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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934 |
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For the fiscal year ended December 31, 2004 |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission file number 0-22570
Solexa, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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94-3161073 |
(State or other jurisdiction of
incorporation or organization) |
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(I.R.S. Employer
Identification No.) |
25861 Industrial Blvd., Hayward, CA 94545
(Address of principal executive offices, including zip
code)
(510) 670-9300
(Registrants telephone number, including area code)
Securities registered pursuant to Section 12(b) of the
Act:
None
Securities registered pursuant to Section 12(g) of the
Act:
Common Stock, $.01 par value per share
Indicate by check mark whether the Registrant: (1) has
filed all reports required to be filed by Section 13 or
15(d) of the Securities and Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the
Registrant was required to file such reports), and (2) has
been subject to such filing requirements for the past
90 days. Yes þ No o
Indicate by check mark if disclosure of delinquent filers
pursuant to Item 405 of Regulation S-K is not
contained herein, and will not be contained, to the best of
Registrants knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this
Form 10-K or any amendment to this
Form 10-K. þ
Indicate by check mark whether the Registrant is an accelerated
filer (as defined in Exchange Act
Rule 12b-2). Yes o No þ
State the aggregate market value of the voting and non-voting
common equity held by non-affiliates of the Registrant computed
by reference to the price at which the common equity was last
sold, or the average bid and asked price of such common equity,
as of the last business day of the registrants most
recently completed second fiscal quarter: $17,041,928.(1)
The number of shares of common stock of the Registrant
outstanding as of March 10, 2005, was 17,597,581.
(1) Based on a closing price of $4.60 per share on June 30,
2004 and 3,763,732 shares outstanding. Share price and number of
shares reflect the Registrants 1 for 2 reverse stock split
effected on March 2, 2005. Excludes 58,965 shares of the
Registrants common stock held by executive officers,
directors and stockholders whose ownership exceed 5% of the
common stock outstanding at June 30, 2004. Exclusion of
these shares should not be construed to indicate that such
persons controls, is controlled by or is under common control
with the Registrant. Determination of affiliate status for the
purposes of this calculation is not necessarily a conclusive
determination for any other purposes.
SOLEXA, INC.
ANNUAL REPORT ON FORM 10-K
FOR THE FISCAL YEAR ENDED
DECEMBER 31, 2004
Table of Contents
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INFORMATION REGARDING FORWARD-LOOKING STATEMENTS
Except for the historical information contained herein, this
report contains certain information that is forward-looking in
nature. Examples of forward-looking statements include
statements regarding our future financial results, operating
results, product successes, business strategies, projected
costs, future products, competitive positions and plans and
objectives of management for future operations. In some cases,
you can identify forward-looking statements by terminology, such
as may, will, should,
expects, plans, optimistic,
anticipates, believes,
estimates, predicts,
potential, envisions, hopes,
intends, confident, could or
continue or the negative of such terms and other
comparable terminology. In addition, statements that refer to
expectations or other characterizations of future events or
circumstances are forward-looking statements. These statements
involve known and unknown risks and uncertainties that may cause
our or our industrys results, levels of activity,
performance or achievements to be materially different from
those expressed or implied by the forward-looking statements.
Factors that may cause or contribute to such differences
include, among others, those discussed under the captions
Item 1. Business Business Risks and
Item 7. Managements Discussion and Analysis of
Financial Condition and Results of Operations. These and
many other factors could affect our future financial and
operating results. We undertake no obligation to update any
forward-looking statement to reflect events after the date of
this report, except as required by law or applicable
regulations.
PART I
Business Combination and Name Change
On March 4, 2005, Lynx Therapeutics, Inc. or Lynx,
completed a business combination with Solexa Limited. Solexa
Limited is a privately held company registered in England and
Wales that develops systems for the comprehensive and economical
analysis of individual genomes. Solexa Limited has become a
wholly-owned subsidiary of Lynx as a result of the transaction.
However, because Solexa Limiteds shareholders own
approximately 80% of the shares of Lynx common stock after the
transaction, Solexa Limiteds designees to the combined
companys board of directors represent a majority of the
combined companys directors and Solexa Limiteds
senior management represent a majority of the initial senior
management of the combined company, Solexa Limited is deemed to
be the acquiring company for accounting purposes. Accordingly,
the assets and liabilities of Lynx will be recorded, as of the
date of the business combination, at their respective fair
values and added to those of Solexa Limited. Reported results of
operations of the combined company issued for periods subsequent
to the combination will reflect those of Solexa Limited, to
which the operations of Lynx will be added from the date of the
consummation of the business combination. The operating results
of the combined company will reflect purchase accounting
adjustments, including increased amortization and depreciation
expense for acquired assets. Additionally, historical financial
condition and results of operations shown for comparative
purposes in periodic filings subsequent to the completion of the
business combination will reflect those of Solexa Limited. Lynx
issued approximately 14.75 million shares or options to
purchase shares of its common stock in exchange for all of the
outstanding share capital and outstanding share options of
Solexa Limited.
In connection with this transaction, Lynx changed its name to
Solexa, Inc. or Solexa. Unless specifically noted otherwise, as
used throughout this document, Lynx Therapeutics or
Lynx refers to the business, operations and
financial results of Lynx prior to the business combination on
March 4, 2005, Solexa Limited refers to the
business of Solexa Limited, Solexa refers to the
business of the combined company after the business combination
and we refers to either the business operations and
financial results of Lynx prior to the business combination or
the business of the combined company after the business
combination, as the context requires.
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Overview
We are in the business of developing and commercializing genetic
analysis technologies. We are currently developing and preparing
to commercialize a novel instrumentation system for genetic
analysis based on our Sequencing-by-Synthesis, or SBS, chemistry
and the DNA cluster technology we acquired in 2004.
