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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
(X) ANNUAL REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE
SECURITIES EXCHANGE ACT OF 1934
FOR THE FISCAL YEAR ENDED DECEMBER 31, 1995
( ) TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Commission File Number 0-12406
IMMUNEX CORPORATION
(exact name of registrant as specified in its charter)
Washington 51-0346580
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(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
51 University Street, Seattle, WA 98101
(Address of principal executive offices)
Registrant's telephone number, including area code (206) 587-0430
Securities registered pursuant to Section 12(b) of the Act:
None
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, $.01 par value
Warrants for the Purchase of Shares of Common Stock, $.01 par value
Series B Junior Participating Preferred Stock, $.01 par value
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 x No
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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 Registrant's knowledge, in definitive Proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendments to
this Form 10-K. [ X ]
The aggregate market value of the voting stock held by non-affiliates of
the registrant as of March 13, 1996 was: $233,046,000. Excludes 24,444,000
shares of common stock held by directors, officers and shareholders whose
ownership exceeds five percent of the shares outstanding at March 13, 1996.
Exclusion of shares held by any person should not be construed to indicate that
such person possesses the power, direct or indirect, to direct or cause the
direction of the management or policies of the registrant, or that such person
is controlled by or is under common control with the registrant.
Common stock outstanding at March 13, 1996: 39,601,899 shares.
Documents incorporated by reference:
(1) Portions of the Company's definitive Proxy Statement for the annual meeting
of stockholders to be held on April 25, 1996 are incorporated by reference
in Part III.
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PART I
ITEM 1. BUSINESS
PRODUCTS
Immunex Corporation ("Immunex" or the "Company") is a biopharmaceutical
company that discovers and develops, manufactures and markets innovative
therapeutic products for the treatment of cancer, infectious diseases and
autoimmune disorders.
Immunex is currently manufacturing and marketing LEUKINE-Registered
Trademark- granulocyte-macrophage colony stimulating factor ("GM-CSF"), and
marketing NOVANTRONE-Registered Trademark- (mitoxantrone) and five additional
oncology products (the foregoing products other than LEUKINE, together with
certain other products under development, are referred to herein as the "Lederle
Oncology Products") in the United States. As a result of the 1993 merger (the
"Merger") of Immunex and Lederle Oncology Corporation, a subsidiary of American
Cyanamid Company ("Cyanamid") created for the purpose of merging Cyanamid's
Lederle Laboratories North American oncology business (the "Lederle Oncology
Business") with the biopharmaceutical business of Immunex, Immunex was assigned
certain rights relating to the Lederle Oncology Products in the United States
and Canada. Cyanamid currently owns approximately 54.3% of the outstanding
common stock of Immunex, on a fully diluted basis. In November 1994, American
Home Products Corporation ("AHP") acquired all of the common stock of Cyanamid.
Prior to the acquisition of Cyanamid by AHP, Immunex and AHP entered into an
agreement under which AHP agreed to protect Immunex's rights under its
agreements with Cyanamid and be bound by Cyanamid's obligations under such
agreements, including certain standstill restrictions agreed to by Cyanamid in
connection with the Merger. As discussed below, AHP or various divisions or
affiliates of AHP, including Wyeth-Ayerst Research, Wyeth-Ayerst Laboratories
and Wyeth-Ayerst International, Inc., have assumed certain of the rights and
obligations of Cyanamid under the various agreements that Immunex and Cyanamid
entered into at the time of the Merger or thereafter. In the following
discussion, "AHP" refers to AHP, or its various divisions or affiliates,
including Cyanamid.
Immunex, alone or with Wyeth-Ayerst Research, is testing five new
proprietary biotechnology products in human clinical trials: soluble tumor
necrosis factor receptor fusion protein ("TNFR-Fc"), PIXY321 (a patented colony
stimulating factor fusion protein), soluble IL-1 receptor ("IL-1R"), soluble IL-
4 receptor ("IL-4R") and a humanized monoclonal antibody conjugate ("CMA-676").
Wyeth-Ayerst Research and Immunex are investigating certain other anticancer
compounds on a preclinical basis, including a second humanized monoclonal
antibody conjugate and chemical-based colony-stimulating factor ("CSF")
inducers.
Pharmaceutical products under development are required to undergo several
phases of testing before receiving approval for marketing. In the preclinical
phase, a product is evaluated in animal models of human disease to enable
preparation of an investigational new drug application ("IND"). There are three
phases of clinical trials. In general, Phase I trials determine the safety of a
proposed therapeutic for administration to patients; Phase II trials examine
efficacy and dosing; and Phase III trials, which may be placebo-controlled,
measure the efficacy of a proposed therapeutic in comparison to approved
therapies. These trials generate the data required for regulatory approval to
market products.
Data from human trials are submitted to the Food and Drug Administration
(the "FDA") in a new drug application ("NDA") or a product license application
("PLA") and, with respect to products to be marketed in Canada, to the Canadian
Health Protection Bureau ("CHPB") in a new drug submission ("NDS"). Data
regarding manufacturing and bioequivalence of generic drug products are
submitted to the FDA in an abbreviated NDA ("ANDA") and to the CHPB in an
abbreviated NDS ("A/NDS"). Preparing an NDA, PLA, NDS, ANDA or A/NDS involves
considerable data collection, verification and analysis.
A summary of the Company's products is provided in the following tables.
The information in the tables is provided solely for convenience of reference
and is qualified in its entirety by the detailed discussion of each product and
the related research and development activities following the tables.
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Products for which Immunex owns marketing rights are described in the table
below.
<TABLE>
<CAPTION>
Geographic Development
Product Market Status Clinical Indications
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<S> <C> <C> <C>
LEUKINE-Registered Trademark-
(GM-CSF) U.S. Marketed Bone marrow transplant
engraftment (autologous and
allogeneic) or failure;
acceleration of neutrophil
recovery and reduction of severe
and life-threatening infections
in patients with acute
myelogenous leukemia ("AML");
peripheral blood progenitor cell
("PBPC") mobilization and
transplantation
PLA Filed (1) Treatment of neutropenia
resulting from chemotherapy in
solid tumors
Phase II/III Infectious disease, burns and
trauma patients, neonatal sepsis
LEUKINE-Registered Trademark- (GM-CSF) Worldwide Preclinical Vaccine adjuvancy
slow release formulation
NOVANTRONE-Registered Trademark- U.S. Marketed Acutenonlymphocytic leukemia
mitoxantrone ("ANLL")
Canada Marketed (2) ANLL, advanced breast cancer,
non-Hodgkin's lymphoma,
hepatoma, relapsed acute
lymphotic leukemia
U.S. Phase III Prostate and breast cancers
Phase I/II Non-Hodgkin's lymphoma, ovarian
cancer
THIOPLEX-Registered Trademark- U.S. and Canada Marketed (2) Palliative treatment of a
lyophilized thiotepa variety of tumors
Methotrexate injectable U.S. and Canada Marketed (2) Various neoplastic diseases
AMICAR-Registered Trademark-
aminocaproic acid U.S. and Canada Marketed (2) Hemostasis
LEVOPROME-Registered Trademark-
methotrimeprazine U.S. Marketed Analgesia
Leucovorin calcium U.S. and Canada Marketed Methotrexate rescue, modulation
of 5-fluorouracil ("5-FU") drug
therapy in advanced colorectal
cancer
Etoposide injection U.S. and Canada ANDA filed Testicular and lung cancers
Paclitaxel injection U.S. and Canada ANDA; A/NDS filings
prepared Breast and ovarian cancers
PIXY321 U.S. and Canada Phase III Treatment of thrombocytopenia
and neutropenia resulting from
chemotherapy
TNFR-Fc U.S. and Canada Phase II Rheumatoid arthritis,
Inflammatory bowel disease
("IBD")
</TABLE>
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<TABLE>
<CAPTION>
Geographic Development
Product Market Status Clinical Indications
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<S> <C> <C> <C>
IL-1R U.S. and Canada Phase I Asthma
IL-4R U.S. and Canada Phase I Asthma
CMA-676 monoclonal U.S. and Canada Phase I AML
antibody conjugate
ISOVORIN-Registered Trademark-
levoleucovorin U.S. and Canada NDA filed Methotrexate rescue in osteosarcoma
Phase II/III Modulation of 5-FU drug therapy in
colorectal, breast, head and neck cancers
Flt3-L Worldwide Preclinical Peripheral blood stem cell recruitment, culture and
transplantation, dendritic cell growth, vaccine
adjuvancy
CD40-L Worldwide Preclinical B-cell Non-Hodgkin's lymphoma, epithelial carcinoma,
Hyper IgM syndrome
IL-15 Worldwide Preclinical Mucositis, immune reconstitution in HIV
patients
CSF inducing compound U.S. and Canada Preclinical Prophylaxis and treatment of neutropenia resulting
from chemotherapy
</TABLE>
_______________________________________
(1) LEUKINE is approved in the United States for the clinical
indications described in the foregoing table. Immunex has submitted amendments
to its GM-CSF product license, seeking FDA approval for additional label
indications for prophylaxis of chemotherapy-induced neutropenia in patients with
solid tumors. In 1994, Immunex and AHP re-acquired all rights in GM-CSF
previously held by Behringwerke AG ("Behringwerke"), a subsidiary of Hoechst AG
("Hoechst"). See "Certain Relationships of Immunex - Relationship With Hoechst
AG."
(2) NOVANTRONE, THIOPLEX, methotrexate injectable, AMICAR and
leucovorin calcium, are currently distributed in Canada by Wyeth-Ayerst
International, Inc. pursuant to a distribution agreement with Immunex.
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Certain Immunex products are being developed for marketing by collaborators
under various license agreements. These products, collaborators and clinical
indications are set forth in the table below:
<TABLE>
<CAPTION>
Licensee or Geographic Development
Product Collaborator Market Status Clinical Indications
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<S> <C> <C> <C> <C>
GM-CSF Wyeth-Ayerst EEC, Canada, Argentina, License application recommended Bone marrow transplant
International Brazil, Mexico, Israel, for approval (Canada) engraftment or failure; AML;
Australia, Korea, application filed Brazil, PBPC mobilization and
New Zealand and certain Argentina, Mexico transplantation
republics of the CIS
Phase III (1) Treatment of neutropenia
resulting from chemotherapy
in solid tumors
PIXY321 Wyeth-Ayerst Worldwide except U.S. and Phase I/II Treatment of
International Canada thrombocytopenia and neutropenia
resulting from chemotherapy
IL-1R Behringwerke Worldwide except U.S. and Phase I/II Asthma
Canada
TNFR-Fc Wyeth-Ayerst Worldwide except U.S. and Phase II Rheumatoid arthritis, Crohn's
International Canada disease
IL-2 Roche/Chiron Worldwide except Japan, Marketed (2) Renal cell cancer, melanoma,
Korea and Taiwan response to HIV infection
IL-2 Ajinomoto Japan, Korea and Taiwan Phase III Renal cell cancer, melanoma
IL-4R Behringwerke Worldwide except U.S. and Phase I Asthma
Canada
</TABLE>
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(1) LEUKINE is approved in the United States for the clinical
indications described in the foregoing tables. Immunex produces all
sargramostim marketed in the United States and employed in clinical testing
worldwide, and has agreed to supply AHP's requirements for marketing outside the
United States.
(2) Hoffmann-La Roche, Inc. and its parent, F. Hoffmann La Roche &
Company, Limited Company of Basel, Switzerland (collectively, "Roche"), and
Chiron are parties to certain IL-2 license and marketing agreements, pursuant to
which Roche and a Chiron subsidiary, EuroCetus B.V., are co-promoting Chiron
IL-2 (PROLEUKIN-Registered Trademark- IL-2) in several European countries.
PROLEUKIN IL-2 was approved by the FDA for marketing in the United States in
June 1992 and is being marketed by Cetus Oncology, a wholly owned subsidiary of
Chiron. Under its agreements with Roche, Immunex is receiving royalties on
sales of IL-2 products in Europe and the United States by Roche or Chiron.
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CYTOKINE PRODUCTS
Most of the Company's biotechnology products are recombinant analogs of
cytokines and cytokine receptors. Cytokines are protein messengers that
coordinate the functions of immune cells (white blood cells) and certain other
cells and tissues. Immune cells include: granulocytes, macrophages and
eosinophils, all of which are scavenger cells specialized for uptake and
disposal of foreign particles or infectious agents; B-cells, which produce
antibodies to "flag" foreign particles or diseased cells for destruction;
cytotoxic T-cells and natural killer cells, which recognize, contact and kill
cancerous or virus-infected cells; and helper T-cells, which control and
coordinate the function of other immune cells. Immunex has developed
recombinant cytokine products capable of expanding and activating these immune
cell populations, all of which must interact to provide a normal immune
response. Immunex has also cloned and expressed genes encoding cytokine
receptors. Using genetic engineering techniques, Immunex has produced soluble
versions of cytokine receptors, including fusions of soluble receptors with
fragments of human antibodies, that have been shown to be capable of suppressing
immune responses by binding to and inactivating cytokines.
LEUKINE (SARGRAMOSTIM, GM-CSF). GM-CSF stimulates the growth and
differentiation of granulocytes and macrophages. In 1984, Immunex cloned and
expressed a human GM-CSF gene, and subsequently designed an altered, or analog,
form of the protein. This analog, which is exclusively manufactured by Immunex
using recombinant yeast technology, has been designated "sargramostim."
Sargramostim possesses the biological activity of natural human GM-CSF but is a
chemically distinct molecule. Immunex has been granted two U.S. patents and one
European patent covering sargramostim. Certain competitors, however, have filed
patent applications or have been issued patents relating to GM-CSF that could
adversely affect the Company's ability to market LEUKINE. See "Patents,
Licenses and Trademarks."
Clinical testing has demonstrated that GM-CSF is effective in facilitating
bone marrow transplant ("BMT") therapies currently used for the treatment of
acute leukemia, lymphoma and Hodgkin's disease and in rescuing patients whose
BMT grafts have failed. In March 1991, the FDA approved GM-CSF for facilitating
BMT engraftment and in December 1991 approved GM-CSF for treatment of BMT graft
failure. In March 1993, Immunex filed an amendment to the LEUKINE PLA to obtain
FDA approval for an additional label indication for prophylaxis of
chemotherapy-induced neutropenia. Since the 1993 filing, Immunex has
supplemented the original filing with additional data as it became available.
In April 1995, the FDA Biological Response Modifiers Committee declined to
recommend approval of LEUKINE for the neutropenia indication. The Committee's
decision not to recommend approval contravened a prior agreement between the FDA
and Immunex regarding the acceptability of surrogate clinical endpoints (e.g.,
neutrophil recovery data) as primary endpoints for approval. In view of this
and certain other issues concerning the Committee's decision making process,
Immunex has continued to seek approval of this indication. Immunex has met with
the FDA to discuss various approaches to approval of this indication and updated
its amendment by filing supplemental data acquired from ongoing clinical
studies. Thus, the PLA amendment for the neutropenia indication is still
pending at the FDA. Although Immunex believes that this amendment to the
LEUKINE PLA is approvable, no assurances can be given regarding the duration or
outcome of the FDA review process.
In April 1994, Immunex filed a second amendment to its LEUKINE PLA to
obtain approval of a label indication for acceleration of neutrophil recovery
and reduction of mortality associated with treatment of patients with AML. This
new indication was approved in September 1995. In late 1995, Immunex received
marketing approval of additional label indications for allogeneic BMT and for
PBPC mobilization and transplantation.
In 1994, Immunex began Phase II/III clinical trials to investigate the
efficacy of GM-CSF therapy for preventing infections in premature neonates and
in surgery and trauma patients. A planned cohort analysis in the neonatal
sepsis trial was completed in November 1995, which indicated that the infants
receiving LEUKINE experienced significantly fewer infections. A Phase III study
in this indication is continuing. In January 1995, Immunex filed a supplemental
PLA with the FDA to obtain approval of a liquid formulation of LEUKINE, which
Immunex plans to provide in 500 microgram and 1 milligram multi-dose vials. The
liquid formulation will be more convenient to use and store than the current
lyophilized formulation. The supplemental PLA is currently being reviewed by
the FDA. Immunex has also developed a proprietary microsphere formulation for
LEUKINE that may permit the drug to be administered in a single injection and
slowly released into the body. This formulation may be useful as a vaccine
adjuvant. In 1995, Immunex entered into a research and license agreement with
Johns Hopkins University (JHU) to evaluate the utility of LEUKINE microspheres
in conjunction with certain tumor vaccines being researched by JHU.
PIXY321. In 1991, Immunex commenced clinical trials of a GM-CSF/IL-3
fusion protein that stimulates the body's production of neutrophils and
platelets. In Phase I/II clinical studies conducted in the United States and
Canada, PIXY321 has shown the ability to raise levels of neutrophils and
platelets in patients receiving myelosuppressive chemotherapy. Immunex has been
granted U.S. and European patents covering GM-CSF/IL-3 fusion proteins and
recombinant DNA technologies for producing such fusion proteins. Additional
patents in other countries covering GM-CSF/IL-3 fusion proteins have been
granted or are pending. Certain competitors, however, have filed patent
applications or have been issued patents relating to GM-CSF or IL-3 that could
adversely affect the Company's ability to commercialize PIXY321. See "Patents,
Licenses and Trademarks."
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In January 1992, Immunex and Bristol-Myers Squibb ("BMS") entered into a
product exchange agreement (the "BMS Agreement") relating to the development and
marketing of PIXY321 and certain other oncology products. The BMS Agreement was
terminated by BMS in December 1993, resulting in the return of product rights to
each party. Following the return of rights by BMS, Immunex licensed exclusive
rights for PIXY321 to AHP in all territories except the U.S. and Canada. See
"Relationship with AHP and Cyanamid."
In October 1995, Immunex completed a preliminary analysis of a multicenter
Phase III clinical study of PIXY321 in treating cancer patients receiving BMT
for non-Hodgkin's lymphoma. The results showed that the product was safe and
raised platelets and neutrophils as well as LEUKINE, the control drug used in
the study. However, a statistically significant improvement over the control
drug was not achieved. A Phase I study of PIXY321 following chemotherapy in
pediatric solid tumor patients indicated improvements in recovery of blood cells
of multiple lineages. A Phase III trial that compared PIXY321 to G-CSF in the
setting of high-dose chemotherapy showed no increased benefit from PIXY321. In
view of these results, Immunex and AHP are currently re-assessing whether
further development of PIXY321 is warranted. There can be no assurances that
any further development activities involving PIXY321 will be undertaken.
INTERLEUKIN-2 ("IL-2"). IL-2 is a cytokine that controls the proliferation
and activation of T cells. It can both augment normal immune function and help
restore deficient immune responses. In 1983, Immunex entered into license
agreements with Roche, pursuant to which Immunex is receiving royalties on
worldwide sales of IL-2 products by Roche and its sublicensees, including
Chiron. Chiron's PROLEUKIN-Registered Trademark- IL-2 was approved for
treatment of metastatic renal cancers in several European countries in 1990 and
1991. In June 1992, the FDA approved the marketing of PROLEUKIN IL-2 for
treating metastatic renal cancer patients who are asymptomatic or who are
symptomatic but ambulatory. PROLEUKIN is a trademark of Chiron.
In February 1990, Immunex and Ajinomoto of Japan entered into certain
agreements concerning IL-2 rights in Japan, Korea and Taiwan. Under these
agreements, Immunex is entitled to royalties based on sales of IL-2 in such
countries by Ajinomoto and its licensees.
NEW CYTOKINES. Immunex scientists have cloned genes encoding several new
cytokines that are now being characterized in preclinical studies.
FLT3-L. In 1992, Immunex cloned cDNAs encoding a ligand for the Flt3
receptor ("Flt3-L"). Flt3-L binds to a receptor that is located on primitive
hematopoietic cells, and has been shown to be capable of mobilizing PBPC in
combination with other cytokines such as GM-CSF or G-CSF. Flt3-L is currently
the subject of manufacturing scale-up and preclinical studies intended to assess
the utility of this factor in augmenting harvest of PBPC and other hematopoietic
precursors for transplantation following chemotherapy. Flt3-L has also been
shown to be useful in culturing dendritic cells, specialized immune cells that
are involved in the presentation of antigens to T-cells and therefore provide a
new approach to developing vaccine adjuvants. Immunex plans to commence Phase I
studies of Flt3-L as a PBPC mobilizer in 1996.
INTERLEUKIN-15. In 1992, Immunex also cloned cDNAs encoding a
cytokine now known as Interleukin-15 ("IL-15"), a T cell growth factor that
mimics the effects of IL-2. IL-15 has also shown the ability to protect the
intestinal epithelial cells in the mucosa from the harmful effects of
chemotherapy or radiation. IL-15 was examined in preclinical studies in 1995,
and such studies are anticipated to be continued in 1996.
CD40-L. In 1992, Immunex cloned cDNAs encoding a ligand for the cell
surface antigen CD40 ("CD40-L"). This ligand appears to be a required signal in
the development of an antibody-based immune response. Thus, CD40-L may be
useful as a vaccine adjuvant. In addition, soluble CD40-L has been shown to be
useful in directly arresting the growth of certain B-cell lymphomas and
epithelical cancers in laboratory experiments. Immunex intends to commence
toxicology studies of CD40-L in 1996.
OTHER NEW CYTOKINES: LERKS. Immunex has cloned and expressed cDNAs
for a family of molecules known as "ligands for eph-related protein kinases" or
"LERKS," of which the ligands for Hek and Elk are members. These ligands and
their receptors appear to be involved in cell-to-cell signaling that occurs in
coordinating growth and differentiation of selected cell types. The ligand for
the cell receptor Hek has shown the ability to stimulate neural cell growth. In
1995, Immunex granted an exclusive, royalty-bearing worldwide license for
neurobiology uses under its LERK patent rights and technology to Genentech, Inc.
