FILED PURSUANT TO RULE 424(B)(3)
Filed Pursuant to Rule 424(b)(3)
Registration No. 333-122473
PROSPECTUS
1,939,600 Shares
PHARMION CORPORATION
Common Stock
The shares of common stock of Pharmion Corporation covered by
this prospectus may be offered and sold to the public by Celgene
Corporation, as the selling stockholder, from time to time, in
one or more offerings. We will not receive any of the proceeds
from such sales. The selling stockholder will bear all sales
commissions and similar expenses.
See Risk Factors on page 2 for a discussion
of matters that you should consider before investing in these
securities.
Our common stock is quoted on the Nasdaq National Market under
the symbol PHRM. On February 22, 2005, the
reported last sale price of our common stock was $34.03 per
share.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or passed upon the adequacy or accuracy of this
prospectus. Any representation to the contrary is a criminal
offense.
The date of this prospectus is February 23, 2005
TABLE OF CONTENTS
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About This Prospectus
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Forward-Looking Statements
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Summary
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Risk Factors
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Use of Proceeds
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Selling Stockholder
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Plan of Distribution
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Legal Matters
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Experts
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Where You Can Find More Information
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Incorporation by Reference
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ABOUT THIS PROSPECTUS
This prospectus is part of a registration statement we filed
with the Securities and Exchange Commission, or the SEC,
pursuant to which the selling stockholder may sell up to
1,939,600 shares of common stock from time to time in one
or more offerings.
This prospectus provides you with a general description of the
shares that the selling stockholder may offer. To the extent
required, the number of shares of our common stock to be sold,
the purchase price, the public offering price, the names of any
agent or dealer and any applicable commission or discount with
respect to a particular offering by the selling stockholder may
be set forth in an accompanying prospectus supplement. You
should read both this prospectus and any prospectus supplement
together with the additional information described in the
sections titled Where You Can Find More Information
and Incorporation By Reference below.
You should rely only on the information incorporated by
reference or provided in this prospectus or any prospectus
supplement. Neither we nor the selling stockholder have
authorized anyone to provide you with different information. If
anyone provides you with different or inconsistent information,
you should not rely on it. The selling stockholder will not make
an offer of these securities in any jurisdiction where it is
unlawful. You should assume that the information in this
prospectus or any prospectus supplement, as well as the
information we have previously filed with the SEC and
incorporated by reference in this prospectus, is accurate only
as of the date of the documents containing the information.
References in this prospectus to we, us,
our or the Company mean Pharmion
Corporation and its subsidiaries. References in this prospectus
to Celgene or the selling stockholder
mean Celgene Corporation.
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FORWARD-LOOKING STATEMENTS
This prospectus contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of
1934. Generally, you can identify these statements because they
use words like anticipates, believes,
expects, future, intends,
plans, and similar terms. These statements are only
our current expectations. Although we do not make
forward-looking statements unless we believe we have a
reasonable basis for doing so, we cannot guarantee their
accuracy, and actual results may differ materially from those we
anticipated due to a number of uncertainties and risks,
including the risks described in this prospectus and other
unforeseen risks. You should not place undue reliance on these
forward-looking statements, which apply only as of the date of
this prospectus.
We believe it is important to communicate our expectations to
our investors. There may be events in the future, however, that
we are unable to predict accurately or over which we have no
control. The factors listed in the section titled Risk
Factors, as well as any cautionary language in this
prospectus, provide examples of risks, uncertainties and events
that may cause our actual results to differ materially from the
expectations we describe in our forward-looking statements.
Before you invest in our common stock, you should be aware that
the occurrence of the events described in the risk factors and
elsewhere in this prospectus could negatively impact our
business, operating results, financial condition and stock price.
You should not rely upon forward-looking statements as
predictions of future events. We cannot assure you that the
events and circumstances reflected in the forward-looking
statements will be achieved or occur and actual results could
differ materially from those projected in the forward-looking
statements.
ii
SUMMARY
About Pharmion
We are creating a global pharmaceutical company focused on
in-licensing, developing and commercializing therapeutic
products for the treatment of hematology and oncology patients.
We have established our own regulatory, development and sales
and marketing organizations covering the U.S., Europe and
Australia. We have also developed a third party distributor
network to serve the hematology and oncology markets in 22
additional countries throughout Europe, the Middle East and
Asia. To date, we have licensed the rights to four products on
either a global or regional basis. Vidaza® was approved for
marketing in the U.S. in May 2004 and we began selling it
on July 1, 2004. We have filed for approval to market
Vidaza in Europe and this submission is under review by European
regulatory authorities. Two of our other products are also
approved for marketing and are being sold by us, Innohep®
in the U.S. and Refludan® in Europe and Australia. We are
currently selling the fourth product, Thalidomide, in Europe and
other international markets on a compassionate use or named
patient basis while we pursue full regulatory marketing
approval. These products were obtained through licensing
arrangements with companies including Pharmacia &
Upjohn Company, now a part of Pfizer, Inc., LEO Pharma A/S,
Schering AG and Celgene Corporation. With our combination of
regulatory, development and commercial capabilities, we intend
to continue to build a balanced portfolio of approved and
pipeline products targeting the hematology and oncology markets.
Our principal executive offices are located at 2525 28th Street,
Boulder, Colorado 80301, and our telephone number is
(720) 564-9100. Our website is located at www.pharmion.com.
We do not incorporate the information on our website into this
prospectus and you should not consider it a part of this
prospectus.
The Offering
Pursuant to this prospectus, from time to time, Celgene
Corporation, the selling stockholder, may sell up to
1,939,600 shares of our common stock in one or more
offerings. See Plan of Distribution below.
