AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON DECEMBER 12, 2003
REGISTRATION NO. 333-
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
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KERYX BIOPHARMACEUTICALS, INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
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DELAWARE 13-4087132
(STATE OR OTHER JURISDICTION OF (I.R.S. EMPLOYER
INCORPORATION OR ORGANIZATION) IDENTIFICATION NO.)
750 LEXINGTON AVENUE
NEW YORK, NEW YORK 10022
(212) 531-5965
(ADDRESS, INCLUDING ZIP CODE, AND TELEPHONE NUMBER, INCLUDING AREA CODE, OF
REGISTRANT'S PRINCIPAL EXECUTIVE OFFICES)
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RON BENTSUR
VICE PRESIDENT FINANCE AND INVESTOR RELATIONS
KERYX BIOPHARMACEUTICALS, INC.
750 LEXINGTON AVENUE
NEW YORK, NEW YORK 10022
(212) 531-5965
(NAME, ADDRESS, INCLUDING ZIP CODE, AND TELEPHONE NUMBER INCLUDING AREA CODE, OF
AGENT FOR SERVICE)
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The Commission is requested to send copies of all communications to:
MARK F. MCELREATH
ALSTON & BIRD LLP
90 PARK AVENUE
NEW YORK, NEW YORK 10016-1387
(212) 210-9400
APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC: From time
to time after the registration statement becomes effective.
If the only securities being registered on this Form are being offered
pursuant to dividend or interest reinvestment plans, please check the following
box. [ ]
If any of the securities being registered on this Form are to be offered
on a delayed or continuous basis pursuant to Rule 415 under the Securities Act
of 1933, other than securities offered only in connection with dividend or
interest reinvestment plans, check the following box. [X]
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following box
and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. [ ]
If this Form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the state offering. [ ]
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. [ ]
CALCULATION OF REGISTRATION FEE
TITLE OF PROPOSED PROPOSED
EACH CLASS OF AMOUNT MAXIMUM MAXIMUM
SECURITIES TO TO BE OFFERING PRICE AGGREGATE AMOUNT OF
BE REGISTERED REGISTERED (1) PER UNIT OFFERING PRICE REGISTRATION FEE
------------- -------------- -------- -------------- ----------------
Common Stock, $0.001 par value per share 3,529,412 shares $4.70 (2) $16,588,236 (2) $ 1,342
Common Stock, $0.001 par value per share 705,883 shares (3) $6.00 (4) $ 4,235,298 (4) $ 343
Common Stock, $0.001 par value per share 50,000 shares (5) $6.00 (6) $ 300,000 (6) $ 24
(1) Pursuant to Rule 416 under the Securities Act of 1933, as amended, such
number of shares of common stock registered hereby shall include an
indeterminate number of shares of common stock that may be issued in
connection with a stock split, stock dividend, recapitalization or similar
event.
(2) Estimated solely for purposes of determining the registration fee. This
amount, calculated pursuant to Rule 457(c), was based on the average of
the high and low prices of the Registrant's common stock on December 11,
2003, as reported on the Nasdaq Stock Market.
(3) Issuable upon exercise of warrants issued to the selling stockholders.
(4) The price is estimated in accordance with Rule 457(g) under the Securities
Act of 1933, as amended, solely for the purpose of calculating the
registration fee and is $6.00, the exercise price of the warrants issued
to the selling stockholders.
(5) Issuable upon exercise of warrants issued to Rodman & Renshaw, Inc.
(6) The price is estimated in accordance with Rule 457(g) under the Securities
Act of 1933, as amended, solely for the purpose of calculating the
registration fee and is $6.00, the exercise price of the warrants issued
to Rodman & Renshaw, Inc.
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR
DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL
FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION
STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(A) OF
THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE SECURITIES AND EXCHANGE COMMISSION, ACTING
PURSUANT TO SAID SECTION 8(A), MAY DETERMINE.
THE INFORMATION IN THIS PROSPECTUS IS NOT COMPLETE AND MAY BE CHANGED. THE
SELLING STOCKHOLDERS NAMED IN THIS PROSPECTUS MAY NOT SELL THESE SECURITIES
UNTIL THE REGISTRATION STATEMENT FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION IS EFFECTIVE. THIS PROSPECTUS IS NOT AN OFFER TO SELL THESE
SECURITIES AND THE SELLING STOCKHOLDERS NAMED IN THIS PROSPECTUS ARE NOT
SOLICITING OFFERS TO BUY THESE SECURITIES IN ANY JURISDICTION WHERE THE OFFER OR
SALE IS NOT PERMITTED.
SUBJECT TO COMPLETION -- DATED DECEMBER __, 2003
PROSPECTUS
4,285,295 SHARES
KERYX BIOPHARMACEUTICALS, INC.
COMMON STOCK
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This prospectus relates to the offer and sale by the selling stockholders
named herein of up to an aggregate of 4,285,295 shares of common stock of Keryx
Biopharmaceuticals, Inc. The number of shares being offered includes 755,883
shares, which are issuable upon the exercise of warrants. The selling
stockholders may, from time to time, sell any or all of their shares of common
stock on the Nasdaq Stock Market or in private transactions using any of the
methods described in the section of this prospectus entitled "Plan of
Distribution." We will not receive any proceeds from the sale of the shares of
our common stock by the selling stockholders other than the exercise price
payable to us upon the exercise of the warrants. We issued these shares of our
common stock to the selling stockholders in a private transaction.
Our common stock is traded on the Nasdaq Stock Market under the symbol
"KERX." On December 11, 2003, the last sales price for the shares of our common
stock as reported on the Nasdaq Stock Market was $4.82 per share.
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INVESTING IN OUR COMMON STOCK INVOLVES A HIGH DEGREE OF RISK. SEE "RISK
FACTORS" BEGINNING ON PAGE 3 OF THIS PROSPECTUS FOR CERTAIN CONSIDERATIONS
RELEVANT TO AN INVESTMENT IN OUR COMMON STOCK.
---------------
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE 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 , 2003
TABLE OF CONTENTS
Page
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Prospectus Summary................................................ 1
Risk Factors...................................................... 3
Forward Looking Statements ....................................... 10
Use of Proceeds................................................... 10
Selling Stockholders.............................................. 11
Plan of Distribution.............................................. 12
Legal Matters..................................................... 12
Experts........................................................... 12
Where You Can Find More Information............................... 12
Incorporation of Certain Information by Reference................. 13
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PROSPECTUS SUMMARY
OUR COMPANY
We are a biopharmaceutical company focused on the acquisition, development
and commercialization of novel pharmaceutical products for the treatment of
life-threatening diseases, including diabetes and cancer.
Our lead compound under development is sulodexide, or KRX-101, to which we
have an exclusive license in North America, Japan and other markets. In 2001,
KRX-101 was granted Fast-Track designation for the treatment of diabetic
nephropathy and, in 2002, we announced that the FDA had agreed, in principle, to
permit us to avail ourselves of the accelerated approval process under subpart H
of the FDA's regulations governing applications for the approval to market a new
drug.
