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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the Fiscal Year Ended December 31, 2006
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the Transition Period from to
Commission File Number: 000-30111
Lexicon Genetics Incorporated
(Exact Name of Registrant as Specified in its Charter)
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Delaware
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76-0474169 |
(State or Other Jurisdiction of
Incorporation or Organization)
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(I.R.S. Employer
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8800 Technology Forest Place |
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(281) 863-3000 |
The Woodlands, Texas 77381
(Address of Principal Executive
Offices and Zip Code)
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(Registrants Telephone Number,
Including Area Code) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of Each Class
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Name of Each Exchange on which Registered |
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Common Stock, par value $0.001 per share
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Nasdaq Global Market |
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act of 1933.
Yes o No þ
Indicate by check mark if the registrant is not required to file reports pursuant to Section
13 or Section 15(d) of the Securities Exchange Act of 1934. Yes o No þ
Indicate by check mark whether the registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports) and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation
S-K is not contained herein, and will not be contained, to the best of registrants knowledge, in
definitive proxy or information statements incorporated by reference in Part III of this Form 10-K
or any amendment to this Form 10-K. o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer or a non-accelerated filer. See definition of accelerated filer and large accelerated
filer in Rule 12b-2 of the Securities Exchange Act of 1934. (check one):
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Large accelerated filer o
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Accelerated filer þ
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Non-accelerated filer o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Securities Exchange Act of 1934). Yes o No þ
The aggregate market value of voting stock held by non-affiliates of the registrant as of the
last day of the registrants most recently completed second quarter was approximately $241.3
million, based on the closing price of the common stock on the Nasdaq National Market on June 30,
2006 of $4.39 per share. For purposes of the preceding sentence only, all directors, executive
officers and beneficial owners of ten percent or more of the registrants common stock are assumed
to be affiliates. As of March 6, 2007, 77,985,736 shares of common stock were outstanding.
Documents Incorporated by Reference
Certain sections of the registrants definitive proxy statement relating to the
registrants 2007 annual meeting of stockholders, which proxy statement will be filed under the
Securities Exchange Act of 1934 within 120 days of the end of the registrants fiscal year ended
December 31, 2006, are incorporated by reference into Part III of this annual report on Form 10-K.
Lexicon Genetics Incorporated
Table of Contents
The Lexicon name and logo, LexVision® and OmniBank® are registered
trademarks and Genome5000, e-Biology and 10TO10 are
trademarks of Lexicon Genetics Incorporated.
In this annual report on Form 10-K, Lexicon Genetics, Lexicon, we, us and our refer
to Lexicon Genetics Incorporated.
Factors Affecting Forward Looking Statements
This annual report on Form 10-K contains forward-looking statements. These statements relate
to future events or our future financial performance. We have attempted to identify
forward-looking statements by terminology including anticipate, believe, can, continue,
could, estimate, expect, intend, may, plan, potential, predict, should or will
or the negative of these terms or other comparable terminology. These statements are only
predictions and involve known and unknown risks, uncertainties and other factors, including the
risks outlined under Item 1. Business Risk Factors, that may cause our or our industrys
actual results, levels of activity, performance or achievements to be materially different from any
future results, levels of activity, performance or achievements expressed or implied by these
forward-looking statements.
Although we believe that the expectations reflected in the forward-looking statements are
reasonable, we cannot guarantee future results, levels of activity, performance or achievements. We
are not under any duty to update any of the forward-looking statements after the date of this
annual report on Form 10-K to conform these statements to actual results, unless required by
law.
PART I
Item 1. Business
Overview
Lexicon Genetics is a biopharmaceutical company focused on the discovery and development of
breakthrough treatments for human disease. We use our proprietary gene knockout technology to
knock out, or disrupt, the function of genes in mice and then employ an integrated platform of
advanced medical technologies to systematically discover the physiological and behavioral functions
and pharmaceutical utility of the genes we have knocked out and the potential drug targets encoded
by the corresponding human genes. For targets that we believe have high pharmaceutical value, we
engage in programs for the discovery and development of potential small molecule, antibody and
protein drugs. We have advanced drug candidates from two of these programs into human clinical
trials, with drug candidates from two additional programs in preclinical development and a number
of additional programs in various stages of preclinical research. We believe that our systematic,
target biology-driven approach to drug discovery will enable us to substantially expand our
clinical pipeline, and we have initiated our 10TO10 program with the goal of advancing
ten drug candidates into human clinical trials by the end of 2010.
We are presently conducting a Phase 1b clinical trial for our most advanced drug candidate,
LX6171, an orally-delivered small molecule compound that we are developing as a potential treatment
for cognitive impairment associated with disorders such as Alzheimers disease, schizophrenia and
vascular dementia. We are conducting a Phase 1a clinical trial for another drug candidate, LX1031,
an orally-delivered small molecule compound that we are developing as a potential treatment for
gastrointestinal disorders such as irritable bowel syndrome. We have advanced drug candidates from
two other drug discovery programs, LX2931 for autoimmune diseases such as rheumatoid arthritis and
LX1032 for gastrointestinal disorders, into preclinical development in preparation for regulatory
filings for the commencement of clinical trials. We have compounds from a number of additional
drug programs in various stages of preclinical research. Through the end of 2006, we had
identified and validated in living mammals, or in vivo, more than 100 targets with promising
profiles for drug discovery in the therapeutic areas of diabetes and obesity, cardiovascular
disease, psychiatric and neurological disorders, cancer, immune system disorders and ophthalmic
disease.
We are working both independently and through strategic collaborations and alliances to
capitalize on our technology and drug target discoveries and to develop and commercialize drug
candidates emerging from our drug discovery and development programs. We are working with
Bristol-Myers Squibb Company to discover and develop new small molecule drugs in the neuroscience
field. We are working with Genentech, Inc. to discover the functions of secreted proteins and
potential antibody targets identified through Genentechs internal drug discovery research, and to
develop new biotherapeutic drugs based on certain targets selected from the alliance. We are
working with N.V. Organon to discover, develop and commercialize new biotherapeutic drugs based on
another group of secreted proteins and potential antibody targets. We are working with Takeda
Pharmaceutical Company Limited for the discovery of new drugs for the treatment of high blood
pressure. In addition, we have established collaborations and license agreements with other
leading pharmaceutical and biotechnology companies, research institutes and academic institutions
under which we receive fees and, in some cases, are eligible to receive milestone and royalty
payments, in return for granting access to some of our technologies and discoveries for use in the
other organizations own drug discovery efforts.
Lexicon Genetics was incorporated in Delaware in July 1995, and commenced operations in
September 1995. Our corporate headquarters are located at 8800 Technology Forest Place, The
Woodlands, Texas 77381, and our telephone number is (281) 863-3000.
Our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K,
and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the
Securities Exchange Act of 1934 are made available free of charge on our corporate website located
at www.lexicon-genetics.com as soon as reasonably practicable after the filing of those reports
with the Securities and Exchange Commission. Information found on our website should not be
considered part of this annual report on Form 10-K.
Our Drug Discovery and Development Process
Our drug discovery and development process begins with our Genome5000 program, in which we are
using our gene knockout and evaluative technologies to discover the physiological and behavioral
functions of 5,000 human genes through analysis of the corresponding mouse knockout models. The
study of the effects of knocking
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out genes in mice has historically proven to be a powerful tool for understanding human genes
because of the close similarity of gene function and physiology between mice and humans, with
approximately 99% of all human genes having a counterpart in the mouse genome. Our Genome5000
efforts are focused on the discovery of the functions in mammalian physiology of proteins encoded
by gene families that we consider to be pharmaceutically important. We have already completed our
physiology- and behavior-based analysis of more than 80% of these 5,000 genes.
We use our patented gene trapping and gene targeting technologies to generate knockout mice
mice whose DNA has been modified to disrupt, or knock out, the function of the altered gene by
altering the DNA of genes in a special variety of mouse cells, called embryonic stem cells, which
can be cloned and used to generate mice with the altered gene. We then study the physiology and
behavior of the knockout mice using a comprehensive battery of advanced medical technologies, each
of which has been adapted specifically for the analysis of mouse physiology. This systematic use
of these evaluative technologies allows us to discover, in vivo, the physiological and behavioral
functions of the genes we have knocked out and assess the prospective pharmaceutical utility of the
potential drug targets encoded by the corresponding human genes.
We then engage in programs for the discovery of potential small molecule, antibody and protein
drugs for those in vivo-validated drug targets that we consider to have high pharmaceutical value.
We have established extensive internal small molecule drug discovery capabilities, in which we use
our own sophisticated libraries of drug-like chemical compounds in high-throughput screening assays
to identify hits, or chemical compounds demonstrating activity, against these targets. We then
employ medicinal chemistry efforts to optimize the potency and selectivity of these hits and to
identify lead compounds for potential development. We have also established substantial internal
antibody and protein drug discovery capabilities, in which we use protein expansion and antibody
technologies to generate and optimize molecules with appropriate characteristics for development.
We have established extensive internal capabilities to characterize the absorption, distribution,
metabolism and excretion of our potential drug candidates and otherwise evaluate their safety in
mammalian models in preparation for preclinical and clinical development. In all of our drug
discovery programs, we use the same physiological analysis technology platform that we use in the
discovery of gene function to analyze the in vivo activity and safety profiles of drug candidates
in mice as part of our preclinical research efforts.
Once we identify a potential drug candidate, we initiate formal preclinical development
studies in preparation for regulatory filings for the commencement of human clinical trials. We
have established internal expertise in each of the critical areas of preclinical and clinical
development, including clinical trial design, study implementation and oversight, and regulatory
affairs, with demonstrated experience by members of our clinical development team in the successful
implementation of Phase 1, 2 and 3 clinical trials and regulatory approval for the
commercialization of therapeutic products.
We believe that our systematic, biology-driven approach and the technology platform that makes
it possible provide us with substantial advantages over alternative approaches to drug target
discovery. In particular, we believe that the comprehensive nature of our approach allows us to
uncover potential drug targets within the context of mammalian physiology that might be missed by
more narrowly focused efforts. We also believe our approach is more likely to reveal those side
effects that may be a direct result of inhibiting or otherwise modulating the drug target and may
limit the utility of potential therapeutics directed at the drug target. We believe these
advantages will contribute to better target selection and, therefore, to a greater likelihood of
success for our drug discovery and development efforts.
Our Drug Pipeline
We have initiated our 10TO10 program with the goal of advancing ten drug candidates
into human clinical trials by the end of 2010. To date, we have initiated clinical trials for two
drug candidates, with drug candidates from two additional programs in preclinical development and a
number of additional programs in various stages of preclinical research:
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LX6171 is an orally-delivered small molecule compound that we are developing for the
potential treatment of disorders characterized by cognitive impairment, such as Alzheimers
disease, schizophrenia or vascular dementia. We initiated a Phase 1b clinical trial for LX6171 in
January 2007. The Phase 1b trial is a randomized, double-blind, placebo-controlled, multiple
ascending-dose study in which LX6171 is being studied in approximately 40 normal healthy
volunteers, including a cohort of elderly subjects. LX6171 was internally generated by our
medicinal chemists, and its target was identified as part of our Genome5000 program as a selective
and potent inhibitor of a membrane protein that is expressed exclusively in the central nervous
system. We conducted a Phase 1a clinical trial for LX6171 in September 2006, during which LX6171
was well tolerated at all dose levels studied. In preclinical studies, LX6171 demonstrated
improved learning and memory in mice.
LX1031 is an orally-delivered small molecule compound that we are developing for the potential
treatment of irritable bowel syndrome and other gastrointestinal disorders. We initiated a Phase
1a clinical trial for LX1031 in January 2007. The Phase 1a trial is a randomized, double-blind,
ascending single dose study in which LX1031 is being studied in approximately 40 normal healthy
volunteers. We have designed LX1031 to act locally in the gastrointestinal tract by reducing the
serotonin available for receptor activation, but without affecting serotonin levels in the brain or
its central nervous system functions. We intend to use serotonin as a biomarker by which to
evaluate the activity of LX1031 in clinical trials. LX1031 was internally generated by our
medicinal chemists, and its target was identified as part of our Genome5000 program as a key
control point for the regulation of peripheral serotonin levels. In preclinical studies, LX1031
demonstrated a dose-dependent reduction of serotonin levels in the gastrointestinal tract of
multiple species with no observed adverse effects across a broad range of medically-relevant
parameters.
LX2931 is an orally-delivered small molecule compound that we are developing for the potential
treatment of autoimmune diseases such as rheumatoid arthritis. We have commenced formal
preclinical development for LX2931 in preparation for the expected filing of an investigational new
drug, or IND, application in 2007. In preclinical studies, LX2931 reduced inflammatory response in
mice and decreased lymphocyte counts in multiple species. LX2931 was internally generated by our
medicinal chemists, and its target was identified as part of our Genome5000 program as a potent
inhibitor of T and B cell levels in the peripheral blood.
LX1032 is an orally-delivered small molecule compound that we are developing for the potential
treatment of gastrointestinal disorders. We have commenced formal preclinical development for
LX1032 in preparation for the expected filing of an IND application in 2007. LX1032 modulates the
same target as LX1031, but the two compounds are chemically distinct. LX1032 was internally
generated by our medicinal chemists and was specifically designed to achieve systemic exposure.
LX1032 may provide an additional therapeutic approach for functional and other gastrointestinal
disorders that require systemic regulation of serotonin levels.
We have also advanced a number of additional drug programs into various stages of preclinical
research in preparation for formal preclinical development studies. Through the end of 2006, we
had identified and validated in vivo more than 100 targets with promising profiles for drug
discovery in the therapeutic areas of diabetes and obesity, cardiovascular disease, psychiatric and
neurological disorders, cancer, immune system disorders and ophthalmic disease.
Our Technology
The core elements of our technology platform include our patented technologies for the
generation of knockout mice, our integrated platform of advanced medical technologies for the
systematic and comprehensive biological analysis of in vivo behavior and physiology and our
industrialized approach to medicinal chemistry and the generation of high-quality, drug-like
compound libraries.
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Gene Knockout Technologies
Gene Targeting. Our gene targeting technology, which is covered by nine issued patents that
we have licensed, enables us to generate highly specific alterations in targeted genes. The
technology replaces DNA of a gene in a mouse embryonic stem cell through a process known as
homologous recombination to disrupt the function of the targeted gene, permitting the generation of
knockout mice. By using this technology in combination with one or more additional technologies,
we are able to generate alterations that selectively disrupt, or conditionally regulate, the
function of the targeted gene for the analysis of the genes function in selected tissues, at
selected stages in the animals development or at selected times in the animals life. We can also
use this technology to replace the targeted gene with its corresponding human gene for use for
preclinical research in our drug programs.
Gene Trapping. Our gene trapping technology, which is covered by nine issued patents that we
own, is a high-throughput method of generating knockout mouse clones that we invented. The
technology uses genetically engineered retroviruses that infect mouse embryonic stem cells in
vitro, integrate into the chromosome of the cell and disrupt the function of the gene into which it
integrates, permitting the generation of knockout mice. This process also allows us to identify
and catalogue each embryonic stem cell clone by DNA sequence from the trapped gene and to select
embryonic stem cell clones by DNA sequence for the generation of knockout mice. We have used our
gene trapping technology in an automated process to create our OmniBank library of more than
270,000 frozen gene knockout embryonic stem cell clones, each identified by DNA sequence in a
relational database. We estimate that our OmniBank library currently contains embryonic stem cell
clones representing more than half of all genes in the mammalian genome and believe it is the
largest library of its kind.
Physiological Analysis Technologies
We employ an integrated platform of advanced analytical technologies to rapidly and
systematically discover the physiological and behavioral effects resulting from loss of gene
function in the mouse knockouts we have generated using our gene trapping and gene targeting
technologies and catalogue those effects in our comprehensive and relational LexVision database.
These analyses include many of the most sophisticated diagnostic technologies and tests currently
available, many of which might be found in a major medical center. Each of these technologies has
been adapted specifically for the analysis of mouse physiology. This state-of-the-art technology
platform enables us to assess the consequences of loss of gene function in a living mammal across a
wide variety of parameters relevant to human disease.
We employ the same physiological analysis technology platform that we use in the discovery of
gene function to analyze the in vivo efficacy and safety profiles of drug candidates in mice. We
believe that this approach will allow us, at an early stage, to identify and optimize drug
candidates for further preclinical and clinical development that demonstrate in vivo efficacy and
to distinguish side effects caused by a specific compound from the target-related side effects that
we defined using the same comprehensive series of tests.
Medicinal Chemistry Technology
We use solution-phase chemistry to generate diverse libraries of optically pure compounds that
are targeted against the same pharmaceutically relevant gene families that we address in our
Genome5000 program. These libraries are built using highly robust and scalable organic reactions
that allow us to generate compound collections of great diversity and to specially tailor the
compound collections to address various therapeutic target families. We design these libraries by
analyzing the chemical structures of drugs that have been proven safe and effective against human
disease and using that knowledge in the design of scaffolds and chemical building blocks for the
generation of large numbers of new drug-like compounds. When we identify a hit against one of our
in vivo-validated targets, we can rapidly reassemble these building blocks to create hundreds or
thousands of variations around the structure of the initial compound, enabling us to accelerate our
medicinal chemistry efforts.
Our medicinal chemistry operations are housed in a state-of-the-art 76,000 square foot
facility in Hopewell, New Jersey. Our lead optimization chemistry groups are organized around
specific discovery targets and work closely with their pharmaceutical biology counterparts in our
facilities in The Woodlands, Texas. The medicinal chemists optimize lead compounds in order to
select clinical candidates with the desired absorption, distribution, metabolism, excretion and
physicochemical characteristics. We have the capability to profile our compounds using the same
battery of in vivo assays that we use to characterize our drug targets. This provides us with
valuable detailed information relevant to the selection of the highest quality compounds for
preclinical and clinical development.
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Our Commercialization Strategy
We are working both independently and through strategic collaborations and alliances with
leading pharmaceutical and biotechnology companies, research institutes and academic institutions
to capitalize on our technology and commercialize our drug programs. Consistent with this
approach, we intend to develop and commercialize certain of our drug programs internally and retain
exclusive rights to the benefits of such programs and to collaborate with third parties with
respect to the development and commercialization of other drug programs.
Our collaboration and alliance strategy involves drug discovery alliances to discover and
develop therapeutics based on our drug target discoveries, particularly when the alliance enables
us to obtain access to technology and expertise that we do not possess internally or is
complementary to our own. These strategic collaborations, as well as our licenses with
pharmaceutical and biotechnology companies, research institutes and academic institutions, enable
us to generate near-term cash and revenues in exchange for access to some of our technologies and
discoveries for use by these third parties in their own drug discovery efforts. These
collaborations and licenses also offer us the potential, in many cases, to receive milestone
payments and royalties on products that our collaborators and licensees develop using our
technology.
Drug Discovery Alliances
Bristol-Myers Squibb Company. We established a drug discovery alliance with Bristol-Myers
Squibb in December 2003 to discover, develop and commercialize small molecule drugs in the
neuroscience field. We initiated the alliance with a number of neuroscience drug discovery
programs at various stages of development and are continuing to use our gene knockout technology to
identify additional drug targets with promise in the neuroscience field. For those targets that
are selected for the alliance, we and Bristol-Myers Squibb are working together, on an exclusive
basis, to identify, characterize and carry out the preclinical development of small molecule drugs,
and share equally both in the costs and in the work attributable to those efforts. As drugs
resulting from the alliance enter clinical trials, Bristol-Myers Squibb will have the first option
to assume full responsibility for clinical development and commercialization.
We received an upfront payment under the agreement and received research funding during the
initial three years of the agreement. Bristol-Myers Squibb extended the target discovery term of
the alliance in May 2006 for an additional two years in exchange for further research funding
payments. We may receive additional cash payments if we exceed specified research productivity
levels. We will also receive clinical and regulatory milestone payments for each drug target for
which Bristol-Myers Squibb develops a drug under the alliance and royalties on sales of drugs
commercialized by Bristol-Myers Squibb. The target discovery portion of the alliance has a term of
five years, as extended.
Genentech, Inc. We established a drug discovery alliance with Genentech in December 2002 to
discover novel therapeutic proteins and antibody targets. We and Genentech expanded the alliance
in November 2005 for the advanced research, development and commercialization of new biotherapeutic
drugs. Under the original alliance agreement, we used our target validation technologies to
discover the functions of secreted proteins and potential antibody targets identified through
Genentechs internal drug discovery research. In the expanded alliance, we are conducting
additional, advanced research on a broad subset of those proteins and targets. We may develop and
commercialize biotherapeutic drugs for up to six of these targets, with Genentech having exclusive
rights to develop and commercialize biotherapeutic drugs for the other targets. Genentech retains
an option on the potential development and commercialization of the biotherapeutic drugs that we
develop from the alliance under a cost and profit sharing arrangement, while we have certain
conditional rights to co-promote drugs on a worldwide basis. We retain certain other rights to
discoveries made in the alliance, including non-exclusive rights, along with Genentech, for the
development and commercialization of small molecule drugs addressing the targets included in the
alliance.
We received upfront payments in connection with both the initiation of the original
collaboration and its expansion and are entitled to receive performance payments for our work in
the collaboration as it is completed. We are also entitled to receive milestone payments and
royalties on sales of therapeutic proteins and antibodies for which Genentech obtains exclusive
rights. Genentech is entitled to receive milestone payments and royalties on sales of therapeutic
proteins and antibodies for which Lexicon obtains exclusive rights. The agreement, as extended,
has an expected collaboration term of six years.
N.V. Organon. We established a drug discovery alliance with Organon in May 2005 to discover,
develop and commercialize novel biotherapeutic drugs. In the collaboration, we are creating and
analyzing knockout mice
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for up to 300 genes selected by the parties that encode secreted proteins or potential
antibody targets, including two of our preexisting drug discovery programs. We and Organon will
jointly select targets for further research and development and will equally share costs and
responsibility for research, preclinical and clinical activities. We and Organon will jointly
determine the manner in which collaboration products will be commercialized and will equally
benefit from product revenue. If fewer than five development candidates are designated under the
collaboration, our share of costs and product revenue will be proportionally reduced. We will
receive a milestone payment for each development candidate in excess of five. Either party may
decline to participate in further research or development efforts with respect to a collaboration
product, in which case such party will receive royalty payments on sales of such collaboration
product rather than sharing in revenue. Organon will have principal responsibility for
manufacturing biotherapeutic products resulting from the collaboration for use in clinical trials
and for worldwide sales.
We received an upfront payment under the agreement and are entitled to receive committed
research funding during the first two years of the agreement. The target discovery portion of the
alliance has an expected term of four years.
Takeda Pharmaceutical Company Limited. We established a drug discovery alliance with Takeda
in July 2004 to discover new drugs for the treatment of high blood pressure. In the collaboration,
we are using our gene knockout technology to identify drug targets that control blood pressure.
Takeda will be responsible for the screening, medicinal chemistry, preclinical and clinical
development and commercialization of drugs directed against targets selected for the alliance, and
will bear all related costs. We received an upfront payment under the agreement and are entitled
to receive research milestone payments for each target selected for therapeutic development. In
addition, we are entitled to receive clinical development and product launch milestone payments for
each product commercialized from the collaboration. We will also earn royalties on sales of drugs
commercialized by Takeda. The target discovery portion of the alliance has a term of three years,
subject to Takedas option to extend the discovery portion of the alliance for an additional two
years in exchange for further research funding payments.
Other Commercial Collaborations
Taconic Farms, Inc. We established a collaboration with Taconic Farms, Inc. in November 2005
for the marketing, distribution and licensing of certain lines of our knockout mice. Taconic is an
industry leader in the breeding, housing, quality control and global marketing and distribution of
rodent models for medical research and drug discovery. Under the terms of the collaboration, we
are presently making available more than 1,000 distinct lines of knockout mice for use by
pharmaceutical and biotechnology companies and other researchers. Taconic provides breeding
services and licenses for these lines and distributes knockout mice to customers. We receive
license fees and royalties from payments received by Taconic from customers obtaining access to
such knockout mice.
Target Validation Collaborations. We have established target validation collaboration
agreements with a number of leading pharmaceutical and biotechnology companies. Under these
collaboration agreements, we generate and, in some cases, analyze knockout mice for genes requested
by the collaborator. In addition, we grant non-exclusive licenses to the collaborator for use of
the knockout mice in its internal drug discovery programs and, if applicable, analysis data that we
generate under the agreement. Some of these agreements also provide for non-exclusive access to
our OmniBank database. We receive fees for knockout mice under these agreements. In some cases,
these agreements also provide for annual minimum commitments and the potential for royalties on
products that our collaborators discover or develop using our technology.
LexVision Collaborations. The collaboration periods have terminated under each of our
LexVision collaborations, pursuant to which our LexVision collaborators obtained non-exclusive
access to our LexVision database of in vivo-validated drug targets for the discovery of small
molecule compounds. We remain entitled to receive milestone payments and royalties on products
those LexVision collaborators develop using our technology.
Academic, Non-Profit and Government Arrangements
Texas Institute for Genomic Medicine. In July 2005, we received an award from the Texas
Enterprise Fund for the creation of a knockout mouse embryonic stem cell library containing 350,000
cell lines using our proprietary gene trapping technology. We are creating the library for the
Texas Institute for Genomic Medicine, or TIGM, a newly formed non-profit institute whose founding
members are Texas A&M University, the Texas A&M University
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System Health Science Center and us. TIGM researchers may also access specific cells from our
current OmniBank library of 270,000 mouse embryonic stem cell lines and will have certain rights to
utilize our gene targeting technologies. In addition, we will equip TIGM with the bioinformatics
software required for the management and analysis of data relating to the library. The Texas
Enterprise Fund also made an award to the Texas A&M University System for the creation of
facilities and infrastructure to house the library.
National Institutes of Health. In October 2005, we entered into a three-year contract to
provide selected knockout mouse lines and related phenotypic data to the United States National
Institutes of Health, or NIH. Under the contract, NIH may select lines of knockout mice and
related phenotypic data from among lines that we have elected to make available. These materials
are related to genes that we have already knocked out and analyzed. NIH will make materials
acquired from us under the contract available to researchers at academic and other non-profit
research institutions, and we retain the sole right to provide these materials to commercial
entities. We are entitled to receive staged payments from NIH following delivery and acceptance of
materials under the contract.