1
RISK FACTORS
Investing in our common stock involves a high degree of risk.
You should carefully consider the risks described below and
other information included or incorporated by reference in this
prospectus before deciding to invest in shares of our common
stock. If any of the following risks occur, the value of our
common stock could decline.
Risks Related To Our Business
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We have a history of net losses, and may not achieve or
maintain profitability. |
We have incurred net losses since our inception, including a net
loss of $20.1 million for the nine months ended
September 30, 2004. As of September 30, 2004, we had
an accumulated deficit of $140.7 million. We expect to make
substantial expenditures to further develop and commercialize
our products, including costs and expenses associated with
completing clinical trials, seeking regulatory approvals and
marketing of our products. We will need to generate
significantly greater revenues to achieve and then maintain
profitability. As a result, we are unsure when we will become
profitable on a sustainable basis, if at all. If we fail to
achieve profitability within the time frame expected by
investors or securities analysts, the market price of our common
stock may decline.
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We have a limited operating history. |
We have a limited operating history. Accordingly, you must
consider our prospects in light of the risks and difficulties
encountered by companies in the early stage of development. As
an early-stage company, we have yet to fully prove our business
plan. Vidaza was approved for marketing by the FDA in May 2004
and commercially launched in the United States shortly after
that date. Because of the recent introduction of Vidaza, we have
limited experience as to the level of sales we can expect to
generate.
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We may not receive regulatory approvals for Thalidomide
Pharmion 50mg or, outside of the U.S., for Vidaza, or approvals
may be delayed. |
Our ability to fully commercialize Thalidomide Pharmion 50mg is
subject to regulatory approval by governmental authorities in
Europe and our other markets, while our ability to commercialize
Vidaza in markets outside the U.S. is subject to regulatory
approval by governmental authorities in Europe and elsewhere. We
cannot assure you that the results of the clinical trials
conducted, we intend to conduct or we are required to conduct
for Thalidomide Pharmion 50mg and Vidaza will support our
applications for these regulatory approvals. The timing of our
submissions, the outcome of reviews by the applicable regulatory
authorities in each relevant market, and the initiation and
completion of clinical trials are subject to uncertainty, change
and unforeseen delays.
Moreover, favorable results in later stage clinical trials do
not ensure regulatory approval to commercialize a product. Some
companies that have believed their products performed
satisfactorily in clinical trials have nonetheless failed to
obtain regulatory approval of their products. We will not be
able to market Thalidomide Pharmion 50mg or Vidaza in any
country where the drug is not approved, and if Thalidomide
Pharmion 50mg or Vidaza is not approved for sale in any market
where we have acquired rights to the product, we will only be
able to sell it in such market, if at all, on a compassionate
use or named patient basis, which may limit sales.
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Thalidomides history of causing birth defects may
prevent it from becoming commercially successful. |
At the time thalidomide first came on the market in the late
1950s and into the early 1960s, it was not known
that the drug could cause birth defects in babies born to women
who had taken the drug while pregnant. Although no proper census
was ever taken, it has been estimated that there were between
10,000 and 20,000 babies born with birth defects as a
result of thalidomide. The majority of these births were in the
U.K. and Germany, two of our largest target markets for sales of
Thalidomide Pharmion 50mg. As a result, thalidomides
historical reputation in our target markets may present a
substantial barrier to its market acceptance. Thalidomides
potential for causing severe birth defects and its negative
historical reputation may
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limit the extent of its market acceptance among both doctors and
patients, despite the efficacy that it has been proven to have
in patients afflicted with a number of different diseases. In
addition, any report of a birth defect attributed to the current
use of thalidomide could result in a material decrease in our
sales of thalidomide, and may result in the forced withdrawal of
thalidomide from the market.
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Although Vidaza has been approved in the U.S., it may not
be commercially successful. |
Vidaza was approved for marketing in the U.S. in May 2004
and we filed for marketing approval in Europe in September of
2004. Although the drug is approved in the U.S., patients and
physicians may not readily accept it, which would limit its
sales.
Acceptance will be a function of Vidaza being clinically useful
and demonstrating superior therapeutic effect with an acceptable
side effect profile as compared to currently existing or future
treatments. In addition, even if Vidaza does achieve market
acceptance, we may not be able to maintain that market
acceptance over time if new products are introduced that are
more favorably received than Vidaza or render Vidaza obsolete.
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If the third party manufacturers upon whom we rely fail to
produce our products in the volumes that we require on a timely
basis, or to comply with stringent regulations applicable to
pharmaceutical drug manufacturers, we may face delays in the
commercialization of, or be unable to meet demand for, our
products and may lose potential revenues. |
We do not manufacture any of our products or product candidates
and we do not plan to develop any capacity to do so. We have
contracted with third-party manufacturers to manufacture each of
our four products. The manufacture of pharmaceutical products
requires significant expertise and capital investment, including
the development of advanced manufacturing techniques and process
controls. Manufacturers of pharmaceutical products often
encounter difficulties in production, especially in scaling up
initial production. These problems include difficulties with
production costs and yields, quality control and assurance and
shortages of qualified personnel, as well as compliance with
strictly enforced federal, state and foreign regulations. Our
third-party manufacturers may not perform as agreed or may
terminate their agreements with us.
We do not have alternate manufacturing plans in place at this
time for any of our products. The number of third-party
manufacturers with the expertise, required regulatory approvals
and facilities to manufacture bulk drug substance on a
commercial scale is extremely limited, and it would take a
significant amount of time to arrange for alternative
manufacturers. If we need to change to other commercial
manufacturers, the FDA and comparable foreign regulators must
approve these manufacturers facilities and processes prior
to our use, which would require new testing and compliance
inspections, and the new manufacturers would have to be educated
in or independently develop the processes necessary for the
production of our products.