In August 2003, we announced that the Collaborative Study Group, the
largest standing renal clinical trial group in the U.S. comprised of academic
and tertiary nephrology care centers, will conduct the U.S.-based Phase II/III
clinical program for KRX-101 for the treatment of diabetic nephropathy.
In October 2003, we announced that we had initiated a multi-center, Phase
II/III clinical program for our diabetic nephropathy drug candidate, KRX-101.
The Phase II portion of the Phase II/III clinical program will be a randomized,
double-blind, placebo-controlled, study, comparing two doses (200mg and 400mg
daily) of KRX-101, versus placebo. The entire Phase II/III program is expected
to enroll between 750 and 1,000 patients, with the Phase II component enrolling
up to approximately 135 patients. The program is designed to assess the safety
and efficacy of KRX-101 in patients with Type 2 Diabetes who continue to have
persistent microalbuminuria following treatment with maximum approved doses of
ACE inhibitors or A2 receptor blockers. The study will evaluate KRX-101's
ability to regress proteinuria in the study population. The treatment period for
the patients in this trial will be six months. Patients will also be evaluated
two months following the discontinuation of therapy.
To date, we have not received approval for the sale of any of our drug
candidates in any market.
We were incorporated in Delaware in October 1998. We commenced operations
in November 1999, following our acquisition of substantially all of the assets
and certain of the liabilities of Partec Ltd., our predecessor company that
began its operations in January 1997. Since commencing operations, our
activities have been primarily devoted to developing our technologies and drug
candidates, raising capital, purchasing assets for our corporate offices and
laboratory facilities and recruiting personnel. We are a development stage
company and have no product sales to date. Our major sources of working capital
have been proceeds from various private placements of equity securities and from
our initial public offering.
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.
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RECENT DEVELOPMENTS
PRIVATE PLACEMENT
On November 20, 2003, we completed a private placement of 3,529,412 shares
of our common stock at $4.25 per share, together with warrants for the purchase
of an aggregate of 705,883 shares of our common stock at an exercise price of
$6.00, for an aggregate consideration of approximately $15 million in gross
proceeds. In addition, we issued to the placement agent, Rodman & Renshaw, Inc.,
a warrant to purchase up to 50,000 shares of our common stock at an exercise
price of $6.00.
In connection with the private placement, we and our subsidiaries agreed
not to issue or sell any common stock or common stock equivalents, excluding the
issuance of securities issued upon the exercise of currently outstanding options
and warrants, prior to the effective date of this registration statement.
WARRANTS
The warrants issued as part of the private placement have an exercise
price of $6.00, subject to adjustments in connection with stock dividends on our
common stock, and subdivisions, combinations and reclassifications of our common
stock. If at any time after one year from November 20, 2003, the issuance date
of the warrants, there is no effective registration statement registering the
resale of the warrant shares by the selling stockholders, the warrants shall be
exercisable by means of a "cashless exercise." The warrants have a term of
exercise of five years.
If we complete a reorganization, reclassification, merger, consolidation
or disposition of assets, then the holders of the warrants shall have the right
thereafter to receive upon exercise of the warrants, the number of shares of
common stock of the successor or acquiring corporation, and other property
receivable upon or as a result of such reclassification, merger, consolidation
or disposition of assets, by a holder of the number of shares of common stock
for which the warrants are exercisable immediately prior to such event.
We may at any time during the term of the warrant reduce the then current
exercise price to any amount and for any period of time deemed appropriate by
our board of directors; provided, however, that we give notice to the holder,
which notice shall state the number of warrant shares (and other securities or
property) purchasable upon the exercise of the warrant and the exercise price of
such warrant shares (and other securities or property) after such adjustment,
setting forth a brief statement of the facts requiring such adjustment and
setting forth the computation by which such adjustment was made.
From and after the date that is one year following the initial exercise
date, if at any time (a) our common stock is then publicly traded, (b) the
closing price for any 20 consecutive trading days is at least 150% of the
exercise price and (c) the warrant shares can be resold without restriction by
the holder, we shall be entitled to redeem the warrants, or any of them, at a
per warrant share redemption price of $0.001. In the event we elect to redeem
the warrant, we shall provide the holder with a redemption notice within three
trading days. The redemption notice shall set forth when the redemption is to
occur, such date to be no less than 10 days and no more than 30 days from the
date of the redemption notice.
REGISTRATION RIGHTS
We entered into a registration rights agreement with the selling
stockholders on November 12, 2003. The registration rights agreement provides
that we must file a registration statement on or prior to the thirtieth day
following November 12, 2003, covering the resale of all of the shares of our
common stock sold by us under the private placement and all shares of our common
stock issuable upon exercise of the warrants issued to the selling stockholders
as part of the private placement. This prospectus is part of the registration
statement filed to meet our obligations under the registration rights agreement.
We must cause this registration statement to become effective as soon as
practicable, but in no event later than the 60th calendar day, or 75th calendar
day in the event of a full review by the SEC, following November 12, 2003. If
this registration statement is not declared effective by the SEC on or before
the 60th day, or 75th day, if applicable, registration deadline, or if after
this registration statement has been declared effective by the SEC, sales of the
shares of common stock covered by the registration statement cannot be made
pursuant to this registration statement for any reason, then at the time of the
event, we are required to make payments to the selling stockholders in the
amount of 2.0% per month of the aggregate purchase price paid in the private
placement by the selling stockholders for the shares of our common stock held by
the selling stockholders. If we fail to make this payment within seven days
after the date payable, we will pay interest at a rate of 15% per annum (or such
lesser maximum amount that is permitted to be paid by applicable law) to the
holder.
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RISK FACTORS
RISKS RELATING TO OUR BUSINESS
WE HAVE A LIMITED OPERATING HISTORY AND HAVE INCURRED SUBSTANTIAL OPERATING
LOSSES SINCE OUR INCEPTION. WE EXPECT TO CONTINUE TO INCUR LOSSES IN THE FUTURE
AND MAY NEVER BECOME PROFITABLE.
We have a limited operating history. You should consider our prospects in
light of the risks and difficulties frequently encountered by early stage
companies. In addition, we have incurred operating losses since our inception,
expect to continue to incur operating losses for the foreseeable future and may
never become profitable. As of September 30, 2003, we had an accumulated deficit
of approximately $52.4 million. As we expand our research and development
efforts, we will incur increasing losses. We may continue to incur substantial
operating losses even if we begin to generate revenues from our drug candidates
or technologies.
We have not yet commercialized any products or technologies and cannot be
sure we will ever be able to do so. Even if we commercialize one or more of our
drug candidates or technologies, we may not become profitable. Our ability to
achieve profitability depends on a number of factors, including our ability to
complete our development efforts, obtain regulatory approval for our drug
candidates and successfully commercialize our drug candidates and technologies.
IF WE ARE UNABLE TO SUCCESSFULLY COMPLETE OUR CLINICAL TRIALS OF KRX-101, OUR
ABILITY TO ACHIEVE OUR CURRENT BUSINESS STRATEGY WILL BE ADVERSELY AFFECTED.
