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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Emergent Biosolutions Inc | NYSE:EBS | NYSE | Common Stock |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|
-0.19 | -1.70% | 11.01 | 11.27 | 10.61 | 11.09 | 1,485,351 | 19:02:01 |
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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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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400 Professional Drive, Gaithersburg , Maryland
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20879
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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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INDEX
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PART I
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PART II
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PART III
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PART IV
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§ |
appropriations for the procurement of BioThrax
®
(Anthrax Vaccine Adsorbed) and our other products addressing public health threats;
|
§ |
our ability to perform under our contracts with the U.S. government related to BioThrax, our NuThrax™ product candidate, and our other public health threat
products, including the timing of and specifications relating to deliveries;
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§ |
our ability to obtain Emergency Use Authorization pre-approval for NuThrax (anthrax vaccine adsorbed with CPG 7909 adjuvant) from the U.S. Food and Drug
Administration, or FDA;
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§ |
the availability of funding for our U.S. government grants and contracts;
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§ |
our ability to secure follow-on procurement contracts for our public health threat products that are under procurement contracts that have expired or will be
expiring;
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§ |
our ability and the ability of our collaborators to protect our intellectual property rights;
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§ |
our ability to identify and acquire companies, businesses, products or product candidates that satisfy our selection criteria;
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§ |
our ability to successfully integrate and realize the benefits of our acquisitions of PaxVax Holding Company Ltd. and Adapt Pharma Limited, both of which were
acquired in October 2018;
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§ |
our ability to successfully identify and respond to new development contracts with the U.S. government, as well as successfully maintain, through achievement
of development milestones, current development contracts with the U.S. government;
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§ |
our ability and the ability of our contractors and suppliers to maintain compliance with current good manufacturing practices and other regulatory
obligations;
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§ |
the results of regulatory inspections;
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§ |
the operating and financial restrictions placed on us and our subsidiaries under our senior secured credit facilities;
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§ |
our ability to obtain and maintain regulatory approvals for our product candidates and the timing of any such approvals;
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§ |
the procurement of products by U.S. government entities under regulatory exemptions prior to approval by the FDA and corresponding procurement by government
entities outside of the United States under regulatory exemptions prior to approval by the corresponding regulatory authorities in the applicable country;
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§ |
the success of our commercialization, marketing and manufacturing capabilities and strategy; and
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§ |
the accuracy of our estimates regarding future revenues, expenses, capital requirements and needs for additional financing.
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·
|
Continue to leverage and expand our leadership position in the PHT market,
now further expanded to encompass the opioid and travelers’ markets as well as the CBRNE and EID markets;
|
·
|
Grow through the acquisition of products and businesses, particularly those
that are revenue-generating and accretive;
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·
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Develop and manufacture innovative products and solutions, particularly
with funding from governments and non-governmental organizations to defray research and development costs;
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·
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Focus on globalization and related international commercial capabilities;
and
|
·
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Diversify our product mix to include products that have Dual Market
potential.
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·
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Unique and valuable commercial and government solutions for PHTs through
formation of public-private partnerships;
|
·
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Quality manufacturing across a spectrum of specialized and complex
manufacturing processes, using multiple platform technologies;
|
·
|
Specialized government relations and contracting operations to support our
government contracting business;
|
·
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Successful completion of business and product acquisitions; and
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·
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Financial discipline driven by a prudent capital allocation strategy
focused on generating positive returns on invested capital.
|
·
|
In August 2018, our collaboration with the Coalition for Epidemic
Preparedness Innovations (“CEPI”) and Profectus BioSciences, Inc. (“Profectus”), under which we intend to advance the development and manufacture of a vaccine against the Lassa virus;
|
·
|
In November 2017, our agreement with Profectus to have the option to
license multiple vector vaccine product candidates, including those for Nipah, and viral hemorrhagic fevers caused by Ebola, Marburg and Lassa viruses;
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·
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In July 2017, our collaboration with Southwest Research Institute, an
independent, nonprofit applied research and development organization headquartered in San Antonio, Texas, under which we are developing an intra-nasal spray device for the treatment of known or suspected acute cyanide poisoning; and
|
·
|
In December 2015, our acquisition of Unither Virology LLC, which held a
broad family of iminosugar small molecules that have activity against a variety of enveloped viruses.
|
VACCINES AND
ANTI-INFECTIVES UNIT
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||
Product
|
Indication(s)
|
Regulatory
Approvals
|
BioThrax
®
(Anthrax Vaccine Adsorbed)
|
GUP - General use prophylaxis of anthrax disease; and
PEP - Post-exposure prophylaxis of anthrax disease in combination with appropriate antibacterial drugs.
|
United States, Germany, Singapore, UK, Germany, Netherlands, France, Poland, Italy and Canada.
|
ACAM2000
®
(Smallpox (Vaccinia) Vaccine, Live)
|
Vaccination for active immunization against smallpox disease for persons determined to be at high risk for
smallpox.
|
United States, Australia, Singapore
|
Vaxchora®
(Cholera Vaccine Live Oral)
|
Oral vaccine for the prevention of cholera.
|
United States
|
Vivotif®
(Typhoid Vaccine Live Oral Ty21a)
|
Oral vaccine for the prevention of typhoid fever.
|
United States, Canada, Australia, New Zealand, Singapore, South Korea, Hong Kong, Malaysia, UK, France, Italy,
Portugal, Spain, Switzerland, Belgium, Luxembourg, The Netherlands, Germany, Austria, Norway, Denmark, Finland, Sweden, The Czech Republic, Slovakia
|
Product Candidate
|
Partner
|
Platform
|
Threat Type
|
NuThrax™
Next generation anthrax vaccine
|
HHS - BARDA
|
Vaccine
|
Biological
|
CHIKUNGUNYA
Chikungunya VLP vaccine
|
--
|
Vaccine
|
EID
|
ADENOVIRUS 4/7
Live, attenuated vaccine
|
DoD - USAMRAA
|
Vaccine
|
EID
|
rVSV-Lassa
Vaccine for prevention of Lassa fever
|
CEPI
|
Vaccine
|
EID
|
rVSV-Marburg
Vaccine for prevention of Marburg hemorrhagic fever
|
--
|
Vaccine
|
Biological
|
rVSV-Sudan
Vaccine for prevention of Sudan hemorrhagic fever
|
--
|
Vaccine
|
Biological
|
rVSV-QUAD
Vaccine for prevention of hemorrhagic fever caused by infection with Lassa, Ebola, Sudan or
Marburg virus
|
NIAID (to Profectus)
|
Vaccine
|
Biological
|
rVSV-Ebola
Vaccine for prevention of Ebola hemorrhagic fever
|
--
|
Vaccine
|
Biological
|
·
|
rVSV-Lassa
, a recombinant vesicular stomatitis virus vectored vaccine for prevention of Lassa fever;
|
·
|
·
|
rVSV-Ebola
, a recombinant vesicular stomatitis virus vectored vaccine for prevention of viral hemorrhagic fever caused by infection with
Zaire ebolaviruses
;
|
·
|
rVSV-Sudan
, a recombinant vesicular stomatitis virus vectored vaccine for prevention of viral hemorrhagic fever caused by infection with Sudan Ebolavirus; and
|
·
|
rVSV-QUAD
, a recombinant vesicular stomatitis virus vectored vaccine for prevention of hemorrhagic fever caused by infection with Lassa, Ebola, Marburg or Sudan virus infections.
|
DEVICES UNIT
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Product
|
Indication(s)
|
Regulatory
Approvals
|
NARCAN®
(naloxone HCl)
Nasal
Spray
|
Emergency treatment of known or suspected opioid overdose as manifested by respiratory and/or central nervous
system depression
|
·
United States
·
Canada
|
RSDL
®
(Reactive Skin Decontamination Lotion Kit)
|
Removal or neutralization of chemical warfare agents and T-2 toxin from the skin: tabun, sarin, soman, cyclohexyl
sarin, VR, VX, mustard gas and T-2 toxin.
|
·
Canada
·
Australia
·
European Union
·
Israel
|
Trobigard™
(atropine sulfate, obidoxime chloride
|
Auto-injector device designed for intramuscular self-injection of atropine sulfate and obidoxime chloride as a
nerve agent countermeasure.
|
Product Candidate
|
Target
Indication |
FLU-IGIV
Seasonal influenza therapeutic
|
Treatment of serious Influenza A infection in hospitalized patients.
|
ZIKV-IG
Zika therapeutic
|
Prophylaxis for Zika infections in at risk populations.
|
§ |
Camden (Baltimore, Maryland).
Primarily supporting
our Contract Development and Manufacturing business unit, our Camden facility has provided manufacturing services to more than 50 domestic and international customers and has manufactured over 20 commercial products distributed in
approximately 50 countries. This fill/finish manufacturing site offers customers a broad portfolio of capabilities essential to their product development and commercialization efforts.
|
§ |
Canton, Massachusetts
. Our Canton, Massachusetts
facility is equipped with large-scale bioreactors for cell culture propagation and viral infection as well as downstream processing equipment for the production of live viral vaccine products, including ACAM2000. This site also operates
as a contract manufacturing operation (“CMO”) facility and we intend to expand on this capability.
|
§ |
Winnipeg, Manitoba, Canada.
Our facilities in
Winnipeg contain the primary location for product development and manufacturing in support of our Antibody Therapeutics business unit. These facilities also support our Contract Development and Manufacturing business unit through
product development and manufacturing support to a number of other customers.
|
§ |
ACAM2000
.
ACAM2000 is the only FDA-licensed approved smallpox vaccine in the United States. Investigational stage competitor vaccine Imvamune® of Bavarian Nordic
may be used in a smallpox emergency under the appropriate regulatory mechanism (
i.e.,
IND or EUA). Imvamune is approved in Canada
and in the European Union where it is marketed under the trade name Imvanex®. It was designed for use in people for whom replicating smallpox vaccines are contraindicated and is indicated for use in immunocompromised patients, including
HIV-infected individuals and those undergoing immunosuppressive therapy. A BLA was submitted by Bavarian Nordic to the FDA in October 2018.
|
§ |
raxibacumab and Anthrasil
.
Raxibacumab is the first FDA licensed fully human anthrax monoclonal antibody therapeutic and Anthrasil is the only polyclonal
antibody therapeutic licensed by the FDA and Health Canada for the treatment of toxemia resulting from inhalational anthrax. However, Elusys Therapeutics, Inc. has obtained FDA licensure for Anthim® (obiltoxaximab) injection, indicated
for the treatment and prophylaxis of inhalational anthrax.
|
§ |
BAT
.
Our botulinum antitoxin immune globulin product is the only heptavalent therapeutic licensed approved by the FDA and Health Canada for the treatment of
botulism and has orphan drug designation. Other companies may be developing therapies aimed at treating or preventing botulism infections, however, direct competition is currently limited.
|
§ |
VIGIV
.
Our VIGIV product is the only therapeutic licensed approved by the FDA and Health Canada to address adverse events from smallpox vaccination with ACAM2000.
Other companies may be developing therapies aimed at treating or preventing vaccinia infections; however, direct competition is currently limited. SIGA Technologies, Inc. is developing Tecovirimat (Arestvyr™, ST-26), an oral therapy
that targets orthopox viruses such as vaccinia and potentially smallpox. Chimerix is also developing brincidofovir, a nucleotide analog lipid conjugate for treatment of smallpox.
|
§ |
RSDL
.
In the United States, the RSDL Kit is the only medical device cleared by the FDA to remove or neutralize chemical warfare agents and T-2 toxin from the skin.
Internationally, various Ministries of Defense have procured Fullers Earth, Dutch Powder and French Powder as a preparedness countermeasure for the decontamination of liquid chemical weapons from the skin.
|
§ |
Vivotif
®. Vivotif is the only
licensed FDA-approved oral typhoid vaccine globally. In the markets where Vivotif is licensed, it competes with Sanofi Pasteur’s Typhim VI® vaccine, an injectable polysaccharide typhoid vaccine.
|
§ |
Vaxchora
®. In the United States, Vaxchora is the only FDA-licensed approved vaccine available indicated to prevent cholera. Dukoral®, an injectable cholera vaccine manufactured by Valneva,
is available outside of the U.S.
|
§ |
Trobigard
.
Trobigard auto-injector delivers obidoxime chloride and atropine sulfate for emergency treatment of organophosphate nerve agent or insecticide
poisoning. Meridian Medical Technologies, a subsidiary of Pfizer, is currently the sole owner of FDA-approved nerve agent antidote auto-injector devices to the USG and many international allied governments. Internationally, the
remaining market is fragmented and served by regional or national-based defense product manufacturers.
|
§ |
Contract Development and Manufacturing
Services Business
.
