Filed
pursuant to Rule 424(b)(5)
|
Registration
No. 333-151654
|
PROSPECTUS
SUPPLEMENT
|
(To
Prospectus dated June 18, 2008)
|
Per
Unit
|
Total
|
|||||||
Public
offering price
|
$ | 0.600 | $ | 16,500,000 | ||||
Underwriting
discount
|
$ | 0.042 | $ | 1,155,000 | ||||
Proceeds
to us (before expenses)
|
$ | 0.558 | $ | 15,345,000 |
Prospectus
Supplement
|
Page
|
Prospectus
|
Page
|
|||
About
this Prospectus Supplement
|
S-1
|
About
This Prospectus
|
1
|
|||
Prospectus
Supplement Summary
|
S-2
|
About
Discovery
|
1
|
|||
Forward-Looking
Statements
|
S-4
|
Risk
Factors
|
2
|
|||
Risk
Factors
|
S-6
|
Forward-Looking
Statements
|
20
|
|||
Recent
Developments
|
S-7
|
Use
of Proceeds
|
21
|
|||
Use
of Proceeds
|
S-9
|
Ratio
of Earnings to Fixed Charges
|
22
|
|||
Dilution
|
S-10
|
Description
of Debt Securities
|
22
|
|||
Description
of Securities We are Offering
|
S-11
|
Description
of Preferred Stock
|
30
|
|||
Underwriting
|
S-12
|
Description
of Common Stock
|
31
|
|||
Legal
Matters
|
S-14
|
Description
of Warrants
|
34
|
|||
Experts
|
S-14
|
Plan
of Distribution
|
36
|
|||
Where
You Can Find More Information and
|
Experts
|
37
|
||||
Incorporation
by Reference
|
S-14
|
Legal
Matters
|
37
|
|||
Annex
A: Form of Warrant
|
A-1
|
Where
You Can Find More Information
|
37
|
|||
Information
Incorporated by Reference
|
38
|
Common
Stock offered
|
27,500,000 shares | ||
Warrants
offered
|
Warrants to purchase up to 13,750,000 shares of common stock. The warrants are exercisable beginning on the date of original issuance and at any time up to the date that is five years after such date at an exercise price of $0.85 per share of common stock. This prospectus also relates to the offering of the shares of common stock issuable upon exercise of the warrants. | ||
Common
stock to be outstanding after this offering(1)
|
149,199,850 shares | ||
Risk
Factors
|
See "Risk Factors" beginning on page S-6 of this prospectus supplement and page 2 of the accompanying prospectus for a discussion of factors you should consider carefully when making an investment decision. | ||
Use
of proceeds
|
The net proceeds from this offering will be used for general corporate purposes, which may include: | ||
• |
Expenses related to resolving the
remaining issue (related to optimization and
revalidation of our fetal rabbit biological activity test (BAT, an
important quality control release and stability test) and establishing
that the BAT is capable of discriminating changes in
Surfaxin drug product over time) that must be addressed to secure
the potential approval of Surfaxin® for the prevention of RDS,
including implementing a comprehensive pre-clinical
program.
|
||
• | Expenses related to ongoing development of our Surfaxin LS™ and Aerosurf® programs, which, together with Surfaxin®, are focused on addressing the most significant respiratory conditions affecting pediatric populations, beginning with RDS. | ||
• | Expenses related to completing the final stages of our Phase 2 trials: to determine if restoration of surfactant with Surfaxin® will improve lung function and result in a shorter duration of mechanical ventilation and hospital stay for children up to two years of age suffering with Acute Respiratory Failure; and an investigator-initiated Phase 2a clinical trial in Cystic Fibrosis patients that has been designed to assess the safety, tolerability and short-term effectiveness of aerosolized KL4 surfactant in CF patients. | ||
See
"Use of Proceeds" on page S-9.