Whether or not and how quickly we complete clinical trials is dependent in
part upon the rate at which we are able to engage clinical trial sites and,
thereafter, the rate of enrollment of patients. Patient enrollment is a function
of many factors, including the size of the patient population, the proximity of
patients to clinical sites, the eligibility criteria for the study and the
existence of competitive clinical trials. If we experience delays in identifying
and contracting with sites and/or in patient enrollment in our clinical trial
program, we may incur additional costs and delay our development program for
KRX-101.
Additionally, we have submitted a subpart H clinical development plan to
the FDA for the clinical development of KRX-101 for diabetic nephropathy. A
final agreement on the specifics of our clinical program for that development
plan has not been agreed to with the FDA and we cannot give any assurance that
an acceptable final agreement on the specifics of such clinical program will
ever be reached with the FDA. In fact, based on the FDA's comments to our most
recent submission, we believe that additional discussions with the FDA will be
required prior to final agreement on the specifics of our subpart H accelerated
approval clinical program. We cannot assure you that those discussions will take
place or, if they do take place, the timing of such discussions, or that the
results of such discussions will be satisfactory to us. Additionally, the FDA
has stated that based on the novelty of the approach that we have discussed with
them, they would want to refer our proposed approach to the Cardio-Renal
Advisory Committee.
Moreover, even if we are able to reach final agreement with the FDA
regarding the specifics of an accelerated approval approach, no assurance can be
given that we will be able to meet the requirements set forth in such agreement.
The subpart H process is complex and requires flawless execution. Many companies
who have been granted the right to utilize an accelerated approval approach have
failed to obtain approval. The clinical timeline, scope and consequent cost for
the development of KRX-101 will depend, in part, on the final outcome of our
discussions with the FDA. Moreover, negative or inconclusive results from the
clinical trials we hope to conduct or adverse medical events could cause us to
have to repeat or terminate the clinical trials. Accordingly, we may not be able
to complete the clinical trials within an acceptable time frame, if at all.
OUR DRUG CANDIDATES MAY NEVER RECEIVE THE NECESSARY REGULATORY APPROVALS.
We have not received, and may never receive, regulatory approval for
commercial sale for any of our drug candidates. We will need to conduct
significant additional research and human testing before we can apply for
product approval with the FDA or with regulatory authorities of other countries.
Preclinical testing and clinical development are long, expensive and uncertain
processes. Satisfaction of regulatory requirements typically depends on the
nature, complexity and novelty of the product and requires the expenditure of
substantial resources. Data obtained from preclinical and clinical tests can be
interpreted in different ways, which could delay, limit or prevent regulatory
approval. It may take us many years to complete the testing of our drug
candidates and failure can occur
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at any stage of this process. Negative or inconclusive results or medical events
during a clinical trial could cause us to delay or terminate our development
efforts.
Clinical trials also have a high risk of failure. A number of companies in
the pharmaceutical industry, including biotechnology companies, have suffered
significant setbacks in advanced clinical trials, even after achieving promising
results in earlier trials. If we experience delays in the testing or approval
process or if we need to perform more or larger clinical trials than originally
planned, our financial results and the commercial prospects for our drug
candidates may be materially impaired. In addition, we have limited experience
in conducting and managing the clinical trials necessary to obtain regulatory
approval in the United States and abroad and, accordingly, may encounter
unforeseen problems and delays in the approval process.
BECAUSE WE LICENSE OUR PROPRIETARY TECHNOLOGIES, TERMINATION OF THESE AGREEMENTS
WOULD PREVENT US FROM DEVELOPING OUR DRUG CANDIDATES.
We do not own KRX-101 or any of our early-stage technologies. We have
licensed these technologies from others. These license agreements require us to
meet development or financing milestones and impose development and
commercialization due diligence on us. In addition, under these agreements we
must pay royalties on sales of products resulting from licensed technologies and
pay the patent filing, prosecution and maintenance costs related to the
licenses. If we do not meet our obligations in a timely manner or if we
otherwise breach the terms of our agreements, our licensors could terminate the
agreements and we would lose the rights to KRX-101 or our early-stage
technologies.
BECAUSE OUR REVISED BUSINESS MODEL IS BASED, IN PART, ON THE ACQUISITION OR
IN-LICENSING OF ADDITIONAL CLINICAL PRODUCT CANDIDATES, IF WE FAIL TO ACQUIRE OR
IN-LICENSE SUCH CLINICAL PRODUCT CANDIDATES, OUR LONG TERM BUSINESS PROSPECTS
WILL BE SUBSTANTIALLY IMPAIRED.
As a major part of our business strategy, we plan to acquire or in-license
clinical stage product candidates. If we fail to acquire or in-license such
product candidates, we may not achieve expectations of our future performance.
Because we do not intend to engage in significant discovery research, we must
rely on third parties to sell or license new product opportunities to us. Other
companies, including some with substantially greater financial, development,
marketing and sales resources, are competing with us to acquire or in-license
such products or product candidates. We may not be able to acquire or in-license
rights to additional products or product candidates on acceptable terms, if at
all.
IF WE DO NOT ESTABLISH OR MAINTAIN DRUG DEVELOPMENT AND MARKETING ARRANGEMENTS
WITH THIRD PARTIES, WE MAY BE UNABLE TO COMMERCIALIZE OUR TECHNOLOGIES INTO
PRODUCTS.
We are an emerging company and do not possess all of the capabilities to
fully commercialize our product candidates on our own. From time to time, we may
need to contract with third parties to:
o assist us in developing, testing and obtaining regulatory approval
for and commercializing some of our compounds and technologies; and
o market and distribute our drug candidates.
For example, we are currently seeking third-party partners to conduct
further preclinical development of several of our early stage programs. There
can be no assurance that we will be able to successfully enter into agreements
with such partners on terms that are acceptable to us. If we are unable to
successfully contract with third parties for these services when needed, or if
existing arrangements for these services are terminated, whether or not through
our actions, or if such third parties do not fully perform under these
arrangements, we may have to delay, scale back or end one or more of our drug
development programs or seek to develop or commercialize our technologies
independently, which could result in delays. Further, such failure could result
in the termination of license rights to one or more of our technologies.
Moreover, if these development or marketing agreements take the form of a
partnership or strategic alliance, such arrangements may provide our
collaborators with significant discretion in determining the efforts and
resources that they will apply to the development and commercialization of
products based on our technologies. Accordingly, to the extent that we rely on
third parties to research, develop or
4
commercialize products based on our technologies, we are unable to control
whether such products will be scientifically or commercially successful.
WE RELY ON THIRD PARTIES TO MANUFACTURE OUR PRODUCTS. IF THESE THIRD PARTIES DO
NOT SUCCESSFULLY MANUFACTURE OUR PRODUCTS, OUR BUSINESS WILL BE HARMED.
We have no experience in manufacturing products for clinical or commercial
purposes and do not have any manufacturing facilities. We intend to continue to
use third parties to manufacture our products for use in clinical trials and for
future sales. We may not be able to enter into future third-party contract
manufacturing agreements on acceptable terms, if at all.
