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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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||
§ |
appropriations for the procurement of BioThrax
®
(Anthrax Vaccine Adsorbed) and our other public health threat products;
|
§ |
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;
|
§ |
the availability of funding for our U.S. government grants and contracts;
|
§ |
our ability to secure follow-on procurement contracts for our public health threat products that are under current procurement contracts that will be expiring;
|
§ |
our ability to successfully integrate and develop the products or product candidates, programs, operations and personnel of any entities, businesses or products that we acquire, including our recently completed acquisitions of the ACAM2000® (Smallpox (Vaccinia) Vaccine, Live) and Raxibacumab and the timing and receipt of required FDA approvals for actions contemplated in connection with our integration of these products;
|
§ |
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 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 facility;
|
§ |
the outcome of the
purported class action
lawsuit;
|
§ |
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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§ |
Vaccines and Anti-Infectives;
|
§ |
Antibody Therapeutics;
|
§ |
Devices; and
|
§ |
Contract Development and Manufacturing.
|
§ |
§ |
ACAM2000
®
(Smallpox (Vaccinia) Vaccine, Live), the only vaccine licensed by the FDA for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.
|
§ |
NuThrax™ (anthrax vaccine adsorbed with CPG 7909 adjuvant), our next generation anthrax vaccine;
|
§ |
VLA1601, a highly purified inactivated vaccine candidate being developed against the Zika virus;
|
§ |
UNI-FLU, a universal influenza vaccine;
|
§ |
EBX-205, an oral therapeutic to treat acute bacterial skin and skin structure infection, including those caused by methicillin-resistant
Staphylococcus aureus
, or MRSA, as well as to treat other serious bacterial infections caused by biothreat pathogens;
|
§ |
GC-072, the lead compound in the EV-035 series of broad-spectrum antibiotics, being developed as an oral and intravenous treatment for
Burkholderia pseudomallei
infection; and
|
§ |
EBI-001, a pan respiratory antiviral from our iminosugar-based discovery program.
|
§ |
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.
|
§ |
FLU-IGIV (NP025), a human polyclonal antibody therapeutic being developed for the treatment of serious influenza A infection in hospitalized patients;
|
§ |
ZIKV-IG
(NP024), a human polyclonal antibody therapeutic being developed as a prophylaxis for Zika infections in at risk populations; and
|
§ |
§ |
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
|
§ |
Trobigard™ (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.
|
§ |
§ |
SIAN (stabilized isoamyl nitrite), a stabilized form of isoamyl nitrite in an intra-nasal spray device being developed as a treatment for known or suspected acute cyanide poisoning.
|
§ |
continue to leverage and expand our leadership position in the PHT market;
|
§ |
grow through the acquisition of products and businesses, particularly those that are revenue-generating and accretive;
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§ |
develop and manufacture innovative products, particularly with funding from governments and non-governmental organizations to defray research and development costs;
|
§ |
expand our portfolio of best-in-class/only-in-class MCMs and services;
|
§ |
focus on globalization and related international marketing and sales capabilities;
|
§ |
diversify our product mix to include products that have both government and non-government market potential, which we refer to as "dual-market."
|
§ |
government relations and contracting;
|
§ |
MCM development and commercialization;
|
§ |
quality manufacturing using multiple platform technologies;
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§ |
company, business and product acquisitions; and
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§ |
financial discipline.
|
Product Candidate
|
Partner
|
Platform
|
Threat Type
|
NuThrax™
Next generation anthrax vaccine
|
HHS - BARDA
|
Vaccine
|
Biological
|
VLA1601
Zika vaccine
|
Valneva
|
Vaccine
|
EID
|
UNI-FLU
Universal flu vaccine
|
--
|
Vaccine
|
EID
|
EBX-205
Broad spectrum antibiotic
|
--
|
Antibacterial
|
EID
|
GC-072
(EV-035 Series)
Burkholderia antibiotic
|
DoD – DTRA
|
Antibacterial
|
Biological
|
EBI-001
Pan-respiratory
iminosugar antiviral
|
--
|
Antiviral
|
EID
|
Product Candidate
|
Target
Indication |
FLU-IGIV
Seasonal influenza therapeutic
|
Treatment of serious Influenza A infection in hospitalized patients.
|
Prophylaxis for Zika infections in at risk populations.
|
|
FILOV
Pan-Ebola therapeutic
|
Prevention or treatment of Ebola or Sudan virus infection.
|
§ |
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 operations, or 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 customers.
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December 31,
|
||||||||||||
in millions
|
2017
|
2016
|
2015
|
|||||||||
Research and development expense
|
$
|
97.4
|
$
|
108.3
|
$
|
119.2
|
||||||
less: Contracts and grants revenue
|
(70.4
|
)
|
(143.4
|
)
|
(117.4
|
)
|
||||||
Net research and development expense (revenue)
|
$
|
27.0
|
$
|
(35.1
|
)
|
$
|
1.8
|
§ |
BioThrax and NuThrax
.
BioThrax is the only vaccine licensed by the FDA for the prevention of anthrax disease. However, we face potential future competition for the supply of anthrax vaccines to the U.S. government if such products are approved. Altimmune, Inc., Pfenex Inc., Soligenix, Inc., Immunovaccine Inc. and NanoBio Corporation are each currently developing anthrax vaccine product candidates.
|
§ |
ACAM2000
.
ACAM2000 is the only FDA-licensed 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 and is marketed under the trade name Imvanex®. It is indicated for use in immunocompromised patients, including HIV-infected individuals and those undergoing immunosuppressive therapy. Phase 3 registration trials are ongoing in the United States.
|
§ |
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 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 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.
|
§ |
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 U.S. government 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.
|
(in millions)
|
2017
|
2016
|
2015
|
|||||||||||||||||||||
United States
|
Ex-U.S.
|
United States
|
Ex-U.S.
|
United States
|
Ex-U.S.
|
|||||||||||||||||||
Total revenues
|
$
|
496.9
|
$
|
64.0
|
$
|
460.6
|
$
|
28.2
|
$
|
467.7
|
$
|
21.6
|
||||||||||||
% of total revenues
|
89
|
%
|
11
|
%
|
94
|
%
|
6
|
%
|
96
|
%
|
4
|
%
|
(in millions)
|
2017
|
2016
|
2015
|
|||||||||||||||||||||
U.S. Government
Customer
|
Non-U.S. Government
Customer
|
U.S. Government
Customer
|
Non-U.S. Government
Customer
|
U.S. Government
Customer
|
Non-U.S. Government
Customer
|
|||||||||||||||||||
Total revenues
|
$
|
439.8
|
$
|
121.1
|
$
|
421.2
|
$
|
67.6
|
$
|
430.6
|
$
|
58.7
|
||||||||||||
% of total revenues
|
78
|
%
|
22
|
%
|
86
|
%
|
14
|
%
|
88
|
%
|
12
|
%
|
(in millions)
|
2017
|
2016
|
2015
|
|||||||||||||||||||||
United States
|
Ex-U.S.
|
United States
|
Ex-U.S.
|
United States
|
Ex-U.S.
|
|||||||||||||||||||
Product sales revenue
|
$
|
377.0
|
$
|
44.5
|
$
|
285.8
|
$
|
10.5
|
$
|
320.0
|
$
|
9.0
|
||||||||||||
% of total revenues
|
67
|
%
|
8
|
%
|
58
|
%
|
2
|
%
|
65
|
%
|
2
|
%
|
§ |
the Federal Acquisition Regulation, or 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, or 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
, or 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, or 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, or 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, or 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 the 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.
|
§ |
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 revolving credit facility, 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;
|
§ |
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 a new 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 U.S. government 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.
|
First Quarter
|
Second Quarter
|
Third Quarter
|
Fourth Quarter
|
|||||||||||||
Year Ended December 31, 2017
|
||||||||||||||||
High
|
$
|
35.00
|
$
|
34.90
|
$
|
40.60
|
$
|
47.90
|
||||||||
Low
|
$
|
28.06
|
$
|
27.94
|
$
|
32.48
|
$
|
36.38
|
||||||||
Year Ended December 31, 2016
|
||||||||||||||||
High
|
$
|
39.29
|
$
|
44.38
|
$
|
34.10
|
$
|
36.64
|
||||||||
Low
|
$
|
31.26
|
$
|
27.01
|
$
|
26.12
|
$
|
24.47
|
Issuer Purchases of Equity Securities
|
||||||||||||||||
|
||||||||||||||||
Period
|
Total number of shares (or units) purchased
|
Average price paid per share (or unit)
|
Total number of shares (or units) purchased as part of publicly announced plans or programs
|
Maximum number (or approximate dollar value) of shares (or units) that may yet be purchased under the plans or programs
|
||||||||||||
First quarter of 2017 (1)
|
2,719
|
$
|
30.63
|
-
|
$
|
-
|
||||||||||
Fourth quarter of 2017 (2)
|
788,894
|
41.84
|
788,894
|
16,992,675
|
||||||||||||
Total
|
791,613
|
$
|
41.81
|
788,894
|
$
|
16,992,675
|
Year Ended December 31,
|
||||||||||||||||||||
(in thousands, except share and per share data)
|
2017
|
2016
|
2015
|
2014
|
2013
|
|||||||||||||||
Statements of operations data:
|
||||||||||||||||||||
Revenues:
|
||||||||||||||||||||
Product sales
|
$
|
421,516
|
$
|
296,278
|
$
|
328,969
|
$
|
281,845
|
$
|
257,922
|
||||||||||
Contract manufacturing
|
68,935
|
49,138
|
42,968
|
30,944
|
-
|
|||||||||||||||
Contracts and grants
|
70,422
|
143,366
|
117,394
|
91,677
|
54,823
|
|||||||||||||||
Total revenues
|
560,873
|
488,782
|
489,331
|
404,466
|
312,745
|
|||||||||||||||
Operating expenses:
|
||||||||||||||||||||
Cost of product sales and contract manufacturing
|
195,707
|
131,284
|
