
|
|
(a)(1) Reports of independent registered accounting firm. |
|
|
|
|
|
Consolidated Balance Sheets as of December 31, 2004 and
2003. |
|
|
|
Consolidated Statements of Operations Years Ended
December 31, 2004, 2003 and 2002. |
|
|
|
Consolidated Statements of Stockholders Equity
Years Ended December 31, 2004, 2003 and 2002. |
|
|
|
Consolidated Statements of Cash Flows Years Ended
December 31, 2004, 2003 and 2002. |
|
|
|
Notes to Consolidated Financial Statements. |
(a)(2) Financial Statement Schedules
|
|
|
|
|
All schedules are omitted because they are not applicable or the
required information is shown in the consolidated financial
statements or notes thereto. |
|
|
|
(a)(3) Index to Exhibits filed in response to Item 601
of Regulation S-K is set forth below. |
EXHIBIT INDEX
|
|
|
|
|
|
|
Exhibit | |
|
|
|
|
Number | |
|
Exhibit Description |
|
Page |
| |
|
|
|
|
|
3 |
.1 |
|
Fifth Amended and Restated Certificate of Incorporation of Corixa |
|
(FF) |
|
3 |
.2 |
|
Certificate of Designation of Rights, Preferences and Privileges
of Series A Preferred Stock |
|
(D) |
|
3 |
.3 |
|
Certificate of Decrease of Shares Designated as Series A
Preferred Stock |
|
(T) |
|
3 |
.4 |
|
Certificate of Designation of Rights, Preferences and Privileges
of Series B Preferred Stock |
|
(E) |
|
3 |
.5 |
|
Certificate of Amendment of Certificate of Incorporation |
|
(DD) |
|
3 |
.6 |
|
Bylaws of Corixa Corporation |
|
(BB) |
|
3 |
.7 |
|
Amendment No. 1 to Bylaws |
|
(KK) |
|
3 |
.8 |
|
Amendment No. 2 to Bylaws |
|
(KK) |
|
4 |
.1 |
|
Indenture dated June 13, 2003 between Corixa Corporation
and Wells Fargo Bank, National Association, as Trustee, for
4.25% Convertible Subordinated Notes due 2008 |
|
(U) |
|
|
|
|
|
|
|
|
|
License, Development, Commercialization and Supply Agreements |
|
|
|
|
|
|
|
|
10 |
.1+ |
|
Multi-Field Vaccine Discovery Collaboration and License
Agreement between Corixa Corporation and SmithKline Beecham plc,
dated September 1, 1998 |
|
(C) |
|
10 |
.2+ |
|
Amendment No. 1, dated May 25, 2000, to the
Multi-Field Vaccine Discovery Collaboration and License
Agreement between Corixa Corporation and SmithKline Beecham plc,
dated September 1, 1998 |
|
(H) |
81
|
|
|
|
|
|
|
Exhibit | |
|
|
|
|
Number | |
|
License, Development, Commercialization and Supply Agreements |
|
Page |
| |
|
|
|
|
|
10 |
.3+ |
|
Letter Agreement, dated August 16, 2001, between Corixa
Corporation and SmithKline Beecham plc, amending the Multi-Field
Vaccine Discovery Collaboration and License Agreement between
Corixa Corporation and SmithKline Beecham plc, dated
September 1, 1998 |
|
(M) |
|
10 |
.4+ |
|
Amendment No. 2, dated January 28, 2003, to the
Multi-Field Vaccine Discovery Collaboration and License
Agreement between Corixa Corporation and SmithKline Beecham plc,
dated September 1, 1998 |
|
(S) |
|
10 |
.5+ |
|
Collaboration and License Agreement dated January 28, 2003
between Corixa Corporation and SmithKline Beecham plc |
|
(S) |
|
10 |
.6+ |
|
Corixa License Agreement dated January 28, 2003 between
Corixa Corporation and SmithKline Beecham plc |
|
(S) |
|
10 |
.7+ |
|
Collaboration Agreement dated May 21, 1999 between Corixa
Corporation Inpharzam International |
|
(L) |
|
10 |
.8+ |
|
Letter Agreement dated November 19, 2001 between Corixa
Corporation and Inpharzam International, amending the
Collaboration Agreement dated May 21, 1999 between Corixa
Corporation Inpharzam International |
|
(S) |
|
10 |
.9+ |
|
Letter Agreement dated November 15, 2002 between Corixa
Corporation and Inpharzam International, amending the
Collaboration Agreement dated May 21, 1999 between Corixa
Corporation Inpharzam International |
|
(S) |
|
10 |
.10+ |
|
Amended and Restated License and Collaborative Research
Agreement dated as of December 19, 2002 between Corixa
Corporation and Japan Tobacco Inc. |
|
(S) |
|
10 |
.11+ |
|
Development and License Agreement dated August 16, 1999
between Zenyaku Kogyo Co., Ltd. and Corixa Corporation |
|
(M) |
|
10 |
.12+ |
|
Letter Agreement between Corixa Corporation and Zenyaku Kogyo
Co., Ltd. dated August 6, 2001 amending the Development and
License Agreement dated August 16, 1999 between Zenyaku
Kogyo Co., Ltd. and Corixa Corporation |
|
(M) |
|
10 |
.13+ |
|
License, Development and Commercialization Agreement dated
November 27, 2002 between Corixa Corporation and Kirin
Brewery Company, Ltd. |
|
(P) |
|
10 |
.14+ |
|
License and Supply Agreement dated May 27, 2003 among
Corixa Corporation, Coulter Pharmaceutical, Inc. and
GlaxoSmithKline Inc. |
|
(V) |
|
10 |
.15+ |
|
Settlement Agreement and License between Biogen Idec Inc.,
Corixa Corporation, Coulter Pharmaceutical, Inc., The Regents of
the University of Michigan and SmithKline Beecham Corporation
d/b/a GlaxoSmithKline, dated February 27, 2004 |
|
(HH) |
|
10 |
.16+ |
|
Letter Amendment to MPL Agreements between Corixa Corporation
and SmithKline Beecham d/b/a GlaxoSmithKline, dated
July 20, 2004 |
|
(II) |
|
10 |
.17* |
|
Asset Purchase Agreement among Corixa Corporation, Coulter
Pharmaceutical, Inc. and SmithKline Beecham d/b/a
GlaxoSmithKline, dated December 12, 2004 |
|
|
|
10 |
.18 |
|
First Amendment, dated December 31, 2004, to the Asset
Purchase Agreement between Corixa Corporation, Coulter
