e424b2
Filed pursuant to Rule 424(b)(2)
Registration No. 333-128087
PROSPECTUS SUPPLEMENT
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(To Prospectus Dated
September 20, 2005)
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1,140,791 Shares
Common Stock
We
are offering 2,228,829 shares of our common stock to selected institutional
investors, 1,140,791 of which will
be offered pursuant to this prospectus supplement and the accompanying prospectus. The common stock
will be purchased at the negotiated price of $13.46 per share.
Our common stock is listed on the Nasdaq
National Market under the symbol BCRX. On December 14, 2005, the last reported sale price of
the common stock on the Nasdaq National Market was $15.55 per share.
Investing in our common stock involves
risks. See Risk Factors beginning on page S-4
of this prospectus supplement.
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Per |
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Maximum |
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Share |
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Offering |
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Offering price to selected institutional investors |
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13.46 |
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30,000,038 |
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Proceeds to BioCryst Pharmaceuticals, Inc. (before expenses) from the offering |
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$ |
13.46 |
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$ |
30,000,038 |
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Proceeds to
BioCryst Pharmaceuticals, Inc. (before expenses) from sales pursuant
to this prospectus supplement and the accompanying prospectus |
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$ |
13.46 |
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$ |
15,355,047 |
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We expect the total offering expenses
to be approximately $100,000 for all sales in the offering.
Neither the Securities and
Exchange Commission nor any state securities commission has
approved or disapproved of these notes, or passed upon the accuracy or adequacy of this prospectus
supplement or the accompanying prospectus. Any representation to the contrary is a criminal
offense.
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December 14, 2005
TABLE OF CONTENTS
Prospectus Supplement
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S-1 |
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S-2 |
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S-4 |
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S-4 |
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S-5 |
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S-6 |
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S-7 |
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S-9 |
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S-9 |
Prospectus
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ABOUT THIS PROSPECTUS
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ABOUT BIOCRYST PHARMACEUTICALS, INC.
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1 |
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RISK FACTORS
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INFORMATION REGARDING FORWARD-LOOKING STATEMENTS
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USE OF PROCEEDS
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PLAN OF DISTRIBUTION
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LEGAL MATTERS
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EXPERTS
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WHERE YOU CAN FIND MORE INFORMATION
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INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
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You should rely only on the information contained in this prospectus supplement, the
accompanying prospectus or the documents incorporated or deemed incorporated by reference herein or
therein. We have not authorized anyone to provide you with information different from
or in addition to that contained in this prospectus supplement, the accompanying prospectus or the
documents incorporated or deemed incorporated by reference herein or therein. We are not making an offer to sell or seeking an offer to buy these securities in any
jurisdiction where the offer or sale is not permitted.
The information contained in this prospectus supplement, the accompanying prospectus and the
documents incorporated or deemed incorporated by reference herein or therein is complete and
accurate as of the date of this prospectus supplement, but may have changed since that date.
i
ABOUT THIS PROSPECTUS SUPPLEMENT
This prospectus supplement and the accompanying prospectus are part of a shelf registration
statement on Form S-3 that we filed with the Securities and Exchange Commission, or the SEC. This
prospectus supplement describes the specific details regarding this offering, including the price,
the amount of common stock being offered and the method of distributing the common stock being
offered. The accompanying prospectus provides general information about us, some of which, such as
the section entitled Plan of Distribution, may not apply to this offering. If information in this
prospectus supplement is inconsistent with the accompanying prospectus, you should rely on this
prospectus supplement. You should read both this prospectus supplement and the accompanying
prospectus together with the additional information about us described in the accompanying
prospectus in the section entitled Where You Can Find More Information.
S-1
PROSPECTUS SUPPLEMENT SUMMARY
The items in the following summary are described in more detail in this prospectus supplement,
the accompanying prospectus or in the documents incorporated or deemed incorporated by reference in
this prospectus supplement or the accompanying prospectus. This summary provides an overview of
selected information and does not contain all of the information that you should consider.
Therefore, you should also read the more detailed information in this prospectus supplement, the
accompanying prospectus and the documents incorporated or deemed incorporated by reference in this
prospectus supplement or the accompanying prospectus. All references to we, us, our, and
similar terms refer to BioCryst Pharmaceuticals, Inc.
The Offering
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Common stock offered
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2,228,829 shares, 1,140,791 of
which will be offered pursuant to this prospectus supplement and the
accompanying prospectus |
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Common stock to be outstanding after the
offering
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28,593,410 shares |
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Use of proceeds
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We intend to use the net
proceeds from the sale of the
common stock offered by this
prospectus supplement for
general corporate purposes,
which may include research and
development activities,
preclinical studies and
clinical trials, capital
expenditures, general working
capital and acquisitions. |
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Nasdaq National Market symbol
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BCRX |
The total number of shares of common stock outstanding after this offering is based upon
26,364,581 shares outstanding as of September 30, 2005, and excludes:
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3,462,552 shares of common stock issuable upon exercise of stock options outstanding as of
September 30, 2005, at a weighted average exercise price of $7.47 per share, under our
stock option plans; |
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567,570 additional shares of common stock reserved for future issuance under our stock
option and stock purchase plans as of September 30, 2005; |
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other changes in our outstanding shares of common stock since
September 30, 2005; and |
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shares issuable upon exercise of rights issued under our stockholder rights
plan. |
Unless otherwise specifically stated, information throughout this prospectus supplement
assumes no exercise of outstanding options to purchase shares of common stock.
Each share of our common stock sold in this offering includes a preferred share purchase right
under our stockholder rights plan.
S-2
1,114,414 of the shares of common stock we are selling in this offering will be
issued to Kleiner Perkins Caulfield & Byers Holdings, LLC, or
KPCB. As part of our stock purchase agreement for the offering, we are entering into a nomination and observer agreement with KPCB under
which we will grant KPCB the right to appoint a member to our board of directors effective as of the closing
of this offering. So long as KPCB and its affiliates continue to own not less than
560,000 shares of our common stock (appropriately adjusted for stock splits, reverse stock
splits, stock dividends and the like), KPCB may appoint a director to serve on our board of directors. The
director may resign from the board of directors at any time without notice, but we may not remove
him or her from the board without cause as defined in the
nomination and observer agreement. The nomination and observer
agreement is included as an
exhibit to our Current Report on Form 8-K that we will file with the Securities and Exchange
Commission in connection with the consummation of this offering. See Where You Can Find More
Information on page 18 of the accompanying prospectus.
S-3
RISK FACTORS
Except for the historical information contained in this prospectus supplement or the
accompanying prospectus or incorporated by reference, this prospectus supplement (and the
information incorporated by reference in this prospectus supplement and the accompanying
prospectus) contains forward-looking statements that involve risks and uncertainties. Our actual
results could differ materially from those discussed here or incorporated by reference. Factors
that could cause or contribute to such differences include, but are not limited to, those discussed
in the section entitled Risk Factors beginning on page 4
of the accompanying prospectus as well as the section entitled
Certain Risk Factors That May Affect Future Results, Financial
Condition and the Market Price of Securities in our most recent
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission. See Where You Can Find More
Information on page 18 of the accompanying prospectus.
Investment in our securities involves a high degree of risk. You should consider carefully the
Risk Factors, as well as other information in this prospectus supplement and the accompanying
prospectus and the documents incorporated by reference herein or therein before purchasing any of
our securities. Each of these risk factors could adversely affect our business, operating results
and financial condition, as well as adversely affect the value of an investment in our securities.
FORWARD-LOOKING STATEMENTS
This prospectus supplement contains or incorporates by reference forward-looking statements,
which are subject to risks and uncertainties. These forward-looking statements can generally be
identified by the use of words such as may, will, intends, plans, believes,
anticipates, expects, estimates, predicts, potential, the negative of these words or
similar expressions. Statements that describe our future plans, strategies, intentions,
expectations, objectives, goals or prospects are also forward-looking statements. Discussions
containing these forward-looking statements are principally contained in Business and
Managements Discussion and Analysis of Financial Condition and Results of Operations
incorporated by reference from our most recent Annual Report on Form 10-K, our Quarterly Reports on
Form 10-Q for the quarters ended since our most recent Annual Report, and our Current Reports on
Form 8-K filed since November 7, 2005, as well as any amendments we make to those filings with the
SEC.
