2015 ANNUAL REPORT
2015 ANNUAL REPORT
Emergent BioSolutions is a global specialty biopharmaceutical company seeking
to protect and enhance life by offering specialized products to healthcare providers
and governments to address medical needs and emerging public health threats.
Additional information may be found at www.emergentbiosolutions.com.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
(Mark One)
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2015
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission file number: 001-33137
EMERGENT BIOSOLUTIONS INC.
(Exact Name of Registrant as Specified in Its Charter)
Delaware
(State or Other Jurisdiction of Incorporation or Organization)
14-1902018
(IRS Employer Identification No.)
400 Professional Drive, Gaithersburg , Maryland
(Address of Principal Executive Offices)
20879
(Zip Code)
Registrant's Telephone Number, Including Area Code: (240) 631-3200
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class
Common stock, $0.001 par value per share
Series A junior participating preferred stock purchase rights
Securities registered pursuant to Section 12(g) of the Act: None
Name of Each Exchange on Which Registered
New York Stock Exchange
New York Stock Exchange
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of Securities Act. Yes No ☐
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes No
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90
days. Yes No
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and
post such files). Yes No
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of
registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company.
See definitions of "large accelerated filer," "accelerated filer," and "smaller reporting company" in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer Accelerated filer ☐ Non-accelerated filer Smaller reporting company
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No
The aggregate market value of voting and non-voting common equity held by non-affiliates of the registrant as of June 30, 2015 was approximately $1.0 billion based
on the price at which the registrant's common stock was last sold on that date as reported on the New York Stock Exchange.
As of February 19, 2016, the registrant had 39,474,295 shares of common stock outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrant's definitive proxy statement for its 2016 annual meeting of stockholders scheduled to be held on May 19, 2016, which is expected
to be filed with the Securities and Exchange Commission not later than 120 days after the end of the registrant's fiscal year ended December 31, 2015, are incorporated
by reference into Part III of this annual report on Form 10-K. With the exception of the portions of the registrant's definitive proxy statement for its 2016 annual
meeting of stockholders that are expressly incorporated by reference into this annual report on Form 10-K, such proxy statement shall not be deemed filed as part of this
annual report on Form 10-K.
EMERGENT BIOSOLUTIONS INC.
ANNUAL REPORT ON FORM 10-K
FOR THE FISCAL YEAR ENDED DECEMBER 31, 2015
INDEX
Business
Risk Factors
Unresolved Staff Comments
Properties
Legal Proceedings
Mine Safety Disclosures
Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Selected Financial Data
Management's Discussion and Analysis of Financial Condition and Results of Operations
Quantitative and Qualitative Disclosures About Market Risk
Financial Statements and Supplementary Data
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Controls and Procedures
Other Information
Directors, Executive Officers and Corporate Governance
Executive Compensation
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Certain Relationships and Related Transactions, and Director Independence
Principal Accountant Fees and Services
PART I
PART II
PART III
PART IV
Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4.
Item 5.
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
Item 10.
Item 11.
Item 12.
Item 13.
Item 14.
Item 15.
Exhibits and Financial Statement Schedules
Signatures
Exhibit Index
Page No.
4
18
33
33
34
34
34
36
37
53
53
80
80
82
82
82
82
82
83
83
84
85
BioThrax® (Anthrax Vaccine Adsorbed), RSDL® (Reactive Skin Decontamination Lotion Kit), BAT™ [Botulism Antitoxin Heptavalent
(A,B,C,D,E,F,G)-(Equine)], Anthrasil™ (Anthrax Immune Globulin Intravenous [human]), HepaGam B® [Hepatitis B Immune Globulin
Intravenous (Human)], VARIZIG® [Varicella Zoster Immune Globulin (Human)], WinRho® SDF [Rh0 (D) Immune Globulin Intravenous
(Human)], NuThrax™ (anthrax vaccine adsorbed with CPG 7909 adjuvant), PreviThrax™ (recombinant protective antigen anthrax vaccine,
purified), VIGIV [Vaccinia Immune Globulin Intravenous (Human)], IXINITY® (coagulation factor IX (recombinant)), Emergard™ and any and all
Emergent BioSolutions Inc. brands, products, services and feature names, logos and slogans are trademarks or registered trademarks of Emergent
BioSolutions Inc. or its subsidiaries in the United States or other countries. All other brands, products, services and feature names or trademarks are
the property of their respective owners.
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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This annual report on Form 10-K and the documents we incorporate by reference include forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including statements regarding the
planned spin-off of our Biosciences business, the timing of any such spin-off, the future earnings and performance of Emergent or any of its
businesses, including the Biodefense and Biosciences businesses on a stand-alone basis if the spin-off is completed, our strategy, future operations,
future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. We
generally identify forward-looking statements by using words like "believes," "expects," "anticipates," "intends," "plans," "forecasts," "estimates" and
similar expressions in conjunction with, among other things, discussions of financial performance or financial condition, growth strategy, product
sales, manufacturing capabilities, product development, regulatory approvals or expenditures. These forward-looking statements are based on our
current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. You
should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially
from our expectations. You are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement
speaks only as of the date on which such statement is made, and, except as required by law, we do not undertake to update any forward-looking
statement to reflect new information, events or circumstances.
There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-
looking statements, including, among others:
appropriations for the procurement of BioThrax® (Anthrax Vaccine Adsorbed), our FDA-licensed anthrax vaccine;
our ability to perform under our contracts with the U.S. government related to BioThrax, including the timing of deliveries;
our ability to obtain new BioThrax sales contracts or modifications to existing contracts;
the availability of funding for our U.S. government grants and contracts;
our ability to successfully execute our growth strategy and achieve our financial and operational goals;
whether the planned spin-off of our Biosciences business is completed, as expected or at all, and the timing of any such spin-off;
whether the conditions to the spin-off can be satisfied;
whether the operational, marketing and strategic benefits of the spin-off can be achieved;
whether the costs and expenses of the spin-off can be controlled within expectations;
our ability to successfully integrate and develop the products or product candidates, programs, operations and personnel of any entities
or businesses that we acquire;
our ability to perform under our contract with the U.S. government to develop and obtain regulatory approval for the manufacturing of
BioThrax in Building 55, our large-scale vaccine manufacturing facility in Lansing, Michigan;
our ability to identify and acquire companies or in-license products or late-stage product candidates that satisfy our selection criteria;
our ability to realize synergies and benefits from acquisitions or in-licenses within expected time periods or at all;
our ability to selectively enter into and maintain collaboration arrangements;
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;
our ability to achieve milestones in our out-licensed and collaboration contracts;
our ability to obtain and maintain intellectual property protection for our products and product candidates;
our ability and plans to expand our manufacturing facilities and capabilities;
our ability and the ability of our contractors and suppliers to maintain compliance with current good manufacturing practices and other
regulatory obligations;
the results of regulatory inspections;
our ability to meet operating and financial restrictions placed on us and our subsidiaries under our senior secured credit facility;
the rate and degree of market acceptance and clinical utility of our products;
the success of our ongoing and planned development programs, non-clinical activities and clinical trials of our product candidates;
the timing of and our ability to obtain and maintain regulatory approvals for our product candidates;
the success of our commercialization, marketing and manufacturing capabilities and strategy; and
the accuracy of our estimates regarding future revenues, expenses, capital requirements and needs for additional financing.
The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-
looking statement. New factors emerge from time to time and it is not possible for management to predict all such factors, nor can it assess the
impact of any such factor on the business or the extent to which any factor, or combination of factors, may cause results to differ materially from
those contained in any forward-looking statement. You should consider this cautionary statement, the risk factors identified in the section entitled
"Risk Factors" in this annual report on Form 10-K and the risk factors identified in our periodic reports filed with the Securities and Exchange
Commission when evaluating our forward-looking statements.
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PART I
ITEM 1. BUSINESS
OVERVIEW
Emergent BioSolutions Inc. is a global specialty biopharmaceutical company seeking to protect and enhance life by offering specialized
products to healthcare providers and governments to address medical needs and emerging public health threats.
We were incorporated in the State of Michigan in May 1998 and subsequently reorganized as a Delaware corporation in June 2004. Our
common stock is traded on the New York Stock Exchange under the ticker symbol "EBS." Our principal executive offices are located at 400
is
Professional Drive, Gaithersburg, Maryland 20879. Our
www.emergentbiosolutions.com.
(240) 631-3200, and our website address
telephone number
is
We have two operating divisions: Biodefense and Biosciences. For financial reporting purposes, we report two business segments that
correspond to these two divisions.
Biodefense
Our Biodefense division is a specialty biopharmaceutical business focused on countermeasures that address public health threats,
specifically Chemical, Biological, Radiological, Nuclear and Explosives, or CBRNE, threats as well as emerging infectious diseases, or EID. The
U.S. government is the primary purchaser of our Biodefense products and often provides us with substantial funding for the development of our
Biodefense product candidates. Our Biodefense portfolio consists of five revenue-generating products and various investigational stage product
candidates.
Our Biodefense division marketed products are:
BioThrax® (Anthrax Vaccine Adsorbed), the only vaccine licensed by the U.S. Food and Drug Administration, or the FDA, for the
general use prophylaxis and post-exposure prophylaxis of anthrax disease;
Anthrasil™ (Anthrax Immune Globulin Intravenous (Human)), the only polyclonal antibody therapeutic licensed by the FDA for the
treatment of inhalational anthrax;
BAT™ (Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-Equine), the only heptavalent therapeutic licensed by the FDA for the
treatment of botulinum disease;
VIGIV (Vaccinia Immune Globulin Intravenous (Human)), the only therapeutic licensed by the FDA to address adverse events from
smallpox vaccination; and
RSDL® (Reactive Skin Decontamination Lotion Kit), the only device cleared by the FDA for the removal or neutralization of chemical
agents, T-2 toxin and many pesticide-related chemicals from the skin.
Our Biodefense division investigational stage product candidates are:
NuThrax™ (anthrax vaccine adsorbed with CPG 7909 adjuvant), a next generation anthrax vaccine;
UV-4B, a novel antiviral being developed for dengue and influenza infections;
GC-072, the lead compound in the EV-035 series of broad spectrum antibiotics, being developed forBurkholderia pseudomallei;
VAX161C, a recombinant pandemic influenza vaccine candidate being developed by VaxInnate, Inc. and for which we have an
exclusive license agreement to manufacture and sell in the event of a surge order from the Biomedical Advanced Research and
Development Authority, or BARDA;
PreviThrax™ (recombinant protective antigen anthrax vaccine, purified), a next generation anthrax vaccine; and
Other Biodefense product candidates focused on public health threats and emerging infectious diseases.
A unique component of our Biodefense division investigational stage product portfolio is that all candidates are under an active
development contract with significant funding from the U.S. government. This allows our development pipeline, along with our marketed products,
to be aligned with the strategic priorities of our U.S. and allied foreign government customers.
Our Biodefense division also has programs that leverage our proven manufacturing infrastructure and expertise. We have responded to
specific Task Order Requests issued by BARDA for the development and manufacture of specific countermeasures as part of our Center for
Innovation in Advanced Development and Manufacturing, or CIADM, program focused on imminent public health threats, including pandemic
influenza and Ebola.
Our Biodefense division also includes multiple platform technologies, including the MVAtorTM (modified vaccinia virus Ankara vector)
platform technology and Emergard™, a military-grade auto-injector device designed for intramuscular self-injection of antidotes and other
emergency response medical treatments that can address exposure to certain chemical agents and other similar emerging threats.
Operations that support this division include manufacturing, regulatory affairs, quality assurance, quality control, international sales and
marketing, and government affairs in support of our marketed products, as well as product development and manufacturing infrastructure in support
of our investigational stage product candidates.
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Biosciences
Our Biosciences division is a specialty biopharmaceutical business focused on therapeutics primarily in hematology/oncology with
secondary areas of focus in transplantation, infectious disease and autoimmunity. Our Biosciences portfolio consists of four revenue-generating
products, all of which were acquired through our acquisition of Cangene Corporation in February 2014, as well as various investigational stage
product candidates and a contract manufacturing services business.
Our Biosciences division marketed products are:
IXINITY® [coagulation factor IX (recombinant)], approved by the FDA for the prevention of bleeding episodes in people with hemophilia
B;
WinRho® SDF [Rho(D) Immune Globulin Intravenous (Human)], for treatment of autoimmune platelet disorder, also called immune
thrombocytopenic purpura, or ITP, and, separately, for the treatment of hemolytic disease of the newborn, or HDN;
HepaGam B® [Hepatitis B Immune Globulin Intravenous (Human)], for post-exposure prophylactic treatment of hepatitis-B; and
VARIZIG® [Varicella Zoster Immune Globulin (Human)], for post-exposure prophylactic treatment of varicella zoster virus, which causes
chickenpox and shingles.
Our Biosciences division investigational stage product candidates include:
otlertuzumab, a protein therapeutic being developed for Chronic Lymphocytic Leukemia, or CLL;
ES414, now known as MOR209/ES414, an immunotherapeutic protein being developed for metastatic castration-resistant prostate cancer
under our collaboration with MorphoSys AG entered into in August 2014;
ES210, a protein therapeutic being developed for inflammation-related indications;
5E3, a monoclonal antibody therapeutic being developed for Alzheimer's disease; and
Other Biosciences protein therapeutic product candidates primarily targeting immuno-oncology.
In addition, our Biosciences division includes our ADAPTIRTM (modular protein technology) platform and our hyperimmune specialty
plasma product manufacturing platform.
Operations that support this division include manufacturing, quality, regulatory affairs, medical affairs, and sales and marketing in support
of our marketed products, as well as additional product development capabilities in support of our investigational stage product candidates.
For information regarding revenue, profit and loss, total assets and other information concerning our results of operations for both
reporting segments for each of the last three fiscal years, please refer to our consolidated financial statements and the accompanying notes to the
consolidated financial statements in Part II, Item 8 of this Annual Report on Form 10-K and "Management's Discussion and Analysis of Financial
Condition and Results of Operations" in Part II, Item 7 of this Annual Report on Form 10-K.
STRATEGY
In January 2016, we announced a new five-year (2016-2020) growth plan, following the completion of our previous three-year (2012-2015)
growth plan. This new growth plan presents our strategic, operational and financial goals to be achieved by the end of 2020 and is centered on our
renewed focus on medical countermeasures addressing a broad spectrum of public health threats. This growth plan outlines how we intend to drive
and accelerate our continued growth through 2020. It is built on a strategy that focuses on (1) expanding our leadership position in the public health
threats market; (2) developing innovative products based on our platforms and with a focus on third-party funding; (3) continuing to grow through
acquisition of revenue-generating and accretive products and businesses; and, (4) continuing to deliver attractive net income growth. In executing on
the growth plan, we are leveraging our core competencies; specifically, government relations and contracting; medical countermeasure development;
quality manufacturing; business and product acquisitions; and, financial discipline. Successful execution of the growth plan will culminate in our
having achieved specific corporate revenue, product development and profitability goals by the end of 2020.
PLANNED SPIN-OFF OF BIOSCIENCES BUSINESS
In August 2015, we announced our plan to pursue a tax-free spin-off of our Biosciences business into a separate, stand-alone publicly
traded company. The spin-off is expected to create two independent public companies with distinct strategic plans, growth strategies, and operational
and development priorities. The new Biosciences company, Aptevo Therapeutics Inc., or Aptevo, will focus on providing novel oncology and
hematology therapeutics to meaningfully improve patients' lives.
The proposed spin-off recognizes that our two operating divisions have evolved into distinct business and investment opportunities. As a
result of the spin-off, Emergent and Aptevo will each become a pure play company with a focused strategy thereby enabling each company to target
investors attracted to its business profile. We will be in a better position to accelerate our growth strategy while Aptevo will be in a position to more
directly invest in novel therapeutics in the highly attractive immuno-oncology field. We expect the spin-off to enhance business focus, better align
resources to achieve strategic priorities, and unlock significant value for both companies.
Aptevo will consist of certain assets currently in our Biosciences division, including commercial products and development programs, and
the ADAPTIR platform technology. Emergent will retain the Biodefense marketed products and development programs, platform technologies,
including the hyperimmune specialty plasma product manufacturing platform, and manufacturing infrastructure, including the contract fill/finish
business. We expect to provide Aptevo with a fixed cash contribution of approximately $60 million. We anticipate that additional sources of funding
to support Aptevo's R&D investment will include commercial product sales and partnership funding.
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Following the spin-off, we will be a global specialty life sciences company focused on providing specialty products for civilian and
military populations that address intentional and naturally emerging public health threats. We will be better positioned to establish ourselves as a pure
play company, recognized as a leader in the public health threats and emerging infectious diseases fields; enhance our financial returns and operating
margins through the elimination of Biosciences related R&D, sales, marketing and G&A costs; and, exercise greater flexibility in our capital
allocation decisions.
Agreements with Pharma Consult and Nemera Development
RECENT ACQUISITIONS AND COLLABORATIONS
In August 2015, we announced the signing of an exclusive worldwide license agreement with Pharma Consult Ges.m.b.H of Austria to
acquire rights to a military-grade auto-injector device, which we are further developing and have branded as Emergard. We also executed a global
manufacturing and supply agreement for Emergard with Nemera Development S.A. We plan to supply cGMP-compliant product through global sales
channels that we currently use to sell our other Biodefense products. Emergard is marketed internationally. It is not approved by the FDA and is not
currently marketed in the U.S., although we intend to pursue FDA approval of products using the device.
In February 2016, we announced that Emergard was selected by the U.S. Department of Defense, or DoD, and Battelle Memorial Institute
to be tested against and developed to U.S. military specifications as a platform for nerve agent antidote delivery. Development and testing of
Emergard is expected to be completed in 2016 and, if successful, could lead to Emergard's future procurement for U.S. military and emergency
responder use. The testing and development of Emergard will be performed under a subcontract with Battelle, which in turn has a prime contract with
the DoD.
Acquisition of Unither Virology LLC
In December 2015, we acquired Unither Virology LLC (UV), a glyco-biology focused drug discovery subsidiary of United Therapeutics
Corporation. Subsequent to the acquisition, UV was re-named Emergent Virology LLC. Emergent Virology's primary asset is the UVX series of
glyco-biologic molecules. The lead molecule within the series, UV-4B, is being developed as a potential oral treatment for dengue and influenza
infections. UV-4B is being developed under a five-year, cost plus fixed fee contract with the National Institute of Allergy and Infectious Diseases, or
NIAID, that was awarded in 2011 with an aggregate value of up to $45 million, of which $28 million has been obligated through the execution of
five out of eight options.
Collaboration with MorphoSys AG to develop MOR209/ES414
In August 2014, we entered into an agreement with MorphoSys AG to co-develop and commercialize our novel oncology
immunotherapeutic protein, MOR 209/ES414, targeting prostate cancer. In December 2015, after a joint review of data from the ongoing Phase 1
dose escalation study of MOR209/ES414 in prostate cancer patients, Emergent and MorphoSys decided to adjust the dosing regimen and
administration of MOR209/ES414. We plan to continue the current clinical trial under an amended protocol with recruitment to start around mid-
2016. As a result of the required dosing regimen and administration change and the impact to overall development timeline and technical risk, the co-
development agreement with MorphoSys was re-structured. Under the terms of the re-structured agreement, MorphoSys' cost sharing in the years
2016 to 2018 was reduced and future milestone payments payable by MorphoSys to Emergent were reduced to a total of up to $74 million. Other
financial terms and the split of the commercial rights remain unchanged.
MARKETED PRODUCT PORTFOLIO
Product
BIODEFENSE
Indication(s)
BioThrax® (Anthrax Vaccine Adsorbed) GUP - General use prophylaxis of anthrax disease; and
PEP - Post-exposure prophylaxis of anthrax disease
Anthrasil (Anthrax Immune Globulin
Intravenous (Human))
BAT™ [(Botulism Antitoxin
Heptavalent (A,B,C,D,E,F,G)-(Equine)]
VIGIV (Vaccinia Immune Globulin
Intravenous (Human)
RSDL® (Reactive Skin Decontamination
Lotion Kit)
Treatment of toxemia associated with inhalational anthrax
Treatment of suspected or documented exposure to botulinum
neurotoxin A, B, C, D, E, F or G
Treatment of complications due to vaccinia vaccination
Removal or neutralization of chemical warfare agents, T-2 toxin
and many pesticide-related chemicals from the skin
Regulatory Approvals
United States – GUP & PEP
Germany - GUP
Singapore - GUP
United States
United States
United States
Canada
United States 510(k)
United Kingdom
Australia
Canada
6
Product
IXINITY [coagulation factor IX
(recombinant)]
WinRho® SDF [(Rho(D) Immune
Globulin Intravenous (Human)]
HepaGam B® [Hepatitis B Immune
Globulin Intravenous (Human)]
BIOSCIENCES
Indication(s)
Control and prevention of bleeding episodes and for perioperative
management in adults and children, ≥12 years of age, with
Hemophilia B.
ITP – immune thrombocytopenic purpura
HDN – hemolytic disease of the newborn
Preventing Rho(D) immunization in Rho(D)(-) women [1]
Treating Rho(D)(-) patients after transfusions with incompatible
Rho(D)(+) blood or erythrocyte products [2]
Post-exposure prophylaxis for hepatitis B
Prevention of hepatitis B recurrence following liver transplantation
in patients who are positive for hepatitis B surface antigen
VARIZIG® [Varicella Zoster Immune
Globulin (Human)]
Post-exposure prophylaxis for varicella (chickenpox) in high-risk
patient groups, including immunocompromised children, newborns
and pregnant women [1]
Prevention and reduction of severity in maternal infections within
four days of exposure to Varicella zoster virus [2]
Regulatory Approvals
United States
Canada – ITP, HDN
United States – ITP, HDN
Portugal – [1] and [2]
United States
Canada
Israel
Kuwait
Turkey
United States – [1]
Canada – [2]
BIODEFENSE DIVISION
Our Biodefense division is a specialty biopharmaceutical business focused on countermeasures that address public health threats and
emerging infectious diseases. Our Biodefense portfolio consists of marketed products and investigational stage product candidates.
Marketed Products
BioThrax® (Anthrax Vaccine Adsorbed). BioThrax is the only vaccine licensed by the FDA for the general use prophylaxis, or GUP, of
anthrax disease. In November 2015, the FDA approved our supplemental Biologics License Application to expand the BioThrax label to include the
post-exposure prophylaxis, or PEP, indication for BioThrax administered in combination with antimicrobial therapy. Anthrax is a potentially fatal
disease caused by the spore forming bacterium, Bacillus anthracis. Inhalational anthrax is the most lethal form of anthrax. Death due to inhalational
anthrax infection often occurs within 24-36 hours of the onset of advanced respiratory complications. BioThrax is administered in a GUP setting by
intramuscular injection in a three-dose primary series over an initial six-month period. The vaccine is protective after completion of this three-dose
primary series. After the primary series, two additional doses are given at 12 and 18 months, with booster doses annually thereafter. BioThrax is
administered in a PEP setting in conjunction with recommended antibacterial drugs following suspected or confirmed Bacillus anthracis exposure.
The vaccination schedule for PEP consists of three doses of BioThrax administered subcutaneously at 0, 2, and 4 weeks post-exposure combined
with antimicrobial therapy. Our current contract with the Centers for Disease Control and Prevention, or CDC, an agency within the U.S. Department
of Health and Human Services, or HHS, specifies that we supply up to 44.75 million doses of BioThrax into the Strategic National Stockpile, or SNS,
over a five-year period ending in September 2016. The maximum amount that could be paid to us under this current contract is approximately $1.25
billion, subject to availability of funding to the CDC. As of December 31, 2015, $1.1 billion in funding has been committed, of which approximately
$1.0 billion has been delivered under the contract, which represents approximately 37 million doses. To date, the principal customer for BioThrax has
been the U.S. government, specifically HHS (including CDC).
We are continuing to identify and pursue opportunities to expand the market for BioThrax to include allied foreign governments, non-
governmental organizations and multinational companies (including transportation, critical infrastructure services and security companies), as well as
health care providers (including hospitals and clinics). In April 2014, the FDA granted Orphan Drug designation to BioThrax for the PEP indication.
Anthrasil™ (Anthrax Immune Globulin Intravenous (Human)). Anthrasil is the only polyclonal antibody therapeutic licensed by the
FDA for the treatment of inhalational anthrax. To date, the principal customer for Anthrasil has been the U.S. government, specifically HHS.
Anthrasil is procured by BARDA for delivery to the SNS. Our current contract with BARDA is a multiple award, indefinite delivery/indefinite
quantity contract, which also includes a development component. The contract also provides for the collection of Anthrasil specialty plasma, as well
as the manufacture of such plasma into bulk drug substance, the further manufacture of bulk drug substance into finished product and delivery of
finished product into the SNS over a four-year period through September 2017. The maximum amount that could be paid to us under this contract is
approximately $264 million, subject to availability of funding. We have recently completed collections of human anti-anthrax plasma and continue
the storage of this plasma under a task order.
BAT®™ [Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-Equine)]. BAT is the only heptavalent therapeutic licensed by the FDA for
botulinum disease. BAT is comprised of purified polyclonal equine immune globulins (antibodies) directed to the seven toxins (A through G)
produced by Clostridium botulinum. BAT was approved in the United States in March 2013 for the treatment of suspected or documented exposure
to botulinum neurotoxin A, B, C, D, E, F or G. Simultaneous with FDA approval, BAT also received Orphan Drug designation, giving it seven years
of market exclusivity in the United States until March 2020. BAT is the only botulism antitoxin available in the United States for treating naturally
occurring non-infant botulism. It can be administered to patients to treat naturally occurring non-infant botulism, as well as under emergency
conditions. Botulinum toxin is a nerve toxin produced by the bacterium Clostridium botulinum that causes botulism, a serious paralytic illness.
Naturally occurring cases are mainly seen in infants or in adults who have consumed improperly processed foods. Botulinum toxin can also be used
as a bioterrorist weapon and has been identified in the United States as one of the highest priority bioterrorism threats. To date, the principal
customer for BAT has been the U.S. government, specifically HHS. We are currently delivering under a $431 million contract with BARDA, which
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calls for delivery of up to 200,000 doses of BAT into the SNS, subject to availability of funding. In addition to domestic government sales, BAT has
been sold to several foreign governments.
VIGIV [Vaccinia Immune Globulin Intravenous (Human)]. VIGIV is the only therapeutic licensed by the FDA to address adverse events
from smallpox vaccination. VIGIV is comprised of purified polyclonal human immune globulins (antibodies) directed to vaccinia virus, the virus that
is used in the smallpox vaccine. Vaccinia is not the virus that causes smallpox, but it is similar enough to elicit a protective immune response when
used as a smallpox vaccine. Individuals who are susceptible to vaccinia may develop an infection from the smallpox vaccination. These patients
benefit from treatment with VIGIV. VIGIV is a therapeutic approved in the United States and in Canada for counteracting certain complications that
can be associated with the smallpox vaccine. To date, the principal customer for VIGIV has been the U.S. government, specifically the supply of
VIGIV to the Strategic National Stockpile under a CDC contract. Our contract with CDC includes the performance of work required to maintain
FDA licensure, to collect plasma, and manufacturing. In August 2015, the CDC exercised options valued at $44 million. This contract modification
increased the total contract value to approximately $80 million.
RSDL® (Reactive Skin Decontamination Lotion Kit). RSDL is the only medical device cleared by the FDA to remove or neutralize
chemical warfare agents, including nerve agents, mustard gas and T-2 toxin (a myco toxin capable of being weaponized) and organophosphate based
pesticides from the skin. RSDL has been cleared as a medical device by the FDA and Health Canada, has a current European Conformity (CE) mark
under European Directives, and is licensed as a Therapeutic Good by Australia's Therapeutics Goods Administration. To date, the principal
customers for RSDL have been agencies of the U.S. government, including the DoD, the Department of State and the National Guard. Our current
contract with the DoD is a five-year indefinite delivery/indefinite quantity contract, including option years, that expires in June 2017. The maximum
amount that could be paid to us under this contract is approximately $243 million, subject to availability of funding to DoD. In addition to domestic
government sales, we have also made sales into 35 foreign countries since launch. Our current strategy is to expand the market for RSDL by
expanding its uses and indications, which may include treatment of toxic industrial chemicals and removal of radioactive metal exposure. In February
2014, we expanded the indication for use against organophosphate-based pesticides.
Product Candidates
NuThrax™ (anthrax vaccine adsorbed with CPG 7909 adjuvant). We are developing NuThrax, an anthrax vaccine product candidate
based on BioThrax combined with CPG 7909, an adjuvant that we license from Pfizer Inc., in part with funding from NIAID. We are developing
NuThrax to potentially elicit a more rapid onset of immune response using fewer doses than BioThrax while still providing protective immunity in
patients. In September 2010, we obtained additional funding for this product candidate through a four-year development contract with NIAID of up
to $28.7 million to support further development, including: manufacturing and stability studies of Phase 2 clinical trial lots, process characterization,
assay validation and clinical trial preparation. Using funds from the 2010 contract, in October 2014, we completed a Phase 2 safety, immunogenicity
and dose ranging clinical trial of NuThrax in which all endpoints were successfully met, including that it may require fewer vaccine doses and
shorten the recommended antibiotic (60-day) regimen for anthrax post-exposure prophylaxis. NuThrax is now positioned for a Phase 3 clinical trial.
We continue to seek additional government funding for NuThrax to advance it toward FDA approval. In September 2014, we also obtained
additional funding for this product through a five-year development contract with NIAID of up to $29 million to support the development of a dry
formulation of NuThrax, including: manufacturing, assay development and non-clinical activities through the preparation of an Investigational New
Drug application to the FDA. The dry formulation of NuThrax is intended to increase stability of the vaccine candidate at ambient and higher
temperatures, with the objective of eliminating the need for cold chain during shipping and storage. In March 2015, we signed a contract with
BARDA valued at $31 million to develop NuThrax for post-exposure prophylaxis of anthrax disease.
UV-4B. We are developing UV-4B, a novel antiviral targeting host alpha-glucosidases as a potential oral treatment for dengue and
influenza infections. This work is being conducted under a five-year cost plus fixed fee contract with NIAID that was awarded in 2011 with an
aggregate value of up to $45 million, of which $28 million has been obligated through the execution of five out of eight options. These options
include a base period and options supporting non-clinical influenza testing, reprotoxicity studies, manufacturing, and Phase 1 a/b and Phase 2a trials.
Completed work to date has included successful production of GMP material, a successful Phase 1a trial in which UV-4B demonstrated good safety
and tolerability in humans, and studies which demonstrated UV-4B has worked against influenza in non-clinical proof of concept models. UV-4B is
part of a broader iminosugar small molecule series, which includes hundreds of novel compounds. We are currently using medicinal chemistry work
to explore other novel uses for these analogues as part of our broader drug discovery program.
GC-072. We are developing GC-072, a novel bacterial type II topoisomerase inhibitor, belonging to the chemical class of 4-oxoquinolizine
as a potential oral and IV treatment for B. pseudomallei under a three-year, $15 million contract with the Defense Threat Reduction Agency, or
DTRA. GC-072 has demonstrated protection in vivo from lethal B. pseudomallei infection when administered orally, and it shows activity not only
on drug-sensitive strains, but also on those resistant to marketed antibiotics (including quinolones). EV-035 molecules have also demonstrated broad-
spectrum activity against pathogens such as S. aureus, S. pneumoniae, E. faecalis, E. coli, P. aeruginosa, A. baumannii and H. influenzae, as well as
several potential biodefense pathogens such as B. pseudomallei, B. anthracis, F. Tularensis, and Y. pestis.
VAX161C. In 2012, we entered into an exclusive license agreement with VaxInnate, Inc. to manufacture and sell VAX161C, a clinical
stage recombinant pandemic influenza vaccine product candidate that is being developed by VaxInnate in part with funding from BARDA.
VAX161C is an E. coli-expressed fusion protein product that fuses segments of the hemagluttin (HA) protein from influenza to a bacterial protein
and has been shown to induce a durable immune response to the particular HA protein, thus imparting protection. VAX161C is expressed at
relatively high levels and, based on preclinical data, requires relatively small amounts of protein to be efficacious.
PreviThrax™ (recombinant protective antigen anthrax vaccine, purified). We are developing PreviThrax, a recombinant protective
antigen anthrax vaccine product candidate, in part with funding from BARDA. PreviThrax contains purified recombinant protective antigen, or rPA,
and is formulated to induce antibodies that neutralize anthrax toxins in a manner similar to BioThrax. In response to a request from BARDA, we have
identified CPG 7909 as a potential adjuvant for this product candidate and are currently finalizing a thermostable formulation to progress towards
initiating a Phase 1 study.
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Our Biodefense division also has programs aimed at providing solutions to the Ebola outbreak, including an MVA-Ebola vaccine
candidate, anti-Ebola monoclonal antibody product candidates and an Ebola hyperimmune product candidate. In March 2015, under several
agreements with the University of Oxford, GlaxoSmithKline plc, and NIAID, we manufactured an MVA-Ebola vaccine candidate, MVA EBOZ, for
use in a Phase 1 clinical study in Senegal and in the UK to evaluate the safety of the vaccine as a heterologous boost to GSK's Chimp Adenovirus
type 3 (ChAd3) Ebola vaccine candidate. In July 2015, we were awarded a BARDA contract valued at $19.7 million to develop and manufacture
cGMP lots of three Ebola monoclonal antibodies. This contract is the first BARDA Task Order for an Ebola countermeasure awarded to Emergent
under the CIADM program.
Research and Development
Our Biodefense division is engaged in research and development and has incurred substantial expenses for these activities. These expenses
generally include the cost of acquiring or inventing new technologies and products, as well as development work on new product candidates.
However, to offset these expenditures, we receive significant development funding through U.S. government contracts and grants, specifically from
HHS. Gross research and development expenses for the Biodefense division for the years ended December 31, 2015, 2014 and 2013 totaled
approximately $111.7 million, $82.0 million and $62.7 million, respectively. Net research and development expenses (net of contracts, grants and
collaborations revenue) for the Biodefense division for the year ended December 31, 2013 totaled approximately $9.0 million. For the years ended
December 31, 2015 and 2014, contracts, grants and collaborations revenue exceeded research and development expenses by $5.7 million and $10.4
million, respectively. See Part II, Item 7 "Management's Discussion and Analysis of Financial Condition and Results of Operations – Research and
Development Expense" for additional information regarding expenditures related to material research and development activities.
Marketing & Sales
We market and sell our Biodefense products to the U.S. government and domestic non-government organizations with a small, specialized
marketing and sales group. Many of the personnel within this specialized marketing and sales group are retired military service or Department of
Justice personnel, with extensive experience in the public and private sector dealing with counterterrorism and CBRNE and EID threat agent
preparedness. We intend to use a similar approach to the marketing and sales of our other Biodefense product candidates that we successfully
develop or acquire.
We have established a marketing and sales capability targeting sales of Biodefense products to allied foreign governments as well as non-
governmental organizations. We have augmented our international efforts by engaging third-party marketing distributors and representatives to
identify potential opportunities to sell our products in key international markets including Europe, the Middle East, Asia and the Pacific Rim. We
anticipate engaging additional representatives as interest in countermeasures for CBRNE threats and EIDs increases.
Competition
Our products and product candidates intended for the treatment or prevention of CBRNE threat agents and EIDs face significant
competition for government funding for both development and procurement. Our products and any product or product candidate that we acquire or
successfully develop and commercialize are likely to compete with currently marketed products that are in development for the same indications.
Specifically, the competition for our products and product candidates includes the following:
BioThrax. Although BioThrax is the only vaccine licensed by the FDA for the prevention of anthrax disease, we face potential future
competition for the supply of anthrax vaccines to the U.S. government. Various agencies of the U.S. government are providing funding to us
and to our competitors for the development of alternative next generation anthrax vaccines. In addition, the United Kingdom Public Health
England manufactures an anthrax vaccine for use by the United Kingdom government. Other countries may also have anthrax vaccines in
development for their own internal use.
Anthrasil. Although Anthrasil is the only polyclonal antibody therapeutic licensed by the FDA for the treatment of toxemia resulting from
inhalational anthrax, GlaxoSmithKline plc has obtained FDA licensure for ABthrax™ (raxibacumab), an anthrax monoclonal antibody
therapeutic. Elusys Therapeutics, Inc. is developing Anthim®™, an anthrax monoclonal antibody therapeutic candidate.
BAT. Our botulinum immune globulin product is the only heptavalent therapeutic licensed by the FDA for the treatment of botulinum
disease. Other companies may be in stages of developing therapies aimed at treating or preventing botulism infections, however, direct
competition is currently limited.
VIGIV. Our VIGIV is the only therapeutic licensed by the FDA to address adverse events from smallpox vaccination. Other companies may
be in stages of developing therapies aimed at treating or preventing vaccinia infections; however, direct competition is currently limited.
SIGA Technologies, Inc. is developing Arestvyr™ an oral therapy that could potentially be used as a treatment for smallpox or vaccinia
infections. SIGA is continuing clinical trials for Arestvyr.
RSDL. In the United States, RSDL is the only FDA-cleared chemical warfare agent decontamination device for use on the skin.
Internationally, various Ministries of Defense have used Fullers Earth, Dutch Powder and French Powder to absorb liquid chemical weapons.