Pharmaceutical, Inc. and SmithKline Beecham d/b/a
GlaxoSmithKline, dated December 12, 2004 |
|
|
|
10 |
.19 |
|
Second Amendment, dated February 2, 2005, to the Asset
Purchase Agreement between Corixa Corporation, Coulter
Pharmaceutical, Inc. and SmithKline Beecham d/b/a
GlaxoSmithKline, dated December 12, 2004 |
|
|
|
|
|
|
|
|
|
|
|
Debt and Equity Investment Agreements |
|
|
|
|
|
|
|
|
10 |
.20+ |
|
Equity Line of Credit and Securities Purchase Agreement between
Corixa Corporation and Castle Gate, L.L.C., dated April 8,
1999 |
|
(D) |
|
10 |
.21+ |
|
Amendment No. 1, dated December 21, 2000, to the
Equity Line of Credit and Securities Purchase Agreement between
Corixa Corporation and Castle Gate, L.L.C., dated April 8,
1999 |
|
(E) |
82
|
|
|
|
|
|
|
Exhibit | |
|
|
|
|
Number | |
|
Debt and Equity Investment Agreements |
|
Page |
| |
|
|
|
|
|
10 |
.22+ |
|
Amendment No. 2, dated December 29, 2000, to the
Equity Line of Credit and Securities Purchase Agreement between
Corixa Corporation and Castle Gate, L.L.C., dated April 8,
1999 |
|
(E) |
|
10 |
.23+ |
|
Registration Rights Agreement between Corixa Corporation and
Castle Gate, L.L.C., dated April 8, 1999 |
|
(D) |
|
10 |
.24+ |
|
Standstill Agreement between Corixa Corporation and Castle Gate,
L.L.C., dated April 8, 1999 |
|
(D) |
|
10 |
.25+ |
|
Warrant Number CG-1 issued by Corixa Corporation to Castle Gate,
L.L.C. on April 8, 1999 |
|
(D) |
|
10 |
.26+ |
|
Warrant Number CG-2 issued by Corixa Corporation to Castle Gate,
L.L.C. on April 8, 1999 |
|
(D) |
|
10 |
.27+ |
|
Form of Warrant Number CG-3 to be issued by Corixa Corporation
to Castle Gate, L.L.C. on the occurrence of certain events in
accordance with the terms of the Equity Line of Credit and
Securities Purchase Agreement |
|
(D) |
|
10 |
.28+ |
|
Form of Warrant Number CG-4 to be issued by Corixa Corporation
to Castle Gate, L.L.C. on the occurrence of certain events in
accordance with the terms of the Equity Line of Credit and
Securities Purchase Agreement |
|
(D) |
|
10 |
.29+ |
|
Warrant Number CG-5 issued by Corixa Corporation to Castle Gate,
L.L.C. on December 29, 2000 |
|
(E) |
|
10 |
.30+ |
|
Loan Agreement between Coulter Pharmaceutical, Inc. and
SmithKline Beecham Corporation, dated October 23, 1998 |
|
(G) |
|
10 |
.31 |
|
First Amendment dated June 28, 2002 to the Loan Agreement
between Coulter Pharmaceutical, Inc. and SmithKline Beecham
Corporation, dated October 23, 1998 |
|
(Q) |
|
10 |
.32 |
|
Second Amendment, dated August 26, 2003, to the Loan
Agreement between Coulter Pharmaceutical, Inc. and SmithKline
Beecham Corporation, dated October 23, 1998 |
|
(W) |
|
10 |
.33+ |
|
Security Agreement between Coulter Pharmaceutical, Inc. and
SmithKline Beecham Corporation, dated October 23, 1998 |
|
(G) |
|
10 |
.34+ |
|
Grant of Security Interest between Coulter Pharmaceutical, Inc.
and SmithKline Beecham Corporation, dated October 23, 1998 |
|
(G) |
|
10 |
.35 |
|
Registration Rights Agreement dated August 26, 2003 between
Corixa Corporation and SmithKline Beecham Corporation |
|
(W) |
|
10 |
.36 |
|
Form of Warrant issued by Corixa Corporation to employees of
Shoreline Pacific, LLC on December 3, 2001 |
|
(K) |
|
10 |
.37 |
|
Loan Agreement between Corixa Corporation and BNP Paribas, dated
August 3, 2001 |
|
(N) |
|
10 |
.38 |
|
Master Security Agreement between Corixa Corporation and General
Electric Capital Corporation dated February 25, 2002 |
|
(GG) |
|
10 |
.39 |
|
Promissory Note dated December 31, 2003 in the principal
amount of $7,000,000, by Corixa Corporation in favor of General
Electric Capital Corporation |
|
(FF) |
|
10 |
.40 |
|
Securities Deposit Pledge Agreement dated December 31, 2004
by Corixa Corporation in favor of General Electric Capital
Corporation |
|
(FF) |
|
10 |
.41 |
|
Securities Purchase Agreement dated August 9, 2002 among
Corixa Corporation and the purchasers named therein |
|
(Z) |
|
10 |
.42 |
|
Registration Rights Agreement dated August 9, 2002 among
Corixa Corporation and the investors named therein |
|
(Z) |
|
10 |
.43 |
|
Registration Rights Agreement dated June 13, 2003 for
4.25% Convertible Subordinated Notes due July 1, 2008 |
|
(U) |
|
10 |
.44+ |
|
Credit Agreement between Corixa Corporation and NDC New Markets
Investments IV, L.P., dated March 2, 2004 |
|
(JJ) |
83
|
|
|
|
|
|
|
Exhibit | |
|
|
|
|
Number | |
|
Debt and Equity Investment Agreements |
|
Page |
| |
|
|
|
|
|
10 |
.45 |
|
Promissory Note dated March 2, 2004 in the principle amount
of $14,550,000, by NDC New Markets Investments IV, L.P. in favor
of Corixa Corporation |
|
(JJ) |
|
10 |
.46 |
|
Security Agreement between Corixa Corporation and NDC New
Markets Investment IV, L.P., dated March 2, 2004 |
|
(JJ) |
|
10 |
.47 |
|
First Amendment, dated February 28, 2005, to the Security
Agreement between Corixa Corporation and NDC New Markets
Investment IV, L.P., dated March 2, 2004 |
|
|
|
|
|
|
|
|
|
|
|
Real Estate Agreements |
|
|
|
|
|
|
|
|
10 |
.48 |
|
Columbia Building Lease dated October 28, 1994 and Columbia
Building Lease First Amendment dated December 29, 1995,
each between Corixa Corporation and Fred Hutchinson Cancer
Research Center |
|
(A) |
|
10 |
.49 |
|
Second Amendment to Columbia Building Lease dated