Any of these factors could cause us to delay or suspend clinical
trials, regulatory submissions, required approvals or
commercialization of our products or product candidates, entail
higher costs and result in our being unable to effectively
commercialize our products. Furthermore, if our third-party
manufacturers failed to deliver the required commercial
quantities of bulk drug substance or finished product on a
timely basis and at commercially reasonable prices, and we were
unable to promptly find one or more replacement manufacturers
capable of production at a substantially equivalent cost, in
substantially equivalent volume and on a timely basis, we would
likely be unable to meet demand for our products and we would
lose potential revenues.
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We may not be able to obtain sufficient product liability
insurance on commercially reasonable terms or with adequate
coverage for Thalidomide Pharmion 50mg. |
Historically, the vast majority of product liability insurers
have been unwilling to write any product liability coverage for
thalidomide. Although we currently have product liability
coverage for Thalidomide Pharmion 50mg that we believe is
appropriate, if our sales of this product grow in the future,
our current coverage may be insufficient. We may be unable to
obtain additional coverage on commercially reasonable terms if
required, or our coverage may be inadequate to protect us in the
event claims are asserted against us.
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In addition, we might be unable to renew our existing level of
coverage if there were a report of a birth defect attributable
to the current use of thalidomide, whether or not sold by us.
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If we breach any of the agreements under which we license
commercialization rights to products or technology from others,
we could lose license rights that are important to our
business. |
We license commercialization rights to products and technology
that are important to our business, and we expect to enter into
similar licenses in the future. For instance, we acquired our
first four products through exclusive licensing arrangements.
Under these licenses we are subject to commercialization and
development, sublicensing, royalty, insurance and other
obligations. If we fail to comply with any of these
requirements, or otherwise breach these license agreements, the
licensor may have the right to terminate the license in whole or
to terminate the exclusive nature of the license. Loss of any of
these licenses or the exclusivity rights provided therein could
harm our financial condition and operating results.
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Our failure to successfully acquire, develop and market
additional product candidates or approved products would impair
our ability to grow. |
As part of our growth strategy, we intend to acquire, develop
and market additional products and product candidates. Because
we neither have, nor currently intend to establish, internal
research capabilities, we are dependent upon pharmaceutical and
biotechnology companies and other researchers to sell or license
products to us. The success of this strategy depends upon our
ability to identify, select and acquire the right pharmaceutical
product candidates and products. To date, we have in-licensed
rights to four products, and our only product acquisitions have
been those associated with our acquisition of Laphal.
Any product candidate we license or acquire may require
additional development efforts prior to commercial sale,
including extensive clinical testing and approval by the Food
and Drug Administration, or the FDA, and applicable foreign
regulatory authorities. All product candidates are prone to the
risks of failure inherent in pharmaceutical product development,
including the possibility that the product candidate will not be
shown to be sufficiently safe and effective for approval by
regulatory authorities. In addition, we cannot assure you that
any products that we develop or acquire that are approved will
be manufactured or produced economically, successfully
commercialized or widely accepted in the marketplace.
Proposing, negotiating and implementing an economically viable
acquisition is a lengthy and complex process. Other companies,
including those with substantially greater financial, marketing
and sales resources, may compete with us for the acquisition of
product candidates and approved products. We may not be able to
acquire the rights to additional product candidates and approved
products on terms that we find acceptable, or at all.
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We face substantial competition, which may result in
others commercializing competing products before or more
successfully than we do. |
Our industry is highly competitive. Our success will depend on
our ability to acquire, develop and commercialize products and
our ability to establish and maintain markets for our products.
Potential competitors in North America, Europe and elsewhere
include major pharmaceutical companies, specialized
pharmaceutical companies and biotechnology firms, and other
research institutions. Many of our competitors have
substantially greater research and development capabilities and
experience, and greater manufacturing, marketing and financial
resources, than we do. Accordingly, our competitors may develop
or license products or other novel technologies that are more
effective, safer or less costly than our existing products or
products that are being developed by us, or may obtain
regulatory approval for products before we do. Clinical
development by others may render our products or product
candidates noncompetitive.
Other pharmaceutical companies may develop generic versions of
our products that are not subject to patent protection or
otherwise subject to orphan drug exclusivity or other
proprietary rights. Governmental and other pressures to reduce
pharmaceutical costs may result in physicians writing
prescriptions for these generic products. Increased competition
from the sale of competing generic pharmaceutical products could
cause a material decrease in revenue from our products.
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The primary competition for our products currently are:
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Thalidomide Pharmion 50mg:
Velcadetm,
from Millennium Pharmaceuticals Inc., and
Revlimidtm,
from Celgene Corporation; |
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Vidaza: Thalomid® and
Revlimidtm,
each from Celgene, and Dacogen, from Supergen Inc. with
marketing rights held by MGI Pharma, Inc.; |
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Innohep: Lovenox®, from Aventis, Fragmin®, from
Pharmacia Corporation and Arixtra, from GlaxoSmithKline plc; |
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Refludan: Argatroban, from GlaxoSmithKline. |
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Our failure to raise additional funds in the future may
affect the development and sale of our products. |
Our operations to date have generated substantial and increasing
needs for cash. The development and approval of our product
candidates and the acquisition and development of additional
products or product candidates by us, as well as the expansion
of our sales, marketing and regulatory organizations, will
require a commitment of substantial funds. Our future capital
requirements are dependent upon many factors and may be
significantly greater than we expect.
