14,000,000
Shares of Common Stock
Warrants
to Purchase 7,000,000 Shares of Common Stock
We are
offering up to 14,000,000 shares of our common stock and warrants to purchase up
to 7,000,000 shares of our common stock in this offering (and the shares of
common stock issuable pursuant to these 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 0.5 of a share of common stock, at an exercise price
of $1.15 per share. Each unit will be sold at a price of $0.81 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 May
7, 2009, the last reported sale price of our common stock on the Nasdaq Global
Market was $0.90 per share.
We are
offering these shares of common stock and warrants to purchase common stock on a
best efforts basis primarily to institutional investors. We have
retained Lazard Capital Markets LLC to act as the exclusive placement agent in
connection with this offering.
Investing
in our common stock involves significant risks. See “Risk Factors”
beginning on page S-3 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.
|
Per
Unit
|
Total
|
Public
offering price
|
$0.81
|
$11,340,000
|
Placement
agent’s fees
|
$0.0486
|
$680,400
|
Proceeds
to us (before expenses)
|
$0.7614
|
$10,659,600
|
We
estimate the total expenses of this offering payable by us, excluding the
placement agent’s fees, will be approximately $200,000. Because there
is no minimum offering amount required as a condition to closing in this
offering, the actual public offering amount, placement agent’s fees and net
proceeds to us, if any, in this offering are not presently determinable and may
be substantially less than the total maximum offering amounts set forth
above. We are not required to sell any specific number or dollar
amount of the shares of common stock offered in this offering, but the placement
agent will use its reasonable best efforts to arrange for the sale of all of the
units offered. Pursuant to an escrow agreement that we may enter into
among us, the placement agent and an escrow agent, a portion of the funds
received in payment for the shares sold in this offering will be wired to a
non-interest bearing escrow account and held until we and the placement agent
notify the escrow agent that the offering has closed, indicating the date on
which the shares are to be delivered to the purchasers and the proceeds are to
be delivered to us.
Lazard
Capital Markets
Prospectus
Supplement dated May 8, 2009
TABLE
OF CONTENTS
Prospectus
Supplement
|
|
Page
|
|
Prospectus
|
|
Page
|
About
this Prospectus Supplement
|
|
S-1
|
|
About
This Prospectus
|
|
1
|
Forward-Looking
Statements
|
|
S-1
|
|
About
Discovery
|
|
1
|
Risk
Factors
|
|
S-3
|
|
Risk
Factors
|
|
2
|
Use
of Proceeds
|
|
S-4
|
|
Forward-Looking
Statements
|
|
20
|
Dilution
|
|
S-5
|
|
Use
of Proceeds
|
|
21
|
Description
of Securities We are Offering
|
|
S-6
|
|
Ratio
of Earnings to Fixed Charges
|
|
22
|
Plan
of Distribution
|
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S-7
|
|
Description
of Debt Securities
|
|
22
|
Legal
Matters
|
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S-8
|
|
Description
of Preferred Stock
|
|
30
|
Where
You Can Find More Information and
|
|
S-8
|
|
Description
of Common Stock
|
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31
|
Incorporation
by Reference
|
|
|
|
Description
of Warrants
|
|
34
|
|
|
|
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Plan
of Distribution
|
|
36
|
|
|
|
|
Experts
|
|
37
|
|
|
|
|
Legal
Matters
|
|
37
|
|
|
|
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Where
You Can Find More Information
|
|
37
|
|
|
|
|
Information
Incorporated by Reference
|
|
38
|
_____________________
This
document is in two parts. The first part is the prospectus supplement, which
describes the specific terms of the securities we are offering 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. Generally, when we refer to this
prospectus, we are referring to both parts of this document combined. 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 placement agent 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.
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. This prospectus supplement
describes the specific details regarding this offering, including the price, the
amount of common stock being offered and the risks of investing in our common
stock. The accompanying prospectus provides more general information,
some of which may not apply to our common stock. 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.”
If
information contained in this prospectus supplement is inconsistent with the
accompanying prospectus, you should rely on this prospectus
supplement.