RECEPTOR PRODUCTS
Cytokines act upon immune cells by binding to specific receptors. The
binding of a cytokine to its receptor triggers a complex series of events within
a responsive cell that transmits the cytokine's signal to that cell. This
signal can stimulate cell division or production of antibodies, enzymes or other
cytokines. In this way, circulating cytokines can control and coordinate the
function of immune cells located throughout the body.
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Using genetic engineering techniques, Immunex scientists have produced
soluble versions of cytokine receptors. A soluble cytokine receptor retains the
ability to bind to a specific cytokine, but lacks that portion of the natural
receptor that is attached to a cell. This property enables the soluble cytokine
receptor to circulate in the body after administration, where it can bind to and
inactivate circulating cytokines, preventing interaction of the cytokines with
immune cells and thereby neutralizing the development of an autoimmune or
inflammatory response. In view of results obtained in certain preclinical and
clinical studies, Immunex believes that soluble cytokine receptors may be
effective as therapeutics to counteract autoimmune or inflammatory diseases.
Immunex owns exclusive rights to IL-1R, IL-4R, IL-7 receptor ("IL-7R") and
TNFR (together, the "Receptor Products") for the United States and Canada.
Pursuant to a 1990 agreement, Immunex granted exclusive rights to Behringwerke
for the Receptor Products for all countries except the United States and Canada.
This grant was made in consideration of a grant by Behringwerke to Immunex of
U.S. comarketing rights for GM-CSF and certain other CSF products. Immunex is
entitled to royalties on future receptor product sales by Behringwerke. In July
1992, Immunex reacquired worldwide rights to TNFR from Behringwerke. See
"Relationship with Hoechst AG." At the effective time of the Merger, Immunex's
rights to TNFR outside the United States and Canada were licensed to Cyanamid
and are currently held by AHP. See "Relationship with Cyanamid and AHP".
TNFR-FC. TNF is a cytokine produced by activated T cells and macrophages
in the course of severe immune reactions, such as the body's response to severe
bacterial infection (sepsis), rheumatoid arthritis, asthma, graft-versus host
disease ("GVHD") and inflammatory bowel disease. Immunex has produced a soluble
TNF receptor fusion protein (p80) that combines two TNF-binding domains derived
from TNF receptor with a fragment of a human antibody molecule. This fusion
protein ("TNFR-Fc") exhibits a long serum half-life and has been shown to be
capable of rapidly lowering serum TNF levels. Immunex has received U.S. and
European patents covering DNAs encoding p80 TNFR and certain related molecules,
and is seeking additional patents covering TNFR-Fc fusions and methods of using
TNFR proteins in treating certain diseases. However, other parties are seeking
or have received patents that could interfere with the commercialization of
TNFR-Fc by the Company or AHP. See "Patents, Licenses and Trademarks."
In November 1995, Immunex completed analysis of a Phase II randomized,
placebo-controlled, blinded clinical study of TNFR-Fc in patients with
rheumatoid arthritis ("RA"), a progressively crippling disorder. Positive and
statistically significant results in favor of treatment with TNFR-Fc were
achieved with respect to multiple clinical endpoints. The Company and AHP
intend to conduct additional Phase III studies of TNFR-Fc in this indication.
The Company has also investigated the use of TNFR-Fc in sepsis and in
Crohn's disease (inflammatory bowel disease). In 1993, Immunex completed a
Phase II dose-ranging, double-blind placebo-controlled trial of TNFR-Fc in
treating patients with sepsis syndrome, a systemic inflammatory response to
infection. Patients in the study were randomly assigned to receive either a
placebo or TNFR-Fc at a low, medium or high dose level. The results of the
study showed no difference between the mortality rate of patients treated with
the lowest dose of TNFR-Fc and those treated with a placebo. Patients treated
at higher doses had worse outcomes than the placebo group. On the basis of this
study, development of TNFR-Fc as a treatment for sepsis has been terminated. A
Phase II study of TNFR-Fc in Crohn's disease patients completed in 1995
indicated drug safety, but beneficial effects were not noted at the doses
studied. Additional trials in the Crohn's disease indication are planned in
order to evaluate alternate dosing regimens.
IL-1R. IL-1R is a molecule that binds both IL-1 alpha and IL-1 beta.
Overproduction or inappropriate production of IL-1 has been implicated in the
development of autoimmune and inflammatory and allergic diseases such as
diabetes, asthma, systemic lupus erythematosis and inflammatory bowel disease,
and also in the development of septic shock. Immunex has produced genetically-
engineered soluble IL-1 receptors of two types, designated Type I and Type II,
and has conducted clinical studies of the Type I receptor. Based upon data
obtained in preclinical and Phase I clinical studies, Immunex believes that
IL-1R may be of therapeutic value in the treatment of a number of diseases and
conditions, including allergy, asthma, chronic and acute myelogenous leukemia,
organ transplant rejection, GVHD and inflammatory bowel disease. Immunex has
been granted five U.S. patents covering mammalian Type I IL-1R DNAs and
proteins, including soluble forms, and two U.S. patent covering Type II IL-1R
DNAs and proteins. Immunex has also been granted two U.S. patents covering
methods of using IL-1R to treat inflammation and allergy.
The Company conducted Phase I/II clinical trials of Type I IL-1R in 1991 in
allergy, rheumatoid arthritis, GVHD, experimental endotoxemia, and asthma
patients. The studies have shown that the product was safe as administered. The
Company is currently evaluating whether it should conduct additional trials
itself or whether it should license its rights in IL-1R to another
pharmaceutical company for further development of an IL-1R product.
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IL-4R. IL-4 is a cytokine that induces the proliferation of activated T
cells and B cells. IL-4 enhances the ability of specific, activated T cells to
kill tumor cells, or infected or transplanted tissue. In addition, IL-4 is
responsible for promoting the production of specific types of antibodies,
including the IgE antibody involved in allergic and asthmatic reactions.
Immunex scientists have cloned genes encoding human and murine IL-4R and have
genetically engineered and produced a soluble receptor which binds IL-4.
Soluble IL-4R has been shown by Immunex and Behringwerke to inhibit IL-4
dependent immune responses in animal models. Based on these preclinical
studies, Immunex believes that soluble IL-4R may be effective in the treatment
of organ transplant rejection, GVHD, allergy, asthma and infectious diseases.
Immunex filed an IND for IL-4R in May 1994. A Phase I/II study of IL-4R in
asthma has recently been completed. The Company is currently evaluating
whether it should conduct additional trials itself or whether it should license
its rights in IL-4R to another pharmaceutical company for further development of
an IL-4R product.
LEDERLE ONCOLOGY PRODUCTS
Effective as of the Merger, Immunex acquired certain intellectual property
rights, including marketing rights, in the United States and Canada relating to
the Lederle Oncology Products, including the following current products:
NOVANTRONE mitoxantrone, leucovorin calcium, thiotepa (including THIOPLEX),
AMICAR aminocaproic acid and LEVOPROME methotrimeprazine. Immunex also acquired
marketing rights in the United States and Canada to methotrexate injectable and
to certain products that are the subject of pending regulatory filings completed
by Cyanamid. These include etoposide, a generic anticancer product that is the
subject of a pending Cyanamid ANDA, and ISOVORIN levoleucovorin. Wyeth-Ayerst
Research and Immunex are also researching and developing certain new
technologies for which Immunex has been assigned U.S. and Canadian rights,
including humanized monoclonal antibody conjugates, a multidrug resistance
reversal agent and an oral CSF inducer. In 1994, Immunex and Cyanamid ceased
developing photodynamic therapy technologies and enloplatin. The rights
acquired by Immunex as a result of the Merger include patents, know-how,
trademarks, clinical and other supporting data, registrations and approvals from
the FDA and the CHPB. Cyanamid also transferred to Immunex its United States
oncology marketing and sales force.
Cyanamid did not transfer any manufacturing facilities, research assets,
other tangible assets or other personnel to Immunex. At the effective time of
the Merger ("Effective Time"), Immunex, Cyanamid and certain of its subsidiaries
entered into agreements providing for, among other things, Immunex's
contribution to and participation in oncology research by Cyanamid, the supply
and toll manufacturing of the Lederle Oncology Products by Cyanamid and Lederle
Parenterals, Inc. ("LPI") and Cyanamid's provision of certain other services to
Immunex. See "Relationship with AHP and Cyanamid."
NOVANTRONE. NOVANTRONE is currently approved for the initial therapy of
ANLL in the United States, and for ANLL, advanced breast cancer, non-Hodgkin's
lymphoma and hepatoma in Canada. NOVANTRONE is an anthracenedione similar in
chemical structure to anthracyclines (doxorubicin and idarubicin), yet lacking
an amino sugar component that is thought to contribute to the cardiotoxicity
characteristic of anthracyclines. NOVANTRONE has a more favorable
nonhematological toxicity profile than anthracyclines; while NOVANTRONE'S use
may result in toxicities similar to those commonly occurring with other
chemotherapeutic agents (nausea, vomiting, alopecia, mucositis and
cardiotoxicity), these can be less frequent and less severe with NOVANTRONE than
with competing anthracycline products. A composition of matter patent covering
mitoxantrone has been assigned to Immunex. This patent expires in August 1997.
However, Immunex owns a U.S. patent, which does not expire until 2006, covering
the use of NOVANTRONE in the treatment of various cancers.
LEUCOVORIN CALCIUM. Leucovorin is a racemic mixture of the dextro- and
levo- isomers of leucovorin used in methotrexate rescue therapy and in
modulation of 5-FU drug therapy in advanced colorectal cancer. Immunex sells
both liquid and tablet formulations of leucovorin. Leucovorin has no
significant patent protection and has significant generic competition. See
"Competition." A liquid formulation of leucovorin is being developed.
THIOTEPA AND THIOPLEX. Thiotepa is a cytotoxic agent approved for the
palliative treatment of a wide variety of tumor types, including adenocarcinomas
of the breast and ovary, superficial papillary bladder cancers and other
lymphomas such as lymphosarcomas and Hodgkin's disease, and for the control of
intracavity effusions secondary to localized or diffuse neoplastic disease of
serosal cavities. Immunex owns manufacturing process patents for thiotepa in
the United States and Canada that expire in 2007. Following FDA approval of an
NDA for THIOPLEX in December 1994, Immunex is now selling and distributing this
lyophilized formulation of thiotepa in the United States. THIOPLEX is more
stable and has a longer shelf life than thiotepa. THIOPLEX is marketed in
Canada by Wyeth-Ayerst International under a distributorship agreement with
Immunex.
METHOTREXATE INJECTABLE. Methotrexate injectable is an antimetabolite used
in the treatment of certain neoplastic diseases. Methotrexate injectable has no
significant patent protection and has significant generic competition. Immunex
distributes methotrexate injectable in the United States pursuant to a
distribution agreement with Cyanamid.
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AMICAR AMINOCAPROIC ACID. AMICAR is a fibrinolysis-inhibitory agent useful
in enhancing hemostasis when fibrinolysis contributes to bleeding, which is
sometimes associated with neoplastic diseases. AMICAR is not subject to any
material patent protection.
LEVOPROME METHOTRIMEPRAZINE. LEVOPROME is a potent injectable analgesic
that is indicated for the relief of pain of moderate to marked degree of
severity in nonambulatory patients. LEVOPROME is not subject to any material
patent protection.
ETOPOSIDE INJECTION. In conjunction with Elkins-Sinn, an AHP affiliate,
the Company is seeking approval of an ANDA for etoposide injection. Etoposide
is a semisynthetic derivative of podophyllotocin used in the treatment of
testicular and small cell lung cancers.
PRODUCT LINE EXTENSIONS
NOVANTRONE MITOXANTRONE. Immunex and Wyeth-Ayerst Research are sponsoring
Phase I and Phase II clinical trials using high dosage NOVANTRONE alone and in
combination with other oncology agents in lung, ovarian, breast and prostate
cancers. One of the protocols being tested involves use of NOVANTRONE in
combination with paclitaxel in breast cancer patients. If successful, these
trials could be expanded and continued to provide the basis for a supplemental
NDA to obtain approval of labeling for new indications.
In May 1995, the Company and its clinical collaborators announced the
completion of a Phase III study of NOVANTRONE in patients with advanced prostate
cancer. When used in combination with steroids, NOVANTRONE therapy had a
significant impact upon pain reduction and quality of life in patients with
hormone-resistant prostate cancer. Patients receiving NOVANTRONE experienced
marked reduction in pain. The drug was well-tolerated, with little or no nausea
or vomiting, and was associated with improvement in various indicators of
quality of life. A second Phase III study of NOVANTRONE in this indication is
scheduled to be completed in 1996. The Company plans to file a supplemental NDA
to obtain approval to market NOVANTRONE for this indication.
LEUCOVORIN CALCIUM. Immunex and Wyeth-Ayerst Research are sponsoring Phase
II clinical trials of leucovorin for use as 5-FU drug modulation therapy in the
treatment of breast, head and neck cancers. In addition, clinical trials of
leucovorin for such therapy in the treatment of advanced colorectal cancer are
nearing completion by third parties. Data from such research may be submitted
to the FDA by Immunex for the foregoing indications. There can be no assurance
that the clinical trial data will be such that Immunex will deem the evidence
adequate to support a supplemental NDA or that, if it does, the FDA will approve
the NDA or will approve it within a time sufficient to permit commercial
success.
ISOVORIN LEVOLEUCOVORIN. As only the levoleucovorin isomer is active
therapeutically, Cyanamid developed and clinically tested a purified, nonracemic
formulation of leucovorin calcium: ISOVORIN levoleucovorin. If approved,
ISOVORIN is expected to be eligible for exclusivity under the Drug Price
Competition and Patent Term Restoration Act of 1984 (the "Waxman-Hatch
Legislation") for three or five years subsequent to any U.S. approval and under
the Orphan Drug Act in the methotrexate rescue indication for seven years
subsequent to any U.S. approval. ISOVORIN is also covered by a compound patent
and a process patent held by third parties and licensed to Cyanamid, each of
which expires in 2005. An NDA for ISOVORIN approval for use in a methotrexate
rescue indication in osteosarcoma was filed in the United States in 1990. There
can be no assurance that the clinical data will be such that the FDA will
approve the NDA or will approve it within a time sufficient to permit commercial
success. Wyeth-Ayerst Research and Immunex are also currently sponsoring Phase
II and Phase III clinical trials investigating ISOVORIN'S benefits in the 5-FU
modulation indication in colorectal, breast, head and neck cancer therapies.
LEDERLE ONCOLOGY PRODUCTS UNDER DEVELOPMENT
HUMANIZED MONOCLONAL ANTIBODY CONJUGATES. The successful clinical
development of mouse monoclonal antibody-based therapies has been limited due to
a human anti-mouse antibody ("HAMA") response. Wyeth-Ayerst Research is
involved in collaborative research and development with Celltech Limited to
develop a series of humanized monoclonal antibody drug conjugates that include a
proprietary calicheamicin antitumor drug previously developed by Cyanamid. In
these conjugates, the mouse amino acid sequences in the antibody portion have
been largely replaced by human amino acid sequences. It is hoped that because
humanized monoclonal antibodies contain a reduced number of mouse amino acid
sequences, they will be less immunogenic and not trigger a HAMA response. Two
lead calicheamicin monoclonal conjugates are expected to be introduced into
clinical trials. The first, CMA-676, was introduced into a Phase I clinical
trial in AML patients in 1995. As with all experimental drugs in preliminary
human clinical trials, there can be no assurance that CMA-676 or other
monoclonal antibody conjugates will prove safe or effective in any clinical
indication.
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PRECLINICAL RESEARCH
Wyeth-Ayerst Research is also investigating, primarily on a preclinical
basis, several other compounds, including agents to combat resistance of tumor
cells to chemotherapeutic drugs and chemical-based CSF inducers to reverse bone
marrow depression, a common side effect of anti-cancer products. No assurance
can be given that any of these compounds will show sufficient safety to enable
commencement of clinical trials or that such trials will show the safety or
efficacy required to gain the regulatory approvals necessary for marketing. Any
commercial products successfully developed from these research projects would be
marketed in the oncology field in the United States and Canada by Immunex. See
"Relationship with AHP and Cyanamid."
PACLITAXEL. Paclitaxel is a chemotherapeutic agent that is extracted from
the bark of the Pacific yew tree. BMS currently markets paclitaxel for
treatment of metastatic breast and ovarian cancers in the United States and
Canada under the trademark TAXOL. At present, BMS is the holder of marketing
exclusivity for paclitaxel in the United States under the Waxman-Hatch
Legislation. The term of this exclusivity expires in December 1997. In 1994,
Cyanamid entered into exclusive supply and research agreements with Hauser
Chemical Research, Inc. ("Hauser") under which Hauser will supply Cyanamid and
its affiliates with their requirements for paclitaxel for development and
marketing worldwide. Cyanamid and Hauser will also collaborate in the
development and testing of new taxane derivatives related to paclitaxel. At the
same time that Cyanamid entered into the research and supply agreements with
Hauser, Immunex and Cyanamid entered into a taxane agreement under which
Cyanamid and Immunex will collaborate in conducting clinical trials and
obtaining regulatory approval of paclitaxel in their respective territories, and
Cyanamid will manufacture and supply product to Immunex for sale in the United
States and Canada. Immunex and AHP will equally share the costs of research and
supply under the Hauser agreements. Currently, Wyeth-Ayerst International and
Immunex are collaborating in the development of paclitaxel for introduction into
the markets for which each holds marketing rights. In 1995, Immunex completed
the filing of an A/NDS for paclitaxel in Canada.
RELATIONSHIP WITH AHP AND CYANAMID
At a special meeting of stockholders held June 1, 1993, the stockholders of
predecessor Immunex Corporation ("Predecessor") approved and adopted an Amended
and Restated Agreement and Plan of Merger dated as of December 15, 1992 (the
"Merger Agreement") among Predecessor, Cyanamid, LPI and Lederle Oncology
Corporation, a wholly owned subsidiary of Cyanamid ("Merger Subsidiary").
Pursuant to the Merger Agreement, Predecessor was merged with and into Merger
Subsidiary in accordance with the General Corporation Law of the State of
Delaware, with the Merger Subsidiary as the surviving corporation. In 1994, the
Company re-incorporated in the state of Washington. Prior to the Merger,
Cyanamid and LPI contributed to Merger Subsidiary certain assets and contractual
obligations of the Lederle Oncology Business, together with $350 million in
cash.
As a result of the Merger, the separate corporate existence of Predecessor
ceased, and the assets and liabilities of Predecessor and Merger Subsidiary
became the assets and liabilities of a new corporation that was renamed "Immunex
Corporation." Each share of Predecessor Common Stock outstanding immediately
prior to the effective time of the Merger ("Effective Time") was converted into
the right to receive $21 in cash (the "Cash Consideration"), and one share of
common stock of the surviving corporation (the "Stock Consideration" and,
together with the Cash Consideration, the "Merger Consideration"). A
substantial portion of the $350 million contributed to Merger Subsidiary by
Cyanamid was used to pay the Cash Consideration.
The common stock of Merger Subsidiary outstanding immediately prior to the
Effective Time, all of which was held by Cyanamid and LPI, was converted into
that number of shares of the Company's Common Stock equal to 53.5% of the total
number of shares of Common Stock outstanding immediately following the Effective
Time on a fully diluted basis. No appraisal rights were perfected. By
acquiring all of the common stock of Cyanamid in late 1994, American Home
Products became the effective owner of the shares of the Company's common stock
held by Cyanamid.
Simultaneously with entering into the Merger Agreement, Predecessor,
Cyanamid and Merger Subsidiary entered into an Amended and Restated Governance
Agreement ("Governance Agreement"), which sets forth, among other things,
certain agreements of the parties relating to (i) the corporate governance of
Immunex, including the composition of its Board of Directors (the "Immunex
Board"), (ii) rights of Cyanamid to purchase additional shares of Immunex Common
Stock from Immunex upon the occurrence of certain events, (iii) future
acquisitions and dispositions of Immunex securities by Cyanamid, (iv) the right
of members of the Immunex Board designated by Cyanamid to approve certain
corporate actions of Immunex, (v) the requirement that a supermajority of the
members of the Immunex Board approve certain corporate actions of Immunex, and
(vi) payments to be made by Cyanamid to Immunex in the event that products of
the Lederle Oncology Business and certain other products of Immunex do not
achieve net sales targets. AHP has agreed to protect Immunex's rights under the
agreement and be bound by certain standstill restrictions set forth there-in.
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The specified net sales targets for the Lederle Oncology Business are as
follows: $120,600,000 in 1993 (reduced proportionately to reflect the portion
of the year Immunex sold products of the Lederle Oncology Business),
$154,600,000 in 1994, $168,600,000 in 1995, $190,500,000 in 1996 and
$216,500,000 in 1997. In the event that the expected revenues are not achieved
for any year, AHP will be obligated to make certain payments. In no event will
AHP's payment obligations exceed $56,000,000 for 1996 and $60,000,000 for 1997.
Pursuant to the Merger Agreement, Cyanamid, Immunex and certain of their
respective subsidiaries entered into certain agreements (collectively, the
"Related Agreements"). The Related Agreements include a Research and
Development Agreement relating to ongoing cooperation in research and
development and the parties' commercialization of products resulting from such
efforts. Pursuant to this agreement, Immunex and Cyanamid established a
collaboration committee to supervise and coordinate oncology research and
development activities. This committee is now comprised of representatives of
Wyeth-Ayerst Research and Immunex. Immunex is providing financial support for
the oncology research and development program conducted by Wyeth-Ayerst
Research. This agreement and another Related Agreement together provide for the
commercialization of new oncology products by Immunex in the United States and
Canada, and by AHP elsewhere. To the extent Immunex develops products or
technology other than new oncology products and determines not to market such
products or technology itself, Immunex has agreed to offer to AHP exclusive
marketing rights to any such products or technology before offering any
marketing rights to third parties. Other Related Agreements provide for, among
other matters, the supply and toll manufacture by Cyanamid or its subsidiaries
for Immunex or its subsidiaries of the oncology products of the Lederle Oncology
Business, the licensing by Cyanamid or its subsidiaries to Immunex of the
LEDERLE and other trademarks for use on Immunex products, and various other
implementing licenses and distribution agreements. The Related Agreements,
together with the Governance Agreement, establish the framework for the ongoing
relationship between Immunex and AHP.