Contract manufacturers often encounter difficulties in scaling up
production, including problems involving production yields, quality control and
assurance, shortage of qualified personnel, compliance with FDA and foreign
regulations, production costs and development of advanced manufacturing
techniques and process controls. Our third-party manufacturers may not perform
as agreed or may not remain in the contract manufacturing business for the time
required by us to successfully produce and market our drug candidates. In
addition, our contract manufacturers will be subject to ongoing periodic,
unannounced inspections by the FDA and corresponding foreign governmental
agencies to ensure strict compliance with, among other things, current good
manufacturing practices, in addition to other governmental regulations and
corresponding foreign standards. We will not have control over, other than by
contract, third-party manufacturers' compliance with these regulations and
standards. Switching or engaging multiple manufacturers may be difficult because
the number of potential manufacturers is limited and, particularly in the case
of KRX-101, the process by which multiple manufacturers make the drug substance
must be identical at each manufacturing facility. It may be difficult for us to
find and engage replacement or multiple manufacturers quickly and on terms
acceptable to us, if at all. Moreover, if we need to change manufacturers, the
FDA and corresponding foreign regulatory agencies must approve these
manufacturers in advance, which will involve testing and additional inspections
to ensure compliance with these regulations and standards.
If third-party manufacturers fail to deliver the required quantities of
our drug candidates on a timely basis and at commercially reasonable prices, and
if we fail to find replacement or multiple manufacturers on acceptable terms,
our ability to develop and deliver products on a timely and competitive basis
may be adversely impacted and our business, financial condition or results of
operations will be materially harmed.
In the event that we are unable to obtain or retain third-party
manufacturers, we will not be able to commercialize our products as planned. The
manufacture of our products for clinical trials and commercial purposes is
subject to FDA and foreign regulations. No assurance can be given that our
third-party manufacturers will comply with these regulations or other regulatory
requirements now or in the future.
We recently entered into a contract manufacturing relationship with a
U.S.-based contract manufacturer for KRX-101 which we believe will be adequate
to satisfy our current clinical and commercial supply needs. However, as we seek
to transition our manufacturing of KRX-101 to our new contract manufacturer, we
will need to create a reproducible manufacturing process that will ensure
consistent manufacture of KRX-101 across multiple batches and sources. As with
all heparin-like compounds, the end product is highly sensitive to the
manufacturing process utilized. Accordingly, the creation of a reproducible
process will be required for the successful commercialization of KRX-101. There
can be no assurance that we will be successful in this endeavor.
IF WE ARE NOT ABLE TO OBTAIN THE RAW MATERIAL REQUIRED FOR THE MANUFACTURE OF
OUR LEAD PRODUCT CANDIDATE, KRX-101, OUR ABILITY TO DEVELOP AND MARKET THIS
PRODUCT CANDIDATE WILL BE SUBSTANTIALLY HARMED.
Source materials for KRX-101, our lead product candidate, are derived from
porcine intestines. Long-term supplies for KRX-101 could be affected by
limitations in the supply of porcine intestines, over which we will have no
control. Additionally, diseases affecting the world supply of pigs could have an
actual or perceived negative impact on our ability, or the ability of our
contract manufacturers, to source, make and/or sell KRX-101. Such negative
impact could materially adversely affect the commercial success of KRX-101.
5
IF OUR COMPETITORS DEVELOP AND MARKET PRODUCTS THAT ARE MORE EFFECTIVE THAN
OURS, OUR COMMERCIAL OPPORTUNITY MAY BE REDUCED OR ELIMINATED.
Our commercial opportunity will be reduced or eliminated if our
competitors develop and market products that are more effective, have fewer side
effects or are less expensive than our drug candidates. Other companies have
products or drug candidates in various stages of preclinical or clinical
development to treat diseases for which we are seeking to discover and develop
drug candidates. Some of these potential competing drugs are further advanced in
development than our drug candidates and may be commercialized earlier. Even if
we are successful in developing effective drugs, our products may not compete
successfully with products produced by our competitors.
Our competitors include pharmaceutical companies and biotechnology
companies, as well as universities and public and private research institutions.
In addition, companies active in different but related fields represent
substantial competition for us. Many of our competitors have significantly
greater capital resources, larger research and development staffs and facilities
and greater experience in drug development, regulation, manufacturing and
marketing than we do. These organizations also compete with us to recruit
qualified personnel, attract partners for joint ventures or other
collaborations, and license technologies that are competitive with ours. As a
result, our competitors may be able to more easily develop technologies and
products that would render our technologies or our drug candidates obsolete or
noncompetitive.
IF WE LOSE OUR KEY PERSONNEL OR ARE UNABLE TO ATTRACT AND RETAIN ADDITIONAL
PERSONNEL, OUR OPERATIONS COULD BE DISRUPTED AND OUR BUSINESS COULD BE HARMED.
We currently have eight full and part-time employees and several other
persons working under research agreements or consulting agreements. To
successfully develop our drug candidates, we must be able to attract and retain
highly skilled personnel. In addition, if we lose the services of our current
personnel, in particular, Michael S. Weiss, our Chairman and Chief Executive
Officer, our ability to continue to develop our lead drug candidates could be
materially impaired. In addition, while we have an employment agreement with Mr.
Weiss, this agreement would not prevent him from terminating his employment with
us.
ANY ACQUISITIONS WE MAKE MAY NOT BE SCIENTIFICALLY OR COMMERCIALLY SUCCESSFUL.
As part of our business strategy, we may effect acquisitions to obtain
additional businesses, products, technologies, capabilities and personnel. If we
make one or more significant acquisitions in which the consideration includes
stock or other securities, your equity in us may be significantly diluted. If we
make one or more significant acquisitions in which the consideration includes
cash, we may be required to use a substantial portion of our available cash.
Acquisitions involve a number of operational risks, including:
o difficulty and expense of assimilating the operations, technology
and personnel of the acquired business;
o inability to retain the management, key personnel and other
employees of the acquired business;
o inability to maintain the acquired company's relationship with key
third parties, such as alliance partners;
o exposure to legal claims for activities of the acquired business
prior to acquisition;
o diversion of management attention; and
o potential impairment of substantial goodwill and write-off of
in-process research and development costs, adversely affecting our
reported results of operations.
RISKS RELATED TO OUR FINANCIAL CONDITION
IF WE ARE UNABLE TO OBTAIN ADDITIONAL FUNDS ON TERMS FAVORABLE TO US, OR AT ALL,
OUR BUSINESS WOULD BE HARMED.
We expect to use rather than generate funds from operations for the
foreseeable future. Based on our current plans, we believe our existing cash and
cash equivalents will be sufficient to fund our operating expenses and capital
6
requirements for at least the next 24 months. However, the actual amount of
funds that we will need prior to or after that date will be determined by many
factors, some of which are beyond our control. As a result, we may need funds
sooner or in different amounts than we currently anticipate. These factors
include:
o the progress of our development activities;
o the progress of our research activities;
o the number and scope of our development programs;
o our ability to establish and maintain current and new licensing or
acquisition arrangements;
o our ability to achieve our milestones under our licensing
arrangements;
o the costs involved in enforcing patent claims and other intellectual
property rights; and
o the costs and timing of regulatory approvals.