This one platform is expected to support many types of genetic
analysis, including DNA sequencing, gene expression, genotyping
and micro-RNA analysis. We believe that this technology, which
can potentially generate over a billion bases of DNA sequence
from a single experiment with a single sample preparation, will
dramatically reduce the cost, and improve the practicality, of
human re-sequencing relative to conventional technologies. We
anticipate launching our first generation whole-genome
sequencing system by the end of 2005. Our longer-term goal is to
further reduce the cost of human re-sequencing to a few thousand
dollars for use in a wide range of applications from basic
research through clinical diagnostics.
We believe our new DNA sequencing system will enable us to
implement a new business model based primarily on the sales of
genomic sequencing equipment, reagents and services to end user
customers. Historically, our business model has been based on
providing genomics discovery services using our Massively
Parallel Sequencing System, or MPSS, and supplying customers
with DNA sequences and other information that result from
experiments. We expect to continue to provide genomics discovery
services for at least the next several years.
In March 2005, we received stockholder approval for, and
effected, a reverse stock split of our common stock at a ratio
of 1-for-2. As a result of the reverse stock split, each
outstanding share of common stock automatically converted into
one-half of a share of common stock, with the par value of each
share of common stock remaining at one cent ($.01) per share.
Accordingly, common stock share and per share amounts for all
periods presented have been adjusted to reflect the impact of
the reverse stock split.
We were incorporated in Delaware in February 1992. Please see a
discussion of our plans under Item 1.
Business Business Risks and Item 7.
Managements Discussion and Analysis of Financial
Condition and Results of Operations Liquidity and
Capital Resources.
Market Opportunity
DNA sequencing is currently used in both research applications
and in medical diagnostic tests. In research, some of the most
common applications are as follows:
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Determining the sequences of additional species, as has been
done for humans. This is called de novo sequencing. |
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Determining how the DNA sequence of an individual varies from
that of a reference genome. This is called re-sequencing, and it
is often performed on just a fraction of a whole genome. The
goal of re-sequencing is to identify mutations or variations
among individuals. Resequencing is a comprehensive scan for
mutations at all locations within the region of the genome being
re-sequenced and therefore is a form of genotyping that is
capable of finding variations without having to know in advance
which region of the genome to examine. |
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Identifying a molecule by its sequence for the purpose of
identifying the presence, or quantifying the number, of
molecules with a given sequence in a sample. This is called tag
sequencing because the sequence determined is used as an
identifier for the overall molecule of which it is a part.
Precision measurements of gene expression can be made using this
approach. Our MPSS DNA sequencing technology is one such
technique. |
As a diagnostic, DNA sequencing has been used several ways,
including:
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Sequencing part of the genetic material of an infectious agent,
such as HIV, to distinguish among differing HIV strains that may
require different medical treatment. |
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Sequencing specific genes which, if mutated, can predispose the
individual with those genes to a specific disease. Myriad
Genetics, Inc., a biopharmaceutical company, for example, offers
a clinical |
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diagnostic service in which it sequences the BRCA1 and BRCA2
genes in order to identify breast cancer susceptibility among
subjects. |
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Sequencing specific genes to determine which subtype of a
genetic disease an individual might have. Some genetic diseases
can be caused by many different mutation locations within a
specific gene, and the severity and progression of a disease can
be determined by which specific mutation an individual possesses. |
The market for DNA sequencing in research is currently larger
than in diagnostics. The market leader, Applied Biosystems, a
business unit of Applera Corporation, has reported revenues in
excess of $500 million for the year ended June 30,
2004 in their DNA sequencing segment. Revenue from clinical
diagnostics based on DNA sequencing is smaller but has been
growing rapidly. We expect to focus our efforts on the research
market for at least the next few years.
Our Products under Development
We are currently developing a DNA sequencing instrument system
for commercial sale, focusing initially on the genomic
resequencing market. This system includes the instrument itself,
a set of biochemical reagents, a set of consumable devices used
in the operation of the instrument (e.g. flow cells) and data
analysis software. We anticipate offering successive generations
of instrument designs to meet different customer needs, serve
different price points and take advantage of improving
technology. We similarly anticipate offering multiple reagent
sets and corresponding software systems for different
applications. We also expect to sell service contracts and spare
parts for the instruments.
Our Service Business
Our service business, which accounted for substantially all of
our revenues in 2004, provides in-depth gene expression
information to customers based on our MPSS technology.
We anticipate that our new instrument system will be phased into
our existing service business and that, over time, it may
replace some or all of our current service offering based on the
MPSS technology. While there are many unknowns because the
design of this new system and its ultimate performance in real
applications have not yet been determined, we are optimistic
that it will provide the basis for a much more broadly cost
competitive service than the MPSS technology, and may enable us
to increase our service business revenues.
Our existing service facility has not previously offered large
scale re-sequencing as a service. If our system is developed as
we expect, we may be able to add this capability as a new
service. As this would tap into an additional market need, it
might significantly expand our service business.
Given that we plan to incorporate our new technologies into
instrument systems that can be sold to customers, the extent to
which customers of the service business may elect to purchase
instrument systems and curtail or discontinue using our services
is not clear. As a result, the revenue and profitability of our
service business could decrease over time.
In addition to its direct revenue role in our business, our
service facility is also expected to serve as a strategic test
facility. By operating a high-throughput in-house laboratory, we
may be able to test new products and product improvements faster
than we would be able to by working only with external customer
test sites.
Collaborations, Customers and Licensees
We have derived substantially all of our revenues from corporate
collaborations, customer agreements and licensing arrangements
related to Lynxs gene expression services business. For
the year ended December 31, 2004, revenues from E.I. DuPont
de Nemours and Company, The National Human Genome Research
Institute and Axaron Bioscience AG, an affiliate of Solexa,
accounted for 35%, 30% and 11%, respectively, of our total
revenues.
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Competition
Competition among entities developing or commercializing
instruments, research tools or services to identify the genes
associated with specific diseases and to develop products based
on such discoveries is intense. We face, and will continue to
face, competition primarily from biotechnology companies, such
as Affymetrix, Inc., Celera Genomics Group, Gene Logic, Inc.,
and Agencourt Biosciences, academic and research institutions
and government agencies, both in the United States and abroad.