We compete for contract manufacturing service business with a number of biopharmaceutical product
development organizations, contract manufacturers of biopharmaceutical products and university research laboratories, including, among others: Lonza Group Ltd., OSO BioPharmaceuticals Manufacturing, LLC, Par Pharmaceutical Companies,
Inc., Jubilant Hollister-Stier Laboratories LLC (a subsidiary of Jubilant Life Sciences Limited), Patheon Inc., Hospira Inc., Ajinomoto Althea, Inc. (a subsidiary of Ajinomoto Co., Inc.), Cook Pharmica LLC (a subsidiary of Cook Group
Inc.), and Albany Molecular Research, Inc. We also compete with in-house research, development and support service departments of other biopharmaceutical companies.
|
§ |
the Federal Acquisition Regulation (“FAR”) and agency-specific regulations supplemental to FAR, which comprehensively regulate the award, formation,
administration and performance of government contracts;
|
§ |
the Defense Federal Acquisition Regulations (“DFARs”) and agency-specific regulations supplemental to DFARs, which comprehensively regulate the award,
formation, administration and performance of DoD government contracts;
|
§ |
the Department of State Acquisition Regulation (“
DOSAR”)
which regulates the relationship between a Department of State organization and a contractor or potential contractor;
|
§ |
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, the Procurement Integrity Act, the False Claims Act and the Foreign Corrupt Practices Act;
|
§ |
export and import control laws and regulations, including but not limited to ITAR (International Traffic in Arms 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.
|
§ |
Phase 1 clinical trials test for safety, dose tolerance, absorption, bio-distribution, metabolism, excretion and clinical pharmacology and, if possible, for
early evidence regarding efficacy.
|
§ |
Phase 2 clinical trials involve a small number of patients with the target disease or disorder and seek to assess the efficacy of the drug for specific
indications to determine dose response and the optimal dose range and to gather additional information relating to safety and potential adverse effects.
|
§ |
Phase 3 clinical trials consist of expanded, larger-scale studies of patients with the target disease or disorder to obtain definitive statistical evidence of
the efficacy and safety of the proposed product candidate using a specific dosing regimen. The safety and efficacy data generated from Phase 3 clinical trials typically form the basis for FDA approval of the product candidate.
|
§ |
Phase 4 clinical trials are sometimes conducted after a product has been approved. These trials can be conducted for a number of purposes, including to
collect long-term safety information or to collect additional data about a specific patient population. As part of a product approval, the FDA may require that certain Phase 4 studies, which are sometimes called post-marketing
commitment studies, be conducted post-approval.
|
§ |
BioThrax for post-exposure prophylaxis of disease following suspected or confirmed
B. anthracis
exposure, when administered in conjunction with recommended antibacterial drugs, with exclusivity though November 2022;
|
§ |
raxibacumab for the treatment of adult and pediatric patients with inhalational anthrax in combination with appropriate antibacterial drugs and for
prophylaxis of inhalational anthrax when alternative therapies are not available or not appropriate, with exclusivity through December 2019;
|
§ |
Anthrasil for the treatment of toxemia associated with inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial
drugs, with exclusivity through March 2022; and
|
§ |
BAT for the treatment of suspected or documented exposure to botulinum neurotoxin A, B, C, D, E, F or G, with exclusivity through March 2020.
|
§ |
Class I devices are those for which safety and effectiveness can be assured by adherence to a set of general controls. These general controls include
compliance with the applicable portions of the FDA’s Quality System Regulation (“QSR”) which sets forth requirements for manufacturing practices, record keeping, reporting of adverse medical events, labeling and promotion only for
cleared or approved intended uses.
|
§ |
Class II devices are also subject to these general controls and to any other special controls as deemed necessary by the FDA to ensure the safety and
effectiveness of the device. Review and clearance by the FDA for these devices is typically accomplished through the 510(k)-pre-market notification procedure. When 510(k) clearance is sought, a sponsor must submit a pre-market
notification demonstrating that the proposed device is substantially equivalent to a device approved by the FDA after May 28, 1976. This previously-cleared device is called the predicate device. If the FDA agrees that the proposed
device is substantially equivalent to the predicate device, then 510(k) clearance to market will be granted. After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that
would constitute a major change in its intended use, requires a new 510(k) clearance or could require pre-market approval.
If a
proposed device is substantially equivalent to a predicate device that was cleared prior to May 28, 1976, the proposed device is cleared based on a pre-amendment and is cleared as an unclassified device.
|
§ |
A Class III device requires approval of a pre-market application (“PMA”) which is an expensive, lengthy and uncertain process requiring many years to
complete. Clinical trials are almost always required to support a PMA. These trials generally require submission of an application for an investigational device exemption (“IDE”). An IDE must be supported by pre-clinical data, such as
animal and laboratory testing results, which show that the device is safe to test in humans and that the study protocols are scientifically sound. The IDE must be approved in advance by the FDA for a specified number of patients, unless
the product is deemed a non-significant risk device and is eligible for more abbreviated investigational device exemption requirements.
|
§ |
the possibility that we may be ineligible to respond to a request for proposal issued by the government;
|
§ |
the commitment of 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;
|
§ |
the submission by third parties of protests to our responses to requests for proposal that could result in delays or withdrawals of those requests for
proposal; and
|
§ |
in the event our competitors protest or challenge contract or grant awards made to us pursuant to competitive bidding, the potential that we may incur
expenses or delays, and that any such protest or challenge could result in the resubmission of bids based on modified specifications, or in the termination, reduction or modification of the awarded contract.
|
§ |
the FAR and agency-specific regulations supplemental to FAR, which comprehensively regulate the award, formation, administration and performance of government
contracts;
|
§ |
the DFARs and agency-specific regulations supplemental to DFARs, which comprehensively regulate the award, formation, administration and performance of DoD
government contracts;
|
§ |
the DOSAR, which regulates the relationship between a Department of State organization and a contractor or potential contractor;
|
§ |
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, the Procurement Integrity Act, the False Claims Act and the Foreign Corrupt Practices Act;
|
§ |
export and import control laws and regulations, including but not limited to International Traffic in Arms 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.
|
§ |
terminate existing contracts, in whole or in part, for any reason or no reason;
|
§ |
unilaterally reduce or modify contracts or subcontracts, including by imposing equitable price adjustments;
|
§ |
cancel multi-year contracts and related orders, if funds for contract performance for any subsequent year become unavailable;
|
§ |
decline, in whole or in part, to exercise an option to purchase product under a procurement contract or to fund additional development under a development
contract;
|
§ |
decline to renew a procurement contract;
|
§ |
claim rights to facilities or to products, including intellectual property, developed under the contract;
|
§ |
require repayment of contract funds spent on construction of facilities in the event of contract default;
|
§ |
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 civil or criminal remedies under acts such as the False Claims Act and False Statements Act; and
|
§ |
control or prohibit the export of products.
|
§ |
warning letters and other communications;
|
§ |
product seizure or withdrawal of the product from the market;
|
§ |
restrictions on the marketing or manufacturing of a product;
|
§ |
suspension or withdrawal of regulatory approvals or refusal to approve pending applications or supplements to approved applications;
|
§ |
fines or disgorgement of profits or revenue; and
|
§ |
injunctions or the imposition of civil or criminal penalties.
|
§ |
equipment malfunctions or failures;
|
§ |
technology malfunctions;
|
§ |
cyber-attacks;
|
§ |
work stoppages or slow-downs;
|
§ |
protests, including by animal rights activists;
|
§ |
injunctions;
|
§ |
damage to or destruction of the facility; and
|
§ |
product contamination or tampering.
|
§ |
retaining existing customers and attracting new customers;
|
§ |
retaining key employees;
|
§ |
diversion of management attention and resources;
|
§ |
conforming internal controls, policies and procedures, business cultures and compensation programs;
|
§ |
consolidating corporate and administrative infrastructures;
|
§ |
successfully executing technology transfers and obtaining required regulatory approvals;
|
§ |
consolidating sales and marketing operations;
|
§ |
identifying and eliminating redundant and underperforming operations and assets;
|
§ |
assumption of known and unknown liabilities;
|
§ |
coordinating geographically dispersed organizations; and
|
§ |
managing tax costs or inefficiencies associated with integrating operations.
|
§ |
successful development, formulation and cGMP scale-up of manufacturing that meets FDA or other foreign regulatory requirements;
|
§ |
successful program partnering;
|
§ |
successful completion of clinical or non-clinical development, including toxicology studies and studies in approved animal models;
|
§ |
receipt of marketing approvals from the FDA and equivalent foreign regulatory authorities;
|
§ |
establishment of commercial manufacturing processes and product supply arrangements;
|
§ |
training of a commercial sales force for the product, whether alone or in collaboration with others;
|
§ |
successful registration and maintenance of relevant patent and/or other proprietary protection; and
|
§ |
acceptance of the product by potential government and other customers.
|
§ |
our inability to manufacture sufficient quantities of materials for use in trials;
|
§ |
the unavailability or variability in the number and types of subjects for each study;
|
§ |
safety issues or inconclusive or incomplete testing, trial or study results;
|
§ |
drug immunogenicity;
|
§ |
lack of efficacy of product candidates during the trials;
|
§ |
government or regulatory restrictions or delays; and
|
§ |
greater than anticipated costs of trials.
|
·
|
Pfizer, Inc. an oligonucleotide adjuvant, CPG 7909, for use in our
NuThrax™ (anthrax vaccine adsorbed with CPG 7909 adjuvant) anthrax
vaccine product candidate.
|
·
|
Pharma Consult GmbH autoinjectors, including the autoinjector used for our Trobigard® (atropine sulfate,
obidoxime chloride) autoinjector.*
|
§ |
requiring us to dedicate a substantial portion of any cash flow from operations to payment on our debt, which would reduce the amounts available to fund other
corporate initiatives;
|
§ |
increasing the amount of interest that we have to pay on debt with variable interest rates, if market rates of interest increase;
|
§ |
subjecting us, as under our senior secured credit facilities, to restrictive covenants that may reduce our ability to take certain corporate actions, acquire
companies, products or technology, or obtain further debt financing;
|
§ |
requiring us to pledge our assets as collateral, which could limit our ability to obtain additional debt financing;
|
§ |
limiting our flexibility in planning for, or reacting to, general adverse economic and industry conditions; and
|
§ |
placing us at a competitive disadvantage compared to our competitors that have less debt, better debt servicing options or stronger debt servicing capacity.
|
§ |
the level, timing and cost of product sales and contract manufacturing services;
|
§ |
the extent to which we acquire or invest in and integrate companies, businesses, products or technologies;
|
§ |
the acquisition of new facilities and capital improvements to new or existing facilities;
|
§ |
the payment obligations under our indebtedness;
|
§ |
the scope, progress, results and costs of our development activities;
|
§ |
our ability to obtain funding from collaborative partners, government entities and non-governmental organizations for our development programs;
|
§ |
the extent to which we repurchase additional common stock under our authorized share repurchase program; and
|
§ |
the costs of commercialization activities, including product marketing, sales and distribution.
|
§ |
decreased demand or withdrawal of a product;
|
§ |
injury to our reputation;
|
§ |
withdrawal of clinical trial participants;
|
§ |
costs to defend the related litigation;
|
§ |
substantial monetary awards to trial participants or patients;
|
§ |
loss of revenue; and
|
§ |
an inability to commercialize products that we may develop.
|
§ |
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;
|
§ |
advance notice requirements for stockholder nominations of candidates for election to the Board 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 a new series of preferred stock without stockholder approval.
|
§ |
contracts, decisions and procurement policies by the USG affecting BioThrax and our other products and product candidates;
|
§ |
the success of competitive products or technologies;
|
§ |
results of clinical and non-clinical trials of our product candidates;
|
§ |
announcements of acquisitions, financings or other transactions by us;
|
§ |
litigation or legal proceedings;
|
§ |
public concern as to the safety of our products;
|
§ |
termination or delay of a development program;
|
§ |
the recruitment or departure of key personnel;
|
§ |
variations in our product revenue and profitability; and
|
§ |
the other factors described in this “Risk Factors” section.
