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ý
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ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
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¨
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TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
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Delaware
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14-1902018
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(State
or Other Jurisdiction of Incorporation or Organization)
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(IRS
Employer Identification No.)
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2273
Research Boulevard, Suite 400, Rockville, Maryland
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20850
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(Address
of Principal Executive Offices)
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(Zip
Code)
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Title
of Each Class
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Name
of Each Exchange on Which Registered
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Common
stock, $0.001 par value per share
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New
York Stock Exchange
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Series
A junior participating preferred stock purchase rights
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New
York Stock Exchange
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PART
I
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Item
1.
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Item
1A.
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Item
1B.
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Item
2.
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Item
3.
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Item
4.
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PART
II
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Item
5.
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Item
6.
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Item
7.
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Item
7A.
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Item
8.
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Item
9.
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Item
9A.
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Item
9B.
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PART
III
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Item
10.
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Item
11.
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Item
12.
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Item
13.
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Item
14.
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PART
IV
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Item
15.
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·
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our
ability to perform under our contracts with the U.S. government for sales
of BioThrax® (Anthrax Vaccine Adsorbed), our FDA-approved anthrax vaccine,
including the timing of deliveries;
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our
plans for future sales of BioThrax, including our ability to obtain new
contracts with the U.S. government;
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our
plans to pursue label expansions and improvements for
BioThrax;
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our
ability to win a development award with the U.S. government for our
recombinant protective antigen anthrax vaccine product
candidate;
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our
ability to win an award with the U.S. government for the scale-up,
qualification and validation of our new manufacturing facility in Lansing,
Michigan for the manufacture of
BioThrax;
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our
plans to expand our manufacturing facilities and
capabilities;
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the
rate and degree of market acceptance and clinical utility of our
products;
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our
ongoing and planned development programs, preclinical studies and clinical
trials;
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our
ability to identify and acquire or in-license products and product
candidates that satisfy our selection
criteria;
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the
potential benefits of our existing collaborations and our ability to
selectively enter into additional collaborative
arrangements;
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the
timing of and our ability to obtain and maintain regulatory approvals for
our product candidates;
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our
commercialization, marketing and manufacturing capabilities and
strategy;
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our
intellectual property portfolio;
and
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our
estimates regarding expenses, future revenues, capital requirements and
needs for additional financing.
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state
and local governments, which we expect may be interested in these products
to protect emergency responders, such as police, fire and emergency
medical personnel;
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foreign
governments, including both defense and public health
agencies;
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non-governmental
organizations and multinational companies, including the U.S. Postal
Service and transportation and security companies;
and
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health
care providers, including hospitals and
clinics.
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Disease
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Product
or Candidate
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Description
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Stage
of Development
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Anthrax
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BioThrax
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The
only FDA approved vaccine for pre-exposure prevention of anthrax
disease
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FDA
approved
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rPA
vaccine*
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Pre/post-exposure
prophylactic
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Phase
II
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Double-mutant
rPA vaccine*
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Pre/post-exposure
prophylactic
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Preclinical
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Immune
globulin*
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Therapeutic
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Phase
I/ II
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Monoclonal
antibody*
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Therapeutic
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Preclinical
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Tuberculosis
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Tuberculosis
vaccine
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Prophylactic
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Phase
II
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Typhoid
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Typhella™
(typhoid
vaccine live oral ZH9)
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Prophylactic
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Phase
II
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Influenza
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Recombinant
virally vectored influenza vaccine
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Prophylactic
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Preclinical
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Chlamydia
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Chlamydia
vaccine
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Prophylactic
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Preclinical
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Reduced dosing schedule.
The CDC completed a clinical trial in December 2009 to evaluate
whether as few as three doses of BioThrax administered over six months,
with booster doses up to three years apart, will confer an adequate immune
response. The CDC trial assessed 1,563 healthy civilian men and women
between the ages of 18 and 61, randomized to one of six groups: Group A
(original vaccination schedule of 0, 2, 4 weeks, and 6, 12, 18 months with
annual boosters out to 42 months), Group B (same schedule as Group A, but
all vaccinations given by intramuscular route), Group C (same as Group B,
but with 2-week dose dropped), Group D (same as Group B, but with 2-week,
12- and 30-month doses dropped), Group E (same as Group B, but with
2-week, 12-, 19-, and 30-month doses dropped), and the control group that
received saline placebo. According to the statistical analysis
plan of the trial, a switch in the dosing schedule would be justified by
demonstrated non-inferiority of immune response of the test arm with a
modified vaccination schedule (Group C, D, or E) to the original approved
schedule (Group A). The primary endpoints for comparison to
determine non-inferiority were (1) geometric mean antibody titer (GMT),
(2) geometric mean antibody concentration (GMC), and (3) the proportion of
subjects achieving 4-fold increase in antibody titer after vaccination.
Noninferiority had to be demonstrated for all primary endpoints in order
to support the use of specific regimens. In accordance with applicable
regulatory guidance and the FDA’s recommendations to the CDC on trial
design, all non-inferiority tests were done at the 0.025 significance
level to insure that results were not due to random
variation. A conclusion of non-inferiority, to be accepted by
the FDA, required that the upper limits of 95% confidence intervals be
less than 1.5 for GMT and GMC ratios (i.e. Group A/Group C, D, or E) and
less than 0.1 for differences in proportions of subjects achieving 4-fold
increase in antibody titer (i.e. Group A – Group C, D, or
E). In this trial, the immunogenicity for Group C, Group
D, and Group E were all non-inferior to Group A for all primary
endpoints. Based on these results, we expect to file a
supplement to our BLA requesting a change in the label to vaccinate people
using a 0, 1, 6 month schedule, with triennial
boosters.
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Expanded label indication to
include post-exposure prophylaxis.
We plan to seek approval of
BioThrax for post-exposure prophylaxis against anthrax disease, to be
administered along with antibiotics. In October 2007, we
completed a human clinical trial of BioThrax for post-exposure indication
using the anticipated dosing schedule of three doses of BioThrax given two
weeks apart to collect data that, in combination with data from
our non-clinical studies, will be used to design our anticipated pivotal
human clinical trial. Emergent is employing he FDA animal rule to attempt
to demonstrate efficacy of BioThrax in an anthrax post-exposure
setting. We have conducted non-clinical studies for a
post-exposure indication to evaluate the effect of a humanized dose of
BioThrax in combination with antibiotics compared to antibiotics alone in
rabbits exposed by inhalation to anthrax
spores.
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BioThrax dual adjuvant
vaccine.
We are developing, in part with funding from
NIAID and BARDA, a product candidate based on BioThrax combined with CpG
7909, an adjuvant that we licensed from Pfizer, Inc. We anticipate that
this candidate will, among other things, have one or more of the following
advanced characteristics: reduced number of doses required to produce a
protective immune response, room temperature storage, enhanced immune
response, longer expiry dating or a novel delivery method. We previously
collaborated with Coley Pharmaceuticals, the owner of CpG 7909 before its
sale to Pfizer, to conduct a double-blind Phase I clinical trial of
BioThrax combined with CpG 7909 that was funded by DARPA. That trial,
which was completed in 2005 and involved 69 healthy volunteers, was
designed to evaluate the safety and immunogenicity of this product
candidate compared to BioThrax alone and to CpG 7909 alone. In this Phase
I trial, the product candidate was administered in three doses by
intramuscular injection at two week intervals, and elicited an enhanced
immune response. We have obtained additional U.S. government funding to
supplement the further development of this vaccine product
candidate.
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rPA vaccine
.
We are developing
a recombinant form of the protective antigen protein as an anthrax
vaccine. This vaccine contains purified rPA formulated with an aluminum
hydroxide adjuvant and is designed to induce antibodies that neutralize
anthrax toxins in a manner similar to BioThrax. The vaccine product
candidate is based on development work at USAMRIID. Our rPA vaccine
product candidate has been the subject of two research and development
grants from NIAID totaling approximately $100 million. It has also been
evaluated in one Phase II clinical trial, but this trial did not achieve
statistically significant results due to product stability
issues. We believe these stability issues have since been
resolved, and that future trials will not be adversely affected by
stability concerns. In December 2009, BARDA cancelled a
previously issued procurement request for proposal, or RFP, for an rPA
vaccine for the SNS in favor of a Broad Agency Announcement, or BAA, for
rPA vaccine development. We submitted a proposal responding to the BAA in
January 2010 to develop our product
candidate.
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Double-mutant rPA vaccine.
We are developing an anthrax vaccine product candidate based on a
double-mutant form of rPA, or dmPA, combined with CpG 7909 and Alhydrogel,
an aluminum hydroxide adjuvant. In September 2009, we received
an award from NIAID under the American Recovery and Reinvestment Act that
included funding for development of a dry powder formulation and for the
manufacture of bulk drug substance and final drug product in a current
Good Manufacturing Practice, or cGMP, environment. We expect
our development efforts for this product candidate to continue throughout
2010.
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Immune globulin therapeutic.
We are developing a human anthrax immune globulin, or AIG,
therapeutic product candidate, which is a polyclonal antibody therapeutic,
as a treatment for patients who have been exposed to anthrax spores and
who present with symptoms of anthrax disease. We expect that, if approved,
this product candidate would be prescribed as an intravenous infusion
either as a monotherapy or in conjunction with a regimen of antibiotics.
We are developing our anthrax immune globulin therapeutic product
candidate using plasma produced by healthy donors who have been immunized
with BioThrax. We have engaged Talecris Biotherapeutics, Inc. to
fractionate, purify and fill our AIG at its FDA-approved facilities, and
have manufactured three full-scale lots under cGMP conditions using the
validated and approved process at Talecris. We plan to rely on the FDA’s
animal rule to support approval of this product
candidate.
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Monoclonal antibody
therapeutic.
We are developing a human monoclonal
antibody therapeutic product candidate as an intravenous treatment for
patients who present with symptoms of anthrax disease. The
development of this product candidate is being funded in part by BARDA
under our contract with NIAID to support efficacy testing in non-clinical
studies and the establishment of a cGMP manufacturing
process. We expect to file an Investigational New Drug
Application, or IND, in 2010 for a Phase I clinical trial to evaluate the
safety and pharmacokinetics this product candidate in healthy human
volunteers.
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An
open-label, non-placebo controlled, pilot study conducted in the United
Kingdom in nine healthy adult volunteers. The purpose of this study was to
evaluate the safety and immunogenicity of our vaccine product candidate.
In this study, Typhella was immunogenic, eliciting both cell mediated and
humoral immune responses, and well
tolerated.
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A
double-blind, placebo controlled, single dose escalating Phase I clinical
trial conducted in the United States in 60 healthy adult volunteers. The
purpose of this trial was to evaluate the safety, tolerability and
immunogenicity of three dose levels of our vaccine product candidate. In
this trial, Typhella was immunogenic and well tolerated at all dose
levels.
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An
open-label, non-placebo controlled, single dose Phase I clinical trial
conducted in the United States in 32 healthy adult volunteers. The purpose
of this trial was to evaluate the safety and immunogenicity of two
different presentations of Typhella, one using bottled water and another
using tap water for reconstitution before administration. We vaccinated 16
subjects with each presentation. Because the two presentations were
similarly immunogenic and both were well tolerated by trial participants,
we selected the tap water presentation for further development based on
its relative convenience.
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A
single-blind, placebo controlled Phase I clinical trial of Typhella in
Vietnam in 27 healthy adult volunteers using the dose and regimen
established in our Phase I clinical trials in the United States. The
Wellcome Trust provided funding for the Phase I trial in Vietnam. The
purpose of the trial was to evaluate the safety and immunogenicity of
Typhella when administered as a single oral dose in adults living in an
endemic area. The primary immunogenicity endpoint for this trial was the
proportion of trial participants with an immune response to
Salmonella typhi
following administration of a single oral dose of
Typhella. Based on initial data from this trial, Typhella met
the criterion for immunogenicity, with approximately 68% of subjects who
received the vaccine product candidate mounting a humoral antibody
response. Typhella was well tolerated by trial participants, with no
serious adverse events reported.
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A
single-blind randomized, placebo controlled, Phase II clinical trial of
Typhella in Vietnam in 151 healthy children between the ages of 5 and 14
years. A total of 101 children received Typhella and 50 children received
placebo. This was our first trial involving a pediatric population. We
conducted this trial in collaboration with the Wellcome Trust, Oxford
University and the Hospital for Tropical Diseases, Ho Chi Minh City,
Vietnam. The Wellcome Trust provided funding for this trial. The purpose
of this trial was to evaluate the safety and immunogenicity of Typhella in
children in an endemic area. The immunogenicity parameter for this trial
was the percentage of trial participants with an immune response to
Salmonella typhi
following administration of a single oral dose of Typhella. In this
trial, 93% of the children receiving a vaccine dose developed an immune
response as measured by increases in serum
Salmonella typhi
LPS-specific IgG antibody levels, 94% of the children receiving a
vaccine dose developed an immune response as measured by increase in serum
Salmonella typhi
LPS-specific IgA antibody levels, and 97% of the children receiving
a vaccine dose developed an immune response, which was statistically
significantly greater than the percentage of children receiving placebo
who developed an immune response. Typhella was well tolerated by trial
participants, with no serious adverse events
reported.