September 25, 1998 between Corixa Corporation and
Alexandria Real Estate Equities, Inc., successor in interest to
Fred Hutchinson Cancer Research Center |
|
(B) |
|
10 |
.50 |
|
Lease dated May 31, 1996 between Corixa Corporation and
Health Science Properties, Inc. |
|
(A) |
|
10 |
.51 |
|
First Amendment to Lease dated January 31, 1997 between
Corixa Corporation and Health Science Properties, Inc. |
|
(N) |
|
10 |
.52 |
|
Second Amendment to Lease dated June 30, 1997 between
Corixa Corporation and Alexandria Real Estate Equities, Inc.,
formerly known as Health Science Properties, Inc. |
|
(N) |
|
10 |
.53 |
|
Third Amendment to Lease dated November 1, 1998 between
Corixa Corporation and Alexandria Real Estate Equities, Inc.,
formerly known as Health Science Properties, Inc. |
|
(N) |
|
10 |
.55+ |
|
Lease dated November 7, 1997 between HMS Gateway Office
L.P. and Coulter Pharmaceutical, Inc. |
|
(AA) |
|
10 |
.55+ |
|
First Amendment to Lease dated November 10, 1998 between
HMS Gateway Office L.P. and Coulter Pharmaceutical, Inc. |
|
(G) |
|
10 |
.56 |
|
Second Amendment to Lease dated May 19, 2000 between HMS
Gateway Office L.P. and Coulter Pharmaceutical, Inc. |
|
(N) |
|
10 |
.57+ |
|
Lease dated May 19, 2000 between HMS Gateway Office L.P.
and Coulter Pharmaceutical, Inc. |
|
(M) |
|
10 |
.58+ |
|
First Amendment to Lease dated January 15, 2002 between
Gateway Boulevard Associates II, LLC, as successor interest
to HMS Gateway Office L.P. and Coulter Pharmaceutical, Inc. |
|
(S) |
|
10 |
.59+ |
|
Lease Agreement dated October 15, 2002 between Corixa
Corporation and Lifesciences Building, LLC |
|
(O) |
|
10 |
.60+ |
|
Sublease Agreement dated April 4, 2003 between Coulter
Pharmaceutical, Inc. and Gryphon Therapeutics, Inc. |
|
(CC) |
|
10 |
.61+ |
|
Sublease Agreement dated May 15, 2003 between Coulter
Pharmaceutical, Inc. and Corgentech, Inc. |
|
(CC) |
|
10 |
.62 |
|
Sublease Agreement dated September 11, 2003 between Coulter
Pharmaceutical, Inc. and Axys Pharmaceuticals, Inc. |
|
(X) |
|
10 |
.63 |
|
First Amendment dated September 29, 2003 to Sublease
Agreement dated September 11, 2003 between Coulter
Pharmaceutical, Inc. and Axys Pharmaceuticals, Inc. |
|
(Y) |
|
10 |
.64 |
|
Standard Form of Agreement Between Owner and Contractor dated
December 22, 2003 between Corixa Corporation and BN
Builders, Inc. |
|
(FF) |
84
|
|
|
|
|
|
|
|
|
Stock, Option and Retirement Plans |
|
|
|
|
|
|
|
|
10 |
.65 |
|
2001 Stock Incentive Plan |
|
(I) |
|
10 |
.66 |
|
1997 Directors Stock Option Plan |
|
(A) |
|
10 |
.67 |
|
2001 Employee Stock Purchase Plan |
|
(J) |
|
10 |
.68 |
|
Corixa Corporation 401(k) Savings & Retirement Plan |
|
(LL) |
|
10 |
.69 |
|
Coulter Pharmaceutical, Inc. 1996 Employee Stock Purchase Plan |
|
(F) |
|
10 |
.70 |
|
Coulter Pharmaceutical, Inc. 1995 Equity Incentive Plan |
|
(F) |
|
10 |
.71 |
|
Coulter Pharmaceutical, Inc. 1996 Equity Incentive Plan |
|
(F) |
|
|
|
|
|
|
|
|
|
Agreements with Officers and Directors |
|
|
|
|
|
|
|
|
10 |
.72 |
|
Form of Indemnification Agreement between Corixa Corporation and
each director and officer of Corixa Corporation |
|
(LL) |
|
10 |
.73 |
|
Form of Corixa Corporation Executive Employment Agreement |
|
(FF) |
|
10 |
.74 |
|
Amendment to Form of Corixa Corporation Executive Employment
Agreement |
|
(KK) |
|
10 |
.75 |
|
Amendment to Form of Corixa Corporation Executive Employment
Agreement entered into between Corixa Corporation and each of
Michelle Burris, David Fanning, Steven Gillis, Ph.D. and
Kathleen McKereghan Deeley |
|
(MM) |
|
10 |
.76 |
|
Schedule of officers party to Corixa Corporation Executive
Employment Agreement |
|
|
|
21 |
.1 |
|
Subsidiaries of Corixa Corporation |
|
|
|
23 |
.1 |
|
Consent of independent registered accounting firm |
|
|
|
24 |
.1 |
|
Power of Attorney (included on signature page) |
|
|
|
31 |
.1 |
|
Certification of Chief Executive Officer of Corixa Corporation
required by Rule 13a-14(a) or Rule 15d-14(a) of the
Securities Exchange Act of 1934, as amended |
|
|
|
31 |
.2 |
|
Certification of Chief Financial Officer of Corixa Corporation
required by Rule 13a-14(a) or Rule 15d-14(a) of the
Securities Exchange Act of 1934, as amended |
|
|
|
32 |
.1 |
|
Certification of Chief Executive Officer and Chief Financial
Officer of Corixa Corporation required by Rule 13a-14(b) or
Rule 15d-14(b) of the Securities Exchange Act of 1934, as
amended, and 18 U.S.C. Section 1350 |
|
|
|
|
|
(A) |
|
Incorporated herein by reference Corixas Form S-1/A
(File No. 333-32147), filed with the Commission on
July 25, 1997. |
|
(B) |
|
Incorporated herein by reference to Corixas Form 10-Q
(File No. 0-22891), filed with the Commission on
November 12, 1998. |
|
(C) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 0-22891), filed with the Commission on
November 10, 1998. |
|
(D) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 0-22891), filed with the Commission on
April 23, 1999. |
|
(E) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 0-22891), filed with the Commission on
January 4, 2001. |
|
(F) |
|
Incorporated herein by reference to Corixas Registration
Statement on Form S-8 (File No. 333-52968), filed with
the Commission on December 29, 2000. |
|
(G) |
|