|
Location
|
Use
|
Approximate square feet
|
Owned/leased
|
Bern, Switzerland
|
Manufacturing facilities and office and laboratory space
|
511,000
|
Owned
|
Lansing, Michigan
|
Manufacturing operations facilities, office space and laboratory space
|
336,000
|
Owned
|
Winnipeg, Manitoba, Canada
|
Manufacturing operations facilities, office space and laboratory space
|
315,000
|
Owned
|
Gaithersburg, Maryland
|
Office space and rental real estate
|
130,000
|
Owned
|
Baltimore, Maryland (Bayview)
|
Manufacturing facilities and office and laboratory space
|
112,000
|
Owned
|
Issuer Purchases of Equity Securities
|
||||||||||||||||
(in millions,
except for per share data)
|
||||||||||||||||
Period
|
Total number of shares (or units) purchased
|
Average price paid per share (or unit)(a)
|
Total number of shares (or units) purchased as part of publicly announced plans or programs(b)
|
Maximum number (or approximate dollar value) of shares (or units) that may yet be purchased
under the plans or programs (a)(b)
|
||||||||||||
October 1, 2018 - October 31, 2018
|
-
|
$
|
-
|
-
|
$
|
-
|
||||||||||
November 1, 2018 - November 30, 2018
|
-
|
-
|
-
|
-
|
||||||||||||
December 1, 2018 - December 31, 2018
|
-
|
-
|
-
|
-
|
||||||||||||
Total
|
-
|
$
|
-
|
-
|
$
|
50.0
|
Year Ended December 31,
|
||||||||||||||||||||
(in millions, except per share data)
|
2018
|
2017
|
2016
|
2015
|
2014
|
|||||||||||||||
Statements of operations data:
|
||||||||||||||||||||
Revenues:
|
||||||||||||||||||||
Product sales
|
$
|
606.5
|
$
|
421.5
|
$
|
296.3
|
$
|
329.0
|
$
|
281.8
|
||||||||||
Contract manufacturing
|
98.9
|
68.9
|
49.1
|
43.0
|
30.9
|
|||||||||||||||
Contracts and grants
|
77.0
|
70.5
|
143.4
|
117.3
|
91.8
|
|||||||||||||||
Total revenues
|
782.4
|
560.9
|
488.8
|
489.3
|
404.5
|
|||||||||||||||
Operating expenses:
|
||||||||||||||||||||
Cost of product sales and contract manufacturing
|
322.3
|
187.7
|
126.3
|
102.1
|
96.6
|
|||||||||||||||
Research and development
|
142.8
|
97.4
|
106.9
|
117.8
|
103.5
|
|||||||||||||||
Selling, general & administrative
|
202.5
|
142.9
|
143.1
|
120.6
|
108.1
|
|||||||||||||||
Amortization of intangible assets
|
25.0
|
8.6
|
7.0
|
7.3
|
7.1
|
|||||||||||||||
Total operating expenses
|
692.6
|
436.6
|
383.3
|
347.8
|
315.3
|
|||||||||||||||
Income from operations
|
89.8
|
124.3
|
105.5
|
141.5
|
89.2
|
|||||||||||||||
Other income (expense):
|
||||||||||||||||||||
Interest expense
|
(9.9
|
)
|
(6.6
|
)
|
(7.6
|
)
|
(6.5
|
)
|
(8.2
|
)
|
||||||||||
Other income (expense), net
|
1.6
|
0.9
|
1.3
|
0.7
|
3.2
|
|||||||||||||||
Total other income (expense), net
|
(8.3
|
)
|
(5.7
|
)
|
(6.3
|
)
|
(5.8
|
)
|
(5.0
|
)
|
||||||||||
Income from continuing operations before provision for income taxes
|
81.5
|
118.6
|
99.2
|
135.7
|
84.2
|
|||||||||||||||
Provision for income taxes
|
18.8
|
36.0
|
36.7
|
44.3
|
29.9
|
|||||||||||||||
Net income from continuing operations
|
62.7
|
82.6
|
62.5
|
91.4
|
54.3
|
|||||||||||||||
Net loss from discontinued operations
|
-
|
-
|
(10.7
|
)
|
(28.5
|
)
|
(17.6
|
)
|
||||||||||||
Net income
|
$
|
62.7
|
$
|
82.6
|
$
|
51.8
|
$
|
62.9
|
$
|
36.7
|
||||||||||
Net income per share from continuing operations-basic
|
$
|
1.25
|
$
|
1.98
|
$
|
1.56
|
$
|
2.37
|
$
|
1.45
|
||||||||||
Net loss per share from discontinued operations-basic
|
-
|
-
|
(0.27
|
)
|
(0.74
|
)
|
(0.47
|
)
|
||||||||||||
Net income per share-basic
|
$
|
1.25
|
$
|
1.98
|
$
|
1.29
|
$
|
1.63
|
$
|
0.98
|
||||||||||
Net income per share from continuing operations-diluted
|
$
|
1.22
|
$
|
1.71
|
$
|
1.35
|
$
|
2.02
|
$
|
1.26
|
||||||||||
Net loss per share from discontinued operations-diluted
|
-
|
-
|
(0.22
|
)
|
(0.61
|
)
|
(0.38
|
)
|
||||||||||||
Net income per share-diluted (1)
|
$
|
1.22
|
$
|
1.71
|
$
|
1.13
|
$
|
1.41
|
$
|
0.88
|
||||||||||
Weighted average number of shares — basic
|
50.1
|
41.8
|
40.2
|
38.6
|
37.3
|
|||||||||||||||
Weighted average number of shares — diluted
|
51.4
|
50.3
|
49.3
|
47.3
|
45.8
|
As of December 31,
|
||||||||||||||||||||
(in millions)
|
2018
|
2017
|
2016
|
2015
|
2014
|
|||||||||||||||
Balance Sheet Data:
|
||||||||||||||||||||
Cash and cash equivalents
|
$
|
112.2
|
$
|
178.3
|
$
|
271.5
|
$
|
308.3
|
$
|
276.8
|
||||||||||
Working capital
|
420.4
|
385.3
|
404.4
|
425.9
|
312.8
|
|||||||||||||||
Total assets
|
2,229.4
|
1,070.2
|
970.1
|
931.8
|
815.6
|
|||||||||||||||
Total long-term liabilities
|
1,018.1
|
57.8
|
268.1
|
274.6
|
281.5
|
|||||||||||||||
Total stockholders’ equity
|
1,010.9
|
912.2
|
596.2
|
575.0
|
454.5
|
§ |
personnel-related expenses;
|
§ |
fees to professional service providers for, among other things, analytical testing, independent monitoring or other administration of our clinical trials and
obtaining and evaluating data from our clinical trials and non-clinical studies;
|
§ |
costs of contract manufacturing services for clinical trial material; and
|
§ |
costs of materials used in clinical trials and research and development.
|
|
Year ended
December 31,
|
|||||||||||||||
(in millions)
|
2018
|
2017
|
$ Change
|
% Change
|
||||||||||||
Product sales:
|
||||||||||||||||
BioThrax
|
$
|
278.0
|
$
|
286.6
|
$
|
(8.6
|
)
|
(3
|
%)
|
|||||||
ACAM2000
|
116.7
|
11.5
|
105.2
|
915
|
%
|
|||||||||||
Other
|
211.8
|
123.4
|
88.4
|
72
|
%
|
|||||||||||
Total product sales
|
606.5
|
421.5
|
185.0
|
44
|
%
|
|||||||||||
Contract manufacturing
|
98.9
|
68.9
|
30.0
|
44
|
%
|
|||||||||||
Contracts and grants
|
77.0
|
70.5
|
6.5
|
9
|
%
|
|||||||||||
Total revenues
|
$
|
782.4
|
$
|
560.9
|
$
|
221.5
|
39
|
%
|
§ |
raxibacumab, acquired in October 2017;
|
§ |
NARCAN® Nasal Spray, acquired in October 2018;
|
§ |
Vivotif, acquired in October 2018; and
|
§ |
Vaxchora; acquired in October 2018.
|
§ |
fill/finish services provided to third parties;
|
§ |
the design, construction and validation of manufacturing capability for a third party at our Lansing, Michigan site; and
|
§ |
manufacturing services performed at our Canton, Massachusetts facility.
|
§ |
manufacturing development activities related to our NuThrax product candidate;
|
§ |
timing of a Phase 2 clinical study and related activities for our FLU-IGIV (NP025) program; and
|
§ |
timing of manufacturing development activities and toxicology/safety studies for our SIAN product candidate.
|
|
Year ended
December 31,
|
|||||||||||||||
(in millions)
|
2017
|
2016
|
$ Change
|
% Change
|
||||||||||||
Product sales:
|
||||||||||||||||
BioThrax
|
$
|
286.6
|
$
|
237.0
|
$
|
49.6
|
21
|
%
|
||||||||
Other
|
134.9
|
59.3
|
75.6
|
127
|
%
|
|||||||||||
Total product sales
|
421.5
|
296.3
|
125.2
|
42
|
%
|
|||||||||||
Contract manufacturing
|
68.9
|
49.1
|
19.8
|
40
|
%
|
|||||||||||
Contracts and grants
|
70.5
|
143.4
|
(72.9
|
)
|
(51
|
%)
|
||||||||||
Total revenues
|
$
|
560.9
|
$
|
488.8
|
$
|
72.1
|
15
|
%
|
§ |
the timing of BAT deliveries of $28.4 million to the SNS;
|
§ |
international sales for VIGIV and Trobigard of $25.3 million; and
|
§ |
sales of ACAM2000® and raxibacumab, both acquired in October 2017, of $20.5 million.
|
§ |
manufacturing services provided to third parties; and
|
§ |
manufacturing services performed for third party development stage product candidates.
|
§ |
decreased development funding of $37.7 million related to our CIADM program. This decrease includes a reduction of $20.5 million related to the timing of
facility construction activities and $17.1 million related to CIADM task orders (primarily the successful completion of manufacturing development for Ebola monoclonal antibodies);
|
§ |
decreased development funding of $34.1 million for VIGIV related to the timing of plasma collection; and
|
§ |
decreased development funding of $6.8 million for large scale manufacturing of BioThrax, primarily due to the successful completion of the Building 55
development program in 2016 that did not recur in 2017.
|
§ |
the increase in RSDL deliveries to the DoD along with the timing of non-cash fair value adjustments to the contingent consideration liability;
|
§ |
timing of BAT sales to the SNS;
|
§ |
timing of international sales for VIGIV and Trobigard;
|
§ |
sales of the newly acquired ACAM2000 and raxibacumab products (both acquired October 2017); and
|
§ |
increased costs associated with the expansion of our contract manufacturing business.
|
§ |
manufacturing development of Ebola monoclonal antibodies related to our CIADM task orders; and
|
§ |
plasma collection related to our VIGIV program.
|
§ |
formulation development activities, along with screening of molecules within the series, related to our EV-035 series of molecules; and
|
§ |
preparation for a clinical trial related to our ZIKV-IG program (which was completed in 2018).
|
|
Year ended December 31,
|
|||||||||||
(in millions)
|
2018
|
2017
|
2016
|
|||||||||
Net cash provided by (used in):
|
||||||||||||
Operating activities(1)
|
$
|
41.6
|
$
|
208.1
|
$
|
54.7
|
||||||
Investing activities
|
(897.2
|
)
|
(249.9
|
)
|
(76.2
|
)
|
||||||
Financing activities
|
788.7
|
(51.4
|
)
|
(19.8
|
)
|
|||||||
Net decrease in cash and cash equivalents
|
$
|
(66.9
|
)
|
$
|
(93.2
|
)
|
$
|
(41.3
|
)
|
§ |
existing cash and cash equivalents;
|
§ |
net proceeds from the sale of our products and contract manufacturing services;
|
§ |
development contracts and grants funding; and
|
§ |
our Senior Secured Credit Facilities and any other lines of credit we may establish from time to time.
|
§ |
the level, timing and cost of product sales and contract manufacturing services;
|
§ |
the extent to which we acquire or invest in and integrate companies, businesses, products or technologies;
|
§ |
the acquisition of new facilities and capital improvements to new or existing facilities;
|
§ |
the payment obligations under our indebtedness;
|
§ |
the scope, progress, results and costs of our development activities;
|
§ |
our ability to obtain funding from collaborative partners, government entities and non-governmental organizations for our development programs;
|
§ |
the extent to which we repurchase additional common stock under our authorized share repurchase program; and
|
§ |
the costs of commercialization activities, including product marketing, sales and distribution.