These statements reflect our current views with respect to future events and are based on
assumptions and subject to risks and uncertainties which may cause our actual results, performance
or achievements to be materially different from any future results, performances or achievements
expressed or implied by the forward-looking statements. Given these uncertainties, you should not
place undue reliance on these forward-looking statements. We discuss many of these risks in greater
detail in the section entitled Risk Factors beginning on
page 4 of the accompanying prospectus.
Also, these forward-looking statements represent our estimates and assumptions only as of the date
of this prospectus supplement.
You should read this prospectus supplement, the accompanying prospectus and the documents that
we incorporate by reference in this prospectus supplement and the accompanying prospectus
completely and with the understanding that our actual future results may be materially different
from what we expect. We may not update these forward-looking statements,
S-4
even though our situation may change in the future. We qualify all of our forward-looking
statements by these cautionary statements.
USE OF PROCEEDS
We estimate that the net proceeds from the sale of the shares of common stock we are offering
will be approximately $29.9 million. Net proceeds is what we expect to receive after paying the
expenses of the offering.
We intend to add the net proceeds of this offering to our general funds and use them for
general corporate purposes, which may include, but are not limited to the purposes set forth in the
accompanying prospectus. The amounts and timing of our actual expenditures for each purpose may
vary significantly depending upon numerous factors, including the status of our product development
efforts, regulatory approvals, competition, marketing and sales activities and the market
acceptance of any products we introduce. Pending such uses, we intend to invest the net proceeds of
this offering in investment grade, interest-bearing securities.
S-5
DILUTION
Our net tangible book value on
September 30, 2005 was approximately $34.1 million, or
approximately $1.29 per share of common stock. Net tangible book value per share is determined by
dividing our net tangible book value, which consists of tangible assets less total liabilities, by
the number of shares of common stock outstanding on that date. Without taking into account any
other changes in the net tangible book value after September 30,
2005, other than to give effect to
our receipt of the estimated net proceeds from the sale of the maximum number of shares issuable in
this offering (2,228,829 shares) at an offering price of $13.46
per share, less our estimated offering
expenses, our net tangible book value as of September 30,
2005 after giving effect to the items above, would have been
approximately $64.0 million, or $2.24
per share. This represents an immediate increase in the net tangible
book value of $0.95 per share
to existing stockholders and an immediate dilution of $11.22 per share to new investors.
The following table illustrates this per share dilution:
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Offering price per share |
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13.46 |
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Net tangible
book value per share as of September 30, 2005 |
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1.29 |
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Increase in net tangible book value per share attributable to the offering |
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0.95 |
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Pro forma net tangible book value per share as of September 30, 2005,
after giving effect to the offering |
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2.24 |
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Dilution per share to new investors in the offering |
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$ |
11.22 |
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The
above table is based on 26,364,581 shares outstanding as of September 30, 2005 and
excludes:
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shares of common stock issuable upon the exercise of outstanding stock options
as of September 30, 2005; |
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shares of common stock available for future grant under our stock option and
stock purchase plans as of September 30, 2005; |
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other changes in our outstanding shares of common stock since
September 30, 2005; and |
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shares issuable upon exercise of rights issued under our stockholder rights
plan. |
S-6
PLAN OF DISTRIBUTION
We
are offering the shares of common stock directly to selected
institutional investors. The offering is not being made through an
underwriter or placement agent. We have entered into a stock purchase
agreement with KPCB, LPTV, LLC and TPG Biotechnology Partners, L.P.
for the full amount of the offering. The stock purchase agreement is
included as an exhibit to our Current Report on Form 8-K that we
will file with the Securities and Exchange Commission in connection
with the consummation of this offering. See Where You Can Find
More Information on page 18 of the accompanying prospectus.
Our obligation to issue and sell shares to the purchasers is subject to the conditions set
forth in the stock purchase agreement, which may be waived by us in our discretion. A purchasers
obligation to purchase shares is subject to conditions set forth in the stock purchase agreement as well,
which also may be waived.
S-7
We
expect that the sale of 2,228,829 shares will be completed on or
about December 16,
2005. We estimate the total expenses of this offering which will be payable by us will be approximately $100,000.
The transfer agent for our common stock is American Stock Transfer & Trust, Inc.
Our common stock is traded on the Nasdaq National Market under the symbol BCRX.
S-8
LEGAL MATTERS
Certain matters with respect to the legality and binding nature of the securities are being
passed upon for us by Holme Roberts & Owen LLP, Denver, Colorado.
EXPERTS
The
consolidated financial statements of BioCryst Pharmaceuticals, Inc.
appearing in BioCryst Pharmaceuticals, Inc.'s Annual Report
(Form 10-K) for the year ended December 31, 2004, have been
audited by Ernst & Young LLP, independent auditors, as set forth
in their report thereon included therein and incorporated herein by reference. Such
consolidated financial statements are incorporated herein by
reference in reliance upon such report given on the authority of such
firm as experts in accounting and auditing.
S-9
PROSPECTUS
$85,000,000
Common Stock
We may sell shares of common stock from time to time in one or
more offerings and the total offering price, in the aggregate,
will not exceed $85,000,000. This means:
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we will provide a prospectus supplement each time we issue
common stock; and |
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the prospectus supplement will inform you about the specific
terms of that offering and may also add, update or change
information contained in this document. |
You should carefully read this prospectus, the information
incorporated by reference in this prospectus and any prospectus
supplement before you decide to invest.
Our common stock, par value $0.01 per share, trades on The
Nasdaq National Market under the symbol BCRX. On
September 1, 2005, the reported last sale price of our
common stock on The Nasdaq National Market was $8.70 per
share.
Investing in our common stock involves risks. See Risk
Factors beginning on page 4 of this prospectus.
The securities may be sold by us to or through underwriters or
dealers, directly to purchasers or through agents designated
from time to time. For additional information on the methods of
sale, you should refer to the section entitled Plan of
Distribution in this prospectus. If any underwriters are
involved in the sale of any securities with respect to which
this prospectus is being delivered, the names of such
underwriters and any applicable discounts or commissions and
over-allotment options will be set forth in a prospectus
supplement. The price to the public of such securities and the
net proceeds we expect to receive from such sale will also be
set forth in a prospectus supplement. This prospectus may not be
used to sell any of the common stock unless accompanied by a
prospectus supplement.
The Securities and Exchange Commission and state securities
regulators have not approved or disapproved 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 September 20, 2005.
TABLE OF CONTENTS
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You should rely only on the information contained or
incorporated by reference into this prospectus or any applicable
prospectus supplement. We have not authorized anyone to provide
you with different information. We are not making an offer of
the common stock to be sold under this prospectus in any
jurisdiction where the offer or sale is not permitted. You
should not assume that the information contained in this
prospectus or any prospectus supplement is accurate as of any
date other than the date on the front of the document, or that
the information contained in any document incorporated by
reference is accurate as of any date other than the date of the
document incorporated by reference, regardless of the time of
delivery of this prospectus or any sale of a security.
About This Prospectus
This prospectus is part of a registration statement that we
filed with the Securities and Exchange Commission, or SEC, using
a shelf registration process. Under this shelf
registration process, we may sell common stock in one or more
offerings up to a total dollar amount of $85,000,000. Each time
we sell any common stock under this prospectus, we will provide
a prospectus supplement that will contain more specific
information about the terms of that offering. We may also add,
update or change in a prospectus supplement any of the
information contained in this prospectus or in documents we have
incorporated by reference into this prospectus. This prospectus,
together with the applicable prospectus supplements and the
documents incorporated by reference into this prospectus,
includes all material information relating to this offering. You
should carefully read both this prospectus and the applicable
prospectus supplement together with the additional information
described under Where You Can Find More Information
before buying our common stock in this offering.
About BioCryst Pharmaceuticals, Inc.
BioCryst Pharmaceuticals, Inc. is a biotechnology company
focused on designing, optimizing and developing novel small
molecule pharmaceuticals that block key enzymes essential for
cancer, cardiovascular diseases, autoimmune diseases and viral
infections. Our most advanced drug candidate,
Fodosinetm
(forodesine hydrochloride), is an investigational
purine nucleoside phosphorylase (PNP) inhibitor
being tested in clinical trials as a treatment option for
patients suffering from certain T-cell and B-cell cancers.
BioCryst is a Delaware corporation originally founded in 1986.
Our principal offices are located at 2190 Parkway Lake
Drive, Birmingham, Alabama 35244, and our telephone number is
(205) 444-4600. Our web site is located at
http://www.biocryst.com. The information on our web site
is not incorporated by reference into this prospectus.