On November 1, 1995, AHP presented Immunex with an offer to acquire the
remaining shares of Immunex stock not held by AHP for $14.50 per share. The
Company's Board of Directors formed a Special Committee to consider the offer,
comprising all directors other than the directors that AHP is entitled to
designate pursuant to the Governance Agreement. The Special Committee retained
Alex. Brown & Sons, Incorporated, as the Special Committee's financial advisor.
After considering the offer and the recommendations of its financial and legal
advisors, the Special Committee informed AHP that it had decided to reject AHP's
offer as being inadequate.
In December 1995, AHP and Immunex entered into certain research and license
agreements under which Immunex granted AHP exclusive worldwide rights to develop
compounds that inhibit an enzyme known as TNF-alpha converting enzyme, or TACE.
TACE is involved in the processing of cell-bound TNF to provide circulating TNF.
There is evidence that inhibiting this enzyme may be beneficial in treating
inflammatory diseases and conditions such as RA. Under the agreements, AHP will
screen compounds using recombinant TACE provided by Immunex. Immunex will
receive license fees, research payments, commercial development milestones and
royalties on any compounds that are commercialized by AHP.
RELATIONSHIP WITH HOECHST AG
Pursuant to a 1984 research and license agreement that has been amended
periodically, Immunex and Hoechst, through its subsidiary Behringwerke, have
conducted an international collaborative research effort focusing on CSFs.
Under the agreement, Immunex granted exclusive worldwide license rights to
Behringwerke to develop, manufacture and market CSF products in consideration
for technology transfer payments, research support payments, and royalties on
sales of licensed products. Immunex and Behringwerke, together with
Behringwerke's U.S. affiliate, Hoechst-Roussel Pharmaceuticals, Inc., ("HRPI")
collaborated in the clinical development of GM-CSF (sargramostim) in the United
States. In 1989, Immunex acquired co-marketing rights to sargramostim in the
United States and from March 1991 to April 1993, Immunex and HRPI co-marketed
sargramostim in the United States. Immunex acquired HRPI's United States rights
in April 1993. Behringwerke applied for European approvals to market
sargramostim for bone marrow transplant indications, and initiated Phase III
clinical trials in Europe for treatment of prophylaxis of neutropenia resulting
from radiotherapy or chemotherapy. However, due to a blocking patent owned by
Sandoz, Behringwerke elected not to attempt to commercialize GM-CSF in Europe.
See "Patents, Licenses and Trademarks." Immunex reacquired worldwide rights to
sargramostim from Behringwerke in 1994, and licensed the rights previously held
by Behringwerke to AHP. Immunex has agreed to supply AHP's requirements for
marketing outside the United States. Immunex also assumed responsibility for
financing the completion of certain European trials begun by Behringwerke, in
order to acquire data useful in obtaining registration of the product in other
countries. In 1990, Immunex also granted Behringwerke exclusive license rights
to the Receptor Products for development and marketing outside the United States
and Canada. Pursuant to a 1992 agreement between Behringwerke and Immunex,
Immunex reacquired Behringwerke's worldwide rights to TNFR, which it has
licensed to AHP. Immunex is entitled to certain payments and royalties on sales
of the other Receptor Products licensed to Behringwerke or its sublicensees.
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RELATIONSHIP WITH TARGETED GENETICS CORPORATION
Targeted Genetics Corporation ("Targeted Genetics") was formed by Immunex
in 1989 to develop proprietary human gene therapy treatments for acquired and
inherited diseases. Targeted Genetics focuses on cytotoxic T lymphocytes as a
therapy for infectious diseases and cancer; in vitro delivery of genes to non-
dividing cells, such as lung cells; and modification of peripheral blood stem
cells in order to correct genetic blood disorders. Immunex currently holds an
equity interest in Targeted Genetics. Immunex granted a worldwide, exclusive
field of use license to Targeted Genetics for certain Immunex technology
applicable to gene therapy. In exchange, Targeted Genetics issued shares of
stock to Immunex and agreed to license to Immunex new technology developed by
Targeted Genetics in the area of cytokines. In addition, Targeted Genetics
granted Immunex a right of first offer with respect to non-cytokine technology
if Targeted Genetics intends to pursue a license agreement with a third party.
MARKETING AND DISTRIBUTION
Immunex sells its products through a specialized oncology-based sales force
that consists of approximately 101 sales representatives and sales managers.
The Company sells its products both to pharmaceutical wholesalers and end users
such as oncology clinics, hospitals and pharmacies. Orders are received and
processed by the Company through a centralized customer service and sales
support group. Shipping, warehousing and certain data processing services are
provided on a fee basis by an outside contractor.
COMPETITION
Competition in researching, developing, manufacturing and marketing
biopharmaceuticals and other oncology products is intense. Immunex is marketing
a group of cancer products and simultaneously developing an extensive portfolio
of cytokines, cytokine receptors and other immunological therapeutic products.
There are other companies, including established pharmaceutical and
biotechnology companies, that are researching, developing and marketing
products, based on related or competing technologies, that will compete with
products being developed by Immunex. Most of the cancer products marketed by
Immunex have established competitors. Significant competitors in the field of
oncology include BMS and Amgen Inc. ("Amgen"). These competitors, in certain
cases, have substantially greater capital resources, greater marketing
experience, and larger research and development staffs and manufacturing
facilities than Immunex.
Several companies are marketing or developing products that compete or are
expected to compete with LEUKINE. One such company, Amgen, has been marketing
its competing G-CSF product since early 1991 and has achieved a majority share
of the U.S. market for CSFs.
Immunex and other pharmaceutical firms compete primarily in performing
research and clinical testing, acquiring patents, developing efficient
manufacturing processes, securing regulatory approvals and marketing the
resulting products to physicians. Immunex believes that its strategic focus on
immunology has resulted in expertise that can be applied to reduce development
times, create innovative and cost-saving research techniques, optimize product
quality, and discover new products and applications. Immunex possesses
manufacturing facilities to produce recombinant protein products using microbial
or mammalian cell culture technologies. Professional clinical, legal,
regulatory affairs, marketing and sales staffs have been developed to enhance
the Company's scientific resources. Immunex possesses a specialized, well-
trained oncology sales force and comprehensive professional services, including
continuing medical educational programs, publications, literature searches and
treatment information. These professional services are important because,
historically, new anticancer drugs have provided incremental treatment advances,
but few outright cures. Therefore, physicians rely heavily on peer-reviewed
clinical data in making treatment decisions.
Competition in the sale of generic pharmaceutical products is intense due
to the entry of multiple sources for each product after expiration of patents
and exclusivity grants previously covering such products. Manufacturers of
generic products compete aggressively, primarily on the basis of price. Immunex
currently faces aggressive generic competition from numerous suppliers on
methotrexate injectable and leucovorin calcium, resulting in lower prices and
lower sales. Thiotepa may be subject to generic competition in the future.
SUPPLY
In general, the raw materials that AHP requires to manufacture the Lederle
Oncology Products are readily available. AHP directly manufactures leucovorin,
THIOPLEX and mitoxantrone. Heinrich Mack Nachf KG ("HMN"), a German company,
currently supplies AHP with all of its requirements of methotrexate.
Methotrexate is purchased pursuant to a supply agreement which commenced in July
1992. The agreement has a minimum term of ten years, with termination requiring
four years' prior notice. Substantially all the raw materials used to
manufacture Immunex's recombinant protein products are available from multiple
sources.
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GOVERNMENT REGULATION
The manufacturing and marketing of pharmaceutical products in the United
States requires the approval of the FDA under the Food, Drug and Cosmetic Act.
Similar approvals by comparable agencies are required in foreign countries. The
FDA has established mandatory procedures and safety standards which apply to the
clinical testing, manufacture and marketing of pharmaceutical and biotechnology
products. Obtaining FDA approval for a new therapeutic product may take several
years and involve expenditure of substantial resources.
The Company's operations are also subject to regulation under, 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 Conservation and Recovery Act, the Comprehensive Environmental
Response, Compensation, and Liability Act, and Title III of the Superfund
Amendments and Reauthorization Act (Community Right-to-Know and Emergency
Response Act).
PATENTS, LICENSES AND TRADEMARKS
Immunex has filed applications for U.S. and foreign patents covering
numerous aspects of its technology. The Company has been granted and maintains
76 U.S. and 258 foreign patents, and currently has 88 patent applications
pending in the United States Patent and Trademark Office (the "USPTO") and 211
applications pending abroad. There can be no assurance that any of its pending
or future applications will result in issued patents. The Company also relies
upon trade secrets, unpatented proprietary know-how and continuing technological
innovation to develop and maintain its competitive position. There can be no
assurance that others will not acquire or independently develop the same or
similar technology, or that the Company's issued patents will not be
circumvented, invalidated or rendered obsolete by new technology.
It is the Company's policy to respect the valid patent rights of others.
Immunex has obtained licenses from various parties covering certain recombinant
DNA technologies it employs to make its products. The Company, however, may
need to acquire additional licenses in the future if its processes are changed
or if patents are awarded to others which cover current processes. The Company
is not aware of the need for any such additional licenses. Competitors of
Immunex, including established pharmaceutical and biotechnology companies, are
seeking to obtain patents covering technologies which Immunex may need to
manufacture or market its products. Competitors of Immunex have obtained or are
seeking patents which, if issued or granted, may have a bearing upon the
Company's ability to successfully commercialize GM-CSF, PIXY321 and TNFR-Fc.
Immunex has been issued three U.S. patents covering an altered, or analog,
form of GM-CSF, that is marketed by the Company under the LEUKINE trademark.
Immunex and several competitors, however, filed patent applications in 1984
disclosing the isolation of mouse and human GM-CSF DNAs. Two such applications
that were filed before Immunex's application included claims which, if such
patents were issued, would be infringed by Immunex's process for making LEUKINE.
A GM-CSF interference proceeding in the United States directed to human GM-CSF
DNAs was declared in July 1990, involving competing U.S. patent applications
filed by or licensed to Immunex, Sandoz AG ("Sandoz"), Research Corporation,
Schering-Plough, Inc. and Biogen, Inc. As of February 1995, all parties to the
intereference except Immunex and Sandoz had been eliminated from future
participation in the priority determination. Proceedings in the interference
were suspended during 1995 to permit the parties to negotiate a settlement of
the interference, and Sandoz and Immunex have discussed the terms of a proposed
settlement. If a settlement cannot be reached and Sandoz were to prevail in the
interference, litigation may result if Sandoz elects to enforce any resulting
GM-CSF patents in the U.S. Sandoz has been granted patents in Europe and
certain other countries covering recombinant GM-CSF technologies that blocks the
Company or its licensees from commercializing GM-CSF in such countries.
Genetics Institute, Inc. owns certain U.S. patents covering recombinant DNA and
protein technologies related to human IL-3. Because PIXY321 is a fusion protein
consisting of analog protein sequences possessing biological activity human
GM-CSF and human IL-3, Sandoz or Genetics Institute may claim that the Company's
making, using or selling of PIXY321 constitutes infringement of such patents.
The outcome of any litigation involving such patents cannot be predicted. If
Immunex were blocked from manufacturing or selling LEUKINE in the United States
or a license could not be obtained upon commercially reasonable terms, the
Company would be materially and adversely affected.
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The TNFR-Fc product being developed by Immunex is a fusion protein
consisting of a dimer of two subunits, each of which comprises a TNF receptor
domain derived from a TNF receptor known as "p80," fused to a segment derived
from a human antibody molecule known as an "Fc domain." Immunex believes that
it was the first to isolate a recombinant DNA encoding p80 TNFR and also the
first to express the protein using recombinant DNA technology. In March 1995,
the Company was granted a U.S. patent covering DNAs encoding p80 TNFR and was
granted a European patent in December 1995. Two other companies, however, BASF
and Yeda Research & Development Co. ("Yeda"), filed patent applications relating
to TNFR proteins shortly prior to the time Immunex filed its patent applications
concerning TNFR DNAs. No patents have been issued to Yeda in the U.S., but two
patents have been granted to Yeda by the European patent office that relate to
TNFR proteins. These patents are the subject of pending opposition proceedings.
Hoffmann-La Roche, Inc. ("Roche") and Synergen Corporation ("Synergen") filed
patent applications directed to p80 TNFR DNAs after the date the Company filed
its application. No patents have been issued to Roche or Synergen. BASF has
been issued a U.S. patent with claims covering certain TNFR proteins that differ
in both structure and function from the fusion protein being tested by Immunex.
If BASF, Roche, Synergen or Yeda were able to assert TNFR patents to cover the
Company's TNFR-Fc product, the Company's or AHP's commercialization of their
TNFR-Fc product would be impeded in any territories in which such patents were
in force. In addition, a U.S. patent was obtained by the Board of Regents of
the University of Texas System that contains claims relating to TNFR-Fc fusions.
However, the Company's TNFR applications disclosing such fusions, as well as
other applications that were filed by other companies after the Company's
application but more than one year prior to the filing date of the Texas
patent, were not considered by the USPTO in its decision to grant a patent to
the Texas applicants. In view of such prior disclosures and publications,
the Company is of the opinion that the relevant claims of the Texas patent
are invalid. Zymogenetics, Inc. and Genentech have been issued U.S. patents
having claims directed to various fusion proteins comprising Fc domains, and
have also filed corresponding European applications which have not yet been
granted. The Company is reviewing the claims of these patents in view of
prior art disclosures of Fc fusion proteins and other technical issues of
patent law to ascertain whether the claims of the Zymogenetics or Genentech
patents can be validly asserted to cover the Company's TNFR-Fc product.
NOVANTRONE is a proprietary product that is covered by several U.S. and
Canadian patents. The last of such patents expires in 2006. Although Immunex
has rights to patents and pending patent applications with respect to
levoleucovorin in the United States and Canada, the protection afforded by these
patents and patent applications does not provide Immunex with patent exclusivity
for levoleucovorin. AHP holds a manufacturing process patent on thiotepa in the
United States and Canada. Although methotrexate is the subject of certain
patents held by AHP, the protection afforded by such patents is not material.
Wyeth-Ayerst Research and Immunex are pursuing several collaborative
preclinical research areas to discover or develop other new oncology products.
AHP and Immunex intend to pursue all protection of all forms of intellectual
property, including, but not limited to, patents, trade secrets, Orphan Drug
exclusivity, and benefits of the Waxman-Hatch legislation, for all inventions,
discoveries and developments in these areas of research.
Under its agreements with licensors of certain patents, Immunex is
obligated to pay process royalties on sales of products produced using certain
basic recombinant DNA processes and related technologies. Certain licenses, for
example the Cohen-Boyer license covering basic recombinant DNA processes, may be
material to the Company; however, the terms of such licenses extend for the life
of the patents licensed and are subject to cancellation by the licensor only
upon default or bankruptcy by Immunex. In addition, Immunex has agreed to pay
Behringwerke product royalties based on sales of LEUKINE, PIXY321 and TNFR-Fc.
Both the process royalties and the product royalties currently payable by the
Company are commensurate in percentage rate to those paid by other companies
developing biotechnology products and are not expected to exceed, in the
aggregate, 10% of net sales. The Company, however, may need to enter into
additional license agreements with other companies concerning LEUKINE, PIXY321
or TNFR-Fc which may require payment of additional product royalties. There can
be no assurance that such license agreements will be available or that the total
royalties payable under such agreements will not adversely affect the Company's
results of operations with respect to such products.
Cyanamid has license arrangements with the University of Strathclyde and
with Eprova AG with respect to levoleucovorin. Cyanamid entered into a
Collaborative Research and Development Agreement with Celltech Limited
("Celltech") concerning the humanized monoclonal antibodies that Wyeth-Ayerst
Research and Immunex are currently developing.
The U.S. and Canadian trademarks for NOVANTRONE, ISOVORIN and THIOPLEX have
been assigned to Immunex. In addition, the LEDERLE trademark in the U.S. and
Canada, and two other trademarks owned and currently used in Canada by Wyeth-
Ayerst International have been licensed to Immunex for use in connection with
current and future oncology products. AHP has the right to terminate the
Lederle trademark licenses in the event that its ownership of Immunex common
stock was to decrease below 50%.
15
<PAGE>
PROPERTIES
In 1986, Immunex purchased for $1.2 million the master lease for the
Immunex Building in Seattle, Washington where its primary laboratory and initial
manufacturing facilities are located. Immunex currently occupies all but a
small percentage of this building. Immunex also leases space in an adjacent
office building that is used for office and administrative purposes. Immunex's
facilities in these two buildings occupy a total of 160,000 square feet. In
1993, the Company signed a lease for 37,000 square feet of additional office
space in a building located near its headquarters. The total of current rental
payments under these leases is approximately $2.8 million per year. The master
lease for the Immunex Building extended through August 1995 and was renewed
through August 2000, with three five-year renewal options. The master lease
calls for rental increases at three-year intervals through 1995 and at five-year
intervals through the renewal periods. An amendment to the master lease in 1994
reduced the rent with no increases through August of 2000. The lease for the
adjacent office building expires in August 2000 and has three five-year renewal
options at market value.
In 1988, Immunex began operating a 10,000 square foot fermentation and
pharmaceutical manufacturing facility located in the Immunex Building for the
production of recombinant protein therapeutics. This facility is designed to
comply with FDA Good Manufacturing Practices, and Immunex has received an
establishment license for this facility as a part of the PLA approval applicable
to GM-CSF. This facility can produce sufficient quantities of recombinant
cytokines using yeast and bacterial fermentation technologies to support
clinical testing, and in addition can produce commercially significant
quantities of GM-CSF. In October 1992, Immunex completed the construction of a
manufacturing and development center in Bothell, Washington which includes a
large-scale microbial manufacturing facility and a separate mammalian cell-based
protein manufacturing facility. These facilities have been used to produce
TNFR-Fc for clinical trials as well as PIXY321. In 1995, both the microbial
manufacturing facility and the mammalian cell facility were used to conduct
contract manufacturing for other companies.
The Company is currently exploring several alternatives in order to meet
its long-term facility needs. The Company also owns approximately 20 acres of
undeveloped land adjacent to its manufacturing and development center in
Bothell, Washington. Immunex has entered into a purchase and sale agreement
with the Port of Seattle concerning the purchase of a 29 acre parcel of land
located in Seattle, Washington, known as Terminal 88. Pursuant to the terms of
the agreement, Immunex will not be committed to complete the purchase until it
has approved the results of complete due diligence review of the property and
obtained a master use permit ("MUP") and other governmental authorizations
needed to enable the property to be developed and used in accordance with the
Company's plans. In 1995, the Company filed an application to the City of
Seattle to obtain the MUP required to develop the site. In February 1996, the
Port of Seattle submitted a environmental impact statement ("EIS") to the City
of Seattle. If the MUP is granted and funding for transportation improvements
is secured by the City of Seattle, the Company must decide whether to close
purchase of the site in the first six months of 1996.
PERSONNEL
As of December 31, 1995, Immunex and its wholly owned subsidiaries employed
a total of 770 persons, of whom 77 hold doctoral degrees, 362 were engaged in
research and development, 132 in manufacturing and 134 in sales and marketing.
Each employee has entered into a confidentiality agreement which contains
provisions requiring disclosure of ideas, developments, discoveries or
inventions conceived during employment, and assignment to the Company of all
proprietary rights to such matters.
ITEM 2. PROPERTIES
See Properties above, under Item 1.
ITEM 3. LEGAL PROCEEDINGS
Immunex is currently a party to a GM-CSF patent interference that may
affect products it is developing or has developed, including GM-CSF and PIXY321.
In addition, an interference may be declared that may affect TNFR-Fc. No
assurance can be given as to the outcome of these interferences. Immunex may be
materially and adversely affected by a negative outcome of any of these
interferences. See Item 1. "Patents, Licenses and Trademarks."
16
<PAGE>
CISTRON LITIGATION. In September 1993, Immunex filed a complaint seeking a
declaratory judgment and injunctive relief against Cistron Biotechnology, Inc.
("Cistron") in the U.S. District Court for the Western District of Washington in
Seattle. On the same day, Cistron filed suit against Immunex in the U.S.
District Court for the District of New Jersey. The New Jersey action was
transferred to the Western District of Washington and Immunex agreed to dismiss
the original Washington action. Immunex has asserted its claim in the original
action as a counterclaim in the transferred action. The case is now pending as
CISTRON BIOTECHNOLOGY, INC. V. IMMUNEX CORPORATION. Cistron asserts that in
1984 Immunex misappropriated information regarding interleukin-1-beta ("IL-1B")
and that such information was used by Immunex in patent applications relating to
IL-1B. Cistron's complaint seeks a declaratory judgment that scientists
associated with Cistron should be named co-inventors of Immunex's patents, and
seeks damages for misappropriation of trade secrets by Immunex and conversion of
Cistron's property interest in certain patents and patent applications. In its
counterclaims Immunex seeks declaratory judgment that it did not misappropriate
any trade secrets of Cistron and seeks entry of an order enjoining Cistron from
engaging in unfair competition by claiming rights in Immunex's patents or patent
applications and by claiming misappropriation of trade secrets. In December
1994, the court granted Cistron's motion to amend its complaint to add a new
claim against Immunex for alleged violation of The Racketeer Influenced and
Corrupt Organizations ("RICO") Act. Cistron also filed a suit against three
former officers of Immunex, alleging that they misappropriated trade secrets and
committed fraud and RICO violations arising from the same facts. The court
consolidated the pending Immunex litigation with the action against the
individual defendants. Claims against one former officer have been dismissed.
