Unassociated Document
PROSPECTUS
$100,000,000
Keryx
Biopharmaceuticals, Inc.
Common
Stock
Warrants
We may
offer and sell an indeterminate number of shares of our common stock and/or
warrants from time to time under this prospectus. You should read this
prospectus and any prospectus supplement carefully before you
invest.
We may offer our common stock and/or
warrants in one or more offerings in amounts, at prices, and on terms determined
at the time of the offering. We may sell our common stock and warrants through
agents we select or through underwriters and dealers we select. If we use
agents, underwriters or dealers, we will name them and describe their
compensation in a prospectus supplement.
This
prospectus provides a general description of the securities we may offer. Each
time we sell securities, we will provide specific terms of the securities
offered in a supplement to this prospectus. The prospectus supplement may also
add, update or change information contained in this prospectus. You should read
this prospectus and the applicable prospectus supplement carefully before you
invest in any securities. This prospectus may not be used to consummate a sale
of securities unless accompanied by the applicable prospectus
supplement.
Our
common stock is traded on the Nasdaq Capital Market under the symbol “KERX.” On
December 31, 2010, the per share closing price of our common stock as reported
on the Nasdaq Capital Market was $4.58 per share.
Investing
in our securities involves certain risks. See “Risk Factors” in our Annual
Report on Form 10-K for the year ended December 31, 2009, as well as our
Quarterly Reports on Form 10-Q for the periods ended March 31, 2010, June 30,
2010 and September 30, 2010, which have been filed with the SEC and are
incorporated by reference into this prospectus. You should read the entire
prospectus carefully before you make your investment decision.
Neither
the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus is
truthful or complete. Any representation to the contrary is a criminal
offense.
The date
of this prospectus
is January 28, 2011.
Table of
Contents
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Page
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Keryx
Biopharmaceuticals, Inc.
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1
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The
Offering
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1
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Where
You Can Find More Information
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1
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Important
Information About This Prospectus
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2
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Incorporation
of Certain Information by Reference
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2
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Description
of Securities We May Offer
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3
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Description
of Common Stock
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3
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Description
of Warrants
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4
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Plan
of Distribution
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5
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Legal
Matters
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6
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Experts
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6
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KERYX
BIOPHARMACEUTICALS, INC.
We are a
biopharmaceutical company focused on the acquisition, development and
commercialization of medically important pharmaceutical products for the
treatment of life-threatening diseases, including cancer and renal disease. We
are developing KRX-0401, which we also refer to as perifosine, a novel,
potentially first-in-class, oral anti-cancer agent that inhibits Akt activation
in the phosphoinositide 3-kinase pathway, and also affects a number of other key
signal transduction pathways, including the JNK pathway, all of which are
pathways associated with programmed cell death, growth, differentiation and
survival. KRX-0401 has demonstrated both safety and clinical efficacy in several
tumor types, both as a single agent and in combination with novel therapies.
KRX-0401 is currently in Phase 3 clinical development for both refractory
advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2 clinical
development for several other tumor types. Each of the KRX-0401 Phase 3 programs
is being conducted under Special Protocol Assessment, or SPA, agreements with
the FDA.
We are
also developing Zerenex™, also known as ferric citrate, an oral, ferric
iron-based compound that has the capacity to bind to phosphate and form
non-absorbable complexes. Zerenex is currently in Phase 3 clinical development,
also under an SPA, as a treatment for hyperphosphatemia (elevated phosphate
levels) in patients with end-stage renal disease. Zerenex has also completed
Phase 2 development in Japan by our Japanese partners, Japan Tobacco Inc. and
Torii Pharmaceutical Co., Ltd.. The Phase 3 program in Japan is pending
commencement.
We also
actively engage in business development activities that include seeking
strategic relationships for our product candidates, as well as evaluating
compounds and companies for in-licensing or acquisition. To date, we have not
received approval for the sale of any of our drug candidates in any market and,
therefore, have not generated any product sales from our drug candidates. We
have generated, and expect to continue to generate, revenue from the licensing
of rights to Zerenex in Japan to our Japanese partners, Japan Tobacco and
Torii.