Incorporated herein by reference to Coulter Pharmaceutical,
Inc.s Form 10-K, (File No. 000-21905), filed
with the Commission on March 30, 1999. |
|
(H) |
|
Incorporated herein by reference to Corixas Form 10-Q
(File No. 000-22891), filed with the Commission on
November 6, 2000. |
|
(I) |
|
Incorporated herein by reference to Corixas Registration
Statement on Form S-8 (File No. 333-65394), filed with
the Commission on July 19, 2001. |
85
|
|
|
(J) |
|
Incorporated herein by reference to Corixas Form 10-Q
(File No. 000-22891), filed with the Commission on
August 10, 2001. |
|
(K) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 000-22891), filed with the Commission on
December 17, 2001. |
|
(L) |
|
Incorporated herein by reference to Corixas Form 10-Q
(File No. 000-22891), filed with the Commission on
August 9, 1999. |
|
(M) |
|
Incorporated herein by reference to Corixas
Form 10-K/A (File No. 000-22891), filed with the
Commission on June 24, 2002. |
|
(N) |
|
Incorporated herein by reference to Corixas Form 10-K
(File No. 000-22891), filed with the Commission on
March 1, 2002. |
|
(O) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 000-22891), filed with the Commission on
October 21, 2002. |
|
(P) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 000-22891), filed with the Commission on
December 5, 2002. |
|
(Q) |
|
Incorporated herein by reference to Corixas Form 10-Q
(File No. 000-22891), filed with the Commission on
August 13, 2002. |
|
(R) |
|
Incorporated herein by reference to Corixas
Form 8-K/A (File No. 000-22891), filed with the
Commission on May 29, 2002. |
|
(S) |
|
Incorporated herein by reference to Corixas Form 10-K
(File No. 000-22891), filed with the Commission on
February 25, 2003. |
|
(T) |
|
Incorporated herein by reference to Corixas Amendment to
Registration Statement on Form 8-A/ A, filed with the
Commission on March 6, 2003. |
|
(U) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 0-22891), filed with the Commission on
June 18, 2003 |
|
(V) |
|
Incorporated herein by reference to Corixas
Form 8-K/A (File No. 000-22891), filed with the
Commission on July 29, 2003. |
|
(W) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 0-22891), filed with the Commission on
September 9, 2003 |
|
(X) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 0-22891), filed with the Commission on
September 11, 2003 |
|
(Y) |
|
Incorporated herein by reference to Corixas
Form 8-K/A (File No. 0-22891), filed with the
Commission on September 29, 2003 |
|
(Z) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 0-22891), filed with the Commission on
August 13, 2002 |
|
(AA) |
|
Incorporated herein by reference to Coulter Pharmaceutical,
Inc.s Form 10-K (File No. 000-21905), filed with
the commission on March 27, 1998 |
|
(BB) |
|
Incorporated herein by reference to Corixas Form 10-K
(File No. 000-22891), filed with the Commission on
March 30, 2001 |
|
(CC) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 0-22891), filed with the Commission on
June 9, 2003 |
|
(DD) |
|
Incorporated herein by reference to Corixas Form 10-Q
(File No. 0-22891), filed with the Commission on
August 14, 2000 |
|
(EE) |
|
Incorporated herein by reference to the Power of
Attorney granted below in this report on Form 10-K. |
|
(FF) |
|
Incorporated herein by reference to Corixas Form 10-K
(File No. 0-22891), filed with the Commission on
March 9, 2004 |
|
(GG) |
|
Incorporated herein by reference to Corixas Form 10-Q
(File No. 0-22891), filed with the Commission on
May 15, 2002 |
|
(HH) |
|
Incorporated herein by reference to Corixas
Form 10-QA (File No. 0-22891), filed with the
Commission on December 13, 2004 |
86
|
|
|
(II) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 0-22891), filed with the Commission on
September 24, 2004 |
|
(JJ) |
|
Incorporated herein by reference to Corixas Form 10-Q
(File No. 0-22891), filed with the Commission on
May 6, 2004 |
|
(KK) |
|
Incorporated herein by reference to Corixas Form 10-Q
(File No. 0-22891), filed with the Commission on
November 9, 2004 |
|
(LL) |
|
Incorporated herein by reference to Corixas Form S-1/
A (File No. 333-32147), filed with the Commission on
September 19, 1997 |
|
(MM) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 0-22891), filed with the Commission on
January 6, 2005 |
|
+ |
|
Confidential treatment granted by order of the SEC. |
|
* |
|
Confidential treatment sought by Corixa Corporation from the SEC. |
|
|
|
Filed herewith. |
87
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.
|
|
|
|
|
Michelle Burris |
|
Senior Vice President and Chief Financial Officer |
Date: March 16, 2005
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose
signature appears below constitutes and appoints Steve Gillis
and Michelle Burris, jointly and severally, his or her
attorneys-in-fact, each with the power of substitution, for him
or her in any and all capacities, to sign any amendments to this
Report on Form 10-K, and to file the same, with exhibits
thereto and other documents in connection therewith with the
Securities and Exchange Commission, hereby ratifying and
confirming all that each of said attorneys-in-fact, or his or
her substitute or substitutes may do or cause to be done by
virtue hereof.