Our Business Strategy
Our business strategy is to use structure-based drug design
technologies to develop innovative, small-molecule
pharmaceuticals to treat a variety of diseases and disorders. We
focus our drug development efforts on building potent, selective
inhibitors of enzymes associated with targeted diseases. Enzymes
are proteins that cause or enable biological reactions necessary
for the progression of the disease or disorder. The specific
enzymes on which we focus are called enzyme targets. The Company
aims to design compounds that will inhibit an enzyme target by
fitting the active site of a particular enzyme. Inhibition means
interfering with the functioning of an enzyme target, thereby
stopping or slowing the progression of the disease or disorder.
The principal elements of our strategy are:
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Select and License Promising Enzyme Targets for the
Development of Small-Molecule Pharmaceuticals. We use our
technical expertise and network of academic and industry
contacts to evaluate and select promising enzyme targets to
license for the development of small-molecule pharmaceuticals.
We choose enzyme targets that meet as many of the following
criteria as possible: |
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serve important functions in disease pathways; |
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have known animal or cell-based models that would be indicative
of results in humans; |
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address large potential markets and significant unmet medical
needs, including pursuing niche markets where the results have
potential application to broader markets and needs; |
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have multiple potential clinical applications; and |
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offer rapid development and commercialization opportunities. |
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Focus on High Value-Added Structure-Based Drug Design
Technologies. We focus our drug discovery activities and
expenditures on applications of structure-based drug design
technologies to design and develop drug candidates.
Structure-based drug design is a process by which we design a
drug candidate through detailed analysis of the enzyme target,
which the drug candidate must inhibit in |
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order to stop the progression of the disease or disorder. We
believe that structure-based drug design is a powerful tool for
efficient development of small-molecule drug candidates that
have the potential to be safe, effective and relatively
inexpensive to manufacture. Our structure-based drug design
technologies typically allow us to design and synthesize
multiple drug candidates that inhibit the same enzyme target. We
believe this strategy can lead to broad patent protection and
enhance the competitive advantages of our compounds. |
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Develop or License Inhibitors that are Promising Candidates
for Commercialization. We test multiple compounds to
identify those that are most promising for clinical development.
We base our selection of promising development candidates on
desirable product characteristics, such as initial indications
of safety and efficacy. We believe that this focused strategy
allows us to eliminate unpromising candidates from consideration
sooner without incurring substantial clinical costs. In
addition, we select drug candidates on the basis of their
potential for relatively efficient Phase I and
Phase II clinical trials that require fewer patients to
initially indicate safety and efficacy. We will consider,
however, more complex candidates with longer development cycles
if we believe that they offer promising commercial opportunities. |
An important element of our business strategy is to control
fixed costs and overhead through contracting and entering into
license agreements with other parties. We maintain a streamlined
corporate infrastructure that focuses on our strongest areas of
expertise. By contracting with other specialty organizations, we
believe that we can control costs, enable our drug candidates to
reach the market more quickly and reduce our business risk. Key
elements of our contracting strategy include:
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Entering into Relationships with Academic Institutions and
Biotechnology Companies. Many academic institutions and
biotechnology companies perform extensive research on the
molecular and structural biology of potential drug development
targets. By entering into relationships with these institutions,
we believe we can significantly reduce the time, cost and risks
involved in drug development. Our collaborative relationships
with such organizations may lead to the licensing of one or more
drug targets or compounds. Upon licensing a drug target or
promising compound from one of these institutions, the
scientists from the institution typically become working
partners as members of our structure-based drug design teams. We
believe this makes us a more attractive development partner to
these scientists. In addition, we collaborate with outside
experts in a number of areas, including crystallography,
molecular modeling, combinatorial chemistry, biology,
pharmacology, oncology, cardiology, immunology and infectious
diseases. These collaborations enable us to complement our
internal capabilities without adding costly overhead. We believe
this strategy allows us to save valuable time and expense, and
further diversify and strengthen our portfolio of drug
candidates. An example of such a collaborative relationship is
the arrangement that we have with The University of Alabama at
Birmingham (UAB), which has resulted in the
initiation of several of our early drug development programs. |
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Developing Drug Product Candidates or Licensing Them to Other
Parties. We generally plan to advance drug candidates
through initial and/or early-stage drug development. For larger
disease indications requiring complex clinical trials, our
strategy is to license drug candidates to pharmaceutical or
biotechnology partners for final development and global
marketing. We believe partnerships are a good source of
development payments, license fees, milestone payments and
royalties. They also reduce the costs and risks, and increase
the effectiveness, of late-stage product development, regulatory
approval, manufacturing and marketing. We believe that focusing
on discovery and early-stage drug development while benefiting
from our partners proven development and commercialization
expertise will reduce our internal expenses and allow us to have
a larger number of drug candidates progress to late-stage drug
development. However, after establishing a lead product
candidate, we are willing to license that candidate during any
stage of the development process we determine to be beneficial
to the company and to the ultimate development and
commercialization of that drug candidate. For some smaller niche
disease indications markets, we may choose to complete
development, manufacture, and where appropriate market and
distribute any approved drugs ourselves, such as
Fodosinetm
for certain T-cell and B-cell cancers. |
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Products in Development
The following table summarizes BioCrysts active
development projects as of August 31, 2005:
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Delivery |
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Development |
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Worldwide |
Program and Candidate Disease Category/Indication |
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Rights |
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PNP Inhibitor
(Fodosinetm,
BCX-1777) Oncology
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Intravenous |
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Phase II |
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BioCryst |
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Oral |
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Phase II |
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BioCryst |
PNP Inhibitor (BCX-4208) Autoimmune diseases
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Oral |
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Phase I |
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BioCryst |
Hepatitis C Polymerase Inhibitors (BCX-4678) Viral
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Oral |
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Preclinical |
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BioCryst |
Neuraminidase Inhibitor (Peramivir) Viral
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IV/IM |
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Preclinical |
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BioCryst |
Tissue Factor/ Factor VIIa Inhibitors Cardiovascular/
Oncology
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Oral |
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Discovery |
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BioCryst |
3
Risk Factors
An investment in our stock involves a high degree of risk.
You should consider carefully the following risks, along with
all of the other information included in or incorporated by
reference into this prospectus and any prospectus supplement,
before deciding to buy our common stock. Additional risks and
uncertainties not currently known to us or that we currently
deem to be immaterial may also impair our business operations.
If we are unable to prevent events that have a negative effect
from occurring, then our business may suffer. Negative events
are likely to decrease our revenue, increase our costs, make our
financial results poorer and/or decrease our financial strength,
and may cause our stock price to decline. In that case, you may
lose all or a part of your investment in our common stock.
Risks Relating to Our Business
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We have incurred substantial losses since our inception in
1986, expect to continue to incur such losses, and may never be
profitable. |
Since our inception in 1986, we have not been profitable. We
expect to incur additional losses for the foreseeable future,
and our losses could increase as our research and development
efforts progress. As of June 30, 2005, our accumulated
deficit was approximately $137.1 million. To become
profitable, we must successfully develop drug product
candidates, enter into profitable agreements with other parties
and our product candidates must receive regulatory approval. We
or these other parties must then successfully manufacture and
market our product candidates. It could be several years, if
ever, before we receive royalties from any future license
agreements or revenues directly from product sales.
Because of the numerous risks and uncertainties associated with
developing our product candidates and their potential for
commercialization, we are unable to predict the extent of any
future losses or when we will become profitable, if at all. Even
if we do achieve profitability, we may not be able to sustain or
increase profitability on a quarterly or annual basis. If we are
unable to achieve and sustain profitability, the market value of
our common stock will likely decline.
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If we fail to obtain additional financing, we may be
unable to complete the development and commercialization of our
product candidates or continue our research and development
programs. |
To date, we have financed our operations primarily from sale of
our equity securities and, to a lesser extent, revenues from
collaborations and interest. In 2004, our operations consumed
approximately $1.5 million per month and the run rate at
the end of the second quarter 2005 was approximately
$2.0 million. We expect that our monthly cash used by
operations will continue to increase for the next several years.
During the second half of 2005, we plan to both expand our
existing clinical programs and initiate clinical programs for
several new disease indications. These additional trials and the
related manufacturing, personnel resources and testing required
to support these studies will consume significant capital
resources and will increase our expenses and our net loss.
