Unassociated Document
The
information in this preliminary prospectus supplement and the accompanying
prospectus is not complete and may be changed.
This
preliminary prospectus supplement and the accompanying prospectus are not an
offer to sell nor do they seek an offer to buy
these
securities in any jurisdiction where the offer or sale is not
permitted.
Filed
pursuant to Rule 424(b)(5)
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Registration
No. 333-151654
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SUBJECT
TO COMPLETION, DATED FEBRUARY 17, 2010
PRELIMINARY
PROSPECTUS SUPPLEMENT
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(To
Prospectus dated June 18, 2008)
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Shares of
Common Stock
Warrants
to Purchase Shares of
Common Stock
We are
offering an aggregate
of shares
of our common stock and warrants to purchase an aggregate
of shares of
our common stock in this offering (and the shares of common stock
issuable from time to time upon exercise of the warrants). The
common stock and warrants will be sold in units, with each unit consisting of
one share of common stock and a warrant to
purchase of a share of
common stock, at an exercise price of
$ per share. Each
unit will be sold at a public offering price of
$ per unit. Units
will not be issued or certificated. The shares of common stock and warrants are
immediately separable and will be issued separately. Our common stock
is listed on The Nasdaq Global Market under the symbol “DSCO.” On
February 16, 2010, the last reported sale price of our common stock on The
Nasdaq Global Market was $0.74 per share.
Investing
in our common stock involves significant risks. See “Risk Factors”
beginning on page S-6 of this prospectus supplement and page 2 of the
accompanying prospectus.
Neither
the Securities and Exchange Commission nor any other regulatory body has
approved or disapproved of these securities, or passed upon the accuracy or
adequacy of this prospectus supplement or the accompanying
prospectus. Any representation to the contrary is a criminal
offense.
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Per
Unit
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Total
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Public
offering price
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$ |
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$ |
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Underwriting
discounts and commissions
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$ |
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$ |
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Proceeds
to us (before expenses)
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$ |
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$ |
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We
estimate the total expenses of this offering payable by us, excluding
underwriting discounts and commissions, will be approximately
$230,000.
We
anticipate that delivery of the shares and warrants will be made on or
about , 2010, subject
to customary closing conditions.
LAZARD
CAPITAL MARKETS
Prospectus
Supplement dated February ,
2010
Prospectus
Supplement
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Page
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Prospectus
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Page
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About
this Prospectus Supplement
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S-1
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About
This Prospectus
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1
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Prospectus
Supplement Summary
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S-2
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About
Discovery
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1
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Forward-Looking
Statements
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S-4
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Risk
Factors
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2
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Risk
Factors
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S-6
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Forward-Looking
Statements
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20
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Recent
Developments
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S-7
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Use
of Proceeds
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21
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Use
of Proceeds
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S-9
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Ratio
of Earnings to Fixed Charges
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22
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Dilution
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S-10
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Description
of Debt Securities
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22
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Description
of Securities We are Offering
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S-11
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Description
of Preferred Stock
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30
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Underwriting
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S-12
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Description
of Common Stock
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31
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Legal
Matters
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S-14
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Description
of Warrants
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34
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Experts
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S-14
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Plan
of Distribution
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36
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Where
You Can Find More Information and
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Experts
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37
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Incorporation
by Reference
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S-14
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Legal
Matters
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37
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Annex
A Form of Warrant
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A-1
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Where
You Can Find More Information
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37
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Information
Incorporated by Reference
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38
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ABOUT THIS PROSPECTUS
SUPPLEMENT
This
document is in two parts. The first part is the prospectus supplement, which
describes the specific terms of the securities we are offering, including the
price, the amount of common stock being offered and the risks of investing in
our common stock, and also adds to and updates information contained in the
accompanying prospectus and the documents incorporated by reference into the
accompanying prospectus. The second part, the accompanying prospectus, including
the documents incorporated by reference, provides more general information, some
of which may not apply to our common stock. 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 on June 13,
2008. Generally, when we refer to this prospectus, we are referring
to both parts of this document combined. You should read both this
prospectus supplement and the accompanying prospectus together with the
additional information about us described in the section entitled “Where You Can
Find More Information and Incorporation by Reference.” To the extent
there is a conflict between the information contained in this prospectus
supplement, on the one hand, and the information contained in the accompanying
prospectus or in any document incorporated by reference that was filed with the
SEC before the date of this prospectus supplement, on the other hand, you should
rely on the information in this prospectus supplement. If any statement in one
of these documents is inconsistent with a statement in another document having a
later date — for example, a document incorporated by reference in the
accompanying prospectus — the statement in the document having the later date
modifies or supersedes the earlier statement.
You
should rely only on the information contained in this prospectus supplement, the
accompanying prospectus and the documents incorporated by reference herein or
therein. We have not, and the underwriter has not, authorized anyone
to provide you with information different from that contained in any of these
documents. If anyone provides you with different or inconsistent
information, you should no rely on it. The information contained in
these documents is accurate only as of the date of each document, as the case
may be, regardless of the time of delivery of this prospectus supplement and
accompanying prospectus or of any sale of common stock. Our business,
financial condition, results of operations and prospects may change after the
date set forth in each document in which the information is
presented.
We are
making offers to sell and seeking offers to buy shares of common stock and
warrants only in jurisdictions where offers and sales are
permitted. Persons outside the United States who come into possession
of this prospectus must inform themselves about, and observe any restrictions
relating to, the offering of the common stock and warrants to purchase common
stock and the distribution of this prospectus outside the United
States. You should not consider this prospectus supplement and the
accompanying prospectus to be an offer to sell, or a solicitation of an offer to
buy, shares of common stock and warrants if the person making the offer or
solicitation is not qualified to do so or if it is unlawful for you to receive
the offer or solicitation.
References
in the prospectus supplement, the accompanying prospectus and the documents
incorporated by reference herein and therein to “we,” “our,” “us” and the
“company” refer to Discovery Laboratories, Inc. and its subsidiary, unless the
context requires otherwise.
PROSPECTUS
SUPPLEMENT SUMMARY
This
summary highlights certain information about us, this offering and information
appearing elsewhere in this prospectus supplement and in the accompanying
prospectus and in the documents we incorporate by reference. This summary is not
complete and does not contain all of the information that you should consider
before investing in our securities. The following summary is qualified in its
entirety by, and should be read in conjunction with, the more detailed
information and financial statements and notes thereto appearing elsewhere in
this prospectus supplement and the accompanying prospectus. Before you decide to
invest in our securities, to fully understand this offering and its consequences
to you, you should carefully read the entire prospectus supplement and the
accompanying prospectus carefully, including the risk factors beginning on page
S-6 of this prospectus supplement and beginning on page 2 of the accompanying
prospectus, and the consolidated financial statements and related notes included
or incorporated by reference in this prospectus supplement, the accompanying
prospectus and the other documents incorporated by reference herein and
therein.
Our
Business
We are a biotechnology company
developing Surfactant Replacement Therapies (SRT) to treat respiratory disorders
and diseases for which there frequently are few or no approved
therapies. Our novel KL4
proprietary technology produces a synthetic, peptide-containing surfactant
(KL4
surfactant) that is structurally similar to pulmonary surfactant, a substance
produced naturally in the lung and essential for survival and normal respiratory
function. In addition, our proprietary capillary aerosol generating
technology (Capillary Aerosolization Technology) produces a dense aerosol with a
defined particle size, to potentially deliver our aerosolized KL4 surfactant
to the deep lung. As many respiratory disorders are associated with
surfactant deficiency or surfactant degradation, we believe that our proprietary
technology platform makes it possible, for the first time, to develop a
significant pipeline of surfactant products targeted to treat a wide range of
previously unaddressed respiratory problems.
Recent
Developments
Financial
Update. As
of December 31, 2009, we had cash and marketable securities of $15.7 million,
representing a net decrease of $1.9 million from the previous quarter ended
September 30, 2009.
Surfaxin® for the Prevention of
Respiratory Distress Syndrome (RDS) in Premature Infants. On November 17, 2009,
after collaborating with leading academic neonatologists, we announced that we
had submitted to the U.S. Food and Drug Administration (FDA) a proposed protocol
for a Surfaxin® limited
clinical trial that incorporated a PD-based clinical trial design. On February
4, 2010, we received a letter from the FDA advising us that, since an acceptable
and well-established animal model (preterm lamb) of Respiratory Distress
Syndrome (RDS) already exists, which could be used as an acceptable alternative
to a clinical trial in human preterm infants, a PD clinical trial approach is
not appropriate. Accordingly, we now plan to focus on a pathway that
would entail solely performing additional preclinical work, instead of
conducting a limited clinical trial, to potentially gain FDA marketing approval
for Surfaxin®. Compared
to the conduct of a PD clinical trial, a comprehensive preclinical program, if
successful, presents an opportunity to significantly reduce the time
and expense required to gain potential Surfaxin® approval
and Discovery Labs believes that a Complete Response could be submitted to the
FDA in the first quarter of 2011.
Non-Compliance
with Minimum Bid Price Requirement. On December 2,
2009, we received a letter from The Nasdaq Stock Market indicating that for 30
consecutive business days our common stock did not maintain a minimum closing
bid price of $1.00 per share as required by Nasdaq Listing Rule
5450(a)(1). Under the Nasdaq Listing Rules, if during the 180
calendar days following the date of the notification, or prior to June 1, 2010,
the closing bid price of our stock is at or above $1.00 for a minimum of 10
consecutive business days, we will regain compliance with the minimum bid price
requirement and the common stock will continue to be eligible for listing on the
Nasdaq Global Market.
If we do not achieve compliance with the
minimum bid price requirement by June 1, 2010, Nasdaq will provide us with
written notification that the common stock is subject to
delisting. We may, at that time, appeal Nasdaq’s determination to a
Nasdaq Hearing Panel. Such an appeal, if granted, would stay delisting until a
ruling by the panel. Alternatively, if we are at that time in
compliance with all initial listing standards for the Nasdaq Capital Market
other than the minimum bid price requirement, we could apply to transfer the
listing of our common stock to the Nasdaq Capital Market and thereby receive an
additional grace period of 180 days to regain compliance with the minimum bid
price requirement.
If our stock price does not exceed the
minimum bid price of $1.00 within the time frames set forth above, our common
stock will be subject to delisting. If our common stock were no
longer listed on The Nasdaq Global Market or the Nasdaq Capital Market,
investors might only be able to trade in the over-the-counter market in the Pink
Sheets® (a quotation medium operated by Pink OTC Markets Inc.) or on the OTC
Bulletin Board® of the Financial Industry Regulatory Authority,
Inc. This would impair the liquidity of our securities not only in
the number of shares that could be bought and sold at a given price, which might
be depressed by the relative illiquidity, but also through delays in the timing
of transactions and reduction in media coverage.
Company
Information
We
maintain our principal offices and research at 2600 Kelly Road, Suite 100,
Warrington, Pennsylvania. Our telephone number is
215-488-9300. Our website address is www.discoverylabs.com. Information
contained in, or accessible through, our website does not constitute a part of
this prospectus supplement or the accompanying prospectus.
THE
OFFERING
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Common
Stock offered
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shares
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Warrants
offered
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Warrants
to purchase up
to shares
of common stock. The warrants are
exercisable beginning on the date of original issuance and at any time up
to the date that is five years after such date at an exercise price
of $ per share of common stock. This
prospectus also relates to the offering of the shares of common stock
issuable upon exercise of the warrants.
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Common
stock to be outstanding after this offering(1)
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shares
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Risk
Factors
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See
"Risk Factors" beginning on page S-6 of this prospectus supplement
and page 2 of the accompanying prospectus for a discussion of factors
you should consider carefully when making an investment
decision.
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Use
of proceeds
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The
net proceeds from this offering will be used for general corporate
purposes, which may include:
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• Expenses related to resolving the
remaining issue (related to optimization and
revalidation of the BAT and establishing that our fetal rabbit
biological activity test (BAT, an impotant quality control release and
stability test) is capable of discriminating changes in Surfaxin drug
product over time) that must be addressed to secure
the potential approval of Surfaxin® for the prevention of RDS,
including implementing a comprehensive pre-clinical
program.
•
Expenses related to ongoing development of our Surfaxin LS™ and
Aerosurf®
programs, which,
together with Surfaxin®, are focused on addressing the
most significant respiratory conditions affecting pediatric populations,
beginning with RDS.
•
Expenses related to completing the final stages of our Phase 2 trials: to
determine if restoration of surfactant with Surfaxin® will improve lung function and
result in a shorter duration of mechanical ventilation and hospital stay
for children up to two years of age suffering with Acute Respiratory
Failure; and an investigator-initiated Phase 2a clinical trial in Cystic
Fibrosis patients that has been designed to assess the safety,
tolerability and short-term effectiveness of aerosolized KL4
surfactant in CF
patients.
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See
"Use of Proceeds" on page S-9.
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The
Nasdaq Global Market Symbol
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DSCO
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____________________
(1)
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The
number of shares of common stock to be outstanding immediately after this
offering as shown above is based on 121,699,850
shares of common stock outstanding as of September 30, 2009. This
number excludes
the shares
issuable upon the exercise of the warrants offered hereby and also
excludes: (i) 16,020,134
shares of our common stock subject to options outstanding as of
September 30, 2009, which have a weighted average exercise price of $3.78
per share; (ii) 14,839,196
shares of common stock issuable upon exercise of warrants
outstanding as of September 30, 2009, at a weighted average exercise price
of $2.89; (iii) 34,419 shares of
common stock issuable upon the vesting of restricted stock awards
outstanding as of September 30, 2009; (iv) 239,022 shares of common stock
reserved for potential future issuance pursuant to our 401(k) Plan as of
September 30, 2009; and (v) 24,453,621 shares of common stock reserved for
potential future issuance pursuant to two Committed Equity Financing
Facilities, as of September 30,
2009.
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This
prospectus supplement, the accompanying prospectus and the documents
incorporated by reference herein and therein, including in “Risk Factors,”
contain “forward-looking statements” within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange Act of
1934. The forward-looking statements are only predictions and provide
our current expectations or forecasts of future events and financial performance
and may be identified by the use of forward-looking terminology, including the
terms “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,”
“may,” “will” or “should” or, in each case, their negative, or other variations
or comparable terminology, though the absence of these words does not
necessarily mean that a statement is not
forward-looking. Forward-looking statements include all matters that
are not historical facts and include, without limitation statements concerning:
our business strategy, outlook, objectives, future milestones, plans,
intentions, goals, and future financial condition, including the period of time
for which our existing resources will enable us to fund our operations; plans
regarding our efforts to gain U.S. regulatory approval for our lead
product, Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome in premature
infants; the possibility, timing and outcome of submitting regulatory filings
for our products under development; our research and development programs for
our KL4 surfactant
technology and our capillary aerosolization technology platform, including
planning for and timing of any clinical trials and potential development
milestones; the development of financial, clinical, manufacturing and
distribution plans related to the potential commercialization of our drug
products, if approved; and plans regarding potential strategic alliances and
other collaborative arrangements with pharmaceutical companies and others to
develop, manufacture and market our products.
We intend
that all forward-looking statements be subject to the safe-harbor provisions of
the Private Securities Litigation Reform Act of 1995. Forward-looking statements
are subject to many risks and uncertainties that could cause our actual results
to differ materially from any future results expressed or implied by the
forward-looking statements. Examples of the risks and uncertainties
include, but are not limited to:
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risks
related generally to our efforts to gain regulatory approval, in the
United States and elsewhere, for our drug product candidates, including
our lead products that we are developing to address Respiratory
Distress Syndrome (RDS) in premature infants: Surfaxin® (lucinactant) for
the prevention of RDS, Surfaxin LS™ (our lyophilized KL4
surfactant) and Aerosurf® (our
initial aerosolized KL4
surfactant);
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the
risk that we and the U.S. Food and Drug Administration (FDA) or other
regulatory authorities will not be able to agree on matters raised during
the regulatory review process, or that we may be required to conduct
significant additional activities to potentially gain approval of our
product candidates, if ever;
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the
risk that the FDA or other regulatory authorities may not accept, or may
withhold or delay consideration of, any applications that we may file, or
may not approve our applications or may limit approval of our products to
particular indications or impose unanticipated label
limitations;
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risks
relating to the rigorous regulatory approval processes, including
pre-filing activities, required for approval of any drug or combination
drug-device products that we may develop, whether independently, with
strategic development partners or pursuant to collaboration
arrangements;
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the
risk that the FDA will not be satisfied with the results of our efforts to
optimize and revalidate our fetal rabbit biological activity test (BAT)
and to demonstrate that the BAT has the ability to distinguish change in
Surfaxin drug product over time, which is needed to advance our KL4 surfactant
pipeline;
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the
risk that changes in the national or international political and
regulatory environment may make it more difficult to gain FDA or other
regulatory approval of our drug product
candidates;
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risks
relating to our research and development activities, which involve
time-consuming and expensive preclinical studies and other efforts, and
potentially multiple clinical trials, which may be subject to potentially
significant delays or regulatory holds, or fail, and which must be
conducted using sophisticated and extensive analytical methodologies,
including an acceptable biological activity test, if required, as well as
other quality control release and stability tests to satisfy the
requirements of the regulatory
authorities;
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risks
relating to our ability to develop and manufacture drug products and
drug-device combination products based on our capillary aerosolization
technology for clinical studies and, if approved, for commercialization of
our products;
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risks
relating to the transfer of our manufacturing technology to third-party
contract manufacturers and
assemblers;
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the
risk that we, our contract manufacturers or any of our third-party
suppliers may encounter problems or delays in manufacturing or assembling
drug products, drug product substances, capillary aerosolization devices
and related components and other materials on a timely basis or in an
amount sufficient to support our development efforts and, if our products
are approved,
commercialization;
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the
risk that we may be unable to identify potential strategic partners or
collaborators with whom we can develop and, if approved, commercialize our
products in a timely manner, if at
all;
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the
risk that we or our strategic partners or collaborators will not be able
to attract or maintain qualified
personnel;
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the
risk that, if approved, market conditions, the competitive landscape or
otherwise may make it difficult to launch and profitably sell our
products;
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the
risk that we, in a challenging financial market, may not be able to raise
additional capital or enter into strategic alliances or collaboration
agreements (including strategic alliances for development or
commercialization of our drug products and combination drug-device
products);
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risks
that the unfavorable credit environment will adversely affect our ability
to fund our activities, that our share price will not reach or remain at
the price level necessary for us to access capital under our Committed
Equity Financing Facilities (CEFFs), that the CEFFs may expire before we
are able to access the full dollar amount potentially available
thereunder, and that additional equity financings could result in
substantial equity dilution;
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the
risk that we will be unable to regain compliance with the Minimum Bid
Price Requirement of The Nasdaq Global Market prior to the expiration of
the grace period currently in effect, which could increase the probability
that our stock will be delisted from Nasdaq and cause our stock price to
decline;
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the
risk that recurring losses, negative cash flows and the inability to raise
additional capital could threaten our ability to continue as a going
concern;
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the
risks that we may be unable to maintain and protect the patents and
licenses related to our products and that other companies may develop
competing therapies and/or
technologies;
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the
risk that we may become involved in securities, product liability and
other litigation;
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risks
related to reimbursement and health care reform that may adversely affect
us;
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the
risk that the FDA may not approve Surfaxin® or
may subject the marketing of Surfaxin® to
onerous requirements that significantly impair marketing
activities;
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the
risk that we may identify unforeseen problems that have not yet been
discovered or the FDA could in the future impose additional requirements
to gain approval of Surfaxin®;
and
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other
risks and uncertainties, including those described in our most recent
Annual Report on Form 10-K, as amended, and other filings with the
Securities and Exchange Commission, on Forms 10-Q and 8-K, and any
amendments thereto.
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Pharmaceutical and biotechnology
companies have suffered significant setbacks in advanced clinical trials, even
after obtaining promising earlier trial results. Data obtained from
such clinical trials are susceptible to varying interpretations, which could
delay, limit or prevent regulatory approval. After gaining approval
of a drug product, pharmaceutical companies face considerable challenges in
marketing and distributing their products, and may never become
profitable.
The
forward-looking statements contained in this prospectus supplement, the
accompanying prospectus or the documents incorporated by reference herein or
therein speak only of their respective dates. Except to the extent
required by applicable laws, rules and regulations, we do not undertake to
publicly announce revisions to any of the forward-looking statements in this
prospectus supplement, the accompanying prospectus or the documents incorporated
by reference herein or therein, whether as a result of new information, future
events or otherwise.
RISK
FACTORS
Investing
in our securities involves a high degree of risk. You should
consider the following risk factors, as well as other information contained or
incorporated by reference in this prospectus supplement and the accompanying
prospectus, including those risks discussed in Part I, Item 1A – Risk Factors of
our Annual Report on Form 10-K for the year ended December 31, 2008, and of our
Quarterly Report on Form 10-Q for the quarter ended September 30, 2009, before
deciding to purchase any of our securities. The risks and
uncertainties described below and incorporated by reference herein are not the
only ones we face. Additional risks and uncertainties not presently
known to us or that we currently deem immaterial also may become important
factors that affect us. If any of these risks occur, our business
could suffer, the market price of our common stock could decline and you could
lose all or part of your investment in our securities.
Risks
Related to Our Products
Our
pending NDA for Surfaxin for the prevention of RDS in premature infants may not
be approved by the FDA in a timely manner, or at all, which would prevent our
commercializing this product in the United States.
On November 17, 2009, we announced that
we had submitted to the U.S. Food and Drug Administration (FDA) our proposed
protocol for a Surfaxin® (lucinactant) limited
clinical trial. We proposed this trial in response to a comment by the FDA that
a limited clinical trial could potentially resolve the remaining issue for
approval of Surfaxin® for the prevention of Respiratory Distress Syndrome (RDS) in
premature infants. The protocol incorporated a clinical trial design
that was primarily intended to assess a pharmacodynamic (PD) response following
Surfaxin administration in preterm infants with RDS. On February 4,
2010, we received a letter from the FDA advising us that, since an acceptable
and well-established animal model (preterm lamb) of RDS already exists, which
could be used as an acceptable alternative to a clinical trial in human preterm
infants, a PD clinical trial approach is not appropriate.
Therefore, to address the remaining
issue to potentially gain marketing approval for Surfaxin, we are now developing
a comprehensive preclinical program that will consist of a series of
prospectively-designed, side-by-side preclinical studies employing an optimized
and revalidated fetal rabbit Biological Activity Test (BAT, an important quality
control release and stability test) and the well-established preterm lamb model
of RDS. The results of these studies are intended to satisfy the FDA
as to the BAT’s ability to adequately discriminate biologically active from
inactive Surfaxin drug product and establish the Surfaxin drug product’s final
acceptance criteria (with respect to biological activity as assessed by the
BAT). See
“Recent Developments – Surfaxin® for the Prevention of
Respiratory Distress Syndrome (RDS) in Premature Infants.” Although
the FDA indicated that our proposed program to optimize and revalidate the BAT
is reasonable, it also indicated that, to gain approval of Surfaxin, data
generated from the preterm lamb model and BAT studies must demonstrate, in a
point-to-point analysis, the same relative changes in respiratory compliance
between both models over time. Even if our current efforts to
optimize and revalidate the BAT (which are well underway and presently meet
pre-specified acceptance criteria) are successful, we may not succeed with our
side-by-side studies or, even if we do succeed with our side-by-side studies,
the FDA may not accept the results or may interpret the data in a different
manner such that, ultimately, the FDA may not approve Surfaxin for RDS in
premature infants. Any failure to secure FDA approval or further delay
associated with the FDA’s review process could potentially delay or prevent the
approval of our other products and would have a material adverse effect on our
business.
Risks
Related to Our Common Stock
If
we are unable to regain compliance with the Minimum Bid Price Requirement of The
Nasdaq Global Market prior to June 1, 2010, our stock price may decline and our
common stock may be subject to delisting from Nasdaq. If our stock
were no longer listed on Nasdaq, the liquidity of our securities would be
impaired.
On December 2, 2009, we received a
letter from The Nasdaq Stock Market indicating that for 30 consecutive business
days our common stock did not maintain a minimum closing bid price of $1.00 per
share as required by Nasdaq Listing Rule 5450(a)(1). Under the Nasdaq
Listing Rules, if during the 180 calendar days following the date of the
notification, or prior to June 1, 2010, the closing bid price of our stock is at
or above $1.00 for a minimum of 10 consecutive business days, we will regain
compliance with the minimum bid price requirement and the common stock will
continue to be eligible for listing on The Nasdaq Global Market.
If we do not achieve compliance with
the minimum bid price requirement by June 1, 2010, Nasdaq will provide us with
written notification that the common stock is subject to
delisting. We may, at that time, appeal Nasdaq’s determination to a
Nasdaq Hearing Panel. Such an appeal, if granted, would stay delisting until a
ruling by the panel. Alternatively, if we are at that time in
compliance with all initial listing standards for the Nasdaq Capital Market
other than the minimum bid price requirement, we could apply to transfer the
listing of our common stock to the Nasdaq Capital Market and thereby receive an
additional grace period of 180 days to regain compliance with the minimum bid
price requirement.
If our stock price does not exceed the
minimum bid price of $1.00 within the time frames set forth above, our common
stock will be subject to delisting. If our common stock were no
longer listed on The Nasdaq Global Market or the Nasdaq Capital Market,
investors might only be able to trade in the over-the-counter market in the Pink
Sheets® (a quotation
medium operated by Pink OTC Markets Inc.) or on the OTC Bulletin Board® of the Financial Industry
Regulatory Authority, Inc. (FINRA). This would impair the liquidity
of our securities not only in the number of shares that could be bought and sold
at a given price, which might be depressed by the relative illiquidity, but also
through delays in the timing of transactions and reduction in media
coverage.
Risks
Related to This Offering
A
substantial number of shares may be sold in the market following this offering,
which may depress the market price for our common stock.
Sales of
a substantial number of shares of our common stock in the public market
following this offering could cause the market price of our common stock to
decline. Upon completion of this offering, we will have outstanding
an aggregate
of shares
of common stock, assuming no exercise of outstanding options or
warrants. A substantial majority of the outstanding shares of our
common stock are, and all of the shares sold in this offering upon issuance will
be, freely tradable without restriction or further registration under the
Securities Act of 1933 unless these shares are purchased by
affiliates. In addition, as of February 1, 2010, 30,417,122 shares of
our common stock are issuable upon exercise of outstanding options and warrants
granted by us, which also have been registered for resale on registration
statements filed with the Securities and Exchange Commission. The
outstanding options have a weighted average exercise price of $3.76 per share
and expire between May 3, 2010 and December 7, 2019. The outstanding
warrants have a weighted average exercise price of $2.65 per share and expire
between September 19, 2010 and November 3, 2014.
Our
management will have broad discretion with respect to the use of the proceeds of
this offering.
Although
we have highlighted the intended use of proceeds for this offering, our
management will have broad discretion as to the application of these net
proceeds 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 chooses to allocate and spend the net
proceeds.
You
will experience immediate dilution in the book value per share of the common
stock you purchase.
You will
suffer substantial immediate dilution in the net tangible book value of the
common stock you purchase in this offering because the price per share of our
common stock being offered hereby is substantially higher than the book value
per share of our common stock. Based on the assumed public offering
price of $0.74 per share and assuming the sale of 20,000,000 shares in
this offering, if you purchase shares of common stock in this offering, you will
suffer immediate and substantial dilution of $0.61 per share in the net tangible
book value of the common stock. See “Dilution” on page S-10 for a
more detailed discussion of the dilution you will incur in this
offering.