107,486
|
101,963
|
62,127
|
|||||||||||||||
Research and development
|
97,384
|
108,290
|
119,186
|
104,721
|
81,759
|
|||||||||||||||
Selling, general & administrative
|
143,497
|
143,686
|
121,145
|
108,594
|
86,844
|
|||||||||||||||
Total operating expenses
|
436,588
|
383,260
|
347,817
|
315,278
|
230,730
|
|||||||||||||||
Income from operations
|
124,285
|
105,522
|
141,514
|
89,188
|
82,015
|
|||||||||||||||
Other income (expense):
|
||||||||||||||||||||
Interest income
|
1,753
|
1,053
|
572
|
320
|
139
|
|||||||||||||||
Interest expense
|
(6,590
|
)
|
(7,617
|
)
|
(6,523
|
)
|
(8,240
|
)
|
-
|
|||||||||||
Other income (expense), net
|
(815
|
)
|
263
|
153
|
2,926
|
409
|
||||||||||||||
Total other income (expense)
|
(5,652
|
)
|
(6,301
|
)
|
(5,798
|
)
|
(4,994
|
)
|
548
|
|||||||||||
Income from continuing operations before provision for income taxes
|
118,633
|
99,221
|
135,716
|
84,194
|
82,563
|
|||||||||||||||
Provision for income taxes
|
36,039
|
36,697
|
44,300
|
29,928
|
12,270
|
|||||||||||||||
Net income from continuing operations
|
82,594
|
62,524
|
91,416
|
54,266
|
70,293
|
|||||||||||||||
Net loss attributable to noncontrolling interest
|
-
|
-
|
-
|
-
|
876
|
|||||||||||||||
Net income attributable to Emergent BioSolutions Inc. from continuing operations
|
82,594
|
62,524
|
91,416
|
54,266
|
71,169
|
|||||||||||||||
Net loss from discontinued operations
|
-
|
(10,748
|
)
|
(28,546
|
)
|
(17,525
|
)
|
(40,034
|
)
|
|||||||||||
Net income
|
$
|
82,594
|
$
|
51,776
|
$
|
62,870
|
$
|
36,741
|
$
|
31,135
|
||||||||||
Net income per share from continuing operations-basic
|
$
|
1.98
|
$
|
1.56
|
$
|
2.37
|
$
|
1.45
|
$
|
1.97
|
||||||||||
Net loss per share from discontinued operations-basic
|
-
|
(0.27
|
)
|
(0.74
|
)
|
(0.47
|
)
|
(1.11
|
)
|
|||||||||||
Net income per share-basic
|
$
|
1.98
|
$
|
1.29
|
$
|
1.63
|
$
|
0.98
|
$
|
0.86
|
||||||||||
Net income per share from continuing operations-diluted
|
$
|
1.71
|
$
|
1.35
|
$
|
2.02
|
$
|
1.26
|
$
|
1.94
|
||||||||||
Net loss per share from discontinued operations-diluted
|
-
|
(0.22
|
)
|
(0.61
|
)
|
(0.38
|
)
|
(1.09
|
)
|
|||||||||||
Net income per share-diluted (1)
|
$
|
1.71
|
$
|
1.13
|
$
|
1.41
|
$
|
0.88
|
$
|
0.85
|
||||||||||
Weighted average number of shares — basic
|
41,816,431
|
40,184,159
|
38,595,435
|
37,344,891
|
36,201,283
|
|||||||||||||||
Weighted average number of shares — diluted
|
50,327,937
|
49,335,112
|
47,255,842
|
45,802,807
|
36,747,556
|
As of December 31,
|
||||||||||||||||||||
(in thousands)
|
2017
|
2016
|
2015
|
2014
|
2013
|
|||||||||||||||
Balance Sheet Data:
|
||||||||||||||||||||
Cash and cash equivalents
|
$
|
178,292
|
$
|
271,513
|
$
|
308,304
|
$
|
276,786
|
$
|
179,338
|
||||||||||
Working capital
|
385,321
|
404,362
|
425,865
|
312,767
|
284,652
|
|||||||||||||||
Total assets
|
1,070,206
|
970,111
|
931,836
|
815,611
|
521,898
|
|||||||||||||||
Total long-term liabilities
|
57,793
|
268,050
|
274,622
|
281,472
|
83,853
|
|||||||||||||||
Total stockholders' equity
|
912,345
|
596,205
|
574,951
|
454,495
|
482,395
|
§ |
BioThrax
®
(Anthrax Vaccine Adsorbed), the only vaccine licensed by the U.S. Food and Drug Administration, or 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 (acquired from Sanofi Pasteur Biologics, LLC in October 2017);
|
§ |
Raxibacumab (Anthrax Monoclonal), the first fully human monoclonal antibody therapeutic licensed by the FDA for the treatment and prophylaxis of inhalational anthrax (acquired from GlaxoSmithKline LLC in October 2017);
|
§ |
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;
|
§ |
VIGIV [Vaccinia Immune Globulin Intravenous (Human)], the only antibody therapeutic licensed by the FDA and Health Canada to address certain complications from smallpox vaccination;
|
§ |
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.
|
§ |
NuThrax™ (anthrax vaccine adsorbed with CPG 7909 adjuvant), a next generation anthrax vaccine;
|
§ |
FLU-IGIV (NP025), a human polyclonal antibody therapeutic being developed for the treatment of serious influenza A infection in hospitalized patients;
|
§ |
ZIKA-IG (NP024), a human polyclonal antibody therapeutic being developed as a prophylaxis for Zika infections in at risk populations;
|
§ |
FILOV (NP026), an equine polyclonal antibody therapeutic being developed to treat hemorrhagic fever caused by Filoviruses (Ebola, Marburg and Sudan);
|
§ |
VLA1601, a highly purified inactivated vaccine against the Zika virus;
|
§ |
UNI-FLU, a universal influenza vaccine;
|
§ |
EBX-205, an oral therapeutic to treat acute bacterial skin and skin structure infection, including those caused by methicillin-resistant
Staphylococcus aureus
, or MRSA, as well as to treat other serious bacterial infections caused by biothreat pathogens;
|
§ |
EBI-001, a pan respiratory antiviral from our iminosugar-based discovery program;
|
§ |
GC-072, an oral and intravenous treatment for
Burkholderia pseudomallei
infection (GC-072 is the lead compound in the EV-035 series of broad-spectrum antibiotics);
|
§ |
D4, a multi-drug auto-injector device being developed for nerve agent antidote delivery (Atropine and Pralidoxime Chloride in combination); and
|
§ |
SIAN (stabilized isoamyl nitrite), a stabilized form of isoamyl nitrite in an intra-nasal spray device being developed as a treatment for known or suspected acute cyanide poisoning.
|
|
there is persuasive evidence of an arrangement;
|
|
delivery has occurred or title has passed to our customer based on contract terms;
|
|
the fee is fixed or determinable; and
|
|
collectability is reasonably assured.
|
Development Programs
|
Funding Source
|
Award Date
|
Performance Period
|
Anthrasil
|
BARDA
|
9/2005
|
9/2005 — 4/2021
|
BARDA
|
9/2013
|
9/2013 — 9/2018
|
|
Auto-injector platform
|
DoD
|
7/2017
|
7/2017 — 6/2022
|
BAT
|
BARDA
|
5/2006
|
5/2006 — 12/2027
|
CIADM
|
BARDA
|
6/2012
|
6/2012 — 6/2037
|
GC-072
|
DTRA
|
8/2014
|
8/2014 — 3/2018
|
Large-scale manufacturing for BioThrax
|
BARDA
|
7/2010
|
7/2010 — 7/2017
|
NuThrax
|
NIAID
|
8/2014
|
8/2014 — 1/2019
|
BARDA
|
3/2015
|
3/2015 — 12/2017
|
|
BARDA
|
9/2016
|
9/2016 — 9/2021
|
|
SIAN
|
BARDA
|
9/2017
|
9/2017 — 9/2022
|
UV-4B
|
NIAID
|
9/2011
|
9/2011 — 9/2018
|
VIGIV
|
CDC
|
8/2012
|
8/2012 — 8/2017
|
§ |
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 thousands)
|
2017
|
2016
|
$ Change
|
% Change
|
||||||||||||
Product sales:
|
||||||||||||||||
BioThrax
|
$
|
286,651
|
$
|
237,030
|
$
|
49,621
|
21
|
%
|
||||||||
Other
|
134,865
|
59,248
|
75,617
|
128
|
%
|
|||||||||||
Total product sales
|
421,516
|
296,278
|
125,238
|
42
|
%
|
|||||||||||
Contract manufacturing
|
68,935
|
49,138
|
19,797
|
40
|
%
|
|||||||||||
Contracts and grants
|
70,422
|
143,366
|
(72,944
|
)
|
(51
|
%)
|
||||||||||
Total revenues
|
$
|
560,873
|
$
|
488,782
|
$
|
72,091
|
15
|
%
|
§ |
the timing of BAT deliveries to the SNS;
|
§ |
international sales for VIGIV and Trobigard; and
|
§ |
sales of ACAM2000 and Raxibacumab, both acquired in October 2017.
|
§ |
manufacturing services for Aptevo;
|
§ |
fill/finish 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.
|
Year ended December 31,
|
||||||||||||||||
(in thousands)
|
2017
|
2016
|
$ Change
|
% Change
|
||||||||||||
NuThrax
|
$
|
30,000
|
$
|
22,478
|
$
|
7,522
|
33
|
%
|
||||||||
UV-4B
|
6,331
|
5,588
|
743
|
13
|
%
|
|||||||||||
Auto-injector program
|
5,245
|
9,000
|
(3,755
|
)
|
(42
|
%)
|
||||||||||
FLU-IGIV (NP025)
|
5,334
|
-
|
5,334
|
N/A
|
||||||||||||
EV-035 series of molecules
|
4,123
|
326
|
3,797
|
1,165
|
%
|
|||||||||||
VLA1601
|
3,509
|
-
|
3,509
|
N/A
|
||||||||||||
BAT
|
2,709
|
3,904
|
(1,195
|
)
|
(31
|
%)
|
||||||||||
ZIKV-IG
|
3,246
|
836
|
2,410
|
288
|
%
|
|||||||||||
CIADM task orders
|
2,321
|
13,955
|
(11,634
|
)
|
(83
|
%)
|
||||||||||
Raxibacumab
|
2,142
|
-
|
2,142
|
N/A
|
||||||||||||
VIGIV
|
1,223
|
12,019
|
(10,796
|
)
|
(90
|
%)
|
||||||||||
BioThrax related programs
|
1,474
|
3,069
|
(1,595
|
)
|
(52
|
%)
|
||||||||||
Anthrasil
|
612
|
1,279
|
(667
|
)
|
(52
|
%)
|
||||||||||
Large-scale manufacturing for BioThrax
|
756
|
6,104
|
(5,348
|
)
|
(88
|
%)
|
||||||||||
Other
|
28,359
|
29,732
|
(1,373
|
)
|
(5
|
%)
|
||||||||||
Total
|
$
|
97,384
|
$
|
108,290
|
$
|
(10,906
|
)
|
(10
|
%)
|
§ |
the timing of device and cartridge supply development work related to our Auto-injector program;
|
§ |
the timing of stability testing related to our BAT program;
|
§ |
the successful completion of manufacturing development for Ebola monoclonal antibodies and Zika under current CIADM-related task order awards;
|
§ |
the timing of plasma collection related to our VIGIV program;
|
§ |
the timing of clinical studies to support applications for label expansion for BioThrax under the auspices of our BioThrax related development programs;
|
§ |
the timing of non-clinical activities related to our Anthrasil program;
|
§ |
the completion of development work and the licensure of Building 55, our large-scale manufacturing facility, in August 2016; and
|
§ |
increased expenses related to our funded pre-clinical product candidates and manufacturing development activities within our other development activities.
|
§ |
manufacturing development activities related to our NuThrax product candidate;
|
§ |
clinical trial activity to evaluate safety and tolerability related to our UV-4B product candidate; we anticipate a reduction in funding by the U.S. government for this product candidate and as a result we will cease further development work on UV-4B and expect the spending to be minimal in the future;
|
§ |
preparation activities and initiation of Phase 2 clinical study related to our FLU-IGIV (NP025) program;
|
§ |
formulation development activities, along with screening of molecules within the series, related to our EV-035 series of molecules;
|
§ |
payment of license fees to Valneva in association with our VLA1601 program;
|
§ |
preparation activities for Phase 1 clinical study for our ZIKV-IG product candidate; and
|
§ |
manufacturing development activities related to Raxibacumab (acquired in October 2017).