Cistron seeks recovery of unspecified actual, punitive and exemplary damages, as
well as costs and attorney's fees.
In December 1994, the court also granted Immunex's motion to amend its
answer and counterclaims to add a new claim against Cistron for a declaration of
non-infringement, invalidity, and unenforceability of Patent No. 4,766,069.
This declaratory judgment claim was withdrawn by Immunex after Cistron filed
declarations agreeing not to sue Immunex for patent infringement.
In October 1995, Immunex filed motions for summary judgment seeking a
ruling that Cistron lost any trade secret protection in 1984, and that all of
Cistron's claims should be dismissed for statute of limitations or laches
reasons. In November 1995, Cistron moved to amend its complaints to add claims
of breach of contract, breach of confidential relationship, and unfair
competition. Cistron's motion to amend its complaint was granted, and Immunex's
motions were denied, by the court in January 1996. Thus, resolution of the
issues raised by the motions has been reserved for trial. Discovery in the case
is substantially complete and trial is scheduled to begin on April 23, 1996.
AHP LITIGATION. On or about November 2, 1995, a purported class action
lawsuit brought on behalf of all of the shareholders of Immunex was filed in the
Superior Court of the State of Washington for King County, titled BARISH V.
FRITZKY ET AL. The defendants are the Company and certain of its officers and
directors as well as AHP. The action arises from the unsolicited offer by AHP
to acquire for cash the 45.7% ownership of the Company which AHP does not
already own. The complaint alleges that the proposed AHP transaction is unfair
and harmful to the Company's minority shareholders. The complaint seeks
injunctive relief against consummation of the proposed AHP transaction. On
November 13, 1995, the Special Committee of the Board of Directors of the
Company advised AHP that it rejected the proposed buy-out offer because it
concluded that the price offered of $14.50 per share was inadequate. Since the
public announcement of that communication, there has been no activity in the
pending case.
Immunex is not a party to any other material litigation.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
No matters were submitted to a vote of the Company's security holders
during the fourth quarter of its fiscal year ended December 31, 1995.
17
<PAGE>
PART II
ITEM 5. MARKET PRICE OF THE REGISTRANT'S COMMON STOCK AND RELATED STOCKHOLDER
MATTERS
The Company's common stock is traded on the Nasdaq National Market under the
symbol IMNX.
The following table sets forth for each period indicated the high and low sales
prices for the Company's common stock as reported on the Nasdaq National Market.
1995 1994
---------------- ----------------
HIGH LOW HIGH LOW
------ ------ ------ ------
1st Quarter 18 1/2 13 3/4 19 3/4 13 3/4
2nd Quarter 18 9 3/4 15 11 1/2
3rd Quarter 17 12 1/4 16 1/2 10 3/4
4th Quarter 17 3/4 11 3/4 18 1/4 11 1/2
There were 1,651 holders of record of the Company's common stock as of December
31, 1995. A significant number of beneficial owners of the Company's common
stock hold their shares in street name.
The Company has not paid any cash dividends since its inception. The Company
currently does not intend to pay any cash dividends in the foreseeable future,
but intends to retain all earnings, if any, for use in its business operations.
ITEM 6. SELECTED FINANCIAL DATA (IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
On June 1, 1993, the Company was merged with and into Lederle Oncology
Corporation, a wholly owned subsidiary of American Cyanamid Company. See Item
7, "Management's Discussion and Analysis of Financial Condition" and the notes
to the consolidated financial statements for a description of the merger. The
selected financial data as of and for the years ended December 31, 1995 and 1994
and the period June 2, 1993 to December 31, 1993, are those of the Company
subsequent to the merger. The selected financial data for the period January 1,
1993 to June 1, 1993 and as of and for the years ended December 31, 1991 and
1992 are those of the Company prior to the merger.
<TABLE>
<CAPTION>
PERIOD PERIOD
6/2/93 1/1/93
TO TO
1995 1994 12/31/93 6/1/93 1992 1991
--------- --------- -------- -------- --------- --------
<S> <C> <C> <C> <C> <C> <C>
Revenues $ 156,616 $ 144,332 $ 95,310 $ 27,556 $ 60,082 $ 51,211
Net income (loss) (11,300) (33,104) (366,135) 64,167) (77,597) 802
Net income (loss)
per common share (.29) (.85) (9.58) (4.17) (5.21) .05
Total assets 174,037 192,665 204,118 - 235,790 254,023
Long-term debt,
including current portion 5,324 50,611 23,450 - 30,224 33,228
Shareholders' equity 136,643 111,927 137,863 - 133,987 212,182
</TABLE>
18
<PAGE>
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
ORGANIZATION
On June 1, 1993, Immunex Corporation (the "Predecessor") was merged into
Lederle Oncology Corporation ("LOC"), a wholly owned subsidiary of American
Cyanamid Company ("Cyanamid"). Prior to the merger, Cyanamid contributed to LOC,
among other things, the rights to certain oncology products in the United States
and Canada ("Lederle Oncology Products") and $350 million in cash. As a result
of the 1993 merger ("Merger"), the assets and liabilities of the Predecessor and
LOC became the assets and liabilities of a new entity which was named Immunex
Corporation (the "Company" or the "Successor"). Holder's of the Predecessor's
common stock received cash consideration of $21 per share and one share of
common stock of the Successor. A substantial portion of the $350 million
contributed by Cyanamid was used to pay the cash consideration of $21 per share.
Cyanamid received that number of shares of Successor common stock equal to 53.5
percent of the Successor's common stock outstanding immediately following the
effective time of the Merger. In addition, pursuant to the Merger, the
Successor and Cyanamid entered into certain agreements relating to cooperation
in research and development activities and the support of manufacturing and
supply of the Lederle Oncology Products.
In November 1994, all of the outstanding shares of common stock of Cyanamid
were acquired by American Home Products Corporation ("AHP"). Prior to the
acquisition of Cyanamid by AHP, the Company and AHP entered into an agreement
under which AHP agreed to protect the Company's rights under its agreements with
Cyanamid. AHP and certain of its divisions or affiliates have assumed certain
of the rights and obligations of Cyanamid under the various agreements that the
Successor and Cyanamid entered into at the time of the Merger or thereafter. As
a result of AHP's acquisition of Cyanamid, AHP now holds a majority interest in
the Successor. All references to AHP include AHP and its various affiliates,
divisions and subsidiaries, including Cyanamid.
The consolidated financial statements for the five months ended June 1,
1993 are those of the Predecessor. The consolidated financial statements for
the seven months ended December 31, 1993 and as of and for the years ended
December 31, 1994 and 1995 are those of the Successor. For comparison to
operating results in 1995 and 1994, operating results of the Predecessor for the
five months ended June 1, 1993 have been combined with operating results of the
Successor for the seven months ended December 31, 1993, unless more meaningful
comparisons could be made by distinguishing between these periods.
RESULTS OF OPERATIONS
OVERVIEW
Following the Merger, revenues of the Company increased due to the addition
of the Lederle Oncology Products to the Predecessor's product line. However, the
revenues generated from the sales of the Lederle Oncology Products were not
sufficient to offset the operating expense levels of the Company. In December
1993, Bristol-Myers Squibb Company ("BMS") terminated a product exchange
agreement with the Company which resulted in the return of marketing rights for
certain products to BMS (the "BMS Products") in early 1994. The loss of the
revenue from the BMS products, combined with the increased operating costs and
funding requirements of the Successor organization, resulted in continued
operating losses in 1994. In response to these developments, the Company
initiated several expense reduction programs including a reorganization of the
sales force, elimination of certain non-essential programs and staffing
reductions across the organization. These expense control measures resulted in
a substantial reduction of operating expenses and improved operating results
during the last six months of 1994.
During 1995, the Company's financial performance improved steadily
throughout the year. For the year ended December 31, 1995, the Company incurred
a net loss of $11.3 million, a reduction of 66 percent compared to the $33.1
million net loss incurred for the year ended December 31, 1994. The improvement
is attributable to a continued focus on controlling operating expenditures and
an increase in operating revenues. The Company has increased operating revenues
in 1995 through a combination of increased product sales, performance of
contract manufacturing services and license fees relating to early stage
research collaborative agreements.
REVENUES
Product sales increased moderately in 1995 to $137.6 million compared to
$135.8 million in 1994 and $119.1 million in 1993. Improvement in product sales
during 1995 is due primarily to growth in sales of NOVANTRONE-Registered
Trademark- (mitoxantrone) and the launch in February 1995 of THIOPLEX-Registered
Trademark- (thiotepa for injection). The increase in product sales in 1994, as
compared to 1993, resulted from the addition of the Lederle Oncology Products to
the Successor's product line following the Merger in June 1993.
19
<PAGE>
Net sales of NOVANTRONE totaled $43.0 million, $39.1 million and $37.2
million in 1995, 1994 and 1993, respectively. The steady increase in NOVANTRONE
sales is attributable to increased sales volume combined with price increases
initiated in 1994 and 1995. In February 1995, the Company launched THIOPLEX,
which is more stable and has a longer shelf life than thiotepa. Following the
product launch and marketing campaign, net sales of THIOPLEX/thiotepa increased
to $20.7 million in 1995, compared to net sales of thiotepa in 1994 and 1993 of
$15.4 million and $14.0 million, respectively. Declining sales volumes and
selling prices resulting from generic competition caused net sales of leucovorin
calcium to decrease to $18.4 million and $19.1 million in 1994 and 1995,
respectively, from $25.4 million in 1993. Sales of the other Lederle Oncology
Products have increased slightly during both 1994 and 1995.
Net sales of LEUKINE-Registered Trademark- (sargramostim) totaled $41.4
million, $45.6 million and $42.1 million in 1995, 1994 and 1993, respectively.
Between the second quarter of 1993 and the first quarter of 1995, sales of
LEUKINE did not fluctuate significantly from quarter to quarter. However, in
early 1995, LEUKINE's unit volume temporarily declined from its historical sales
levels due to what is believed to be certain distribution programs initiated by
a competitor. Sales rebounded in the third quarter and returned to historically
normal levels in the fourth quarter of 1995. The Company's primary strategy
for increasing market share is to expand LEUKINE's approved label indications.
In late 1995, the Company received Food and Drug Administration ("FDA") approval
to market LEUKINE for treatment of acute myelogenous leukemia, allogeneic bone
marrow transplantation and for mobilizing and post transplantion support of
peripheral blood progenitor cells. Although the Company has initiated marketing
campaigns using the expanded label approvals, it is uncertain what the impact,
if any, the expanded label approvals will have on future sales of LEUKINE. In
addition, the Company is seeking an expanded label indication for treatment of
chemotherapy-induced neutropenia in solid tumors. In April 1995, the FDA
advisory committee declined recommendation of LEUKINE in this indication. The
Company subsequently met with the FDA to discuss approaches for approval of
LEUKINE for treatment of chemotherapy-induced neutropenia and has updated its
amendment by filing supplemental data acquired from ongoing clinical studies.
There can be no assurance that the Company will receive approval of this
expanded label indication.
Net LEUKINE revenues could be adversely affected by the resolution of
certain patent and contractual matters. No U.S. patents have been issued with
respect to GM-CSF, but the Company is a party to a patent interference
proceeding directed at establishing which of the parties to the proceeding was
first to invent recombinant DNA technologies for producing GM-CSF. If a patent
were to be granted to the other party, the Company might be required to pay
royalties with respect to future sales of LEUKINE.
In 1992, the Predecessor and BMS entered into a product exchange agreement
whereby the Predecessor received the U.S. marketing rights to the BMS Products
in exchange for the foreign marketing rights to PIXY321. In December 1993, BMS
exercised its option to terminate the agreement and the licenses to each party's
products were returned. As a result, the Company ceased marketing the BMS
Products in early 1994. The BMS Products generated revenues of $2.7 million and
$25.5 million in the years ended December 31, 1994 and 1993, respectively.
Royalty and contract revenue increased to $19.0 million in 1995 compared to
$8.5 million and $3.8 million in 1994 and 1993, respectively. In 1995, the
Company commenced a program of utilizing the available capacity at its
manufacturing development center to perform contract manufacturing services for
certain customers. Revenue recognized from performing these services totaled
$6.4 million in 1995. No related revenue was recognized during the 1994 and
1993 periods. The amount of revenue from these services will fluctuate from
period to period depending on the available capacity at the manufacturing
development center and the demand for these services. The Company also
recognized revenue in 1995 under certain collaborative research agreements. In
December 1995, the Company entered into research and license agreements with AHP
covering tumor necrosis factor alpha converting enzymes ("TACE"), whereby AHP
was licensed exclusive worldwide rights to TACE technology. The Company
received a license fee of $2.0 million upon signing of the agreement and will
receive quarterly payments of $1.0 million beginning in 1996. The TACE
agreement includes milestone payments and royalties on future product sales.
Pursuant to a research and development agreement between the Company and AHP,
the Company is also receiving quarterly payments of $1.0 million from AHP to
support the development of tumor necrosis factor receptor ("TNFR"). The
payments began in 1994 and will continue through 1997 unless AHP elects to
discontinue support of TNFR, in which case rights to TNFR outside North America
will revert to the Company. The Company earns royalties on sales of the Lederle
Oncology Products by AHP outside of North America and generates royalty income
under technology license agreements with other entities. Royalties earned in
1995, 1994 and 1993 totaled $5.8 million, $4.4 million and $2.5 million,
respectively.
20
<PAGE>
OPERATING EXPENSES
Cost of product sales, as a percentage of product sales, decreased to 18
percent for the year ended December 31, 1995 compared to 21 percent and 27
percent for the years ended December 31, 1994 and 1993, respectively. The
decrease in cost of product sales as a percentage of product sales during 1995
is primarily attributable to the February 1995 launch of THIOPLEX, which has a
lower production cost than thiotepa, combined with a favorable change in the mix
of product sales to include a higher percentage of the Company's products with
relatively lower production costs. In addition, the Company has reduced its
trademark royalty obligations on the sale of the Lederle Oncology Products which
bear the Lederle trademark. In 1994, the Company began the process of
discontinuing use of the Lederle trademark. As of the end of 1995 nearly all
of the former Lederle Oncology Products were sold using the Immunex trademark.
Royalties incurred under this agreement decreased to $0.3 million in 1995
compared to $1.7 million and $0.9 million for the year ended December 31, 1994
and the period June 2, 1993 to December 31, 1993, respectively. The cost of
product sales percentage decreased in 1994 from the seven-month period ended
December 31, 1993 due to cessation of the BMS Product sales in early 1994. The
cost of the BMS Products was approximately 40 percent of net sales in 1993.
Cost of product sales, as a percentage of product sales, will fluctuate
moderately from period to period, reflecting any change in the mix of product
sales. Significant fluctuations are not expected to occur unless the mix of
product sales changes substantially or if substantial period costs are incurred
at any of the manufacturing facilities utilized by the Company.
Research and development expense increased to $83.5 million in 1995
compared to $77.6 million and $72.5 million in 1994 and 1993, respectively.
Research and development expense fluctuates from period to period depending on
the number of products under development and the progress those products make
towards commercialization. The focus of the Company's manufacturing activities
also impacts research and development expense from period to period. The costs
to produce products for resale are capitalized to inventory whereas the cost of
producing clinical materials and performing contract manufacturing services are
expensed to research and development. Research and development expense has
increased in each successive period due to the progression of commercial drug
candidates into clinical trials and increased medical development efforts in
pursuit of expanded label indications for existing commercial products. In
addition, the use of the Company's manufacturing resources for the production of
clinical material and performance of contract manufacturing services increased
in 1995, as compared to 1994. Manufacturing costs expensed to research and
development increased in 1994, as compared to 1993, following construction and
validation of the manufacturing development center in April 1993.
Following the Merger, the Company began making payments to fund a portion
of AHP's oncology research and development programs. Payments under this
agreement totaled $15.8 million, $15.3 million and $17.8 million in 1995, 1994,
and the seven-month period ended December 31, 1993, respectively. Under the
terms of the research and development agreement with AHP, the Company's funding
obligation is forecasted to increase to $26.1 million in 1996. Funding of other
external research collaborations increased to $3.7 million in 1995 compared to
$1.1 million and $0.3 million in 1994 and 1993, respectively.
Selling, general and administrative expense declined in 1995 to $59.3
million from $67.7 million and $62.1 million in 1994 and 1993, respectively. The
decrease in selling, general and administrative expenditures in 1995 resulted
primarily from continuation of certain expense reduction and cost control
measures implemented in 1994. These activities included reorganizing and
reducing the size of the sales force, scaling back or eliminating certain non-
essential programs and reducing staff in other areas of the organization. In
connection with the staffing reductions, a charge of $1.7 million was made to
selling, general and administrative expense to cover severance and termination
benefits in the third quarter of 1994. In addition, in 1995, the Company
eliminated, or brought in-house, virtually all of the services provided by AHP
under a transitional services agreement entered into at the time of the Merger.
Costs incurred under this agreement totaled $1.0 million, $6.8 million and $5.9
million in 1995, 1994 and 1993, respectively. These cost reductions have, to a
certain extent, been offset by transition costs and ongoing support costs
associated with bringing these services in-house. The reductions in selling,
general and administrative expense realized in 1995 have also been partially
offset by increased legal defense costs related to litigation between the
Company and Cistron Biotechnology, Inc. ("Cistron"). The Company has incurred
costs totaling approximately $3.7 million in defense of this lawsuit in 1995
compared to $1.2 million in 1994. Trial is currently scheduled for April 1996
and these costs are expected to continue until such time that the litigation is
resolved. Additional expenses were incurred in selling, general and
administrative expense in the fourth quarter of 1995 following AHP's unsolicited
offer to acquire the remaining shares of the Company which it does not already
own. The Company incurred expenses totaling approximately $2.2 million related
to the adoption of certain employee retention programs and costs associated with
investment banking, legal and increased board fees. Additional costs will be
incurred in 1996 related to AHP's offer.
21
<PAGE>
The increase in selling, general and administrative expenses in 1994, as
compared to 1993, was due primarily to the addition of the LOC sales
organization for a full twelve month period, expanded sales and marketing
programs to encompass the Lederle Oncology Products and administrative costs to
support the Successor organization. In addition, the Company began incurring
increased legal fees associated with the Cistron litigation, as noted above.
These increased costs were partially offset by the cessation of certain costs to
market and support the BMS Products which the Company ceased marketing early in
1994.
The Merger resulted in three one-time charges to operations. The Merger
was accounted for using the purchase method, under which the purchase price is
allocated to assets and liabilities acquired based on fair values. In
accordance with generally accepted accounting principles, all of the purchase
price allocated to in-process research and development, totaling $346.4 million,
was expensed by the Company in June 1993. In connection with the Merger,
holders of employee stock options of the Predecessor were given the right to
exercise their options on a cashless basis, whereby employees tendered a portion
of the shares subject to option to satisfy the exercise price. This resulted in
a charge to the Predecessor's compensation expense in May 1993 of $25.6 million.
The Predecessor incurred other Merger-related expenses during the five months
ended June 1, 1993, totaling $14.8 million.
OTHER INCOME (EXPENSE)
Following the receipt of $35.8 million from AHP in March 1995, as
settlement of the 1994 revenue shortfall obligation, the Company paid the $34.0
million outstanding balance on its loan with AHP and made the final $10.6
million payment on its construction loan. No additional borrowings were made
during the year. These developments, combined with significant improvements in
cash generated from operations, led to a moderate increase in interest income in
1995. In addition, interest expense decreased to $1.1 million in 1995 compared
to $2.5 million in 1994. Interest expense in 1994 increased from the 1993 level
due to an increase in borrowings under the AHP loan agreement from $10.0 million
at December 31, 1993 to $34.0 million at December 31, 1994.
Other income (expense) in 1995 consists primarily of the Company's loss
related to its equity investment in Targeted Genetics Corporation ("TGC"). For
the years ended December 31, 1995 and 1994 and the seven-month period June 2,
1993 to December 31, 1993, the Company recorded losses of $0.5 million, $1.0
million and $0.9 million, respectively, related to its equity investment in TGC.
Future losses, if any, are dependent upon TGC's use of its existing cash
reserves and the timing and ability of TGC to generate additional capital. In
no circumstance will future losses exceed the carrying value of the Company's
investment in TGC, which, at December 31, 1995 was $2.4 million. In December
1993, BMS terminated a product exchange agreement with the Company. The Company
had recorded a reserve of $5.4 million related to the potential that additional
consideration would be payable to BMS to retain the exclusive rights to the BMS
Products. This non-cash provision was reversed to other income following
notification of termination of the agreement. This addition to other income was
offset by a charge of $4.5 million in December 1993 related to the settlement of
a class action lawsuit.
The Company's provision for income tax consists of the tax obligation of
the Company's operations in Puerto Rico and income taxes incurred in the states
in which the Company sells its products. In order to reduce current taxes, in
1994, the Company dissolved two of its subsidiaries, including the Puerto Rico
corporation. As a result, the provision for income taxes decreased to $0.2
million for the year ended December 31, 1995, compared to $2.0 million and $1.1
million for the year ended December 31, 1994 and the period June 2, 1993 to
December 31, 1993, respectively. At December 31, 1995, the Company had a net
operating tax loss carryforward of approximately $200 million. The provision
for income taxes is not expected to be significant in 1996.
LIQUIDITY AND CAPITAL RESOURCES
Cash, cash equivalents and securities available-for-sale totaled $20.4
million and $24.7 million at December 31, 1995 and 1994, respectively.
Reflecting the Company's improved financial performance, operating activities
generated cash of $11.4 million in 1995, compared to cash used in operating
activities of $15.7 million in 1994. The cash generated in 1995 was used
primarily for capital expenditures and repayment of a construction loan.