As of June 30, 2005, we had $40.0 million in cash,
cash equivalents and securities. We raised cash totaling
$23.9 million gross (approximately $22.7 million net
of expenses) through the sale of equity during February 2005 to
provide the resources necessary to continue the development of
our existing programs, while prudently maintaining our cash
position. We expect our monthly burn rate to increase to
approximately $2.5 million during the second half of 2005,
as our lead candidates advance through the clinical trials
currently ongoing and planned for 2005. This monthly burn rate
could vary significantly depending on many factors, including
our ability to raise additional capital, our ability to
establish partnerships for our drug product candidates, the
progress of our current and proposed clinical trials for
Fodosinetm,
BCX-4208 and BCX-4678, and the progression of our other
programs. Our long-term capital requirements and the adequacy of
our available funds will depend upon many factors, including:
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the progress of our research, drug discovery and development
programs; |
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changes in existing collaborative relationships; |
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our ability to establish additional collaborative relationships; |
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our ability to negotiate favorable development and marketing
alliances for our drug product candidates; |
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the magnitude of our research and development programs; |
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the scope and results of preclinical studies and clinical trials
to identify drug product candidates; |
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competitive and technological advances; |
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the time and costs involved in obtaining regulatory approvals; |
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the costs involved in preparing, filing, prosecuting,
maintaining and enforcing patent claims; |
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our dependence on others for development and commercialization
of our product candidates; and |
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successful commercialization of our products consistent with our
licensing strategy. |
We will be required to raise additional capital to complete the
development and commercialization of our current product
candidates. Additional funding, whether through additional sales
of securities or collaborative or other arrangements with
corporate partners or from other sources, may not be available
when needed or on terms acceptable to us. The issuance of
preferred or common stock or convertible securities, with terms
and prices significantly more favorable than those of the
currently outstanding common stock, could have the effect of
diluting or adversely affecting the holdings or rights of our
existing stockholders. In addition, collaborative arrangements
may require us to transfer certain material rights to such
corporate partners. Insufficient funds may require us to delay,
scale-back or eliminate certain of our research and development
programs.
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We have not commercialized any products or technologies
and our future revenue generation is uncertain. |
We have not yet commercialized any products or technologies, and
we may never be able to do so. Our revenue from collaborative
agreements is dependent upon the status of our preclinical and
clinical programs. If we fail to advance these programs to the
point of being able to enter into successful collaborations, we
will not receive any future milestone or other collaborative
payments.
Any future revenue directly from product sales would depend on
our ability to successfully complete clinical studies, obtain
regulatory approvals, manufacture, market and commercialize any
approved drugs.
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If our development collaborations with other parties fail,
the development of our drug product candidates will be delayed
or stopped. |
We rely heavily upon other parties for many important stages of
our drug development programs, including:
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discovery of proteins that cause or enable biological reactions
necessary for the progression of the disease or disorder, called
enzyme targets; |
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licensing or design of enzyme inhibitors for development as drug
product candidates; |
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execution of some preclinical studies and late-stage development
for our compounds and product candidates; |
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management of our clinical trials, including medical monitoring
and data management; |
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execution of additional toxicology studies that may be required
to obtain approval for our product candidates; |
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manufacturing the starting materials required to formulate our
drug compounds; |
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management of our regulatory function; and |
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manufacturing, sales, marketing and distribution of our product
candidates. |
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Our failure to engage in successful collaborations at any one of
these stages would greatly impact our business. If we do not
license enzyme targets or inhibitors from academic institutions
or from other biotechnology companies on acceptable terms, our
product development efforts would suffer. Similarly, if the
contract research organizations that conduct our initial or
late-stage clinical trials or manage our regulatory function
breached their obligations to us, this would delay or prevent
the development of our product candidates.
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If we fail to establish collaborative relationships to
commercialize certain of our drug product candidates or if any
collaborator terminates or fails to perform its obligations
under agreements with us, the commercialization of our product
candidates could be delayed or terminated. |
A key aspect of our business strategy is to enter into
successful collaborative arrangements with pharmaceutical
companies, research institutions, the United States government
and universities for the late-stage clinical development,
regulatory approval, marketing, domestic and international sales
and distribution of our drug product candidates. Our general
strategy is to rely upon other parties for all of these steps so
that we can focus exclusively on the key areas of our expertise.
For some smaller niche markets, we may perform these steps
ourselves and outsource those functions where we do not have the
internal expertise.
Currently, we have no established collaborative relationships
with pharmaceutical companies or government agencies. The
process of establishing collaborative relationships is
difficult, time-consuming and involves significant uncertainty.
Moreover, even if we do establish collaborative relationships,
heavy reliance upon third parties for these critical functions
presents several risks, including:
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our collaborators may seek to renegotiate or terminate their
relationships with us due to unsatisfactory clinical results, a
change in business strategy, a change of control or other
reasons; |
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our contracts for collaborative arrangements may expire; |
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our partners may choose to pursue alternative technologies,
including those of our competitors; |
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we may have disputes with a partner that could lead to
litigation or arbitration; |
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our partners may not devote sufficient capital or resources
towards our product candidates; and |
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our partners may not comply with applicable government
regulatory requirements. |
If any collaborator fails to fulfill its responsibilities in a
timely manner, or at all, our commercialization efforts related
to that collaboration could be delayed or terminated, or it may
be necessary for us to assume responsibility for activities that
would otherwise have been the responsibility of our
collaborator. If we are unable to establish and maintain
collaborative relationships on acceptable terms, we may have to
delay or discontinue further development of one or more of our
product candidates, undertake commercialization activities at
our own expense or find alternative sources of funding. Any
delay in the development or commercialization of our compounds
would severely affect our business, because if our compounds do
not reach the market in a timely manner, or at all, we may never
receive any milestone, product or royalty payments.
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Because we have limited manufacturing experience, we
depend on third-party manufacturers to manufacture our drug
product candidates and the materials for our product candidates.
If we cannot rely on third-party manufacturers, we will be
required to incur significant costs and potential delays in
finding new third-party manufacturers. |
We have limited manufacturing experience and only a small scale
manufacturing facility. We currently rely upon third-party
manufacturers to manufacture the materials required for our drug
product candidates and most of the preclinical and clinical
quantities of our product candidates. We depend on these
third-party manufacturers to perform their obligations in a
timely manner and in accordance with applicable governmen-
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tal regulations. Our third-party manufacturers may encounter
difficulties with meeting our requirements, including problems
involving:
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inconsistent production yields; |
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interruption of the delivery of materials required for the
manufacturing process; |
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scheduling of plant time with other vendors or unexpected
equipment failure; |
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poor quality control and assurance or inadequate process
controls; and |
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lack of compliance with regulations and specifications set forth
by the FDA or other foreign regulatory agencies. |
These contract manufacturers may not be able to manufacture the
materials required or our drug product candidates at a cost or
in quantities necessary to make them commercially viable. We
also have no control over whether third-party manufacturers
breach their agreements with us or whether they may terminate or
decline to renew agreements with us. To date, our third party
manufacturers have met our manufacturing requirements, but we
cannot assure you that they will continue to do so. Furthermore,
changes in the manufacturing process or procedure, including a
change in the location where the drug is manufactured or a
change of a third-party manufacturer, may require prior review
and approval in accordance with the FDAs current Good
Manufacturing Practices, or cGMPs, and comparable foreign
requirements. This review may be costly and time-consuming and
could delay or prevent the launch of a product. The FDA or
similar foreign regulatory agencies at any time may also
implement new standards, or change their interpretation and
enforcement of existing standards for manufacture, packaging or
testing of products. If we or our contract manufacturers are
unable to comply, we or they may be subject to regulatory
action, civil actions or penalties.
If we are unable to enter into agreements with additional
manufacturers on commercially reasonable terms, or if there is
poor manufacturing performance on the part of our third party
manufacturers, we may not be able to complete development of, or
market, our product candidates.
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We may be unable to establish sales, marketing and
distribution capabilities necessary to successfully
commercialize products we may successfully develop. |
We currently have no marketing capability and no direct or
third-party sales or distribution capabilities. If we
successfully develop a drug product candidate and decide to
commercialize it ourselves rather than relying on third parties,
as we are considering doing in the United States for
Fodosinetm,
we may be unable to establish marketing, sales and distribution
capabilities necessary to commercialize and gain market
acceptance for that product.