|
|
Year ended December 31,
|
|||||||||||||||
(in thousands)
|
2016
|
2015
|
$ Change
|
% Change
|
||||||||||||
Product sales:
|
||||||||||||||||
BioThrax
|
$
|
237,030
|
$
|
293,921
|
$
|
(56,891
|
)
|
(19
|
%)
|
|||||||
Other
|
59,248
|
35,048
|
24,200
|
69
|
%
|
|||||||||||
Total product sales
|
296,278
|
328,969
|
(32,691
|
)
|
(10
|
%)
|
||||||||||
Contract manufacturing
|
49,138
|
42,968
|
6,170
|
14
|
%
|
|||||||||||
Contracts and grants
|
143,366
|
117,394
|
25,972
|
22
|
%
|
|||||||||||
Total revenues
|
$
|
488,782
|
$
|
489,331
|
$
|
(549
|
)
|
0
|
%
|
Year ended December 31,
|
||||||||||||||||
(in thousands)
|
2016
|
2015
|
$ Change
|
% Change
|
||||||||||||
NuThrax
|
$
|
22,478
|
$
|
12,560
|
$
|
9,918
|
79
|
%
|
||||||||
UV-4B
|
5,588
|
-
|
5,588
|
N/A
|
||||||||||||
Auto-injector program
|
9,000
|
4,643
|
4,357
|
94
|
%
|
|||||||||||
EV-035 series of molecules
|
326
|
6,801
|
(6,475
|
)
|
(95
|
%)
|
||||||||||
BAT
|
3,904
|
4,867
|
(963
|
)
|
(20
|
%)
|
||||||||||
ZIKV-IG
|
836
|
-
|
836
|
N/A
|
||||||||||||
CIADM task orders
|
13,955
|
2,957
|
10,998
|
372
|
%
|
|||||||||||
VIGIV
|
12,019
|
3,060
|
8,959
|
293
|
%
|
|||||||||||
BioThrax related programs
|
3,069
|
3,511
|
(442
|
)
|
(13
|
%)
|
||||||||||
Anthrasil
|
1,279
|
25,986
|
(24,707
|
)
|
(95
|
%)
|
||||||||||
Large-scale manufacturing for BioThrax
|
6,104
|
9,911
|
(3,807
|
)
|
(38
|
%)
|
||||||||||
Other
|
29,732
|
44,890
|
(15,158
|
)
|
(34
|
%)
|
||||||||||
Total
|
$
|
108,290
|
$
|
119,186
|
$
|
(10,896
|
)
|
(9
|
%)
|
§ |
pharmacologic and formulation activities and a third quarter 2015 non-cash impairment charge of $9.8 million due to toxicity related issues, partially offset by a net decrease of $3.3 million (2016 vs. 2015) for the contingent consideration associated with the estimated timing and probability of achievement for certain development and regulatory milestones related to our EV-035 series of molecules program;
|
§ |
stability testing and plasma collection related to our BAT program;
|
§ |
timing of plasma collection services related to our Anthrasil program;
|
§ |
clinical studies to support applications for label expansion for BioThrax related to BioThrax related programs;
|
§ |
timing of manufacturing development activities and due to the successful licensure of the large-scale manufacturing facility in August 2016 related to our Large-scale manufacturing of BioThrax program; and
|
§ |
decreased expenses related to our manufacturing development activities within our other development activities.
|
§ |
non-clinical animal studies and manufacturing development activities related to our NuThrax product candidate;
|
§ |
clinical trial activity to evaluate safety and tolerability related to our UV-4B product candidate;
|
§ |
Auto-injector program, primarily for device and cartridge supply development;
|
§ |
preparation for a clinical trial related to our ZIKV-IG program;
|
§ |
manufacturing development of Ebola monoclonal antibodies related to our CIADM task orders; and
|
§ |
plasma collection related to our VIGIV program.
|
|
Year ended December 31,
|
|||||||||||
(in thousands)
|
2017
|
2016
|
2015
|
|||||||||
Net cash provided by (used in):
|
||||||||||||
Operating activities(1)
|
$
|
208,112
|
$
|
54,752
|
$
|
42,367
|
||||||
Investing activities
|
(249,932
|
)
|
(76,257
|
)
|
(45,462
|
)
|
||||||
Financing activities
|
(51,401
|
)
|
(19,777
|
)
|
35,391
|
|||||||
Net (decrease) increase in cash and cash equivalents
|
$
|
(93,221
|
)
|
$
|
(41,282
|
)
|
$
|
32,296
|
Payments due by period
|
||||||||||||||||||||
Less than
|
1 to 3
|
3 to 5
|
More than
|
|||||||||||||||||
(in thousands)
|
Total
|
1 year
|
Years
|
Years
|
5 years
|
|||||||||||||||
Contractual obligations:
|
||||||||||||||||||||
Long-term indebtedness
|
$
|
14,529
|
$
|
305
|
$
|
610
|
$
|
13,614
|
$
|
-
|
||||||||||
Operating lease obligations
|
10,730
|
1,626
|
2,730
|
2,689
|
3,685
|
|||||||||||||||
Deemed mandatory repatriation tax (1)
|
13,584
|
1,087
|
3,260
|
5,841
|
3,396
|
|||||||||||||||
Purchase commitments
|
7,015
|
3,095
|
3,920
|
-
|
-
|
|||||||||||||||
Total contractual obligations
|
$
|
45,858
|
$
|
6,113
|
$
|
10,520
|
$
|
22,144
|
$
|
7,081
|
§ |
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; and
|
§ |
the costs of commercialization activities, including product marketing, sales and distribution.
|
December 31,
|
||||||||
2017
|
2016
|
|||||||
ASSETS
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
178,292
|
$
|
271,513
|
||||
Restricted cash
|
1,043
|
-
|
||||||
Accounts receivable, net
|
143,653
|
138,478
|
||||||
Inventories
|
142,812
|
74,002
|
||||||
Income tax receivable, net
|
2,432
|
9,996
|
||||||
Prepaid expenses and other current assets
|
17,157
|
16,229
|
||||||
Total current assets
|
485,389
|
510,218
|
||||||
Property, plant and equipment, net
|
407,210
|
376,448
|
||||||
Intangible assets, net
|
119,597
|
33,865
|
||||||
Goodwill
|
49,130
|
41,001
|
||||||
Deferred tax assets, net
|
2,834
|
6,096
|
||||||
Other assets
|
6,046
|
2,483
|
||||||
Total assets
|
$
|
1,070,206
|
$
|
970,111
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
41,751
|
$
|
34,649
|
||||
Accrued expenses and other current liabilities
|
4,831
|
6,368
|
||||||
Accrued compensation
|
37,882
|
34,537
|
||||||
Notes payable
|
-
|
20,000
|
||||||
Contingent consideration, current portion
|
2,372
|
3,266
|
||||||
Deferred revenue, current portion
|
13,232
|
7,036
|
||||||
Total current liabilities
|
100,068
|
105,856
|
||||||
Contingent consideration, net of current portion
|
9,902
|
9,919
|
||||||
Long-term indebtedness
|
13,457
|
248,094
|
||||||
Income taxes payable, net of current
|
12,500
|
-
|
||||||
Deferred revenue, net of current portion
|
17,259
|
8,433
|
||||||
Other liabilities
|
4,675
|
1,604
|
||||||
Total liabilities
|
157,861
|
373,906
|
||||||
Commitments and contingencies
|
||||||||
Stockholders' equity:
|
||||||||
Preferred stock, $0.001 par value; 15,000,000 shares authorized, 0 shares issued and outstanding at both December 31, 2017 and December 31, 2016
|
-
|
-
|
||||||
Common stock, $0.001 par value; 200,000,000 shares authorized, 50,619,808 shares issued and 49,405,365 shares outstanding at December 31, 2017; 40,996,890 shares issued and 40,574,060 shares outstanding at December 31, 2016
|
50
|
41
|
||||||
Treasury stock, at cost, 1,214,443 and 422,830 common shares at December 31, 2017 and December 31, 2016, respectively
|
(39,497
|
)
|
(6,420
|
)
|
||||
Additional paid-in capital
|
618,416
|
352,435
|
||||||
Accumulated other comprehensive loss
|
(3,698
|
)
|
(4,331
|
)
|
||||
Retained earnings
|
337,074
|
254,480
|
||||||
Total stockholders' equity
|
912,345
|
596,205
|
||||||
Total liabilities and stockholders' equity
|
$
|
1,070,206
|
$
|
970,111
|
Year Ended December 31,
|
||||||||||||
2017
|
2016
|
2015
|
||||||||||
Revenues:
|
||||||||||||
Product sales
|
$
|
421,516
|
$
|
296,278
|
$
|
328,969
|
||||||
Contract manufacturing
|
68,935
|
49,138
|
42,968
|
|||||||||
Contracts and grants
|
70,422
|
143,366
|
117,394
|
|||||||||
Total revenues
|
560,873
|
488,782
|
489,331
|
|||||||||
Operating expenses:
|
||||||||||||
Cost of product sales and contract manufacturing
|
195,707
|
131,284
|
107,486
|
|||||||||
Research and development
|
97,384
|
108,290
|
119,186
|
|||||||||
Selling, general and administrative
|
143,497
|
143,686
|
121,145
|
|||||||||
Income from operations
|
124,285
|
105,522
|
141,514
|
|||||||||
Other income (expense):
|
||||||||||||
Interest income
|
1,753
|
1,053
|
572
|
|||||||||
Interest expense
|
(6,590
|
)
|
(7,617
|
)
|
(6,523
|
)
|
||||||
Other income (expense), net
|
(815
|
)
|
263
|
153
|
||||||||
Total other expense, net
|
(5,652
|
)
|
(6,301
|
)
|
(5,798
|
)
|
||||||
Income from continuing operations before provision for income taxes
|
118,633
|
99,221
|
135,716
|
|||||||||
Provision for income taxes
|
36,039
|
36,697
|
44,300
|
|||||||||
Net income from continuing operations
|
82,594
|
62,524
|
91,416
|
|||||||||
Net loss from discontinued operations
|
-
|
(10,748
|
)
|
(28,546
|
)
|
|||||||
Net income
|
$
|
82,594
|
$
|
51,776
|
$
|
62,870
|
||||||
Net income per share from continuing operations-basic
|
$
|
1.98
|
$
|
1.56
|
$
|
2.37
|
||||||
Net loss per share from discontinued operations-basic
|
-
|
(0.27
|
)
|
(0.74
|
)
|
|||||||
Net income per share-basic
|
$
|
1.98
|
$
|
1.29
|
$
|
1.63
|
||||||
Net income per share from continuing operations-diluted
|
$
|
1.71
|
$
|
1.35
|
$
|
2.02
|
||||||
Net loss per share from discontinued operations-diluted
|