22
<PAGE>
During the year ended December 31, 1995, the Company invested $5.2 million
in plant and equipment. The Company is currently evaluating certain property in
the vicinity of its corporate headquarters for possible development and
relocation of its corporate offices and research facilities. The development of
this property would allow for the potential future expansion of its research
facilities and would support long-term growth of the organization. The Company
has an option on the property and has performed initial environmental impact and
other site studies. In addition to certain remaining purchase contingencies,
management is evaluating the timing and feasibility of this project in the
Company's current operating environment. If the Company moves forward with this
project in 1996, expenditures for land and related closing costs would be
approximately $15 million. Exclusive of the campus development project,
expenditures for furniture and equipment are expected to remain at levels
consistent with 1995. Additionally, in accordance with a 1992 settlement
agreement with Hoechst Roussel Pharmaceutical, Inc. ("HRPI"), a payment of $2.0
million will be made to HRPI if the Company receives an expanded label
indication for LEUKINE for treatment of chemotherapy-induced neutropenia.
The Company used cash of $9.9 million in financing activities during 1995.
In March 1995, the Company received $35.8 million from AHP as settlement of its
1994 revenue shortfall obligation. These funds were used to pay the outstanding
balance on the AHP loan of $34.0 million. In addition, the Company made the
final $10.6 million payment on its construction loan and used $1.0 million for
payment of lease debt and other long-term obligations. The loan agreement with
AHP, under which there were no borrowings at December 31, 1995, expires in March
1996. The Company has not entered into any discussions at this time to extend
the loan agreement and it is uncertain if other sources of short-term financing
could be secured. Under the terms of the Amended and Restated Governance
Agreement, portions of which were assumed by AHP, AHP will make annual payments
to the Company if revenues from the Lederle Oncology Products do not achieve
certain sales levels through 1997. The maximum amount payable with respect to
1996 and 1997 are $56.0 million and $60.0 million, respectively. At December
31, 1995, the Company had a receivable from AHP of $45.3 million, which was
received in March 1996. Other financing activities are not expected to be
significant in 1996.
The positive cash flow gains comparable to those in 1995 may not be
achieved in 1996 due to increases in payments that may be due under the research
and development agreement with AHP. The Company will rely on cash generated
from operations and, if necessary, the revenue shortfall obligation payments
under the Governance Agreement to meet its near-term cash needs. The ability to
meet its cash needs beyond 1997 are largely dependent on the Company's ability
to expand the revenue base of its existing products and to realize value from
its research and development pipeline.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Page in
FORM 10-K
Consolidated Balance Sheets at December 31, 1995 and 1994. 24
Consolidated Statements of Operations for the years ended
December 31, 1995 and 1994 and the periods June 2, 1993 to
December 31, 1993 and January 1, 1993 to June 1, 1993. 25
Consolidated Statements of Shareholders' Equity for the
years ended December 31, 1995 and 1994 and the periods
June 2, 1993 to December 31, 1993 and January 1, 1993
to June 1, 1993. 26
Consolidated Statements of Cash Flows for the years ended
December 31, 1995 and 1994 and the periods June 2, 1993 to
December 31, 1993 and January 1, 1993 to June 1, 1993. 27
Notes to Consolidated Financial Statements for the years
ended December 31, 1995 and 1994 and the periods June 2,
1993 to December 31, 1993 and January 1, 1993 to June 1,
1993. 28 - 39
Report of Ernst and Young LLP, Independent Auditors. 40
23
<PAGE>
IMMUNEX CORPORATION
CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
<TABLE>
<CAPTION>
December 31,
1995 1994
-----------------------
<S> <C> <C>
ASSETS
Current assets:
Cash and cash equivalents $ 20,437 $ 14,818
Securities available-for-sale - 9,919
Accounts receivable - trade, net 17,499 15,517
Accounts receivable - related parties 1,792 1,590
Accounts receivable - other 1,406 1,152
Inventories 8,302 11,725
Other current assets 979 2,618
-------- --------
Total current assets 50,415 57,339
Property, plant and equipment, net 87,540 96,323
Other assets:
Property held for future development or sale, net 5,670 5,658
Investment in affiliate 2,812 3,164
Intangible product rights, net 8,477 9,253
Goodwill, net 15,295 17,358
Patent costs and other, net 3,828 3,570
-------- --------
$174,037 $192,665
-------- --------
-------- --------
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable $18,887 $16,983
Accounts payable - related parties 2,773 4,537
Accrued compensation and related items 8,397 4,109
Current portion of long-term debt 715 11,595
Other current liabilities 2,013 4,498
-------- --------
Total current liabilities 32,785 41,722
Note payable - AHP -- 34,000
Long-term debt and other obligations 4,609 5,016
Shareholders' equity:
Preferred stock, $.01 par value, 5,000,000 shares authorized,
none outstanding -- --
Common stock, $.01 par value, 100,000,000
shares authorized, 39,601,899 and 39,449,199
outstanding at December 31, 1995 and 1994, respectively 592,470 547,182
Guaranty payment receivable from AHP (45,288) (35,768)
Accumulated deficit (410,539) (399,487)
-------- --------
Total shareholders' equity 136,643 111,927
-------- --------
$174,037 $192,665
-------- --------
-------- --------
</TABLE>
See accompanying notes.
24
<PAGE>
IMMUNEX CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
<TABLE>
<CAPTION>
SUCCESSOR PREDECESSOR
Period Period
Year Ended Year Ended June 2, 1993 January 1, 1993
December 31, December 31, to December 31, to June 1,
1995 1994 1993 1993
------------ ------------ -------------- ---------------
<S> <C> <C> <C> <C>
Revenues:
Product sales $137,639 $135,795 $ 92,222 $ 26,833
Royalty and contract revenue 18,977 8,537 3,088 723
-------- -------- --------- --------
156,616 144,332 95,310 27,556
Operating expenses:
Cost of product sales 24,555 28,180 23,537 9,091
Research and development 83,463 77,553 49,715 22,771
Selling, general and administrative 59,318 67,729 41,150 20,985
In-process research and development -- -- 346,359 --
Compensation expense related to
stock option plan modifications -- -- -- 25,624
Merger-related costs -- -- -- 14,830
-------- -------- --------- --------
167,336 173,462 460,761 93,301
-------- -------- --------- --------
Operating loss (10,720) (29,130) (365,451) (65,745)
Other income (expense):
Interest income 1,123 925 645 1,283
Interest expense (1,145) (2,528) (1,021) (159)
Other income (expense), net (312) (413) 777 454
-------- -------- --------- --------
(334) (2,016) 401 1,578
-------- -------- --------- --------
Loss before income taxes (11,054) (31,146) (365,050) (64,167)
Provision for income taxes 246 1,958 1,085 --
-------- -------- --------- --------
Net loss $(11,300) $(33,104) $(366,135) $(64,167)
-------- -------- --------- --------
-------- -------- --------- --------
Net loss per common share $ (.29) $ (.85) $ (9.58) $ (4.17)
-------- -------- --------- --------
-------- -------- --------- --------
Number of shares used for per
share amounts 39,590 39,170 38,203 15,380
-------- -------- --------- --------
-------- -------- --------- --------
</TABLE>
See accompanying notes.
25
<PAGE>
IMMUNEX CORPORATION
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY
(In thousands, except share data)
<TABLE>
<CAPTION>
Guaranty
Common Stock, Payments
$.01 Par Value Receivable Accumu-
------------------------- from lated
Shares Amount AHP Deficit Total
---------- ----------- ---------- ----------- -----------
<S> <C> <C> <C> <C> <C>
Balance, January 1, 1993 (Predecessor) 15,235,526 $ 247,952 $ - $ (113,965) $ 133,987
Issuance of common stock upon the exercise of
stock options and redemption of warrants 504,838 5,050 - - 5,050
Repayment of loans to employees for
exercise of stock options - 62 - - 62
Compensation expense related to stock option
plan modifications - 25,624 - - 25,624
Net loss for the period January 1, 1993 to June 1, 1993 - - - (64,167) (64,167)
---------- ----------- ---------- ----------- -----------
Balance, June 1, 1993 (Predecessor) 15,740,364 $ 278,688 $ - $ (178,132) $ 100,556
---------- ----------- ---------- ----------- -----------
Balance, June 2, 1993 (Successor) 15,740,364 $ 100,556 $ - $- $100,556
Contribution by AHP pursuant to
Merger agreement 21,188,752 733,449 - - 733,449
Payment of $21 per share to shareholders - (386,405) - - (386,405)
Issuance of common stock upon the exercise
of stock options and redemption of warrants 1,790,391 50,561 - - 50,561
Repayment of loans to employees for
exercise of stock options - 5,837 - - 5,837
Guaranty payment receivable from AHP - 7,373 (7,373) - -
Net loss for the period June 2, 1993
to December 31, 1993 - - - (366,135) (366,135)
---------- ----------- ---------- ----------- -----------
Balance, December 31, 1993 38,719,507 511,371 (7,373) (366,135) 137,863
---------- ----------- ---------- ----------- -----------
Issuance of common stock upon the redemption
of warrants 729,692 - - - -
Unrealized loss from securities available-for-sale - - - (248) (248)
Guaranty payment received from AHP - - 7,416 - 7,416
Guaranty payment receivable from AHP - 35,811 (35,811) - -
Net loss for the year ended December 31, 1994 - - - (33,104) (33,104)
---------- ----------- ---------- ----------- -----------
Balance, December 31, 1994 39,449,199 547,182 (35,768) (399,487) 111,927
---------- ----------- ---------- ----------- -----------
Issuance of common stock upon the redemption
of warrants 152,700 - - - -
Change in unrealized loss from securities
available-for-sale - - - 248 248
Guaranty payment received from AHP - - 35,768 - 35,768
Guaranty payment receivable from AHP - 45,288 (45,288) - -
Net loss for the year ended December 31, 1995 - - - (11,300) (11,300)
---------- ----------- ---------- ----------- -----------
Balance, December 31, 1995 39,601,899 $ 592,470 $ (45,288) $ (410,539) $ 136,643
---------- ----------- ---------- ----------- -----------
</TABLE>
See accompanying notes.
26
<PAGE>
IMMUNEX CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
<TABLE>
<CAPTION>
Successor Predecessor
----------------------------------------- ---------
Period Period
June 2, 1993 January 1, 1993
Year Ended Year Ended to to
December 31, December 31, December 31, June 1,
1995 1994 1993 1993
---------- --------- ---------- ---------
<S> <C> <C> <C> <C>
Cash flows from operating activities:
Net loss $ (11,300) $ (33,104) $ (366,135) $ (64,167)
Adjustments to reconcile net loss
to net cash provided by (used in) operating activities:
Depreciation and amortization 15,901 14,559 7,894 2,888
Equity in loss of affiliate 514 974 886 -
In-process research and development - - 346,359 -
Compensation expense related to
stock option plan modifications - - - 25,624
Loss on write-off of property and equipment - - - 3,060
Provision for (reversal of) contractual obligation
under licensing agreement, net - - (3,825) 1,125
Provision for termination benefit payable to former officers - - - 1,680
(Increase) decrease in trade and other receivables (2,438) 5,855 (11,689) (3,440)
(Increase) decrease in inventories 3,423 1,462 (4,653) (1,034)
(Increase) decrease in interest receivable
from securities available-for-sale 128 10 (45) 907
(Increase) decrease in other current assets 1,619 (1,397) 1,301 969
Increase (decrease) in accounts payable, accrued
compensation and other current liabilities 3,551 (4,094) (1,364) 20,300
---------- --------- ---------- ---------
Net cash provided by (used in) operating activities 11,398 (15,735) (31,271) (12,088)
Cash flows from investing activities:
Purchases of property, plant and equipment (5,246) (7,791) (6,119) (5,119)
Proceeds from sales and maturities of securities available-for-sale 9,897 4,076 15,035 71,726
Purchases of securities available-for-sale - (3,917) (11,291) (4,576)
Proceeds from sale of properties - 12,045 - -
Payment of obligation to purchase Receptech common stock - - - (59,774)
Patent costs and other (567) (1,411) (453) 51
---------- --------- ---------- ---------
Net cash provided by (used in) investing activities 4,084 3,002 (2,828) 2,308
Cash flows from financing activities:
Guaranty payment received from AHP 35,768 7,416 - -
AHP line of credit (34,000) 24,000 10,000 -
Construction loan payments (10,600) (4,800) (3,600) (1,200)
Principal payments under capitalized lease obligations (574) (1,612) (892) (691)
Cash contribution by AHP pursuant to Merger - - 350,000 -
Payments to shareholders pursuant to Merger - - (339,437) -
Net proceeds from issuance of common stock - - 4,169 5,050
Repayment of loans for exercise of stock options - - 5,837 62
Other (457) (421) - -
---------- --------- ---------- ---------
Net cash provided by (used in) financing activities (9,863) 24,583 26,077 3,221
---------- --------- ---------- ---------
Net increase (decrease) in cash and cash equivalents 5,619 11,850 (8,022) (6,559)
Cash and cash equivalents, beginning of period 14,818 2,968 10,990 17,549
---------- --------- ---------- ---------
Cash and cash equivalents, end of period $ 20,437 $ 14,818 $ 2,968 $ 10,990
---------- --------- ---------- ---------
</TABLE>
See accompanying notes.
27
<PAGE>
IMMUNEX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1. ORGANIZATION AND BASIS OF PRESENTATION
Immunex Corporation (the "Company") is a biotechnology company that discovers,
develops, manufactures and markets human therapeutic products to treat cancer,
infectious diseases and autoimmune disorders.
The Company operates in a highly regulated and competitive environment. The
manufacturing and marketing of pharmaceutical products requires approval from
and is subject to ongoing oversight by the Food and Drug Administration in the
United States and by comparable agencies in other countries. Obtaining approval
for a new therapeutic product is never certain and may take several years and
involve expenditure of substantial resources. Competition in researching,
developing and marketing pharmaceutical products is intense. Any of the
technologies covering the Company's existing products or products under
development could become obsolete or diminished in value by discoveries and
developments of other organizations.
The Company's market for pharmaceutical products is the United States, Canada
and Puerto Rico. The Company has arrangements with Wyeth-Ayerst Canada, Inc.
and Wyeth-Ayerst Laboratories Puerto Rico, Inc. for distribution and sale of its
pharmaceutical products in Canada and Puerto Rico, respectively. Products are
sold primarily to wholesalers, oncology distributors, clinics and hospitals in
the United States.
The financial statements are prepared in conformity with generally accepted
accounting principles which require management estimates and assumptions that,
to a certain extent, affect the amounts reported on the balance sheet and
disclosure of contingent liabilities at the financial statement date and the
amounts of revenues and expenses reported during the reporting period. Actual
results could differ from those estimates.
On June 1, 1993, the shareholders of Immunex Corporation (the "Predecessor")
approved the Amended and Restated Agreement and Plan of Merger dated as of
December 15, 1992 between the Predecessor, American Cyanamid Company
("Cyanamid"), Lederle Parenterals Inc., ("LPI") a wholly owned subsidiary of
Cyanamid, and Lederle Oncology Corporation, a wholly owned subsidiary of
Cyanamid ("Merger Subsidiary"). Pursuant to this agreement, among other things,
the Predecessor was merged (the "Merger") with and into Merger Subsidiary (see
Note 11). The surviving corporation was named Immunex Corporation, referred to
herein as the "Successor."
Prior to the Merger, Cyanamid and LPI contributed to Merger Subsidiary, among
other things, the rights to certain oncology products in the United States and
Canada, referred to herein as the "Lederle Oncology Products," and $350 million.
Each share of common stock of the Predecessor outstanding immediately prior to
the effective time of the Merger ("Effective Time") was converted pursuant to
the Merger into the right to receive $21 in cash consideration and one share of
common stock of the Successor; and the common stock of Merger Subsidiary
outstanding immediately prior to the Effective Time, all of which was held by
Cyanamid and LPI, was converted pursuant to the Merger into that number of
shares of Successor common stock equal to 53.5% of the total number of shares of
Successor common stock outstanding immediately following the Effective Time, on
a fully diluted basis. A substantial portion of the $350 million contributed by
Cyanamid to Merger Subsidiary was used to pay the cash consideration to
Predecessor shareholders.
In November 1994, all of the outstanding shares of common stock of Cyanamid were
acquired by American Home Products Corporation ("AHP"). Prior to the merger of
Cyanamid and AHP, the Company and AHP entered into an agreement under which AHP
agreed to protect the Company's rights under its agreements with Cyanamid. AHP
and certain of its divisions or affiliates have assumed the rights and
obligations of Cyanamid under the various agreements that the Successor and
Cyanamid entered into at the time of the Merger or thereafter. As a result, AHP
now holds a majority interest in the Successor. All references to AHP include
AHP and its various affiliates, divisions and subsidiaries, including Cyanamid.
The consolidated financial statements for the period January 1, 1993 to June 1,
1993 are those of the Predecessor. The consolidated financial statements as of
December 31, 1995, 1994 and 1993 and for the period June 2, 1993 to December 31,
1993 are those of the Successor.
28
<PAGE>
IMMUNEX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
PRINCIPLES OF CONSOLIDATION
The consolidated financial statements include the accounts of the Company and
its wholly owned subsidiaries. All significant intercompany accounts and
transactions have been eliminated in consolidation.
CASH EQUIVALENTS
Cash equivalents consist principally of deposits in money market accounts
available on demand or securities with purchased maturities of 90 days or less.
SECURITIES AVAILABLE-FOR-SALE
Effective January 1, 1994, the Successor adopted Statement of Financial
Accounting Standards No. 115, "Accounting for Certain Investments in Debt and
Equity Securities. Statement No. 115 requires the classification of certain
investments in debt and equity securities as either held-to-maturity securities,
trading securities or available-for-sale securities. The Successor's
investments are considered available-for-sale, and such securities are stated at
fair value, with the unrealized gains and losses included in accumulated deficit
on the Successor's balance sheet. Cost of securities is calculated using the
specific-identification method. Securities available-for-sale at December 31,
1994 consist primarily of U.S. Government securities, all of which mature within
three years.
INVENTORIES
Inventories are stated at the lower of cost, using a weighted-average method, or
market. The components of inventories at December 31, 1995 and 1994 are as
follows (in thousands):
<TABLE>
<CAPTION>
1995 1994
------- -------
<S> <C> <C>
Raw materials $ 1,295 $ 1,600
Work in process 3,947 6,253
Finished goods 3,060 3,872
------- -------
$ 8,302 $11,725
------- -------
------- -------
</TABLE>
DEPRECIATION AND AMORTIZATION
Depreciation of buildings, equipment and capital leases is calculated using the
straight-line method over the estimated useful lives of the related assets which
range from 3 to 31.5 years. Leasehold improvements are amortized on a straight-
line basis over the lesser of the estimated useful life or the term of the
lease. The costs of acquiring leasehold interests are amortized over the
remaining term of the lease.
PROPERTY HELD FOR FUTURE DEVELOPMENT
The Company owns certain properties intended for the possible future expansion
of its manufacturing facilities which are recorded at cost.
INVESTMENT IN AFFILIATE
The Company owns a 21% equity interest in Targeted Genetics Corporation ("TGC"),
a biotechnology company engaged in developing human gene therapy products for
the treatment of acquired and inherited diseases. The Company records its share
of the net losses of TGC to the extent its cash investment exceeds its interest
in the net tangible assets of TGC. Losses of $514,000, $974,000 and $886,000
were recorded for the years ended December 31, 1995 and 1994 and the period June
2, 1993 to December 31, 1993, respectively. No losses were recorded for the
period January 1, 1993 to June 1, 1993. The market value of the Successor's
investment in TGC at December 31, 1995 is $14,699,000.
29
<PAGE>
IMMUNEX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, CONTINUED
GOODWILL AND OTHER INTANGIBLE ASSETS
Goodwill recorded pursuant to the Merger is being amortized using the straight-
line method over a 10-year period. Accumulated amortization at December 31,
1995 and 1994 totaled $5,271,000 and $3,208,000, respectively.
Intangible product rights recorded pursuant to the Merger are amortized using
the straight-line method over their estimated useful lives ranging from 11 to 15
years. Accumulated amortization at December 31, 1995 and 1994 totaled
$2,006,000 and $1,230,000, respectively.
The Company seeks patent protection on processes and products in various
countries. Patent application costs are capitalized and amortized over their
estimated useful lives, not exceeding 17 years, on a straight-line basis from
the date the related patents are issued. Accumulated amortization at December
31, 1995 and 1994 totaled $210,000 and $194,000, respectively.
REVENUES
Product sales are recognized when product is shipped. The Company performs
ongoing credit evaluations of its customers and does not require collateral.
Product sales are recorded net of reserves for estimated chargebacks, returns,
discounts, Medicaid rebates and administrative fees. The Company maintains
reserves at a level which management believes is sufficient to cover estimated
future requirements. Allowances for discounts, returns and bad debts, which are
netted against accounts receivable, totaled $6,276,000 and $6,536,000 at
December 31, 1995 and 1994, respectively. Reserves for chargebacks, Medicaid
rebates and administrative fees are included in accounts payable and totaled
$9,303,000 and $5,822,000 at December 31, 1995 and 1994, respectively.
Revenues received under royalty, licensing and contract manufacturing agreements
are recognized based on the terms of the underlying contractual agreements.
Expenses related to the performance of contract manufacturing are included in
research and development expense.
NET LOSS PER COMMON SHARE
Net loss per common share is calculated by dividing net loss by the weighted
average number of common shares.
IMPACT OF RECENTLY ISSUED ACCOUNTING STANDARDS
In March 1995, the FASB issued Statement No. 121,"Accounting for the Impairment
of Long-Lived Assets and for Long-Lived Assets to Be Disposed Of," which
requires impairment losses to be recorded on long-lived assets used in
operations when indicators of impairment are present and the undiscounted cash
flows estimated to be generated by those assets are less than the assets'
carrying amount. The Company will adopt Statement No. 121 in the first quarter
of 1996, as allowed for in the statement, and based on current circumstances,
does not believe the effect of adoption will be material.