We are aware that certain entities are using a variety of gene
expression analysis methodologies, including chip-based systems,
to attempt to identify disease-related genes and to perform
clinical diagnostic tests. A number of large companies offer DNA
sequencing equipment including Applera Corporation, Beckman
Coulter, Inc., and the Amersham Biosciences business of General
Electric. A number of other smaller companies are also in the
process of developing novel techniques for DNA sequencing. These
companies include 454 Corporation, Helicos Biosciences,
Nanofluidics, Visigen and Genovoxx. In order to successfully
compete against existing and future technologies, we will need
to demonstrate to potential customers that our technologies and
capabilities are superior to those of our competitors.
Many of our competitors have substantially greater capital
resources, research and development staffs, facilities,
manufacturing and marketing experience, distribution channels
and human resources than we do. These competitors may develop or
commercialize genetic analysis technologies in advance of us or
that are more effective than those we have developed. Moreover,
our competitors may obtain patent protection or other
intellectual property rights that could limit our rights to
offer genetic analysis products or services.
Intellectual Property
We are pursuing a strategy designed to obtain United States and
foreign patent protection for our core technologies. Our
long-term commercial success will be dependent in part on our
ability to obtain commercially valuable patent claims and to
protect our intellectual property portfolio.
In addition to acquiring patent protection for our core analysis
technologies, as part of our business strategy, we may file for
patent protection on sets of genes, both known and newly
discovered, that have diagnostic or prognostic applications,
novel genes that may serve as drug development targets, genetic
maps and sets of genetic markers, such a SNPs, that are
associated with traits or conditions of medical or economic
importance. However, there is substantial uncertainty regarding
the availability of such patent protection.
Patent law relating to the scope of claims in the technology
field in which we operate is still evolving. The degree to which
we will be able to protect our technology with patents,
therefore, is uncertain. Others may independently develop
similar or alternative technologies, duplicate any of our
technologies and, if patents are licensed or issued to us,
design around the patented technologies licensed to or developed
by us. In addition, we could incur substantial costs in
litigation if we are required to defend ourselves in patent
suits brought by third parties or if we initiate such suits.
With respect to proprietary know-how that is not patentable and
for processes for which patents are difficult to enforce, we
rely on trade secret protection and confidentiality agreements
to protect our interests. We intend to maintain several
important aspects of our technology platform as trade secrets.
While we require all employees, consultants, collaborators,
customers and licensees to enter into confidentiality
agreements, we cannot be certain that proprietary information
will not be disclosed or that others will not independently
develop substantially equivalent proprietary information.
Employees
As of December 31, 2004, Lynx employed 75 full-time
employees, of which 65 were engaged in production and research
and development activities.
Following completion of the combination with Solexa Limited, as
of March 4, 2005, we engaged 60 full-time employees,
of which 54 were engaged in research and development.
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We believe we have been successful in attracting skilled and
experienced scientific personnel; however, competition for such
personnel is intense. None of our employees are covered by
collective bargaining agreements, and management considers
relations with our employees to be good.
Available Information
We maintain sites on the World Wide Web at www.solexa.com and
www.lynxgen.com; however, information found on our websites are
not incorporated by reference into this report. We make
available free of charge on or through our website 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 Act of 1934, as amended, as soon as
reasonably practicable after we electronically file such
material with, or furnish it to, the SEC. Materials we file with
the SEC may be read and copied at the SECs Public
Reference Room at 450 Fifth Street, NW,
Washington, D.C. 20549. This information may also be
obtained by calling the SEC at 1-800-SEC-0330. The SEC also
maintains an internet website that contains reports, proxy and
information statements, and other information regarding issuers
that file electronically with the SEC at www.sec.gov.
Business Risks
Our business faces significant risks. These risks include
those described below and may include additional risks of which
we are not currently aware or which we currently do not believe
are material. If any of the events or circumstances described in
the following risks actually occurs, our business, financial
condition or results of operations could be harmed. These risks
should be read in conjunction with the other information set
forth in this report.
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We have a history of net losses, expect to continue to
incur net losses and may not achieve or maintain
profitability. |
We have incurred net losses each year since our inception in
1992 and we have an accumulated deficit of approximately
$123.2 million as of December 31, 2004. Our net loss
in 2004 was $15.5 million and we had cash and equivalents
of $2.2 million at December 31, 2004. Ernst &
Young LLP, independent registered public accounting firm for
Lynx, has noted in its report on Lynxs consolidated
financial statements included in this Annual Report on
Form 10-K for the year ended December 31, 2004 that
our financial condition raises substantial doubt about our
ability to continue as a going concern. In addition, Solexa
Limited has incurred net losses each year since its inception in
1998. Net losses for the combined company may continue for the
next several years as the combined company proceeds with the
development and commercialization of its technologies. The
presence and size of these potential net losses will depend, in
part, on the rate of growth, if any, in revenues and on the
level of expenses. Research and development expenditures and
general and administrative costs have exceeded revenues to date,
and these expenses may increase in the future. We will need to
generate significant revenues to achieve profitability, and even
if we are successful in achieving profitability, there is no
assurance we will be able to sustain profitability.
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We will need to raise additional funding, which may not be
available on favorable terms, if at all. |
We will need to raise additional capital through public or
private equity or debt financings in order to satisfy our
projected capital needs. We estimate that we will require
approximately $35 million in capital to meet our needs
through 2006. The amount of additional capital we would need to
raise would depend on many factors, including:
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the progress and scope of research and development programs; |
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the progress of efforts to develop and commercialize new
products and services, and |
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the costs involved in preparing, filing, prosecuting,
maintaining and enforcing patent claims and other intellectual
property rights. |
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We cannot be certain that additional capital will be available
when needed or that our actual cash requirements will not be
greater than anticipated. If we require additional capital at a
time when investment in biotechnology companies or in the
marketplace in general is limited due to the then prevailing
market or other conditions, we may not be able to raise such
funds at the time that we desire or any time thereafter. If we
are unable to obtain financing on terms favorable to us, we may
be unable to execute our business plan and may be required to
cease or reduce development or commercialization of our
products, to sell some of all of our technology or assets or to
merge with another entity. In addition, if we are unable to
obtain such financing, we may not have sufficient funds to repay
our loan from Silicon Valley Bank. See the risk factor entitled
If we do not obtain additional funding, we may default
under the loan and security agreement with Silicon Valley
Bank.