|
|||
The
Nasdaq Global Market Symbol
|
DSCO
|
(1)
|
The
number of shares of common stock to be outstanding immediately after this
offering as shown above is based on 121,699,850
shares of common stock outstanding as of September 30, 2009. This
number excludes the 13,750,000 shares issuable upon the exercise of the
warrants offered hereby and also excludes: (i) 16,020,134
shares of our common stock subject to options outstanding as of
September 30, 2009, which have a weighted average exercise price of $3.78
per share; (ii) 14,839,196
shares of common stock issuable upon exercise of warrants
outstanding as of September 30, 2009, at a weighted average exercise price
of $2.89; (iii) 34,419 shares of
common stock issuable upon the vesting of restricted stock awards
outstanding as of September 30, 2009; (iv) 239,022 shares of common stock
reserved for potential future issuance pursuant to our 401(k) Plan as of
September 30, 2009; and (v) 24,453,621 shares of common stock reserved for
potential future issuance pursuant to two Committed Equity Financing
Facilities, as of September 30,
2009.
|
•
|
risks
related generally to our efforts to gain regulatory approval, in the
United States and elsewhere, for our drug product candidates, including
our lead products that we are developing to address Respiratory
Distress Syndrome (RDS) in premature infants: Surfaxin® (lucinactant) for
the prevention of RDS, Surfaxin LS™ (our lyophilized KL4
surfactant) and Aerosurf® (our
initial aerosolized KL4
surfactant);
|
•
|
the
risk that we and the U.S. Food and Drug Administration (FDA) or other
regulatory authorities will not be able to agree on matters raised during
the regulatory review process, or that we may be required to conduct
significant additional activities to potentially gain approval of our
product candidates, if ever;
|
•
|
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
strategic development partners or pursuant to collaboration
arrangements;
|
•
|
the
risk that the FDA will not be satisfied with the results of our efforts to
optimize and revalidate our fetal rabbit biological activity test (BAT)
and to demonstrate that the BAT has the ability to distinguish change in
Surfaxin drug product over time, which is needed to advance our KL4 surfactant
pipeline;
|
•
|
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 preclinical studies and other efforts, and
potentially multiple clinical trials, which may be subject to potentially
significant delays or regulatory holds, or fail, and which must be
conducted using sophisticated and extensive analytical methodologies,
including an acceptable biological activity test, if required, as well as
other quality control release and stability tests to satisfy the
requirements of the regulatory
authorities;
|
•
|
risks
relating to our ability to develop and manufacture drug products and
drug-device combination products based on our capillary aerosolization
technology for clinical studies and, if approved, for commercialization of
our products;
|
•
|
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 product substances, capillary aerosolization devices
and related components and other materials on a timely basis or in an
amount sufficient to support our development efforts and, if our products
are approved,
commercialization;
|
•
|
the
risk that we may be unable to identify potential strategic partners or
collaborators with whom we can develop and, if approved, commercialize our
products in a timely manner, if at
all;
|
•
|
the
risk that we or our strategic partners or collaborators will not be able
to attract or maintain qualified
personnel;
|
•
|
the
risk that, if approved, market conditions, the competitive landscape or
otherwise may make it difficult to launch and profitably sell our
products;
|
•
|
the
risk that we, in a challenging financial market, may not be able to raise
additional capital or enter into strategic alliances or collaboration
agreements (including strategic alliances for development or
commercialization of our drug products and combination drug-device
products);
|
•
|
risks
that the unfavorable credit environment will adversely affect our ability
to fund our activities, that our share price will not reach or remain at
the price level necessary for us to access capital under our Committed
Equity Financing Facilities (CEFFs), that the CEFFs may expire before we
are able to access the full dollar amount potentially available
thereunder, and that additional equity financings could result in
substantial equity dilution;
|
•
|
the
risk that we will be unable to regain compliance with the Minimum Bid
Price Requirement of The Nasdaq Global Market prior to the expiration of
the grace period currently in effect, which could increase the probability
that our stock will be delisted from Nasdaq and cause our stock price to
decline;
|
•
|
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 products 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;
|
•
|
the
risk that the FDA may not approve Surfaxin® or
may subject the marketing of Surfaxin® to
onerous requirements that significantly impair marketing
activities;
|
•
|
the
risk that we may identify unforeseen problems that have not yet been
discovered or the FDA could in the future impose additional requirements
to gain approval of Surfaxin®;
and
|
•
|
other
risks and uncertainties, including those described in our most recent
Annual Report on Form 10-K, as amended, and other filings with the
Securities and Exchange Commission, on Forms 10-Q and 8-K, and any
amendments thereto.