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If the clinical trials of our drug product candidates
fail, our product candidates will not be marketed, which would
result in a complete absence of product related revenue. |
To receive the regulatory approvals necessary for the sale of
our product candidates, we or our licensees must demonstrate
through preclinical studies and clinical trials that each
product candidate is safe and effective. If we or our licensees
are unable to demonstrate that our product candidates are safe
and effective, our product candidates will not receive
regulatory approval and will not be marketed, which would result
in a complete absence of product related revenue. The clinical
trial process is complex and uncertain. Because of the cost and
duration of clinical trials, we may decide to discontinue
development of product candidates that are either unlikely to
show good results in the trials or unlikely to help advance a
product to the point of a meaningful collaboration. Positive
results from preclinical studies and early clinical trials do
not ensure positive results in clinical trials designed to
permit application for regulatory approval, called pivotal
clinical trials. We may suffer significant setbacks in pivotal
clinical trials, even after earlier clinical trials show
promising results. Any of our product candidates may produce
undesirable side effects in humans. These side effects could
cause us or regulatory authorities to interrupt, delay or halt
clinical trials of a product candidate. These side effects could
also result in the FDA or foreign regulatory authorities
refusing to approve the product candidate for any targeted
indications. We, our licensees, the FDA or foreign regulatory
authorities
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may suspend or terminate clinical trials at any time if we or
they believe the trial participants face unacceptable health
risks. Clinical trials may fail to demonstrate that our product
candidates are safe or effective.
We are seeking a special protocol assessment, or SPA, of the
clinical trial protocol for the proposed Phase IIb clinical
trial of
Fodosinetm
in T-cell leukemia. A special protocol assessment is an
agreement between an applicant and the FDA on the design and the
size of clinical trials that is intended to form the basis of a
New Drug Application. In connection with an SPA, an applicant
may decide, or the FDA may require the applicant, to modify the
proposed protocol by, for example, changing the proposed primary
endpoint, the size of the study or otherwise, which may result
in a delay in the initiation or completion of the clinical
trials that are the subject of the SPA. These changes could
arise from a change in the standard of care for the proposed
indication or other aspects of the protocol for the proposed
clinical trials. If the FDA and an applicant reach an agreement
on an SPA, the SPA cannot be changed after the clinical trial
begins, except in limited circumstances such as a change in the
science or clinical knowledge about the conditions being
studied. Any significant change to the protocols for a clinical
trial subject to an SPA would require prior FDA approval, which
could delay implementation of such a change and continuation and
completion of the related clinical trial.
Clinical trials are lengthy and expensive. We or our licensees
incur substantial expense for, and devote significant time to,
preclinical testing and clinical trials, yet cannot be certain
that the tests and trials will ever result in the commercial
sale of a product. For example, clinical trials require adequate
supplies of drug and sufficient patient enrollment. Delays in
patient enrollment can result in increased costs and longer
development times. Even if we or our licensees successfully
complete clinical trials for our product candidates, we or our
licensees might not file the required regulatory submissions in
a timely manner and may not receive regulatory approval for the
product candidate.
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If we or our licensees do not obtain and maintain
governmental approvals for our products under development, we or
our partners will not be able to sell these potential products,
which would significantly harm our business because we will
receive no revenue. |
We or our licensees must obtain regulatory approval before
marketing or selling our future drug products. If we or our
licensees are unable to receive regulatory approval and do not
market or sell our future drug products, we will never receive
any revenue from such product sales. In the United States, we or
our partners must obtain FDA approval for each drug that we
intend to commercialize. The FDA approval process is typically
lengthy and expensive, and approval is never certain. Products
distributed abroad are also subject to foreign government
regulation. The FDA or foreign regulatory agencies have not
approved any of our drug product candidates. If we or our
licensees fail to obtain regulatory approval we will be unable
to market and sell our future drug products. We have several
drug products in various stages of preclinical and clinical
development; however, we are unable to determine when, if ever,
any of these products will be commercially available. Because of
the risks and uncertainties in biopharmaceutical development,
our product candidates could take a significantly longer time to
gain regulatory approval than we expect or may never gain
approval. If the FDA delays regulatory approval of our product
candidates, our managements credibility, our
companys value and our operating results may suffer. Even
if the FDA or foreign regulatory agencies approve a product
candidate, the approval may limit the indicated uses for a
product candidate and/or may require post-marketing studies.
The FDA regulates, among other things, the record keeping and
storage of data pertaining to potential pharmaceutical products.
We currently store most of our preclinical research data at our
facility. While we do store duplicate copies of most of our
clinical data offsite, we could lose important preclinical data
if our facility incurs damage. If we get approval to market our
potential products, whether in the United States or
internationally, we will continue to be subject to extensive
regulatory requirements. These requirements are wide ranging and
govern, among other things:
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adverse drug experience reporting regulations; |
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product promotion; |
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product manufacturing, including good manufacturing practice
requirements; and |
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product changes or modifications. |
Our failure to comply with existing or future regulatory
requirements, or our loss of, or changes to, previously obtained
approvals, could have a material adverse effect on our business
because we will not receive product or royalty revenues if we or
our licensees do not receive approval of our products for
marketing.
In June 1995, we notified the FDA that we submitted incorrect
data for our Phase II studies of BCX-34 applied to the skin
for CTCL and psoriasis. The FDA inspected us in November 1995
and issued us a List of Inspectional Observations, Form FDA
483, which cited our failure to follow good clinical practices.
The FDA also inspected us in June 1996. The focus was on the two
1995 Phase II dose-ranging studies of topical BCX-34 for
the treatment of CTCL and psoriasis. As a result of the
investigation, the FDA issued us a Form FDA 483, which
cited our failure to follow good clinical practices. We are no
longer developing BCX-34; however, as a consequence of these two
investigations, our ongoing and future clinical studies may
receive increased scrutiny, which may delay the regulatory
review process.
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If our drug product candidates do not achieve broad market
acceptance, our business may never become profitable. |
Our drug product candidates may not gain the market acceptance
required for us to be profitable even if they successfully
complete initial and final clinical trials and receive approval
for sale by the FDA or foreign regulatory agencies. The degree
of market acceptance of any product candidates that we or our
partners develop will depend on a number of factors, including:
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our clinical evidence of safety and efficacy; |
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cost-effectiveness, convenience and ease of use of our product
candidates; |
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their safety, availability and effectiveness relative to
alternative treatments; |
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the actual and potential side effects or other reactions; |
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reimbursement policies of government and third-party
payers; and |
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the effectiveness of marketing and distribution support for our
product candidates. |
Physicians, patients, payers or the medical community in general
may not accept or use our product candidates even after the FDA
or foreign regulatory agencies approve the drug candidates. If
our product candidates do not achieve significant market
acceptance, we will not have enough revenues to become
profitable.
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We face intense competition, and if we are unable to
compete effectively, the demand for our products, if any, may be
reduced. |
The biotechnology and pharmaceutical industries are highly
competitive and subject to rapid and substantial technological
change. We face, and will continue to face, competition in the
licensing of desirable disease targets, licensing of desirable
drug product candidates, and development and marketing of our
product candidates from academic institutions, government
agencies, research institutions and biotechnology and
pharmaceutical companies. Competition may also arise from, among
other things:
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other drug development technologies; |
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methods of preventing or reducing the incidence of disease,
including vaccines; and |
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new small molecule or other classes of therapeutic agents. |
Developments by others may render our product candidates or
technologies obsolete or noncompetitive.
We are performing research on or developing products for the
treatment of several disorders including T-cell mediated
disorders (T-cell cancers, psoriasis, and rheumatoid arthritis),
cardiovascular, oncology, and
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hepatitis C, and there are a number of competitors to
products in our research pipeline. If one or more of our
competitors products or programs are successful, the
market for our products may be reduced or eliminated.
Compared to us, many of our competitors and potential
competitors have substantially greater:
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capital resources; |
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research and development resources, including personnel and
technology; |
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regulatory experience; |
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preclinical study and clinical testing experience; |
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manufacturing and marketing experience; and |
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production facilities. |
Any of these competitive factors could reduce demand for our
products.