The Wellcome Trust. In November 2006, we entered into a contract to provide selected knockout
mouse lines and related phenotypic data to the National Research Center for Environment and Health
GmbH, or GSF, under terms substantially similar to those under which knockout mouse lines and
related phenotypic data are available to NIH. Under the contract, the Wellcome Trust Limited, in
its capacity as trustee of The Wellcome Trust, will work with GSF to select lines of knockout mice
and related phenotypic data from among lines that we have elected to make available and has
separately agreed to provide a grant to GSF to obtain such knockout mice and phenotypic data.
These materials are related to genes that we have already knocked out and analyzed. GSF will make
materials acquired from us under the contract available to researchers at academic and other
non-profit research institutions, and we retain the sole right to provide these materials to
commercial entities. We are entitled to receive staged payments from GSF following delivery and
acceptance of materials under the contract.
e-Biology Collaboration Program. We provide access to our OmniBank database through the
Internet to subscribing researchers at academic and non-profit research institutions. Our
bioinformatics software allows subscribers to mine our OmniBank database for genes of interest, and
we permit subscribers to acquire OmniBank knockout mice or embryonic stem cells on a non-exclusive
basis in our e-Biology collaboration program. We receive fees for knockout mice or embryonic stem
cells provided to collaborators in this program and, with participating institutions, rights to
license inventions or to receive royalties on products discovered using our materials. In all cases
we retain rights to use the same OmniBank knockout mice in our own gene function research and with
commercial collaborators. We have entered into more than 250 agreements under our e-Biology
collaboration program with researchers at leading institutions throughout the world.
Technology Licenses
We have granted non-exclusive, internal research-use sublicenses under certain of our gene
targeting patent rights to a total of 15 leading pharmaceutical and biotechnology companies. Many
of these agreements extend for the life of the patents. Others have terms of one to three years,
in some cases with provisions for subsequent renewals. We typically receive up-front license fees
and, in some cases, receive additional license fees or milestone payments on products that the
sublicensee discovers or develops using our technology.
Our Executive Officers
Our executive officers and their ages and positions are listed below.
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Name |
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Age |
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Position with the Company |
Arthur T. Sands, M.D., Ph.D.
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45 |
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President and Chief Executive Officer and Director |
Julia P. Gregory
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54 |
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Executive Vice President, Corporate Development and
Chief Financial Officer |
Alan J. Main, Ph.D.
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53 |
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Executive Vice President of Pharmaceutical Research |
Jeffrey L. Wade, J.D.
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42 |
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Executive Vice President and General Counsel |
Brian P. Zambrowicz, Ph.D.
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44 |
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Executive Vice President and Chief Scientific Officer |
Lance K. Ishimoto, Ph.D., J.D.
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47 |
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Senior Vice President of Intellectual Property |
James R. Piggott, Ph.D.
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52 |
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Senior Vice President of Pharmaceutical Biology |
Philip M. Brown, M.D., J.D.
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45 |
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Vice President of Clinical Development |
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Arthur T. Sands, M.D., Ph.D. co-founded our company and has been our president and chief
executive officer and a director since September 1995. At Lexicon, Dr. Sands pioneered the
development of large-scale gene knockout technology for use in drug discovery. Before founding
Lexicon, Dr. Sands served as an American Cancer Society postdoctoral fellow in the Department of
Human and Molecular Genetics at Baylor College of Medicine. Dr. Sands is a member of the board of
directors of the Texas Institute for Genomic Medicine. He received his B.A. in economics and
political science from Yale University and his M.D. and Ph.D. from Baylor College of Medicine.
Julia P. Gregory has been our executive vice president, corporate development and chief
financial officer since August 2003 and served as our executive vice president and chief financial
officer from February 2000 until August 2003. From 1998 to February 2000, Ms. Gregory served as
the head of investment banking for Punk, Ziegel & Company, a specialty investment banking firm
focusing on technology and healthcare and, from 1996 to February 2000, as the head of the firms
life sciences practice. From 1980 to 1996, Ms. Gregory was an investment banker, primarily with
Dillon, Read & Co., Inc., where she represented life sciences companies beginning in 1986. Ms.
Gregory is a member of the board of directors and the scientific advisory board of the Estee Lauder
Foundations Institute for the Study of Aging, Inc. and a member of the International Council for
George Washington Universitys Elliott School of International Affairs. She received her B.A. in
international affairs from George Washington University and her M.B.A. from the Wharton School of
the University of Pennsylvania.
Alan J. Main, Ph.D. has been our executive vice president of pharmaceutical research since
February 2007 and served as our senior vice president, Lexicon Pharmaceuticals from July 2001 until
February 2007. Dr. Main was president and chief executive officer of Coelacanth Corporation, a
leader in using proprietary chemistry technologies to rapidly discover new chemical entities for
drug development, from January 2000 until our acquisition of Coelacanth in July 2001. Dr. Main was
formerly senior vice president, U.S. Research at Novartis Pharmaceuticals Corporation, where he
worked for 20 years before joining Coelacanth. Dr. Main holds a B.S. from the University of
Aberdeen, Scotland and a Ph.D. in organic chemistry from the University of Liverpool, England and
completed postdoctoral studies at the Woodward Research Institute.
Jeffrey L. Wade, J.D. has been our executive vice president and general counsel since February
2000 and was our senior vice president and chief financial officer from January 1999 to February
2000. From 1988 through December 1998, Mr. Wade was a corporate securities and finance attorney
with the law firm of Andrews & Kurth L.L.P., for the last two years as a partner, where he
represented companies in the biotechnology, information technology and energy industries. Mr. Wade
is a member of the boards of directors of the Texas Healthcare and Bioscience Institute, the Texas
Institute for Genomic Medicine and the Texas Life Science Center for Innovation and
Commercialization. He received his B.A. and J.D. from the University of Texas.
Brian P. Zambrowicz, Ph.D. co-founded our company and has been our executive vice president
and chief scientific officer since February 2007. Dr. Zambrowicz served as our executive vice
president of research from August 2002 until February 2007, senior vice president of genomics from
February 2000 to August 2002, vice president of research from January 1998 to February 2000 and
senior scientist from April 1996 to January 1998. From 1993 to April 1996, Dr. Zambrowicz served
as a National Institutes of Health postdoctoral fellow at the Fred Hutchinson Cancer Center in
Seattle, Washington, where he studied gene trapping and gene targeting technology. Dr. Zambrowicz
is a member of the board of directors of the Texas Institute for Genomic Medicine. He received his
B.S. in biochemistry from the University of Wisconsin. He received his Ph.D. from the University
of Washington, where he studied tissue-specific gene regulation using transgenic mice.
Lance K. Ishimoto, J.D., Ph.D. has been our senior vice president of intellectual property
since February 2004. Dr. Ishimoto served as our vice president of intellectual property from July
1998 to February 2004. From 1994 to July 1998, Dr. Ishimoto was a biotechnology patent attorney at
the Palo Alto, California office of the law firm of Pennie & Edmonds LLP. Dr. Ishimoto received
his B.A. and Ph.D. from the University of California at Los Angeles, where he studied molecular
mechanisms of virus assembly and the regulation of virus ultrastructure. After receiving his
Ph.D., Dr. Ishimoto served as a National Institutes of Health postdoctoral fellow at the University
of Washington School of Medicine. He received his J.D. from Stanford University.
James R. Piggott, Ph.D. has been our senior vice president of pharmaceutical biology since
January 2000. From 1990 through October 1999, Dr. Piggott worked for ZymoGenetics, Inc., a
subsidiary of Novo Nordisk, a company focused on the discovery, development and commercialization
of therapeutic proteins for the treatment of human disease, most recently as senior vice
president-research biology from 1997 to October 1999. Dr. Piggotts pharmaceutical research
experience also includes service at the Smith Kline & French Laboratories Ltd. unit of
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SmithKline Beecham plc and the G.D. Searle & Co. unit of Monsanto Company. Dr. Piggott
received his B.A. and Ph.D. from Trinity College, Dublin.
Philip M. Brown, M.D., J.D. has been our vice president of clinical development since April
2003. Dr. Brown served as vice president of clinical development for Encysive Pharmaceuticals Inc.
(formerly Texas Biotechnology Corporation), a biopharmaceutical company, from June 2000 until April
2003, and was senior medical director within the organization from December 1998 until June 2000.
From July 1994 to December 1998, Dr. Brown served as associate vice president of medical affairs
for Pharmaceutical Research Associates, a clinical research organization. He has conducted numerous
clinical trials as an investigator in a variety of therapeutic areas, as well as managed programs
from IND through NDA and product commercialization. He is a fellow of the American College of Legal
Medicine and serves as an adjunct faculty member at the Massachusetts General Hospital, Institute
of Health Professions in Boston. He received his B.A. from Hendrix College, his M.D. from Texas
Tech University School of Medicine, and his J.D. from the University of Texas.
Patents and Proprietary Rights
We will be able to protect our proprietary rights from unauthorized use by third parties only
to the extent that those rights are covered by valid and enforceable patents or are effectively
maintained as trade secrets. Accordingly, patents and other proprietary rights are an essential
element of our business. We seek patent protection for the genes, proteins, drug targets and
potential drug candidates that we discover. Specifically, we seek patent protection for:
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the sequences of genes that we believe to be novel, including full-length human
genes and partial human and mouse gene sequences, the proteins they encode and their
predicted utility as a drug target or therapeutic protein; |
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the utility of genes and the drug targets or therapeutic proteins they encode based
on our discoveries of their biological functions using knockout mice; |
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drug discovery assays for our in vivo-validated targets; |
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chemical compounds and their use in treating human diseases and conditions; and |
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various enabling technologies in the fields of mutagenesis, embryonic stem cell
manipulation and transgenic or knockout mice. |
We own or have exclusive rights to nine issued United States patents that are directed to our
gene trapping technology, 89 issued United States patents that are directed to full-length
sequences of potential drug targets identified in our gene discovery programs, and five issued
United States patents that are directed to specific knockout mice and discoveries of the functions
of genes made using knockout mice. We have licenses under 93 additional United States patents, and
corresponding foreign patents and patent applications, directed to gene targeting, gene trapping
and genetic manipulation of mouse embryonic stem cells. These include patents to which we hold
exclusive rights in certain fields, including a total of nine United States patents directed to the
use of gene targeting technologies known as positive-negative selection and isogenic DNA targeting,
as well as patents directed to the use of site specific genetic recombination technology known as
Cre/lox technology.
We have filed or have exclusive rights to more than 400 pending patent applications in the
United States Patent and Trademark Office, the European Patent Office, the national patent offices
of other foreign countries or under the Patent Cooperation Treaty, directed to our gene trapping
technology, the DNA sequences of genes, the uses of specific drug targets, drug discovery assays,
and other products and processes. Collectively, these patent applications are directed to, among
other things, approximately 200 full-length human gene sequences, more than 50,000 partial human
gene sequences, and more than 45,000 knockout mouse clones and corresponding mouse gene sequence
tags. Patents typically have a term of no longer than 20 years from the date of filing.
As noted above, we hold rights to a number of these patents and patent applications under
license agreements with third parties. In particular, we license our principal gene targeting
technologies from GenPharm International, Inc. and our Cre/lox technology from DuPont
Pharmaceuticals Company, now a subsidiary of Bristol-Myers Squibb. Many of these licenses are
nonexclusive, although some are exclusive in specified fields. Most of the licenses, including
those licensed from GenPharm and DuPont, have terms that extend for the life of the licensed
patents. In the case of our license from GenPharm, the license generally is exclusive in specified
fields, subject to specific rights held by third parties, and we are permitted to grant
sublicenses.
9
All of our employees, consultants and advisors are required to execute a proprietary
information agreement upon the commencement of employment or consultation. In general, the
agreement provides that all inventions conceived by the employee or consultant, and all
confidential information developed or made known to the individual during the term of the
agreement, shall be our exclusive property and shall be kept confidential, with disclosure to third
parties allowed only in specified circumstances. We cannot assure you, however, that these
agreements will provide useful protection of our proprietary information in the event of
unauthorized use or disclosure of such information.
Competition
The biotechnology and pharmaceutical industries are highly competitive and characterized by
rapid technological change. We face significant competition in each of the aspects of our business
from numerous for-profit companies, many of which have substantially greater financial, scientific
and human resources than we do. In addition, a large number of universities and other
not-for-profit institutions, many of which are funded by the U.S. and foreign governments, are also
conducting research to discover genes and their functions.
Many of our competitors in drug discovery and development have substantially greater research
and product development capabilities and financial, scientific, marketing and human resources than
we do. As a result, our competitors may succeed in developing products earlier than we do,
obtaining approvals from the FDA or other regulatory agencies for those products more rapidly than
we do, or developing products that are more effective than those we propose to develop. Similarly,
our collaborators face similar competition from other competitors who may succeed in developing
products more quickly, or developing products that are more effective, than those developed by our
collaborators. We expect that competition in this field will intensify.
Government Regulation
Regulation of Pharmaceutical Products
The development, manufacture and sale of any pharmaceutical or biological products developed
by us or our collaborators will be subject to extensive regulation by United States and foreign
governmental authorities, including federal, state and local authorities. In the United States,
new drugs are subject to regulation under the Federal Food, Drug and Cosmetic Act and the
regulations promulgated thereunder, or the FDC Act, and biological products are subject to
regulation both under certain provisions of the FDC Act and under the Public Health Services Act
and the regulations promulgated thereunder, or the PHS Act. The FDA regulates, among other things,
the development, preclinical and clinical testing, manufacture, safety, efficacy, record keeping,
reporting, labeling, storage, approval, advertising, promotion, sale, distribution and export of
drugs and biologics. The process of obtaining FDA approval has historically been costly and
time-consuming.
The standard process required by the FDA before a pharmaceutical or biological product may be
marketed in the United States includes:
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preclinical laboratory and animal tests performed under the FDAs current Good
Laboratory Practices regulations; |
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submission to the FDA of an Investigational New Drug application, or IND, which must
become effective before human clinical trials may commence; |
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adequate and well-controlled human clinical trials to establish the safety and
efficacy of the drug or biologic in our intended application; |
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for drugs, submission of a New Drug Application, or NDA, and, for biologics,
submission of a Biologic License Application, or BLA, with the FDA; and |
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FDA approval of the NDA or BLA prior to any commercial sale or shipment of the
product. |
Among other things, the FDA reviews an NDA to determine whether a product is safe and
effective for its intended use and a BLA to determine whether a product is safe, pure and potent
and the facility in which it is manufactured, processed, packed, or held meets standards designed
to assure the products continued safety, purity and potency.
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In addition to obtaining FDA approval for each product, each drug or biologic manufacturing
establishment must be inspected and approved by the FDA. All manufacturing establishments are
subject to inspections by the FDA and by other federal, state and local agencies and must comply
with current Good Manufacturing Practices requirements. Non-compliance with these requirements can
result in, among other things, total or partial suspension of production, failure of the government
to grant approval for marketing and withdrawal, suspension or revocation of marketing approvals.
Preclinical studies can take several years to complete, and there is no guarantee that an IND
based on those studies will become effective to even permit clinical testing to begin. Once
clinical trials are initiated, they take years to complete. In addition, the FDA may place a
clinical trial on hold or terminate it if, among other reasons, the agency concludes that clinical
subjects are being exposed to an unacceptable health risk. After completion of clinical trials of
a new drug or biologic product, FDA marketing approval of the NDA or BLA must be obtained. An NDA
or BLA, depending on the submission, must contain, among other things, information on chemistry,
manufacturing controls and potency and purity, non-clinical pharmacology and toxicology, human
pharmacokinetics and bioavailability and clinical data. The process of obtaining approval requires
substantial time and effort and there is no assurance that the FDA will accept the NDA or BLA for
filing and, even if filed, that approval will be granted. The FDAs approval of an NDA or BLA can
take years and can be delayed if questions arise. Limited indications for use or other conditions
could also be placed on any approvals that could restrict the commercial applications of products.
Once the FDA approves a product, a manufacturer must provide certain updated safety and
efficacy information. Product changes as well as certain changes in a manufacturing process or
facility would necessitate additional FDA review and approval. Other post-approval changes may
also necessitate further FDA review and approval. Additionally, a manufacturer must meet other
requirements including those related to adverse event reporting and record keeping.
Violations of the FDC Act, the PHS Act or regulatory requirements may result in agency
enforcement action, including voluntary or mandatory recall, license suspension or revocation,
product seizure, fines, injunctions and civil or criminal penalties.
In addition to regulatory approvals that must be obtained in the United States, a drug or
biological product is also subject to regulatory approval in other countries in which it is
marketed. The conduct of clinical trials of drugs and biological products in countries other than
the United States is likewise subject to regulatory oversight in such countries. The requirements
governing the conduct of clinical trials, product licensing, pricing, and reimbursement vary widely
from country to country. No action can be taken to market any drug or biological product in a
country until the regulatory authorities in that country have approved an appropriate application.
FDA approval does not assure approval by other regulatory authorities. The current approval
process varies from country to country, and the time spent in gaining approval varies from that
required for FDA approval. In some countries, the sale price of a drug or biological product must
also be approved. The pricing review period often begins after marketing approval is granted.
Even if a foreign regulatory authority approves a drug or biological product, it may not approve
satisfactory prices for the product.
Other Regulations
In addition to the foregoing, our business is and will be subject to regulation under various
state and federal environmental laws, including the Occupational Safety and Health Act, the
Resource Conservation and Recovery Act and the Toxic Substances Control Act. These and other laws
govern our use, handling and disposal of various biological, chemical and radioactive substances
used in and wastes generated by our operations. We believe that we are in material compliance with
applicable environmental laws and that our continued compliance with these laws will not have a
material adverse effect on our business. We cannot predict, however, whether new regulatory
restrictions on the production, handling and marketing of biotechnology products will be imposed by
state or federal regulators and agencies or whether existing laws and regulations will adversely
affect us in the future.
Research and Development Expenses
In 2006, 2005 and 2004, respectively, we incurred expenses of $106.7 million, $93.6 million
and $90.6 million in company-sponsored as well as collaborative research and development
activities, including $4.4 million, ($21,000) and $0.4 million of stock-based compensation expense
in 2006, 2005 and 2004, respectively.
11
Employees and Consultants
We believe that our success will be based on, among other things, achieving and retaining
scientific and technological superiority and identifying and retaining capable management. We have
assembled a highly qualified team of scientists as well as executives with extensive experience in
the biotechnology industry.
As of February 28, 2007, we employed 585 persons, of whom 139 hold M.D., Ph.D. or D.V.M.
degrees and another 91 hold other advanced degrees. We believe that our relationship with our
employees is good.
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Item 1A. Risk Factors
The following risks and uncertainties are important factors that could cause actual results or
events to differ materially from those indicated by forward-looking statements. The factors
described below are not the only ones we face and additional risks and uncertainties not presently
known to us or that we currently deem immaterial also may impair our business operations.
Risks Related to Our Need for Additional Financing and Our Financial Results
We will need additional capital in the future and, if it is unavailable, we will be forced to
significantly curtail or cease operations. If it is not available on reasonable terms we will be
forced to obtain funds by entering into financing agreements on unattractive terms.
As of December 31, 2006, we had cash, cash equivalents and short-term investments (net of
restricted cash and investments) of $79.6 million. We anticipate that our existing capital
resources and the cash and revenues we expect to derive from drug discovery alliances,
collaborations for the development and, in some cases, analysis of the physiological effects of
genes altered in knockout mice, government grants and contracts and technology licenses will enable
us to fund our currently planned operations for at least the next twelve months. Our currently
planned operations for that time period consist of the continuation of our efforts to discover the
physiological functions of 5,000 human genes that we consider to be pharmaceutically important, the
expansion of our medicinal chemistry, biotherapeutics and preclinical research operations and the
initiation and conduct of additional clinical trials. However, we caution you that we may generate
less cash and revenues or incur expenses more rapidly than we currently anticipate.
Although difficult to accurately predict, the amount of our future capital requirements will
be substantial and will depend on many factors, including:
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our ability to obtain additional funds from alliances, collaborations, government
grants and contracts and technology licenses; |
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the amount and timing of payments under such agreements; |
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the level and timing of our research and development expenditures; |
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future results from clinical trials that we initiate; |
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the cost and timing of regulatory approvals of products that we successfully develop; and |
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market acceptance of products that we successfully develop and commercially launch. |
Our capital requirements will increase substantially to the extent we advance potential
therapeutics into clinical development. Our capital requirements will also be affected by any
expenditures we make in connection with license agreements and acquisitions of and investments in
complementary products and technologies. For all of these reasons, our future capital requirements
cannot easily be quantified.
If our capital resources are insufficient to meet future capital requirements, we will have to
raise additional funds to continue our currently planned operations. If we raise additional
capital by issuing equity securities, our then-existing stockholders will experience dilution and
the terms of any new equity securities may have preferences over our common stock. We cannot be
certain that additional financing, whether debt or equity, will be available in amounts or on terms
acceptable to us, if at all. We may be unable to raise sufficient additional capital on reasonable
terms; if so, we will be forced to significantly curtail or cease operations or obtain funds by
entering into financing agreements on unattractive terms.
We have a history of net losses, and we expect to continue to incur net losses and may not achieve
or maintain profitability.
We have incurred net losses since our inception, including net losses of $54.3 million for the
year ended December 31, 2006, $36.3 million for the year ended December 31, 2005 and $47.2 million
for the year ended December 31, 2004. As of December 31, 2006, we had an accumulated deficit of
$351.7 million. We are unsure when we will become profitable, if ever. The size of our net losses
will depend, in part, on the rate of growth, if any, in our revenues and on the level of our
expenses.
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We derive substantially all of our revenues from drug discovery alliances, collaborations for
the development and, in some cases, analysis of the physiological effects of genes altered in
knockout mice, government grants and contracts and technology licenses, and will continue to do so
for the foreseeable future. Our future revenues from alliances, collaborations and government
grants and contracts are uncertain because our existing agreements have fixed terms or relate to
specific projects of limited duration. Our future revenues from technology licenses are uncertain
because they depend, in part, on securing new agreements. Our ability to secure future
revenue-generating agreements will depend upon our ability to address the needs of our potential
future collaborators, granting agencies and licensees, and to negotiate agreements that we believe
are in our long-term best interests. We may determine that our interests are better served by
retaining rights to our discoveries and advancing our therapeutic programs to a later stage, which
could limit our near-term revenues. Given the early-stage nature of our operations, we do not
currently derive any revenues from sales of pharmaceutical products.
A large portion of our expenses is fixed, including expenses related to facilities, equipment
and personnel. In addition, we expect to spend significant amounts to enhance our core
technologies and fund our research and development activities, including the conduct of clinical
trials and the advancement of additional potential therapeutics into clinical development. As a
result, we expect that our operating expenses will continue to increase significantly as additional
drug programs progress into human clinical trials and, consequently, we will need to generate
significant additional revenues to achieve profitability. Even if we do achieve profitability, we
may not be able to sustain or increase profitability on a quarterly or annual basis.
Our operating results have been and likely will continue to fluctuate, and we believe that
period-to-period comparisons of our operating results are not a good indication of our future
performance.
Our operating results and, in particular, our ability to generate additional revenues are
dependent on many factors, including:
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our ability to establish new collaborations and alliances, government grants and
contracts, and technology licenses, and the timing of such arrangements; |
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the expiration or other termination of collaborations and alliances, which may not
be renewed or replaced; |
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the success rate of our discovery efforts leading to opportunities for new
collaborations, alliances and licenses, as well as milestone payments and royalties; |
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the timing and willingness of our collaborators to commercialize pharmaceutical
products that would result in milestone payments and royalties; and |
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general and industry-specific economic conditions, which may affect our and our
collaborators research and development expenditures. |
Because of these and other factors, including the risks and uncertainties described in this
section, our operating results have fluctuated in the past and are likely to do so in the future.
Due to the likelihood of fluctuations in our revenues and expenses, we believe that
period-to-period comparisons of our operating results are not a good indication of our future
performance.
Risks Related to Our Business
We are an early-stage company, and we may not successfully develop or commercialize any
therapeutics that we have identified.
Our business strategy of using our technology platform and, specifically, the discovery of the
functions of genes using knockout mice to select promising drug targets and developing and
commercializing drugs based on our discoveries, in significant part through collaborations and
alliances, is unproven. Our success will depend upon our ability to successfully develop potential
therapeutics for drug targets we consider to have pharmaceutical value, whether on our own or
through collaborations, and to select an appropriate commercialization strategy for each potential
therapeutic we choose to pursue.
Biotechnology and pharmaceutical companies have successfully developed and commercialized only
a limited number of genomics-derived pharmaceutical products to date. We have not proven our
ability to develop or commercialize therapeutics or drug targets that we identify. We do not know
that any pharmaceutical products
14
based on our drug target discoveries can be successfully commercialized. In addition, we may
experience unforeseen technical complications in the processes we use to discover and develop
potential therapeutics. These complications could materially delay or limit the use of our
resources, substantially increase the anticipated cost of generating them or prevent us from
implementing our processes at appropriate quality and throughput levels.
Clinical testing of our drug candidates in humans is an inherently risky and time-consuming process
that may fail to demonstrate safety and efficacy, which could result in the delay, limitation or
prevention of regulatory approval.
In order to obtain regulatory approvals for the commercial sale of any products that we may
develop, we will be required to complete extensive clinical trials in humans to demonstrate the
safety and efficacy of our drug candidates. We or our collaborators may not be able to obtain
authority from the United States Food and Drug Administration, or FDA, or other equivalent foreign
regulatory agencies to initiate or complete any clinical trials. In addition, we have limited
internal resources for making regulatory filings and dealing with regulatory authorities.