|
·
|
Expenses
related to resolving the remaining issue (related
to optimization and revalidation of the BAT and establishing that the BAT
is capable of discriminating changes in Surfaxin®
drug product over time) that must be addressed to secure the
potential approval of Surfaxin®
for the prevention of RDS, including implementing a comprehensive
pre-clinical program.
|
·
|
Expenses
related to ongoing development of our Surfaxin LS™ and Aerosurf®
programs, which, together with Surfaxin, are focused on addressing
the most significant respiratory conditions affecting pediatric
populations, beginning with RDS. Surfaxin LS is a lyophilized
formulation of Surfaxin that is manufactured as a dry powder and
reconstituted as a liquid prior to administration and offers ease of
administration and other potential benefits. Aerosurf, our
KL4
surfactant in aerosolized form, is a drug-device combination product based
on our proprietary capillary aerosolization technology and potentially can
be administered without the invasive procedures that are required for the
currently-approved surfactants. Expenses related to Surfaxin LS
include our preclinical development program and costs to meet with the FDA
and the European regulatory authorities to discuss our proposed Phase 3
global registration clinical program. Expenses related to
Aerosurf include activities to advance our ongoing device development and
preclinical work and the costs of preparing an IND filing in anticipation
of our planned Phase 2 clinical program. We plan to initiate
the Surfaxin LS and Aerosurf clinical development programs after we have
secured additional capital resources in the form of strategic alliances or
other financial alternatives.
|
·
|
Expenses
related to completing the final stages of our Phase 2 trials: to determine
if restoration of surfactant with Surfaxin will improve lung function and
result in a shorter duration of mechanical ventilation and hospital stay
for children up to two years of age suffering with Acute Respiratory
Failure; and an investigator-initiated Phase 2a clinical trial in Cystic
Fibrosis patients that has been designed to assess the safety,
tolerability and short-term effectiveness of aerosolized KL4
surfactant in CF patients. Results from these trials are
anticipated in 2010.
|
Public offering
price per share included in each unit
|
$0.60
|
|||||||
Net
tangible book value per share as of September 30, 2009
|
|
$0.04
|
||||||
|
||||||||
Increase
per share after the offering
|
|
$0.10
|
|
|||||
|
||||||||
Pro
forma net tangible book value per share as of September 30, 2009, after
giving effect to this offering
|
$0.14
|
|
||||||
Dilution
per share to new investors
|
$0.46
|
·
|
16,020,134
shares of common stock issuable upon exercise of options outstanding as of
September 30, 2009, at a weighted average exercise price of $3.78 per
share;
|
·
|
14,839,196
shares of common stock issuable upon exercise of warrants outstanding as
of September 30, 2009, at a weighted average exercise price of
$2.89;
|
·
|
34,419
shares of common stock issuable upon the vesting of restricted stock
awards outstanding as of September 30,
2009;
|
·
|
239,022
shares of common stock reserved for potential future issuance pursuant to
our 401(k) Plan as of September 30, 2009;
and
|
·
|
24,453,621
shares of common stock reserved for potential future issuance pursuant
to two Committed Equity Financing Facilities, as of September 30,
2009.
|
Underwriter
|
Number of
Units
|
|||
Lazard
Capital Markets LLC
|
27,500,000 | |||
Total:
|
27,500,000 |
Per Unit
|
Total
|
|||||||
Public
offering price
|
$ | 0.600 | $ | 16,500,000 | ||||
Underwriting
discount
|
$ | 0.042 | $ | 1,155,000 | ||||
Proceeds,
before expenses, to us
|
$ | 0.558 | $ | 15,345,000 |
Net Number =
|
(A x B) - (A x C)
|
B
|
|
For purposes of the foregoing
formula:
|
A=
|
the
total number of shares with respect to which this Warrant is then being
exercised.
|
B=
|
the
arithmetic average of the Closing Sale Prices of the shares of Common
Stock for the five (5) consecutive Trading Days ending on the Trading Day
immediately preceding the date of the Exercise Notice.
|
C=
|
the
Exercise Price then in effect for the applicable Warrant Shares at the
time of such
exercise.