88
Pursuant to the requirements of the Securities Exchange Act of
1934, the following persons on behalf of the registrant and in
the capacities and on the dates indicated have signed this
report below.
|
|
|
|
|
|
|
Signature |
|
Title |
|
Date |
|
|
|
|
|
|
/s/ STEVEN GILLIS
Steven
Gillis |
|
Chairman and Chief Executive Officer (Principal Executive
Officer) |
|
March 15, 2005 |
|
/s/ MICHELLE BURRIS
Michelle
Burris |
|
Senior Vice President and Chief Financial Officer (Principal
Financial and Accounting Officer) |
|
March 15, 2005 |
|
/s/ RON HUNT
Ron
Hunt |
|
Director |
|
March 16, 2005 |
|
/s/ GREGORY SESSLER
Gregory
Sessler |
|
Director |
|
March 16, 2005 |
|
/s/ ARNOLD ORONSKY
Arnold
Oronsky |
|
Director |
|
March 16, 2005 |
|
/s/ JAMES YOUNG
James
Young |
|
Director |
|
March 16, 2005 |
|
/s/ ROBERT MOMSEN
Robert
Momsen |
|
Director |
|
March 16, 2005 |
|
/s/ SAMUEL R. SAKS
Samuel
R. Saks |
|
Director |
|
March 16, 2005 |
89
EXHIBIT INDEX
|
|
|
|
|
Exhibit |
|
|
|
|
Number |
|
Exhibit Description |
|
Page |
|
|
|
|
|
3.1
|
|
Fifth Amended and Restated Certificate of Incorporation of Corixa |
|
(FF) |
3.2
|
|
Certificate of Designation of Rights, Preferences and Privileges
of Series A Preferred Stock |
|
(D) |
3.3
|
|
Certificate of Decrease of Shares Designated as Series A
Preferred Stock |
|
(T) |
3.4
|
|
Certificate of Designation of Rights, Preferences and Privileges
of Series B Preferred Stock |
|
(E) |
3.5
|
|
Certificate of Amendment of Certificate of Incorporation |
|
(DD) |
3.6
|
|
Bylaws of Corixa Corporation |
|
(BB) |
3.7
|
|
Amendment No. 1 to Bylaws |
|
(KK) |
3.8
|
|
Amendment No. 2 to Bylaws |
|
(KK) |
4.1
|
|
Indenture dated June 13, 2003 between Corixa Corporation
and Wells Fargo Bank, National Association, as Trustee, for
4.25% Convertible Subordinated Notes due 2008 |
|
(U) |
|
|
|
|
|
|
|
License, Development, Commercialization and Supply Agreements |
|
|
|
|
|
|
|
10.1+
|
|
Multi-Field Vaccine Discovery Collaboration and License
Agreement between Corixa Corporation and SmithKline Beecham plc,
dated September 1, 1998 |
|
(C) |
10.2+
|
|
Amendment No. 1, dated May 25, 2000, to the
Multi-Field Vaccine Discovery Collaboration and License
Agreement between Corixa Corporation and SmithKline Beecham plc,
dated September 1, 1998 |
|
(H) |
10.3+
|
|
Letter Agreement, dated August 16, 2001, between Corixa
Corporation and SmithKline Beecham plc, amending the Multi-Field
Vaccine Discovery Collaboration and License Agreement between
Corixa Corporation and SmithKline Beecham plc, dated
September 1, 1998 |
|
(M) |
10.4+
|
|
Amendment No. 2, dated January 28, 2003, to the
Multi-Field Vaccine Discovery Collaboration and License
Agreement between Corixa Corporation and SmithKline Beecham plc,
dated September 1, 1998 |
|
(S) |
10.5+
|
|
Collaboration and License Agreement dated January 28, 2003
between Corixa Corporation and SmithKline Beecham plc |
|
(S) |
10.6+
|
|
Corixa License Agreement dated January 28, 2003 between
Corixa Corporation and SmithKline Beecham plc |
|
(S) |
10.7+
|
|
Collaboration Agreement dated May 21, 1999 between Corixa
Corporation Inpharzam International |
|
(L) |
10.8+
|
|
Letter Agreement dated November 19, 2001 between Corixa
Corporation and Inpharzam International, amending the
Collaboration Agreement dated May 21, 1999 between Corixa
Corporation Inpharzam International |
|
(S) |
10.9+
|
|
Letter Agreement dated November 15, 2002 between Corixa
Corporation and Inpharzam International, amending the
Collaboration Agreement dated May 21, 1999 between Corixa
Corporation Inpharzam International |
|
(S) |
10.10+
|
|
Amended and Restated License and Collaborative Research
Agreement dated as of December 19, 2002 between Corixa
Corporation and Japan Tobacco Inc. |
|
(S) |
10.11+
|
|
Development and License Agreement dated August 16, 1999
between Zenyaku Kogyo Co., Ltd. and Corixa Corporation |
|
(M) |
10.12+
|
|
Letter Agreement between Corixa Corporation and Zenyaku Kogyo