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In the event that we raise additional capital through
issuance of equity securities or strategic alliances with third
parties, our stockholders could experience substantial
additional dilution or we may have to relinquish certain
technology or product rights. |
If we raise additional capital by issuing equity securities or
convertible debt securities, our existing stockholders may incur
substantial dilution and any shares so issued will likely have
rights, preferences and privileges superior to the rights,
preferences and privileges of our outstanding common stock. If
we raise additional funds through collaboration, licensing or
other arrangements with third parties, we may be required to
relinquish rights or grant licenses on unfavorable terms to
certain of our technologies or products that we would otherwise
seek to develop or commercialize on our own. These actions,
while necessary for the continuance of operations during a time
of cash constraints and a shortage of working capital, could
make it difficult or impossible to implement our long-term
business plans or could harm our business, financial condition
and results of operations.
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We may not realize the benefits we expect from the
combination of Lynx and Solexa Limited. |
The integration of Lynx and Solexa Limited will be complex, time
consuming and expensive, and may disrupt our businesses. We will
need to overcome significant challenges in order to realize any
benefits or synergies from the combination of Lynx and Solexa
Limited. These challenges include the timely, efficient and
successful execution of a number of post-transaction events.
We may not succeed in addressing these risks or any other
problems encountered in connection with the combination. The
inability to successfully integrate the operations, technology
and personnel of Lynx and Solexa Limited, or any significant
delay in achieving integration, could hurt our business and, as
a result, the market price of our common stock.
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If management is unable to effectively manage the
increased size and complexity of the combined company, our
operating results will suffer. |
On March 4 2005, Solexa Limiteds 60 employees based
outside of Cambridge, U.K. were added to Lynxs existing 75
employees based in Hayward, California. As a result we will face
challenges inherent in efficiently managing an increased number
of employees over large geographic distances, including the need
to implement appropriate systems, financial controls, policies,
standards and benefits and compliance programs. The inability to
successfully manage the substantially larger and internationally
diverse organization, or any significant delay in achieving
successful management, could hurt our business.
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We will have a new management team that may not be able to
define or execute on our business plan. |
Effective March 4, 2005, John West was named chief
executive officer of Solexa. Mr. West has been the chief
executive officer of Solexa Limited since August 2004. Effective
March 10, 2005, Peter Lundberg was named vice president and
chief technical officer of Solexa. Effective March 22,
2005, Linda Rubinstein was named vice president and, effective
with the filing of this Form 10-K, chief financial officer
of Solexa. In addition we anticipate hiring during 2005 to fill
executive positions in marketing and manufacturing. While
Mr. West has experience managing private genomics companies
and large genomics teams within public
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U.S. companies, he has not previously been chief executive
of a public company in the U.S. Mr. West anticipates
dividing his time between our operations in California and our
operations in the U.K. for the foreseeable future. These
executives are new to our company and may not be effective,
individually or as a group, in executing our business plan, and
our operating results may suffer as a result.
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We could lose key personnel, which could materially affect
our business and require us to incur substantial costs to
recruit replacements for lost personnel. |
As a result of the combination, current and prospective
employees of the combined company could experience uncertainty
about their future roles within the combined company. Any of our
key personnel could terminate their employment, sometimes
without notice, at any time. People key to the operation and
management of the combined company are John West, our chief
executive officer; Peter Lundberg, our chief technical officer,
Mary Schramke, vice president and general manager of genomic
services, Linda Rubinstein, vice president, and Tony Smith, our
vice president and chief scientific officer. We are also highly
dependent on the principal members of our scientific staff. The
loss of any of these persons services might adversely
impact the achievement of our objectives and the continuation of
existing customer, collaborative and license agreements. In
addition, recruiting and retaining qualified scientific
personnel to perform future research and development work will
be critical to our success. There is currently a shortage of
skilled executives and employees with technical expertise, and
this shortage is likely to continue. As a result, competition
for skilled personnel is intense and turnover rates are high.
Competition for experienced scientists from numerous companies,
academic and other research institutions may limit our ability
to attract and retain such personnel.
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Our officers, and directors and their affiliated entities
have substantial control over the company. |
Our executive officers, directors and entities affiliated with
them, in the aggregate, beneficially own approximately 78% of
our common stock. These stockholders, if acting together, will
be able to influence significantly all matters requiring
approval by our stockholders, including the election of
directors and the approval of mergers or other changes in
corporate control.
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We intend to implement a new business model that is
different from our former services business model. |
Our new business model that we plan to implement is based
primarily on sales of genomic sequencing equipment and future
sales of reagents and services to support customers in their use
of that equipment. Our historical business model was based
primarily on providing genomics discovery services using MPSS
and supplying customers with DNA sequences and other information
that result from experiments. A change in emphasis from our
former business model may cause our current customers to delay,
defer or cancel any purchasing decisions with respect to new or
existing agreements. To date, we have not been contacted by any
current customer with respect to any such delay, deferral or
cancellation of any existing agreement. There is no assurance
that we will be successful in changing the emphasis of our
business model from providing sequencing services to selling
equipment, reagents and support services to new or existing
customers.