|
DISCOVERY
LABORATORIES, INC.
|
||
By:
|
||
Name:
|
||
Title:
|
|
____________
|
a
"Cash
Exercise" with respect to _________________ Warrant Shares;
and/or
|
|
____________
|
a
"Cashless
Exercise" with respect to _______________ Warrant
Shares.
|
Name
of Registered Holder
|
By:
|
||
Name:
|
||
Title:
|
DISCOVERY
LABORATORIES, INC
|
||
By:
|
||
Name:
|
||
Title:
|
Holder’s
Signature:
|
|||
Holder’s
Address:
|
|||
Signature
Guaranteed:
|
·
|
our
secured or unsecured debt securities, in one or more series, which may be
either senior, senior subordinated or subordinated debt securities;
|
·
|
shares
of our preferred stock in one or more series;
|
·
|
shares
of our common stock;
|
·
|
debt
warrants;
|
·
|
equity
warrants; and
|
·
|
any
combination of the foregoing.
|
Page
|
|
ABOUT
THIS PROSPECTUS
|
1
|
ABOUT
DISCOVERY
|
1
|
RISK
FACTORS
|
2
|
FORWARD-LOOKING
STATEMENTS
|
20
|
USE
OF PROCEEDS
|
21
|
RATIO
OF EARNINGS TO FIXED CHARGES
|
22
|
DESCRIPTION
OF DEBT SECURITIES
|
22
|
DESCRIPTION
OF PREFERRED STOCK
|
30
|
DESCRIPTION
OF COMMON STOCK
|
31
|
DESCRIPTION
OF WARRANTS
|
34
|
PLAN
OF DISTRIBUTION
|
36
|
EXPERTS
|
37
|
LEGAL
MATTERS
|
37
|
WHERE
YOU CAN FIND MORE INFORMATION
|
37
|
INFORMATION
INCORPORATED BY REFERENCE
|
38
|
·
|
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;
|
·
|
receive
the necessary regulatory approvals;
|
·
|
obtain
adequate supplies of surfactant active drug substances, manufactured to
our specifications and on commercially reasonable terms;
|
·
|
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;
|
·
|
successfully
resolve the remaining matters identified by the FDA in the May 1, 2008
Approvable Letter;
|
·
|
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;
|
·
|
successfully
develop and implement a manufacturing strategy for our aerosolization
systems and related materials to support clinical studies of Aerosurf;
and
|
·
|
obtain
capital necessary to fund our research and development efforts, including
our supportive operations, manufacturing and clinical trials
requirements.
|
·
|
slow
patient enrollment;
|
·
|
long
treatment time required to demonstrate
effectiveness;
|
·
|
lack
of sufficient clinical supplies and
material;
|
·
|
adverse
medical events or side effects in treated
patients;
|
·
|
lack
of compatibility with complementary
technologies;
|
·
|
failure
of a product candidate to demonstrate effectiveness;
and
|
·
|
lack
of sufficient funds.
|
·
|
the
number of clinical sites;
|
·
|
the
size of the patient population;
|
·
|
the
proximity of patients to the clinical
sites;
|
·
|
the
eligibility and enrollment criteria for the
study;
|
·
|
the
willingness of patients or their parents or guardians to participate in
the clinical trial;
|
·
|
the
existence of competing clinical trials;
|
·
|
the
existence of alternative available products;
and
|
·
|
geographical
and geopolitical considerations.
|
· |
the
need to make necessary modifications to qualify and validate a
facility;
|
· |
difficulties
with production and yields, including scale-up requirements and achieving
adequate capacity;
|
· |
availability
of raw materials and supplies;
|
· |
quality
control and assurance; and
|
· |
shortages
of qualified personnel.
|
· |
equipment
malfunctions or failures;
|
· |
technology
malfunctions;
|
· |
work
stoppages or slowdowns;
|
· |
damage
to or destruction of the facility;
|
· |
regional
power shortages; and
|
· |
product
tampering.