RECENT
DEVELOPMENTS
Financial
Update
As of December 31, 2009, we had cash
and marketable securities of $15.7 million, representing a net decrease of $1.9
million from the previous quarter ended September 30, 2009, primarily due to:
(i) $6.0 million used for operating activities and $0.2 million used for debt
service, partially offset by (ii) aggregate proceeds of $4.3 million from the
issuance of 4.6 million shares of common stock pursuant to financings under our
Committed Equity Financing Facilities (CEFFs). We had approximately 126.4
million common shares outstanding as of December 31, 2009 and February 16,
2010.
As of December 31, 2009, we had $10.5
million outstanding under our loan with Novaquest, a strategic investment group
of Quintiles Transnational Corp. The outstanding principal and all accrued
interest is due and payable on April 30, 2010. Although we are planning,
and have had discussions with Quintiles, to potentially extend or otherwise
strategically restructure this loan, if Quintiles does not wish to restructure
the loan, and we are unable to use our CEFFs to provide funds to satisfy all or
a portion of the Quintiles loan, we may have to rely on other sources of
financing to repay the Quintiles loan. There can be no assurance that
any such restructuring will occur or financing alternatives will be
available. In addition, if this offering yields net proceeds to us of
approximately $15 million, we may become obligated to make a lump sum additional
severance payment of approximately $1 million to Robert G. Capetola, Ph.D., our
former President and Chief Executive Officer, under a Separation of Employment
Agreement and General Release dated August 13, 2009 between ourselves and Dr.
Capetola.
Surfaxin® for the Prevention of
Respiratory Distress Syndrome (RDS) in Premature Infants
At a September 2009 teleconference with
the FDA, we and the FDA focused on the remaining Chemistry,
Manufacturing & Control (CMC) issue regarding the final validation of the
BAT that must be addressed to gain marketing approval for Surfaxin® (lucinactant) for the
prevention of RDS in premature infants. We discussed in detail with
the FDA our plans to optimize the precision of the BAT method and its subsequent
validation. We also discussed the design of a proposed limited
clinical trial and whether conducting such a trial while simultaneously
employing the optimized BAT could potentially resolve the remaining FDA
requirement for Surfaxin approval. We proposed a limited clinical
trial design intended primarily to assess a pharmacodynamic (PD) response
following Surfaxin administration in preterm infants with RDS. The FDA indicated
that a PD-based approach is consistent with their expectation for a limited
clinical trial and, subject to further review and ethical
consideration, provided direction regarding trial design
specifics.
On November 17, 2009, after
collaborating with leading academic neonatologists, we announced that we had
submitted to the FDA a proposed protocol for a Surfaxin limited clinical trial
that incorporated a PD-based clinical trial design. On February 4, 2010, we
received a letter from the FDA advising us that, since an acceptable and
well-established animal model (preterm lamb) of RDS already exists, which could
be used as an acceptable alternative to a clinical trial in human preterm
infants, a PD clinical trial approach is not appropriate. Accordingly,
we now plan to focus on a pathway that would entail solely performing additional
preclinical work, instead of conducting a limited clinical trial, to potentially
gain FDA marketing approval for Surfaxin. Compared to the conduct of
a PD clinical trial, a comprehensive preclinical program, if
successful, presents an opportunity to significantly reduce the time
and expense required to gain potential Surfaxin approval and Discovery Labs
believes that a Complete Response could be submitted to the FDA in the first
quarter of 2011.
Upon successful conclusion of BAT
optimization and revalidation, a process which is well underway and presently
meets all pre-specified acceptance criteria, we plan to conduct a series of
prospectively-designed, side-by-side preclinical studies employing the optimized
BAT and the well-established preterm lamb model of RDS. The results
from these studies are intended to demonstrate to the FDA’s satisfaction that
the BAT is able to adequately discriminate biologically active Surfaxin drug
product from inactive Surfaxin drug product and establish the Surfaxin drug
product’s final acceptance criteria with respect to biological activity (as
assessed by the BAT) for release and ongoing stability. We believe
that implementing the method improvements to optimize the BAT makes it more
likely that the results of the planned preclinical program will demonstrate the
level of comparability between data generated using the BAT and the
preterm lamb model that the FDA requires.
The comprehensive preclinical program
will employ several different Surfaxin batches to assess the short-term
physiologic responses to Surfaxin (via measurement of respiratory compliance)
after administration in both the preterm lamb model and the optimized BAT at
various time points. The resulting data will be examined to evaluate
the relative changes, over time, in biological activity upon Surfaxin
administration to determine the degree of comparability between the
optimized BAT and the preterm lamb model. The FDA has previously
invited us to seek FDA advice with respect to the ongoing BAT optimization and
revalidation process and we plan to seek FDA advice regarding important aspects
of the preclinical program, including study design and appropriate success
criteria. We believe that continued interactions with the FDA are an
important element in assuring the adequacy of the preclinical
program.
Non-Compliance
with Minimum Bid Price Requirement
On December 2, 2009, we received a
letter from The Nasdaq Stock Market indicating that for 30 consecutive business
days our common stock did not maintain a minimum closing bid price of $1.00 per
share as required by Nasdaq Listing Rule 5450(a)(1). Under the Nasdaq
Listing Rules, if during the 180 calendar days following the date of the
notification, or prior to June 1, 2010, the closing bid price of our stock is at
or above $1.00 for a minimum of 10 consecutive business days, we will regain
compliance with the minimum bid price requirement and the common stock will
continue to be eligible for listing on The Nasdaq Global Market. The
consequences of not achieving compliance by that date are described
above in “Risk
Factors - Risks Related to Our Common Stock - If we are unable to regain compliance
with the Minimum Bid Price Requirement of The Nasdaq Global Market prior to June
1, 2010, our stock price may decline and our common stock may be subject to
delisting from Nasdaq. If our stock were no longer listed on
Nasdaq, the liquidity of our securities would be impaired.”
USE
OF PROCEEDS
We
estimate the net proceeds from the securities offered pursuant to this
prospectus to be approximately $13.5 million after deducting the estimated
underwriting discounts and commissions and other estimated offering expenses,
assuming the sale of 20,000,000 units and a public offering price of $0.74
per share, which was the last reported sale price of our common stock on The
Nasdaq Global Market on February 16, 2010. The actual net proceeds could be
less or greater than $13.5 million, depending on the actual offering price and
the actual number of units to be sold. Except as described in any
later prospectus supplement or post-effective amendment, we currently anticipate
using the net proceeds from the sale of our common stock and warrants primarily
to support our general corporate activities and for expenses associated with
maintaining our research and development operations, including manufacturing,
quality and analytical capabilities, product development and clinical
operations, which include:
·
|
Expenses
related to resolving the remaining issue (related
to optimization and revalidation of the BAT and establishing that the BAT
is capable of discriminating changes in Surfaxin®
drug product over time) that must be addressed to secure the
potential approval of Surfaxin®
for the prevention of RDS, including implementing a comprehensive
pre-clinical program.
|
·
|
Expenses
related to ongoing development of our Surfaxin LS™ and Aerosurf®
programs, which, together with Surfaxin, are focused on addressing
the most significant respiratory conditions affecting pediatric
populations, beginning with RDS. Surfaxin LS is a lyophilized
formulation of Surfaxin that is manufactured as a dry powder and
reconstituted as a liquid prior to administration and offers ease of
administration and other potential benefits. Aerosurf, our
KL4
surfactant in aerosolized form, is a drug-device combination product based
on our proprietary capillary aerosolization technology and potentially can
be administered without the invasive procedures that are required for the
currently-approved surfactants. Expenses related to Surfaxin LS
include our preclinical development program and costs to meet with the FDA
and the European regulatory authorities to discuss our proposed Phase 3
global registration clinical program. Expenses related to
Aerosurf include activities to advance our ongoing device development and
preclinical work and the costs of preparing an IND filing in anticipation
of our planned Phase 2 clinical program. We plan to initiate
the Surfaxin LS and Aerosurf clinical development programs after we have
secured additional capital resources in the form of strategic alliances or
other financial alternatives.
|
·
|
Expenses
related to completing the final stages of our Phase 2 trials: to determine
if restoration of surfactant with Surfaxin will improve lung function and
result in a shorter duration of mechanical ventilation and hospital stay
for children up to two years of age suffering with Acute Respiratory
Failure; and an investigator-initiated Phase 2a clinical trial in Cystic
Fibrosis patients that has been designed to assess the safety,
tolerability and short-term effectiveness of aerosolized KL4
surfactant in CF patients. Results from these trials are
anticipated in 2010.
|
The
amounts and timing of the expenditures may vary significantly depending on
numerous factors, such as the progress of our research and development efforts,
technological advances and the competitive environment for Surfaxin and our
other SRT drug candidates and their intended uses. Pending the
application of the net proceeds, we intend to invest the proceeds in short-term,
interest-bearing instruments or other investment-grade securities.
DILUTION
The net
tangible book value of our common stock on September 30, 2009, was approximately
$5.4 million, or approximately $0.04 per share. Net tangible book
value per share is equal to the amount of our total tangible assets, less total
liabilities, divided by the aggregate number of shares of common stock
outstanding. Dilution in net tangible book value per share represents
the difference between the amount per share paid by purchasers of shares of our
common stock in this offering and the net tangible book value per share of our
common stock immediately after this offering. For purposes of this
calculation, the entire purchase price for the unit is being allocated to the
common stock contained in the unit. Assuming
the sale of 20,000,000 shares of our common stock in this
offering at an assumed offering price equal to $0.74 per share (which was the
last reported sale price of our common stock on The Nasdaq Global Market on
February 16, 2010), and after deducting the estimated underwriting discounts and
commissions and the estimated offering expenses, our net tangible book value on
September 30, 2009 would have been approximately $19.0 million, or approximately
$0.13 per share. This represents an immediate increase in the net
tangible book value per share of $0.09 per share to existing shareholders and an
immediate dilution of $0.61 per share to new investors purchasing shares of
common stock in this offering. The following table illustrates this
dilution:
Assumed
offering price per share included in each unit
|
|
|
|
|
|
$0.74
|
|
|
|
|
|
|
|
|
|
Net
tangible book value per share as of September 30, 2009
|
|
|
|
|
|
|
$0.04
|
|
|
|
|
|
|
|
|
|
|
Increase
per share after the offering
|
|
|
|
|
|
|
$0.09
|
|
|
|
|
|
|
|
|
|
|
Pro
forma net tangible book value per share as of September 30, 2009, after
giving effect to this offering
|
|
|
|
|
|
|
$0.13
|
|
|
|
|
|
|
|
|
|
|
Dilution
per share to new investors
|
|
|
|
|
|
|
$0.61
|
|
In
addition, investors that purchase common stock upon the exercise of the warrants
offered hereby may experience dilution depending on our net tangible book value
at the time of exercise. The foregoing table does not take into
account further dilution to new investors that could occur upon the exercise of
outstanding options and warrants having a per share exercise price less than the
per share offering price to the public in this offering. As of
September 30, 2009, there were 121,699,850 shares of common stock outstanding,
which does not include:
·
|
16,020,134
shares of common stock issuable upon exercise of options outstanding as of
September 30, 2009, at a weighted average exercise price of $3.78 per
share;
|
·
|
14,839,196
shares of common stock issuable upon exercise of warrants outstanding as
of September 30, 2009, at a weighted average exercise price of
$2.89;
|
·
|
34,419
shares of common stock issuable upon the vesting of restricted stock
awards outstanding as of September 30,
2009;
|
·
|
239,022
shares of common stock reserved for potential future issuance pursuant to
our 401(k) Plan as of September 30, 2009;
and
|
·
|
24,453,621
shares of common stock reserved for potential future issuance pursuant
to two Committed Equity Financing Facilities, as of September 30,
2009.
|
DESCRIPTION
OF SECURITIES WE ARE OFFERING
In this
offering, we are offering a maximum
of units,
consisting
of shares
of common stock and warrants to purchase up to an
additional shares
of common stock. Each unit consists of one share of common stock and a warrant
to purchase of
a share of common stock at an exercise price of
$ per share. Units will not be
issued or certificated. The shares of common stock and warrants are immediately
separable and will be issued separately. This prospectus supplement also relates
to the offering of shares of our common stock upon exercise, if any, of the
warrants.
Common
Stock
The
material terms and provisions of our common stock and each other class of our
securities which qualifies or limits our common stock are described under the
caption “Description of Common Stock” starting on page 31 of the accompanying
prospectus.
Warrants
The
following summary of certain terms and provisions of the warrants offered hereby
is not complete and is subject to, and qualified in its entirety by reference
to, the terms and provisions set forth in the form of warrant attached as Annex
A to this prospectus supplement. Prospective investors should carefully
review the terms and provisions set forth in the form of warrant.
Exercisability. The
warrants are exercisable beginning on the date of original issuance and at any
time up to the date that is five years after such date. The warrants will be
exercisable, at the option of each holder, in whole or in part by delivering to
us a duly executed exercise notice accompanied by payment in full for the number
of shares of our common stock purchased upon such exercise (except in the case
of a cashless exercise as discussed below). Unless otherwise specified in the
warrant, the holder will not have the right to exercise any portion of the
warrant if the holder (together with its affiliates) would beneficially own in
excess of 9.99% of the number of shares of our common stock outstanding
immediately after giving effect to the exercise, as such percentage ownership is
determined in accordance with the terms of the warrants.
Cashless
Exercise. In the event that a registration statement covering
shares of common stock underlying the warrants, or an exemption from
registration, is not available for the resale of such shares of common stock
underlying the warrants, the holder may, in its sole discretion, exercise the
warrant in whole or in part and, in lieu of making the cash payment otherwise
contemplated to be made to us upon such exercise in payment of the aggregate
exercise price, elect instead to receive upon such exercise the net number of
shares of common stock determined according to the formula set forth in the
warrant.
Exercise
Price. The exercise price per share of common stock
purchasable upon exercise of the warrants is
$ per share of common
stock being purchased. The exercise price is subject to appropriate adjustment
in the event of certain stock dividends and distributions, stock splits, stock
combinations, reclassifications or similar events affecting our common stock and
also upon any distributions of assets, including cash, stock or other property
to our stockholders.
Transferability. Subject
to applicable laws, the warrants may be offered for sale, sold, transferred or
assigned without our consent.
Exchange
Listing. We do not plan on making an application to list the
warrants on The Nasdaq Global Market, any other national securities exchange or
other nationally recognized trading system.
Fundamental
Transactions. We will not enter into or be party to a
fundamental transaction, which is a merger or other change of control
transaction, as described in the warrants, unless the successor entity, as
described in the warrants, assumes the warrants and delivers new warrants that
are substantially similar. If we enter into, or are a party to, a fundamental
transaction pursuant to which our stockholders are entitled or required to
receive securities issued by another company or cash or other assets in exchange
for shares of our common stock, which we refer to as a corporate event, a holder
of a warrant will have the right to receive, upon an exercise of the warrant,
consideration as if the holder had exercised its warrant immediately prior to
such corporate event.
Rights as a Stockholder.
Except as otherwise provided in the warrants or by virtue of such holder’s
ownership of shares of our common stock, the holder of a warrant does not have
the rights or privileges of a holder of our common stock, including any voting
rights, until the holder exercises the warrant.
Waivers and Amendments. Any
term of the warrants may be amended or waived with our written consent and the
written consent of the holders of warrants.
Under the
terms and subject to the conditions in an underwriting agreement dated the date
of this prospectus supplement, Lazard Capital Markets LLC, as the sole
underwriter, has agreed to purchase, and we have agreed to sell to it, the
number of units (each unit consisting of one share of common stock
and one warrant to
purchase of
a share of common stock) at the public offering price, less the
underwriting discounts and commissions, as set forth on the cover page of this
prospectus supplement, as indicated below:
|
|
Number of
Units
|
|
Lazard
Capital Markets LLC
|
|
|
|
|
|
|
|
|
|
Total:
|
|
|
|
|
|
|
|
|
|
The underwriter is offering the units
subject to its acceptance of the securities included in the units from us and
subject to prior sale. The underwriting agreement provides that the obligations
of the underwriter to pay for and accept delivery of the units offered by this
prospectus supplement are subject to the approval of certain legal matters by
its counsel and to other conditions. The underwriter is obligated to take and
pay for all of the units offered by this prospectus supplement if any such units
are taken.
The
underwriter initially proposes to offer the units directly to the public at the
public offering price listed on the cover page of this prospectus supplement.
After the initial offering of the units, the offering price and other selling
terms may from time to time be varied by the underwriter.
The
underwriting agreement provides that the obligations of the underwriter is
subject to certain conditions precedent, including the absence of any material
adverse change in our business and the receipt of customary legal opinions,
letters and certificates.
Commissions
and Discounts
The
following table summarizes the public offering price, underwriting discount and
proceeds before expenses to us:
|
Per Unit
|
|
Total
|
|
Public
offering price
|
|
$ |
|
|
|
$ |
|
|
Underwriting
discount
|
|
|
|
|
|
|
|
|
Proceeds,
before expenses, to us
|
|
|
|
|
|
|
|
|
The
expenses of the offering, not including the underwriting discount, payable by us
are estimated to be $230,000, which includes $75,000 that we have agreed to
reimburse the underwriter for its legal fees incurred by it in connection with
this offering. Lazard Frères & Co. LLC referred this transaction
to Lazard Capital Markets LLC and will receive a referral fee from Lazard
Capital Markets LLC in connection therewith; however, such referral fee is not
in addition to the fee paid by us to Lazard Capital Markets LLC described
above.
Quotation
on The Nasdaq Global Market
Our
shares of common stock included in the units are listed on The Nasdaq Global
Market under the symbol “DSCO.” Our registrar and transfer agent for
all shares of common stock is Continental Stock Transfer & Trust
Company.
No
Sales of Similar Securities
We, each of our executive officers and
directors and certain of our stockholders, subject to certain exceptions, have
agreed with Lazard Capital Markets LLC not to dispose of or hedge any of our
shares of common stock or securities convertible into or exercisable or
exchangeable for common stock for 90 days after the date of this prospectus
without first obtaining the written consent of Lazard Capital Markets LLC. The
90-day “lock-up” period is subject to extension such that, in the event that
either (i) during the last 17 days of the “lock-up” period, we issue
an earnings or financial results release or material news or a material event
relating to us occurs, or (ii) prior to the expiration of the “lock-up”
period, we announce that we will release earnings or financial results during
the 16-day period beginning on the last day of the “lock-up” period, then in
either case the expiration of the “lock-up” period will be extended until the
expiration of the 18-day period beginning on the issuance of the earnings or
financial results release or the occurrence of the material news or material
event, as applicable, unless Lazard Capital Markets LLC waives, in writing, such
an extension. One of
the exceptions to our “lock-up” permits us to issue shares of common stock
pursuant to the CEFFs entered into with Kingsbridge Capital Limited beginning on
the date that is 31 days after the date of this prospectus. For the
45 days following such 30 day period (but not thereafter), the issuance of
such shares is limited to an aggregate of two percent of our outstanding common
stock. Another exception permits us to issue securities to restructure or
satisfy our obligations under a loan with Quintiles Transnational Corp. or to
issue up to $3 million of securities under our CEFFS to satisfy
such loan.
Price
Stabilization, Short Positions
In order
to facilitate the offering of the units, the underwriter may engage in
transactions that stabilize, maintain or otherwise affect the price of our
common stock. Specifically, the underwriter may sell more units than it is
obligated to purchase under the underwriting agreement, creating a short
position. The underwriter must close out any short position by purchasing shares
of common stock in the open market. A short position may be created if the
underwriter is concerned that there may be downward pressure on the price of the
common stock in the open market after pricing that could adversely affect
investors who purchased in this offering. As an additional means of facilitating
this offering, the underwriter may bid for, and purchase, shares of our common
stock in the open market to stabilize the price of the common stock. These
activities may raise or maintain the market price of our common stock above
independent market levels or prevent or slow a decline in the market price of
our common stock. The underwriter is not required to engage in these activities,
and may end any of these activities at any time.
We and
the underwriter have agreed to indemnify each other, and we have also agreed to
indemnify Lazard Frères & Co. LLC, against certain liabilities, including
liabilities under the Securities Act of 1933, as amended, and liabilities
arising from breaches of representations and warranties contained in the
underwriting agreement. We have also agreed to contribute to payments
the underwriter and Lazard Frères & Co. LLC may be required to make in
respect of such liabilities.
A
prospectus in electronic format may be made available on websites maintained by
the underwriter. The underwriter may agree to allocate a number of units to
other underwriters for sale to its online brokerage account holders. Internet
distributions will be allocated by the underwriter on the same basis as other
allocations.
United
Kingdom
This
document is only being distributed to and is only directed at (i) persons
who are outside the United Kingdom or (ii) to investment professionals
falling within Article 19(5) of the Financial Services and Markets Act 2000
(Financial Promotion) Order 2005 (the “Order”) or (iii) high net worth
entities, and other persons to whom it may lawfully be communicated, falling
within Article 49(2)(a) to (e) of the Order (all such persons together
being referred to as “relevant persons”). The units are only available to, and
any invitation, offer or agreement to subscribe, purchase or otherwise acquire
such units will be engaged in only with, relevant persons. Any person who is not
a relevant person should not act or rely on this document or any of its
contents.
The
underwriter has represented and agreed that:
(a) it
has only communicated or caused to be communicated and will only communicate or
cause to be communicated an invitation or inducement to engage in investment
activity (within the meaning of Section 21 of the Financial Services and
Markets Act 2000 or FSMA) received by it in connection with the issue or sale of
the units in circumstances in which Section 21(1) of the FSMA does not
apply to us, and
(b) it
has complied with, and will comply with all applicable provisions of FSMA with
respect to anything done by it in relation to the units in, from or otherwise
involving the United Kingdom.
European
Economic Area
To the
extent that the offer of the units is made in any Member State of the European
Economic Area that has implemented the Prospectus Directive before the date of
publication of a prospectus in relation to the units which has been approved by
the competent authority in the Member State in accordance with the Prospectus
Directive (or, where appropriate, published in accordance with the Prospectus
Directive and notified to the competent authority in the Member State in
accordance with the Prospectus Directive), the offer (including any offer
pursuant to this document) is only addressed to qualified investors in that
Member State within the meaning of the Prospectus Directive or has been or will
be made otherwise in circumstances that do not require us to publish a
prospectus pursuant to the Prospectus Directive.
In
relation to each Member State of the European Economic Area which has
implemented the Prospectus Directive (each, a “Relevant Member State”), the
underwriter has represented and agreed that with effect from and including the
date on which the Prospectus Directive is implemented in that Relevant Member
State (the “Relevant Implementation Date”) it has not made and will not make an
offer of shares to the public in that Relevant Member State prior to the
publication of a prospectus in relation to the shares which has been approved by
the competent authority in that Relevant Member State or, where appropriate,
approved in another Relevant Member State and notified to the competent
authority in that Relevant Member State, all in accordance with the Prospectus
Directive, except that it may, with effect from and including the Relevant
Implementation Date, make an offer of units to the public in that Relevant
Member State at any time:
(a) to
legal entities which are authorized or regulated to operate in the financial
markets or, if not so authorized or regulated, whose corporate purpose is solely
to invest in securities,
(b) to
any legal entity which has two or more of (1) an average of at least
250 employees during the last financial year; (2) a total balance
sheet of more than €43,000,000 and (3) an annual net turnover of more than
€50,000,000, as shown in its last annual or consolidated
accounts, or
(c) in
any other circumstances which do not require the publication by us of a
prospectus pursuant to Article 3 of the Prospectus Directive. For the
purposes of this provision, the expression an “offer of units to the public” in
relation to any shares in any Relevant Member State means the communication in
any form and by any means of sufficient information on the terms of the offer
and the units to be offered so as to enable an investor to decide to purchase or
subscribe the units, as the same may be varied in that Relevant Member State by
any measure implementing the Prospectus Directive in that Relevant Member State
and the expression “Prospectus Directive” means Directive 2003/71/EC and
includes any relevant implementing measure in each Relevant Member
State.
The EEA
selling restriction is in addition to any other selling restrictions set out
below. In relation to each Relevant Member State, each purchaser of units (other
than the underwriter) will be deemed to have represented, acknowledged and
agreed that it will not make an offer of units to the public in any Relevant
Member State, except that it may, with effect from and including the date on
which the Prospectus Directive is implemented in the Relevant Member State, make
an offer of units to the public in that Relevant Member State at any time in any
circumstances which do not require the publication by us of a prospectus
pursuant to Article 3 of the Prospectus Directive, provided that such
purchaser agrees that it has not and will not make an offer of any units in
reliance or purported reliance on Article 3(2)(b) of the Prospectus
Directive. For the purposes of this provision, the expression an “offer of units
to the public” in relation to any units in any Relevant Member State has the
same meaning as in the preceding paragraph.
LEGAL
MATTERS
The
validity of the issuance of the shares of common stock offered hereby will be
passed upon by Sonnenschein Nath & Rosenthal LLP, New York, New
York. Proskauer Rose LLP, New York, New York, is acting as counsel
for the underwriter in connection with this offering.
EXPERTS
Ernst
& Young LLP, independent registered public accounting firm, has audited our
consolidated financial statements included in our Annual Report on Form 10-K for
the year ended December 31, 2008, and the effectiveness of our internal control
over financial reporting as of December 31, 2008, as set forth in their reports,
which are incorporated by reference in this prospectus supplement and elsewhere
in the registration statement. Our financial statements are incorporated by
reference in reliance on Ernst & Young LLP’s reports, given on their
authority as experts in accounting and auditing.
WHERE
YOU CAN FIND MORE INFORMATION AND INCORPORATION BY REFERENCE
We file
annual, quarterly and periodic reports, proxy statements and other information
with the SEC. You may read and copy any materials that we file with the SEC at
the SEC’s Public Reference Room at 100 F Street, N.E., Washington,
D.C. 20549. You may obtain information on the operation of the Public
Reference Room by calling the SEC at 1-800-SEC-0330. Many of our SEC filings are
also available to the public from the SEC’s Website at “http://www.sec.gov.” We
make available free of charge our annual, quarterly and current reports, proxy
statements and other information upon request. To request such materials, please
send an e-mail to ir@DiscoveryLabs.com or contact John G. Cooper, our Executive
Vice President, Chief Financial Officer, at our address as set forth in the
accompanying prospectus.
We
maintain a website at “http://www.DiscoveryLabs.com” (this is not a hyperlink,
you must visit this website through an Internet browser). Our website and the
information contained therein or connected thereto are not incorporated into
this prospectus supplement.
We have
filed with the Securities and Exchange Commission a registration statement on
Form S-3 under the Securities Act relating to the common stock we are offering
by this prospectus supplement. The SEC allows us to “incorporate by reference”
the information that we file with it, which means that we can disclose important
information to you by referring you to those documents. The information
incorporated by reference is considered to be part of this prospectus
supplement, and information that we file later with the SEC will automatically
update and supersede information in this prospectus supplement. We incorporate
by reference the documents listed below and any future filings we make with the
SEC pursuant to Section 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act
of 1934, as amended, until this offering is completed:
1. Our
Annual Report on Form 10-K for the fiscal year ended December 31, 2008, filed on
March 13, 2009, and Amendment No. 1 thereto, filed on April 30,
2009;
2.
Our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2009, June
30, 2009 and September 30, 2009, filed on May 11, 2009, August 10, 2009 and
November 9, 2009, respectively;
3.