|
Payments due by period
|
||||||||||||||||||||
Less than
|
1 to 3
|
3 to 5
|
More than
|
|||||||||||||||||
(in millions)
|
Total
|
1 year
|
Years
|
Years
|
5 years
|
|||||||||||||||
Contractual obligations:
|
||||||||||||||||||||
Long-term indebtedness
|
$
|
836.6
|
$
|
14.3
|
$
|
103.3
|
$
|
719.0
|
$
|
-
|
||||||||||
Operating lease obligations
|
15.5
|
3.4
|
5.0
|
4.6
|
2.5
|
|||||||||||||||
Deemed mandatory repatriation tax (1)
|
11.3
|
1.1
|
4.2
|
6.0
|
-
|
|||||||||||||||
Purchase commitments
|
66.7
|
60.1
|
6.6
|
-
|
-
|
|||||||||||||||
Total contractual obligations
|
$
|
930.1
|
$
|
78.9
|
$
|
119.1
|
$
|
729.6
|
$
|
2.5
|
December 31,
|
||||||||
2018
|
2017
|
|||||||
ASSETS
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
112.2
|
$
|
178.3
|
||||
Restricted cash
|
0.2
|
1.0
|
||||||
Accounts receivable, net
|
262.5
|
143.7
|
||||||
Inventories
|
205.8
|
142.8
|
||||||
Income tax receivable, net
|
8.6
|
2.4
|
||||||
Prepaid expenses and other current assets
|
31.5
|
17.2
|
||||||
Total current assets
|
620.8
|
485.4
|
||||||
Property, plant and equipment, net
|
510.2
|
407.2
|
||||||
Intangible assets, net
|
761.6
|
119.6
|
||||||
In-process research and development
|
50.0
|
-
|
||||||
Goodwill
|
259.7
|
49.1
|
||||||
Deferred tax assets, net
|
13.4
|
2.8
|
||||||
Other assets
|
13.7
|
6.1
|
||||||
Total assets
|
$
|
2,229.4
|
$
|
1,070.2
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
80.7
|
$
|
41.8
|
||||
Accrued expenses and other current liabilities
|
30.7
|
4.8
|
||||||
Accrued compensation
|
58.2
|
37.9
|
||||||
Long-term indebtedness, current portion
|
10.1
|
-
|
||||||
Contingent consideration, current portion
|
5.6
|
2.4
|
||||||
Income taxes payable, net
|
4.5
|
-
|
||||||
Deferred revenue, current portion
|
10.6
|
13.2
|
||||||
Total current liabilities
|
200.4
|
100.1
|
||||||
Contingent consideration, net of current portion
|
54.4
|
9.9
|
||||||
Long-term indebtedness, net of current portion
|
784.5
|
13.5
|
||||||
Deferred tax liability
|
67.5
|
-
|
||||||
Income taxes payable
|
11.2
|
12.5
|
||||||
Deferred revenue, net of current portion
|
62.5
|
17.3
|
||||||
Other liabilities
|
38.0
|
4.6
|
||||||
Total liabilities
|
1,218.5
|
157.9
|
||||||
Stockholders’ equity:
|
||||||||
Preferred stock, $0.001 par value; 15.0 shares authorized, 0 shares
issued and outstanding at both December 31, 2018 and 2017
|
-
|
-
|
||||||
Common stock, $0.001 par value; 200.0 shares authorized, 52.4 shares
issued and 51.2 shares outstanding at December 31, 2018; 50.6 shares issued and 49.4 shares outstanding at December 31, 2017
|
0.1
|
0.1
|
||||||
Treasury stock, at cost, 1.2 common shares at both December 31, 2018 and
2017
|
(39.6
|
)
|
(39.5
|
)
|
||||
Additional paid-in capital
|
688.6
|
618.3
|
||||||
Accumulated other comprehensive loss
|
(5.5
|
)
|
(3.7
|
)
|
||||
Retained earnings
|
367.3
|
337.1
|
||||||
Total stockholders’ equity
|
1,010.9
|
912.3
|
||||||
Total liabilities and stockholders’ equity
|
$
|
2,229.4
|
$
|
1,070.2
|
Year Ended December 31,
|
||||||||||||
2018
|
2017
|
2016
|
||||||||||
Revenues:
|
||||||||||||
Product sales
|
$
|
606.5
|
$
|
421.5
|
$
|
296.3
|
||||||
Contract manufacturing
|
98.9
|
68.9
|
49.1
|
|||||||||
Contracts and grants
|
77.0
|
70.5
|
143.4
|
|||||||||
Total revenues
|
782.4
|
560.9
|
488.8
|
|||||||||
Operating expenses:
|
||||||||||||
Cost of product sales and contract manufacturing
|
322.3
|
187.7
|
126.3
|
|||||||||
Research and development
|
142.8
|
97.4
|
106.9
|
|||||||||
Selling, general and administrative
|
202.5
|
142.9
|
143.1
|
|||||||||
Amortization of intangible assets
|
25.0
|
8.6
|
7.0
|
|||||||||
Total operating expenses
|
692.6
|
436.6
|
383.3
|
|||||||||
Income from operations
|
89.8
|
124.3
|
105.5
|
|||||||||
Other income (expense):
|
||||||||||||
Interest expense
|
(9.9
|
)
|
(6.6
|
)
|
(7.6
|
)
|
||||||
Other income (expense), net
|
1.6
|
0.9
|
1.3
|
|||||||||
Total other income (expense), net
|
(8.3
|
)
|
(5.7
|
)
|
(6.3
|
)
|
||||||
Income from continuing operations before provision for income taxes
|
81.5
|
118.6
|
99.2
|
|||||||||
Provision for income taxes
|
18.8
|
36.0
|
36.7
|
|||||||||
Net income from continuing operations
|
62.7
|
82.6
|
62.5
|
|||||||||
Net loss from discontinued operations
|
-
|
-
|
(10.7
|
)
|
||||||||
Net income
|
$
|
62.7
|
$
|
82.6
|
$
|
51.8
|
||||||
Net income per share from continuing operations-basic
|
$
|
1.25
|
$
|
1.98
|
$
|
1.56
|
||||||
Net loss per share from discontinued operations-basic
|
-
|
-
|
(0.27
|
)
|
||||||||
Net income per share-basic
|
$
|
1.25
|
$
|
1.98
|
$
|
1.29
|
||||||
Net income per share from continuing operations-diluted
|
$
|
1.22
|
$
|
1.71
|
$
|
1.35
|
||||||
Net loss per share from discontinued operations-diluted
|
-
|
-
|
(0.22
|
)
|
||||||||
Net income per share-diluted (1)
|
$
|
1.22
|
$
|
1.71
|
$
|
1.13
|
||||||
Weighted-average number of shares - basic
|
50.1
|
41.8
|
40.2
|
|||||||||
Weighted-average number of shares - diluted
|
51.4
|
50.3
|
49.3
|
December 31,
|
||||||||||||
2018
|
2017
|
2016
|
||||||||||
Net income
|
$
|
62.7
|
$
|
82.6
|
$
|
51.8
|
||||||
Other comprehensive income (loss), net of tax:
|
||||||||||||
Currency translation adjustments
|
(1.6
|
)
|
0.6
|
(1.6
|
)
|
|||||||
Unrealized losses on pension benefit obligation
|
(0.2
|
)
|
-
|
-
|
||||||||
Other comprehensive income (loss), net of tax
|
(1.8
|
)
|
0.6
|
(1.6
|
)
|
|||||||
Comprehensive income
|
$
|
60.9
|
$
|
83.2
|
$
|
50.2
|
Year Ended December 31,
|
||||||||||||
2018
|
2017
|
2016
|
||||||||||
Cash flows from operating activities:
|
||||||||||||
Net income
|
$
|
62.7
|
$
|
82.6
|
$
|
51.8
|
||||||
Adjustments to reconcile to net cash provided by (used in) operating
activities:
|
||||||||||||
Stock-based compensation
|
23.2
|
15.2
|
18.5
|
|||||||||
Depreciation and amortization
|
62.2
|
42.6
|
38.2
|
|||||||||
Deferred income taxes
|
8.6
|
3.3
|
5.2
|
|||||||||
Change in fair value of contingent obligations
|
3.1
|
7.8
|
(10.8
|
)
|
||||||||
Impairment and abandonment of long-lived assets
|
-
|
1.9
|
5.6
|
|||||||||
Excess tax benefits from stock-based compensation
|
-
|
-
|
(10.6
|
)
|
||||||||
Other
|
1.1
|
1.0
|
1.0
|
|||||||||
Changes in operating assets and liabilities, net of business
acquisitions:
|
||||||||||||
Accounts receivable
|
(94.2
|
)
|
(4.8
|
)
|
(22.4
|
)
|
||||||
Inventories
|
(1.9
|
)
|
6.1
|
(9.0
|
)
|
|||||||
Income taxes
|
(5.1
|
)
|
20.1
|
(3.4
|
)
|
|||||||
Prepaid expenses and other assets
|
(7.9
|
)
|
(3.7
|
)
|
(2.1
|
)
|
||||||
Accounts payable
|
(7.0
|
)
|
16.1
|
(14.8
|
)
|
|||||||
Accrued expenses and other liabilities
|
(11.6
|
)
|
1.6
|
0.6
|
||||||||
Accrued compensation
|
8.4
|
3.3
|
2.2
|
|||||||||
Deferred revenue
|
0.2
|
15.0
|
4.6
|
|||||||||
Net cash provided by operating activities
|
41.8
|
208.1
|
54.6
|
|||||||||
Cash flows from investing activities:
|
||||||||||||
Purchases of property, plant and equipment
|
(72.1
|
)
|
(54.8
|
)
|
(76.2
|
)
|
||||||
Proceeds from sale of assets
|
2.6
|
-
|
-
|
|||||||||
Asset acquisitions
|
-
|
(77.6
|
)
|
-
|
||||||||
Business acquisitions, net of cash acquired
|
(827.7
|
)
|
(117.5
|
)
|
-
|
|||||||
Net cash used in investing activities
|
(897.2
|
)
|
(249.9
|
)
|
(76.2
|
)
|
||||||
Cash flows from financing activities:
|
||||||||||||
Proceeds from long-term debt obligations
|
798.0
|
-
|
-
|
|||||||||
Proceeds from issuance of common stock upon exercise of stock options
|
15.9
|
19.3
|
17.1
|
|||||||||
Excess tax benefits from stock-based compensation
|
-
|
-
|
10.6
|
|||||||||
Debt issuance costs
|
(13.4
|
)
|
(1.4
|
)
|
-
|
|||||||
Taxes paid on behalf of employees for equity activity
|
(6.6
|
)
|
(4.3
|
)
|
(1.1
|
)
|
||||||
Principal payments on long-term indebtedness
|
(2.8
|
)
|
-
|
-
|
||||||||
Payment of notes payable to Aptevo
|
-
|
(20.0
|
)
|
-
|
||||||||
Distribution to Aptevo
|
-
|
-
|
(45.0
|
)
|
||||||||
Contingent consideration payments
|
(3.4
|
)
|
(10.9
|
)
|
(1.4
|
)
|
||||||
Receipts and payments of restricted cash
|
1.1
|
(1.0
|
)
|
-
|
||||||||
Purchase of treasury stock
|
(0.1
|
)
|
(33.1
|
)
|
-
|
|||||||
Net cash (used in) provided by financing activities
|
788.7
|
(51.4
|
)
|
(19.8
|
)
|
|||||||
Effect of exchange rate changes on cash and cash equivalents
|
(0.2
|
)
|
-
|
0.1
|
||||||||
Net decrease in cash and cash equivalents
|
(66.9
|
)
|
(93.2
|
)
|
(41.3
|
)
|
||||||
Cash and cash equivalents at beginning of year (1)
|
179.3
|
272.5
|
312.8
|
|||||||||
Cash and cash equivalents at end of year (1)
|
$
|
112.4
|
$
|
179.3
|
$
|
271.5
|
||||||
Supplemental disclosure of cash flow information:
|
||||||||||||
Cash paid during the year for interest
|
$
|
10.2
|
$
|
8.4
|
$
|
8.2
|
||||||
Cash paid during the year for income taxes
|
$
|
14.0
|
$
|
12.0
|
$
|
10.1
|
||||||
Supplemental information on non-cash investing and financing activities:
|
||||||||||||
Issuance of common stock to acquire Adapt Pharma
|
$
|
37.7
|
$
|
-
|
$
|
-
|
||||||
Purchases of property, plant and equipment unpaid at year end
|
$
|
14.7
|
$
|
4.6
|
$
|
13.5
|
$0.001 Par Value Common Stock
|
Additional Paid-In
|
Treasury Stock
|
Accumulated Other Comprehensive
|
Retained
|
Total Stockholders'
|
|||||||||||||||||||||||||||
Shares
|
Amount
|
Capital
|
Shares
|
Amount
|
Loss
|
Earnings
|
Equity
|
|||||||||||||||||||||||||
Balance at December 31, 2015
|
39.8
|
$
|
-
|
$
|
318.0
|
(0.4
|
)
|
$
|
(6.4
|
)
|
$
|
(2.7
|
)
|
$
|
351.1
|
$
|
660.0
|
|||||||||||||||
Employee equity plans activity
|
1.2
|
-
|
34.4
|
-
|
-
|
-
|
-
|
34.4
|
||||||||||||||||||||||||
Separation of Aptevo
|
-
|
-
|
-
|
-
|
-
|
-
|
(148.4