Clinical trials are inherently risky and the results from preclinical testing of a drug
candidate that is under development may not be predictive of results that will be obtained in human
clinical trials. In addition, the results of early human clinical trials may not be predictive of
results that will be obtained in larger scale, advanced stage clinical trials. A number of
companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical
trials, even after achieving positive results in earlier trials. Negative or inconclusive results
from a preclinical study or a clinical trial could cause us, one of our collaborators or the FDA to
terminate a preclinical study or clinical trial or require that we repeat it. Furthermore, we, one
of our collaborators or a regulatory agency with jurisdiction over the trials may suspend clinical
trials at any time if the subjects or patients participating in such trials are being exposed to
unacceptable health risks or for other reasons.
Any preclinical or clinical test may fail to produce results satisfactory to the FDA or
foreign regulatory authorities. Preclinical and clinical data can be interpreted in different
ways, which could delay, limit or prevent regulatory approval. The FDA or institutional review
boards at the medical institutions and healthcare facilities where we sponsor clinical trials may
suspend any trial indefinitely if they find deficiencies in the conduct of these trials. Clinical
trials must be conducted in accordance with the FDAs current Good Clinical Practices. The FDA and
these institutional review boards have authority to oversee our clinical trials, and the FDA may
require large numbers of test subjects. In addition, we must manufacture, or contract for the
manufacture of, the product candidates that we use in our clinical trials under the FDAs current
Good Manufacturing Practices.
The rate of completion of clinical trials is dependent, in part, upon the rate of enrollment
of patients. Patient accrual is a function of many factors, including the size of the patient
population, the proximity of patients to clinical sites, the eligibility criteria for the study,
the nature of the study, the existence of competitive clinical trials and the availability of
alternative treatments. Delays in planned patient enrollment may result in increased costs and
prolonged clinical development, which in turn could allow our competitors to bring products to
market before we do and impair our ability to commercialize our products or potential products.
We or our collaborators may not be able to successfully complete any clinical trial of a
potential product within any specified time period. In some cases, we or our collaborators may not
be able to complete the trial at all. Moreover, clinical trials may not show our potential products
to be both safe and effective. Thus, the FDA and other regulatory authorities may not approve any
products that we develop for any indication or may limit the approved indications or impose other
conditions.
We are dependent upon our collaborations with major pharmaceutical companies. If we are unable to
achieve milestones under those collaborations or if our collaborators efforts fail to yield
pharmaceutical products on a timely basis, our business will suffer.
We have derived a substantial majority of our revenues to date from collaborative drug
discovery alliances with a limited number of major pharmaceutical companies. Revenues from our
drug discovery alliances depend upon continuation of the collaborations, the achievement of
milestones and payment of royalties we earn from any future products developed under the
collaborations. If our relationship terminates with any of our collaborators, our reputation in
the business and scientific community may suffer and revenues will be negatively impacted to the
extent such losses are not offset by additional collaboration agreements. If we are unable to
achieve milestones or our collaborators are unable to successfully develop products from which
royalties are payable, we will not earn the revenues contemplated by those drug discovery
alliances. In addition, some of our alliances are exclusive and preclude us from entering into
additional collaborative arrangements with other parties in the field of exclusivity.
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We have limited or no control over the resources that any collaborator may devote to the
development and commercialization of products under our alliances. Any of our present or future
collaborators may not perform their obligations as expected. These collaborators may breach or
terminate their agreements with us or otherwise fail to conduct product discovery, development or
commercialization activities successfully or in a timely manner. Further, our collaborators may
elect not to develop pharmaceutical products arising out of our collaborative arrangements or may
not devote sufficient resources to the development, approval, manufacture, marketing or sale of
these products. If any of these events occurs, we may not be able to develop or commercialize
potential pharmaceutical products.
Conflicts with our collaborators could jeopardize the success of our collaborative agreements and
harm our product development efforts.
We may pursue opportunities in specific disease and therapeutic modality fields that could
result in conflicts with our collaborators, if any of our collaborators takes the position that our
internal activities overlap with those activities that are exclusive to our collaboration.
Moreover, disagreements could arise with our collaborators over rights to our intellectual property
or our rights to share in any of the future revenues of compounds or therapeutic approaches
developed by our collaborators. Any conflict with or among our collaborators could result in the
termination of our collaborative agreements, delay collaborative research or development
activities, impair our ability to renew or obtain future collaborative agreements or lead to costly
and time consuming litigation. Conflicts with our collaborators could also have a negative impact
on our relationship with existing collaborators, materially impairing our business and revenues.
Some of our collaborators are also potential competitors or may become competitors in the future.
Our collaborators could develop competing products, preclude us from entering into collaborations
with their competitors or terminate their agreements with us prematurely. Any of these events
could harm our product development efforts.
If we are unable to internally establish drug development and commercialization capabilities or
arrange for the provision of such functions by third parties, our ability to develop and
commercialize pharmaceutical products would be significantly impaired.
Our ability to develop and commercialize pharmaceutical products on our own will depend on our
ability to internally develop preclinical, clinical, regulatory and sales and marketing
capabilities, or enter into arrangements with third parties to provide these functions. It will be
expensive and will require significant time for us to develop these capabilities internally. We
may not be successful in developing these capabilities or entering into agreements with third
parties on favorable terms, or at all. Further, our reliance upon third parties for these
capabilities could reduce our control over such activities and could make us dependent upon these
parties. If these third parties do not successfully carry out their contractual duties or
regulatory obligations or meet expected deadlines, our drug development activities may be delayed,
suspended or terminated. Such a failure by these third parties, or our inability to develop or
contract for these capabilities, would significantly impair our ability to develop and
commercialize pharmaceutical products.
We lack the capability to manufacture materials for preclinical studies, clinical trials or
commercial sales and will rely on third parties to manufacture our potential products, which may
harm or delay our product development and commercialization efforts.
We currently do not have the manufacturing capabilities or experience necessary to produce
materials for preclinical studies, clinical trials or commercial sales and intend to rely on
collaborators and third-party contractors to produce such materials. We will rely on selected
manufacturers to deliver materials on a timely basis and to comply with applicable regulatory
requirements, including the current Good Manufacturing Practices of the FDA, which relate to
manufacturing and quality control activities. These manufacturers may not be able to produce
material on a timely basis or manufacture material at the quality level or in the quantity required
to meet our development timelines and applicable regulatory requirements. In addition, there are a
limited number of manufacturers that operate under the FDAs current Good Manufacturing Practices
and that are capable of producing such materials, and we may experience difficulty finding
manufacturers with adequate capacity for our needs. If we are unable to contract for the
production of sufficient quantity and quality of materials on acceptable terms, our product
development and commercialization efforts may be delayed. Moreover, noncompliance with the FDAs
current Good Manufacturing Practices can result in, among other things, fines, injunctions, civil
and criminal penalties, product recalls or seizures, suspension of production, failure to obtain
marketing approval and withdrawal, suspension or revocation of marketing approvals.
16
We face substantial competition in our drug discovery and product development efforts.
We face significant competition in our drug discovery and product development efforts from
other biotechnology and pharmaceutical companies, as well as from universities and other
not-for-profit institutions. In particular, certain competing companies such as Human Genome
Sciences, Inc., Millennium Pharmaceuticals, Inc. and Exelixis, Inc. utilize a genetics-based
approach to target discovery and validation that is similar to our own. Many of our competitors
have substantially greater financial, scientific and human resources than we do. As a result, our
competitors may succeed in developing products earlier than we do, obtaining regulatory approvals
faster than we do and developing products that are more effective or safer than any that we may
develop.
We may engage in future acquisitions, which may be expensive and time consuming and from which we
may not realize anticipated benefits.
We may acquire additional businesses, technologies and products if we determine that these
businesses, technologies and products complement our existing technology or otherwise serve our
strategic goals. If we do undertake any transactions of this sort, the process of integrating an
acquired business, technology or product may result in operating difficulties and expenditures and
may not be achieved in a timely and non-disruptive manner, if at all, and may absorb significant
management attention that would otherwise be available for ongoing development of our business. If
we fail to integrate acquired businesses, technologies or products effectively or if key employees
of an acquired business leave, the anticipated benefits of the acquisition would be jeopardized.
Moreover, we may never realize the anticipated benefits of any acquisition, such as increased
revenues and earnings or enhanced business synergies. Future acquisitions could result in
potentially dilutive issuances of our equity securities, the incurrence of debt and contingent
liabilities and amortization expenses related to intangible assets, which could materially impair
our results of operations and financial condition.
If we lose our key personnel or are unable to attract and retain additional personnel, we may be
unable to successfully develop and commercialize our own products.
We are highly dependent on the principal members of our management and scientific staff. We
do not carry key man insurance on any key personnel and the loss of any of these personnel could
negatively impact our business, financial condition or results of operations and could inhibit our
product development and commercialization efforts. Although we have entered into employment
agreements with some of our key personnel, these employment agreements are all at will. In
addition, not all key personnel have employment agreements.
Recruiting and retaining qualified scientific personnel to perform future research and
development work will be critical to our success. Competition for experienced scientists is
intense. Failure to recruit and retain scientific personnel on acceptable terms could prevent us
from achieving our business objectives.
Any contamination among our knockout mouse population could negatively affect the reliability of
our scientific research or cause us to incur significant remedial costs.
Our generation and analysis of knockout mice are conducted in a specific pathogen-free
environment. Any contamination of our knockout mouse population could distort or compromise the
quality of our research and negatively impact the reliability of our scientific discoveries.
Although we have expended substantial resources in order to secure our facilities from such risk,
in the event such a contamination were to occur, our drug discovery efforts could be significantly
harmed or delayed and our reputation within the scientific community could be eroded. In addition,
we may incur significant remedial costs relating to the elimination of any pathogens present in our
facilities.
Because all of our target validation operations are located at a single facility, the occurrence of
a disaster could significantly disrupt our business.
Our OmniBank mouse clone library and its backup are stored in liquid nitrogen freezers located
at our facility in The Woodlands, Texas, and our knockout mouse research operations are carried out
entirely at the same facility. While we have developed redundant and emergency backup systems to
protect these resources and the facilities in which they are stored, they may be insufficient in
the event of a severe fire, flood, hurricane, tornado, mechanical failure or similar disaster. If
such a disaster significantly damages or destroys the facility in which these resources are
maintained, our business could be disrupted until we could regenerate the affected resources and,
as a
17
result, our stock price could decline. Our business interruption insurance may not be
sufficient to compensate us in the event of a major interruption due to such a disaster.
We use hazardous chemicals and radioactive and biological materials in our business; any disputes
relating to improper handling, storage or disposal of these materials could be time consuming and
costly.
Our research and development processes involve the use of hazardous materials, including
chemicals and radioactive and biological materials. Our operations also produce hazardous waste
products. We cannot eliminate the risk of accidental contamination or discharge or any resultant
injury from these materials. Federal, state and local laws and regulations govern the use,
manufacture, storage, handling and disposal of these materials. We could be subject to civil
damages in the event of an improper or unauthorized release of, or exposure of individuals to,
these hazardous materials. In addition, claimants may sue us for injury or contamination that
results from our use or the use by third parties of these materials, and our liability may exceed
our total assets. Compliance with environmental laws and regulations may be expensive, and current
or future environmental regulations may impair our research, development or production efforts. We
do not currently maintain insurance coverage that would cover these types of environmental
liabilities.
Risks Related to Our Industry
Our ability to patent our inventions is uncertain because patent laws and their interpretation are
highly uncertain and subject to change.
The patent positions of pharmaceutical and biotechnology companies generally are highly
uncertain and involve complex legal and factual questions that will determine who has the right to
develop or use a particular technology or product. No clear policy has emerged regarding the scope
of protection provided in gene, drug target and biopharmaceutical patents. In addition, certain
uses of technologies and products covered by some of these patents may be subject to statutory
exemptions from infringement under applicable law. The biopharmaceutical patent situation outside
the United States is similarly uncertain. Changes in, or different interpretations of, patent laws
in the United States or other countries might allow others to use our inventions or to develop and
commercialize any technologies or products that we may develop without any compensation to us. We
anticipate that these uncertainties will continue for a significant period of time.
If we are unable to adequately protect our intellectual property, third parties may be able to use
our technology, which could negatively impact our ability to compete in the market.
Our success will depend, in part, upon our ability to obtain patents and maintain adequate
protection of the intellectual property related to our technologies and future products. We will
be able to protect our intellectual property rights from unauthorized use by third parties only to
the extent that our technologies are covered by valid and enforceable patents or are effectively
maintained as trade secrets.
Pending patent applications do not provide protection against competitors because they are not
enforceable until they issue as patents. Further, the disclosures contained in our current and
future patent applications may not be sufficient to meet statutory requirements for patentability.
Once issued, patents still may not provide commercially meaningful protection. If anyone infringes
upon our or our collaborators patent rights, enforcing these rights may be difficult, costly and
time-consuming and, as a result, it may not be cost-effective or otherwise expedient to pursue
litigation to enforce those patent rights. Others may be able to design around these patents or
develop unique products providing effects similar to any products that we may develop. Other
companies or institutions may challenge our or our collaborators patents or independently develop
similar products that could result in an interference proceeding in the United States Patent and
Trademark Office or a legal action.
Patent applications can take many years to issue and there may be currently pending patent
applications of our competitors that later result in issued patents covering our discoveries. If
any such patents are issued to other entities, we will be unable to obtain patent protection for
the same or similar discoveries that we make. Moreover, we may be blocked from using or developing
some of our existing or proposed technologies and products, or may be required to obtain a license
that may not be available on reasonable terms, if at all. Further, others may discover uses for
our technologies or therapeutic products other than those covered in our issued or pending patents,
and these other uses may be separately patentable. Even if we have a patent claim on a particular
technology or therapeutic product, the holder of a patent covering the use of that technology or
therapeutic product could exclude us from selling a product that is based on the same use of that
product.
18
Additionally, significant aspects of our intellectual property are not protected by patents.
As a result, we seek to protect the proprietary nature of this intellectual property as trade
secrets through proprietary information agreements and other measures. While we have entered into
proprietary information agreements with all of our employees, consultants, advisers and
collaborators, we may not be able to prevent the disclosure of our trade secrets. In addition,
other companies or institutions may independently develop substantially equivalent information and
techniques.
We may be involved in patent litigation and other disputes regarding intellectual property rights
and may require licenses from third parties for our discovery and development and planned
commercialization activities. We may not prevail in any such litigation or other dispute or be
able to obtain required licenses.
Our discovery and development efforts as well as our potential products and those of our
collaborators may give rise to claims that they infringe the patents of others. This risk will
increase as the biotechnology industry expands and as other companies and institutions obtain more
patents covering the sequences, functions and uses of genes and the drug targets they encode. We
are aware that other companies and institutions have conducted research on many of the same targets
that we have identified and have filed patent applications potentially covering many of the genes
and encoded drug targets that are the focus of our drug discovery programs. In some cases, patents
have issued from these applications. In addition, many companies and institutions have
well-established patent portfolios directed to common techniques, methods and means of developing,
producing and manufacturing pharmaceutical products. Other companies or institutions could bring
legal actions against us or our collaborators for damages or to stop us or our collaborators from
engaging in certain discovery or development activities or from manufacturing and marketing any
resulting therapeutic products. If any of these actions are successful, in addition to our
potential liability for damages, these entities would likely require us or our collaborators to
obtain a license in order to continue engaging in the infringing activities or to manufacture or
market the resulting therapeutic products or may force us to terminate such activities or
manufacturing and marketing efforts.
We may need to pursue litigation against others to enforce our patents and intellectual
property rights and may be the subject of litigation brought by third parties to enforce their
patent and intellectual property rights. In addition, we may become involved in litigation based
on intellectual property indemnification undertakings that we have given to certain of our
collaborators. Patent litigation is expensive and requires substantial amounts of management
attention. The eventual outcome of any such litigation is uncertain and involves substantial
risks.
We believe that there will continue to be significant litigation in our industry regarding
patent and other intellectual property rights. We have expended and many of our competitors have
expended and are continuing to expend significant amounts of time, money and management resources
on intellectual property litigation. If we become involved in future intellectual property
litigation, it could consume a substantial portion of our resources and could negatively affect our
results of operations.
We use intellectual property that we license from third parties. If we do not comply with these
licenses, we could lose our rights under them.
We rely, in part, on licenses to use certain technologies that are important to our business,
such as certain gene targeting technology licensed from GenPharm International, Inc. and
conditional knockout technology licensed from DuPont Pharmaceuticals Company, now a subsidiary of
Bristol-Myers Squibb Company. We do not own the patents that underlie these licenses. Most of
these licenses, however, including those licensed from GenPharm and DuPont, have terms that extend
for the life of the licensed patents. Our rights to use these technologies and practice the
inventions claimed in the licensed patents are subject to our abiding by the terms of those
licenses and the licensors not terminating them. We are currently in compliance with all
requirements of these licenses. In many cases, we do not control the filing, prosecution or
maintenance of the patent rights to which we hold licenses and rely upon our licensors to prosecute
infringement of those rights. The scope of our rights under our licenses may be subject to dispute
by our licensors or third parties.
We have not sought patent protection outside of the United States for some of our inventions, and
some of our licensed patents only provide coverage in the United States. As a result, our
international competitors could be granted foreign patent protection with respect to our
discoveries.
We have decided not to pursue patent protection with respect to some of our inventions outside
the United States, both because we do not believe it is cost-effective and because of
confidentiality concerns. Accordingly, our international competitors could develop, and receive
foreign patent protection for, genes or gene sequences, uses of
19
those genes or gene sequences, gene products and drug targets, assays for identifying
potential therapeutic products, potential therapeutic products and methods of treatment for which
we are seeking United States patent protection. In addition, most of our gene trapping patents and
our licensed gene targeting patents cover only the United States and do not apply to discovery
activities conducted outside of the United States or, in some circumstances, to importing into the
United States products developed using this technology.
Our industry is subject to extensive and uncertain government regulatory requirements, which could
significantly hinder our ability, or the ability of our collaborators, to obtain, in a timely
manner or at all, regulatory approval of potential therapeutic products, or to commercialize such
products.
Our drug candidates, as well as the activities associated with their research, development and
commercialization, are subject to extensive regulation by the FDA or other equivalent foreign
regulatory agencies. Our failure to obtain regulatory approval for a drug candidate would prevent
us from commercializing that drug candidate. The regulatory approval process is expensive,
time-consuming and can vary substantially depending on the modality, complexity and novelty of the
drug candidate. The regulatory process includes extensive preclinical studies and human clinical
trials, which can take many years and may require substantial expenditures. Such preclinical
studies or clinical trials may fail to produce results satisfactory to the FDA or other equivalent
foreign regulatory agencies. Even if we obtain regulatory approval, the FDA or other equivalent
foreign regulatory agency may impose restrictions as to the approved use and labeling of our
product or the types of patients to which we can market and sell our product. We have limited
internal resources with respect to the regulatory process and have only limited experience in the
preparation and filing of the applications necessary to obtain regulatory approval.
If our potential products receive regulatory approval, we or our collaborators will remain subject
to extensive and rigorous ongoing regulation.
If we or our collaborators obtain initial regulatory approvals from the FDA or foreign
regulatory authorities for any products that we may develop, we or our collaborators will be
subject to extensive and rigorous ongoing domestic and foreign government regulation of, among
other things, the research, development, testing, manufacture, labeling, promotion, advertising,
distribution and marketing of our products and product candidates. The failure to comply with
these requirements or the identification of safety problems during commercial marketing could lead
to the need for product marketing restrictions, product withdrawal or recall or other voluntary or
regulatory action, which could delay further marketing until the product is brought into
compliance. The failure to comply with these requirements may also subject us or our collaborators
to stringent penalties.
Moreover, several of our product development areas involve relatively new technology and have
not been the subject of extensive product testing in humans. The regulatory requirements governing
these products and related clinical procedures remain uncertain and the products themselves may be
subject to substantial review by foreign governmental regulatory authorities that could prevent or
delay approval in those countries. Regulatory requirements ultimately imposed on any products that
we may develop could limit our ability to test, manufacture and, ultimately, commercialize such
products.
The uncertainty of pharmaceutical pricing and reimbursement may decrease the commercial potential
of any products that we or our collaborators may develop and affect our ability to raise capital.
Our ability and the ability of our collaborators to successfully commercialize pharmaceutical
products will depend, in part, on the extent to which reimbursement for the cost of such products
and related treatment will be available from government health administration authorities, private
health coverage insurers and other organizations. The pricing, availability of distribution
channels and reimbursement status of newly approved pharmaceutical products is highly uncertain.
As a result, adequate third-party coverage may not be available for us to maintain price levels
sufficient for realization of an appropriate return on our investment in product discovery and
development.
In certain foreign markets, pricing or profitability of healthcare products is subject to
government control. In the United States, there have been, and we expect that there will continue
to be, a number of federal and state proposals to implement similar governmental control. In
addition, an increasing emphasis on managed care in the United States has increased and will
continue to increase the pressure on pharmaceutical pricing. While we cannot predict the adoption
of any such legislative or regulatory proposals or the effect such proposals or managed care
efforts may have on our business, the announcement of such proposals or efforts could harm our
ability to raise capital, and the adoption of such proposals or efforts could harm our results of
operations. Further, to the extent that
20
such proposals or efforts harm other pharmaceutical companies that are our prospective
collaborators, our ability to establish corporate collaborations would be impaired. In addition,
third-party payers are increasingly challenging the prices charged for medical products and
services. We do not know whether consumers, third-party payers and others will consider any
products that we or our collaborators develop to be cost-effective or that reimbursement to the
consumer will be available or will be sufficient to allow us or our collaborators to sell such
products on a profitable basis.
We may be sued for product liability.
We or our collaborators may be held liable if any product that we or our collaborators
develop, or any product that is made with the use or incorporation of any of our technologies,
causes injury or is found otherwise unsuitable during product testing, manufacturing, marketing or
sale. Although we currently have and intend to maintain product liability insurance, this
insurance may become prohibitively expensive or may not fully cover our potential liabilities. Our
inability to obtain sufficient insurance coverage at an acceptable cost or otherwise to protect
against potential product liability claims could prevent or inhibit the commercialization of
products developed by us or our collaborators. If we are sued for any injury caused by our or our
collaborators products, our liability could exceed our total assets.
Public perception of ethical and social issues may limit or discourage the use of our technologies,
which could reduce our revenues.
Our success will depend, in part, upon our ability to develop products discovered through our
knockout mouse technologies. Governmental authorities could, for ethical, social or other
purposes, limit the use of genetic processes or prohibit the practice of our knockout mouse
technologies. Claims that genetically engineered products are unsafe for consumption or pose a
danger to the environment may influence public perceptions. The subject of genetically modified
organisms, like knockout mice, has received negative publicity and aroused public debate in some
countries. Ethical and other concerns about our technologies, particularly the use of genes from
nature for commercial purposes and the products resulting from this use, could reduce the
likelihood of maintaining market acceptance of our technologies.
21
Item 1B. Unresolved Staff Comments
None.
Item 2. Properties
We currently own approximately 300,000 square feet of space for our corporate offices and
laboratories in buildings located in The Woodlands, Texas, a suburb of Houston, Texas, and lease
approximately 76,000 square feet of space for offices and laboratories near Princeton, New Jersey.
Our facilities in The Woodlands, Texas include two state-of-the art animal facilities totaling
approximately 100,000 square feet. These facilities, completed in 1999 and 2002, respectively,
were custom designed for the generation and analysis of knockout mice and are accredited by AAALAC
International (Association for Assessment and Accreditation of Laboratory Animal Care). These
facilities enable us to maintain in-house control over our entire in vivo validation process, from
the generation of embryonic stem cell clones through the completion of in vivo analysis, in a
specific pathogen free environment. We believe these facilities, which are among the largest and
most sophisticated of their kind in the world, provide us with significant strategic and
operational advantages relative to our competitors. Because of the size and sophistication of our
facilities, it would require the investment of significant resources over an extended period of
time for any competitor to develop facilities with the scale, efficiency and productivity with
respect to the analysis of the functionality of genes that our facilities provide.
In April 2004, we purchased our facilities in The Woodlands, Texas from the lessor under our
previous synthetic lease agreement. In connection with such purchase, we repaid the $54.8 million
funded under the synthetic lease with proceeds from a $34.0 million third-party mortgage financing
and $20.8 million in cash. The mortgage loan has a ten-year term with a 20-year amortization and
bears interest at a fixed rate of 8.23%. As a result of the refinancing, all restrictions on the
cash and investments that had secured the obligations under the synthetic lease were eliminated.
In May 2002, our subsidiary Lexicon Pharmaceuticals (New Jersey), Inc. entered into a lease
for a 76,000 square-foot facility in Hopewell, New Jersey. The term of the lease extends until
June 30, 2013. The lease provides for an escalating yearly base rent payment of $1.3 million in
the first year, $2.1 million in years two and three, $2.2 million in years four to six, $2.3
million in years seven to nine and $2.4 million in years ten and eleven. We are the guarantor of
the obligations of our subsidiary under the lease.
We believe that our facilities are well-maintained, in good operating condition and acceptable
for our current operations.
Item 3. Legal Proceedings
None.
Item 4. Submission of Matters to a Vote of Security Holders
None.
22
PART II
Item 5. Market for Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Our common stock is quoted on The Nasdaq Global Market under the symbol LEXG. The following
table sets forth, for the periods indicated, the high and low sales prices for our common stock as
reported on The Nasdaq Global Market.
|
|
|
|
|
|
|
|
|
|
|
High |
|
Low |
2005 |
|
|
|
|
|
|
|
|
First Quarter |
|
$ |
8.00 |
|
|
$ |
4.90 |
|
Second Quarter |
|
$ |
5.20 |
|
|
$ |
4.15 |
|
Third Quarter |
|
$ |
6.50 |
|
|
$ |
3.82 |
|
Fourth Quarter |
|
$ |
4.47 |
|
|
$ |
3.19 |
|
2006 |
|
|
|
|
|
|
|
|
First Quarter |
|
$ |
5.83 |
|
|
$ |
3.60 |
|
Second Quarter |
|
$ |
5.85 |
|
|
$ |
4.01 |
|
Third Quarter |
|
$ |
4.52 |
|
|
$ |
3.65 |
|
Fourth Quarter |
|
$ |
4.40 |
|
|
$ |
3.40 |
|
As of February 28, 2007, there were approximately 226 holders of record of our common stock.