Our Current Reports on Form 8-K filed with the SEC on March 13, 2009 (excluding
the matters in Item 2.02 and Exhibit 99.1 therein, which are not incorporated by
reference herein), April 24, 2009, April 29, 2009 (excluding the matters in Item
2.02 and Exhibit 99.1 therein, which are not incorporated by reference herein),
May 8, 2009, May 12, 2009, May 15, 2009, July 2, 2009, August 3, 2009 (excluding
the matters in Item 2.02 and Exhibit 99.1 therein, which are not incorporated by
reference herein), August 19, 2009, September 4, 2009, September 11, 2009,
September 30, 2009, November 4, 2009 (excluding the matters in Item 2.02 and
Exhibit 99.1 therein, which are not incorporated by reference herein), November
18, 2009, December 4, 2009, December 9, 2009 and February 16, 2010;
and
4.
The description of our common stock contained in our Registration Statement on
Form 8-A filed with the SEC on July 13, 1995 and February 6, 2004.
Furthermore,
all reports and other documents subsequently filed (but not furnished) by us
with the SEC pursuant to Sections 13(a), 13(c), 14, or 15(d) of the Securities
Exchange Act of 1934 prior to the termination of this offering shall be deemed
to be incorporated by reference in this prospectus supplement and to be a part
of this prospectus supplement from the date of filing of such reports and
documents. We are not incorporating by reference any documents or
portions thereof that are not deemed "filed" with the SEC, including information
"furnished" pursuant to Items 2.02 or 7.01 of Form 8-K. Any statement
contained in any document incorporated or deemed to be incorporated by reference
herein shall be deemed to be modified or superseded for purposes of this
prospectus supplement to the extent that a statement contained in this
prospectus supplement or in any other subsequently filed document which also is
or is deemed to be incorporated by reference in this prospectus supplement
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 supplement.
This
prospectus supplement and the accompanying prospectus are only part of a
registration statement on Form S-3 that we have filed with the SEC under the
Securities Act and therefore omits certain information contained in the
registration statement. We have also filed exhibits and schedules with the
registration statement that are excluded from this prospectus supplement and the
accompanying prospectus. Statements contained in this prospectus supplement as
to the contents of any contract or other document are qualified by reference to
the copy of that contract or document filed as an exhibit to the registration
statement or that will be filed as an exhibit to the current report on Form 8-K
upon completion of this offering.
Each
person to whom a copy of this prospectus supplement is delivered may request a
copy of any or all of the information incorporated by reference in this
prospectus supplement, including the exhibits to any filings incorporated by
reference herein, from us, at no charge, or from the Securities and Exchange
Commission in the above described manner.
DISCOVERY
LABORATORIES, INC.
Form
of Warrant To Purchase Common Stock
Warrant
No.:
Number of
Shares of Common Stock:_____________
Date of
Issuance: [ ], 2010 ("Issuance Date")
Discovery
Laboratories, Inc., a Delaware corporation (the "Company"), hereby certifies
that, for good and valuable consideration, the receipt and sufficiency of which
are hereby acknowledged, [INVESTOR NAME], the registered holder hereof or its
permitted assigns (the "Holder"), is entitled, subject
to the terms set forth below, to purchase from the Company, at the Exercise
Price (as defined below) then in effect, upon surrender of this Warrant to
Purchase Common Stock (including any Warrants to Purchase Common Stock issued in
exchange, transfer or replacement hereof, the "Warrant"), at any time or
times on or after the date hereof (the “Exercisability Date”), but not
after 11:59 p.m., New York time, on the Expiration Date (as defined below),
[______________ (_____________)]1 fully paid nonassessable shares of Common
Stock (as defined below) (the "Warrant
Shares"). Except as otherwise defined herein, capitalized
terms in this Warrant shall have the meanings set forth in Section
15. This Warrant is the Warrant to purchase Common Stock (this
"Warrant") issued
pursuant to (i) Sections 1 and 2 of
that certain Underwriting Agreement (the “Underwriting Agreement”), dated as of
[ ], 2010 (the "Pricing Date"), by and between
the Company and Lazard Capital Markets LLC, as underwriter and (ii) the
Company’s Registration Statement on Form S-3 (File number 333-151654) (the
“Registration
Statement”).
1. EXERCISE OF
WARRANT.
(a) Mechanics of
Exercise. Subject to the terms and conditions hereof, this
Warrant may be exercised by the Holder on any day on or after the Exercisability
Date, in whole or in part, by (i) delivery of a written notice, in the form
attached hereto as Exhibit A (the "Exercise Notice"), of the
Holder's election to exercise this Warrant and (ii) (A) payment to the
Company of an amount equal to the applicable Exercise Price multiplied by the
number of Warrant Shares as to which this Warrant is being exercised (the "Aggregate Exercise Price") in
cash or by wire transfer of immediately available funds or (B) provided the
conditions for cashless exercise set forth in Section 1(d) are
satisfied, by notifying the Company that this Warrant is being exercised
pursuant to a Cashless Exercise (as defined in Section
1(d)). The Holder shall not be required to deliver the
original Warrant in order to effect an exercise hereunder. Execution
and delivery of the Exercise Notice with respect to less than all of the Warrant
Shares shall have the same effect as cancellation of the original Warrant and
issuance of a new Warrant evidencing the right to purchase the remaining number
of Warrant Shares. On or before the first (1st)
Business Day following the date on which the Company has received each of the
Exercise Notice and the Aggregate Exercise Price (or notice of a Cashless
Exercise) (collectively, the "Exercise Delivery Documents"),
the Company shall transmit by facsimile [or electronic mail] an acknowledgment
of receipt of the Exercise Delivery Documents to the Holder and Continental
Stock Transfer & Trust Company (the Company’s "Transfer
Agent"). On or before the third (3rd)
Business Day following the date on which the Company has received all of the
Exercise Delivery Documents (the "Share Delivery Date"), the
Company shall (X) provided that the Transfer Agent is participating in The
Depository Trust Company ("DTC") Fast Automated
Securities Transfer Program, upon the request of the Holder, credit such
aggregate number of Warrant Shares to which the Holder is entitled pursuant to
such exercise to the Holder's or its designee's balance account with DTC through
its Deposit/Withdrawal At Custodian (“DWAC”) system, or (Y) if the
Transfer Agent is not participating in the DTC Fast Automated Securities
Transfer Program or the Holder does not request delivery of the Warrant Shares
via DWAC, issue and dispatch by overnight courier to the address as specified in
the Exercise Notice, a certificate, registered in the Company's share register
in the name of the Holder or its designee, for the number of Warrant Shares to
which the Holder is entitled pursuant to such exercise. Upon delivery
of the Exercise Delivery Documents, the Holder shall be deemed for all corporate
purposes to have become the holder of record of the Warrant Shares with respect
to which this Warrant has been exercised, irrespective of the date such Warrant
Shares are credited to the Holder's DTC account or the date of delivery of the
certificates evidencing such Warrant Shares, as the case may be. If
this Warrant is submitted in connection with any exercise pursuant to this Section 1(a) and the
number of Warrant Shares represented by this Warrant submitted for exercise is
greater than the number of Warrant Shares being acquired upon an exercise, then
the Company shall as soon as practicable and in no event later than three
Business Days after any exercise and at its own expense, issue a new Warrant (in
accordance with Section 7(d))
representing the right to purchase the number of Warrant Shares purchasable
immediately prior to such exercise under this Warrant, less the number of
Warrant Shares with respect to which this Warrant is exercised. No
fractional shares of Common Stock are to be issued upon the exercise of this
Warrant, but rather the number of shares of Common Stock to be issued shall be
rounded down to the nearest whole number. The Company shall pay any
and all taxes which may be payable with respect to the issuance and delivery of
Warrant Shares upon exercise of this Warrant.
1 Insert
a number of shares equal to [ ]% of the number of Common Shares
purchased under the Underwriting Agreement.
(b) Exercise
Price. For purposes of this Warrant, "Exercise Price" means
$[ ], subject to adjustment as provided herein.
(c) Company's Failure to Timely
Deliver Securities. If the Company shall fail for any reason
or for no reason to issue to the Holder within three (3) Business Days of
receipt of the Exercise Delivery Documents in compliance with the terms of this
Section 1, a
certificate for the number of shares of Common Stock to which the Holder is
entitled and register such shares of Common Stock on the Company's share
register or to credit the Holder's balance account with DTC for such number of
shares of Common Stock to which the Holder is entitled upon the Holder's
exercise of this Warrant, and if on or after such Trading Day the Holder
purchases (in an open market transaction or otherwise) shares of Common Stock to
deliver in satisfaction of a sale by the Holder of shares of Common Stock
issuable upon such exercise that the Holder anticipated receiving from the
Company (a "Buy-In"),
then the Company shall, within three (3) Business Days after the Holder's
request and in the Holder's discretion, either (i) pay cash to the Holder in an
amount equal to the Holder's total purchase price (including brokerage
commissions, if any) for the shares of Common Stock so purchased (the "Buy-In Price"), at which
point the Company's obligation to deliver such certificate (and to issue such
Warrant Shares) shall terminate, or (ii) promptly honor its obligation to
deliver to the Holder a certificate or certificates representing such Warrant
Shares and pay cash to the Holder in an amount equal to the excess (if any) of
the Buy-In Price over the product of (A) such number of shares of Common Stock,
times (B) the Closing Bid Price on the date of exercise.
(d) Cashless Exercise.
Notwithstanding
anything contained herein to the contrary, if and only if neither (i) a
registration statement covering the Warrant Shares that are the subject of the
Exercise Notice (the "Unavailable Warrant Shares"),
nor (ii) an exemption from registration, is
available for the resale of such Unavailable Warrant Shares, the Holder may, in
its sole discretion, exercise this Warrant in whole or in part and, in lieu of
making the cash payment otherwise contemplated to be made to the Company upon
such exercise in payment of the Aggregate Exercise Price, elect instead to
receive upon such exercise the "Net Number" of shares of Common Stock determined
according to the following formula (a "Cashless
Exercise"):
Net Number = (A x B) - (A x
C)
B
For purposes of the foregoing
formula:
A=
|
the
total number of shares with respect to which this Warrant is then being
exercised.
|
B=
|
the
arithmetic average of the Closing Sale Prices of the shares of Common
Stock for the five (5) consecutive Trading Days ending on the Trading Day
immediately preceding the date of the Exercise
Notice.
|
C=
|
the
Exercise Price then in effect for the applicable Warrant Shares at the
time of such exercise.
|
(e) Rule
144. For purposes of Rule 144(d) promulgated under the
Securities Act, as in effect on the date hereof, it is intended that the Warrant
Shares issued in a Cashless Exercise shall be deemed to have been acquired by
the Holder, and the holding period for the Warrant Shares shall be deemed to
have commenced, on the date this Warrant was originally issued pursuant to the
Underwriting Agreement.
(f) Disputes. In
the case of a dispute as to the determination of the Exercise Price or the
arithmetic calculation of the Warrant Shares, the Company shall promptly issue
to the Holder the number of Warrant Shares that are not disputed, and all such
disputes shall be resolved pursuant to Section
12.
(g) Beneficial
Ownership. The Company shall not effect the exercise of this
Warrant, and the Holder shall not have the right to exercise this Warrant, to
the extent that after giving effect to such exercise, such Person (together with
such Person's affiliates) would beneficially own in excess of 9.99% (the "Maximum Percentage") of the
shares of Common Stock outstanding immediately after giving effect to such
exercise. For purposes of the foregoing sentence, the aggregate
number of shares of Common Stock beneficially owned by such Person and its
affiliates shall include the number of shares of Common Stock issuable upon
exercise of this Warrant with respect to which the determination of such
sentence is being made, but shall exclude shares of Common Stock which would be
issuable upon (i) exercise of the remaining, unexercised portion of this Warrant
beneficially owned by such Person and its affiliates and (ii) exercise or
conversion of the unexercised or unconverted portion of any other securities of
the Company beneficially owned by such Person and its affiliates (including,
without limitation, any convertible notes or convertible preferred stock or
warrants) subject to a limitation on conversion or exercise analogous to the
limitation contained herein. Except as set forth in the preceding
sentence, for purposes of this paragraph, beneficial ownership shall be
calculated in accordance with Section 13(d) of the Securities Exchange Act of
1934, as amended. For purposes of this Warrant, in determining the
number of outstanding shares of Common Stock, the Holder may rely on the number
of outstanding shares of Common Stock as reflected in (1) the Company's most
recent Form 10-K, Form 10-Q, Current Report on Form 8-K or other public filing
with the Securities and Exchange Commission, as the case may be, (2) a more
recent public announcement by the Company or (3) any other notice by the Company
or the Transfer Agent setting forth the number of shares of Common Stock
outstanding. To the extent that the limitation contained in this Section 1(g) applies,
the determination of whether this Warrant is exercisable (in relation to other
securities owned by such Holder) and of which a portion of this Warrant is
exercisable shall be in the sole discretion of a Holder, and the submission of
an Exercise Notice of shall be deemed to be each Holder’s determination of
whether this Warrant is exercisable (in relation to other securities owned by
such Holder) and of which portion of this Warrant is exercisable, in each case
subject to such aggregate percentage limitation, and the Company shall have no
obligation to verify or confirm the accuracy of such
determination. For any reason at any time, upon the written or
oral request of the Holder, the Company shall within two (2) Business Days
confirm to the Holder the number of shares of Common Stock then
outstanding. In any case, the number of outstanding shares of Common
Stock shall be determined after giving effect to the conversion or exercise of
securities of the Company, including this Warrant, by the Holder and its
affiliates since the date as of which such number of outstanding shares of
Common Stock was reported. By written notice to the Company, the
Holder may from time to time increase or decrease the Maximum Percentage to any
other percentage not in excess of 9.99% specified in such notice; provided that (i) any such
increase will not be effective until the sixty-first (61st) day
after such notice is delivered to the Company, and (ii) any such increase or
decrease will apply only to the Holder. The provisions of this
paragraph shall be construed and implemented in a manner otherwise than in
strict conformity with the terms of this Section 1(g) to
correct this paragraph (or any portion hereof) which may be defective or
inconsistent with the intended beneficial ownership limitation herein contained
or to make changes or supplements necessary or desirable to properly give effect
to such limitation.
2. ADJUSTMENT OF EXERCISE PRICE
AND NUMBER OF WARRANT SHARES. The Exercise Price and the
number of Warrant Shares shall be adjusted from time to time as
follows:
(a) Adjustment upon Subdivision
or Combination of Common Stock. If the Company at any time on
or after the Pricing Date subdivides (by any stock split, stock dividend,
recapitalization, reorganization, scheme, arrangement or otherwise) one or more
classes of its outstanding shares of Common Stock into a greater number of
shares, the Exercise Price in effect immediately prior to such subdivision will
be proportionately reduced and the number of Warrant Shares will be
proportionately increased. If the Company at any time on or after the
Pricing Date combines (by any stock split, stock dividend, recapitalization,
reorganization, scheme, arrangement or otherwise) one or more classes of its
outstanding shares of Common Stock into a smaller number of shares, the Exercise
Price in effect immediately prior to such combination will be proportionately
increased and the number of Warrant Shares will be proportionately
decreased. Any adjustment under this Section 2(a) shall
become effective at the close of business on the date the subdivision or
combination becomes effective.
(b) Other
Events. If any event occurs of the type contemplated by the
provisions of this Section 2 but not
expressly provided for by such provisions (including, without limitation, the
granting of stock appreciation rights, phantom stock rights or other rights with
equity features), then the Company's Board of Directors will make an appropriate
adjustment in the Exercise Price and the number of Warrant Shares so as to
protect the rights of the Holder; provided that no such adjustment pursuant to
this Section
2(b) will increase the Exercise Price or decrease the number of Warrant
Shares as otherwise determined pursuant to this Section
2.
3. RIGHTS UPON DISTRIBUTION OF
ASSETS. If the Company shall declare or make any dividend or
other distribution of its assets (or rights to acquire its assets) to all
holders of shares of Common Stock, by way of return of capital or otherwise
(including, without limitation, any distribution of cash, stock or other
securities, property or options by way of a dividend, spin off,
reclassification, corporate rearrangement, scheme of arrangement or other
similar transaction) (a "Distribution"), at any time
after the issuance of this Warrant, then, in each such case:
(a) any
Exercise Price in effect immediately prior to the close of business on the
record date fixed for the determination of holders of shares of Common Stock
entitled to receive the Distribution shall be reduced, effective as of the close
of business on such record date, to a price determined by multiplying such
Exercise Price by a fraction of which (i) the numerator shall be the Closing Bid
Price of the shares of Common Stock on the Trading Day immediately preceding
such record date minus the value of the Distribution (as determined in good
faith by the Company's Board of Directors) applicable to one share of Common
Stock, and (ii) the denominator shall be the Closing Bid Price of the shares of
Common Stock on the Trading Day immediately preceding such record date;
and
(b) the
number of Warrant Shares shall be increased to a number of shares equal to the
number of shares of Common Stock obtainable immediately prior to the close of
business on the record date fixed for the determination of holders of shares of
Common Stock entitled to receive the Distribution multiplied by the reciprocal
of the fraction set forth in the immediately preceding paragraph (a); provided that in the event
that the Distribution is of shares of Common Stock (or common stock) ("Other Shares of Common Stock")
of a company whose common shares are traded on a national securities exchange or
a national automated quotation system, then the Holder may elect to receive a
warrant to purchase Other Shares of Common Stock in lieu of an increase in the
number of Warrant Shares, the terms of which shall be identical to those of this
Warrant, except that such warrant shall be exercisable into the number of shares
of Other Shares of Common Stock that would have been payable to the Holder
pursuant to the Distribution had the Holder exercised this Warrant immediately
prior to such record date and with an aggregate exercise price equal to the
product of the amount by which the exercise price of this Warrant was decreased
with respect to the Distribution pursuant to the terms of the immediately
preceding paragraph (a) and the number of Warrant Shares calculated in
accordance with the first part of this paragraph (b).
4. PURCHASE RIGHTS; FUNDAMENTAL
TRANSACTIONS.
(a) Purchase
Rights. In addition to any adjustments pursuant to Section 2 above, if
at any time the Company grants, issues or sells any Options, Convertible
Securities or rights to purchase stock, warrants, securities or other property
pro rata to the record holders of any class of shares of Common Stock (the
"Purchase Rights"), then
the Holder will be entitled to acquire, upon the terms applicable to such
Purchase Rights, the aggregate Purchase Rights which the Holder could have
acquired if the Holder had held the number of shares of Common Stock acquirable
upon complete exercise of this Warrant (without regard to any limitations on the
exercise of this Warrant) immediately before the date on which a record is taken
for the grant, issuance or sale of such Purchase Rights, or, if no such record
is taken, the date as of which the record holders of shares of Common Stock are
to be determined for the grant, issue or sale of such Purchase
Rights.
(b) Fundamental
Transactions. The Company shall not enter into or be party to
a Fundamental Transaction unless the Successor Entity assumes this Warrant in
accordance with the provisions of this Section (4)(b),
including agreements to deliver to each holder of Warrants in exchange for such
Warrants a security of the Successor Entity evidenced by a written instrument
substantially similar in form and substance to this Warrant, including, without
limitation, an adjusted exercise price equal to the value for the shares of
Common Stock reflected by the terms of such Fundamental Transaction, and
exercisable for a corresponding number of shares of capital stock equivalent to
the shares of Common Stock acquirable and receivable upon exercise of this
Warrant (without regard to any limitations on the exercise of this Warrant)
prior to such Fundamental Transaction, and satisfactory to the
Holder. Upon the occurrence of any Fundamental Transaction, the
Successor Entity shall succeed to, and be substituted for (so that from and
after the date of such Fundamental Transaction, the provisions of this Warrant
referring to the “Company” shall refer instead to the Successor Entity), and may
exercise every right and power of the Company and shall assume all of the
obligations of the Company under this Warrant with the same effect as if such
Successor Entity had been named as the Company herein. Upon
consummation of the Fundamental Transaction, the Successor Entity shall deliver
to the Holder confirmation that there shall be issued upon exercise of this
Warrant at any time after the consummation of the Fundamental Transaction, in
lieu of the shares of the Common Stock (or other securities, cash, assets or
other property) purchasable upon the exercise of the Warrant prior to such
Fundamental Transaction, such shares of stock, securities, cash, assets or any
other property whatsoever (including warrants or other purchase or subscription
rights) which the Holder would have been entitled to receive upon the happening
of such Fundamental Transaction had this Warrant been converted immediately
prior to such Fundamental Transaction, as adjusted in accordance with the
provisions of this Warrant. In addition to and not in substitution for any other
rights hereunder, prior to the consummation of any Fundamental Transaction
pursuant to which holders of shares of Common Stock are entitled to receive
securities or other assets with respect to or in exchange for shares of Common
Stock (a “Corporate
Event”), the Company shall make appropriate provision to insure that the
Holder will thereafter have the right to receive upon an exercise of this
Warrant at any time after the consummation of the Fundamental Transaction but
prior to the Expiration Date, in lieu of the shares of the Common Stock (or
other securities, cash, assets or other property) purchasable upon the exercise
of the Warrant prior to such Fundamental Transaction, such shares of stock,
securities, cash, assets or any other property whatsoever (including warrants or
other purchase or subscription rights) which the Holder would have been entitled
to receive upon the happening of such Fundamental Transaction had the Warrant
been exercised immediately prior to such Fundamental Transaction. If
holders of Common Stock are given any choice as to the securities, cash or
property to be received in a Fundamental Transaction, then the Holder shall be
given the same choice as to the consideration it receives upon any exercise of
this Warrant following such Fundamental Transaction. The
provisions of this Section 4 shall apply
similarly and equally to successive Fundamental Transactions and Corporate
Events and shall be applied without regard to any limitations on the exercise of
this Warrant.
5. NONCIRCUMVENTION. The
Company hereby covenants and agrees that the Company will not, by amendment of
its Certificate of Incorporation, Bylaws or through any reorganization, transfer
of assets, consolidation, merger, scheme of arrangement, dissolution, issue or
sale of securities, or any other voluntary action, avoid or seek to avoid the
observance or performance of any of the terms of this Warrant, and will at all
times in good faith carry out all the provisions of this Warrant and take all
action as may be required to protect the rights of the
Holder. Without limiting the generality of the foregoing, the Company
(i) shall not increase the par value of any shares of Common Stock
receivable upon the exercise of this Warrant above the Exercise Price then in
effect, (ii) shall take all such actions as may be necessary or appropriate
in order that the Company may validly and legally issue fully paid and
nonassessable shares of Common Stock upon the exercise of this Warrant, and
(iii) shall, so long as this Warrant is outstanding, take all action necessary
to reserve and keep available out of its authorized and unissued shares of
Common Stock, solely for the purpose of effecting the exercise of this Warrant,
100% of the number of shares of Common Stock issuable upon exercise of this
Warrant then outstanding (without regard to any limitations on
exercise).
6. WARRANT HOLDER NOT DEEMED A
STOCKHOLDER. Except as otherwise specifically provided herein,
the Holder, solely in such Person's capacity as a holder of this Warrant, shall
not be entitled to vote or receive dividends or be deemed the holder of share
capital of the Company for any purpose, nor shall anything contained in this
Warrant be construed to confer upon the Holder, solely in such Person's capacity
as the Holder of this Warrant, any of the rights of a stockholder of the Company
or any right to vote, give or withhold consent to any corporate action (whether
any reorganization, issue of stock, reclassification of stock, consolidation,
merger, conveyance or otherwise), receive notice of meetings, receive dividends
or subscription rights, or otherwise, prior to the issuance to the Holder of the
Warrant Shares which such Person is then entitled to receive upon the due
exercise of this Warrant. In addition, nothing contained in this
Warrant shall be construed as imposing any liabilities on the Holder to purchase
any securities (upon exercise of this Warrant or otherwise) or as a stockholder
of the Company, whether such liabilities are asserted by the Company or by
creditors of the Company.
7. REISSUANCE OF
WARRANTS.
(a) Transfer of
Warrant. If this Warrant is to be transferred, the Holder
shall surrender this Warrant to the Company together with a written assignment
of this Warrant in the form attached hereto as Exhibit B duly
executed by the Holder or its agent or attorney, whereupon the Company will
forthwith, subject to compliance with any applicable securities laws, issue and
deliver upon the order of the Holder a new Warrant (in accordance with Section 7(d)),
registered as the Holder may request, representing the right to purchase the
number of Warrant Shares being transferred by the Holder and, if less then the
total number of Warrant Shares then underlying this Warrant is being
transferred, a new Warrant (in accordance with Section 7(d)) to the Holder
representing the right to purchase the number of Warrant Shares not being
transferred.
(b) Lost, Stolen or Mutilated
Warrant. Upon receipt by the Company of evidence reasonably
satisfactory to the Company of the loss, theft, destruction or mutilation of
this Warrant, and, in the case of loss, theft or destruction, of any
indemnification undertaking by the Holder to the Company in customary form and,
in the case of mutilation, upon surrender and cancellation of this Warrant, the
Company shall execute and deliver to the Holder a new Warrant (in accordance
with Section
7(d)) representing the right to purchase the Warrant Shares then
underlying this Warrant.
(c) Exchangeable for Multiple
Warrants. This Warrant is exchangeable, upon the surrender
hereof by the Holder at the principal office of the Company, for a new Warrant
or Warrants (in accordance with Section 7(d))
representing in the aggregate the right to purchase the number of Warrant Shares
then underlying this Warrant, and each such new Warrant will represent the right
to purchase such portion of such Warrant Shares as is designated by the Holder
at the time of such surrender; provided, however, that no Warrants for
fractional shares of Common Stock shall be given.
(d) Issuance of New
Warrants. Whenever the Company is required to issue a new
Warrant pursuant to the terms of this Warrant, such new Warrant (i) shall be of
like tenor with this Warrant, (ii) shall represent, as indicated on the face of
such new Warrant, the right to purchase the Warrant Shares then underlying this
Warrant (or in the case of a new Warrant being issued pursuant to Section 7(a) or Section 7(c), the
Warrant Shares designated by the Holder which, when added to the number of
shares of Common Stock underlying the other new Warrants issued in connection
with such issuance, does not exceed the number of Warrant Shares then underlying
this Warrant), (iii) shall have an issuance date, as indicated on the face of
such new Warrant, which is the same as the Issuance Date, and (iv) shall have
the same rights and conditions as this Warrant.
8. NOTICES. Whenever
notice is required to be given under this Warrant, unless otherwise provided
herein, such notice shall be given in accordance with
[ ]. The Company shall provide the Holder with
prompt written notice of all actions taken pursuant to this Warrant, including
in reasonable detail a description of such action and the reason
therefore.
9. AMENDMENT AND
WAIVER. Except as otherwise provided herein, the provisions of
this Warrant may be amended only with the written consent of the Company and the
Holder, and the Company may take any action herein prohibited, or omit to
perform any act herein required to be performed by it, only with the written
consent of the Holder.
10. GOVERNING
LAW. This Warrant shall be governed by and construed and
enforced in accordance with, and all questions concerning the construction,
validity, interpretation and performance of this Warrant shall be governed by,
the internal laws of the State of New York, without giving effect to any choice
of law or conflict of law provision or rule (whether of the State of New York or
any other jurisdictions) that would cause the application of the laws of any
jurisdictions other than the State of New York.
11. CONSTRUCTION;
HEADINGS. This Warrant shall be deemed to be jointly drafted
by the Company and the Holder and shall not be construed against any person as
the drafter hereof. The headings of this Warrant are for convenience
of reference and shall not form part of, or affect the interpretation of, this
Warrant.