|
)
|
(148.4
|
)
|
||||||||||||||||||||||
Net income
|
-
|
-
|
-
|
-
|
-
|
-
|
51.8
|
51.8
|
||||||||||||||||||||||||
Other comprehensive loss
|
-
|
-
|
-
|
-
|
-
|
(1.6
|
)
|
-
|
(1.6
|
)
|
||||||||||||||||||||||
Balance at December 31, 2016
|
41.0
|
$
|
-
|
$
|
352.4
|
(0.4
|
)
|
$
|
(6.4
|
)
|
$
|
(4.3
|
)
|
$
|
254.5
|
$
|
596.2
|
|||||||||||||||
Employee equity plans activity
|
1.1
|
-
|
28.0
|
-
|
-
|
-
|
-
|
28.0
|
||||||||||||||||||||||||
Shares issued to extinguish convertible notes
|
8.5
|
0.1
|
237.9
|
-
|
-
|
-
|
-
|
238.0
|
||||||||||||||||||||||||
Treasury stock
|
-
|
-
|
-
|
(0.8
|
)
|
(33.1
|
)
|
-
|
-
|
(33.1
|
)
|
|||||||||||||||||||||
Net income
|
-
|
-
|
-
|
-
|
-
|
-
|
82.6
|
82.6
|
||||||||||||||||||||||||
Other comprehensive income
|
-
|
-
|
-
|
-
|
-
|
0.6
|
-
|
0.6
|
||||||||||||||||||||||||
Balance at December 31, 2017
|
50.6
|
$
|
0.1
|
$
|
618.3
|
(1.2
|
)
|
$
|
(39.5
|
)
|
$
|
(3.7
|
)
|
$
|
337.1
|
$
|
912.3
|
|||||||||||||||
Adoption of new accounting standard (ASC 606), net of tax
|
-
|
-
|
-
|
-
|
-
|
-
|
(32.5
|
)
|
(32.5
|
)
|
||||||||||||||||||||||
Balance at January 1, 2018
|
50.6
|
0.1
|
618.3
|
(1.2
|
)
|
(39.5
|
)
|
(3.7
|
)
|
304.6
|
879.8
|
|||||||||||||||||||||
Employee equity plans activity
|
1.1
|
-
|
32.6
|
-
|
-
|
-
|
-
|
32.6
|
||||||||||||||||||||||||
Issuance of common stock in acquisition
|
0.7
|
-
|
37.7
|
-
|
-
|
-
|
-
|
37.7
|
||||||||||||||||||||||||
Treasury stock
|
-
|
-
|
-
|
-
|
(0.1
|
)
|
-
|
-
|
(0.1
|
)
|
||||||||||||||||||||||
Net income
|
-
|
-
|
-
|
-
|
-
|
-
|
62.7
|
62.7
|
||||||||||||||||||||||||
Other comprehensive loss
|
-
|
-
|
-
|
-
|
-
|
(1.8
|
)
|
-
|
(1.8
|
)
|
||||||||||||||||||||||
Balance at December 31, 2018
|
52.4
|
$
|
0.1
|
$
|
688.6
|
(1.2
|
)
|
$
|
(39.6
|
)
|
$
|
(5.5
|
)
|
$
|
367.3
|
$
|
1,010.9
|
§ |
BioThrax
®
(Anthrax Vaccine Adsorbed), the only vaccine licensed by the U.S. Food and Drug Administration ("FDA"), for the general use prophylaxis
and post-exposure prophylaxis of anthrax disease;
|
§ |
ACAM2000
®
(Smallpox (Vaccinia) Vaccine, Live), the only smallpox vaccine licensed by the FDA for active immunization against smallpox disease for
persons determined to be at high risk for smallpox infection;
|
§ |
Vaxchora® (Cholera Vaccine, Live, Oral), the only FDA-licensed vaccine for the prevention of cholera; and
|
§ |
Vivotif® (Typhoid Vaccine Live Oral Ty21a), the only oral vaccine licensed by the FDA for the prevention of typhoid fever.
|
§ |
NARCAN® (naloxone HCl) Nasal Spray, the first and only needle-free formulation of naloxone approved by the FDA and Health Canada, for the emergency treatment
of known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression;
|
§ |
RSDL
®
(Reactive Skin Decontamination Lotion Kit), the only medical device cleared by the FDA to remove or neutralize the following chemical warfare
agents from the skin: tabun, sarin, soman, cyclohexyl sarin, VR, VX, mustard gas and T-2 toxin; and
|
§ |
Tro
bigard™ (atropine sulfate, obidoxime chloride),
an
auto-injector device designed for intramuscular self-injection
of atropine sulfate and obidoxime chloride, as a nerve agent
countermeasure. This product is not currently approved or cleared by the FDA or any similar regulatory body and is only distributed to authorized government buyers for use outside the United States. This product is not distributed in
the United States.
|
§ |
raxibacumab (Anthrax Monoclonal), the first fully human monoclonal antibody therapeutic licensed by the FDA for the treatment and prophylaxis of inhalational
anthrax;
|
§ |
Anthrasil
®
[Anthrax Immune Globulin Intravenous (Human)], the only polyclonal antibody therapeutic licensed
by the FDA and Health Canada for the treatment of inhalational anthrax;
|
§ |
BAT® [Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine)], the only heptavalent antibody therapeutic licensed by the FDA and Health Canada for the
treatment of botulism; and
|
§ |
VIGIV [Vaccinia Immune Globulin Intravenous (Human)], the only antibody therapeutic licensed by the FDA and Health Canada to address certain complications
from smallpox vaccination.
|
Level 1 — |
Observable inputs for identical assets or liabilities such as quoted prices in active markets;
|
Level 2 — |
Inputs other than quoted prices in active markets that are either directly or indirectly observable; and
|
Level 3 — |
Unobservable inputs in which little or no market data exists, which are therefore developed by the Company using estimates and assumptions that reflect
those that a market participant would use.
|
Buildings
|
31-39 years
|
Building improvements
|
10-39 years
|
Furniture and equipment
|
3-15 years
|
Software
|
3-7 years or product life
|
Leasehold improvements
|
Lesser of the asset life or lease term
|
§ |
personnel-related expenses;
|
§ |
fees to professional service providers for, among other things, analytical testing, independent monitoring or other administration of the Company's clinical
trials and obtaining and evaluating data from the Company's clinical trials and non-clinical studies;
|
§ |
costs of contract manufacturing services for clinical trial material; and
|
§ |
costs of materials used in clinical trials and research and development.
|
|
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 — a measure of the amount by which a financial variable, such as share price, has fluctuated (historical volatility) or is expected to
fluctuate (implied volatility) during a period. The Company analyzed its own historical volatility to estimate expected volatility over the same period as the expected average life of the options.
|
|
Risk-free interest rate — the range of U.S. Treasury rates with a term that most closely resembles the expected life of the option as of the date on which
the option is granted.
|
|
Expected average life of options — the period of time that options granted are expected to remain outstanding, based primarily on the Company's expectation
of optionee exercise behavior subsequent to vesting of options.
|
(in millions)
|
Year Ended December 31, 2018
|
|||||||||||
|
U.S
|
Non-U.S.
|
||||||||||
|
Government
|
Government
|
Total
|
|||||||||
|
||||||||||||
Product sales
|
$
|
526.1
|
$
|
80.4
|
$
|
606.5
|
||||||
Contract manufacturing
|
—
|
98.9
|
98.9
|
|||||||||
Contracts and grants
|
71.5
|
5.5
|
77.0
|
|||||||||
Total revenues
|
$
|
597.6
|
$
|
184.8
|
$
|
782.4
|
(in millions)
|
||||
Balance at December 31, 2017
|
$
|
30.5
|
||
Adoption of new accounting standard (ASC 606)
|
42.4
|
|||
Balance at January 1, 2018
|
72.9
|
|||
Deferral of revenue
|
29.3
|
|||
Recognition of revenue included in beginning of year contract liability
|
(29.1
|
)
|
||
Balance at December 31, 2018
|
$
|
73.1
|
December 31,
|
||||||||
(in millions)
|
2018
|
2017
|
||||||
Billed, net
|
$
|
234.0
|
$
|
118.9
|
||||
Unbilled
|
28.5
|
24.8
|
||||||
Total, net
|
$
|
262.5
|
$
|
143.7
|
(in millions)
|
2016
|
|||
Revenues:
|
||||
Product sales
|
$
|
21.2
|
||
Collaborations
|
0.2
|
|||
Total revenues
|
21.4
|
|||
Operating expense:
|
||||
Cost of product sales
|
11.6
|
|||
Research and development
|
18.0
|
|||
Selling, general and administrative
|
23.8
|
|||
Total operating expense
|
53.4
|
|||
Loss from discontinued operations before benefit from income taxes
|
(32.0
|
)
|
||
Benefit from income taxes
|
(21.3
|
)
|
||
Net loss from discontinued operations
|
$
|
(10.7
|
)
|
Year ended
December 31,
|
||||
(in millions)
|
2016
|
|||
Net cash used in operating activities
|
$
|
(10.3
|
)
|
|
Net cash used in investing activities
|
(1.9
|
)
|
||
Net cash provided by financing activities
|
7.7
|
|||
Net decrease in cash and cash equivalents
|
$
|
(4.5
|
)
|
(in millions)
|
October 15, 2018
|
|||
Cash
|
$
|
581.5
|
||
Equity
|
37.7
|
|||
Fair value of contingent purchase consideration
|
48.0
|
|||
Total preliminary purchase consideration
|
$
|
667.2
|
(in millions)
|
October 15, 2018
|
|||
Estimated fair value of tangible assets acquired and liabilities assumed:
|
||||
Cash
|
$
|
17.7
|
||
Accounts receivable
|
21.3
|
|||
Inventory
|
41.4
|
|||
Prepaid expenses and other assets
|
7.8
|
|||
Accounts payable
|
(32.2
|
)
|
||
Accrued expenses and other liabilities
|
(50.4
|
)
|
||
Deferred tax liability, net
|
(62.4
|
)
|
||
Total estimated fair value of tangible assets acquired and liabilities assumed
|
(56.8
|
)
|
||
Acquired in-process research and development
|
41.0
|
|||
Acquired intangible asset
|
534.0
|
|||
Goodwill
|
149.0
|
|||
Total purchase price
|
$
|
667.2
|
(in millions)
|
October 4, 2018
|
|||
Estimated fair value of tangible assets acquired and liabilities assumed:
|
||||
Cash
|
$
|
9.0
|
||
Accounts receivable
|
4.1
|
|||
Inventory
|
19.7
|
|||
Prepaid expenses and other assets
|
12.2
|
|||
Property, plant and equipment
|
57.8
|
|||
Deferred tax assets, net
|
3.8
|
|||
Accounts payable
|
(3.5
|
)
|
||
Accrued expenses and other liabilities
|
(33.6
|
)
|
||
Total estimated fair value of tangible assets acquired and liabilities assumed
|
69.5
|
|||
Acquired in-process research and development
|
9.0
|
|||
Acquired intangible assets
|
133.0
|
|||
Goodwill
|
61.6
|
|||
Total purchase consideration
|
$
|
273.1
|
§ |
the allocation of purchase price and related adjustments, including adjustments to amortization expense related to the fair value of intangible assets
acquired;
|
§ |
impacts of debt financing, including interest for debt issued and amortization of debt issuance costs;
|
§ |
the exclusion of acquisition-related costs incurred during the year-ended December 31, 2018; and
|
§ |
associated tax-related impacts of adjustments.