We believe, based on our current operating plan, including
anticipated sales of our products, that our cash, cash
equivalents and short-term investments will be sufficient to
fund our operations for the foreseeable future. If we acquire
additional products or product candidates, we may need to sell
additional equity or debt securities. If we are unable to obtain
this additional financing, we may be required to delay the
acquisition of additional products, thereby limiting our ability
to execute our growth strategy.
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We may not be able to manage our business effectively if
we are unable to attract and retain key personnel. |
Our industry has experienced a high rate of turnover of
management personnel in recent years. We are highly dependent on
our senior management, especially Patrick J. Mahaffy, our
President and Chief Executive Officer, and Judith A. Hemberger,
our Executive Vice President and Chief Operating Officer, whose
services are critical to the successful implementation of our
product acquisition, development and regulatory strategies. If
we lose their services or the services of one or more of the
other members of our senior management or other key employees,
our ability to successfully implement our business strategy
could be seriously harmed. We are not aware of any present
intention of any of these individuals to leave our company. We
do not maintain key person life insurance on any of the members
of our senior management. Replacing key employees may be
difficult and may take an extended period of time because of the
limited number of individuals in our industry with the breadth
of skills and experience required to develop, gain regulatory
approval of and commercialize products successfully. Competition
to hire from this limited pool is intense, and we may be unable
to hire, train, retain or motivate these additional key
personnel.
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We have only limited patent protection for our current
products, and we may not be able to obtain, maintain and protect
proprietary rights necessary for the development and
commercialization of our products or product candidates. |
Our commercial success will depend in part on obtaining and
maintaining a strong proprietary position for our products both
in the U.S., Europe and elsewhere. Of our four current products,
only Thalidomide Pharmion 50mg and Refludan® currently have
any patent protection under issued patents. As a result, we must
rely in large part on orphan drug exclusivity, trade secrets,
process patents, know-how and continuing technological
innovations to protect our intellectual property and to enhance
our competitive position. Even if we are granted orphan drug
exclusivity, competitors are not prohibited from developing or
marketing different drugs for an indication. As a result, the
competitive advantage gained by orphan drug exclusivity can be
overcome by other products. Until we are granted a marketing
authorization, while we are selling Thalidomide Pharmion 50mg on
a compassionate use and named patient basis, we do not have
orphan drug exclusivity, which means competitors may sell
thalidomide in our markets.
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We also rely on protection derived from trade secrets, process
patents, know-how and technological innovation. To maintain the
confidentiality of trade secrets and proprietary information, we
generally seek to enter into confidentiality agreements with our
employees, consultants and collaborators upon the commencement
of a relationship with us. However, we may not obtain these
agreements in all circumstances. In addition, adequate remedies
may not exist in the event of unauthorized use or disclosure of
this information. The loss or exposure of our trade secrets,
know-how and other proprietary information could harm our
operating results, financial condition and future growth
prospects. Furthermore, others may have developed, or may
develop in the future, substantially similar or superior
know-how and technology.
We intend to seek patent protection whenever it is available for
any products or product candidates we acquire in the future.
However, any patent applications for future products may not
issue as patents, and any patent issued on such products may be
challenged, invalidated, held unenforceable or circumvented.
Furthermore, the claims in patents which have been issued on
products we may acquire in the future may not be sufficiently
broad to prevent third parties from commercializing competing
products. In addition, the laws of various foreign countries in
which we compete may not protect the intellectual property on
which we may rely to the same extent as do the laws of the
U.S. If we fail to obtain adequate patent protection for
our products, our ability to compete could be impaired.
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Fluctuations in our operating results could affect the
price of our common stock. |
Our operating results may vary significantly from period to
period due to many factors, including the amount and timing of
sales of our products, the availability and timely delivery of a
sufficient supply of our products, the timing and expenses of
preclinical and clinical trials, announcements regarding
clinical trial results and product introductions by us or our
competitors, the availability and timing of third-party
reimbursement and the timing of regulatory submissions and
approvals. If our operating results do not match the
expectations of securities analysts and investors as a result of
these and other factors, the trading price of our common stock
will likely decrease.
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We may undertake acquisitions in the future and any
difficulties from integrating such acquisitions could damage our
ability to attain or maintain profitability. |
We may acquire additional businesses, products or product
candidates that complement or augment our existing business. To
date, our only experience in acquiring and integrating a
business involved our acquisition of Laphal in March 2003.
Integrating any newly acquired business or product could be
expensive and time-consuming. We may not be able to integrate
any acquired business or product successfully or operate any
acquired business profitably. Moreover, we may need to raise
additional funds through public or private debt or equity
financing to make acquisitions, which may result in dilution for
stockholders and the incurrence of indebtedness.
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Our business is subject to economic, political, regulatory
and other risks associated with international sales and
operations. |
Since we sell our products in Europe, Australia and many
additional countries, our business is subject to risks
associated with conducting business internationally. We
anticipate that revenue from international operations will
continue to represent a substantial portion of our total
revenue. In addition, a number of our suppliers are located
outside the United States. Accordingly, our future results could
be harmed by a variety of factors, including:
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difficulties in compliance with foreign laws and regulations; |
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changes in foreign regulations and customs; |
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changes in foreign currency exchange rates and currency controls; |
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changes in a specific countrys or regions political
or economic environment; |
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trade protection measures, import or export licensing
requirements or other restrictive actions by the U.S. or
foreign governments; |
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negative consequences from changes in tax laws; |
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difficulties associated with staffing and managing foreign
operations; |
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longer accounts receivable cycles in some countries; and |
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differing labor regulations. |
Risks Related To Our Industry
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Our ability to generate revenue from our products will
depend on reimbursement and drug pricing policies and
regulations. |
Our ability to achieve acceptable levels of reimbursement for
drug treatments by governmental authorities, private health
insurers and other organizations will have an effect on our
ability to successfully commercialize, and attract collaborative
partners to invest in the development of, product candidates. We
cannot be sure that reimbursement in the U.S., Europe or
elsewhere will be available for any products we may develop or,
if already available, will not be decreased or eliminated in the
future. If reimbursement is not available or is available only
at limited levels, we may not be able to successfully
commercialize our products, and may not be able to obtain a
satisfactory financial return on our products.