NuThrax and PreviThrax. PharmAthene, Inc., PaxVax Inc., Vaxin Inc., Pfenex Inc., Soligenix, Inc., Immunovaccine Inc., and NanoBio
Corporation are each currently developing anthrax vaccine product candidates with funding provided by NIAID and BARDA.
GC-072. Basilea Pharmaceutica Ltd., The Medicines Company, Rempex Pharmaceuticals, Inc., Cempra, Inc., Tetraphase Pharmaceuticals,
Inc., Achaogen, Inc., GlaxoSmithKline plc and others are each currently developing broad spectrum antibiotic product candidates with
funding provided by DTRA, NIAID and BARDA.
VAX161C Pandemic Flu Vaccine. FluBlok® (Protein Sciences Corporation), Pandemrix™ (GlaxoSmithKline plc), Emerflu® (Sanofi Pasteur
Inc.) are licensed vaccines. Nanotherapeutics Inc., CSL Behring, and other companies are developing pandemic influenza vaccines that are
not dependent on egg-based manufacturing.
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Customer Reliance
Historically within our Biodefense division, we have derived substantially all of our product revenues from sales to the U.S. government,
specifically HHS and DoD. We expect that this will continue for the foreseeable future. In 2015, Biodefense division product revenues were $328.9
million, consisting of $317.3 million from sales to the U.S. government and $11.6 million from international and other domestic customers. In 2014,
Biodefense division product revenues were $281.8 million, consisting of $270.5 million from sales to the U.S. government and $11.3 million from
international and other domestic customers. In 2013, Biodefense division product revenues were $257.9 million, consisting of $254.0 million from
sales to the U.S. government and $3.9 million from international and other domestic customers. We are focused on increasing sales of our Biodefense
products to the U.S. government, expanding the market for these products through growth in sales to international and other domestic customers and
pursuing ongoing product enhancements.
A second significant source of revenue within our Biodefense division is our contracts, grants and collaborations revenue, which represents
development funding primarily from the U.S. government, specifically HHS for our Biodefense investigational product candidates. We expect that
this will continue to be a significant source of revenue for the foreseeable future. Contracts, grants and collaborations revenue was $117.4 million in
2015, $88.8 million in 2014 and $54.6 million in 2013. These revenues substantially offset our costs in developing Biodefense investigational
product candidates. We are focused on continuing to secure additional development funding for our Biodefense investigational product candidates.
BIOSCIENCES DIVISION
Our Biosciences division is a specialty biopharmaceutical business focused on therapeutics primarily in hematology/oncology with
secondary areas of focus in transplantation, infectious disease and autoimmunity. Our Biosciences portfolio consists of marketed products,
investigational stage product candidates and contract manufacturing services.
Marketed Products
IXINITY® [coagulation factor IX (recombinant)]. IXINITY is an intravenous recombinant human coagulation factor IX therapeutic that
was approved by the FDA in April 2015 for the prevention of bleeding episodes in people with hemophilia B. Hemophilia B, also known as
Christmas disease, is a rare, inherited bleeding disorder. The blood of hemophilia B patients has an impaired clotting ability, which results from its
substantially reduced or missing factor IX activity. People with hemophilia B require factor IX injections to restore normal blood coagulation and to
prevent frequent bleeding that could otherwise result in pain, irreversible joint damage or life-threatening hemorrhages. Prophylaxis or on-demand
treatment in hemophilia B typically requires multiple injections of factor IX (current therapies are either plasma-derived or recombinant products) to
maintain adequate levels of clotting factor in the blood.
WinRho® SDF [Rho(D) Immune Globulin Intravenous (Human)]. WinRho SDF is comprised of purified polyclonal human immune
globulins (antibodies) directed to Rho(D)(+) red blood cells. As antibodies that are directed to the Rho(D) antigen on these red blood cells, WinRho
SDF can generally be referred to as an anti-D product. WinRho SDF is approved in the United States and Canada to treat an autoimmune platelet
disorder called immune thrombocytopenic purpura, or ITP, a disease in which platelets are destroyed by a patient's own immune system. Because
platelets are required for blood clotting, this disorder can result in uncontrolled bleeding, either spontaneously or as a result of even minor trauma.
According to a study published in 2010 in the American Journal of Hematology, U.S. incidence rates of ITP are about 3.3 cases per 100,000 people
per year in adults and up to 6.4 cases per 100,000 people per year in children. WinRho SDF is also approved in the United States and Canada to
prevent hemolytic disease of the newborn, or HDN. HDN results from an Rho(D)(-) female giving birth to an Rho(D)(+) child.
HepaGam B® [Hepatitis B Immune Globulin Intravenous (Human)]. HepaGam B is a comprised of purified polyclonal human immune
globulins (antibodies) that are directed to the hepatitis B surface antigen. In the United States, HepaGam B has been approved for two indications: for
the prevention of Hepatitis B reinfection after liver transplantation and for use as a post-exposure prophylaxis (i.e., treatment following exposure to
the hepatitis B virus). Hepatitis B is a chronic infection and a major global health concern. HepaGam B is the first hepatitis B immune globulin
product to be licensed in the United States. for the liver transplant-related indication. HepaGam B is licensed to us from Apotex Corporation. We
have ongoing royalty payment obligations to Apotex based on net sales of HepaGam B until June 2016. HepaGam B is also approved for both the
post-exposure prophylaxis of hepatitis B and the post-liver transplantation indication in Canada, Israel, Kuwait and Turkey.
VARIZIG® [Varicella Zoster Immune Globulin (Human)]. VARIZIG is comprised of purified polyclonal human immune globulins
(antibodies) directed to the Varicella zoster virus, the disease agent that causes chickenpox and shingles. While most North American adults have
developed immunity to chickenpox, certain at-risk patient populations may be susceptible to infection. VARIZIG is approved in the United States for
post-exposure prophylaxis of varicella (chickenpox) in high-risk patient groups, including immunocompromised children, newborns and pregnant
women. VARIZIG has orphan drug exclusivity in the United States through December 2019. In Canada, VARIZIG is approved for the prevention
and reduction of severity in maternal infections within four days of exposure to Varicella zoster virus.
Product Candidates
Our Biosciences portfolio also includes investigational product candidates, including:
otlertuzumab. otlertuzumab (formerly known as TRU-016) is a humanized anti-CD37 ADAPTIR mono-specific protein therapeutic
intended for the treatment of Chronic Lymphocytic Leukemia, or CLL. CLL is a type of cancer that affects the blood and bone marrow and is caused
by B-cells within the blood and bone marrow that abnormally proliferate and die. We believe that otlertuzumab's novel properties may provide
patients with improved therapeutic options and enhanced efficacy when used in combination with chemotherapy or other targeted therapeutics. We
completed a Phase 2 study evaluating the combination of otlertuzumab and bendamustine (a chemotherapy agent) versus bendamustine alone in
people with relapsed CLL (Study 16201). We amended our Phase 1b single-arm, open-label study evaluating the safety and efficacy of otlertuzumab
in combination with rituximab, an anti-CD-20 directed biologic, to include evaluating otlertuzumab in combination with obinutuzumab in people
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with previously untreated CLL (Study 16009). Study 16009 was further amended to add a cohort to evaluate otlertuzumab in combination with
rituximab and idelalisib. Patients began enrolling in this arm of the study mid-2015. The preliminary data showed that the combination was active
and well tolerated. We continue to evaluate opportunities for this product candidate in CLL.
MOR209/ES414. MOR209/ES414 is a targeted immunotherapeutic protein under development for metastatic castration-resistant prostate
cancer. MOR209/ES414, a bispecific protein constructed using our ADAPTIR platform technology, activates host T-cell immunity specifically
against cells expressing Prostate Specific Membrane Antigen, or PSMA, an antigen commonly overexpressed on prostate cancer cells.
MOR209/ES414 selectively binds to the T cell receptor on cytotoxic T cells and PSMA on tumor cells. MOR209/ES414 contains two pairs of
binding domains, each targeting a unique antigen, linked to opposite ends of an immunoglobulin Fc domain to extend the half-life and enable use of a
purification process typical of Ig-based molecules. In preclinical studies, MOR209/ES414 has been shown to redirect T-cell cytotoxicity towards
prostate cancer cells expressing PSMA. According to the American Cancer Society, prostate cancer is the most common cancer in men in the United
States. Screening, radiation, surgery and hormone ablation therapy have greatly improved the detection and treatment of early stage prostate cancer.
However, the new therapies only improve life expectancy by a few months for patients with metastatic castration-resistant prostate cancer.
ES210. ES210 is a targeted cytokine therapeutic under development for ulcerative colitis. The ES210 molecule was engineered using our
ADAPTIR platform technology to deliver a safer form of the immunosuppressive cytokine IL-10 to CD86-expressing antigen presenting cells.
ES210 contains NIL-10, coupled to binding sites specific for CD86, linked by an immunoglobulin Fc domain to extend the half-life and enable use of
a purification process typical of Ig-based molecules. The mechanism of action of ES210 results in the suppression of T-cell responses, through
inhibition of antigen presentation. ES210 displays potent in vitro and in vivo blockade of T-cell proliferation in human mixed lymphocyte reactions
and in a humanized graft-versus-host disease model. Antigen presenting cells play a central role in the generation and regulation of immunity;
therefore, inhibiting their function represents a therapeutic opportunity to suppress immunopathological processes in autoimmune disease. This
ADAPTIR molecule has potential applications in the treatment of transplant rejection as well as autoimmune and inflammatory diseases such as
Crohn's disease, ulcerative colitis, and rheumatoid arthritis.
5E3. 5E3 is a humanized anti-amyloid beta oligomer monoclonal antibody, or mAb, under development for the treatment of Alzheimer's
disease. 5E3 selectively binds the toxic oligomeric form of amyloid beta through targeting a unique conformational epitope that is not present on the
monomer or plaque forms. This selective profile of binding has been demonstrated in pre-clinical studies and linked to slowing progress of
neurodegeneration. Currently, no disease modifying therapies are available to treat this disease. According to the Alzheimer's Association, this
disease affects approximately 5.3 million Americans and is anticipated to grow to 7.1 million by 2025. The 5E3 mAb and the cSNK epitope, on
which preliminary data as a vaccine candidate are available, are also being evaluated in the development of diagnostics under research grants from
Brain Canada and the Canadian Institutes of Research, or CIHR.
Research and Development
Our Biosciences division is engaged in research and development and has incurred substantial expenses for these activities. These expenses
generally include the cost of acquiring or inventing new technologies and products, as well as development work on new product candidates. We
pursue partnerships with various third parties to offset these expenditures. Gross research and development expenses for the Biosciences division for
the years ended December 31, 2015, 2014 and 2013 totaled approximately $37.8 million, $60.8 million and $50.7 million, respectively. Net research
and development expenses (net of contracts and grants revenue and net loss attributable to noncontrolling interests) for the Biosciences division for
the years ended December 31, 2015, 2014 and 2013 totaled approximately $32.3 million, $42.3 million and $48.6 million, respectively. See Part II,
Item 7 "Management's Discussion and Analysis of Financial Condition and Results of Operations – Research and Development Expense" for
additional information regarding expenditures related to material research and development activities.
Contract Manufacturing Services
Within our Biosciences division, we provide contract manufacturing services to third-party customers. The majority of these services are
performed at our facility located in Baltimore, Maryland. At this facility we perform pharmaceutical product development and filling services for
injectable and other sterile products, as well as process design, technical transfer, manufacturing validations, laboratory support, aseptic filling,
lyophilization, final packaging and accelerated and ongoing stability studies. We manufacture both vial and pre-filled syringe formats for a wide
variety of drug products — small molecule and biological — in all stages of development and commercialization, including 20 licensed products,
which are currently sold in more than 40 countries. This facility produces finished units of clinical and commercial drugs for a variety of customers
ranging from small biopharmaceutical companies to major multinationals. The facility is an approved manufacturing facility under the regulatory
regimes in the United States, Canada, Japan, Brazil, the Middle East and several countries in the European Union.
Distribution
Our products are sold in the United States by our commercial sales force and distributed to end-users through major U.S. distributors and
wholesalers, including Cardinal Health, Inc., McKesson Corporation, AmerisourceBergen Corporation and other specialty distributors. In Canada, all
of our commercial products are exclusively distributed by Canadian Blood Services and Héma-Québec. Outside of North America, our commercial
products are distributed primarily through third-party distributors.
Marketing & Sales
We have specialty biopharmaceutical commercial operations and medical affairs teams with experience in sales, marketing, distribution,
reimbursement and medical support.
The commercial operations team includes a U.S.-based field sales force that focuses its selling efforts on hospitals, hematology clinics,
medical oncology clinics, transplant centers and public and private hospitals. This team is also responsible for managing day-to-day relationships
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with third parties, including managed care organizations, pharmacy benefit managers, group purchasing organizations, wholesalers, specialty
distributors and specialty pharmacies. Outside the United States, our products are sold through a network of regional independent distributors. The
commercial operations team also includes a marketing team with experience in building pharmaceutical, biological and device brands across all
stages of the product life cycle. Reimbursement support, patient assistance/compassionate use and non-medical customer inquiries are handled by
customer service personnel within our commercial operations team.
Our medical affairs team includes field-based medical science liaisons, who respond to customer requests for information, establish and
maintain company relationships with researchers and clinicians, train our product specialists and sales personnel and interface with clinical trial
investigators. Our medical affairs team also supports customers by providing medical information, drug safety and pharmacovigilance services.
Competition
Our Biosciences products, product candidates, and CMO services face significant competition. Any product or product candidate that we
acquire or successfully develop and commercialize is likely to compete with currently marketed products, as well as other novel product candidates
that are in development for the same indications. Specifically, the competition with respect to our products, product candidates, and CMO services
includes the following:
IXINITY. Currently, five competitive products are marketed in North America: Rixubis (Baxter International Inc.), Benefix (Pfizer Inc.)
and Alprolix (Biogen Idec Inc.) recombinant FIX products as well as AlphaNine (Grifols USA, LLC) and MonoNine (CSL Behring, a
subsidiary of CSL Limited), which are FIX preparations derived from human plasma. We expect that Novo Nordisk Inc. and CSL Behring
will also launch additional long acting recombinant factor IX agents in the future.
WinRho SDF. In the United States, the use of WinRho SDF is primarily for the ITP indication. In the U.S. ITP market, WinRho SDF
competes with Rhophlac® (CSL Behring, a subsidiary of CSL Limited), Nplate® (Amgen Inc.) and Promacta® (GlaxoSmithKline plc). In
Canada, the use of WinRho SDF is primarily for the HDN indication. WinRho SDF is the only anti-D product available for the prevention
of HDN and treatment of ITP in Canada.
HepaGam B. Two competitive products are marketed in North America: Nabi-HB® (Biotest Pharmaceuticals Corporation) and HyperHEP
B® S/D (Grifols USA, LLC). Nabi-HB® and HyperHEP B® S/D are both licensed to treat acute exposure to blood containing hepatitis B
surface antigen and administered via intramuscular injection. HepaGam B is currently the only intravenous hepatitis B immune globulin
licensed for the liver transplantation indication in the United States and Canada.
VARIZIG. No other currently manufactured competitive product is licensed in the North American markets.
otlertuzumab. If approved for CLL, we anticipate that otlertuzumab would compete with, or be combined with, other B-cell depleting
therapies, targeted therapies and chemotherapeutics, including: Rituxan® (Genentech, Inc., a member of the Roche Group), Treanda®
(Cephalon, a subsidiary of Teva Pharmaceutical Industries Ltd.), Arzerra® (GlaxoSmithKline plc and Genmab A/S), Imbruvica™
(Pharmacyclics, Inc. and Johnson and Johnson), Gayzva™ (Genentech USA, Inc., a member of the Roche Group) and Zydelig® (Gilead
Sciences, Inc.). In addition, Boehringer Ingelheim GmbH and ImmunoGen, Inc. are in early stage development for monoclonal antibodies
directed to CD37. AbbVie Inc. is developing ABT-199, a B-cell lymphoma 2 inhibitor, for treatment of CLL in collaboration with
Genentech, Inc.
MOR209/ES414. If approved, we anticipate that MOR209/ES414 would compete with Taxotere (Sanofi), Jevtana (Sanofi), Zytiga
(Janssen), Xtandi (Astellas), Xofigo (Bayer/Algeta), Provenge (Dendreon) and potentially other products currently under development.
ES210. If approved, we anticipate that ES210 would compete with products indicated for inflammatory bowel diseases such as ulcerative
colitis, including: HUMIRA® (Abbvie Inc.), Remicade® (Janssen Pharmaceuticals, Inc. of Johnson and Johnson) and Entyvio (Takeda
Pharmaceuticals U.S.A., Inc., a subsidiary of Takeda Pharmaceutical Company Limited). Depending on what ES210 is approved for, we
anticipate that it could also compete with products indicated for Moderate to Severe Crohns Disease, including: Stelara (Janssen
Pharmaceuticals, Inc. of Johnson and Johnson) and Xeljanz (Pfizer Inc.).
5E3. The U.S. has only approved 5 drugs for Alzheimer's disease that temporarily improve symptoms (cholinesterase inhibitors: Aricept®,
Exelon®, Razadyne® and Cognex® and an N-methyl D-aspartate (NMDA) receptor antagonist, Namenda®); however, none of the
treatments available today alters the underlying course of this terminal disease. To date, there are no approved therapeutics for the
treatment of Alzheimer's disease, but monoclonal antibodies have figured prominently in addressing this unmet clinical need. Amongst the
candidates are Ponezumab (Pfizer, discontinued at PII), Bapineuzumab (Janssen/Pfizer, discontinued), Solanezumab (Eli Lilly, PIII),
Crenezumab (Genentech, PII), BAN2401 (Biogen, Eisai Co., PII) and more recently Aducanumab (Biogen, PIII). What differentiates the
5E3 monoclonal antibody is the selectivity against a conformational epitope targeting neurotoxic amyloid beta oligomers, but not soluble
monomers, fibrils or insoluble plaque. Acumen Pharmaceuticals is developing an amyloid-beta oligomer specific antibody, ACU-193, and
claims to be about approximately one year from IND filing, but further development appears to be dependent upon partnering or financing.
Contract Manufacturing Services Business. We compete for contract service business with several 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. Although many of
these competitors do not offer the same range of services that we do, they can and do compete effectively against certain areas of our
business, including our biopharmaceutical production capabilities. We also compete with in-house research, development and support
service departments of other biopharmaceutical companies.
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Biodefense Division
MANUFACTURING
We have a manufacturing facility, Building 12, focused on bacterial fermentation located at our 12.5 acre, multi-building campus in
Lansing, Michigan. We currently manufacture BioThrax at the 100-liter scale in Building 12. To expand our existing BioThrax manufacturing
capabilities, we have constructed adjacent to Building 12 a large-scale, multi-product facility, or Building 55, capable of producing BioThrax at the
1320-liter scale. In July 2010, we entered into a multi-year development contract with BARDA that provides up to $104 million of funding to
support the work needed to approve the manufacturing of BioThrax in Building 55. We continue to pursue FDA approval for BioThrax at this larger
production scale. In February 2015, we completed the in-life phase of a pivotal nonclinical efficacy study designed to demonstrate that BioThrax
manufactured at large scale in Building 55, is comparable to the BioThrax currently manufactured in Building 12. Analysis of data shows that the
primary endpoints were met. Data from this study will be used to support an expected mid-2016 submission of an sBLA to the FDA for Building 55
licensure, which we anticipate by year end 2016. Building 12 produces 8 to 10 million doses of BioThrax annually. Building 55 has the potential to
increase manufacturing capacity to an estimated 20 to 25 million doses annually, on a single manufacturing train.
We also have a manufacturing facility focused on disposable manufacturing for viral and non-viral products located in Baltimore,
Maryland. This facility has been designed to take advantage of single-use bioreactor technology and is capable of manufacturing several different
products, including products derived from cell culture or microbial systems. In June 2012, we entered into a contract with BARDA, which
established this facility as a Center for Innovation in Advanced Development and Manufacturing, or CIADM. The CIADM contract with BARDA
provides us with funding for manufacturing and development activities relating to VAX161C. We envision this facility supporting future CIADM
development and manufacturing activities for chemical, biological, radiological, nuclear and explosive threat countermeasures, as well as our current
and future non-CIADM product development and manufacturing needs. In July 2015, we were awarded a BARDA contract valued at $19.7 million to
develop and manufacture cGMP lots of three Ebola monoclonal antibodies in Chinese hamster ovary, or CHO, cell lines at a 2000 Liter scale. Under
the two-year contract, we will conduct process development, analytical method development, execute small-scale production runs, and perform
cGMP cell banking leading to cGMP manufacture of bulk drug substance under the CIADM program.
We also currently lease a packaging facility at The University of Southern Mississippi's Accelerator, a technology innovation and
commercialization center. This facility is equipped to package RSDL. A significant portion of the doses of RSDL that we sell to domestic customers
can be packaged at this facility. In August 2013, we entered into a three-year Contract Manufacturing Organization, or CMO, agreement with Bracco
Diagnostics Inc., and its wholly-owned subsidiary, E-Z-EM Canada Inc. (dba Therapex), to manufacture bulk quantities of RSDL's active ingredient
and to package RSDL units. RSDL's active ingredient and other raw materials are shipped to and subsequently finished and packaged at our
Mississippi facility.
Biosciences Division
We own facilities with manufacturing and other capabilities located in Winnipeg, Manitoba, Canada. These facilities include space for
plasma-derived hyperimmune therapeutics manufacturing, chromatography-based plasma fractionation, bacterial fermentation, downstream
processing capability, aseptic filling, packaging and warehousing, quality assurance and control, development laboratories and office space. At these
facilities, we manufacture our hyperimmune specialty plasma products, including for our Biosciences division, WinRho SDF, HepaGam B and
VARIZIG, and for our Biodefense division Anthrasil, BAT and VIGIV.
We also own a manufacturing facility focused on contract manufacturing services located in Baltimore, Maryland. This site provides
pharmaceutical product development and filling services for injectable and other sterile products, as well as process design, technical transfer,
manufacturing validations, laboratory support, aseptic filling, lyophilization, final packaging and accelerated and ongoing stability studies. This
facility is an approved manufacturing facility under the regulatory regimes in the United States, Canada, Japan, Brazil, the Middle East and several
countries in the European Union. The facility includes warehousing space used for cold-storage and freezer capacity to support our Biosciences
product distribution activities within the United States. This facility and its capabilities may be utilized in the future to fill and finish our development
and commercial stage products, for which we currently rely on third-party fill/finish providers.
Neither of these facilities will be included with the assets that are contributed to Aptevo in the planned spin-off of our Biosciences
business.
Supplies and Raw Materials
We currently rely on contract manufacturers and other third parties to manufacture some of the supplies we require for pre-clinical studies
and clinical trials, as well as supplies and raw materials used in the production of our products. Typically we acquire these supplies and raw materials
on a purchase order basis and, when possible, in quantities we believe adequate to meet our needs. With respect to Alhydrogel® adjuvant 2%, used to
manufacture BioThrax and NuThrax, from a single-source supplier for which we have no alternative source of supply. However, we maintain stored
supplies of this adjuvant sufficient to meet our expected manufacturing needs for these products. We also utilize a single-source supplier for the
following other raw materials for our other product: the sponge applicator device and the active ingredient used to make RSDL and limited-source
suppliers for various types of hyperimmune specialty plasmas used to manufacture our hyperimmune specialty plasma products, such as BAT,
Anthrasil, VIGIV, WinRho SDF, HepaGam B and VARIZIG.
INTELLECTUAL PROPERTY
We actively seek to protect the intellectual property that arises from our activities. It is our policy to respect the intellectual property rights
of others. In general and where possible, we pursue worldwide patent protection for new and innovative processes and products that we develop. The
term of protection for various patents associated with and expected to be associated with our marketed products and product candidates extend for
varying periods of time depending on the date of filing of the patent application or the date of patent issuance and the legal term of patents in the
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countries in which they are obtained. The protection afforded by a patent varies on a product-by-product basis and country-to-country basis and
depends upon many factors, including the type of patent, the scope of its coverage, the availability of regulatory-related extensions, the availability of
legal remedies in a particular country and the validity and enforceability of the patents. In some cases, we may decide that the best way to protect the
intellectual property is to retain proprietary information as trade secrets and confidential information rather than to apply for patents, which would
involve disclosure of proprietary information to the public. In other cases, we may be required to rely on trade secret protection on the basis that the
subject matter is either not patentable or unlikely to be granted broad or useful claims. We take a number of measures to protect our trade secrets and
confidential information, including entering into confidentiality agreements with employees and third parties. In general and where possible, we also
pursue registered trademarks for our product candidates and marketed products. We are a party to a number of license agreements under which we
license patents, patent applications and other intellectual property. We enter into these agreements to augment our own intellectual property and to
secure freedom to operate where necessary. These agreements impose various commercial diligence and financial payment obligations on us. We
expect to continue to enter into these types of license agreements in the future.
Regulations in the United States and other countries have a significant impact on our product development, manufacturing and marketing
REGULATION
activities.
Government Contracting
Our status as a U.S. government contractor means that we are subject to various statutes and regulations, including the Federal Acquisition
Regulation, or FAR, which governs the procurement of goods and services by agencies of the U.S. government. These regulations can impose stricter
penalties than those normally applicable to commercial contracts, such as criminal and civil liability and suspension and debarment from future
government contracting. In addition, pursuant to various regulations, our government contracts can be subject to unilateral termination or
modification by the government for convenience, detailed auditing and accounting systems requirements, statutorily controlled pricing, sourcing and
subcontracting restrictions, and statutorily mandated processes for adjudicating contract disputes.
Project BioShield. The Project BioShield Act of 2004, or Project BioShield, provides expedited procedures for bioterrorism-related
procurement and the awarding of research grants, making it easier for HHS to quickly commit funds to countermeasure projects. Project BioShield
relaxes procedures under the FAR for procuring property or services used in performing, administering or supporting biomedical countermeasure
research and development. In addition, if the Secretary of HHS deems that there is a pressing need, Project BioShield authorizes the Secretary to use
an expedited award process, rather than the normal peer review process, for grants, contracts and cooperative agreements related to biomedical
countermeasure research and development activity. Under Project BioShield, in limited specified circumstances, HHS can contract to purchase
unapproved countermeasures for the SNS and authorize the emergency use of medical products that have not yet been approved by the FDA.
Product Development for Therapeutics
Pre-Clinical Testing. Before beginning testing of any compounds with potential therapeutic value in human subjects in the United States,
stringent government requirements for pre-clinical data must be satisfied. Pre-clinical testing includes both in vitro, or in an artificial environment
outside of a living organism, and in vivo, or within a living organism, laboratory evaluation and characterization of the safety and efficacy of a drug
and its formulation. We perform pre-clinical testing on all of our product candidates before we initiate any human trials.
Investigational New Drug Application. Before clinical testing may begin, the results of pre-clinical testing, together with manufacturing
information, analytical data and any other available clinical data or literature, must be submitted to the FDA as part of an Investigational New Drug
Application, or IND. The sponsor must also include an initial protocol detailing the first phase of the proposed clinical investigation. The pre-clinical
data must provide an adequate basis for evaluating both the safety and the scientific rationale for the initial clinical studies in human volunteers. The
IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA imposes a clinical hold within that 30-day time period.
Clinical Trials. Clinical trials involve the administration of the drug to healthy human volunteers or to patients under the supervision of a
qualified physician (also called an investigator) pursuant to an FDA-reviewed protocol. Human clinical trials typically are conducted in three
sequential phases, although the phases may overlap with one another. Clinical trials must be conducted under protocols that detail the objectives of
the study, the parameters to be used to monitor safety and the efficacy criteria, if any, to be evaluated. Each protocol must be submitted to the FDA as
part of the IND.
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 sample of individuals with the target disease or disorder and seek to assess the efficacy of the drug for
specific targeted 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, large-scale studies of patients with the target disease or disorder to obtain definitive statistical
evidence of the efficacy and safety of the proposed product and 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 population. As part of a product approval, the
FDA may require that certain Phase 4 studies, which are called post-marketing commitment studies, be conducted post-approval.
Good Clinical Practice. All of the phases of clinical studies must be conducted in conformance with the FDA's bioresearch monitoring
regulations and Good Clinical Practices, or GCP, which are ethical and scientific quality standards for conducting, recording and reporting clinical
trials to assure that the data and reported results are credible and accurate and that the rights, safety and well-being of trial participants are protected.
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Animal Rule. For product candidates that are intended to treat or prevent infection from rare life-threatening diseases, conducting controlled
clinical trials to determine efficacy may be unethical or unfeasible. Under regulations issued by the FDA in 2002, often referred to as "the Animal
Rule," under some circumstances, approval of such product candidates can be based on clinical data from trials in healthy subjects that demonstrate
adequate safety, immunogenicity and efficacy data from adequate and well-controlled animal studies. Among other requirements, the animal studies
must establish that the drug or biological product is reasonably likely to produce clinical benefit in humans. Because the FDA must agree that data
derived from animal studies may be extrapolated to establish safety and efficacy in humans, these studies add complexity and uncertainty to the
testing and approval process. In addition, products approved under the Animal Rule are subject to additional requirements, including post-marketing
study requirements, restrictions imposed on marketing or distribution or requirements to provide information to patients.
Marketing Approval – Biologics and Drugs
Biologics License Application/New Drug Application. All data obtained from a comprehensive development program, including research
and product development, manufacturing, pre-clinical and clinical trials, labeling and related information are submitted in a Biologics License
Application, or BLA, to the FDA and in similar regulatory filings with the corresponding agencies in other countries for review and approval. For
small molecule drugs, this information is submitted in a filing called a New Drug Application, or NDA. The submission of an application is not a
guarantee that the FDA will find the application complete and accept it for filing. The FDA may refuse to file the application and request additional
information rather than accept the application for filing, in which case the application must be resubmitted with the supplemental information. Once
an application is accepted for filing, the U.S. Food, Drug and Cosmetic Act, or FDCA, requires the FDA to review the application within 180 days of
its filing, although in practice, longer review times often occur.
In addition, under the Pediatric Research Equity Act of 2003, or PREA, BLAs, NDAs and certain supplements must contain data to assess
the safety and efficacy of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for
each pediatric subpopulation for which the product is safe and effective. The FDA may grant deferrals for submission of data or full or partial
waivers. Unless otherwise required by regulation, PREA does not apply to any drug or biologic for an indication for which orphan designation has
been granted.
In reviewing a BLA or NDA, the FDA may grant approval, deny the application if it determines the application does not provide an
adequate basis for approval or again request additional information. Even if such additional information and data are submitted, the FDA may
ultimately decide that the BLA or NDA does not satisfy the criteria for approval. The receipt of regulatory approval often takes many years,
involving the expenditure of substantial financial resources. The speed with which approval is granted often depends on a number of factors,
including the severity of the disease in question, the availability of alternative treatments and the risks and benefits demonstrated in clinical trials.
The FDA may also impose conditions upon approval. For example, it may require a Risk Evaluation and Mitigation Strategy, or REMS, for a
product. This can include various required elements, such as publication of a medication guide, patient package insert, a communication plan to
educate health care providers of the drug's risks and/or restrictions on distribution and use such as limitations on who may prescribe or dispense the
drug. The FDA may also significantly limit the indications approved for a given product and/or require, as a condition of approval, enhanced
labeling, special packaging or labeling, post-approval clinical trials, expedited reporting of certain adverse events, pre-approval of promotional
materials or restrictions on direct-to-consumer advertising, any of which could negatively impact the commercial success of a drug.
Fast Track Designation. The FDA may designate a product as a fast track drug if it is intended for the treatment of a serious or life-
threatening disease or condition and demonstrates the potential to address unmet medical needs for this disease or condition. Sponsors granted a fast
track designation for a drug are granted more opportunities to interact with the FDA during the approval process and are eligible for FDA review of
the application on a rolling basis, before the application has been completed. The FDA has designated our following investigational product
candidates for fast track status: otlertuzumab and NuThrax.
Orphan Drugs. Under the Orphan Drug Act, an applicant can request the FDA to designate a product as an ''orphan drug'' in the United
States if the drug is intended to treat an orphan, or rare, disease or condition. A disease or condition is considered orphan if it affects fewer than
200,000 people in the United States. Orphan Drug designation must be requested before submitting a BLA or NDA. Products designated as orphan
drugs are eligible for special grant funding for research and development, FDA assistance with the review of clinical trial protocols, potential tax
credits for research, reduced filing fees for marketing applications and a special seven-year period of market exclusivity after marketing approval.
Orphan drug exclusivity (afforded to the first applicant to receive approval for an orphan designated drug) prevents FDA approval of applications by
others for the same drug for the designated orphan disease or condition. The FDA may approve a subsequent application from another applicant if the
FDA determines that the application is for a different drug or different use, or if the FDA determines that the subsequent product is clinically
superior, or that the holder of the initial orphan drug approval cannot assure the availability of sufficient quantities of the drug to meet the public's
need. A grant of an orphan designation is not a guarantee that a product will be approved.
Our products with current Orphan Drug exclusivity include the following:
BioThrax for post-exposure prophylaxis of disease following suspected or confirmedB. anthracis exposure, when administered in
conjunction with recommended antibacterial drugs, with exclusivity though 2022;
Anthrasil for the treatment of toxemia associated with inhalational anthrax in adult and pediatric patients in combination with appropriate
antibacterial drugs, with exclusivity through 2022;
BAT with exclusivity through March 2020 for treatment of suspected or documented exposure to botulinum neurotoxin A, B, C, D, E, F or
G; and
VARIZIG with exclusivity through December 2019 for post-exposure prophylaxis of varicella (chickenpox) in high-risk patient groups,
including immunocompromised children, newborns and pregnant women.
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Post-Approval Requirements. Any drug, biologic or medical device product for which we receive FDA approval will be subject to
continuing regulation by the FDA, including, among other things, record keeping requirements, reporting of adverse experiences, providing the FDA
with updated safety and efficacy information, product sampling and distribution requirements, current good manufacturing practices, or cGMP, and
restrictions on advertising and promotion. Adverse events that are reported after marketing approval can result in additional limitations being placed
on the product's distribution or use and, potentially, withdrawal or suspension of the product from the market. In addition, the FDA has post-approval
authority to require post-approval clinical trials and/or safety labeling changes if warranted by the appearance of new safety information. In certain
circumstances, the FDA may impose a REMS after a product has been approved. Facilities involved in the manufacture and distribution of approved
products are required to register their establishments with the FDA and certain state agencies and are subject to periodic unannounced inspections by
the FDA for compliance with cGMP and other laws. The FDA also closely monitors advertising and promotional materials we may disseminate for
our products for compliance with restrictions on off-label promotion and other laws. We may not promote our products for conditions of use that are
not included in the approved package inserts for our products. Certain additional restrictions on advertising and promotion exist for products that
have so-called "black box warnings" in their approved package inserts, such as WinRho SDF.
Vaccine and Immune Globulin Product Lot Release and FDA Review. Because the manufacturing process for biological products is very
complex, the FDA requires for many biologics, including most vaccines and immune globulin products, that each product lot undergo thorough
testing for purity, potency, identity and sterility. Before a lot of BioThrax can be used, we must submit a sample of the vaccine lot and a lot release
protocol to the FDA. The lot release protocol documents reflect the results of our tests for potency, safety, sterility, any additional assays mandated
by our BLA for BioThrax and a summary of relevant manufacturing details. The FDA reviews the manufacturing and testing information provided in
the lot release protocol and may elect to perform confirmatory testing on lot samples that we submit. We cannot distribute a lot of BioThrax until the
FDA releases it. The length of the FDA review process depends on a number of factors, including reviewer questions, license supplement approval,
reviewer availability and whether our internal testing of product samples is completed before or concurrently with FDA testing.
Marketing Approval – Medical Devices
Medical devices are also subject to FDA clearance or approval and extensive regulation under the U.S. Food, Drug and Cosmetic Act, or
FDCA. Under the FDCA, medical devices are classified into one of three classes: Class I, Class II or Class III. The classification of a device
generally depends on the degree of risk associated with the medical device and the extent of control needed to ensure safety and efficacy. RSDL is
regulated as a Class II medical device.
Class I devices are those for which safety and efficacy 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 efficacy of the device. Review and clearance by the FDA for these devices is typically accomplished through the so-called
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-approved 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
efficacy, 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 approved prior to May 28, 1976, the proposed
device is approved based on a pre-amendment and is approved 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 and are sometimes required for a 510(k) pre-market
notification. 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.
Both before and after a medical device is commercially distributed, manufacturers and marketers of the device have ongoing
responsibilities under FDA regulations. The FDA reviews design and manufacturing practices, record keeping, reports of adverse events, labeling and
other information to identify potential problems with marketed medical devices. Device manufacturers are subject to periodic and unannounced
inspection by the FDA for compliance with cGMP requirements that govern the methods used in, and the facilities and controls used for, the design,
manufacture, packaging, servicing, labeling, storage, installation and distribution of all finished medical devices intended for human use. If the FDA
finds that a manufacturer has failed to comply or that a medical device is ineffective or poses an unreasonable health risk, it can institute or seek a
wide variety of enforcement actions and remedies, ranging from a public warning letter to more severe actions, including:
fines, injunctions, and civil penalties;
recall or seizure of products;
operating restrictions, partial suspension or total shutdown of production;
refusal of requests for 510(k) clearance or PMA approval of new products;
withdrawal of 510(k) clearance or PMA approvals already granted; and
criminal prosecution.