|
|
December 31,
|
|||||||
(in millions, except per share value)
|
2018
|
2017
|
||||||
(Unaudited)
|
||||||||
Revenues
|
$
|
949.3
|
$
|
683.8
|
||||
Net income
|
$
|
27.7
|
$
|
12.3
|
||||
Net income per share - basic
|
$
|
0.55
|
$
|
0.29
|
||||
Net income per share - diluted
|
$
|
0.54
|
$
|
0.28
|
(in millions)
|
||||
Amount of cash paid to Sanofi
|
$
|
117.5
|
||
Fair value of contingent purchase consideration
|
2.2
|
|||
Total purchase price
|
$
|
119.7
|
(in millions)
|
||||
Fair value of tangible assets acquired:
|
||||
Inventory
|
$
|
74.9
|
||
Property, plant and equipment
|
20.0
|
|||
Total fair value of tangible assets acquired
|
94.9
|
|||
|
||||
Acquired intangible asset
|
16.7
|
|||
Goodwill
|
8.1
|
|||
Total purchase price
|
$
|
119.7
|
(in millions)
|
December 31, 2018
|
December 31, 2017
|
||||||
Revenue
|
$
|
167.8
|
$
|
11.5
|
||||
Operating income (loss)
|
$
|
13.4
|
$
|
(0.9
|
)
|
(in millions)
|
||||
Balance at December 31, 2016
|
$
|
13.2
|
||
(Income) expense included in earnings
|
7.8
|
|||
Settlements
|
(10.9
|
)
|
||
Additions due to acquisition
|
2.2
|
|||
Balance at December 31, 2017
|
$
|
12.3
|
||
(Income) expense included in earnings
|
3.1
|
|||
Settlements
|
(3.4
|
)
|
||
Additions due to acquisition
|
48.0
|
|||
Balance at December 31, 2018
|
$
|
60.0
|
December 31,
|
||||||||
(in millions)
|
2018
|
2017
|
||||||
Raw materials and supplies
|
$
|
51.8
|
$
|
36.1
|
||||
Work-in-process
|
103.2
|
76.6
|
||||||
Finished goods
|
50.8
|
30.1
|
||||||
Total inventories
|
$
|
205.8
|
$
|
142.8
|
December 31,
|
||||||||
(in millions)
|
2018
|
2017
|
||||||
Land and improvements
|
$
|
44.6
|
$
|
21.8
|
||||
Buildings, building improvements and leasehold improvements
|
216.2
|
160.0
|
||||||
Furniture and equipment
|
293.9
|
206.8
|
||||||
Software
|
55.2
|
50.8
|
||||||
Construction-in-progress
|
71.8
|
100.2
|
||||||
681.7
|
539.6
|
|||||||
Less: Accumulated depreciation and amortization
|
(171.5
|
)
|
(132.4
|
)
|
||||
Total property, plant and equipment, net
|
$
|
510.2
|
$
|
407.2
|
(in millions)
|
Total
|
|||
Cost basis
|
||||
Balance at December 31, 2017
|
$
|
151.4
|
||
Additions
|
667.0
|
|||
Balance at December 31, 2018
|
$
|
818.4
|
||
Accumulated amortization
|
||||
Balance at December 31, 2017
|
$
|
(31.8
|
)
|
|
Amortization
|
(25.0
|
)
|
||
Balance at December 31, 2018
|
$
|
(56.8
|
)
|
|
Net book value at December 31, 2018
|
$
|
761.6
|
(in millions)
|
||||
2019
|
$
|
57.7
|
||
2020
|
57.6
|
|||
2021
|
56.1
|
|||
2022
|
53.4
|
|||
2023 and beyond
|
536.8
|
|||
Total remaining amortization
|
$
|
761.6
|
Year Ended December 31,
|
||||||||
(in millions)
|
2018
|
2017
|
||||||
Balance at beginning of the year
|
$
|
49.1
|
$
|
41.0
|
||||
Additions
|
210.6
|
8.1
|
||||||
Balance at end of the year
|
$
|
259.7
|
$
|
49.1
|
December 31,
|
||||||||
(in millions)
|
2018
|
2017
|
||||||
Senior secured credit agreement - Term loan due 2023
|
$
|
447.2
|
$
|
-
|
||||
Senior secured credit agreement - Revolver loan due 2023
|
348.0
|
-
|
||||||
2.875% Convertible Senior Notes due 2021
|
10.6
|
10.6
|
||||||
Other
|
3.0
|
3.0
|
||||||
Total long-term indebtedness
|
$
|
808.8
|
$
|
13.6
|
||||
Current portion of long-term indebtedness, net of debt issuance costs
|
(10.1
|
)
|
-
|
|||||
Unamortized debt issuance costs
|
(14.2
|
)
|
(0.1
|
)
|
||||
Noncurrent portion of long-term indebtedness
|
$
|
784.5
|
$
|
13.5
|
(in millions)
|
December 31, 2018
|
|||
2019
|
$
|
11.3
|
||
2020
|
14.1
|
|||
2021
|
35.9
|
|||
2022
|
33.8
|
|||
2023 and thereafter
|
713.7
|
|||
Total long-term indebtedness
|
$
|
808.8
|
Year Ended December 31,
|
||||||
|
2018
|
|
2017
|
|
2016
|
|
Expected dividend yield
|
0%
|
0%
|
0%
|
|||
Expected volatility
|
38-39%
|
37-40%
|
31-33%
|
|||
Risk-free interest rate
|
2.54-3.03%
|
1.66-1.88%
|
0.93-1.22%
|
|||
Expected average life of options
|
4.5 years
|
4.3 years
|
4.3 years
|
Emergent Plan
|
||||||||||||
(in millions, except share and per share data)
|
Number of Shares
|
Weighted-Average Exercise Price
|
Aggregate Intrinsic Value
|
|||||||||
Outstanding at December 31, 2017
|
2,121,405
|
$
|
25.48
|
$
|
44.5
|
|||||||
Granted
|
460,902
|
51.39
|
||||||||||
Exercised
|
(665,183
|
)
|
21.36
|
|||||||||
Forfeited
|
(45,656
|
)
|
33.14
|
|||||||||
Outstanding at December 31, 2018
|
1,871,468
|
$
|
32.59
|
$
|
50.1
|
|||||||
Exercisable at December 31, 2018
|
1,081,513
|
$
|
26.13
|
$
|
35.9
|
|||||||
Options expected to vest at December 31, 2018
|
696,083
|
$
|
41.10
|
$
|
12.8
|
(in millions, except share and per share data)
|
Number of Shares
|
Weighted-Average Grant Price
|
Aggregate Intrinsic Value
|
|||||||||
Outstanding at December 31, 2017
|
851,720
|
$
|
30.84
|
$
|
39.6
|
|||||||
Granted
|
557,767
|
52.70
|
||||||||||
Vested
|
(427,610
|
)
|
30.12
|
|||||||||
Forfeited
|
(60,784
|
)
|
38.77
|
|||||||||
Outstanding at December 31, 2018
|
921,093
|
$
|
42.82
|
$
|
54.6
|
Year Ended December 31,
|
||||||||||||
(in millions)
|
2018
|
2017
|
2016
|
|||||||||
Cost of product sales
|
$
|
1.7
|
$
|
1.1
|
$
|
1.0
|
||||||
Research and development
|
3.1
|
2.5
|
2.3
|
|||||||||
Selling, general and administrative
|
18.4
|
11.6
|
14.1
|
|||||||||
Continuing operations
|
23.2
|
15.2
|
17.4
|
|||||||||
Discontinued operations
|
-
|
-
|
1.1
|
|||||||||
Total stock-based compensation expense
|
$
|
23.2
|
$
|
15.2
|
$
|
18.5
|
Year Ended December 31,
|
||||||||||||
(in millions)
|
2018
|
2017
|
2016
|
|||||||||
Current
|
||||||||||||
Federal
|
$
|
1.8
|
$
|
29.4
|
$
|
29.2
|
||||||
State
|
2.4
|
3.0
|
2.3
|
|||||||||
International
|
6.0
|
0.3
|
1.0
|
|||||||||
Total current
|
10.2
|
32.7
|
32.5
|
|||||||||
Deferred
|
||||||||||||
Federal
|
7.5
|
(6.0
|
)
|
10.0
|
||||||||
State
|
3.0
|
(0.6
|
)
|
(0.2
|
)
|
|||||||
International
|
(1.9
|
)
|
9.9
|
(5.6
|
)
|
|||||||
Total deferred
|
8.6
|
3.3
|
4.2
|
|||||||||
Total provision for income taxes
|
$
|
18.8
|
$
|
36.0
|
$
|
36.7
|
December 31,
|
||||||||
(in millions)
|
2018
|
2017
|
||||||
Federal losses carryforward
|
$
|
10.7
|
$
|
1.6
|
||||
State losses carryforward
|
18.1
|
17.2
|
||||||
Research and development carryforward
|
10.1
|
3.5
|
||||||
State research and development carryforward
|
5.0
|
-
|
||||||
Scientific research and experimental development credit carryforward
|
13.1
|
16.5
|
||||||
Stock compensation
|
7.5
|
5.3
|
||||||
Foreign NOLs
|
35.4
|
34.1
|
||||||
Deferred revenue
|
11.6
|
-
|
||||||
Inventory reserves
|
3.4
|
1.6
|
||||||
Other
|
4.9
|
3.9
|
||||||
Deferred tax asset
|
119.8
|
83.7
|
||||||
Fixed assets
|
(46.4
|
)
|
(23.1
|
)
|
||||
Intangible assets
|
(60.4
|
)
|
(2.2
|
)
|
||||
Other
|
(0.7
|
)
|
(10.5
|
)
|
||||
Deferred tax liability
|
(107.5
|
)
|
(35.8
|
)
|
||||
Valuation allowance
|
(66.4
|
)
|
(45.1
|
)
|
||||
Net deferred tax asset (liability)
|
$
|
(54.1
|
)
|
$
|
2.8
|
Year ended December 31,
|
||||||||||||
(in millions)
|
2018
|
2017
|
2016
|
|||||||||
US
|
$
|
71.0
|
$
|
80.7
|
$
|
63.3
|
||||||
International
|
10.5
|
37.9
|
35.9
|
|||||||||
Earnings before taxes on income
|
81.5
|
118.6
|
99.2
|
|||||||||
Federal tax at statutory rates
|
$
|
17.1
|
$
|
41.5
|
$
|
34.7
|
||||||
State taxes, net of federal benefit
|
4.3
|
1.3
|
0.5
|
|||||||||
Impact of foreign operations
|
2.8
|
(2.2
|
)
|
(9.9
|
)
|
|||||||
Change in valuation allowance
|
(0.1
|
)
|
0.3
|
10.5
|
||||||||
Tax credits
|
(1.8
|
)
|
(1.9
|
)
|
(1.6
|
)
|
||||||
Transition tax
|
(0.2
|
)
|
13.6
|
-
|
||||||||
Change in U.S. tax rate
|
(4.5
|
)
|
(13.4
|
)
|
-
|
|||||||
Stock compensation
|
(5.8
|
)
|
(4.0
|
)
|
-
|
|||||||
Other differences
|
(0.9
|
)
|
0.4
|
(0.6
|
)
|
|||||||
Return to provision true-ups
|
1.1
|
(0.5
|
)
|
1.7
|
||||||||
Transaction costs
|
5.4
|
-
|
-
|
|||||||||
GILTI, net
|
0.4
|
-
|
-
|
|||||||||
Permanent differences
|
1.0
|
0.9
|
1.4
|
|||||||||
Provision for income taxes
|
$
|
18.8
|
$
|
36.0
|
$
|
36.7
|
(in millions)
|
||||
Gross unrecognized tax benefits at December 31, 2015
|
$
|
1.5
|
||
Increases for tax positions for prior years
|
-
|
|||
Decreases for tax positions for prior years
|
-
|
|||
Increases for tax positions for current year
|
0.3
|
|||
Settlements
|
-
|
|||
Lapse of statute of limitations
|
-
|
|||
Gross unrecognized tax benefits at December 31, 2016
|
1.8
|
|||
Increases for tax positions for prior years
|
-
|
|||
Decreases for tax positions for prior years
|
-
|
|||
Increases for tax positions for current year
|
0.5
|
|||
Settlements
|
(0.3
|
)
|
||
Lapse of statute of limitations
|
-
|
|||
Gross unrecognized tax benefits at December 31, 2017
|
2.0
|
|||
Increases for tax positions for prior years
|
-
|
|||
Unrecognized tax benefits acquired in business combinations
|
6.5
|
|||
Decreases for tax positions for prior years
|
-
|
|||
Increases for tax positions for current year
|
0.3
|
|||
Settlements
|
-
|
|||
Lapse of statute of limitations
|
-
|
|||
Gross unrecognized tax benefits at December 31, 2018
|
$
|
8.8
|
December 31,
|
||||