Third-party payors increasingly are challenging prices charged
for medical products and services. Also, the trend toward
managed health care in the U.S. and the changes in health
insurance programs, as well as legislative proposals to reform
health care or reduce government insurance programs, may result
in lower prices for pharmaceutical products, including any
products that may be offered by us. Cost-cutting measures that
health care providers are instituting, and the effect of any
health care reform, could harm our ability to sell any products
that are successfully developed by us and approved by
regulators. Moreover, we are unable to predict what additional
legislation or regulation, if any, relating to the health care
industry or third-party coverage and reimbursement may be
enacted in the future or what effect this legislation or
regulation would have on our business. In the event that
governmental authorities enact legislation or adopt regulations
which affect third-party coverage and reimbursement, demand for
our products may be reduced thereby harming our sales and
profitability.
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If product liability lawsuits are brought against us, we
may incur substantial liabilities. |
The clinical testing and commercialization of pharmaceutical
products involves significant exposure to product liability
claims. If losses from such claims exceed our liability
insurance coverage, we may incur substantial liabilities.
Whether or not we were ultimately successful in product
liability litigation, such litigation could consume substantial
amounts of our financial and managerial resources, and might
result in adverse publicity, all of which would impair our
business. We may not be able to maintain our clinical trial
insurance or product liability insurance at an acceptable cost,
if at all, and this insurance may not provide adequate coverage
against potential claims or losses. If we are required to pay a
product liability claim, we may not have sufficient financial
resources to complete development or commercialization of any of
our product candidates and our business and results of
operations will be harmed.
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If our promotional activities fail to comply with the
regulations and guidelines of the various relevant regulatory
agencies, we may be subject to warnings or enforcement action
that could harm our business. |
Physicians may prescribe drugs for uses that are not described
in the products labeling for uses that differ from those
tested in clinical studies and approved by the FDA or similar
regulatory authorities in other countries. These
off-label uses are common across medical specialties
and may constitute the best treatment for many patients in
varied circumstances. Regulatory authorities generally do not
regulate the behavior of physicians in their choice of
treatments. Regulatory authorities do, however, restrict
communications on the subject of off-label use. Companies cannot
actively promote approved drugs for off-label uses, but in some
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countries outside of the E.U. they may disseminate to physicians
articles published in peer-reviewed journals that discuss
off-label uses of approved products. To the extent allowed, we
may disseminate peer-reviewed articles on our products to our
physician customers. We believe our promotional activities are
currently in compliance with the regulations and guidelines of
the various regulatory authorities. If, however, our promotional
activities fail to comply with these regulations or guidelines,
we may be subject to warnings from, or enforcement action by,
these authorities. Furthermore, if the discussion of off-label
use in peer-reviewed journals, or the dissemination of these
articles, is prohibited, it may harm demand for our products.
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We are subject to numerous complex regulatory requirements
and failure to comply with these regulations, or the cost of
compliance with these regulations, may harm our business. |
The testing, development and manufacturing of our products are
subject to regulation by numerous governmental authorities in
the U.S., Europe and elsewhere. These regulations govern or
affect the testing, manufacture, safety, labelling, storage,
record-keeping, approval, advertising and promotion of our
products and product candidates, as well as safe working
conditions and the experimental use of animals. Noncompliance
with any applicable regulatory requirements can result in
refusal of the government to approve products for marketing,
criminal prosecution and fines, recall or seizure of products,
total or partial suspension of production, prohibitions or
limitations on the commercial sale of products or refusal to
allow us to enter into supply contracts. Regulatory authorities
typically have the authority to withdraw approvals that have
been previously granted.
The regulatory requirements relating to the manufacturing,
testing, and marketing of our products may change from time to
time. For example, at present, member states in the E.U. are in
the process of incorporating into their domestic laws the
provisions contained in the E.U. Directive on the implementation
of good clinical practice in the conduct of clinical trials. The
Directive imposes more onerous requirements in relation to
certain aspects of the conduct of clinical trials than are
currently in place in many member states. This may impact our
ability to conduct clinical trials and the ability of
independent investigators to conduct their own research with
support from us.
Risks Related to Our Common Stock
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Our certificate of incorporation, our bylaws and Delaware
law contain provisions that could discourage, delay or prevent a
change in control or management of Pharmion. |
Our amended and restated certificate of incorporation and bylaws
contain provisions which could delay or prevent a third party
from acquiring shares of our common stock or replacing members
of our board of directors, each of which certificate of
incorporation provisions can only be amended or repealed upon
the consent of 80% of our outstanding shares. Our amended and
restated certificate of incorporation allows our board of
directors to issue up to 10,000,000 shares of preferred
stock. The board can determine the price, rights, preferences
and privileges of those shares without any further vote or
action by the stockholders. As a result, our board of directors
could make it difficult for a third party to acquire a majority
of our outstanding voting stock, for example by adopting a
stockholders rights plan.