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A
randomized, double blind, placebo controlled, single dose, dose escalating
Phase II clinical trial conducted in the United States in 187 healthy
adult volunteers. The purpose of this trial was to determine the
immunogenicity, safety and tolerability of the vaccine product candidate
manufactured at a new facility at dose levels across the range of the
proposed manufacturing potency specification. The primary
immunogenicity endpoint for this trial was the proportion of trial
participants with an immune response to
Salmonella typhi
following administration of a single oral dose of Typhella. In this
trial, the vaccine was immunogeneic and well tolerated across the range of
doses tested.
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Phase II clinical trial.
We plan to conduct a Phase II clinical trial in India in children
under five years of age as a step towards conducting a Phase III clinical
trial in an area where the incidence of disease is prevalent. The purpose
of this Phase II trial is to evaluate the safety and immunogenicity of
Typhella in this endemic population in preparation for our planned Phase
III clinical trial.
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Challenge study
. We
plan to initiate a vaccine protection study using a human challenge model,
pending the provision of funding by Oxford to establish that
model.
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Disease surveillance study.
We plan to conduct a disease surveillance study in India to confirm
that a sufficient number of subjects will be included in our planned Phase
III clinical trial. The Wellcome Trust has provided funding for a portion
of this surveillance study.
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Phase III clinical trial.
We plan to conduct a single-blind Phase III clinical trial in
India, where typhoid is endemic. The purpose of this trial will be to
evaluate the efficacy of Typhella in children who are likely to be exposed
to the typhoid bacterium. We expect to undertake the primary analysis of
the data from the trial after approximately one year, which, if the
results are favorable, we plan to use the data to support the filing with
the FDA of a BLA for marketing approval of Typhella. We plan to continue
to monitor the incidence of typhoid in the trial participants for several
years after vaccination. We are currently seeking external funding to
support this trial.
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Tolerability and
immunogenicity study.
Concurrently with our planned Phase III
clinical trial in India, we plan to conduct a Phase III clinical trial in
the United States or Europe in healthy volunteers. The purpose of this
trial will be to evaluate the safety and immunogenicity of Typhella to
support marketing approval in the United States and Europe. It
is not practicable to demonstrate clinical efficacy in travelers from the
United States or Europe due to the prohibitively large number of subjects
that would be needed. We will seek to establish an immune correlate of
protection in the Phase III efficacy trial to allow us to extrapolate
efficacy to developed world populations. The currently approved
typhoid vaccines relied on similar clinical trials for regulatory
approval.
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the
need for significant, long-term investment in research and
development;
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the
importance of manufacturing capacity, capability and specialty know-how,
such as techniques, processes and biological starting materials;
and
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the
high regulatory burden for prophylactic products, which generally are
administered to healthy people.
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BioThrax.
Although
BioThrax is the only product approved by the FDA for human use for the
prevention of anthrax infection, we face significant potential competition
for the supply of anthrax vaccines to the U.S. government. Various
agencies of the U.S. government are providing funding to our competitors
for development of an anthrax vaccine based on recombinant protective
antigen. In addition, the United Kingdom Health Protection Agency, or HPA,
manufactures an anthrax vaccine for use by the government of the United
Kingdom. Other countries as well may have anthrax vaccines for use by or
in development for their own internal
purposes.
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rPA vaccine.
PharmAthene is currently developing a recombinant protective antigen based
anthrax vaccine. BARDA has awarded a modification to an existing
development contract to PharmAthene to fund the development of their rPA
vaccine. Panacea is also developing an rPA
vaccine.
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BioThrax related programs and
d
ouble-mutant rPA
vaccine
. PharmAthene is currently developing a recombinant
protective antigen based anthrax vaccine as well as a third-generation
anthrax vaccine.
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Anthrax immune globulin and
monoclonal antibody therapeutic
.
Cangene is currently
developing an anthrax immune globulin therapeutic based on plasma
collected from military personnel who have been vaccinated with BioThrax;
Human Genome Sciences is developing a monoclonal antibody to
Bacillus anthracis,
referred to as ABthrax
™
,
as a post-exposure therapeutic for anthrax infection; Elusys Therapeutics
is developing a monoclonal antibody to
Bacillus anthracis,
known as Anthim
™
,
as a pre-exposure and post-exposure prophylaxis against anthrax infection,
as well as an active treatment of disease; and PharmAthene and Medarex are
collaborating to develop a human antibody to
Bacillus anthracis,
known as Valortim
™
,
to protect human cells from damage by anthrax toxins. The FDA has granted
Fast Track designation and orphan drug status for ABthrax and Valortim.
HHS awarded development and procurement contracts to Human Genome Sciences
and Cangene to supply their anthrax therapeutics for evaluation of
efficacy as a post-exposure therapeutic for anthrax
infection.
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Typhella (typhoid vaccine live
oral ZH9).
One oral typhoid vaccine and one type of injectable
typhoid vaccine are currently approved and administered in the United
States and Europe. In addition, combination vaccines are available for the
prevention of hepatitis A and typhoid infections. Antibiotics typically
are used to treat typhoid after infection. Vi-conjugable injectable
vaccines are also in development.
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Tuberculosis vaccine.
The Aeras Global Tuberculosis Vaccine Foundation is developing or
supporting the development of five tuberculosis vaccine product
candidates, one of which is in a Phase II clinical trial, and the rest of
which are either in Phase I clinical trials or close to commencing Phase I
clinical trials. The Aeras Global Tuberculosis Vaccine Foundation is also
the sponsor of the Phase IIb clinical trial of our tuberculosis vaccine
product candidate.
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Influenza vaccine
.
Seasonal and pandemic influenza vaccines produced using conventional
egg-based manufacturing methodologies have been licensed and are being
sold in both the United States and internationally by GlaxoSmith Kline,
Novartis, MedImmune and others. Several flu vaccine
manufacturers are transitioning the production of their seasonal and
pandemic vaccines from egg-based processes to cell culture in an effort to
increase supply of these products. These cell culture-based
products are in various stages of advanced development. New
influenza vaccines containing hemagglutinin (HA) antigens and/or other flu
antigens produced using recombinant DNA technology and/or incorporate
adjuvants are also under development. Some of these second
generation flu vaccine candidates are in clinical
development.
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Chlamydia vaccine.
There is no vaccine currently on the market for chlamydia. Although
we are not aware of any competing chlamydia vaccine product candidate in
clinical development, competitors may have chlamydia vaccine product
candidates in preclinical development. Screening tests and targeted
antibiotic treatments have been effective at containing chlamydia in the
United States and Europe, which may have the effect of decreasing demand
for a vaccine.
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Typhella (typhoid vaccine).
We hold four U.S. patents relating to Typhella. These patents have
claims to the composition of matter of the vaccine product candidate and
methods of use of live attenuated
Salmonella typhi
bacteria as vaccines for the treatment and prevention of typhoid
and for the delivery of vaccine antigens. In addition, we have two pending
U.S. patent applications with claims to additional compositions and
methods of therapy that are generally related to Typhella. Our issued U.S.
patents expire, and, if issued, our U.S. patent applications would expire,
between 2015 and 2020. We hold 107 foreign counterpart patents to our
issued U.S. patents relating to Typhella, including counterparts under the
European Patent Convention and in Japan, that expire, and 14 foreign
patent applications that, if issued, would expire, between 2015 and 2020.
Additional patents relating to Typhella and delivery of vaccine antigens
are discussed below under “STM
technology.”
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STM technology.
We own
four U.S. patents with claims to methods for the identification of
virulence genes using our signature tagged mutagenesis, or STM,
technology, which we used to identify and develop the gene mutations that
form the basis of our typhoid vaccine product candidate. In
addition, we have one pending U.S. patent application with additional
claims to methods for identifying virulence genes using our STM
technology. We also own 50 foreign counterpart patents,
including counterparts under the European Patent Convention and in Japan.
These patents relating to the STM method will expire in 2015. We also hold
14 foreign patent applications that, if issued would expire in 2015. Our
rights under these patents are licensed on a limited non-exclusive basis
to third parties to practice the STM method with respect to specific
microorganisms, not including
Salmonella typhi
or
hepatitis virus.
|
|
|
·
|
laboratory
and preclinical tests, including animal
testing;
|
|
|
·
|
submission
to the FDA of an Investigational New Drug application, or IND, which must
become effective before clinical trials may
begin;
|
|
|
·
|
completion
of human clinical trials and other studies evaluating the safety and
efficacy of the proposed product for each intended
use;
|
|
|
·
|
FDA
inspection of facilities in which the product is manufactured, processed,
filled, packed and held to determine compliance with cGMP;
and
|
|
|
·
|
submission
to the FDA and approval of an NDA, in the case of a drug, or a BLA
containing, among other things, preclinical, nonclinical and clinical
data; proposed labeling; and information to demonstrate that
the product will be safe and effective (in the case of an NDA) or safe,
pure and potent (in the case of a BLA), and manufactured to appropriate
standards of identity, purity and
quality.
|
|
|
·
|
In
a Phase I clinical trial, the drug or biologic is initially administered
into healthy human subjects or subjects with the target condition and
tested for safety, dosage tolerance, absorption, distribution, metabolism
and excretion.
|
|
|
·
|
In
a Phase II clinical trial, the drug or biologic is administered to a
limited subject population to identify possible adverse effects and safety
risks, and preliminary information related to the efficacy of the product
for specific targeted diseases, dosage tolerance and optimal
dosage.
|
|
|
·
|
A
Phase III clinical trial is undertaken if a Phase II clinical trial
demonstrates that a dosage range of the drug has the potential to be
effective and appears to potentially have an acceptable safety profile. In
a Phase III clinical trial, the drug or biologic is administered to an
expanded population, often at geographically dispersed clinical trial
sites, to further evaluate the dosage amount(s), clinical efficacy, and
safety. Prior to commencing Phase III clinical trials , many sponsors
elect to meet with FDA officials to discuss the conduct and design of the
proposed trial or trials.
|
|
|
·
|
recordkeeping
requirements;
|
|
|
·
|
periodic
reporting requirements;
|
|
|
·
|
cGMP
requirements related to all stages of manufacturing, testing, storage,
packaging, labeling and distribution of finished dosage forms of the
product;
|
|
|
·
|
reporting
of adverse experiences with the product;
and
|
|
|
·
|
advertising
and promotion restrictions.
|
|
|
·
|
restrictions
on the marketing or manufacturing of a
product;
|
|
|
·
|
Warning
Letters or Untitled Letters from the FDA asking us, our collaborators or
third party contractors to take or refrain from taking certain
actions;
|
|
|
·
|
withdrawal
of the product from the market;
|
|
|
·
|
FDA’s
refusal to approve pending applications or supplements to approved
applications;
|
|
|
·
|
voluntary
or mandatory product recall;
|
|
|
·
|
fines
or disgorgement of profits or
revenue;
|
|
|
·
|
suspension
or withdrawal of regulatory
approvals;
|
|
|
·
|
refusal
to permit the import or export of
products;
|
|
|
·
|
product
seizure; and
|
|
|
·
|
injunctions
or the imposition of civil or criminal
penalties.
|
|
|
·
|
the
agent for which the countermeasure is designed can cause serious or
life-threatening disease;
|
|
|
·
|
the
product may reasonably be believed to be effective in detecting,
diagnosing, treating or preventing the
disease;
|
|
|
·
|
the
known and potential benefits of the product outweigh its known and
potential risks; and
|
|
|
·
|
there
is no adequate alternative to the product that is approved and
available.
|
|
|
·
|
develop
and implement biosafety, security and emergency response
plans;
|
|
|
·
|
restrict
access to select agents and toxins;
|
|
|
·
|
provide
appropriate training to our employees for safety, security and emergency
response;
|
|
|
·
|
comply
with strict requirements governing transfer of select agents and
toxins;
|
|
|
·
|
provide
timely notice to the government of any theft, loss or release of a select
agent or toxin; and
|
|
|
·
|
maintain
detailed records of information necessary to give a complete accounting of
all activities related to select agents and
toxins.
|
| ITEM 1A. | RISK FACTORS |
|
|
·
|
the
need to devote substantial time and attention of management and key
employees to the preparation of bids and proposals for contracts that may
not be awarded to us;
|
|
|
·
|
the
need to accurately estimate the resources and cost structure that will be
required to perform any contract that we might be
awarded;
|
|
|
·
|
that
we may be ineligible to respond to a request for proposal issued by the
government;
|
|
|
·
|
that
third parties could submit protests to our responses to requests for
proposal that could result in delays or withdrawals of those requests for
proposal; and
|
|
|
·
|
that
we may incur or could suffer expenses or delays if our competitors protest
or challenge contract awards made to us pursuant to competitive bidding
and that any such protest or challenge would result in the resubmission of
bids based on modified specifications, or in termination, reduction or
modification of the awarded
contract.
|
|
|
·
|
procurement
integrity;
|
|
|
·
|
export
control;
|
|
|
·
|
government
security regulations;
|
|
|
·
|
employment
practices;
|
|
|
·
|
protection
of the environment;
|
|
|
·
|
accuracy
of records and the recording of
costs; and
|
|
|
·
|
foreign
corrupt practices.