12. DISPUTE
RESOLUTION. In the case of a dispute as to the determination
of the Exercise Price or the arithmetic calculation of the Warrant Shares, the
Company shall submit the disputed determinations or arithmetic calculations via
facsimile [or electronic mail] within two (2) Business Days of receipt of the
Exercise Notice giving rise to such dispute, as the case may be, to the
Holder. If the Holder and the Company are unable to agree upon such
determination or calculation of the Exercise Price or the Warrant Shares within
three Business Days of such disputed determination or arithmetic calculation
being submitted to the Holder, then the Company shall, within two (2) Business
Days submit via facsimile [or electronic mail] (a) the disputed determination of
the Exercise Price to an independent, reputable investment bank selected by the
Company and approved by the Holder or (b) the disputed arithmetic calculation of
the Warrant Shares to the Company's independent, outside
accountant. The Company shall cause at its expense the investment
bank or the accountant, as the case may be, to perform the determinations or
calculations and notify the Company and the Holder of the results no later than
ten Business Days from the time it receives the disputed determinations or
calculations. Such investment bank's or accountant's determination or
calculation, as the case may be, shall be binding upon all parties absent
demonstrable error.
13. REMEDIES, OTHER OBLIGATIONS,
BREACHES AND INJUNCTIVE RELIEF. The remedies provided in this
Warrant shall be cumulative and in addition to all other remedies available
under this Warrant, at law or in equity (including a decree of specific
performance and/or other injunctive relief), and nothing herein shall limit the
right of the Holder to pursue actual damages for any failure by the Company to
comply with the terms of this Warrant.
14. TRANSFER. Subject
to compliance with any applicable securities laws, this Warrant may be offered
for sale, sold, transferred or assigned without the consent of the
Company.
15. CERTAIN
DEFINITIONS. For purposes of this Warrant, the following terms
shall have the following meanings:
(a) "Bloomberg" means Bloomberg
Financial Markets.
(b) "Business Day" means any day
other than Saturday, Sunday or other day on which commercial banks in The City
of New York are authorized or required by law to remain closed.
(c) "Change of Control" means any
Fundamental Transaction other than (A) any reorganization, recapitalization or
reclassification of the Common Stock, in which holders of the Company's voting
power immediately prior to such reorganization, recapitalization or
reclassification continue after such reorganization, recapitalization or
reclassification to hold publicly traded securities and, directly or indirectly,
the voting power of the surviving entity or entities necessary to elect a
majority of the members of the board of directors (or their equivalent if other
than a corporation) of such entity or entities, or (B) pursuant to a migratory
merger effected solely for the purpose of changing the jurisdiction of
incorporation of the Company.
(d) "Closing Bid Price" and "Closing Sale Price" means, for
any security as of any date, the last closing bid price and last closing trade
price, respectively, for such security on the Principal Market, as reported by
Bloomberg, or, if the Principal Market begins to operate on an extended hours
basis and does not designate the closing bid price or the closing trade price,
as the case may be, then the last bid price or the last trade price,
respectively, of such security prior to 4:00:00 p.m., New York time, as reported
by Bloomberg, or, if the Principal Market is not the principal securities
exchange or trading market for such security, the last closing bid price or last
trade price, respectively, of such security on the principal securities exchange
or trading market where such security is listed or traded as reported by
Bloomberg, or if the foregoing do not apply, the last closing bid price or last
trade price, respectively, of such security in the over-the-counter market on
the electronic bulletin board for such security as reported by Bloomberg, or, if
no closing bid price or last trade price, respectively, is reported for such
security by Bloomberg, the average of the bid prices, or the ask prices,
respectively, of any market makers for such security as reported in the "pink
sheets" by Pink Sheets LLC (formerly the National Quotation Bureau,
Inc.). If the Closing Bid Price or the Closing Sale Price cannot be
calculated for a security on a particular date on any of the foregoing bases,
the Closing Bid Price or the Closing Sale Price, as the case may be, of such
security on such date shall be the fair market value as determined by the Board
of Directors of the Company in the exercise of its good faith
judgment. All such determinations to be appropriately adjusted for
any stock dividend, stock split, stock combination or other similar transaction
during the applicable calculation period.
(e) "Common Stock" means
(i) the Company's shares of Common Stock, par value $0.001 per share, and
(ii) any share capital into which such Common Stock shall have been changed
or any share capital resulting from a reclassification of such Common
Stock.
(f) RESERVED
(g) "Convertible Securities" means
any stock or securities (other than Options) directly or indirectly convertible
into or exercisable or exchangeable for shares of Common Stock.
(h) "Eligible Market" means the
Principal Market, The New York Stock Exchange, Inc., The American Stock
Exchange, The NASDAQ Global Select Market or The NASDAQ Capital
Market.
(i) "Expiration Date" means the
date five (5) years following the Date of Issuance or, if such date falls on a
day other than a Business Day or on which trading does not take place on the
Principal Market (a "Holiday"), the next date that
is not a Holiday.
(j) "Fundamental Transaction" means
that the Company shall, directly or indirectly, in one or more related
transactions, (i) consolidate or merge with or into (whether or not the Company
is the surviving corporation) another Person, or (ii) sell, assign, transfer,
convey or otherwise dispose of all or substantially all of the properties or
assets of the Company to another Person, or (iii) allow another Person to make a
purchase, tender or exchange offer that is accepted by the holders of more than
the 50% of the outstanding shares of Common Stock (not including any shares of
Common Stock held by the Person or Persons making or party to, or associated or
affiliated with the Persons making or party to, such purchase, tender or
exchange offer), or (iv) consummate a stock purchase agreement or other business
combination (including, without limitation, a reorganization, recapitalization,
spin-off or scheme of arrangement) with another Person whereby such other Person
acquires more than the 50% of the outstanding shares of Common Stock (not
including any shares of Common Stock held by the other Person or other Persons
making or party to, or associated or affiliated with the other Persons making or
party to, such stock purchase agreement or other business combination), (v)
reorganize, recapitalize or reclassify its Common Stock, or (vi) any "person" or
"group" (as these terms are used for purposes of Sections 13(d) and 14(d) of the
Exchange Act) is or shall become the "beneficial owner" (as defined in Rule
13d-3 under the Exchange Act), directly or indirectly, of 50% of the aggregate
ordinary voting power represented by issued and outstanding Common
Stock.
(k) “Options" means any rights,
warrants or options to subscribe for or purchase shares of Common Stock or
Convertible Securities.
(l) "Parent Entity" of a Person
means an entity that, directly or indirectly, controls the applicable Person and
whose common stock or equivalent equity security is quoted or listed on an
Eligible Market, or, if there is more than one such Person or Parent Entity, the
Person or Parent Entity with the largest public market capitalization as of the
date of consummation of the Fundamental Transaction.
(m) "Person" means an individual, a
limited liability company, a partnership, a joint venture, a corporation, a
trust, an unincorporated organization, any other entity and a government or any
department or agency thereof.
(n) "Principal Market" means The
NASDAQ Global Market.
(o) RESERVED
(p) "Successor Entity" means the
Person (or, if so elected by the Holder, the Parent Entity) formed by, resulting
from or surviving any Fundamental Transaction or the Person (or, if so elected
by the Holder, the Parent Entity) with which such Fundamental Transaction shall
have been entered into.
(q) "Trading Day" means any day on
which the Common Stock are traded on the Principal Market, or, if the Principal
Market is not the principal trading market for the Common Stock, then on the
principal securities exchange or securities market on which the Common Stock are
then traded; provided
that "Trading Day" shall not include any day on which the Common Stock are
scheduled to trade on such exchange or market for less than 4.5 hours or any day
that the Common Stock are suspended from trading during the final hour of
trading on such exchange or market (or if such exchange or market does not
designate in advance the closing time of trading on such exchange or market,
then during the hour ending at 4:00:00 p.m., New York time).
(r) "Weighted Average Price" means,
for any security as of any date, the dollar volume-weighted average price for
such security on the Principal Market during the period beginning at 9:30:01
a.m., New York City time, and ending at 4:00:00 p.m., New York City time, as
reported by Bloomberg through its "Volume at Price" function or, if the
foregoing does not apply, the dollar volume-weighted average price of such
security in the over-the-counter market on the electronic bulletin board for
such security during the period beginning at 9:30:01 a.m., New York City time,
and ending at 4:00:00 p.m., New York City time, as reported by Bloomberg, or, if
no dollar volume-weighted average price is reported for such security by
Bloomberg for such hours, the average of the highest closing bid price and the
lowest closing ask price of any of the market makers for such security as
reported in the "pink sheets" by Pink Sheets LLC (formerly the National
Quotation Bureau, Inc.). If the Weighted Average Price cannot be
calculated for such security on such date on any of the foregoing bases, the
Weighted Average Price of such security on such date shall be the fair market
value as mutually determined by the Company and the Holder. If the
Company and the Holder are unable to agree upon the fair market value of such
security, then such dispute shall be resolved pursuant to Section 12 with the
term "Weighted Average Price" being substituted for the term "Exercise Price."
All such determinations shall be appropriately adjusted for any share dividend,
share split or other similar transaction during such period.
[Signature Page
Follows]
IN WITNESS WHEREOF, the
Company has caused this Warrant to Purchase Common Stock to be duly executed as
of the Issuance Date set out above.
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DISCOVERY
LABORATORIES, INC.
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By:
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Name:
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Title:
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EXHIBIT
A
EXERCISE
NOTICE
TO
BE EXECUTED BY THE REGISTERED HOLDER TO EXERCISE THIS
WARRANT
TO PURCHASE COMMON STOCK
DISCOVERY
LABORATORIES, INC.
The undersigned holder hereby exercises
the right to purchase _________________ of the shares of Common Stock ("Warrant Shares") of Discovery
Laboratories, Inc, a Delaware corporation (the "Company"), evidenced by the
attached Warrant to Purchase Common Stock (the "Warrant"). Capitalized
terms used herein and not otherwise defined shall have the respective meanings
set forth in the Warrant.
1. Form of Exercise
Price. The Holder intends that payment of the Exercise Price shall be
made as:
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a
"Cash
Exercise" with respect to _________________ Warrant Shares;
and/or
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a
"Cashless
Exercise" with respect to _______________ Warrant
Shares.
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2. Payment of Exercise
Price. In the event that the holder has elected a Cash Exercise with
respect to some or all of the Warrant Shares to be issued pursuant hereto, the
holder shall pay the Aggregate Exercise Price in the sum of $___________________
to the Company in accordance with the terms of the Warrant.
3. Delivery of Warrant
Shares. The Company shall deliver __________ Warrant Shares in the
name of the undersigned holder or in the name of ______________________ in
accordance with the terms of the Warrant to the following DWAC Account Number or
by physical delivery of a certificate to:
Date:
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Name
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By: |
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Name:
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Title:
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ACKNOWLEDGMENT
The Company hereby acknowledges this
Exercise Notice and hereby directs Continental Stock Transfer & Trust
Company to issue the above indicated number of shares of Common Stock in
accordance with the Transfer Agent Instructions dated
[ ], 2010 from the Company and acknowledged and agreed to
by Continental Stock Transfer & Trust Company.
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DISCOVERY
LABORATORIES, INC
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By:
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Name |
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Title |
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EXHIBIT
B
ASSIGNMENT
FORM
(To
assign the foregoing warrant, execute
this form
and supply required information.
Do not
use this form to exercise the warrant.)
FOR VALUE
RECEIVED, [____] all of or [_______] shares of the foregoing Warrant and all
rights evidenced thereby are hereby assigned to
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Dated: |
______________, _______ |
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Holder’s Signature:
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Holder’s Address:
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NOTE: The
signature to this Assignment Form must correspond with the name as it appears on
the face of the Warrant, without alteration or enlargement or any change
whatsoever, and must be guaranteed by a bank or trust
company. Officers of corporations and those acting in a fiduciary or
other representative capacity should file proper evidence of authority to assign
the foregoing Warrant.
$150,000,000
Discovery
Laboratories, Inc.
Debt
Securities, Preferred Stock, Common Stock,
Debt
Warrants and Equity Warrants
We may
sell from time to time in one or more offerings up to $150,000,000 in the
aggregate of:
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our
secured or unsecured debt securities, in one or more series, which may be
either senior, senior subordinated or subordinated debt securities;
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shares
of our preferred stock in one or more series;
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shares
of our common stock;
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any
combination of the foregoing.
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When we
decide to sell particular securities, we will provide you with the specific
terms and the public offering price of the securities we are then offering in
one or more prospectus supplements to this prospectus. The prospectus supplement
may add to, change or update information contained in this prospectus. The
prospectus supplement may also contain important information about U.S. Federal
income tax consequences. You should carefully read this prospectus, together
with any prospectus supplements and information incorporated by reference in
this prospectus and any prospectus supplements, before you decide to invest.
This prospectus may not be used to
offer or sell any securities unless accompanied by a prospectus
supplement.
Our
common stock is quoted on The Nasdaq Global Market under the trading symbol
“DSCO.” Any
common stock sold pursuant to this prospectus or any prospectus supplement will
be listed on that exchange, subject to official notice of issuance. Each
prospectus supplement to this prospectus will contain information, where
applicable, as to any other listing on any national securities exchange or The
Nasdaq Global Market of the securities covered by the prospectus
supplement.
Investing in our securities involves
significant risks. See “Risk Factors” beginning on page 6.
Neither the Securities and Exchange
Commission nor any state securities commission has approved or disapproved of
these securities or determined if this prospectus is truthful or complete. Any
representation to the contrary is a criminal offense.
The date
of this prospectus is June 18, 2008.
TABLE OF
CONTENTS
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Page
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ABOUT
THIS PROSPECTUS
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1
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ABOUT
DISCOVERY
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1
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RISK
FACTORS
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2
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FORWARD-LOOKING
STATEMENTS
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20
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USE
OF PROCEEDS
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21
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RATIO
OF EARNINGS TO FIXED CHARGES
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22
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DESCRIPTION
OF DEBT SECURITIES
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22
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DESCRIPTION
OF PREFERRED STOCK
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30
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DESCRIPTION
OF COMMON STOCK
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31
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DESCRIPTION
OF WARRANTS
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34
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PLAN
OF DISTRIBUTION
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36
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EXPERTS
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37
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LEGAL
MATTERS
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37
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WHERE
YOU CAN FIND MORE INFORMATION
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37
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INFORMATION
INCORPORATED BY REFERENCE
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38
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This prospectus is part of a
registration statement we filed with the Securities and Exchange Commission. You
should rely only on the information we have provided or incorporated by
reference in this prospectus or any prospectus supplement. We have not
authorized anyone to provide you with additional or different information. We
are not making an offer of these securities in any state where the offer is not
permitted. You should not assume that the information in this prospectus is
accurate as of any date other than the date on the front of the
prospectus.
ABOUT THIS
PROSPECTUS
This
prospectus is part of a registration statement that we filed with the Securities
and Exchange Commission (the “SEC”) utilizing a “shelf” registration process or
continuous offering process, which allows us to offer and sell any combination
of the securities described in this prospectus in one or more offerings. Using
this prospectus, we may offer up to a total dollar amount of $150,000,000 of
these securities.
This
prospectus provides you with a general description of the securities we may
offer. Each time we offer to sell securities pursuant to this registration
statement and the prospectus contained herein, we will provide a prospectus
supplement that will contain specific information about the terms of that
offering. That prospectus supplement may include additional risk factors about
us and the terms of that particular offering. Prospectus supplements may also
add to, update or change the information contained in this prospectus. To the
extent that any statement that we make in a prospectus supplement is
inconsistent with statements made in this prospectus, the statements made in
this prospectus will be deemed modified or superseded by those made in such
prospectus supplement. In addition, as we describe in the section entitled
“Where You Can Find More Information,” we have filed and plan to continue to
file other documents with the SEC that contain information about us and the
business conducted by us and our subsidiaries. Before you decide whether to
invest in any of these securities, you should read this prospectus, the
prospectus supplement that further describes the offering of these securities
and the information we file with the SEC.
In this
prospectus and any prospectus supplement, unless otherwise indicated, the terms
“Discovery”, “the Company”, “we”, “us” and “our” refer and relate to Discovery
Laboratories, Inc., and its consolidated subsidiaries.
ABOUT DISCOVERY
Discovery
Laboratories, Inc. is a biotechnology company developing Surfactant Replacement
Therapies (SRT) for respiratory disorders and diseases. Our proprietary
technology produces a peptide-containing synthetic surfactant that is
structurally similar to pulmonary surfactant, a substance produced naturally in
the lung and essential for survival and normal respiratory function. We believe
that our proprietary technology makes it possible, for the first time, to
develop a series of SRT respiratory therapies to treat conditions for which
there are few or no approved therapies available for patients in the Neonatal
Intensive Care Unit (NICU), Pediatric Intensive Care Unit (PICU), Intensive Care
Unit (ICU) and other hospital settings.
Our SRT
pipeline is focused initially on the most significant respiratory conditions
prevalent in the NICU and PICU. We have
filed a New Drug Application (NDA) with the U.S. Food and Drug Administration
(FDA) for our lead product, Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in
premature infants. The FDA recently issued to us an Approvable Letter, which
does not require additional clinical trials. We are also developing Surfaxin for
other neonatal and pediatric respiratory conditions, including Bronchopulmonary
Dysplasia (BPD), a debilitating and chronic lung disease typically affecting
premature infants who have suffered RDS, and Acute Respiratory Failure (ARF).
Aerosurf™ is our proprietary SRT in aerosolized form and is being developed
initially to treat premature infants in the NICU. Aerosurf has the potential to
obviate the need for endotracheal intubation and conventional mechanical
ventilation and holds the promise to significantly expand the use of SRT in
respiratory medicine.
We also
believe that our SRT will potentially address a variety of debilitating
respiratory conditions such as Acute Lung Injury (ALI), cystic fibrosis (CF),
chronic obstructive pulmonary disease (COPD), and asthma, that affect other
pediatric, young adult and adult patients in the ICU and other hospital
settings.
We have
implemented a long-term business strategy that includes: (i) ongoing investment
in the development of our SRT pipeline programs, with a primary focus on efforts
intended to gain regulatory approval to market and sell Surfaxin for the
prevention of RDS in premature infants in the United States, life cycle
development of Surfaxin for other respiratory conditions prevalent in the NICU
and PICU, and developing Aerosurf for neonatal and pediatric conditions;
(ii) preparing for the potential commercial launch of Surfaxin in the
United States; (iii) seeking collaboration agreements and strategic partnerships
in the international and domestic markets for the development and potential
commercialization of our SRT pipeline; (iv) continued investment in our
quality systems and manufacturing capabilities to meet the anticipated
pre-clinical, clinical and potential future commercial requirements of Surfaxin,
Aerosurf and our other SRT products; and (v) seeking investments of
additional capital, including potentially from business alliances, commercial
and development partnerships, equity financings and other similar opportunities,
although there can be no assurance that we will identify or enter into any
specific actions or transactions.
Corporate
Information
Surfaxin® and
Aerosurf™
are our
trademarks. This prospectus also includes product names, trademarks and trade
names of other companies, which names are the exclusive property of the holders
thereof.
Our
principal offices located at 2600 Kelly Road, Suite 100, Warrington,
Pennsylvania. Our telephone number is 215-488-9300 and our facsimile number is
(215) 488-9301. We maintain a website on the Internet at www.discoverylabs.com.
Information contained in our web site is not a part of this prospectus. Our
common stock is listed on The Nasdaq Global Market, where our symbol is
DSCO.
RISK FACTORS
An investment in our common stock
involves significant risks. You should carefully consider the risks described
below or in any applicable prospectus supplement and other information,
including our financial statements and related notes previously included in our
periodic reports filed with the SEC, and in the documents incorporated therein
by reference before deciding to invest in our securities. The risks described
below are not the only ones that we face. Additional risks not presently known
to us or that we currently deem immaterial may also impair our business
operations. The following risks, among others, could cause our actual results,
performance, achievements or industry results to differ materially from those
expressed in our forward-looking statements contained herein and presented
elsewhere by management from time to time. If any of the following risks
actually occurs, our business prospects, financial condition or results of
operations could be materially harmed. In such case, the market price of our
securities would likely and you could lose all or part of your
investment.
We may not successfully develop and
market our products, and even if we do, we may not become
profitable.
We
currently have no products approved for marketing and sale and are conducting
research and development on our product candidates. As a result, we have not
begun to market or generate revenues from the commercialization of any of our
products. Our long-term viability will be impaired if we are unable to obtain
regulatory approval for, or successfully market, our product
candidates.
To date,
we have only generated revenues from investments, research grants and
collaborative research and development agreements. We need to continue to engage
in significant, time-consuming and costly research, development, pre-clinical
studies, clinical testing and regulatory approval activities for our products
under development before their commercialization. In addition, pre-clinical or
clinical studies may show that our products are not effective or safe for one or
more of their intended uses. We may fail in the development and
commercialization of our products. As of March 31, 2008, we have an accumulated
deficit of approximately $298.0 million and we expect to continue to incur
significant increasing operating losses over the next several years. If we
succeed in the development of our products, we still may not generate sufficient
or sustainable revenues or we may not be profitable.
The regulatory approval process for
our products is expensive and time-consuming, and the outcome is uncertain. We
may not obtain required regulatory approvals for the commercialization of our
products.
To sell
our products under development, including Surfaxin, we must receive regulatory
approvals for each product. The FDA and foreign regulators extensively and
rigorously regulate the testing, manufacture, distribution, advertising, pricing
and marketing of drug products like our products. This approval process includes
preclinical studies and clinical trials of each pharmaceutical compound to
establish the safety and effectiveness of each product and the confirmation by
the FDA and foreign regulators that, in manufacturing the product, we maintain
good laboratory and manufacturing practices during testing and manufacturing.
Even if favorable testing data are generated by clinical trials of drug
products, the FDA or a foreign regulator, such as the European Medicines Agency
(EMEA), may not accept or approve an NDA or Marketing Authorization Application
(MAA) filed by a pharmaceutical or biotechnology company for such drug product.
To market our products or conduct clinical trials outside the United States, we
also must comply with foreign regulatory requirements governing marketing
approval for pharmaceutical products and the conduct of human clinical
trials.
We have
filed an NDA with the FDA for Surfaxin for the prevention of RDS in premature
infants, which is the subject of a third Approvable Letter. On May 1, 2008, the
FDA issued a third Approvable Letter to us. We have requested a meeting with the
FDA, which is scheduled to occur on June 18, 2008 by teleconference, to confirm
our approach to responding to certain items identified in this Approvable
Letter. If our approach is confirmed, we anticipate submitting our response to
the Approvable Letter in June 2008. This timeline could be extended based on our
discussions with the FDA as well as other factors. If the FDA accepts our formal
response to the Approvable Letter as a complete response, we believe that the
FDA may classify our response as a Class 1 resubmission, which will result in a
60-day target review period. The FDA might still delay its approval of our NDA
or reject our NDA, which would have a material adverse effect on our business.
See also “Risk Factors – Our pending NDA for Surfaxin for the prevention of
RDS in premature infants may not be approved by the FDA in a timely manner, or
at all, which would prevent our commercializing this product in the United
States and adversely impact our ability to commercialize this product
elsewhere.”
We filed
an MAA with the EMEA for clearance to market Surfaxin for the prevention of RDS
in premature infants in Europe. In April 2006, ongoing analysis of Surfaxin
process validation batches that had been manufactured for us in 2005 by our
then-contract manufacturer as a requirement for our NDA indicated that certain
stability parameters no longer met acceptance criteria. As we determined that we
could not resolve the related manufacturing issues within the regulatory time
frames mandated by the EMEA procedure for consideration of our MAA, in June
2006, we voluntarily withdrew the MAA without fully resolving certain
outstanding clinical issues related to the Surfaxin Phase 3 clinical trials. We
plan in the future to have further discussions with the EMEA and potentially
develop a strategy to gain approval for Surfaxin in Europe.
If the FDA and foreign regulators do
not approve our products, we will not be able to market our
products.
The FDA
and foreign regulators have not yet approved any of our products under
development for marketing in the United States or elsewhere. Without regulatory
approval, we are not able to market our products. Further, even if we were to
succeed in gaining regulatory approvals for any of our products, the FDA or a
foreign regulator could at any time withdraw any approvals granted if there is a
later discovery of unknown problems or if we fail to comply with other
applicable regulatory requirements at any stage in the regulatory process, or
the FDA or a foreign regulator may restrict or delay our marketing of a product
or force us to make product recalls. In addition, the FDA could impose other
sanctions such as fines, injunctions, civil penalties or criminal prosecutions.
Any failure to obtain regulatory approval or any withdrawal or significant
restriction on our ability to market our products after approval would have a
material adverse effect on our business.
Our pending NDA for Surfaxin for the
prevention of RDS in premature infants may not be approved by the FDA in a
timely manner, or at all, which would prevent our commercializing this product
in the United States and adversely impact our ability to commercialize this
product elsewhere.
In April
2006, the FDA issued a second Approvable Letter to us with respect to our NDA
for Surfaxin for the prevention of RDS in premature infants. In October 2007, we
filed our complete response to the second Approvable Letter and the FDA
established May 1, 2008 as its target to complete review of our NDA. On May 1,
2008, the FDA issued to us a third Approvable Letter. Of the items listed in the
Approvable Letter, we believe that the most important involve justifying and
finalizing one acceptance criterion for Surfaxin biological activity and limited
acceptance criteria for lipid drug substance impurities and that we and the FDA
can reach agreement on these acceptance criteria. We have requested a meeting
with the FDA, which is scheduled to occur on June 18, 2008 by teleconference, to
confirm our approach to respond to these and certain other limited items
identified in this Approvable Letter. If this meeting confirms our approach, we
anticipate submitting our response to the Approvable Letter in June 2008.
However, this timeline could be extended based on our discussions with the FDA
as well as other factors. If the FDA accepts our response as a complete
response, we believe that the FDA may classify our complete response as a Class
1 resubmission, which will result in a 60-day target review period (as compared
to a Class 2 resubmission would result in a 6-month target review period).
Ultimately, the FDA may not approve Surfaxin for RDS in premature infants. Any
failure to obtain FDA approval or further delay associated with the FDA’s review
process would adversely impact our ability to commercialize our lead product.
Even though some of our drug
candidates have qualified for expedited review, the FDA may not approve them at
all or any sooner than other drug candidates that do not qualify for expedited
review.
The FDA
has notified us that two of our intended indications for our
precision-engineered SRT, BPD in premature infants and ARDS in adults have been
granted designation as “Fast Track” products under provisions of the Food and
Drug Administration Modernization Act of 1997. We believe that other potential
products in our SRT pipeline may also qualify for Fast Track designation.
Designation as a “Fast Track” product means that the FDA has determined that the
drug is intended for the treatment of a serious or life-threatening condition
and demonstrates the potential to address unmet medical needs, and that the FDA
will facilitate and expedite the development and review of the application for
the approval of the product. The FDA generally will review an NDA for a drug
granted Fast Track designation within six months. Fast Track designation does
not accelerate clinical trials nor does it mean that the regulatory requirements
are less stringent. Our products may cease to qualify for expedited review and
our other drug candidates may fail to qualify for Fast Track designation or
expedited review. Moreover, even if we are successful in gaining Fast Track
designation, other factors could result in significant delays in our development
activities with respect to our Fast Track products.