-
|
(0.22
|
)
|
(0.61
|
)
|
|||||||
Net income per share-diluted (1)
|
$
|
1.71
|
$
|
1.13
|
$
|
1.41
|
||||||
Weighted-average number of shares - basic
|
41,816,431
|
40,184,159
|
38,595,435
|
|||||||||
Weighted-average number of shares - diluted
|
50,327,937
|
49,335,112
|
47,255,842
|
December 31,
|
||||||||||||
2017
|
2016
|
2015
|
||||||||||
Net income
|
$
|
82,594
|
$
|
51,776
|
$
|
62,870
|
||||||
Foreign currency translations, net of tax
|
633
|
(1,618
|
)
|
295
|
||||||||
Comprehensive income
|
$
|
83,227
|
$
|
50,158
|
$
|
63,165
|
Year Ended December 31,
|
||||||||||||
2017
|
2016
|
2015
|
||||||||||
Cash flows from operating activities:
|
||||||||||||
Net income
|
$
|
82,594
|
$
|
51,776
|
$
|
62,870
|
||||||
Adjustments to reconcile to net cash provided by (used in) operating activities:
|
||||||||||||
Stock-based compensation expense
|
15,213
|
18,477
|
15,848
|
|||||||||
Depreciation and amortization
|
42,572
|
38,229
|
35,335
|
|||||||||
Deferred income taxes
|
3,259
|
5,190
|
3,464
|
|||||||||
Change in fair value of contingent obligations
|
7,830
|
(10,838
|
)
|
(10,599
|
)
|
|||||||
Impairment of intangible assets (including IPR&D)
|
-
|
701
|
9,827
|
|||||||||
Impairment and abandonment of long-lived assets
|
1,936
|
5,569
|
1,147
|
|||||||||
Bad debt expense
|
-
|
-
|
3,481
|
|||||||||
Excess tax benefits from stock-based compensation
|
-
|
(10,619
|
)
|
(11,281
|
)
|
|||||||
Other
|
1,011
|
452
|
271
|
|||||||||
Changes in operating assets and liabilities:
|
||||||||||||
Accounts receivable
|
(4,810
|
)
|
(22,446
|
)
|
(64,351
|
)
|
||||||
Inventories
|
6,066
|
(9,026
|
)
|
(11,262
|
)
|
|||||||
Income taxes
|
20,067
|
(3,424
|
)
|
(5,492
|
)
|
|||||||
Prepaid expenses and other assets
|
(3,730
|
)
|
(2,089
|
)
|
2,319
|
|||||||
Accounts payable
|
16,134
|
(14,791
|
)
|
4,749
|
||||||||
Accrued expenses and other liabilities
|
1,626
|
624
|
45
|
|||||||||
Accrued compensation
|
3,349
|
2,236
|
2,680
|
|||||||||
Provision for chargebacks
|
-
|
-
|
(8
|
)
|
||||||||
Deferred revenue
|
15,022
|
4,602
|
3,474
|
|||||||||
Net cash provided by operating activities
|
208,139
|
54,623
|
42,517
|
|||||||||
Cash flows from investing activities:
|
||||||||||||
Purchases of property, plant and equipment
|
(54,828
|
)
|
(76,257
|
)
|
(44,812
|
)
|
||||||
Acquisitions
|
(195,104
|
)
|
-
|
(650
|
)
|
|||||||
Net cash used in investing activities
|
(249,932
|
)
|
(76,257
|
)
|
(45,462
|
)
|
||||||
Cash flows from financing activities:
|
||||||||||||
Proceeds from long-term debt obligations
|
-
|
-
|
2,000
|
|||||||||
Issuance of common stock upon exercise of stock options
|
19,346
|
17,125
|
25,961
|
|||||||||
Excess tax benefits from stock-based compensation
|
-
|
10,619
|
11,281
|
|||||||||
Debt issuance costs
|
(1,426
|
)
|
-
|
-
|
||||||||
Taxes paid on behalf of employees for equity activity
|
(4,260
|
)
|
(1,136
|
)
|
1,942
|
|||||||
Payments of notes payable
|
(20,000
|
)
|
-
|
-
|
||||||||
Distribution to Aptevo
|
-
|
(45,000
|
)
|
-
|
||||||||
Contingent consideration payments
|
(10,941
|
)
|
(1,385
|
)
|
(5,693
|
)
|
||||||
Restricted cash
|
(1,043
|
)
|
-
|
-
|
||||||||
Purchase of treasury stock
|
(33,077
|
)
|
-
|
(100
|
)
|
|||||||
Net cash (used in) provided by financing activities
|
(51,401
|
)
|
(19,777
|
)
|
35,391
|
|||||||
Effect of exchange rate changes on cash and cash equivalents
|
(27
|
)
|
129
|
(150
|
)
|
|||||||
Net (decrease) increase in cash and cash equivalents
|
(93,221
|
)
|
(41,282
|
)
|
32,296
|
|||||||
Cash and cash equivalents at beginning of year
|
271,513
|
312,795
|
280,499
|
|||||||||
Cash and cash equivalents at end of year
|
$
|
178,292
|
$
|
271,513
|
$
|
312,795
|
||||||
Supplemental disclosure of cash flow information:
|
||||||||||||
Cash paid during the year for interest
|
$
|
8,416
|
$
|
8,210
|
$
|
7,751
|
||||||
Cash paid during the year for income taxes
|
$
|
11,977
|
$
|
10,081
|
$
|
28,271
|
||||||
Supplemental information on non-cash investing and financing activities:
|
||||||||||||
Purchases of property, plant and equipment unpaid at year end
|
$
|
4,587
|
$
|
13,459
|
$
|
4,379
|
$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, 2014
|
38,129,872
|
$
|
38
|
$
|
274,222
|
(420,189
|
)
|
$
|
(6,320
|
)
|
$
|
(3,008
|
)
|
$
|
288,269
|
$
|
553,201
|
|||||||||||||||
Employee equity plans activity
|
1,699,536
|
2
|
43,749
|
-
|
-
|
-
|
-
|
43,751
|
||||||||||||||||||||||||
Treasury stock
|
-
|
-
|
-
|
(2,641
|
)
|
(100
|
)
|
-
|
(100
|
)
|
||||||||||||||||||||||
Net income
|
-
|
-
|
-
|
-
|
-
|
-
|
62,870
|
62,870
|
||||||||||||||||||||||||
Foreign currency translation, net of tax
|
-
|
-
|
-
|
-
|
-
|
295
|
-
|
295
|
||||||||||||||||||||||||
Balance at December 31, 2015
|
39,829,408
|
$
|
40
|
$
|
317,971
|
(422,830
|
)
|
$
|
(6,420
|
)
|
$
|
(2,713
|
)
|
$
|
351,139
|
$
|
660,017
|
|||||||||||||||
Employee equity plans activity
|
1,167,482
|
1
|
34,464
|
-
|
-
|
34,465
|
||||||||||||||||||||||||||
Separation of Aptevo
|
-
|
-
|
-
|
-
|
-
|
-
|
(148,435
|
)
|
(148,435
|
)
|
||||||||||||||||||||||
Treasury stock
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
||||||||||||||||||||||||
Net income
|
-
|
-
|
-
|
-
|
-
|
-
|
51,776
|
51,776
|
||||||||||||||||||||||||
Foreign currency translation, net of tax
|
-
|
-
|
-
|
-
|
-
|
(1,618
|
)
|
-
|
(1,618
|
)
|
||||||||||||||||||||||
Balance at December 31, 2016
|
40,996,890
|
$
|
41
|
$
|
352,435
|
(422,830
|
)
|
$
|
(6,420
|
)
|
$
|
(4,331
|
)
|
$
|
254,480
|
$
|
596,205
|
|||||||||||||||
Employee equity plans activity
|
1,114,830
|
1
|
27,951
|
-
|
-
|
-
|
-
|
27,952
|
||||||||||||||||||||||||
Shares issued to extinguish convertible notes
|
8,508,088
|
8
|
238,030
|
-
|
-
|
-
|
-
|
238,038
|
||||||||||||||||||||||||
Treasury stock
|
-
|
-
|
-
|
(791,613
|
)
|
(33,077
|
)
|
-
|
-
|
(33,077
|
)
|
|||||||||||||||||||||
Net income
|
-
|
-
|
-
|
-
|
-
|
-
|
82,594
|
82,594
|
||||||||||||||||||||||||
Foreign currency translation, net of tax
|
-
|
-
|
-
|
-
|
-
|
633
|
-
|
633
|
||||||||||||||||||||||||
Balance at December 31, 2017
|
50,619,808
|
$
|
50
|
$
|
618,416
|
(1,214,443
|
)
|
$
|
(39,497
|
)
|
$
|
(3,698
|
)
|
$
|
337,074
|
$
|
912,345
|
§ |
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 (acquired from Sanofi Pasteur Biologics, LLC in October 2017);
|
§ |
Raxibacumab (Anthrax Monoclonal), the first fully human monoclonal antibody therapeutic licensed by the FDA for the treatment and prophylaxis of inhalational anthrax (acquired from GlaxoSmithKline LLC in October 2017);
|
§ |
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;
|
§ |
VIGIV [Vaccinia Immune Globulin Intravenous (Human)], the only therapeutic licensed by the FDA and Health Canada to address certain complications from smallpox vaccination;
|
§ |
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.
|
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
|
|
there is persuasive evidence of an arrangement;
|
|
delivery has occurred or title has passed to the Company's customer;
|
|
the fee is fixed or determinable; and
|
|
collectability is reasonably assured.
|
§ |
BAT product sales upon delivery to the SNS;
|
§ |
stability testing based on the required testing schedule of the product;
|
§ |
extended product expiry based on achievement of the extension;
|
§ |
horse maintenance based on a per horse basis; and
|
§ |
plasma collection on a per liter basis.
|
§ |
VIGIV and Anthrasil product sales upon delivery to the CDC;
|
§ |
stability testing based on the required testing schedule of the product;
|
§ |
extended product expiry based on achievement of the extension; and
|
§ |
plasma collection on a per liter basis.
|
·
|
development services for the NuThrax product candidate under the BARDA NuThrax Contract; and
|
·
|
procurement of BioThrax under the BARDA BioThrax Contract.
|
·
|
$137.1 million was allocated to the development services for the NuThrax product candidate under the BARDA NuThrax Contract; and
|
·
|
$93.6 million was allocated to the procurement of BioThrax under the BARDA BioThrax Contract.
|
§ |
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,
|
||||||
|
2017
|
|
2016
|
|
2015
|
|
Expected dividend yield
|
0%
|
0%
|
0%
|
|||
Expected volatility
|
37-40%
|
31-33%
|
34-35%
|
|||
Risk-free interest rate
|
1.66-1.88%
|
0.93-1.22%
|
1.27-1.61%
|
|||
Expected average life of options
|
4.3 years
|
4.3 years
|
4.3 years
|
|
Expected dividend yield — the Company does not pay regular dividends on its common stock and does not anticipate paying any dividends in the foreseeable future.