Our amended and restated certificate of incorporation also
provides that the members of the board are divided into three
classes. Each year the terms of approximately one-third of the
directors will expire. Our bylaws do not permit our stockholders
to call a special meeting of stockholders. Under our bylaws,
only our Chief Executive Officer, Chairman of the Board or a
majority of the board of directors are able to call special
meetings. The staggering of directors terms of office and
the limitation on the ability of stockholders to call a special
meeting may make it difficult for stockholders to remove or
replace the board of directors should they desire to do so.
Since management is appointed by the board of directors, any
inability to effect a change in the board may result in the
entrenchment of management. Our bylaws also require that
stockholders give advance notice to our Secretary of any
nominations for director or other business to be brought by
stockholders at any stockholders meeting. These provisions
may delay or prevent changes of control or management, either by
third parties or by stockholders seeking to change control or
management.
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We are also subject to the anti-takeover provisions of
Section 203 of the Delaware General Corporation Law. Under
these provisions, if anyone becomes an interested
stockholder, we may not enter into a business
combination with that person for three years without
special approval, which could discourage a third party from
making a takeover offer and could delay or prevent a change of
control. For purposes of Section 203, interested
stockholder means, generally, someone owning 15% or more
of our outstanding voting stock or an affiliate of ours that
owned 15% or more of our outstanding voting stock during the
past three years, subject to certain exceptions as described in
Section 203.
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Our stock price has been and may continue to be volatile
and your investment in our common stock could suffer a decline
in value. |
We only recently completed our initial public offering. An
active trading market for our common stock may not continue to
develop or be sustained. Since our initial public offering, the
price of our common stock as reported by the Nasdaq National
Market has ranged from a low of $11.00 to a high of $58.49.
Some specific factors that may have a significant effect on our
common stock market price include:
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actual or anticipated fluctuations in our operating results; |
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our announcements or our competitors announcements of
clinical trial results or new products; |
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changes in our growth rates or our competitors growth
rates; |
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the timing or results of regulatory submissions or actions with
respect to our products; |
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public concern as to the safety of our products; |
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changes in health care, drug pricing or reimbursement policies
in a country where we sell our products; |
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our inability to raise additional capital; |
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conditions of the pharmaceutical industry or in the financial
markets or economic conditions in general; and |
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changes in stock market analyst recommendations regarding our
common stock, other comparable companies or the pharmaceutical
industry generally. |
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If our officers, directors and the venture capital firms
with which they are affiliated choose to act together, they
could significantly influence matters requiring approval by
stockholders and their interests might not always coincide with
the interests of other stockholders. |
Our officers and directors, and the venture capital firms with
which certain of our directors are affiliated, beneficially own
approximately 17% of our common stock. Accordingly, were these
stockholders to act together they would have significant
influence on all matters requiring approval by our stockholders,
including the election of directors and the approval of mergers
or other business combinations. They may exercise this ability
in a manner that advances their best interests and not
necessarily those of other stockholders.
USE OF PROCEEDS
The proceeds from the sale of common stock pursuant to the
prospectus are solely for the account of the selling
stockholder. We will not receive any proceeds from the sale of
the shares by the selling stockholder.
9
SELLING STOCKHOLDER
The prospectus covers offers and sales of 1,939,600 shares
of our common stock by Celgene.
The table below presents certain information regarding the
beneficial ownership of our common stock outstanding as of
January 27, 2005 by Celgene.
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Maximum | |
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Number of | |
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Shares Owned Prior to Any Offering | |
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Shares Being | |
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Shares Owned After the Completion of | |
Under This Prospectus | |
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Sold Under | |
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the Offering(s) Under This Prospectus(1) | |
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This | |
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Percentage(2) | |
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Prospectus | |
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Percentage(2) | |
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1,939,600 |
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6.1 |
% |
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1,939,600 |
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0 |
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0% |
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(1) |
Assuming that Celgene sells the maximum number of shares
registered under this prospectus. |
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(2) |
The number and percentage of shares beneficially owned is
determined in accordance with Rule 13d-3 of the Securities
Exchange Act of 1934, as amended, and the information is not
necessarily indicative of beneficial ownership for any other
purpose. Under such rule, beneficial ownership includes any
shares as to which Celgene has sole or shared voting power or
investment power and also any shares that Celgene has the right
to acquire within 60 days after January 27, 2005
through the exercise of any stock options or other rights. To
our knowledge, Celgene has sole voting and investment power with
respect to the shares shown as beneficially owned. The
percentages of beneficial ownership are based on
31,809,150 shares of our common stock outstanding as of
January 27, 2005 (assuming no exercise of outstanding stock
options after that date). We do not know when or in what amounts
Celgene may offer shares for sale. Celgene might not sell any or
all of the shares offered by this prospectus. Because Celgene
may offer all or some of the shares pursuant to this prospectus,
we cannot estimate the number of the shares that will be held by
Celgene after completion of any offering. For purposes of this
table only, we have assumed that, after completion of the
offering, none of the shares covered by this prospectus will be
held by Celgene. |
Relationship and Agreements with Celgene
In November 2001, we issued warrants to Celgene to purchase in
the aggregate 1,701,805 shares of Series B preferred
stock at an exercise price of $2.09 per share of
Series B preferred stock. In November 2003, these warrants
were converted to warrants to purchase in the aggregate
425,452 shares of common stock at an exercise price of
$8.36 per share. In September 2004, these warrants were
exercised.
In April 2003, we issued warrants to Celgene to purchase in the
aggregate 363,637 shares of common stock at an exercise
price of $11.00 per share. In September 2004, these
warrants were exercised.
In April 2003, we issued a promissory note to Celgene in the
aggregate principal amount of $12,000,000 due April 8,
2008. The promissory note accrued interest at a rate of
6% per annum and was convertible into common stock at a
price of $11.00 per share. The note was converted into
1,150,511 shares of common stock on March 1, 2004.