|
·
|
the
perceived safety and efficacy of our
products;
|
·
|
the
potential advantages over alternative
treatments;
|
·
|
the
prevalence and severity of any side
effects;
|
·
|
the
relative convenience and ease of
administration;
|
·
|
cost
effectiveness;
|
·
|
the
willingness of the target patient population to try new products and of
physicians to prescribe our
products;
|
·
|
the
effectiveness of our marketing strategy and distribution support;
and
|
·
|
the
sufficiency of coverage or reimbursement by third
parties.
|
·
|
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;
|
·
|
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;
|
·
|
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
|
·
|
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.
|
·
|
we
may be required to relinquish important rights to our products or product
candidates;
|
·
|
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;
|
·
|
our
distributors or collaborators may experience financial
difficulties;
|
·
|
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
|
·
|
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.
|
· |
announcements
of the results of clinical trials by us or our
competitors;
|
· |
patient
adverse reactions to drug products;
|
· |
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;
|
· |
changes
in the United States or foreign regulatory policy during the period of
product development;
|
· |
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;
|
· |
developments
in patent or other proprietary rights, including any third party
challenges of our intellectual property
rights;
|
· |
announcements
of technological innovations by us or our
competitors;
|
· |
announcements
of new products or new contracts by us or our competitors;
|
· |
actual
or anticipated variations in our operating results due to the level of
development expenses and other
factors;
|
· |
changes
in financial estimates by securities analysts and whether our earnings
meet or exceed the estimates;
|
· |
conditions
and trends in the pharmaceutical and other
industries;
|
· |
new
accounting standards; and
|
· |
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.
|
·
|
defend
our patents and otherwise prevent others from infringing on our
proprietary rights;
|
·
|
protect
trade secrets; and
|
·
|
operate
without infringing upon the proprietary rights of others, both in the
United States and in other
countries.
|
·
|
agreements
may be breached;
|
·
|
agreements
may not provide adequate remedies for the applicable type of
breach;
|
·
|
our
trade secrets or proprietary know-how may otherwise become known;
|
·
|
our
competitors may independently develop similar technology;
or
|
·
|
our
competitors may independently discover our proprietary information and
trade secrets.
|
·
|
developing
products;
|
·
|
undertaking
preclinical testing and human clinical trials;
|
·
|
obtaining
FDA and other regulatory approvals or products;
and
|
·
|
manufacturing
and marketing products.
|
·
|
uninsured
expenses related to defense or payment of substantial monetary awards to
claimants;
|
·
|
a
decrease in demand for our product candidates;
|
·
|
damage
to our reputation; and
|
·
|
an
inability to complete clinical trial programs or to commercialize our
product candidates, if approved.
|
· |
safe,
effective and medically necessary;
|
· |
appropriate
for the specific patient;
|
· |
cost-effective;
and
|
· |
neither
experimental nor investigational.
|
·
|
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;
|
·
|
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;
|
·
|
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;
|
·
|
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;
|
·
|
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;
|
·
|
risks
relating to the transfer of our manufacturing technology to third-party
contract manufacturers;
|
·
|
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;
|
·
|
the
risk that we may not successfully and profitably market our
products;
|
·
|
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;
|
·
|
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;
|
·
|
the
risk that we or our development partners, collaborators or marketing
partners will not be able to attract or maintain qualified
personnel;
|
·
|
the
risk that our product candidates will not gain market acceptance by
physicians, patients, healthcare payers and others in the medical
community;
|
·
|
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.
|
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.
|
·
|
whether
the debt securities will be senior or subordinated;
|
·
|
the
offering price;
|
·
|
the
title;
|
·
|
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;
|
·
|
the
date the principal will be payable;
|
·
|
the
interest rate, if any, the date interest will accrue, the interest payment
dates and the regular record dates;
|
·
|
the
place where payments may be made;
|
·
|
any
mandatory or optional redemption provisions;
|
·
|
if
applicable, the method for determining how the principal, premium, if any,
or interest will be calculated by reference to an index or formula;
|
·
|
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;
|
·
|
the
portion of the principal amount that will be payable upon acceleration of
stated maturity, if other than the entire principal amount;
|
·
|
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;
|
·
|
any
defeasance provisions if different from those described below under
“Satisfaction and Discharge; Defeasance;”
|
·
|
any
conversion or exchange provisions;
|
·
|
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;”
|
·
|
any
deletions of, or changes or additions to, the events of default or
covenants; and
|
·
|
any
other specific terms of such debt
securities.