Co., Ltd. dated August 6, 2001 amending the Development and
License Agreement dated August 16, 1999 between Zenyaku
Kogyo Co., Ltd. and Corixa Corporation |
|
(M) |
10.13+
|
|
License, Development and Commercialization Agreement dated
November 27, 2002 between Corixa Corporation and Kirin
Brewery Company, Ltd. |
|
(P) |
10.14+
|
|
License and Supply Agreement dated May 27, 2003 among
Corixa Corporation, Coulter Pharmaceutical, Inc. and
GlaxoSmithKline Inc. |
|
(V) |
|
|
|
|
|
Exhibit |
|
|
|
|
Number |
|
License, Development, Commercialization and Supply Agreements |
|
Page |
|
|
|
|
|
10.15+
|
|
Settlement Agreement and License between Biogen Idec Inc.,
Corixa Corporation, Coulter Pharmaceutical, Inc., The Regents of
the University of Michigan and SmithKline Beecham Corporation
d/b/a GlaxoSmithKline, dated February 27, 2004 |
|
(HH) |
10.16+
|
|
Letter Amendment to MPL Agreements between Corixa Corporation
and SmithKline Beecham d/b/a GlaxoSmithKline, dated
July 20, 2004 |
|
(II) |
10.17*
|
|
Asset Purchase Agreement among Corixa Corporation, Coulter
Pharmaceutical, Inc. and SmithKline Beecham d/b/a
GlaxoSmithKline, dated December 12, 2004 |
|
|
10.18
|
|
First Amendment, dated December 31, 2004, to the Asset
Purchase Agreement between Corixa Corporation, Coulter
Pharmaceutical, Inc. and SmithKline Beecham d/b/a
GlaxoSmithKline, dated December 12, 2004 |
|
|
10.19
|
|
Second Amendment, dated February 2, 2005, to the Asset
Purchase Agreement between Corixa Corporation, Coulter
Pharmaceutical, Inc. and SmithKline Beecham d/b/a
GlaxoSmithKline, dated December 12, 2004 |
|
|
|
|
|
|
|
|
|
Debt and Equity Investment Agreements |
|
|
|
|
|
|
|
10.20+
|
|
Equity Line of Credit and Securities Purchase Agreement between
Corixa Corporation and Castle Gate, L.L.C., dated April 8,
1999 |
|
(D) |
10.21+
|
|
Amendment No. 1, dated December 21, 2000, to the
Equity Line of Credit and Securities Purchase Agreement between
Corixa Corporation and Castle Gate, L.L.C., dated April 8,
1999 |
|
(E) |
10.22+
|
|
Amendment No. 2, dated December 29, 2000, to the
Equity Line of Credit and Securities Purchase Agreement between
Corixa Corporation and Castle Gate, L.L.C., dated April 8,
1999 |
|
(E) |
10.23+
|
|
Registration Rights Agreement between Corixa Corporation and
Castle Gate, L.L.C., dated April 8, 1999 |
|
(D) |
10.24+
|
|
Standstill Agreement between Corixa Corporation and Castle Gate,
L.L.C., dated April 8, 1999 |
|
(D) |
10.25+
|
|
Warrant Number CG-1 issued by Corixa Corporation to Castle Gate,
L.L.C. on April 8, 1999 |
|
(D) |
10.26+
|
|
Warrant Number CG-2 issued by Corixa Corporation to Castle Gate,
L.L.C. on April 8, 1999 |
|
(D) |
10.27+
|
|
Form of Warrant Number CG-3 to be issued by Corixa Corporation
to Castle Gate, L.L.C. on the occurrence of certain events in
accordance with the terms of the Equity Line of Credit and
Securities Purchase Agreement |
|
(D) |
10.28+
|
|
Form of Warrant Number CG-4 to be issued by Corixa Corporation
to Castle Gate, L.L.C. on the occurrence of certain events in
accordance with the terms of the Equity Line of Credit and
Securities Purchase Agreement |
|
(D) |
10.29+
|
|
Warrant Number CG-5 issued by Corixa Corporation to Castle Gate,
L.L.C. on December 29, 2000 |
|
(E) |
10.30+
|
|
Loan Agreement between Coulter Pharmaceutical, Inc. and
SmithKline Beecham Corporation, dated October 23, 1998 |
|
(G) |
10.31
|
|
First Amendment dated June 28, 2002 to the Loan Agreement
between Coulter Pharmaceutical, Inc. and SmithKline Beecham
Corporation, dated October 23, 1998 |
|
(Q) |
10.32
|
|
Second Amendment, dated August 26, 2003, to the Loan
Agreement between Coulter Pharmaceutical, Inc. and SmithKline
Beecham Corporation, dated October 23, 1998 |
|
(W) |
10.33+
|
|
Security Agreement between Coulter Pharmaceutical, Inc. and
SmithKline Beecham Corporation, dated October 23, 1998 |
|
(G) |
10.34+
|
|
Grant of Security Interest between Coulter Pharmaceutical, Inc.