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It is uncertain whether we will be able to successfully
develop and commercialize our new products or to what extent we
can increase our revenues or become profitable. |
We have set out to develop new genomics sequencing technologies
and we are now using those technologies to develop new
equipment, reagents and services. If our strategy does not
result in the development of products that we can commercialize,
we will be unable to generate significant revenues. Although we
have developed genomics sequencing machines and have provided
gene expression services to customers with our machines, these
were based on the MPSS technology that we previously developed
rather than the new technologies under development. We cannot be
certain that we can successfully develop any new products or
that they will receive commercial acceptance, in which case we
may not be able to recover our investment in the product
development.
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We will need to develop manufacturing capacity by
ourselves or with a partner. |
If we are successful in achieving market acceptance for our new
machines, we will need to either build internal manufacturing
capacity or contract it to a manufacturing partner. There is no
assurance that we will be able to build the capacity internally,
or find a manufacturing partner, to meet both the volume and
quality requirements necessary to be successful in the market.
Any delay in establishing or inability to expand our
manufacturing capacity could hurt our business.
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Our technology platform is in the early stages of
commercialization and is unproven for market acceptance. |
While some of our gene expression technology has been
commercialized and is currently in use, we are developing
additional technologies to generate information about gene
sequences that may enable scientists to better understand
complex biological processes. These technologies are still in
development, and we may not be able to successfully
commercialize them. Our success depends on many factors,
including:
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technical performance of our technologies in relation to
existing technologies; |
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the acceptance of our technologies in the market place; |
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the ability to establish an instrument manufacturing capability,
or to obtain instruments from another manufacturer; and |
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the ability to manufacture reagents, or obtain licenses to
resell reagents. |
You must evaluate us in light of the uncertainties and
complexities affecting an early stage genetic analysis company.
Our technologies are in too early a stage of development to
determine whether they can be successfully implemented. Our
technologies also depend on the successful integration of
independent technologies, each of which has its own development
risks. Furthermore, we are anticipating that, if our technology
is able to successfully reduce the cost of genetic analysis
relative to existing providers, our technology may be able to
displace current technology as well as to expand the market for
genetic analysis to include new applications that are not
practical with current technology. There is no guarantee, even
if our technology is able to successfully reduce the cost of
genetic analysis relative to existing providers, that we will be
able to induce customers with installed bases of conventional
genetic analysis instruments to purchase our system or to expand
the market for genetic analysis to include new applications.
Furthermore, if we are able to successfully commercialize our
genetic analysis systems only as a replacement for existing
technology, we may face a much smaller market.
|
|
|
We are dependent on our genetic analysis service customers
and collaborators and will need to find additional genetic
analysis customers and collaborators in the future. |
Our strategy for the development and commercialization of our
technologies and potential products includes entering into
collaborations, customer agreements or licensing arrangements
with pharmaceutical, biotechnology and agricultural companies
and research institutes. We have derived substantially all of
our revenues, to date, from corporate collaborations, customer
agreements and licensing arrangements. Furthermore, our revenues
from collaborations, customer agreements and licenses declined
by 39% from 2003 to
10
2004. To date, we have received, and expect to continue to
receive in the future, a significant portion of our revenues
from a small number of collaborators, customers and licensees,
as shown in the following table:
| |
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Year Ended December 31, | |
| |
|
| |
| |
|
2004 | |
|
2003 | |
|
2002 | |
| |
|
| |
|
| |
|
| |
|
E.I. DuPont de Nemours and Company
|
|
|
35 |
% |
|
|
28 |
% |
|
|
32 |
% |
|
The National Human Genome Research Institute
|
|
|
30 |
% |
|
|
1 |
% |
|
|
|
|
|
Axaron
|
|
|
11 |
% |
|
|
4 |
% |
|
|
4 |
% |
|
Takara Bio Inc.
|
|
|
2 |
% |
|
|
39 |
% |
|
|
16 |
% |
|
BASF AG
|
|
|
|
|
|
|
14 |
% |
|
|
11 |
% |
|
Bayer CropScience
|
|
|
|
|
|
|
4 |
% |
|
|
14 |
% |
|
Geron Corporation
|
|
|
|
|
|
|
|
|
|
|
15 |
% |
Thus, until we are able to commercialize our new products under
development, we will be dependent on a small number of customers
to continue our current business, and the loss of one or more of
those customers could harm our results of operations.
|
|
|
We operate in an intensely competitive industry with
rapidly evolving technologies, and our competitors may develop
products and technologies that make ours obsolete. |
The biotechnology industry is highly fragmented and is
characterized by rapid technological change. In particular, the
areas of genetic analysis platforms and genomics research are
rapidly evolving fields. Competition among entities developing
genetic analysis platform or using such platforms to attempt to
identify genes and proteins associated with specific diseases
and to develop products based on such discoveries is intense.
Many of our competitors have substantially greater research and
product development capabilities and financial, scientific and
marketing resources than we do.
In our genetic analysis platform business, we face, and will
continue to face, competition primarily from biotechnology
companies, such as Affymetrix, Inc., Celera Genomics Group, Gene
Logic, Inc., and Agencourt Biosciences, academic and research
institutions and government agencies, both in the United States
and abroad. We are aware that certain entities are using a
variety of gene expression analysis methodologies, including
chip-based systems, to attempt to identify disease-related genes
and to perform clinical diagnostic tests. A number of large
companies offer DNA sequencing equipment including Applera
Corporation, Beckman Coulter, Inc., and the Amersham Biosciences
business of General Electric. A number of other smaller
companies are also in the process of developing novel techniques
for DNA sequencing. These companies include 454 Corporation,
Helicos Biosciences, Nanofluidics, Visigen and Genovoxx. In
order to successfully compete against existing and future
technologies, we will need to demonstrate to potential customers
that our technologies and capabilities are superior to those of
our competitors. Some of our competitors may be:
|
|
|
| |
|
attempting to identify and patent randomly sequenced genes and
gene fragments and proteins; |
| |
| |
|
pursuing a gene identification, characterization and product
development strategy based on positional cloning, which uses
disease inheritance patterns to isolate the genes that are
linked to the transmission of disease from one generation to the
next; and |
| |
| |
|
using a variety of different gene and protein expression
analysis methodologies, including the use of chip-based systems,
to attempt to identify disease-related genes and proteins. |
In addition, numerous pharmaceutical, biotechnology and
agricultural companies are developing genomics research
programs, either alone or in partnership with our competitors.