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If we fail to adequately protect or enforce our
intellectual property rights or secure rights to patents of
others, the value of those rights would diminish. |
Our success will depend in part on our ability and the abilities
of our collaborators to obtain patent protection for our
products, methods, processes and other technologies we may
license or develop, to preserve our trade secrets, and to
operate without infringing the proprietary rights of third
parties both domestically and abroad. The patent position of
biotechnology companies is generally highly uncertain, involves
complex legal and factual questions and has recently been the
subject of much litigation. Neither the United States Patent and
Trademark Office, or PTO, nor the courts have a consistent
policy regarding the breadth of claims allowed or the degree of
protection afforded under many biotechnology patents. The
validity, enforceability and commercial value of these rights,
therefore, is highly uncertain.
If we or our partners are unable to adequately protect or
enforce our intellectual property rights for our products,
methods, processes and other technologies, the value of the drug
product candidates that we license to derive revenue would
diminish. Additionally, if our products, methods, processes and
other technologies infringe the proprietary rights of other
parties, we could incur substantial costs. The U.S. Patent
and Trademark Office has issued to us a number of
U.S. patents for our various inventions and we have
in-licensed several patents from various institutions. We have
filed additional patent applications and provisional patent
applications with the U.S. Patent and Trademark Office. We
have filed a number of corresponding foreign patent applications
and intend to file additional foreign and U.S. patent
applications, as appropriate. We cannot assure you as to:
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the degree and range of protection any patents will afford
against competitors with similar products; |
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if and when patents will issue; or |
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whether or not others will obtain patents claiming aspects
similar to those covered by our patent applications. |
If the U.S. Patent and Trademark Office upholds patents
issued to others or if the U.S. Patent and Trademark Office
grants patent applications filed by others, we may have to:
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obtain licenses or redesign our products or processes to avoid
infringement; |
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stop using the subject matter claimed in those patents; or |
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pay damages. |
We may initiate, or others may bring against us, litigation or
administrative proceedings related to intellectual property
rights, including proceedings before the U.S. Patent and
Trademark Office. Any judgment adverse to us in any litigation
or other proceeding arising in connection with a patent or
patent application could materially and adversely affect our
business, financial condition and results of operations. In
addition, the costs of any such proceeding may be substantial
whether or not we are successful.
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Our success is also dependent upon the skills, knowledge and
experience, none of which is patentable, of our scientific and
technical personnel. To help protect our rights, we require all
employees, consultants, advisors and collaborators to enter into
confidentiality agreements that prohibit the disclosure of
confidential information to anyone outside of our company and
require disclosure and assignment to us of their ideas,
developments, discoveries and inventions. These agreements may
not provide adequate protection for our trade secrets, know-how
or other proprietary information in the event of any
unauthorized use or disclosure or the lawful development by
others of such information, and if any of our proprietary
information is disclosed, our business will suffer because our
revenues depend upon our ability to license our technology and
any such events would significantly impair the value of such a
license.
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If we fail to retain our existing key personnel or fail to
attract and retain additional key personnel, the development of
our drug product candidates and the expansion of our business
will be delayed or stopped. |
We are highly dependent upon our senior management and
scientific team, the loss of whose services might impede the
achievement of our development and commercial objectives.
Competition for key personnel with the experience that we
require is intense and is expected to continue to increase. Our
inability to attract and retain the required number of skilled
and experienced management, operational and scientific
personnel, will harm our business because we rely upon these
personnel for many critical functions of our business. In
addition, we rely on members of our scientific advisory board
and consultants to assist us in formulating our research and
development strategy. All of the members of the scientific
advisory board and all of our consultants are otherwise employed
and each such member or consultant may have commitments to other
entities that may limit their availability to us.
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If users of our drug products are not reimbursed for use,
future sales of our drug products will decline. |
The lack of reimbursement for the use of our product candidates
by hospitals, clinics, patients or doctors will harm our
business. Medicare, Medicaid, health maintenance organizations
and other third-party payers may not authorize or otherwise
budget for the reimbursement of our products. Governmental and
third-party payers are increasingly challenging the prices
charged for medical products and services. We cannot be sure
that third-party payers would view our product candidates as
cost-effective, that reimbursement will be available to
consumers or that reimbursement will be sufficient to allow our
product candidates to be marketed on a competitive basis.
Changes in reimbursement policies, or attempts to contain costs
in the health care industry could limit or restrict
reimbursement for our product candidates and would materially
and adversely affect our business, because future product sales
would decline and we would receive less product or royalty
revenue.
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The recent Medicare prescription drug coverage legislation
and future legislative or regulatory reform of the healthcare
system may affect our ability to sell our products
profitably. |
In the United States, there have been a number of legislative
and regulatory proposals, at both the federal and state
government levels, to change the healthcare system in ways that
could affect our ability to sell our products profitably, if
approved. For example, the Medicare Prescription Drug and
Modernization Act of 2003, or MMA, will change the types of
drugs covered by Medicare, and the methodology used to determine
the price for such drugs. Further federal and state proposals
and healthcare reforms are likely. Our business could be harmed
by the MMA, by the possible effect of this legislation on
amounts that private payors will pay and by other healthcare
reforms that may be enacted or adopted in the future.
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There is a substantial risk of product liability claims in
our business. If we are unable to obtain sufficient insurance, a
product liability claim against us could adversely affect our
business. |
We face an inherent risk of product liability exposure related
to the testing of our product candidates in human clinical
trials and will face even greater risks upon any
commercialization by us of our product candidates. We have
product liability insurance covering our clinical trials in the
amount of $7 million, which we currently believe is
adequate to cover any product liability exposure we may have.
Clinical trial and product
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liability insurance is becoming increasingly expensive. As a
result, we may be unable to obtain sufficient insurance or
increase our existing coverage at a reasonable cost to protect
us against losses that could have a material adverse effect on
our business. An individual may bring a product liability claim
against us if one of our products or product candidates causes,
or is claimed to have caused, an injury or is found to be
unsuitable for consumer use. Any product liability claim brought
against us, with or without merit, could result in:
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liabilities that substantially exceed our product liability
insurance, which we would then be required to pay from other
sources, if available; |
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an increase of our product liability insurance rates or the
inability to maintain insurance coverage in the future on
acceptable terms, or at all; |
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withdrawal of clinical trial volunteers or patients; |
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damage to our reputation and the reputation of our products,
resulting in lower sales; |
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regulatory investigations that could require costly recalls or
product modifications; |
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litigation costs; and |
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the diversion of managements attention from managing our
business. |
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If our computer systems fail, our business will
suffer. |
Our drug development activities depend on the security,
integrity and performance of the computer systems supporting
them, and the failure of our computer systems could delay our
drug development efforts. We currently store most of our
preclinical and clinical data at our facility. Duplicate copies
of most critical data are stored off-site in a bank vault. Any
significant degradation or failure of our computer systems could
cause us to inaccurately calculate or lose our data. Loss of
data could result in significant delays in our drug development
process and any system failure could harm our business and
operations.
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If, because of our use of hazardous materials, we violate
any environmental controls or regulations that apply to such
materials, we may incur substantial costs and expenses in our
remediation efforts. |
Our research and development involves the controlled use of
hazardous materials, chemicals and various radioactive
compounds. We are subject to federal, state and local laws and
regulations governing the use, storage, handling and disposal of
these materials and some waste products. Accidental
contamination or injury from these materials could occur. In the
event of an accident, we could be liable for any damages that
result and any liabilities could exceed our resources.
Compliance with environmental laws and regulations could require
us to incur substantial unexpected costs, which would materially
and adversely affect our results of operations.
Risks Relating to Our Common Stock
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Our stock price is likely to be highly volatile and the
value of your investment could decline significantly. |
The market prices for securities of biotechnology companies in
general have been highly volatile and may continue to be highly
volatile in the future. Moreover, our stock price has fluctuated
frequently, and these fluctuations are often not related to our
financial results. For the twelve months ended June 30,
2005, the 52-week range of the market price of our stock was
from $3.68 to $7.56 per share. The following factors, in
addition to other risk factors described in this section, may
have a significant impact on the market price of our common
stock:
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announcements of technological innovations or new products by us
or our competitors; |
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developments or disputes concerning patents or proprietary
rights; |
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status of new or existing licensing or collaborative agreements; |
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we or our licensees achieving or failing to achieve development
milestones; |
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publicity regarding actual or potential medical results relating
to products under development by us or our competitors; |
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regulatory developments in both the United States and foreign
countries; |
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public concern as to the safety of pharmaceutical products; |
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actual or anticipated fluctuations in our operating results; |
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changes in financial estimates or recommendations by securities
analysts; |
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changes in the structure of healthcare payment systems,
including developments in price control legislation; |
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announcements by us or our competitors of significant
acquisitions, strategic partnerships, joint ventures or capital
commitments; |
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additions or departures of key personnel or members of our board
of directors; |
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sales of substantial amounts of our stock by existing
stockholders, including officers or directors; |
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economic and other external factors or other disasters or
crises; and |
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period-to-period fluctuations in our financial results. |
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Because stock ownership is concentrated, you and other
investors will have limited influence on stockholder
decisions. |
As of June 30, 2005, our directors, executive officers and
some principal stockholders and their affiliates beneficially
owned approximately 43.9% (directors and officers, together with
their relevant affiliates owned 25.5%) of our outstanding common
stock and common stock equivalents. As a result, these holders,
if acting together, are able to significantly influence matters
requiring stockholder approval, including the election of
directors. This concentration of ownership may delay, defer or
prevent a change in our control.