We have never paid cash dividends on our common stock. We anticipate that we will retain all
of our future earnings, if any, for use in the expansion and operation of our business and do not
anticipate paying cash dividends in the foreseeable future.
Equity Compensation Plan Information
The following table presents aggregate summary information as of December 31, 2006 regarding
the common stock that may be issued upon exercise of options, warrants and rights under all of our
existing equity compensation plans, including our 2000 Equity Incentive Plan, 2000 Non-Employee
Directors Stock Option Plan and Coelacanth Corporation 1999 Stock Option Plan.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
|
(b) |
|
|
(c) |
|
|
|
|
|
|
|
|
|
|
|
Number of securities remaining |
|
|
|
Number of securities to be |
|
|
Weighted average |
|
|
available for future issuance under |
|
|
|
issued upon exercise of |
|
|
exercise price per share |
|
|
equity compensation plans |
|
|
|
outstanding options, |
|
|
of outstanding options, |
|
|
(excluding securities reflected in |
|
Plan Category |
|
warrants and rights |
|
|
warrants and rights |
|
|
column (a)) |
|
Equity compensation plans
approved by security holders (1) |
|
|
15,740,947 |
|
|
$ |
6.0072 |
|
|
|
1,685,527 |
(3)(4)(5) |
Equity compensation plans not
approved by security holders (2) |
|
|
73,271 |
|
|
|
2.3026 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
15,814,218 |
|
|
$ |
5.9900 |
|
|
|
1,685,527 |
|
|
|
|
(1) |
|
Consists of shares of our common stock issuable upon the exercise of options
granted under our 2000 Equity Incentive Plan and 2000 Non-Employee Directors Stock Option
Plan or remaining available for issuance under those plans. |
|
(2) |
|
Consists of shares of our common stock issuable upon the exercise of options granted
under the Coelacanth Corporation 1999 Stock Option Plan, which we assumed in connection with
our July 2001 acquisition of Coelacanth Corporation, but does not include warrants to purchase
16,483 shares of common stock at a weighted average exercise price of $11.93 per share, which
we also assumed in connection with our acquisition of Coelacanth. |
|
(3) |
|
Includes 1,389,527 shares available for future issuance under our 2000 Equity
Incentive Plan, some or all of which may be awarded as stock bonuses. |
|
(4) |
|
Our 2000 Equity Incentive Plan provides that on each January 1, the number of shares
available for issuance under the plan will be automatically increased by the greater of (i)
five percent of our outstanding shares on a fully-diluted basis or (ii) the number of shares
that could be issued under awards granted under the plan during the prior year. Our board of
directors may provide for a lesser increase in the number of shares available for issuance
under the plan. |
|
(5) |
|
Our 2000 Non-Employee Directors Stock Option Plan provides that on the day
following each annual meeting of stockholders, the number of shares available for issuance
under the plan will be automatically increased by the greater of (i) 0.3% of our outstanding
shares on a fully-diluted basis or (ii) the number of shares that could be issued under
options granted under the plan during the prior year. Our board of directors may provide for
a lesser increase in the number of shares available for issuance under the plan. |
23
Performance Graph
The following performance graph compares the performance of our common stock to the Nasdaq
Composite Index and the Nasdaq Biotechnology Index for the period beginning December 31, 2001 and
ending December 31, 2006. The graph assumes that the value of the investment in our common stock
and each index was $100 at December 31, 2001, and that all dividends were reinvested.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
|
2001 |
|
|
2002 |
|
|
2003 |
|
|
2004 |
|
|
2005 |
|
|
2006 |
|
|
Lexicon Genetics Incorporated |
|
|
|
100 |
|
|
|
|
41 |
|
|
|
|
51 |
|
|
|
|
67 |
|
|
|
|
32 |
|
|
|
|
31 |
|
|
|
Nasdaq Composite Index |
|
|
|
100 |
|
|
|
|
68 |
|
|
|
|
103 |
|
|
|
|
112 |
|
|
|
|
113 |
|
|
|
|
124 |
|
|
|
Nasdaq Biotechnology Index |
|
|
|
100 |
|
|
|
|
55 |
|
|
|
|
80 |
|
|
|
|
85 |
|
|
|
|
87 |
|
|
|
|
88 |
|
|
|
The foregoing stock price performance comparisons shall not be deemed filed for purposes of
Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that
section, nor shall it be deemed incorporated by reference by any general statement incorporating by
reference this annual report on Form 10-K into any filing under the Securities Act of 1933 or under
the Securities Exchange Act of 1934, except to the extent that we specifically incorporate such
comparisons by reference.
24
Item 6. Selected Financial Data
The statement of operations data for the years ended December 31, 2006, 2005 and 2004 and the
balance sheet data as of December 31, 2006 and 2005 have been derived from our audited financial
statements included elsewhere in this annual report on Form 10-K. The statements of operations
data for the years ended December 31, 2003 and 2002, and the balance sheet data as of December 31,
2004, 2003 and 2002 have been derived from our audited financial statements not included in this
annual report on Form 10-K. Our historical results are not necessarily indicative of results to be
expected for any future period. The data presented below has been derived from financial
statements that have been prepared in accordance with accounting principles generally accepted in
the United States and should be read with our financial statements, including the notes, and with
Managements Discussion and Analysis of Financial Condition and Results of Operations included
elsewhere in this annual report on Form 10-K.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
|
2003 |
|
|
2002 |
|
|
|
(in thousands, except per share data) |
|
Statements of Operations Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
$ |
72,798 |
|
|
$ |
75,680 |
|
|
$ |
61,740 |
|
|
$ |
42,838 |
|
|
$ |
35,200 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development, including stock-based
compensation of $4,394 in 2006, ($21) in 2005, $426 in 2004,
$5,048 in 2003 and $5,155 in 2002 |
|
|
106,695 |
|
|
|
93,625 |
|
|
|
90,586 |
|
|
|
82,198 |
|
|
|
74,859 |
|
General and administrative, including stock-based
compensation of $2,636 in 2006, $0 in 2005, $412 in 2004,
$5,067 in 2003 and $5,113 in 2002 |
|
|
21,334 |
|
|
|
18,174 |
|
|
|
18,608 |
|
|
|
23,233 |
|
|
|
23,234 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
128,029 |
|
|
|
111,799 |
|
|
|
109,194 |
|
|
|
105,431 |
|
|
|
98,093 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(55,231 |
) |
|
|
(36,119 |
) |
|
|
(47,454 |
) |
|
|
(62,593 |
) |
|
|
(62,893 |
) |
Interest and other income, net |
|
|
801 |
|
|
|
(77 |
) |
|
|
282 |
|
|
|
1,471 |
|
|
|
3,223 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before taxes and cumulative effect of a change in
accounting principle |
|
|
(54,430 |
) |
|
|
(36,196 |
) |
|
|
(47,172 |
) |
|
|
(61,122 |
) |
|
|
(59,670 |
) |
Income tax provision |
|
|
119 |
|
|
|
(119 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before cumulative effect of a change in
accounting principle |
|
|
(54,311 |
) |
|
|
(36,315 |
) |
|
|
(47,172 |
) |
|
|
(61,122 |
) |
|
|
(59,670 |
) |
Cumulative effect of a change in accounting principle (1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,076 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(54,311 |
) |
|
$ |
(36,315 |
) |
|
$ |
(47,172 |
) |
|
$ |
(64,198 |
) |
|
$ |
(59,670 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share basic and diluted: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before cumulative effect of a change in accounting principle |
|
$ |
(0.81 |
) |
|
$ |
(0.57 |
) |
|
$ |
(0.74 |
) |
|
$ |
(1.08 |
) |
|
$ |
(1.14 |
) |
Cumulative effect of a change in accounting principle |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(0.05 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share, basic and diluted |
|
$ |
(0.81 |
) |
|
$ |
(0.57 |
) |
|
$ |
(0.74 |
) |
|
$ |
(1.13 |
) |
|
$ |
(1.14 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing net loss per common
share, basic and diluted |
|
|
66,876 |
|
|
|
63,962 |
|
|
|
63,327 |
|
|
|
56,820 |
|
|
|
52,263 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, |
|
|
2006 |
|
2005 |
|
2004 |
|
2003 |
|
2002 |
|
|
(in thousands) |
Balance Sheet Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and investments, including restricted
cash and investments of $430 in 2006 $430 in 2005,
$430 in 2004, $57,514 in 2003 and $57,710 in 2002 |
|
$ |
79,999 |
|
|
$ |
99,695 |
|
|
$ |
87,558 |
|
|
$ |
161,001 |
|
|
$ |
123,096 |
|
Working capital |
|
|
39,586 |
|
|
|
48,584 |
|
|
|
60,038 |
|
|
|
139,739 |
|
|
|
111,833 |
|
Total assets |
|
|
190,266 |
|
|
|
218,714 |
|
|
|
211,980 |
|
|
|
284,199 |
|
|
|
201,772 |
|
Long-term debt, net of current portion |
|
|
31,372 |
|
|
|
32,189 |
|
|
|
32,940 |
|
|
|
56,344 |
|
|
|
4,000 |
|
Accumulated deficit |
|
|
(351,741 |
) |
|
|
(297,430 |
) |
|
|
(261,115 |
) |
|
|
(213,943 |
) |
|
|
(149,745 |
) |
Stockholders equity |
|
|
85,501 |
|
|
|
85,802 |
|
|
|
121,594 |
|
|
|
166,216 |
|
|
|
169,902 |
|
|
|
|
(1) |
|
Upon adoption of FASB Interpretation No. 46, or FIN 46, Consolidation of Variable Interest Entities An
Interpretation of ARB No. 51, the Company consolidated the assets of the variable interest entity, which were comprised of property and
improvements funded under a synthetic lease. These assets had a carrying value of $54.8 million, net of accumulated depreciation of $3.1
million on December 31, 2003. The Company also consolidated the variable interest entitys debt of $52.3 million and non-controlling
interests of $2.5 million, which amounts are included in long-term debt and other long-term liabilities, respectively. Additionally, the
Company recorded a cumulative effect of a change in accounting principle equal to the accumulated depreciation of $3.1 million for the
period from the date the buildings were placed in service under the synthetic lease through December 31, 2003. In April 2004, Lexicon
purchased the facilities subject to the synthetic lease, repaying the amounts funded under the synthetic lease with proceeds from a
mortgage financing and cash. |
25
Item 7. Managements Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis should be read with Selected Financial Data and our
financial statements and notes included elsewhere in this annual report on Form 10-K.
Overview
We are a biopharmaceutical company focused on the discovery and development of breakthrough
treatments for human disease. We use our proprietary gene knockout technology to knock out, or
disrupt, the function of genes in mice and then employ an integrated platform of advanced medical
technologies to systematically discover the physiological and behavioral functions and
pharmaceutical utility of the genes we have knocked out and the potential drug targets encoded by
the corresponding human genes. For targets that we believe have high pharmaceutical value, we
engage in programs for the discovery and development of potential small molecule, antibody and
protein drugs. We have advanced drug candidates from two of these programs into human clinical
trials, with drug candidates from two additional programs in preclinical development and a number
of additional programs in various stages of preclinical research. We believe that our systematic,
target biology-driven approach to drug discovery will enable us to substantially expand our
clinical pipeline and we have initiated our 10TO10 program with the goal of advancing
ten drug candidates into human clinical trials by the end of 2010.
We are working both independently and through strategic collaborations and alliances to
capitalize on our technology and drug target discoveries and to develop and commercialize drug
candidates emerging from our drug discovery and development programs. We have established
alliances with Bristol-Myers Squibb Company to discover and develop novel small molecule drugs in
the neuroscience field; with Genentech, Inc. for the discovery of therapeutic proteins and antibody
targets and the development of antibody and protein drugs based on those targets; with N.V. Organon
for the discovery of another group of therapeutic proteins and antibody targets and the development
and commercialization of antibody and protein drugs based on those targets; and with Takeda
Pharmaceutical Company Limited to discover new drugs for the treatment of high blood pressure. In
addition, we have established collaborations and license agreements with other leading
pharmaceutical and biotechnology companies, research institutes and academic institutions under
which we receive fees and, in some cases, are eligible to receive milestone and royalty payments,
in return for granting access to some of our technologies and discoveries for use in the other
organizations own drug discovery efforts.
We derive substantially all of our revenues from drug discovery alliances, target validation
collaborations for the development and, in some cases, analysis of the physiological effects of
genes altered in knockout mice, academic, non-profit and government arrangements, and technology
licenses. To date, we have generated a substantial portion of our revenues from a limited number
of sources.
Our operating results and, in particular, our ability to generate additional revenues are
dependent on many factors, including our success in establishing collaborations, alliances and
technology licenses, expirations of our collaborations and alliances, the success rate of our
discovery efforts leading to opportunities for new collaborations, alliances and licenses, as well
as milestone payments and royalties, the timing and willingness of collaborators to commercialize
products which may result in royalties, and general and industry-specific economic conditions which
may affect research and development expenditures. Our future revenues from collaborations,
alliances and academic, non-profit and government arrangements are uncertain because our existing
agreements have fixed terms or relate to specific projects of limited duration. Our future revenues
from technology licenses are uncertain because they depend, in large part, on securing new
agreements. Our ability to secure future revenue-generating agreements will depend upon our
ability to address the needs of our potential future collaborators, granting agencies and
licensees, and to negotiate agreements that we believe are in our long-term best interests. We may
determine that our interests are better served by retaining rights to our discoveries and advancing
our therapeutic programs to a later stage, which could limit our near-term revenues. Because of
these and other factors, our operating results have fluctuated in the past and are likely to do so
in the future, and we do not believe that period-to-period comparisons of our operating results are
a good indication of our future performance.
Since our inception, we have incurred significant losses and, as of December 31, 2006, we had
an accumulated deficit of $351.7 million. Our losses have resulted principally from costs incurred
in research and development, general and administrative costs associated with our operations, and
non-cash stock-based compensation expenses associated with stock options granted to employees and
consultants. Research and development expenses consist primarily of salaries and related personnel
costs, material costs, facility costs, depreciation on property and equipment, legal expenses
resulting from intellectual property prosecution and other
26
expenses related to our drug discovery and development programs, the development and analysis
of knockout mice and our other target validation research efforts, and the development of compound
libraries. General and administrative expenses consist primarily of salaries and related expenses
for executive and administrative personnel, professional fees and other corporate expenses
including information technology, facilities costs and general legal activities. In connection
with our ongoing target validation research efforts and the expansion of our drug discovery and
development programs, we expect to incur increasing research and development and general and
administrative costs. As a result, we will need to generate significantly higher revenues to
achieve profitability.
As of December 31, 2006 we had net operating loss carryforwards of approximately $267.4
million. We also had research and development tax credit carryforwards of approximately $14.4
million. The net operating loss and credit carryforwards will expire at various dates beginning in
2011, if not utilized. Utilization of the net operating losses and credits may be significantly
limited due to a change in ownership as defined by provisions of the Internal Revenue Code of 1986
and similar state provisions. The annual limitation may result in the expiration of net operating
losses and credits before utilization. We recorded a $119,000 income tax provision representing
alternative minimum tax payable based on estimated taxable income for the year ended December 31,
2005. This amount was subsequently reversed in 2006.
Critical Accounting Policies
Revenue Recognition
We recognize revenues when persuasive evidence of an arrangement exists, delivery has occurred
or services have been rendered, the price is fixed or determinable, and collectibility is
reasonably assured. Payments received in advance under these arrangements are recorded as deferred
revenue until earned.
Upfront fees under our drug discovery alliances are recognized as revenue on a straight-line
basis over the estimated period of service, generally the contractual research term, to the extent
they are non-refundable. Research funding under these alliances is recognized as services are
performed to the extent they are non-refundable, either on a straight-line basis over the estimated
service period, generally the contractual research term; or as contract research costs are
incurred. Milestone-based fees are recognized upon completion of specified milestones according to
contract terms. Payments received under target validation collaborations and government grants and
contracts are recognized as revenue as we perform our obligations related to such research to the
extent such fees are non-refundable. Non-refundable technology license fees are recognized as
revenue upon the grant of the license when performance is complete and there is no continuing
involvement.
Revenues recognized from multiple element contracts are allocated to each element of the
arrangement based on the relative fair value of the elements. The determination of fair value of
each element is based on objective evidence. When revenues for an element are specifically tied to
a separate earnings process, revenue is recognized when the specific performance obligation
associated with the element is completed. When revenues for an element are not specifically tied
to a separate earnings process, they are recognized ratably over the term of the agreement.
A change in our revenue recognition policy or changes in the terms of contracts under which we
recognize revenues could have an impact on the amount and timing of our recognition of revenues.
Research and Development Expenses
Research and development expenses consist of costs incurred for company-sponsored as well as
collaborative research and development activities. These costs include direct and research-related
overhead expenses and are expensed as incurred. Patent costs and technology license fees for
technologies that are utilized in research and development and have no alternative future use are
expensed when incurred.
We have initiated a Phase 1b clinical trial for our most advanced drug program, LX6171 for
cognitive impairment associated with disorders such as Alzheimers disease, schizophrenia and
vascular dementia. We have also initiated a Phase 1a clinical trial for another of our drug
programs, LX1031 for gastrointestinal disorders such as irritable bowel syndrome. We have advanced
two other drug programs, LX2931 for autoimmune diseases such as multiple sclerosis and rheumatoid
arthritis and LX1032 for gastrointestinal disorders, into preclinical development in preparation
for regulatory filings for the commencement of clinical trials and a number of additional drug
programs into various stages of preclinical research. The drug development process takes many
years to complete. The cost
27
and length of time varies due to many factors, including the type, complexity and intended use
of the drug candidate. We estimate that drug development activities are typically completed over
the following periods:
|
|
|
|
|
|
|
Estimated |
Phase |
|
Completion Period |
Preclinical development |
|
1-2 years |
Phase 1 clinical trials |
|
1-2 years |
Phase 2 clinical trials |
|
1-2 years |
Phase 3 clinical trials |
|
2-4 years |
We expect research and development costs to increase in the future as our drug programs
advance in preclinical development and clinical trials. Due to the variability in the length of
time necessary for drug development, the uncertainties related to the cost of these activities and
ultimate ability to obtain governmental approval for commercialization, accurate and meaningful
estimates of the ultimate costs to bring our potential drug candidates to market are not available.
We record our research and development costs by type or category, rather than by project.
Significant categories of costs include personnel, facilities and equipment costs, laboratory
supplies and third-party and other services. In addition, a significant portion of our research
and development expenses is not tracked by project as it benefits multiple projects. Consequently,
fully-loaded research and development cost summaries by project are not available.
Stock-Based Compensation
On January 1, 2006, we adopted Statement of Financial Accounting Standards Board No. 123
(Revised), Share-Based Payment, SFAS No. 123(R). This statement requires companies to recognize
compensation expense in the statement of operations for share-based payments, including stock
options issued to employees, based on their fair values on the date of the grant, with the
compensation expense recognized over the period in which an employee is required to provide service
in exchange for the stock award. We adopted this statement using the modified prospective
transition method, which applies the compensation expense recognition provisions to new awards and
to any awards modified, repurchased or canceled after the January 1, 2006 adoption date.
Additionally, for any unvested awards outstanding at the adoption date, we will recognize
compensation expense over the remaining vesting period. Stock-based compensation expense is
recognized on a straight-line basis. The adoption of SFAS No. 123(R) resulted in stock-based
compensation expense of $7.0 million for the year ended December 31, 2006, or $0.11 per share.
There is no impact on cash flows from operating activities or financing activities. As of December
31, 2006, stock-based compensation cost for all outstanding unvested options was $11.6 million,
which is expected to be recognized over a weighted-average period of 1.2 years.
Prior to the adoption of SFAS No. 123(R), our stock-based compensation plans were accounted
for under the recognition and measurement provisions of Accounting Principles Board Opinion No. 25,
Accounting for Stock Issued to Employees, and Related Interpretations, APB No. 25. Under the
intrinsic value method described in APB No. 25, no compensation expense was recorded because the
exercise price of the employee stock options equaled the market price of the underlying stock on
the date of grant.
We record expense for options issued to non-employee consultants at fair value and re-measures
the fair value at each reporting date. We reversed stock-based compensation expense of $21,000
during the year ended December 31, 2005 and recognized $0.8 million during 2004, which was
primarily related to option grants made prior to Lexicons April 2000 initial public offering.
The fair value of stock options is estimated at the date of grant using the Black-Scholes
method. The Black-Scholes option-pricing model requires the input of subjective assumptions. For
purposes of determining the fair value of stock options granted subsequent to the adoption of SFAS
No. 123(R), the Company segregated its options into two homogeneous groups, based on exercise and
post-vesting employment termination behaviors, resulting in a change in the assumptions used for
expected option lives and forfeitures. Expected volatility is based on the historical volatility
in the Companys stock price. The following weighted-average assumptions were used for options
granted in the years ended December 31, 2006, 2005 and 2004, respectively:
28
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Risk-free |
|
|
|
|
|
|
|
|
Expected |
|
Interest |
|
Expected |
|
Estimated |
|
Dividend |
|
|
Volatility |
|
Rate |
|
Term |
|
Forfeitures |
|
Rate |
December 31, 2006: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employees |
|
|
69 |
% |
|
|
4.6 |
% |
|
|
7 |
|
|
|
18 |
% |
|
|
0 |
% |
Officers and non-employee directors |
|
|
69 |
% |
|
|
4.7 |
% |
|
|
9 |
|
|
|
3 |
% |
|
|
0 |
% |
December 31, 2005: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employees, officers and non-employee directors |
|
|
72 |
% |
|
|
4.2 |
% |
|
|
7 |
|
|
|
3 |
% |
|
|
0 |
% |
December 31, 2004: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employees, officers and non-employee directors |
|
|
92 |
% |
|
|
3.7 |
% |
|
|
7 |
|
|
|
3 |
% |
|
|
0 |
% |
Goodwill Impairment
Goodwill is not amortized, but is tested at least annually for impairment at the reporting
unit level. We have determined that the reporting unit is the single operating segment disclosed
in our current financial statements. Impairment is the condition that exists when the carrying
amount of goodwill exceeds its implied fair value. The first step in the impairment process is to
determine the fair value of the reporting unit and then compare it to the carrying value, including
goodwill. We determined that the market capitalization approach is the most appropriate method of
measuring fair value of the reporting unit. Under this approach, fair value is calculated as the
average closing price of our common stock for the 30 days preceding the date that the annual
impairment test is performed, multiplied by the number of outstanding shares on that date. A
control premium, which is representative of premiums paid in the marketplace to acquire a
controlling interest in a company, is then added to the market capitalization to determine the fair
value of the reporting unit. If the fair value exceeds the carrying value, no further action is
required and no impairment loss is recognized. Additional impairment assessments may be performed
on an interim basis if we encounter events or changes in circumstances that would indicate that,
more likely than not, the carrying value of goodwill has been impaired. There was no impairment of
goodwill in 2006.
Recent Accounting Pronouncement
In July 2006, the FASB issued FASB Interpretation No. 48, Accounting for Uncertainty in
Income Taxes, an interpretation of FASB Statement No. 109 (FIN 48). FIN 48 clarifies the
accounting for uncertainty in income taxes recognized in a companys financial statements and
prescribes a recognition threshold and measurement attribute for the financial statement
recognition and measurement of a tax position taken or expected to be taken in an income tax
return. FIN 48 also provides guidance on derecognition, classification, interest and penalties,
accounting in interim periods, disclosure and transition. FIN 48 is effective for the Company as
of January 1, 2007. The Company is currently evaluating the effect, if any, of this statement on
its financial condition and results of operations.
In September 2006, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standards No. 157, Fair Value Measurements (SFAS No. 157). The statement
defines fair value, establishes a framework for measuring fair value in generally accepted
accounting principles, and expands disclosures about fair value measurements. This statement
applies under other accounting pronouncements that require or permit fair value measurements, the
FASB having previously concluded in those accounting pronouncements that fair value is the relevant
measurement attribute. Accordingly, this statement does not require any new fair value
measurements. SFAS No. 157 is effective January 1, 2008. The Company is currently evaluating the
impact of this statement on its financial condition and results of operation.
Results of Operations Comparison of Years Ended December 31, 2006, 2005 and 2004
Revenues
Total revenues and dollar and percentage changes as compared to the prior year are as follows
(dollar amounts are presented in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
2006 |
|
2005 |
|
2004 |
Total revenues |
|
$ |
72.8 |
|
|
$ |
75.7 |
|
|
$ |
61.7 |
|
Dollar increase (decrease) |
|
$ |
(2.9 |
) |
|
$ |
14.0 |
|
|
|
|
|
Percentage increase (decrease) |
|
|
(4% |
) |
|
|
23% |
|
|
|
|
|
29
Years Ended December 31, 2006 and 2005
|
|
|
Collaborative research Revenue from collaborative research decreased 2% in 2006 to
$68.4 million, primarily as a result of the achievement of two performance milestone
payments under our Genentech alliance in 2005. This decrease was offset in part by a
milestone achieved under our Takeda alliance, as well as increased revenues from The
National Institutes of Health, Texas Enterprise Fund and Organon alliance. |
|
|
|
|
Subscription and license fees Revenue from subscriptions and license fees
decreased 28% in 2006 to $4.4 million due to lower technology license fees from
Deltagen. |
Years Ended December 31, 2005 and 2004
|
|
|
Collaborative research Revenue from collaborative research increased 40% in 2005
to $69.6 million, primarily due to the commencement in May 2005 of our alliance with
Organon, our completion of two performance milestones under our alliance with
Genentech, and our award from the Texas Enterprise Fund. Revenue in 2004 included
performance milestone payments under our Genentech and Takeda alliances as well as
revenues recognized under our therapeutic protein discovery alliance with Incyte, for
which the collaboration period ended in June 2004. |
|
|
|
|
Subscription and license fees Revenue from subscriptions and license fees
decreased 49% in 2005 to $6.1 million due to the expiration of Bristol-Myers Squibbs
and Incytes subscriptions to our LexVision database in December 2004 and June 2004,
respectively. This was offset in part by higher technology license fees in the current
year. |
In 2006, Bristol-Myers Squibb, Organon and Takeda represented 35%, 21% and 12% of revenues,
respectively. In 2005, Bristol-Myers Squibb, Genentech and Organon represented 34%, 30% and 16% of
revenues, respectively. In 2004, Bristol-Myers Squibb, Genentech and Incyte represented 43%, 26%
and 8% of revenues, respectively.