In October 1995, the FASB issued Statement No. 123, "Accounting for Stock-Based
Compensation," which requires stock-based compensation expense to be measured
using either the intrinsic-value method as prescribed by Accounting Principles
Board Opinion ("APB") No. 25 or the fair-value method described in Statement No.
123. Companies choosing the intrinsic-value method will be required to disclose
the pro-forma impact of the fair-value method on net income and earnings per
share. The Company will adopt Statement No. 123 in the first quarter of 1996,
as allowed for in the statement, using the intrinsic-value method of APB Opinion
No. 25.; there will be no effect of adopting the Statement on the Company's
financial position and results of operations.
30
<PAGE>
IMMUNEX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 3. PROPERTY, PLANT AND EQUIPMENT
Property, plant and equipment, at cost, consist of the following at December 31,
1995 and 1994 (in thousands):
<TABLE>
<CAPTION>
1995 1994
-------- --------
<S> <C> <C>
Land $ 2,140 $ 2,140
Buildings and improvements 49,352 49,304
Equipment 42,747 39,752
Leasehold improvements 19,327 18,902
-------- --------
113,566 110,098
Less accumulated depreciation and amortization (26,026) (13,775)
-------- --------
Net property, plant and equipment $ 87,540 $ 96,323
-------- --------
-------- --------
</TABLE>
Equipment, principally laboratory and office equipment, includes $1,001,000 and
$3,542,000 at December 31, 1995 and 1994, respectively, under capitalized lease
arrangements. Related accumulated amortization was $856,000 and $2,953,000 at
December 31, 1995 and 1994, respectively. The leases contain purchase options
at the end of the lease terms.
NOTE 4. LONG-TERM DEBT AND OTHER OBLIGATIONS
Long-term debt and other obligations consist of the following at December 31,
1995 and 1994 (in thousands):
<TABLE>
<CAPTION>
1995 1994
--------- ---------
<S> <C> <C>
Deferred state sales tax on manufacturing
facility, due in annual installments from 1996 to 2000 $ 3,442 $ 3,442
Termination benefits payable to a former officer 1,125 1,396
Capitalized lease obligations 150 724
Variable rate construction loan - 10,600
Other 607 449
--------- ---------
5,324 16,611
Less current portion (715) (11,595)
--------- ---------
$ 4,609 $ 5,016
--------- ---------
--------- ---------
</TABLE>
In connection with the Merger, termination benefits were awarded to a former
Chief Executive Officer who retired from the Predecessor. Benefits are payable
over approximately 20 years in varying amounts and have been discounted using a
rate of 7%.
Scheduled annual maturities of other obligations in 1997 and the three
subsequent years are as follows: $539,000, $713,000, $886,000 and $1,067,000,
respectively.
Interest paid on all borrowings was $1,226,000, $2,515,000, $1,021,000, and
$159,000 for the years ended December 31, 1995 and 1994, the period June 2, 1993
to December 31, 1993 and the period January 1, 1993 to June 1, 1993,
respectively.
NOTE 5. FAIR VALUES OF FINANCIAL INSTRUMENTS
At December 31, 1995 and 1994, the Company had several categories of financial
instruments. With the exception of the deferred state sales tax, the balance
sheet carrying value for all categories of financial instruments approximate
fair value at December 31, 1995 and December 31, 1994. The fair value of the
deferred state sales tax on the Company's manufacturing facility was estimated
by discounting the future cash flows using the Company's current estimated
incremental borrowing rate for similar types of borrowing arrangements. At
December 31, 1995 and 1994, the fair value of the deferred state sales tax was
$2,685,000 and $2,423,000, respectively, compared to a balance sheet carrying
value of $3,442,000.
31
<PAGE>
IMMUNEX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 6. SHAREHOLDERS' EQUITY
STOCK OPTIONS
Prior to the Merger, Merger Subsidiary adopted the 1993 Stock Option Plan (the
"Plan") which provides for the issuance of incentive and non-qualified stock
options to employees and officers. There have been 6,225,000 shares of common
stock reserved for the plan. Options are granted by a committee of the
Successor's Board of Directors. Under policy of the Successor, options are not
granted at less than the fair market value of the Successor's common stock at
the date of grant. Each outstanding option has a term of ten years from the
date of grant and, depending on the option, becomes exercisable at a rate of 20%
or 33% per year beginning one year from the date of grant.
Information with respect to the Plan follows (in thousands, except per share
amounts):
<TABLE>
<CAPTION>
Shares Subject
to Option Price per Share
-------------- ---------------
<S> <C> <C>
Balance at December 31, 1993 838 $ 17.50 - 31.50
Granted 179 11.75 - 18.88
Canceled (186) 13.13 - 31.50
-------------- ---------------
Balance at December 31, 1994 831 11.75 - 31.50
Granted 445 12.25 - 15.00
Canceled (191) 11.75 - 31.50
-------------- ---------------
Balance at December 31, 1995 1,085 $ 11.75 - 31.50
-------------- ---------------
-------------- ---------------
Options exercisable at
December 31, 1995 249
--------------
--------------
Shares available for future
grants at December 31, 1995 5,140
--------------
--------------
</TABLE>
GUARANTY PAYMENTS RECEIVABLE FROM AHP
Under the terms of the Amended and Restated Governance Agreement, AHP has agreed
to make certain payments or contribute products to the Successor if revenues
from the Lederle Oncology Products do not achieve certain levels ("Expected
Revenues") through December 31, 1997. The revenue shortfall obligation is
limited to a maximum amount in each year ("Maximum Guaranty Obligation"). Such
payments are treated as additional contributions to the capital of the
Successor.
AHP's Maximum Guaranty Obligation and the Expected Revenues for the years ending
December 31, 1996 and December 31, 1997 are as follows (in thousands):
Maximum
Guaranty Expected
Year Ending December 31, Obligation Revenues
- ------------------------ ---------- ---------
1996 $ 56,000 $ 190,500
1997 60,000 216,500
The Successor recorded a receivable from AHP of $45,288,000 and $35,768,000 for
the revenue shortfall related to the Lederle Oncology Products for the years
ended December 31, 1995 and 1994, respectively.
32
<PAGE>
IMMUNEX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 7. INCOME TAXES
The Successor's deferred tax assets consist primarily of the benefit to be
derived from unused net operating tax loss carryforwards of approximately $200
million and carryforwards of approximately $11.5 million for research and
experimental credits at December 31, 1995. The carryforwards expire from 1996
through 2010. Net operating tax loss carryforwards and research and
experimental credits of $113,000 and $6,000, respectively, expired in 1995. Due
to the uncertainty regarding the Successor's ability to generate taxable income
in the future to realize the benefit from its net deferred tax assets at
December 31, 1995 and 1994, a valuation allowance of $79.3 million and $75.2
million, respectively, has been recognized for financial reporting purposes to
offset the excess of the Successor's deferred tax assets over its deferred tax
liabilities. This represents an increase in the valuation allowance of $4.1
million and $17.0 million for the years ended December 31, 1995 and 1994,
respectively. In the event the Successor is able to utilize its net operating
tax loss carryforwards, the carryforwards would be used to first reduce the
unamortized balance of goodwill, followed by the unamortized balance of
intangible product rights and, lastly, federal income tax expense.
The significant components of the Successor's deferred tax assets and
liabilities at December 31, 1995 and 1994 are as follows (in thousands):
<TABLE>
<CAPTION>
1995 1994
--------- ---------
<S> <C> <C>
Deferred tax assets:
Net operating loss carryforwards $70,049 $67,933
Research and experimental credits 11,538 9,564
In-process research and development 1,519 1,818
Accounts receivable allowances 2,196 2,288
Other 3,235 2,296
--------- ---------
Total deferred tax assets 88,537 83,899
Valuation allowance for deferred tax assets (79,261) (75,227)
--------- ---------
Net deferred tax assets 9,276 8,672
Deferred tax liabilities:
Tax over book depreciation 3,989 3,575
Purchase accounting adjustments 3,767 3,783
Other 1,520 1,314
--------- ---------
Total deferred tax liabilities 9,276 8,672
--------- ---------
$ - $ -
--------- ---------
--------- ---------
</TABLE>
The provision for income taxes consist of the following (in thousands):
<TABLE>
<CAPTION>
Period
June 2, 1993 to
Year Ended December 31, December 31,
1995 1994 1993
--------- ---------- ---------------
<S> <C> <C> <C>
Foreign $ - $ 1,616 $ 1,085
State 267 342 -
--------- ---------- ---------------
$ 267 $ 1,958 $ 1,085
--------- ---------- ---------------
--------- ---------- ---------------
</TABLE>
The entire provision for the period is current. Income taxes paid during the
years ended December 31, 1995 and 1994 totaled $1,289,000 and $1,347,000,
respectively. No income taxes were paid during the period June 2, 1993 to
December 31, 1993. For the period January 1, 1993 to June 1, 1993, the
Predecessor was in a net operating loss position for domestic federal income tax
purposes and was not subject to foreign income taxes.
33
<PAGE>
IMMUNEX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 7. INCOME TAXES, CONTINUED
Reconciliation of the U.S. federal tax rate to the Successor's effective tax
rate is as follows:
<TABLE>
<CAPTION>
Period
June 2, 1993 to
Year Ended December 31, December 31,
1995 1994 1993
------- ------- ---------------
<S> <C> <C> <C>
U.S. federal statutory tax rate (35.0)% (35.0)% (35.0)%
Non-deductible amortization of goodwill 6.5 2.3 0.1
Non-deductible merger expense - (4.1) -
In-process research and development - - 33.2
Other 4.0 0.2 0.4
Increase in valuation reserve 36.6 50.5 1.3
Foreign taxes - 5.2 0.3
State taxes 2.4 1.1 -
Foreign income subject to different rates (6.8) (6.5) -
Tax benefit from research and development
expenses and credits (5.3) (7.4) -
---- ---- ----
Effective tax rate 2.4% 6.3% 0.3%
---- ---- ----
< ---- ---- ----
</TABLE>
NOTE 8. EMPLOYEE BENEFITS
As a retirement vehicle, the Successor has a defined contribution plan covering
all full-time salaried employees. The plan is a salary deferral arrangement
pursuant to Internal Revenue Code section 401(k) and is subject to the
provisions of the Employee Retirement Income Security Act of 1974 ("ERISA").
The Successor matches 100% of the first 2% of an employee's deferred salary and
50% of the next 4% of an employee's deferred salary. Employees with five or
more years of service receive a match of 100% of the first 2% of deferred salary
and 75% of the next 4% of deferred salary. The matching contributions to the
plan were $1,370,000, $1,656,000, $773,000 and $408,000 for the years ended
December 31, 1995 and 1994, the period from June 2, 1993 to December 31, 1993
and the period from January 1, 1993 to June 31, 1993, respectively.
NOTE 9. RELATED PARTY TRANSACTIONS
On June 1, 1993, the Predecessor merged with a subsidiary of Cyanamid. In
November 1994, all of the outstanding shares of common stock of Cyanamid were
acquired by AHP. AHP, its subsidiaries and affiliates have assumed the rights
and obligations of Cyanamid under various agreements entered into at the time of
the Merger or thereafter. Significant transactions under these agreements are
summarized below.
GOVERNANCE AGREEMENT
Under the terms of the governance agreement, AHP is required to make certain
payments or contribute products to the Successor if revenues from the Lederle
Oncology Products do not achieve certain established levels through December 31,
1997 (see Note 6). At December 31, 1995 and December 31, 1994, the Successor
had recorded a receivable from AHP of $45,288,000 and $35,768,000 related to the
revenue shortfall for the years ended December 31, 1995 and 1994, respectively.
34
<PAGE>
IMMUNEX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 9. RELATED PARTY TRANSACTIONS, CONTINUED
RESEARCH AND DEVELOPMENT AGREEMENT
The Successor and AHP are parties to a research and development agreement under
which the parties cooperate to research, develop and commercialize new products.
Under the terms of the research and development agreement, the Successor is
required to support AHP's worldwide oncology research and development programs
by paying certain amounts to AHP. In return, the Successor receives the North
American rights to any products resulting from AHP's research programs in
oncology. For the years ended December 31, 1995 and 1994 and the period June 2,
1993 to December 31, 1993, the Successor paid $15,800,000, $15,300,000 and
$17,799,000, respectively, to AHP under the research and development agreement,
which represented it's entire 1995, 1994 and 1993 obligations. For the years
1996 and 1997, the Successor's forcasted funding obligations under the research
and development agreement are $26,100,000 and $38,300,000, respectively, which
represents 37.5% and 50% of AHP's forecasted oncology research and development
budget for each respective year. For years after 1997, the Successor is
obligated to contribute 50% of the cost of AHP's oncology research and
development programs. In order to retain the international rights to TNFR , AHP
is required to pay the Successor $4,000,000 per year through 1997. AHP's entire
1995 and 1994 TNFR obligations were received during each respective year.
ONCOLOGY PRODUCT LICENSE AGREEMENT
The Successor and AHP are parties to an oncology product license agreement under
which AHP has an exclusive license to manufacture in North America certain
oncology products for ultimate sale by AHP and its sub-licensees outside North
America. The Successor earns a royalty equal to 5% of the net sales of the
oncology products sold under this agreement. The Successor recognized revenue
under this agreement of $2,546,000, $2,571,000 and $650,000 for the years ended
December 31, 1995 and 1994 and the period June 2, 1993 to December 31, 1993,
respectively. At December 31, 1995 and 1994, $800,000 was due from AHP.
NEW ONCOLOGY PRODUCT LICENSE AGREEMENT
The Successor and AHP have entered into a new oncology product license agreement
under which AHP has a co-exclusive license to make, have made, use and sell
outside North America new oncology products resulting from the research and
development efforts of the Successor ("New Oncology Products"). AHP is required
to pay a royalty equal to 5% of the net sales of the New Oncology Products sold
under this agreement. In the event that a New Oncology Product is to be
manufactured by the Successor for AHP or by AHP for the Successor, the
manufacturing party will supply such product at a price that will reimburse the
manufacturing party for its manufacturing, process development and overhead
costs allocable to such product, plus a reasonable profit. The Successor
recognized revenue under this agreement of $651,000 and $327,000 for the years
ended December 31, 1995 and 1994, respectively, of which $61,000 and $327,000
was receivable at December 31, 1995 and 1994, respectively. Under the terms of
a subsequent related agreement, the Successor incurred costs of $2,434,000 for
the year ended December 31, 1995 of which $1,472,000 was payable at December 31,
1995.
TACE AGREEMENTS
In December 1995, the Successor licensed exclusive worldwide rights to tumor
necrosis factor alpha converting enzyme ("TACE") technology to AHP. The
Successor received a license fee of $2.0 million upon signing of the agreement
and will receive quarterly payments of $1.0 million beginning in 1996. The TACE
agreements also include milestone payments and royalties on future product
sales. Under the agreements, AHP will be responsible for developing inhibitors
of TACE.
SUPPLY AGREEMENT, TOLL MANUFACTURING AGREEMENT AND METHOTREXATE DISTRIBUTORSHIP
AGREEMENT
The Successor and AHP are parties to a supply agreement and toll manufacturing
agreement under which AHP manufactures and supplies the reasonable commercial
requirements of certain oncology products at a price equal to 125% of AHP's or
its subsidiaries' manufacturing costs. The Successor and AHP also have a
methotrexate distributorship agreement whereby AHP agreed to supply methotrexate
at certain established prices which are adjusted annually. The Successor and
its subsidiaries purchased $9,536,000 and $10,062,000 of inventory from AHP and
its subsidiaries under these agreements during the years ended December 31, 1995
and 1994, of which $976,000 and $1,426,000 was payable at December 31, 1995 and
1994, respectively. In addition, AHP billed the Successor $659,000 and $677,000
for other expenses for the years ended December 31, 1995 and 1994, respectively,
of which the entire 1995 amount was paid during the year and $83,000 was payable
at December 31, 1994.
35
<PAGE>
IMMUNEX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 9. RELATED PARTY TRANSACTIONS, CONTINUED
DISTRIBUTORSHIP AGREEMENT FOR CANADA
The Successor and Wyeth-Ayerst Canada, Inc. ("Wyeth-Ayerst Canada"), a wholly
owned subsidiary of AHP, are parties to a distributorship agreement under which
Wyeth-Ayerst Canada distributes certain oncology products in Canada. The
Successor supplies the oncology products to Wyeth-Ayerst Canada at certain
established prices which are subject to annual adjustment. The Successor sold
$1,631,000, $1,894,000 and $1,642,000 of inventory to Wyeth-Ayerst Canada during
the years ended December 31, 1995 and 1994 and the period from June 2, 1993 to
December 31, 1993, respectively, of which $801,000 and $265,000 was receivable
at December 31, 1995 and 1994, respectively.
TRADEMARK LICENSE AGREEMENT
The Successor and AHP are parties to a trademark license agreement under which
the Successor received the right to use certain trademarks relating to oncology
products. The Successor incurs a royalty of 2% of net sales of the products
sold under these trademarks. The royalty incurred by the Successor for the
years ended December 31, 1995 and 1994 and the period from June 2, 1993 to
December 31, 1993 totaled $267,000, $1,702,000 and $889,000, respectively, of
which $52,000 and $509,000 was payable at December 31, 1995 and 1994,
respectively.
UNITED STATES SERVICES AGREEMENT
The Successor and AHP are parties to a transitionary services agreement under
which AHP agreed to provide certain services, including, among other things,
marketing, customer service, distribution, and credit and collections related to
the Lederle Oncology Products. The Successor incurred costs under this
agreement totaling $968,000, $6,759,000 and $5,937,000 for the years ended
December 31, 1995 and 1994 and the period from June 2, 1993 to December 31,
1993, respectively, of which $7,000 and $563,000 was payable at December 31,
1995 and 1994, respectively. In 1994 and 1993, AHP also incurred certain
additional expenses not included in the service fees for which the Successor
agreed to directly reimburse AHP. These expenses totaled $893,000 and
$1,341,000 for the year ended December 31, 1994 and the period from June 2, 1993
to December 31, 1993, of which $1,705,000 was payable at December 31, 1994. The
Successor has terminated nearly all of the services provided under this
agreement. Accordingly, future costs will not be significant.
LOAN AGREEMENT
The Successor has a loan agreement with a subsidiary of AHP whereby the
subsidiary agreed to provide to the Successor a $50 million line of credit,
which expires March 31, 1996. At December 31, 1994, the Successor had borrowed
$34,000,000 under the agreement. The Successor repaid the $34,000,000 in March
1995 and no additional borrowings were made during the year. Interest accrues
at LIBOR plus 1% and is payable upon maturity of individual borrowings under the
loan. For the years ended December 31, 1995 and 1994 and the period from June
2, 1993 to December 31, 1993, the Successor recorded interest expense of
$510,000, $1,143,000 and $50,000 related to the loan, respectively. No interest
was owed at December 31, 1995 and $39,000 was payable at December 31, 1994.
36
<PAGE>
IMMUNEX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 10. COMMITMENTS AND CONTINGENCIES
The Successor leases office and laboratory facilities under certain
noncancelable operating leases which expire through August 2000. These leases
provide the Successor with options to renew the leases at fair market rentals
through August 2015. A summary of minimum rental commitments under
noncancelable operating and capital leases at December 31, 1995 follows (in
thousands):
<TABLE>
<CAPTION>
Year Ended December 31, Operating Capital
- ----------------------- --------- -------
<S> <C> <C>
1996 $2,855 $245
1997 2,865 --
1998 2,343 --
1999 2,171 --
2000 1,411 --
Thereafter -- --
------- ----
Total minimum lease payments $11,645 245
-------
-------
Less amount representing interest (95)
----
Present value of minimum capital lease payments $150
----
----
</TABLE>
Rental expense on operating leases was $2,704,000, $2,572,000, $1,122,000 and
$1,001,000 for the years ended December 31, 1995 and 1994, the period from June
2, 1993 to December 31, 1993 and the period from January 1, 1993 to June 1,
1993, respectively.
Following AHPs' unsolicited offer in November 1995 to acquire for cash the 45.7%
ownership interest of Immunex which AHP does not already own, a class action
lawsuit was filed on behalf of the shareholders of Immunex in the Superior Court
of Washington for King County. The complaint alleges that the proposed AHP
transaction is unfair and harmful to the minority shareholders of Immunex and
seeks injunctive relief against consummation of the proposed AHP transaction. A
special committee of Immunex's Board of Directors subsequently advised AHP that
it rejected the proposed buy-out offer because it concluded that the price
offered of $14.50 per share was inadequate. Since that announcement, there has
been no activity in the pending case. The suit is not expected to have a
material adverse impact on the financial condition or results of operations of
the Company.
In September 1993, Cistron Biotechnology, Inc. ("Cistron") filed suit against
Immunex asserting that Immunex had misappropriated information regarding
Interleukin-1 beta ("IL-1 beta") and that such information was used by Immunex
in patent applications relating to IL-1 beta. Immunex filed a countersuit
seeking a declaratory judgment and injunctive relief against Cistron asserting
that it did not misappropriate any trade secrets of Cistron. Cistron has
subsequently amended its complaint to include violation of the Racketeer
Influenced and Corruption Organization's ("RICO") Act and also filed suit
against three former officers of Immunex, alleging that they misappropriated
trade secrets and committed fraud and RICO violations arising from the same
facts. Claims against one of the former officers have been dismissed. Immunex
has also amended its counterclaim for a declaration of non-infringement,
invalidity and unenforceability of Patent No. 4,766,069. This counterclaim was
withdrawn by Immunex following Cistron's agreement not to sue Immunex for patent
infringement. Cistron moved to amend its complaint in November 1995 to include
breach of contract, breach of confidential relationship and unfair competition.
Cistron is seeking unspecified actual, punitive and exemplary damages and costs
and attorney's fees. Trial is scheduled to begin in April 1996. The Company
has and intends to continue to vigorously defend the allegations of the suit.