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We have anti-takeover provisions in our corporate charter
documents that may result in outcomes with which you do not
agree. |
Our board of directors has the authority to issue up to
3,178,500 shares of undesignated preferred stock and to
determine the rights, preferences, privileges and restrictions
of those shares without further vote or action by our
stockholders. The rights of the holders of any preferred stock
that may be issued in the future may adversely affect the rights
of the holders of common stock. The issuance of preferred stock
could make it more difficult for third parties to acquire a
majority of our outstanding voting stock.
In addition, our certificate of incorporation provides for
staggered terms for the members of the board of directors and
supermajority approval of the removal of any member of the board
of directors and prevents our stockholders from acting by
written consent. Our certificate also requires supermajority
approval of any amendment of these provisions. These provisions
and other provisions of our by-laws and of Delaware law
applicable to us could delay or make more difficult a merger,
tender offer or proxy contest involving us.
In June 2002, our board of directors adopted a stockholder
rights plan and, pursuant thereto, issued preferred stock
purchase rights (Rights) to the holders of our
common stock. The Rights have certain anti-takeover effects. If
triggered, the Rights would cause substantial dilution to a
person or group of persons who acquires more than 15% (19.9% for
William W. Featheringill, a Director who owned approximately 11%
as of June 30, 2005, but owned more than 15% at the time
the Rights were put in place) of our common stock on terms not
approved by the board of directors.
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We have never paid dividends on our common stock and do
not anticipate doing so in the foreseeable future. |
We have never paid cash dividends on our stock. We currently
intend to retain all future earnings, if any, for use in the
operation of our business. Accordingly, we do not anticipate
paying cash dividends on our common stock in the foreseeable
future.
Risks Relating to This Offering
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The projections contained in this prospectus or any
applicable prospectus supplement, and the registration statement
of which this prospectus or any applicable prospectus supplement
may be a part, are based on assumptions that may not
materialize. |
The projections of our business included in this prospectus or
any applicable prospectus supplement are based on assumptions
which we believe are reasonable as of the date of the prospectus
or prospectus supplement. No assurance can be given, however,
regarding the attainability of the projections or the
reliability of the assumptions on which they are based. Certain
of the assumptions used may not materialize and unanticipated
events may occur. Therefore, our actual results of operations
may vary from the projections contained within this prospectus
or any applicable prospectus supplement, and such variations may
be material.
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Management will have broad discretion as to the use of the
proceeds from this offering, and we may not use the proceeds
effectively. |
We have not designated the amount of net proceeds we will use
for any particular purpose. Accordingly, our management will
have broad discretion as to the application of the net proceeds
from this offering and could use them for purposes other than
those contemplated at the time of this offering. Our
stockholders may not agree with the manner in which our
management proposes to allocate and spend the net proceeds.
Moreover, our management may use the net proceeds for corporate
purposes that may not increase our market value or make us
profitable.
Information Regarding Forward-Looking Statements
This prospectus contains forward-looking statements that involve
risks and uncertainties. All statements other than statements of
historical facts contained in this prospectus are
forward-looking statements. In some cases, you can identify
forward-looking statements by terminology such as
may, could, will,
should, expect, plan,
anticipate, believe,
estimate, intend, predict,
seek, potential or continue
or the negative of these terms or other comparable terminology.
These forward-looking statements include, but are not limited
to, statements about:
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the initiation, timing, progress and results of our preclinical
and clinical trials, research and development programs; |
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the further preclinical or clinical development and
commercialization of our product candidates; |
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the implementation of our business model, strategic plans for
our business, product candidates and technology; |
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our ability to establish and maintain corporate collaborations; |
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the scope of protection we are able to establish and maintain
for intellectual property rights covering our product candidates
and technology; |
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our ability to operate our business without infringing the
intellectual property rights of others; |
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estimates of our expenses, future revenues, capital requirements
and our needs for additional financing; |
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the timing or likelihood of regulatory filings and approvals; |
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our intention to seek a special protocol assessment from the FDA
in 2005; |
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our use of proceeds from any offerings under this prospectus; |
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our financial performance; and |
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competitive companies, technologies and our industry. |
These statements relate to future events or to our future
financial performance and involve known and unknown risks,
uncertainties and other factors that may cause our actual
results, performance or achievements to be materially different
from any future results, performance or achievements expressed
or implied by these forward-looking statements. Factors that may
cause actual results to differ materially from current
expectations include, among other things, those listed under
Risk Factors and elsewhere in this prospectus. Any
forward-looking statement in this prospectus reflects our
current views with respect to future events and is subject to
these and other risks, uncertainties and assumptions relating to
our operations, results of operations, industry and future
growth. Except as required by law, we assume no obligation to
update or revise these forward-looking statements for any
reason, even if new information becomes available in the future.
Discussions containing these forward-looking statements are also
contained in Managements Discussion and Analysis of
Financial Condition and Results of Operations incorporated
by reference from our most recent Annual Report on
Form 10-K, our Quarterly Reports on Form 10-Q for the
quarters ended since our most recent Annual Report, as well as
any amendments we make to those filings with the SEC.
Use of Proceeds
Except as otherwise described in the applicable prospectus
supplement, the net proceeds from the sale of the common stock
offered hereunder will be added to our general funds and used
for general corporate purposes, which may include, but are not
limited to:
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research and development activities; |
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preclinical studies and clinical trials; |
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increased manufacturing of compounds for clinical trials,
toxicology studies and validation of both the manufacturing and
formulation processes; |
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capital expenditures; and |
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general working capital. |
We may also use a portion of the net proceeds to acquire or
invest in businesses, assets, products and technologies that are
complementary to our own, although we are not currently
contemplating or negotiating any such acquisitions.
The amounts and timing of our actual expenditures for each
purpose may vary significantly depending upon numerous factors,
including the status of our product development efforts,
regulatory approvals, competition, marketing and sales
activities and the market acceptance of any products we
introduce. Pending such uses, we intend to invest the net
proceeds of this offering in investment grade, interest-bearing
securities.
Plan of Distribution
We may sell the securities being offered hereby at prices and
under terms then prevailing, at prices related to the then
current market price or in negotiated transactions from time to
time in one or more of the following ways:
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directly to one or more purchasers; |
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through one or more underwriters on a firm commitment or
best-efforts basis; |
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through broker-dealers, who may act as agents or principals,
including a block trade in which a broker or dealer so engaged
will attempt to sell the shares as agent but may position and
resell a portion of the block as principal to facilitate the
transaction; |
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through agents; |
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in privately negotiated transactions; or |
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in any combination of these methods of sale. |
We will set forth in a prospectus supplement the terms of the
offering of securities, including:
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the name or names of any agents or underwriters, dealers or
agents; |
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the number of shares and purchase price of the common stock
being offered and the proceeds we will receive from the sale; |
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any underwriting discounts and commissions or agency fees and
other items constituting underwriters or agents
compensation; |
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any over-allotment options under which underwriters may purchase
additional securities from us; |
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any discounts or concessions allowed or re-allowed or paid to
dealers; and |
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any securities exchange on which the common stock may be listed. |
The distribution of the common stock may be effected from time
to time in one or more transactions at a fixed price or prices,
which may be changed, at market prices prevailing at the time of
sale, at prices related to the prevailing market prices or at
negotiated prices.