The FDA also has the authority to require repair, replacement or refund of the cost of any medical device. The FDA also administers
certain controls over the export of medical devices from the United States, as international sales of medical devices that have not received FDA
approval are subject to FDA export requirements. Additionally, each foreign country subjects such medical devices to its own regulatory
requirements. In the European Union, a harmonized medical device directive legislates approval requirements. Within this framework, the CE Mark,
an attestation of conformity with European Union legislation, allows for the legal marketing of the product in all member states.
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Pricing and Reimbursement
In the United States and internationally, sales of our Biosciences products and our ability to generate revenues on such sales are dependent,
in significant part, on the availability and level of reimbursement from third-party payors, including state and federal governments and private
insurance plans. Insurers have implemented cost-cutting measures and other initiatives to enforce more stringent reimbursement standards and likely
will continue to do so in the future. These measures include the establishment of more restrictive formularies and increases in the out-of-pocket
obligations of patients for such products. In addition, particularly in the United States and increasingly in other countries, we are required to provide
discounts and pay rebates to state and federal governments and agencies in connection with purchases of our products that are reimbursed by such
entities. Various provisions of the Patient Protection and Affordable Care Act (as amended by the Health Care and Education Reconciliation
Act), collectively referred to as the Affordable Care Act, increased the levels of rebates and discounts that we have to provide in connection with
sales of such products that are paid for, or reimbursed by, certain state and federal government agencies and programs. It is possible that future
legislation in the United States and other jurisdictions could be enacted, which could potentially impact the reimbursement rates for our Biosciences
products and also could further impact the levels of discounts and rebates we are required to pay to state and federal government entities. The most
significant governmental reimbursement programs in the United States relevant to our products are described below:
Medicare Part B. Medicare Part B covers drug products provided in a physician's office or hospital outpatient setting under a
payment methodology using "average sales price," or ASP, information. We are required to provide ASP information to the Centers for Medicare and
Medicaid Services, or CMS, on a quarterly basis. Medicare payment rates are currently set at ASP plus six percent, although this rate could change in
future years. If we fail to timely or accurately submit ASP, we could be subject to civil and criminal penalties. IXINITY, WinRho SDF, HepaGam B
and VARIZIG are all eligible to be reimbursed under Medicare Part B.
Medicaid Rebate Program. For products to be covered by Medicaid, drug manufacturers must enter into a rebate agreement with the
Secretary of HHS on behalf of the states and must regularly submit certain pricing information to CMS. The pricing information submitted, including
information about the "average manufacturer price," or AMP, and "best price" for each of our covered drugs, determines the amount of the rebate we
must pay. The total rebate also includes an "additional" rebate, which functions as an "inflation penalty." The Affordable Care Act increased the
amount of the basic rebate and, for some "line extensions," increased the additional rebate. It also requires manufacturers to pay rebates on utilization
by enrollees in managed care organizations. If we fail to timely or accurately submit required pricing information, we could be subject to civil and
criminal penalties. In addition, the Affordable Care Act made changes to the definition of AMP, which still need to be clarified by CMS and could
affect the rebate liability for our products. Sales of IXINITY, WinRho SDF, HepaGam B and VARIZIG that are reimbursed through Medicaid are
subject to the obligations related to this program.
340B/PHS Drug Pricing Program. The availability of federal funds to pay for IXINITY, WinRho SDF, HepaGam B and VARIZIG under
the Medicaid and Medicare Part B programs requires that we extend discounts under the 340B/Public Health Service, or PHS, drug pricing program.
The 340B/PHS drug pricing program requires participating manufacturers to charge no more than a statutorily-determined "ceiling" price to a variety
of community health clinics and other entities that receive health services grants from the PHS, as well as the outpatient departments of hospitals that
serve a disproportionate share of Medicaid and Medicare beneficiaries. A product's ceiling price for a quarter reflects its Medicaid AMP from two
quarters earlier less its Medicaid rebate amount from two quarters earlier. Therefore, the above-mentioned revisions to the Medicaid rebate formula
and AMP definition enacted by the Affordable Care Act could cause the discount produced by the ceiling price to increase. Under the Affordable
Care Act, four additional classes of entities were made eligible for these discounts, increasing the volume of sales for which we must now offer the
340B/PHS discounts.
Federal Supply Schedule. We make IXINITY, WinRho SDF, HepaGam B and VARIZIG available for purchase by authorized users of the
Federal Supply Schedule, or FSS, administered by the Department of Veterans Affairs, or DVA, pursuant to our FSS contract with the DVA. Under
the Veterans Health Care Act of 1992, we are required to offer deeply discounted FSS contract pricing to four federal agencies—the DVA, the DoD,
the Coast Guard and the PHS (including the Indian Health Service)—for federal funding to be made available for reimbursement of any of our
products under the Medicaid program, Medicare Part B and for our products to be eligible to be purchased by those four federal agencies and certain
federal grantees. FSS pricing to those four federal agencies must be equal to or less than the "Federal Ceiling Price," which is, at a minimum, 24%
less than the Non-Federal Average Manufacturer Price for the prior fiscal year.
Foreign Regulation
Currently, we maintain a commercial presence in the United States and Canada as well as select foreign countries. In the future, we may
further expand our commercial presence to additional foreign countries and territories. In the European Union, medicinal products are authorized
following a process similarly demanding as the process required in the United States. Medicinal products must be authorized in one of two ways,
either through the decentralized procedure, which provides for the mutual recognition procedure of national approval decisions by the competent
authorities of the EU Member States or through the centralized procedure by the European Commission, which provides for the grant of a single
marketing authorization that is valid for all EU member states. The authorization process is essentially the same irrespective of which route is used.
We are also subject to many of the same continuing post-approval requirements in the EU as we are in the United States (e.g., good manufacturing
practices).
Anti-Corruption Laws
We are subject to various federal and state laws pertaining to health care "fraud and abuse," including state and federal anti-kickback laws
and false claims laws. Anti-kickback laws make it illegal for a drug manufacturer to solicit, offer, receive or pay any remuneration in exchange for, or
to induce, the referral of business, including the purchase or prescription of a particular drug. Due to the breadth of the statutory provisions and the
absence of guidance in the form of regulations and very few court decisions addressing industry practices, it is possible that our practices might be
challenged under anti-kickback or similar laws. False claims laws prohibit anyone from knowingly and willingly presenting, or causing to be
presented for payment, to third-party payors (including Medicare and Medicaid) claims for reimbursed drugs or services that are false or fraudulent,
claims for items or services not provided as claimed or claims for medically unnecessary items or services. Our activities relating to the sale and
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marketing of our products may be subject to scrutiny under these laws. If we violate the kickback or false claims laws, we could be subject to civil
and criminal penalties, including exclusion from participation in federal healthcare programs such as Medicare and Medicaid. Similar restrictions are
imposed on the promotion and marketing of medicinal products in the European Union and other countries. Laws (including those governing
promotion, marketing and anti-kickback provisions), industry regulations and professional codes of conduct are often strictly enforced. Even in those
countries where we are not directly responsible for the promotion and marketing of our products, inappropriate activity by our international
distribution partners can have implications for us. In addition, as part of the Affordable Care Act, the federal government has enacted the Physician
Payment Sunshine Act. Manufacturers of drugs are required to publicly report payments and transfers of value made to physicians and teaching
hospitals. This information is posted on a public website. Failure to timely and accurately submit required information could subject us to civil
penalties. Many of these requirements are new and uncertain and the extent to which the laws will be enforced is not always clear.
Our operations are also subject to compliance with the Foreign Corrupt Practices Act, or FCPA, which prohibits corporations and
individuals from paying, offering to pay, or authorizing the payment of anything of value to any foreign government official, government staff
member, political party or political candidate in an attempt to obtain or retain business or to otherwise influence a person working in an official
capacity. We also may be implicated under the FCPA by the activities of our partners, collaborators, contract research organizations, vendors or other
agents. As a public company, the FCPA also requires us to make and keep books and records that accurately and fairly reflect all of our transactions
and to devise and maintain an adequate system of internal accounting controls. Our operations are also subject to compliance with the U.K. Bribery
Act, which applies to bribery activities both in the public and private sector, Canada's Corruption of Foreign Public Officials Act and similar laws in
other countries.
Other Regulation
Our present and future business has been and will continue to be subject to various other laws and regulations. Various laws, regulations
and recommendations relating to safe working conditions, laboratory practices, the experimental use of animals, and the purchase, storage,
movement, import, export, use and disposal of hazardous or potentially hazardous substances, including radioactive compounds and infectious
disease agents used in connection with our product development, are or may be applicable to our activities.
EMPLOYEES
As of February 19, 2016, we had 1,292 full-time employees. We believe that our future success will depend in part on our continued ability
to attract, hire and retain qualified personnel. None of our employees are represented by a labor union or covered by collective bargaining
agreements. We believe that our relations with our employees are good.
AVAILABLE INFORMATION
We maintain a website at www.emergentbiosolutions.com. We make available, free of charge on our website, our annual report on Form
10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and all amendments to those reports filed or furnished pursuant to Section 13(a)
or 15(d) of the Securities Exchange Act of 1934, or the Exchange Act, as soon as reasonably practicable after we electronically file those reports
with, or furnish them to, the Securities and Exchange Commission, or SEC.
We also make available, free of charge on our website, the reports filed with the SEC by our executive officers, directors and 10%
stockholders pursuant to Section 16 under the Exchange Act as soon as reasonably practicable after copies of those filings are provided to us by those
persons. In addition, we intend to make available on our website all disclosures that are required to be posted by applicable law, the rules of the SEC
or the New York Stock Exchange listing standards regarding any amendment to, or waiver of, our code of business conduct and ethics. We have
included our website address as an inactive textual reference only. The information contained on, or that can be accessed through, our website is not a
part of, or incorporated by reference into, this Annual Report on Form 10-K.
ITEM 1A. RISK FACTORS
You should carefully consider, among other matters, the following risk factors in addition to the other information in this Annual Report on
Form 10-K when evaluating our business because these risk factors may have a significant impact on our business, financial condition, operating
results or cash flow. If any of the risks described below or in subsequent reports we file with the SEC actually occur, they may materially harm our
business, financial condition, operating results or cash flow. Additional risks and uncertainties that we have not yet identified or that we presently
consider to be immaterial may also materially harm our business, financial condition, operating results or cash flow.
THE PLANNED SPIN-OFF OF OUR BIOSCIENCES BUSINESS
Our plan to pursue a spin-off of our biosciences business into a separate, stand-alone publicly-traded company is subject to material conditions
and may not be completed on the currently contemplated timeline or at all.
In August 2015, we announced a plan to pursue a spin-off of our biosciences business into a separate, stand-alone publicly-traded
company, Aptevo Therapeutics Inc., which is subject to board approval of the final terms, through a tax-free distribution to Emergent shareholders of
publicly-traded stock in the new biosciences company. We expect to complete the spin-off by mid-year 2016. Unanticipated developments, including
possible delays in obtaining a tax opinion, covenant waivers or other required clearances, uncertainty of the financial markets and challenges in
establishing infrastructure or processes, could delay or prevent the proposed spin-off or cause it to occur on terms or conditions that are less favorable
or different than expected. Expenses incurred to accomplish the proposed spin-off will be significant and may be significantly higher than what we
currently anticipate, and may not yield a discernible benefit if we do not execute the transaction. Executing the proposed spin-off also requires
significant time and attention from management and employees, which could distract them from other tasks in operating our business and, as a result,
negatively impact our operations and our earnings.
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If the proposed spin-off is consummated, we may not realize some or all of the anticipated benefits due to a number of factors.
Even if the transaction is completed, we may not realize some or all of the anticipated strategic, financial or other benefits from the spin-
off. If consummated, the two independent companies will be smaller, less diversified with a narrower business focus and may be more vulnerable to
changing market conditions, which could materially and adversely affect Emergent's business, financial condition and results of operations.
Execution of the spin-off transaction presents a number of significant risks to our internal processes, including the failure to maintain an adequate
control environment due to changes to our IT systems and financial reporting processes, both as we execute the transaction and following
consummation. There may also be dis-synergies from separating the businesses that could negatively impact the financial condition and results of
operations of either or both businesses. Further, the combined value of the common stock of the two publicly-traded companies may not be equal to
or greater than what the value of our common stock would have been had the proposed spin-off not occurred.
GOVERNMENT CONTRACTING RISKS
We derive the majority of our revenue from sales of BioThrax to our principal customer, the U.S. government. If the U.S. government's demand
for BioThrax is reduced, our business, financial condition, operating results and cash flow could be materially harmed.
We have derived and expect for the foreseeable future to derive the majority of our revenue from sales of BioThrax, our anthrax vaccine
licensed by the U.S. Food and Drug Administration, or FDA, to the U.S. government. We are currently party to a contract with the Centers for
Disease Control and Prevention, or CDC, for the supply of up to 44.75 million doses of BioThrax for placement into the Strategic National Stockpile,
or SNS, over a five-year period ending in September 2016.
The procurement of doses of BioThrax by the CDC is subject to the availability of funding. Our existing contract with the CDC does not
guarantee that funding for the procurement of doses will be made available. If the SNS priorities change, funding to procure doses of BioThrax may
be limited or not available, and our business, financial condition and operating results would be materially harmed. The success of our business and
our operating results for the foreseeable future are significantly dependent on funding for the procurement of BioThrax and the terms of our
BioThrax sales to the U.S. government, including the price per dose, the number of doses and the timing of deliveries.
Our U.S. government procurement and development contracts require ongoing funding decisions by the U.S. government. Reduced or
discontinued funding of these contracts could cause our business, financial condition, operating results and cash flow to suffer materially.
Our principal customer for BioThrax, BAT, Anthrasil, VIGIV and RSDL is the U.S. government. We anticipate that the U.S. government
will also be a principal customer for other biodefense products that we successfully acquire or develop. Additionally, a significant portion of our
revenue comes from U.S. government development contracts and grants. Over its lifetime, a U.S. government procurement or development program
may be implemented through the award of many different individual contracts and subcontracts. The funding for such government programs is
subject to Congressional appropriations, generally made on a fiscal year basis, even for programs designed to continue for several years. These
appropriations can be subject to political considerations and stringent budgetary constraints. For example, sales of BioThrax supplied under our
multi-year procurement contract with the CDC are subject to available funding, mostly from annual appropriations. Additionally, our government-
funded development contracts typically give the U.S. government the right, exercisable in its sole discretion, to extend these contracts for successive
option periods following a base period of performance. The value of the services to be performed during these option periods may constitute the
majority of the total value of the underlying contract. For example, the development contract we were awarded in August 2014 for development of a
dry formulation of PreviThrax consists of a two-year base period of performance valued at approximately $7.3 million and thirteen options over a
five-year period valued at a total of approximately $29 million. If levels of government expenditures and authorizations for biodefense decrease or
shift to programs in areas where we do not offer products or are not developing product candidates, or if the U.S. government otherwise declines to
exercise its options under our contracts, our business, revenues and operating results would suffer.
The government contracting process is typically a competitive bidding process and involves unique risks and requirements.
We expect that a significant portion of our near-term business will be under government contracts and grants, which may be awarded
through competitive bidding. Competitive bidding for government contracts presents a number of risks and requirements, some of which are not
typically present in the commercial contracting process, including:
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 possibility that we may be ineligible to respond to a request for proposal issued by the government;
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 would result in the resubmission of bids based on modified
specifications, or in the termination, reduction or modification of the awarded contract.
The U.S. government may choose not to award us future contracts for the development of our Biodefense product candidates or for the
procurement of our Biodefense products, and may instead award such contracts to our competitors. If we are unable to win particular contracts, we
may not be able to operate in the market for products that are provided under those contracts for a number of years. Additionally, if we are unable to
consistently win new contract awards over an extended period, or if we fail to anticipate all of the costs or resources that we will be required to
secure and, if applicable, perform under such contract awards, our growth strategy and our business, financial condition and operating results could
be materially and adversely affected.
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Laws and regulations affecting government contracts make it more costly and difficult for us to successfully conduct our business. Failure to
comply with these laws could result in significant civil and criminal penalties and materially damage our relationship with the U.S. government.
We must comply with numerous laws and regulations relating to the procurement, formation, administration and performance of
government contracts. Among the most significant government contracting regulations that affect the business of our Biodefense division are:
the Federal Acquisition Regulation, or FAR, and agency-specific regulations supplemental to FAR, which comprehensively regulate the
procurement, 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 procurement, formation, administration and performance of U.S. Department of Defense, or DoD, government contracts;
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.
U.S. government agencies routinely audit and investigate government contractors for compliance with applicable laws and standards. If we
are audited and such audit were to uncover improper or illegal activities, we could be subject to civil and criminal penalties, administrative sanctions,
including suspension or debarment from government contracting and significant reputational harm.
The amount we are paid under our fixed price government procurement contracts is based on estimates we have made of the time, resources and
expenses required for us to perform under those contracts. If our actual costs exceed our estimates, we may not be able to earn an adequate
return or may incur a loss under these contracts, which could harm our operating results and materially reduce our net income.
Some of our current contracts with the U.S. Department of Health and Human Services, or HHS, and the DoD for the procurement of our
Biodefense products are fixed price contracts. We expect that our potential future contracts with the U.S. government for our Biodefense products
also may be fixed price contracts. Under a fixed price contract, we are required to deliver our products at a fixed price regardless of the actual costs
we incur. Estimating costs that are related to performance in accordance with contract specifications is difficult, particularly where the period of
performance is over several years. Our failure to anticipate technical problems, estimate costs accurately or control costs during performance of a
fixed price contract could reduce the profitability of such a contract or cause a loss, which could harm our operating results and materially reduce our
net income.
Unfavorable provisions in government contracts, some of which may be customary, may subject our business to material limitations, restrictions
and uncertainties and may have a material adverse impact on our financial condition and operating results.
Government contracts customarily contain provisions that give the U.S. government substantial rights and remedies, many of which are not
typically found in commercial contracts, including provisions that allow the U.S. government to:
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 contract or renew a 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.
Generally, government contracts, including our contract for procurement of BioThrax, contain provisions permitting unilateral termination
or modification, in whole or in part, at the U.S. government's convenience. Under general principles of government contracting law, if the U.S.
government terminates a contract for convenience, the government contractor may recover only its incurred or committed costs, settlement expenses
and profit on work completed prior to the termination. If the U.S. government terminates a contract for default, the government contractor is entitled
to recover costs incurred and associated profits on accepted items only and may be liable for excess costs incurred by the government in procuring
undelivered items from another source. Our CDC contract for the procurement of BioThrax is, and our future U.S. government procurement and
development contracts are likely to be, terminable at the U.S. government's convenience with these potential consequences.
Our U.S. government contracts grant the U.S. government the right to use technologies developed by us under the government contract or
the right to share data related to our technologies, for or on behalf of the U.S. government. Under our U.S. government contracts, we might not be
able to prohibit third parties, including our competitors, from accessing such technology or data, including intellectual property, in providing
products and services to the U.S. government.
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COMMERCIALIZATION RISKS
We face substantial competition, which may result in others developing or commercializing products before or more successfully than we do.
The development and commercialization of new biopharmaceutical products is highly competitive and subject to rapid technological advances.
We may face future competition with respect to our products, any products that we acquire, our current product candidates and any products we may seek
to develop or commercialize in the future from other companies and governments, universities and other non-profit research organizations. Our
competitors may develop products that are safer, more effective, more convenient or less costly than any products that we may develop or market. Our
competitors may devote greater resources to market or sell their products, adapt more quickly to new technologies, scientific advances or patient
preferences and needs, initiate or withstand substantial price competition more successfully than we can, or more effectively negotiate third-party
licensing and collaborative arrangements.
There are a number of companies with biodefense products or product candidates competing with us for both U.S. government procurement
and development resources. For example, in terms of additional procurement of licensed countermeasures, HHS awarded a development and SNS
procurement contract to GlaxoSmithKline plc for ABThrax™ (raxibacumab), an anthrax monoclonal antibody therapeutic.
We believe that our most significant competitors in the hematology/oncology and transplantation markets include: AbbVie Inc., Amgen Inc.,
Baxter International Inc., CSL Behring, a subsidiary of CSL Limited, Genentech Inc. (a subsidiary of F. Hoffmann-La Roche Ltd.), Gilead Sciences, Inc.,
Grifols USA LLC, Johnson & Johnson and Novartis AG.
Any reduction in demand for our products as a result of a competing product could lead to reduced revenues, reduced margins, reduced levels
of profitability and loss of market share for our products. These competitive pressures could adversely affect our business and operating results.
We rely on third parties to distribute some of our products and those third parties may not perform.
A portion of our revenues from product sales is derived from sales through exclusive distributors in Canada and international markets. For
example, in Canada, only two distributors have rights to our WinRho SDF, HepaGam B and VARIZIG products. As a result, we rely on the sales and
marketing strength of these distributors and the distribution channels through which they operate for a portion of our revenues. We may not be able to
retain these distribution relationships indefinitely and these distributors may not adequately support the sales, marketing and distribution efforts of our
products in these markets. If third parties do not successfully carry out their contractual duties in maximizing the commercial potential of our products, or
if there is a delay or interruption in the distribution of our products, it could negatively impact our revenues from product sales.
The commercial success of our Biosciences products will depend upon the degree of market acceptance by government customers, physicians,
patients, healthcare payors and others in the medical community.
Our Biosciences products may not gain or maintain market acceptance by potential government customers, physicians, patients, third-party
payors and others in the medical community. In particular, the success of our Biosciences products, including our hyperimmune specialty products, will
depend upon, among other things, their acceptance by physicians, patients, third-party payors and other members of the medical community as a
therapeutic and cost-effective alternative to competing products and treatments. If any of our products do not achieve and maintain an adequate level of
acceptance, we may not generate material revenues from sales of these products. The degree of market acceptance of our products will depend on a
number of factors, including:
our ability to provide acceptable evidence of safety and efficacy;
the prevalence and severity of any side effects;
availability, relative cost and relative efficacy of alternative and competing treatments;
the ability to offer our products for sale at competitive prices;
the relative convenience and ease of administration;
the willingness of the target patient population to try new products and of physicians to prescribe these products;
the strength of marketing and distribution support;
publicity concerning our products or competing products and treatments; and
the sufficiency of coverage or reimbursement by third parties.
If our products and product candidates do not become widely accepted by potential government customers, physicians, patients, third-party
payors and other members of the medical community, our business, financial condition and operating results could be materially and adversely affected.
Changes in health care systems and payor reimbursement policies could result in a decline in our potential sales and a reduction in our expected
revenue from our products.
The revenues and profitability of biopharmaceutical companies like ours may be affected by the continuing efforts of government and third-
party payors to contain or reduce the costs of health care through various means. For example, in certain foreign markets, the pricing or profitability of
therapeutic and other pharmaceutical products is subject to governmental control. In the United States, there have been, and we expect that there will
continue to be, a number of federal and state proposals to implement similar governmental control. Recent U.S. legislation, rules and regulations
instituted significant changes to the U.S. healthcare system that could have a material adverse effect on our business, financial condition and profitability.
We cannot predict what effects, if any, this legislation might have on our company and our products as this legislation continues to be further
implemented over the next few years, nor can we predict whether additional legislative or regulatory proposals may be adopted.
In addition, in the United States and elsewhere sales of therapeutic and other pharmaceutical products depend, in part, on the availability of
reimbursement from third-party payors, such as government and private insurance plans. Third-party payors are increasingly challenging the prices
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charged for medical products and services. Third-party payors may limit access to biopharmaceutical products through the use of prior authorizations and
step therapy. Any reimbursement granted may not be maintained, or limits on reimbursement available from third parties may reduce the demand for or
negatively affect the price and profitability of those products. Payors may pursue aggressive cost cutting initiatives such as comparing the effectiveness,
benefits and costs of similar treatments, which could result in lower reimbursement and therefore demand for these products. Policies that decrease
reimbursement would likely have a material adverse effect on our business, financial condition and results of operations. Our ability to successfully
commercialize our products and product candidates and the demand for our products depend, in part, on the extent to which reimbursement and access is
available from such third-party payors.
Our Biologic Products may face risks of competition from biosimilar manufacturers.
Competition for BioThrax, WinRho SDF, BAT, Anthrasil, HepaGam B, VARIZIG and VIGIV, or our "Biologic Products," may be affected by
follow-on biologics, or "biosimilars," in the United States and other jurisdictions. Regulatory and legislative activity in the United States and other
countries may make it easier for generic drug manufacturers to manufacture and sell biological drugs similar or identical to our Biologic Products, which
might affect the profitability or commercial viability of our Biologic Products. Under the Biologics Price Competition and Innovation Act of 2010, the
FDA cannot approve a biosimilar application until the 12-year exclusivity period for the innovator biologic has expired. Regulators in the European
Union and in other foreign jurisdictions have already approved biosimilars, although the European Medicines Agency has expressly excluded blood or
plasma-derived products and their recombinant alternatives from the biosimilar pathway for a period of time. Vaccine and allergen products are
considered on a case-by-case basis. The specific regulatory framework for this new approval pathway, whether the FDA will permit biosimilars for blood
products and vaccines, and the extent to which an approved biosimilar would be substituted for the innovator biologic are not yet clear and will depend
on many factors that are currently unknown. If a biosimilar version of one of our Biologic Products were approved, it could have a material adverse effect
on the sales and gross profits of the affected Biologic Product and could adversely affect our business and operating results.
Political or social factors may delay or impair our ability to market our products and may require us to spend significant management time and
financial resources to address these issues.
Products developed to treat diseases caused by or to combat CBRNE (Chemical, Biological, Radiological, Nuclear and Explosives) threats are
subject to changing political and social environments. The political responses and social awareness of the risks of biowarfare and bioterrorism attacks on
military personnel or civilians may vary over time. If the threat of terrorism were to decline, then the public perception of the risk of bioterrorism may be
reduced. This perception, as well as political or social pressures, could delay or cause resistance to bringing our products to market or limit pricing or
purchases of our products, any of which could negatively affect our revenues.
In addition, substantial delays or cancellations of purchases could result from protests or challenges from third parties. Lawsuits brought
against us by third parties or activists, even if not successful, could require us to spend significant management time and financial resources defending the
related litigation and could potentially damage the public's perception of us and our products. Any publicity campaigns or other negative publicity may
adversely affect the degree of market acceptance of our Biodefense products and thereby limit the demand for our Biodefense products, which would
adversely affect our revenues.
REGULATORY AND COMPLIANCE RISKS
Our long term success depends, in part, upon our ability to develop, receive regulatory approval for and commercialize product candidates and, if
we are not successful, our business and operating results may suffer.
Our product candidates and the activities associated with their development, including testing, manufacture, recordkeeping, storage and
approval, are subject to comprehensive regulation by the FDA and other regulatory agencies in the United States and by comparable authorities in other
countries. Except under limited circumstances related to certain government sales, failure to obtain regulatory approval for a product candidate will
prevent us from commercializing the product candidate. We have limited experience in preparing, filing and prosecuting the applications necessary to
gain regulatory approvals and expect to rely on third-party contract research organizations and consultants to assist us in this process.
In the United States, to obtain approval from the FDA to market any of our future biologic products, we will be required to submit a biologics
license application, or BLA, to the FDA. Ordinarily, the FDA requires a sponsor to support a BLA with substantial evidence of the product's safety and
efficacy in treating the targeted indication based on data derived from adequate and well-controlled clinical trials, including Phase III safety and efficacy
trials conducted in patients with the disease or condition being targeted.
However, NuThrax and PreviThrax are subject to a different regulatory approval pathway. Specifically, because humans are rarely exposed to
anthrax toxins under natural conditions, and cannot be intentionally exposed, statistically significant efficacy for these product candidates cannot be
demonstrated in humans. Instead, efficacy must be demonstrated, in part, by utilizing animal models instead of testing in humans. This is known as the
FDA's "Animal Rule." We cannot guarantee that the FDA will permit us to proceed with licensure of NuThrax, PreviThrax or any Biodefense product
candidates under the Animal Rule. Even if we are able to proceed pursuant to the Animal Rule, the FDA may decide that our data are insufficient to
support approval and require additional preclinical, clinical or other studies, refuse to approve our products, or place restrictions on our ability to
commercialize those products. Furthermore, products approved under the Animal Rule are subject to certain additional post-marketing requirements. For
example, to the extent feasible and ethical, manufacturers of products approved pursuant to the Animal Rule must conduct post-marketing studies, such
as field studies, to verify and describe the drug's clinical benefit and to assess its safety when used as indicated. We cannot guarantee that we will be able
to meet this regulatory requirement even if one or more of our product candidates are approved under the Animal Rule.
The process of obtaining these regulatory approvals is expensive, often takes many years if approval is obtained at all, and can vary
substantially based upon the type, complexity and novelty of the product candidate involved. Changes in the regulatory approval process during the
development period, changes in or the enactment of additional statutes or regulations, or changes in the regulatory review for a submitted product
application may cause delays in the approval or rejection of an application.
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The FDA has substantial discretion in the approval process and may refuse to accept any application or may decide that our data are
insufficient to support approval and require additional preclinical, clinical or other studies. In addition, varying interpretations of the data obtained
from preclinical and clinical testing could delay, limit or prevent regulatory approval of a product candidate.
Even after regulatory approval is received, if we fail to comply with regulatory requirements, or if we experience unanticipated problems with our
approved products, they could be subject to restrictions, penalties or withdrawal from the market.
Any vaccine, therapeutic product or medical device for which we obtain marketing approval, along with the manufacturing processes, post-
approval clinical data, labeling, advertising and promotional activities for such product, will be subject to continual requirements of and review by
the FDA and other regulatory bodies. Our approved products are subject to these requirements and ongoing review. These requirements include
submissions of safety and other post-marketing information and reports, registration requirements, current good manufacturing practices, or cGMP,
requirements relating to quality control, quality assurance, restrictions on advertising and promotion, import and export restrictions and
recordkeeping requirements. In addition, various state laws require that companies that manufacture and/or distribute drug products within the state
obtain and maintain a manufacturer or distributor license, as appropriate. Because of the breadth of these laws, it is possible that some of our business
activities could be subject to challenge under one or more of such laws.
The FDA enforces its cGMP and other requirements through periodic unannounced inspections of manufacturing facilities. The FDA is
authorized to inspect domestic manufacturing facilities without prior notice at reasonable times and in a reasonable manner. The FDA conducts
periodic inspections of our facilities. For example, our Lansing facility was inspected most recently in November 2013, our Winnipeg manufacturing
facility was inspected most recently in January 2015, and our Baltimore (Camden) facility was most recently inspected in August 2015. Following
each of these inspections, the FDA has issued inspectional observations, some of which were significant, but all of which are being addressed
through corrective actions. If, in connection with any future inspection, the FDA finds that we are not in substantial compliance with cGMP
requirements, or if the FDA is not satisfied with the corrective actions we take, the FDA may undertake enforcement action against us, which may
include:
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.
Similar action may be taken against us should we fail to comply with regulatory requirements, or later discover previously unknown
problems with our products or manufacturing processes. Even if regulatory approval of a product is granted, the approval may be subject to
limitations on the indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for costly post-
marketing testing and surveillance to monitor the safety or efficacy of the product. If we experience any of these post-approval events, our business,
financial condition and operating results could be materially and adversely affected.
Failure to obtain or maintain regulatory approval in international jurisdictions could prevent us from marketing our products abroad and could
limit the growth of our business.
We currently sell and intend to sell our products outside the United States. To market our products in the European Union and many other
foreign jurisdictions, we may need to obtain separate regulatory approvals and comply with numerous and varying regulatory requirements. Approval
by the FDA does not ensure approval by foreign regulatory authorities. The approval procedures in foreign jurisdictions can vary widely and can
involve additional clinical trials and data review. We and our collaborators may not be able to obtain foreign regulatory approvals on a timely basis,
if at all, and therefore we may be unable to commercialize our products internationally.
Our international operations increase our risk of exposure to potential claims of bribery and corruption.
As we expand our commercialization activities outside of the United States, we are subject to an increased risk of inadvertently conducting
activities in a manner that violates the U.S. Foreign Corrupt Practices Act, or FCPA, the U.K. Bribery Act, Canada's Corruption of Foreign Public
Officials Act, or other similar foreign laws, which prohibit corporations and individuals from paying, offering to pay, or authorizing the payment of
anything of value to any foreign government official, government staff member, political party, or political candidate in an attempt to obtain or retain
business or to otherwise influence a person working in an official capacity. In the course of establishing and expanding our commercial operations
and seeking regulatory approvals outside of the United States, we will need to establish and expand business relationships with various third parties
and will interact more frequently with foreign officials, including regulatory authorities and physicians employed by state-run healthcare institutions
who may be deemed to be foreign officials under the FCPA or similar foreign laws. If our business practices outside the United States are found to be
in violation of the FCPA or similar foreign laws, we and our senior management may be subject to significant civil and criminal penalties, potential
debarment from public procurement and reputational damage, which could have a material adverse effect on our business, financial condition, results
of operations and growth prospects.
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MANUFACTURING RISKS
Our biologic products and product candidates are complex to manufacture and ship, which could cause us to experience delays in product
manufacturing or development and resulting delays in revenues.
BioThrax, WinRho SDF, BAT, Anthrasil, HepaGam B, VARIZIG, VIGIV, IXINITY and many of our current product candidates are
biologics. Manufacturing biologic products, especially in large quantities, is complex. The products must be made consistently and in compliance
with a clearly defined manufacturing process. Problems may arise during manufacturing for a variety of reasons, including problems with raw
materials, equipment malfunction and failure to follow specific protocols and procedures. In addition, slight deviations anywhere in the
manufacturing process, including obtaining materials, maintaining master seed or cell banks and preventing genetic drift, seed or cell growth,
fermentation, contamination including from, among other things, particulates, filtration, filling, labeling, packaging, storage and shipping, and quality
control testing, may result in lot failures or manufacturing shut-down, delays in the release of lots, product recalls, spoilage or regulatory action. Such
deviations may require us to revise manufacturing processes or change manufacturers. Additionally, as our equipment ages, it will need to be
replaced. Replacement of equipment has the potential to introduce variations in the manufacturing process that may result in lot failures or
manufacturing shut-down, delay in the release of lots, product recalls, spoilage or regulatory action. Success rates can also vary dramatically at
different stages of the manufacturing process, which can reduce yields and increase costs. From time to time, we may experience deviations in the
manufacturing process that may take significant time and resources to resolve and, if unresolved, may affect manufacturing output and could cause us
to fail to satisfy customer orders or contractual commitments, lead to a termination of one or more of our contracts, lead to delays in our clinical
trials, result in litigation or regulatory action against us, including warning letters and other restrictions on the marketing or manufacturing of a
product, or cause the FDA to cease releasing product until the deviations are explained and corrected, any of which could be costly to us, damage our
reputation and negatively impact our business.
For example, FDA approval is required for the release of each lot of BioThrax. A "lot" is approximately 186,000 doses. We are not able to
sell any lots that fail to satisfy the release testing specifications. For example, we must provide the FDA with the results of certain tests, including
potency tests, before lots are released for sale. Potency testing of each lot of BioThrax is performed against a qualified control lot that we maintain.
We have one mechanism for conducting this potency testing that is reliant on a unique animal strain for which we currently have no alternative. We
continually monitor the status of our control lot and periodically produce and qualify a new control lot to replace the existing control lot. If we are not
able to produce and qualify a new control lot or otherwise satisfy the FDA's requirements for release of BioThrax, our ability to sell BioThrax would
be impaired until such time as we become able to meet the FDA's requirements, which would significantly impact our revenues, require us to utilize
our cash balances to help fund our ongoing operations and otherwise harm our business.
We are contractually required to ship our biologic products at a prescribed temperature range and variations from that temperature range
could result in loss of product and could significantly impact our revenues. Delays, lot failures, shipping deviations, spoilage or other loss during
shipping could cause us to fail to satisfy customer orders or contractual commitments, lead to a termination of one or more of our contracts, lead to
delays in potential clinical trials or result in litigation or regulatory action against us, any of which could be costly to us and otherwise harm our
business.
We are in the process of expanding our manufacturing facilities. Delays in completing our facilities, or delays or failures in obtaining regulatory
approvals for our new manufacturing facilities, could impact our future revenues.
We have constructed Building 55, a large-scale manufacturing facility on our Lansing, Michigan campus for which we received a
development contract from BARDA in July 2010 to fund the scale-up, qualification and validation of manufacturing BioThrax at an expanded scale.
Additionally, in 2009, we acquired a facility in Baltimore, Maryland, which we intend to utilize for certain product development or manufacturing
projects, including projects performed under a separate development contract from Biomedical Advanced Research and Development Authority, or
BARDA, to establish a Center for Innovation in Advanced Development and Manufacturing. The process for qualifying and validating these
facilities may result in unanticipated delays and may cost more than expected due to a number of factors, including regulatory requirements. The
costs and time required to comply with cGMP regulations or similar foreign regulatory requirements for sales of our products may be significant. In
addition, if we experience delays, we may be in breach of the obligations under our government-funded development contracts. We have experienced
such delays in the past and may experience further delays in the future. If our facility licensure activities are delayed, we may not be able to utilize
Building 55 to increase our production of BioThrax or manufacture product candidates in our Baltimore facility, which could significantly impact our
future revenues.