Based on the available information, management of the Company does not expect
the suit to have a material adverse impact on the financial condition or results
of operations of the Company.
37
<PAGE>
IMMUNEX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 10. COMMITMENTS AND CONTINGENCIES, CONTINUED
The outcomes of certain unresolved patent situations could have a material
adverse impact on the Successor's future product sales. The Successor is a
party to a patent interference proceeding directed to human GM-CSF DNAs. If a
patent were to be granted to one of the other parties to the proceeding, the
Successor might be sued for patent infringement in a lawsuit seeking damages,
royalties, or an injunction barring the Successor from making, using or selling
LEUKINE-Registered Trademark- (Sargramostim). PIXY321 is a protein under
development that is designed to combine the effects of GM-CSF and Interleukin-3
("IL-3") in a single molecule. A competitor holds patents covering recombinant
DNA technologies related to IL-3. This competitor, or a competitor holding a
GM-CSF DNA patent, could claim that PIXY321 infringes either or both such
patents. The outcome of these unresolved patent situations is uncertain;
however, management of the Company does not expect these patent interferences to
have a material adverse impact on the financial condition or results of
operations of the Company.
In accordance with a 1992 settlement agreement with Hoechst Roussel
Pharmaceuticals, Inc. ("HRPI"), a payment of $2.0 million will be made to HRPI
if the Successor receives an expanded label indication for LEUKINE for treatment
of chemotherapy-induced neutropenia.
The Successor has certain agreements to fund third-party research. Commitments
under these agreements are estimated at $3.1 million and $1.6 million in 1996
and 1997, respectively. Funding under one agreement beyond 1997 is dependent
upon several factors.
Various license agreements exist which require the Successor to pay royalties
based on a percentage of sales of products manufactured using licensed
technology or sold under license. Expenses incurred under these agreements are
included in cost of product sales and totaled $5,844,000, $6,194,000,
$3,307,000, and $1,751,000 for the years ended December 31, 1995 and 1994, the
period June 2, 1993 to December 31, 1993 and the period January 1, 1993 to June
1, 1993, respectively. Certain of these agreements contain minimum annual
royalty provisions which range from $10,000 to $3,750,000 per year in 1996 and
1997 and from $10,000 to $3,500,000 in 1998 and beyond.
NOTE 11. BUSINESS COMBINATION
The Merger, described in Note 1, was accounted for by the Successor using the
purchase method of accounting. Accordingly, assets and liabilities acquired
from the Predecessor were recorded at historical cost adjusted by the amount of
excess purchase price (53.5% of the excess of the aggregated market value of the
Predecessor's common stock outstanding at the Effective Time, on a fully diluted
basis, over the shareholders' equity of the Predecessor). Excess purchase price
was allocated to the Predecessor's assets and liabilities acquired based on
estimated fair market values at the Effective Time.
The allocation of excess purchase price was as follows (in thousands):
<TABLE>
<S> <C>
Inventories $ 892
Property, plant and equipment 5,296
Property held for future development or sale 535
Investment in affiliate 1,391
Intangible assets 31,049
In-process research and development 346,359
Liabilities assumed (2,073)
--------
Total $383,449
--------
--------
</TABLE>
Excess purchase price allocated to in-process research and development was
expensed by the Successor, as required under generally accepted accounting
principles, which resulted in a significant non-cash charge against earnings of
$346.4 million for the period June 2, 1993 to December 31, 1993.
38
<PAGE>
IMMUNEX CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 12. BRISTOL-MYERS SQUIBB AGREEMENT
The Predecessor and Bristol-Myers Squibb Company ("BMS") entered into a product
exchange agreement in 1992. Pursuant to the agreement, the Predecessor licensed
exclusive foreign marketing rights to PIXY321, to BMS in exchange for exclusive
U.S. marketing rights to HYDREA and RUBEX (collectively, "the BMS Products").
In December 1993, BMS terminated the product exchange agreement which resulted
in the return of each party's product rights in January 1994. The Successor had
recorded a non-cash charge to cost of sales related to the potential that
additional consideration would be payable to BMS to retain the exclusive rights
to the BMS Products. The charge totaled $1.6 million and $1.1 million for the
periods June 2, 1993 to December 31, 1993 and January 1, 1993 to June 1, 1993,
respectively. Upon termination of the agreement in December 1993, the reserve,
totaling $5.4 million, was reversed and included in other income.
NOTE 13. RECEPTECH CORPORATION
In 1989, Receptech was formed to accelerate the development of soluble cytokine
receptor products licensed to Receptech by the Predecessor. At the time of the
Receptech units offering, in exchange for warrants to purchase 2,290,000 shares
of the Predecessor's common stock, the Predecessor received an option to
purchase all of the outstanding shares of Receptech common stock at specified
prices. In December 1992, the Predecessor exercised its option to purchase all
outstanding shares of Receptech common stock. Payment of $26 per share was made
to Receptech Shareholders in February 1993 for a total cost to the Predecessor
of $59,774,000.
39
<PAGE>
Report of Ernst and Young LLP, Independent Auditors
Board of Directors
Immunex Corporation
We have audited the accompanying consolidated balance sheets of Immunex
Corporation (Successor, see Note 1) as of December 31, 1995 and 1994, and the
related consolidated statements of operations, shareholders' equity, and cash
flows for the years then ended and the period June 2, 1993 through December 31,
1993, and the related consolidated statements of operations, shareholders'
equity, and cash flows of Immunex Corporation (Predecessor, see Note 1) for the
period January 1, 1993 through June 1, 1993. Our audits also included the
financial statement schedule listed in the Index at Item 14(a). These financial
statements and schedule are the responsibility of the Company's management. Our
responsibility is to express an opinion on these financial statements and
schedule based on our audits.
We conducted our audits in accordance with generally accepted auditing
standards. 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 consolidated financial statements referred to above present
fairly, in all material respects, the consolidated financial position of Immunex
Corporation (Successor) as of December 31, 1995 and 1994, and the consolidated
results of its operations and its cash flows for the years then ended and for
the period June 2, 1993 through December 31, 1993, and the consolidated results
of operations and cash flows of Immunex Corporation (Predecessor) for the period
January 1, 1993 through June 1, 1993, in conformity with generally accepted
accounting principles. Also, in our opinion the related financial statement
schedule, when considered in relation to the basic financial statements taken as
a whole, present fairly in all material respects the information set forth
therein.
Ernst & Young, LLP
Seattle, Washington
January 19, 1996
40
<PAGE>
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
None.
PART III
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT
The information required by this item is incorporated by reference from the
section labeled "Election of Directors" and "Executive Officers" in the
Company's definitive Proxy Statement for the annual meeting to be held on
April 25, 1996.
ITEM 11. EXECUTIVE COMPENSATION
The information required by this item is incorporated by reference from the
section labeled "Executive Compensation" in the Company's definitive Proxy
Statement for the annual meeting to be held on April 25, 1996.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The information required by this item is incorporated by reference from the
sections labeled "Principal Holders of Voting Securities" in the Company's
definitive Proxy Statement for the annual meeting to be held on April 25, 1996.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
The information required by this item is incorporated by reference from the
sections labeled "Relationship with American Home Products Corporation and
American Cyanamid" in the Company's definitive Proxy Statement for the annual
meeting to be held on April 25, 1996.
41
<PAGE>
PART IV
ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K
(a) The following documents are filed as part of this Form 10-K:
1. FINANCIAL STATEMENTS. The following Financial Statements are included
in Part II, Item 8:
Page in
Form 10-K
---------
Consolidated Balance Sheets at December 31, 1995 and 1994. 24
Consolidated Statements of Operations for the years ended
December 31, 1995 and 1994 and the periods June 2, 1993 to
December 31, 1993 and January 1, 1993 to June 1, 1993. 25
Consolidated Statements of Shareholders' Equity for the
years ended December 31, 1995 and 1994 and the periods
June 2, 1993 to December 31, 1993 and January 1, 1993
to June 1, 1993. 26
Consolidated Statements of Cash Flows for the years ended
December 31, 1995 and 1994 and the periods June 2, 1993 to
December 31, 1993 and January 1, 1993 to June 1, 1993. 27
Notes to Consolidated Financial Statements for the years
ended December 31, 1995 and 1994 and the periods June 2,
1993 to December 31, 1993 and January 1, 1993 to June 1,
1993. 28-39
Report of Ernst and Young LLP, Independent Auditors. 40
2. FINANCIAL STATEMENT SCHEDULE. The following schedule supporting the
foregoing Financial Statements for the years ended December 31, 1995
and 1994 and the periods June 2, 1993 to December 31, 1993 and January
1, 1993 to June 1, 1993 is filed as part of this Form 10-K:
Page in
Form 10-K
---------
II - Valuation and Qualifying Accounts 46
All other schedules are omitted because they are not applicable, or
not required, or because the required information is included in the
consolidated financial statements or notes thereto.
42
<PAGE>
3. EXHIBITS
Exhibit
Number Description
------ -----------
3.1 Certificate of Incorporation, as filed with
the Secretary of State of Washington on
April 14, 1994. (Exhibit 3.1) (G)
3.2 Amended and Restated Bylaws. (Exhibit 3.4) (C)
10.1 Real Estate Purchase and Sale Agreement by
and between Cornerstone-Columbia Development
Company ("CCDC") and the Company dated
November 12, 1986; Master Lease, dated as of
August 20, 1981 between OTR, an Ohio General
Partnership, and CCDC; Assignment of Master
Lease between CCDC and the Company dated
December 17, 1986; Consent to Assignment of
Master Lease from OTR to CCDC, the Company
and Weyerhaeuser Real Estate Company, dated
December 8, 1986. (Exhibit 10.22) (A)
10.2 Amendment to Master Lease dated May 1, 1994,
between the Company and Watumull Enterprises,
LTD. (Exhibit 10.2) (G)
10.3 Amended and Restated Lease Agreement dated
December 21, 1994, between the Company and
the Central Life Assurance Company.
(Exhibit 10.3) (G)
**10.4 Amended and Restated Agreement and Plan of
Merger, dated as of December 15, 1992, among
the Company, American Cyanamid Company,
Lederle Parenterals, Inc. and Lederle
Oncology Corporation. (Exhibit 2.1) (C)
10.5 Amended and Restated Governance Agreement,
dated as of December 15, 1992, among the
Company, American Cyanamid Company and
Lederle Oncology Corporation. (Exhibit 2.2) (C)
10.6 Settlement Agreement, dated as of July 22,
1992, among the Company, Hoechst-Roussel
Pharmaceuticals Inc. and Behringwerke AG.
(Exhibit 10.13) (B)
10.7 Research and Development Agreement between
the Company and American Cyanamid Company
Dated June 1, 1993. (Exhibit 10.1) (D)
*10.8 Oncology Product License Agreement between
the Company and American Cyanamid Company
dated as of June 1, 1993. (Exhibit 10.2) (D)
10.9 Immunex New Oncology Product License
Agreement between the Company and American
Cyanamid Company dated as of June 1, 1993.
(Exhibit 10.3) (D)
10.10 United States Service Agreement between the
Company and American Cyanamid Company dated
as of June 1, 1993. (Exhibit 10.4) (D)
*10.11 United States Royalty-Bearing Trademark
License Agreement between the Company and
American Cyanamid Company dated as of June 1,
1993. (Exhibit 10.5) (D)
10.12 Toll Manufacturing Agreement between Immunex
Carolina Corporation, a wholly owned subsidiary
of the Company, and Lederle Parenterals, Inc.
dated as of June 1, 1993. (Exhibit 10.6) (D)
*10.13 Supply Agreement between the Company and
American Cyanamid Company dated as of June 1,
1993. (Exhibit 10.7) (D)
43
<PAGE>
*10.14 Separation Agreement between the Company and
Stephen A. Duzan dated as of May 26, 1993.
(Exhibit 10.8) (D)
**10.15 Loan Agreement between the Company and
Cyanamid Agricultural de Puerto Rico, Inc.
dated as of September 30, 1993. (Exhibit 10.21) (E)
10.16 Director Stock Option Plan (Exhibit 4.1) (F)
10.17 Second Amendment to Loan Agreement between
the Company and Cyanamid Agriculture de Puerto
Rico, Inc. dated as of November 18, 1994.
(Exhibit 10.23) (G)
10.18 Agreement between the Company and American
Home Products dated as of September 23, 1994.
(Exhibit 10.24) (G)
10.19 Amended and Restated 1993 Stock Option Plan.
(Exhibit 4.1) (H)
10.20 Form of Employment Agreement, together with
schedule of actual agreements. 47-57
21.1 Subsidiaries of the Registrant. 58
23.1 Consent of Independent Auditors. 59
24.1 Power of Attorney. 60
27.1 Financial Data Schedule. 61
____________________________________
* Confidential treatment granted as to certain portions.
** Executive compensation plan or arrangement.
(A) Incorporated by reference to designated exhibit included with the
Company's Annual Report on Form 10-K for the fiscal year ended
December 31, 1986.
(B) Incorporated by reference to designated exhibit included with the
Company's Annual Report on Form 10-K for the fiscal year ended
December 31, 1992.
(C) Incorporated by reference to designated exhibit included in the
Registration Statement on Form S-4 (SEC File No. 33-60254) filed by
Lederle Oncology Corporation March 18, 1993.
(D) Incorporated by reference to designated exhibit included with the
Company Current Report on Form 8-K dated June 4, 1993.
(E) Incorporated by reference to designated exhibit included with the
Company's Annual Report on Form 10-K for the fiscal year ended
December 31, 1993.
(F) Incorporated by reference to designated exhibit included in the
Registration Statement on Form S-8 (SEC File No. 33-78694) filed by
Immunex Corporation on May 6, 1994.
(G) Incorporated by reference to designated exhibit included with the
Company's Annual Report on Form 10-K for the fiscal year ended
December 31, 1994.
(H) Incorporated by reference to designated exhibit included in the
Registration Statement on Form S-8 (SEC File No. 33-59061) filed by
Immunex Corporation on May 3, 1995.
(b) REPORTS ON FORM 8-K.
Not applicable.
44
<PAGE>
SIGNATURES
Pursuant to the requirements of Section 13 of the Securities Exchange Act of
1934, the registrant has duly caused this Annual Report to be signed on its
behalf by the undersigned, thereunto duly authorized.
IMMUNEX CORPORATION
REGISTRANT
By: /s/ Douglas G. Southern March 13, 1996
------------------------------------
Douglas G. Southern
Senior Vice President, Treasurer and
Chief Financial Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, this report
has been signed below by the following persons on behalf of the registrant and
in the capacities and on the dates indicated:
/s/ Edward V. Fritzky March 13, 1996
---------------------------------------------------
Edward V. Fritzky
Chief Executive Officer, Chairman of the Board and
Director
(Principal Executive Officer)
/s/ Michael L. Kranda March 13, 1996
---------------------------------------------------
President, Chief Operating Officer and Director
/s/ Douglas G. Southern March 13, 1996
---------------------------------------------------
Douglas G. Southern
Senior Vice President, Treasurer and
Chief Financial Officer
(Principal Financial and Accounting Officer)
Joseph J. Carr* March 13, 1996
---------------------------------------------------
Joseph J. Carr
Director
Kirby L. Cramer* March 13, 1996
---------------------------------------------------
Kirby L. Cramer
Director
Steven Gillis* March 13, 1996
---------------------------------------------------
Steven Gillis
Director
Richard L. Jackson* March 13, 1996
---------------------------------------------------
Richard L. Jackson
Director
John E. Lyons* March 13, 1996
---------------------------------------------------
John E. Lyons
Director
*By: /s/ Douglas G. Southern March 13, 1996
--------------------------------------
Douglas G. Southern
Attorney-in-Fact
45
<PAGE>
SCHEDULE II
IMMUNEX CORPORATION
VALUATION AND QUALIFYING ACCOUNTS
The periods January 1, 1993 to June 1, 1993 and
June 2, 1993 to December 31, 1993,
and the years ended December 31, 1994 and 1995
(in thousands)
<TABLE>
<CAPTION>
Balance at Additions Charged to Balance at
Beginning of Period Product Sales Deductions End of Period
------------------- -------------------- ---------- --------------
<S> <C> <C> <C> <C>
For the Period January 1, 1993 to June 1, 1993:
Reserve for discounts, returns
and bad debts $1,875 $ 2,235 $ 1,140 $2,970
------ ------- ------- ------
------ ------- ------- ------
For the Period June 2, 1993 to December 31, 1993:
Reserve for discounts, returns
and bad debts $2,970 $ 6,537 $ 2,573 $6,934
------ ------- ------- ------
------ ------- ------- ------
Reserve for chargebacks and
Medicaid rebates $ 0 $26,071 $19,499 $6,572
------ ------- ------- ------
------ ------- ------- ------
Year ended December 31, 1994:
Reserve for discounts, returns
and bad debts $6,934 $11,215 $11,613 $6,536
------ ------- ------- ------
------ ------- ------- ------
Reserve for chargebacks and
Medicaid rebates $6,572 $39,583 $40,333 $5,822
------ ------- ------- ------
------ ------- ------- ------
Year ended December 31, 1995:
Reserve for discounts, returns
and bad debts $6,536 $10,323 $10,583 $6,276
------ ------- ------- ------
------ ------- ------- ------
Reserve for chargebacks, Medicaid rebates
and administrative fees $5,822 $38,571 $35,090 $9,303
------ ------- ------- ------
------ ------- ------- ------
</TABLE>
46
<PAGE>
Exhibit 10.20
The following executives of the Company have each entered into Employment
Agreements with the Company in substantially the form of the attached:
Mr. Edward V. Fritzky
Mr. Michael L. Kranda
Mr. Scott G. Hallquist
Ms. Peggy V. Phillips
Mr. Douglas G. Southern
Mr. Leonard R. Stevens
Dr. Douglas E. Williams
47
<PAGE>
Exhibit 10.20
EMPLOYMENT AGREEMENT
EMPLOYMENT AGREEMENT, dated as of November __, 1995 between IMMUNEX CORPORATION,
a Washington corporation (the "Company"), and _____________ (the "Executive").
RECITALS
A. The Executive is and has been employed by the Company pursuant to an
Employment Agreement dated _______ (the "Original Agreement").
B. The Executive and the Company desire to terminate the Original Agreement.
C. The Company desires to continue to employ the Executive upon the terms and
conditions set forth herein and the Executive is willing to provide services to
the Company upon the terms and conditions set forth herein.
AGREEMENT
1. TERMINATION OF ORIGINAL AGREEMENT
The Company and the Executive agree that the Original Agreement is hereby
terminated and is of no further force and effect. The Company and the Executive
further agree that neither party shall be liable to the other under any
provision of the Original Agreement, and that this Agreement shall govern the
terms and conditions of the Executive's employment with the Company from and
after the date hereof.
2. EMPLOYMENT PERIOD
The Company hereby agrees to continue the Executive in its employ or in the
employ of its subsidiaries, and the Executive hereby agrees to remain in the
employ of the Company or its subsidiaries, in accordance with the terms and
provisions of this Agreement for a period of three years commencing on the date
of this Agreement (the "Employment Period").
3. TERMS OF EMPLOYMENT
(a) POSITION AND DUTIES
(i) During the Employment Period, (A) the Executive's position
(including status, offices, titles and reporting requirements),
authority, duties and responsibilities shall be at least
commensurate in all material respects with those held, exercised
and assigned immediately preceding the date of this Agreement
and (B) unless otherwise agreed to in writing by the Executive,
and except for travel
48
<PAGE>
consistent with the Executive's responsibilities, the
Executive's services shall be performed at the location where
the Executive was employed immediately preceding the date of
this Agreement or any office which is the headquarters of the
Company and is less than 35 miles from such location.
(ii) During the Employment Period, and excluding any periods of
vacation and sick leave to which the Executive is entitled, the
Executive agrees to devote his full attention and time during
normal business hours to the business and affairs of the Company
and its subsidiaries and, to the extent necessary to discharge
the responsibilities assigned to the Executive hereunder, to use
the Executive's reasonable best efforts to perform faithfully
and efficiently such responsibilities. During the Employment
Period, it shall not be a violation of this Agreement for the
Executive to (A) serve on corporate, civic or charitable boards
or committees, (B) deliver lectures, fulfill speaking
engagements or teach at educational institutions, or (C) manage
personal investments, so long as such activities described in
clauses (A), (B) and (C) do not significantly interfere with the
performance of the Executive's responsibilities in accordance
with this Agreement.
(b) COMPENSATION
(i) BASE SALARY. During the Employment Period, the Executive shall
receive an annual base salary (the "Annual Base Salary") at the
rate of $______ (before all customary payroll deductions), which
shall be paid in equal installments in accordance with the
Company's normal payroll practices. The Annual Base Salary
shall be subject to review by the Board of Directors of the
Company (the "Board") from time to time and may be increased but
not decreased during the Employment Period. Any increase in
Annual Base Salary shall not serve to limit or reduce any other
obligation to the Executive under this Agreement.
(ii) ANNUAL INCENTIVE BONUS. In addition to the Annual Base Salary,
the Executive shall be entitled to receive an annual incentive
bonus (the "Annual Incentive Bonus"), the amount of which shall
be determined by the Compensation Committee of the Board in its
sole discretion. Any such Annual Incentive Bonus shall be paid
no later than the end of the third month of the fiscal year next
following the fiscal year for which the Annual Incentive Bonus
is awarded, unless the Executive shall elect to defer the
receipt of such Annual Incentive Bonus. During the Employment
Period the Company may increase but not
49
<PAGE>
decrease the Executive's opportunity to receive an Annual
Incentive Bonus upon achievement of target performance levels.
(iii) BENEFIT PLANS. During the Employment Period, the Executive
shall be entitled to participate in all incentive, savings,
retirement, welfare and fringe benefit, and vacation plans,
practices, policies and programs of the Company in accordance
with their terms. The benefit package coverage the Executive is
entitled to receive may be modified during the Employment Period
only if such modified benefit package coverage (in the
aggregate) is substantially equivalent to, or better than, the
Executive's benefit package coverage (in the aggregate) prior to
such modification.