FORWARD-LOOKING
STATEMENTS
This
prospectus supplement, the accompanying prospectus and the documents
incorporated by reference herein and therein, including in “Risk Factors,” which
are not historical, 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, and the possibility, timing and outcome of
submitting regulatory filings for our products under development; our research
and development programs for our Surfactant Replacement Therapies (SRT)
technology and our aerosolization systems, including our capillary
aerosolization technology, including planning for and timing of any clinical
trials and potential development milestones; our plans related to the
establishment of our own commercial and medical affairs capabilities to support
the launch of Surfaxin in the United States, if approved, and our other
products; the development of financial, clinical, manufacturing and distribution
plans related to the potential commercialization of our drug products; plans
regarding potential strategic alliances and collaboration 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:
|
·
|
the
risk that we and the U.S. Food and Drug Administration (FDA) will not be
able to agree on the matters raised by the FDA in its Complete Response
letter dated April 17, 2009, or the FDA may require us to conduct
significant additional activities to potentially gain approval of
Surfaxin;
|
|
·
|
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;
|
|
·
|
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
development partners or pursuant to collaboration
arrangements;
|
|
·
|
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;
|
|
·
|
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;
|
|
·
|
risks
relating to our ability to develop and manufacture drug products and
aerosolization systems, including systems based on our novel capillary
aerosolization technology, for initiation and completion of our clinical
studies, and, if approved, commercialization of our drug and combination
drug-device products.
|
|
·
|
risks
relating to the transfer of our manufacturing technology to third-party
contract manufacturers and
assemblers;
|
|
·
|
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 substances, 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;
|
|
·
|
the
risk that, if approved, we may be unable, for reasons related to market
conditions, the competitive landscape or otherwise, to successfully launch
and profitably sell our products;
|
|
·
|
risks
relating to our ability identify strategic partners with whom we can
commercialize our products, if approved, in a timely manner, if at all,
and that we, our strategic partners and our marketing and advertising
consultants will not succeed in developing market awareness of our
products, or that our product candidates will not gain market acceptance
by physicians, patients, healthcare payers and others in the medical
community;
|
|
·
|
the
risk that we or our strategic partners, collaborators or marketing
partners will not be able to attract or maintain qualified
personnel;
|
|
·
|
the
risk that we may not be able in a changing financial market to raise
additional capital or enter into strategic alliances or collaboration
agreements (including strategic alliances for development or
commercialization of our Surfactant Replacement Therapies (SRT) and
combination drug-device products);
|
|
·
|
risks
that the ongoing credit crisis could adversely affect our ability to fund
our activities, that our share price will not remain at a level that would
permit us to access capital from our Committed Equity Financing Facilities
(CEFFs) and that the CEFFs may expire before we are able to access the
full dollar amount potentially available under the CEFFs, and that
additional financings could result in significant equity
dilution;
|
|
·
|
the
risk that we will be unable to maintain The Nasdaq Global Market listing
requirements, which would likely cause the price of our shares of common
stock to decline;
|
|
·
|
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;
|
|
·
|
the
risks that we may be unable to maintain and protect the patents and
licenses related to our SRT and that other companies may develop competing
therapies and/or technologies;
|
|
·
|
the
risk that we may become involved in securities, product liability and
other litigation;
|
|
·
|
risks
related to reimbursement and health care reform that may adversely affect
us;
|
|
·
|
and
other risks and uncertainties 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.
|
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.
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.
Investing
in our common stock 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, before
deciding to purchase any shares of our common stock. 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 common stock.
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 119,726,667 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 May 7, 2009, 24,570,594 shares of
our common stock are issuable upon exercise of outstanding options and warrants
and vesting of restricted stock units granted by us, which also have been
registered for resale on registration statements filed with the Securities and
Exchange Commission.
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 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 public offering price of $0.81 per
share in this offering, if you purchase shares of common stock in this offering,
you will suffer immediate and substantial dilution of $0.68 per share in the net
tangible book value of the common stock. See “Dilution” on page S-5
for a more detailed discussion of the dilution you will incur in this
offering.
We expect
the net proceeds from the securities offered pursuant to this prospectus to be
approximately $10.5 million after deducting the estimated placement agent’s fees
and other estimated offering expenses. 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
for expenses associated with maintaining our research and development
operations, including manufacturing, quality and analytical capabilities,
product development and clinical operations and regulatory for the further
development of certain of the Company’s pipeline products,
including:
|
·
|
Expenses
related to development of Surfaxin LS™, the Company’s lyophilized
formulation of Surfaxin, which is manufactured as a dry powder and
reconstituted as a liquid prior to administration, including preclinical
and clinical experiments and costs associated with a planned meeting with
U.S. and European regulatory authorities later this year, in preparation
for an anticipated worldwide, late-stage clinical development program in
2010 for Surfaxin LS for the prevention of
RDS;
|
|
·
|
Costs
associated with research, engineering and development studies related to
Aerosurf®,
KL4
surfactant in aerosolized form using the Company’s proprietary Capillary
Aerosolization Technology, as well as the costs of preparing an IND filing
in anticipation of a planned Phase 2 clinical program, which is expected
to begin in late 2009 or early
2010;
|
|
·
|
Expenses
associated with the ongoing clinical trial to determine if restoration of
surfactant with Surfaxin will improve lung function and result in a
shorter duration of mechanical ventilation and NICU/PICU stay for children
up to two years of age suffering with Acute Respiratory Failure, which was
extended due to low enrollment associated with recent mild viral seasons;
and
|
|
·
|
Regulatory
activities associated with gaining the potential approval of Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome, with
respect to which the Company received a Complete Response letter from the
U.S. Food and Drug Administration (FDA) on April 17, 2009. The
Company is seeking an end of review meeting with the FDA and, if that
meeting is successful, believes that Surfaxin may potentially be approved
in 2009.