Our
principal executive offices are located at 750 Lexington Avenue, New York, New
York 10022, and our telephone number is (212) 531-5965. We maintain a website on
the Internet at www.keryx.com and our e-mail address is info@keryx.com. Our
Internet website, and the information contained on it, are not to be considered
part of this prospectus.
THE
OFFERING
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Use
of Proceeds
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We
intend to use the net proceeds of any offering as set forth in the
applicable prospectus supplement.
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Nasdaq
Symbol
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KERX
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WHERE
YOU CAN FIND MORE INFORMATION
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We file
annual, quarterly and current reports, proxy statements and other information
with the Securities and Exchange Commission, or SEC. You may read and copy, at
prescribed rates, any documents we have filed with the SEC at its Public
Reference Room located at 100 F Street, N.E., Washington, D.C. 20549. You may
obtain information on the operation of the Public Reference Room by calling the
SEC at 1-800-SEC-0330. We also file these documents with the SEC electronically.
You can access the electronic versions of these filings on the SEC’s Internet
website found at http://www.sec.gov. You can also obtain copies of materials we
file with the SEC from our Internet website found at www.keryx.com. Our stock is
quoted on the Nasdaq Capital Market under the symbol “KERX.”
IMPORTANT
INFORMATION ABOUT THIS PROSPECTUS
This
prospectus is part of a “shelf” registration statement that we filed with the
SEC. By using a shelf registration statement, we may sell our securities, as
described in this prospectus, from time to time in one or more offerings. We may
use the shelf registration statement to offer and sell securities described in
this prospectus. Each time we sell securities, we will provide a prospectus
supplement to this prospectus that contains specific information about the terms
of such offering. The supplement may also add, update or change information
contained in this prospectus. Before purchasing any securities, you should
carefully read both this prospectus and any supplement, together with the
additional information incorporated into this prospectus or described under the
heading “Where You Can Find More Information.”
You
should rely only on the information contained or incorporated by reference in
this prospectus and any prospectus supplement. We have not authorized any other
person to provide you with different information. If anyone provides you with
different or inconsistent information, you should not rely on it. We will not
make an offer to sell securities in any jurisdiction where the offer or sale is
not permitted. You should assume that the information appearing in this
prospectus, as well as information we previously filed with the SEC and have
incorporated by reference, is accurate as of the date on the front cover of this
prospectus only, or when such document was filed with the SEC. Our business,
financial condition, results of operations and prospects may have changed since
the relevant date.
We will
not use this prospectus to offer and sell securities unless it is accompanied by
a prospectus supplement that more fully describes the terms of the
offering.
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
The SEC
allows us to “incorporate by reference” into this prospectus the information we
file with the SEC. This means that we can disclose important information to you
by referring you to those documents without restating that information in this
document. The information incorporated by reference into this prospectus is
considered to be part of this prospectus, and information we file with the SEC
pursuant to Section 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of
1934, as amended, or the Exchange Act, after the date of this prospectus and
prior to the termination of this offering, will automatically update and
supersede the information contained in this prospectus and documents listed
below. We incorporate by reference into this prospectus the documents listed
below, except to the extent information in those documents differs from
information contained in this prospectus, and any future filings made by us with
the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act, including
exhibits:
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(a)
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Our
Annual Report on Form 10-K for the year ended December 31,
2009;
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(b)
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Our
Quarterly Report on Form 10-Q for the quarter ended March 31,
2010;
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(c)
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Our
Quarterly Report on Form 10-Q for the quarter ended June 30,
2010;
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(d)
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Our
Quarterly Report on Form 10-Q for the quarter ended September 30,
2010;
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(e)
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Our
Current Reports on Form 8-K filed with the SEC on January 5, 2010, January
25, 2010, July 14, 2010, July 21, 2010, August 5, 2010, September 29,
2010, October 26, 2010 and November 30, 2010;
and
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(f)
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The
description of our common stock contained in our registration statement on
Form 8-A filed with the SEC on June 30, 2000 (File No.
000-30929).