Our research and development
activities involve significant risks and uncertainties that are inherent in the
clinical development and regulatory approval processes.
Development
risk factors include, but are not limited to whether we, or our third party
collaborators and providers, will be able to:
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complete
our pre-clinical and clinical trials of our SRT product candidates with
scientific results that are sufficient to support further development
and/or regulatory approval;
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receive
the necessary regulatory approvals;
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obtain
adequate supplies of surfactant active drug substances, manufactured to
our specifications and on commercially reasonable terms;
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perform
under agreements to supply the drug substances, medical device components
and related services necessary to manufacture our SRT drug product
candidates, including Surfaxin and
Aerosurf;
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successfully
resolve the remaining matters identified by the FDA in the May 1, 2008
Approvable Letter;
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provide
for sufficient manufacturing capabilities, at our manufacturing operations
in Totowa and with third-party contract manufacturers, to produce
sufficient SRT drug product, including Surfaxin, and aerosolization
systems to meet our pre-clinical and clinical development
requirements;
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successfully
develop and implement a manufacturing strategy for our aerosolization
systems and related materials to support clinical studies of Aerosurf;
and
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obtain
capital necessary to fund our research and development efforts, including
our supportive operations, manufacturing and clinical trials
requirements.
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Because
these factors, many of which are outside our control, could have a potentially
significant effect on our development activities, the success, timing of
completion, and ultimate cost of development of any of our product candidates is
highly uncertain and cannot be estimated with any degree of certainty. The
timing and cost to complete drug trials alone may be impacted by, among other
things:
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slow
patient enrollment;
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long
treatment time required to demonstrate
effectiveness;
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lack
of sufficient clinical supplies and
material;
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adverse
medical events or side effects in treated
patients;
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lack
of compatibility with complementary
technologies;
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failure
of a product candidate to demonstrate effectiveness;
and
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lack
of sufficient funds.
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If we do
not successfully complete clinical trials, we will not receive regulatory
approval to market our SRT products. Failure to obtain and maintain regulatory
approval and generate revenues from the sale of our products would have a
material adverse effect on our financial condition and results of operations and
could reduce the market value of our common stock.
Our ongoing clinical trials may be
delayed, or fail, which will harm our business.
Clinical
trials generally take two to five years or more to complete. Like many
biotechnology companies, we may suffer significant setbacks in advanced clinical
trials, even after obtaining promising results in earlier trials or in
preliminary findings for such clinical trials. Data obtained from clinical
trials are susceptible to varying interpretations that may delay, limit or
prevent regulatory approval. In addition, we may be unable to enroll patients
quickly enough to meet our expectations for completing any or all of these
trials. The timing and completion of current and planned clinical trials of our
product candidates depend on many factors, including the rate at which patients
are enrolled. Delays in patient enrollment in clinical trials may occur, which
would be likely to result in increased costs, program delays, or both.
Patient
enrollment is a function of many factors, including:
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the
number of clinical sites;
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the
size of the patient population;
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the
proximity of patients to the clinical
sites;
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the
eligibility and enrollment criteria for the
study;
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the
willingness of patients or their parents or guardians to participate in
the clinical trial;
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the
existence of competing clinical trials;
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the
existence of alternative available products;
and
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geographical
and geopolitical considerations.
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If we
succeed in achieving our patient enrollment targets, patients that enroll in our
clinical trials could suffer adverse medical events or side effects that are
known to occur with the administration of the surfactant class of drugs
generally, such as a decrease in the oxygen level of the blood upon
administration. It is also possible that the FDA or foreign regulators could
interrupt, delay or halt any one or more of our clinical trials for any of our
product candidates. If we or any regulator believe that trial participants face
unacceptable health risks, any one or more of our trials could be suspended or
terminated. We also may not reach agreement with the FDA or a foreign regulator
on the design of any one or more of the clinical studies necessary for approval.
Conditions imposed by the FDA and foreign regulators on our clinical trials
could significantly increase the time required for completion of such clinical
trials and the costs of conducting the clinical trials.
In
addition to our efforts to gain approval of Surfaxin for the prevention of RDS
in premature infants, we are currently conducting a Phase 2 clinical trial to
evaluate the use of Surfaxin in children up to two years of age suffering from
Acute Respiratory Failure. We are also planning to initiate clinical studies in
support of other products in our SRT pipeline, including planned Phase 2
clinical trials with respect to Aerosurf for the treatment and prevention of RDS
in premature infants in the NICU. All of these clinical trials will be
time-consuming and potentially costly. Should we fail to complete our clinical
development programs or should such programs yield unacceptable results, such
failures would have a material adverse effect on our business.
The manufacture of our drug products
is a highly exacting and complex process, and if we, our contract manufacturers
or any of our materials suppliers encounter problems manufacturing our products
or drug substances, this could cause us to delay any potential clinical program
or product launch or, following approval, cause us to experience shortages of
products inventories.
The FDA
and foreign regulators require manufacturers to register manufacturing
facilities. The FDA and foreign regulators also periodically inspect these
facilities to confirm compliance with current good manufacturing procedures
(cGMP) or other similar requirements that the FDA or foreign regulators
establish. Surfaxin is a complex drug and, unlike many drugs, contains four
active ingredients. It must be aseptically manufactured at our facility as a
sterile, liquid suspension and requires ongoing monitoring of drug product
stability and conformance to specifications.
The
manufacture of pharmaceutical products requires significant expertise and
compliance with strictly enforced federal, state and foreign regulations. We,
our contract manufacturers or our materials and drug substances suppliers may
experience manufacturing or quality control problems that could result in a
failure to maintain compliance with the FDA’s cGMP requirements, or those of
foreign regulators, which is necessary to continue manufacturing our drug
products, materials or drug substances. Other problems that may be encountered
include:
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the
need to make necessary modifications to qualify and validate a
facility;
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difficulties
with production and yields, including scale-up requirements and achieving
adequate capacity;
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availability
of raw materials and supplies;
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quality
control and assurance; and
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shortages
of qualified personnel.
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Such a
failure could result in product production and shipment delays or an inability
to obtain materials or drug substances supplies.
Manufacturing
or quality control problems have already occurred and may again occur at our
Totowa, New Jersey facility or may occur at the facilities of a contract
manufacturer or our materials or drug substances suppliers. Such problems may
require potentially complex, time-consuming and costly comprehensive
investigations to determine the root causes of such problems and may also
require detailed and time-consuming remediation efforts, which can further delay
a return to normal manufacturing and production activities. Any failure by our
own manufacturing operations or by the manufacturing operations of any of our
suppliers to comply with cGMP requirements or other FDA or foreign regulatory
requirements could adversely affect our ability to manufacture our drug
products, which in turn would adversely affect our clinical research activities
and our ability to develop and gain regulatory approval to market our drug
products.
Since we
acquired our manufacturing operations in Totowa, New Jersey in December 2005, we
have been manufacturing our drug products. This is the only facility at which we
produce our drug product. Any interruption in manufacturing operations at this
location could result in our inability to satisfy our needs for planned clinical
trials, and, if approved, commercial requirements for Surfaxin. A number of
factors could cause interruptions, including:
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equipment
malfunctions or failures;
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technology
malfunctions;
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work
stoppages or slowdowns;
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damage
to or destruction of the facility;
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regional
power shortages; and
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To assure
adequate drug supplies and continued compliance with cGMP and other FDA or
foreign regulatory requirements, we own certain specialized manufacturing
equipment, employ experienced manufacturing senior executive and managerial
personnel, and continue to invest in enhanced quality systems and manufacturing
capabilities. However, we may nevertheless be unable to produce Surfaxin and our
other SRT drug candidates to appropriate standards. If we are unable to
successfully develop and maintain our manufacturing capabilities and comply with
cGMP, it will adversely affect our clinical development activities and,
potentially, the sales of our products.
If we fail to maintain relationships
with our manufacturers, assemblers and integrator of our aerosolization systems,
or if we fail to identify additional, qualified replacement manufacturers,
assemblers and integrators to manufacture subcomponents and integrate our
initial prototype aerosolization system or our anticipated next-generation and
later development versions of our capillary aerosolization technology, the
timeline of our plans for the development and, if approved, commercialization of
Aerosurf could suffer.
In connection with the development of aerosol formulations of our
SRT, including Aerosurf, we currently plan to rely on third-party contract
manufacturers to manufacture, assemble and integrate the subcomponents of our
capillary aerosolization technology to support our clinical studies and
potential commercialization of Aerosurf. Certain of these key components must be
manufactured in an environmentally-controlled area and, when assembled, the
critical product-contact components and patient interface systems must be
packaged and sterilized. Each of the aerosolization system devices must be
quality-control tested prior to release and monitored for conformance to
designated product specifications, and each manufacturer, assembler and
integrator must be registered with the FDA and conduct its manufacturing
activities in compliance with cGMP requirements or other FDA or foreign
regulatory requirements.
We
currently have identified component manufacturers and an integrator to
manufacture and integrate our initial prototype aerosolization system that we
currently plan to use in early Phase 2 clinical trials. However, we may not be
able to identify qualified additional or replacement manufacturers and
integrators to manufacture subcomponents and integrate our current prototype or
next generation and later development versions of our aerosolization systems or
we may not be able to enter into agreements with them on terms and conditions
favorable and acceptable to us. In addition, the manufacturers and assemblers
and integrators that we identify may be unable to timely comply with FDA, or
other foreign regulatory agency, requirements regulating manufactures of
combination drug-device products. If we do not successfully identify and enter
into a contractual agreements with aerosolization systems and components
manufacturers, assemblers and integrators, it will adversely affect the timeline
of our plans for the development and, if approved, commercialization of
Aerosurf.
If the parties we depend on for
supplying our active drug substance and certain manufacturing-related services
do not timely supply these products and services, it may delay or impair our
ability to develop, manufacture and market our products.
We rely
on suppliers for our active drug substances, materials and excipient products,
and third parties for certain manufacturing-related services to produce drug
material that meets appropriate content, quality and stability standards for use
in clinical trials and, if approved, for commercial distribution. To succeed,
clinical trials require adequate supplies of drug substance and drug product,
which may be difficult or uneconomical to procure or manufacture. The
manufacturing process for Aerosurf, a combination drug-device product, includes
the integration of a number of components, many of which are comprised of a
large number of subcomponent parts that we expect will be produced by
potentially a number of manufacturers. We and our suppliers may not be able to
(i) produce our drug substances, drug product or drug product devices or
related subcomponent parts to appropriate standards for use in clinical studies,
(ii) perform to applicable specifications under any definitive manufacturing,
supply or service agreements with us, or (iii) remain in business for a
sufficient time to successfully produce and market our product candidates.
In some
cases, we are dependent upon a single supplier to produce our full requirement
of drug substances, drug product or drug product devices. If we do not maintain
important manufacturing and service relationships, we may fail to find a
replacement supplier or vendor and may not be able to develop our own
manufacturing capabilities, which could delay or impair our ability to obtain
regulatory approval for our products and substantially increase our costs or
deplete our profit margins, if any. Even if we are able to find replacement
manufacturers, suppliers and vendors when needed, we may not be able to enter
into agreements with them on terms and conditions favorable to us or there could
be a substantial delay before such manufacturer, vendor or supplier, or a
related new facility is properly qualified and registered with the FDA or other
foreign regulatory authorities. Such delays could have a material adverse effect
on our development activities and our business.
If we do not adequately forecast
customer demand for our product candidates, including Surfaxin, if approved, our
business could suffer.
The
timing and amount of customer demand is difficult to predict and the commercial
requirements to meet changing customer demand is difficult to predict. If we are
successful in gaining regulatory approval of our products, we may not be able to
accurately forecast customer demand for our product candidates, including
Surfaxin, or respond effectively to unanticipated increases in demand. This
could have an adverse effect on our business. If we overestimate customer
demand, or attempt to commercialize products for which the market is smaller
than we anticipate, we could incur significant unrecoverable costs from creating
excess capacity. In addition, if we do not successfully develop and timely
commercialize our product candidates, we may never require the production
capacity that we expect to have available.
Our limited sales and marketing
experience may restrict our success in commercializing our product candidates.
We have
limited experience in marketing or selling pharmaceutical products and have a
limited marketing and sales team. In the second quarter 2006, following receipt
of the second Approvable Letter and the occurrence of the process validation
stability failures, we discontinued our commercial activities. Therefore, if we
are successful in gaining approval to market Surfaxin, we will have to
re-establish satisfactory marketing, sales and distribution capabilities
necessary to commercialize and gain market acceptance for Surfaxin or our other
product candidates, if approved.
We expect
to rely primarily on our marketing and sales team to market Surfaxin, if
approved, in the United States. Our pre-approval preparations have included the
hiring of experienced management personnel. We have also begun to invest in our
medical affairs capabilities to provide for increased scientific and medical
educational activities. We do not plan to hire our sales representatives until
after we have received approval to market Surfaxin. Developing a marketing and
sales team to market and sell products is a difficult, expensive and
time-consuming process. Recruiting, training and retaining qualified sales
personnel is critical to our success. Competition for skilled personnel can be
intense, and we may be unable to attract and retain a sufficient number of
qualified individuals to successfully launch Surfaxin. Additionally, we may not
be able to provide adequate incentive to our sales force. If we are unable to
successfully motivate and expand our marketing and sales force and further
develop our sales and marketing capabilities, we will have difficulty selling,
maintaining and increasing the sales of our products.
We expect
to incur significant expenses in developing our marketing and sales team. Our
ability to make that investment and also execute our current operating plan is
dependent on numerous factors, including, potentially, the performance of third
party collaborators with whom we may contract. Accordingly, we may not have
sufficient funds to successfully commercialize Surfaxin or any other potential
product in the United States or elsewhere.
The commercial success of our product
candidates will depend upon the degree of market acceptance by physicians,
patients, healthcare payers and others in the medical
community.
Any
potential products that we bring to market may not gain or maintain market
acceptance by governmental purchasers, group purchasing organizations,
physicians, patients, healthcare payers and others in the medical community. If
any products that we develop do not achieve an adequate level of acceptance, we
may not generate material revenues with these products. The degree of market
acceptance of our product candidates, if approved for commercial sale, will
depend on a number of factors, including:
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the
perceived safety and efficacy of our
products;
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the
potential advantages over alternative
treatments;
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the
prevalence and severity of any side
effects;
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the
relative convenience and ease of
administration;
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the
willingness of the target patient population to try new products and of
physicians to prescribe our
products;
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the
effectiveness of our marketing strategy and distribution support;
and
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the
sufficiency of coverage or reimbursement by third
parties.
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Our strategy with respect to
development and marketing of our products, in many cases, is to enter into
collaboration agreements and strategic partnerships with third parties. If we
fail to enter into these agreements, or if we or the third parties fail to
perform under such agreements, it could impair our ability to develop and
commercialize our products.
To fund
development, clinical testing and marketing and commercialization of our
products, our strategy, in many cases, depends upon collaboration arrangements
and strategic partnerships with pharmaceutical and other biotechnology companies
to develop, market, commercialize and distribute our products. In addition to
funding our activities, we may depend on our collaborators’ expertise and
dedication of sufficient resources to develop and commercialize the covered
products. In addition, if our current collaboration arrangements fail to timely
meet our objectives, we may need to enter into additional collaboration
agreements and our success may depend upon obtaining such additional
collaboration partners.
Our
collaboration arrangement with Esteve for Surfaxin and certain other of our
product candidates is focused on key southern European markets. If we or Esteve
should fail to conduct our respective collaboration-related activities in a
timely manner, or otherwise breach or terminate the agreements that make up our
collaboration arrangements, or if a dispute should arise under our collaboration
arrangements, such events could impair our ability to commercialize or develop
our products for the Esteve territory in Europe covered by the arrangement. In
such events, we may need to seek other partners and collaboration agreements, or
we may have to develop our own internal capabilities to market the covered
products in the Esteve territory without a collaboration
arrangement.
We have
recently restructured our strategic alliance with Philip Morris USA, Inc. d/b/a/
Chrysalis (PM USA). Under the restructured arrangement, we are now responsible
for finalizing design development for the initial prototype aerosolization
device platform and disposable dose packets. Prior to June 30, 2008, PM USA is
responsible to make a technology transfer to us of its capillary aerosolization
technology to permit us to fully practice our license to this technology in all
respects. We expect to rely on our own engineering expertise as well as design
engineers, medical device experts and other third party collaborators to advance
the development of our capillary aerosolization technology. If PM USA should
fail to complete the technology transfer to us, or if we are unable to identify
design engineers and medical device experts to support our program in the
future, or if we should fail to complete development of the initial prototype
aerosolization system as well as next generation versions of the aerosolization
system, such events could impair our ability to commercialize or develop our
aerosolized SRT products.
We may,
in the future, grant to our present or additional collaboration partners rights
to license and commercialize our pharmaceutical products. Under such
arrangements, our collaboration partners may control key decisions relating to
the development and commercialization of the covered products. By granting such
rights to our collaboration partners, we would likely limit our flexibility in
considering alternative strategies to develop and commercialize our products. If
we were to fail to successfully develop these relationships, or if our
collaboration partners were to fail to successfully develop, market or
commercialize any of the covered products, such failures may delay or prevent us
from developing or commercializing our products in a competitive and timely
manner and would have a material adverse effect on the commercialization of
Surfaxin and our other SRT product candidates. See “Risk Factors – Our
limited sales and marketing experience may restrict our success in
commercializing our product candidates.”
Under our restructured collaboration
arrangement with PM USA, we are responsible for future
development of the capillary aerosolization technology, which will require us to
build internal development capabilities or enter into future collaboration or
other arrangements to gain the engineering expertise required to further develop
the technology.
In March
2008, we restructured our collaboration arrangement with PM USA. We now have
responsibility for the development of the capillary aerosolization technology
and will not have development support from PM USA after June 30, 2008. Our
future development of the capillary aerosolization technology is subject to
certain risks and uncertainties, including, without limitation:
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We
may not be able to complete the development of the initial prototype
aerosolization device, if at all, on a timely basis and such inability may
delay or prevent initiation of our planned Phase 2 clinical trials;
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We
will require sophisticated engineering expertise to continue the
development of the capillary aerosolization technology. Although we are
building our own internal medical device engineering expertise and have
recently begun working with a leading engineering and design firm that has
a successful track record of developing innovative devices for major
companies in the medical and pharmaceutical industries, there is no
assurance that our efforts will be successful or that we will be able to
identify other potential collaborators to complete the development of the
next-generation aerosolization system and enter into agreements with such
collaborators on terms and conditions that are favorable to us, and,
if we are unable to identify or retain design engineers and medical
device experts to support our development program, this could impair our
ability to commercialize or develop it’s aerosolized drug
products;
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We
currently hold an exclusive license to the capillary aerosolization
technology in the United States from PM USA and outside the United States
from Philip Morris Products S.A. (PMPSA). PM USA and PMPSA are no longer
affiliated entities; as such, there is a risk that, if we were to require
the consent of PMPSA and PM Philip Morris Products S.A. (PMPSA)under the
License Agreements, they may not agree on the appropriate course and we
may be forced to develop the capillary aerosolization technology in the
two territories under different circumstances. Such inconsistencies could
have an adverse effect on the our ability to develop the capillary
aerosolization technology or to successfully commercialize the Licensed
Products in one or both of the territories;
and
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We
have additional rights under the US License Agreement that are not
provided under the International License Agreement. Although the
International License Agreement provides for the potential expansion of
rights with the consent of PMPSA, there can be no assurance that PMPSA
would agree to any such expansion and, as a result, we may be unable to
develop and commercialize Licensed Products under its expanded rights
outside the United States markets.
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To market and distribute our
products, we may enter into distribution arrangements and marketing alliances,
which could require us to give up rights to our product
candidates.
We may
rely on third-party distributors to distribute our products or enter into
marketing alliances to sell our products, either internationally or in the
United States. We may not be successful in identifying such third parties or
finalizing such arrangements on terms and conditions that are favorable to us.
Our failure to successfully enter into these arrangements on favorable terms
could delay or impair our ability to commercialize our product candidates and
could increase our costs of commercialization. Our dependence on distribution
arrangements and marketing alliances to commercialize our product candidates
will subject us to a number of risks, including:
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we
may be required to relinquish important rights to our products or product
candidates;
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we
may not be able to control the amount and timing of resources that our
distributors or collaborators may devote to the commercialization of our
product candidates;
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our
distributors or collaborators may experience financial
difficulties;
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our
distributors or collaborators may not devote sufficient time to the
marketing and sales of our products thereby exposing us to potential
expenses in terminating such distribution agreements; and
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business
combinations or significant changes in a collaborator’s business strategy
may adversely affect a collaborator’s willingness or ability to complete
its obligations under any
arrangement.
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We also
may need to enter into additional co-promotion arrangements with third parties
where our own sales force is neither well situated nor large enough to achieve
maximum penetration in the market. We may not be successful in entering into any
co-promotion arrangements, and the terms of any co-promotion arrangements may
not be favorable to us. In addition, if we enter into co-promotion arrangements
or market and sell additional products directly, we may need to further expand
our sales force and incur additional costs.
If we
fail to enter into arrangements with third parties in a timely manner or if such
parties fail to perform, it could adversely affect sales of our products. We and
our third-party collaborators must also market our products in compliance with
federal, state and local laws relating to the providing of incentives and
inducements. Violation of these laws can result in substantial penalties.
We intend
to market and sell Surfaxin outside of the United States, if approved, through
one or more marketing partners. Although our agreement with Esteve provides for
collaborative efforts in directing a global commercialization effort, we have
somewhat limited influence over the decisions made by Esteve or its sublicensees
or the resources that they may devote to the marketing and distribution of
Surfaxin products in their licensed territory, and Esteve or its sublicensees
may not meet their obligations in this regard. Our marketing and distribution
arrangement with Esteve may not be successful, and, as a result, we may not
receive any revenues from it. Also, we may not be able to enter into marketing
and sales agreements for Surfaxin on acceptable terms, if at all, in territories
not covered by the Esteve agreement, or for any of our other product candidates.
We will need additional capital and
our ability to continue all of our existing planned research and development
activities is uncertain. Any additional financing could result in equity
dilution.
We will
need substantial additional funding to conduct our presently planned research
and product development activities. Our operating plans require that
expenditures will only be committed if we achieve important development and
regulatory milestones and have the necessary working capital resources.
Therefore, our existing capital will allow us to continue operations into 2009.
Our future capital requirements will depend on a number of factors that are
uncertain, including the results of our research and development activities,
clinical studies and trials, competitive and technological advances and the
regulatory process, among others. We will likely need to raise substantial
additional funds through collaborative ventures with potential corporate
partners and through additional debt or equity financings. We may also continue
to seek additional funding through new capital financing arrangements, if
available. In some cases, we may elect to develop products on our own instead of
entering into collaboration arrangements, which would increase our cash
requirements for research and development.
We have
not entered into arrangements to obtain any additional financing, except for the
Committed Equity Financing Facility that we entered with Kingsbridge Capital
Limited (Kingsbridge) in April 2006 (the 2006 CEFF), the Committed Equity
Financing Facility that we entered with Kingsbridge on May 22, 2008 (the 2008
CEFF), our loan with PharmaBio Development Inc. d/b/a NovaQuest (PharmaBio), the
strategic investment group of Quintiles Transnational Corp., and our equipment
financing facility with GE Business Financial Services Inc. (formerly known as
Merrill Lynch Business Financial Services Inc.) (GE). Any future financing could
be on unattractive terms or result in significant dilution of stockholders’
interests and, in such event, the market price of our common stock may decline.
Furthermore, if the market price of our common stock were to decline, we could
cease to meet the financial requirements to maintain the listing of our
securities on The Nasdaq Global Market.
If we
fail to enter into collaborative ventures or to receive additional funding, we
may have to delay, scale back or discontinue certain of our research and
development operations and consider licensing the development and
commercialization of products that we consider valuable and which we otherwise
would have developed ourselves. If we are unable to raise required capital, we
may be forced to limit many, if not all, of our research and development
programs and related operations, curtail commercialization of our product
candidates and, ultimately, cease operations. See also “Risk Factors – Our
Committed Equity Financing Facilities may have a dilutive impact on our
stockholders.”
We
continue to consider multiple strategic alternatives, including, but not limited
to potential additional financings as well as potential business alliances,
commercial and development partnerships and other similar opportunities,
although we cannot assure you that we will take any further specific actions or
enter into any transactions.
The terms of our indebtedness may
impair our ability to conduct our business.
Our
capital requirements are funded in part by an $8.5 million loan with PharmaBio,
which is secured by substantially all of our assets and contains a number of
covenants and restrictions that, with certain exceptions, restricts our ability
to, among other things, incur additional indebtedness, borrow money or issue
guarantees, use assets as security in other transactions, and sell assets to
other companies. We may not be able to engage in these types of transactions,
even if we believe that a specific transaction would be in our best interests.
Moreover, our ability to comply with these restrictions could be affected by
events outside our control. A breach of any of these restrictions could result
in a default under the PharmaBio loan documents. If a default were to occur,
PharmaBio would have the right to declare all borrowings to be immediately due
and payable. If we are unable to pay when due amounts owed to PharmaBio, whether
at maturity or in connection with acceleration of the loan following a default,
PharmaBio would have the right to proceed against the collateral securing the
indebtedness.
We have
financed the acquisition of personal property, machinery and equipment through a
$12.5 million equipment financing facility with GE under a Credit and Security
Agreement that we entered with GE in May 2007. Our ability to draw under this
facility expired in May 2008; however, we and GE recently agreed to extend this
facility for six months into November 2008 to finance capital expenditure of up
to $300,000, which represents our anticipated capital requirements for this
period. If we require additional funds to support our activities during this
period, as well as after this facility expires, there can be no assurance that
GE or any other lender will be willing to provide us funding to support our
capital programs.
In
addition, the aggregate amount of our indebtedness may adversely affect our
financial condition, limit our operational and financing flexibility and
negatively impact our business.
Our Committed Equity Financing
Facilities may have a dilutive impact on our stockholders.
The
issuance of shares of our common stock under the 2006 CEFF and the 2008 CEFF
(the CEFFs) and upon exercise of the warrants we issued to Kingsbridge will have
a dilutive impact on our other stockholders and the issuance, or even potential
issuance, of such shares could have a negative effect on the market price of our
common stock. In addition, if we access the CEFFs, we will issue shares of our
common stock to Kingsbridge at a discount (6% to 10% for the 2006 CEFF and 6% to
12% for the 2008 CEFF) to the daily volume weighted average price of our common
stock during the eight trading-day period after we access the CEFF. Issuing
shares at a discount will further dilute the interests of other
stockholders.
To the
extent that Kingsbridge sells to third parties the shares of our common stock
that we issue to Kingsbridge under the CEFFs, our stock price may decrease due
to the additional selling pressure in the market. The perceived risk of dilution
from sales of stock to or by Kingsbridge may cause holders of our common stock
to sell their shares, or it may encourage short sales of our common stock or
other similar transactions. This could contribute to a decline in the stock
price of our common stock.
If we are
unable to meet the conditions provided under the CEFFs, we may not be able to
issue any portion of the shares potentially available for issuance for future
financings, subject to the terms and conditions of the CEFFs. Kingsbridge has
the right under certain circumstances to terminate the CEFFs, including in the
event of a material adverse event. In addition, even if we meet all conditions
provided under the CEFFs, we are dependent upon the financial ability of
Kingsbridge to perform its obligations and purchase shares of our common stock
under the CEFFs. Any inability on our part to use at least one of the CEFFs or
any failure by Kingsbridge to perform its obligations under the CEFFs could have
a material adverse effect upon us.