|
|
Expected volatility — 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 thousands)
|
2016
|
2015
|
||||||
Revenues:
|
||||||||
Product sales
|
$
|
21,183
|
$
|
27,947
|
||||
Collaborations
|
187
|
5,511
|
||||||
Total revenues
|
21,370
|
33,458
|
||||||
Operating expense:
|
||||||||
Cost of product sales
|
11,556
|
16,809
|
||||||
Research and development
|
18,024
|
34,811
|
||||||
Selling, general and administrative
|
23,792
|
27,313
|
||||||
Loss from operations
|
(32,002
|
)
|
(45,475
|
)
|
||||
Other income (expense), net:
|
(41
|
)
|
(472
|
)
|
||||
Loss from discontinued operations before benefit from income taxes
|
(32,043
|
)
|
(45,947
|
)
|
||||
Benefit from income taxes
|
(21,295
|
)
|
(17,401
|
)
|
||||
Net loss from discontinued operations
|
$
|
(10,748
|
)
|
$
|
(28,546
|
)
|
Years ended December 31,
|
||||||||
(in thousands)
|
2016
|
2015
|
||||||
Net cash used in operating activities
|
$
|
(10,299
|
)
|
$
|
(12,716
|
)
|
||
Net cash used in investing activities
|
(1,926
|
)
|
(1,518
|
)
|
||||
Net cash provided by financing activities
|
7,733
|
15,012
|
||||||
Net increase (decrease) in cash and cash equivalents
|
$
|
(4,492
|
)
|
$
|
778
|
(in thousands)
|
||||
Amount of cash paid to Sanofi
|
$
|
117,500
|
||
Fair value of contingent purchase consideration
|
2,200
|
|||
Total purchase price
|
$
|
119,700
|
(in thousands)
|
||||
Fair value of tangible assets acquired and liabilities assumed:
|
||||
Inventory
|
$
|
74,876
|
||
Property, plant and equipment
|
19,995
|
|||
Total fair value of tangible assets acquired and liabilities assumed
|
94,871
|
|||
|
||||
Acquired intangible asset
|
16,700
|
|||
Goodwill
|
8,129
|
|||
Total purchase price
|
$
|
119,700
|
(in thousands)
|
||||
Balance at December 31, 2015
|
$
|
25,155
|
||
(Income) expense included in earnings
|
(10,857
|
)
|
||
Settlements
|
(1,113
|
)
|
||
Balance at December 31, 2016
|
$
|
13,185
|
||
(Income) expense included in earnings
|
7,830
|
|||
Settlements
|
(10,941
|
)
|
||
Purchases, sales and issuances
|
2,200
|
|||
Balance at December 31, 2017
|
$
|
12,274
|
December 31,
|
||||||||
(in thousands)
|
2017
|
2016
|
||||||
Billed
|
$
|
118,918
|
$
|
90,439
|
||||
Unbilled
|
24,735
|
48,039
|
||||||
Total
|
$
|
143,653
|
$
|
138,478
|
December 31,
|
||||||||
(in thousands)
|
2017
|
2016
|
||||||
Raw materials and supplies
|
$
|
36,069
|
$
|
30,687
|
||||
Work-in-process
|
76,610
|
19,821
|
||||||
Finished goods
|
30,133
|
23,494
|
||||||
Total inventories
|
$
|
142,812
|
$
|
74,002
|
December 31,
|
||||||||
(in thousands)
|
2017
|
2016
|
||||||
Land and improvements
|
$
|
21,843
|
$
|
20,340
|
||||
Buildings, building improvements and leasehold improvements
|
160,005
|
147,130
|
||||||
Furniture and equipment
|
206,819
|
190,157
|
||||||
Software
|
50,829
|
52,564
|
||||||
Construction-in-progress
|
100,088
|
77,813
|
||||||
539,584
|
488,004
|
|||||||
Less: Accumulated depreciation and amortization
|
(132,374
|
)
|
(111,556
|
)
|
||||
Total property, plant and equipment, net
|
$
|
407,210
|
$
|
376,448
|
(in thousands)
|
Total
|
|||
Cost basis
|
||||
Balance at December 31, 2016
|
$
|
57,099
|
||
Additions
|
94,304
|
|||
Balance at December 31, 2017
|
$
|
151,403
|
||
Accumulated amortization
|
||||
Balance at December 31, 2016
|
$
|
(23,234
|
)
|
|
Amortization
|
(8,572
|
)
|
||
Balance at December 31, 2017
|
$
|
(31,806
|
)
|
|
Net book value at December 31, 2017
|
$
|
119,597
|
(in thousands)
|
||||
2018
|
$
|
15,647
|
||
2019
|
15,168
|
|||
2020
|
15,087
|
|||
2021
|
13,596
|
|||
2022 and beyond
|
60,099
|
|||
Total remaining amortization
|
$
|
119,597
|
(in thousands)
|
Therapeutics and vaccines
|
Contract manufacturing
|
Devices
|
Total
|
||||||||||||
Cost Basis
|
||||||||||||||||
Balance at December 31, 2016
|
$
|
24,349
|
$
|
6,736
|
$
|
9,916
|
$
|
41,001
|
||||||||
Additions
|
8,129
|
-
|
-
|
8,129
|
||||||||||||
Balance at December 31, 2017
|
$
|
32,478
|
$
|
6,736
|
$
|
9,916
|
$
|
49,130
|
2006 Plan
|
||||||||||||
Number of Shares
|
Weighted-Average Exercise Price
|
Aggregate Intrinsic Value
|
||||||||||
Outstanding at December 31, 2016
|
2,559,331
|
$
|
22.94
|
$
|
25,348,245
|
|||||||
Granted
|
427,821
|
31.13
|
||||||||||
Exercised
|
(792,795
|
)
|
19.95
|
|||||||||
Forfeited
|
(72,952
|
)
|
29.30
|
|||||||||
Outstanding at December 31, 2017
|
2,121,405
|
$
|
25.48
|
$
|
44,518,585
|
|||||||
Exercisable at December 31, 2017
|
1,307,330
|
$
|
22.63
|
$
|
31,170,967
|
|||||||
Options expected to vest at December 31, 2017
|
632,954
|
$
|
29.91
|
$
|
10,480,716
|
Number of Shares
|
Weighted-Average Grant Price
|
Aggregate Intrinsic Value
|
||||||||||
Outstanding at December 31, 2016
|
875,584
|
$
|
28.94
|
$
|
28,754,179
|
|||||||
Granted
|
480,959
|
31.49
|
||||||||||
Vested
|
(423,840
|
)
|
30.52
|
|||||||||
Forfeited
|
(80,983
|
)
|
29.21
|
|||||||||
Outstanding at December 31, 2017
|
851,720
|
$
|
30.84
|
$
|
39,579,428
|
Year Ended December 31,
|
||||||||||||
(in thousands)
|
2017
|
2016
|
2015
|
|||||||||
Cost of product sales
|
$
|
1,076
|
$
|
997
|
$
|
1,183
|
||||||
Research and development
|
2,526
|
2,297
|
2,324
|
|||||||||
Selling, general and administrative
|
11,611
|
14,062
|
11,234
|
|||||||||
Continuing operations
|
15,213
|
17,356
|
14,741
|
|||||||||
Discontinued operations
|
-
|
1,121
|
1,107
|
|||||||||
Total stock-based compensation expense
|
$
|
15,213
|
$
|
18,477
|
$
|
15,848
|
Year Ended December 31,
|
||||||||||||
(in thousands)
|
2017
|
2016
|
2015
|
|||||||||
Current
|
||||||||||||
Federal
|
$
|
29,441
|
$
|
29,244
|
$
|
38,957
|
||||||
State
|
2,983
|
2,331
|
2,221
|
|||||||||
International
|
356
|
1,002
|
2,029
|
|||||||||
Total current
|
32,780
|
32,577
|
43,207
|
|||||||||
Deferred
|
||||||||||||
Federal
|
(6,045
|
)
|
9,979
|
(119
|
)
|
|||||||
State
|
(592
|
)
|
(272
|
)
|
(111
|
)
|
||||||
International
|
9,896
|
(5,587
|
)
|
1,323
|
||||||||
Total deferred
|
3,259
|
4,120
|
1,093
|
|||||||||
Total provision for income taxes
|
$
|
36,039
|
$
|
36,697
|
$
|
44,300
|
December 31,
|
||||||||
(in thousands)
|
2017
|
2016
|
||||||
Federal losses carryforward
|
$
|
1,603
|
$
|
4,130
|
||||
State losses carryforward
|
17,234
|
13,682
|
||||||
Research and development carryforward
|
3,534
|
3,647
|
||||||
Scientific research and experimental development credit carryforward
|
16,493
|
16,594
|
||||||
Stock compensation
|
5,344
|
8,389
|
||||||
Foreign deferrals
|
34,072
|
58,647
|
||||||
Inventory reserves
|
1,607
|
2,273
|
||||||
Other
|
3,889
|
5,569
|
||||||
Deferred tax asset
|
83,776
|
112,931
|
||||||
Fixed assets
|
(23,121
|
)
|
(30,728
|
)
|
||||
Intangible assets
|
(2,229
|
)
|
(5,882
|
)
|
||||
Other
|
(10,451
|
)
|
(16,047
|
)
|
||||
Deferred tax liability
|
(35,801
|
)
|
(52,657
|
)
|
||||
Valuation allowance
|
(45,141
|
)
|
(54,178
|
)
|
||||
Net deferred tax asset
|
$
|
2,834
|
$
|
6,096
|
Year ended December 31,
|
||||||||||||
(in thousands)
|
2017
|
2016
|
2015
|
|||||||||
US
|
$
|
80,690
|
$
|
63,330
|
$
|
117,385
|
||||||
International
|
37,943
|
35,891
|
18,331
|
|||||||||
Earnings before taxes on income
|
118,633
|
99,221
|
135,716
|
|||||||||
Federal tax at statutory rates
|
$
|
41,522
|
$
|
34,738
|
$
|
47,475
|
||||||
State taxes, net of federal benefit
|
1,274
|
529
|
852
|
|||||||||
Impact of foreign operations
|
(2,168
|
)
|
(9,937
|
)
|
(1,640
|
)
|
||||||
Change in valuation allowance
|
314
|
10,458
|
(950
|
)
|
||||||||
Tax credits
|
(1,918
|
)
|
(1,572
|
)
|
(2,088
|
)
|
||||||
Transition tax
|
13,585
|
-
|
-
|
|||||||||
Change in U.S. tax rate
|
(13,403
|
)
|
-
|
-
|
||||||||
Stock compensation
|
(3,978
|
)
|
-
|
-
|
||||||||
Other differences
|
(118
|
)
|
1,103
|
733
|
||||||||
Permanent differences
|
929
|
1,378
|
(82
|
)
|
||||||||
Provision for income taxes
|
$
|
36,039
|
$
|
36,697
|
$
|
44,300
|
(in thousands)
|
||||
Gross unrecognized tax benefits at December 31, 2014
|
$
|
1,248
|
||
Increases for tax positions for prior years
|
150
|
|||
Decreases for tax positions for prior years
|
-
|
|||
Increases for tax positions for current year
|
59
|
|||
Settlements
|
-
|
|||
Lapse of statute of limitations
|
-
|
|||
Gross unrecognized tax benefits at December 31, 2015
|
1,457
|
|||
Increases for tax positions for prior years
|
5
|
|||
Decreases for tax positions for prior years
|
-
|
|||
Increases for tax positions for current year
|
299
|
|||
Settlements
|
-
|
|||
Lapse of statute of limitations
|
-
|
|||
Gross unrecognized tax benefits at December 31, 2016
|
1,761
|
|||
Increases for tax positions for prior years
|
-
|
|||
Decreases for tax positions for prior years
|
-
|
|||
Increases for tax positions for current year
|
531
|
|||
Settlements
|
(318
|
)
|
||
Lapse of statute of limitations
|
-
|
|||
Gross unrecognized tax benefits at December 31, 2017
|
$
|
1,974
|
(in thousands)
|
||||
2017
|
$
|
1,626
|
||
2018
|
1,391
|
|||
2019
|
1,339
|
|||
2020
|
1,343
|
|||
2021
|
1,346
|
|||
2022 and beyond
|
3,685
|
|||
Total minimum lease payments
|
$
|
10,730
|
Years ended December 31,
|
||||||||||||
(in thousands, except share and per share data)
|
2017
|
2016
|
2015
|
|||||||||
Numerator:
|
||||||||||||
Net income from continuing operations
|
$
|
82,594
|
$
|
62,524
|
$
|
91,416
|
||||||
Interest expense, net of tax