Research and Development Expenses
Research and development expenses and dollar and percentage changes as compared to the prior
year are as follows (dollar amounts are presented in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
2006 |
|
2005 |
|
2004 |
Total research and development expense |
|
$ |
106.7 |
|
|
$ |
93.6 |
|
|
$ |
90.6 |
|
Dollar increase |
|
$ |
13.1 |
|
|
$ |
3.0 |
|
|
|
|
|
Percentage increase |
|
|
14% |
|
|
|
3% |
|
|
|
|
|
Research and development expenses consist primarily of salaries and other
personnel-related expenses, facility and equipment costs, laboratory supplies, third-party and
other services and stock-based compensation expenses.
Years Ended December 31, 2006 and 2005
|
|
|
Personnel Personnel costs increased 11% in 2006 to $51.3 million, primarily due to
increased personnel for the expansion of our drug discovery programs and to support the
research performed in connection with our award from the Texas Enterprise Fund,
merit-based pay increases and increased medical claims costs for employees. Salaries,
bonuses, employee benefits, payroll taxes, recruiting and relocation costs are included
in personnel costs. |
|
|
|
|
Facilities and equipment Facilities and equipment costs increased 1% in 2006 to
$21.2 million. |
|
|
|
|
Laboratory supplies Laboratory supplies expense increased 9% in 2006 to $14.8
million, primarily due to research performed in connection with our award from the
Texas Enterprise Fund. |
|
|
|
|
Third-party and other services Third-party and other services increased 36% in
2006 to $9.9 million, primarily due an increase in third-party pre-clinical and
clinical research costs. Third-party and other |
30
|
|
|
services include third-party research, technology licenses, legal and patent fees and
subscriptions to third-party databases. |
|
|
|
|
Stock-based compensation Stock-based compensation expense increased $4.4 million,
as a result of our adoption of SFAS No. 123(R), Share Based Payment, on January 1,
2006. |
|
|
|
|
Other Other costs decreased 8% in 2006 to $5.1 million. |
Years Ended December 31, 2005 and 2004
|
|
|
Personnel Personnel increased 7% in 2005 to $46.3 million, primarily due to
increased personnel to support the expansion of our drug discovery programs and
merit-based pay increases for employees. |
|
|
|
|
Facilities and equipment Facilities and equipment costs increased 4% in 2005 to
$21.0 million, primarily due to an increase in utility costs. |
|
|
|
|
Laboratory supplies Laboratory supplies expense decreased 4% in 2005 to $13.5
million, primarily due to decreased purchases of specialty reagents and compounds. |
|
|
|
|
Third-party and other services Third-party and other services decreased 4% in 2005
to $7.2 million, primarily due to the termination of our subscription to a third-party
database offset, in part, by an increase in third-party research costs. |
|
|
|
|
Stock-based compensation Stock-based compensation expense decreased $0.4 million
in 2005 due to the fact that all deferred stock compensation related to options grants
made prior to our April 2000 initial public offering was fully amortized as of January
31, 2004. |
|
|
|
|
Other Other costs increased by 11% in 2005 to $5.6 million. |
General and Administrative Expenses
General and administrative expenses and dollar and percentage changes as compared to the prior
year are as follows (dollar amounts are presented in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
2006 |
|
2005 |
|
2004 |
Total general and administrative expense |
|
$ |
21.3 |
|
|
$ |
18.2 |
|
|
$ |
18.6 |
|
Dollar increase (decrease) |
|
$ |
3.1 |
|
|
$ |
(0.4 |
) |
|
|
|
|
Percentage increase (decrease) |
|
|
17% |
|
|
|
(2% |
) |
|
|
|
|
General and administrative expenses consist primarily of personnel costs to support our
research activities, facility and equipment costs, professional fees such as legal fees, and
stock-based compensation expenses.
Years Ended December 31, 2006 and 2005
|
|
|
Personnel Personnel costs increased 9% in 2006 to $11.8 million, primarily due to
merit-based pay increases and increased medical claims costs for employees. Salaries,
bonuses, employee benefits, payroll taxes, recruiting and relocation costs are included
in personnel costs. |
|
|
|
|
Facilities and equipment Facilities and equipment costs were $3.1 million in 2006,
consistent with the prior year. |
|
|
|
|
Professional fees Professional fees decreased 15% in 2006 to $1.6 million
primarily due to decreased consulting costs. |
|
|
|
|
Stock-based compensation Stock-based compensation expense increased $2.6 million
as a result of our adoption of SFAS No. 123(R), Share Based Payment, on January 1,
2006. |
|
|
|
|
Other Other costs decreased 7% to $2.2 million. |
31
Years Ended December 31, 2005 and 2004
|
|
|
Personnel Personnel costs increased 2% in 2005 to $10.8 million. |
|
|
|
|
Facilities and equipment Facilities and equipment costs were $3.1 million in 2005,
consistent with the prior year. |
|
|
|
|
Professional fees Professional fees decreased 10% in 2005 to $1.9 million,
primarily due to decreased litigation costs. |
|
|
|
|
Stock-based compensation Stock-based compensation expense decreased $0.4 million
in 2005 due to the fact that all deferred stock compensation related to options grants
made prior to our April 2000 initial public offering was fully amortized as of January
31, 2004. |
|
|
|
|
Other Other costs were $2.4 million in 2005, consistent with the prior year. |
Interest Income, Interest Expense and Other Income, Net
Interest Income. Interest income increased 38% in 2006 to $3.7 million from $2.6
million in 2005, and increased 61% in 2005 from $1.6 million in 2004, primarily due to higher
interest rates.
Interest Expense. Interest expense was $3.3 million in 2006, consistent with the
prior year, and increased 23% in 2005 from $2.7 million in 2004. In April 2004, we purchased our
facilities in The Woodlands, Texas from the lessor under our previous synthetic lease agreement,
using the proceeds from a $34.0 million mortgage and cash. Interest expense increased in 2005 as
compared to 2004 as a result of a full year of interest expense under the mortgage.
Other Income. Other income decreased 28% in 2006 to $0.4 million from $0.6 million in 2005,
and decreased 57% in 2005 from $1.3 million in 2004. Other income in 2004 included a settlement
with our former insurance provider for a disputed claim under our insurance policy.
Net Loss and Net Loss per Common Share
Net Loss and Net Loss per Common Share. Net loss increased to $54.3 million in 2006 from
$36.3 million in 2005 and decreased from $47.2 million in 2004. Net loss per common share
increased to $0.81 in 2006 from $0.57 in 2005 and decreased from $0.74 in 2004.
Liquidity and Capital Resources
We have financed our operations from inception primarily through sales of common and preferred
stock, contract and milestone payments to us under our drug discovery alliance, target validation,
database subscription, and license agreements, government grants and contracts, and financing
obtained under debt and lease arrangements. From our inception through December 31, 2006, we had
received net proceeds of $336.9 million from issuances of common and preferred stock, including
$203.2 million of net proceeds from the initial public offering of our common stock in April 2000,
$50.1 million from our July 2003 common stock offering and $37.5 million from our October 2006
common stock offering. In addition, from our inception through December 31, 2006, we received
$398.1 million in cash payments from drug discovery alliances, target validation collaborations,
database subscription and technology license fees, sales of compound libraries and reagents and
government grants and contracts, of which $341.6 million had been recognized as revenues through
December 31, 2006.
As of December 31, 2006, we had $80.0 million in cash, cash equivalents and short-term
investments, as compared to $99.7 million as of December 31, 2005. We used cash of $56.9 million
in operations in 2006. This consisted primarily of the net loss for the year of $54.3 million
offset by non-cash charges of $10.6 million related to depreciation expense, $7.0 million related
to stock-based compensation expense and $0.6 million related to amortization of intangible assets
other than goodwill; a $23.6 million decrease in deferred revenue; and changes in other operating
assets and liabilities of $2.8 million. Investing activities provided cash of $24.5 million,
primarily due to net maturities of short-term investments of $28.0 million. This was offset by
purchases of property and equipment of $3.5 million. Financing activities provided cash of $40.7
million in the year ended December 31, 2006, due primarily to net proceeds of $37.5 million from
our registered direct offering of common stock in October 2006 and $3.6 million from our sale of
common stock to Azimuth Opportunity Ltd. in September 2006, as well as
32
proceeds of $0.4 million from stock option exercises. This was offset by $0.8 million in
principal repayments on our mortgage loan.
In June 2006, we entered into an agreement with Azimuth Opportunity Ltd. under which we may
offer and sell, and Azimuth is committed to purchase, up to $75 million of our common stock, or the
number of shares which is one less than twenty percent of the issued and outstanding shares of our
common stock as of the effective date of the agreement, whichever is fewer. At our sole
discretion, we may initiate up to 24 draw downs during the approximately 18-month term of the
agreement by delivering notice to Azimuth. Each draw down notice will specify (a) the aggregate
dollar amount of our common stock, not to exceed $6,000,000, to be sold to Azimuth during such draw
down and (b) the minimum threshold price at which we will sell such shares, which will not be less
than $3.00 per share. Azimuth will be required to purchase a pro rata portion of the shares for
each trading day during a pricing period of 10 consecutive trading days on which the daily volume
weighted average price for our common stock exceeds the minimum threshold price. The per share
purchase price for these shares will equal the daily volume weighted average price of our common
stock on such date, less a discount ranging from 3.75% to 5.5%, depending on the minimum threshold
price. In connection with any such draw down, at our sole discretion, we may also grant Azimuth
the right, during the relevant draw down pricing period, to purchase additional shares of our
common stock by specifying in the draw down notice an optional aggregate dollar amount and a
minimum threshold price for such optional shares. The per share purchase price for these optional
shares will equal the greater of the daily volume weighted average price of our common stock on the
day Azimuth notifies us of its election to exercise such right or the minimum threshold price for
such optional shares, less a discount ranging from 3.75% to 5.5%. Upon each sale of common stock
to Azimuth, we will pay to Reedland Capital Partners, an Institutional Division of Financial West
Group, a placement fee equal to one percent of the aggregate dollar amount received by us from such
sale.
In September 2006, we issued 1,000,000 shares of our common stock to Azimuth under this
agreement at a purchase price of approximately $3.67 per share. After deducting offering expenses,
we received net proceeds from the sale of approximately $3.6 million.
In October 2006, we completed the registered direct offering and sale of 10,582,011 shares of
our common stock to selected institutional investors at a price of $3.78 per share, resulting in
net proceeds of $37.5 million, after deducting placement agent fees of $2.4 million and estimated
offering expenses of $0.1 million. We currently intend to use the net proceeds for research and
development and general corporate purposes, including preclinical and clinical development of our
lead programs, capital expenditures and working capital needs, but may use a portion of the net
proceeds to acquire or invest in businesses, products and technologies that are complementary to
our own.
In April 2004, we obtained a $34.0 million mortgage on our facilities in The Woodlands, Texas.
The mortgage loan has a ten-year term with a 20-year amortization and bears interest at a fixed
rate of 8.23%. In May 2002, our subsidiary Lexicon Pharmaceuticals (New Jersey), Inc. signed a
ten-year lease for a 76,000 square-foot facility in Hopewell, New Jersey. The term of the lease
extends until June 30, 2013. The lease provides for an escalating yearly base rent payment of $1.3
million in the first year, $2.1 million in years two and three, $2.2 million in years four to six,
$2.3 million in years seven to nine and $2.4 million in years ten and eleven. We are the guarantor
of the obligations of our subsidiary under the lease.
In December 2002, we borrowed $4.0 million under a note agreement with Genentech. The note
accrued interest at an annual rate of 8%, compounded quarterly, and was payable, at any time, at
our option, in cash, in shares of our common stock valued at the then-current market value, or in a
combination of cash and shares, subject to certain limitations. On November 30, 2005, the note
agreement was amended to extend the maturity date of the loan by one year to December 31, 2006. On
December 31, 2006, we repaid the note by issuing 1,511,670 shares of our common stock to Genentech.
33
Including the lease and debt obligations described above, we had incurred the following
contractual obligations as of December 31, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments due by period (in millions) |
|
|
|
|
|
|
|
Less than |
|
|
|
|
|
|
|
|
|
|
More than |
|
Contractual Obligations |
|
Total |
|
|
1 year |
|
|
1-3 years |
|
|
3-5 years |
|
|
5 years |
|
Debt |
|
$ |
32.2 |
|
|
$ |
0.8 |
|
|
$ |
1.8 |
|
|
$ |
2.2 |
|
|
$ |
27.4 |
|
Interest payment obligations |
|
|
17.5 |
|
|
|
2.6 |
|
|
|
5.1 |
|
|
|
4.8 |
|
|
|
5.0 |
|
Operating leases |
|
|
16.2 |
|
|
|
2.4 |
|
|
|
4.9 |
|
|
|
5.0 |
|
|
|
3.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
65.9 |
|
|
$ |
5.8 |
|
|
$ |
11.8 |
|
|
$ |
12.0 |
|
|
$ |
36.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our future capital requirements will be substantial and will depend on many factors,
including our ability to obtain alliance, collaboration and technology license agreements, the
amount and timing of payments under such agreements, the level and timing of our research and
development expenditures, market acceptance of our products, the resources we devote to developing
and supporting our products and other factors. Our capital requirements will also be affected by
any expenditures we make in connection with license agreements and acquisitions of and investments
in complementary technologies and businesses. We expect to devote substantial capital resources to
continue our research and development efforts, to expand our support and product development
activities, and for other general corporate activities. We believe that our current unrestricted
cash and investment balances and cash and revenues we expect to derive from drug discovery
alliances, target validation collaborations, government grants and contracts, and technology
licenses will be sufficient to fund our operations for at least the next twelve months. During or
after this period, if cash generated by operations is insufficient to satisfy our liquidity
requirements, we will need to sell additional equity or debt securities or obtain additional credit
arrangements. Additional financing may not be available on terms acceptable to us or at all. The
sale of additional equity or convertible debt securities may result in additional dilution to our
stockholders.
Disclosure about Market Risk
We are exposed to limited market and credit risk on our cash equivalents which have maturities
of three months or less at the time of purchase. We maintain a short-term investment portfolio
which consists of U.S. government agency debt obligations, investment grade commercial paper,
corporate debt securities and certificates of deposit that mature three to twelve months from the
time of purchase and auction rate securities that mature greater than twelve months from the time
of purchase, which we believe are subject to limited market and credit risk. We currently do not
hedge interest rate exposure or hold any derivative financial instruments in our investment
portfolio.
We have operated primarily in the United States and substantially all sales to date have been
made in U.S. dollars. Accordingly, we have not had any material exposure to foreign currency rate
fluctuations.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
See Disclosure about Market Risk under Item 7. Managements Discussion and Analysis of
Financial Condition and Results of Operations for quantitative and qualitative disclosures about
market risk.
Item 8. Financial Statements and Supplementary Data
The financial statements required by this Item are incorporated under Item 15 in Part IV of this report.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
None.
Item 9A. Controls and Procedures
Our chief executive officer and chief financial officer have concluded that our disclosure
controls and procedures (as defined in rules 13a-15(e) and 15d-15(e) under the Securities Exchange
Act of 1934) are sufficiently effective to ensure that the information required to be disclosed by
us in the reports we file under the Securities Exchange Act is gathered, analyzed and disclosed
with adequate timeliness, accuracy and completeness, based on an evaluation of such controls and
procedures as of the end of the period covered by this report.
34
Subsequent to our evaluation, there were no significant changes in internal controls or other
factors that could significantly affect internal controls, including any corrective actions with
regard to significant deficiencies and material weaknesses.
Management Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over
financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange
Act).
Because of its inherent limitations, internal control over financial reporting may not prevent
or detect misstatements. Projections of any evaluation of effectiveness to future periods are
subject to the risk that controls may become inadequate because of changes in conditions, or that
the degree of compliance with the policies or procedures may deteriorate.
Our management assessed the effectiveness of our internal control over financial reporting as
of December 31, 2006. In making this assessment, management used the criteria set forth by the
Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated
Framework.
Based on such assessment using those criteria, management believes that, as of December 31,
2006, our internal control over financial reporting is effective.
Our independent auditors have issued an audit report on our assessment of our internal control
over financial reporting which appears on page F-2 and is incorporated under Item 15 in Part IV of
this report.
Item 9B. Other Information
None.
35
PART III
Item 10. Directors, Executive Officers and Corporate Governance
The information required by this Item is hereby incorporated by reference from (a) the
information appearing under the captions Election of Directors, Stock Ownership of Certain
Beneficial Owners and Management, Corporate Governance and Executive and Director Compensation
in our definitive proxy statement which involves the election of directors and is to be filed with
the Securities and Exchange Commission pursuant to the Securities Exchange Act of 1934 within 120
days of the end of our fiscal year on December 31, 2006 and (b) the information appearing under
Item 1 in Part I of this report.
Item 11. Executive Compensation
The information required by this Item is hereby incorporated by reference from the information
appearing under the captions Corporate Governance and Executive and Director Compensation in
our definitive proxy statement which involves the election of directors and is to be filed with the
Commission pursuant to the Securities Exchange Act of 1934 within 120 days of the end of our fiscal
year on December 31, 2006. Notwithstanding the foregoing, in accordance with the instructions to
Item 407(e)(5) of Regulation S-K, the information contained in our proxy statement under the
sub-heading Compensation Committee Report shall not be deemed to be filed as part of or
incorporated by reference into this annual report on Form 10-K.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required by this Item is hereby incorporated by reference from (a) the
information appearing under the caption Stock Ownership of Certain Beneficial Owners and
Management in our definitive proxy statement which involves the election of directors and is to be
filed with the Commission pursuant to the Securities Exchange Act of 1934 within 120 days of the
end of our fiscal year on December 31, 2006 and (b) the information appearing under Item 5 in Part
II of this report.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this is hereby incorporated by reference from the information
appearing under the caption Corporate Governance in our definitive proxy statement which involves
the election of directors and is to be filed with the Commission pursuant to the Securities
Exchange Act of 1934 within 120 days of the end of our fiscal year on December 31, 2006.
Item 14. Principal Accounting Fees and Services
The information required by this Item as to the fees we pay our principal accountant is hereby
incorporated by reference from the information appearing under the caption Ratification and
Approval of Independent Auditors in our definitive proxy statement which involves the election of
directors and is to be filed with the Commission pursuant to the Securities Exchange Act of 1934
within 120 days of the end of our fiscal year on December 31, 2006.
36
PART IV
Item 15. Exhibits and Financial Statement Schedules
(a) Documents filed as a part of this report:
1. Consolidated Financial Statements
|
|
|
|
|
|
|
Page |
|
|
|
F-1 |
|
|
|
|
F-2 |
|
|
|
|
F-3 |
|
|
|
|
F-4 |
|
|
|
|
F-5 |
|
|
|
|
F-6 |
|
|
|
|
F-7 |
|
2. Financial Statement Schedules
All other financial statement schedules are omitted because they are not applicable or not
required, or because the required information is included in the financial statements or notes
thereto.
3. Exhibits
|
|
|
|
|
|
|
Exhibit No. |
|
|
|
|
Description |
|
|
|
|
|
|
|
|
3.1 |
|
|
|
|
Restated Certificate of Incorporation (filed as Exhibit 3.1 to the Companys
Registration Statement on Form S-1 (Registration No. 333-96469) and
incorporated by reference herein). |
|
|
|
|
|
|
|
|
3.2 |
|
|
|
|
Restated Bylaws (filed as Exhibit 3.2 to the Companys Registration Statement
on Form S-1 (Registration No. 333-96469) and incorporated by reference
herein). |
|
|
|
|
|
|
|
|
10.1 |
|
|
|
|
Restated Employment Agreement with Arthur T. Sands, M.D., Ph.D. (filed as
Exhibit 10.1 to the Companys Annual Report on Form 10-K for the period ended
December 31, 2005 and incorporated by reference herein). |
|
|
|
|
|
|
|
|
10.2 |
|
|
|
|
Employment Agreement with Jeffrey L. Wade, J.D. (filed as Exhibit 10.3 to the
Companys Registration Statement on Form S-1 (Registration No. 333-96469) and
incorporated by reference herein). |
|
|
|
|
|
|
|
|
10.3 |
|
|
|
|
Employment Agreement with Brian P. Zambrowicz, Ph.D. (filed as Exhibit 10.4
to the Companys Registration Statement on Form S-1 (Registration No.
333-96469) and incorporated by reference herein). |
|
|
|
|
|
|
|
|
10.4 |
|
|
|
|
Employment Agreement with Julia P. Gregory (filed as Exhibit 10.5 to the
Companys Registration Statement on Form S-1 (Registration No. 333-96469) and
incorporated by reference herein). |
|
|
|
|
|
|
|
|
10.5 |
|
|
|
|
Employment Agreement with Alan Main, Ph.D. (filed as Exhibit 10.1 to the
Companys Quarterly Report on Form 10-Q for the period ended September 30,
2001 and incorporated by reference herein). |
|
|
|
|
|
|
|
|
10.6 |
|
|
|
|
Consulting Agreement with Alan S. Nies, M.D. dated February 19, 2003, as
amended (filed as Exhibit 10.1 to the Companys Quarterly Report on Form 10-Q
for the period ended March 31, 2004 and incorporated by reference herein). |
|
|
|
|
|
|
|
|
10.7 |
|
|
|
|
Consulting Agreement with Robert J. Lefkowitz, M.D. dated March 31, 2003
(filed as Exhibit 10.1 to the Companys Quarterly Report on Form 10-Q for the
period ended March 31, 2003 and incorporated by reference herein). |
37
|
|
|
|
|
|
|
Exhibit No. |
|
|
|
|
Description |
|
|
10.8 |
|
|
|
|
Form of Indemnification Agreement with Officers and Directors (filed as
Exhibit 10.7 to the Companys Registration Statement on Form S-1
(Registration No. 333-96469) and incorporated by reference herein). |
|
|
|
|
|
|
|
|
10.9 |
|
|
|
|
Summary of Non-Employee Director Compensation (filed as Exhibit 10.11 to
the Companys Annual Report on Form 10‑K for the period ended December 31,
2005 and incorporated by reference herein). |
|
|
|
|
|
|
|
|
10.10 |
|
|
|
|
Summary of 2007 Named Executive Officer Cash Compensation (filed as
Exhibit 10.1 to the Companys Current Report on Form 8-K dated February 13,
2007 and incorporated by reference herein). |
|
|
|
|
|
|
|
|
10.11 |
|
|
|
|
2000 Equity Incentive Plan (filed as Exhibit 10.10 to the Companys Annual
Report on Form 10-K for the period ended December 31, 2004 and incorporated
by reference herein). |
|
|
|
|
|
|
|
|
10.12 |
|
|
|
|
2000 Non-Employee Directors Stock Option Plan (filed as Exhibit 10.14 to the
Companys Annual Report on Form 10-K for the period ended December 31, 2005
and incorporated by reference herein). |
|
|
|
|
|
|
|
|
10.13 |
|
|
|
|
Coelacanth Corporation 1999 Stock Option Plan (filed as Exhibit 99.1 to the
Companys Registration Statement on Form S-8 (Registration No. 333-66380) and
incorporated by reference herein). |
|
|
|
|
|
|
|
|
10.14 |
|
|
|
|
Form of Stock Option Agreement with Officers under the 2000 Equity
Incentive Plan (filed as Exhibit 10.2 to the Companys Quarterly Report on
Form 10-Q for the period ended September 30, 2004 and incorporated by
reference herein). |
|
|
|
|
|
|
|
|
10.15 |
|
|
|
|
Form of Stock Option Agreement with Chairman of Board of Directors under
the 2000 Equity Incentive Plan (filed as Exhibit 10.17 to the Companys
Annual Report on Form 10-K for the period ended December 31, 2005 and
incorporated by reference herein). |
|
|
|
|
|
|
|
|
10.16 |
|
|
|
|
Form of Stock Option Agreement with Directors under the 2000
Non-Employee Directors Stock Option Plan (filed as Exhibit 10.3 to the
Companys Quarterly Report on Form 10-Q for the period ended September 30,
2004 and incorporated by reference herein). |
|
|
|
|
|
|
|
|
10.17 |
|
|
|
|
Collaboration and License Agreement, dated December 17, 2003, with
Bristol-Myers Squibb Company (filed as Exhibit 10.15 to the amendment to the
Companys Annual Report on Form 10-K/A for the period ended December 31,
2003, as filed on July 16, 2004, and incorporated by reference herein). |
|
|
|
|
|
|
|
|
10.18 |
|
|
|
|
First Amendment, dated May 30, 2006, to Collaboration and License Agreement,
dated December 17, 2003, with Bristol-Myers Squibb Company (filed as Exhibit
10.2 to the Companys Quarterly Report on Form 10-Q for the period ended June
30, 2006, and incorporated by reference herein). |
|
|
|
|
|
|
|
|
10.19 |
|
|
|
|
Collaboration Agreement, dated July 27, 2004, with Takeda Pharmaceutical
Company Limited (filed as Exhibit 10.1 to the Companys Quarterly Report on
Form 10-Q for the period ended September 30, 2004 and incorporated by
reference herein). |
|
|
|
|
|
|
|
|
10.20 |
|
|
|
|
Collaboration and License Agreement, dated May 16, 2005, with N.V. Organon
and (only with respect to Section 9.4 thereof) Intervet Inc. (filed as
Exhibit 10.1 to the Companys Quarterly Report on Form 10-Q for the period
ended June 30, 2005 and incorporated by reference herein). |
|
|
|
|
|
|
|
|
10.21 |
|
|
|
|
Second Amended and Restated Collaboration and License Agreement, dated
November 30, 2005, with Genentech, Inc. (filed as Exhibit 10.22 to the
Companys Annual Report on Form 10-K for the period ended December 31, 2005
and incorporated by reference herein). |
38
|
|
|
|
|
|
|
Exhibit No. |
|
|
|
|
Description |
|
|
10.22 |
|
|
|
|
Economic Development Agreement dated July 15, 2005, with the State of Texas
and the Texas A&M University System (filed as Exhibit 10.1 to the Companys
Quarterly Report on Form 10-Q for the period ended September 30, 2005 and
incorporated by reference herein). |
|
|
|
|
|
|
|
|
10.23 |
|
|
|
|
Collaboration and License Agreement, dated July 15, 2005, with the Texas A&M
University System and the Texas Institute for Genomic Medicine (filed as
Exhibit 10.2 to the Companys Quarterly Report on Form 10-Q for the period
ended September 30, 2005 and incorporated by reference herein). |
|
|
|
|
|
|
|
|
10.24 |
|
|
|
|
Common Stock Purchase Agreement, dated June 12, 2006, with Azimuth
Opportunity Ltd. (filed as Exhibit 10.1 to the Companys Current Report on
Form 8-K dated June 12, 2006 and incorporated by reference herein). |
|
|
|
|
|
|
|
|
10.25 |
|
|
|
|
Loan and Security Agreement, dated April 21, 2004, between Lex-Gen Woodlands,
L.P. and iStar Financial Inc. (filed as Exhibit 10.18 to the Companys Annual
Report on Form 10-K for the period ended December 31, 2004 and incorporated
by reference herein). |
|
|
|
|
|
|
|
|
10.26 |
|
|
|
|
Lease Agreement, dated May 23, 2002, between Lexicon Pharmaceuticals (New
Jersey), Inc. and Townsend Property Trust Limited Partnership (filed as
Exhibit 10.2 to the Companys Quarterly Report on Form 10-Q for the period
ended June 30, 2002 and incorporated by reference herein). |
|
|
|
|
|
|
|
|
21.1 |
|
|
|
|
Subsidiaries (filed as Exhibit 21.1 to the Companys Annual Report on Form
10-K for the year ended December 31, 2004 and incorporated by reference
herein). |
|
|
|
|
|
|
|
|
*23.1 |
|
|
|
|
Consent of Independent Registered Public Accounting Firm |
|
|
|
|
|
|
|
|
*24.1 |
|
|
|
|
Power of Attorney (contained in signature page) |
|
|
|
|
|
|
|
|
*31.1 |
|
|
|
|
Certification of CEO Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
|
|
|
|
|
*31.2 |
|
|
|
|
Certification of CFO Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
|
|
|
|
|
*32.1 |
|
|
|
|
Certification of CEO and CFO Pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002 |
|
|
|
* |
|
Filed herewith. |
|
|
|
Confidential treatment has been requested for a portion of this exhibit. The
confidential portions of this exhibit have been omitted and filed separately with the
Securities and Exchange Commission. |
39
Signatures
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
thereunto duly authorized.