Currently, only Building 12, our small-scale manufacturing facility in Lansing, Michigan, has regulatory approval to manufacture BioThrax. A
significant interruption of the ability of this facility to manufacture BioThrax would reduce our revenues and materially harm our business,
financial condition, operating results and cash flow.
We currently rely on our manufacturing facility at a single location in Lansing, Michigan, Building 12, for the production of BioThrax.
Any interruption in manufacturing operations at this location could result in our inability to satisfy the product demand of the U.S. government or
other BioThrax customers. A number of factors could cause interruptions, including:
equipment malfunctions or failures;
technology malfunctions;
cyber-attacks;
work stoppages or slow-downs;
protests, including by animal rights activists;
damage to or destruction of the facility; or
product contamination or tampering.
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Providers of bioterrorism countermeasures could be subject to an increased risk of terrorist activities. The U.S. government has designated
both our Lansing, Michigan and our Biodefense Baltimore facility as facilities requiring additional security. Although we continually evaluate and
update security measures, there can be no assurance that any additional security measures would protect our facilities from terrorist efforts
determined to disrupt our manufacturing activities.
The factors listed above could also cause disruptions at our other facilities, including our manufacturing facility in Winnipeg, Manitoba,
Canada. Any such disruption, damage, or destruction of these facilities could impede our ability to manufacture our Biologic Products and our
product candidates, result in losses and delays, including delay in the performance of our contractual obligations or delay in our clinical trials, any of
which could be costly to us and materially harm our business, financial condition and operating results.
If we are unable to obtain supplies for the manufacture of BioThrax or our other products and product candidates in sufficient quantities and at
an acceptable cost, our ability to manufacture BioThrax or to develop and commercialize our other products and product candidates could be
impaired, which could harm our revenues, lead to a termination of one or more of our contracts, lead to delays in clinical trials or otherwise
harm our business.
We depend on certain single-source suppliers for key materials and services necessary for the manufacture of BioThrax and our other
products and product candidates. For example, we rely on a single-source supplier to provide us with Alhydrogel in sufficient quantities to meet our
needs to manufacture BioThrax and NuThrax. We also rely on single-source suppliers for the sponge applicator device and the active ingredient used
to make RSDL and the specialty plasma in our hyperimmune specialty plasma products. A disruption in the availability of such materials or services
from these suppliers could require us to qualify and validate alternative suppliers. If we are unable to locate or establish alternative suppliers, our
ability to manufacture our products and product candidates could be adversely affected and could harm our revenues, cause us to fail to satisfy
contractual commitments, lead to a termination of one or more of our contracts or lead to delays in our clinical trials, any of which could be costly to
us and otherwise harm our business, financial condition and operating results.
We are currently dependent on third-party manufacturers for the manufacture of RSDL. Certain of our third-party manufacturers currently
constitute the sole source supplier for these products, and we have and will continue to have limited control over the manufacturing process and
costs of these products.
Third-party manufacturers currently supply a significant amount of RSDL pursuant to contractual arrangements. Certain manufacturers
currently constitute the sole source for RSDL. For example, E-Z-EM Canada Inc. (dba Therapex) is our sole source manufacturer for RSDL. Because
of contractual restraints and the lead-time necessary to obtain FDA approval of a new manufacturer, replacement of any of these manufacturers may
be expensive and time consuming and may cause interruptions in our supply of these products to our customers.
We have a limited ability to control the manufacturing process or costs related to the third-party manufacture of our products. Increases in
the prices we pay our manufacturers, interruptions in the supply of our products or lapses in quality could adversely impact our margins, profitability
and cash flows. We are reliant on our third-party manufacturers to maintain the facilities at which they manufacture our products in compliance with
all FDA and other applicable regulatory requirements. If these manufacturers fail to maintain compliance with FDA or other applicable regulatory
requirements, they could be ordered to cease manufacturing, which could have a materially adverse impact on our revenues and operating results.
We may be forced to consider entering into additional manufacturing arrangements with other third-party manufacturers. In each case, we
will incur significant costs and time in obtaining the regulatory approvals for these third-party facilities and in taking the necessary steps to prepare
these third parties for the manufacture of our products.
Our operations, including our use of hazardous materials, chemicals, bacteria and viruses, require us to comply with regulatory requirements
and expose us to significant potential liabilities.
Our operations involve the use of hazardous materials, including chemicals, bacteria, viruses and radioactive materials, and may produce
dangerous waste products. Accordingly, we, along with the third parties that conduct clinical trials and manufacture our products and product
candidates on our behalf, are subject to federal, state, local and foreign laws and regulations that govern the use, manufacture, distribution, storage,
handling, exposure, disposal and recordkeeping with respect to these materials. Under the Federal Select Agent Program, pursuant to the Public
Health Security and Bioterrorism Preparedness and Response Act, we are required to register with and be inspected by the CDC and the Animal and
Plant Health Inspection Service if we have in our possession, or if we use or transfer, select biological agents or toxins that could pose a threat to
public health and safety, to animal or plant health or to animal or plant products. This legislation requires stringent safeguards and security measures
for these select agents and toxins, including controlled access and the screening of entities and personnel and establishes a comprehensive national
database of registered entities. We are also subject to a variety of environmental and occupational health and safety laws. Compliance with current or
future laws and regulations can require significant costs and we could be subject to substantial fines and penalties in the event of noncompliance. In
addition, the risk of contamination or injury from these materials cannot be completely eliminated. In such event, we could be held liable for
substantial civil damages or costs associated with the cleanup of hazardous materials. From time to time, we have been involved in remediation
activities and may be so involved in the future. Any related cost or liability might not be fully covered by insurance, could exceed our resources and
could have a material adverse effect on our business. In addition to complying with environmental and occupational health and safety laws, we must
comply with special regulations relating to biosafety administered by the CDC, HHS, U.S. Department of Agriculture and the DoD, as well as
regulatory authorities in Canada.
PRODUCT DEVELOPMENT RISKS
Our business depends on our success in developing and commercializing our product candidates. If we are unable to commercialize these product
candidates, or experience significant delays or unanticipated costs in doing so, our business would be materially and adversely affected.
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We have invested significant efforts and financial resources in the development of our vaccines, therapeutics and medical device product
candidates and the acquisition of additional product candidates. In addition to our product sales, our ability to generate revenue is dependent on a
number of factors, including the success of our development programs, the U.S. government's interest in providing development funding for or
procuring certain of our Biodefense division product candidates, the interest of non-governmental organizations and other commercial entities in
providing grant funding for development of certain of our Biosciences division product candidates and the commercial viability of our acquired or
developed product candidates. The commercial success of our product candidates will depend on many factors, including accomplishing the
following in an economical manner:
successful development, formulation and cGMP scale-up of manufacturing that meets FDA 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 customers, physicians, patients, healthcare payors and others in the medical community.
For example, if we are unable to successfully partner our otlertuzumab program, there may be a delay in conducting pivotal clinical trials
necessary to seek approval from the FDA, which in turn could delay or prevent the commercialization of oltertuzumab. If we are delayed or
prevented from developing or commercializing a product candidate in a profitable manner, or if doing so requires us to incur significant
unanticipated costs, our growth could be materially and adversely affected.
Clinical trials of product candidates are expensive and time-consuming, and their outcome is uncertain. We must invest substantial amounts of
time and financial resources in these trials, which may not yield viable products.
Before obtaining regulatory approval for the sale of our product candidates, we and our collaborative partners where applicable must
conduct extensive preclinical studies and clinical trials to establish proof of concept and demonstrate the safety and efficacy of our product
candidates. Preclinical and clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to
outcome. Success in preclinical testing and early clinical trials does not ensure that later clinical trials or animal efficacy studies will be successful,
and interim results of a clinical trial or animal efficacy study do not necessarily predict final results. An unexpected result in one or more of our
clinical trials can occur at any stage of testing.
For certain of our Biodefense product candidates, we expect to rely on the Animal Rule to obtain regulatory approval. The Animal Rule
permits, in certain limited circumstances, the use of animal efficacy studies, together with human clinical safety and immunogenicity trials, to
support an application for marketing approval. For a product approved under the Animal Rule, certain additional post-marketing requirements apply.
For example, to the extent feasible and ethical, applicants must conduct post-marketing studies, such as field studies, to verify and describe the drug's
clinical benefit and to assess its safety when used as indicated. We have limited experience in the application of these rules to the product candidates
that we are developing. It is possible that results from these animal efficacy studies may not be predictive of the actual efficacy of our product
candidates in humans. Under the Project BioShield Act of 2004, or Project BioShield, the Secretary of HHS can contract to purchase
countermeasures for the SNS prior to FDA approval of the countermeasure in specified circumstances. Project BioShield also allows the FDA
commissioner to authorize the emergency use of medical products that have not yet been approved by the FDA under an Emergency Use
Authorization. If our Biodefense product candidates are not selected under this Project BioShield authority, they generally will have to be approved
by the FDA through traditional regulatory mechanisms.
We may experience unforeseen events or issues during, or as a result of, preclinical testing, clinical trials or animal efficacy studies. These
issues and events, which could delay or prevent our ability to receive regulatory approval for a product candidate, include, among others:
our inability to manufacture sufficient quantities of materials for use in trials;
the unavailability or variability in the number and types of subjects for each study;
safety issues or inconclusive or incomplete testing, trial or study results;
drug immunogenicity;
lack of efficacy of product candidates during the trials;
government or regulatory restrictions or delays; and
greater than anticipated costs of trials.
For example, in February 2013, we announced the results of a Phase IIb clinical trial evaluating the safety and efficacy of MVA85A in
preventing tuberculosis in infants, which indicated that a single dose of MVA85A was not sufficient to confer statistically significant protection
against tuberculosis in infants. As a consequence of these results, we ceased further development work on MVA85A.
We depend on third parties to conduct our clinical and non-clinical trials. If these third parties do not perform as contractually required or as we
expect, we may not be able to obtain regulatory approval for or commercialize our product candidates and, as a result, our business may suffer.
We do not have the ability to independently conduct the clinical and non-clinical trials required to obtain regulatory approval for our
product candidates. We depend on third parties, such as independent clinical investigators, contract research organizations and other third-party
service providers to conduct the clinical and non-clinical trials of our product candidates and expect to continue to do so. We rely heavily on these
third parties for successful execution of our clinical and non-clinical trials, but do not exercise day-to-day control over their activities. Our reliance
on these service providers does not relieve us of our regulatory responsibilities, including ensuring that our trials are conducted in accordance with
good clinical practice regulations and the plan and protocols contained in the relevant regulatory application. In addition, these organizations may not
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complete these activities on our anticipated or desired timeframe. We also may experience unexpected cost increases that are beyond our control.
Problems with the timeliness or quality of the work of a contract research organization may lead us to seek to terminate the relationship and use an
alternative service provider, which may prove difficult, costly and result in a delay of our trials. Any delay in or inability to complete our trials could
delay or prevent the development, approval and commercialization of our product candidates.
In certain cases, government entities and non-government organizations conduct studies of our product candidates, and we may seek to rely
on these studies in applying for marketing approval for certain of our product candidates. These government entities and non-government
organizations have no obligation or commitment to us to conduct or complete any of these studies or clinical trials and may choose to discontinue
these development efforts at any time. Furthermore, government entities depend on annual Congressional appropriations to fund their development
efforts.
If we are unable to obtain any necessary third-party services on acceptable terms or if these service providers do not successfully carry out
their contractual duties or meet expected deadlines, our efforts to obtain regulatory approvals for our product candidates may be delayed or
prevented.
We may fail to select or capitalize on the most scientifically, clinically or commercially promising or profitable product candidates.
We continue to evaluate our business strategy and, as a result, may modify our strategy in the future. In this regard, we may, from time to
time, focus our product development efforts on different product candidates or may delay or halt the development of various product candidates. For
example, in February 2013, as a consequence of clinical trial results, we ceased further development work on MVA85A, our tuberculosis vaccine
candidate. As a result of changes in our strategy, we may change or refocus our existing product development, commercialization and manufacturing
activities. This could require changes in our facilities and our personnel. Any product development changes that we implement may not be
successful. In particular, we may fail to select or capitalize on the most scientifically, clinically or commercially promising or profitable product
candidates. Our decisions to allocate our research and development, management and financial resources toward particular product candidates or
therapeutic areas may not lead to the development of viable commercial products and may divert resources from better opportunities. Similarly, our
decisions to delay or terminate product development programs may also prove to be incorrect and could cause us to miss valuable opportunities.
INTELLECTUAL PROPERTY RISKS
If we are unable to protect our proprietary rights, our business could be harmed.
Our success, particularly with respect to the Biosciences business and small molecule product candidates, will depend, in large part, on our
ability to obtain and maintain protection in the United States and other countries for the intellectual property covering or incorporated into our
technology, products and product candidates. Obtaining and maintaining this protection is very costly. The patentability of technology in the
biopharmaceutical field generally is highly uncertain and involves complex legal and scientific questions.
We may not be able to obtain additional issued patents relating to our technology or products. Even if issued, patents may inadvertently lapse
or be challenged, narrowed, invalidated or circumvented, which could limit our ability to stop competitors from marketing similar products or limit the
duration of patent protection we may have for our products. In the past, we have abandoned the prosecution and/or maintenance of patent applications
related to patent families in the ordinary course of business. In the future we may choose to abandon such prosecution and/or maintenance in a similar
fashion. If these patent rights are later determined to be valuable or necessary to our business, our competitive position may be adversely affected.
Changes in patent laws or administrative patent office rules or changes in interpretations of patent laws in the United States and in other countries may
diminish the value of our intellectual property or narrow the scope of our patent protection, or result in costly defensive measures.
The cost of litigation to uphold the validity of patents to prevent infringement or to otherwise protect or enforce our proprietary rights could be
substantial and, from time to time, our patents are subject to opposition proceedings. Some of our competitors may be better able to sustain the costs of
complex patent litigation because they may have substantially greater financial resources. Intellectual property lawsuits are expensive and unpredictable
and would consume management's time and attention and other resources, even if the outcome were successful. In addition, there is a risk that a court
would decide that our patents are not valid and that we do not have the right to stop the other party from using the inventions covered by or incorporating
them. There is also a risk that, even if the validity of a patent were upheld, a court would refuse to stop the other party from using the invention(s),
including on the grounds that its activities do not infringe the patent. If any of these events were to occur, our business, financial condition and operating
results could be materially and adversely affected.
Our collaborators and licensors may not adequately protect our intellectual property rights. These third parties may have the first right to
maintain or defend intellectual property rights in which we have an interest and, although we may have the right to assume the maintenance and defense
of such intellectual property rights if these third parties do not do so, our ability to maintain and defend such intellectual property rights may be
compromised by the acts or omissions of these third parties. For example, we license from Pfizer, Inc. an oligonucleotide adjuvant, CPG 7909, for use in
our anthrax vaccine product candidate NuThrax.
We also will rely on current and future trademarks to establish and maintain recognized brands. If we fail to acquire and protect such
trademarks, our ability to market and sell our products, and therefore our business, financial condition and operating results, could be materially and
adversely affected.
Third parties may choose to file patent infringement claims against us; defending ourselves from such allegations would be costly, time-
consuming, distracting to management and could materially affect our business.
Our development and commercialization activities, as well as any product candidates or products resulting from these activities, may infringe
or be claimed to infringe patents and other intellectual property rights of third parties under which we do not hold sufficient licenses or other rights.
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Additionally, third parties may be successful in obtaining patent protection for technologies that cover development and commercialization activities in
which we are already engaged. Third parties may own or control these patents and intellectual property rights in the United States and abroad. These third
parties may have substantially greater financial resources than us and could bring claims against us that could cause us to incur substantial expenses to
defend against these claims and, if successful against us, could cause us to pay substantial damages. Further, if a patent infringement or other similar suit
were brought against us, we could be forced to stop or delay development, manufacturing or sales of the product or product candidate that is the subject
of the suit. Intellectual property litigation in the biopharmaceutical industry is common, and we expect this trend to continue.
As a result of patent infringement or other similar claims, or to avoid potential claims, we may choose or be required to seek a license from the
third party and be required to pay license fees or royalties or both. These licenses may not be available on acceptable terms, or at all. Even if we were able
to obtain a license, the rights may be non-exclusive, which could result in our competitors gaining access to the same intellectual property. Ultimately, we
could be prevented from commercializing a product, or be forced to cease some aspect of our business operations, if, as a result of actual or threatened
patent infringement claims, we are unable to enter into licenses on acceptable terms, if at all, or if an injunction is granted against us, which could harm
our business significantly.
If we fail to comply with our obligations in our intellectual property licenses with third parties, we could lose license rights that are important to
our business.
We are a party to a number of license agreements and expect to enter into additional license agreements in the future. Our existing licenses
impose, and we expect future licenses will impose, various diligence, milestone payment, royalty, insurance and other obligations on us. If we fail to
comply with these obligations, the licensor may have the right to terminate the license and/or sue us for breach, which could cause us to not be able
to market any product that is covered by the licensed patents and may be subject to damages.
If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be
adversely affected.
In addition to patented technology, we rely upon unpatented proprietary technology, processes and know-how, particularly as to our
proprietary manufacturing processes. Because we do not have patent protection for any of our current products, our only intellectual property
protection for these products, other than trademarks, is confidentiality regarding our manufacturing capability and specialty know-how, such as
techniques, processes and unique starting materials. However, these types of trade secrets can be difficult to protect. We seek to protect this
confidential information, in part, through agreements with our employees, consultants and third parties as well as confidentiality policies and audits,
although these may not be successful in protecting our trade secrets and confidential information.
These agreements may be breached, and we may not have adequate remedies for any such breach. In addition, our trade secrets may
otherwise become known, including through a potential cyber security breach, or may be independently developed by competitors. If we are unable
to protect the confidentiality of our proprietary information and know-how, competitors may be able to use this information to develop products that
compete with our products, which could adversely impact our business.
RISKS RELATED TO STRATEGIC ACQUISITIONS AND COLLABORATIONS
Our strategy of generating growth through acquisitions may not be successful.
Our business strategy includes growing our business through acquisition and in-licensing transactions. We may not be successful in
identifying, effectively evaluating, acquiring or in-licensing, and developing and commercializing additional products on favorable terms, or at all.
Competition for attractive product opportunities is intense and may require us to devote substantial resources, both managerial and financial, to an
acquisition opportunity. A number of more established companies are also pursuing strategies to acquire or in-license products in the
biopharmaceutical field. These companies may have a competitive advantage over us due to their size, cash resources, cost of capital, effective tax
rate and greater clinical development and commercialization capabilities.
Acquisition efforts can consume significant management attention and require substantial expenditures, which could detract from our other
programs. In addition, we may devote significant resources to potential acquisitions that are never completed. Even if we are successful in acquiring
a product or company, it may not result in a successfully developed or commercialized product or, even if an acquired product is commercialized,
competing products or technologies could render a product noncompetitive, uneconomical or obsolete. Moreover, the cost of acquiring other
companies or in-licensing products could be substantial, and in order to acquire companies or new products, we may need to incur substantial debt or
issue dilutive securities. For example, in part to fund our acquisition of Cangene Corporation, we issued $250 million of senior convertible notes in
January 2014. If we are unsuccessful in our efforts to acquire other companies or in-license and develop additional products, or if we acquire or in-
license unproductive assets, it could have a material adverse effect on the growth of our business, and we could be compelled to record significant
impairment charges to write-down the carrying value of our acquired intangible assets, which could materially harm our financial results.
Our failure to successfully integrate acquired assets into our operations could adversely affect our ability to realize the benefits of such
acquisitions and, therefore, to grow our business.
We may not be able to integrate any acquired business successfully or operate any acquired business profitably. In addition, cost synergies,
if achieved at all, may be less than we expect, or may take greater time to achieve than we anticipate.
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Issues that could delay or prevent successful integration or cost synergies of an acquired business include, among others:
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;
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.
If we are unable to successfully integrate future acquisitions with our existing businesses, or operate any acquired business profitably, we
may not obtain the advantages that the acquisitions were intended to create, which may materially adversely affect the growth of our business.
We may not be successful in establishing and maintaining collaborations that leverage our capabilities in pursuit of developing and
commercializing our product candidates.
For each of our product candidates, including otlertuzumab, our humanized anti-CD37 therapeutic, we plan to evaluate the merits of entering
into collaboration arrangements with third parties, including leading biopharmaceutical companies or non-governmental organizations. We expect to
selectively pursue collaboration arrangements with third parties that have particular technology, expertise or resources for the development or
commercialization of our product candidates or for accessing particular markets. We face, and will continue to face, significant competition in seeking
appropriate partners for our product candidates. If we are unable to identify partners whose capabilities complement and integrate well with ours and
reach collaboration arrangements with such partners on acceptable terms, or if the arrangements we establish are unproductive for us, we may fail to meet
our business objectives for the particular product candidate.
Any collaboration that we enter into may not be successful and the success of our collaboration arrangements will depend heavily on the efforts
and activities of our collaborators. It is likely that our collaborators will have significant discretion in determining the efforts and resources that they will
apply to these collaborations.
The risks that we are subject to in any of our collaborations include, among others:
our collaborators may not commit adequate resources to the development, marketing and distribution of any collaboration products,
limiting our potential revenues from these products;
our collaborators may experience financial difficulties and may therefore be unable to meet their commitments to us;
our collaborators may pursue a competing product candidate developed either independently or in collaboration with others, including our
competitors; and
our collaborators may terminate our relationship.
For example, in 2011, our previous collaboration partner Abbott Laboratories, or Abbott, terminated its collaboration with us for the
development of otlertuzumab following a portfolio reprioritization process by Abbott.
Failure of any of our future collaboration partners to perform as expected could place us at a competitive disadvantage and adversely affect us
financially, including delay and increased costs of development, loss of market opportunities, lower than expected revenues and impairment of the value
of the related product candidate.
FINANCIAL RISKS
Servicing our debt requires a significant amount of cash, and we may not have sufficient cash flow from our operations to pay our substantial debt.
As of December 31, 2015, our total consolidated indebtedness was $253 million, including $250 million of obligations under our senior
convertible notes. Our ability to make scheduled payments of the principal of, to pay interest on or to refinance our indebtedness, including the senior
convertible notes, depends on our future performance, which is subject to economic, financial, competitive and other factors beyond our control. Our
business may not continue to generate cash flow from operations in the future sufficient to service our debt and make necessary capital expenditures. If
we are unable to generate such cash flow, we may be required to adopt one or more alternatives, such as selling assets, restructuring debt or obtaining
additional equity capital on terms that may be onerous or highly dilutive. Our ability to refinance our indebtedness will depend on the capital markets and
our financial condition at such time. We may not be able to engage in any of these activities or engage in these activities on desirable terms, which could
result in a default on our debt obligations.
Our current indebtedness and any additional debt financing may restrict the operation of our business and limit the cash available for investment
in our business operations.
In addition to our current debt, we also have a senior secured revolving credit facility with available capacity of up to $100 million,
effective until December 11, 2018 (or such earlier date to the extent required by the terms of this facility). We may seek additional debt financing to
support our ongoing activities or to provide additional financial flexibility. Debt financing could have significant adverse consequences for our
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business, including:
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.
We may not have sufficient funds or be able to obtain additional financing to pay the amounts due under our indebtedness. In addition,
failure to comply with the covenants under our debt instruments could result in an event of default under those instruments. An event of default could
result in the acceleration of amounts due under a particular debt instrument and a cross default and acceleration under other debt instruments, and we
may not have sufficient funds or be able to obtain additional financing to make any accelerated payments. Under these circumstances, our lenders
could seek to enforce security interests, if any, in our assets securing our indebtedness.
We may require significant additional funding and may be unable to raise capital when needed or on acceptable terms, which would harm our
ability to grow our business, results of operations and financial condition.
We may require significant additional funding to grow our business, including to acquire other companies or products, in-license and
develop additional products, enhance our manufacturing capacity, support commercial marketing activities or otherwise provide additional financial
flexibility. We may also require additional funding to support our ongoing operations in the event that our ability to sell BioThrax to the U.S.
government is interrupted for an extended period of time, reducing our BioThrax revenues and decreasing our cash balances.
As of December 31, 2015, we had approximately $312.8 million of cash and cash equivalents. Our future capital requirements will depend
on many factors, including, among others:
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 costs of commercialization activities, including product marketing, sales and distribution; and
the costs associated with the planned spin-off our Biosciences business, including funding that may be provided to the Biosciences business
and costs of the transaction.
If our capital resources are insufficient to meet our future capital requirements, we will need to finance our cash needs through public or
private equity or debt offerings, bank loans or collaboration and licensing arrangements. In May 2015, we filed an automatic shelf registration
statement, which immediately became effective under SEC rules. For so long as we continue to satisfy the requirements to be deemed a "well-known
seasoned issuer" under SEC rules, this shelf registration statement, effective until May 2018, allows us to issue an unrestricted amount of equity, debt
and certain other types of securities through one or more future primary or secondary offerings. If we raise funds by issuing equity securities, our
stockholders may experience dilution. Public or bank debt financing, if available, may involve agreements that include covenants, like those
contained in our senior secured revolving credit facility, limiting or restricting our ability to take specific actions, such as incurring additional debt,
making capital expenditures, pursuing acquisition opportunities or declaring dividends. If we raise funds through collaboration and licensing
arrangements with third parties, it may be necessary to relinquish valuable rights to our technologies or product candidates or grant licenses on terms
that may not be favorable to us. We are not restricted under the terms of the indenture governing our senior convertible notes from incurring
additional debt, securing existing or future debt, recapitalizing our debt or taking a number of other actions that could have the effect of diminishing
our ability to make payments on our indebtedness. However, our credit facility restricts our ability to incur additional indebtedness, including secured
indebtedness.
Current economic conditions may make it difficult to obtain financing on attractive terms, or at all. If financing is unavailable or lost, our
business, results of operations and financial condition would be adversely affected and we could be forced to delay, reduce the scope of or eliminate
many of our planned activities.
We may not maintain profitability in future periods or on a consistent basis.
Although we have been profitable for each of the last five fiscal years, we have not been profitable for every quarter during that time. For
example, we incurred a net loss in the first quarters of 2015, 2014, 2013 and 2012. Our profitability has been substantially dependent on BioThrax
product sales, which historically have fluctuated significantly from quarter to quarter, and we expect that they will continue to fluctuate significantly
based primarily on the timing of our fulfillment of orders from the U.S. government. Additionally, our profitability may be adversely affected as we
progress through various stages of ongoing or planned clinical trials for our product candidates. We may not be able to achieve consistent
profitability on a quarterly basis or sustain or increase profitability on an annual basis.
30
OTHER BUSINESS RISKS
We face product liability exposure, which could cause us to incur substantial liabilities and negatively affect our business, financial condition
and results of operations.
We face an inherent risk of product liability exposure related to the sale of our products, any other products that we successfully acquire or
develop and the testing of our product candidates in clinical trials.
One measure of protection against such lawsuits is coverage under the Public Readiness and Emergency Preparedness Act, or PREP Act,
which was signed into law in December 2005. The PREP Act creates immunity for manufacturers of biodefense countermeasures when the Secretary
of HHS issues a declaration for their manufacture, administration or use. A PREP Act declaration is meant to provide immunity from all claims under
federal or state law for loss arising out of the administration or use of a covered countermeasure. The Secretary of HHS has issued PREP Act
declarations identifying BioThrax, BAT, Anthrasil and VIGIV as covered countermeasures. These declarations expire in 2022. Manufacturers are not
entitled to protection under the PREP Act in cases of willful misconduct. We cannot predict whether the Secretary of HHS will renew the
declarations when they expire, whether Congress will fund the relevant PREP Act compensation programs, or whether the necessary prerequisites for
immunity would be triggered with respect to our products or product candidates.
Additionally, BioThrax and RSDL are certified anti-terrorism products covered under the protections of the Support Anti-Terrorism by
Fostering Effective Technology Act of 2002, or SAFETY Act. The SAFETY Act creates product liability limitations for qualifying anti-terrorism
technologies for claims arising from or related to an act of terrorism. Although we are entitled to the benefits of the SAFETY Act for BioThrax and
RSDL, the SAFETY Act may not provide adequate protection from claims made against us.
If we cannot successfully defend ourselves against future claims that our products or product candidates caused injuries and if we are not
entitled to indemnity by the U.S. government, or the U.S. government does not honor its obligations to us under the PREP Act or SAFETY Act, or if
the indemnification under the PREP Act and SAFETY Act is not adequate to cover all claims, we may incur substantial liabilities. Regardless of
merit or eventual outcome, product liability claims may result in:
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 amount of insurance that we currently hold may not be adequate to cover all liabilities that may occur. Further product liability
insurance may be difficult and expensive to obtain. We may not be able to maintain insurance coverage at a reasonable cost and we may not be able
to obtain insurance coverage that will be adequate to satisfy all potential liabilities. For example, we may not have sufficient insurance against
potential liabilities associated with a possible large scale deployment of BioThrax as a countermeasure to a bioterrorism threat. We rely on PREP Act
protection for BioThrax, BAT, Anthrasil and VIGIV and SAFETY Act protection for BioThrax and RSDL in addition to our insurance coverage to
help mitigate our product liability exposure for these products. Claims or losses in excess of our product liability insurance coverage could have a
material adverse effect on our business, financial condition and results of operations.
We rely significantly on information technology systems and any failure, inadequacy, interruption or security lapse of that technology, including
any cyber security incidents, could harm our ability to operate our business effectively or result in data leakage of proprietary and confidential
business and employee information.
Our business is increasingly dependent on critical, complex and interdependent information technology systems, including Internet-based
systems, to support business processes as well as internal and external communications. The size and complexity of our computer systems make them
potentially vulnerable to interruption, invasion, computer viruses, destruction, malicious intrusion and additional related disruptions, which may
result in the impairment of production and key business processes.
In addition, our systems are potentially vulnerable to data security breaches—whether by employee error, malfeasance or other
disruption—which may expose sensitive data to unauthorized persons. Such data security breaches could lead to the loss of trade secrets or other
intellectual property, or could lead to the public exposure of personal information, including sensitive personal information, of our employees,
clinical trial patients, customers and others.
A significant business disruption or a breach in security resulting in misappropriation, theft or sabotage with respect to our proprietary and
confidential business and employee information could result in financial, legal, business or reputational harm to us, any of which could adversely
affect our business, financial condition and operating results.
Our success is dependent on our continued ability to attract, motivate and retain key personnel, and any failure to attract or retain key personnel
may negatively affect our business.
Because of the specialized scientific nature of our business, our ability to develop products and to compete with our current and future
competitors largely depends upon our ability to attract, retain and motivate highly qualified managerial and key scientific and technical personnel. If
we are unable to retain the services of one or more of the principal members of senior management or other key employees, our ability to implement
our business strategy could be materially harmed. We face intense competition for qualified employees from biopharmaceutical companies, research
31
organizations and academic institutions. Attracting, retaining or replacing these personnel on acceptable terms may be difficult and time-consuming
given the high demand in our industry for similar personnel. We believe part of being able to attract, motivate and retain personnel is our ability to
offer a competitive compensation package, including equity incentive awards. If we cannot offer a competitive compensation package or otherwise
attract and retain the qualified personnel necessary for the continued development of our business, we may not be able to maintain our operations or
grow our business.
RISKS RELATED TO OWNERSHIP OF OUR COMMON STOCK
Fuad El-Hibri, executive chairman of our Board of Directors, has significant influence over us through his substantial beneficial ownership of
our common stock, including an ability to influence the election of the members of our Board of Directors, or delay or prevent a change
of control of us.
Mr. El-Hibri has the ability to significantly influence the election of the members of our Board of Directors due to his substantial beneficial
ownership of our common stock. As of February 19, 2016, Mr. El-Hibri was the beneficial owner of approximately 14% of our outstanding common
stock. As a result, Mr. El-Hibri could delay or prevent a change of control of us that may be favored by other directors or stockholders and otherwise
exercise substantial control over all corporate actions requiring board or stockholder approval, including any amendment of our certificate of
incorporation or by-laws. The control by Mr. El-Hibri may prevent other stockholders from influencing significant corporate decisions. In addition,
Mr. El-Hibri's significant beneficial ownership of our shares could present the potential for a conflict of interest.
Provisions in our certificate of incorporation and by-laws and under Delaware law may discourage acquisition proposals, delay a change in
control or prevent transactions that stockholders may consider favorable.
Provisions in our certificate of incorporation and by-laws may discourage, delay or prevent a merger, acquisition or other changes in
control that stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares.
These provisions may also prevent or frustrate attempts by our stockholders to replace or remove our management.
These provisions include:
the classification of our directors;
limitations on changing the number of directors then in office;
limitations on the removal of directors;
limitations on filling vacancies on the board;
limitations on the removal and appointment of the chairman of our Board of Directors;
advance notice requirements for stockholder nominations 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.
The affirmative vote of holders of our capital stock representing at least 75% of the voting power of all outstanding stock entitled to vote is
required to amend or repeal the above provisions of our certificate of incorporation. The affirmative vote of either a majority of the directors present
at a meeting of our Board of Directors or holders of our capital stock representing at least 75% of the voting power of all outstanding stock entitled to
vote is required to amend or repeal our by-laws.
In addition, Section 203 of the General Corporation Law of Delaware prohibits a corporation from engaging in a business combination with
an interested stockholder, generally a person which, together with its affiliates, owns or within the last three years has owned 15% or more of the
corporation's voting stock, for a period of three years after the date of the transaction in which the person became an interested stockholder, unless
the business combination is approved in a prescribed manner. Accordingly, Section 203 may discourage, delay or prevent a change in control of us.
Our stockholder rights plan could prevent a change in control of us in instances in which some stockholders may believe a change in control is in
their best interests.
Under our stockholder rights plan, we issue to each of our stockholders one preferred stock purchase right for each outstanding share of our
common stock. Each right, when exercisable, will entitle its holder to purchase from us a unit consisting of one one-thousandth of a share of series A
junior participating preferred stock at a purchase price of $150 in cash, subject to adjustments.
Our stockholder rights plan is intended to protect stockholders in the event of an unfair or coercive offer to acquire us and to provide our
Board of Directors with adequate time to evaluate unsolicited offers. The rights plan may have anti-takeover effects. The rights plan will cause
substantial dilution to a person or group that attempts to acquire us on terms that our Board of Directors does not believe are in our best interests or
those of our stockholders and may discourage, delay or prevent a merger or acquisition that stockholders may consider favorable, including
transactions in which stockholders might otherwise receive a premium for their shares.
Our stock price is volatile and purchasers of our common stock could incur substantial losses.
Our stock price has been, and is likely to continue to be, volatile. The market price of our common stock could fluctuate significantly for
many reasons, including in response to the risks described in this "Risk Factors" section, or for reasons unrelated to our operations, such as reports by
industry analysts, investor perceptions or negative announcements by our customers, competitors or suppliers regarding their own performance, as
well as industry conditions and general financial, economic and political instability. From November 15, 2006, when our common stock first began
trading on the New York Stock Exchange, through February 19, 2016, our common stock has traded as high as $40.49 per share and as low as $4.40
32
per share. The stock market in general as well as the market for biopharmaceutical companies in particular have experienced extreme volatility that
has often been unrelated to the operating performance of particular companies. The market price of our common stock may be influenced by many
factors, including, among others:
decisions and procurement policies by the U.S. government affecting BioThrax;
the success of competitive products or technologies;
results of clinical and non-clinical trials of our product candidates;
announcements of acquisitions, collaborations, financings or other transactions by us;
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.
Because we currently do not pay dividends, investors will benefit from an investment in our common stock only if it appreciates in value.
We currently do not pay dividends on our common stock. Our senior secured credit facility and any future debt agreements that we enter
into may limit our ability to pay dividends. As a result, capital appreciation, if any, of our common stock will be the sole source of gain for our
stockholders for the foreseeable future.
A significant portion of our shares may be sold into the market at any time. This could cause the market price of our common stock to
drop significantly.
Sales of a substantial number of shares of our common stock in the public market could occur at any time. These sales or the perception in
the market that the holders of a large number of shares intend to sell shares could reduce the market price of our common stock. Moreover, holders of
an aggregate of approximately 6 million shares of our common stock outstanding as of February 19, 2016, have the right to require us to register
these shares of common stock under specified circumstances. In May 2015, we filed an automatic shelf registration statement, which immediately
became effective under SEC rules. For so long as we continue to satisfy the requirements to be deemed a "well-known seasoned issuer" under SEC
rules, this shelf registration statement, effective until May 2018, would provide for a secondary offering of these shares from time to time.
ITEM 1B. UNRESOLVED STAFF COMMENTS
Not applicable.
ITEM 2. PROPERTIES
The following table sets forth general information regarding our materially important properties:
Location
Lansing, Michigan
Baltimore, Maryland
Use
Manufacturing operations facilities, office space
and laboratory space
Manufacturing facilities and office and laboratory
space
Office and laboratory space
Manufacturing facilities
Gaithersburg, Maryland
Hattiesburg, Mississippi
Winnipeg, Manitoba, Canada Manufacturing operations facilities, office space
Baltimore, Maryland
Seattle, Washington
Gaithersburg, Maryland
Biodefense
and laboratory space
Manufacturing facilities and office and laboratory
space
Office and laboratory space
Office space/rental real estate
Segment
Biodefense
Approximate
square feet
Owned/leased
336,000
Owned/leased
Owned
Biodefense
56,000
Owned
Biodefense
Biodefense
Biosciences
48,000
4,000
315,000
Owned
Lease expires 2020
Owned
Biosciences
70,000
Owned
Biosciences
Biodefense/Biosciences
51,000
130,000
Leases expire 2020
Owned
Lansing, Michigan. We own a multi-building campus on approximately 12.5 acres in Lansing, Michigan that includes facilities for current
and future bulk manufacturing of BioThrax, including fermentation, filtration and formulation, as well as for raw material storage and in-process and
final product warehousing. The campus is secured through perimeter fencing, limited and controlled ingress and egress and 24-hour on-site security
personnel.