If our capital resources are insufficient to meet future capital requirements,
we will have to raise additional funds. If we are unable to obtain additional
funds on terms favorable to us or at all, we may be required to cease or reduce
our operating activities or sell or license to third parties some or all of our
technology. If we raise additional funds by selling additional shares of our
capital stock, the ownership interests of our stockholders will be diluted. If
we raise additional funds through the sale or license of our technology, we may
be unable to do so on terms favorable to us.
OUR RESTRUCTURINGS MAY RESULT IN ADDITIONAL ISRAELI TAX LIABILITIES.
In September 2001, one of our Israeli subsidiaries received the status of
an "Approved Enterprise," a status which grants certain tax benefits in Israel
in accordance with the "Law for the Encouragement of Capital Investments, 1959."
Through September 30, 2003, our Israeli subsidiary has received tax benefits in
the form of exemptions of approximately $731,000 as a result of our subsidiary's
status as an "Approved Enterprise." As part of the restructuring implemented
during the first quarter of 2003, we decided to close down our Jerusalem
laboratory facility. In October 2003, the subsidiary received a letter from the
Israeli Ministry of Industry and Trade that its Approved Enterprise status was
cancelled as of July 2003 and that past benefits would not need to be repaid.
The Israeli tax authorities have yet to confirm this position. However, we
believe that, based on the letter received from the Ministry of Industry and
Trade, it is unlikely that past benefits will need to be repaid, and therefore,
we have not recorded any charge with respect to this potential liability. There
can be no assurances that the Israeli tax authorities will confirm this
position. As a result, we may be liable to repay some or all of the tax benefits
received to date, which could adversely affect our cash flow and results of
operations.
RISKS RELATED TO OUR INTELLECTUAL PROPERTY
IF WE ARE UNABLE TO ADEQUATELY PROTECT OUR INTELLECTUAL PROPERTY, THIRD PARTIES
MAY BE ABLE TO USE OUR TECHNOLOGY, WHICH COULD ADVERSELY AFFECT OUR ABILITY TO
COMPETE IN THE MARKET.
Our commercial success will depend in part on our ability and the ability
of our licensors to obtain and maintain patent protection on our drug products
and technologies and successfully defend these patents and technologies against
third-party challenges. The patent positions of pharmaceutical and biotechnology
companies can be highly uncertain and involve complex legal and factual
questions. No consistent policy regarding the breadth of claims allowed in
biotechnology patents has emerged to date. Accordingly, the patents we use 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 patented
technologies. The patents we use may be challenged or invalidated or may fail to
provide us with any competitive advantage.
Moreover, we rely on trade secrets to protect technology where we believe
patent protection is not appropriate or obtainable. However, trade secrets are
difficult to protect. While we require our employees, collaborators and
consultants to enter into confidentiality agreements, this may not be sufficient
to adequately protect our trade secrets or other proprietary information. In
addition, we share ownership and publication rights to data relating to some of
7
our drug candidates with our research collaborators and scientific advisors. If
we cannot maintain the confidentiality of this information, our ability to
receive patent protection or protect our proprietary information will be at
risk.
LITIGATION OR THIRD-PARTY CLAIMS OF INTELLECTUAL PROPERTY INFRINGEMENT COULD
REQUIRE US TO SPEND SUBSTANTIAL TIME AND MONEY DEFENDING SUCH CLAIMS AND
ADVERSELY AFFECT OUR ABILITY TO DEVELOP AND COMMERCIALIZE OUR PRODUCTS.
Third parties may assert that we are using their proprietary technology
without authorization. In addition, third parties may have or obtain patents in
the future and claim that our technologies infringe their patents. If we are
required to defend against patent suits brought by third parties, or if we sue
third parties to protect our patent rights, we may be required to pay
substantial litigation costs, and our management's attention may be diverted
from operating our business. In addition, any legal action against our licensors
or us that seeks damages or an injunction of our commercial activities relating
to the affected technologies could subject us to monetary liability and require
our licensors or us to obtain a license to continue to use the affected
technologies. We cannot predict whether our licensors or we would prevail in any
of these types of actions or that any required license would be made available
on commercially acceptable terms, if at all.
RISKS RELATED TO OUR COMMON STOCK
CONCENTRATION OF OWNERSHIP OF OUR COMMON STOCK AMONG OUR EXISTING EXECUTIVE
OFFICERS, DIRECTORS AND PRINCIPAL STOCKHOLDERS MAY PREVENT NEW INVESTORS FROM
INFLUENCING SIGNIFICANT CORPORATE DECISIONS.
As of September 30, 2003, our executive officers, directors and principal
stockholders (including their affiliates) beneficially owned, in the aggregate,
approximately 32.50% of our outstanding common stock, including, for this
purpose, currently exercisable options and warrants held by our executive
officers, directors and principal stockholders. As a result, these persons,
acting together, may have the ability to effectively determine the outcome of
all matters submitted to our stockholders for approval, including the election
and removal of directors and any merger, consolidation or sale of all or
substantially all of our assets. In addition, such persons, acting together, may
have the ability to effectively control our management and affairs. Accordingly,
this concentration of ownership may harm the market price of our common stock by
discouraging a potential acquirer from attempting to acquire us.
OUR STOCK PRICE COULD BE VOLATILE AND YOUR INVESTMENT COULD DECLINE IN VALUE.
The trading price of our common stock is likely to be highly volatile and
subject to wide fluctuations in price in response to various factors, many of
which are beyond our control. These factors include:
o developments concerning our drug candidates;
o announcements of technological innovations by us or our competitors;
o introduction or announcement of new products by us or our
competitors;
o changes in financial estimates by securities analysts;
o actual or anticipated variations in quarterly operating results;
o expiration or termination of licenses, research contracts or other
collaboration agreements;
o conditions or trends in the regulatory climate and the biotechnology
and pharmaceutical industries;
o changes in the market valuations of similar companies; and
o additions or departures of key personnel.
In addition, equity markets in general, and the market for biotechnology and
life sciences companies in particular, have experienced extreme price and volume
fluctuations that have often been unrelated or disproportionate to the operating
performance of companies traded in those markets. These broad market and
industry factors may materially affect the market price of our common stock,
regardless of our development and operating performance. In the past, following
periods of volatility in the market price of a company's securities, securities
class-action
8
litigation has often been instituted against that company. Such litigation, if
instituted against us, could cause us to incur substantial costs to defend such
claims and divert management's attention and resources, which could seriously
harm our business.
ANTI-TAKEOVER PROVISIONS IN OUR CHARTER DOCUMENTS AND DELAWARE LAW COULD MAKE A
THIRD-PARTY ACQUISITION OF US DIFFICULT. THIS COULD LIMIT THE PRICE INVESTORS
MIGHT BE WILLING TO PAY IN THE FUTURE FOR OUR COMMON STOCK.