|
|
|
|
|
|
Lexicon Genetics Incorporated
|
|
Date: March 12, 2007 |
By: |
/s/ Arthur T. Sands
|
|
|
|
Arthur T. Sands, M.D., Ph.D. |
|
|
|
President and Chief Executive Officer |
|
|
|
|
|
Date: March 12, 2007 |
By: |
/s/ Julia P. Gregory
|
|
|
|
Julia P. Gregory |
|
|
|
Executive Vice President, Corporate Development
and Chief Financial Officer |
|
|
Power of Attorney
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below
constitutes and appoints Julia P. Gregory and Jeffrey L. Wade, or either of them, each with the
power of substitution, his or her attorney-in-fact, to sign any amendments to this Form 10-K, and
to file the same, with exhibits thereto and other documents in connection therewith, with the
Securities and Exchange Commission, here ratifying and confirming all that each of said
attorneys-in-fact, or his or her substitute or substitutes, may do or cause to be done by virtue
hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been
signed below by the following persons on behalf of the registrant and in the capacities and on the
dates indicated.
|
|
|
|
|
Signature |
|
Title |
|
Date |
|
|
|
|
|
/s/ Arthur T. Sands
Arthur T. Sands, M.D., Ph.D.
|
|
President and Chief Executive Officer
(Principal Executive Officer)
|
|
March 12, 2007 |
|
|
|
|
|
/s/ Julia P. Gregory
Julia P. Gregory
|
|
Executive Vice President, Corporate
Development and Chief Financial Officer
(Principal Financial and Accounting Officer)
|
|
March 12, 2007 |
|
|
|
|
|
/s/ Samuel L. Barker
Samuel L. Barker, Ph.D.
|
|
Chairman of the Board of Directors
|
|
March 12, 2007 |
|
|
|
|
|
/s/ Robert J. Lefkowitz
Robert J. Lefkowitz, M.D.
|
|
Director
|
|
March 12, 2007 |
|
|
|
|
|
/s/ Barry Mills
Barry Mills, J.D., Ph.D.
|
|
Director
|
|
March 12, 2007 |
|
|
|
|
|
/s/ Alan S. Nies
Alan S. Nies, M.D.
|
|
Director
|
|
March 12, 2007 |
|
|
|
|
|
/s/ Frank P. Palantoni
Frank P. Palantoni
|
|
Director
|
|
March 12, 2007 |
|
|
|
|
|
/s/ Clayton S. Rose
Clayton S. Rose
|
|
Director
|
|
March 12, 2007 |
|
|
|
|
|
/s/ Kathleen M. Wiltsey
Kathleen M. Wiltsey
|
|
Director
|
|
March 12, 2007 |
40
Report of Independent
Registered Public Accounting Firm
To the Board of Directors and Stockholders
of Lexicon Genetics Incorporated:
We have audited the accompanying consolidated balance sheets of Lexicon Genetics Incorporated and
subsidiaries as of December 31, 2006 and 2005 and the related consolidated statements of
operations, stockholders equity, and cash flows for each of the three years in the period ended
December 31, 2006. These financial statements are the responsibility of the Companys management.
Our responsibility is to express an opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material misstatement. An
audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the
financial statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in all material
respects, the consolidated financial position of Lexicon Genetics Incorporated and subsidiaries at
December 31, 2006 and 2005, and the consolidated results of their operations and their cash flows
for each of the three years in the period ended December 31, 2006, in conformity with U.S.
generally accepted accounting principles.
As discussed in Note 2 to the consolidated financial statements, in fiscal 2006, Lexicon Genetics
Incorporated and subsidiaries changed its method of accounting for stock-based compensation in
accordance with guidance provided in the Statement of Financial Standards No. 123(R), Share-Based
Payment.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight
Board (United States), the effectiveness of Lexicon Genetics Incorporateds internal control over
financial reporting as of December 31, 2006, based on criteria established in Internal
ControlIntegrated Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission and our report dated March 2, 2007 expressed an unqualified opinion thereon.
/s/ Ernst & Young LLP
Houston, Texas
March 2, 2007
F-1
Report of Independent
Registered Public Accounting Firm
To the Board of Directors and Stockholders
of Lexicon Genetics Incorporated:
We have audited managements assessment, included in the accompanying Managements Report on
Internal Control Over Financial Reporting, that Lexicon Genetics Incorporated maintained effective
internal control over financial reporting as of December 31, 2006, based on criteria established in
Internal ControlIntegrated Framework issued by the Committee of Sponsoring Organizations of the
Treadway Commission (the COSO criteria). Lexicon Genetics Incorporateds management is responsible
for maintaining effective internal control over financial reporting and for its assessment of the
effectiveness of internal control over financial reporting. Our responsibility is to express an
opinion on managements assessment and an opinion on the effectiveness of the companys internal
control over financial reporting based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether effective internal control over financial reporting was
maintained in all material respects. Our audit included obtaining an understanding of internal
control over financial reporting, evaluating managements assessment, testing and evaluating the
design and operating effectiveness of internal control, and performing such other procedures as we
considered necessary in the circumstances. We believe that our audit provides a reasonable basis
for our opinion.
A companys internal control over financial reporting is a process designed to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally accepted accounting principles. A
companys internal control over financial reporting includes those policies and procedures that (1)
pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the
transactions and dispositions of the assets of the company; (2) provide reasonable assurance that
transactions are recorded as necessary to permit preparation of financial statements in accordance
with generally accepted accounting principles, and that receipts and expenditures of the company
are being made only in accordance with authorizations of management and directors of the company;
and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized
acquisition, use, or disposition of the companys assets that could have a material effect on the
financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or
detect misstatements. Also, projections of any evaluation of effectiveness to future periods are
subject to the risk that controls may become inadequate because of changes in conditions, or that
the degree of compliance with the policies or procedures may deteriorate.
In our opinion, managements assessment that Lexicon Genetics Incorporated maintained effective
internal control over financial reporting as of December 31, 2006, is fairly stated, in all
material respects, based on the COSO criteria. Also, in our opinion, Lexicon Genetics Incorporated
maintained, in all material respects, effective internal control over financial reporting as of
December 31, 2006, based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight
Board (United States), the consolidated balance sheets of Lexicon Genetics Incorporated and
subsidiaries as of December 31, 2006 and 2005, and the related consolidated statements of
operations, stockholders equity, and cash flows for each of the three years in the period ended
December 31, 2006 of Lexicon Genetics Incorporated and subsidiaries and our report dated March 2,
2007 expressed an unqualified opinion thereon.
/s/ Ernst & Young LLP
Houston, Texas
March 2, 2007
F-2
Lexicon Genetics Incorporated
Consolidated Balance Sheets
(In thousands, except par value)
|
|
|
|
|
|
|
|
|
|
|
As of December 31, |
|
|
|
2006 |
|
|
2005 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
30,226 |
|
|
$ |
21,970 |
|
Short-term investments, including restricted investments of $430 |
|
|
49,773 |
|
|
|
77,725 |
|
Accounts receivable, net of allowances of $35 and $45, respectively |
|
|
1,186 |
|
|
|
2,608 |
|
Prepaid expenses and other current assets |
|
|
4,367 |
|
|
|
3,744 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
85,552 |
|
|
|
106,047 |
|
Property and equipment, net of accumulated depreciation and amortization
of $56,905 and $47,926, respectively |
|
|
78,192 |
|
|
|
85,265 |
|
Goodwill |
|
|
25,798 |
|
|
|
25,798 |
|
Intangible assets, net of amortization of $6,000 and $5,360, respectively |
|
|
|
|
|
|
640 |
|
Other assets |
|
|
724 |
|
|
|
964 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
190,266 |
|
|
$ |
218,714 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
6,513 |
|
|
$ |
6,883 |
|
Accrued liabilities |
|
|
7,325 |
|
|
|
6,787 |
|
Current portion of deferred revenue |
|
|
31,312 |
|
|
|
39,042 |
|
Current portion of long-term debt |
|
|
816 |
|
|
|
4,751 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
45,966 |
|
|
|
57,463 |
|
Deferred revenue, net of current portion |
|
|
26,688 |
|
|
|
42,540 |
|
Long-term debt |
|
|
31,372 |
|
|
|
32,189 |
|
Other long-term liabilities |
|
|
739 |
|
|
|
720 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
104,765 |
|
|
|
132,912 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity: |
|
|
|
|
|
|
|
|
Preferred stock, $.01 par value; 5,000 shares authorized;
no shares issued and outstanding |
|
|
|
|
|
|
|
|
Common stock, $.001 par value; 120,000 shares authorized;
77,804 and 64,554 shares issued and outstanding, respectively |
|
|
78 |
|
|
|
64 |
|
Additional paid-in capital |
|
|
437,180 |
|
|
|
383,222 |
|
Deferred stock compensation |
|
|
|
|
|
|
(2 |
) |
Accumulated deficit |
|
|
(351,741 |
) |
|
|
(297,430 |
) |
Accumulated other comprehensive loss |
|
|
(16 |
) |
|
|
(52 |
) |
|
|
|
|
|
|
|
Total stockholders equity |
|
|
85,501 |
|
|
|
85,802 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
190,266 |
|
|
$ |
218,714 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
F-3
Lexicon Genetics Incorporated
Consolidated Statements of Operations
(In thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative research |
|
$ |
68,373 |
|
|
$ |
69,567 |
|
|
$ |
49,736 |
|
Subscription and license fees |
|
|
4,425 |
|
|
|
6,113 |
|
|
|
12,004 |
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
72,798 |
|
|
|
75,680 |
|
|
|
61,740 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development, including stock-based
compensation of $4,394, $(21), and $426, respectively |
|
|
106,695 |
|
|
|
93,625 |
|
|
|
90,586 |
|
General and administrative, including stock-based
compensation of $2,636, $0, and $412 respectively |
|
|
21,334 |
|
|
|
18,174 |
|
|
|
18,608 |
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
128,029 |
|
|
|
111,799 |
|
|
|
109,194 |
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(55,231 |
) |
|
|
(36,119 |
) |
|
|
(47,454 |
) |
Interest income |
|
|
3,653 |
|
|
|
2,645 |
|
|
|
1,638 |
|
Interest expense |
|
|
(3,253 |
) |
|
|
(3,280 |
) |
|
|
(2,660 |
) |
Other income, net |
|
|
401 |
|
|
|
558 |
|
|
|
1,304 |
|
|
|
|
|
|
|
|
|
|
|
Loss before taxes |
|
|
(54,430 |
) |
|
|
(36,196 |
) |
|
|
(47,172 |
) |
Income tax provision |
|
|
119 |
|
|
|
(119 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(54,311 |
) |
|
$ |
(36,315 |
) |
|
$ |
(47,172 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share, basic and diluted |
|
$ |
(0.81 |
) |
|
$ |
(0.57 |
) |
|
$ |
(0.74 |
) |
|
|
|
|
|
|
|
|
|
|
Shares used in computing net loss per common share,
basic and diluted |
|
|
66,876 |
|
|
|
63,962 |
|
|
|
63,327 |
|
The accompanying notes are an integral part of these consolidated financial statements.
F-4
Lexicon Genetics Incorporated
Consolidated Statements of Stockholders Equity
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
Deferred |
|
|
|
|
|
|
Accumulated Other |
|
|
Total |
|
|
|
Common Stock |
|
|
Paid-In |
|
|
Stock |
|
|
Accumulated |
|
|
Comprehensive |
|
|
Stockholders |
|
|
|
Shares |
|
|
Par Value |
|
|
Capital |
|
|
Compensation |
|
|
Deficit |
|
|
Loss |
|
|
Equity |
|
Balance at December 31, 2003 |
|
|
62,827 |
|
|
$ |
63 |
|
|
$ |
380,995 |
|
|
$ |
(899 |
) |
|
$ |
(213,943 |
) |
|
$ |
|
|
|
$ |
166,216 |
|
Deferred stock compensation, net of
reversals |
|
|
|
|
|
|
|
|
|
|
(41 |
) |
|
|
41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of deferred stock
compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
838 |
|
|
|
|
|
|
|
|
|
|
|
838 |
|
Exercise of common stock options |
|
|
664 |
|
|
|
|
|
|
|
1,712 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,712 |
|
Net and comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(47,172 |
) |
|
|
|
|
|
|
(47,172 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004 |
|
|
63,491 |
|
|
|
63 |
|
|
|
382,666 |
|
|
|
(20 |
) |
|
|
(261,115 |
) |
|
|
|
|
|
|
121,594 |
|
Deferred stock compensation, net of
reversals |
|
|
|
|
|
|
|
|
|
|
(39 |
) |
|
|
39 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of deferred stock
compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(21 |
) |
|
|
|
|
|
|
|
|
|
|
(21 |
) |
Exercise of common stock options |
|
|
1,063 |
|
|
|
1 |
|
|
|
595 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
596 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(36,315 |
) |
|
|
|
|
|
|
(36,315 |
) |
Unrealized loss on investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(52 |
) |
|
|
(52 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(36,367 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005 |
|
|
64,554 |
|
|
|
64 |
|
|
|
383,222 |
|
|
|
(2 |
) |
|
|
(297,430 |
) |
|
|
(52 |
) |
|
|
85,802 |
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
7,030 |
|
|
|
2 |
|
|
|
|
|
|
|
|
|
|
|
7,032 |
|
Direct placement of common stock,
net of offering costs |
|
|
11,582 |
|
|
|
12 |
|
|
|
41,084 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
41,096 |
|
Common stock issued for note
repayment |
|
|
1,512 |
|
|
|
2 |
|
|
|
5,489 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,491 |
|
Exercise of common stock options |
|
|
156 |
|
|
|
|
|
|
|
355 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
355 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(54,311 |
) |
|
|
|
|
|
|
(54,311 |
) |
Unrealized gain on investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
36 |
|
|
|
36 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(54,275 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006 |
|
|
77,804 |
|
|
$ |
78 |
|
|
$ |
437,180 |
|
|
$ |
|
|
|
$ |
(351,741 |
) |
|
$ |
(16 |
) |
|
$ |
85,501 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
F-5
Lexicon Genetics Incorporated
Consolidated Statements of Cash Flows
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(54,311 |
) |
|
$ |
(36,315 |
) |
|
$ |
(47,172 |
) |
Adjustments to reconcile net loss to net cash provided by
(used in) operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation |
|
|
10,561 |
|
|
|
10,456 |
|
|
|
10,834 |
|
Amortization of intangible assets, other than goodwill |
|
|
640 |
|
|
|
1,200 |
|
|
|
1,200 |
|
Stock-based compensation |
|
|
7,030 |
|
|
|
(21 |
) |
|
|
838 |
|
(Gain) loss on disposal of property and equipment |
|
|
35 |
|
|
|
10 |
|
|
|
(11 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Decrease in receivables |
|
|
1,423 |
|
|
|
3,789 |
|
|
|
174 |
|
(Increase) decrease in prepaid expenses and other current assets |
|
|
(623 |
) |
|
|
1,049 |
|
|
|
(860 |
) |
(Increase) decrease in other assets |
|
|
240 |
|
|
|
57 |
|
|
|
(841 |
) |
Increase (decrease) in accounts payable and other liabilities |
|
|
1,678 |
|
|
|
(773 |
) |
|
|
3,682 |
|
Increase (decrease) in deferred revenue |
|
|
(23,582 |
) |
|
|
43,990 |
|
|
|
(10,100 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) operating activities |
|
|
(56,909 |
) |
|
|
23,442 |
|
|
|
(42,256 |
) |
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(3,579 |
) |
|
|
(11,281 |
) |
|
|
(11,811 |
) |
Proceeds from disposal of property and equipment |
|
|
56 |
|
|
|
123 |
|
|
|
91 |
|
Decrease in restricted cash |
|
|
|
|
|
|
|
|
|
|
14,372 |
|
Purchase of short-term investments |
|
|
(67,688 |
) |
|
|
(175,235 |
) |
|
|
(178,355 |
) |
Sale of short-term investments |
|
|
95,676 |
|
|
|
170,404 |
|
|
|
216,182 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
24,465 |
|
|
|
(15,989 |
) |
|
|
40,479 |
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock |
|
|
41,451 |
|
|
|
596 |
|
|
|
1,712 |
|
Proceeds from debt borrowings |
|
|
|
|
|
|
|
|
|
|
34,000 |
|
Repayment of debt borrowings |
|
|
(751 |
) |
|
|
(691 |
) |
|
|
(52,713 |
) |
Repayment of other long-term liabilities |
|
|
|
|
|
|
|
|
|
|
(2,466 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities |
|
|
40,700 |
|
|
|
(95 |
) |
|
|
(19,467 |
) |
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
8,256 |
|
|
|
7,358 |
|
|
|
(21,244 |
) |
Cash and cash equivalents at beginning of year |
|
|
21,970 |
|
|
|
14,612 |
|
|
|
35,856 |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of year |
|
$ |
30,226 |
|
|
$ |
21,970 |
|
|
$ |
14,612 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for interest |
|
$ |
2,725 |
|
|
$ |
2,783 |
|
|
$ |
1,985 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of noncash investing and financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on investments |
|
$ |
36 |
|
|
$ |
(52 |
) |
|
$ |
|
|
Deferred stock compensation, net of reversals |
|
$ |
2 |
|
|
$ |
39 |
|
|
$ |
41 |
|
Retirement of property and equipment |
|
$ |
1,673 |
|
|
$ |
4,554 |
|
|
$ |
963 |
|
Issuance of common stock to repay note and accrued interest |
|
$ |
5,491 |
|
|
$ |
|
|
|
$ |
|
|
The accompanying notes are an integral part of these consolidated financial statements.
F-6
Lexicon Genetics Incorporated
Notes to Consolidated Financial Statements
December 31, 2006
1. Organization and Operations
Lexicon Genetics Incorporated (Lexicon or the Company) is a Delaware corporation incorporated on
July 7, 1995. Lexicon was organized to discover the functions and pharmaceutical utility of genes
and use those gene function discoveries in the discovery and development of pharmaceutical products
for the treatment of human disease.
Lexicon has financed its operations from inception primarily through sales of common and preferred
stock, payments received under collaboration and alliance agreements, database subscription
agreements, government grants and contracts, technology licenses, and financing obtained under debt
and lease arrangements. The Companys future success is dependent upon many factors, including, but
not limited to, its ability to discover and develop pharmaceutical products for the treatment of
human disease, discover additional promising candidates for drug discovery and development using
its gene knockout technology, establish additional collaboration and license agreements, achieve
milestones under such agreements, obtain and enforce patents and other proprietary rights in its
discoveries, comply with federal and state regulations, and maintain sufficient capital to fund its
activities. As a result of the aforementioned factors and the related uncertainties, there can be
no assurance of the Companys future success.
2. Summary of Significant Accounting Policies
Basis of Presentation: The accompanying consolidated financial statements include the accounts of
Lexicon and its subsidiaries. Intercompany transactions and balances are eliminated in
consolidation.
Use of Estimates: The preparation of financial statements in conformity with U. S. generally
accepted accounting principles requires management to make estimates and assumptions that affect
the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities
at the date of the financial statements and the reported amounts of revenues and expenses during
the period. Actual results could differ from those estimates.
Cash, Cash Equivalents and Short-term Investments: Lexicon considers all highly-liquid investments
with original maturities of three months or less to be cash equivalents. Short-term investments
consist of certificates of deposit, U.S. government agency debt obligations, corporate debt
securities and auction rate securities. Short-term investments are classified as
available-for-sale securities and are carried at fair value, based on quoted market prices of the
securities. The Company views its available-for-sale securities as available for use in current
operations regardless of the stated maturity date of the security. Unrealized gains and losses on
such securities are reported as a separate component of stockholders equity. Net realized gains
and losses, interest and dividends are included in interest income. The cost of securities sold is
based on the specific identification method.
Restricted Cash and Investments: Lexicon is required to maintain restricted cash or investments to
collateralize standby letters of credit for the lease on its office and laboratory facilities in
Hopewell, New Jersey (see Note 9). As of December 31, 2006 and 2005, restricted cash and
investments were $0.4 million.
Concentration of Credit Risk: Lexicons cash equivalents, short-term investments and accounts
receivable represent potential concentrations of credit risk. The Company minimizes potential
concentrations of risk in cash equivalents and short-term investments by placing investments in
high-quality financial instruments. The Companys accounts receivable are unsecured and are
concentrated in pharmaceutical and biotechnology companies located in the United States, Europe and
Japan. The Company has not experienced any significant credit losses to date. In 2006, customers
in the United States, Europe and Japan represented 66%, 21% and 13% of revenue, respectively. In
2005, customers in the United States, Europe and Japan represented 78%, 16% and 6% of revenue,
respectively. In 2004, customers in the United States, Japan and Europe represented 93%, 6% and 1%
of revenue, respectively. At December 31, 2006, management believes that the Company has no
significant concentrations of credit risk.
Segment Information and Significant Customers: Lexicon operates in one business segment, which
primarily focuses on the discovery of the functions and pharmaceutical utility of genes and the use
of those gene function
F-7
discoveries in the discovery and development of pharmaceutical products for the treatment of human
disease. Substantially all of the Companys revenues have been derived from drug discovery
alliances, target validation collaborations for the development and, in some cases, analysis of the
physiological effects of genes altered in knockout mice, technology licenses, subscriptions to its
databases, government grants and contracts and compound library sales. In 2006, Bristol-Myers
Squibb Company, N.V. Organon and Takeda represented 35%, 21% and 12% of revenues, respectively. In
2005, Bristol-Myers Squibb, Genentech, Inc. and Organon represented 34%, 30% and 16% of revenues,
respectively. In 2004, Bristol-Myers Squibb, Genentech and Incyte Corporation represented 43%,
26% and 8% of revenues, respectively.
Property and Equipment: Property and equipment are carried at cost and depreciated using the
straight-line method over the estimated useful life of the assets which ranges from three to 40
years. Maintenance, repairs and minor replacements are charged to expense as incurred. Leasehold
improvements are amortized over the shorter of the estimated useful life or the remaining lease
term. Significant renewals and betterments are capitalized.
Impairment of Long-Lived Assets: Under Statement of Financial Accounting Standards (SFAS) No. 144,
Accounting for the Impairment or Disposal of Long-Lived Assets, long-lived assets and certain
identifiable intangible assets to be held and used are reviewed for impairment when events or
changes in circumstances indicate that the carrying amount of such assets may not be recoverable.
Determination of recoverability is based on an estimate of undiscounted future cash flows resulting
from the use of the asset and its eventual disposition. In the event that such cash flows are not
expected to be sufficient to recover the carrying amount of the assets, the assets are written down
to their estimated fair values.
Goodwill Impairment: Under SFAS No. 142, Goodwill and Other Intangible Assets, goodwill is not
amortized, but is tested at least annually for impairment at the reporting unit level. Impairment
is the condition that exists when the carrying amount of goodwill exceeds its implied fair value.
The first step in the impairment process is to determine the fair value of the reporting unit and
then compare it to the carrying value, including goodwill. If the fair value exceeds the carrying
value, no further action is required and no impairment loss is recognized. Additional impairment
assessments may be performed on an interim basis if the Company encounters events or changes in
circumstances that would indicate that, more likely than not, the carrying value of goodwill has
been impaired. There was no impairment of goodwill in 2006, 2005 or 2004.
Revenue Recognition: Revenues are recognized under Staff Accounting Bulletin (SAB) No. 104,
Revenue Recognition, when persuasive evidence of an arrangement exists, delivery has occurred or
services have been rendered, the price is fixed or determinable and collectibility is reasonably
assured. Payments received in advance under these arrangements are recorded as deferred revenue
until earned. Revenues are earned from drug discovery alliances, target validation collaborations,
database subscriptions, technology licenses, and government grants and contracts.