Baltimore, Maryland. We own a 56,000 square foot manufacturing facility in Baltimore, Maryland. We are using this facility to support our
future product development and manufacturing needs, including those of our pipeline product candidates, as well as to meet the requirements under
the Center for Innovation in Advanced Development and Manufacturing contract. Our future use of this facility will be dependent on the progress of
our existing development programs and the outcome of our efforts to acquire new product candidates.
33
Gaithersburg, Maryland. We own a facility in Gaithersburg, Maryland that is approximately 48,000 square feet and contains a combination
of laboratory and office space.
Hattiesburg, Mississippi. In connection with our acquisition of the Healthcare Protective Products Division of Bracco Diagnostics Inc., we
acquired rights to a manufacturing and packaging facility at The University of Southern Mississippi's Accelerator, a technology innovation and
commercialization center. This facility is equipped to manufacture and package RSDL.
Biosciences
Winnipeg, Manitoba, Canada. With our acquisition of Cangene Corporation, or Cangene, on February 21, 2014, we acquired facilities in
Winnipeg, Manitoba, Canada including a manufacturing facility focused primarily on plasma-derived hyperimmune therapeutics and a
manufacturing facility focused primarily on bacterial fermentation.
Baltimore, Maryland. Additionally, as part of the Cangene acquisition, we acquired a manufacturing facility focused on pharmaceutical
product development and filling services for injectable and other sterile products, as well as process design, technical transfer, manufacturing
validations, laboratory support, aseptic filling, lyophilization, final packaging and accelerated and ongoing stability studies.
Seattle, Washington. We lease a facility in Seattle, Washington that is approximately 51,000 square feet and contains a combination of
laboratory and office space.
Biodefense and Biosciences
Gaithersburg, Maryland. In 2013, we acquired a 130,000 square foot building in Gaithersburg, Maryland, a portion of which we utilize as
our corporate headquarters, while continuing to rent a portion of the remainder of the space to third parties.
ITEM 3. LEGAL PROCEEDINGS
From time to time, we are involved in various routine legal proceedings incident to the ordinary course of our business. We believe that the
outcome of all pending legal proceedings in the aggregate is unlikely to have a material adverse effect on our business, financial condition or results
of operations.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
PART II
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES
OF EQUITY SECURITIES
Market Information and Holders
Our common stock trades on the New York Stock Exchange under the symbol "EBS". The following table sets forth the high and low sales
prices per share of our common stock during each quarter of the years ended December 31, 2015 and December 31, 2014:
Year Ended December 31, 2015
High
Low
Year Ended December 31, 2014
High
Low
First Quarter
Second
Quarter
Third
Quarter
Fourth
Quarter
$
$
$
$
30.96 $
25.97 $
28.48 $
21.72 $
33.84 $
28.33 $
27.17 $
20.04 $
36.20 $
27.82 $
25.41 $
20.11 $
40.49
27.68
28.08
19.31
As of February 19, 2016, the closing price per share of our common stock on the New York Stock Exchange was $37.69 and we had 24
holders of record of our common stock. This number does not include beneficial owners whose shares are held by nominees in street name.
Dividend Policy
We have not declared or paid any cash dividends on our common stock since becoming a publicly traded company in November 2006. We
currently intend to retain all of our future earnings to finance the growth and development of our business.
34
Recent Sales of Unregistered Securities
None.
Use of Proceeds
Not applicable.
Purchases of Equity Securities
The table below presents information regarding shares of our common stock that we repurchased during the month ended December 31,
2015. We did not purchase any shares of our common stock during the period from October 1, 2015 through November 30, 2015.
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
December 1 to December 31, 2015 (1)
Total
2,641 $
2,641 $
37.87
37.87
0 $
0 $
0.00
0.00
(1) In December 2015, in a form of stock option transaction provided for under the terms of our stock incentive plan and the stock option
agreement, we engaged in transactions with our chief executive office in which we acquired 2,641 shares of common stock as payment for the
exercise price of 4,140 stock options.
35
ITEM 6. SELECTED CONSOLIDATED FINANCIAL DATA
You should read the following selected consolidated financial data together with our consolidated financial statements and the related notes
included in this annual report on Form 10-K and the "Management's Discussion and Analysis of Financial Condition and Results of Operations"
section of this annual report.
We have derived the consolidated statement of operations data for the years ended December 31, 2015, 2014, and 2013 and the
consolidated balance sheet data as of December 31, 2015, and 2014 from our audited consolidated financial statements, which are included in this
annual report on Form 10-K. We have derived the consolidated statements of operations data for the years ended December 31, 2012, and 2011 and
the consolidated balance sheet data as of December 31, 2013, 2012, and 2011 from our audited consolidated financial statements, which are not
included in this annual report on Form 10-K. Our historical results for any prior period are not necessarily indicative of results to be expected in any
future period.
(in thousands, except share and per share data)
2015
Year Ended December 31,
2013
2014
2012
2011
Statements of operations data:
Revenues:
Product sales
Contract manufacturing
Contracts, grants and collaborations
Total revenues
Operating expenses:
Cost of product sales and contract manufacturing
Research and development
Selling, general & administrative
Impairment of in-process research and development
Total operating expenses
Income from operations
Other income (expense):
Interest income
Interest expense
Other income (expense), net
Total other income (expense)
Income before provision for income taxes
Provision for income taxes
Net income
Net loss attributable to noncontrolling interest
Net income attributable to Emergent BioSolutions Inc.
Earnings per share — basic
Earnings per share — diluted (1)
Weighted average number of shares — basic
Weighted average number of shares — diluted
(in thousands)
Balance Sheet Data:
Cash and cash equivalents
Working capital
Total assets
Total long-term liabilities
Total stockholders' equity
$
$
$
$
$
356,916 $
42,968
122,905
522,789
124,295
153,997
148,458
-
426,750
96,039
572
(6,523)
(319)
(6,270)
89,769
26,899
62,870
-
62,870 $
311,881 $
30,944
107,313
450,138
118,412
150,829
122,841
-
392,082
58,056
320
(8,240)
2,926
(4,994)
53,062
16,321
36,741
-
36,741 $
257,922 $
-
54,823
312,745
62,127
119,933
87,883
-
269,943
42,802
139
-
426
565
43,367
13,108
30,259
876
31,135 $
215,879 $
-
66,009
281,888
46,077
120,226
76,018
9,600
251,921
29,967
134
(6)
1,970
2,098
32,065
13,922
18,143
5,381
23,524 $
202,409
-
70,975
273,384
42,171
124,832
74,282
-
241,285
32,099
105
-
(261)
(156)
31,943
15,830
16,113
6,906
23,019
1.63 $
1.41 $
38,595,435
47,255,842
0.98 $
0.88 $
37,344,891
45,802,807
0.86 $
0.85 $
36,201,283
36,747,556
0.65 $
0.65 $
36,080,495
36,420,662
0.65
0.64
35,658,907
36,206,052
2015
2014
As of December 31,
2013
2012
2011
312,795 $
439,001
1,043,592
283,964
660,017
280,499 $
339,239
938,691
292,554
553,201
179,338 $
216,464
626,630
80,814
489,165
141,666 $
201,440
564,230
60,195
442,128
143,901
183,364
546,864
59,083
416,727
(1) See Note 18 "Earnings per share" for details on calculation.
36
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations together with our financial
statements and the related notes and other financial information included elsewhere in this annual report on Form 10-K. Some of the information
contained in this discussion and analysis or set forth elsewhere in this annual report on Form 10-K, including statements regarding the planned spin-
off of our Biosciences business, the timing of any such spin-off, the future earnings and performance of Emergent or any of its businesses, including
the Biodefense and Biosciences businesses on a stand-alone basis if the spin-off is completed, information with respect to our plans and strategy for
our business and financing, includes forward-looking statements that involve risks and uncertainties. You should review the "Special Note Regarding
Forward-Looking Statements" and "Risk Factors" sections of this annual report on Form 10-K for a discussion of important factors that could cause
actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion
and analysis.
Overview
Product Portfolio
Emergent BioSolutions Inc. is a global specialty biopharmaceutical company seeking to protect and enhance life by offering specialized
products to healthcare providers and governments to address medical needs and emerging public health threats. We develop, manufacture, and
deliver a portfolio of medical countermeasures primarily for government agencies in the areas of biological and chemical threats and emerging
infectious diseases. We also develop and commercialize therapeutics and other specialty products for hospitals and clinics in the areas of
hematology/oncology, transplantation, infectious diseases and autoimmune disorders. We have two operating divisions: Biodefense and Biosciences.
For financial reporting purposes, we operate in two business segments that correspond to these two divisions.
Biodefense
Our Biodefense division is a specialty biopharmaceutical business focused on countermeasures that address public health threats,
specifically Chemical, Biological, Radiological, Nuclear and Explosive, or CBRNE, threats as well as emerging infectious diseases, or EID. The U.S.
government is the primary purchaser of our Biodefense products and often provides us with substantial funding for the development of our
Biodefense product candidates. Our Biodefense portfolio consists of five revenue-generating products and various investigational stage product
candidates.
Our Biodefense division marketed products are:
BioThrax® (Anthrax Vaccine Adsorbed), the only vaccine licensed by the U.S. Food and Drug Administration, or the FDA, for the general
use prophylaxis and post-exposure prophylaxis of anthrax disease;
Anthrasil™ (Anthrax Immune Globulin Intravenous (Human)), the only polyclonal antibody therapeutic licensed by the FDA for the
treatment of inhalational anthrax;
BAT™ (Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-Equine), the only heptavalent therapeutic licensed by the FDA for the treatment
of botulinum disease;
VIGIV (Vaccinia Immune Globulin Intravenous (Human)), the only therapeutic licensed by the FDA to address adverse events from
smallpox vaccination; and
RSDL® (Reactive Skin Decontamination Lotion Kit), the only device cleared by the FDA for the removal or neutralization of chemical
agents, T-2 toxin and many pesticide-related chemicals from the skin.
Our Biodefense division investigational stage product candidates are:
NuThrax™ (anthrax vaccine adsorbed with CPG 7909 adjuvant), a next generation anthrax vaccine;
UV-4B, a novel antiviral being developed for dengue and influenza infections;
GC-072, the lead compound in the EV-035 series of broad spectrum antibiotics, being developed forBurkholderia pseudomallei;
VAX161C, a recombinant pandemic influenza vaccine candidate being developed by VaxInnate, Inc. and for which we have an exclusive
license agreement to manufacture and sell in the event of a surge order from the Biomedical Advanced Research and Development
Authority, or BARDA;
PreviThrax™ (recombinant protective antigen anthrax vaccine, purified), a next generation anthrax vaccine; and
Other Biodefense product candidates focused on public health threats and emerging infectious diseases.
A unique component of our Biodefense division investigational stage product portfolio is that most of our candidates are under an active
development contract with significant funding from the U.S. government. This allows our development pipeline, along with our marketed products,
to be aligned with the strategic priorities of our U.S. and allied foreign government customers.
Our Biodefense division also has programs that leverage our proven manufacturing infrastructure and expertise. We have responded to
specific Task Order Requests issued by BARDA for the development and manufacture of specific countermeasures as part of our Center for
Innovation in Advanced Development and Manufacturing, or CIADM, program focused on imminent public health threats, including pandemic
influenza and Ebola.
Our Biodefense division also includes multiple platform technologies, including the MVAtorTM (modified vaccinia virus Ankara vector)
platform technology and Emergard™, a military-grade auto-injector device designed for intramuscular self-injection of antidotes and other
emergency response medical treatments that can address exposure to certain chemical agents and other similar emerging threats. In February 2016,
we announced that Emergard was selected by the U.S. Department of Defense, or DoD, and Battelle Memorial Institute to be tested against and
37
developed to U.S. military specifications as a platform for nerve agent antidote delivery. Development and testing of Emergard is expected to be
completed in 2016 and, if successful, could lead to Emergard's future procurement for U.S. military and emergency responder use. The testing and
development of Emergard will be performed under a subcontract with Battelle, which in turn has a prime contract with the DoD.
Operations that support this division include manufacturing, regulatory affairs, quality assurance, quality control, international sales and
marketing, and government affairs in support of our marketed products, as well as product development and manufacturing infrastructure in support
of our investigational stage product candidates.
We have derived the majority of our historical product sales revenues from BioThrax sales to the U.S. government. We are currently a
party to a contract with the Centers for Disease Control and Prevention, or CDC, an operating division of the U.S. Department of Health and Human
Services, or HHS, to supply up to 44.75 million doses of BioThrax for placement into the Strategic National Stockpile, or SNS, over a five-year
period ending September 30, 2016. We expect to continue to derive a majority of product sales revenues from our sales of BioThrax to the U.S.
government. We are focused on increasing the sales of our Biodefense products to U.S. government customers and expanding the market for our
product portfolio to other customers domestically and internationally.
On March 24, 2015, we signed a contract with BARDA for the advanced development of NuThrax. The contract, valued at $31.0 million,
consists of a 30-month base period of performance to develop NuThrax for post-exposure prophylaxis of anthrax disease. Activities to be completed
under the contract include process validation, consistency lot manufacture, assay validation, non-clinical studies, and start-up activities in preparation
for the Phase 3 clinical trial.
On July 20, 2015, we were awarded a $19.7 million contract by BARDA to develop and manufacture Ebola monoclonal antibodies. This
contract is the first BARDA Task Order for an Ebola countermeasure awarded to us under the CIADM program. Under the scope of this two-year
contract, we will perform process development, analytical method development, small-scale production runs, and current good manufacturing
practices, or cGMP, cell banking leading to cGMP manufacturing of bulk drug substance.
On August 13, 2015, the CDC exercised options under the contract for the supply of VIGIV into the SNS. The contract options, valued at
$44.0 million over two years, will require us to collect plasma for future manufacturing in addition to current collection requirements, conduct
manufacturing runs, and conduct additional activities in support of maintaining the FDA licensure of VIGIV.
Our Biodefense segment has generated net income for each of the last five years.
Biosciences
Our Biosciences division is a specialty biopharmaceutical business focused on therapeutics primarily in hematology/oncology with
secondary areas of focus in transplantation, infectious disease and autoimmunity. Our Biosciences portfolio consists of four revenue-generating
products, all of which were acquired through our acquisition of Cangene Corporation in February 2014, as well as various investigational stage
product candidates and a contract manufacturing services business.
Our Biosciences division marketed products are:
IXINITY® [coagulation factor IX (recombinant)], approved by the FDA for the prevention of bleeding episodes in people with
hemophilia B;
WinRho® SDF [Rho(D) Immune Globulin Intravenous (Human)], for treatment of autoimmune platelet disorder, also called immune
thrombocytopenic purpura, or ITP, and, separately, for the treatment of hemolytic disease of the newborn, or HDN;
HepaGam B® [Hepatitis B Immune Globulin Intravenous (Human)], for post-exposure prophylactic treatment of hepatitis-B; and
VARIZIG® [Varicella Zoster Immune Globulin (Human)], for post-exposure prophylactic treatment of varicella zoster virus, which
causes chickenpox and shingles.
Our Biosciences division investigational stage product candidates include the following:
otlertuzumab, a protein therapeutic being developed for Chronic Lymphocytic Leukemia;
ES414, now known as MOR209/ES414, an immunotherapeutic protein being developed for metastatic castration-resistant prostate
cancer under our collaboration with MorphoSys AG entered into in August 2014;
ES210, a protein therapeutic being developed for inflammation-related indications;
5E3, a monoclonal antibody therapeutic being developed for Alzheimer's disease; and
Other Biosciences protein therapeutic product candidates primarily targeting immuno-oncology.
Our Biosciences division platform technologies include:
ADAPTIRTM (modular protein technology); and
hyperimmune specialty plasma product manufacturing.
Our Biosciences segment has generated revenue for each of the last five years through product sales, development contracts and
collaborative funding but has incurred a net loss for each of those years.
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Biosciences Spin-off
In August 2015, we announced our plan to pursue a tax-free spin-off of our Biosciences business into a separate, stand-alone publicly
traded company. The spin-off is expected to create two independent public companies with distinct strategic plans, growth strategies, and operational
and development priorities. The new Biosciences company, Aptevo Therapeutics Inc., or Aptevo, will focus on providing novel oncology and
hematology therapeutics to meaningfully improve patients' lives.
The proposed spin-off recognizes that our two operating divisions have evolved into distinct business and investment opportunities. As a
result of the spin-off, Emergent and Aptevo will each become a pure play company with a focused strategy thereby enabling each company to target
investors attracted to its business profile. We will be in a better position to accelerate our growth strategy while Aptevo will be in a position to more
directly invest in novel therapeutics in the highly attractive immuno-oncology field. We expect the spin-off to enhance business focus, better align
resources to achieve strategic priorities, and unlock significant value for both companies.
Aptevo will consist of certain assets currently in our Biosciences division, including commercial products and development programs, and
the ADAPTIR platform technology. Emergent will retain the Biodefense marketed products and development programs, platform technologies,
including the hyperimmune specialty plasma product manufacturing platform, and manufacturing infrastructure, including the contract fill/finish
business. We expect to provide Aptevo with a fixed cash contribution of approximately $60 million. We anticipate that additional sources of funding
to support Aptevo's research and development investment will include commercial product sales and partnership funding.
Following the spin-off, we will be a global specialty life sciences company focused on providing specialty products for civilian and
military populations that address intentional and naturally emerging public health threats. We will be better positioned to establish ourselves as a pure
play company, recognized as a leader in the public health threats and emerging infectious diseases fields; enhance our financial returns and operating
margins through the elimination of Biosciences related research and development, sales, marketing and general and administrative costs; and,
exercise greater flexibility in our capital allocation decisions.
Product Sales
We have derived a majority of our historical product sales revenues from BioThrax sales to the U.S. government. We are currently a party
to a contract with the CDC, an operating division of the HHS to supply up to 44.75 million doses of BioThrax for placement into the Strategic
National Stockpile, or SNS, over a five-year period. Our total revenues from BioThrax sales were $293.9 million, $245.9 million and $246.7 million
for the years ended December 31, 2015, 2014 and 2013, respectively. We expect to continue to derive a majority of our product sales revenues from
sales of BioThrax to the U.S. government. We are focused on increasing the sales of our Biodefense products to U.S. government customers and
expanding the market for our product portfolio to other customers domestically and internationally.
Contracts and Grants
We seek to advance development of our product candidates through external funding arrangements. We may slow down development
programs or place them on hold during periods that are not covered by external funding. We have received funding from the U.S. government for a
number of our development programs. We continue to actively pursue additional government sponsored development contracts and grants and
commercial collaborative relationships. Both governmental agencies and philanthropic organizations may provide development funding or conduct
clinical studies of our product candidates.
Manufacturing Infrastructure
Biodefense
We have a manufacturing facility focused on bacterial fermentation located at our 12.5 acre, multi-building campus in Lansing, Michigan.
We currently manufacture BioThrax at the 100 liter scale at this facility. To augment our existing BioThrax manufacturing capabilities, we have
constructed a large-scale, multi-product facility capable of producing BioThrax at the 1320 liter scale. In July 2010, we entered into a contract with
BARDA which provides funding to support the work needed to approve manufacturing of BioThrax at the larger scale.
We also have a manufacturing facility focused on disposable manufacturing for viral and non-viral products located at our Biodefense
manufacturing facility in Baltimore, Maryland. This facility has been designed to leverage single-use bioreactor technology and is capable of making
several different products. The facility is designed to produce proteins derived from cell culture or microbial systems. In June 2012, we entered into a
contract with BARDA, which established our Baltimore facility as a CIADM. The CIADM contract with BARDA provides us with funding for
manufacturing and development activities relating to a clinical stage pandemic flu vaccine candidate that we in-licensed from a third party. We
envision our Biodefense Baltimore facility supporting future CIADM development and manufacturing activities for chemical, biological,
radiological, nuclear and explosive threat countermeasures, as well as our current and future non-CIADM product development and manufacturing
needs.
In connection with our August 2013 acquisition of the Healthcare Protective Products Division, or HPPD, of Bracco Diagnostics Inc., or
Bracco, we acquired rights to a manufacturing and packaging facility at The University of Southern Mississippi's Accelerator, a technology
innovation and commercialization center. This facility is equipped to manufacture and package RSDL. A significant portion of the doses of RSDL
that we sell to domestic customers are packaged at this facility. We also entered into a three year manufacturing agreement with Bracco and its
wholly-owned subsidiary, E-Z-EM Canada Inc. (dba Therapex), to manufacture finished RSDL units and bulk quantities of RSDL's active ingredient.
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Biosciences
In connection with the Cangene acquisition, we acquired facilities with manufacturing and other capabilities located in Winnipeg,
Manitoba, Canada. These facilities include space for plasma-derived hyperimmune therapeutics manufacturing, chromatography-based plasma
fractionation, bacterial fermentation, downstream processing capability, aseptic filling, packaging and warehousing, quality assurance and control,
development laboratories and office space. This facility has the potential capacity to provide additional contract research and manufacturing activities
if needed.
Additionally, as part of Cangene acquisition, we acquired a manufacturing facility located in Baltimore, Maryland focused on
pharmaceutical product development and filling services for injectable and other sterile products, as well as process design, technical transfer,
manufacturing validations, laboratory support, aseptic filling, lyophilization, final packaging and accelerated and ongoing stability studies and is an
approved manufacturing facility under the regulatory regimes in the United States, Canada, Japan, Brazil, the Middle East and several countries in
the European Union. The facility includes warehousing space used for cold-storage and freezer capacity to support our Biosciences product
distribution activities within the United States. This facility and its capabilities may be utilized in the future to fill and finish our development and
commercial stage products, which currently rely upon third party fill/finish providers.
Neither of these facilities will be included with the assets that are contributed to Aptevo in the planned spin-off of our Biosciences
business.
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been
prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us
to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses.
On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses, income taxes, stock-based
compensation, inventory, in-process research and development and goodwill. We base our estimates on historical experience and on various other
assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying
values of assets and liabilities and the reported amounts of revenues and expenses that are not readily apparent from other sources. Actual results may
differ from these estimates under different assumptions or conditions.
We believe the following critical accounting policies affect the more significant judgments and estimates used in the preparation of our
financial statements.
Revenue Recognition
We recognize revenues from product sales and contract manufacturing if four basic criteria have been met:
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.
All revenues from product sales are recorded net of applicable allowances for sales, rebates, special promotional programs, and discounts.
We estimate allowances for revenue reducing obligations using a combination of information received from third parties including market data,
inventory reports from major wholesalers, historical information and analysis. These estimates are subject to the inherent limitations of estimates that
rely on third-party data, as certain third-party information may itself rely on estimates and reflect other limitations. Provisions for estimated rebates
and right of returns, along with other allowances, such as discounts and promotional and other credits, are estimated based on historical payment
experience, historical relationship to revenues, estimated customer inventory levels and contract terms, and actual discounts offered.
We market and sell our Biosciences products through commercial wholesalers (direct customers) who purchase the products at a price
referred to as the wholesale acquisition cost, or WAC. Additionally, we enter into agreements with indirect customers for a contracted price that is
less than the WAC. The indirect customers, such as group-purchasing organizations, physician practice-management groups and hospitals, purchase
our products from the wholesalers. Under these agreements with the wholesalers, we guarantee to credit them for the difference between the WAC
and the indirect customers' contracted price. This credit is referred to as a chargeback. Adjustments to our chargeback provisions are made
periodically to reflect new facts and circumstances that may indicate that historical experience may not be indicative of current and/or future results.
We make subjective judgments primarily based on evaluation of current market conditions and trade inventory levels related to the products. This
evaluation may result in an increase or decrease in the experience rate that is applied to current and future sales, or as an adjustment to past sales, or
both.
We have generated BioThrax sales revenues under U.S. government contracts with HHS and the CDC. Under our current contract with the
CDC, we invoice the CDC and recognize the related revenues upon acceptance by the government at the delivery site, at which time title to the
product passes to the CDC.
From time to time, we are awarded reimbursement contracts and grants for development services by government entities and philanthropic
organizations. Under these contracts, we typically are reimbursed for our costs as we perform specific development activities, and we may also be
entitled to additional fees. Revenue on our reimbursable contracts is recognized as costs are incurred, generally based on the allowable costs incurred
during the period, plus any recognizable earned fee. The amounts that we receive under these contracts vary greatly from quarter to quarter,
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depending on the scope and nature of the work performed. We record the reimbursement of our costs and any associated fees as contracts, grants and
collaborations revenue and the associated costs as research and development expense.
Contracts, grants and collaborations revenues are subject to the estimation processes to the extent that the reimbursable costs underlying
these revenues are incurred but not billed and agreed to on a timely basis, and are subject to change in future periods when actual costs are known. To
date we have not made material adjustments to these estimates.
We analyze our multiple element revenue-generating arrangements to determine whether the elements can be separated and accounted for
individually as separate units of accounting. An item can generally be considered a separate unit of accounting if both of the following criteria are
met: (1) the delivered item(s) has value to the customer on a stand-alone basis and (2) if the arrangement includes a general right of return and
delivery or performance of the undelivered item(s) is considered probable and substantially in our control. Items that cannot be divided into separate
units are combined with other units of accounting, as appropriate. Consideration received is allocated among the separate units based on the unit's
relative selling price and is recognized in full when the appropriate revenue recognition criteria are met. We deem services to be rendered if no
continuing obligation exists on our part.
Our contract with BARDA to establish a CIADM is a service arrangement that includes multiple elements. The CIADM contract requires
us to provide a flexible infrastructure to supply medical countermeasures to the U.S. government over the contract period and includes such items as
construction and facility design, workforce development and licensure of a pandemic flu vaccine. Since none of the individual elements by
themselves satisfy the purpose of the contract, we have concluded that the CIADM contract elements cannot be separated as they do not have stand-
alone value to the U.S. government. Therefore, we have concluded that there is a single unit of accounting associated with the CIADM contract. We
recognize revenue under the CIADM contract on a straight-line basis, based upon its estimate of the total payments to be received under the contract.
We analyze the estimated payments to be received on a quarterly basis to determine if an adjustment to revenue is required. Changes in estimates
attributed to modifications in the estimate of total payments to be received are recorded prospectively.
Revenue associated with non-refundable upfront license fees that can be treated as a single unit of accounting is recognized when all
ongoing obligations have been delivered. Revenue associated with non-refundable upfront license fees under arrangements where the license fees and
any research and development activities cannot be accounted for as separate units of accounting is deferred and recognized as revenue either on a
straight-line basis over our continued involvement in the research and development process or based on the proportional performance of our expected
future obligation under the contract. Revenues from the achievement of research and development milestones, if deemed substantive, are recognized
as revenue when the milestones are achieved, and the milestone payments are due and collectible. If not deemed substantive, we recognize such
milestone as revenue on a straight-line basis over the remaining expected term of continued involvement in the research and development process or
based on the proportional performance of our expected future obligations under the contract.
In May 2014, the FASB issued ASU No. 2014-09, Summary and Amendments That Create Revenue from Contracts with Customers
(Topic 606) and Other Assets and Deferred Costs—Contracts with Customers (Subtopic 340-40). ASU No. 2014-09 supersedes the revenue
recognition requirements in Topic 605, Revenue Recognition, as well as most industry-specific guidance, and significantly enhances comparability of
revenue recognition practices across entities and industries by providing a principles-based, comprehensive framework for addressing revenue
recognition issues. In order for a provider of promised goods or services to recognize as revenue the consideration that it expects to receive in
exchange for the promised goods or services, the provider should apply the following five steps: (1) identify the contract with a customer(s); (2)
identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance
obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation. ASU No. 2014-09 also specifies the
accounting for some costs to obtain or fulfill a contract with a customer and provides enhanced disclosure requirements. The FASB has deferred
ASU No. 2014-09 for one year, and with that deferral, the standard will be effective for annual reporting periods beginning after December 15, 2017,
including interim periods within that reporting period, which for Emergent will be its 2018 first quarter. We are permitted to use either the
retrospective or the modified retrospective method when adopting ASU No. 2014-09. We are still assessing the potential impact that ASU No. 2014-
09 will have on our financial statements and disclosures, but believe that there could be changes to the revenue recognition for government contracts
and our collaboration agreement.
Income Taxes
Under the asset and liability method of income tax accounting, deferred tax assets and liabilities are determined based on the differences
between the financial reporting and the tax basis of assets and liabilities and are measured using the tax rates and laws that are expected to apply to
taxable income in the years in which those temporary differences are expected to be recovered or settled. A net deferred tax asset or liability is
reported on the balance sheet. Our deferred tax assets include the unamortized portion of in-process research and development expenses, the
anticipated future benefit of net operating losses and other timing differences between the financial reporting and tax basis of assets and liabilities.
We have historically incurred net operating losses for income tax purposes in some states and foreign jurisdictions. The amount of the
deferred tax assets on our balance sheet reflects our expectations regarding our ability to use our net operating losses and research and development
tax credit carryforwards, to offset future taxable income. The applicable tax rules in particular jurisdictions limit our ability to use net operating
losses and research and development tax credit carryforwards as a result of ownership changes.
We review our deferred tax assets on an annual basis to assess our ability to realize the benefit from these deferred tax assets. If we
determine that it is more likely than not that the amount of our expected future taxable income will not be sufficient to allow us to fully utilize our
deferred tax assets, we increase our valuation allowance against deferred tax assets by recording a provision for income taxes on our income
statement, which reduces net income or increases net loss for that period and reduces our deferred tax assets on our balance sheet. If we determine
that the amount of our expected future taxable income will allow us to utilize net operating losses in excess of our net deferred tax assets, we reduce
our valuation allowance by recording a benefit from income taxes on our income statement, which increases net income or reduces net loss for that
period and increases our deferred tax assets on our balance sheet.
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Uncertainty in income taxes is accounted for using a recognition threshold and measurement attribute for the financial statement
recognition and measurement of a tax position taken or expected to be taken in a tax return. We recognize in our financial statements the impact of a
tax position if that position is more likely than not of being sustained on audit, based on the technical merits of the position.
Mergers and Acquisitions
In a business combination, the acquisition method of accounting requires that the assets acquired and liabilities assumed be recorded as of
the date of the merger or acquisition at their respective fair values with limited exceptions. Assets acquired and liabilities assumed in a business
combination that arise from contingencies are recognized at fair value if fair value can reasonably be estimated. If the acquisition date fair value of an
asset acquired or liability assumed that arises from a contingency cannot be determined, the asset or liability is recognized if probable and reasonably
estimable; if these criteria are not met, no asset or liability is recognized. Fair value is defined as the exchange price that would be received for an
asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction
between market participants on the measurement date. Accordingly, we may be required to value assets at fair value measures that do not reflect our
intended use of those assets. Any excess of the purchase price (consideration transferred) over the estimated fair values of net assets acquired is
recorded as goodwill. Transaction costs and costs to restructure the acquired company are expensed as incurred. The operating results of the acquired
business are reflected in our consolidated financial statements after the date of the merger or acquisition. If we determine the assets acquired do not
meet the definition of a business under the acquisition method of accounting, the transaction will be accounted for as an acquisition of assets rather
than a business combination and, therefore, no goodwill will be recorded. The fair values of intangible assets, including acquired in-process research
and development, or IPR&D, are determined utilizing information available near the merger or acquisition date based on expectations and
assumptions that are deemed reasonable by management. Given the considerable judgment involved in determining fair values, we typically obtain
assistance from third-party valuation specialists for significant items. Amounts allocated to acquired IPR&D are capitalized and accounted for as
indefinite-lived intangible assets. Upon successful completion of each project, we will make a separate determination as to the then useful life of the
asset and begin amortization. The judgments made in determining estimated fair values assigned to assets acquired and liabilities assumed in a
business combination, as well as asset lives, can materially affect our results of operations.
The fair values of identifiable intangible assets related to currently marketed products and product rights are primarily determined by using
an "income approach" through which fair value is estimated based on each asset's discounted projected net cash flows. Our estimates of market
participant net cash flows take into consideration the following factors: historical and projected pricing, margins and expense levels, the performance
of competing products where applicable, relevant industry and therapeutic area growth drivers and factors, current and expected trends in technology
and product life cycles, the time and investment that will be required to develop products and technologies, the ability to obtain marketing and
regulatory approvals, the ability to manufacture and commercialize the products, the extent and timing of potential new product introductions by our
competitors, and the life of each asset's underlying patent, if any. The net cash flows are then probability-adjusted where appropriate to consider the
uncertainties associated with the underlying assumptions, as well as the risk profile of the net cash flows utilized in the valuation. The probability-
adjusted future net cash flows of each product are then discounted to present value utilizing an appropriate discount rate.
The fair values of identifiable intangible assets related to IPR&D are determined using an income approach, through which fair value is
estimated based on each asset's probability-adjusted future net cash flows, which reflect the different stages of development of each product and the
associated probability of successful completion. The net cash flows are then discounted to present value using an appropriate discount rate. Intangible
assets are tested for impairment whenever events or changes in circumstances indicate that its carrying amount may not be recoverable.
Contingent Consideration
We record contingent consideration associated with both (a) sales based royalties and (b) development and regulatory milestones at fair
value. The fair value model used to calculate this obligation is based on the income approach (a discounted cash flow model) that has been risk
adjusted based on the probability of achievement of net sales and achievement of the milestones. The inputs we use for determining the fair value of
the contingent consideration associated with sales based royalties and development and regulatory milestones are Level 3 fair value measurements.
We re-evaluate the fair value on a quarterly basis. Changes in the fair value can result from adjustments to the discount rates and updates in the
assumed timing of or achievement of net sales. Any future increase in the fair value of the contingent consideration associated with sales based
royalties along with development and regulatory milestones are based on an increased likelihood that the underlying net sales or milestones will be
achieved.
The associated payment or payments which will therefore become due and payable for sales based royalties associated with marketed
products will result in a charge to cost of product sales and contract manufacturing in the period in which the increase is determined. Similarly, any
future decrease in the fair value of contingent consideration associated with sales based royalties will result in a reduction in cost of product sales and
contract manufacturing. The changes in fair value for potential future sales based royalties associated with product candidates in development will
result in a charge to selling, general and administrative expense in the period in which the increase is determined. Similarly, any future decrease in
the fair value of contingent consideration associated with potential future sales based royalties for products candidates will result in a reduction in
selling, general and administrative expense.
The associated payment or payments which will therefore become due and payable for development and regulatory milestones will result in
a charge to research and development expense in the period in which the increase is determined. Similarly, any future decrease in the fair value for
development and regulatory milestones will result in a reduction in research and development expense.
Provision for Chargebacks
We record sales for our Bioscience products primarily net of provisions for chargebacks, administration fees, rebates and other
adjustments. These provisions are primarily estimated based on historical experience, future expectations, contractual arrangements with wholesalers
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and indirect customers, and other factors known to management at the time of accrual. Provisions for chargebacks, administration fees, rebates and
other adjustments require varying degrees of subjectivity. While rebates generally are based on contractual terms and require minimal estimation,
chargebacks require management to make more subjective assumptions.
The provision for chargebacks is a significant and complex estimate used in the recognition of revenue. We sell our products directly
primarily to large commercial wholesale distributors. We also sell our products indirectly to group-purchasing organizations, physician practice-
management groups and hospitals, collectively referred to as "indirect customers." We enter into agreements with our indirect customers to establish
pricing for certain of our products. The indirect customers then independently select a wholesaler from which to purchase the products. If the price
paid by the indirect customers is lower than the price paid by the wholesaler, we will provide a credit, called a chargeback, to the wholesaler for the
difference between the contractual price with the indirect customers and the wholesaler purchase price. The provision for chargebacks is based on
expected sell-through levels by our wholesale customers to the indirect customers and estimated wholesaler inventory levels.
As sales to the large wholesale customers fluctuate the reserve for chargebacks will also generally fluctuate in the same direction.
However, the degree of the fluctuation depends on product mix and the amount of sales made to indirect customers with which we have specific
chargeback agreements.
On a quarterly basis management reviews actual payments for provisions, wholesaler and distributor sales to our indirect customers,
inventory balances at the wholesalers and distributors, as well as any known market factors that may impact our estimate, and we make adjustments
when we believe that actual expected chargebacks may differ from the actual chargeback reserve.
Financial Operations Overview
Revenues
Effective September 30, 2011, we entered into a contract with the CDC to supply up to 44.75 million doses of BioThrax to the CDC over a
five-year period. The period of performance under the contract is from September 30, 2011 through September 30, 2016. The maximum amount that
could be paid to us under the contract is $1.25 billion, subject to availability of funding by the U.S. government. As of December 31, 2015, the U.S.
government has committed approximately $1.1 billion for the procurement of BioThrax doses under this contract. Through December 31, 2015, we
have delivered and, upon CDC acceptance, recognized revenue on approximately 37 million doses, representing approximately $1.0 billion in
revenue under this contract.