and SmithKline Beecham Corporation, dated October 23, 1998 |
|
(G) |
10.35
|
|
Registration Rights Agreement dated August 26, 2003 between
Corixa Corporation and SmithKline Beecham Corporation |
|
(W) |
|
|
|
|
|
Exhibit |
|
|
|
|
Number |
|
Debt and Equity Investment Agreements |
|
Page |
|
|
|
|
|
10.36
|
|
Form of Warrant issued by Corixa Corporation to employees of
Shoreline Pacific, LLC on December 3, 2001 |
|
(K) |
10.37
|
|
Loan Agreement between Corixa Corporation and BNP Paribas, dated
August 3, 2001 |
|
(N) |
10.38
|
|
Master Security Agreement between Corixa Corporation and General
Electric Capital Corporation dated February 25, 2002 |
|
(GG) |
10.39
|
|
Promissory Note dated December 31, 2003 in the principal
amount of $7,000,000, by Corixa Corporation in favor of General
Electric Capital Corporation |
|
(FF) |
10.40
|
|
Securities Deposit Pledge Agreement dated December 31, 2004
by Corixa Corporation in favor of General Electric Capital
Corporation |
|
(FF) |
10.41
|
|
Securities Purchase Agreement dated August 9, 2002 among
Corixa Corporation and the purchasers named therein |
|
(Z) |
10.42
|
|
Registration Rights Agreement dated August 9, 2002 among
Corixa Corporation and the investors named therein |
|
(Z) |
10.43
|
|
Registration Rights Agreement dated June 13, 2003 for
4.25% Convertible Subordinated Notes due July 1, 2008 |
|
(U) |
10.44+
|
|
Credit Agreement between Corixa Corporation and NDC New Markets
Investments IV, L.P., dated March 2, 2004 |
|
(JJ) |
10.45
|
|
Promissory Note dated March 2, 2004 in the principle amount
of $14,550,000, by NDC New Markets Investments IV, L.P. in favor
of Corixa Corporation |
|
(JJ) |
10.46
|
|
Security Agreement between Corixa Corporation and NDC New
Markets Investment IV, L.P., dated March 2, 2004 |
|
(JJ) |
10.47
|
|
First Amendment, dated February 28, 2005, to the Security
Agreement between Corixa Corporation and NDC New Markets
Investment IV, L.P., dated March 2, 2004 |
|
|
10.48
|
|
Columbia Building Lease dated October 28, 1994 and Columbia
Building Lease First Amendment dated December 29, 1995,
each between Corixa Corporation and Fred Hutchinson Cancer
Research Center |
|
(A) |
10.49
|
|
Second Amendment to Columbia Building Lease dated
September 25, 1998 between Corixa Corporation and
Alexandria Real Estate Equities, Inc., successor in interest to
Fred Hutchinson Cancer Research Center |
|
(B) |
10.50
|
|
Lease dated May 31, 1996 between Corixa Corporation and
Health Science Properties, Inc. |
|
(A) |
10.51
|
|
First Amendment to Lease dated January 31, 1997 between
Corixa Corporation and Health Science Properties, Inc. |
|
(N) |
10.52
|
|
Second Amendment to Lease dated June 30, 1997 between
Corixa Corporation and Alexandria Real Estate Equities, Inc.,
formerly known as Health Science Properties, Inc. |
|
(N) |
10.53
|
|
Third Amendment to Lease dated November 1, 1998 between
Corixa Corporation and Alexandria Real Estate Equities, Inc.,
formerly known as Health Science Properties, Inc. |
|
(N) |
10.55+
|
|
Lease dated November 7, 1997 between HMS Gateway Office
L.P. and Coulter Pharmaceutical, Inc. |
|
(AA) |
10.55+
|
|
First Amendment to Lease dated November 10, 1998 between
HMS Gateway Office L.P. and Coulter Pharmaceutical, Inc. |
|
(G) |
10.56
|
|
Second Amendment to Lease dated May 19, 2000 between HMS
Gateway Office L.P. and Coulter Pharmaceutical, Inc. |
|
(N) |
10.57+
|
|
Lease dated May 19, 2000 between HMS Gateway Office L.P.
and Boulevard Associates II, LLC, as successor interest to
HMS Gateway Office L.P. and Coulter Pharmaceutical, Inc. |
|
(S) |
10.58+
|
|
First Amendment to Lease dated January 15, 2002 between
Gateway Boulevard Associates II, LLC, as successor interest
to HMS Gateway Office L.P. and Coulter Pharmaceutical, Inc. |
|
(S) |
|
|
|
|
|
Exhibit |
|
|
|
|
Number |
|
Real Estate Agreements |
|
Page |
|
|
|
|
|
10.59+
|
|
Lease Agreement dated October 15, 2002 between Corixa
Corporation and Lifesciences Building, LLC |
|
(O) |
10.60+
|
|
Sublease Agreement dated April 4, 2003 between Coulter
Pharmaceutical, Inc. and Gryphon Therapeutics, Inc. |
|
(CC) |
10.61+
|
|
Sublease Agreement dated May 15, 2003 between Coulter
Pharmaceutical, Inc. and Corgentech, Inc. |
|
(CC) |
10.62
|
|
Sublease Agreement dated September 11, 2003 between Coulter
Pharmaceutical, Inc. and Axys Pharmaceuticals, Inc. |
|
(X) |
10.63
|
|
First Amendment dated September 29, 2003 to Sublease
Agreement dated September 11, 2003 between Coulter
Pharmaceutical, Inc. and Axys Pharmaceuticals, Inc. |
|
(Y) |
10.64
|
|
Standard Form of Agreement Between Owner and Contractor dated
December 22, 2003 between Corixa Corporation and BN
Builders, Inc. |
|
(FF) |
|
|
Stock, Option and Retirement Plans |
|
|
|
|
|
|
|
|
10.65
|
|
2001 Stock Incentive Plan |
|
(I) |
10.66
|
|
1997 Directors Stock Option Plan |
|
(A) |
10.67
|
|
2001 Employee Stock Purchase Plan |
|
(J) |
10.68
|
|
Corixa Corporation 401(k) Savings & Retirement Plan |
|
(LL) |
10.69
|
|
Coulter Pharmaceutical, Inc. 1996 Employee Stock Purchase Plan |
|
(F) |
10.70
|
|
Coulter Pharmaceutical, Inc. 1995 Equity Incentive Plan |
|
(F) |
10.71
|
|
Coulter Pharmaceutical, Inc. 1996 Equity Incentive Plan |
|
(F) |
|
|
Agreements with Officers and Directors |
|
|
|
|
|
|
|
|
10.72
|
|
Form of Indemnification Agreement between Corixa Corporation and
each director and officer of Corixa Corporation |
|
(LL) |
10.73
|
|
Form of Corixa Corporation Executive Employment Agreement |
|
(FF) |
10.74
|
|
Amendment to Form of Corixa Corporation Executive Employment
Agreement |
|
(KK) |
10.75
|
|
Amendment to Form of Corixa Corporation Executive Employment
Agreement entered into between Corixa Corporation and each of
Michelle Burris, David Fanning, Steven Gillis, Ph.D. and
Kathleen McKereghan Deeley |
|
(MM) |
10.76
|
|
Schedule of officers party to Corixa Corporation Executive
Employment Agreement |
|
|
21.1
|
|
Subsidiaries of Corixa Corporation |
|
|
23.1
|
|