|
2,606
|
3,255
|
3,019
|
|||||||||
Amortization of debt issuance costs, net of tax
|
681
|
781
|
868
|
|||||||||
Net income, adjusted from continuing operations
|
85,881
|
66,560
|
95,303
|
|||||||||
Net loss from discontinued operations
|
-
|
(10,748
|
)
|
(28,546
|
)
|
|||||||
Net income, adjusted
|
$
|
85,881
|
$
|
55,812
|
$
|
66,757
|
||||||
Denominator:
|
||||||||||||
Weighted-average number of shares-basic
|
41,816,431
|
40,184,159
|
38,595,435
|
|||||||||
Dilutive securities-equity awards
|
1,115,244
|
1,054,453
|
939,882
|
|||||||||
Dilutive securities-convertible debt
|
7,396,262
|
8,096,500
|
7,720,525
|
|||||||||
Weighted-average number of shares-diluted
|
50,327,937
|
49,335,112
|
47,255,842
|
|||||||||
Net income per share-basic from continuing operations
|
$
|
1.98
|
$
|
1.56
|
$
|
2.37
|
||||||
Net loss per share-basic from discontinued operations
|
-
|
(0.27
|
)
|
(0.74
|
)
|
|||||||
Net income per share-basic
|
$
|
1.98
|
$
|
1.29
|
$
|
1.63
|
||||||
Net income per share-diluted from continuing operations
|
$
|
1.71
|
$
|
1.35
|
$
|
2.02
|
||||||
Net loss per share-diluted from discontinued operations
|
-
|
(0.22
|
)
|
(0.61
|
)
|
|||||||
Net income per share-diluted
|
$
|
1.71
|
$
|
1.13
|
$
|
1.41
|
Incurred in
|
Inception
|
|||||||
(in thousands)
|
2017
|
To Date
|
||||||
Termination benefits
|
$
|
40
|
$
|
5,286
|
||||
Abandonment of equipment
|
-
|
3,749
|
||||||
Other costs
|
-
|
691
|
||||||
Total
|
$
|
40
|
$
|
9,726
|
Termination
|
||||
(in thousands)
|
Benefits
|
|||
Balance at December 31, 2016
|
$
|
4,357
|
||
Expenses incurred
|
40
|
|||
Amount paid
|
(4,387
|
)
|
||
Balance at December 31, 2017
|
$
|
10
|
Quarter Ended
|
||||||||||||||||
(in thousands, except per share data)
|
March 31,
|
June 30,
|
September 30,
|
December 31,
|
||||||||||||
2017:
|
||||||||||||||||
Revenue
|
$
|
116,858
|
$
|
100,772
|
$
|
149,434
|
$
|
193,809
|
||||||||
Income from operations
|
14,910
|
8,529
|
47,769
|
53,077
|
||||||||||||
Net income
|
10,485
|
4,616
|
33,551
|
33,942
|
||||||||||||
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
|
||||||||
2016:
|
||||||||||||||||
Revenue
|
$
|
102,964
|
$
|
91,241
|
$
|
142,914
|
$
|
151,663
|
||||||||
Income (loss) from operations
|
21,157
|
(2,042
|
)
|
35,478
|
50,929
|
|||||||||||
Net income (loss) from continuing operations
|
11,889
|
(2,042
|
)
|
20,388
|
32,289
|
|||||||||||
Net income (loss) from discontinued operations (1)
|
(7,898
|
)
|
(8,905
|
)
|
952
|
5,103
|
||||||||||
Net income (loss)
|
3,991
|
(10,947
|
)
|
21,340
|
37,392
|
|||||||||||
Net income (loss) per share from continuing operations-basic
|
$
|
0.30
|
$
|
(0.05
|
)
|
$
|
0.50
|
$
|
0.80
|
|||||||
Net income (loss) per share from discontinued operations-basic
|
(0.20
|
)
|
(0.22
|
)
|
0.02
|
0.13
|
||||||||||
Net income (loss) per share-basic
|
$
|
0.10
|
$
|
(0.27
|
)
|
$
|
0.52
|
$
|
0.93
|
|||||||
Net income (loss) per share from continuing operations-diluted
|
$
|
0.26
|
$
|
(0.05
|
)
|
$
|
0.43
|
$
|
0.67
|
|||||||
Net income (loss) per share from discontinued operations-diluted
|
(0.16
|
)
|
(0.22
|
)
|
0.02
|
0.10
|
||||||||||
Net income (loss) per share-diluted
|
$
|
0.10
|
$
|
(0.27
|
)
|
$
|
0.45
|
$
|
0.77
|
|||||||
(in thousands)
|
Beginning Balance
|
Charged to costs and expenses
|
Deductions
|
Ending Balance
|
||||||||||||
Year Ended December 31, 2017
|
||||||||||||||||
Inventory allowance
|
$
|
3,535
|
$
|
8,846
|
$
|
(8,532
|
)
|
$
|
3,849
|
|||||||
Prepaid expenses and other current assets allowance
|
4,868
|
466
|
-
|
5,334
|
||||||||||||
Year Ended December 31, 2016
|
||||||||||||||||
Inventory allowance
|
$
|
1,637
|
$
|
9,950
|
$
|
(8,052
|
)
|
$
|
3,535
|
|||||||
Prepaid expenses and other current assets allowance
|
1,981
|
2,887
|
-
|
4,868
|
||||||||||||
Year Ended December 31, 2015
|
||||||||||||||||
Inventory allowance
|
$
|
1,314
|
$
|
6,258
|
$
|
(5,935
|
)
|
$
|
1,637
|
|||||||
Prepaid expenses and other current assets allowance
|
1,885
|
96
|
-
|
1,981
|
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).
|
|
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
|
*
|
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).
|
10.3
|
*
|
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).
|
10.4
|
*
|
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).
|
10.5
|
*
|
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).
|
10.6
|
*
|
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).
|
10.7
|
*
|
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).
|
10.8
|
*
|
Form of Director Nonstatutory Stock Option Agreement
(incorporated by reference to Exhibit 10.5 to the Company's Annual Report on Form 10-K filed on March 8, 2013).
|
10.9
|
#*
|
|
10.10
|
*
|
Form of Non-Qualified Stock Option Agreement
(incorporated by reference to Exhibit 10.7 to the Company's Annual Report on Form 10-K filed on March 8, 2013).
|
10.11
|
#*
|
|
10.12
|
#*
|
Form of Restricted Stock Unit Award Agreement
– Canadian Participant.
|
10.13
|
*
|
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).
|
10.14
|
*
|
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).
|
10.15
|
*
|
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).
|
10.16
|
*
|
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).
|
10.17
|
*
|
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).
|
10.18
|
*
|
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).
|
10.19
|
*
|
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).
|
10.20
|
|
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).
|
10.21
|
†
|
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).
|
10.22
|
#
|
Modification No. 1
, effective January 27, 2017, to the CDC BioThrax Procurement Contract
|
10.23
|
#††
|
Modification No. 2
, effective February 23,2017, to the CDC BioThrax Procurement Contract
|
10.24
|
#
|
Modification No. 3
, effective March 22, 2017, to the CDC BioThrax Procurement Contract
|
10.25
|
#††
|
Modification No. 4
, effective April 5, 2017, to the CDC BioThrax Procurement Contract
|
10.26
|
†
|
Modification No. 5
, effective September 8, 2017, 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 November 3, 2017).
|
10.27
|
#††
|
Modification No. 6
, effective September 21, 2017, to the CDC BioThrax Procurement Contract
|
10.28
|
†
|
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).
|
10.29
|
†
|
Modification No. 1 to the BARDA NuThrax Contract
, effective March 16, 2017 (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).
|
10.30
|
†
|
Award/Contract
(the "BARDA BioThrax Contract"), effective March 16, 2017, between the BioMedical Advanced Research and Development Authority and Emergent Biodefense Operations Lansing LLC. (incorporated by reference to Exhibit 10.3 to the Company's Quarterly Report on Form 10-Q filed on May 5, 2017).
|
#
|
Ratio of Earnings to Fixed Charges.
|
|
#
|
Subsidiaries of the Company.
|
|
#
|
Consent of Independent Registered Public Accounting Firm.
|
|
#
|
Certification of the Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a).
|
|
#
|
Certification of the Chief Financial Officer pursuant to Exchange Act Rule 13a-14(a).
|
|
#
|
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.
|
|
#
|
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/ Daniel J. Abdun-Nabi
|
|
Daniel J. Abdun-Nabi
|
|
President and Chief Executive Officer
|
|
Date: February 22, 2018
|
Signature
|
Title
|
Date
|
|||
/s/Daniel J. Abdun-Nabi
Daniel J. Abdun-Nabi
|
President, Chief Executive Officer and Director
(Principal Executive Officer)
|
February 22, 2018
|
|||
/s/Robert G. Kramer, Sr
Robert G. Kramer, Sr
|
Executive Vice President, Chief Financial Officer and Treasurer
(Principal Financial and Accounting Officer)
|
February 22, 2018
|
|||
/s/Fuad El-Hibri
Fuad El-Hibri
|
Executive Chairman of the Board of Directors
|
February 22, 2018
|
|||
/s/Zsolt Harsanyi, Ph.D.
Zsolt Harsanyi, Ph.D.
|
Director
|
February 22, 2018
|
|||
/s/Kathryn Zoon, Ph.D.
|
|||||
Kathryn Zoon, Ph.D.
|
Director
|
February 22, 2018
|
|||
/s/Ronald B. Richard
Ronald B. Richard
|
Director
|
February 22, 2018
|
|||
/s/Louis W. Sullivan, M.D.
Louis W. Sullivan, M.D.
|
Director
|
February 22, 2018
|
|||
/s/Dr. Sue Bailey
Dr. Sue Bailey
|
Director
|
February 22, 2018
|
|||
/s/George Joulwan
George Joulwan
|
Director
|
February 22, 2018
|
|||
/s/Jerome Hauer, Ph.D.
Jerome Hauer, Ph.D.
|
Director
|
February 22, 2018
|
Date:
|
|
Participant:
|
|
Grant Date:
|
|
Number of RSUs:
|
|
EMERGENT BIOSOLUTIONS INC.
__________________________
Name:
Title:
|
PARTICIPANT
__________________________
Name:
|
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
|
1. CONTRACT ID CODE
|
PAGE
1 |
OF PAGES
2 |
|||||||
2. AMENDMENT/MODIFICATION NO.
00001 |
3.
EFFECTIVE DATE
01/27/2017 |
4. REQUISITION/PURCHASE NO.
0000HCGE-2017-07331 |
5. PROJECT NO.
(If applicable)
|
|||||||
6. ISSUED BY
CODE
|
2543
|
7. ADMINISTERED BY
(If other than Item 6)
CODE
|
2543
|
|||||||
Centers for Disease Control and Prevention
|
Centers for Disease Control and Prevention
|
|||||||||
Office of Acquisition Services (OAS)
|
Office of Acquisition Services (OAS)
|
|||||||||
2920 Brandywine Rd, RM 3000
|
2920 Brandywine Rd, RM 3000
|
|||||||||
Atlanta, GA 30341-5539
|
Atlanta, GA 30341-5539
|
|||||||||
8.