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We will
provide to each person, including any beneficial owner, to whom a copy of this
prospectus is delivered, a copy of any or all of the information that we have
incorporated by reference into this prospectus. We will provide this information
upon written or oral request at no cost to the requester. You may request this
information by contacting our corporate headquarters at the following address:
750 Lexington Avenue, New York, New York 10022, Attn: Chief Financial Officer,
or by calling (212) 531-5965.
DESCRIPTION
OF SECURITIES WE MAY OFFER
This
prospectus contains summary descriptions of our common stock and warrants to
purchase common stock that we may offer from time to time. These summary
descriptions are not meant to be complete descriptions of each security. The
particular terms of any security will be described in the related prospectus
supplement.
DESCRIPTION
OF COMMON STOCK
The
following summary of the terms of our common stock may not be complete and is
subject to, and qualified in its entirety by reference to, the terms and
provisions of our amended and restated certificate of incorporation and our
amended and restated bylaws. You should refer to, and read this summary together
with, our amended and restated certificate of incorporation and amended and
restated bylaws to review all of the terms of our common stock that may be
important to you.
Common
Stock
Under our
certificate of incorporation, we are authorized to issue a total of 95,000,000
shares of common stock, par value $0.001 per share. As of December 31, 2010 we
had issued and outstanding 61,441,535 shares of our common stock. There are
approximately 63 holders of record. All outstanding shares of our common stock
are fully paid and nonassessable. Our common stock is listed on the Nasdaq
Capital Market under the symbol “KERX.”
Dividends
Holders
of our common stock are entitled to participate equally in dividends when our
Board of Directors declares dividends on our common stock out of legally
available funds. We have never declared or paid any cash dividends on our common
stock and do not anticipate paying any such cash dividends in the foreseeable
future. Future dividends, if any, will be determined by our Board of Directors
and will be based upon our earnings, capital requirements and operating and
financial condition, among other factors, at the time any such dividends are
considered by our Board of Directors.
Voting
Rights
The
holders of our common stock are entitled to one vote for each share of common
stock held. Generally, the vote of the majority of the shares represented at a
meeting of the stockholders and entitled to vote is sufficient for actions that
require a vote of the stockholders.
Liquidation
and Dissolution
In the
event of our liquidation, dissolution, or winding up, voluntarily or
involuntarily, holders of our common stock will have the right to a ratable
portion of the assets remaining after satisfaction in full of the prior rights
of our creditors and of all liabilities.
Other
Holders
of our common stock are not entitled to any preemptive or preferential right to
purchase or subscribe for shares of capital stock of any class and have no
conversion or sinking fund rights.
Transfer
Agent
American
Stock Transfer and Trust Company serves as the transfer agent and registrar for
all of our common stock.
DESCRIPTION
OF WARRANTS
We may
issue warrants to purchase shares of our common stock. We may issue warrants
independently or together with other securities. Warrants sold with other
securities may be attached to or separate from the other
securities.
The
prospectus supplement relating to any warrants we offer will include specific
terms relating to the offering. These terms will include some or all of the
following:
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the
title of the warrants;
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the
aggregate number of warrants
offered;
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the
designation, number and terms of the shares of common stock purchasable
upon exercise of the warrants and procedures by which those numbers may be
adjusted;
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the
exercise price of the warrants;
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the
dates or periods during which the warrants are
exercisable;
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the
designation and terms of any securities with which the warrants are
issued;
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if
the warrants are issued as a unit with another security, the date on and
after which the warrants and the other security will be separately
transferable;
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if
the exercise price is not payable in U.S. dollars, the foreign currency,
currency unit or composite currency in which the exercise price is
denominated;
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any
minimum or maximum amount of warrants that may be exercised at any one
time;
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any
terms relating to the modification of the
warrants;
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any
terms, procedures and limitations relating to the transferability,
exchange or exercise of the warrants;
and
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any
other specific terms of the
warrants.