Provisions in our amended and restated certificate of incorporation and
bylaws could have the effect of making it more difficult for a third party to
acquire, or of discouraging a third party from attempting to acquire, or control
us. These provisions could limit the price that certain investors might be
willing to pay in the future for shares of our common stock. Our amended and
restated certificate of incorporation allows us to issue preferred stock with
rights senior to those of the common stock without any further vote or action by
the stockholders and our amended and restated bylaws eliminate the right of
stockholders to call a special meeting of stockholders, which could make it more
difficult for stockholders to effect certain corporate actions. These provisions
could also have the effect of delaying or preventing a change in control. The
issuance of preferred stock could decrease the amount of earnings and assets
available for distribution to the holders of our common stock or could adversely
affect the rights and powers, including voting rights, of such holders. In
certain circumstances, such issuance could have the effect of decreasing the
market price of our common stock.
9
FORWARD LOOKING STATEMENTS
When used in this prospectus and elsewhere by management or us from time
to time, the words "anticipate," "believe," "estimate," "may," "expect" and
similar expressions are generally intended to identify forward-looking
statements. These forward-looking statements include, but are not limited to,
statements about our:
o expectations for increases in expenses;
o expectations for increases in research and development and general
and administrative expenses in order to develop and in-license new
products and manufacture commercial quantities of products;
o expectations for the development, manufacturing, and approval of
KRX-101 or any other products we may acquire or in-license;
o expectations for incurring additional capital expenditures to expand
our research and development capabilities;
o expectations for generating revenue or becoming profitable on a
sustained basis;
o ability to enter into marketing and other partnership agreements;
o ability to enter into product acquisition and in-licensing
transactions;
o estimate of the sufficiency of our existing cash and cash
equivalents and investments to finance our operating and capital
requirements;
o expected losses; and
o expectations for future capital requirements.
Our actual results could differ materially from those results expressed
in, or implied by, these forward-looking statements. Potential risks and
uncertainties that could affect our actual results include those discussed in
this prospectus under the heading "Risk Factors." Such risks and uncertainties
also include the possibility that we may fail to establish and correctly apply
our critical accounting policies and estimates to our financial statements. The
list of factors that may affect future performance and the accuracy of
forward-looking statements is illustrative, but by no means exhaustive.
Accordingly, all forward looking-statements should be evaluated with the
understanding of their inherent uncertainty.
Although we believe that the expectations reflected in the forward-looking
statements are reasonable, we cannot guarantee future results, events, levels of
activity, performance or achievements. We do not assume responsibility for the
accuracy and completeness of the forward-looking statements.
We do not intend to update any of the forward-looking statements after the
date of this prospectus to conform them to actual results.
USE OF PROCEEDS
Except for proceeds, if any, received in connection with the exercise of
warrants, we will not receive any proceeds from the sale of the shares of common
stock by the selling stockholders. Any proceeds received in connection with the
exercise of warrants will be used for general corporate purposes.
10
SELLING STOCKHOLDERS
We issued shares of our common stock in a private placement offering on
November 20, 2003. Selling stockholders, including any non-sale transferees,
pledgees or donees or their successors, may from time to time offer and sell any
or all of the common stock pursuant to this prospectus. Because the selling
stockholders may offer all or some portion of the common stock, no estimate can
be given as to the amount of the common stock that will be held by the selling
stockholders upon consummation or termination of any sales.
Information about the selling stockholders may change over time. Any
changed information given to us by the selling stockholders will be set forth in
prospectus supplements or amendments to this prospectus if and when necessary.
The table below sets forth information as of December 8, 2003 with respect to
the number of shares of common stock beneficially owned by each of the selling
stockholders and the number of shares being offered for sale by each selling
stockholder.
NUMBER OF SHARES OF COMMON NUMBER OF SHARES OF NUMBER OF SHARES OF COMMON
STOCK BENEFICIALLY OWNED PRIOR COMMON STOCK STOCK BENEFICIALLY OWNED
NAME OF SELLING STOCKHOLDER TO OFFERING REGISTERED HEREIN AFTER THIS OFFERING (1)
--------------------------- ----------- ----------------- -----------------------
Atlas Fund, LLC 720,000 (2) 720,000 (2) 0
Albert Fried & Company, LLC 225,882 (3) 225,882 (3) 0
Alpha Capital AG 84,706 (4) 84,706 (4) 0
Biomedical Value Fund, L.P. 282,353 (5) 282,353 (5) 0
Biotechnology Development Fund IV, L.P. 282,354 (6) 282,354 (6) 0
Bristol Investment Fund, Ltd. 141,176 (7) 141,176 (7) 0
Cranshire Capital, L.P. 289,412 (8) 289,412 (8) 0
Gryphon Master Fund, LP 141,176 (9) 141,176 (9) 0
Magellan International, Ltd. 56,470 (10) 56,470 (10) 0
MPM BioEquities Master Fund, LP 558,676 (11) 558,676 (11) 0
MPM BioEquities Fund GmbH & Co. KG 6,030 (12) 6,030 (12) 0
Omicron Master Trust 240,000 (13) 240,000 (13) 0
SF Capital Partners Ltd. 360,000 (14) 360,000 (14) 0
S.A.C. Healthco Fund, LLC 564,706 (15) 564,706 (15) 0
Smithfield Fiduciary LLC (19) 141,178 (16) 141,178 (16) 0
Spectra Capital Management 141,176 (17) 141,176 (17) 0
Rodman & Renshaw, Inc. 50,000 (18) 50,000 (18) 0
--------- --------- -
TOTAL 4,285,295 4,285,295 0
========= ========= =
----------
(1) Assumes sale of all of the shares of common stock offered hereby.
(2) Includes 120,000 shares of common stock issuable upon the exercise of
warrants.
(3) Includes 37,647 shares of common stock issuable upon the exercise of
warrants.
(4) Includes 14,118 shares of common stock issuable upon the exercise of
warrants.
(5) Includes 47,059 shares of common stock issuable upon the exercise of
warrants.
(6) Includes 47,059 shares of common stock issuable upon the exercise of
warrants.
(7) Includes 23,529 shares of common stock issuable upon the exercise of
warrants.
(8) Includes 48,235 shares of common stock issuable upon the exercise of
warrants.
(9) Includes 23,529 shares of common stock issuable upon the exercise of
warrants.
(10) Includes 9,412 shares of common stock issuable upon the exercise of
warrants.
(11) Includes 93,113 shares of common stock issuable upon the exercise of
warrants.
(12) Includes 1,005 shares of common stock issuable upon the exercise of
warrants.
(13) Includes 40,000 shares of common stock issuable upon the exercise of
warrants.
(14) Includes 60,000 shares of common stock issuable upon the exercise of
warrants.
(15) Includes 94,118 shares of common stock issuable upon the exercise of
warrants.
(16) Includes 23,530 shares of common stock issuable upon the exercise of
warrants.
(17) Includes 23,529 shares of common stock issuable upon the exercise of
warrants.
(18) Includes 50,000 shares of common stock issuable upon the exercise of
warrants.
11
(19) Highbridge Capital Management, LLC is the trading manager of Smithfield
Fiduciary LLC and consequently has voting control and investment
discretion over securities held by Smithfield. Glenn Dubin and Henry
Swieca control Highbridge. Each of Highbridge, Glenn Dubin and Henry
Swieca disclaims beneficial ownership of the securities held by
Smithfield.