We have licensed rights relating to the use of thalidomide from
Celgene and separately have a thalidomide supply agreement with
Celgene UK Manufacturing II Limited (formerly known as
Penn T Limited), or CUK. The territory licensed from
Celgene is for all countries other than the United States,
Canada, Mexico, Japan and all provinces of China (except Hong
Kong), or the Territory. More specifically, under
agreements with Celgene, we obtained the rights in the Territory
to Celgenes formulation of thalidomide, Thalomid®,
exclusive licenses or sublicenses for the intellectual property
owned or licensed by Celgene relating to thalidomide, as well as
all existing and future clinical data relating to thalidomide
developed by Celgene, and an exclusive license to employ
Celgenes patented and proprietary S.T.E.P.S. program in
connection with the distribution of thalidomide in the
Territory. Under agreements with CUK, CUK supplies to us a
formulation of thalidomide that we sell in certain territories
licensed to us by Celgene. We pay (i) Celgene a
royalty/license fee of 8% on our net sales of thalidomide under
the terms of the license agreements and (ii) CUK product
supply payments equal to 15.5% of our net sales of thalidomide
under the
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terms of the product supply agreement. In connection with our
ongoing relationship with Celgene, and to further the clinical
development of thalidomide, particularly in multiple myeloma, we
have also agreed to fund an aggregate of $10 million,
including amounts remaining under the initial 2003 clinical
trials agreement, of Celgenes clinical trial development
costs for clinical studies of thalidomide incurred between
January 1, 2005 and December 31, 2007. The agreements
with Celgene and CUK each have a ten-year term running from the
date of receipt of our first regulatory approval for thalidomide
in the United Kingdom. In October of 2004, Celgene acquired CUK.
Celgene is a party to that certain Amended and Restated
Investors Rights Agreement, dated as of November 30,
2001, as amended April 8, 2003, by and among the
Registrant, the founders and the holders of the
Registrants Preferred Stock, as amended.
PLAN OF DISTRIBUTION
We are registering 1,939,600 shares of common stock on
behalf of the selling stockholder. The selling stockholder may
sell the shares from time to time in one or more transactions on
the Nasdaq National Market or otherwise, at market prices
prevailing at the time of sale, at a fixed offering price which
may be changed, at varying prices determined at the time of sale
or at negotiated prices. The selling stockholder may, subject to
market conditions, dispose of its entire holding of our common
stock shortly after the registration statement relating to this
prospectus is declared effective. The shares may be sold at
various times by one or more means, including but not limited to
the following:
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through underwriters, brokers or dealers (who may act as agent
or principal and who may receive compensation in the form of
discounts, concessions or commissions from the selling
stockholder, the purchaser or such other persons who may be
effecting sales hereunder) for resale to the public or to
institutional investors at various times; |
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through negotiated transactions, including, but not limited to,
block trades in which the broker or dealer so engaged will
attempt to sell the shares as agent but may position and resell
a portion of the block as principal to facilitate the
transaction; |
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through purchases by a broker or dealer as principal and resale
by that broker or dealer for its account; |
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on any national securities exchange or quotation service on
which the shares may be listed or quoted at the time of sale at
market prices prevailing at the time of sale, at prices related
to such prevailing market prices, or at negotiated prices; |
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in private transactions other than exchange or quotation service
transactions; |
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short sales, purchases or sales of put, call or other types of
options, forward delivery contracts, swaps, offerings of
structured equity-linked securities or other derivative
transactions or securities; |
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hedging transactions, including, but not limited to: |
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transactions with a broker-dealer or its affiliate, whereby the
broker-dealer or its affiliate will engage in short sales of
shares and may use shares to close out its short position; |
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options or other types of transactions that require the delivery
of shares to a broker-dealer or an affiliate thereof, who will
then resell or transfer the shares; or |
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loans or pledges of shares to a broker-dealer or an affiliate,
who may sell the loaned shares or, in an event of default in the
case of a pledge, sell the pledged shares; |
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through offerings of securities exercisable, convertible or
exchangeable for shares, including, without limitation,
securities issued by trusts, investment companies or other
entities; |
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offerings directly to one or more purchasers, including
institutional investors; |
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through ordinary brokerage transactions and transactions in
which a broker solicits purchasers; |
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through distribution to the securityholders of the selling
stockholder; |
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by pledge to secure debts and other obligations; |
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through a combination of any such methods of sale; or |
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through any other method permitted under applicable law and not
otherwise prohibited by this prospectus. |
The selling stockholder also may resell all or a portion of its
shares in open market transactions in reliance upon
Rule 144 under the Securities Act of 1933, as amended,
provided it meets the criteria and conforms to the requirements
of Rule 144.
The selling stockholder may offer and sell shares other than for
cash. In such event, any required details of the transaction
will be set forth in a prospectus supplement.
To the extent required, a prospectus supplement will set forth
the terms of any offering of the shares by the selling
stockholder including but not limited to the following:
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the name or names of any underwriters, dealers or agents and the
amounts of shares underwritten or purchased by each of
them; and |
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the public offering price of the shares and the proceeds to the
selling stockholder and any discounts, commissions or
concessions allowed or reallowed or paid to dealers. |
Any public offering price and any discounts or concessions
allowed or reallowed or paid to dealers may be changed from time
to time. Broker-dealers engaged by the selling stockholder may
allow other broker-dealers to participate in resales.