Consent of independent registered accounting firm |
|
|
24.1
|
|
Power of Attorney (included on signature page) |
|
|
31.1
|
|
Certification of Chief Executive Officer of Corixa Corporation
required by Rule 13a-14(a) or Rule 15d-14(a) of the
Securities Exchange Act of 1934, as amended |
|
|
31.2
|
|
Certification of Chief Financial Officer of Corixa Corporation
required by Rule 13a-14(a) or Rule 15d-14(a) of the
Securities Exchange Act of 1934, as amended |
|
|
32.1
|
|
Certification of Chief Executive Officer and Chief Financial
Officer of Corixa Corporation required by Rule 13a-14(b) or
Rule 15d-14(b) of the Securities Exchange Act of 1934, as
amended, and 18 U.S.C. Section 1350 |
|
|
|
|
|
(A) |
|
Incorporated herein by reference Corixas Form S-1/ A
(File No. 333-32147), filed with the Commission on
July 25, 1997. |
|
(B) |
|
Incorporated herein by reference to Corixas Form 10-Q
(File No. 0-22891), filed with the Commission on
November 12, 1998. |
|
(C) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 0-22891), filed with the Commission on
November 10, 1998. |
|
(D) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 0-22891), filed with the Commission on
April 23, 1999. |
|
(E) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 0-22891), filed with the Commission on
January 4, 2001. |
|
(F) |
|
Incorporated herein by reference to Corixas Registration
Statement on Form S-8 (File No. 333-52968), filed with
the Commission on December 29, 2000. |
|
(G) |
|
Incorporated herein by reference to Coulter Pharmaceutical,
Inc.s Form 10-K, (File No. 000-21905), filed
with the Commission on March 30, 1999. |
|
(H) |
|
Incorporated herein by reference to Corixas Form 10-Q
(File No. 000-22891), filed with the Commission on
November 6, 2000. |
|
(I) |
|
Incorporated herein by reference to Corixas Registration
Statement on Form S-8 (File No. 333-65394), filed with
the Commission on July 19, 2001. |
|
(J) |
|
Incorporated herein by reference to Corixas Form 10-Q
(File No. 000-22891), filed with the Commission on
August 10, 2001. |
|
(K) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 000-22891), filed with the Commission on
December 17, 2001. |
|
(L) |
|
Incorporated herein by reference to Corixas Form 10-Q
(File No. 000-22891), filed with the Commission on
August 9, 1999. |
|
(M) |
|
Incorporated herein by reference to Corixas
Form 10-K/ A (File No. 000-22891), filed with the
Commission on June 24, 2002. |
|
(N) |
|
Incorporated herein by reference to Corixas Form 10-K
(File No. 000-22891), filed with the Commission on
March 1, 2002. |
|
(O) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 000-22891), filed with the Commission on
October 21, 2002. |
|
(P) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 000-22891), filed with the Commission on
December 5, 2002. |
|
(Q) |
|
Incorporated herein by reference to Corixas Form 10-Q
(File No. 000-22891), filed with the Commission on
August 13, 2002. |
|
(R) |
|
Incorporated herein by reference to Corixas Form 8-K/
A (File No. 000-22891), filed with the Commission on
May 29, 2002. |
|
(S) |
|
Incorporated herein by reference to Corixas Form 10-K
(File No. 000-22891), filed with the Commission on
February 25, 2003. |
|
(T) |
|
Incorporated herein by reference to Corixas Amendment to
Registration Statement on Form 8-A/ A, filed with the
Commission on March 6, 2003. |
|
(U) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 0-22891), filed with the Commission on
June 18, 2003 |
|
(V) |
|
Incorporated herein by reference to Corixas Form 8-K/
A (File No. 000-22891), filed with the Commission on
July 29, 2003. |
|
(W) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 0-22891), filed with the Commission on
September 9, 2003 |
|
(X) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 0-22891), filed with the Commission on
September 11, 2003 |
|
(Y) |
|
Incorporated herein by reference to Corixas Form 8-K/
A (File No. 0-22891), filed with the Commission on
September 29, 2003 |
|
(Z) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 0-22891), filed with the Commission on
August 13, 2002 |
|
|
|
(AA) |
|
Incorporated herein by reference to Coulter Pharmaceutical,
Inc.s Form 10-K (File No. 000-21905), filed with
the commission on March 27, 1998 |
|
(BB) |
|
Incorporated herein by reference to Corixas Form 10-K
(File No. 000-22891), filed with the Commission on
March 30, 2001 |
|
(CC) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 0-22891), filed with the Commission on
June 9, 2003 |
|
(DD) |
|
Incorporated herein by reference to Corixas Form 10-Q
(File No. 0-22891), filed with the Commission on
August 14, 2000 |
|
(EE) |
|
Incorporated herein by reference to the Power of
Attorney granted below in this report on Form 10-K. |
|
(FF) |
|
Incorporated herein by reference to Corixas Form 10-K
(File No. 0-22891), filed with the Commission on
March 9, 2004 |
|
(GG) |
|
Incorporated herein by reference to Corixas Form 10-Q
(File No. 0-22891), filed with the Commission on
May 15, 2002 |
|
(HH) |
|
Incorporated herein by reference to Corixas
Form 10-QA (File No. 0-22891), filed with the
Commission on December 13, 2004 |
|
(II) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 0-22891), filed with the Commission on
September 24, 2004 |
|
(JJ) |
|
Incorporated herein by reference to Corixas Form 10-Q
(File No. 0-22891), filed with the Commission on
May 6, 2004 |
|
(KK) |
|
Incorporated herein by reference to Corixas Form 10-Q
(File No. 0-22891), filed with the Commission on
November 9, 2004 |
|
(LL) |
|
Incorporated herein by reference to Corixas Form S-1/
A (File No. 333-32147), filed with the Commission on
September 19, 1997 |
|
(MM) |
|
Incorporated herein by reference to Corixas Form 8-K
(File No. 0-22891), filed with the Commission on
January 6, 2005 |
|
+ |
|
Confidential treatment granted by order of the SEC. |
|
* |
|
Confidential treatment sought by Corixa Corporation from the SEC. |
|
|
|
Filed herewith. |