(in millions)
|
2018
|
|||
Fair value of plan assets, beginning of year
|
$
|
—
|
||
Acquisitions
|
18.2
|
|||
Employer contributions
|
0.2
|
|||
Employee contributions
|
0.1
|
|||
Benefits paid
|
0.3
|
|||
Actual administration expenses
|
—
|
|||
Actual return on plan assets
|
—
|
|||
Settlements
|
(0.6
|
)
|
||
Currency impact
|
—
|
|||
Fair value of plan assets, end of year
|
18.2
|
|||
Projected Benefit Obligation, beginning of year
|
$
|
—
|
||
Acquisitions
|
28.3
|
|||
Service cost
|
0.3
|
|||
Interest Cost
|
0.1
|
|||
Employee contributions
|
0.1
|
|||
Actuarial loss
|
0.3
|
|||
Benefits paid (refunded)
|
(0.1
|
)
|
||
Actual administration expenses, taxes
|
—
|
|||
Plan amendment
|
0.1
|
|||
Settlements
|
(0.6
|
)
|
||
Currency impact
|
0.1
|
|||
Projected benefit obligation, end of year
|
$
|
28.6
|
||
Funded status, end of year
|
$
|
(10.4
|
)
|
|
Accumulated benefit obligation, end of year
|
$
|
25.6
|
December 31,
|
||||
(in millions)
|
2018
|
|||
Service cost
|
$
|
0.3
|
||
Interest cost
|
0.1
|
|||
Expected return on plan assets
|
(0.1
|
)
|
||
Amortization of loss
|
—
|
|||
Amortization of prior service cost
|
—
|
|||
Net periodic benefit cost
|
$
|
0.3
|
December 31,
|
|
2018
|
|
Discount rate
|
0.9%
|
Expected rate of return
|
3.0%
|
Rate of future compensation increases
|
1.5%
|
Year Ended December 31,
|
||||
(in millions)
|
2018
|
|||
Net actuarial loss
|
$
|
0.1
|
||
Prior service cost
|
0.1
|
|||
Total recognized in accumulated other comprehensive loss
|
$
|
0.2
|
(In millions)
|
December 31, 2018
|
|||
2019
|
$
|
1.0
|
||
2020
|
2.0
|
|||
2021
|
0.8
|
|||
2022
|
1.4
|
|||
2023
|
0.9
|
|||
Thereafter
|
5.8
|
|||
Total
|
$
|
11.9
|
(in millions)
|
||||
2019
|
$
|
3.4
|
||
2020
|
2.5
|
|||
2021
|
2.5
|
|||
2022
|
2.0
|
|||
2023
|
2.6
|
|||
2024 and beyond
|
2.5
|
|||
Total minimum lease payments
|
$
|
15.5
|
Year ended December 31,
|
||||||||||||
(in millions, except per share data)
|
2018
|
2017
|
2016
|
|||||||||
Numerator:
|
||||||||||||
Net income from continuing operations
|
$
|
62.7
|
$
|
82.6
|
$
|
62.5
|
||||||
Interest expense, net of tax
|
-
|
2.6
|
3.3
|
|||||||||
Amortization of debt issuance costs, net of tax
|
-
|
0.7
|
0.8
|
|||||||||
Net income, adjusted from continuing operations
|
62.7
|
85.9
|
66.6
|
|||||||||
Net loss from discontinued operations
|
-
|
-
|
(10.7
|
)
|
||||||||
Net income, adjusted
|
$
|
62.7
|
$
|
85.9
|
$
|
55.9
|
||||||
Denominator:
|
||||||||||||
Weighted-average number of shares-basic
|
50.1
|
41.8
|
40.2
|
|||||||||
Dilutive securities-equity awards
|
1.3
|
1.1
|
1.0
|
|||||||||
Dilutive securities-convertible debt
|
-
|
7.4
|
8.1
|
|||||||||
Weighted-average number of shares-diluted
|
51.4
|
50.3
|
49.3
|
|||||||||
Net income per share-basic from continuing operations
|
$
|
1.25
|
$
|
1.98
|
$
|
1.56
|
||||||
Net loss per share-basic from discontinued operations
|
-
|
-
|
(0.27
|
)
|
||||||||
Net income per share-basic
|
$
|
1.25
|
$
|
1.98
|
$
|
1.29
|
||||||
Net income per share-diluted from continuing operations
|
$
|
1.22
|
$
|
1.71
|
$
|
1.35
|
||||||
Net loss per share-diluted from discontinued operations
|
-
|
-
|
(0.22
|
)
|
||||||||
Net income per share-diluted
|
$
|
1.22
|
$
|
1.71
|
$
|
1.13
|
(in millions)
|
Year Ended December 31,
|
|||||||||||||||||||||||||||||||||||
2018
|
2017
|
2016
|
||||||||||||||||||||||||||||||||||
U.S
|
Non-U.S.
|
U.S
|
Non-U.S.
|
U.S
|
Non-U.S.
|
|||||||||||||||||||||||||||||||
Government
|
Government
|
Total
|
Government
|
Government
|
Total
|
Government
|
Government
|
Total
|
||||||||||||||||||||||||||||
Product sales
|
$
|
526.1
|
$
|
80.4
|
$
|
606.5
|
$
|
374.8
|
$
|
46.7
|
$
|
421.5
|
$
|
283.2
|
$
|
13.1
|
$
|
296.3
|
||||||||||||||||||
Contract manufacturing
|
-
|
98.9
|
98.9
|
-
|
68.9
|
68.9
|
-
|
49.1
|
49.1
|
|||||||||||||||||||||||||||
Contracts and grants
|
71.5
|
5.5
|
77.0
|
65.1
|
5.4
|
70.5
|
138.1
|
5.3
|
143.4
|
|||||||||||||||||||||||||||
Total revenues
|
$
|
597.6
|
$
|
184.8
|
$
|
782.4
|
$
|
439.9
|
$
|
121.0
|
$
|
560.9
|
$
|
421.3
|
$
|
67.5
|
$
|
488.8
|
|
2018
|
|
2017
|
|
2016
|
|
% of product sales:
|
||||||
BioThrax
|
46%
|
68%
|
80%
|
|||
ACAM2000
|
19%
|
0%
|
0%
|
|||
Other
|
35%
|
32%
|
20%
|
Quarter Ended
|
||||||||||||||||
(in millions, except per share data)
|
March 31,
|
June 30,
|
September 30,
|
December 31,
|
||||||||||||
2018:
|
||||||||||||||||
Revenue
|
$
|
117.8
|
$
|
220.2
|
$
|
173.7
|
$
|
270.7
|
||||||||
Income (loss) from operations
|
(9.5
|
)
|
66.8
|
21.3
|
11.2
|
|||||||||||
Net income (loss)
|
(4.9
|
)
|
50.1
|
20.9
|
(3.4
|
)
|
||||||||||
Net income (loss) per share-basic
|
$
|
(0.10
|
)
|
$
|
1.00
|
$
|
0.42
|
$
|
(0.07
|
)
|
||||||
Net income (loss) per share-diluted
|
$
|
(0.10
|
)
|
$
|
0.98
|
$
|
0.41
|
$
|
(0.07
|
)
|
||||||
2017:
|
||||||||||||||||
Revenue
|
$
|
116.9
|
$
|
100.8
|
$
|
149.4
|
$
|
193.8
|
||||||||
Income from operations
|
14.9
|
8.5
|
47.8
|
53.1
|
||||||||||||
Net income
|
10.5
|
4.6
|
33.6
|
33.9
|
||||||||||||
Net income per share-basic
|
$
|
0.26
|
$
|
0.11
|
$
|
0.81
|
$
|
0.77
|
||||||||
Net income per share-diluted
|
$
|
0.23
|
$
|
0.11
|
$
|
0.68
|
$
|
0.67
|
(in millions)
|
Beginning Balance
|
Charged to costs and expenses
|
Deductions
|
Ending Balance
|
||||||||||||
Year Ended December 31, 2018
|
||||||||||||||||
Inventory allowance
|
$
|
3.8
|
$
|
14.6
|
$
|
(8.8
|
)
|
$
|
9.6
|
|||||||
Prepaid expenses and other current assets allowance
|
5.3
|
-
|
(1.0
|
)
|
4.3
|
|||||||||||
Year Ended December 31, 2017
|
||||||||||||||||
Inventory allowance
|
$
|
3.5
|
$
|
8.8
|
$
|
(8.5
|
)
|
$
|
3.8
|
|||||||
Prepaid expenses and other current assets allowance
|
4.9
|
0.4
|
-
|
5.3
|
||||||||||||
Year Ended December 31, 2016
|
||||||||||||||||
Inventory allowance
|
$
|
1.6
|
$
|
10.0
|
$
|
(8.1
|
)
|
$
|
3.5
|
|||||||
Prepaid expenses and other current assets allowance
|
2.0
|
2.9
|
-
|
4.9
|
Exhibit
|
|
|
Number
|
|
Description
|
2.1
|
Contribution Agreement, dated July 29, 2016, by and among Emergent BioSolutions Inc., Aptevo Therapeutics Inc., Aptevo Research and Development LLC and Aptevo BioTherapeutics LLC
(incorporated by reference to Exhibit 2.1 to the Company's Current Report on Form 8-K, filed on August 4, 2016).
|
|
2.2
|
Separation and Distribution Agreement, dated July 29, 2016, by and between Emergent BioSolutions Inc. and Aptevo Therapeutics Inc.
(incorporated by reference to Exhibit 2.2 to the Company's Current Report on Form 8-K, filed on August 4, 2016).
|
|
2.3
|
Asset Purchase Agreement, dated July 14, 2017, among Sanofi Pasteur Biologics, LLC, Acambis Research Ltd. and Emergent BioSolutions Inc.
(incorporated by reference to Exhibit 2 to the Company's Current Report on Form 8-K, filed on July 14, 2017).
|
|
2.4
|
Asset Purchase Agreement, dated July 19, 2017, among GlaxoSmithKline LLC, Human Genome Sciences, Inc., and Emergent BioSolutions Inc.
(incorporated by reference to Exhibit 2 to the Company's Current Report on Form 8-K, filed on October 3, 2017).
|
|
2.5
|
†
|
Merger Agreement, dated August 8, 2018, by and among Emergent BioSolutions Inc., PaxVax Holding Company Ltd., Panama Merger Sub Ltd., and PaxVax SH Representative
LLC
(incorporated by reference to Exhibit 2 to the Company's Current Report on Form 8-K, filed on October 5, 2018).
|
2.6
|
†
|
Share Purchase Agreement, dated August 28, 2018, by and among Emergent BioSolutions Inc., the Sellers identified therein, Seamus Mulligan and Adapt Pharma Limited
(incorporated by reference to Exhibit 2 to the Company's Current Report on Form 8-K, filed on October 15, 2018).
|
3.1
|
Third Restated Certificate of Incorporation of the Company
(incorporated by reference to Exhibit 3 to
the Company's Quarterly Report on Form 10-Q filed on August 5, 2016).
|
|
3.2
|
Amended and Restated By-laws of the Company
(incorporated by reference to Exhibit 3 to the
Company's Current Report on Form 8-K filed on August 16, 2012).
|
|
4.1
|
Specimen Common Stock Certificate
(incorporated by reference to Exhibit 4.1
to Amendment No. 3 to the Company's Registration Statement on Form S-1 filed on October 20, 2006) (Registration No. 333-136622).
|
|
4.2
|
Registration Rights Agreement, dated as of September 22, 2006, among the Company and the stockholders listed on Schedule 1 thereto
(incorporated by reference to Exhibit 4.3 to Amendment No. 1 to the Company's Registration Statement on Form S-1 filed on September 25, 2006) (Registration No. 333-136622).
|
|
4.3
|
Indenture, dated as of January 29, 2014, between the Company and Wells Fargo Bank, National Association, including the form of 2.875% Convertible Senior Notes due 2021
(incorporated by reference to Exhibit 4.1 to the Company's Current Report on Form 8-K filed on January 29, 2014).
|
|
9.1
|
Voting and Right of First Refusal Agreement, dated as of 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 Company's Registration Statement on Form S-1 filed on August 14, 2006) (Registration No. 333-136622).