The market price of our stock may be
adversely affected by market volatility.
The
market price of our common stock, like that of many other development stage
pharmaceutical or biotechnology companies, has been and is likely to be
volatile. In addition to general economic, political and market conditions, the
price and trading volume of our stock could fluctuate widely in response to many
factors, including:
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announcements
of the results of clinical trials by us or our
competitors;
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patient
adverse reactions to drug products;
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governmental
approvals, delays in expected governmental approvals or withdrawals of any
prior governmental approvals or public or regulatory agency concerns
regarding the safety or effectiveness of our
products;
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changes
in the United States or foreign regulatory policy during the period of
product development;
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changes
in the United States or foreign political environment and the passage of
laws, including tax, environmental or other laws, affecting the product
development business;
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developments
in patent or other proprietary rights, including any third party
challenges of our intellectual property
rights;
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announcements
of technological innovations by us or our
competitors;
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announcements
of new products or new contracts by us or our competitors;
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actual
or anticipated variations in our operating results due to the level of
development expenses and other
factors;
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changes
in financial estimates by securities analysts and whether our earnings
meet or exceed the estimates;
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conditions
and trends in the pharmaceutical and other
industries;
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new
accounting standards; and
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the
occurrence of any of the risks described in these “Risk Factors” or
elsewhere in our Annual Report on Form 10-K or our other publics
filings.
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Our
common stock is listed for quotation on The Nasdaq Global Market. During the 12
months ended June 3, 2008, the price of our common stock ranged from $1.29 to
$3.58. We expect
the price of our common stock to remain volatile. The average daily trading
volume in our common stock varies significantly. For the 12 months ended June 3,
2008, the average daily trading volume in our common stock was approximately
1,017,594 shares and the average number of transactions per day was
approximately 2,576. The variability of our average volume and average number of
transactions per day may affect the ability of our stockholders to sell their
shares in the public market at prevailing prices and a more active market may
never develop.
In
addition, we may not be able to continue to adhere to the strict listing
criteria of The Nasdaq Global Market. If the common stock were no longer listed
on The Nasdaq Global Market, investors might only be able to trade in the
over-the-counter market in the Pink Sheets® (a
quotation medium operated by the National Quotation Bureau, LLC) or on the OTC
Bulletin Board® of the
National Association of Securities Dealers, Inc. This would impair the liquidity
of our securities not only in the number of shares that could be bought and sold
at a given price, which might be depressed by the relative illiquidity, but also
through delays in the timing of transactions and reduction in media
coverage.
In the
past, following periods of volatility in the market price of the securities of
companies in our industry, securities class action litigation has often been
instituted against companies in our industry. We recently won dismissal of such
an action, which was brought against us and certain of our former and current
executive officers. Even if they or other actions that we may face in the future
are ultimately determined to be meritless or unsuccessful, such actions involve
substantial costs and a diversion of management attention and resources, which
could negatively impact our business.
Future sales and issuances of our
common stock or rights to purchase our common stock, including pursuant to our
stock incentive plans and upon the exercise of outstanding securities
exercisable for shares of our common stock, could result in substantial
additional dilution of our stockholders, cause our stock price to fall and
adversely affect our ability to raise capital.
We expect
that we will require significant additional capital to continue to execute our
business plan and advance our research and development efforts. To the extent
that we raise additional capital through the issuance of additional equity
securities and through the exercise of outstanding warrants, our stockholders
may experience substantial dilution. We may sell shares of our common stock in
one or more transactions at prices that may be at a discount to the then-current
market value of our common stock and on such other terms and conditions as we
may determine from time to time. Any such transaction could result in
substantial dilution of our existing stockholders. If we sell shares of our
common stock in more than one transaction, stockholders who purchase our common
stock may be materially diluted by subsequent sales. Such sales could also cause
a drop in the market price of our common stock. As of June 3, 2008, we had
96,693,377 shares of common stock issued and outstanding.
We have a
universal shelf registration statement on Form S-3 (File No. 333-128929), filed
with the SEC on October 11, 2005, for the proposed offering from time to time of
up to $100 million of our debt or equity securities, of which $24.8 million is
remaining. We may issue securities pursuant to this shelf registration statement
from time to time in response to market conditions or other circumstances on
terms and conditions that will be determined at such time.
Additionally,
there are (i) 375,000 shares of our common stock that are currently reserved for
issuance with respect to the Class B Investor Warrant, (ii) approximately 5.2
million shares of our common stock that are currently reserved for issuance
under the 2006 CEFF, including 490,000 shares reserved for issuance with respect
to the Class C Investor Warrant issued to Kingsbridge in connection with the
2006 CEFF, and (iii) approximately 19.33 million shares of our common stock
that are currently reserved for issuance under the new 2008 CEFF with
Kingsbridge dated May 22, 2008, and 825,000 shares of our common stock reserved
for issuance with respect to the Warrant that we issued to Kingsbridge in
connection with the new 2008 CEFF. See “Risk Factors: Our Committed Equity
Financing Facility may have a dilutive impact on our stockholders.”
As of
June 3, 2008, 18,631,821 shares of our common stock are reserved for issuance
pursuant to our equity incentive plans (including 13,880,283 shares underlying
outstanding stock options and 55,913 shares underlying unvested restricted stock
awards), 7,164,196 shares of our common stock are reserved for issuance upon
exercise of outstanding warrants, and 169,756 shares of our common stock are
reserved for issuance pursuant to our 401(k) Plan. The exercise of stock options
and other securities could cause our stockholders to experience substantial
dilution. Moreover, holders of our stock options and warrants are likely to
exercise them, if ever, at a time when we otherwise could obtain a price for the
sale of our securities that is higher than the exercise price per security of
the options or warrants. Such exercises, or the possibility of such exercises,
may impede our efforts to obtain additional financing through the sale of
additional securities or make such financing more costly. It may also reduce the
price of our common stock.
If,
during the term of certain of our warrants, we declare or make any dividend or
other distribution of our assets to holders of shares of our common stock, by
way of return of capital or otherwise (including any distribution of cash, stock
or other securities, property or options by way of a dividend, spin off,
reclassification, corporate rearrangement or other similar transaction), then
the exercise price of such warrants may adjust downward and the number of shares
of common stock issuable upon exercise of such warrants would increase. As a
result, we may be required to issue more shares of common stock than previously
anticipated, which could result in further dilution of our existing
stockholders.
Directors, executive officers,
principal stockholders and affiliated entities own a significant percentage of
our capital stock, and they may make decisions that you do not consider to be in
your best interest.
As of
March 31, 2008, our directors, executive officers, principal stockholders and
affiliated entities beneficially owned, in the aggregate, approximately 17% of
the issued and outstanding shares of our common stock. For the purpose of
computing this amount, an affiliated entity includes any entity that is known to
us to be the beneficial owner of more than five percent of our issued and
outstanding common stock. As a result, if some or all of them acted together,
they would have the ability to exert substantial influence over the election of
our Board of Directors and the outcome of issues requiring approval by our
stockholders. This concentration of ownership may have the effect of delaying or
preventing a change in control of our company that may be favored by other
stockholders. This could prevent transactions in which stockholders might
otherwise recover a premium for their shares over current market prices.
Our technology platform is based
solely on our proprietary precision-engineered surfactant technology.
Our
technology platform is based solely on the scientific rationale of using our
precision-engineered surfactant technology to treat life-threatening respiratory
disorders and as the foundation for the development of novel respiratory
therapies and products. Our business is dependent upon the successful
development and approval of our product candidates based on this technology
platform. Any material problems with our technology platform could have a
material adverse effect on our business.
If we cannot protect our intellectual
property, other companies could use our technology in competitive products. If
we infringe the intellectual property rights of others, other companies could
prevent us from developing or marketing our products.
We seek
patent protection for our drug candidates to prevent others from commercializing
equivalent products in substantially less time and at substantially lower
expense. The pharmaceutical industry places considerable importance on obtaining
patent and trade secret protection for new technologies, products and processes.
Our success will depend in part on our ability and that of parties from whom we
license technology to:
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defend
our patents and otherwise prevent others from infringing on our
proprietary rights;
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protect
trade secrets; and
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operate
without infringing upon the proprietary rights of others, both in the
United States and in other
countries.
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The
patent position of firms relying upon biotechnology is highly uncertain and
involves complex legal and factual questions for which important legal
principles are unresolved. To date, the United States Patent and Trademark
Office (USPTO) has not adopted a consistent policy regarding the breadth of
claims that it will allow in biotechnology patents or the degree of protection
that these types of patents afford. As a result, there are risks that we may not
develop or obtain rights to products or processes that are or may appear to be
patentable.
Even if we obtain patents to protect
our products, those patents may not be sufficiently broad or they may expire and
others could then compete with us.
We, and
the parties licensing technologies to us, have filed various United States and
foreign patent applications with respect to the products and technologies under
our development, and the USPTO and foreign patent offices have issued patents
with respect to our products and technologies. These patent applications include
international applications filed under the Patent Cooperation Treaty. Our
pending patent applications, those we may file in the future or those we may
license from third parties may not result in the USPTO or foreign patent office
issuing patents. In addition, if patent rights covering our products are not
sufficiently broad, they may not provide us with sufficient proprietary
protection or competitive advantages against competitors with similar products
and technologies. Furthermore, even if the USPTO or foreign patent offices were
to issue patents to us or our licensors, others may challenge the patents or
circumvent the patents, or the patent office or the courts may invalidate the
patents. Thus, any patents we own or license from or to third parties may not
provide us any protection against competitors.
The
patents that we hold also have a limited life. We have licensed a series of
patents from Johnson & Johnson and its wholly-owned subsidiary, Ortho
Pharmaceutical Corporation (Ortho Pharmaceutical), and from PM USA and PMPSA,
which are important, either individually or collectively, to our strategy of
commercializing our surfactant technology. These patents, which include relevant
European patents, expire on various dates beginning in 2009 and ending in 2017
or, in some cases, possibly later. For our aerosolized SRT, we hold exclusive
licenses in the United States and outside the United States to PM USA’s
capillary aerosolization technology for use with pulmonary surfactants for all
respiratory diseases. Our exclusive license in the United States also extends to
other drugs to treat specified target indications in specified target
populations. The capillary aerosolization technology patents expire on various
dates beginning in May 2016 and ending in 2022, or, in some cases, possibly
later. We have filed, and when possible and appropriate, will file, other patent
applications with respect to our products and processes in the United States and
in foreign countries. We may not be able to develop enhanced or additional
products or processes that will be patentable under patent law and, if we do
enhance or develop additional products that we believe are patentable,
additional patents may not be issued to us. See also “Risk Factors – If we
cannot meet requirements under our license agreements, we could lose the rights
to our products.”
Intellectual property rights of third
parties could limit our ability to develop and market our products.
Our
commercial success also depends upon our ability to operate our business without
infringing the patents or violating the proprietary rights of others. The USPTO
keeps United States patent applications confidential while the applications are
pending. As a result, we cannot determine in advance what inventions third
parties may claim in their pending patent applications. We may need to defend or
enforce our patent and license rights or to determine the scope and validity of
the proprietary rights of others through legal proceedings, which would be
costly, unpredictable and time consuming. Even in proceedings where the outcome
is favorable to us, they would likely divert substantial resources, including
management time, from our other activities. Moreover, any adverse determination
could subject us to significant liability or require us to seek licenses that
third parties might not grant to us or might only grant at rates that diminish
or deplete the profitability of our products. An adverse determination could
also require us to alter our products or processes or cease altogether any
product sales or related research and development activities.
If we cannot meet requirements under
our license agreements, we could lose the rights to our
products.
We depend
on licensing agreements with third parties to maintain the intellectual property
rights to our products under development. Presently, we have licensed rights
from Johnson & Johnson, Ortho Pharmaceutical, PM USA and PMPSA. These
agreements require us to make payments and satisfy performance obligations to
maintain our rights under these licensing agreements. All of these agreements
last either throughout the life of the patents, or with respect to other
licensed technology, for a number of years after the first commercial sale of
the relevant product.
In
addition, we are responsible for the cost of filing and prosecuting certain
patent applications and maintaining certain issued patents licensed to us. If we
do not meet our obligations under our license agreements in a timely manner, we
could lose the rights to our proprietary technology.
Finally,
we may be required to obtain licenses to patents or other proprietary rights of
third parties in connection with the development and use of our products and
technologies. Licenses required under any such patents or proprietary rights
might not be made available on terms acceptable to us, if at all.
We rely on confidentiality agreements
that could be breached and may be difficult to enforce.
Although
we believe that we take reasonable steps to protect our intellectual property,
including the use of agreements relating to the non-disclosure of our
confidential information to third parties, as well as agreements that provide
for disclosure and assignment to us of all rights to the ideas, developments,
discoveries and inventions of our employees and consultants while we employ
them, such agreements can be difficult and costly to enforce. Although we
generally seek to enter into these types of agreements with our consultants,
advisors and research collaborators, to the extent that such parties apply or
independently develop intellectual property in connection with any of our
projects, disputes may arise concerning allocation of the related proprietary
rights. If a dispute were to arise, enforcement of our rights could be costly
and the result unpredictable. In addition, we also rely on trade secrets and
proprietary know-how that we seek to protect, in part, through confidentiality
agreements with our employees, consultants, advisors or others.
Despite
the protective measures we employ, we still face the risk that:
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agreements
may be breached;
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agreements
may not provide adequate remedies for the applicable type of
breach;
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our
trade secrets or proprietary know-how may otherwise become known;
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our
competitors may independently develop similar technology;
or
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our
competitors may independently discover our proprietary information and
trade secrets.
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We depend upon key employees and
consultants in a competitive market for skilled personnel. If we are unable to
attract and retain key personnel, it could adversely affect our ability to
develop and market our products.
We are
highly dependent upon the principal members of our management team, especially
our Chief Executive Officer, Robert J. Capetola, Ph.D., and our directors, as
well as our scientific advisory board members, consultants and collaborating
scientists. Many of these people have been involved in our formation or have
otherwise been involved with us for many years, have played integral roles in
our progress and we believe that they will continue to provide value to us. A
loss of any of our key personnel may have a material adverse effect on aspects
of our business and clinical development and regulatory programs.
Following
receipt of the second Approvable Letter and the occurrence of the process
validation stability failures in April 2006, we reduced our staff levels by
approximately 50 people and reorganized our corporate structure. To retain and
provide incentives to our key executives and certain officers, in 2006, we
entered into amended and new employment agreements that generally include
provisions such as a stated term, enhanced severance benefits in the event of a
change of control and equity incentives in the form of stock and option grants.
As of February 29, 2008, we have employment agreements with 13 officers, three
of which expire in May 2010 and the remainder in December 2008. Each employment
agreement provides that its term shall automatically be extended for one
additional year, unless at least 90 days prior to the renewal date either party
gives notice that it does not wish to extend the agreement. Although these
employment agreements generally include non-competition covenants and provide
for severance payments that are contingent upon the applicable employee’s
refraining from competition with us, the applicable noncompete provisions can be
difficult and costly to monitor and enforce. The loss of any of these persons’
services would adversely affect our ability to develop and market our products
and obtain necessary regulatory approvals. Further, we do not maintain key-man
life insurance.
Our
future success also will depend in part on the continued service of our key
scientific and management personnel and our ability to identify, hire and retain
additional personnel. We may experience intense competition for qualified
personnel and the existence of non-competition agreements between prospective
employees and their former employers may prevent us from hiring those
individuals or subject us to suit from their former employers.
While we
attempt to provide competitive compensation packages to attract and retain key
personnel, some of our competitors are likely to have greater resources and more
experience than we have, making it difficult for us to compete successfully for
key personnel.
Our industry is highly competitive
and we have less capital and resources than many of our competitors, which may
give them an advantage in developing and marketing products similar to ours or
make our products obsolete.
Our
industry is highly competitive and subject to rapid technological innovation and
evolving industry standards. We compete with numerous existing companies
intensely in many ways. We intend to market our products under development for
the treatment of diseases for which other technologies and treatments are
rapidly developing and, consequently, we expect new companies to enter our
industry and that competition in the industry will increase. Many of these
companies have substantially greater research and development, manufacturing,
marketing, financial, technological, personnel and managerial resources than we
have. In addition, many of these competitors, either alone or with their
collaborative partners, have significantly greater experience than we do
in:
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undertaking
preclinical testing and human clinical trials;
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obtaining
FDA and other regulatory approvals or products;
and
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manufacturing
and marketing products.
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Accordingly,
our competitors may succeed in obtaining patent protection, receiving FDA or
comparable foreign approval or commercializing products before us. If we
commence commercial product sales, we will compete against companies with
greater marketing and manufacturing capabilities who may successfully develop
and commercialize products that are more effective or less expensive than ours.
These are areas in which, as yet, we have limited or no experience. In addition,
developments by our competitors may render our product candidates obsolete or
noncompetitive.
We also
face, and will continue to face, competition from colleges, universities,
governmental agencies and other public and private research organizations. These
competitors are becoming more active in seeking patent protection and licensing
arrangements to collect royalties for use of technology that they have
developed. Some of these technologies may compete directly with the technologies
that we are developing. These institutions will also compete with us in
recruiting highly qualified scientific personnel. We expect that therapeutic
developments in the areas in which we are active may occur at a rapid rate and
that competition will intensify as advances in this field are made. As a result,
we need to continue to devote substantial resources and efforts to research and
development activities.
If product liability claims are
brought against us, it may result in reduced demand for our products or damages
that exceed our insurance coverage and we may incur substantial
costs.
The
clinical testing, marketing and use of our products exposes us to product
liability claims if the use or misuse of our products causes injury, disease or
results in adverse effects. Use of our products in clinical trials, as well as
commercial sale, could result in product liability claims. In addition, sales of
our products through third party arrangements could also subject us to product
liability claims. We presently carry product liability insurance with coverage
of up to $10 million per occurrence and $10 million in the aggregate. However,
this insurance coverage includes various deductibles, limitations and exclusions
from coverage, and in any event might not fully cover any potential claims. We
may need to obtain additional product liability insurance coverage, including by
insurers licensed in countries where we conduct our clinical trials, before
initiating clinical trials. We expect to obtain product liability insurance
coverage before commercializing any of our product candidates; however, such
insurance is expensive and may not be available when we need it.
In the
future, we may not be able to obtain adequate insurance, with acceptable limits
and retentions, at an acceptable cost. Any product liability claim, even one
that is within the limits of our insurance coverage or one that is meritless
and/or unsuccessful, could adversely affect the availability or cost of
insurance generally and our cash available for other purposes, such as research
and development. In addition, such claims could result in:
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uninsured
expenses related to defense or payment of substantial monetary awards to
claimants;
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·
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a
decrease in demand for our product candidates;
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damage
to our reputation; and
|
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·
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an
inability to complete clinical trial programs or to commercialize our
product candidates, if approved.
|
Moreover,
the existence of a product liability claim could affect the market price of our
common stock.
Our corporate compliance program
cannot ensure that we are in compliance with all applicable laws and regulations
affecting our activities in the jurisdictions in which we may sell our products,
if approved, and a failure to comply with such regulations or prevail in
litigation related to noncompliance could harm our business.
Many of
our activities, including the research, development, manufacture, sale and
marketing of our products, are subject to extensive laws and regulation,
including without limitation, health care "fraud and abuse" laws, such as the
federal false claims act, the federal anti-kickback statute, and other state and
federal laws and regulations. We have developed and implemented a corporate
compliance policy and oversight program based upon what we understand to be
current industry best practices, but we cannot assure you that this program will
protect us from governmental investigations or other actions or lawsuits
stemming from a failure to be in compliance with such laws or regulations. If
any such investigations, actions or lawsuits are instituted against us, and if
we are not successful in defending or disposing of them without liability, such
investigations, actions or lawsuits could result in the imposition of
significant fines or other sanctions and could otherwise have a significant
impact on our business.
We expect to face uncertainty over
reimbursement and healthcare reform.
In both
the United States and other countries, sales of our products will depend in part
upon the availability of reimbursement from third-party payers, which include
governmental health administration authorities, managed care providers and
private health insurers. Third party payers are increasingly challenging the
price and examining the cost effectiveness of medical products and services.
Moreover, the current political environment in the United States and abroad may
result in the passage of significant legislation that could, among other things,
restructure the markets in which we operate and restrict pricing strategies of
drug development companies. If, for example, price restrictions were placed on
the distribution of drugs such as our SRT, we may be forced to curtail
development of our pipeline products and this could have a material adverse
effect on our business, results of operations and financial condition. Even if
we succeed in commercializing our SRT, uncertainties regarding health care
policy, legislation and regulation, as well as private market practices, could
affect our ability to sell our products in quantities or at prices that will
enable us to achieve profitability.
To obtain
reimbursement from a third party payer, it must determine that our drug product
is a covered benefit under its health plan, which is likely to require a
determination that our product is:
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safe,
effective and medically necessary;
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appropriate
for the specific patient;
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neither
experimental nor investigational.
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Obtaining
a determination that a product is a covered benefit may be a time-consuming and
costly process that could require us to provide supporting scientific, clinical
and cost-effectiveness data about our products to each payer. We may not be able
to provide sufficient data to gain coverage.
Even when
a payer determines that a product is covered, the payer may impose limitations
that preclude payment for some uses that are approved by the FDA or other
regulatory authorities. Moreover, coverage does not imply that any product will
be covered in all cases or that reimbursement will be available at a rate that
would permit a health care provider to cover its costs of using our
product.
Provisions of our Restated
Certificate of Incorporation, Shareholder Rights Agreement and Delaware law
could defer a change of our management and thereby discourage or delay offers to
acquire us.
Provisions
of our Restated Certificate of Incorporation, as amended, our Shareholder Rights
Agreement and Delaware law may make it more difficult for someone to acquire
control of us or for our stockholders to remove existing management, and might
discourage a third party from offering to acquire us, even if a change in
control or in management would be beneficial to our stockholders. For example,
our Restated Certificate of Incorporation, as amended, allows us to issue shares
of preferred stock without any vote or further action by our stockholders. Our
Board of Directors has the authority to fix and determine the relative rights
and preferences of preferred stock. Our Board of Directors also has the
authority to issue preferred stock without further stockholder approval. As a
result, our Board of Directors could authorize the issuance of a series of
preferred stock that would grant to holders the preferred right to our assets
upon liquidation, the right to receive dividend payments before dividends are
distributed to the holders of common stock and the right to the redemption of
the shares, together with a premium, before the redemption of our common stock.
In addition, our Board of Directors, without further stockholder approval, could
issue large blocks of preferred stock. We have adopted a Shareholder Rights
Agreement, which under certain circumstances would significantly impair the
ability of third parties to acquire control of us without prior approval of our
Board of Directors thereby discouraging unsolicited takeover proposals. The
rights issued under the Shareholder Rights Agreement would cause substantial
dilution to a person or group that attempts to acquire us on terms not approved
in advance by our Board of Directors.
The failure to prevail in litigation
or the costs of litigation, including securities class action and patent claims,
could harm our financial performance and business operations.
We are
potentially susceptible to litigation. For example, as a public company, we are
subject to claims asserting violations of securities laws. In early May 2006,
four shareholder class actions and two derivative actions were filed in the
United States District Court for the Eastern District of Pennsylvania naming as
defendants the Company and certain of its current and former executive officers
and directors. The derivative actions were consolidated under the caption “In
re: Discovery Laboratories Securities Litigation” and the class actions were
consolidated under the caption “In re: Discovery Laboratories Securities
Litigation”. The District Court granted our motions to dismiss two Consolidated
Amended Complaints in each proceeding. The derivative actions were not appealed
and that matter is concluded. In April 2008, the Third Circuit Court of Appeals
affirmed the District Court’s dismissal of the second Consolidated Amended
Complaint in the class actions for the reasons set forth in the District Court
opinion, and this matter is now concluded.
Even if
actions such as these are found to be without merit, the potential impact of
such actions, all of which generally seek unquantified damages, attorneys fees
and expenses, is uncertain. Additional actions based upon similar allegations,
or otherwise, may be filed in the future. There can be no assurance that an
adverse result in any future proceeding would not have a potentially material
adverse effect on our business, results of operations and financial condition.
We have
from time to time been involved in disputes and proceedings arising in the
ordinary course of business, including in connection with the conduct of
clinical trials and the termination of certain pre-launch commercial programs
following the April 2006 manufacturing issues. Such claims, with or without
merit, if not resolved, could be time-consuming and result in costly litigation.
Although we believe such claims are unlikely to have a material adverse effect
on our financial condition or results of operations, it is impossible to predict
with certainty the eventual outcome of such claims and there can be no assurance
that we will be successful in any proceeding to which we may be a
party.
In
addition, as the USPTO keeps United States patent applications confidential
while the applications are pending, we cannot ensure that our products or
methods do not infringe upon the patents or other intellectual property rights
of third parties. As the biotechnology and pharmaceutical industries expand and
more patents are filed and issued, the risk increases that our patents or patent
applications for our product candidates may give rise to a declaration of
interference by the USPTO, or to administrative proceedings in foreign patent
offices, or that our activities lead to claims of patent infringement by other
companies, institutions or individuals. These entities or persons could bring
legal proceedings against us seeking substantial damages or seeking to enjoin us
from conducting research and development activities.
FORWARD-LOOKING
STATEMENTS
This
prospectus contains “forward-looking statements” within the meaning of Section
27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934
(Exchange Act). The forward-looking statements are only predictions and provide
our current expectations or forecasts of future events and financial performance
and may be identified by the use of forward-looking terminology, including the
terms “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,”
“may,” “will” or “should” or, in each case, their negative, or other variations
or comparable terminology, though the absence of these words does not
necessarily mean that a statement is not forward-looking. Forward-looking
statements include all matters that are not historical facts and include,
without limitation statements concerning: our business strategy, outlook,
objectives, future milestones, plans, intentions, goals, and future financial
condition; plans regarding the May 2008 Approvable Letter that we received from
the FDA for Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome in premature
infants; our research and development programs and planning for and timing of
any clinical trials; the possibility, timing and outcome of submitting
regulatory filings for our products under development; plans regarding strategic
alliances and collaboration arrangements with pharmaceutical companies and
others to develop, manufacture and market our drug products; research and
development of particular drug products, technologies and aerosolization drug
devices; the development of financial, clinical, manufacturing and marketing
plans related to the potential approval and commercialization of our drug
products, and the period of time for which our existing resources will enable us
to fund our operations.