|
|
|
·
|
terminate
existing contracts, in whole or in part, for any reason or no
reason;
|
|
|
·
|
unilaterally
reduce or modify contracts or subcontracts, including equitable price
adjustments;
|
|
|
·
|
cancel
multi-year contracts and related orders if funds for contract performance
for any subsequent year become
unavailable;
|
|
|
·
|
decline
to exercise an option to renew a
contract;
|
|
|
·
|
exercise
an option to purchase only the minimum amount, if any, specified in a
contract;
|
|
|
·
|
decline
to exercise an option to purchase the maximum amount, if any, specified in
a contract;
|
|
|
·
|
claim
rights to products, including intellectual property, developed under the
contract;
|
|
|
·
|
take
actions that result in a longer development timeline than
expected;
|
|
|
·
|
direct
the course of a development program in a manner not chosen by the
government contractor;
|
|
|
·
|
suspend
or debar the contractor from doing business with the government or a
specific government agency;
|
|
|
·
|
pursue
criminal or civil remedies under the False Claims Act and False Statements
Act; and
|
|
|
·
|
control
or prohibit the export of products.
|
|
|
·
|
requiring
us to dedicate a substantial portion of any cash flow from operations to
the payment of interest on, and principal of, our debt, which will reduce
the amounts available to fund working capital, capital expenditures,
product development efforts and other general corporate
purposes;
|
|
|
·
|
increasing
the amount of interest that we have to pay on debt with variable interest
rates if market rates of interest
increase;
|
|
|
·
|
increasing
our vulnerability to general adverse economic and industry
conditions;
|
|
|
·
|
limiting
our flexibility in planning for, or reacting to, changes in our business
and the industry in which we
compete; and
|
|
|
·
|
placing
us at a competitive disadvantage compared to our competitors that have
less debt.
|
|
|
·
|
the
level and timing of BioThrax product sales and cost of product
sales;
|
|
|
·
|
the
acquisition of, and capital improvements to, new
facilities;
|
|
|
·
|
the
timing of, and the costs involved in, completion of qualification and
validation activities related to our manufacturing facility in Lansing,
Michigan, the build out of our new manufacturing facility in Baltimore,
and any other new facilities;
|
|
|
·
|
the
scope, progress, results and costs of our preclinical and clinical
development activities;
|
|
|
·
|
the
costs, timing and outcome of regulatory review of our product
candidates;
|
|
|
·
|
the
number of, and development requirements for, other product candidates that
we may pursue;
|
|
|
·
|
the
costs of commercialization activities, including product marketing, sales
and distribution;
|
|
|
·
|
the
extent to which we lend money to third
parties;
|
|
|
·
|
the
costs involved in preparing, filing, prosecuting, maintaining and
enforcing patent claims and other patent-related costs, including
litigation costs and the results of such
litigation;
|
|
|
·
|
the
extent to which we acquire or invest in companies, businesses, products
and technologies;
|
|
|
·
|
our
ability to obtain development funding from government entities and
non-government and philanthropic
organizations; and
|
|
|
·
|
our
ability to establish and maintain
collaborations.
|
|
|
·
|
equipment
malfunctions or failures;
|
|
|
·
|
technology
malfunctions;
|
|
|
·
|
work
stoppages or slow downs;
|
|
|
·
|
protests,
including by animal rights
activists;
|
|
|
·
|
damage
to or destruction of the facility;
|
|
|
·
|
regional
power shortages; or
|
|
|
·
|
product
tampering.
|
|
|
·
|
fines,
injunctions and civil penalties;
|
|
|
·
|
refusal
by regulatory authorities to grant marketing approval of our product
candidates;
|
|
|
·
|
delays,
suspension or withdrawal of regulatory approvals, including license
revocation;
|
|
|
·
|
seizures
or recalls of product candidates or
products;
|
|
|
·
|
operating
restrictions; and
|
|
|
·
|
criminal
prosecutions.
|
|
|
·
|
successful
development, formulation and cGMP scale-up of biological manufacturing
that meets FDA requirements;
|
|
|
·
|
successful
development of animal models by the
U.S. government;
|
|
|
·
|
successful
completion of non-clinical development, including studies in approved
animal models;
|
|
|
·
|
the
expense of filing, prosecuting, defending and enforcing any patent claims
and other intellectual property
rights;
|
|
|
·
|
successful
completion of clinical trials;
|
|
|
·
|
receipt
of marketing approvals from the FDA and similar foreign regulatory
authorities;
|
|
|
·
|
a
determination by the Secretary of HHS that our biodefense product
candidates should be purchased for the SNS prior to FDA
approval;
|
|
|
·
|
establishing
commercial manufacturing processes of our own or arrangements with
contract manufacturers;
|
|
|
·
|
manufacturing
stable commercial supplies of product candidates, including materials
based on recombinant technology;
|
|
|
·
|
launching
commercial sales of the product, whether alone or in collaboration with
others; and
|
|
|
·
|
acceptance
of the product by potential government customers, physicians, patients,
healthcare payors and others in the medical
community.
|
|
|
·
|
regulators
or institutional review boards may not authorize us to commence a clinical
trial or conduct a clinical trial at a prospective trial
site;
|
|
|
·
|
we
may decide, or regulators may require us, to conduct additional
preclinical testing or clinical trials, or we may abandon projects that we
expect to be promising, if our preclinical tests, clinical trials or
animal efficacy studies produce negative or inconclusive
results;
|
|
|
·
|
we
might have to suspend or terminate our clinical trials if the participants
are being exposed to unacceptable health
risks;
|
|
|
·
|
regulators
or institutional review boards may require that we hold, suspend or
terminate clinical development for various reasons, including
noncompliance with regulatory
requirements;
|
|
|
·
|
the
cost of our clinical trials could escalate and become cost
prohibitive;
|
|
|
·
|
any
regulatory approval we ultimately obtain may be limited or subject to
restrictions or post-approval commitments that render the product not
commercially viable;
|
|
|
·
|
we
may not be successful in recruiting a sufficient number of qualifying
subjects for our clinical
trials; and
|
|
|
·
|
the
effects of our product candidates may not be the desired effects or may
include undesirable side effects or the product candidates may have other
unexpected characteristics.
|
|
|
·
|
be
delayed in obtaining marketing approval for our product
candidates;
|
|
|
·
|
not
be able to obtain marketing
approval; or
|
|
|
·
|
obtain
approval for indications that are not as broad as
intended.
|
|
|
·
|
the
prevalence and severity of any side
effects;
|
|
|
·
|
the
efficacy and potential advantages over alternative
treatments;
|
|
|
·
|
the
ability to offer our product candidates for sale at competitive
prices;
|
|
|
·
|
the
relative convenience and ease of
administration;
|
|
|
·
|
the
willingness of the target patient population to try new products and of
physicians to prescribe these
products;
|
|
|
·
|
the
strength of marketing and distribution
support; and
|
|
|
·
|
the
sufficiency of coverage or reimbursement by third
parties.
|
|
|
·
|
decreased
demand for any product candidates or products that we may
develop;
|
|
|
·
|
injury
to our reputation;
|
|
|
·
|
withdrawal
of clinical trial participants;
|
|
|
·
|
withdrawal
of a product from the market;
|
|
|
·
|
costs
to defend the related litigation;
|
|
|
·
|
substantial
monetary awards to trial participants or
patients;
|
|
|
·
|
loss
of revenue; and
|
|
|
·
|
the
inability to commercialize any products that we may
develop.
|
|
|
·
|
a
covered benefit under its health
plan;
|
|
|
·
|
safe,
effective and medically necessary;
|
|
|
·
|
appropriate
for the specific patient;
|
|
|
·
|
cost-effective; and
|
|
|
·
|
neither
experimental nor investigational.
|
|
|
·
|
termination
of contracts;
|
|
|
·
|
forfeiture
of profits;
|
|
|
·
|
suspension
of payments;
|
|
|
·
|
fines; and
|
|
|
·
|
suspension
or prohibition from conducting business with the
U.S. government.
|
|
|
·
|
the
Federal Acquisition Regulations, and agency-specific regulations
supplemental to the Federal Acquisition Regulations, which comprehensively
regulate the procurement, formation, administration and performance of
government contracts;
|
|
|
·
|
the
business ethics and public integrity obligations, which govern conflicts
of interest and the hiring of former government employees, restrict the
granting of gratuities and funding of lobbying activities and incorporate
other requirements such as the Anti-Kickback Act and the
FCPA;
|
|
|
·
|
export
and import control laws and
regulations; and
|
|
|
·
|
laws,
regulations and executive orders restricting the use and dissemination of
information classified for national security purposes and the exportation
of certain products and technical
data.
|
|
|
·
|
restrictions
on the marketing or manufacturing of a
product;
|
|
|
·
|
warning
letters;
|
|
|
·
|
withdrawal
of the product from the market;
|
|
|
·
|
refusal
to approve pending applications or supplements to approved
applications;
|
|
|
·
|
voluntary
or mandatory product recall;
|
|
|
·
|
fines
or disgorgement of profits or
revenue;
|
|
|
·
|
suspension
or withdrawal of regulatory approvals, including license
revocation;
|
|
|
·
|
shut
down, or substantial limitations of the operations in, manufacturing
facilities;
|
|
|
·
|
refusal
to permit the import or export of
products;
|
|
|
·
|
product
seizure; and
|
|
|
·
|
injunctions
or the imposition of civil or criminal
penalties.
|
|
|
·
|
our
collaboration agreements are likely to be for fixed terms and subject to
termination by our collaborators in the event of a material breach by
us;
|
|
|
·
|
our
collaborators may have the first right to maintain or defend our
intellectual property rights and, although we may have the right to assume
the maintenance and defense of our intellectual property rights if our
collaborators do not do so, our ability to maintain and defend our
intellectual property rights may be compromised by our collaborators’ acts
or omissions;
|
|
|
·
|
our
collaborators may utilize our intellectual property rights in such a way
as to invite litigation that could jeopardize or invalidate our
intellectual property rights or expose us to potential
liability; or
|
|
|
·
|
our
collaborators may decide not to continue to work with us in the
development of product candidates.
|
|
|
·
|
we
may be unable to license or acquire the relevant technology on terms that
would allow us to make an appropriate return on the
product;
|
|
|
·
|
companies
that perceive us to be their competitor may be unwilling to assign or
license their product rights to
us; or
|
|
|
·
|
we
may be unable to identify suitable products or product candidates within
our areas of expertise.
|
|
|
·
|
use
of cash resources;
|
|
|
·
|
higher
than anticipated acquisition costs and
expenses;
|
|
|
·
|
potentially
dilutive issuances of equity
securities;
|
|
|
·
|
the
incurrence of debt and contingent liabilities, impairment losses or
restructuring charges;
|
|
|
·
|
large
write-offs and difficulties in assessing the relative percentages of
in-process research and development expense that can be immediately
written off as compared to the amount that must be amortized over the
appropriate life of the
asset; and
|
|
|
·
|
amortization
expenses related to other intangible
assets.
|
|
|
·
|
challenges
associated with managing an increasingly diversified
business;
|
|
|
·
|
prioritizing
product portfolios;
|
|
|
·
|
disruption
of our ongoing business;
|
|
|
·
|
difficulty
and expense in assimilating and integrating the operations, products,
technology, information systems or personnel of the acquired
company;
|
|
|
·
|
diversion
of management’s time and attention from other business
concerns;
|
|
|
·
|
inability
to maintain uniform standards, controls, procedures and
policies;
|
|
|
·
|
the
assumption of known and unknown liabilities of the acquired company,
including intellectual property
claims;
|
|
|
·
|
challenges
and costs associated with reductions in work
force; and
|
|
|
·
|
subsequent
loss of key personnel.
|
|
|
·
|
the
classification of our directors;
|
|
|
·
|
limitations
on changing the number of directors then in
office;
|
|
|
·
|
limitations
on the removal of directors;
|
|
|
·
|
limitations
on filling vacancies on the board;
|
|
|
·
|
limitations
on the removal and appointment of the chairman of our Board of
Directors;
|
|
|
·
|
advance
notice requirements for stockholder nominations for election of directors
and other proposals;
|
|
|
·
|
the
inability of stockholders to act by written
consent;
|
|
|
·
|
the
inability of stockholders to call special
meetings; and
|
|
|
·
|
the
ability of our Board of Directors to designate the terms of and issue new
series of preferred stock without stockholder
approval.
|
|
|
·
|
the
success of competitive products or
technologies;
|
|
|
·
|
results
of clinical trials of our product candidates or those of our
competitors;
|
|
|
·
|
decisions
and procurement policies by the U.S. government affecting BioThrax
and our biodefense product
candidates;
|
|
|
·
|
regulatory
developments in the U.S. and foreign
countries;
|
|
|
·
|
developments
or disputes concerning patents or other proprietary
rights;
|
|
|
·
|
the
recruitment or departure of key
personnel;
|
|
|
·
|
variations
in our financial results or those of companies that are perceived to be
similar to us;
|
|
|
·
|
market
conditions in the pharmaceutical and biotechnology sectors and issuance of
new or changed securities analysts’ reports or
recommendations;
|
|
|
·
|
general
economic, industry and market
conditions; and
|
|
|
·
|
the
other factors described in this “Risk Factors”
section.