|
|
10.1
|
Credit Agreement, dated September 29, 2017, among Emergent BioSolutions Inc., the lenders party thereto from time to time, and Wells Fargo Bank, National Association, as the
Administrative Agent
(incorporated by reference to Exhibit 10 to the Company's Current Report on Form 8-K, filed on October 2, 2017).
|
|
10.2
|
Amended and Restated Credit Agreement, dated October 15, 2018, by and among Emergent BioSolutions Inc., the lenders party thereto from time to time, and Wells Fargo
Bank, National Association, as the Administrative Agent
(incorporated by reference to Exhibit 10 to the Company's Current Report on Form 8-K, filed
on October 15, 2018).
|
|
10.3
|
*
|
Emergent BioSolutions Inc. Employee Stock Option Plan, as amended and restated on January 26, 2005
(incorporated by reference to Exhibit 10.1 to the Company's Registration Statement on Form S-1 filed on August 14, 2006) (Registration No. 333-136622).
|
10.4
|
*
|
Emergent BioSolutions Inc. 2006 Stock Incentive Plan
(incorporated by
reference to Exhibit 10.3 to Amendment No. 5 to the Company's Registration Statement on Form S-1 filed on October 30, 2006) (Registration No. 001-33137).
|
10.5
|
*
|
Amended and Restated Emergent BioSolutions Inc. 2006 Stock Incentive Plan
(incorporated by reference
to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q filed on August 7, 2009).
|
10.6
|
*
|
Second Amended and Restated Emergent BioSolutions Inc. 2006 Stock Incentive Plan
(incorporated by reference to Appendix A to the Company's definitive proxy statement on Schedule 14A filed on April 6, 2012).
|
10.7
|
*
|
Third Amended and Restated Emergent BioSolutions Inc. 2006 Stock Incentive Plan
(incorporated by reference to Appendix A to the Company's definitive proxy statement on Schedule 14A filed on April 7, 2014).
|
10.8
|
*
|
Fourth Amended and Restated Emergent BioSolutions Inc. 2006 Stock Incentive Plan
(incorporated
by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q filed on August 5, 2016).
|
10.9
|
Emergent BioSolutions Inc. Stock Incentive Plan
(incorporated by reference to Exhibit 99 to
Registration Statement on Form S-8, filed on May 30, 2018.)
|
|
10.10
|
#*
|
Form of Director Nonstatutory Stock Option Agreement.
|
10.11
|
#*
|
Form of Director Restricted Stock Unit Agreement.
|
10.12
|
#*
|
Form of Non-Qualified Stock Option Agreement.
|
10.13
|
#*
|
Form of Restricted Stock Unit Agreement.
|
10.14
|
#*
|
Form of Non-Qualified Stock Option Agreement. – Canadian Participant.
|
10.15
|
#*
|
Form of Restricted Stock Unit Agreement. – Canadian Participant.
|
10.16
|
#*
|
Form of Non-Qualified Stock Option Agreement. – UK Participant.
|
10.17
|
#*
|
Form of Restricted Stock Unit Agreement. – UK Participant.
|
10.18
|
#*
|
Form of Non-Qualified Stock Option Agreement. – Swiss Participant.
|
10.19
|
#*
|
Form of Restricted Stock Unit Agreement. – Swiss Participant.
|
10.20
|
#*
|
Form of Non-Qualified Stock Option Agreement. – Irish Participant.
|
10.21
|
#*
|
Form of Restricted Stock Unit Agreement. – Irish Participant.
|
10.22
|
*
|
Form of Performance-Based Stock Unit Award Agreement
(incorporated by
reference to Exhibit 10 to the Company’s Current Report on Form 8-K filed on February 21, 2017).
|
10.23
|
*
|
Form of 2018-2020 Performance-Based Stock Unit Award Agreement
(incorporated by reference to
Exhibit 10 to the Company’s Current Report on Form 8-K filed on February 14, 2018).
|
10.24
|
*
|
Form of 2019-2021 Performace-Based Stock Unit Award Agreement
(incorporated by reference to
Exhibit 10 to the Company’s Current Report on Form 8-K filed on February 12, 2019).
|
10.25
|
*
|
Form of Indemnity Agreement for directors and senior officers
(incorporated by reference to
Exhibit 10 to the Company's Current Report on Form 8-K filed on January 18, 2013).
|
10.26
|
*
|
Director Compensation Program
(incorporated by reference to Exhibit 10.10 to
the Company's Annual Report on Form 10-K filed on March 8, 2013).
|
10.27
|
*
|
Annual Bonus Plan for Executive Officers
(incorporated by reference to Exhibit 10.7 to the
Company's Annual Report on Form 10-K filed on March 5, 2010).
|
10.28
|
*
|
Amended and Restated Senior Management Severance Plan
(incorporated by reference to Exhibit
10.1 to the Company's Current Report on Form 8-K filed on December 22, 2011).
|
10.29
|
*
|
Second Amended and Restated Senior Management Severance Plan
(incorporated by reference to
Exhibit 10 to the Company's Current Report on Form 8-K filed on July 16, 2015).
|
10.30
|
Amended and Restated Marketing Agreement, dated as of November 5, 2008, between Emergent Biodefense Operations Lansing LLC
(formerly known as Emergent Biodefense Operations Lansing Inc.) and Intergen N.V. (incorporated by reference to Exhibit 10.27 to the Company's Annual Report on Form 10-K filed on March 6,
2009).
|
|
10.31
|
†
|
Solicitation/Contract/Order for Commercial Items (the "CDC BioThrax Procurement Contract"), effective December 8, 2016, from the Centers for Disease Control and
Prevention to Emergent Biodefense Operations Lansing LLC
(incorporated by reference to Exhibit 10.24 to the Company’s Annual Report on Form 10-K,
filed on February 28, 2017).
|
10.32
|
†
|
Modification No. 1, effective January 27, 2017, to the CDC BioThrax Procurement Contract
(incorporated by reference to Exhibit 10.22 to the Company's Annual Report on Form 10-K filed on February 23, 2018).
|
10.33
|
†
|
Modification No. 2, effective February 23,2017, to the CDC BioThrax Procurement Contract
(incorporated by reference to Exhibit 10.23 to the Company's Annual Report on Form 10-K filed on February 23, 2018).
|
10.34
|
Modification No. 3, effective March 22, 2017, to the CDC BioThrax Procurement Contract
(incorporated by reference to Exhibit 10.24 to the Company's Annual Report on Form 10-K filed on February 23, 2018).
|
|
10.35
|
†
|
Modification No. 4, effective April 5, 2017, to the CDC BioThrax Procurement Contract
(incorporated by reference to Exhibit 10.25 to the Company's Annual Report on Form 10-K filed on February 23, 2018).
|
10.36
|
†
|
Modification No. 5, effective September 8, 2017, to the CDC BioThrax Procurement Contract
(incorporated by reference to Exhibit 10.26 to the Company's Quarterly Report on Form 10-Q filed on November 3, 2017).
|
10.37
|
†
|
Modification No. 6, effective September 21, 2017, to the CDC BioThrax Procurement Contract
(incorporated by reference to Exhibit 10.27 the Company’s Annual Report on Form 10-K filed on February 23, 2018).
|
10.38
|
†
|
Modification No. 7, effective February 26, 2018, to the CDC BioThrax Procurement Contract
(incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q filed on May 4, 2018).
|
10.39
|
Modification No. 8, effective March 6, 2018, to the CDC BioThrax Procurement Contract
(incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q filed on May 4, 2018).
|
|
10.40
|
†
|
Modification No. 9, effective June 6, 2018, to the CDC BioThrax Procurement Contract
(incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q filed on August 3, 2018).
|
10.41
|
†
|
Modification No. 10, effective June 18, 2018, to the CDC BioThrax Procurement Contract.
(incorporated by reference to Exhibit 10.3 to the Company's Quarterly Report on Form 10-Q filed on August 3, 2018).
|
10.42
|
†
|
Modification No. 11, effective June 20, 2018, to the CDC BioThrax Procurement Contract.
(incorporated by reference to Exhibit 10.4 to the Company's Quarterly Report on Form 10-Q filed on August 3, 2018).
|
10.43
|
†
|
Modification No. 12, effective June 21, 2018, to the CDC BioThrax Procurement Contract.
(incorporated by reference to Exhibit 10.5 to the Company's Quarterly Report on Form 10-Q filed on August 3, 2018).
|
10.44
|
†
|
Modification No. 13, effective December 6, 2018 to the CDC BioThrax Procurement
(incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q filed on November 2, 2018).
|
10.45
|
#††
|
Modification No. 14, effective October 1, 2018, to the CDC BioThrax Procurement Contract
|
10.46
|
#††
|
Modification No. 15, effective December 7, 2018, to the CDC BioThrax Procurement Contract
|
10.47
|
#
|
Modification No. 16, effective December 8, 2018, to the CDC BioThrax Procurement Contract
|
10.48
|
†
|
Award/Contract (the “BARDA NuThrax Contract”), effective September 30, 2016, from the BioMedical Advanced Research and Development Authority to Emergent Product
Development Gaithersburg Inc.
(incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q filed on November 9, 2016).
|
10.49
|
†
|
Modification No. 1, effective March 16, 2017, to the BARDA NuThrax Contract
(incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q filed on November 9, 2016) (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q filed on May 5, 2017).
|
10.50
|
†
|
Modification No. 2, effective August 29, 2018, to the BARDA NuThrax Contract
(incorporated by reference to Exhibit 10.3 to the Company's Quarterly Report on Form 10-Q filed on November 2, 2018).
|
10.51
|
#††
|
License Agreement, dated as of December 15, 2014, by and between Opiant Pharmaceuticals, Inc. (formerly known
as Lightlake Therapeutics Inc.) and Adapt Pharma Operations Limited.
|
10.52
|
#††
|
Amendment No. 1 to License Agreement, dated as of December 13, 2016, by and between Opiant Pharmaceuticals, Inc.
and Adapt Pharma Operations Limited.
|
21
|
#
|
Subsidiaries of the Company.
|
23
|
#
|
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.
|
101.INS
|
XBRL Instance Document
|
|
101.SCH
|
XBRL Taxonomy Extension Schema Document
|
|
101.CAL
|
XBRL Taxonomy Calculation Linksbase Document
|
|
101.DEF
|
XBRL Taxonomy Definition Linksbase Document
|
|
101.LAB
|
XBRL Taxonomy Label Linksbase Document
|
|
101.PRE
|
XBRL Taxonomy Presentation Linksbase Document
|
|
#
|
Filed herewith
|
|
†
|
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.
|
EMERGENT BIOSOLUTIONS INC.
|
|
By:
/s/RICHARD S. LINDAHL
|
|
Richard S. Lindahl
|
|
Executive Vice President, Chief Financial Officer and Treasurer
|
|
Date: February 21, 2019
|
Signature
|
Title
|
Date
|
|||
/s/Daniel J. Abdun-Nabi
Daniel J. Abdun-Nabi
|
Chief Executive Officer and Director
(Principal Executive Officer)
|
February 21, 2019
|
|||
/s/Richard S. Lindahl
Richard S. Lindahl
|
Executive Vice President, Chief Financial Officer and Treasurer
(Principal Financial and Accounting Officer)
|
February 21, 2019
|
|||
/s/Fuad El-Hibri
Fuad El-Hibri
|
Executive Chairman of the Board of Directors
|
February 21, 2019
|
|||
/s/Zsolt Harsanyi, Ph.D.
Zsolt Harsanyi, Ph.D.
|
Director
|
February 21, 2019
|
|||
/s/Kathryn Zoon, Ph.D.
|
|||||
Kathryn Zoon, Ph.D.
|
Director
|
February 21, 2019
|
|||
/s/Ronald B. Richard
Ronald B. Richard
|
Director
|
February 21, 2019
|
|||
/s/Louis W. Sullivan, M.D.
Louis W. Sullivan, M.D.
|
Director
|
February 21, 2019
|
|||
/s/Dr. Sue Bailey
Dr. Sue Bailey
|
Director
|
February 21, 2019
|
|||
/s/George Joulwan
George Joulwan
|
Director
|
February 21, 2019
|
|||
/s/Jerome Hauer, Ph.D.
Jerome Hauer, Ph.D.
|
Director
|
February 21, 2019
|
1 Year Emergent Biosolutions Chart |
1 Month Emergent Biosolutions Chart |
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