PLAN OF DISTRIBUTION
The selling stockholders and any of their transferees, pledgees, donees,
assignees and successors-in-interest may, from time to time, sell any or all of
their shares of common stock on any stock exchange, market or trading facility
on which the shares are then listed, admitted to unlisted trading privileges or
included for quotation or in private transactions. These sales may be at fixed
or negotiated prices. The selling stockholders may use any one or more of the
following methods when selling shares:
o ordinary brokerage transactions and transactions in which the
broker-dealer solicits purchasers;
o one or more block trades in which the broker-dealer will attempt to
sell the shares as agent but may position and resell a portion of
the block as principal to facilitate the transaction;
o purchases by a broker-dealer as principal and resale by the
broker-dealer for its account;
o an exchange distribution in accordance with the rules of the
applicable exchange;
o privately negotiated transactions;
o settlement of short sales created after the date of the private
placement;
o broker-dealers may agree with the selling stockholders to sell a
specified number of such shares at a stipulated price per share;
o a combination of any such methods of sale; and
o any other method permitted pursuant to applicable law.
The selling stockholders may also sell shares under Rule 144 under the
Securities Act, if available, rather than under this prospectus.
Broker-dealers engaged by the selling stockholders may arrange for other
broker-dealers to participate in sales. Broker-dealers may receive commissions,
discounts or concessions from the selling stockholders (or, if any broker-dealer
acts as agent for the purchaser of shares, from the purchaser) in amounts to be
negotiated. The selling stockholders do not expect these commissions and
discounts to exceed what is customary in the types of transactions involved.
The selling stockholders may from time to time pledge or grant a security
interest in some or all of the shares of common stock or warrants owned by them
and, if they default in the performance of their secured obligations, the
pledgees or secured parties may offer and sell the shares of common stock from
time to time under this prospectus, or under an amendment to this prospectus
under the applicable provision of the Securities Act of 1933 amending the list
of selling stockholders to include the pledgee, transferee or other successors
in interest as selling stockholders under this prospectus.
The selling stockholders also may transfer the shares of common stock in
other circumstances, in which case the transferees, pledgees, donees, assignees
or other successors-in-interest will be the selling beneficial owners for
purposes of this prospectus.
The selling stockholders and any broker-dealers or agents that are
involved in selling the shares may be deemed to be "underwriters" within the
meaning of the Securities Act in connection with such sales. In such event, any
commissions received by such broker-dealers or agents and any profit on the
resale of the shares purchased by them may be deemed to be underwriting
commissions or discounts under the Securities Act. The selling stockholders have
informed us that none of them has any agreement or understanding, directly or
indirectly, with any person to distribute the common stock.
12
We are required to pay all fees and expenses that we incur incident to the
registration of the shares. We have agreed to indemnify the selling stockholders
against certain losses, claims, damages and liabilities, including liabilities
under the Securities Act.
The anti-manipulation rules under the Exchange Act may apply to sales of
the shares of common stock in the market and to the activities of the selling
stockholders and their affiliates.
We have agreed to use our best efforts to keep this registration statement
continuously effective under the Securities Act until the date which is two
years after the date that this registration statement is declared effective by
the Securities and Exchange Commission or such earlier date when all shares of
the common stock covered by this registration statement has been sold or may be
sold without volume restrictions pursuant to Rule 144(k) as determined by our
counsel pursuant to a written opinion letter to such effect, addressed and
acceptable to our transfer agent and the affected selling stockholders.
LEGAL MATTERS
The validity of the shares of common stock 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. as
of December 31, 2002 and 2001, and for each of the years in the three-year
period ended December 31, 2002, have been incorporated by reference herein in
reliance upon the report of Somekh Chaikin, a member firm of KPMG International,
independent accountants, incorporated by reference herein, and upon the
authority of said firm as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and special reports, proxy statements and other
information with the SEC. You may read and copy, at prescribed rates, any
documents we have filed with the Securities and Exchange Commission at its
Public Reference Room located at 450 Fifth Street, N.W., Washington, D.C. 20549.
You may obtain information on the operation of the Public Reference Room by
calling the Securities and Exchange Commission at 1-800-SEC-0330. We also file
these documents with the Securities and Exchange Commission 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 Securities and Exchange Commission from our Internet website found
at www.keryx.com. Our stock is quoted on The Nasdaq Stock Market under the
symbol "KERX."
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The Securities and Exchange Commission allows us to "incorporate by
reference" into this prospectus the information we file with the Securities and
Exchange Commission. 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
Securities and Exchange Commission from the date of this prospectus 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 and any future filings made by us with the Securities and
Exchange Commission under Sections 13(a), 13(c), 14 or 15(d) of the Exchange
Act, including exhibits, until the termination of the offering by the selling
stockholders pursuant to this prospectus:
(a) Our Annual Report on Form 10-K for the year ended December 31, 2002;
(b) Our quarterly reports on Forms 10-Q for the quarters ended March 31,
2003, June 30, 2003, and September 30, 2003;
(c) Our current reports on Forms 8-K dated March 31, 2003, May 14, 2003,
August 13, 2003, November 13, 2003 and November 19, 2003; and
(d) The description of our capital stock and accompanying rights
contained in our registration statement on Form 8-A dated June 28,
2000 (File No. 000-30929).
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
13
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: Vice President Finance and Investor Relations.
You should rely only on the information contained in or incorporated by
reference into this prospectus. We have not authorized any dealer, salesperson
or other person to give you different information. This prospectus is not an
offer to sell nor is it seeking an offer to buy the securities referred to in
this prospectus in any jurisdiction where the offer or sale is not permitted.
The information contained in this prospectus is correct only as of the date of
this prospectus, regardless of the time of the delivery of this prospectus or
any sale of the securities referred to in this prospectus.
14
PART II
INFORMATION NOT REQUIRED IN THE PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION.
The table below itemizes the expenses payable by the Registrant in
connection with the registration and issuance of the securities being registered
hereunder, other than underwriting discounts and commissions. All amounts except
the Securities and Exchange Commission registration fee are estimated.
Securities and Exchange Commission Registration Fee.................. $1,709
Legal Fees and Expenses.............................................. *
Accountants' Fees and Expenses....................................... *
Printing and Duplicating Expenses.................................... *
Miscellaneous Expenses............................................... *
------
Total................................................................ *
======
* To be completed by amendment.
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS.
Under the General Corporation Law of the State of Delaware, or DGCL, a
corporation may include provisions in its certificate of incorporation that will
relieve its directors of monetary liability for breaches of their fiduciary duty
to the corporation, except under certain circumstances, including a breach of
the director's duty of loyalty, acts or omissions of the director not in good
faith or which involve intentional misconduct or a knowing violation of law, the
approval of an improper payment of a dividend or an improper purchase by the
corporation of stock or any transaction from which the director derived an
improper personal benefit. The Registrant's Amended and Restated Certificate of
Incorporation, as amended, eliminates the personal liability of directors to the
Registrant or its stockholders for monetary damages for breach of fiduciary duty
as a director with certain limited exceptions set forth in the DGCL.