|
| ITEM 1B. | UNRESOLVED STAFF COMMENTS |
| ITEM 2. | PROPERTIES |
|
Location
|
Use
|
Segment
|
Approximate
square feet
|
Owned/leased
|
|
Lansing,
Michigan
|
Manufacturing
operations facilities, office space and laboratory space
|
Biodefense
|
214,000
|
Owned
|
|
Baltimore,
Maryland
|
Future
manufacturing facilities and office and laboratory space
|
Biodefense/Commercial
|
56,000
|
Owned
|
|
Gaithersburg,
Maryland
|
Office
and laboratory space
|
Biodefense/Commercial
|
48,000
|
Owned
|
|
Wokingham,
England
|
Office
and laboratory space
|
Commercial
|
29,000
|
Leases
expire 2016
|
|
Rockville,
Maryland
|
Office
space
|
Biodefense/Commercial
|
23,000
|
Lease
expires 2016
|
|
Munich,
Germany
|
Office
and laboratory space
|
Commercial
|
16,000
|
Lease
expires 2015
|
|
Frederick,
Maryland
|
Held
for sale
|
Biodefense/Commercial
|
290,000
|
Owned
|
| ITEM 3 . | LEGAL PROCEEDINGS |
|
ITEM
4.
|
|
First
|
Second
|
Third
|
Fourth
|
|||||||||||||
|
Quarter
|
Quarter
|
Quarter
|
Quarter
|
|||||||||||||
|
Year
Ended December 31, 2009
|
||||||||||||||||
|
High
|
$ | 27.00 | $ | 15.31 | $ | 19.95 | $ | 18.25 | ||||||||
|
Low
|
$ | 12.23 | $ | 9.15 | $ | 12.09 | $ | 12.36 | ||||||||
|
Year
Ended December 31, 2008
|
||||||||||||||||
|
High
|
$ | 9.17 | $ | 11.14 | $ | 15.17 | $ | 26.40 | ||||||||
|
Low
|
$ | 4.93 | $ | 8.22 | $ | 9.62 | $ | 11.22 | ||||||||
|
Year
Ended December 31,
|
||||||||||||||||||||
|
(in thousands, except share and
per share data)
|
2009
|
2008
|
2007
|
2006
|
2005
|
|||||||||||||||
|
Statements of operations
data:
|
||||||||||||||||||||
|
Revenues:
|
||||||||||||||||||||
|
Product
sales
|
$ | 217,172 | $ | 169,124 | $ | 169,799 | $ | 147,995 | $ | 127,271 | ||||||||||
|
Contracts
and grants
|
17,614 | 9,430 | 13,116 | 4,737 | 3,417 | |||||||||||||||
|
Total
revenues
|
234,786 | 178,554 | 182,915 | 152,732 | 130,688 | |||||||||||||||
|
Operating
expenses (income):
|
||||||||||||||||||||
|
Cost
of product sales
|
46,262 | 34,081 | 40,309 | 24,125 | 31,603 | |||||||||||||||
|
Research
and development
|
74,588 | 59,470 | 53,958 | 45,501 | 18,381 | |||||||||||||||
|
Selling,
general & administrative
|
73,786 | 55,076 | 55,555 | 44,601 | 42,793 | |||||||||||||||
|
Purchased
in-process research and development
|
- | - | - | 477 | 26,575 | |||||||||||||||
|
Litigation
settlement
|
- | - | - | - | (10,000 | ) | ||||||||||||||
|
Total
operating expenses
|
194,636 | 148,627 | 149,822 | 114,704 | 109,352 | |||||||||||||||
|
Income
from operations
|
40,150 | 29,927 | 33,093 | 38,028 | 21,336 | |||||||||||||||
|
Other
income (expense):
|
||||||||||||||||||||
|
Interest
income
|
1,418 | 1,999 | 2,809 | 846 | 485 | |||||||||||||||
|
Interest
expense
|
(7 | ) | (47 | ) | (71 | ) | (1,152 | ) | (767 | ) | ||||||||||
|
Other
income (expense), net
|
(50 | ) | 134 | 156 | 293 | 55 | ||||||||||||||
|
Total
other income (expense)
|
1,361 | 2,086 | 2,894 | (13 | ) | (227 | ) | |||||||||||||
|
Income
before provision for income taxes
|
41,511 | 32,013 | 35,987 | 38,015 | 21,109 | |||||||||||||||
|
Provision
for income taxes
|
14,966 | 12,055 | 13,051 | 15,222 | 5,325 | |||||||||||||||
|
Net
income
|
$ | 26,545 | $ | 19,958 | $ | 22,936 | $ | 22,793 | $ | 15,784 | ||||||||||
|
Net
loss attributable to noncontrolling interest
|
4,599 | 724 | - | - | - | |||||||||||||||
|
Net
income attributable to Emergent BioSolutions Inc.
|
$ | 31,144 | $ | 20,682 | $ | 22,936 | $ | 22,793 | $ | 15,784 | ||||||||||
|
Earnings
per share — basic
|
$ | 1.02 | $ | 0.69 | $ | 0.79 | $ | 0.99 | $ | 0.77 | ||||||||||
|
Earnings
per share — diluted
|
$ | 0.99 | $ | 0.68 | $ | 0.77 | $ | 0.93 | $ | 0.69 | ||||||||||
|
Weighted
average number of shares — basic
|
30,444,485 | 29,835,134 | 28,995,667 | 23,039,794 | 20,533,471 | |||||||||||||||
|
Weighted
average number of shares — diluted
|
31,375,305 | 30,458,098 | 29,663,127 | 24,567,302 | 22,751,733 | |||||||||||||||
|
As
of December 31,
|
||||||||||||||||||||
|
(in
thousands)
|
2009 | 2008 | 2007 | 2006 | 2005 | |||||||||||||||
|
Balance
Sheet Data:
|
||||||||||||||||||||
|
Cash
and cash equivalents
|
$ | 102,924 | $ | 91,473 | $ | 105,730 | $ | 76,418 | $ | 36,294 | ||||||||||
|
Working
capital
|
139,113 | 98,866 | 88,649 | 82,990 | 29,023 | |||||||||||||||
|
Total
assets
|
344,689 | 290,788 | 273,508 | 238,255 | 100,332 | |||||||||||||||
|
Total
long-term liabilities
|
46,173 | 37,418 | 46,688 | 35,436 | 10,502 | |||||||||||||||
|
Total
stockholders’ equity
|
243,815 | 199,349 | 171,159 | 138,472 | 59,737 | |||||||||||||||
|
·
|
BioThrax
post-exposure prophylaxis
|
|
·
|
BioThrax dual
adjuvant vaccine
|
|
·
|
Anthrax
immune globulin therapeutic
|
|
·
|
Anthrax
monoclonal antibody therapeutic
|
|
·
|
Advanced
double-mutant protective antigen
|
|
·
|
Recombinant
botulinum vaccine
|
|
·
|
Typhella
(typhoid vaccine live oral ZH9)
|
|
|
·
|
there
is persuasive evidence of an
arrangement;
|
|
|
·
|
delivery
has occurred or title has passed to our customer based on contract
terms;
|
|
|
·
|
the
fee is fixed and determinable and no further obligation
exists; and
|
|
|
·
|
collectibility
is reasonably assured.
|
|
Product
Candidate
|
Funding
Source
|
Award
Date
|
Amount
(Up
to)
|
Performance
Period
|
|
Anthrax
immune globulin therapeutic
|
NIAID
|
September-2007
|
$9.5
million
|
9/2007 — 12/2011
|
|
Recombinant
botulinum vaccine
|
NIAID
|
June-2008
|
$1.8
million
|
6/2008 — 5/2011
|
|
BioThrax
dual adjuvant vaccine
|
NIAID
|
July-2008
|
$2.8
million
|
7/2008 — 6/2013
|
|
Anthrax
monoclonal antibody therapeutic
|
NIAID/BARDA
|
September-2008
|
$24.3
million
|
9/2008 — 8/2012
|
|
BioThrax
dual adjuvant vaccine
|
NIAID/BARDA
|
September-2008
|
$29.7
million
|
9/2008 — 9/2011
|
|
Double-mutant
protective antigen anthrax vaccine
|
NIAID
|
September-2009
|
$4.9
million
|
9/2009 — 8/2011
|
|
|
·
|
salaries
and related expenses for personnel;
|
|
|
·
|
fees
to professional service providers for, among other things, preclinical and
analytical testing, independently monitoring our clinical trials and
acquiring and evaluating data from our clinical trials and non-clinical
studies;
|
|
|
·
|
costs
of contract manufacturing services for clinical trial
material;
|
|
|
·
|
costs
of materials used in clinical trials and research and
development;
|
|
|
·
|
depreciation
of capital assets used to develop our
products; and
|
|
|
·
|
operating
costs, such as the operating costs of facilities and the legal costs of
pursuing patent protection of our intellectual
property.
|
|
Year
ended
|
||||||||
|
December 31,
|
||||||||
|
(in
thousands)
|
2009
|
2008
|
||||||
|
Biodefense:
|
||||||||
|
BioThrax
related programs
|
$ | 15,748 | $ | 7,159 | ||||
|
Recombinant
protective antigen anthrax vaccine
|
8,450 | 6,563 | ||||||
|
Double
mutant protective antigen vaccine
|
560 | 2,540 | ||||||
|
Anthrax
immune globulin therapeutic
|
6,890 | 6,126 | ||||||
|
Anthrax
monoclonal therapeutic
|
7,215 | 1,062 | ||||||
|
Botulinum
vaccines
|
4,011 | 2,871 | ||||||
|
Total
biodefense
|
42,874 | 26,321 | ||||||
|
Commercial:
|
||||||||
|
Tuberculosis
vaccine
|
11,711 | 2,145 | ||||||
|
Typhella
|
5,083 | 15,431 | ||||||
|
Influenza
vaccine
|
2,822 | 1,511 | ||||||
|
Hepatitis
B therapeutic vaccine
|
3,521 | 3,010 | ||||||
|
Group
B streptococcus vaccine
|
202 | 6,539 | ||||||
|
Chlamydia
vaccine
|
567 | 1,220 | ||||||
|
Meningitis
B vaccine
|
158 | 1,313 | ||||||
|
Total
commercial
|
24,064 | 31,169 | ||||||
|
Other
|
7,650 | 1,980 | ||||||
|
Total
|
$ | 74,588 | $ | 59,470 | ||||
|
Year
ended
|
||||||||
|
December 31,
|
||||||||
|
(in
thousands)
|
2008
|
2007
|
||||||
|
Biodefense:
|
||||||||
|
BioThrax
related programs
|
$ | 7,159 | $ | 5,175 | ||||
|
Recombinant
protective antigen anthrax vaccine
|
6,563 | - | ||||||
|
Advanced
anthrax vaccines
|
2,540 | 2,719 | ||||||
|
Anthrax
immune globulin therapeutic
|
6,126 | 7,717 | ||||||
|
Anthrax
monoclonal therapeutic
|
1,062 | - | ||||||
|
Botulinum
vaccines
|
2,871 | 9,133 | ||||||
|
Total
biodefense
|
26,321 | 24,744 | ||||||
|
Commercial:
|
||||||||
|
Tuberculosis
vaccine
|
2,145 | - | ||||||
|
Typhella
|
15,431 | 9,641 | ||||||
|
Influenza
vaccine
|
1,511 | - | ||||||
|
Hepatitis
B therapeutic vaccine
|
3,010 | 5,370 | ||||||
|
Group
B streptococcus vaccine
|
6,539 | 6,790 | ||||||
|
Chlamydia
vaccine
|
1,220 | 3,146 | ||||||
|
Meningitis
B vaccine
|
1,313 | 1,212 | ||||||
|
Total
commercial
|
31,169 | 26,159 | ||||||
|
Other
|
1,980 | 3,055 | ||||||
|
Total
|
$ | 59,470 | $ | 53,958 | ||||
|
Year ended
December 31,
|
||||||||||||
|
(in
thousands)
|
2009
|
2008
|
2007
|
|||||||||
|
Net
cash provided by (used in):
|
||||||||||||
|
Operating
activities(1)
|
$ | 29,894 | $ | 7,588 | $ | 54,790 | ||||||
|
Investing
activities
|
(33,287 | ) | (30,813 | ) | (43,969 | ) | ||||||
|
Financing
activities
|
14,844 | 8,968 | 18,491 | |||||||||
|
Total
net cash provided (used in)
|
$ | 11,451 | $ | (14,257 | ) | $ | 29,312 | |||||
|
Payments
due by period
|
||||||||||||||||||||||||||||
|
(in
thousands)
|
Total
|
2010
|
2011
|
2012
|
2013
|
2014
|
After
2014
|
|||||||||||||||||||||
|
Contractual
obligations:
|
||||||||||||||||||||||||||||
|
Long-term
indebtedness
|
$ | 50,718 | $ | 5,791 | $ | 14,724 | $ | 2,331 | $ | 2,331 | $ | 25,541 | $ | - | ||||||||||||||
|
Operating
lease obligations
|
11,950 | 1,817 | 1,800 | 1,767 | 1,786 | 1,806 | 2,974 | |||||||||||||||||||||
|
Contractual
settlement liabilities
|
- | - | - | - | - | - | - | |||||||||||||||||||||
|
Total contractual
obligations
|
$ | 62,668 | $ | 7,608 | $ | 16,524 | $ | 4,098 | $ | 4,117 | $ | 27,347 | $ | 2,974 | ||||||||||||||
|
|
·
|
$2.5
million outstanding under a loan from the Department of Business and
Economic Development of the State of Maryland used to finance eligible
costs incurred to purchase our first facility in Frederick,
Maryland;
|
|
|
·
|
$6.0
million outstanding under a mortgage loan from PNC Bank used to finance
the remaining portion of the purchase price for our first Frederick
facility;
|
|
|
·
|
$7.3
million outstanding under a mortgage loan from HSBC Realty Credit
Corporation used to finance the purchase price for our second facility on
the Frederick site;
|
|
|
·
|
$22.8
million outstanding under a term loan from HSBC Realty Credit Corporation
used to finance a portion of the costs of our facility expansion in
Lansing, Michigan;
|
|
|
·
|
$7.0
million outstanding under a mortgage loan from HSBC Realty Credit
Corporation used to finance the purchase of our facility in Baltimore,
Maryland;
|
|
|
·
|
$5.l
million outstanding under a mortgage loan from HSBC Realty Credit
Corporation used to finance the purchase of our facility in Gaithersburg,
Maryland; and
|
|
|
·
|
$15.0
million outstanding under a $15.0 million revolving line of credit with
Fifth Third Bank, the balance of which we repaid in January
2010.