We have received development funding from BARDA, the CDC, Defense Threat Reduction Agency, or DTRA, and National Institute of
Allergy and Infectious Diseases, or NIAID, for the following development programs:
Development Programs
Anthrasil
BAT
Anthrasil
BAT
Post-Exposure Prophylaxis indication for BioThrax (PEP)
Large-scale manufacturing for BioThrax
NuThrax
PreviThrax
CIADM
VIGIV
Anthrasil
NuThrax
GC-072
NuThrax
Funding Source
BARDA
CDC
BARDA
BARDA
BARDA
BARDA
NIAID
BARDA
BARDA
CDC
BARDA
NIAID
DTRA
BARDA
Award Date
Sep-02
Jan-03
Sep-05
May-06
Sep-07
Jul-10
Jul-10
Sep-10
Jun-12
Aug-12
Sep-13
Aug-14
Aug-14
Mar-15
Performance Period
9/2002 — 12/2015
1/2003 — 1/2015
9/2005 — 4/2021
5/2006 — 5/2026
9/2007 — 3/2016
7/2010 — 7/2016
8/2010 — 4/2015
9/2010 — 9/2015
6/2012 — 6/2037
8/2012 — 8/2017
9/2013 — 9/2018
8/2014 — 10/2019
8/2014 — 8/2017
3/2015 — 8/2017
Our revenue, operating results and profitability have varied, and we expect that they will continue to vary on a quarterly basis, primarily
due to the timing of our fulfilling orders for BioThrax and work done under new and existing grants and development contracts, and collaborative
relationships.
Cost of Product Sales and Contract Manufacturing
The primary expense that we incur to deliver to our customers our marketed vaccines and therapeutics and to perform for our customers
our contract manufacturing operations is manufacturing costs consisting of fixed and variable costs. Variable manufacturing costs consist primarily
of costs for materials and personnel-related expenses for direct and indirect manufacturing support staff, contract manufacturing and filling
operations, and sales-based royalties. Fixed manufacturing costs include facilities, utilities and amortization of intangible assets. We determine the
cost of product sales for products sold during a reporting period based on the average manufacturing cost per unit in the period those units were
manufactured. In addition to the fixed and variable manufacturing costs described above, the cost of product sales depends on utilization of available
manufacturing capacity.
The primary expense that we incur to deliver our medical devices to our customers is the cost per unit of production from our third-party
contract manufacturers. Other associated expenses include sales-based royalties, amortization of intangible assets, shipping, logistics and the cost of
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support functions.
Research and Development Expenses
We expense research and development costs as incurred. Our research and development expenses consist primarily of:
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.
We intend to focus our product development efforts on promising late-stage candidates that we believe satisfy well-defined criteria and
seek to utilize collaborations or non-dilutive funding. We plan to seek funding for development activities from external sources and third parties,
such as governments and non-governmental organizations, or through collaborative partnerships. We expect our research and development spending
will be dependent upon such factors as the results from our clinical trials, the availability of reimbursement of research and development spending,
the number of product candidates under development, the size, structure and duration of any clinical programs that we may initiate, the costs
associated with manufacturing our product candidates on a large-scale basis for later stage clinical trials, and our ability to use or rely on data
generated by government agencies, such as studies involving BioThrax conducted by the CDC.
Selling, General and Administrative Expenses
Selling, general and administrative expenses consist primarily of personnel-related costs and professional fees in support of our executive,
sales and marketing, business development, government affairs, finance, accounting, information technology, legal and human resource functions.
Other costs include facility costs not otherwise included in cost of product sales and contract manufacturing or research and development expense.
Collaboration with MorphoSys AG
In August 2014, we entered into a collaboration agreement ("MorphoSys Agreement") with MorphoSys AG ("MorphoSys") for the joint
worldwide development and commercialization of MOR209/ES414, a targeted immunotherapeutic protein, which activates host T-cell immunity
specifically against cancer cells expressing prostate specific membrane antigen, an antigen commonly overexpressed on prostate cancer cells.
MOR209/ES414 was constructed using our proprietary ADAPTIR platform technology. In accordance with the terms of the initial MorphoSys
Agreement, we received a nonrefundable $20.0 million upfront payment and could have received up to $163.0 million in additional contingent
payments, of which $80.0 million and $83.0 million, respectively, were due upon the achievement of specified development and regulatory
milestones. We determined that payments for the achievement of the development and regulatory milestones are substantive milestones and will be
accounted for as revenue in the period in which the milestone is achieved. We will jointly fund further development of MOR209/ES414. Under the
original MorphoSys Agreement, we were responsible for 36% of the total development cost and MorphoSys was responsible for the remainder, with
our funding requirement capped at $186.0 million. We retain commercialization rights in the U.S. and Canada, with a tiered royalty obligation to
MorphoSys, ranging from mid-single digit up to 20%. MorphoSys has worldwide commercialization rights excluding the U.S. and Canada, with a
low single digit royalty obligation to us. Our current obligations under the collaboration include the performance of non-clinical, clinical,
manufacturing and regulatory activities.
In December 2015, after a joint review of data from the ongoing Phase 1 dose escalation study of MOR209/ES414 in prostate cancer
patients, Emergent and MorphoSys decided to adjust the dosing regimen and administration of MOR209/ES414. We plan to continue the current
clinical trial under an amended protocol with recruitment to start around mid-2016. As a result of the required dosing regimen and administration
change and the impact to overall development timeline and technical risk, the co-development agreement with MorphoSys was re-structured. In
December 2015, Emergent and MorphoSys amended the collaboration agreement to decrease the additional contingent payments due upon the
achievement of specified development and regulatory milestones to $32.5 million and $41.5 million, respectively. In addition, the amended
collaboration agreement changed the total expected funding requirement for us to $460.0 million and changed the jointly funded development cost
allocation to the following:
2016: Emergent is responsible for 75%; MorphoSys responsible for 25%
2017-2018: Emergent is responsible for 49%; MorphoSys responsible for 51%
2019 and beyond: Emergent is responsible for 36%; MorphoSys responsible for 64%
We evaluated the MorphoSys agreement and have determined that it is a revenue arrangement with multiple deliverable or performance
obligations. We determined that there were two units of accounting under the MorphoSys Agreement: (1) the license to further develop and
commercialize MOR209/ES414 and (2) development services. We determined the license had stand-alone value as the drug candidate has been (1)
developed and was Phase 1 clinical trial ready; (2) MorphoSys possesses the knowledge, technology, skills, experience and infrastructure necessary
for all further development of the drug through commercialization; and (3) MorphoSys has the right to sublicense the product. We allocated the $20.0
million upfront payment to the two units of accounting using the relative selling price method. We determined the estimated selling price of the
license using the income approach. The estimated selling price includes unobservable inputs such as estimated revenues and operating margins, the
time and resources needed to complete the development and approval, and risks related to the viability of and potential for alternative treatments. The
estimated selling price of the development services is based on the estimated number of full-time equivalent personnel at a contracted rate defined in
the MorphoSys Agreement, which are approximate terms of other service related contracts both entered into by us and observed generally through
other collaboration negotiations.
44
During the year ended December 31, 2015, we recorded revenue of $5.5 million pursuant to the MorphoSys Agreement, including a $5.0
million development milestone and continued amortization of the upfront payment, which is included in contracts, grants and collaborations revenues
within our Biosciences segment.
In-process Research and Development and Goodwill
IXINITY
In the acquisition of Cangene we acquired the IXINITY product candidate, an in-process research and development, or IPR&D, intangible
asset. As part of the purchase price allocation, our management determined that the estimated acquisition date fair value related to the IXINITY
IPR&D asset was $8.3 million. The estimated fair value was determined using the income approach, which discounts expected future cash flows to
present value. The projected cash flows used in determining the fair value of IXINITY were based on key assumptions, including: estimates of
revenues and operating profits considering its stage of development on the acquisition date, the time and resources needed to complete the
development and approval of the product candidate, the life of the potential commercialized product and associated risks, including the inherent
difficulties and uncertainties in developing a product candidate such as obtaining marketing approval from the FDA and other regulatory agencies,
and risks related to the viability of and potential alternative treatments in any future target markets.
In April 2015, the FDA approved IXINITY for the treatment of Hemophilia B in adults and children. As a result, the $8.3 million IXINITY
IPR&D asset was reclassified as a definite-live intangible asset and is being amortized over 10 years.
EV-035
In the acquisition of the EV-035 series of molecules, or EV-035, from Evolva Holding SA, or Evolva, in December 2014, we acquired
another IPR&D asset. As part of the purchase price allocation, management determined that the estimated acquisition date fair value related to the
EV-035 IPR&D asset was $10.5 million. The fair value was determined using the income approach, which discounts expected future cash flows to
present value. The projected cash flows used in determining the fair value of the EV-035 series of molecules were based on key assumptions,
including: estimates of revenues and operating profits considering its stage of development on the acquisition date, the time and resources needed to
complete the development and approval of the product candidate, the life of the potential commercialized product and associated risks, including the
inherent difficulties and uncertainties in developing a product candidate such as obtaining marketing approval from the FDA and other regulatory
agencies, and risks related to the viability of any potential alternative treatments in any future target markets. The EV-035 IPR&D asset is considered
to be indefinite-lived until the completion or abandonment of the associated research and development efforts.
In September 2015, we received data for the leading molecule in the series, GC-072, that indicated a potential toxicity issue. We considered
this information an indicator of impairment for the EV-035 series of molecules IPR&D asset, and completed an impairment assessment of this asset.
Based on this assessment, we recorded a non-cash impairment charge of $9.8 million, which was included in our statement of operations as research
and development expense within the Biodefense segment. The carrying value of the EV-035 series of molecules IPR&D asset was reduced to $0.7
million at December 31, 2015, and is included in the Biodefense segment.
We have completed our annual impairment assessments for the IPR&D assets and goodwill as of October 1, 2015 and 2014, respectively,
and determined that the fair value of the IPR&D assets and goodwill were in excess of carrying value. The following table summarizes our IPR&D
and goodwill by reporting unit:
Reporting unit (in thousands)
Biosciences therapeutics
Biosciences contracts manufacturing
Biosciences subtotal
Biodefense therapeutics and vaccines
Biodefense medical device(s)
Biodefense subtotal
December 31, 2015
December 31, 2014
IPR&D
Goodwill
IPR&D
Goodwill
$
41,800 $
-
41,800
701
-
701
13,902 $
6,736
20,638
24,348
9,916
34,264
50,100 $
-
50,100
10,528
-
10,528
13,902
6,736
20,638
22,031
9,916
31,947
Total
$
42,501 $
54,902 $
60,628 $
52,585
45
Results of Operations
Year Ended December 31, 2015 Compared to Year Ended December 31, 2014
Revenue
(in thousands)
Product sales:
BioThrax
Other Biodefense
Total Biodefense
Biosciences products
Total product sales
Contract manufacturing
Contracts, grants and collaborations
Total revenues
Product Sales:
Year ended December 31,
2015
2014
Change
% Change
$
$
293,921 $
34,989
328,910
28,006
356,916
42,968
122,905
522,789 $
245,905 $
35,889
281,794
30,087
311,881
30,944
107,313
450,138 $
48,016
(900)
47,116
(2,081)
45,035
12,024
15,592
72,651
20%
(3%)
17%
(7%)
14%
39%
15%
16%
The increase in BioThrax sales was primarily due to the timing of deliveries under our contract with the CDC. BioThrax product sales
revenues during the year ended December 31, 2015 consisted of sales to the CDC of $292.8 million and aggregate international and other sales of
$1.1 million. BioThrax product sales revenues during the year ended December 31, 2014 consisted primarily of BioThrax sales to the CDC of $242.2
million and aggregate international and other sales of $3.7 million.
The decrease in Biosciences product sales revenue was primarily related to sales of WinRho® due to reduced international sales.
Contract Manufacturing:
The increase in contract manufacturing revenues was primarily due to a full year of revenues from our fill/finish facility in Baltimore and
our plasma based manufacturing facility in Winnipeg, both of which we acquired in February 2014. In addition, contract manufacturing revenue
increased by $3.8 million due to services related to the production of an MVA Ebola vaccine candidate.
Contracts, Grants and Collaborations:
The increase in contracts, grants and collaboration revenues was primarily due to the following:
increased development funding of $11.0 million for our Anthrasil program, related to plasma collection; and
increased development funding of $9.4 million related to our CIADM program, including a $5.0 million milestone payment from BARDA
and $3.0 million from new CIADM task orders.
These increases were partially offset by a decrease of approximately $10.0 million in revenue from our collaboration with Morphosys,
primarily related to recognition of over $15.0 million in revenue in 2014 related to the upfront payment.
Cost of Product Sales and Contract Manufacturing
Cost of product sales and contract manufacturing increased by $5.9 million, or 5%, to $124.3 million for 2015 from $118.4 million for
2014. Cost of product sales and contract manufacturing increased primarily due to an increase in the number of BioThrax doses delivered to the
CDC, partially offset by decreased costs from our biosciences products and RSDL due primarily to the related decrease in sales revenue.
Research and Development Expense
Research and development expenses increased by $3.2 million, or 2%, to $154.0 million for 2015 from $150.8 million for 2014. This
increase primarily reflects higher contract service costs and includes increased expenses of $29.7 million for product candidates and manufacturing
development categorized in the Biodefense segment, that is partially offset by decreased expenses of $23.0 million for product candidates and
technology platform development activities categorized in the Biosciences segment and decreased expenses of $3.5 million in other research and
development, which are in support of central research and development activities. Net of contract, grants and collaborations revenues, we incurred
research and development expenses of $31.1 million and $43.5 million, during 2015 and 2014, respectively.
46
Our principal research and development expenses for 2015 and 2014 are shown in the following table:
(in thousands)
Biodefense:
Large-scale manufacturing for BioThrax
BioThrax related programs
PreviThrax
NuThrax
Pandemic influenza
Anthrasil
Botulinum antitoxin
MVA Ebola
EV-035 series of molecules
CIADM task orders
VIGIV
Emergard
Other Biodefense
Total Biodefense
Biosciences:
MOR209/ES414
IXINITY
otlertuzumab
5E3 (formerly Alzheimer's)
Other ADAPTIR related programs
Other Biosciences
Total Biosciences
Other
Total
Year ended December 31,
2015
2014
Change
% Change
$
$
9,911 $
3,511
7,152
12,560
6,583
26,000
4,867
1,490
6,801
2,957
2,864
4,643
22,323
111,662
5,856
14,627
4,854
2,733
6,314
3,433
37,817
4,518
153,997 $
13,625 $
7,157
10,737
9,428
469
19,513
7,351
-
-
-
737
-
12,959
81,976
11,818
17,456
8,818
1,838
5,800
15,090
60,820
8,033
150,829 $
(3,714)
(3,646)
(3,585)
3,132
6,114
6,487
(2,484)
1,490
6,801
2,957
2,127
4,643
9,364
29,686
(5,962)
(2,829)
(3,964)
895
514
(11,657)
(23,003)
(3,515)
3,168
(27%)
(51%)
(33%)
33%
N/A
33%
(34%)
N/A
N/A
N/A
289%
N/A
72%
36%
(50%)
(16%)
(45%)
49%
9%
(77%)
(38%)
(44%)
2%
The decrease in expense for large-scale manufacturing for BioThrax was primarily due to the timing of manufacturing development
activities. The decrease in expense for BioThrax related programs primarily reflects the timing of clinical studies to support applications for label
expansion for BioThrax. The decrease in expense for PreviThrax was primarily due to the timing of non-clinical studies. The increase in expense for
NuThrax was primarily due to increased clinical trial activities. The increase in expense for Pandemic influenza was primarily due to a milestone
payment to VaxInnate Corporation. The increase in expense for our Anthrasil program was primarily due to plasma collection services. The decrease
in expense for our Botulinum antitoxin program was primarily for stability testing and the timing of plasma collection. The expense for MVA Ebola
was primarily due to process development. The expense for EV-035 series of molecules, acquired in December 2014, was primarily due to
pharmacologic and formulation activities and a non-cash impairment charge of $9.8 million due to toxicity related issues, partially offset by a $6.3
million reduction of future contingent consideration payable, associated with the estimated timing and probability of achievement for certain
development and regulatory milestones, and reduced projected future sales of EV-035. The expense for CIADM task orders awarded in 2015 was
primarily for manufacturing development for a monoclonal antibody. The increase in expense for VIGIV was primarily for plasma collection and
stability testing. The expense for Emergard was primarily for formulation development. The increase in expense for our Other Biodefense activities
was primarily due to increased expense related to our funded pre-clinical product candidates and manufacturing development activities.
The decrease in expense for our MOR209/ES414 product candidate was primarily due to the timing of manufacturing development along
with reimbursement from MorphoSys for development activities under our cost sharing arrangement. The decrease in expense for our IXINITY
product candidate (which was approved by the FDA in April 2015) was primarily for manufacturing activities and the timing of clinical trial
activities. The decrease in expense for our otlertuzumab product candidate was primarily related to the timing of clinical trial activities. The increase
in expense for 5E3 was primarily due to early stage non-clinical activities. The increase in expense for Other ADAPTIR related programs was
primarily due to characterization and non-clinical activities. The decrease in expense for our Other Biosciences activities was primarily due to
reduced costs associated with other programs acquired through the acquisition of Cangene.
The decrease in expense for Other activities was primarily due to centralized research and development activities attributable to product
candidates.
Selling, General and Administrative Expenses
(in thousands)
Year ended December 31,
2015
2014
Change
% Change
Biodefense
Biosciences
Total selling, general and administrative expenses
$
$
76,861 $
71,597
148,458 $
69,583 $
53,258
122,841 $
7,278
18,339
25,617
10 %
34 %
21 %
47
The increase in selling, general and administrative expenses includes additional post-acquisition selling, general and administrative costs of
$13.0 million associated with the operations acquired through the acquisition of Cangene in February 2014, including product launch costs for
IXINITY, initial costs associated with the spin-off of certain components of our Biosciences division, a $3.5 million reserve for the potential write-
off of accounts receivable, along with increased professional services to support our strategic growth initiatives.
Total Other Expense
Total net other expense increased by $1.3 million, or 26%, to $6.3 million for 2015 from $5.0 million for 2014. The increase was primarily
attributable to a $2.7 million decrease in rental income partially offset by a $1.8 million charge for debt issuance costs associated with the termination
of our $125 million term loan facility in 2014.
Income Taxes
Provision for income taxes increased by $10.6 million, or 65%, to $26.9 million for 2015 from $16.3 million for 2014. The provision for
income taxes for 2015 resulted primarily from our income before provision for income taxes of $89.8 million and an effective annual tax rate of
approximately 30%. The provision for income taxes for 2014 resulted primarily from our income before provision for income taxes of $53.1 million
and an effective annual tax rate of approximately 31%. The provision for income taxes for 2015 and 2014 reflects net tax credits associated with
research and developments activities of $4.8 million and $6.0 million, respectively.
Year Ended December 31, 2014 Compared to Year Ended December 31, 2013
Revenues
(in thousands)
Product sales:
BioThrax
Other Biodefense
Total Biodefense
Biosciences products
Total product sales
Contract manufacturing
Contracts, grants and collaborations
Total revenues
Product Sales:
Year ended December 31,
2014
2013
Change
% Change
$
$
$
245,905 $
35,889
281,794
30,087
311,881 $
30,944
107,313
450,138 $
246,688 $
11,234
257,922
-
257,922 $
-
54,823
312,745 $
(783)
24,655
23,872
30,087
53,959
30,944
52,490
137,393
0 %
219 %
9 %
N/ A
21 %
N/ A
96 %
44 %
BioThrax product sales revenues during the year ended December 31, 2014 consisted of sales to the CDC of $242.2 million and aggregate
international and other sales of $3.7 million. BioThrax product sales revenues during the year ended December 31, 2013 consisted primarily of
BioThrax sales to the CDC of $244.1 million and aggregate international and other sales of $2.5 million.
Contract Manufacturing:
Contract manufacturing (acquired from Cangene in February 2014) revenues primarily consists of contract services to third parties.
Contracts, Grants and Collaborations:
The increase in contracts, grants and collaboration revenues was primarily due to the following:
development funding of $27.8 million for Anthrasil (acquired in February 2014);
development funding of $17.0 million for BAT (acquired in February 2014); and
recognition of $15.6 million, primarily related to license fee revenue, from our collaboration with MorphoSys (executed in August 2014).
These increases were partially offset by decreased revenue of $12.6 million under our development contracts for PreviThrax and large-
scale manufacturing of BioThrax, primarily due to the timing of development efforts.
Cost of Product Sales and Contract Manufacturing
Cost of product sales and contract manufacturing increased by $56.3 million, or 91%, to $118.4 million 2014 from $62.1 million for 2013.
The increase was primarily attributable to the following:
product and contract manufacturing costs of $48.6 million for 2014 associated with revenues acquired in February, 2014 as part of the
Cangene acquisition; and
increased costs of $9.4 million for RSDL, which we acquired in August 2013.
48
Research and Development Expense
Research and development expenses increased by $30.9 million, or 26%, to $150.8 million for 2014 from $119.9 million for 2013. This
increase primarily reflects higher contract service costs and includes increased expenses of $19.3 million for product candidates and manufacturing
development categorized in the Biodefense segment, increased expenses of $10.2 million for product candidates and technology platform
development activities categorized in the Biosciences segment and increased expenses of $1.4 million in other research and development, which are
in support of central research and development activities. Net of contract, grants and collaborations revenues along with the net loss attributable to
noncontrolling interests, we incurred research and development expenses of $40.0 million and $64.2 million, during 2014 and 2013, respectively.
Our principal research and development expenses for 2014 and 2013 are shown in the following table:
(in thousands)
Biodefense:
Large-scale manufacturing for BioThrax
BioThrax related programs
PreviThrax
NuThrax
Botulinum antitoxin
Anthrasil
Pandemic influenza
Other Biodefense
Total Biodefense
Biosciences:
MOR209/ES414
IXINITY
Otlertuzumab
Tuberculosis vaccine
Other Biosciences
Total Biosciences
Other
Total
Year ended December 31,
2014
2013
Change
% Change
$
$
13,625 $
7,157
10,737
9,428
7,351
19,513
-
14,164
81,975
11,818
17,456
8,818
-
22,729
60,821
8,033
150,829 $
17,876 $
10,613
14,953
9,236
-
-
2,545
7,440
62,663
7,719
-
27,035
4,882
11,016
50,652
6,618
119,933 $
(4,251)
(3,456)
(4,216)
192
7,351
19,513
(2,545)
6,724
19,312
4,099
17,456
(18,217)
(4,882)
11,713
10,169
1,415
30,896
(24%)
(33%)
(28%)
2%
N/A
N/A
(100%)
90%
31%
53%
N/A
(67%)
(100%)
106%
106%
20%
21%
The decrease in spending for large-scale manufacturing for BioThrax was primarily due to the timing of manufacturing development
activities. The decrease in spending for BioThrax related programs was primarily due to the timing of clinical studies to support applications for label
expansion for BioThrax. The decrease in spending for PreviThrax was primarily due to the timing of stability and non-clinical studies. The spending
for NuThrax was primarily due to clinical trial activities. The spending for our Botulinum Antitoxin program (which we acquired from Cangene) was
primarily due to plasma collection services and stability testing. The spending for our Anthrasil program (which we acquired from Cangene) was due
to plasma collection services and manufacturing activities. The decrease in spending for pandemic influenza was related to a license fee for the rights
to manufacture and sell pandemic influenza products during 2013. The increase in spending for Other Biodefense activities was primarily due to
increased spending related to manufacturing development.
The increase in spending for our ES414 (formerly T-Scorp) product candidate was primarily due to ongoing manufacturing development.
The spending for our IXINITY product candidate was primarily for clinical trial and manufacturing activities. The decrease in spending for our
otlertuzumab (formerly TRU-016) product candidate was primarily related to the timing of clinical trial activities. The spending for our tuberculosis
vaccine product candidate during 2013 was for manufacturing development activities. The increase in spending for Other Biosciences activities was
primarily due to increased costs associated with the development of platform technologies.
The spending for other activities was primarily due to centralized research and development activities not attributable to product
candidates.
Selling, General and Administrative Expenses
(in thousands)
Year ended December 31,
2014
2013
Change
% Change
Biodefense
Biosciences
Total selling, general and administrative expenses
$
$
69,583 $
53,258
122,841 $
60,911 $
26,972
87,883 $
8,672
26,286
34,958
14 %
97 %
40 %
The increase in selling general and administrative expenses includes increased spending for professional services of $8.1 million associated
with acquisition and integration activities, along with ongoing post-acquisition selling, general and administrative costs of $26.2 million associated
with the operations of Cangene and in support of RSDL.
The increase in Biodefense selling, general and administrative expense was primarily due to post acquisition costs associated with our
49
acquisitions of Cangene and the RSDL product from Bracco. The increase in the Biosciences selling, general and administrative expense was due to
professional services to support due diligence along with other acquisition-related activities and post-acquisition operations associated with our
acquisition of Cangene.
Total Other Income (Expense)
Total net other income (expense) decreased by $5.6 million to a net other expense of $5.0 million for 2014, from a net other income of
$565,000 for 2013. The decrease was primarily due to interest expense of $5.0 million that was not capitalized in 2014, $1.8 million of costs
associated with the termination of our $125 million term loan facility and $1.4 million of loan fee amortization expense associated with our 2.875%
Convertible Senior Notes due 2021, or the Notes, and our revolver loan facility, partially offset by $3.1 million in rental income.
Income Taxes
Provision for income taxes increased by $3.2 million, or 25%, to $16.3 million for 2014 from $13.1 million for 2013. The provision for
income taxes for 2014 resulted primarily from our income before provision for income taxes and the loss attributable to noncontrolling interest of
$53.1 million and an effective annual tax rate of approximately 31%. The provision for income taxes for 2013 resulted primarily from our income
before provision for income taxes and the loss attributable to noncontrolling interest of $44.2 million and an effective annual tax rate of
approximately 30%. The provision for income taxes for 2014 and 2013 reflects net tax credits associated with research and developments activities of
$6.0 million and $5.9 million, respectively.
Net Loss Attributable to Noncontrolling Interest
Net loss attributable to noncontrolling interest decreased to $0 for 2014 from $876,000 for 2013. The decrease resulted from the liquidation
of our noncontrolling interest in the Oxford Emergent Tuberculosis Consortium during 2013.
Liquidity and Capital Resources
Sources of Liquidity
From inception through 2015, we have funded our cash requirements principally with a combination of revenues from sales of BioThrax,
debt financing, development funding from government entities and non-government and philanthropic organizations and collaborative partners, and
the net proceeds from our initial public offering and the sale of our common stock upon exercise of stock options. We have operated profitably for
each of the five years ended December 31, 2015. As of December 31, 2015, we had cash and cash equivalents of $312.8 million.
Cash Flows
The following table provides information regarding our cash flows for the years ended December 31, 2015, 2014 and 2013.
(in thousands)
Net cash provided by (used in):
Operating activities(1)
Investing activities
Financing activities
Net increase in cash and cash equivalents
Year ended December 31,
2014
2015
2013
$
$
44,309 $
(45,462)
33,449
32,296 $
112,339 $
(210,052)
198,874
101,161 $
96,954
(67,894)
8,612
37,672
(1) Includes the effect of exchange rate changes on cash and cash equivalents.
Net cash provided by operating activities of $44.3 million in 2015 was primarily due to our net income of $62.9 million, non-cash charges
of $35.3 million for depreciation and amortization, $15.8 million for stock-based compensation and an increase in accounts payable of $4.7 million
associated with increased infrastructure activities and spin-off related liabilities, partially offset by an increase in accounts receivable of $64.4 million
related to the timing of collection of amounts billed primarily to the CDC and a $11.3 million increase in inventory due to raw material purchases for
RSDL.
Net cash provided by operating activities of $112.3 million in 2014 was primarily due to our net income of $36.7 million, a decrease in
accounts receivable of $21.4 million related to the timing of collection of amounts billed primarily to the CDC, along with the effect of non-cash
charges of $12.8 million for stock-based compensation and $32.5 million for depreciation and amortization.
Net cash provided by operating activities of $97.0 million in 2013 was primarily due to our net income of $31.1 million, a decrease in
accounts receivable of $35.5 million related to the timing of collection of amounts billed primarily to the CDC, along with the effect of non-cash
charges of $11.2 million for stock-based compensation and $19.0 million for depreciation and amortization.
Net cash used in investing activities of $45.5 million in 2015 was primarily due to software, infrastructure and equipment investments.
Net cash used in investing activities of $210.1 million in 2014 was primarily due to the acquisition of Cangene for $177.9 million, which is
net of $43.6 million of acquired cash, and capital expenditures of $30.7 million for infrastructure and equipment investments.
50
Net cash used in investing activities of $67.9 million in 2013 was primarily due to the acquisition of HPPD from Bracco for $25.9 million
and capital expenditures of $42.0 million, which includes the purchase of a new headquarters facility, construction and renovation of facilities at our
Lansing, Michigan campus, and costs of other infrastructure and equipment investments.
Net cash provided by financing activities of $33.4 million in 2015 was primarily due to $26.0 million in proceeds from the issuance of
common stock pursuant to employee equity plans, $11.3 million in excess tax benefits from the exercise of stock options and $2.0 million in proceeds
from long-term indebtedness, partially offset by $5.7 million in contingent obligation payments.
Net cash provided by financing activities of $198.9 million in 2014 was primarily due to net proceeds from our Notes of $241.6 million,
$14.1 million in proceeds from the issuance of common stock pursuant to employee equity plans and $6.0 million in excess tax benefits from the
exercise of stock options, partially offset by a principal payment on indebtedness of $62.0 million under our revolving credit facility
Net cash provided by financing activities of $8.6 million in 2013 was primarily due to proceeds of $62.0 million from our revolving credit
facility with Bank of America N.A., $6.8 million in proceeds from employee equity plans and $3.1 million in excess tax benefits from the exercise of
stock options, partially offset by principal payments on indebtedness of $62.8 million (which includes the repayment of $40.4 million for our loans
with PNC Bank and $22.3 million for our loans with HSBC Realty Credit).
Contractual Obligations
The following table summarizes our contractual obligations at December 31, 2015:
(in thousands)
Contractual obligations:
2.875% Convertible Senior Notes due 2021 (Notes)
Contractual interest due on Notes
Long-term indebtedness (excluding Notes)
Purchase commitments
Operating lease obligations
Total contractual obligations
Less than
1 year
Payments due by period
1 to 3
Years
Total
3 to 5
Years
More than
5 years
$
$
250,000 $
36,236
3,000
7,500
11,994
308,730 $
- $
7,188
-
7,500
2,577
17,265 $
- $
14,376
-
-
4,368
18,744 $
- $
14,376
-
-
2,912
17,288 $
250,000
296
3,000
-
2,137
255,433
There are a number of uncertainties that we face in the development of new product candidates that prevent us from making a reasonable
estimate of the cash obligations under our material license agreements. Because of these uncertainties, the preceding table excludes contingent
contractual payments that we may become obligated to make under such agreements. These agreements typically provide for the payment of
milestone fees upon achievement of specified research, development and commercialization milestones, such as the commencement of clinical trials,
the receipt of funding awards, the receipt of regulatory approvals, and the achievement of sales milestones. The amount of contingent contractual
milestone payments that we may become obligated to make is variable based on the actual achievement and timing of the applicable milestones and
the characteristics of any products or product candidates that are developed, including factors such as number of products or product candidates
developed, type and number of components of each product or product candidate, ownership of the various components and the specific markets
affected. The aggregate payments could be as much as approximately $183 million. The success of our efforts to commercialize our product
candidates is highly uncertain and depends on many factors, including those set forth in "Risk Factors—Our business depends on our success in
developing and commercializing our product candidates. If we are unable to commercialize these product candidates, or experience significant
delays or unanticipated costs in doing so, our business would be materially and adversely affected." Even if these efforts are successful, the timing of
success is highly unpredictable and variable. The same is true for any contingent contractual royalty payments that we may be obligated to make
upon successful commercialization of these product candidates. We do not expect that any such payments would have an adverse effect on our
financial position, operations and capital resources because, if payable, we expect that the benefits associated with the achievement of the relevant
milestones or the achievement of revenue would offset the burden of making these payments. We are not obligated to pay any minimum royalties
under our existing contracts. Deferred income taxes and liabilities for unrecognized income tax benefits are excluded from the above table since they
are not contractually fixed as to timing and amount.
Debt Financing
On January 29, 2014, we issued $250.0 million aggregate principal amount of our Notes. The Notes bear interest at a rate of 2.875% per
year, payable semi-annually in arrears on January 15 and July 15 of each year, commencing July 15, 2014. The Notes mature on January 15, 2021,
unless earlier purchased by us, redeemed or converted. The conversion rate is equal to 30.8821 shares of common stock per $1,000 principal amount
of notes, which is equivalent to a conversion price of approximately $32.38 per share of common stock. The conversion rate is subject to adjustment
upon the occurrence of certain specified events including the planned spin-off of our Biosciences business, but will not be adjusted for accrued and
unpaid interest.
On December 11, 2013, we entered into a senior secured credit agreement, or the Credit Agreement, with the three lending financial
institutions. The Credit Agreement provides for a revolving credit facility of up to $100.0 million through December 11, 2018, or such earlier date
required by the terms of the Credit Agreement, and a term loan facility of up to $125.0 million to be drawn in full, if at all, on or prior to March 31,
2014. In connection with the entry into the Credit Agreement, we borrowed $62.0 million under the revolving credit facility primarily to repay
obligations under existing loan agreements.
51
On January 29, 2014, in connection with our issuance of the Notes, the unused $125.0 million term loan portion of our Credit Agreement
terminated automatically in accordance with the terms of the senior secured credit agreement, dated December 11, 2013. In addition, following the
issuance of the Notes, we repaid the $62.0 million outstanding indebtedness under the revolving credit portion of the credit facility, which restored
the full $100.0 million revolving credit capacity under this facility. As of December 31, 2015 and 2014, no amounts were drawn under the revolving
credit facility.
Our payment obligations under the Credit Agreement are secured by a lien on substantially all of our assets, including the stock of all of the
our subsidiaries, and the assets of the subsidiary guarantors, including mortgages over certain of their real properties, including our large-scale
vaccine manufacturing facility in Lansing, Michigan and our biodefense facility in Baltimore, Maryland. Under the Credit Agreement, we are
required to make quarterly interest payments calculated using a combination of conventional base-rate measures plus a margin over those rates. The
base rates consist of LIBOR rates and prime rates. The actual rates will depend on the level of these underlying rates plus a margin based on our
leverage, on a consolidated basis, from quarter to quarter.
The Credit Agreement, as amended, contains affirmative and negative covenants customary for financings of this type. Negative covenants
in the Credit Agreement, among other things, limit our ability to incur indebtedness and liens; dispose of assets; make investments including loans,
advances or guarantees; and enter into certain mergers or similar transactions. The Credit Agreement also contains financial covenants, tested
quarterly and in connection with any triggering events under the Credit Agreement: (1) a minimum consolidated debt service coverage ratio of 2.50
to 1.00, (2) a maximum consolidated leverage ratio of 3.50 to 1.00 and (3) a minimum liquidity requirement of $50.0 million. Upon the occurrence
and continuance of an event of default under the Credit Agreement, the commitments of the lenders to make loans under the Credit Agreement may
be terminated and our payment obligations under the Credit Agreement may be accelerated. The events of default under the Credit Agreement
include, among others, subject in some cases to specified cure periods, payment defaults; inaccuracy of representations and warranties in any material
respect; defaults in the observance or performance of covenants; bankruptcy and insolvency related defaults; the entry of a final judgment in excess
of a threshold amount; change of control; and the invalidity of loan documents relating to the Credit Agreement.
Funding Requirements
We expect to continue to fund our anticipated operating expenses, capital expenditures and debt service requirements from existing cash
and cash equivalents, revenues from product sales; development contract, grant and collaboration funding; contract manufacturing services and our
revolving credit facility and any other lines of credit we may establish from time to time. There are numerous risks and uncertainties associated with
product sales and with the development and commercialization of our product candidates. We may seek additional external financing to provide
additional financial flexibility. Our future capital requirements will depend on many factors, including:
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 costs of commercialization activities, including product marketing, sales and distribution; and
the costs associated with the planned spin-off of our Biosciences business, including funding that may be provided to the Biosciences
business and costs of the transaction.
If our capital resources are insufficient to meet our future capital requirements, we will need to finance our cash needs through public or
private equity or debt offerings, bank loans or collaboration and licensing arrangements. In May 2015, we filed an automatic shelf registration
statement, which immediately became effective under SEC rules. For so long as we continue to satisfy the requirements to be deemed a "well-known
seasoned issuer" under SEC rules, this shelf registration statement, effective until May 2018, allows us to issue an unrestricted amount of equity, debt
and certain other types of securities through one or more future primary or secondary offerings. If we raise funds by issuing equity securities, our
stockholders may experience dilution. Public or bank debt financing, if available, may involve agreements that include covenants, like those
contained in our senior secured revolving credit facility, which could limit or restrict our ability to take specific actions, such as incurring additional
debt, making capital expenditures, pursuing acquisition opportunities, buying back shares or declaring dividends. If we raise funds through
collaboration and licensing arrangements with third parties, it may be necessary to relinquish valuable rights to our technologies or product
candidates or grant licenses on terms that may not be favorable to us.