Upfront fees under drug discovery alliances are recognized as revenue on a straight-line basis over
the estimated period of service, generally the contractual research term, to the extent they are
non-refundable. Research funding under these alliances is recognized as services are performed to
the extent they are non-refundable, either on a straight-line basis over the estimated service
period, generally the contractual research term; or as contract research costs are incurred.
Milestone-based fees are recognized upon completion of specified milestones according to contract
terms. Payments received under target validation collaborations and government grants and
contracts are recognized as revenue as Lexicon performs its obligations related to such research to
the extent such fees are non-refundable. Non-refundable technology license fees are recognized as
revenue upon the grant of the license when performance is complete and there is no continuing
involvement.
Revenues recognized from multiple element contracts are allocated to each element of the
arrangement based on the relative fair values of the elements. The determination of fair value of
each element is based on objective evidence. When revenues for an element are specifically tied to
a separate earnings process, revenue is recognized when the specific performance obligation
associated with the element is completed. When revenues for an element are not specifically tied
to a separate earnings process, they are recognized ratably over the term of the agreement.
Research and Development Expenses: Research and development expenses consist of costs incurred for
company-sponsored as well as collaborative research and development activities. These costs include
direct and research-related overhead expenses and are expensed as incurred. Patent costs and
technology license fees for
F-8
technologies that are utilized in research and development and have no alternative future use are
expensed when incurred.
Stock-Based Compensation: On January 1, 2006, Lexicon adopted Statement of Financial Accounting
Standards Board No. 123 (Revised), Share-Based Payment, SFAS No. 123(R). This statement requires
companies to recognize compensation expense in the statement of operations for share-based
payments, including stock options issued to employees, based on their fair values on the date of
the grant, with the compensation expense recognized over the period in which an employee is
required to provide service in exchange for the stock award. The Company adopted this statement
using the modified prospective transition method, which applies the compensation expense
recognition provisions to new awards and to any awards modified, repurchased or canceled after the
January 1, 2006 adoption date. Additionally, for any unvested awards outstanding at the adoption
date, the Company will recognize compensation expense over the remaining vesting period.
Stock-based compensation expense is recognized on a straight-line basis. The adoption of SFAS No.
123(R) resulted in stock-based compensation expense of $7.0 million for the year ended December 31,
2006, or $0.11 per share. There is no impact on cash flows from operating activities or financing
activities. As of December 31, 2006, stock-based compensation cost for all outstanding unvested
options was $11.6 million, which is expected to be recognized over a weighted-average period of 1.2
years.
Prior to the adoption of SFAS No. 123(R), Lexicons stock-based compensation plans were accounted
for under the recognition and measurement provisions of Accounting Principles Board Opinion No. 25,
Accounting for Stock Issued to Employees, and Related Interpretations, APB No. 25. Under the
intrinsic value method described in APB No. 25, no compensation expense was recorded because the
exercise price of the employee stock options equaled the market price of the underlying stock on
the date of grant.
Lexicon records expenses for options issued to non-employee consultants at fair value and
re-measures the fair value of unvested options at each reporting date. Lexicon reversed
stock-based compensation expense of $21,000 during the year ended December 31, 2005 and recognized
$0.8 million during 2004, which was primarily related to option grants made prior to Lexicons
April 2000 initial public offering. The following table illustrates the effect on net loss and net
loss per share if the fair value recognition provisions of SFAS No. 123, Accounting for Stock
Based Compensation, had been applied to all outstanding and unvested awards in each period:
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2005 |
|
|
2004 |
|
|
|
(in thousands) |
|
Net loss, as reported |
|
$ |
(36,315 |
) |
|
$ |
(47,172 |
) |
Add: Stock-based compensation expense included
in reported net loss |
|
|
(21 |
) |
|
|
838 |
|
Deduct: Total stock-based compensation expense
determined under fair value based method
for all awards |
|
|
(11,496 |
) |
|
|
(16,189 |
) |
|
|
|
|
|
|
|
Pro forma net loss |
|
$ |
(47,832 |
) |
|
$ |
(62,523 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share, basic and diluted |
|
|
|
|
|
|
|
|
As reported |
|
$ |
(0.57 |
) |
|
$ |
(0.74 |
) |
|
|
|
|
|
|
|
Pro forma |
|
$ |
(0.75 |
) |
|
$ |
(0.99 |
) |
|
|
|
|
|
|
|
The fair value of stock options is estimated at the date of grant using the Black-Scholes method.
The Black-Scholes option-pricing model requires the input of subjective assumptions. Because the
Companys employee stock options have characteristics significantly different from those of traded
options, and because changes in the subjective input assumptions can materially affect the fair
value estimate, in managements opinion, the existing models do not necessarily provide a reliable
single measure of the fair value of its employee stock options. For purposes of determining the
fair value of stock options granted subsequent to the adoption of SFAS No. 123(R), the Company
segregated its options into two homogeneous groups, based on exercise and post-vesting employment
termination behaviors, resulting in a change in the assumptions used for expected option lives and
forfeitures. Expected volatility is based on the historical volatility in the Companys stock
price. The following weighted-average assumptions were used for options granted in the years ended
December 31, 2006, 2005 and 2004, respectively:
F-9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Risk-free |
|
|
|
|
|
|
|
|
Expected |
|
Interest |
|
Expected |
|
Estimated |
|
Dividend |
|
|
Volatility |
|
Rate |
|
Term |
|
Forfeitures |
|
Rate |
December 31, 2006: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employees |
|
|
69 |
% |
|
|
4.6 |
% |
|
|
7 |
|
|
|
18 |
% |
|
|
0 |
% |
Officers and non-employee directors |
|
|
69 |
% |
|
|
4.7 |
% |
|
|
9 |
|
|
|
3 |
% |
|
|
0 |
% |
December 31, 2005: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employees, officers and non-employee directors |
|
|
72 |
% |
|
|
4.2 |
% |
|
|
7 |
|
|
|
3 |
% |
|
|
0 |
% |
December 31, 2004: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employees, officers and non-employee directors |
|
|
92 |
% |
|
|
3.7 |
% |
|
|
7 |
|
|
|
3 |
% |
|
|
0 |
% |
Net Loss per Common Share: Net loss per common share is computed using the weighted average
number of shares of common stock outstanding. Shares associated with stock options and warrants are
not included because they are antidilutive.
Comprehensive Loss: Comprehensive loss is comprised of net loss and unrealized gains and losses on
available-for-sale securities. Comprehensive loss is reflected in the consolidated statements of
stockholders equity. There were $36,000 of unrealized gains in the year ended December 31, 2006,
$52,000 of unrealized losses in the year ended December 31, 2005, and no unrealized gains or losses
in the year ended December 31, 2004.
3. Recent Accounting Pronouncement
In July 2006, the FASB issued FASB Interpretation No. 48, Accounting for Uncertainty in Income
Taxes, an interpretation of FASB Statement No. 109 (FIN 48). FIN 48 clarifies the accounting
for uncertainty in income taxes recognized in a companys financial statements and prescribes a
recognition threshold and measurement attribute for the financial statement recognition and
measurement of a tax position taken or expected to be taken in an income tax return. FIN 48 also
provides guidance on derecognition, classification, interest and penalties, accounting in interim
periods, disclosure and transition. FIN 48 is effective for the Company as of January 1, 2007.
The Company is currently evaluating the effect, if any, of this statement on its financial
condition and results of operations.
In September 2006, the Financial Accounting Standards Board (FASB) issued Statement of Financial
Accounting Standards No. 157, Fair Value Measurements (SFAS No. 157). The statement defines
fair value, establishes a framework for measuring fair value in generally accepted accounting
principles, and expands disclosures about fair value measurements. This statement applies under
other accounting pronouncements that require or permit fair value measurements, the FASB having
previously concluded in those accounting pronouncements that fair value is the relevant measurement
attribute. Accordingly, this statement does not require any new fair value measurements. SFAS No.
157 is effective January 1, 2008. The Company is currently evaluating the effect, if any, of this
statement on its financial condition and results of operation.
4. Cash and cash equivalents and investments
The fair value of cash and cash equivalents and investments held at December 31, 2006 and 2005 are
as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2006 |
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Amortized |
|
|
Gross Unrealized |
|
|
Unrealized |
|
|
Estimated Fair |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
|
|
|
|
|
|
(In thousands) |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
30,239 |
|
|
$ |
|
|
|
$ |
(13 |
) |
|
$ |
30,226 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Securities maturing within one year: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit |
|
|
6,193 |
|
|
|
1 |
|
|
|
(1 |
) |
|
|
6,193 |
|
Corporate debt securities |
|
|
5,008 |
|
|
|
|
|
|
|
(3 |
) |
|
|
5,005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities maturing within one year |
|
|
11,201 |
|
|
|
1 |
|
|
|
(4 |
) |
|
|
11,198 |
|
Securities maturing after ten years: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Auction rate securities |
|
|
38,575 |
|
|
|
|
|
|
|
|
|
|
|
38,575 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total available-for-sale investments |
|
$ |
49,776 |
|
|
$ |
1 |
|
|
$ |
(4 |
) |
|
$ |
49,773 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cash and cash equivalents and investments |
|
$ |
80,015 |
|
|
$ |
1 |
|
|
$ |
(17 |
) |
|
$ |
79,999 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2005 |
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Amortized |
|
|
Gross Unrealized |
|
|
Unrealized |
|
|
Estimated Fair |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
|
|
|
|
|
|
(In thousands) |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
21,982 |
|
|
$ |
|
|
|
$ |
(12 |
) |
|
$ |
21,970 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Securities maturing within one year: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit |
|
|
574 |
|
|
|
|
|
|
|
|
|
|
|
574 |
|
Corporate debt securities |
|
|
18,941 |
|
|
|
|
|
|
|
(45 |
) |
|
|
18,896 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities maturing within one year |
|
|
19,515 |
|
|
|
|
|
|
|
(45 |
) |
|
|
19,470 |
|
Securities maturing after ten years: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Auction rate securities |
|
|
58,250 |
|
|
|
5 |
|
|
|
|
|
|
|
58,255 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total available-for-sale investments |
|
$ |
77,765 |
|
|
$ |
5 |
|
|
$ |
(45 |
) |
|
$ |
77,725 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cash and cash equivalents and investments |
|
$ |
99,747 |
|
|
$ |
5 |
|
|
$ |
(57 |
) |
|
$ |
99,695 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
There were no realized gains or losses for the years ended December 31, 2006, 2005 and 2004.
5. Property and Equipment
Property and equipment at December 31, 2006 and 2005 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated |
|
|
|
|
|
|
Useful Lives |
|
|
As of December 31, |
|
|
|
In Years |
|
|
2006 |
|
|
2005 |
|
|
|
|
|
|
|
(In thousands) |
|
Computers and software |
|
|
3-5 |
|
|
$ |
12,259 |
|
|
$ |
12,768 |
|
Furniture and fixtures |
|
|
5-7 |
|
|
|
7,593 |
|
|
|
7,596 |
|
Laboratory equipment |
|
|
3-7 |
|
|
|
38,642 |
|
|
|
36,306 |
|
Leasehold improvements |
|
|
7-10 |
|
|
|
9,740 |
|
|
|
9,740 |
|
Buildings |
|
|
15-40 |
|
|
|
63,299 |
|
|
|
63,217 |
|
Land ` |
|
|
|
|
|
|
3,564 |
|
|
|
3,564 |
|
|
|
|
|
|
|
|
|
|
|
|
Total property and equipment |
|
|
|
|
|
|
135,097 |
|
|
|
133,191 |
|
Less: Accumulated depreciation and amortization |
|
|
|
|
|
|
(56,905 |
) |
|
|
(47,926 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net property and equipment |
|
|
|
|
|
$ |
78,192 |
|
|
$ |
85,265 |
|
|
|
|
|
|
|
|
|
|
|
|
6. Income Taxes
Lexicon recognizes deferred tax liabilities and assets for the expected future tax consequences of
events that have been recognized differently in the financial statements and tax returns. Under
this method, deferred tax liabilities and assets are determined based on the difference between the
financial statement carrying amounts and tax bases of liabilities and assets using enacted tax
rates and laws in effect in the years in which the differences are expected to reverse. Deferred
tax assets are evaluated for realization based on a more-likely-than-not criteria in determining if
a valuation allowance should be provided.
F-11
The components of Lexicons deferred tax assets (liabilities) at December 31, 2006 and 2005 are as
follows:
|
|
|
|
|
|
|
|
|
|
|
As of December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
|
(In thousands) |
|
Deferred tax assets: |
|
|
|
|
|
|
|
|
Net operating loss carryforwards |
|
$ |
93,601 |
|
|
$ |
64,645 |
|
Research and development tax credits |
|
|
14,449 |
|
|
|
12,391 |
|
Stock-based compensation |
|
|
6,880 |
|
|
|
6,001 |
|
Deferred revenue |
|
|
15,505 |
|
|
|
28,546 |
|
Other |
|
|
875 |
|
|
|
724 |
|
|
|
|
|
|
|
|
Total deferred tax assets |
|
|
131,310 |
|
|
|
112,307 |
|
Deferred tax liabilities: |
|
|
|
|
|
|
|
|
Property and equipment |
|
|
(929 |
) |
|
|
(1,262 |
) |
Other |
|
|
(380 |
) |
|
|
(346 |
) |
|
|
|
|
|
|
|
Total deferred tax liabilities |
|
|
(1,309 |
) |
|
|
(1,608 |
) |
Less: Valuation allowance |
|
|
(130,001 |
) |
|
|
(110,699 |
) |
|
|
|
|
|
|
|
Net deferred tax assets |
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
At December 31, 2006, Lexicon had net operating loss carryforwards of approximately $267.4
million and research and development tax credit carryforwards of approximately $14.4 million
available to reduce future income taxes. These carryforwards will begin to expire in 2011. A
change in ownership, as defined by federal income tax regulations, could significantly limit the
Companys ability to utilize its carryforwards. Based on the federal tax law limits and the
Companys cumulative loss position, Lexicon concluded it was appropriate to establish a full
valuation allowance for its net deferred tax assets until an appropriate level of profitability is
sustained. During 2006, the valuation allowance increased $19.3 million primarily due to the
Companys current year net loss. Lexicon recorded a $119,000 income tax provision representing
alternative minimum tax payable based on estimated taxable income for the year ended December 31,
2005. This amount was subsequently reversed in 2006.
7. Goodwill and Other Intangible Assets
On July 12, 2001, Lexicon completed the acquisition of Coelacanth Corporation in a merger.
Coelacanth, now Lexicon Pharmaceuticals (New Jersey), Inc., forms the core of Lexicon
Pharmaceuticals, the division of the Company responsible for small molecule compound discovery.
The results of Lexicon Pharmaceuticals (New Jersey), Inc. are included in the Companys results of
operations for the period subsequent to the acquisition.
Goodwill associated with the acquisition of $25.8 million, which represents the excess of the $36.0
million purchase price over the fair value of the underlying net identifiable assets, was assigned
to the consolidated entity, Lexicon. There was no change in the carrying amount of goodwill for
the year ended December 31, 2006. In accordance with SFAS No. 142, the goodwill balance is not
subject to amortization, but is tested at least annually for impairment at the reporting unit
level, which is the Companys single operating segment. The Company performed an impairment test
of goodwill on its annual impairment assessment date. This test did not result in an impairment of
goodwill.
Other intangible assets represent Coelacanths technology platform, which consists of its
proprietary ClickChem reactions, novel building blocks and compound sets, automated
production systems, high-throughput ADMET (Absorption, Distribution, Metabolism, Excretion and
Toxicity) capabilities, and its know-how and trade secrets. The Company amortizes other intangible
assets on a straight-line basis over an estimated life of five years.
The amortization expense for the year ended December 31, 2006 was $0.6 million. Other intangible
assets are now fully amortized.
8. Debt Obligations
Genentech Loan: On December 31, 2002, Lexicon borrowed $4.0 million under an unsecured note
agreement with Genentech, Inc. The proceeds of the loan were to be used to fund research efforts
under the alliance agreement with Genentech discussed in Note 13. On November 30, 2005, the note
agreement was amended to extend the maturity date of the loan by one year to December 31, 2006. No
other terms of the note agreement were changed. The note permitted the Company to repay the note,
at any time, at its option, in cash, in shares of common stock valued at the
F-12
then-current market price, or in a combination of cash and shares, subject to certain limitations.
The note accrued interest at an annual rate of 8%, compounded quarterly. On December 31, 2006, the
Company repaid in full the principal and accrued interest outstanding under the note by issuing to
Genentech 1,511,670 shares of common stock.
Mortgage Loan: In October 2000, Lexicon entered into a synthetic lease agreement under which the
lessor purchased the Companys existing laboratory and office buildings and animal facility in The
Woodlands, Texas and agreed to fund the construction of additional facilities. Including the
purchase price for the Companys existing facilities, the synthetic lease, as amended, provided
funding of $54.8 million in property and improvements and required that the Company maintain
restricted cash or investments to collateralize these borrowings. In April 2004, Lexicon purchased
the facilities subject to the synthetic lease, repaying the $54.8 million funded under the
synthetic lease with proceeds from a $34.0 million third-party mortgage financing and $20.8 million
in cash. The mortgage loan has a ten-year term with a 20-year amortization and bears interest at a
fixed rate of 8.23%. As a result of the refinancing, all restrictions on the cash and investments
that had secured the obligations under the synthetic lease were eliminated. The buildings and land
that serve as collateral for the mortgage loan are included in property and equipment at $63.3
million and $3.6 million, respectively, before accumulated depreciation.
The following table includes the aggregate future principal payments of the Companys long-term
debt as of December 31, 2006:
|
|
|
|
|
|
|
For the Year Ending December 31 |
|
|
|
(In thousands) |
|
2007 |
|
$ 816 |
|
2008 |
|
880 |
|
2009 |
|
963 |
|
2010 |
|
1,047 |
|
2011 |
|
1,138 |
|
Thereafter |
|
27,344 |
|
|
|
32,188 |
|
Less current portion |
|
(816) |
|
Total long-term debt |
|
$ 31,372 |
|
The fair value of Lexicons debt financial instruments approximates their carrying value. The fair
value of Lexicons long-term debt is estimated using discounted cash flow analysis, based on the
Companys estimated current incremental borrowing rate.
9. Commitments and Contingencies
Operating Lease Obligations: A Lexicon subsidiary leases laboratory and office space in Hopewell,
New Jersey under an agreement that expires in June 2013. The lease provides for two five-year
renewal options at 95% of the fair market rent and includes escalating lease payments. Rent
expense is recognized on a straight-line basis over the original lease term. Lexicon is the
guarantor of the obligation of its subsidiary under this lease. The Company is required to
maintain restricted investments to collateralize a standby letter of credit for this lease. The
Company had $0.4 million in restricted investments as collateral as of December 31, 2006 and 2005.
Additionally, Lexicon leases certain equipment under operating leases.
F-13
Rent expense for all operating leases was approximately $2.4 million, $2.4 million and $2.3
million, for the years ended December 31, 2006, 2005 and 2004, respectively. The following table
includes non-cancelable, escalating future lease payments for the facility in New Jersey:
|
|
|
|
|
|
|
For the Year Ending December 31 |
|
|
|
(In thousands) |
|
2007 |
|
$ 2,355 |
|
2008 |
|
2,416 |
|
2009 |
|
2,476 |
|
2010 |
|
2,476 |
|
2011 |
|
2,541 |
|
Thereafter |
|
3,908 |
|
Total |
|
$ 16,172 |
|
Employment Agreements: Lexicon has entered into employment agreements with certain of its corporate
officers. Under the agreements, each officer receives a base salary, subject to adjustment, with an
annual discretionary bonus based upon specific objectives to be determined by the compensation
committee. The employment agreements are at-will and contain non-competition agreements. The
agreements also provide for a termination clause, which requires either a six or 12-month payment
based on the officers salary, in the event of termination or change in corporate control.
10. Capital Stock
Common Stock: In September 2006, Lexicon issued and sold 1,000,000 shares of its common stock to
Azimuth Opportunity Ltd. under its June 2006 equity line agreement with Azimuth at a purchase price
of approximately $3.67 per share. After deducting offering expenses, Lexicon received net proceeds
from the sale of approximately $3.6 million.
In October 2006, Lexicon completed the registered direct offering and sale of 10,582,011 shares of
its common stock to selected institutional investors at a price of $3.78 per share, resulting in
net proceeds of $37.5 million, after deducting placement agent fees of $2.4 million and offering
expenses of $0.1 million.
11. Stock Options and Warrants
Stock Option Plans
2000 Equity Incentive Plan: In September 1995, Lexicon adopted the 1995 Stock Option Plan, which
was subsequently amended and restated in February 2000 as the 2000 Equity Incentive Plan (the
Equity Incentive Plan). The Equity Incentive Plan will terminate in 2010 unless the Board of
Directors terminates it sooner. The Equity Incentive Plan provides that it will be administered by
the Board of Directors, or a committee appointed by the Board of Directors, which determines
recipients and types of options to be granted, including number of shares under the option and the
exercisability of the shares. The Equity Incentive Plan is presently administered by the
Compensation Committee of the Board of Directors.
The Equity Incentive Plan provides for the grant of incentive stock options to employees and
nonstatutory stock options to employees, directors and consultants of the Company. The plan also
permits the grant of stock bonuses and restricted stock purchase awards. Incentive stock options
have an exercise price of 100% or more of the fair market value of our common stock on the date of
grant. Nonstatutory stock options may have an exercise price as low as 85% of fair market value on
the date of grant. The purchase price of other stock awards may not be less than 85% of fair market
value. However, the plan administrator may award bonuses in consideration of past services without
a purchase payment. Shares may be subject to a repurchase option in the discretion of the plan
administrator.
The Board of Directors initially authorized and reserved an aggregate of 11,250,000 shares of
common stock for issuance under the Equity Incentive Plan. On January 1 of each year for ten years,
beginning in 2001, the number of shares reserved for issuance under the Equity Incentive Plan
automatically will be increased by the greater of:
F-14
|
|
|
5% of Lexicons outstanding shares on a fully-diluted basis; or |
|
|
|
|
that number of shares that could be issued under awards granted under the Equity
Incentive Plan during the prior 12-month period; |
provided that the Board of Directors may provide for a lesser increase in the number of shares
reserved under the Equity Incentive Plan for any year. The total number of shares reserved in the
aggregate may not exceed 30,000,000 shares over the ten-year period.
As of December 31, 2006, an aggregate of 20,500,000 shares of common stock had been reserved for
issuance, options to purchase 15,437,347 shares were outstanding, and 3,673,526 shares had been
issued upon the exercise of stock options issued under the Equity Incentive Plan.
2000 Non-Employee Directors Stock Option Plan: In February 2000, Lexicon adopted the 2000
Non-Employee Directors Stock Option Plan (the Directors Plan) to provide for the automatic
grant of options to purchase shares of common stock to non-employee directors of the Company. Under
the Directors Plan, non-employee directors first elected after the closing of the Companys
initial public offering receive an initial option to purchase 30,000 shares of common stock. In
addition, on the day following each of the Companys annual meetings of stockholders, beginning
with the annual meeting in 2001, each non-employee director who has been a director for at least
six months was automatically granted an option to purchase 6,000 shares of common stock. Beginning
with the annual meeting in 2005, the annual grant was increased to an option to purchase 10,000
shares of common stock. Initial option grants become vested and exercisable over a period of five
years and annual option grants become vested over a period of 12 months from the date of grant.
Options granted under the Directors Plan have an exercise price equal to the fair market value of
the Companys common stock on the date of grant and term of ten years from the date of grant.
The Board of Directors initially authorized and reserved a total of 600,000 shares of its common
stock for issuance under the Directors Plan. On the day following each annual meeting of Lexicons
stockholders, for 10 years, starting in 2001, the share reserve will automatically be increased by
a number of shares equal to the greater of:
|
|
|
0.3% of the Companys outstanding shares on a fully-diluted basis; or |
|
|
|
|
that number of shares that could be issued under options granted under the Directors
Plan during the prior 12-month period; |
provided that the Board of Directors may provide for a lesser increase in the number of shares
reserved under the Directors Plan for any year.
As of December 31, 2006, an aggregate of 600,000 shares of common stock had been reserved for
issuance, options to purchase 304,000 shares were outstanding, and no options had been exercised
under the Directors Plan.
Coelacanth Corporation 1999 Stock Option Plan: Lexicon assumed the Coelacanth Corporation 1999
Stock Option Plan (the Coelacanth Plan) and the outstanding stock options under the plan in
connection with our July 2001 acquisition of Coelacanth Corporation. The Company will not grant
any further options under the plan. As outstanding options under the plan expire or terminate, the
number of shares authorized for issuance under the plan will be correspondingly reduced.
The purpose of the plan was to provide an opportunity for employees, directors and consultants of
Coelacanth to acquire a proprietary interest, or otherwise increase their proprietary interest, in
Coelacanth as an incentive to continue their employment or service. Both incentive and
nonstatutory options are outstanding under the plan. Most outstanding options vest over time and
expire ten years from the date of grant. The exercise price of options awarded under the plan was
determined by the plan administrator at the time of grant. In general, incentive stock options
have an exercise price of 100% or more of the fair market value of Coelacanth common stock on the
date of grant and nonstatutory stock options have an exercise price as low as 85% of fair market
value on the date of grant.
As of December 31, 2006, an aggregate of 122,649 shares of common stock had been reserved for
issuance, options to purchase 73,271 shares of common stock were outstanding, options to purchase
22,333 shares of common stock had been canceled, and 27,045 shares of common stock had been issued
upon the exercise of stock options issued under the Coelacanth Plan.