|
|
|
Some
of our debt instruments contain financial and operating covenants. In
particular:
|
|
|
·
|
Under
our loan from the State of Maryland, we are not required to repay the
principal amount of the loan if beginning December 31, 2009 and through
2012 we maintain a specified number of employees at the Frederick site, by
December 31, 2009 we have invested at least $42.9 million in total funds
toward financing the purchase of the buildings on the site and for related
improvements and operation of the facility, and we occupy the facility
through 2012. Our plans for this facility have changed, and we currently
plan to sell both Frederick buildings. As such we have not met the
requirements for the loan to be forgivable as of December 31, 2009. We
have reached an agreement with the State of Maryland to repay the loan in
full by September 30, 2010, with an earlier repayment due upon sale of the
building.
|
|
|
·
|
Under
our mortgage loan from PNC Bank for our Frederick facility, we are
required to maintain at all times a minimum tangible net worth of not less
than $5.0 million. In addition, we are required to maintain at all times a
ratio of earnings before interest, taxes, depreciation and amortization to
the sum of current obligations under capital leases and principal
obligations and interest expenses for borrowed money, in each case due and
payable within the following 12 months, of not less than 1.1 to
1.0.
|
|
|
·
|
Under
our term loan with HSBC Realty Credit Corporation to finance a portion of
the costs of our facility expansion in Lansing, Michigan, we are required
to maintain on an annual basis a book leverage ratio of less than 1.00. In
addition, we are required to maintain on a quarterly basis a debt coverage
ratio of not less than 1.25 to
1.00.
|
|
|
·
|
Under
our mortgage loan with HSBC Realty Credit Corporation for our Gaithersburg
facility, we are required to maintain on an annual basis a book leverage
ratio of less than 1.00. In addition, we are required to maintain on a
quarterly basis a debt coverage ratio of not less than 1.25 to
1.00.
|
|
|
·
|
Under
our mortgage loan with HSBC Realty Credit Corporation for our Baltimore
facility, we are required to maintain on an annual basis a book leverage
ratio of less than 1.00. In addition, we are required to maintain on a
quarterly basis a debt coverage ratio of not less than 1.25 to
1.00.
|
|
|
·
|
Under
our revolving line of credit with Fifth Third Bank, our wholly owned
subsidiary, Emergent BioDefense Operations, is required to maintain at all
times a ratio of total liabilities to tangible net worth of not more than
2.5 to 1.0.
|
|
|
·
|
the
level and timing of BioThrax product sales and cost of product
sales;
|
|
|
·
|
the
acquisition of, and capital improvements to new
facilities;
|
|
|
·
|
the
timing of, and the costs involved in, completion of qualification and
validation activities related to our manufacturing facility in Lansing,
Michigan and, any new facilities;
|
|
|
·
|
the
scope, progress, results and costs of our preclinical and clinical
development activities;
|
|
|
·
|
the
costs, timing and outcome of regulatory review of our product
candidates;
|
|
|
·
|
the
number of, and development requirements for, other product candidates that
we may pursue;
|
|
|
·
|
the
costs of commercialization activities, including product marketing, sales
and distribution;
|
|
|
·
|
the
extent to which we lend money to third
parties;
|
|
|
·
|
the
costs involved in preparing, filing, prosecuting, maintaining and
enforcing patent claims and other patent-related costs, including
litigation costs and the results of such
litigation;
|
|
|
·
|
the
extent to which we acquire or invest in businesses, products and
technologies;
|
|
|
·
|
our
ability to obtain development funding from government entities and
non-government and philanthropic
organizations; and
|
|
|
·
|
our
ability to establish and maintain
collaborations.
|
| ITEM 7A. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
|
|
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
|
|
Emergent
BioSolutions Inc. and Subsidiaries
|
||||||||
|
(in
thousands, except share and per share data)
|
||||||||
|
December
31,
|
||||||||
|
2009
|
2008
|
|||||||
|
ASSETS
|
||||||||
|
Current
assets:
|
||||||||
|
Cash
and cash equivalents
|
$ | 102,924 | $ | 91,473 | ||||
|
Accounts
receivable
|
54,872 | 24,855 | ||||||
|
Inventories
|
13,521 | 18,325 | ||||||
|
Note
receivable
|
10,000 | 10,000 | ||||||
|
Deferred
tax assets, net
|
1,870 | - | ||||||
|
Income
tax receivable, net
|
2,574 | - | ||||||
|
Restricted
cash
|
215 | 208 | ||||||
|
Prepaid
expenses and other current assets
|
7,838 | 8,026 | ||||||
|
Total
current assets
|
193,814 | 152,887 | ||||||
|
Property,
plant and equipment, net
|
131,834 | 124,656 | ||||||
|
Assets
held for sale
|
13,960 | - | ||||||
|
Deferred
tax assets, net
|
3,894 | 12,073 | ||||||
|
Other
assets
|
1,187 | 1,172 | ||||||
|
Total
assets
|
$ | 344,689 | $ | 290,788 | ||||
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
|
Current
liabilities:
|
||||||||
|
Accounts
payable
|
$ | 17,159 | $ | 18,254 | ||||
|
Accrued
expenses and other current liabilities
|
1,570 | 1,399 | ||||||
|
Accrued
compensation
|
14,926 | 11,380 | ||||||
|
Indebtedness
under line of credit
|
15,000 | 15,000 | ||||||
|
Long-term
indebtedness, current portion
|
5,791 | 6,248 | ||||||
|
Income
taxes payable
|
- | 951 | ||||||
|
Deferred
tax liabilities, net
|
- | 557 | ||||||
|
Deferred
revenue
|
255 | 232 | ||||||
|
Total
current liabilities
|
54,701 | 54,021 | ||||||
|
Long-term
indebtedness, net of current portion
|
44,927 | 35,935 | ||||||
|
Other
liabilities
|
1,246 | 1,483 | ||||||
|
Total
liabilities
|
100,874 | 91,439 | ||||||
|
Commitments
and contingencies
|
- | - | ||||||
|
Stockholders’
equity:
|
||||||||
|
Preferred
stock, $0.001 par value; 15,000,000 shares authorized,
|
||||||||
| 0 shares issued and outstanding at December 31, 2009 and 2008, respectively | - | - | ||||||
|
Common
stock, $0.001 par value; 100,000,000 shares authorized,
|
||||||||
| 30,831,360 and 30,159,546 shares issued and outstanding at | ||||||||
| December 31, 2009 and 2008, respectively | 31 | 30 | ||||||
|
Additional
paid-in capital
|
120,492 | 109,170 | ||||||
|
Accumulated
other comprehensive loss
|
(1,476 | ) | (859 | ) | ||||
|
Retained
earnings
|
122,152 | 91,008 | ||||||
|
Total
Emergent BioSolutions Inc. stockholders' equity
|
241,199 | 199,349 | ||||||
|
Noncontrolling
interest in subsidiary
|
2,616 | - | ||||||
|
Total
stockholders’ equity
|
243,815 | 199,349 | ||||||
|
Total
liabilities and stockholders’ equity
|
$ | 344,689 | $ | 290,788 | ||||
|
Emergent
BioSolutions Inc. and Subsidiaries
|
||||||||||||
|
(in
thousands, except share and per share data)
|
||||||||||||
|
Year
Ended December 31,
|
||||||||||||
|
2009
|
2008
|
2007
|
||||||||||
|
Revenues:
|
||||||||||||
|
Product
sales
|
$ | 217,172 | $ | 169,124 | $ | 169,799 | ||||||
|
Contracts
and grants
|
17,614 | 9,430 | 13,116 | |||||||||
|
Total
revenues
|
234,786 | 178,554 | 182,915 | |||||||||
|
Operating
expense:
|
||||||||||||
|
Cost
of product sales
|
46,262 | 34,081 | 40,309 | |||||||||
|
Research
and development
|
74,588 | 59,470 | 53,958 | |||||||||
|
Selling,
general and administrative
|
73,786 | 55,076 | 55,555 | |||||||||
|
Income
from operations
|
40,150 | 29,927 | 33,093 | |||||||||
|
Other
income (expense):
|
||||||||||||
|
Interest
income
|
1,418 | 1,999 | 2,809 | |||||||||
|
Interest
expense
|
(7 | ) | (47 | ) | (71 | ) | ||||||
|
Other
income (expense), net
|
(50 | ) | 134 | 156 | ||||||||
|
Total
other income (expense)
|
1,361 | 2,086 | 2,894 | |||||||||
|
Income
before provision for income taxes
|
41,511 | 32,013 | 35,987 | |||||||||
|
Provision
for income taxes
|
14,966 | 12,055 | 13,051 | |||||||||
|
Net
income
|
26,545 | 19,958 | 22,936 | |||||||||
|
Net
loss attributable to noncontrolling interest
|
4,599 | 724 | - | |||||||||
|
Net
income attributable to Emergent BioSolutions Inc.