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PLAN
OF DISTRIBUTION
We may
sell the securities covered in this prospectus in any of three ways (or in any
combination):
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through
underwriters or dealers;
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directly
to a limited number of purchasers or to a single purchaser;
or
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Each time
that we use this prospectus to sell securities, we will also provide a
prospectus supplement that contains the specific terms of the offering. The
prospectus supplement will set forth the terms of the offering of the
securities, including:
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the
name or names of any underwriters, dealers or agents and the amounts of
any securities underwritten or purchased by each of them;
and
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the
public offering price of the common stock and the proceeds to us and any
discounts, commissions or concessions allowed or reallowed or paid to
dealers.
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Any
public offering price and any discounts or concessions allowed or reallowed or
paid to dealers may be changed from time to time.
If
underwriters are used in the sale of any securities, the securities 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 securities may be either offered to the public through underwriting
syndicates represented by managing underwriters, or directly by underwriters.
Generally, the underwriters’ obligations to purchase the securities will be
subject to certain conditions precedent. The underwriters will be obligated to
purchase all of the securities if they purchase any of securities.
We may
sell the securities through agents from time to time. The prospectus supplement
will name any agent involved in the offer or sale of the securities and any
commissions we pay to them. Generally, any agent will be acting on a best
efforts basis for the period of its appointment.
We may
authorize underwriters, dealers or agents to solicit offers by certain
purchasers to purchase the securities from us at the public offering price set
forth in the prospectus supplement pursuant to delayed delivery contracts
providing for payment and delivery on a specified date in the future. The
contracts will be subject only to those conditions set forth in the prospectus
supplement, and the prospectus supplement will set forth any commissions we pay
for solicitation of these contracts.
Agents
and underwriters may be entitled to indemnification by 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 us in the ordinary
course of business.
We may
enter into derivative transactions with third parties, or sell securities not
covered by this prospectus to third parties in privately negotiated
transactions. If the applicable prospectus supplement indicates, in connection
with those derivatives, the third parties may sell securities covered by this
prospectus and the applicable prospectus supplement, including in short sale
transactions. If so, the third party may use securities pledged by us or
borrowed from us or others to settle those sales or to close out any related
open borrowings of securities, and may use securities received from us in
settlement of those derivatives to close out any related open borrowings of
securities. The third party in such sale transactions will be an underwriter and
will be identified in the applicable prospectus supplement (or a post-effective
amendment).
In
compliance with the guidelines of the Financial Services Regulatory Authority,
Inc., or FINRA, the maximum compensation to be received by a FINRA member or
independent broker-dealer may not exceed 8% of the offering proceeds. It is
anticipated that the maximum compensation to be received in any particular
offering of securities will be less than this amount.
LEGAL
MATTERS
The
legality and validity of the securities offered from time to time under this
prospectus will be passed upon by Alston & Bird LLP, New York, New
York.
EXPERTS
The
consolidated financial statements of Keryx Biopharmaceuticals, Inc. and
subsidiaries as of December 31, 2009, and for the year ended December 31, 2009,
have been incorporated by reference herein and in the registration statement in
reliance upon the report of UHY LLP, independent registered public accounting
firm, incorporated by reference herein, and upon the authority of said firm as
experts in accounting and auditing.
The
consolidated financial statements of Keryx Biopharmaceuticals, Inc. and
subsidiaries as of December 31, 2008, and for the years ended December 31, 2008
and December 31, 2007, have been incorporated by reference herein and in the
registration statement in reliance upon the report of KPMG LLP, independent
registered public accounting firm, incorporated by reference herein, and upon
the authority of said firm as experts in accounting and auditing. The
audit report covering the consolidated financial statements of Keryx
Biopharmaceuticals, Inc. and subsidiaries as of December 31, 2008, and for the
years ended December 31, 2008 and December 31, 2007, contains an explanatory
paragraph that states that our substantial recurring losses from operations,
deficiency in equity, limited cash, cash equivalents and short-term investment
securities, and illiquid investments in auction rate securities raise
substantial doubt about our ability to continue as a going concern. The
consolidated financial statements do not include any adjustments that might
result from the outcome of that uncertainty. The audit report also refers to our
change in method of accounting for the fair value of financial assets and
liabilities in 2008 due to the adoption of a new accounting requirement issued
by the Financial Accounting Standards Board.