F-15
Stock Option Activity: The following is a summary of option activity under Lexicons stock option
plans:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
2005 |
|
2004 |
|
|
|
|
|
|
Weighted |
|
|
|
|
|
Weighted |
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Average |
|
|
|
|
|
Average |
|
|
|
|
|
Average |
|
|
|
|
|
|
Exercise |
|
|
|
|
|
Exercise |
|
|
|
|
|
Exercise |
(In thousands, except exercise price data) |
|
Options |
|
Price |
|
Options |
|
Price |
|
Options |
|
Price |
Outstanding at beginning of year |
|
|
13,802 |
|
|
$ |
6.36 |
|
|
|
13,299 |
|
|
$ |
6.20 |
|
|
|
12,889 |
|
|
$ |
6.12 |
|
Granted |
|
|
2,651 |
|
|
|
4.07 |
|
|
|
2,104 |
|
|
|
5.55 |
|
|
|
1,935 |
|
|
|
7.40 |
|
Exercised |
|
|
(156 |
) |
|
|
2.30 |
|
|
|
(1,063 |
) |
|
|
0.56 |
|
|
|
(664 |
) |
|
|
2.65 |
|
Canceled |
|
|
(482 |
) |
|
|
7.14 |
|
|
|
(538 |
) |
|
|
10.79 |
|
|
|
(861 |
) |
|
|
10.44 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at end of year |
|
|
15,815 |
|
|
|
5.99 |
|
|
|
13,802 |
|
|
|
6.36 |
|
|
|
13,299 |
|
|
|
6.20 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at end of year |
|
|
11,675 |
|
|
$ |
6.40 |
|
|
|
10,312 |
|
|
$ |
6.50 |
|
|
|
9,908 |
|
|
$ |
5.96 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted average estimated grant date fair value of options granted during the years ended
December 31, 2006, 2005 and 2004 were $2.99, $3.93, and $5.95, respectively. The total intrinsic
value of options exercised during the years ended December 31, 2006, 2005, and 2004 were $343,000,
$4,503,000 and $2,678,000, respectively.
Stock Options Outstanding: The following table summarizes information about stock options
outstanding at December 31, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
Options Exercisable |
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
Weighted |
|
|
|
|
|
Weighted |
Range of |
|
Outstanding as of |
|
Contractual |
|
Average |
|
Exercisable as of |
|
Average |
Exercise Price |
|
December 31, 2006 |
|
Life (In Years) |
|
Exercise Price |
|
December 31, 2006 |
|
Exercise Price |
|
|
(In thousands) |
|
|
|
|
|
|
|
|
|
(In thousands) |
|
|
|
|
$ 1.67 2.50 |
|
|
4,645 |
|
|
|
2.3 |
|
|
$ |
2.41 |
|
|
|
4,645 |
|
|
$ |
2.41 |
|
3.16 4.72 |
|
|
3,882 |
|
|
|
8.1 |
|
|
|
4.00 |
|
|
|
1,306 |
|
|
|
3.97 |
|
4.76 7.12 |
|
|
2,575 |
|
|
|
7.7 |
|
|
|
5.77 |
|
|
|
1,403 |
|
|
|
5.80 |
|
7.15 10.55 |
|
|
2,907 |
|
|
|
5.9 |
|
|
|
8.56 |
|
|
|
2,515 |
|
|
|
8.71 |
|
10.87 16.00 |
|
|
1,323 |
|
|
|
4.3 |
|
|
|
12.64 |
|
|
|
1,323 |
|
|
|
12.64 |
|
16.63 22.06 |
|
|
356 |
|
|
|
3.3 |
|
|
|
19.70 |
|
|
|
356 |
|
|
|
19.70 |
|
25.25 31.63 |
|
|
28 |
|
|
|
3.8 |
|
|
|
26.23 |
|
|
|
28 |
|
|
|
26.23 |
|
38.00 38.50 |
|
|
99 |
|
|
|
3.7 |
|
|
|
38.49 |
|
|
|
99 |
|
|
|
38.49 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,815 |
|
|
|
5.5 |
|
|
$ |
5.99 |
|
|
|
11,675 |
|
|
$ |
6.40 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At December 31, 2006, the aggregate intrinsic value of the outstanding options and the
exercisable options was $5,567,000.
Warrants
In connection with the acquisition of Coelacanth in July 2001, Lexicon assumed Coelacanths
outstanding warrants to purchase 25,169 shares of common stock. The warrants expire on March 31,
2009. The fair value of the warrants was included in the total purchase price for the acquisition.
As of December 31, 2006, warrants to purchase 16,483 shares of common stock, with an exercise
price of $11.93 per share, remained outstanding.
Aggregate Shares Reserved for Issuance
As of December 31, 2006 an aggregate of 15,831,101 shares of common stock were reserved for
issuance upon exercise of outstanding stock options and warrants and 1,685,127 additional shares
were available for future grants under Lexicons stock option plans.
12. Benefit Plans
Lexicon has established an Annual Profit Sharing Incentive Plan (the Profit Sharing Plan). The
purpose of the Profit Sharing Plan is to provide for the payment of incentive compensation out of
the profits of the Company to certain of its employees. Participants in the Profit Sharing Plan are
entitled to an annual cash bonus equal to their proportionate share (based on salary) of 15 percent
of the Companys annual pretax income, if any.
F-16
Lexicon maintains a defined-contribution savings plan under Section 401(k) of the Internal Revenue
Code. The plan covers substantially all full-time employees. Participating employees may defer a
portion of their pretax earnings, up to the Internal Revenue Service annual contribution limit.
Beginning in 2000, the Company was required to match employee contributions according to a
specified formula. The matching contributions totaled $907,000, $821,000, and $776,000 in 2006,
2005 and 2004, respectively. Company contributions are vested based on the employees years of
service, with full vesting after four years of service.
13. Collaboration and License Agreements
Lexicon has derived substantially all of its revenues from drug discovery alliances, target
validation collaborations for the development and, in some cases, analysis of the physiological
effects of genes altered in knockout mice, government grants and contracts, technology licenses,
subscriptions to its databases and compound library sales.
Drug Discovery Alliances
Lexicon has entered into the following alliances for the discovery and development of therapeutics
based on its in vivo drug target discovery efforts:
Bristol-Myers Squibb Company: Lexicon established an alliance with Bristol-Myers Squibb in December
2003 to discover, develop and commercialize small molecule drugs in the neuroscience field.
Lexicon initiated the alliance with a number of drug discovery programs at various stages of
development and is continuing to use its gene knockout technology to identify additional drug
targets with promise in the neuroscience field. For those targets that are selected for the
alliance, Lexicon and Bristol-Myers Squibb are working together, on an exclusive basis, to
identify, characterize and carry out the preclinical development of small molecule drugs, and will
share equally both in the costs and in the work attributable to those efforts. As drugs resulting
from the collaboration enter clinical trials, Bristol-Myers Squibb will have the first option to
assume full responsibility for clinical development and commercialization.
Lexicon received an upfront payment of $36.0 million and research funding of $30.0 million in the
initial three years of the agreement. Bristol-Myers Squibb extended the target discovery term of
the alliance in May 2006 for an additional two years in exchange for $20.0 million in additional
research funding over the two year extension, which commences in January 2007. Lexicon may receive
additional cash payments for exceeding specified research productivity levels. Lexicon will also
receive clinical and regulatory milestone payments for each drug target for which Bristol-Myers
Squibb develops a drug under the alliance. Lexicon will earn royalties on sales of drugs
commercialized by Bristol-Myers Squibb. The party with responsibility for the clinical development
and commercialization of drugs resulting from the alliance will bear the costs of those efforts.
Revenue recognized under this agreement was $21.8 million, $21.8 million and $21.5 million for the
years ended December 31, 2006, 2005 and 2004, respectively.
Genentech, Inc. Lexicon established an alliance with Genentech in December 2002 to discover novel
therapeutic proteins and antibody targets. Under the original alliance agreement, Lexicon used its
target validation technologies to discover the functions of secreted proteins and potential
antibody targets identified through Genentechs internal drug discovery research. Lexicon received
an upfront payment of $9.0 million and funding under a $4.0 million loan in 2002. The terms of the
loan are discussed in Note 8. In addition, Lexicon received $24.0 million in performance payments
for its work in the collaboration as it was completed.
In November 2005, Lexicon and Genentech expanded the alliance to include the advanced research,
development and commercialization of new biotherapeutic drugs. Lexicon will receive a total of
$25.0 million in upfront and milestone payments and research funding for the three-year advanced
research portion of the expanded alliance. In the expanded alliance, Lexicon is conducting
advanced research on a broad subset of targets validated in the original collaboration using
Lexicons proprietary gene knockout technology.
Lexicon may develop and commercialize drugs for up to six of the targets included in the alliance.
Genentech retains an option on the potential development and commercialization of these drugs under
a cost and profit sharing arrangement, with Lexicon having certain conditional rights to co-promote
drugs on a worldwide basis. Genentech is entitled to receive milestone payments in the event of
regulatory approval and royalties on net sales of products commercialized by Lexicon outside of a
cost and profit sharing arrangement. Lexicon will receive payments from Genentech upon achievement
of milestones related to the development and regulatory approval of certain drugs
F-17
resulting from the alliance that are developed and commercialized by Genentech. Lexicon is also
entitled to receive royalties on net sales of these products, provided they are not included in a
cost and profit sharing arrangement. Lexicon retains non-exclusive rights for the development and
commercialization of small molecule drugs addressing the targets included in the alliance.
Revenue recognized under this agreement was $5.0 million, $22.6 million and $16.0 million for the
years ended December 31, 2006, 2005 and 2004, respectively
Incyte Corporation. Lexicon established an alliance with Incyte in June 2001 to discover novel
therapeutic proteins using the Companys target validation technologies in the discovery of the
functions of secreted proteins from Incytes LifeSeq® Gold database. Under the alliance
agreement, the Company and Incyte each had the right to obtain exclusive commercialization rights,
including sublicensing rights, for an equal number of qualifying therapeutic proteins, and will
each receive milestone payments and royalties on sales of therapeutic proteins from the alliance
that are commercialized by the other party or a third party sublicensee. Lexicon received research
funding of $15.0 million under the agreement and recognized revenue of $2.5 million for the year
ended December 31, 2004. The collaboration period under the agreement ended in June 2004.
N.V. Organon. Lexicon established an alliance with Organon in May 2005 to jointly discover,
develop and commercialize novel biotherapeutic drugs. In the alliance, Lexicon is creating and
analyzing knockout mice for up to 300 genes selected by the parties that encode secreted proteins
or potential antibody targets, including two of Lexicons existing drug discovery programs. The
parties will jointly select targets for further research and development and will equally share
costs and responsibility for research, preclinical and clinical activities. The parties will
jointly determine the manner in which alliance products will be commercialized and will equally
benefit from product revenue. If fewer than five development candidates are designated under the
alliance, Lexicons share of costs and product revenue will be proportionally reduced. Lexicon
will receive a milestone payment for each development candidate in excess of five. Either party
may decline to participate in further research or development efforts with respect to an alliance
product, in which case such party will receive royalty payments on sales of such alliance product
rather than sharing in revenue. Organon will have principal responsibility for manufacturing
biotherapeutic products resulting from the alliance for use in clinical trials and for worldwide
sales.
Lexicon received an upfront payment of $22.5 million from Organon in exchange for access to
Lexicons drug target discovery capabilities and the exclusive right to co-develop biotherapeutic
drugs for the 300 genes selected for the alliance. This upfront payment will be recognized as
revenue over the four-year target function discovery portion of the alliance. Organon will also
provide Lexicon with annual research funding totaling up to $50.0 million for its 50% share of the
alliances costs during this same period. Revenue recognized under this agreement was $15.5
million and $11.8 million for the years ended December 31, 2006 and 2005, respectively.
Takeda Pharmaceutical Company Limited. Lexicon established an alliance with Takeda in July 2004 to
discover new drugs for the treatment of high blood pressure. In the collaboration, Lexicon is
using its gene knockout technology to identify drug targets that control blood pressure. Takeda
will be responsible for the screening, medicinal chemistry, preclinical and clinical development
and commercialization of drugs directed against targets selected for the alliance, and will bear
all related costs. Lexicon received an upfront payment of $12.0 million from Takeda for the
initial, three-year term of the agreement. This upfront payment will be recognized as revenue over
the three-year contractual service period. Takeda has the option to extend the discovery portion
of the alliance for an additional two years in exchange for further committed funding. Takeda will
make research milestone payments to Lexicon for each target selected for therapeutic development.
In addition, Takeda will make clinical development and product launch milestone payments to Lexicon
for each product commercialized from the collaboration. Lexicon will also earn royalties on sales
of drugs commercialized by Takeda. Revenue recognized under this agreement was $9.0 million, $4.0
million and $3.2 million for the years ended December 31, 2006, 2005 and 2004, respectively.
Other Collaborations and Arrangements
Lexicon has entered into the following other collaborations and arrangements:
Bristol-Myers Squibb Company. Lexicon established a LexVision collaboration with Bristol-Myers
Squibb in September 2000, under which Bristol-Myers Squibb was granted non-exclusive access to the
Companys LexVision
F-18
database and OmniBank library for the discovery of small molecule drugs. The Company received
annual access fees under this agreement, and is entitled to receive milestone payments and
royalties on products Bristol-Myers Squibb develops using the Companys technology. The
collaboration period under the agreement, as amended, expired in December 2004. Revenue recognized
under this agreement was $5.0 million for the year ended December 31, 2004.
Lexicon entered into a drug target validation agreement with Bristol-Myers Squibb in December 2004.
Under this agreement, Lexicon developed mice and phenotypic data for certain genes previously
requested by Bristol-Myers Squibb under its LexVision agreement, but that Lexicon was not required
to deliver thereunder, and certain additional genes requested by Bristol-Myers Squibb. The
collaboration term under the agreement expires after the final phenotypic data set has been
delivered by Lexicon. The Company received payments totaling $5.0 million under the agreement.
Revenue recognized under this agreement was $1.4 million and $3.5 million for the years ended
December 31, 2006 and 2005, respectively.
Lexicon also entered into separate drug target validation agreements with Bristol-Myers Squibb in
January 2006 and October 2006, under which Lexicon will develop mice and phenotypic data for
certain additional genes requested by Bristol-Myers Squibb under those agreements. The
collaboration term under each of these agreements will expire after the final phenotypic data set
has been delivered by Lexicon under that agreement. The Company received payments totaling $2.5
million under these agreements. Revenue recognized under these agreements was $1.4 million for the
year ended December 31, 2006.
Incyte Corporation. Lexicon established a LexVision collaboration with Incyte in June 2001, under
which Incyte was granted non-exclusive access to the Companys LexVision database and OmniBank
library for the discovery of small molecule drugs. The Company received annual access fees under
this agreement, and is entitled to receive milestone payments and royalties on products Incyte
develops using the Companys technology. The collaboration period under the agreement terminated
in June 2004. Revenue recognized under this agreement was $2.5 million for the year ended December
31, 2004.
Texas Institute for Genomic Medicine. In July 2005, Lexicon was awarded $35.0 million from the
Texas Enterprise Fund for the creation of a knockout mouse embryonic stem cell library containing
350,000 cell lines using Lexicons proprietary gene trapping technology. Lexicon is creating the
library for the Texas Institute for Genomic Medicine (TIGM), a newly formed non-profit institute
whose founding members are Texas A&M University, the Texas A&M University System Health Science
Center and Lexicon. TIGM researchers may also access specific cells from Lexicons current gene
trap library of 270,000 mouse embryonic stem cell lines and will have certain rights to utilize
Lexicons patented gene targeting technologies. In addition, Lexicon will equip TIGM with the
bioinformatics software required for the management and analysis of data relating to the library.
The Texas Enterprise Fund has also awarded $15.0 million to the Texas A&M University System for the
creation of facilities and infrastructure to house the library. Revenue recognized under this
agreement was $7.0 million and $3.1 million for the years ended December 31, 2006 and 2005,
respectively.
Under the terms of the award, Lexicon is responsible for the creation of a specified number of jobs
beginning in 2006, reaching an aggregate of 1,616 new jobs in Texas by December 31, 2015. Lexicon
will obtain credits based on funding received by TIGM and certain related parties from sources
other than the State of Texas that it may offset against its potential liability for any job
creation shortfalls. Lexicon will also obtain credits against future jobs commitment liabilities
for any surplus jobs it creates. Subject to these credits, if Lexicon fails to create the
specified number of jobs, the state may require Lexicon to repay $2,415 for each job Lexicon falls
short. Lexicons maximum aggregate exposure for such payments, if Lexicon fails to create any new
jobs, is approximately $14.4 million, without giving effect to any credits to which Lexicon may be
entitled. The Texas A&M University System, together with TIGM, has independent job creation
obligations and is obligated for an additional period to maintain an aggregate of 5,000 jobs,
inclusive of those Lexicon creates.
F-19
14. Selected Quarterly Financial Data
The table below sets forth certain unaudited statements of operations data, and net income (loss)
per common share data, for each quarter of 2006 and 2005.
(In thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter Ended |
|
|
March 31 |
|
June 30 |
|
September 30 |
|
December 31 |
|
(Unaudited) |
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
$ |
20,955 |
|
|
$ |
16,164 |
|
|
$ |
19,613 |
|
|
$ |
16,066 |
|
Loss from operations |
|
$ |
(11,020 |
) |
|
$ |
(16,933 |
) |
|
$ |
(12,706 |
) |
|
$ |
(14,572 |
) |
Net loss |
|
$ |
(10,831 |
) |
|
$ |
(16,902 |
) |
|
$ |
(12,755 |
) |
|
$ |
(13,823 |
) |
Net loss per common share, basic and diluted |
|
$ |
(0.17 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.19 |
) |
Shares used in computing net loss per common share |
|
|
64,566 |
|
|
|
64,627 |
|
|
|
64,832 |
|
|
|
73,405 |
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
$ |
13,925 |
|
|
$ |
13,898 |
|
|
$ |
13,963 |
|
|
$ |
33,894 |
|
Income (loss) from operations |
|
$ |
(13,267 |
) |
|
$ |
(14,519 |
) |
|
$ |
(14,055 |
) |
|
$ |
5,722 |
|
Net income (loss) |
|
$ |
(13,266 |
) |
|
$ |
(14,842 |
) |
|
$ |
(14,121 |
) |
|
$ |
5,914 |
|
Net income (loss) per common share, basic and diluted |
|
$ |
(0.21 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.22 |
) |
|
$ |
0.09 |
|
Shares used in computing net income (loss) per common share, basic |
|
|
63,525 |
|
|
|
63,636 |
|
|
|
64,134 |
|
|
|
64,539 |
|
Shares used in computing net income (loss) per common share, diluted |
|
|
63,525 |
|
|
|
63,636 |
|
|
|
64,134 |
|
|
|
67,317 |
|
F-20
Exhibit Index
|
|
|
|
|
Exhibit No. |
|
|
|
Description |
|
|
|
|
|
3.1
|
|
|
|
Restated Certificate of Incorporation (filed as Exhibit 3.1 to the Companys
Registration Statement on Form S-1 (Registration No. 333-96469) and
incorporated by reference herein). |
|
|
|
|
|
3.2
|
|
|
|
Restated Bylaws (filed as Exhibit 3.2 to the Companys Registration Statement
on Form S-1 (Registration No. 333-96469) and incorporated by reference
herein). |
|
|
|
|
|
10.1
|
|
|
|
Restated Employment Agreement with Arthur T. Sands, M.D., Ph.D. (filed as
Exhibit 10.1 to the Companys Annual Report on Form 10-K for the period ended
December 31, 2005 and incorporated by reference herein). |
|
|
|
|
|
10.2
|
|
|
|
Employment Agreement with Jeffrey L. Wade, J.D. (filed as Exhibit 10.3 to the
Companys Registration Statement on Form S-1 (Registration No. 333-96469) and
incorporated by reference herein). |
|
|
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10.3
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Employment Agreement with Brian P. Zambrowicz, Ph.D. (filed as Exhibit 10.4
to the Companys Registration Statement on Form S-1 (Registration No.
333-96469) and incorporated by reference herein). |
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10.4
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Employment Agreement with Julia P. Gregory (filed as Exhibit 10.5 to the
Companys Registration Statement on Form S-1 (Registration No. 333-96469) and
incorporated by reference herein). |
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10.5
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Employment Agreement with Alan Main, Ph.D. (filed as Exhibit 10.1 to the
Companys Quarterly Report on Form 10‑Q for the period ended September 30,
2001 and incorporated by reference herein). |
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10.6
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Consulting Agreement with Alan S. Nies, M.D. dated February 19, 2003, as
amended (filed as Exhibit 10.1 to the Companys Quarterly Report on Form 10-Q
for the period ended March 31, 2004 and incorporated by reference herein). |
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10.7
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Consulting Agreement with Robert J. Lefkowitz, M.D. dated March 31, 2003
(filed as Exhibit 10.1 to the Companys Quarterly Report on Form 10-Q for the
period ended March 31, 2003 and incorporated by reference herein). |
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10.8
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Form of Indemnification Agreement with Officers and Directors (filed as
Exhibit 10.7 to the Companys Registration Statement on Form S-1
(Registration No. 333-96469) and incorporated by reference herein). |
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10.9
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Summary of Non-Employee Director Compensation (filed as Exhibit 10.11 to
the Companys Annual Report on Form 10-K for the period ended December 31,
2005 and incorporated by reference herein). |
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10.10
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Summary of 2007 Named Executive Officer Cash Compensation (filed as
Exhibit 10.1 to the Companys Current Report on Form 8-K dated February 13,
2007 and incorporated by reference herein). |
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10.11
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2000 Equity Incentive Plan (filed as Exhibit 10.10 to the Companys Annual
Report on Form 10-K for the period ended December 31, 2004 and incorporated
by reference herein). |
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10.12
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2000 Non-Employee Directors Stock Option Plan (filed as Exhibit 10.14 to the
Companys Annual Report on Form 10-K for the period ended December 31, 2005
and incorporated by reference herein). |
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10.13
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Coelacanth Corporation 1999 Stock Option Plan (filed as Exhibit 99.1 to the
Companys Registration Statement on Form S-8 (Registration No. 333-66380) and
incorporated by reference herein). |
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Exhibit No. |
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Description |
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10.14
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Form of Stock Option Agreement with Officers under the 2000 Equity
Incentive Plan (filed as Exhibit 10.2 to the Companys Quarterly Report on
Form 10-Q for the period ended September 30, 2004 and incorporated by
reference herein). |
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10.15
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Form of Stock Option Agreement with Chairman of Board of Directors under
the 2000 Equity Incentive Plan (filed as Exhibit 10.17 to the Companys
Annual Report on Form 10-K for the period ended December 31, 2005 and
incorporated by reference herein). |
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10.16
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Form of Stock Option Agreement with Directors under the 2000
Non-Employee Directors Stock Option Plan (filed as Exhibit 10.3 to the
Companys Quarterly Report on Form 10-Q for the period ended September 30,
2004 and incorporated by reference herein). |
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10.17
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Collaboration and License Agreement, dated December 17, 2003, with
Bristol-Myers Squibb Company (filed as Exhibit 10.15 to the amendment to the
Companys Annual Report on Form 10-K/A for the period ended December 31,
2003, as filed on July 16, 2004, and incorporated by reference herein). |
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10.18
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First Amendment, dated May 30, 2006, to Collaboration and License Agreement,
dated December 17, 2003, with Bristol-Myers Squibb Company (filed as Exhibit
10.2 to the Companys Quarterly Report on Form 10-Q for the period ended June
30, 2006, and incorporated by reference herein). |
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10.19
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Collaboration Agreement, dated July 27, 2004, with Takeda Pharmaceutical
Company Limited (filed as Exhibit 10.1 to the Companys Quarterly Report on
Form 10-Q for the period ended September 30, 2004 and incorporated by
reference herein). |
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10.20
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Collaboration and License Agreement, dated May 16, 2005, with N.V. Organon
and (only with respect to Section 9.4 thereof) Intervet Inc. (filed as
Exhibit 10.1 to the Companys Quarterly Report on Form 10-Q for the period
ended June 30, 2005 and incorporated by reference herein). |
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10.21
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Second Amended and Restated Collaboration and License Agreement, dated
November 30, 2005, with Genentech, Inc. (filed as Exhibit 10.22 to the
Companys Annual Report on Form 10-K for the period ended December 31, 2005
and incorporated by reference herein). |
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10.22
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Economic Development Agreement dated July 15, 2005, with the State of Texas
and the Texas A&M University System (filed as Exhibit 10.1 to the Companys
Quarterly Report on Form 10-Q for the period ended September 30, 2005 and
incorporated by reference herein). |
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10.23
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Collaboration and License Agreement, dated July 15, 2005, with the Texas A&M
University System and the Texas Institute for Genomic Medicine (filed as
Exhibit 10.2 to the Companys Quarterly Report on Form 10-Q for the period
ended September 30, 2005 and incorporated by reference herein). |
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10.24
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Common Stock Purchase Agreement, dated June 12, 2006, with Azimuth
Opportunity Ltd. (filed as Exhibit 10.1 to the Companys Current Report on
Form 8-K dated June 12, 2006 and incorporated by reference herein). |
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10.25
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Loan and Security Agreement, dated April 21, 2004, between Lex-Gen Woodlands,
L.P. and iStar Financial Inc. (filed as Exhibit 10.18 to the Companys Annual
Report on Form 10-K for the period ended December 31, 2004 and incorporated
by reference herein). |
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10.26
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Lease Agreement, dated May 23, 2002, between Lexicon Pharmaceuticals (New
Jersey), Inc. and Townsend Property Trust Limited Partnership (filed as
Exhibit 10.2 to the Companys Quarterly Report on Form 10-Q for the period
ended June 30, 2002 and incorporated by reference herein). |
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Exhibit No. |
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Description |
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21.1
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Subsidiaries (filed as Exhibit 21.1 to the Companys Annual Report on Form
10-K for the year ended December 31, 2004 and incorporated by reference
herein). |
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*23.1
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Consent of Independent Registered Public Accounting Firm |
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*24.1
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Power of Attorney (contained in signature page) |
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*31.1
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Certification of CEO Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
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*31.2
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Certification of CFO Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
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*32.1
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Certification of CEO and CFO Pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002 |
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* |
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Filed herewith. |
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Confidential treatment has been requested for a portion of this exhibit. The
confidential portions of this exhibit have been omitted and filed separately with the
Securities and Exchange Commission. |