|
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 March 31, 2009, was approximately
$4.8 million, or approximately $0.25 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. After giving effect to
the sale of 14,000,000 shares of our common stock in this offering at an
offering price equal to $0.81 per share, and after deducting the estimated
underwriting discount and the estimated offering expenses, our net tangible book
value at March 31, 2009, would have been approximately $15.3 million, or
approximately $0.13 per share. This represents an immediate increase
in the net tangible book value per share of $0.08 per share to existing
shareholders and an immediate dilution of $0.68 per share to new investors
purchasing shares of common stock in this offering. The following
table illustrates this dilution:
Offering
price per share
|
|
|
|
|
|
$0.81
|
|
|
|
|
|
|
|
|
|
Net
tangible book value per share as of September 30, 2007
|
|
|
$0.05
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase
per share after the offering
|
|
|
$0.08
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
tangible book value per share as of September 30, 2007, after giving
effect to this offering
|
|
|
|
|
|
|
$0.13
|
|
|
|
|
|
|
|
|
|
|
Dilution
per share to new investors
|
|
|
|
|
|
|
$0.68
|
|
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 March 31, 2009, there were 103,647,293 shares of
common stock outstanding, which does not include:
·
|
16,913,308
shares of common stock issuable upon exercise of options outstanding as of
March 31, 2009, at a weighted average exercise price of $3.73 per
share;
|
·
|
7,839,196
shares of common stock issuable upon exercise of warrants outstanding as
of March 31, 2009, at a weighted average exercise price of
$4.44.
|
·
|
50,375
shares of common stock issuable upon the vesting of restricted stock
awards outstanding as of March 31,
2009.
|
·
|
243,947
shares of common stock reserved for potential future issuance pursuant to
a 401(k) Plan, as of March 31,
2009.
|
·
|
32,819,917
shares of common stock reserved for potential future issuance pursuant to
a Committed Equity Financing Facility, as of March 31,
2009.
|
In this
offering, we are offering a maximum of 14,000,000 units, consisting of
14,000,000 shares of common stock and warrants to purchase up to an additional
7,000,000 shares of common stock. Each unit consists of one share of common
stock and a warrant to purchase 0.5 of a share of common stock at an exercise
price of $1.15 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. 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, except upon at least 61 days’ prior notice from the holder to us, 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 $1.15 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.
PLAN
OF DISTRIBUTION
We are
offering units through a placement agent, with each unit consisting of one share
of common stock and a warrant to purchase 0.5 of a share of common
stock. Subject to the terms and conditions contained in the placement
agent agreement, dated May 8, 2009, Lazard Capital Markets LLC has agreed to act
as the placement agent for the sale of up to an aggregate of 14,000,000 units.
The placement agent is not purchasing or selling any shares of common stock or
warrants by this prospectus supplement or the accompanying prospectus, nor is it
required to arrange for the purchase or sale of any specific number or dollar
amount of units, but has agreed to use its reasonable best efforts to arrange
for the sale of all units.
The
placement agent agreement provides that the obligations of the placement agent
and the investors are 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.
Confirmations
and definitive prospectuses will be distributed to all investors who agree to
purchase the units, informing investors of the closing date as to such units. We
currently anticipate that closing of the sale of units will take place on or
about May 13, 2009. Investors will also be informed of the date and manner in
which they must transmit the purchase price for their units.
On the
scheduled closing date, the following will occur:
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we
will receive funds in the amount of the aggregate purchase price;
and
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Lazard
Capital Markets LLC will receive the placement agent’s fee in accordance
with the terms of the placement agent
agreement.
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We will
pay the placement agent an aggregate cash commission equal to 6% of the gross
proceeds of the sale of units. We will also reimburse the placement agent for up
to $75,000 in legal expenses incurred by it in connection with this
offering. In addition, pursuant to an engagement letter between us
and the placement agent, the placement agent has a right of first refusal to act
as placement agent with respect to a public offering by us and to earn mutually
agreed upon compensation in connection therewith. The estimated
offering expenses payable by us, in addition to the placement agent’s fee of
$680,400, are approximately $200,000 which includes legal, accounting and
printing costs and various other fees associated with registering and listing
the common stock. After deducting certain fees due to the placement
agent and our estimated offering expenses, we expect the net proceeds from this
offering to be approximately $10.5 million.
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.