|
$ | 31,144 | $ | 20,682 | $ | 22,936 | ||||||
|
Earnings
per share - basic
|
$ | 1.02 | $ | 0.69 | $ | 0.79 | ||||||
|
Earnings
per share - diluted
|
$ | 0.99 | $ | 0.68 | $ | 0.77 | ||||||
|
Weighted-average
number of shares - basic
|
30,444,485 | 29,835,134 | 28,995,667 | |||||||||
|
Weighted-average
number of shares - diluted
|
31,375,305 | 30,458,098 | 29,663,127 | |||||||||
|
Emergent
BioSolutions Inc. and Subsidiaries
|
||||||||||||
|
(in
thousands)
|
||||||||||||
|
Year
Ended December 31,
|
||||||||||||
|
2009
|
2008
|
2007
|
||||||||||
|
Cash
flows from operating activities:
|
||||||||||||
|
Net
income
|
$ | 26,545 | $ | 19,958 | $ | 22,936 | ||||||
|
Adjustments
to reconcile to net cash provided by operating activities:
|
||||||||||||
|
Stock-based
compensation expense
|
5,007 | 2,510 | 2,541 | |||||||||
|
Depreciation
and amortization
|
4,999 | 4,964 | 4,817 | |||||||||
|
Deferred
income taxes
|
7,604 | 2,006 | 5,589 | |||||||||
|
Non-cash
development expenses from joint venture
|
7,215 | 724 | - | |||||||||
|
Loss
(gain) on disposal of property and equipment
|
61 | (135 | ) | 24 | ||||||||
|
Provision
for impairment of long-lived assets
|
7,328 | - | - | |||||||||
|
Excess
tax benefits from stock-based compensation
|
(1,852 | ) | (1,336 | ) | (6,003 | ) | ||||||
|
Changes
in operating assets and liabilities:
|
||||||||||||
|
Accounts
receivable
|
(30,017 | ) | (6,038 | ) | 24,514 | |||||||
|
Inventories
|
6,207 | (1,428 | ) | 9,337 | ||||||||
|
Income
taxes
|
(3,525 | ) | (6,714 | ) | (5,169 | ) | ||||||
|
Prepaid
expenses and other assets
|
(1,230 | ) | (4,949 | ) | (2,828 | ) | ||||||
|
Accounts
payable
|
(1,334 | ) | (457 | ) | (12 | ) | ||||||
|
Accrued
expenses and other liabilities
|
(66 | ) | (523 | ) | (1,557 | ) | ||||||
|
Accrued
compensation
|
3,546 | 1,878 | 2,312 | |||||||||
|
Deferred
revenue
|
23 | (3,143 | ) | (1,054 | ) | |||||||
|
Net
cash provided by operating activities
|
30,511 | 7,317 | 55,447 | |||||||||
|
Cash
flows from investing activities:
|
||||||||||||
|
Purchases
of property, plant and equipment
|
(33,287 | ) | (20,813 | ) | (43,969 | ) | ||||||
|
Issuance
of note receivable
|
- | (10,000 | ) | - | ||||||||
|
Net
cash used in investing activities
|
(33,287 | ) | (30,813 | ) | (43,969 | ) | ||||||
|
Cash
flows from financing activities:
|
||||||||||||
|
Restricted
cash release (deposit)
|
(7 | ) | 4,992 | (5,008 | ) | |||||||
|
Proceeds
from borrowings on long-term indebtedness and line of
credit
|
57,183 | 60,000 | 33,195 | |||||||||
|
Issuance
of common stock subject to exercise of stock options
|
4,464 | 3,391 | 2,471 | |||||||||
|
Principal
payments on long-term indebtedness and line of credit
|
(48,648 | ) | (60,751 | ) | (18,015 | ) | ||||||
|
Excess
tax benefits from stock-based compensation
|
1,852 | 1,336 | 6,003 | |||||||||
|
Debt
issuance costs
|
- | - | (155 | ) | ||||||||
|
Net
cash provided by financing activities
|
14,844 | 8,968 | 18,491 | |||||||||
|
Effect
of exchange rate changes on cash and cash equivalents
|
(617 | ) | 271 | (657 | ) | |||||||
|
Net
increase (decrease) in cash and cash equivalents
|
11,451 | (14,257 | ) | 29,312 | ||||||||
|
Cash
and cash equivalents at beginning of year
|
91,473 | 105,730 | 76,418 | |||||||||
|
Cash
and cash equivalents at end of year
|
102,924 | 91,473 | 105,730 | |||||||||
|
Supplemental
disclosure of cash flow information:
|
||||||||||||
|
Cash
paid during the year for interest
|
$ | 1,627 | $ | 3,216 | $ | 3,094 | ||||||
|
Cash
paid during the year for income taxes
|
$ | 15,155 | $ | 16,788 | $ | 14,329 | ||||||
|
Supplemental
information on non-cash investing and financing
activities:
|
||||||||||||
|
Purchases
of property, plant and equipment unpaid at year end
|
$ | 2,749 | $ | 2,510 | $ | 4,056 | ||||||
|
(in
thousands, except share and per share data)
|
||||||||||||||||||||||||||||
|
$0.001
Par Value Common Stock
|
Additional
Paid-In
|
Accumulated
Other
Comprehensive
|
Noncontrolling
Interest
|
Retained
|
Total
Stockholders'
|
|||||||||||||||||||||||
|
Shares
|
Amount
|
Capital
|
Loss
|
in
Subsidiary
|
Earnings
|
Equity
|
||||||||||||||||||||||
|
Balance
at December 31, 2006
|
27,596,249 | $ | 28 | $ | 90,920 | $ | (473 | ) | $ | - | $ | 47,997 | $ | 138,472 | ||||||||||||||
|
Exercise
of stock options
|
2,153,988 | 2 | 2,469 | - | - | - | 2,471 | |||||||||||||||||||||
|
Stock-based
compensation expense
|
- | - | 2,541 | - | - | - | 2,541 | |||||||||||||||||||||
|
Cumulative
effect of change in accounting principle (FIN 48)
|
- | - | - | - | - | (607 | ) | (607 ) | ||||||||||||||||||||
|
Excess
tax benefits from exercises of stock options
|
- | - | 6,003 | - | - | - | 6,003 | |||||||||||||||||||||
|
Net
income
|
- | - | - | - | - | 22,936 | 22,936 | |||||||||||||||||||||
|
Foreign
currency translation
|
- | - | - | (657 | ) | - | (657 | ) | ||||||||||||||||||||
|
Comprehensive
income
|
- | - | - | - | - | - | 22,279 | |||||||||||||||||||||
|
Balance
at December 31, 2007
|
29,750,237 | $ | 30 | $ | 101,933 | $ | (1,130 | ) | $ | - | $ | 70,326 | $ | 171,159 | ||||||||||||||
|
Exercise
of stock options
|
409,309 | - | 3,391 | - | - | - | 3,391 | |||||||||||||||||||||
|
Stock-based
compensation expense
|
- | - | 2,510 | - | - | - | 2,510 | |||||||||||||||||||||
|
Excess
tax benefits from exercises of stock options
|
- | - | 1,336 | - | - | - | 1,336 | |||||||||||||||||||||
|
Net
income
|
- | - | - | - | - | 20,682 | 20,682 | |||||||||||||||||||||
|
Foreign
currency translation
|
- | - | - | 271 | - | 271 | ||||||||||||||||||||||
|
Comprehensive
income
|
- | - | - | - | - | - | 20,953 | |||||||||||||||||||||
|
Balance
at December 31, 2008
|
30,159,546 | $ | 30 | $ | 109,170 | $ | (859 | ) | $ | $ | 91,008 | $ | 199,349 | |||||||||||||||
|
Exercise
of stock options
|
671,814 | 1 | 4,463 | - | - | - | 4,464 | |||||||||||||||||||||
|
Stock-based
compensation expense
|
- | - | 5,007 | - | - | - | 5,007 | |||||||||||||||||||||
|
Excess
tax benefits from exercises of stock options
|
- | - | 1,852 | - | - | - | 1,852 | |||||||||||||||||||||
|
Non-cash
development expenses from joint venture
|
7,215 | 7,215 | ||||||||||||||||||||||||||
|
Net
loss attributable to noncontrolling interest
|
- | - | - | - | (4,599 | ) | - | (4,599 | ) | |||||||||||||||||||
|
Net
income
|
- | - | - | - | 31,144 | 31,144 | ||||||||||||||||||||||
|
Foreign
currency translation
|
- | - | - | (617 | ) | - | - | (617 | ) | |||||||||||||||||||
|
Comprehensive
income
|
- | - | - | - | - | - | 30,527 | |||||||||||||||||||||
|
Balance
at December 31, 2009
|
30,831,360 | $ | 31 | $ | 120,492 | $ | (1,476 | ) | $ | 2,616 | $ | 122,152 | $ | 243,815 | ||||||||||||||
|
2.
|
Summary
of significant accounting policies
|
|
Buildings
|
31-39
years
|
|
Building improvements
|
10-39
years
|
|
Furniture and equipment
|
3-7
years
|
|
Software
|
Lesser
of 3-5 years or product life
|
|
Leasehold improvements
|
Lesser
of the asset life or lease
term
|
|
|
·
|
there
is persuasive evidence of an
arrangement;
|
|
|
·
|
delivery
has occurred and title has passed to the Company’s
customer;
|
|
|
·
|
the
fee is fixed and determinable and no further obligation exists;
and
|
|
|
·
|
collectibility
is reasonably assured.
|
|
Year
Ended December 31,
|
||||||||||||
|
(in thousands, except share and
per share data)
|
2009
|
2008
|
2007
|
|||||||||
|
Numerator:
|
||||||||||||
|
Net
income
|
$ | 31,144 | $ | 20,682 | $ | 22,936 | ||||||
|
Denominator:
|
||||||||||||
|
Weighted-average
number of shares—basic
|
30,444,485 | 29,835,134 | 28,995,667 | |||||||||
|
Dilutive
securities—stock options
|
930,820 | 622,964 | 667,460 | |||||||||
|
Weighted-average
number of shares—diluted
|
31,375,305 | 30,458,098 | 29,663,127 | |||||||||
|
Earnings
per share-basic
|
$ | 1.02 | $ | 0.69 | $ | 0.79 | ||||||
|
Earnings
per share-diluted
|
$ | 0.99 | $ | 0.68 | $ | 0.77 | ||||||
|
Year
Ended December 31,
|
||||||||||||
|
2009
|
2008
|
2007
|
||||||||||
|
Expected
dividend yield
|
0 | % | 0 | % | 0 | % | ||||||
|
Expected
volatility
|
55 | % | 65 | % | 50 | % | ||||||
|
Risk-free
interest rate
|
1.32-1.72 | % | 1.63-2.75 | % | 2.99-5.09 | % | ||||||
|
Expected
average life of options
|
3.3
years
|
3.0
years
|
3.0
years
|
|||||||||
|
|
·
|
Expected
dividend yield — The Company does not pay regular dividends on its common
stock and does not anticipate paying any dividends in the foreseeable
future.
|
|
|
·
|
Expected
volatility — Volatility is a measure of the amount by which a financial
variable, such as share price, has fluctuated (historical volatility) or
is expected to fluctuate (expected volatility) during a period. The
Company analyzed the volatility used by similar companies at a similar
stage of development to estimate expected volatility. The volatility used
by these similar companies ranged from 40% to 80%, with an average
estimated volatility of 55%. The Company used a rate of 55% for grants
made in 2009, approximately the mid-point of this
range.
|
|
|
·
|
Risk-free
interest rate — This is the range of U.S. Treasury rates with a term that
most closely resembles the expected life of the option as of the date in
which the option was granted.
|
|
|
·
|
Expected
average life of options — This is the period of time that the options
granted are expected to remain outstanding. This estimate is based
primarily on the Company’s expectation of optionee exercise behavior
subsequent to vesting of options.
|
|
December 31,
|
||||||||
|
(in
thousands)
|
2009
|
2008
|
||||||
|
Billed
|
$ | 51,782 | $ | 23,005 | ||||
|
Unbilled
|
3,090 | 1,850 | ||||||
|
Total
|
$ | 54,872 | $ | 24,855 | ||||
|
December 31,
|
||||||||
|
(in
thousands)
|
2009
|
2008
|
||||||
|
Raw
materials and supplies
|
$ | 1,565 | $ | 1,352 | ||||
|
Work-in-process
|
9,870 | 14,459 | ||||||
|
Finished
goods
|
2,086 | 2,514 | ||||||
|
Total
inventories
|
$ | 13,521 | $ | 18,325 | ||||
|
December 31,
|
||||||||
|
(in
thousands)
|
2009
|
2008
|
||||||
|
Land
and improvements
|
$ | 2,932 | $ | 5,050 | ||||
|
Buildings,
building improvements and leasehold improvements
|
18,661 | 28,119 | ||||||
|
Furniture
and equipment
|
27,086 | 22,657 | ||||||
|
Software
|
6,833 | 6,423 | ||||||
|
Construction-in-progress
|
98,178 | 82,518 | ||||||
| 153,690 | 144,767 | |||||||
|
Less:
Accumulated depreciation and amortization
|
(21,856 | ) | (20,111 | ) | ||||
|
Total
Property, plant and equipment, net
|
$ | 131,834 | $ | 124,656 | ||||
|
December 31,
|
||||||||
|
(in
thousands)
|
2009
|
2008
|
||||||
|
Term
loan dated December 2009; three month LIBOR plus 3.25%, due December
2014
|
$ | 22,750 | $ | 25,500 | ||||
|
Term
loan dated November 2009; three month LIBOR plus 3.25%, due November
2014
|
6,981 | - | ||||||
|
Term
loan dated November 2009; three month LIBOR plus 3.25%, due November
2014
|
5,134 | - | ||||||
|
Term
loan dated April 2006; three month LIBOR plus 3.0%, due April
2011
|
7,308 | 7,809 | ||||||
|
Loan
dated October 2004; 3.0%, due September 2010
|
2,500 | 2,500 | ||||||
|
Term
loan dated October 2004; 6.625%, due October 2011