|
·
|
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.
|
·
|
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
|
·
|
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.
|
·
|
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.
|
·
|
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;
|
·
|
an
event of default is continuing; or
|
·
|
any
other circumstances described in a prospectus supplement.
|
·
|
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
|
·
|
will
not be considered to be holders of those debt securities under the
indentures.
|
·
|
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.
|
·
|
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.
|
·
|
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.
|
·
|
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”.
|
·
|
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.
|
·
|
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;
|
·
|
our
indebtedness to any of our majority-owned subsidiaries; and
|
·
|
subordinated
debt securities.
|
·
|
the
title and stated value of the preferred stock;
|
·
|
the
number of shares of the preferred stock offered, the liquidation
preference per share and the purchase price of the preferred stock;
|
·
|
the
dividend rate(s), period(s) and/or payment date(s) or the method(s) of
calculation for dividends;
|
·
|
whether
dividends shall be cumulative or non-cumulative and, if cumulative, the
date from which dividends on the preferred stock shall accumulate;
|
·
|
the
procedures for any auction and remarketing, if any, for the preferred
stock;
|
·
|
the
provisions for a sinking fund, if any, for the preferred stock;
|
·
|
the
provisions for redemption, if applicable, of the preferred stock;
|
·
|
any
listing of the preferred stock on any securities exchange or market;
|
·
|
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;
|
·
|
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;
|
·
|
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;
|
·
|
whether
interests in the preferred stock will be represented by depositary shares;
|
·
|
the
relative ranking and preferences of the preferred stock as to dividend
rights and rights upon liquidation, dissolution or winding up of our
affairs;
|
·
|
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
|
·
|
any
other specific terms, preferences, rights, limitations or restrictions on
the preferred stock.
|
·
|
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;
|
·
|
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
|
·
|
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).
|
·
|
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;
|
·
|
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;
|
·
|
5,170,024
shares of common stock reserved for potential future issuance pursuant to
the 2006 CEFF.
|
·
|
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;
|
·
|
55,913
shares of common stock issuable upon the vesting of restricted stock
awards outstanding as of June 3,
2008;
|
·
|
4,695,625
shares of common stock available for future grant under our 2007 Long-Term
Incentive Plan; and
|
·
|
169,756
shares of common stock reserved for potential future issuance pursuant to
a 401(k) Plan, as of June 3, 2008.
|
·
|
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
|
·
|
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”).
|
·
|
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.
|
·
|
the
title of the debt warrants;
|
·
|
the
aggregate number of the debt
warrants;
|
·
|
the
price or prices at which the debt warrants will be
issued;
|
·
|
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;
|
·
|
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;
|
·
|
the
principal amount of debt securities purchasable upon exercise of each debt
warrant;
|
·
|
the
date on which the right to exercise the debt warrants will commence, and
the date on which this right will
expire;
|
·
|
the
maximum or minimum number of debt warrants which may be exercised at any
time;
|
·
|
a
discussion of any material federal income tax considerations;
and
|
·
|
any
other terms of the debt warrants and terms, procedures and limitations
relating to the exercise of debt
warrants.
|
·
|
the
title of the equity warrants;
|
·
|
the
securities (i.e., preferred stock or common stock) for which the equity
warrants are exercisable;
|
·
|
the
price or prices at which the equity warrants will be
issued;
|
·
|
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
|
·
|
any
other terms of the equity warrants, including terms, procedures and
limitations relating to the exchange and exercise of equity
warrants.
|
·
|
a
fixed price or prices, which may be
changed;
|
·
|
market
prices prevailing at the time of
sale;
|
·
|
prices
related to such prevailing market
prices;
|
·
|
varying
prices determined at the time of sale;
or
|
·
|
negotiated
prices.
|
1.
|
Our
Annual Report on Form 10-K for the fiscal year ended December 31, 2007,
filed on March 14, 2008;
|
2.
|
Our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2008, filed
on May 9, 2008;
|
3.
|
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;
|
4.
|
The
description of our common stock contained in our Registration Statement on
Form 8-A filed with the SEC on July 13, 1995;
and
|
5.
|
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.
|