Agents
We may designate agents who agree to use their reasonable
efforts to solicit purchases for the period of their appointment
or to sell common stock on a continuing basis. Agents may
receive compensation in the form of commissions, discounts or
concessions from us. Agents may also receive compensation from
the purchasers of the common stock for whom they sell as
principals. Each particular agent will receive compensation in
amounts negotiated in connection with the sale, which might be
in excess of customary commissions. Agents and any other
participating broker-dealers may be deemed to be
underwriters within the meaning of
Section 2(11) of the Securities Act in connection with
sales of the shares. Accordingly, any commission, discount or
concession received by them and any profit on the resale of the
common stock purchased by them may be deemed to be underwriting
discounts or commissions under the Securities Act. We have not
entered into any agreements, understandings or arrangements with
any underwriters or broker-dealers regarding the sale of their
securities. As of the date of this prospectus, there are no
special selling arrangements between any broker-dealer or other
person and us. No period of time has been fixed within which the
shares will be offered or sold.
If required under applicable state securities laws, we will sell
the common stock only through registered or licensed brokers or
dealers. In addition, in some states, we may not sell shares of
common stock unless they have been registered or qualified for
sale in the applicable state or an exemption from the
registration or qualification requirement is available and
complied with.
Underwriters
If we use underwriters for a sale of common stock, the
underwriters will acquire the common stock for their own
account. The underwriters may resell the common stock 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 obligations of the underwriters to purchase
the common stock will be subject to the conditions set forth in
the applicable underwriting agreement. We may change from time
to time any initial public offering price and any discounts or
concessions the underwriters allow or re-allow or pay to
dealers. We may use underwriters with
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whom we have a material relationship. We will describe in the
prospectus supplement naming the underwriter the nature of any
such relationship.
Direct Sales
We may also sell common stock directly to one or more purchasers
without using underwriters or agents. Underwriters, dealers and
agents that participate in the distribution of the common stock
may be underwriters as defined in the Securities Act and any
discounts or commissions they receive from us and any profit on
their resale of the common stock may be treated as underwriting
discounts and commissions under the Securities Act. We will
identify in the applicable prospectus supplement any
underwriters, dealers or agents and will describe their
compensation. We may have agreements with the underwriters,
dealers and agents to indemnify them against specified civil
liabilities, including liabilities under the Securities Act.
Underwriters, dealers and agents may engage in transactions with
or perform services for us in the ordinary course of their
businesses.
Stabilization Activities
Any underwriter may engage in overallotment, stabilizing
transactions, short covering transactions and penalty bids in
accordance with Regulation M under the Exchange Act.
Overallotment involves sales in excess of the offering size,
which create a short position. Stabilizing transactions permit
bids to purchase the underlying security so long as the
stabilizing bids do not exceed a specified maximum. Short
covering transactions involve purchases of the common stock in
the open market after the distribution is completed to cover
short positions. Penalty bids permit the underwriters to reclaim
a selling concession from a dealer when the common stock
originally sold by the dealer are purchased in a covering
transaction to cover short positions. Those activities may cause
the price of the common stock to be higher than it would
otherwise be. If commenced, the underwriters may discontinue any
of the activities at any time. These transactions may be
effected on The Nasdaq National Market or otherwise.
Passive Market Making
Any underwriters who are qualified market makers on The Nasdaq
National Market may engage in passive market making transactions
in the common stock on The Nasdaq National Market in accordance
with Rule 103 of Regulation M, during the business day
before the pricing of the offering, before the commencement of
offers or sales of the common stock. Passive market makers must
comply with applicable volume and price limitations and must be
identified as passive market makers. In general, a passive
market maker must display its bid at a price not in excess of
the highest independent bid for such security; if all
independent bids are lowered below the passive market
makers bid, however, the passive market makers bid
must then be lowered when certain purchase limits are exceeded.
Costs
We will bear all costs, expenses and fees in connection with the
registration of the common stock, as well as the expense of all
commissions and discounts, if any, attributable to sales of the
common stock by us.
Legal Matters
The validity of the common stock offered hereby will be passed
on for us by Holme Roberts & Owen LLP, Denver,
Colorado. As of August 20, 2005, a partner of Holme
Roberts & Owen LLP beneficially owned a total of
5,000 shares of our common stock.
Experts
Ernst & Young LLP, independent registered public
accounting firm, has audited our financial statements included
in our Annual Report on Form 10-K for the year ended
December 31, 2004, and managements assessment of the
effectiveness of our internal control over financial reporting
as of December 31, 2004, as set forth in their reports,
which are incorporated by reference in this prospectus and
elsewhere in the registration
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statement. Our financial statements and managements
assessment are incorporated by reference in reliance on
Ernst & Young LLPs reports, given on their
authority 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 Securities and Exchange
Commission under the Securities Exchange Act of 1934. You may
read and copy this information at the following location at the
SEC:
100 F Street, N.E., Room 1580
Washington, D.C. 20549
You can also obtain copies of this information by mail from the
Public Reference Room of the SEC, 100 F Street, N.E.,
Room 1580, Washington D.C. 20549, at prescribed rates.
You may obtain information on the operation of the Public
Reference Room by calling the SEC at (800) SEC-0330.
The SEC also maintains an Internet world wide web site that
contains reports, proxy statements and other information about
issuers, like BioCryst, that file electronically with the SEC.
The address of that site is http://www.sec.gov.
We have filed with the SEC a registration statement on
Form S-3 that registers the securities we are offering. The
registration statement, including the attached exhibits and
schedules, contains additional relevant information about us and
our securities. The rules and regulations of the SEC allow us to
omit certain information included in the registration statement
from this prospectus.
Incorporation of Certain Documents by Reference
The SEC allows us to incorporate by reference
information into this prospectus. This means that we can
disclose important information to you by referring you to
another document filed separately with the SEC. The information
incorporated by reference is considered to be part of this
prospectus, except for any information that is superseded by
information that is included directly in this document.
This prospectus includes by reference the documents listed below
that we have previously filed with the SEC and that are not
included in or delivered with this document. They contain
important information about BioCryst and its financial condition.
(a) Our Annual Report on Form 10-K for the year ended
December 31, 2004;
(b) Our Quarterly Reports on Form 10-Q for the
quarters ended March 31, 2005 and June 30, 2005;
(c) Our Current Reports on Form 8-K filed with the SEC
on February 7, 2005, February 17, 2005, March 9,
2005, March 15, 2005, March 21, 2005, May 10,
2005, June 20, 2005, July 1, 2005, August 9, 2005
(two filings) and August 31, 2005;
(d) Our Definitive Proxy Statement on Schedule 14A
filed with the SEC on April 6, 2005;
(e) The description of our common stock which is contained
in our Registration Statement on Form 8-A filed with the
SEC on January 8, 1994, including any amendment or reports
filed for the purpose of updating such description; and
(f) The description of our preferred share purchase rights
which is contained in our Registration Statement on
Form 8-A filed with the SEC on June 17, 2002,
including any amendment or reports filed for the purpose of
updating such description.
All documents filed by us pursuant to Section 13(a), 13(c),
14 or 15(d) of the Exchange Act after the date of this
prospectus and prior to the termination of this offering shall
be deemed to be incorporated by reference herein and to be a
part of this prospectus from the date of filing of such
documents, excluding any information furnished under
Item 2.02 or Item 7.01 of any Current Report on
Form 8-K. Any statement contained in a document
incorporated by reference herein shall be deemed to be modified
or superseded for
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purposes of this prospectus to the extent that a statement
contained herein or in any other subsequently filed document
which also is or is deemed to be incorporated by reference
herein modifies or supersedes such statement. Any statement so
modified or superseded shall not be deemed, except as so
modified or superseded, to constitute a part of this prospectus.
You can obtain any of the documents incorporated by reference in
this document from us without charge, excluding any exhibits to
those documents unless the exhibit is specifically incorporated
by reference as an exhibit to this prospectus. You can obtain
documents incorporated by reference in this prospectus by
requesting them in writing or by telephone from us at the
following address:
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Michael A. Darwin |
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Chief Financial Officer and Secretary |
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BioCryst Pharmaceuticals, Inc. |
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2190 Parkway Lake Drive |
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Birmingham, Alabama 35244 |
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(205) 444-4600 |
We have not authorized anyone to give any information or make
any representation about us that is different from, or in
addition to, that contained in this prospectus or in any of the
materials that we have incorporated by reference into this
document. Therefore, if anyone does give you information of this
sort, you should not rely on it. If you are in a jurisdiction
where offers to sell, or solicitations of offers to purchase,
the securities offered by this document are unlawful, or if you
are a person to whom it is unlawful to direct these types of
activities, then the offer presented in this document does not
extend to you.
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