Section 145 of the DGCL grants to corporations the power to indemnify each
officer and director against liabilities and expenses incurred by reason of the
fact that he or she is or was an officer or director of the corporation if he or
she acted in good faith and in a manner he or she reasonably believed to be in
or not opposed to the best interests of the corporation and, with respect to any
criminal action or proceeding, had no reasonable cause to believe his or her
conduct was unlawful. The Registrant's Amended and Restated Certificate of
Incorporation, as amended, and Amended and Restated Bylaws provide for
indemnification of each officer and director of the Registrant to the fullest
extent permitted by the DGCL. Section 145 of the DGCL also empowers corporations
to purchase and maintain insurance on behalf of any person who is or was an
officer or director of the corporation against liability asserted against or
incurred by him in any such capacity, whether or not the corporation would have
the power to indemnify such officer or director against such liability under the
provisions of Section 145.
II-1
ITEM 16. EXHIBITS.
EXHIBIT
NUMBER DESCRIPTION
------ -----------
3.1 Amended and Restated Certificate of Incorporation.*
5.1 Opinion of Alston & Bird LLP.*
10.1 Securities Purchase Agreement dated November 12, 2003, by and
between Keryx Biopharmaceuticals, Inc. and the purchasers named
therein.
10.2 Registration Rights Agreement dated November 12, 2003, by and
between Keryx Biopharmaceuticals, Inc. and the purchasers named
therein.
10.3 Form of Common Stock Purchase Warrant dated November 20, 2003,
issued to the purchasers under the Securities Purchase Agreement.
10.4 Form of Common Stock Purchase Warrant dated November 20, 2003,
issued to Rodman & Renshaw, Inc.
23.1 Consent of KPMG.
* To be filed by amendment.
II-2
ITEM 17. UNDERTAKINGS.
(a) The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a
post-effective amendment to this registration statement:
(i) To include any prospectus required by section 10(a)(3) of the
Securities Act of 1933;
(ii) To reflect in the prospectus any facts or events arising after
the effective date of the registration statement (or the most recent
post-effective amendment thereof) which, individually or in the aggregate,
represent a fundamental change in the information set forth in the
registration statement. Notwithstanding the foregoing, any increase or
decrease in the volume of securities offered (if the total dollar value of
securities offered would not exceed that which was registered) and any
deviation from the low or high end of the estimated maximum offering range
may be reflected in the form of prospectus filed with the Commission
pursuant to Rule 424(b)) if, in the aggregate, the changes in volume and
price represent no more than 20% change in the maximum aggregate offering
price set forth in the "Calculation of Registration Fee" table in the
effective registration statement; and
(iii) To include any material information with respect to the plan
of distribution not previously disclosed in the registration statement or
any material change to such information in the registration statement;
provided, however, that paragraphs (a)(1)(i) and (a)(1)(ii) above shall
not apply if the information required to be included in a post-effective
amendment by those paragraphs is contained in periodic reports filed with
or furnished to the Commission by the registrant pursuant to Section 13 or
Section 15(d) of the Securities Exchange Act of 1934 that are incorporated
by reference in the registration statement.
(2) That, for the purpose of determining any liability under the
Securities Act of 1933, each such post-effective amendment shall be deemed to be
a new registration statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be initial bona fide
offering thereof.
(3) To remove from registration by means of a post-effective amendment any
of the securities being registered which remain unsold at the termination of the
offering.
(b) The undersigned registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act of 1933, each filing of the
registrant's annual report pursuant to Section 13(a) or 15(d) of the Securities
Exchange Act of 1934 (and, where applicable, each filing of an employee benefit
plan's annual report pursuant to Section 15(d) of the Securities Exchange Act of
1934) that is incorporated by reference in the registration statement shall be
deemed to be a new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof.
(h) Insofar as indemnification for liabilities arising under the Securities Act
of 1933 may be permitted to directors, officers and controlling persons of the
registrant pursuant to the foregoing provisions, or otherwise, the registrant
has been advised that in the opinion of the Securities and Exchange Commission
such indemnification is against public policy as expressed in the Act and is,
therefore, unenforceable. In the event that a claim for indemnification against
such liabilities (other than the payment by the registrant of expenses incurred
or paid by a director, officer or controlling person of the registrant in the
successful defense of any action, suit or proceeding) is asserted by such
director, officer or controlling person in connection with the securities being
registered, the registrant will, unless in the opinion of its counsel the matter
has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against public
policy as expressed in the Securities Act of 1933 and will be governed by the
final adjudication of such issue.
II-3
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as amended,
the registrant certifies that it has reasonable grounds to believe that it meets
all of the requirements for filing on Form S-3 and has duly caused this
registration statement to be signed on its behalf by the undersigned, thereunto
duly authorized in the City of New York, State of New York, on December 12,
2003.
KERYX BIOPHARMACEUTICALS, INC.
By: /s/ MICHAEL S. WEISS
------------------------------------
Michael S. Weiss
Chairman and Chief Executive Officer
POWER OF ATTORNEY
KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears
below constitutes and appoints each of Michael S. Weiss and Ron Bentsur, his
true and lawful attorney-in-fact and agent, with full power of substitution and
resubstitution, for him and his name, place and stead, in any and all
capacities, to sign any or all amendments (including post-effective amendments)
to this registration statement, and to file the same, with all exhibits thereto
and other documents in connection therewith, with the SEC, granting unto said
attorney-in-fact and agent, full power and authority to do and perform each and
every act and thing requisite and necessary to be done in and about the
premises, as fully to all intents and purposes as he might or could do in
person, hereby ratifying and confirming all that said attorney-in-fact and agent
or any of his substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, as amended,
this registration statement has been signed by the following persons in the
capacities indicated as of December 12, 2003.
Signatures Title
---------- -----
/s/ MICHAEL S. WEISS
------------------------------ Chairman and Chief Executive Officer
Michael S. Weiss (principal executive officer)
/s/ RON BENTSUR
------------------------------ Vice President Finance and Investor Relations
Ron Bentsur (principal financial and accounting officer)
/s/ PETER MORGAN KASH
------------------------------
Peter Morgan Kash Vice Chairman and Director
------------------------------
Malcolm Hoenlein Director
------------------------------
Lindsay A. Rosenwald, M.D. Director
/s/ LAWRENCE JAY KESSEL, M.D.
------------------------------
Lawrence Jay Kessel, M.D. Director
/s/ PETER SALOMON, M.D.
---------------------------
Peter Salomon, M.D. Director
EXHIBIT INDEX
EXHIBIT
NUMBER DESCRIPTION
------ -----------
3.1 Amended and Restated Certificate of Incorporation.*
5.1 Opinion of Alston & Bird LLP.*
10.1 Securities Purchase Agreement dated November 12, 2003, by and
between Keryx Biopharmaceuticals, Inc. and the purchasers named
therein.
10.2 Registration Rights Agreement dated November 12, 2003, by and
between Keryx Biopharmaceuticals, Inc. and the purchasers named
therein.
10.3 Form of Common Stock Purchase Warrant dated November 20, 2003,
issued to the purchasers under the Securities Purchase Agreement.
10.4 Form of Common Stock Purchase Warrant dated November 20, 2003,
issued to Rodman & Renshaw, Inc.
23.1 Consent of KPMG.
* To be filed by amendment.