|
6,045 | 6,369 | ||||||
|
Other
|
- | 5 | ||||||
|
Total
long-term indebtedness
|
50,718 | 42,183 | ||||||
|
Less
current portion of long-term indebtedness
|
(5,791 | ) | (6,248 | ) | ||||
|
Noncurrent
portion of long-term indebtedness
|
$ | 44,927 | $ | 35,935 | ||||
|
(in
thousands)
|
||||
|
2010
|
$ | 5,791 | ||
|
2011
|
14,724 | |||
|
2012
|
2,331 | |||
|
2013
|
2,331 | |||
|
2014
|
25,541 | |||
|
2015
and beyond
|
- | |||
| $ | 50,718 | |||
|
2006
Plan
|
2004
Plan
|
|||||||||||||||||||
|
Number
of Shares
|
Weighted-Average
Exercise Price
|
Number
of Shares
|
Weighted-Average
Exercise Price
|
Aggregate
Intrinsic Value
|
||||||||||||||||
|
Outstanding
at December 31, 2008
|
2,466,519 | $ | 8.76 | 438,628 | $ | 5.52 | 51,826,012 | |||||||||||||
|
Exercisable
at December 31, 2008
|
487,148 | $ | 10.00 | 383,486 | $ | 4.68 | 16,063,651 | |||||||||||||
|
Granted
|
1,514,437 | 18.00 | - | - | ||||||||||||||||
|
Exercised
|
(406,424 | ) | 8.53 | (265,390 | ) | 3.76 | ||||||||||||||
|
Forfeited
|
(89,033 | ) | 11.76 | (43,156 | ) | 10.28 | ||||||||||||||
|
Outstanding
at December 31, 2009
|
3,485,499 | 12.72 | 130,082 | 7.52 | 11,178,792 | |||||||||||||||
|
Exercisable
at December 31, 2009
|
936,933 | 9.56 | 130,082 | 7.52 | 4,768,507 | |||||||||||||||
|
Years
Ended
|
||||||||
|
December
31,
|
||||||||
|
(in
thousands)
|
2009
|
2008
|
||||||
|
Cost
of sales
|
$ | 200 | $ | 100 | ||||
|
Research
and development
|
1,103 | 520 | ||||||
|
General
and administrative
|
3,704 | 1,890 | ||||||
|
Total
stock-based compensation expense
|
$ | 5,007 | $ | 2,510 | ||||
|
2006
Plan
|
2004
Plan
|
|||||||||||||||
|
Number
of Shares
|
Weighted
Average Grant Date Fair Value
|
Number
of Shares
|
Weighted
Average Grant Date Fair Value
|
|||||||||||||
|
Nonvested
at December 31, 2008
|
1,979,371 | $ | 3.57 | 55,142 | $ | 4.24 | ||||||||||
|
Granted
|
1,514,437 | 18.00 | - | - | ||||||||||||
|
Exercised
|
- | - | - | - | ||||||||||||
|
Vested
|
(856,209 | ) | 3.62 | (40,757 | ) | 4.33 | ||||||||||
|
Forfeited
|
(89,033 | ) | 11.76 | (14,385 | ) | 3.98 | ||||||||||
|
Nonvested
at December 31, 2009
|
2,548,566 | $ | 3.57 | - | $ | - | ||||||||||
|
Options
expected to vest at December 31, 2009
|
1,703,399 | - | ||||||||||||||
|
(in
thousands)
|
2009
|
2008
|
2007
|
|||||||||
|
Current
|
||||||||||||
|
Federal
|
$ | 8,254 | $ | 11,186 | $ | 11,189 | ||||||
|
State
|
902 | 98 | 2,275 | |||||||||
|
International
|
58 | 101 | - | |||||||||
|
Total
current
|
9,214 | 11,385 | 13,464 | |||||||||
|
Deferred
|
||||||||||||
|
Federal
|
5,799 | (1,174 | ) | 2,832 | ||||||||
|
State
|
(47 | ) | 1,844 | (3,245 | ) | |||||||
|
Total
deferred
|
5,752 | 670 | (413 | ) | ||||||||
|
Total
provision for income taxes
|
$ | 14,966 | $ | 12,055 | $ | 13,051 | ||||||
|
December 31,
|
||||||||
|
(in
thousands)
|
2009
|
2008
|
||||||
|
Net
operating loss carryforward
|
$ | 10,304 | $ | 8,458 | ||||
|
Research
and development carryforward
|
1,578 | 1,714 | ||||||
|
Stock
compensation
|
1,358 | 730 | ||||||
|
Foreign
deferrals
|
52,059 | 46,151 | ||||||
|
Other
|
(452 | ) | 1,902 | |||||
|
Deferred
tax asset
|
64,847 | 58,955 | ||||||
|
Fixed
assets
|
(3,104 | ) | (851 | ) | ||||
|
Other
|
(2,783 | ) | (2,051 | ) | ||||
|
Deferred
tax liability
|
(5,887 | ) | (2,902 | ) | ||||
|
Valuation
allowance
|
(53,196 | ) | (44,537 | ) | ||||
|
Net
deferred tax asset
|
$ | 5,764 | $ | 11,516 | ||||
|
Year
ended December 31,
|
||||||||||||
|
(in
thousands)
|
2009
|
2008
|
2007
|
|||||||||
|
US
|
$ | 74,758 | $ | 66,326 | $ | 62,016 | ||||||
|
International
|
(28,648 | ) | (33,589 | ) | (26,029 | ) | ||||||
|
Earnings
before taxes on income
|
46,110 | 32,737 | 35,987 | |||||||||
|
Federal
tax at statutory rates
|
$ | 16,138 | $ | 11,458 | $ | 12,595 | ||||||
|
State
taxes, net of federal benefit
|
(1,172 | ) | (2,118 | ) | 701 | |||||||
|
Impact
of foreign operations
|
(7,156 | ) | (8,384 | ) | (7,106 | ) | ||||||
|
Change
in valuation allowance
|
9,025 | 10,835 | 6,419 | |||||||||
|
Effect
of change in rates
|
- | - | 493 | |||||||||
|
Effect
of foreign rates
|
(17 | ) | (11 | ) | 154 | |||||||
|
Tax
credits
|
(835 | ) | (819 | ) | (880 | ) | ||||||
|
Other
differences
|
(2,056 | ) | 185 | (617 | ) | |||||||
|
Permanent
differences
|
1,039 | 909 | 1,292 | |||||||||
|
Provision
for income taxes
|
$ | 14,966 | $ | 12,055 | $ | 13,051 | ||||||
|
(in
thousands)
|
||||
|
Gross
unrecognized tax benefits at January 1, 2007
|
$ | 607 | ||
|
Increases
for tax positions for prior years
|
262 | |||
|
Decreases
for tax positions for prior years
|
(65 | ) | ||
|
Increases
for tax positions for current year
|
100 | |||
|
Settlements
|
(201 | ) | ||
|
Lapse
of statue of limitations
|
(426 | ) | ||
|
Gross
unrecognized tax benefits at December 31, 2007
|
277 | |||
|
Increases
for tax positions for prior years
|
28 | |||
|
Decreases
for tax positions for prior years
|
- | |||
|
Increases
for tax positions for current year
|
- | |||
|
Settlements
|
- | |||
|
Lapse
of statue of limitations
|
(35 | ) | ||
|
Gross
unrecognized tax benefits at December 31, 2008
|
270 | |||
|
Increases
for tax positions for prior years
|
15 | |||
|
Decreases
for tax positions for prior years
|
(80 | ) | ||
|
Increases
for tax positions for current year
|
55 | |||
|
Settlements
|
- | |||
|
Lapse
of statue of limitations
|
- | |||
|
Gross
unrecognized tax benefits at December 31, 2009
|
$ | 260 | ||
|
(in
thousands)
|
||||
|
2010
|
$ | 1,817 | ||
|
2011
|
1,800 | |||
|
2012
|
1,767 | |||
|
2013
|
1,786 | |||
|
2014
|
1,806 | |||
|
2015
and beyond
|
2,974 | |||
|
Total
minimum lease payments
|
$ | 11,950 | ||
|
Reportable
Segments
|
||||||||||||||||
|
(in
thousands)
|
Biodefense
|
Commercial
|
All
Other
|
Total
|
||||||||||||
|
Year
Ended December 31, 2009
|
||||||||||||||||
|
External
revenue
|
$ | 234,574 | $ | 212 | $ | - | $ | 234,786 | ||||||||
|
Intersegment
revenue (expense)
|
- | - | - | - | ||||||||||||
|
Research
and development
|
42,874 | 24,064 | 7,650 | 74,588 | ||||||||||||
|
Interest
revenue
|
- | - | 1,418 | 1,418 | ||||||||||||
|
Interest
expense
|
- | - | (7 | ) | (7 | ) | ||||||||||
|
Depreciation
and amortization
|
3,867 | 852 | 280 | 4,999 | ||||||||||||
|
Net
income (loss)
|
87,850 | (43,770 | ) | (12,936 | ) | 31,144 | ||||||||||
|
Assets
|
215,786 | 25,350 | 103,553 | 344,689 | ||||||||||||
|
Expenditures
for long-lived assets
|
26,583 | 5,933 | 771 | 33,287 | ||||||||||||
|
Year
Ended December 31, 2008
|
||||||||||||||||
|
External
revenue
|
$ | 174,061 | $ | 4,346 | $ | 147 | $ | 178,554 | ||||||||
|
Intersegment
revenue (expense)
|
- | - | - | - | ||||||||||||
|
Research
and development
|
26,321 | 31,169 | 1,980 | 59,470 | ||||||||||||
|
Interest
revenue
|
- | - | 1,999 | 1,999 | ||||||||||||
|
Interest
expense
|
- | - | (47 | ) | (47 | ) | ||||||||||
|
Depreciation
and amortization
|
3,438 | 1,114 | 412 | 4,964 | ||||||||||||
|
Net
income (loss)
|
69,770 | (41,313 | ) | (7,775 | ) | 20,682 | ||||||||||
|
Assets
|
161,091 | 23,450 | 106,247 | 290,788 | ||||||||||||
|
Expenditures
for long-lived assets
|
20,014 | 64 | 735 | 20,813 | ||||||||||||
|
Three
months ended
|
||||||||||||||||
|
(in
thousands)
|
March
31,
|
June
30,
|
September
30,
|
December
31,
|
||||||||||||
|
Fiscal
year 2009
|
||||||||||||||||
|
Revenue
|
$ | 64,519 | $ | 73,191 | $ | 43,272 | $ | 53,804 | ||||||||
|
Income
(loss) from operations
|
17,266 | 22,710 | (3,951 | ) | 4,125 | |||||||||||
|
Net
income
|
11,119 | 14,842 | 949 | 4,234 | ||||||||||||
|
Net
income per share, basic
|
0.37 | 0.49 | 0.03 | 0.14 | ||||||||||||
|
Net
income per share, diluted
|
0.35 | 0.48 | 0.03 | 0.13 | ||||||||||||
|
Fiscal
year 2008
|
||||||||||||||||
|
Revenue
|
$ | 42,720 | $ | 43,485 | $ | 56,599 | $ | 35,750 | ||||||||
|
Income
from operations
|
11,175 | 2,558 | 15,338 | 856 | ||||||||||||
|
Net
income
|
7,024 | 1,815 | 10,386 | 1,457 | ||||||||||||
|
Net
income per share, basic
|
0.24 | 0.06 | 0.35 | 0.05 | ||||||||||||
|
Net
income per share, diluted
|
0.24 | 0.06 | 0.34 | 0.05 | ||||||||||||
| ITEM 9A. | CONTROLS AND PROCEDURES |
|
ITEM
9B.
|
| ITEM 11. | EXECUTIVE COMPENSATION |
|
ITEM
12.
|
| ITEM 14. | PRINCIPAL ACCOUNTANT FEES AND SERVICES |
| ITEM 15. | EXHIBITS AND FINANCIAL STATEMENT SCHEDULES |
|
Signature
|
Title
|
Date
|
||
|
/s/Fuad El-Hibri
Fuad
El-Hibri
|
Chief
Executive Officer and Chairman of the Board of Directors
(Principal
Executive Officer)
|
March
5, 2010
|
||
|
/s/R. Don Elsey
R.
Don Elsey
|
Senior
Vice President Finance, Chief Financial Officer and Treasurer
(Principal
Financial and Accounting Officer)
|
March
5, 2010
|
||
|
/s/Daniel Abdun-Nabi
Daniel
Abdun-Nabi
|
Director
|
March
5, 2010
|
||
|
/s/Zsolt Harsanyi, Ph.D.
Zsolt
Harsanyi, Ph.D.
|
Director
|
March
5, 2010
|
||
|
/s/Jerome M. Hauer
Jerome
M. Hauer
|
Director
|
March
5, 2010
|
||
|
/s/Ronald B. Richard
Ronald
B. Richard
|
Director
|
March
5, 2010
|
||
|
/s/Louis W. Sullivan, M.D.
Louis
W. Sullivan, M.D.
|
Director
|
March
5, 2010
|
||
|
/s/Dr. Sue Bailey
Dr.
Sue Bailey
|
Director
|
March
5, 2010
|
||
|
Exhibit
|
||
|
Number
|
Description
|
|
|
3.1
|
Restated
Certificate of Incorporation of the Registrant (Incorporated by reference
to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-8
(File No. 333-139190 filed on December 8, 2006)
|
|
|
3.2
|
Amended
and Restated By-laws of the Registrant, as amended (Incorporated by
reference to Exhibit 3.2 to the Registrant’s Annual Report on Form 10-K
for the year ended December 31, 2007 (File No.
001-33137))
|
|
|
4.1
|
Specimen
Certificate Evidencing Shares of Common Stock (Incorporated by reference
to Exhibit 4.1 to Amendment No. 3 to the Registrant’s Registration
Statement on Form S-1 (File No. 333-136622) filed on October 20,
2006)
|
|
|
4.2
|
Registration
Rights Agreement, dated September 22, 2006, among the Registrant and the
entities listed on Schedule 1 thereto (Incorporated by reference to
Exhibit 4.3 to Amendment No. 1 to the Registrant’s Registration Statement
on Form S-1 (File No. 333-136622) filed on September 25,
2006)
|
|
|
4.3
|
Rights
Agreement, dated November 14, 2006, between the Registrant and American
Stock Transfer & Trust Company (Incorporated by reference to Exhibit
4.3 to the Registrant’s Registration Statement on Form S-8 (File No.
333-139190) filed on December 8, 2006)
|
|
|
9.1
|
Voting
and Right of First Refusal Agreement, dated October 21, 2005, between the
William J. Crowe, Jr. Revocable Living Trust and Fuad El-Hibri
(Incorporated by reference to Exhibit 9.1 to the Registrant’s Registration
Statement on Form S-1 (File No. 333-136622) filed on August 14,
2006)
|
|
|
10.1*
|
Employee
Stock Option Plan, as amended and restated (Incorporated by reference to
Exhibit 10.1 to the Registrant’s Registration Statement on Form S-1 (File
No. 333-136622) filed on August 14, 2006)
|
|
|
10.2*
|
Form
of Director Stock Option Agreement (Incorporated by reference to Exhibit
10.2 to the Registrant’s Registration Statement on Form S-1 (File No.