We are not restricted under the terms of the indenture governing our senior convertible notes from incurring additional debt, securing
existing or future debt, recapitalizing our debt or taking a number of other actions that are not limited by the terms of the indenture governing our
notes that could have the effect of diminishing our ability to make payments on our indebtedness. However, our credit facility restricts our ability to
incur additional indebtedness, including secured indebtedness.
Current economic conditions may make it difficult to obtain financing on attractive terms, or at all. If financing is unavailable or lost, our
business, results of operations and financial condition would be adversely affected and we could be forced to delay, reduce the scope of or eliminate
many of our planned activities.
52
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our exposure to market risk is currently confined to our cash and cash equivalents. We currently do not hedge interest rate exposure or
foreign currency exchange exposure, and the movement of foreign currency exchange rates could have an adverse or positive impact on our results of
operations. We have not used derivative financial instruments for speculation or trading purposes. Because of the short-term maturities of our cash
and cash equivalents, we believe that an increase in market rates would likely not have a significant impact on the realized value of our investments,
but any increase in market rates would likely increase the interest expense associated with our debt.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTRY DATA
Report of Ernst & Young LLP,
Independent Registered Public Accounting Firm,
on the Audited Consolidated Financial Statements
The Board of Directors and Stockholders of Emergent BioSolutions Inc. and subsidiaries
We have audited the accompanying consolidated balance sheets of Emergent BioSolutions Inc. and subsidiaries as of December 31, 2015
and 2014, and the related consolidated statements of operations, comprehensive income, changes in stockholders' equity and cash flows for each of
the three years in the period ended December 31, 2015. Our audits also included the financial statement schedule listed in the Index at Item 15(a).
These financial statements and schedule are the responsibility of the Company's management. Our responsibility is to express an opinion on these
financial statements and schedule based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit
also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of
Emergent BioSolutions Inc. and subsidiaries at December 31, 2015 and 2014, and the consolidated results of their operations and their cash flows for
each of the three years in the period ended December 31, 2015, in conformity with U.S. generally accepted accounting principles. Also, in our
opinion, the related financial statement schedule, when considered in relation to the basic financial statements taken as a whole, presents fairly in all
material respects the information set forth therein.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), Emergent
BioSolutions Inc. and subsidiaries' internal control over financial reporting as of December 31, 2015, based on criteria established in Internal
Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), and our
report dated February 29, 2016 expressed an unqualified opinion thereon.
/s/ Ernst & Young LLP
McLean, Virginia
February 29, 2016
53
Emergent BioSolutions Inc. and Subsidiaries
Consolidated Balance Sheets
(in thousands, except share and per share data)
ASSETS
Current assets:
Cash and cash equivalents
Accounts receivable, net
Inventories
Deferred tax assets, current portion, net
Income tax receivable, net
Prepaid expenses and other current assets
Total current assets
Property, plant and equipment, net
In-process research and development
Intangible assets, net
Goodwill
Deferred tax assets, long-term portion, net
Other assets
Total assets
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable
Accrued expenses and other current liabilities
Accrued compensation
Contingent consideration, current portion
Provisions for chargebacks
Deferred revenue, current portion
Total current liabilities
Contingent consideration, net of current portion
Long-term indebtedness
Deferred revenue, net of current portion
Other liabilities
Total liabilities
Commitments and contingencies
$
December 31,
2015
2014
312,795 $
120,767
76,936
-
6,573
21,541
538,612
331,856
42,501
57,375
54,902
11,286
7,060
280,499
58,834
65,674
1,710
1,357
24,101
432,175
313,979
60,628
58,344
52,585
12,764
8,216
$
1,043,592 $
938,691
$
45,966 $
6,229
34,683
2,553
2,238
7,942
99,611
23,046
253,000
6,590
1,328
383,575
40,930
6,274
31,654
6,487
2,246
5,345
92,936
34,599
251,000
5,713
1,242
385,490
Stockholders' equity:
Preferred stock, $0.001 par value; 15,000,000 shares authorized, 0 shares issued and outstanding at both
December 31, 2015 and December 31, 2014
Common stock, $0.001 par value; 100,000,000 shares authorized, 39,829,408 shares issued and 39,406,578
shares outstanding at December 31, 2015; 38,129,872 shares issued and 37,709,683 shares outstanding at
December 31, 2014
Treasury stock, at cost, 422,830 and 420,189 common shares at December 31, 2015 and 2014, respectively
Additional paid-in capital
Accumulated other comprehensive loss
Retained earnings
Total stockholders' equity
Total liabilities and stockholders' equity
-
-
40
(6,420)
317,971
(2,713)
351,139
660,017
1,043,592 $
38
(6,320)
274,222
(3,008)
288,269
553,201
938,691
$
The accompanying notes are an integral part of the consolidated financial statements.
54
Emergent BioSolutions Inc. and Subsidiaries
Consolidated Statements of Operations
(in thousands, except share and per share data)
Revenues:
Product sales
Contract manufacturing
Contracts, grants and collaborations
Total revenues
Operating expense:
Cost of product sales and contract manufacturing
Research and development
Selling, general and administrative
Income from operations
Other income (expense):
Interest income
Interest expense
Other income (expense), net
Total other income (expense), net
Income before provision for income taxes
Provision for income taxes
Net income
Net loss attributable to noncontrolling interest
Net income attributable to Emergent BioSolutions Inc.
Earnings per share - basic
Earnings per share - diluted (1)
Weighted-average number of shares - basic
Weighted-average number of shares - diluted
Year Ended December 31,
2014
2015
2013
$
356,916 $
42,968
122,905
522,789
311,881 $
30,944
107,313
450,138
257,922
-
54,823
312,745
124,295
153,997
148,458
96,039
118,412
150,829
122,841
58,056
62,127
119,933
87,883
42,802
572
(6,523)
(319)
(6,270)
89,769
26,899
62,870
-
62,870 $
320
(8,240)
2,926
(4,994)
53,062
16,321
36,741
-
36,741 $
1.63 $
1.41 $
0.98 $
0.88 $
139
-
426
565
43,367
13,108
30,259
876
31,135
0.86
0.85
38,595,435
47,255,842
37,344,891
45,802,807
36,201,283
36,747,556
$
$
$
(1) See Note 18 "Earnings per share" for details on calculation.
The accompanying notes are an integral part of the consolidated financial statements.
55
Emergent BioSolutions Inc. and Subsidiaries
Consolidated Statements of Comprehensive Income
(in thousands)
2015
December 31,
2014
2013
Net income
Reclassification of cumulative foreign currency translation adjustment to income, net of tax
Foreign currency translations, net of tax
Comprehensive income
$
$
62,870 $
-
295
63,165 $
36,741 $
-
457
37,198 $
31,135
58
606
31,799
The accompanying notes are an integral part of the consolidated financial statements.
56
Emergent BioSolutions Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(in thousands)
Cash flows from operating activities:
Net income
Adjustments to reconcile to net cash provided by (used in) operating activities:
Stock-based compensation expense
Depreciation and amortization
Deferred income taxes
Non-cash development expenses from joint venture
Change in fair value of contingent obligations
Write off of debt issuance costs
Impairment of in-process research and development
Impairment of long-lived assets
Bad debt expense
Excess tax benefits from stock-based compensation
Other
Changes in operating assets and liabilities:
Accounts receivable
Inventories
Income taxes
Prepaid expenses and other assets
Accounts payable
Accrued expenses and other liabilities
Accrued compensation
Provision for chargebacks
Deferred revenue
Net cash provided by operating activities
Cash flows from investing activities:
Purchases of property, plant and equipment
Acquisitions, net of acquired cash
Net cash used in investing activities
Cash flows from financing activities:
Proceeds from convertible debenture, net of bank fees
Proceeds from long-term debt obligations
Issuance of common stock upon exercise of stock options
Excess tax benefits from stock-based compensation
Principal payments on long-term indebtedness
Contingent obligation payments
Purchase of treasury stock
Net cash provided by financing activities
Year Ended December 31,
2014
2015
2013
$
62,870 $
36,741 $
30,259
15,848
35,335
3,464
-
(10,599)
-
9,827
1,147
3,481
(11,281)
271
(64,351)
(11,262)
(3,550)
2,319
4,749
45
2,680
(8)
3,474
44,459
12,829
32,453
16,493
-
3,133
1,831
-
-
-
(5,987)
1,284
21,405
4,229
(4,711)
(8,472)
(9,279)
2,685
4,539
299
2,846
112,318
(44,812)
(650)
(45,462)
(30,673)
(179,379)
(210,052)
-
2,000
25,961
11,281
-
(5,693)
(100)
33,449
241,588
1,000
14,078
5,987
(62,000)
(1,579)
(200)
198,874
11,238
18,958
13,858
(347)
735
-
1,172
-
(3,099)
51
35,456
518
(7,179)
(6,226)
(551)
7
2,092
-
26
96,968
(42,021)
(25,873)
(67,894)
-
62,000
6,848
3,099
(62,774)
(348)
(213)
8,612
Effect of exchange rate changes on cash and cash equivalents
(150)
21
(14)
Net increase in cash and cash equivalents
Cash and cash equivalents at beginning of year
Cash and cash equivalents at end of year
Supplemental disclosure of cash flow information:
Cash paid during the year for interest
Cash paid during the year for income taxes
Supplemental information on non-cash investing and financing activities:
Purchases of property, plant and equipment unpaid at year end
32,296
280,499
312,795 $
101,161
179,338
280,499 $
37,672
141,666
179,338
7,751 $
28,271 $
3,761 $
4,711 $
2,055
6,331
4,379 $
5,394 $
2,755
$
$
$
$
The accompanying notes are an integral part of the consolidated financial statements.
57
Emergent BioSolutions Inc. and Subsidiaries
Consolidated Statement of Changes in Stockholders' Equity
(in thousands, except share and per share data)
$0.001 Par Value
Common Stock
Additional
Paid-In
Treasury Stock
Shares
Amount Capital Shares
Amount
Accumulated
Other
Comprehensive
Loss
Noncontrolling
Interest
Retained
in Subsidiary Earnings
Total
Stockholders'
Equity
Balance at
December 31,
2012
Employee equity
award plans
activity
Non-cash
development
expenses from
joint venture
Net loss
attributable to
noncontrolling
interest
Treasury stock
Net income
Foreign currency
translation, net
of tax
Balance at
December 31,
2013
Employee equity
award plans
activity
Non-cash
development
expenses from
joint venture
Treasury stock
Net income
Foreign currency
translation, net
of tax
Balance at
December 31,
2014
Employee equity
award plans
activity
Treasury stock
Net income
Foreign currency
translation, net
of tax
Balance at
December 31,
2015
58
36,272,550 $
36 $ 230,964 (403,158) $
(5,906) $
(4,129) $
770 $ 220,393 $
442,128
764,446
1
16,673
-
-
-
-
-
16,674
-
-
-
-
-
-
(347)
-
(347)
-
-
-
-
-
-
-
-
-
-
(9,795)
-
-
(213)
-
-
-
-
(876)
-
-
-
31,135
(876)
(213)
31,135
-
-
-
-
-
664
-
-
664
37,036,996 $
37 $ 247,637 (412,953) $
(6,119) $
(3,465) $
(453) $ 251,528 $
489,165
1,092,876
1
26,585
-
-
-
26,586
-
-
-
-
-
-
-
-
-
-
(7,236)
-
-
(201)
-
-
-
-
453
-
-
-
36,741
453
(201)
36,741
-
-
-
-
-
457
-
-
457
38,129,872 $
38 $ 274,222 (420,189) $
(6,320) $
(3,008) $
- $ 288,269 $
553,201
1,699,536
-
-
2
-
-
43,749
-
-
-
(2,641)
-
-
(100)
-
-
-
-
-
-
-
-
62,870
43,751
(100)
62,870
-
-
-
-
-
295
-
-
295
39,829,408 $
40 $ 317,971 (422,830) $
(6,420) $
(2,713) $
- $ 351,139 $
660,017
The accompanying notes are an integral part of the consolidated financial statements.
Emergent BioSolutions Inc. and Subsidiaries
Notes to consolidated financial statements
1. Nature of the business and organization
Emergent BioSolutions Inc. (the "Company" or "Emergent") is a global specialty biopharmaceutical company seeking to protect and
enhance life by offering specialized products to healthcare providers and governments to address medical needs and emerging public health threats.
The Company develops, manufactures, and delivers a portfolio of medical countermeasures primarily for government agencies in the areas of
biological and chemical threats and emerging infectious diseases. The Company also develops and commercializes therapeutics and other specialty
products for hospitals and clinics in the areas of hematology/oncology, transplantation, infectious diseases and autoimmune disorders. The Company
has two operating divisions: Biodefense and Biosciences. The Company commenced operations as BioPort Corporation ("BioPort") in September
1998 through an acquisition of the Michigan Biologic Products Institute, which included: acquired rights to the marketed product BioThrax, vaccine
manufacturing facilities at a multi-building campus on approximately 12.5 acres in Lansing, Michigan and vaccine development and production
know-how. In December 2001, the U.S. Food and Drug Administration ("FDA") approved a supplement to the Company's manufacturing facility
license for the manufacture of BioThrax. In June 2004, the Company completed a corporate reorganization ("Reorganization").
As a result of the Reorganization, BioPort became a wholly owned subsidiary of the Company. The Company subsequently renamed and
converted this subsidiary to Emergent Biodefense Operations Lansing LLC. The Company acquired a portion of its portfolio of vaccine and
therapeutic product candidates through an acquisition of Microscience Limited ("Microscience") in a share exchange in June 2005, and acquisitions
of substantially all of the assets, for cash, of Antex Biologics Inc. in May 2003 and ViVacs GmbH, Germany in July 2006. The Company renamed
Microscience as Emergent Product Development UK Limited. The assets acquired from Antex are held in an entity incorporated as Emergent
Product Development Gaithersburg Inc., and the assets acquired from ViVacs are held in an entity incorporated as Emergent Product Development
Germany GmbH. On October 28, 2010, the Company acquired Trubion Pharmaceuticals, Inc. ("Trubion") for cash, equity and contingent value
rights. Concurrent with the acquisition, the Company converted Trubion to Emergent Product Development Seattle, LLC. In August 2013, the
Company acquired substantially all of the assets of the Health Protective Products Division of Bracco Diagnostics Inc. ("Bracco") for cash along with
contingent purchase consideration obligations. In February 2014, the Company acquired all the shares of Cangene Corporation ("Cangene") for cash.
2. Summary of significant accounting policies
Basis of presentation and consolidation
The accompanying consolidated financial statements include the accounts of Emergent and its wholly owned and majority owned
subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation. For investments in variable interest
entities, the Company consolidates when it is determined to be the primary beneficiary.
Use of estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires
management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and
liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could
differ from those estimates.
Cash and cash equivalents
Cash equivalents are highly liquid investments with a maturity of 90 days or less at the date of purchase and consist of time deposits and
investments in money market funds with commercial banks and financial institutions. Also, the Company maintains cash balances with financial
institutions in excess of insured limits. The Company does not anticipate any losses with such cash balances.
Fair value of measurements
The Company measures and records cash equivalents and investment securities considered available-for-sale at fair value in the
accompanying financial statements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability, an
exit price, in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the
measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of
unobservable inputs. The three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value include:
Level 1 — Observable inputs for identical assets or liabilities such as quoted prices in active markets;
Level 2 —
Level 3 — Unobservable inputs in which little or no market data exists, which are therefore developed by the Company using estimates and
Inputs other than quoted prices in active markets that are either directly or indirectly observable; and
assumptions that reflect those that a market participant would use.
The carrying amounts of the Company's short-term financial instruments, which include cash and cash equivalents, accounts receivable and
accounts payable, approximate their fair values due to their short maturities.
59
Significant customers and accounts receivable
For the years ended December 31, 2015, 2014 and 2013, the Company's primary customer was the U.S. Department of Health and Human
Services ("HHS"). For the years ended December 31, 2015, 2014 and 2013, revenues from HHS and HHS agencies comprised 81%, 74% and 95%,
respectively, of total revenues and are included in the Company's Biodefense segment. As of December 31, 2015 and 2014, the Company's accounts
receivable balances were comprised of 78% and 40%, respectively, from this customer. The overall increase in the percentage of accounts receivable
attributed to HHS was due primarily to the timing of payments received for BioThrax product sales from the Centers for Disease Control ("CDC"),
an operating division of HHS, under the Company's contract with CDC. As of December 31, 2015 and 2014, unbilled accounts receivable, which is
included in accounts receivable, were $18.6 million and $18.9 million, respectively. Unbilled accounts receivable relates to various service contracts
for which work has been performed, though invoicing has not yet occurred. Accounts receivable are stated at invoice amounts and consist primarily
of amounts due from the U.S. government and collaborative partners, as well as amounts due under reimbursement contracts with other government
entities and non-government and philanthropic organizations. If necessary, the Company records a provision for doubtful receivables to allow for any
amounts which may be unrecoverable. This provision is based upon an analysis of the Company's prior collection experience, customer
creditworthiness and current economic trends.
Concentrations of credit risk
Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents
and accounts receivable. The Company places its cash and cash equivalents with high quality financial institutions. Management believes that the
financial risks associated with its cash and cash equivalents are minimal. Because accounts receivable consist primarily of amounts due from the U.S.
government for product sales and from government agencies under government grants and development contracts, management deems there to be
minimal credit risk.
Inventories
Inventories are stated at the lower of cost or market with cost being determined using a standard cost method, which approximates average
cost. Average cost consists primarily of material, labor and manufacturing overhead expenses (including fixed production-overhead costs) and
includes the services and products of third party suppliers. The Company analyzes its inventory levels quarterly and writes down, in the applicable
period, inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value and inventory in excess of
expected customer demand. The Company also writes off, in the applicable period, the costs related to expired inventory. Costs of purchased
inventories are recorded using weighted-average costing. The Company determines normal capacity for each production facility and allocates fixed
production-overhead costs on that basis.
Property, plant and equipment
Property, plant and equipment are stated at cost. Depreciation is computed using the straight-line method over the following estimated
useful lives:
Buildings
Building improvements
Furniture and equipment
Software
Leasehold improvements
31-39 years
10-39 years
3-15 years
3-7 years or product life
Lesser of the asset life or lease term
Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any
resulting gain or loss is credited or charged to operations. Repairs and maintenance costs are expensed as incurred.
The Company capitalizes internal-use software when both (a) the software is internally developed, acquired, or modified solely to meet the
entity's internal needs and (b) during the software's development or modification, no substantive plan either exists or is being developed to market the
software externally. Capitalization of qualifying internal-use software costs begins when the preliminary project stage is completed, management
with the relevant authority, implicitly or explicitly, authorizes and commits to the funding of the software project, and it is probable that the project
will be completed and the software will be used to perform the function intended.
Income taxes
Income taxes are accounted for using the liability method. Deferred tax assets and liabilities are recognized for future tax consequences
attributable to differences between financial statement carrying amounts of existing assets and liabilities and their respective tax bases and net
operating loss and research and development tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates
expected to apply to taxable income in the year in which those temporary differences are expected to be recovered or settled.
The Company's ability to realize deferred tax assets depends upon future taxable income as well as the limitations discussed below. For
financial reporting purposes, a deferred tax asset must be reduced by a valuation allowance if it is more likely than not that some portion or all of the
deferred tax assets will not be realized prior to expiration. The Company considers future taxable income and ongoing tax planning strategies in
assessing the need for valuation allowances. In general, if the Company determines that it is more likely than not to realize more than the recorded
amounts of net deferred tax assets in the future, the Company will reverse all or a portion of the valuation allowance established against its deferred
tax assets, resulting in a decrease to the provision for income taxes in the period in which the determination is made. Likewise, if the Company
determines that it is not more likely than not to realize all or part of the net deferred tax asset in the future, the Company will establish a valuation
60
allowance against deferred tax assets, with an offsetting increase to the provision for income taxes, in the period in which the determination is made.
Under sections 382 and 383 of the Internal Revenue Code, if an ownership change occurs with respect to a "loss corporation", as defined,
there are annual limitations on the amount of net operating losses and deductions that are available. The Company believes the use of net operating
losses and research and development tax credits acquired in the Trubion acquisition will not be significantly limited. Due to the acquisition of
Microscience in 2005 and the Company's initial public offering, the Company believes the use of the operating losses incurred prior to 2005 will be
significantly limited.
Because tax laws are complex and subject to different interpretations, significant judgment is required. As a result, the Company make
certain estimates and assumptions, in (1) calculating the Company's income tax expense, deferred tax assets and deferred tax liabilities,
(2) determining any valuation allowance recorded against deferred tax assets and (3) evaluating the amount of unrecognized tax benefits, as well as
the interest and penalties related to such uncertain tax positions. The Company's estimates and assumptions may differ significantly from tax benefits
ultimately realized.
In November 2015, the Financial Accounting Standards Board ("FASB") issued ASU No. 2015-17, Balance Sheet Classification of
Deferred Taxes ("ASU No. 2015-17"). The amendments in ASU No. 2015-17 change the presentation requirements for deferred tax assets and
liabilities, along with any related valuation allowance, to classify the balances solely as noncurrent on the balance sheet. As a result, each jurisdiction
will now only have one net noncurrent deferred tax asset or liability. The amendments in ASU No. 2015-17 are effective for years beginning after
December 15, 2017, and early adoption is permitted. The Company has elected to prospectively adopt the accounting standard for the year ended
December 31, 2015. Prior periods in the Company's consolidated financial statements were not retrospectively adjusted.
Revenue recognition
The Company recognizes revenues from product sales and contract manufacturing if four basic criteria have been met:
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.
All revenues from product sales are recorded net of applicable allowances for sales rebates, special promotional programs, and discounts.
The Company estimates allowances for revenue reducing obligations using a combination of information received from third parties including market
data, inventory reports from major wholesalers, historical information and analysis. These estimates are subject to the inherent limitations of
estimates that rely on third-party data, as certain third-party information may itself rely on estimates and reflect other limitations. Provisions for
estimated rebates and right of returns along with other allowances, such as discounts and promotional and other credits, are estimated based on
historical payment experience, historical relationship to revenues, estimated customer inventory levels and contract terms, and actual discounts
offered.
The Company markets and sells its Biosciences products through commercial wholesalers (direct customers) who purchase the products at
a price referred to as the wholesale acquisition cost ("WAC"). Additionally, the Company enters into agreements with indirect customers for a
contracted price that is less than the WAC. The indirect customers, such as group-purchasing organizations, physician practice-management groups
and hospitals, purchase the Company's products from the wholesalers. Under these agreements with wholesalers, the Company guarantees to credit
the wholeseller for the difference between the WAC and the indirect customers' contracted price. This credit is referred to as a chargeback.
Adjustments to the Company's chargeback provisions are made periodically to reflect new facts and circumstances that may indicate that historical
experience may not be indicative of current and/or future results. The Company makes subjective judgments primarily based on its evaluation of
current market conditions and trade inventory levels related to the Company's products. This evaluation may result in an increase or decrease in the
experience rate that is applied to current and future sales, or as an adjustment to past sales, or both.
Under previous contracts with HHS, the Company invoiced HHS and recognized the related revenues upon delivery of the product to the
government carrier, at which time title to the product passed to HHS. Effective September 30, 2011, the Company has a contract with the CDC, to
supply up to 44.75 million doses of BioThrax over a five year period. Under the Company's contract with the CDC, the Company invoices the CDC
and recognizes the related revenue upon acceptance by the government at delivery site, at which time title to the product passes to the CDC.
Collaborative research and development agreements can provide for one or more of upfront license fees, research payments, and milestone
payments. The Company analyzes its multiple element revenue-generating arrangements to determine whether the elements can be separated and
accounted for individually as separate units of accounting. An item can generally be considered a separate unit of accounting if both of the following
criteria are met: the delivered item(s) has value to the customer on a stand-alone basis and if the arrangement includes a general right of return and
delivery or performance of the undelivered item(s) is considered probable and substantially in the control of the Company. Items that cannot be
divided into separate units are combined with other units of accounting, as appropriate. Consideration received is allocated among the separate units
based on the unit's relative selling price and is recognized when the appropriate revenue recognition criteria are met. The Company deems services to
be rendered if no continuing obligation exists on the part of the Company.
The Company's contract with the Biomedical Advanced Research and Development Authority ("BARDA") to establish a Center for
Innovation in Advanced Development and Manufacturing ("CIADM") is a service arrangement that includes multiple elements. The CIADM
contract requires the Company to provide a flexible infrastructure to supply medical countermeasures to the U.S. government over the contract period
and includes such items as construction and facility design, workforce development and licensure of a pandemic flu vaccine. Since none of the
individual elements by themselves satisfy the purpose of the contract, the Company has concluded that the CIADM contract elements cannot be
61
separated as they do not have stand-alone value to the U.S. government. Therefore, the Company has concluded that there is a single unit of
accounting associated with the CIADM contract. The Company recognizes revenue under the CIADM contract on a straight-line basis, based upon
its estimate of the total payments to be received under the contract. The Company analyzes the estimated payments to be received on a quarterly basis
to determine if an adjustment to revenue is required. Changes in estimates attributed to modifications in the estimate of total payments to be received
are recorded prospectively.
Revenue associated with non-refundable upfront license fees under arrangements where the license fees and research and development
activities cannot be accounted for as separate units of accounting is deferred and recognized as revenue either on a straight-line basis over the
Company's continued involvement in the research and development process or based on the proportional performance of the Company's expected
future obligation under the contract. Revenues from the achievement of research and development milestones, if deemed substantive, are recognized
as revenue when the milestones are achieved, and the milestone payments are due and collectible. If not deemed substantive, the Company
recognizes such milestone as revenue on a straight-line basis over the remaining expected term of continued involvement in the research and
development process.
Milestones are considered substantive if all of the following conditions are met: (1) the milestone is non-refundable, (2) achievement of the
milestone was not reasonably assured at the inception of the arrangement, (3) substantive effort is involved to achieve the milestone, and (4) the
amount of the milestone appears reasonable in relation to the effort expended. Payments received in advance of work performed are recorded as
deferred revenue.
The Company generates contract and grant revenue from cost-plus-fee contracts. Revenues on reimbursable contracts are recognized as
costs are incurred, generally based on allowable costs incurred during the period, plus any recognizable earned fee. The Company considers fixed
fees under cost-plus-fee contracts to be earned in proportion to the allowable costs incurred in performance of the contract. The Company analyzes
costs for contracts and reimbursable grants to ensure reporting of revenues gross versus net is appropriate. For each of the three years in the period
ended December 31, 2015, the costs incurred under the contracts and grants approximated the revenue earned.
Revenue associated with non-refundable upfront license fees that can be treated as a single unit of accounting are recognized when all
ongoing obligations have been delivered. Revenue associated with non-refundable upfront license fees under arrangements where the license fees and
research and development activities cannot be accounted for as separate units of accounting are deferred and recognized as revenue either on a
straight-line basis over the Company's continued involvement in the research and development process or based on the proportional performance of
the Company's expected future obligations under the contract.
In May 2014, the FASB issued ASU No. 2014-09, Summary and Amendments That Create Revenue from Contracts with Customers
(Topic 606) and Other Assets and Deferred Costs—Contracts with Customers (Subtopic 340-40). ASU No. 2014-09 supercedes the revenue
recognition requirements in Topic 605, Revenue Recognition, as well as most industry-specific guidance, and significantly enhances comparability of
revenue recognition practices across entities and industries by providing a principles-based, comprehensive framework for addressing revenue
recognition issues. In order for a provider of promised goods or services to recognize as revenue the consideration that it expects to receive in
exchange for the promised goods or services, the provider should apply the following five steps: (1) identify the contract with a customer(s); (2)
identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance
obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation. ASU No. 2014-09 also specifies the
accounting for some costs to obtain or fulfill a contract with a customer and provides enhanced disclosure requirements. The FASB has deferred
ASU No. 2014-09 for one year, and with that deferral, the standard will be effective for annual reporting periods beginning after December 15, 2017,
including interim periods within that reporting period, which for the Company will be its 2018 first quarter. The Company is permitted to use either
the retrospective or the modified retrospective method when adopting ASU No. 2014-09. The Company is still assessing the potential impact that
ASU No. 2014-09 will have on its financial statements and disclosures, but believe that there could be changes to the revenue recognition for
government contracts and its collaboration agreement.
Mergers and Acquisitions
In a business combination, the acquisition method of accounting requires that the assets acquired and liabilities assumed be recorded as of
the date of the merger or acquisition at their respective fair values with limited exceptions. Assets acquired and liabilities assumed in a business
combination that arise from contingencies are recognized at fair value if fair value can reasonably be estimated. If the acquisition date fair value of an
asset acquired or liability assumed that arises from a contingency cannot be determined, the asset or liability is recognized if probable and reasonably
estimable; if these criteria are not met, no asset or liability is recognized. Fair value is defined as the exchange price that would be received for an
asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction
between market participants on the measurement date. Accordingly, the Company may be required to value assets at fair value measures that do not
reflect the Company's intended use of those assets. Any excess of the purchase price (consideration transferred) over the estimated fair values of net
assets acquired is recorded as goodwill. Transaction costs and costs to restructure the acquired company are expensed as incurred. The operating
results of the acquired business are reflected in the Company's consolidated financial statements after the date of the merger or acquisition. If the
Company determines the assets acquired do not meet the definition of a business under the acquisition method of accounting, the transaction will be
accounted for as an acquisition of assets rather than a business combination and, therefore, no goodwill will be recorded.
The fair values of intangible assets, including acquired in-process research and development ("IPR&D"), are determined utilizing
information available near the merger or acquisition date based on expectations and assumptions that are deemed reasonable by management. Given
the considerable judgment involved in determining fair values, the Company typically obtains assistance from third-party valuation specialists for
significant items. Amounts allocated to acquired IPR&D are capitalized and accounted for as indefinite-lived intangible assets. Upon successful
completion of each project, the Company will make a separate determination as to the then useful life of the asset and begin amortization. The
judgments made in determining estimated fair values assigned to assets acquired and liabilities assumed in a business combination, as well as asset
62
lives, can materially affect the Company's results of operations.
The fair values of identifiable intangible assets related to currently marketed products and product rights are primarily determined by using
an "income approach" through which fair value is estimated based on each asset's discounted projected net cash flows. The Company's estimates of
market participant net cash flows consider historical and projected pricing, margins and expense levels, the performance of competing products
where applicable, relevant industry and therapeutic area growth drivers and factors, current and expected trends in technology and product life cycles,
the time and investment that will be required to develop products and technologies, the ability to obtain marketing and regulatory approvals, the
ability to manufacture and commercialize the products, the extent and timing of potential new product introductions by the Company's competitors,
and the life of each asset's underlying patent, if any. The net cash flows are then probability-adjusted where appropriate to consider the uncertainties
associated with the underlying assumptions, as well as the risk profile of the net cash flows utilized in the valuation. The probability-adjusted future
net cash flows of each product are then discounted to present value utilizing an appropriate discount rate.
The fair values of identifiable intangible assets related to IPR&D are determined using an income approach, through which fair value is
estimated based on each asset's probability-adjusted future net cash flows, which reflect the different stages of development of each product and the
associated probability of successful completion. The net cash flows are then discounted to present value using an appropriate discount rate.
Indefinite-lived intangible assets are tested for impairment annually or whenever events or changes in circumstances indicate that its carrying amount
may not be recoverable.
In process research and development and long-lived assets
The Company assesses IPR&D assets for impairment on an annual basis or more frequently if indicators of impairment are present. The
Company's annual assessment includes a comparison of the fair value of IPR&D assets to existing carrying value, and recognizes an impairment
when the carrying value is greater than the determined fair value. The Company believes that the assumptions used in valuing the intangible and
IPR&D assets are reasonable and are based upon its best estimate of likely outcomes of sales and clinical development. The underlying assumptions
and estimates used to value these assets are subject to change in the future, and actual results may differ significantly from the assumptions and
estimates. The Company has selected October 1 as its annual impairment test date for indefinite-lived intangible assets.
The Company assesses the recoverability of its long-lived assets or asset groups for which an indicator of impairment exists by determining
whether the carrying value of such assets can be recovered through undiscounted future operating cash flows. If the Company concludes that the
carrying value will not be recovered, the Company measures the amount of such impairment by comparing the fair value to the carrying value of the
assets or asset groups.
Goodwill
The Company assesses the carrying value of goodwill on an annual basis, or whenever events or changes in circumstances indicate the
carrying value of goodwill may not be recoverable, to determine whether any impairment in this asset may exist and, if so, the extent of such
impairment. The provisions of the relevant accounting guidance require that the Company perform a two-step impairment test. In the first step, the
Company compares the fair value of its reporting unit to the carrying value of the reporting unit. If the carrying value of the reporting unit exceeds
the fair value of the reporting unit, then the second step of the impairment test is performed in order to determine the implied fair value of the
reporting unit's goodwill. If the carrying value of the reporting unit's goodwill exceeds its implied fair value, an impairment loss equal to the
difference is recognized. The Company calculates the fair value of the reporting unit utilizing the income approach. The income approach utilizes a
discounted cash flow model, using a discount rate based on the Company's estimated weighted average cost of capital. The Company also evaluates
goodwill for all reporting units using the qualitative assessment method, which permits companies to qualitatively assess whether it is more-likely-
than-not that the fair value of a reporting unit is less than its carrying amount. The Company considers developments in its operations, the industry in
which it operates and overall macroeconomic factors that could have affected the fair value of the reporting unit since the date of the most recent
quantitative analysis of a reporting unit's fair value.
The determination of the fair value of a reporting unit is judgmental in nature and involves the use of significant estimates and assumptions.
The estimates and assumptions used in calculating fair value include identifying future cash flows, which requires that the Company makes a number
of critical legal, economic, market and business assumptions that reflect best estimates as of the testing date. The Company's assumptions and
estimates may differ significantly from actual results, or circumstances could change that would cause the Company to conclude that an impairment
now exists or that it previously understated the extent of impairment. The Company selected October 1 as its annual impairment test date.
Contingent Consideration
The Company records contingent consideration associated with (a) sales based royalties and (b) development and regulatory milestones at
fair value. The fair value model used to calculate this obligation is based on the income approach (a discounted cash flow model) that has been risk
adjusted based on the probability of achievement of net sales and achievement of the milestones. The inputs the Company use for determining the
fair value of the contingent consideration associated with sales based royalties and development and regulatory milestones are Level 3 fair value
measurements. The Company re-evaluates the fair value on a quarterly basis. Changes in the fair value can result from adjustments to the discount
rates and updates in the assumed timing of or achievement of net sales. Any future increase in the fair value of the contingent consideration
associated with sales based royalties along with development and regulatory milestones are based on an increased likelihood that the underlying net
sales or milestones will be achieved.
The associated payment or payments which will therefore become due and payable for sales based royalties associated with marketed
products will result in a charge to cost of product sales and contract manufacturing in the period in which the increase is determined. Similarly, any
future decrease in the fair value of contingent consideration associated with sales based royalties will result in a reduction in cost of product sales and
63
contract manufacturing. The changes in fair value for potential future sales based royalties associated with product candidates in development will
result in a charge to selling, general and administrative expense in the period in which the increase is determined. Similarly, any future decrease in
the fair value of contingent consideration associated with potential future sales based royalties for products candidates will result in a reduction in
selling, general and administrative expense.
The associated payment or payments which will therefore become due and payable for development and regulatory milestones will result in
a charge to research and development expense in the period in which the increase is determined. Similarly, any future decrease in the fair value for
development and regulatory milestones will result in a reduction in research and development expense.
Research and development
Research and development costs are expensed as incurred. Research and development costs primarily consist of salaries and fees paid to
outside service providers and the costs of materials used in clinical trials and research and development. Other research and development expenses
include fees paid to consultants, materials and related expenses for personnel and facility expenses.
Comprehensive income
Comprehensive income is comprised of net income and other changes in equity that are excluded from net income. The Company includes
translation gains and losses incurred when converting its subsidiaries' financial statements from their functional currency to the U.S. dollar in
accumulated other comprehensive income.
Foreign currencies
Except for the Company's Canadian subsidiaries, the local currency is the functional currency for the Company's foreign subsidiaries and,
as such, assets and liabilities are translated into U.S. dollars at year-end exchange rates. Income and expense items are translated at average exchange
rates during the year. Translation adjustments resulting from this process are charged or credited to other comprehensive income. The Company's
Canadian subsidiaries functional currency is U.S. dollars due primarily to a significant amount of the transactions of the subsidiaries being
denominated in U.S. dollars.
Capitalized interest
The Company capitalizes interest based on the cost of major ongoing capital projects which have not yet been placed in service. For the
years ended December 31, 2015, 2014 and 2013, the Company incurred interest of $7.8 million, $7.5 million and $2.0 million, respectively. Of these
amounts, the Company capitalized $2.9 million, $2.5 million and $2.0 million, respectively.
Certain risks and uncertainties
The Company has derived a majority of its revenue from sales of BioThrax under contracts with the U.S. government. The Company's
current CDC contract does not necessarily increase the likelihood that it will secure future comparable contracts with the U.S. government. The
Company expects that a significant portion of the business that it will seek in the near future, in particular for BioThrax, will be under government
contracts that present a number of risks that are not typically present in the commercial contracting process. U.S. government contracts for BioThrax
are subject to unilateral termination or modification by the government. The Company may fail to achieve significant sales of BioThrax to customers
in addition to the U.S. government, which would harm its growth opportunities. The Company may not be able to sustain or increase profitability.