Our future success will depend on our ability to maintain a
competitive position with respect to technological advances.
Rapid technological development by others may make our
technologies and future products obsolete.
Any products developed through our technologies will compete in
highly competitive markets. Our competitors may be more
effective at using their technologies to develop commercial
products. Moreover, our competitors may introduce novel genetic
analysis platforms before we do, which, if adopted by customers,
11
could eliminate the market for our new genetic analysis systems.
Further, our competitors may obtain intellectual property rights
that would limit the use of our technologies or the
commercialization of diagnostic or therapeutic products using
our technologies. As a result, our competitors products or
technologies may render our technologies and products, and those
of our collaborators, obsolete or noncompetitive.
|
|
|
We have limited experience in sales and marketing and thus
may be unable to further commercialize our products and
services. |
Our ability to achieve profitability depends on attracting
customers for our products and services. There are a limited
number of pharmaceutical, biotechnology and agricultural
companies and research institutes that are potential customers
for our products and services. To market our technologies and
products, we intend to develop a sales and marketing group with
the appropriate technical expertise. We may not successfully
build such a sales force. In addition, we may seek to enlist a
third party to assist with sales and distribution globally or in
certain regions of the world. There is no guarantee, if we do
seek to enter into such an arrangement, that we will be
successful in attracting a desirable sales and distribution
partner, or that we will be able to enter into such an
arrangement on favorable terms. If our sales and marketing
efforts, or those of any third-party sales and distribution
partner, are not successful, our technologies and products may
not gain market acceptance.
|
|
|
Our sales cycle for our service business is lengthy, and
we may spend considerable resources on unsuccessful sales
efforts or may not be able to enter into agreements on the
schedule we anticipate. |
Our ability to obtain collaborators and customers for our
technologies and products depends in significant part upon the
perception that our technologies and products can help
accelerate their drug discovery and genomics efforts. Our sales
cycle for our service business is typically lengthy, up to
approximately nine months, because we need to educate our
potential collaborators and customers and sell the benefits of
our products to a variety of constituencies within such
companies. In addition, we may be required to negotiate
agreements containing terms unique to each collaborator or
customer. We may expend substantial funds and management effort
without any assurance that we will successfully sell our
technologies and products. Actual and proposed consolidations of
pharmaceutical companies have negatively affected, and may in
the future negatively affect, the timing and progress of our
sales efforts.
|
|
|
We currently utilize a single supplier to purchase PacI,
an enzyme used in our MPSS service. |
PacI is a restriction enzyme used to digest the PCR product that
is loaded onto 5-micron beads prior to MPSS sequencing. We
currently purchase PacI from New England BioLabs under a supply
agreement, the term of which is scheduled to expire on
August 15, 2005. Our reliance on a sole vendor involves
several risks, including:
|
|
|
| |
|
the inability to obtain an adequate supply due to manufacturing
capacity constraints, a discontinuance of a product by a
third-party manufacturer or other supply constraints; |
| |
| |
|
the potential lack of leverage in contract negotiations with the
sole vendor; |
| |
| |
|
reduced control over quality and pricing of components; and |
| |
| |
|
delays and long lead times in receiving materials from vendors. |
We do not believe, however, that our business is dependent
substantially on PacI or the intellectual property associated
with PacI. We believe that we would be able to purchase
alternative enzymes from other providers without incurring
significant additional expenses or time delays should the need
arise. In addition, if we are able to successfully implement new
SBS sequencing technologies under development in our genetic
services business, we will no longer require PacI or an
alternative enzyme. We have not yet determined if we will seek
to extend or renew our contract with New England BioLabs but we
believe we could do so without unreasonable effort or expense.
12
|
|
|
We use hazardous chemicals and radioactive and biological
materials in our business. Any claims relating to improper
handling, storage or disposal of these materials could be time
consuming and costly. |
Our research and development processes involve the controlled
use of hazardous materials, including chemicals and radioactive
and biological materials. Our operations produce hazardous waste
products. We cannot eliminate the risk of accidental
contamination or discharge and any resultant injury from these
materials. We may be sued for any injury or contamination that
results from our use or the use by third parties of these
materials, and our liability may exceed our insurance coverage
and our total assets. Federal, state and local laws and
regulations govern the use, manufacture, storage, handling and
disposal of hazardous materials. Compliance with environmental
laws and regulations may be expensive, and current or future
environmental regulations may impair our research, development
and production efforts.
|
|
|
If we fail to adequately protect our proprietary
technologies, third parties may be able to use our technologies,
which could prevent us from competing in the market. |
Our success depends in part on our ability to obtain patents and
maintain adequate protection of the intellectual property
related to our technologies and products. The patent positions
of biotechnology companies, including us, are generally
uncertain and involve complex legal and factual questions. We
will be able to protect our proprietary rights from unauthorized
use by third parties only to the extent that our proprietary
technologies are covered by valid and enforceable patents or are
effectively maintained as trade secrets. The laws of some
foreign countries do not protect proprietary rights to the same
extent as the laws of the U.S., and many companies have
encountered significant problems in protecting and defending
their proprietary rights in foreign jurisdictions. We have
applied and will continue to apply for patents covering our
technologies, processes and products, as and when we deem
appropriate. However, third parties may challenge these
applications, or these applications may fail to result in issued
patents. Our existing patents and any future patents we obtain
may not be sufficiently broad to prevent others from practicing
our technologies or from developing competing products.
Furthermore, others may independently develop similar or
alternative technologies or design around our patents. In
addition, our patents may be challenged or invalidated or fail
to provide us with any competitive advantage.