333-136622) filed on August 14, 2006)
|
|
|
10.3*
|
Amended
and Restated 2006 Stock Incentive Plan (Incorporated by reference to
Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q for the
quarter ended June 30, 2009 (File No. 001-33137))
|
|
|
10.4*
|
Form
of Incentive Stock Option Agreement under 2006 Stock Incentive Plan
(Incorporated by reference to Exhibit 10.4 to Amendment No. 5 to the
Registrant’s Registration Statement on Form S-1 (File No. 333-136622)
filed on October 30, 2006)
|
|
|
10.5*
|
Form
of Nonstatutory Stock Option Agreement under 2006 Stock Incentive Plan
(Incorporated by reference to Exhibit 10.5 to Amendment No. 5 to the
Registrant’s Registration Statement on Form S-1 (File No. 333-136622)
filed on October 30, 2006)
|
|
|
10.6#
|
Form
of Restricted Stock Unit Agreement under Amended and Restated 2006 Stock
Incentive Plan
|
|
|
10.7#
|
Annual
Bonus Plan for Executive Officers
|
|
|
10.8*
|
Director
Compensation Program (Incorporated by reference to Exhibit 10.6 to the
Registrant’s Annual Report on Form 10-K for the year ended December 31,
2007 (File No. 001-33137))
|
|
|
10.9†
*
|
Severance
Plan and Termination Protection Program (Incorporated by reference to
Exhibit 10.6 to Amendment No. 3 to the Registrant’s Registration Statement
on Form S-1 (File No. 333-136622) filed on October 20,
2006)
|
|
|
10.10*
|
Election
of Fuad El-Hibri to Participate in the Severance Plan and Termination
Protection Program (Incorporated by reference to Exhibit 10.35 to
Amendment No. 1 to the Registrant’s Registration Statement on Form S-1
(File No. 333-136622) filed on September 25, 2006)
|
|
|
10.11
|
Form
of Indemnity Agreement (Incorporated by reference to Exhibit 10.7 to the
Registrant’s Registration Statement on Form S-1 (File No. 333-136622)
filed on August 14, 2006)
|
|
|
10.12†
|
Contract
No. HHSO100200700037C, dated September 25, 2007, between Emergent
BioDefense Operations Lansing Inc., and the Department of Health and Human
Services (Incorporated by reference to Exhibit 10.1 to the Registrant’s
Quarterly Report on Form 10-Q for the quarter ended September 30, 2007
(File No. 001-33137))
|
|
|
10.13†
|
Contract
No. HHS0100200800091C between the Department of Health and Human Services
and Emergent BioDefense Operations Lansing Inc. dated September 30, 2008
(Incorporated by reference to Exhibit 10.6 to the Registrant’s Quarterly
Report on Form 10-Q for the quarter ended September 30, 2008 (File No.
001-33137))
|
|
|
10.14†
|
Filling
Services Agreement, dated March 18, 2002, between Emergent BioDefense
Operations Lansing Inc., formerly BioPort Corporation, and Hollister-Stier
Laboratories LLC, as amended (Incorporated by reference to Exhibit 10.10
to the Registrant’s Registration Statement on Form S-1 (File No.
333-136622) filed on August 14, 2006)
|
|
|
10.15
|
Amendment
No. 5 to the Filling Services Agreement, effective May 14, 2007 between
Emergent BioDefense Operations Lansing Inc., formerly BioPort Corporation,
and Hollister-Stier Laboratories LLC (Incorporated by reference to Exhibit
10.6 to the Registrant’s Quarterly Report on Form 10-Q for the quarter
ended June 30, 2007 (File No. 001-33137))
|
|
|
10.16†
|
Exclusive
Commercial License of Technology by and among Oxford-Emergent Tuberculosis
Consortium Limited, Emergent Product Development UK Limited, Emergent
BioSolutions Inc. and Isis Innovation Limited dated July 18, 2008
(Incorporated by reference to Exhibit 10.5 to the Registrant’s Quarterly
Report on Form 10-Q for the quarter ended September 30, 2008 (File No.
001-33137))
|
|
|
10.17†
|
Product
Supply Agreement, dated June 12, 2006, between Emergent Product
Development Gaithersburg Inc. and Talecris Biotherapeutics, Inc.
(Incorporated by reference to Exhibit 10.34 to Amendment No. 3 to the
Registrant’s Registration Statement on Form S-1 (File No. 333-136622)
filed on October 20, 2006)
|
|
Exhibit
|
||
|
Number
|
Description
|
|
|
10.18#††
|
Amendment
No. 1 to Product Supply Agreement, effective December 19, 2006, between
Emergent Product Development Gaithersburg Inc. and Talecris
Biotherapeutics Inc.
|
|
|
10.19#
|
Amendment
No. 2 to Product Supply Agreement, effective June 25, 2007, between
Emergent Product Development Gaithersburg Inc. and Talecris
Biotherapeutics Inc.
|
|
|
10.20#††
|
Amendment
No. 3 to Product Supply Agreement, effective August 29, 2007, between
Emergent Product Development Gaithersburg Inc. and Talecris
Biotherapeutics Inc.
|
|
|
10.21#
|
Amendment
No. 4 to Product Supply Agreement, effective November 17, 2009, between
Emergent Product Development Gaithersburg Inc. and Talecris
Biotherapeutics Inc.
|
|
|
10.22#††
|
First
Addendum to Product Supply Agreement, effective September 1, 2009, between
Emergent Product Development Gaithersburg Inc. and Talecris
Biotherapeutics Inc.
|
|
|
10.23†
|
Agreement,
dated June 16, 2005, between the Free State of Bavaria and Emergent
Product Development UK, formerly ViVacs GmbH (Incorporated by reference to
Exhibit 10.43 to Amendment No. 3 to the Registrant’s Registration
Statement on Form S-1 (File No. 333-136622) filed on October 20,
2006)
|
|
|
10.24†
|
License
Agreement between U.S. Army Medical Research Institute of Infectious
Diseases and the Registrant dated October 7, 2003 (Incorporated by
reference to Exhibit 10.21 of the Registrant’s Annual Report on Form 10-K
for the year ended December 31, 2008 (File No. 001-33137), filed on March
6, 2009)
|
|
|
10.25
|
Investment
Agreement relating to Microscience Holdings plc, dated March 18, 2005,
among the Wellcome Trust, Microscience Investments Limited, formerly
Microscience Holdings plc, and Emergent Product Development UK Limited,
formerly Microscience Limited, as amended (Incorporated by reference to
Exhibit 10.16 to the Registrant’s Registration Statement on Form S-1 (File
No. 333-136622) filed on August 14, 2006)
|
|
|
10.26#
|
Consulting
Services Agreement, effective April 1, 2009, between the Registrant and
The Hauer Group
|
|
|
10.27
|
Services
Agreement, dated August 1, 2006, between East West Resources Corporation
and the Registrant (Incorporated by reference to Exhibit 10.36 to
Amendment No. 1 to the Registrant’s Registration Statement on Form S-1
(File No. 333-136622) filed on September 25, 2006)
|
|
|
10.28
|
Amended
and Restated Marketing Agreement entered into on February 10, 2009 between
Emergent BioDefense Operations Lansing Inc.and Intergen N.V. (Incorporated
by reference to Exhibit 10.27 to the Registrant's Annual Report on Form
10-K for the year ended December 31,2008 (File No. 001-33137), filed on
March 6, 2009)
|
|
|
10.29
|
Lease
(540 Eskdale Road, Winnersh Triangle, Wokingham, Berkshire), dated
December 13, 1996, between Slough Properties Limited and Azur
Environmental Limited, as assigned to Emergent Product Development UK
Limited, formerly Microscience Limited (Incorporated by reference to
Exhibit 10.22 to the Registrant’s Registration Statement on Form S-1 (File
No. 333-136622) filed on August 14, 2006)
|
|
|
10.30
|
Lease
(545 Eskdale Road, Winnersh Triangle, Wokingham, Berkshire), dated
December 13, 1996, between Slough Properties Limited and Azur
Environmental Limited, as assigned to Emergent Product Development UK
Limited, formerly Microscience Limited (Incorporated by reference to
Exhibit 10.23 to the Registrant’s Registration Statement on Form S-1 (File
No. 333-136622) filed on August 14, 2006)
|
|
|
10.31
|
Lease
Agreement, dated May 10, 2007, among Slough Estates (Winnerish) Limited,
Emergent Product Development UK Limited and the Registrant (Incorporated
by reference to Exhibit 10.5 to the Registrant’s Quarterly Report on Form
10-Q for the quarter ended June 30, 2007 (File No.
001-33137))
|
|
|
10.32
|
Lease
Agreement, dated June 27, 2006, between Brandywine Research LLC and the
Registrant (Incorporated by reference to Exhibit 10.24 to Amendment No. 1
to the Registrant’s Registration Statement on Form S-1 (File No.
333-136622) filed on September 25, 2006)
|
|
|
10.33
|
Loan
and Security Agreement, dated October 14, 2004, among the Registrant,
Emergent Commercial Operations Frederick Inc., formerly Advanced
BioSolutions, Inc., Antex Biologics Inc., Emergent BioDefense Operations
Lansing Inc., formerly BioPort Corporation, and Mercantile Potomac Bank
(Incorporated by reference to Exhibit 10.26 to the Registrant’s
Registration Statement on Form S-1 (File No. 333-136622) filed on August
14, 2006)
|
|
|
10.34
|
Promissory
Note, dated October 14, 2004, from Emergent Commercial Operations
Frederick Inc., formerly Advanced BioSolutions, Inc., to Mercantile
Potomac Bank (Incorporated by reference to Exhibit 10.27 to the
Registrant’s Registration Statement on Form S-1 (File No. 333-136622)
filed on August 14, 2006)
|
|
|
10.35
|
Loan
Agreement, dated October 15, 2004, between Emergent Commercial Operations
Frederick Inc., formerly Advanced BioSolutions, Inc., and the Department
of Business and Economic Development (Incorporated by reference to Exhibit
10.28 to the Registrant’s Registration Statement on Form S-1 (File No.
333-136622) filed on August 14, 2006)
|
|
|
10.36
|
Deed
of Trust Note, dated October 14, 2004, between Emergent Commercial
Operations Frederick Inc., formerly Advanced BioSolutions, Inc., and the
Department of Business and Economic Development (Incorporated by reference
to Exhibit 10.29 to the Registrant’s Registration Statement on Form S-1
(File No. 333-136622) filed on August 14, 2006)
|
|
|
10.37
|
Bond
Purchase Agreement, dated March 31, 2005, between the County Commissioners
of Frederick County, Emergent Commercial Operations Frederick Inc.,
formerly Emergent Biologics Inc., and Mercantile Potomac Bank
(Incorporated by reference to Exhibit 10.32 to the Registrant’s
Registration Statement on Form S-1 (File No. 333-136622) filed on August
14, 2006)
|
|
|
10.38
|
Loan
Agreement, dated April 25, 2006, among the Registrant, Emergent Frederick
LLC and HSBC Realty Credit Corporation (USA) (Incorporated by reference to
Exhibit 10.31 to the Registrant’s Registration Statement on Form S-1 (File
No. 333-136622) filed on August 14, 2006)
|
|
|
10.39
|
Promissory
Note, dated April 25, 2006, from Emergent Frederick LLC to HSBC Realty
Credit Corporation (USA) (Incorporated by reference to Exhibit 10.39 to
Amendment No. 1 to the Registrant’s Registration Statement on Form S-1
(File No. 333-136622) filed on September 25, 2006)
|
|
|
10.40#
|
Loan
Agreement, dated December 30, 2009, among the Registrant, Emergent
BioDefense Operations Lansing Inc., and HSBC Realty Credit Corporation
(USA)
|
|
|
10.41#
|
Promissory
Note, dated December 30, 2009, from Emergent BioDefense Operations Lansing
Inc. to HSBC Realty Credit Corporation
(USA)
|
|
Exhibit
|
||
|
Number
|
Description
|
|
|
10.42
|
Loan
Agreement, dated June 8, 2007, between Emergent BioDefense Operations
Lansing Inc., formerly BioPort Corporation, and Fifth Third Bank
(Incorporated by reference to Exhibit 10.3 to the Registrant’s Quarterly
Report on Form 10-Q for the quarter ended June 30, 2007 (File No.
001-33137))
|
|
|
10.43
|
Amendment
to Loan Agreement between Emergent BioDefense Operations Lansing, Inc. and
Fifth Third Bank dated August 15, 2008 (Incorporated by reference to
Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q for the
quarter ended September 30, 2008 (File No. 001-33137))
|
|
|
10.44
|
Revolving
Credit Note made by Emergent BioDefense Operations Lansing, Inc. in favor
of Fifth Third Bank dated August 15, 2008 (Incorporated by reference to
Exhibit 10.4 to the Registrant’s Quarterly Report on Form 10-Q for the
quarter ended September 30, 2008 (File No. 001-33137))
|
|
|
10.45*
|
Employment
Agreement dated September 21, 2007, between Emergent Product
Development UK Ltd and Dr. Stephen Lockhart (Incorporated by reference to
Exhibit 10.1 to the Registrant’s Current Report on Form 8-K dated December
10, 2009 (File No. 001-33137))
|
|
|
21.1#
|
Subsidiaries
of the Registrant
|
|
|
23.1#
|
Consent
of Independent Registered Public Accounting Firm
|
|
|
31.1#
|
Certification
of the Chief Executive Officer pursuant to Exchange Act
Rule 13a-14(a)
|
|
|
31.2#
|
Certification
of the Chief Financial Officer pursuant to Exchange Act
Rule 13a-14(a)
|
|
|
32.1
#
|
Certification
of the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
|
|
32.2
#
|
Certification
of the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
|
|
†
|
Confidential
treatment granted by the Securities and Exchange Commission as to certain
portions. Confidential materials omitted and filed separately with the
Securities and Exchange Commission.
|
|
††
|
Confidential
treatment requested by the Securities and Exchange Commission as to
certain portions. Confidential materials omitted and filed separately with
the Securities and Exchange
Commission.
|
|
*
|
Management
contract or compensatory plan or arrangement filed herewith in response to
Item 15(a) of Form 10-K.
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|