NAME AND ADDRESS OF CONTRACTOR
(No., Street, county, State and ZIP Code)
|
(√))
|
9A. AMENDMENT OF SOLICITATION NO.
|
||||||||
EMERGENT BIODEFENSE OPERATIONS LANSING LLC
|
||||||||||
3500 N MARTIN LUTHER KING JR BLVD
|
9B. DATED
(SEE ITEM 11)
|
|||||||||
LANSING, MI 48906-2933
|
10A. MODIFICATION OF CONTRACT/ORDER NO.
|
|||||||||
x
|
200-2017-92634
|
|||||||||
10B. DATED
(SEE ITEM 13)
|
||||||||||
CODE 026489018
|
FACILITY CODE
|
12/08/2016
|
||||||||
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
|
||||||||||
☐
The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers
☐
is extended,
☐
is not extended.
Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:
(a) By completing Items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or
(c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.
|
||||||||||
12. ACCOUNTING AND APPROPRIATION DATA
(If required)
See Section B |
||||||||||
13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,
IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. |
||||||||||
☒
|
A. THIS CHANGE ORDER IS ISSUED PURSUANT TO:
(Specify authority)
THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.
|
|||||||||
☒
|
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES
(such as changes in paying office, appropriation date, etc)
SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).
|
|||||||||
☐
|
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
|
|||||||||
☐
|
D. OTHER
(Specify type of modification and authority)
52.217-7 Option for Increased Quantity-Separately Priced Line Item. |
|||||||||
E. IMPORTANT: Contractor
☒
is not,
☐
is required to sign this document and return ________ copies to the issuing office.
|
||||||||||
14. DESCRIPTION OF AMENDMENT/MODIFICATION
(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
This modification Is issued to change the Contracting Officer's Representative from David Allen to Dikia Anderson
Contact information for Dikia Anderson is:
Phone: 770.488.2522
Email:
bmk7@cdc.gov
All other terms and conditions remain the same.
|
||||||||||
Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.
|
||||||||||
15A. NAME AND TITLE OF SIGNER
(Type or print)
|
16A. NAME AND TITLE OF CONTRACTING OFFICER
(Type or print)
Sherrie N Randall |
|||||||||
15B. CONTRACTOR/OFFEROR
(Signature of person authorized to sign)
|
15C. DATE SIGNED
|
16B. UNITED STATES OF AMERICA
By /s/Sherrie N Randall
(Signature of Contracting Officer)
|
16C. DATE SIGNED
01/27/2017
|
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
|
1. CONTRACT ID CODE
|
PAGE
1 |
OF PAGES
2 |
|||||||
2. AMENDMENT/MODIFICATION NO.
00002 |
3.
EFFECTIVE DATE
02/23/2017 |
4. REQUISITION/PURCHASE NO.
0000HCGE-2017-07902 |
5. PROJECT NO.
(If applicable)
|
|||||||
6. ISSUED BY
CODE
|
2543
|
7. ADMINISTERED BY
(If other than Item 6)
CODE
|
2543
|
|||||||
Centers for Disease Control and Prevention
|
Centers for Disease Control and Prevention
|
|||||||||
Office of Acquisition Services (OAS)
|
Office of Acquisition Services (OAS)
|
|||||||||
2920 Brandywine Rd, RM 3000
|
2920 Brandywine Rd, RM 3000
|
|||||||||
Atlanta, GA 30341-5539
|
Atlanta, GA 30341-5539
|
|||||||||
8.
NAME AND ADDRESS OF CONTRACTOR
(No., Street, county, State and ZIP Code)
|
√
|
9A. AMENDMENT OF SOLICITATION NO.
|
||||||||
EMERGENT BIODEFENSE OPERATIONS LANSING LLC
|
||||||||||
3500 N MARTIN LUTHER KING JR BLVD # 1
|
9B. DATED
(SEE ITEM 11)
|
|||||||||
LANSING, MI 48906-2933
|
||||||||||
10A. MODIFICATION OF CONTRACT/ORDER NO.
|
||||||||||
200-2017-92634
|
||||||||||
X
|
10B. DATED
(SEE ITEM 13)
|
|||||||||
CODE 026489018
|
FACILITY CODE
|
12/08/2016
|
||||||||
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
|
||||||||||
☐
The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers
☐
is extended,
☐
is not extended.
Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:
(a) By completing Items 8 and 15, and returning _____ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.
|
||||||||||
12. ACCOUNTING AND APPROPRIATION DATA
(If required)
See Section B |
||||||||||
13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,
IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. |
||||||||||
☒
|
A. THIS CHANGE ORDER IS ISSUED PURSUANT TO:
(Specify authority)
THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.
|
|||||||||
☐
|
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES
(such as changes in paying office, appropriation date, etc)
SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).
|
|||||||||
☐
|
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
|
|||||||||
☒
|
D. OTHER
(Specify type of modification and authority)
52.217-7 Option for Increased Quantity-Separately Priced Line Item. |
|||||||||
E. IMPORTANT: Contractor
☒
is not,
☐
is required to sign this document and return ________ copies to the issuing office.
|
||||||||||
14. DESCRIPTION OF AMENDMENT/MODIFICATION
(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
This modification is issued to:
1.
Exercise alternate SubCLIN 1003 from Optional CLIN 0001
2.
Increase and fund [**] doses on CLIN 1003 in the amount of $[**]
3.
Total fundng for this contract
has increased by $[**]
from
[**] to $[**]
All other terms and conditions remain the same . |
||||||||||
Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.
|
||||||||||
15A. NAME AND TITLE OF SIGNER
(Type or print)
|
16A. NAME AND TITLE OF CONTRACTING OFFICER
(Type or print)
Sherrie N Randall |
|||||||||
15B. CONTRACTOR/OFFEROR
(Signature of person authorized to sign)
|
15C. DATE SIGNED
|
16B. UNITED STATES OF AMERICA
By /s/ Sherrie N. Randall
(Signature of Contracting Officer)
|
16C. DATE SIGNED
2/23/2017
|
ITEM
|
SUPPLIES / SERVICES
|
QTY / UNIT
|
UNIT PRICE
|
NOT TO EXCEED
|
||||||||
0001
|
BioThrax [**] product
[**] upon date of delivery: [**] product at a unit price of $[**] estimated per the [**] unit price.
Delivery Address: Contractor's Facility
Delivery is estimated to occur by [**]
|
[**] Doses
|
$
|
[
|
**]
|
$
|
[
|
**]
|
ITEM
|
SUPPLIES / SERVICES
|
QTY / UNIT
|
UNIT PRICE
|
NOT TO EXCEED
|
||||||||
1003
|
BioThrax [**] product
[**] upon date of delivery: [**] product at a unit price of $[**] estimated per the [**] unit price.
Delivery Address: Contractor's Facility
Delivery is estimated to occur by [**]
|
[**] Doses
|
$
|
[
|
**]
|
$
|
[
|
**]
|
||||
Line(s) Of Accounting:
93907PY 2642 2017 75-X-0956 5664711101 $[**] 93907WF 2642 2017 75-X-0943 5664311101 $[**] 939ZWUX 2642 2017 75-X-0956 5664711101 $[**] |
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
|
1. CONTRACT ID CODE
|
PAGE
1 |
OF PAGES
2 |
|||||||
2. AMENDMENT/MODIFICATION NO.
00003 |
3.
EFFECTIVE DATE
03/22/2017 |
4. REQUISITION/PURCHASE NO.
0000HCGE-2017-09648 |
5. PROJECT NO.
(If applicable)
|
|||||||
6. ISSUED BY
CODE
|
2543
|
7. ADMINISTERED BY
(If other than Item 6)
CODE
|
2543
|
|||||||
Centers for Disease Control and Prevention
|
Centers for Disease Control and Prevention
|
|||||||||
Office of Acquisition Services (OAS)
|
Office of Acquisition Services (OAS)
|
|||||||||
2920 Brandywine Rd, RM 3000
|
2920 Brandywine Rd, RM 3000
|
|||||||||
Atlanta, GA 30341-5539
|
Atlanta, GA 30341-5539
|
|||||||||
8.
NAME AND ADDRESS OF CONTRACTOR
(No., Street, county, State and ZIP Code)
|
√)
|
9A. AMENDMENT OF SOLICITATION NO.
|
||||||||
EMERGENT BIODEFENSE OPERATIONS LANSING LLC
|
||||||||||
3500 N MARTIN LUTHER KING JR BLVD # 1
|
9B. DATED
(SEE ITEM 11)
|
|||||||||
LANSING, MI 48906-2933
|
10A. MODIFICATION OF CONTRACT/ORDER NO.
|
|||||||||
200-2017-92634
|
||||||||||
x
|
10B. DATED
(SEE ITEM 13)
|
|||||||||
CODE 026489018
|
FACILITY CODE
|
12/08/2016
|
||||||||
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
|
||||||||||
☐
The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers
☐
is extended,
☐
is not extended.
Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:
(a) By completing Items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or
(c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.
|
||||||||||
12. ACCOUNTING AND APPROPRIATION DATA
(If required)
N/A |
||||||||||
13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,
IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. |
||||||||||
☒
|
A. THIS CHANGE ORDER IS ISSUED PURSUANT TO:
(Specify authority)
THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.
|
|||||||||
☐
|
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES
(such as changes in paying office, appropriation date, etc)
SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).
|
|||||||||
☒
|
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
FAR 43.103 (a) Mutual Agreement of the Parties |
|||||||||
☒
|
D. OTHER
(Specify type of modification and authority)
FAR 52.232-23 Assignment of Claims (May 2014) |
|||||||||
E. IMPORTANT: Contractor
☐
is not,
☒
is required to sign this document and return ____
1
____ copies to the issuing office.
|
||||||||||
14. DESCRIPTION OF AMENDMENT/MODIFICATION
(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
See the Summary of Changes on Page 2.
|
||||||||||
Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.
|
||||||||||
15A. NAME AND TITLE OF SIGNER
(Type or print)
Robert G. Kramer / CFO |
16A. NAME AND TITLE OF CONTRACTING OFFICER
(Type or print)
Sherrie N. Randall |
|||||||||
15B. CONTRACTOR/OFFEROR
/s/ Robert G. Kramer
(Signature of person authorized to sign)
|
15C. DATE SIGNED
4/5/2015
|
16B. UNITED STATES OF AMERICA
BY /s/ Sherrie N. Randall
(Signature of Contracting Officer)
|
16C. DATE SIGNED
4/5/2017
|
Contract#
|
Date
|
Agency
|
Description
|
200-2017-92634, as amended
|
12/08/2016
|
Centers for Disease Control and Prevention, Office of Acquisition Services
2920 Brandywine Road Atlanta, GA 30341-5539
|
Manufacture and deliver BioThrax in accordance with the terms of the Contact and other services related thereto as more particularly described in the Contract
|
To: |
Sherrie N. Randall
Contracting Officer Centers for Disease Control and Prevention Office of Acquisition Services 2920 Brandywine Road Atlanta, GA 30341-5539 |
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
|
1. CONTRACT ID CODE
|
PAGE
1 |
OF PAGES
2 |
|||||||
2. AMENDMENT/MODIFICATION NO.
00004 |
3.