We intend
that all forward-looking statements be subject to the safe-harbor provisions of
the Private Securities Litigation Reform Act of 1995. These forward-looking
statements are only predictions and reflect our views as of the date they are
made with respect to future events and financial performance. Forward-looking
statements are subject to many risks and uncertainties that could cause our
actual results to differ materially from any future results expressed or implied
by the forward-looking statements. Examples of the risks and uncertainties
include, but are not limited to:
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the
risk that we may not be able to timely respond to the Approvable Letter
that we recently received for Surfaxin and that any response that we do
file will not satisfy the FDA;
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the
risk that the FDA or other regulatory authorities may not accept, or may
withhold or delay consideration of, any applications that we may file,
including our New Drug Application (NDA) for Surfaxin, or may not approve
our applications or may limit approval of our products to particular
indications or impose unanticipated label limitations;
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risks
relating to the rigorous
regulatory approval processes, including pre-NDA activities, required for
approval of any drug or medical device products that we may develop,
independently, with development partners or pursuant to collaboration
arrangements;
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·
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the
risk that changes in the national or international political and
regulatory environment may make it more difficult to gain FDA or other
regulatory approval of our drug product
candidates;
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·
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risks
relating to
our research and development
activities, which involve time-consuming and expensive pre-clinical
studies, multi-phase clinical trials and other studies and other efforts,
and which may be subject to potentially significant delays or regulatory
holds, or fail;
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·
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the
risk that we, our contract manufacturers or any of our materials suppliers
encounter problems manufacturing our products or drug substances on a
timely basis or in an amount sufficient to meet
demand;
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risks
relating to the transfer of our manufacturing technology to third-party
contract manufacturers;
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·
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risks
relating to the ability of our development partners and third-party
suppliers of materials, drug substances and aerosolization systems and
related components to timely provide us with adequate supplies and
expertise to support development and manufacture of drug product and
aerosolization systems for initiation and completion of our clinical
studies, and, if approved, commercialization of our drug and combination
drug-device products;
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·
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the
risk that we may not successfully and profitably market our
products;
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·
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the
risk that, even if approved, we may be unable, for reasons related to
market conditions, the competitive landscape or otherwise, to successfully
launch and market our products;
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risks
relating to our ability to develop a successful sales and marketing
organization to market Surfaxin, if approved, and our other product
candidates, in a timely manner, if at all, and that we or our marketing
and advertising consultants will not succeed in developing market
awareness of our products;
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the
risk that we or our development partners, collaborators or marketing
partners will not be able to attract or maintain qualified
personnel;
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the
risk that our product candidates will not gain market acceptance by
physicians, patients, healthcare payers and others in the medical
community;
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the
risk that we may
not be able to raise additional capital or enter into additional
collaboration agreements (including strategic alliances for development
or commercialization of SRT);
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the
risk that recurring losses, negative cash flows and the inability to raise
additional capital could threaten our ability to continue as a going
concern;
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·
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risks
relating to reimbursement and health care
reform;
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risks
that financial market conditions may change, additional financings could
result in equity dilution, or we will be unable to maintain The Nasdaq
Global Market listing requirements, causing the price of our shares of
common stock to decline;
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·
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the
risk that we may be unable to maintain and protect the
patents
and licenses
related to
our SRT;
other companies may
develop competing therapies and/or technologies or
health care reform may adversely affect
us;
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·
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the
risk that we may become involved in securities, product liability and
other litigation;
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other
risks and uncertainties detailed in “Risk Factors” and in the documents
incorporated by reference in this prospectus.
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Pharmaceutical
and biotechnology companies have suffered significant setbacks in advanced
clinical trials, even after obtaining promising earlier trial results. Data
obtained from such clinical trials are susceptible to varying interpretations,
which could delay, limit or prevent regulatory approval. After gaining approval
of a drug product, pharmaceutical companies face considerable challenges in
marketing and distributing their products, and may never become
profitable.
Except to
the extent required by applicable laws, rules and regulations, we do not
undertake any obligation or duty to update any forward-looking statements or to
publicly announce revisions to any of the forward-looking statements, whether as
a result of new information, future events or otherwise.
USE OF PROCEEDS
Except as
described in any prospectus supplement or post-effective amendment, we will
retain broad discretion over the use of the net proceeds from the sale of our
securities offered hereby and the net proceeds from the sales of securities
offered by this prospectus will be used to meet working capital requirements
for: (i) development of our SRT pipeline programs, including Surfaxin, life
cycle development of Surfaxin for other respiratory conditions prevalent in the
NICU and PICU, and Aerosurf for neonatal and pediatric conditions; (ii) efforts
intended to gain regulatory approval to market and sell, and preparing for the
potential commercial launch in the United States of, Surfaxin for the prevention
of RDS in premature infants; (iii) continued investment in our quality systems
and manufacturing capabilities to meet the anticipated pre-clinical, clinical
and potential future commercial requirements of Surfaxin, Aerosurf and our other
SRT products; and (iv) seeking collaboration agreements and strategic
partnerships in the international and domestic markets for the development and
potential commercialization of our neonatal and pediatric pipeline for Surfaxin
and Aerosurf™ and for the development and potential commercialization of our SRT
for respiratory conditions and disorders affecting adult patients. We expect,
from time to time, to evaluate the acquisition of businesses, products and
technologies for which a portion of the net proceeds may be used.
The
amounts and timing of the expenditures may vary significantly depending on
numerous factors, such as the progress of our research and development efforts,
technological advances and the competitive environment for Surfaxin and its
intended uses. Pending application of the net proceeds, we expect to invest the
proceeds in short-term, interest-bearing instruments or other investment-grade
securities.
RATIO OF EARNINGS TO FIXED
CHARGES
Our
earnings were insufficient to cover fixed charges in each of the years in the
five-year period ended December 31, 2007 and in the three-month period ended
March 31, 2008. Our fixed charges do not include any dividend requirements with
respect to preferred stock because, as of the date of this prospectus and for
the five preceding fiscal years, we have had no preferred stock
outstanding.
We
compute the ratio of earnings to fixed charges by dividing (i) earnings (loss),
which consists of net income from continuing operations before income taxes plus
fixed charges and amortization of capitalized interest less interest capitalized
during the period and adjusted for undistributed earnings in equity investments,
by (ii) fixed charges, which consist of interest expense, capitalized interest
and the interest portion of rental expense under operating leases estimated to
be representative of the interest factor.
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Fiscal
year Ended December 31,
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Three Months
Ended
March 31,
2008
|
|
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|
2003
|
|
2004
|
|
2005
|
|
2006
|
|
2007
|
|
|
|
|
|
(in
thousands)
|
|
Ratio
of earnings to fixed charges (1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Coverage
deficiency
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$
|
(24,280
|
)
|
$
|
(46,203
|
)
|
$
|
(58,904
|
)
|
$
|
(46,333
|
)
|
$
|
(40,005
|
)
|
$
|
(9,714
|
)
|
(1)
|
Adjusted
earnings, as described above, were insufficient to cover fixed charges in
each period. We have not included a ratio of earnings to combined fixed
charges and preferred stock dividends because we do not have any preferred
stock outstanding.
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DESCRIPTION OF DEBT
SECURITIES
The
following description, together with the additional information we include in
any applicable prospectus supplements, summarizes the material terms and
provisions of the debt securities that we may offer under this prospectus. While
the terms we have summarized below will apply generally to any future debt
securities we may offer under this prospectus, we will describe the particular
terms of any debt securities that we may offer in more detail in the applicable
prospectus supplement. The terms of any debt securities we offer under a
prospectus supplement may differ from the terms we describe below. However, no
prospectus supplement shall fundamentally change the terms that are set forth in
this prospectus or offer a security that is not registered and described in this
prospectus at the time of its effectiveness. As of March 31, 2008, we have $15.0
million in outstanding indebtedness including accrued interest.
We will
issue the senior debt securities under the senior indenture that we will enter
into with the trustee named in the senior indenture. We will issue the
subordinated debt securities under the subordinated indenture that we will enter
into with the trustee named in the subordinated indenture. We have filed forms
of these documents as exhibits to the registration statement which includes this
prospectus. We use the term “indentures” in this prospectus to refer to both the
senior indenture and the subordinated indenture.
The
indentures will be qualified under the Trust Indenture Act of 1939. We use the
term “trustee” to refer to either the senior trustee or the subordinated
trustee, as applicable.
The
following summaries of material provisions of the senior debt securities, the
subordinated debt securities and the indentures are subject to, and qualified in
their entirety by reference to, all the provisions of the indenture applicable
to a particular series of debt securities. Except as we may otherwise indicate,
the terms of the senior indenture and the subordinated indenture are
identical.
General
Debt
securities may be issued in separate series without limitation as to aggregate
principal amount. We may specify a maximum aggregate principal amount for the
debt securities of any series.
We are
not limited as to the amount of debt securities we may issue under the
indentures. The prospectus supplement will set forth:
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whether
the debt securities will be senior or subordinated;
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any
limit on the aggregate principal amount;
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the
person who shall be entitled to receive interest, if other than the record
holder on the record date;
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the
date the principal will be payable;
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the
interest rate, if any, the date interest will accrue, the interest payment
dates and the regular record dates;
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the
place where payments may be made;
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any
mandatory or optional redemption provisions;
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if
applicable, the method for determining how the principal, premium, if any,
or interest will be calculated by reference to an index or formula;
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if
other than U.S. currency, the currency or currency units in which
principal, premium, if any, or interest will be payable and whether we or
the holder may elect payment to be made in a different
currency;
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the
portion of the principal amount that will be payable upon acceleration of
stated maturity, if other than the entire principal amount;
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if
the principal amount payable at stated maturity will not be determinable
as of any date prior to stated maturity, the amount which will be deemed
to be the principal amount;
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|
any
defeasance provisions if different from those described below under
“Satisfaction and Discharge; Defeasance;”
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any
conversion or exchange provisions;
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any
obligation to redeem or purchase the debt securities pursuant to a sinking
fund;
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·
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whether
the debt securities will be issuable in the form of a global security;
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·
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any
subordination provisions, if different from those described below under
“Subordinated Debt Securities;”
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any
deletions of, or changes or additions to, the events of default or
covenants; and
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any
other specific terms of such debt
securities.
|
Unless
otherwise specified in the prospectus supplement:
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·
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the
debt securities will be registered debt securities; and
|
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·
|
registered
debt securities denominated in U.S. dollars will be issued in
denominations of $1,000 or an integral multiple of $1,000.
|
Debt
securities may be sold at a substantial discount below their stated principal
amount, bearing no interest or interest at a rate which at the time of issuance
is below market rates.
Exchange and Transfer
Debt
securities may be transferred or exchanged at the office of the security
registrar or at the office of any transfer agent designated by us.
We will
not impose a service charge for any transfer or exchange, but we may require
holders to pay any tax or other governmental charges associated with any
transfer or exchange.
In the
event of any potential redemption of debt securities of any series, we will not
be required to:
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issue,
register the transfer of, or exchange, any debt security of that series
during a period beginning at the opening of business 15 days before the
day of mailing of a notice of redemption and ending at the close of
business on the day of the mailing; or
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register
the transfer of or exchange any debt security of that series selected for
redemption, in whole or in part, except the unredeemed portion being
redeemed in part.
|
We may
initially appoint the trustee as the security registrar. Any transfer agent, in
addition to the security registrar, initially designated by us will be named in
the prospectus supplement. We may designate additional transfer agents or change
transfer agents or change the office of the transfer agent. However, we will be
required to maintain a transfer agent in each place of payment for the debt
securities of each series.
Global Securities
The debt
securities of any series may be represented, in whole or in part, by one or more
global securities. Each global security will:
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be
registered in the name of a depositary that we will identify in a
prospectus supplement;
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be
deposited with the depositary or nominee or custodian; and
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bear
any required legends.
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No global
security may be exchanged in whole or in part for debt securities registered in
the name of any person other than the depositary or any nominee unless:
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the
depositary has notified us that it is unwilling or unable to continue as
depositary or has ceased to be qualified to act as depositary;
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an
event of default is continuing; or
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any
other circumstances described in a prospectus supplement.
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As long
as the depositary, or its nominee, is the registered owner of a global security,
the depositary or nominee will be considered the sole owner and holder of the
debt securities represented by the global security for all purposes under the
indenture. Except in the above limited circumstances, owners of beneficial
interests in a global security:
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will
not be entitled to have the debt securities registered in their names,
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will
not be entitled to physical delivery of certificated debt securities, and
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will
not be considered to be holders of those debt securities under the
indentures.
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Payments
on a global security will be made to the depositary or its nominee as the holder
of the global security. Some jurisdictions have laws that require that certain
purchasers of securities take physical delivery of such securities in definitive
form. These laws may impair the ability to transfer beneficial interests in a
global security.
Institutions
that have accounts with the depositary or its nominee are referred to as
“participants.” Ownership of beneficial interests in a global security will be
limited to participants and to persons that may hold beneficial interests
through participants. The depositary will credit, on its book-entry registration
and transfer system, the respective principal amounts of debt securities
represented by the global security to the accounts of its participants.
Ownership
of beneficial interests in a global security will be shown on and effected
through records maintained by the depositary, with respect to participants’
interests, or any participant, with respect to interests of persons held by
participants on their behalf.
Payments,
transfers and exchanges relating to beneficial interests in a global security
will be subject to policies and procedures of the depositary.
The
depositary policies and procedures may change from time to time. Neither we nor
the trustee will have any responsibility or liability for the depositary’s or
any participant’s records with respect to beneficial interests in a global
security.
Payment and Paying Agent
The
provisions of this paragraph will apply to debt securities unless otherwise
indicated in the prospectus supplement. Payment of interest on a debt security
on any interest payment date will be made to the person in whose name the debt
security is registered at the close of business on the regular record date.
Payment on debt securities of a particular series will be payable at the office
of a paying agent or paying agents designated by us. However, at our option, we
may pay interest by mailing a check to the record holder. The corporate trust
office will be designated as our sole paying agent.
We may
also name any other paying agents in the prospectus supplement. We may designate
additional paying agents, change paying agents or change the office of any
paying agent. However, we will be required to maintain a paying agent in each
place of payment for the debt securities of a particular series.
All
moneys paid by us to a paying agent for payment on any debt security which
remain unclaimed at the end of two years after such payment was due will be
repaid to us. Thereafter, the holder may look only to us for such
payment.
Consolidation, Merger and Sale of
Assets
We may
not consolidate with or merge into any other person, in a transaction in which
we are not the surviving corporation, or convey, transfer or lease our
properties and assets substantially as an entirety to, any person, unless:
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the
successor, if any, is a U.S. corporation, limited liability company,
partnership, trust or other entity;
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the
successor assumes our obligations on the debt securities and under the
indenture;
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immediately
after giving effect to the transaction, no default or event of default
shall have occurred and be continuing; and
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certain
other conditions are met.
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If the
debt securities are convertible for our other securities or securities of other
entities, the person with whom we consolidate or merge or to whom we sell all of
our property must make provisions for the conversion of the debt securities into
securities which the holders of the debt securities would have received if they
had converted the debt securities before the consolidation, merger or
sale.
Events of Default
Unless we
inform you otherwise in the prospectus supplement, the indenture will define an
event of default with respect to any series of debt securities as one or more of
the following events:
(1)
failure to pay principal of or any premium on any debt security of that series
when due and payable;
(2)
failure to pay any interest on any debt security of that series when it becomes
due and payable, and continuation of that failure for a period of 90 days
(unless the entire amount of such payment is deposited by us with the trustee or
paying agent prior to the expiration of the 90-day period);
(3)
failure to deposit any sinking fund payment, when and as due in respect of any
debt security of that series;
(4)
failure to perform or breach of any other covenant or warranty by us in the
indenture (other than a covenant or warranty that has been included in the
indenture solely for the benefit of a series of debt securities other than the
series), which failure continues uncured for a period of 90 days after we
receive the notice required in the indenture;
(5) our
bankruptcy, insolvency or reorganization; and
(6) any
other event of default with respect to debt securities of that series that is
described in the applicable prospectus supplement accompanying this prospectus.
An event
of default of one series of debt securities is not necessarily an event of
default for any other series of debt securities.
If an
event of default, other than an event of default described in clause (5) above,
shall occur and be continuing, either the trustee or the holders of at least 25%
in aggregate principal amount of the outstanding securities of that series may
declare the principal amount of the debt securities of that series to be due and
payable immediately.
If an
event of default described in clause (5) above shall occur, the principal amount
of all the debt securities of that series will automatically become immediately
due and payable. Any payment by us on the subordinated debt securities following
any such acceleration will be subject to the subordination provisions described
below under “Subordinated Debt Securities.”
After
acceleration the holders of a majority in aggregate principal amount of the
outstanding securities of that series may, under certain circumstances, rescind
and annul such acceleration if all events of default, other than the non-payment
of accelerated principal, or other specified amount, have been cured or waived.
Other
than the duty to act with the required care during an event of default, the
trustee will not be obligated to exercise any of its rights or powers at the
request of the holders unless the holders shall have offered to the trustee
reasonable indemnity. Generally, the holders of a majority in aggregate
principal amount of the outstanding debt securities of any series will have the
right to direct the time, method and place of conducting any proceeding for any
remedy available to the trustee or exercising any trust or power conferred on
the trustee.
A holder
will not have any right to institute any proceeding under the indentures, or for
the appointment of a receiver or a trustee, or for any other remedy under the
indentures, unless:
(1) the
holder has previously given to the trustee written notice of a continuing event
of default with respect to the debt securities of that series;
(2) the
holders of at least 25% in aggregate principal amount of the outstanding debt
securities of that series have made a written request and have offered
reasonable indemnity to the trustee to institute the proceeding; and
(3) the
trustee has failed to institute the proceeding and has not received direction
inconsistent with the original request from the holders of a majority in
aggregate principal amount of the outstanding debt securities of that series
within 90 days after the original request.
Holders
may, however, sue to enforce the payment of principal, premium or interest on
any debt security on or after the due date or to enforce the right, if any, to
convert any debt security without following the procedures listed in (1) through
(3) above.
We will
furnish the trustee an annual statement by our officers as to whether or not we
are in default in the performance of the indenture and, if so, specifying all
known defaults.
Modification and Waiver
We and
the trustee may make modifications and amendments to the indentures with the
consent of the holders of a majority in aggregate principal amount of the
outstanding securities of each series affected by the modification or amendment.
However,
neither we nor the trustee may make any modification or amendment without the
consent of the holder of each outstanding security of that series affected by
the modification or amendment if such modification or amendment would:
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change
the stated maturity of any debt security;
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reduce
the principal, premium, if any, or interest on any debt security;
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reduce
the principal of an original issue discount security or any other debt
security payable on acceleration of maturity;
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reduce
the rate of interest on any debt security;
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change
the currency in which any debt security is payable;
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impair
the right to enforce any payment after the stated maturity or redemption
date;
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waive
any default or event of default in payment of the principal of, premium or
interest on any debt security;
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waive
a redemption payment or modify any of the redemption provisions of any
debt security;
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adversely
affect the right to convert any debt security in any material respect; or
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change
the provisions in the indenture that relate to modifying or amending the
indenture.
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Satisfaction and Discharge;
Defeasance
We may be
discharged from our obligations on the debt securities of any series that have
matured or will mature or be redeemed within one year if we deposit with the
trustee enough cash to pay all the principal, interest and any premium due to
the stated maturity date or redemption date of the debt securities.
Each
indenture will contain a provision that permits us to elect:
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to
be discharged from all of our obligations, subject to limited exceptions,
with respect to any series of debt securities then outstanding; and/or
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to
be released from our obligations under the following covenants and from
the consequences of an event of default resulting from a breach of these
covenants: (1) the subordination provisions under a subordinated
indenture; and (2) covenants as to payment of taxes and maintenance of
corporate existence.
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To make
either of the above elections, we must deposit in trust with the trustee enough
money to pay in full the principal, interest and premium on the debt securities.
This amount may be made in cash and/or U.S. government obligations. As a
condition to either of the above elections, we must deliver to the trustee an
opinion of counsel that the holders of the debt securities will not recognize
income, gain or loss for Federal income tax purposes as a result of the action.
If any of
the above events occurs, the holders of the debt securities of the series will
not be entitled to the benefits of the indenture, except for the rights of
holders to receive payments on debt securities or the registration of transfer
and exchange of debt securities and replacement of lost, stolen or mutilated
debt securities.
Notices
Notices
to holders will be given by mail to the addresses of the holders in the security
register.
Governing Law
The
indentures and the debt securities will be governed by, and construed under, the
law of the State of New York.
Regarding the Trustee
The
indentures will limit the right of the trustee, should it become a creditor of
us, to obtain payment of claims or secure its claims.
The
trustee will be permitted to engage in certain other transactions. However, if
the trustee, acquires any conflicting interest, and there is a default under the
debt securities of any series for which they are trustee, the trustee must
eliminate the conflict or resign.
Subordinated Debt Securities
Payment
on subordinated debt securities will, to the extent provided in the indenture,
be subordinated in right of payment to the prior payment in full of all of our
senior indebtedness. Subordinated debt securities also are effectively
subordinated to all debt and other liabilities, including trade payables and
lease obligations, if any, of our subsidiaries.
Upon any
distribution of our assets upon any dissolution, winding up, liquidation or
reorganization, the payment of the principal of and interest on subordinated
debt securities will be subordinated in right of payment to the prior payment in
full in cash or other payment satisfactory to the holders of senior indebtedness
of all senior indebtedness. In the event of any acceleration of the subordinated
debt securities because of an event of default, the holders of any senior
indebtedness would be entitled to payment in full in cash or other payment
satisfactory to such holders of all senior indebtedness obligations before the
holders of subordinated debt securities are entitled to receive any payment or
distribution. The indentures will require us or the trustee to promptly notify
holders of designated senior indebtedness if payment of subordinated debt
securities is accelerated because of an event of default.
We may
not make any payment on subordinated debt securities, including upon redemption
at the option of the holder of any subordinated debt securities or at our
option, if:
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a
default in the payment of the principal, premium, if any, interest, rent
or other obligations in respect of designated senior indebtedness occurs
and is continuing beyond any applicable period of grace, which is called a
“payment default”; or
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a
default other than a payment default on any designated senior indebtedness
occurs and is continuing that permits holders of designated senior
indebtedness to accelerate its maturity, and the trustee receives notice
of such default, which is called a “payment blockage notice from us or any
other person permitted to give such notice under the indenture, which is
called a “non-payment default”.
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We may
resume payments and distributions on subordinated debt securities:
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in
the case of a payment default, upon the date on which such default is
cured or waived or ceases to exist; and
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in
the case of a non-payment default, the earlier of the date on which such
nonpayment default is cured or waived or ceases to exist and 179 days
after the date on which the payment blockage notice is received by the
trustee, if the maturity of the designated senior indebtedness has not
been accelerated.
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No new
period of payment blockage may be commenced pursuant to a payment blockage
notice unless 365 days have elapsed since the initial effectiveness of the
immediately prior payment blockage notice and all scheduled payments of
principal, premium and interest, including any liquidated damages, on the notes
that have come due have been paid in full in cash. No non-payment default that
existed or was continuing on the date of delivery of any payment blockage notice
shall be the basis for any later payment blockage notice unless the non-payment
default is based upon facts or events arising after the date of delivery of such
payment blockage notice.
If the
trustee or any holder of the notes receives any payment or distribution of our
assets in contravention of the subordination provisions on subordinated debt
securities before all senior indebtedness is paid in full in cash, property or
securities, including by way of set-off, or other payment satisfactory to
holders of senior indebtedness, then such payment or distribution will be held
in trust for the benefit of holders of senior indebtedness or their
representatives to the extent necessary to make payment in full in cash or
payment satisfactory to the holders of senior indebtedness of all unpaid senior
indebtedness.
In the
event of our bankruptcy, dissolution or reorganization, holders of senior
indebtedness may receive more, ratably, and holders of subordinated debt
securities may receive less, ratably, than our other creditors (including our
trade creditors). This subordination will not prevent the occurrence of any
event of default under the indenture.
As of
March 31, 2008, $15.0 million in senior indebtedness was outstanding. Unless we
inform you otherwise in the prospectus supplement, we will not be prohibited
from incurring debt, including senior indebtedness, under any indenture relating
to subordinated debt securities. We may from time to time incur additional debt,
including senior indebtedness.
We are
obligated to pay reasonable compensation to the trustee and to indemnify the
trustee against certain losses, liabilities or expenses incurred by the trustee
in connection with its duties relating to subordinated debt securities. The
trustee’s claims for these payments will generally be senior to those of
noteholders in respect of all funds collected or held by the trustee.
Certain Definitions
“indebtedness”
means:
(1) all
indebtedness, obligations and other liabilities for borrowed money, including
overdrafts, foreign exchange contracts, currency exchange agreements, interest
rate protection agreements, and any loans or advances from banks, or evidenced
by bonds, debentures, notes or similar instruments, other than any account
payable or other accrued current liability or obligation incurred in the
ordinary course of business in connection with the obtaining of materials or
services;
(2) all
reimbursement obligations and other liabilities with respect to letters of
credit, bank guarantees or bankers’ acceptances;
(3) all
obligations and liabilities in respect of leases required in conformity with
generally accepted accounting principles to be accounted for as capitalized
lease obligations on our balance sheet;
(4) all
obligations and liabilities, contingent or otherwise, as lessee under leases for
facility equipment (and related assets leased together with such equipment) and
under any lease or related document (including a purchase agreement, conditional
sale or other title retention or synthetic lease agreement) in connection with
the lease of real property or improvement thereon (or any personal property
included as part of any such lease) which provides that such Person is
contractually obligated to purchase or cause a third party to purchase the
leased property or pay an agreed upon residual value of the leased property,
including the obligations under such lease or related document to purchase or
cause a third party to purchase such leased property (whether or not such lease
transaction is characterized as an operating lease or a capitalized lease in
accordance with GAAP) or pay an agreed upon residual value of the leased
property to the lessor;
(5) all
obligations with respect to an interest rate or other swap, cap or collar
agreement or other similar instrument or agreement or foreign currency hedge,
exchange, purchase agreement or other similar instrument or agreement;
(6) all
direct or indirect guaranties or similar agreements in respect of, and our
obligations or liabilities to purchase, acquire or otherwise assure a creditor
against loss in respect of, indebtedness, obligations or liabilities of others
of the type described in (1) through (5) above;
(7) any
indebtedness or other obligations described in (1) through (6) above secured by
any mortgage, pledge, lien or other encumbrance existing on property which is
owned or held by us; and
(8) any
and all refinancings, replacements, deferrals, renewals, extensions and
refundings of, or amendments, modifications or supplements to, any indebtedness,
obligation or liability of the kind described in clauses (1) through (7) above.
“senior
indebtedness” means the principal, premium, if any, interest, including any
interest accruing after bankruptcy, and rent or termination payment on or other
amounts due on our current or future indebtedness, whether created, incurred,
assumed, guaranteed or in effect guaranteed by us, including any deferrals,
renewals, extensions, refundings, amendments, modifications or supplements to
the above. However, senior indebtedness does not include:
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indebtedness
that expressly provides that it shall not be senior in right of payment to
subordinated debt securities or expressly provides that it is on the same
basis or junior to subordinated debt securities;
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our
indebtedness to any of our majority-owned subsidiaries; and
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subordinated
debt securities.
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DESCRIPTION OF PREFERRED
STOCK
We
currently have authorized 5,000,000 shares of preferred stock, par value $.001
per share. As of June 3, 2008, we do not have any shares of preferred stock
outstanding. Under our Restated Certificate of Incorporation, our Board of
Directors is authorized to issue shares of our preferred stock from time to
time, in one or more classes or series, without stockholder approval. Prior to
the issuance of shares of each series, the Board of Directors is required by the
General Corporation Law of the State of Delaware and our Restated Certificate of
Incorporation to adopt resolutions and file a Certificate of Designation with
the Secretary of State of the State of Delaware, fixing for each such series the
designations, powers, preferences, rights, qualifications, limitations and
restrictions of the shares of such series. Any exercise of our Board of
Directors of its rights to do so may affect the rights and entitlements of the
holders of our common stock as set forth below.
Our Board
of Directors could authorize the issuance of shares of preferred stock with
terms and conditions which could have the effect of discouraging a takeover or
other transaction which holders of some, or a majority, of such shares might
believe to be in their best interests or in which holders of some, or a
majority, of such shares might receive a premium for their shares over the
then-market price of such shares.