We have
agreed to indemnify the placement agent and 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 placement agent agreement. We have also agreed to contribute to
payments the placement agent and Lazard Frères & Co. LLC may be required to
make in respect of such liabilities.
We, along
with our executive officers and directors, have agreed to certain lock-up
provisions with regard to future sales of our common stock and other securities
convertible into or exercisable or exchangeable for common stock for a period of
ninety (90) days after the offering as set forth in the placement agent
agreement.
The
placement agent agreement is included as an exhibit to our Current Report on
Form 8-K that we will file with the SEC in connection with the consummation of
this offering.
The
transfer agent for our common stock to be issued in this offering is Continental
Stock Transfer & Trust Company.
Our common stock is traded on the
Nasdaq Global Market under the symbol “DSCO.”
LEGAL
MATTERS
The
validity of the issuance of the shares of common stock offered hereby will be
passed upon by Dickstein Shapiro LLP, New York, New York. Proskauer
Ross LLP, New York, New York, is acting as counsel for the placement agent in
connection with this offering.
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:
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Our
Annual Report on Form 10-K for the fiscal year ended December 31, 2008,
including the amendment thereto filed on April 30,
2009;
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Our
Current Reports on Form 8-K filed with the SEC on May 8, 2009, 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);
and
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The
description of our capital stock contained in our Registration Statements
on Form 8-A, filed on July 13, 1995 and on February 6,
2004.
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This
prospectus supplement does not contain all of the information set forth in the
registration statement, the exhibits, schedules and the prospectus attached
thereto. Please refer to the registration statement, the exhibits,
schedules and the prospectus attached thereto for further information with
respect to us and the common stock offered hereby. Statements
contained in this prospectus supplement 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. 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.
PROSPECTUS
$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.
|
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.
|
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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a
decrease in demand for our product candidates;
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damage
to our reputation; and
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an
inability to complete clinical trial programs or to commercialize our
product candidates, if approved.
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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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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 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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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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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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the
risk that we may not successfully and profitably market our
products;
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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);
|
|
·
|
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;
|
|
·
|
risks
relating to reimbursement and health care
reform;
|
|
·
|
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;
|
|
·
|
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;
|
|
·
|
the
risk that we may become involved in securities, product liability and
other litigation;
|
|
·
|
other
risks and uncertainties detailed in “Risk Factors” and in the documents
incorporated by reference in this prospectus.
|
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.
|
|
Fiscal
year Ended December 31,
|
|
Three Months
Ended
March 31,
2008
|
|
|
|
2003
|
|
2004
|
|
2005
|
|
2006
|
|
2007
|
|
|
|
|
|
(in
thousands)
|
|
Ratio
of earnings to fixed charges (1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Coverage
deficiency
|
|
$
|
(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.
|
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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·
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whether
the debt securities will be senior or subordinated;
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|
·
|
any
limit on the aggregate principal amount;
|
|
·
|
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;
|
|
·
|
whether
the debt securities will be issuable in the form of a global security;
|
|
·
|
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:
|
·
|
the
debt securities will be registered debt securities; and
|
|
·
|
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;
|
|
·
|
be
deposited with the depositary or nominee or custodian; and
|
|
·
|
bear
any required legends.
|
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
|
|
·
|
any
other circumstances described in a prospectus supplement.
|
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,
|
|
·
|
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.
|
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:
|
·
|
the
successor, if any, is a U.S. corporation, limited liability company,
partnership, trust or other entity;
|
|
·
|
the
successor assumes our obligations on the debt securities and under the
indenture;
|
|
·
|
immediately
after giving effect to the transaction, no default or event of default
shall have occurred and be continuing; and
|
|
·
|
certain
other conditions are met.
|
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;
|
|
·
|
reduce
the principal, premium, if any, or interest on any debt security;
|
|
·
|
reduce
the principal of an original issue discount security or any other debt
security payable on acceleration of maturity;
|
|
·
|
reduce
the rate of interest on any debt security;
|
|
·
|
change
the currency in which any debt security is payable;
|
|
·
|
impair
the right to enforce any payment after the stated maturity or redemption
date;
|
|
·
|
waive
any default or event of default in payment of the principal of, premium or
interest on any debt security;
|
|
·
|
waive
a redemption payment or modify any of the redemption provisions of any
debt security;
|
|
·
|
adversely
affect the right to convert any debt security in any material respect; or
|
|
·
|
change
the provisions in the indenture that relate to modifying or amending the
indenture.
|
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
|
|
·
|
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.
|
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:
|
·
|
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
|
|
·
|
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”.
|
We may
resume payments and distributions on subordinated debt securities:
|
·
|
in
the case of a payment default, upon the date on which such default is
cured or waived or ceases to exist; and
|
|
·
|
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.
|
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:
—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;
—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
—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.
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
14,000,000
Shares of Common Stock