EFFECTIVE DATE
04/05/2017 |
4. REQUISITION/PURCHASE NO.
0000HCGE-2017-10684 |
5. PROJECT NO.
(If applicable)
|
|||||||
6. ISSUED BY
CODE
|
2543
|
7. ADMINISTERED BY
(If other than Item 6)
CODE
|
2543
|
|||||||
Centers for Disease Control and Prevention
|
Centers for Disease Control and Prevention
|
|||||||||
Office of Acquisition Services (OAS)
|
Office of Acquisition Services (OAS)
|
|||||||||
2920 Brandywine Rd, RM 3000
|
2920 Brandywine Rd, RM 3000
|
|||||||||
Atlanta, GA 30341-5539
|
Atlanta, GA 30341-5539
|
|||||||||
8.
NAME AND ADDRESS OF CONTRACTOR
(No., Street, county, State and ZIP Code)
|
(√)
|
9A. AMENDMENT OF SOLICITATION NO.
|
||||||||
EMERGENT BIODEFENSE OPERATIONS LANSING LLC
|
||||||||||
3500 N MARTIN LUTHER KING JR BLVD # 1
|
9B. DATED
(SEE ITEM 11)
|
|||||||||
LANSING, MI 48906-2933
|
||||||||||
10A. MODIFICATION OF CONTRACT/ORDER NO.
|
||||||||||
200-2017-92634
|
||||||||||
X
|
10B. DATED
(SEE ITEM 13)
|
|||||||||
CODE 026489018
|
FACILITY CODE
|
12/08/2016
|
||||||||
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
|
||||||||||
☐
The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers
☐
is extended,
☐
is not extended.
Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:
(a) By completing Items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or
(c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.
|
||||||||||
12. ACCOUNTING AND APPROPRIATION DATA
(If required)
See Section B |
||||||||||
13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,
IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. |
||||||||||
(√)
|
A. THIS CHANGE ORDER IS ISSUED PURSUANT TO:
(Specify authority)
THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.
|
|||||||||
☒
|
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES
(such as changes in paying office, appropriation date, etc)
SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).
|
|||||||||
☐
|
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
|
|||||||||
☐
|
D. OTHER
(Specify type of modification and authority)
|
|||||||||
E. IMPORTANT: Contractor
☒
is not,
☐
is required to sign this document and return ________ copies to the issuing office.
|
||||||||||
14. DESCRIPTION OF AMENDMENT/MODIFICATION
(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
|
||||||||||
Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.
|
||||||||||
15A. NAME AND TITLE OF SIGNER
(Type or print)
|
16A. NAME AND TITLE OF CONTRACTING OFFICER
(Type or print)
Sherrie N Randall |
|||||||||
15B. CONTRACTOR/OFFEROR
(Signature of person authorized to sign)
|
15C. DATE SIGNED
|
16B. UNITED STATES OF AMERICA
By /s/ Sherrie N. Randall
(Signature of Contracting Officer)
|
16C. DATE SIGNED
4/5/2017
|
ITEM
|
SUPPLIES / SERVICES
|
QTY / UNIT
|
UNIT PRICE
|
NOT TO EXCEED
|
||||||||
1003
|
BioThrax [**] product
[**] upon date of delivery: [**]
product at a unit price of $[**]
estimated per the [**] unit price.
Delivery Address: Contractor's Facility
Delivery is estimated to occur by
[**]
|
[**]
Doses |
$
|
[
|
**]
|
$
|
[
|
**]
|
||||
Line(s) Of Accounting:
93907PY 2642 2017 75-X-0956
5664711101 [**]
93907WF 2642 2017 75-X-0943
5664311101 [**]
939ZWUX 2642 2017 75-X-0956
5664711101 [**]
|
ITEM
|
SUPPLIES / SERVICES
|
QTY / UNIT
|
UNIT PRICE
|
EXTENDED PRICE
|
||||||||
0001
|
BioThrax [**] product
[**] upon date of delivery:
[**] product at a unit price of $[**] estimated per the [**] unit price.
Delivery Address: Contractor's Facility
This optional line has been fully exercised.
|
[**] Doses
|
$
|
[
|
**]
|
$
|
[
|
**]
|
||||
1006
|
BioThrax [**] product
[**] upon date of delivery:
[**] product at a unit price of $[**] estimated per the [**] unit price.
Delivery Address: Contractor's Facility
Delivery to be NLT than [**]
|
[**] Doses
|
$
|
[
|
**]
|
$
|
[
|
**]
|
||||
Line(s) Of Accounting:
93908JJ 2642 2017 75-17-0942
5623RF1101 $[**]
|
ITEM
|
SUPPLIES / SERVICES
|
QTY / UNIT
|
UNIT PRICE
|
EXTENDED PRICE
|
||||||||
0002
|
BioThrax [**] product
[**] upon date of delivery:
[**] product at a unit price of $[**]
Delivery Address: Contractor's Facility
Delivery to be [**] from the date of exercise of option.
|
[**] Doses
|
$
|
[
|
**]
|
$
|
[
|
**]
|
||||
2001
|
BioThrax [**] product
[**] upon date of delivery:
[**]
product at a unit price of $[**]
Delivery Address: Contractor's Facility
Delivery to be NLT [**]
|
[**] Doses
|
$
|
[
|
**]
|
$
|
[
|
**]
|
||||
Line(s) Of Accounting:
93908JJ 2642 2017
75-17-0943
5623RF1101 $[**]
939092K 2642 2017
75-17-0943
5623RF1101 $[**]
93909GJ 2642 2017
75-17-0943
5623RF1101 $[**]
939ZWUX 2642 2017 75-X-0956
5664711101 $[**]
|
ITEM
|
SUPPLIES / SERVICES
|
QTY / UNIT
|
UNIT PRICE
|
NOT TO EXCEED
|
||||||||
0003
|
BioThrax [**] product
[**] upon date of delivery:
[**]
product at a unit price of $[**]
Delivery Address: Contractor's Facility
Delivery to be [**] from the date of exercise of option.
|
[**] Doses
|
$
|
[
|
**]
|
$
|
[
|
**]
|
ITEM
|
SUPPLIES / SERVICES
|
QTY / UNIT
|
UNIT PRICE
|
NOT TO EXCEED
|
||||||||
0004
|
BioThrax [**] product
[**] upon date of delivery
[**]
product at a unit price of $[**]
Delivery Address: Contractor's Facility
Delivery to be [**] from the date of exercise of option.
|
[**] Doses
|
$
|
[
|
**]
|
$
|
[
|
**]
|
ITEM
|
SUPPLIES / SERVICES
|
QTY / UNIT
|
UNIT PRICE
|
NOT TO EXCEED
|
||||||||
0005
|
BioThrax [**] product
[**] upon date of delivery:
[**]
product at a unit price of $[**]
Delivery Address: Contractor's Facility
Delivery to be [**] from the date of exercise of option.
|
[**] Doses
|
$
|
[
|
**]
|
$
|
[
|
**]
|
Ratio of Earnings to Fixed Charges
|
||||||||||||||||||||
|
Year Ended December 31,
|
|||||||||||||||||||
(in thousands)
|
2017
|
2016
|
2015
|
2014
|
2013
|
|||||||||||||||
|
||||||||||||||||||||
Pretax income from continuing operations (1)
|
$
|
118,633
|
$
|
99,221
|
$
|
135,716
|
$
|
84,194
|
$
|
83,439
|
||||||||||
Fixed charges
|
||||||||||||||||||||
Interest expense
|
6,987
|
8,270
|
7,834
|
7,480
|
1,973
|
|||||||||||||||
Debt issuance cost
|
1,759
|
1,526
|
1,564
|
3,290
|
319
|
|||||||||||||||
Total fixed charges (2)
|
8,746
|
9,796
|
9,398
|
10,770
|
2,292
|
|||||||||||||||
Noncontrolling interest in pretax income (3)
|
-
|
-
|
-
|
-
|
876
|
|||||||||||||||
Capitalized interest (4)
|
2,156
|
2,179
|
2,875
|
2,530
|
1,973
|
|||||||||||||||
Earnings ((1) + (2) -(3) -(4))
|
125,223
|
106,838
|
142,239
|
92,434
|
82,882
|
|||||||||||||||
Fixed charges
|
8,746
|
9,796
|
9,398
|
10,770
|
2,292
|
|||||||||||||||
Ratio of earnings to fixed charges
|
14.3
|
10.9
|
15.1
|
8.6
|
36.2
|
Name of Subsidiary
|
Jurisdiction of Incorporation or Organization
|
Domestic
|
|
400 Professional LLC
|
Delaware
|
Cangene bioPharma, LLC
|
Maryland
|
Emergent Commercial Operations Frederick Inc.
|
Maryland
|
Emergent Biodefense Operations Lansing LLC
|
Delaware
|
Emergent Europe Inc.
|
Delaware
|
Emergent International Inc.
|
Delaware
|
Emergent Manufacturing Operations Baltimore LLC
|
Delaware
|
Emergent Product Development Gaithersburg Inc.
|
Delaware
|
Emergent Protective Products USA Inc.
|
Delaware
|
Emergent Virology LLC
|
Delaware
|
International
|
|
3579299 Manitoba Ltd.
|
Manitoba
|
Emergent BioSolutions Canada Inc. (f/k/a Cangene Corporation)
|
Ontario
|
Emergent BioSolutions Malaysia SDN. BHD.
|
Malaysia
|
Emergent Countermeasures International Ltd.
|
England
|
Emergent Global Health Foundation Limited
|
England
|
Emergent Product Development Germany GmbH
|
Germany
|
Emergent Product Development UK Limited
|
England
|
Emergent Sales and Marketing Australia Pty Limited
|
Australia
|
Emergent Sales and Marketing Germany GmbH
|
Germany
|
Emergent Sales and Marketing Singapore Pte. Ltd.
|
Singapore
|
EPIC Bio Pte. Limited
|
Singapore
|
(1)
|
Registration Statement (Form S-8 No. 333-139190) pertaining to the Employee Stock Option Plan, as amended and restated, the 2006 Stock Incentive Plan and individual director options agreements of Emergent BioSolutions Inc.,
|
(2)
|
Registration Statement (Form S-8 No. 333-161154) pertaining to the Amended and Restated 2006 Stock Incentive Plan of Emergent BioSolutions Inc.,
|
(3)
|
Registration Statement (Form S-4 No. 333-169351) of Emergent BioSolutions Inc. and Subsidiaries,
|
(4)
|
Registration Statement (Form S-3 No. 333-181133) of Emergent BioSolutions Inc. and Subsidiaries,
|
(5)
|
Registration Statement (Form S-8 No. 333-184699) pertaining to the 2012 Employee Stock Purchase Plan and the Second Amended and Restated Emergent BioSolutions Inc. 2006 Stock Incentive Plan,
|
(6)
|
Registration Statement (Form S-8 No. 333-196232) pertaining to the Third Amended and Restated Emergent BioSolutions Inc. 2006 Stock Incentive Plan,
|
(7)
|
Registration Statement (Form S-3 No. 333-204405) of Emergent BioSolutions Inc. and Subsidiaries, and
|
(8)
|
Registration Statement (Form S-8 No. 333-216294) pertaining to the Fourth Amended and Restated Emergent BioSolutions Inc. 2006 Stock Incentive Plan;
|