General
Subject
to limitations prescribed by the General Corporation Law of the State of
Delaware, our Restated Certificate of Incorporation and our Amended and Restated
By-Laws (“By-Laws”), our Board of Directors is authorized to fix the number of
shares constituting each series of preferred stock and the designations, powers,
preferences, rights, qualifications, limitations and restrictions of the shares
of such series, including such provisions as may be desired concerning voting,
redemption, dividends, dissolution or the distribution of assets, conversion or
exchange, and such other subjects or matters as may be fixed by resolution of
the Board of Directors. Each series of preferred stock that we offer under this
prospectus will, when issued, be fully paid and nonassessable and will not have,
or be subject to, any preemptive or similar rights.
The
applicable prospectus supplement(s) will describe the following terms of the
series of preferred stock in respect of which this prospectus is being
delivered:
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the
title and stated value of the preferred stock;
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the
number of shares of the preferred stock offered, the liquidation
preference per share and the purchase price of the preferred stock;
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the
dividend rate(s), period(s) and/or payment date(s) or the method(s) of
calculation for dividends;
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whether
dividends shall be cumulative or non-cumulative and, if cumulative, the
date from which dividends on the preferred stock shall accumulate;
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the
procedures for any auction and remarketing, if any, for the preferred
stock;
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the
provisions for a sinking fund, if any, for the preferred stock;
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the
provisions for redemption, if applicable, of the preferred stock;
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any
listing of the preferred stock on any securities exchange or market;
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the
terms and conditions, if applicable, upon which the preferred stock will
be convertible into common stock or another series of our preferred stock,
including the conversion price (or its manner of calculation) and
conversion period;
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the
terms and conditions, if applicable, upon which preferred stock will be
exchangeable into our debt securities, including the exchange price, or
its manner of calculation, and exchange period;
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voting
rights, if any, of the preferred stock; a discussion of any material
and/or special United States federal income tax considerations applicable
to the preferred stock;
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whether
interests in the preferred stock will be represented by depositary shares;
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the
relative ranking and preferences of the preferred stock as to dividend
rights and rights upon liquidation, dissolution or winding up of our
affairs;
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any
limitations on issuance of any series of preferred stock ranking senior to
or on a parity with the preferred stock as to dividend rights and rights
upon liquidation, dissolution or winding up of our affairs; and
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any
other specific terms, preferences, rights, limitations or restrictions on
the preferred stock.
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Unless
otherwise specified in the prospectus supplement, the preferred stock will, with
respect to dividend rights and rights upon liquidation, dissolution or winding
up of Discovery rank:
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senior
to all classes or series of our common stock, and to all equity securities
issued by us the terms of which specifically provide that such equity
securities rank junior to the preferred stock with respect to dividend
rights or rights upon the liquidation, dissolution or winding up of us;
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on
a parity with all equity securities issued by us that do not rank senior
or junior to the preferred stock with respect to dividend rights or rights
upon the liquidation, dissolution or winding up of us; and
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junior
to all equity securities issued by us the terms of which do not
specifically provide that such equity securities rank on a parity with or
junior to the preferred stock with respect to dividend rights or rights
upon the liquidation, dissolution or winding up of us (including any
entity with which we may be merged or consolidated or to which all or
substantially all of our assets may be transferred or which transfers all
or substantially all of our assets).
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As used
for these purposes, the term “equity securities” does not include convertible
debt securities.
Transfer Agent and Registrar
The
transfer agent and registrar for any series of preferred stock will be set forth
in the applicable prospectus supplement.
DESCRIPTION OF COMMON
STOCK
This
description of our common stock is a summary. You should keep in mind, however,
that it is our Restated Certificate of Incorporation and our By-Laws, and not
this summary, which define any rights you may acquire as a stockholder. There
may be other provisions in such documents which are also important to you. You
should read such documents for a full description of the terms of our capital
stock, along with the applicable provisions of Delaware law.
We
currently have authorized 180,000,000 shares of common stock, par value $0.001
per share. As of June 3, 2008, there were 96,693,377 shares of common stock
outstanding, which does not include:
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13,880,283
shares of common stock issuable upon exercise of options outstanding as of
June 3, 2008, at a weighted average exercise price of $4.23 per
share;
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7,164,196
shares of common stock issuable upon exercise of warrants outstanding as
of June 3, 2008, at a weighted average exercise price of
$4.71;
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5,170,024
shares of common stock reserved for potential future issuance pursuant to
the 2006 CEFF.
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an
indeterminate number of shares of common stock issuable under our shelf
registration statement on Form S-3 (No. 333-128929) dated October 11,
2005;
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55,913
shares of common stock issuable upon the vesting of restricted stock
awards outstanding as of June 3,
2008;
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4,695,625
shares of common stock available for future grant under our 2007 Long-Term
Incentive Plan; and
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169,756
shares of common stock reserved for potential future issuance pursuant to
a 401(k) Plan, as of June 3, 2008.
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Subject
to any preferential rights of any preferred stock created by our Board of
Directors, as a holder of our common stock you are entitled to such dividends as
our Board of Directors may declare from time to time out of funds that we can
legally use to pay dividends. The holders of common stock possess exclusive
voting rights, except to the extent our Board of Directors specifies voting
power for any preferred stock that, in the future, may be
issued.
As a
holder of our common stock, you are entitled to one vote for each share of
common stock and do not have any right to cumulate votes in the election of
directors. Upon our liquidation, dissolution or winding-up, you will be entitled
to receive on a proportionate basis any assets remaining after provision for
payment of creditors and after payment of any liquidation preferences to holders
of preferred stock. Holders of our common stock have no preemptive rights and no
conversion rights or other subscription rights. There are no redemption or
sinking fund provisions applicable to our common stock. All the outstanding
shares of common stock are, and the shares offered by this prospectus, when
issued and paid for, will be, validly issued, fully paid and nonassessable. Our
common stock is quoted on The Nasdaq Global Market under the symbol “DSCO.
Stockholder Rights
Plan
The
summary description of the Rights set out herein does not purport to be
complete, and is qualified in its entirety by reference to the terms and
provisions of our Shareholder Rights Agreement, dated as of February 6,
2004.
On
February 6, 2004, our Board of Directors adopted a shareholder rights agreement
(the Rights Agreement). Pursuant to the Rights Agreement our Board of Directors
(i) declared that each stockholder of record as of the close of business on
February 6, 2004, would be issued a dividend of one preferred stock purchase
right (a “Right”) for each share of our common stock held by such stockholder
and (ii) determined that each share of common stock issued by us after such date
through the Final Expiration Date (as defined below) shall be issued with a
tandem Right. Each Right represents the right to purchase one ten-thousandth of
a share of our Series A Junior Participating Cumulative Preferred Stock (“Series
A Preferred”) at an exercise price equal to $50 per Right (as the same may be
adjusted, the “Exercise Price”). The Rights shall be evidenced by certificates
for our common stock until the earlier to occur of:
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10
days following a public announcement that a person or group of affiliated
or associated persons (with certain exceptions, an “Acquiring Person”)
have acquired beneficial ownership of 15% or more of the outstanding
shares of our common stock; and
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10
business days (or such later date as may be determined by action of the
Board of Directors before such time as any person or group of affiliated
persons becomes an Acquiring Person) following the commencement of, or
announcement of an intention to make, a tender offer or exchange offer the
consummation of which would result in the beneficial ownership by a person
or group of 15% or more of the outstanding shares of Common Stock (the
earlier of such dates being called the “Distribution
Date”).
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The
Rights are not exercisable until the Distribution Date. Until a Right is
exercised, the holder thereof, as such, will have no rights as a Discovery
stockholder, including, without limitation, the right to vote or to receive
dividends.
The
Rights will expire upon the close of business on February 6, 2014 (the “Final
Expiration Date”), unless the Rights are earlier redeemed or exchanged by us, in
each case as described below.
The
shares of Series A Preferred purchasable upon exercise of the Rights will be
entitled, when, as and if declared, to a minimum preferential quarterly dividend
payment of 10,000 times the per share amount of dividends declared on our common
stock. If no common stock dividend is declared in a quarter, a preferred stock
quarterly dividend of $1.00 per share will be required. Upon our liquidation,
holders of Series A Preferred will be entitled to a preferential distribution
payment of at least 10,000 times the payment made per share of common stock.
Each share of Series A Preferred will entitle the holder to 10,000 votes, voting
together with our common stock. Upon any merger, consolidation or other
transaction in which shares of our common stock are converted or exchanged, the
holders of Series A Preferred will be entitled to receive 10,000 times the
amount of consideration received per share of our common stock in respect of
such transaction. The Rights are protected by customary anti-dilution
provisions.
Because
of the nature of the Series A Preferred dividend and liquidation rights, the
fair market value of the one ten-thousandth of a share of Series A Preferred
purchasable upon exercise of each Right should approximate the fair market value
of one share of our common stock. If any person or group of affiliated or
associated persons becomes an Acquiring Person, each holder of a Right, (other
than Rights beneficially owned by the Acquiring Person, which become void), will
have the right to receive upon exercise and payment of the then current Exercise
Price, that number of shares of our common stock having a market value of two
times the Exercise Price.
If, after
a person or group has become an Acquiring Person, we are acquired in a merger or
other business combination transaction, or 50% or more of our consolidated
assets or earning power are sold, proper provision will be made so that each
holder of a Right (other than Rights beneficially owned by an Acquiring Person,
which become void) will thereafter have the right to receive, upon exercise at
the then current Exercise Price, that number of shares of common stock of the
person with whom we engaged in the foregoing transaction (or its parent), which
at the time of such transaction will have a market value of two times the
Exercise Price. In lieu of exercise, our Board of Directors may exchange the
Rights (other than Rights owned by an Acquiring Person, which become void), in
whole or in part, for such securities or other property or rights as the Board
may determine, including any class or series of our common stock or preferred
stock.
At any
time before the time an Acquiring Person becomes such, our Board of Directors
may redeem the Rights in whole, but not in part, at a price of $.001 per Right,
subject to adjustment.
We may
amend the Rights to the extent and on the conditions set out in the Rights
Agreement.
Anti-Takeover
Provisions
As a
corporation organized under the laws of the State of Delaware, we are subject to
Section 203 of the General Corporation Law of the State of Delaware, which
restricts our ability to enter into business combinations with an interested
stockholder or a stockholder owning 15% or more of our outstanding voting stock,
or that stockholder’s affiliates or associates, for a period of three years.
These restrictions do not apply if:
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before
becoming an interested stockholder, our Board of Directors approves either
the business combination or the transaction in which the stockholder
becomes an interested stockholder;
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upon
consummation of the transaction in which the stockholder becomes an
interested stockholder, the interested stockholder owns at least 85% of
our voting stock outstanding at the time the transaction commenced,
subject to exceptions; or
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on
or after the date a stockholder becomes an interested stockholder, the
business combination is both approved by our Board of Directors and
authorized at an annual or special meeting of our stockholders by the
affirmative vote of at least two-thirds of the outstanding voting stock
not owned by the interested stockholder.
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Number of Directors;
Removal
Our
By-Laws provide that our Board of Directors shall consist of at least three
directors and may consist of such larger number as may be determined, from
time-to-time, by the Board of Directors. Our By-laws provide that directors may
be removed with or without cause by the affirmative vote of holders of a
majority of the total voting power of all outstanding securities.
This
provision and the Board of Directors’ right to issue shares of our preferred
stock from time to time, in one or more classes or series without stockholder
approval are intended to enhance the likelihood of continuity and stability in
the composition of the policies formulated by our Board of Directors. These
provisions are also intended to discourage some tactics that may be used in
proxy fights.
Transfer Agent and
Registrar
The
Transfer Agent and Registrar for our common stock is Continental Stock Transfer
& Trust Company.
DESCRIPTION OF
WARRANTS
Outstanding
Warrants
As of
June 3, 2008, there are 7,164,196 shares of common stock issuable upon exercise
of warrants outstanding, at a weighted average exercise price of
$4.71.
We may
issue, in one or more series, debt warrants to purchase debt securities, as well
as equity warrants to purchase preferred stock or common stock. The warrants may
be issued independently or together with any securities and may be attached to
or separate from the securities. If the warrants are issued pursuant to warrant
agreements, we will so specify in the prospectus supplement relating to the
warrants being offered pursuant to the prospectus supplement. While the
following the terms described below will apply generally to any warrants we may
offer, we will describe the particular terms of any series of warrants in the
applicable prospectus supplement. The terms of any warrants offered under a
prospectus supplement for a particular series of warrants may specify different
or additional terms than those specified below.
Debt Warrants
The
applicable prospectus supplement will describe the terms of debt warrants
offered, the warrant agreement relating to the debt warrants and the debt
warrant certificates representing the debt warrants, including the
following:
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the
title of the debt warrants;
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the
aggregate number of the debt
warrants;
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the
price or prices at which the debt warrants will be
issued;
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the
designation, aggregate principal amount and terms of the debt securities
purchasable upon exercise of the debt warrants, and the procedures and
conditions relating to the exercise of the debt
warrants;
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the
designation and terms of any related debt securities with which the debt
warrants are issued, and the number of the debt warrants issued with each
debt security;
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the
principal amount of debt securities purchasable upon exercise of each debt
warrant;
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the
date on which the right to exercise the debt warrants will commence, and
the date on which this right will
expire;
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the
maximum or minimum number of debt warrants which may be exercised at any
time;
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a
discussion of any material federal income tax considerations;
and
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any
other terms of the debt warrants and terms, procedures and limitations
relating to the exercise of debt
warrants.
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Debt
warrant certificates will be exchangeable for new debt warrant certificates of
different denominations, and debt warrants may be exercised at the corporate
trust office of the warrant agent or any other office indicated in the
prospectus supplement, by delivering the properly completed and duly executed
warrant certificate and paying the required amount to the warrant agent in
immediately available funds. Prior to the exercise of their debt warrants,
holders of debt warrants will not have any of the rights of holders of the debt
securities purchasable upon exercise and will not be entitled to payment of
principal of or any premium, if any, or interest on the debt securities
purchasable upon exercise.
Equity Warrants
The
applicable prospectus supplement will describe the following terms of equity
warrants offered:
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the
title of the equity warrants;
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the
securities (i.e., preferred stock or common stock) for which the equity
warrants are exercisable;
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the
price or prices at which the equity warrants will be
issued;
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if
applicable, the designation and terms of the preferred stock or common
stock with which the equity warrants are issued, and the number of equity
warrants issued with each share of preferred stock or common stock;
and
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any
other terms of the equity warrants, including terms, procedures and
limitations relating to the exchange and exercise of equity
warrants.
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Holders
of equity warrants will not be entitled, by virtue of being such holders, to
vote, consent, receive dividends, receive notice as stockholders with respect to
any meeting of stockholders for the election of our directors or any other
matter, or to exercise any rights whatsoever as our stockholders.
The
exercise price payable and the number of shares of common stock or preferred
stock purchasable upon the exercise of each equity warrant will be subject to
adjustment in certain events, including the issuance of a stock dividend to
holders of common stock or preferred stock or a stock split, reverse stock
split, combination, subdivision or reclassification of common stock or preferred
stock. In lieu of adjusting the number of shares of common stock or preferred
stock purchasable upon exercise of each equity warrant, we may elect to adjust
the number of equity warrants. No adjustments in the number of shares
purchasable upon exercise of the equity warrants will be required until
cumulative adjustments require an adjustment of at least 1% thereof. We may, at
our option, reduce the exercise price at any time. No fractional shares will be
issued upon exercise of equity warrants, but we will pay the cash value of any
fractional shares otherwise issuable. Notwithstanding the foregoing, in case of
any consolidation, merger, or sale or conveyance of our property as an entirety
or substantially as an entirety, the holder of each outstanding equity warrant
shall have the right to the kind and amount of shares of stock and other
securities and property, including cash, receivable by a holder of the number of
shares of common stock or preferred stock into which the equity warrant was
exercisable immediately prior to the transaction.
Exercise of
Warrants
Each
warrant will entitle the holder to purchase for cash such principal amount of
securities or shares of stock at such exercise price as shall in each case be
set forth in, or be determinable as set forth in, the prospectus supplement
relating to the warrants offered thereby. Warrants may be exercised at any time
up to the close of business on the expiration date set forth in the prospectus
supplement relating to the warrants offered thereby. After the close of business
on the expiration date, unexercised warrants will become void.
The
warrants may be exercised as set forth in the prospectus supplement relating to
the warrants offered. Upon receipt of payment and the taking of other action
specified in the applicable prospectus supplement, we will, as soon as
practicable, forward the securities purchasable upon exercise. If less than all
of the warrants represented by such warrant certificate are exercised, a new
warrant certificate will be issued for the remaining warrants.
Each
warrant agent will act solely as our agent under the applicable warrant
agreement and will not assume any obligation or relationship of agency or trust
with any holder of any warrant. A single bank or trust company may act as
warrant agent for more than one issue of warrants. A warrant agent will have no
duty or responsibility in case of any default by us under the applicable warrant
agreement or warrant, including any duty or responsibility to initiate any
proceedings at law or otherwise, or to make any demand upon us. Any holder of a
warrant may, without the consent of the related warrant agent or the holder of
any other warrant, enforce by appropriate legal action its right to exercise,
and receive the securities purchasable upon exercise of, its
warrants.
PLAN OF
DISTRIBUTION
We may
sell the securities being offered by us in this prospectus pursuant to
underwritten public offerings, negotiated transactions, block trades or any
combination of such methods. We may sell the securities to or through
underwriters, dealers, agents or directly to one or more purchasers. We and our
agents reserve the right to accept and to reject in whole or in part any
proposed purchase of securities. A prospectus supplement or post-effective
amendment, which we will file each time we effect an offering of any securities,
will provide the names of any underwriters, dealers or agents, if any, involved
in the sale of such securities, and any applicable fees, commissions, or
discounts to which such persons shall be entitled to in connection with such
offering.
We and
our agents, dealers and underwriters, as applicable, may sell the securities
being offered by us in this prospectus from time to time in one or more
transactions at:
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a
fixed price or prices, which may be
changed;
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market
prices prevailing at the time of
sale;
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prices
related to such prevailing market
prices;
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varying
prices determined at the time of sale;
or
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We may
determine the price or other terms of the securities offered under this
prospectus by use of an electronic auction. We will describe how any auction
will determine the price or any other terms, how potential investors may
participate in the auction and the nature of the underwriters’ obligations in
the applicable prospectus supplement or amendment.
We may
solicit directly offers to purchase securities. We may also designate agents
from time to time to solicit offers to purchase securities. Any agent that we
designate, who may be deemed to be an underwriter as that term is defined in the
Securities Act, may then resell such securities to the public at varying prices
to be determined by such agent at the time of resale.
We may
engage in at the market offerings of our common stock. An at the market offering
is an offering of our common stock at other than a fixed price to or through a
market maker. We shall name any underwriter that we engage for an at the market
offering in a post-effective amendment to the registration statement containing
this prospectus. We shall also describe any additional details of our
arrangement with such underwriter, including commissions or fees paid, or
discounts offered, by us and whether such underwriter is acting as principal or
agent, in the related prospectus supplement.
If we use
underwriters to sell securities, we will enter into an underwriting agreement
with the underwriters at the time of the sale to them, which agreement shall be
filed as an exhibit to the related prospectus supplement. Underwriters may also
receive commissions from purchasers of the securities. Underwriters may also use
dealers to sell securities. In such an event, the dealers may receive
compensation in the form of discounts, concessions or commissions from the
underwriters and/or commissions from the purchasers for whom they may act as
agents.
Underwriters,
dealers, agents and other persons may be entitled, under agreements that may be
entered into with us, to indemnification by us against certain civil
liabilities, including liabilities under the Securities Act or to contribution
with respect to payments which they may be required to make in respect of such
liabilities. Underwriters and agents may engage in transactions with, or perform
services for, us in the ordinary course of business.
Any
underwriter may engage in over-allotment, stabilizing and syndicate short
covering transactions and penalty bids in accordance with Regulation M of the
Exchange Act. Over-allotment involves sales in excess of the offering size,
which create a short position. Stabilizing transactions involve bids to purchase
the underlying security so long as the stabilizing bids do not exceed a
specified maximum. Syndicate short covering transactions involve purchases of
securities in the open market after the distribution has been completed in order
to cover syndicate short positions. Penalty bids permit the underwriters to
reclaim selling concessions from dealers when the securities originally sold by
such dealers are purchased in covering transactions to cover syndicate short
positions. These transactions may cause the price of the securities sold in an
offering to be higher than it would otherwise be. These transactions, if
commenced, may be discontinued by the underwriters at any time.
Our
common stock is quoted on Nasdaq Global Market under the symbol “DSCO.” The
other securities are not listed on any securities exchange or other stock market
and, unless we state otherwise in the applicable prospectus supplement, we do
not intend to apply for listing of the other securities on any securities
exchange or other stock market. Any underwriters to whom we sell securities for
public offering and sale may make a market in the securities that they purchase,
but the underwriters will not be obligated to do so and may discontinue any
market making at any time without notice. Accordingly, we give you no assurance
as to the development or liquidity of any trading market for the securities.
The
anticipated date of delivery of the securities offered hereby will be set forth
in the applicable prospectus supplement relating to each offering.
In order
to comply with certain state securities laws, if applicable, the securities may
be sold in such jurisdictions only through registered or licensed brokers or
dealers. In certain states, the securities may not be sold unless the securities
have been registered or qualified for sale in such state or an exemption from
regulation or qualification is available and is complied with. Sales of
securities must also be made by us in compliance with all other applicable state
securities laws and regulations.
We shall
pay all expenses of the registration of the securities.
EXPERTS
The
consolidated financial statements of Discovery incorporated by reference in
Discovery Laboratories, Inc. Annual Report (Form 10-K) for the year ended
December 31, 2007, and the effectiveness of Discovery’s internal control over
financial reporting as of December 31, 2007 have been audited by Ernst &
Young LLP, independent registered public accounting firm, as set forth in their
reports thereon, incorporated by reference therein, and incorporated herein by
reference. Such consolidated financial statements are incorporated herein by
reference in reliance upon such reports given on the authority of such firm as
experts in accounting and auditing.
LEGAL MATTERS
If and
when offered, the validity of the securities being registered hereunder will be
passed upon for us by Dickstein Shapiro LLP.
WHERE YOU CAN FIND MORE
INFORMATION
We file
annual, quarterly and periodic reports, proxy statements and other information
with the SEC. You may read and copy any materials that we file with the SEC at
the SEC’s Public Reference Room at 100 F Street, N.E., Washington, D.C. 20549.
You may obtain information on the operation of the Public Reference Room by
calling the SEC at 1-800-SEC-0330. Many of our SEC filings are also available to
the public from the SEC’s Website at “http://www.sec.gov.” We make available
free of charge our annual, quarterly and current reports, proxy statements and
other information upon request. To request such materials, please send an e-mail
to ir@DiscoveryLabs.com or contact John G. Cooper, our Executive Vice President,
Chief Financial Officer, at the following address or telephone number: Discovery
Laboratories, Inc., 2600 Kelly Road, Suite 100, Warrington, Pennsylvania 18976,
Attention: John G. Cooper; (215) 488-9300. Exhibits
to the documents will not be sent, unless those exhibits have specifically been
incorporated by reference in this prospectus.
We
maintain a Website at “http://www.DiscoveryLabs.com”. Our Website and the
information contained therein or connected thereto are not incorporated into
this Registration Statement.
We have
filed with the SEC a registration statement on Form S-3 under the Securities Act
relating to the securities we are offering by this prospectus. This prospectus
does not contain all of the information set forth in the registration statement
and the exhibits and schedules to the registration statement. Please refer to
the registration statement and its exhibits and schedules for further
information with respect to us and our securities. Statements contained in this
prospectus as to the contents of any contract or other document are not
necessarily complete and, in each instance, we refer you to the copy of that
contract or document filed as an exhibit to the registration statement. You may
read and obtain a copy of the registration statement and its exhibits and
schedules from the SEC, as described in the preceding paragraph.
INFORMATION INCORPORATED BY
REFERENCE
The SEC
allows us to “incorporate by reference” the information we file with them, which
means that we can disclose important information to you by referring you to
those documents. The information incorporated by reference is considered to be
part of this prospectus, and information that we file later with the SEC will
automatically update and supersede this information. We incorporate by reference
the documents filed with SEC listed below:
1.
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Our
Annual Report on Form 10-K for the fiscal year ended December 31, 2007,
filed on March 14, 2008;
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2.
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Our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2008, filed
on May 9, 2008;
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3.
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Our
Current Reports on Form 8-K filed with the SEC on January 3, 2008 and
February 15, 2008 (excluding the matters in Item 2.02 and Exhibit 99.1
therein, which are not incorporated by reference herein), April 3, 2008,
April 11, 2008, May 2, 2008, May 8, 2008(excluding the matters in Item
2.02 and Exhibit 99.1 therein, which are not incorporated by reference
herein), May 19, 2008, May 28, 2008, May 29, 2008, and June 2,
2008;
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4.
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The
description of our common stock contained in our Registration Statement on
Form 8-A filed with the SEC on July 13, 1995;
and
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5.
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All
documents we have filed with the SEC pursuant to Sections 13(a), 13(c), 14
or 15(d) of the Exchange Act after the date of this registration statement
and before the effectiveness of the registration statement, as well as
after the date of this prospectus and before the termination of this
offering, shall be deemed to be incorporated by reference into this
prospectus and to be a part of this prospectus from the date of the filing
of the documents.
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All
reports and other documents subsequently filed by us with the SEC pursuant to
Sections 13(a), 13(c), 14, or 15(d) of the Securities Exchange Act of 1934 after
the date of this prospectus and before the termination of the offering shall be
deemed to be incorporated by reference in this prospectus and to be a part of
this prospectus from the date of filing of such reports and documents. This
prospectus also incorporates by reference any documents that we file with the
SEC after the date of the initial registration statement and before the
effectiveness of the registration statement. Any statement contained in any
document incorporated or deemed to be incorporated by reference herein shall be
deemed to be modified or superseded for purposes of this prospectus to the
extent that a statement contained in this prospectus or in any other
subsequently filed document which also is or is deemed to be incorporated by
reference in this prospectus 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 may
request a copy of these filings, at no cost, by sending an e-mail to
ir@DiscoveryLabs.com and requesting any one or more of such filings or by
contacting John G. Cooper, our Executive Vice President, Chief Financial
Officer, at the following address or telephone number: Discovery Laboratories,
Inc., 2600 Kelly Road, Suite 100, Warrington, Pennsylvania 18976-3622,
Attention: John G. Cooper; (215) 488-9300. Exhibits to the documents will not be
sent, unless those exhibits have specifically been incorporated by reference in
this prospectus.
$150,000,000
Discovery
Laboratories, Inc.
Debt
Securities, Preferred Stock and Common Stock,
Debt
Warrants and Equity Warrants
No dealer, salesperson or other
person is authorized to provide you with information or to represent anything
not contained in this prospectus. You must not rely on any unauthorized
information or representations. We are offering to sell, and seeking offers to
buy, only the securities of Discovery Laboratories, Inc. covered by this
prospectus, and only under circumstances and in jurisdictions where it is lawful
to do so. The information contained in this prospectus is current only as of its
date, regardless of the time of delivery of this prospectus or of any sale of
the shares.
June
18,
2008
Shares
of Common Stock
Warrants
to
Purchase Shares
of Common Stock
PROSPECTUS
SUPPLEMENT
LAZARD
CAPITAL MARKETS
February ,
2010