The selling stockholder will bear all underwriting discounts and
selling commissions and fees and disbursements of their own
counsel related to the sale of the shares. In compliance with
NASD guidelines, the maximum commission or discount to be
received by any NASD member or independent broker dealer may not
exceed 8% of the aggregate amount of the securities offered
pursuant to this prospectus and any applicable prospectus
supplement. We have agreed to pay substantially all of the other
expenses incidental to the registration, offering and sale of
the shares.
If underwriters are used in the sale of any shares, the shares
will be acquired by the underwriters for their own account and
may be resold from time to time in one or more transactions,
including negotiated transactions, at a fixed public offering
price or at varying prices determined at the time of sale. The
shares may be offered to the public either through underwriting
syndicates represented by managing underwriters or directly by
underwriters. Generally, the underwriters obligations to
purchase the shares will be subject to certain conditions
precedent.
The selling stockholder may sell the shares through agents from
time to time. To the extent required, the prospectus supplement
will name any agent involved in the offer or sale of the shares
and any commissions the selling stockholder pay to them.
Generally, any agent will be acting on a best efforts basis for
the period of its appointment.
Agents and underwriters may be entitled to indemnification by
the selling stockholder and/or us against certain civil
liabilities, including liabilities under the Securities Act of
1933, as amended, or to contribution with respect to payments
which the agents or underwriters may be required to make in
respect thereof. Agents and underwriters may be customers of,
engage in transactions with, or perform services for the selling
stockholder and/or us in the ordinary course of business.
Any underwriters, broker-dealers or agents participating in the
distribution of the shares covered by this prospectus may be
deemed to be underwriters within the meaning of the
Securities Act of 1933, as amended, and any commissions received
by any of those underwriters, broker-dealers or agents may be
deemed to be underwriting commissions under the Securities Act
of 1933, as amended.
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LEGAL MATTERS
The validity of the issuance of the common stock offered by this
prospectus and certain other legal matters are being passed upon
for us by our counsel, Willkie Farr & Gallagher LLP,
New York, New York. Peter H. Jakes, a partner at Willkie
Farr & Gallagher LLP, owns 9,202 shares of our
common stock, as a joint tenant with his spouse.
EXPERTS
The consolidated financial statements of Pharmion Corporation
appearing in Pharmion Corporations Annual Report
(Form 10-K) for the year ended December 31, 2003, have
been audited by Ernst & Young LLP, independent
registered public accounting firm, as set forth in their report
thereon included therein and incorporated herein by reference.
Such consolidated financial statements are incorporated herein
by reference in reliance upon such report given on the authority
of such firm as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and current reports, proxy statements
and other information with the SEC. We have also filed with the
SEC a registration statement on Form S-3 to register the
common stock being offered pursuant to this prospectus. This
prospectus, which forms part of the registration statement, does
not contain all of the information included in the registration
statement. For further information about us or Celgene and the
shares of common stock offered pursuant to this prospectus, you
should refer to the registration statement and its exhibits.
Our annual reports on Form 10-K, along with all other
reports and amendments filed with or furnished to the SEC are
publicly available free of charge on the investor relations
section of our website as soon as reasonably practicable after
we file such materials with, or furnish them to, the SEC. Our
website is located at http://www.pharmion.com. The information
on our website is not part of this or any other report that we
file with, or furnish to, the SEC. The SEC maintains an Internet
site (http://www.sec.gov) that contains reports, proxy and
information statements, and other information regarding issuers
that file electronically with the SEC. You may also read and
copy any documents we file with the SEC at its Public Reference
Room at 450 Fifth Street, N.W., Judiciary Plaza, Washington
D.C. 20549. You may obtain information on the operations of the
Public Reference Room by calling the SEC at 1-800-SEC-0330.
INCORPORATION BY REFERENCE
We are incorporating by reference in the prospectus the
information we file with the SEC. This means that we can
disclose important information to you by referring you to those
documents. The information incorporated by reference is an
important part of this prospectus, and information that we file
later with the SEC will automatically update and supersede this
information. We are incorporating by reference our documents
listed below and any filings we make with the SEC under
Section 13(a), 13(c), 14 or 15(d) of the Securities
Exchange Act of 1934 after the date of the initial registration
statement of which this prospectus is a part and before the
effective date of the registration statement or after the date
of such initial registration statement until all of the
securities offered under this prospectus are sold.
The following documents filed with the SEC are incorporated by
reference in this prospectus:
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Our Annual Report on Form 10-K for the fiscal year ended
December 31, 2003; |
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Our Quarterly Reports on Form 10-Q for the quarters ended
March 31, 2004, June 30, 2004 and September 30,
2004; |
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Our Current Reports on Form 8-K dated February 12,
2004, February 23, 2004, March 10, 2004, May 4,
2004, May 5, 2004, May 20, 2004, May 21, 2004,
June 9, 2004, July 1, 2004, July 2, 2004,
August 4, 2004, September 22, 2004, September 27,
2004, October 15, 2004, October 18, 2004,
October 26, 2004, December 9, 2004, December 15,
2004 and January 12, 2005; and |
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The description of our common stock contained in our
Registration Statement on Form 8-A, filed on
October 30, 2003, including any amendment or report filed
for the purpose of updating such description. |
You may request a copy of these filings at no cost, by writing
or telephoning us at the following address:
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Pharmion Corporation |
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2525 28th Street |
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Boulder, CO 80301 |
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(720) 564-9100 |
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Attn: Investor Relations |
You should rely only on the information incorporated by
reference or provided in this prospectus. Neither we nor the
selling stockholder have authorized anyone else to provide you
with different information. The selling stockholder is not
making an offer of these securities in any state where the offer
is not permitted. You should not assume that the information in
this prospectus is accurate as of any date other than the date
on the front of those documents.
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