We also rely on trade secret protection for our confidential and
proprietary information. However, trade secrets are difficult to
protect. We protect our proprietary information and processes,
in part, with confidentiality agreements with employees,
collaborators and consultants. However, third parties may breach
these agreements, we may not have adequate remedies for any such
breach or our trade secrets may still otherwise become known by
our competitors. In addition, our competitors may independently
develop substantially equivalent proprietary information.
|
|
|
Litigation or third-party claims of intellectual property
infringement could require us to spend substantial time and
money and adversely affect our ability to develop and
commercialize our technologies and products. |
Our commercial success depends in part on our ability to avoid
infringing patents and proprietary rights of third parties and
not breaching any licenses that we have entered into with regard
to our technologies. Other parties have filed, and in the future
are likely to file, patent applications covering genes, gene
fragments, proteins, the analysis of gene expression and protein
expression and the manufacture and use of DNA chips or
microarrays, which are tiny glass or silicon wafers on which
tens of thousands of DNA molecules can be arrayed on the surface
for subsequent analysis. We intend to continue to apply for
patent protection for methods relating to gene expression and
protein expression and for the individual disease genes and
proteins and drug discovery targets that we discover. If patents
covering technologies required by our operations are issued to
others, we may have to rely on licenses from third parties,
which may not be available on commercially reasonable terms, or
at all.
Third parties may accuse us of employing their proprietary
technology without authorization. In addition, third parties may
obtain patents that relate to our technologies and claim that
use of such technologies infringes these patents. Regardless of
their merit, such claims could require us to incur substantial
costs,
13
including the diversion of management and technical personnel,
in defending ourselves against any such claims or enforcing our
patents. In the event that a successful claim of infringement is
brought against us, we may need to pay damages and obtain one or
more licenses from third parties. We may not be able to obtain
these licenses at a reasonable cost, or at all. Defense of any
lawsuit or failure to obtain any of these licenses could
adversely affect our ability to develop and commercialize our
technologies and products and thus prevent us from achieving
profitability.
|
|
|
Ethical, legal and social issues may limit the public
acceptance of, and demand for, our technologies and
products. |
Our collaborators and customers may seek to develop diagnostic
products based on genes or proteins. The prospect of broadly
available gene-based diagnostic tests raises ethical, legal and
social issues regarding the appropriate use of gene-based
diagnostic testing and the resulting confidential information.
It is possible that discrimination by third-party payors, based
on the results of such testing, could lead to the increase of
premiums by such payors to prohibitive levels, outright
cancellation of insurance or unwillingness to provide coverage
to individuals showing unfavorable gene or protein expression
profiles. Similarly, employers could discriminate against
employees with gene or protein expression profiles indicative of
the potential for high disease-related costs and lost employment
time. Finally, government authorities could, for social or other
purposes, limit or prohibit the use of such tests under certain
circumstances. These ethical, legal and social concerns about
genetic testing and target identification may delay or prevent
market acceptance of our technologies and products.
Although our technology does not depend on genetic engineering,
genetic engineering plays a prominent role in our approach to
product development. The subject of genetically modified food
has received negative publicity, which has aroused public
debate. Adverse publicity has resulted in greater regulation
internationally and trade restrictions on imports of genetically
altered agricultural products. Claims that genetically
engineered products are unsafe for consumption or pose a danger
to the environment may influence public attitudes and prevent
genetically engineered products from gaining public acceptance.
The commercial success of our future products may depend, in
part, on public acceptance of the use of genetically engineered
products, including drugs and plant and animal products.
|
|
|
Our facilities in Hayward, California are located near
known earthquake fault zones, and the occurrence of an
earthquake or other catastrophic disaster could cause damage to
our facilities and equipment, which could require us to cease or
curtail operations. |
Our facilities in Hayward, California are located near known
earthquake fault zones and are vulnerable to damage from
earthquakes. We are also vulnerable to damage from other types
of disasters, including fire, floods, power loss, communications
failures and similar events. If any disaster were to occur, our
ability to operate our business at our facilities would be
seriously, or potentially completely, impaired. In addition, the
unique nature of our research activities could cause significant
delays in our programs and make it difficult for us to recover
from a disaster. The insurance we maintain may not be adequate
to cover our losses resulting from disasters or other business
interruptions. Accordingly, an earthquake or other disaster
could materially and adversely harm our ability to conduct
business.
|
|
|
Our stock price may be extremely volatile. |
We believe that the market price of our common stock will remain
highly volatile and may fluctuate significantly due to a number
of factors. The market prices for securities of many
publicly-held, early-stage biotechnology companies have in the
past been, and can in the future be expected to be, especially
volatile. For example, during the two-year period from
January 1, 2003 to December 31, 2004, the closing
sales price of our common stock as quoted on the Nasdaq National
Market and Nasdaq SmallCap Market fluctuated from a low of $2.96
to a high of $15.88 per share. In addition, the securities
markets have from time to time experienced significant price and
volume fluctuations that may be unrelated to the operating
performance of particular companies. The following factors and
events may have a significant and adverse impact on the market
price of our common stock:
14
|
|
|
| |
|
fluctuations in our operating results; |
| |
| |
|
announcements of technological innovations or new commercial
products by us or our competitors; |
| |
| |
|
release of reports by securities analysts; |
| |
| |
|
developments or disputes concerning patent or proprietary rights; |
| |
| |
|
developments in our relationships with current or future
collaborators, customers or licensees; and |
| |
| |
|
general market conditions. |
Many of these factors are beyond our control. These factors may
cause a decrease in the market price of our common stock,
regardless of our operating performance.
|
|
|
Our securities have been transferred from the Nasdaq
National Market to the Nasdaq SmallCap Market, which has
subjected us to various statutory requirements and may have
adversely affected the liquidity of our common stock, and a
failure by us to meet the listing maintenance standards of the
Nasdaq SmallCap Market could result in delisting from the Nasdaq
SmallCap Market. |
Effective May 22, 2003, a Nasdaq Qualifications Panel
terminated our Nasdaq National Market Listing and transferred
our securities to the Nasdaq SmallCap Market. In order to
maintain the listing of our securities on the Nasdaq SmallCap
Market, we must be able to demonstrate compliance with all
applicable listing maintenance requirements. In the event we are
unable to do so, our securities will be delisted from the Nasdaq
Stock Market.