(iv) EXPENSES. During the Employment Period, the Executive shall be
entitled to receive prompt reimbursement for all reasonable
employment expenses incurred by the Executive in accordance with
the expense reimbursement policy of the Company.
4. TERMINATION OF EMPLOYMENT.
Employment of the Executive pursuant to this Agreement may be terminated as
follows:
(a) BY THE COMPANY. With or without Cause (as defined below), the Company may
terminate the employment of the Executive at any time during the Employment
Period upon giving Notice of Termination (as defined below).
(b) BY THE EXECUTIVE. With or without Good Reason (as defined below), the
Executive may terminate his employment at any time during the Employment Period
upon giving Notice of Termination.
(c) AUTOMATIC TERMINATION. The Executive's employment shall terminate
automatically upon the death or Disability (as defined below) of the Executive.
If the Company determines in good faith that the Disability of the Executive has
occurred during the Employment Period, it may give to the Executive written
notice in accordance with Section 5(c) of its intention to terminate the
Executive's employment. In such event, the Executive's employment with the
Company or its subsidiaries shall terminate effective on the 30th day after
receipt of such notice by the Executive (the "Disability Effective Date"),
provided that, within the 30 days after such receipt, the Executive shall not
have returned to full-time performance of the Executive's duties. For purposes
of this Agreement, "Disability" shall mean the absence of the Executive from the
Executive's duties with the Company or its subsidiaries on a full-time basis for
180 business days within any 365-day period as a result of incapacity due to
mental or physical illness which is determined to be reasonably likely to be
total and permanent by a physician selected by the Company or its insurers and
acceptable to the Executive or the Executive's legal representative (such
agreement as to acceptability not to be withheld unreasonably).
50
<PAGE>
5. CERTAIN DEFINITIONS
(a) CAUSE. "Cause" means (i) a material breach by the Executive of the
Executive's obligations under Section 3(a) (other than as a result of incapacity
due to a physical or mental illness) or Section 7 which is not remedied, if
capable of being remedied, within a reasonable period of time following receipt
of written notice from the Company specifying such breach; (ii) any material act
or fraud or dishonesty or other gross misconduct involving the business or
finances of the Company; or (iii) the conviction of the Executive of a felony.
(b) GOOD REASON. "Good Reason" means the occurrence of any of the following
without the consent of the Executive:
(i) At any time within the period commencing 90 days following the
date on which there is a change in control of the Company
whereby the successor is required to assume this Agreement under
Section 9(c) (whether or not such successor does expressly
assume this Agreement) and ending 365 days thereafter, the
resignation of the Executive for any reason, in his sole
discretion;
(ii) the assignment to the Executive of any duties materially
inconsistent with and detrimental to, the Executive's position,
authority, duties or responsibilities as contemplated by
Section 3(a), excluding an isolated insubstantial and
inadvertent action not taken in bad faith and which is remedied
by the Company promptly after receipt of notice given by the
Executive; provided, however, that the reduction of the
Executive's position, authority, duties and responsibilities by
the Company following Executive's written notice to the Company
that he intends to resign his position with the Company shall
not constitute "Good Reason" under this Agreement;
(iii) any failure by the Company to comply in any material respect
with any of the provisions of Section 3(a), other than as
contemplated by the proviso in clause (ii) of this
subparagraph (b) or an isolated, insubstantial and inadvertent
failure not occurring in bad faith and which is remedied by the
Company promptly after the receipt of notice thereof given by
the Executive;
(iv) the Company's requiring the Executive to be based (other than
pursuant to reasonable travel requirements contemplated
hereunder) at any office or location other than that described
in Section 3(a)(i)(B), except for an isolated, insubstantial and
inadvertent action of the Company not occurring in bad faith and
which is remedied by the Company promptly after the receipt of
notice thereof given by the Executive;
51
<PAGE>
(v) any failure by the Company to comply with and satisfy
Section 9(c), provided that such successor has received at least
ten days' prior written notice from the Company or the Executive
of the requirements of Section 9(c) other than an isolated,
insubstantial and inadvertent failure not occurring in bad faith
and which is remedied by the Company promptly after the receipt
of notice thereof given by the Executive.
(c) NOTICE OF TERMINATION. "Notice of Termination" means a written notice
which (i) indicates the specific termination provision in this Agreement relied
upon, (ii) to the extent applicable, sets forth in reasonable detail the facts
and circumstances claimed to provide a basis for termination of the Executive's
employment under the provision so indicated, and (iii) if the Date of
Termination (as defined below) is other than the date of receipt of such notice,
specifies the termination date (which date shall not be more than 15 days after
the giving of such notice). The failure by the Executive or the Company to set
forth in the Notice of Termination any fact or circumstance which contributes to
a showing of Good Reason or Cause shall not waive any right of the Executive or
the Company hereunder or preclude the Executive or the Company from asserting
such omitted fact or circumstance in enforcing the Executive's or the Company's
rights hereunder.
(d) DATE OF TERMINATION. "Date of Termination" means (i) if the Executive's
employment is terminated by the Company or its Subsidiaries for Cause, or by the
Executive with Good Reason, the date of receipt of the Notice of Termination or
any later date specified therein, as the case may be, (ii) if the Executive's
employment is terminated by the Company other than for Cause or Disability, the
Date of Termination shall be the date on which the Company notifies the
Executive of such termination, and (iii) if the Executive's employment is
terminated by reason of death or Disability, the Date of Termination shall be
the date of death of the Executive or the Disability Effective Date, as the case
may be.
6. TERMINATION PAYMENTS
In the event of termination of the employment of the Executive, all compensation
and benefits set forth in this Agreement shall terminate except as specifically
provided in this Section 6:
(a) TERMINATION BY THE COMPANY. If the Company terminates the Executive's
employment without Cause prior to the end of the Employment Period, the
Executive shall be entitled to (i) receive payment of his Annual Base Salary and
Annual Incentive Bonus (assuming target performance had been achieved at the
100% level) until the second anniversary of the Date of Termination; (ii) the
Annual Incentive Bonus the Executive would otherwise have been entitled to
receive attributable to the portion of the year preceding the Date of
Termination, assuming his employment had continued until the end of the year and
assuming target performance had been achieved at the 100% level; (iii) continued
participation in the Company's medical, dental, life, accidental death and
disability, and long-term disability (to the extent allowed by the insurer)
insurance programs under the same terms as similarly situated active employees
of the Company until the earlier of (A) the second anniversary of the Date of
Termination or (B) the effective date of substantially equivalent coverage of
the Executive under similar programs of a subsequent employer; (iv) individual
executive outplacement services, including customized counseling,
52
<PAGE>
financial planning, research assistance, office space and enhanced
administrative/secretarial support services; and (v) any unpaid Annual Base
Salary which has accrued for services already performed as of the Date of
Termination. The payment of the amounts payable to the Executive under
clause (i) above shall be made, at the election of the Executive, either as (a)
a lump sum payment made no later than two business days following the Date of
Termination or (b) as salary continuation payments made at the same time as
active employees of the Company are paid (in which case each payment shall
include the portion of the Executive's Annual Base Salary and Annual Incentive
Bonus attributable to that pay period). The payment of amounts payable to the
Executive under clause (ii) above shall be made no later than two business days
following the Date of Termination. Continued participation in the Company's
medical and dental plans pursuant to clause (iii) above constitutes COBRA
coverage and the period during which the Executive is entitled to continue such
participation shall be applied against the COBRA continuation period.
If the Executive is terminated by the Company for Cause, the Executive shall not
be entitled to receive any of the foregoing benefits, other than payment of
accrued Annual Base Salary as set forth in clause (v) above.
(b) TERMINATION BY THE EXECUTIVE. In the case of the termination of the
Executive's employment by the Executive with Good Reason, the Executive shall be
entitled to receive the benefits set forth in clauses (i), (ii), (iii), (iv) and
(v) of subparagraph (a) hereof. If the Executive terminates his employment
without Good Reason, the Executive shall not be entitled to any payments
hereunder, other than payment of accrued Annual Base Salary as set forth in
clause (v) of subparagraph (a) hereof and continuation of the benefits, at the
Executive's expense, specified in clause (iii) of subparagraph (a) hereof until
the earlier of the first anniversary of the Date of Termination or effective
date of substantially equivalent coverage of the Executive under similar
programs of a subsequent employer. Continued participation in the Company's
medical and dental plans pursuant to this subsection (b) constitutes COBRA
coverage and the period during which the Executive is entitled to continue such
participation shall be applied against the COBRA continuation period.
(c) AUTOMATIC TERMINATION. In the case of the termination of the Executive's
employment due to death or Disability, the Executive or his legal representative
shall be entitled to receive the payment of accrued Annual Base Salary as set
forth in clause (v) of subparagraph (a) hereof plus an amount equal to (i) in
the case of death, the amount by which the compensation payable in clause (i) of
subparagraph (a) exceeds the death benefits payable under the Company's group
term life insurance plan (assuming the Executive had elected to receive the
maximum insurance coverage available thereunder) and (ii) in the case of
disability, the benefits set forth in clauses (ii) and (iii) of subparagraph (a)
hereof plus the amount by which the aggregate compensation payable pursuant to
clause (i) of subparagraph (a) hereof exceeds the 24 times the amount of monthly
benefits received by the Executive under the Company's long-term disability plan
and from Social Security.
7. RESTRICTIVE COVENANTS
(a) NO COMPETING EMPLOYMENT. For so long as the Executive is employed by the
Company or any Affiliate (as defined below) and continuing following the
Executive's termination of
53
<PAGE>
employment for any reason until the later of (i) the end of the period of time
with respect to which the Executive receives severance compensation pursuant to
Section 6 of this Agreement, or (ii) the first anniversary of the Date of
Termination (such period being referred to hereinafter as the "Restricted
Period"), the Executive shall not, directly or indirectly, engage in any work or
other activity--whether as owner, shareholder, partner, officer, consultant,
employee or otherwise--involving a product or process similar to a product or
process on which the Executive worked for the Company (or any Affiliate) at any
time during the period of two years immediately prior to termination of
employment, if such work or other activity is then competitive with that of the
Company (or any Affiliate), provided, that this restriction shall not apply if
the Executive has disclosed to the Company in writing all the known facts
relating to such work or activity and has received a release in writing from an
officer of the Company to engage in such work or activity. For purposes of this
covenant, the Executive shall be deemed to have worked on any product that was
marketed or being developed for marketing by the Company during the two years
prior to termination of employment. Ownership by the Executive of five percent
or less of the outstanding shares of stock of any company either (i) listed on a
national securities exchange or (ii) having at least 100 shareholders shall not
make the Executive a "shareholder" within the meaning of that term as used in
this paragraph. Nothing in this paragraph shall limit the rights or remedies of
the Company arising, directly or indirectly, from such competitive employment
including, without limitation, claims based upon breach of fiduciary duty,
misappropriation, or theft of confidential information. The term "Affiliate"
shall mean the Company and any entity controlling, controlled by or under common
control with the Company.
(b) NO INTERFERENCE. During the Restricted Period, the Executive shall not,
whether for his own account or for the account of any other individual,
partnership, firm, corporation or other business organization (other than the
Company or any Affiliate), intentionally solicit, endeavor to entice away from
the Company or any Affiliate, or otherwise interfere with the relationship of
the Company or any Affiliate with, any person who is employed by or otherwise
engaged to perform services for the Company or any Affiliate (including, but not
limited to, any independent sales representatives or organizations) or any
person or entity who is, or was within the then most recent 12-month period, a
customer or client of the Company or any Affiliate.
(c) CONFIDENTIALITY AND INVENTIONS. The Executive agrees to abide by the terms
of the Invention Disclosure and Confidentiality Agreement attached as Appendix A
hereto, PROVIDED, HOWEVER, that such agreement shall also cover Proprietary
Information and Inventions of any Affiliate.
(d) INJUNCTIVE RELIEF. The Executive acknowledges that a breach of any of the
covenants contained in this Section or Appendix A may result in material
irreparable injury to the Company for which there is no adequate remedy at law,
that it will not be possible to measure damages for such injuries precisely and
that, in the event of such a breach or threat thereof, the Company shall be
entitled to obtain a temporary restraining order and/or a preliminary or
permanent injunction restraining the Executive from engaging in activities
prohibited by this Section or such other relief as may be required to
specifically enforce any of the covenants in this Section. The Executive hereby
agrees and consents that such injunctive relief may be sought EX PARTE in any
state or federal court of record in the State of Washington, or in the state and
county in which such violation may occur or in any other court having
jurisdiction, at the election of the
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<PAGE>
Company. The Executive agrees to and hereby submits to IN PERSONAM jurisdiction
before each and every such court for that purpose.
8. FULL SETTLEMENT: RESOLUTION OF DISPUTES
(a) The Company's obligation to make the payments provided for in this
Agreement and otherwise to perform its obligations hereunder shall not be
affected by any set-off, counterclaim, recoupment, defense or other claim, right
or action which the Company may have against the Executive or others, except as
set forth in Section 6(a)(iii)(B). In no event shall the Executive be obligated
to seek other employment or take any other action by way of mitigation of the
amounts payable to the Executive under any of the provisions of this Agreement
and such amounts shall not be reduced whether or not the Executive obtains other
employment. The Company agrees to pay, to the full extent permitted by law, all
legal fees and expenses which the Executive may reasonably incur as a result of
any successful contest by the Executive, or any unsuccessful contest by the
Company, regarding the terms of this Agreement, plus interest on any delayed
payment at the Applicable Federal Mid-Term Rate (as defined in Section 1274(d)
of the Internal Revenue Code of 1986, as amended) at the time when the amounts
were first payable. For purposes of this provision, a contest shall be
successful with respect to the Executive if the Executive ultimately prevails on
a preponderance of the substantive issues and shall be unsuccessful with respect
to the Company if the Company fails to prevail on a preponderance of the
substantive issues.
(b) If there shall be any good faith dispute between the Company and the
Executive (i) in the event of any termination of the Executive's employment by
the Company, whether such termination was for Cause, or (ii) in the event of any
termination of employment by the Executive, whether Good Reason existed, then,
unless and until there is a final, nonappealable judgment by a court of
competent jurisdiction declaring that such termination was for Cause or that the
Executive terminated for Good Reason, the Company shall pay all amounts, and
provide all benefits, to the Executive and to the Executive's family or other
beneficiaries, as the case may be, that the Company would be required to pay or
provide pursuant to Section 6(a) or 6(b) as though such termination were by the
Company without Cause or by the Executive with Good Reason; PROVIDED, HOWEVER,
that the Company shall not be required to pay any disputed amounts pursuant to
this paragraph except upon receipt of an undertaking by or on behalf of the
Executive to repay all such amounts to which the Executive is ultimately
adjudged by such court not to be entitled.
9. SUCCESSORS
(a) This Agreement is personal to the Executive and without the prior written
consent of the Company shall not be assignable by the Executive otherwise than
by will or the laws of descent and distribution. This Agreement shall inure to
the benefit of and be enforceable by the Executive's legal representatives.
(b) This Agreement shall inure to the benefit of and be binding upon the
Company and its successors and assigns.
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<PAGE>
(c) The Company shall require any successor (by purchase, merger, consolidation
or otherwise) to all or substantially all of the business or assets of the
Company to assume expressly and agree to perform this Agreement in the same
manner and to the same extent that the Company could be required to perform as
if no such succession had taken place. As used in this Agreement, "Company"
shall mean the Company as herein before defined and any successor to its
business or assets as aforesaid which assumes and agrees to perform this
Agreement by operation of law, or otherwise.
10. RELEASE
The Executive's eligiblity to receive the termination payments under
Section 6(a) or 6(b) of this Agreement will be conditioned upon the Executive's
execution, at the time his employment is terminated, of a waiver of all legal
claims he may have against the Company relating to or arising from his
employment or the termination of his employment in form and substance reasonably
acceptable to the Company. This release shall not affect any contractual or
statutory claims for indemnification that the Executive may have against the
Company.
11. MISCELLANEOUS
(a) This Agreement shall be governed by and construed in accordance with the
laws of the State of Washington, without reference to principles of conflict of
laws. The captions of this Agreement are not part of the provisions hereof and
shall have not force or effect. This Agreement may not be amended or modified
otherwise than by a written agreement executed by the parties hereto or their
respective successors and legal representatives.
(b) All notices and other communications hereunder shall be in writing and
shall be given by hand delivery to the other party or by registered or certified
mail, return receipt requested, postage prepaid, addressed as follows:
IF TO THE EXECUTIVE:
_____________
_____________
_____________
IF TO THE COMPANY:
Immunex Corporation
51 University Street
Seattle, Washington 98101
Attention: Secretary
or to such other address as either party shall have furnished to the other in
writing in accordance herewith. The effective date of any notice or other
communication shall be three days from the date on which it is sent by the
addresser or the date on which it is personally delivered.
56
<PAGE>
(c) If the final determination of a court of competent jurisdiction declares,
after the expiration of the time within which judicial review (if permitted) of
such determination may be perfected, that any term or provision hereof is
invalid or unenforceable, (i) the remaining terms and provisions hereof shall be
unimpaired and (ii) the invalid or unenforceable term or provision shall be
deemed replaced by a term or provision that is valid and unenforceable and that
comes closest to expressing the intention of the invalid or unenforceable term
or provision.
(d) The Company may withhold from any amount payable under this Agreement such
federal, state or local taxes as shall be required to be withheld pursuant to
any applicable law or regulation.
(e) The Executive's or the Company's failure to insist upon strict compliance
with any provision hereof or any other provision of this Agreement or the
failure to assert any right the Executive or the Company may have hereunder,
shall not be deemed to be a waiver of such provision or right to any other
provision or right of this Agreement.
(f) The Executive and the Company agree to keep the terms of this Agreement
confidential, except to the extent disclosure may be required by law.
(g) This Agreement may be executed by either of the parties hereto in
counterparts, each of which shall be deemed to be an original, but all such
counterparts shall together constitute one and the same instrument.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the
date first written above.
IMMUNEX CORPORATION
By_______________________
Its___________________
EXECUTIVE:
_________________________
57
<PAGE>
Exhibit 21.1
SUBSIDIARIES OF THE REGISTRANT
SUBSIDIARIES:
Immunex Manufacturing Corporation
Incorporated in the State of Washington
51 University Street
Seattle, WA 98101
58
<PAGE>
Exhibit 23.1
CONSENT OF ERNST & YOUNG LLP, INDEPENDENT AUDITORS
We consent to the incorporation by reference in the Registration Statements
(Form S-8 \Nos. 33-59061 and 33-78694) pertaining to the Immunex Corporation
Stock Option Plan and Director Stock Option Plan of our report dated January 19,
1996, with respect to the consolidated financial statements and schedule of
Immunex Corporation included in the Annual Report (Form 10-K) for the year ended
December 31, 1995.
Ernst & Young, LLP
Seattle, Washington
March 15, 1996
59
<PAGE>
Exhibit 24.1
POWER OF ATTORNEY
KNOW ALL BY THESE PRESENTS that the individuals whose signatures appear
below, in their capacities as officers and directors of Immunex Corporation (the
"Company"), hereby constitute and appoint Douglas G. Southern their true and
lawful attorney-in-fact, with full power of substitution, to sign on behalf of
the undersigned the Company's Annual Report on Form 10-K for the 1995 fiscal
year pursuant to Section 13 of the Securities and Exchange Act of 1934 and to
file the same, with exhibits thereto and any other documents in connection
therewith, with the Securities and Exchange Commission. Each of the undersigned
does hereby ratify and confirm all that such attorney-in-fact may do or cause to
be done by virtue hereof.
Signature Title Date
- --------- ----- ----
/s/ Joseph J. Carr Director March 8, 1996
- -------------------- ----------------
(Joseph J. Carr)
/s/ Kirby L. Cramer Director March 12, 1996
- ---------------------- ----------------
(Kirby L. Cramer)
/s/ Steven Gillis Director March 13, 1996
- ---------------------- ----------------
(Steven Gillis)
/s/ Richard L. Jackson Director March 12, 1996
- ---------------------- ----------------
(Richard L. Jackson)
/s/ John E. Lyons Director March 12, 1996
- ---------------------- ----------------
(John E. Lyons)
60
<TABLE> <S> <C>
<PAGE>
<ARTICLE> 5
<LEGEND>
THE SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE
CONSOLIDATED BALANCE SHEET AS OF DECEMBER 31, 1995, AND THE CONSOLIDATED
STATEMENT OF OPERATIONS FOR THE YEAR ENDED DECEMBER 31, 1995, AND IS
QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<MULTIPLIER> 1,000
<S> <C>
<PERIOD-TYPE> 12-MOS
<FISCAL-YEAR-END> DEC-31-1995
<PERIOD-START> JAN-01-1995
<PERIOD-END> DEC-31-1995
<CASH> 20,437
<SECURITIES> 0
<RECEIVABLES> 17,499
<ALLOWANCES> 380
<INVENTORY> 8,302
<CURRENT-ASSETS> 50,415
<PP&E> 113,566
<DEPRECIATION> 26,026
<TOTAL-ASSETS> 174,037
<CURRENT-LIABILITIES> 32,785
<BONDS> 0
592,470
0
<COMMON> 0
<OTHER-SE> (455,827)
<TOTAL-LIABILITY-AND-EQUITY> 174,037
<SALES> 137,639
<TOTAL-REVENUES> 156,616
<CGS> 24,555
<TOTAL-COSTS> 167,336
<OTHER-EXPENSES> 312
<LOSS-PROVISION> 252
<INTEREST-EXPENSE> 1,145
<INCOME-PRETAX> (11,054)
<INCOME-TAX> 246
<INCOME-CONTINUING> (11,300)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (11,300)
<EPS-PRIMARY> (.29)
<EPS-DILUTED> (.29)
</TABLE>