With our securities listed on the Nasdaq SmallCap Market, we
face a variety of legal and other consequences that will likely
negatively affect our business including, without limitation,
the following:
|
|
|
| |
|
we may have lost our exemption from the provisions of
Section 2115 of the California Corporations Code, which
imposes aspects of California corporate law on certain
non-California corporations operating within California. As a
result, (i) our stockholders may be entitled to cumulative
voting and (ii) we may be subject to more stringent
stockholder approval requirements and more stockholder-favorable
dissenters rights in connection with certain strategic
transactions; |
| |
| |
|
the state securities law exemptions available to us are more
limited, and, as a result, future issuances of our securities
may require time-consuming and costly registration statements
and qualifications; |
| |
| |
|
due to the application of different securities law exemptions
and provisions, we have been required to amend our stock option
plan, suspend our stock purchase plan and must comply with
time-consuming and costly administrative procedures; |
| |
| |
|
the coverage of our company by securities analysts may decrease
or cease entirely; and |
| |
| |
|
we may lose current or potential investors. |
In addition, we are required to satisfy various listing
maintenance standards for our common stock to be quoted on the
Nasdaq SmallCap Market. If we fail to meet such standards, our
common stock would likely be delisted from the Nasdaq SmallCap
Market and trade on the over-the-counter bulletin board,
commonly referred to as the pink sheets. This
alternative is generally considered to be a less efficient
market and would seriously impair the liquidity of our common
stock and limit our potential to raise future capital through
the sale of our common stock, which could materially harm our
business.
|
|
|
If we do not obtain additional funding, we may default
under the loan and security agreement with Silicon Valley
Bank. |
If we do not obtain additional funding, we may not have
sufficient funds to repay the loan from Silicon Valley Bank when
the loan is due and payable. The loan is due on the earlier to
occur of fifteen days after the receipt by us of gross proceeds
in the amount of $10 million for the issuance of equity in
a private placement transaction, or July 31, 2005. If we
default under the loan and security agreement and the default
continues,
15
Silicon Valley Bank has the right to accelerate repayment of the
loan and to realize on its security interest, including without
limitation, to reclaim and sell the collateral under the loan
and security agreement, including but not limited to all of our
goods, equipment, inventory, contract rights, licenses and
intellectual property rights.
|
|
|
Anti-takeover provisions in our charter documents and
under Delaware law may make it more difficult to acquire us or
to effect a change in our management, even though an acquisition
or management change may be beneficial to our
stockholders. |
Under our certificate of incorporation, our board of directors
has the authority, without further action by the holders of our
common stock, to issue 2,000,000 additional shares of preferred
stock from time to time in series and with preferences and
rights as it may designate. These preferences and rights may be
superior to those of the holders of our common stock. For
example, the holders of preferred stock may be given a
preference in payment upon our liquidation or for the payment or
accumulation of dividends before any distributions are made to
the holders of common stock.
Any authorization or issuance of preferred stock, while
providing desirable flexibility in connection with financings,
possible acquisitions and other corporate purposes, could also
have the effect of making it more difficult for a third party to
acquire a majority of our outstanding voting stock or making it
more difficult to remove directors and effect a change in
management. The preferred stock may have other rights, including
economic rights senior to those of our common stock, and, as a
result, an issuance of additional preferred stock could lower
the market value of our common stock. Provisions of Delaware law
may also discourage, delay or prevent someone from acquiring or
merging with us.
In February 1998, we entered into a noncancelable operating
lease for facilities space of approximately
111,000 square-feet in two buildings in Hayward,
California. In July 2000, we leased approximately
37,000 square feet of additional space in one of the
buildings for further expansion purposes. Our corporate
headquarters, principal research and development facilities and
production facilities are currently located in one of the two
buildings. The remaining space will be developed and occupied in
phases, depending on our growth. The leases run through December
2008. We have an option to extend the lease for an additional
five-year period, subject to certain conditions. In addition, we
lease approximately 16,000 square feet in Little
Chesterford, England which is occupied by Solexa Limited, our
wholly-owned subsidiary. The lease expires in 2005 but we
believe that the lease can be renewed on satisfactory terms or
that alternative facilities can be found nearby on satisfactory
terms.
|
|
| Item 3. |
Legal Proceedings |
We are not a party to any material legal proceedings.
|
|
| Item 4. |
Submission of Matters to a Vote of Security Holders |
No matters were submitted to a vote of security holders during
the quarter ended December 31, 2004.
16
PART II
|
|
| Item 5. |
Market For Registrants Common Equity, Related
Stockholder Matters and Issuer Purchases of Equity
Securities |
Effective May 22, 2003, our common stock under the symbol
LYNX was transferred from the Nasdaq National Market Listing to
the Nasdaq SmallCap Market. Effective March 7, 2005, in
connection with the change of our name from Lynx Therapeutics,
Inc. to Solexa, Inc., we changed our symbol to SLXA. The
following table sets forth, for the periods indicated, the high
and low closing bid information for our common stock as reported
by the Nasdaq Stock Market and Nasdaq SmallCap Market, as
adjusted to reflect the effect of a 1-for-2 reverse split of our
common stock effected on March 2, 2005:
| |
|
|
|
|
|
|
|
|
|
| |
|
Common Stock Price | |
| |
|
| |
| |
|
High | |
|
Low | |
| |
|
| |
|
| |
|
Year Ended December 31, 2004:
|
|
|
|
|
|
|
|
|
| |
First quarter
|
|
$ |
13.72 |
|
|
$ |
8.98 |
|
| |
Second quarter
|
|
|
10.60 |
|
|
|
3.98 |
|
| |
Third quarter
|
|
|
5.02 |
|
|
|
2.96 |
|
|   |