The Company may not be able to manufacture BioThrax consistently in accordance with FDA specifications.
Earnings per share
The Company calculates basic earnings per share by dividing net income by the weighted average number of shares of common stock
outstanding during the period.
For the years ended December 31, 2015 and 2014, the Company calculated diluted earnings per share using the if-converted method by
dividing the adjusted net income by the adjusted weighted average number of shares of common stock outstanding during the period. The adjusted
net income is adjusted for interest expense and amortization of debt issuance cost, both net of tax, associated with the Company's 2.875% Convertible
Senior Notes due 2021 (the "Notes"). The weighted average number of diluted shares is adjusted for the potential dilutive effect of the exercise of
stock options and the vesting of restricted stock units along with the assumption of the conversion of the Notes, each at the beginning of the period.
For the year ended December 31, 2013, diluted earnings per share is computed using the treasury method by dividing net income by the
weighted average number of shares of common stock outstanding during the period, adjusted for the potential dilutive effect of other securities if
such securities were converted or exercised.
64
Accounting for stock-based compensation
The Company has two stock-based employee compensation plans, the Third Amended and Restated Emergent BioSolutions Inc. 2006
Stock Incentive Plan (the "2006 Plan") and the Emergent BioSolutions Employee Stock Option Plan (the "2004 Plan" and together with the 2006
Plan, the "Emergent Plans"). The Company has granted options to purchase shares of common stock under the Emergent Plans and has granted
restricted stock units under the 2006 Plan. The Emergent Plans have both incentive and non-qualified stock option features. The Company no longer
grants equity awards under the 2004 Plan.
On May 22, 2014, the Company's shareholders approved an amendment to the 2006 Plan, which increased the number of shares of
common stock available for issuance under plan awards by 4.0 million. As part of this amendment, awards of restricted stock units granted after May
22, 2014 are counted against the maximum aggregate number of shares of common stock available for issuance under the 2006 Plan as 2.3 shares of
common stock for every one restricted stock unit granted. The maximum number of shares subject to awards that may be granted per year under the
2006 Plan to a single participant is 1.0 million.
As of December 31, 2015, an aggregate of 15.2 million shares of common stock were authorized for issuance under the 2006 Plan, of
which a total of 3.4 million shares of common stock remain available for future awards to be made to plan participants. The exercise price of each
option must be not less than 100% of the fair market value of the shares underlying such option on the date of grant. Awards granted under the 2006
Plan have a contractual life of no more than 10 years. The terms and conditions of equity awards (such as price, vesting schedule, term and number of
shares) under the Emergent Plans are determined by the compensation committee of the Company's board of directors, which administers the
Emergent Plans. Each equity award granted under the Emergent Plans vests as specified in the relevant agreement with the award recipient and no
option can be exercised after ten years from the date of grant.
On May 17, 2012, the Company's shareholders approved the 2012 Employee Stock Purchase Plan ("ESPP"). All employees of the
Company are eligible to participate in the ESPP, except those owning 5% or more of the Company's stock. One million shares of common stock have
been authorized for issuance under the ESPP. The ESPP has two plan periods each year: December 1 to May 31 and June 1 to November 30.
Employees are permitted to contribute between 1% and 10% of compensation during a plan period. The ESPP allows for employees to purchase
shares of the Company's stock at a 15% discount at the end of each plan period based on the share price at that time. The maximum number of shares
an employee may purchase during any plan period is 800 shares. The Company utilizes the Black-Scholes valuation model for estimating the fair
value of all shares under its ESPP. The fair value of each ESPP share is estimated at the beginning of each plan period.
The Company determines the fair value of restricted stock units using the closing market price of the Company's common stock on the day
prior to the date of grant. The Company utilizes the Black-Scholes valuation model for estimating the fair value of all stock options granted. Set forth
below are the assumptions used in valuing the stock options granted and a discussion of the Company's methodology for developing each of the
assumptions used:
Expected dividend yield
Expected volatility
Risk-free interest rate
Expected average life of options
Year Ended December 31,
2015
2014
2013
0%
34-35%
1.27-1.61%
4.3 years
0%
35-38%
1.14-1.65%
4.5 years
0%
39-49%
0.32-0.70%
4.4 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.
3. Acquisitions
EV-035 series of molecules
On December 17, 2014, the Company acquired the EV-035 series of molecules from Evolva Holding SA ("Evolva") for $1.5 million in
cash along with contingent consideration payable to Evolva, triggered upon the future achievement of various milestones. The EV-035 series is a
group of novel small molecule broad spectrum antibiotics of the 4-oxoquinolizine class and targets bacterial type IIa topoisomerase. The lead
molecule in the series, GC-072, had demonstrated protection in vivo from lethal B. pseudomallei infection when administered orally. GC-072 is being
developed as a potential oral and intravenous treatment for B. pseudomallei under a three-year, $15.0 million contract with the Defense Threat
Reduction Agency ("DTRA") of the U.S. Department of Defense. B. pseudomallei is a gram-negative pathogen classified by the CDC as a Category
B bioterrorism agent and a priority threat capable of being easily weaponized and disseminated. The acquisition diversifies the Biodefense segment
by adding a preclinical stage product candidate that is currently being funded through preclinical development. The acquisition has been accounted
for as a business combination. The Company's fair values are based on the information, which have no observable market (Level 3), that was
available as of the acquisition date.
65
The contingent value rights are based on the novation of the DTRA contract ($4.0 million) along with the achievement of certain
development ($15.0 million) and regulatory filing ($50.0 million) milestones. In addition, the Company is required to make sales-based royalty
payments of between 5%-10% based on levels of annual net sales.
During the first half of 2015, based on facts that existed at the date of acquisition, the Company obtained additional information and
analysis and recast the fair value of the total purchase consideration transferred to Evolva via a measurement period adjustment, as follows.
The table below summarizes the total purchase price:
(in thousands)
Amount of cash paid to Evolva Holdings SA
Fair value of contingent consideration
Total purchase price
Purchase
Price
Measurement
Period
Adjustment
Recast
Purchase
Price
$
$
1,500 $
28,200
29,700 $
- $
(6,571)
(6,571) $
1,500
21,629
23,129
In conjunction with the revision to the total purchase price and based on this same information and analysis, the Company has recast of the
fair value of the in-process research and development ("IPR&D") asset attributed to the EV-035 series of molecules, via a measurement period
adjustment through June 30, 2015. The table below summarizes the recast allocation of the purchase price based upon fair values of assets acquired.
(in thousands)
Acquired intangible assets
Goodwill
Total purchase price
Purchase
Price
Allocation
Measurement
Period
Adjustment
Recast
Purchase
Price
Allocation
$
$
27,700 $
2,000
29,700 $
(17,172) $
10,601
(6,571) $
10,528
12,601
23,129
The recast fair value was determined using the income approach, which discounts expected future cash flows to present value. The
Company estimated the fair value using a discount rate of 12%. The Company believes this rate is comparable to the estimated internal rate of return
for the acquisition and represents the rate that market participants would use to value this IPR&D asset. The projected cash flows for EV-035 series
of molecules were based on key assumptions including: estimates of revenues and operating profits considering its stage of development on the
acquisition date, the time and resources needed to complete the development and approval of the product candidate, the life of the potential
commercialized product and associated risks, including the inherent difficulties and uncertainties in developing a product candidate, such as
obtaining marketing approval from the FDA and other regulatory agencies, and risks related to the viability of and potential for alternative treatments
in any future target markets. IPR&D assets are considered to be indefinite-lived until the completion or abandonment of the associated research and
development efforts.
The Company recorded approximately $12.6 million in goodwill related to the EV-035 series of molecules, representing the purchase price
paid in excess of the fair value of the IPR&D assets acquired. None of the goodwill generated is expected to be deductible for tax purposes.
The Company has recast, in this filing, the historical December 31, 2014 balance sheet line items for in-process research and development,
goodwill and contingent consideration.
(in thousands)
Assets:
In-process research and development
Goodwill
Total assets
Liabilities:
Contingent consideration, net of current portion
Total liabilities
Balance as of
December 31,
2014
EV-035
Purchase
Price
Adjustments
Adjusted
Balance as of
December 31,
2014
$
$
$
$
77,800 $
41,984
119,784 $
(17,172) $
10,601
(6,571) $
60,628
52,585
113,213
41,170 $
41,170 $
(6,571) $
(6,571) $
34,599
34,599
In addition, the Company has reflected the impact of the above adjustments to the disclosures in Notes 4 and 9.
In September 2015, the Company received data for the leading molecule in the series, GC-072, that indicated a potential toxicity issue. The
Company considered this information an indicator of impairment of the related EV-035 series of molecules IPR&D asset, and completed an
impairment assessment of this asset. Based on this assessment, the Company recorded a non-cash impairment charge of $9.8 million, which is
included in the Company's statement of operations as research and development expense within the Biodefense segment. The remaining carrying
value of the EV-035 series of molecules IPR&D asset of $0.7 million is included in the Biodefense segment. The impairment assessment was
performed using the income approach which discounts expected future cash flows to present value. The projected cash flows for the EV-035 series of
66
molecules were based on key assumptions including: estimates of revenues and operating profits considering its stage of development, the time and
resources needed to complete the development and approval of the product candidate, the life of the potential commercialized product and associated
risks, including the inherent difficulties and uncertainties in developing a product candidate, such as obtaining marketing approval from the FDA and
other regulatory agencies, and risks related to the viability of and potential for alternative treatments in any future target markets.
As a result of the impairment of the EV-035 series of molecules IPR&D asset, the Company also performed an interim goodwill qualitative
impairment assessment of the Biodefense Therapeutics and Vaccines reporting unit, a component of the Biodefense segment, which contains $22.0
million of the goodwill reported on the Company's consolidated balance sheets as of September 30, 2015. Based on the assessment, the Company
concluded that the goodwill was not impaired.
The fair value of contingent consideration obligations are based on management's assessment of certain development and regulatory
milestones, along with updates in the assumed achievement of potential future net sales for the EV-035 series of molecules, which are inputs that
have no observable market (Level 3). For year ended December 31, 2015, the contingent consideration obligation decreased by $9.4 million. The
change was primarily due to the estimated timing and probability of success for certain development and regulatory milestones and the estimated
timing and volume of potential future sales of EV-035. For the year ended December 31, 2015, $3.2 million and $6.2 million, respectively, of the
adjustment was recorded in the Company's statement of operations as a reduction in selling, general and administrative expense and research and
development expense within the Biodefense segment. During the year ended December 31, 2015, the Company received novation of the DTRA
contract and paid the $4.0 million milestone to Evolva in the second quarter of 2015.
Cangene Corporation
On February 21, 2014, the Company acquired 100% of the voting interest of Cangene for $3.24 per share in cash (on a fully-diluted basis),
which represents a total purchase price of $221.5 million. This transaction was accounted for by the Company under the acquisition method of
accounting, with the Company as the acquirer. Under the acquisition method of accounting, the assets and liabilities of Cangene were recorded as of
the acquisition date, at their respective fair values, and combined with those of the Company. This acquisition diversified the product portfolio of the
Company's Biodefense and Biosciences divisions and expanded the Company's manufacturing capabilities.
The table below summarizes the allocation of the purchase price based upon estimated fair values of assets acquired and liabilities assumed
at February 21, 2014.
(in thousands)
Fair value of tangible assets acquired and liabilities assumed:
Cash
Accounts receivable
Inventory (i)
Prepaid expenses and other assets
Property, plant and equipment
Deferred taxes, net
Income tax receivable
Accounts payable and accrued liabilities
Provision for chargebacks
Contingent purchase consideration
Deferred revenue
Total fair value of tangible assets acquired and liabilities assumed
Acquired in-process research and development
Acquired intangible assets
Goodwill
Total purchase price
$
$
43,631
19,652
55,259
2,375
40,264
21,337
2,452
(22,918)
(1,946)
(1,284)
(6,378)
152,444
8,300
36,200
24,566
221,510
(i) Acquired inventory reflects a $8.8 million adjustment to record inventory at fair value, referred to as a step-up adjustment. The $8.8 million step-
up is estimated to be amortized through cost of product sales and contract manufacturing over the next five years based on expected inventory
turnover, which will increase cost of product sales and contract manufacturing during such period.
67
The table below summarizes the fair value of intangible assets acquired and the estimated amortization periods:
( in thousands)
Corporate Trade Name
Marketed Products
Licensed Products
Biodefense Products
Contract Manufacturing
Total identified intangible assets
Amortization
Period
in years
Amount
$
2,800
8,100
3,100
16,700
5,500
$
36,200
5.0
10.0
7.0
12.0
8.0
The Company determined the fair value of the intangible assets using the income approach, which is based on the present value of future
cash flows. The fair value measurements are based on significant unobservable inputs that are developed by the Company using estimates and
assumptions of the respective market and market penetration of the Company's products.
A portion of the assets acquired from Cangene consisted of intangible assets. The Marketed Products intangible asset consists of WinRho®
SDF [Rho(D) Immune Globulin Intravenous (Human)] and VARIZIG® (Varicella Zoster Immune Globulin (Human)]. The Licensed Products
intangible asset primarily consists of HepaGam B® (Hepatitis B Immune Globulin Intravenous (Human). The Biodefense Products intangible asset
consists of BATTM [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-Equine], Anthrasil (Anthrax Immune Globulin Intravenous (Human)) and
VIGIV (Vaccinia Immune Globulin Intravenous (Human)). The Contract Manufacturing intangible asset is primarily related to contract
manufacturing contracts with current and expected future third-party customers.
The Company determined the fair value of the Marketed, Licensed and Biodefense Products intangible assets using the income approach
with a present value discount rate of 15%, based on the estimated weighted-average cost of capital for companies with profiles substantially similar
to that of Cangene. This is comparable to the estimated internal rate of return for the acquisition and represents the rate that market participants
would use to value these intangible assets. The projected cash flows from these Marketed, Licensed and Biodefense Products intangible assets were
based on key assumptions, including: estimates of revenues and operating profits, the life of the potential commercialized product and associated
risks, and risks related to the viability of and potential alternative treatments in any future target markets.
The Company determined the fair value of the Contract Manufacturing intangible asset using the income approach with a present value
discount rate of 15%, based on the estimated weighted-average cost of capital for companies with profiles substantially similar to that of Cangene.
This is comparable to the estimated internal rate of return for the acquisition and represents the rate that market participants would use to value this
intangible asset. The projected cash flows from the Contract Manufacturing intangible asset were based on key assumptions, including: estimates of
revenues and operating profits, and viability of attaining/maintaining future third-party manufacturing relationships with the Company's customers.
The Company determined the fair value of the Corporate Trade Name intangible asset using the relief of royalty method with a present
value discount rate of 15%, based on the estimated weighted-average cost of capital for companies with profiles substantially similar to that of
Cangene. This is comparable to the estimated internal rate of return for the acquisition and represents the rate that market participants would use to
value this intangible asset.
The intangible asset associated with IPR&D acquired from Cangene is the IXINITY product candidate. Management determined that the
estimated acquisition-date fair value of intangible assets related to IPR&D was $8.3 million. The estimated fair value was determined using the
income approach, which discounts expected future cash flows to present value. The Company estimated the fair value using a present value discount
rate of 16%, which is based on the estimated weighted-average cost of capital for companies with that profiles substantially similar to that of
Cangene and IPR&D assets at a similar stage of development as IXINITY. This is comparable to the estimated internal rate of return for the
acquisition and represents the rate that market participants would use to value the IPR&D. The projected cash flows for IXINITY were based on key
assumptions including: estimates of revenues and operating profits, considering its stage of development on the acquisition date, the time and
resources needed to complete the development and approval of the product candidate, the life of the potential commercialized product and associated
risks, including the inherent difficulties and uncertainties in developing a product candidate, such as obtaining marketing approval from the FDA and
other regulatory agencies, and risks related to the viability of and potential for alternative treatments in any future target markets. IPR&D assets are
considered to be indefinite-lived until the completion or abandonment of the associated research and development efforts (see Note 9).
The Company recorded approximately $24.6 million in goodwill related to the Cangene acquisition, representing the purchase price paid in
the acquisition that was in excess of the fair value of the tangible and intangible assets acquired. None of the goodwill generated from the Cangene
acquisition is expected to be deductible for tax purposes.
The Company has incurred transaction costs related to the Cangene acquisition of approximately $3.7 million and $3.3 million for the years
ended December 31, 2014 and 2013, respectively, which has been recorded in selling, general and administrative expenses within the Company's
Biosciences segment.
68
The following pro forma information is presented as if the acquisition had occurred on January 1, 2013, and combines the historical results
of operations of the Company and Cangene for the year ended December 31, 2014 and 2013.
(in thousands)
Pro forma revenue
Pro forma net income
4. Fair value measurements
December 31,
2014
2013
$
$
462,446 $
34,624 $
428,194
10,994
The following table represents the Company's fair value hierarchy for its financial assets and liabilities measured at fair value on a
recurring basis:
(in thousands)
Assets:
Investment in money market funds (1)
Total assets
Liabilities:
Contingent consideration
Total liabilities
(in thousands)
Assets:
Investment in money market funds (1)
Total assets
Liabilities:
Contingent price consideration
Total liabilities
Level 1
At December 31, 2015
Level 2
Level 3
Total
3,323 $
3,323 $
- $
- $
- $
- $
3,323
3,323
- $
- $
- $
- $
25,599 $
25,599 $
25,599
25,599
Level 1
At December 31, 2014
Level 2
Level 3
Total
8,069 $
8,069 $
- $
- $
- $
- $
8,069
8,069
- $
- $
- $
- $
41,086 $
41,086 $
41,086
41,086
$
$
$
$
$
$
$
$
(1) Included in cash and cash equivalents in accompanying consolidated balance sheets.
As of December 31, 2015 and 2014, the Company did not have any transfers between Level 1 and Level 2 assets or liabilities.
In addition to the contingent consideration obligations to Evolva, the fair value of contingent consideration obligations changes as a result
of management's assessment of adjustments to the discount rates and updates in the assumed and actual achievement of future net sales for RSDL and
HepaGam B, which are inputs that have no observable market (Level 3). For the years ended December 31, 2015 and 2014, the contingent purchase
consideration obligation decreased by $1.2 million and increased by $3.1 million, respectively. The decrease and increase are primarily due to an
adjustment to the actual and expected timing and volume of RSDL and HepaGam B sales. The changes for RSDL and HepaGam b are classified in
the Company's statement of operations as cost of product sales and contract manufacturing, within the Biodefense and Biosciences segments,
respectively.
The following table is a reconciliation of the beginning and ending balance of the liabilities measured at fair value using significant
unobservable inputs (Level 3) during the years ended December 31, 2015 and 2014.
(in thousands)
Balance at December 31, 2013
Expense (income) included in earnings
Settlements
Purchases, sales and issuances
Transfers in/(out) of Level 3
Balance at December 31, 2014
Expense (income) included in earnings
Settlements
Purchases, sales and issuances
Transfers in/(out) of Level 3
Balance at December 31, 2015
$
$
$
16,619
3,133
(1,579)
22,913
-
41,086
(10,599)
(5,693)
805
-
25,599
Separate disclosure is required for assets and liabilities measured at fair value on a recurring basis from those measured at fair value on a
non-recurring basis. As of December 31, 2015, the EV-035 series of molecules IPR&D asset was measured at fair value on a non-recurring basis due
to the toxicity issue. As of December 31, 2015, the assets acquired and liabilities assumed as part of the December 2014 acquisition of the EV-035
series of molecules were measured at fair value on a non-recurring basis. During the year ended December 31, 2014, the assets acquired and
69
liabilities assumed as part of the February 2014 acquisition of Cangene Corporation and EV-035 series of molecules acquisitions (Note 3) and the
evaluation of the IXINITY IPR&D asset for impairment (Note 9) were measured at fair value on a non-recurring basis.
5. MorphoSys collaboration agreement
In August 2014, the Company entered into a collaboration agreement ("MorphoSys Agreement") with MorphoSys AG ("MorphoSys") for
the joint worldwide development and commercialization of MOR209/ES414, a targeted immunotherapeutic protein, which activates host T-cell
immunity specifically against cancer cells expressing prostate specific membrane antigen, an antigen commonly overexpressed on prostate cancer
cells. MOR209/ES414 was constructed using the Company's proprietary ADAPTIR platform technology. In accordance with the initial terms of the
MorphoSys Agreement, the Company received a nonrefundable $20.0 million upfront payment and could have received up to $163.0 million in
additional contingent payments, of which $80.0 million and $83.0 million, respectively, were due upon the achievement of specified development
and regulatory milestones. The Company determined that payments for the achievement of the development and regulatory milestones are
substantive milestones and will be accounted for as revenue in the period in which the milestone is achieved. MorphoSys and the Company jointly
fund further development of Mor209/ES414, with the Company responsible for 36% of the total development costs and MorphoSys responsible for
the remainder, with the funding requirement capped at $186.0 million. The Company retains commercialization rights in the U.S. and Canada, with a
tiered royalty obligation to MorphoSys, ranging from mid-single digit up to 20%. MorphoSys has worldwide commercialization rights excluding the
U.S. and Canada, with a low single digit royalty obligation to the Company. The Company's current obligations under the collaboration includes the
performance of non-clinical, clinical, manufacturing and regulatory activities.
In December 2015, after a joint review of data from the ongoing Phase 1 dose escalation study of MOR209/ES414 in prostate cancer
patients, the Company and MorphoSys decided to adjust the dosing regimen and administration of MOR209/ES414. The Company plans to continue
the current clinical trial under an amended protocol with recruitment to start around mid-2016. As a result of the required dosing regimen and
administration change and the impact to overall development timeline and technical risk, the co-development agreement with MorphoSys was re-
structured. In December 2015, the Company and MorphoSys amended the collaboration agreement to decrease the additional contingent payments
due upon the achievement of specified development and regulatory milestones to $32.5 million and $41.5 million, respectively. In addition, the
amended collaboration agreement changed the total expected funding requirement for the Company to $460.0 million and changed the jointly funded
development cost allocation to the following:
2016: Company is responsible for 75%; MorphoSys responsible for 25%
2017-2018: Company is responsible for 49%; MorphoSys responsible for 51%
2019 and beyond: Company is responsible for 36%; MorphoSys responsible for 64%
The Company evaluated the MorphoSys Agreement and determined that it was a revenue arrangement with multiple deliverables, or
performance obligations. The Company determined there were two units of accounting under the collaboration agreement with MorphoSys: (1) the
delivered license to further develop and commercialize MOR209/ES414 and (2) undelivered items related to development services. The Company
determined that the license had stand-alone value as the drug candidate has been (1) developed and is currently Phase 1 clinical trial ready, (2)
MorphoSys possesses the knowledge, technology, skills, experience and infrastructure necessary to complete all further development of the drug
through commercialization, and (3) MorphoSys has the right to further sublicense the product. The Company allocated the $20.0 million upfront
payment to the two units of accounting using the relative selling price method. The Company determined the estimated selling price for the license
using the income approach and a discount rate of 12%. The estimated selling price includes unobservable inputs (Level 3), such as estimates of
revenues and operating margins; the time and resources needed to complete the development and approval of the product candidate; and the risk
related to the viability of and potential for alternative treatments. The Company determined the estimated selling price of the development services
unit of accounting based on the estimated number of full-time equivalent personnel at the contractual rate as defined in the MorphoSys Agreement,
which represents the approximate terms of other service related contracts both entered by the Company and observed generally through other
collaboration negotiations. The allocation resulted in $15.3 million of the upfront payment being allocated to the license and $4.7 million being
allocated to the development services. The Company determined the license fee unit of accounting was delivered on the date the MorphoSys
agreement was executed and therefore has recognized revenue of $15.3 million, which is included in contracts, grants and collaborations revenues
within the Company's Biosciences segment. Revenue related to the undelivered item will be recognized as the services are performed. The current
estimated service period for the undelivered item under the MorphoSys Agreement is through 2022.
The amount allocable to the units of accounting is limited to the amount that is not contingent upon the delivery of additional items or
meeting other specified performance conditions (the noncontingent amount). As such, the Company excluded from the allocable arrangement
consideration the milestone payments and royalties regardless of the probability of receipt.
For the years ended December 31, 2015 and 2014, respectively, the collaboration provides for sharing of development and clinical costs,
with the Company responsible for 36% of such costs and MorphoSys responsible for the remainder. In the event the Company's share of the total cost
for a given quarter exceeds 36% of the total costs for the project, the Company records a net receivable in its financial statements equal to the
difference between the Company's costs and 36% of the total costs for the period, and reduces research and development expense in this amount. For
the years ended December 31, 2015 and 2014, the Company has recorded a net reduction to research and development expense of $4.3 million and
$1.5 million, respectively. During the year ended December 31, 2015, the Company received a $5.0 million milestone payment from MorphoSys
reflecting the initiation of a Phase I clinical study to evaluate the safety, tolerability, and clinical activity of MOR209/ES414 in patients with
metastatic castration-resistant prostate cancer. The Company recorded this payment in contracts, grants and collaborations revenue within the
Company's statement of operations.
As of December 31, 2015 and 2014, accounts receivable from MorphoSys was $0.5 million and $1.0 million, respectively. As of December
31, 2015 and 2014, deferred revenue related to the MorphoSys Agreement consisted of $0.7 million and $0.9 million and $3.2 million and $3.5
million of current and long-term deferred revenue, respectively.
70
6. Accounts receivable
Accounts receivable consist of the following:
(in thousands)
Billed
Unbilled
Total
December 31,
2015
2014
$
$
102,155 $
18,612
120,767 $
39,948
18,886
58,834
For the year ended December 31, 2015, the Company recorded an allowance for doubtful accounts for a customer account of
approximately $3.5 million within the Company's Biosciences segment. As of December 31, 2014, no allowance for doubtful accounts was recorded
as the collection history from the Company's customers indicated that collection was probable.
7. Inventories
Inventories consist of the following:
(in thousands)
Raw materials and supplies
Work-in-process
Finished goods
Total inventories
8. Property, plant and equipment
Property, plant and equipment consist of the following:
(in thousands)
Land and improvements
Buildings, building improvements and leasehold improvements
Furniture and equipment
Software
Construction-in-progress
Less: Accumulated depreciation and amortization
Total property, plant and equipment, net
December 31,
2015
2014
$
$
23,099 $
37,209
16,628
76,936 $
17,375
33,477
14,822
65,674
December 31,
2015
2014
16,520 $
111,060
136,528
39,784
127,489
431,381
(99,525)
331,856 $
12,838
107,202
130,131
25,354
117,884
393,409
(79,430)
313,979
$
$
For the years ended December 31, 2015 and 2014, construction-in-progress primarily included costs related to Building 55, the Company's
large-scale manufacturing facility, for which the Company is in the process of receiving regulatory approval.
Depreciation and amortization expense was $24.5 million, $23.0 million and $17.0 million for the years ended December 31, 2015, 2014
and 2013, respectively. The increase in depreciation expense for December 31, 2014 as compared to December 31, 2013 was primarily due to the
Company's Baltimore facility being placed-in-service in December 2013.
For the years ended December 31, 2015 and 2014, the Company had $10.7 million and $2.4 million, respectively, of capitalized software
development costs. For the year ended December 31, 2015, the Company recorded amortization of capitalized software of $0.4 million. There was no
amortization of capitalized software costs for the year ended December 31, 2014 and 2013.
9. Intangible assets, in-process research and development and goodwill
For the year ended December 31, 2015, the Company had $41.8 million of IPR&D assets included in the Biosciences business segment
related to the Company's otlertuzumab product candidate. For the year ended December 31, 2014, the Company had $50.1 million of IPR&D assets
included in the Biosciences business segment. This included $41.8 million related to the Company's otlertuzumab product candidate and $8.3 million
related to the Company's IXINITY product candidate.
On April 29, 2015, the FDA approved IXINITY for the treatment of Hemophilia B. As a result of the approval, the $8.3 million IXINITY
IPR&D asset was reclassified to intangible assets in the Company's consolidated balance sheets and is being amortized over 10 years from the
approval date.
71
The Company completed its annual impairment assessments for its IPR&D assets and goodwill as of October 1, 2015 and 2014,
respectively, and determined that the fair value of the Company's IPR&D assets and reporting units was significantly in excess of carrying value. As
of October 1, 2015, the Company performed a qualitative assessment of goodwill associated with the Bioscience Therapeutics and the Bioscience
Contract Manufacturing reporting units, components of the Biosciences segment, along with the Biodefense Medical Device and the Biodefense
Therapeutics and Vaccines reporting units, components of the Biodefense segment. As of October 1, 2014, the Company performed a quantitative
assessment of goodwill associated with the Bioscience Therapeutics and Contract Manufacturing reporting units, along with the Biodefense Medical
Device reporting unit. As of October 1, 2014, the Company performed a qualitative assessment of goodwill associated with the Biodefense
Therapeutics and Vaccines reporting unit.
Intangible assets consisted of the following:
(in thousands)
Cost basis
Balance at December 31, 2014
Additions
Balance at December 31, 2015
Accumulated amortization
Balance at December 31, 2014
Amortization
Balance at December 31, 2015
Net book value at December 31, 2015
Amortization expense consisted of the following:
(in thousands)
Biodefense segment
Biosciences segment
Total amortization expense
Biodefense Biosciences
Segment
Segment
Total
$
$
$
$
$
$
$
48,799 $
-
48,799 $
19,500 $
8,300
27,800 $
68,299
8,300
76,599
(7,820) $
(6,209)
(14,029) $
(2,135) $
(3,060)
(5,195) $
(9,955)
(9,269)
(19,224)
34,770 $
22,605 $
57,375
2015
December 31,
2014
2013
6,209 $
3,060
9,269 $
5,869 $
2,135
8,004 $
1,951
-
1,951
As of December 31, 2015, the weighted average amortization period remaining for intangible assets in the Biodefense and Biosciences
segments was 88 and 90 months, respectively.
Future amortization expense as of December 31, 2015 is as follows:
(in thousands)
2016
2017
2018
2019
2020 and beyond
Total remaining amortization
$
$
8,976
8,300
8,300
7,821
23,978
57,375
The following table is a summary of changes in goodwill by reporting unit:
(in thousands)
Cost Basis
Balance at December 31, 2014
Additions
Balance at December 31, 2015
Biosciences
therapeutics
Biosciences
contracts
manufacturing
Biodefense
therapeutics
and vaccines
Biodefense
medical
device(s)
Total
$
$
13,902 $
-
13,902 $
6,736 $
-
6,736 $
22,031 $
2,317
24,348 $
9,916 $
-
9,916 $
52,585
2,317
54,902
72
10. Long-term debt
On January 29, 2014, the Company issued $250.0 million aggregate principal amount of 2.875% Convertible Senior Notes due 2021 (the
"Notes"). The Notes bear interest at a rate of 2.875% per year, payable semi-annually in arrears on January 15 and July 15 of each year. The Notes
mature on January 15, 2021, unless earlier purchased by the Company or converted. The conversion rate is equal to 30.8821 shares of common stock
per $1,000 principal amount of notes (which is equivalent to a conversion price of approximately $32.38 per share of common stock). The conversion
rate is subject to adjustment upon the occurrence of certain specified events but will not be adjusted for accrued and unpaid interest. The Company
incurred approximately $8.3 million in debt issuance costs associated with the Notes, which has been capitalized on the consolidated balance sheets
and is being amortized over seven years.
On December 11, 2013, the Company entered into a senior secured credit agreement (the "Credit Agreement") with three lending financial
institutions. The Credit Agreement originally provided for a revolving credit facility of up to $100.0 million through December 11, 2018 (or such
earlier date required by the terms of the Credit Agreement) and a term loan facility of up to $125.0 million to be drawn in full, if at all, on or prior to
March 31, 2014. In connection with the Credit Agreement, the Company borrowed $62.0 million under the revolving credit facility primarily to
repay obligations under existing loan agreements. On January 29, 2014, in connection with the Company's issuance of the Notes, the unused $125.0
million term loan portion of the Credit Agreement terminated automatically in accordance with the terms of the Credit Agreement. In addition,
following the closing of the Notes offering, the Company repaid the $62.0 million outstanding indebtedness under the revolving credit facility, which
restored the full $100.0 million revolving credit capacity under this facility. Under the revolving credit facility, the Company is required to pay an
unused fee of approximately 0.5% annually, on a quarterly basis. In addition, during the year ended December 31, 2014, the Company expensed $1.8
million of debt issuance cost associated with the term loan facility. As of December 31, 2015, no amounts were drawn under the revolving credit
facility.
The Company's payment obligations under the Credit Agreement are secured by a lien on substantially all of the Company's assets,
including the stock of all of the Company's subsidiaries, and the assets of the subsidiary guarantors, including mortgages over certain of their real
properties, including the Company's large-scale vaccine manufacturing facility in Lansing, Michigan and the Company's product development and
manufacturing facility in Baltimore, Maryland.
The Credit Agreement, as amended, contains affirmative and negative covenants customary for financings of this type. Negative covenants
in the Credit Agreement limit the Company's ability to, among other things: incur indebtedness (other than the issuance of the Notes) and liens;
dispose of assets; make investments including loans, advances or guarantees; and enter into certain mergers or similar transactions. The Credit
Agreement also contains financial covenants, tested quarterly and in connection with any triggering events under the Credit Agreement that include
the maintenance of: (1) a minimum consolidated debt service coverage ratio of 2.50 to 1.00, (2) a maximum consolidated leverage ratio for the period
ending on or prior to September 30, 2014 of 4.00 to 1.00, for the measurement period ending December 31, 2014 of 3.75 to 1.00, and thereafter of
3.50 to 1.00, and (3) a minimum liquidity requirement of $50.0 million. Upon the occurrence and continuance of an event of default under the Credit
Agreement, the commitments of the lenders to make loans under the Credit Agreement may be terminated and the Company's payment obligations
under the Credit Agreement may be accelerated. The events of default under the Credit Agreement include, among others, subject in some cases to
specified cure periods: payment defaults; inaccuracy of representations and warranties in any material respect; defaults in the observance or
performance of covenants; bankruptcy and insolvency related defaults; the entry of a final judgment in excess of a threshold amount; change of
control; and the invalidity of loan documents relating to the Credit Agreement. The Company was in compliance with these covenants as of
December 31, 2015 and 2014.
In April 2015, the FASB issued ASU No. 2015-03, Interest - Imputation of Interest (Subtopic 835-30), which simplifies the presentation of
debt issuance costs. ASU 2015-03 requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct
deduction from the carrying amount of that debt liability, consistent with debt discounts. Prior to the issuance of ASU 2015-03, debt issuance costs
were required to be presented as an asset in the balance sheet. ASU 2015-03 is effective for interim and annual periods beginning after December 15,
2015 and early adoption is permitted.
As of December 31, 2015, the Company had debt issuance costs of $1.5 million and $5.6 million, respectively, classified in the
consolidated balance sheet as prepaid expenses and other current assets and other assets, of which $1.2 million and $4.9 million, respectively, would
have been reclassified in the consolidated balance sheet as a reduction to long-term debt. As of December 31, 2014, the Company had debt issuance
costs of $1.5 million and $7.1 million, respectively, classified in the consolidated balance sheet as prepaid expenses and other current assets and other
assets, of which $1.2 million and $6.1 million, respectively, would have been reclassified in the consolidated balance sheet to long-term debt. As of
December 31, 2015 and 2014, based on ASU 2015-03, the Company's long-term debt would be $246.9 million and $243.7 million.
11. Stockholders' equity
Preferred stock
The Company is authorized to issue up to 15.0 million shares of preferred stock, $0.001 par value per share ("Preferred Stock"). Any
Preferred Stock issued may have dividend rights, voting rights, conversion privileges, redemption characteristics, and sinking fund requirements as
approved by the Company's board of directors.
Common stock
The Company currently has one class of common stock, $0.001 par value per share common stock ("Common Stock"), authorized and
outstanding. The Company is authorized to issue up to 100.0 million shares of Common Stock. Holders of Common Stock are entitled to one vote for
each share of Common Stock held on all matters, except as may be provided by law.
73
Stock options and restricted stock units
The following is a summary of option award activity under the Emergent Plans:
Outstanding at December 31, 2014
Granted
Exercised
Forfeited
Outstanding at December 31, 2015
Exercisable at December 31, 2015
Options expected to vest at December 31, 2015
2006 Plan
2004 Plan
Number of
Shares
3,837,993 $
690,221
(1,360,955)
(189,439)
2,977,820 $
1,442,178 $
1,195,677 $
Weighted-
Average
Exercise
Price
Number of
Shares
20.04
29.03
18.09
24.29
22.74
19.12
25.76
43,156 $
-
(13,457)
-
29,699 $
29,699 $
- $
Weighted-
Average
Exercise
Price
Aggregate
Intrinsic
Value
10.28 $ 29,181,534
-
10.28
-
10.28 $ 52,324,284
10.28 $ 31,006,178
- $ 17,043,405
The following is a summary of restricted stock unit award activity under the 2006 Plan:
Outstanding at December 31, 2014
Granted
Vested
Forfeited
Outstanding at December 31, 2015
Number of
Shares
Weighted-
Average
Grant Price
Aggregate
Intrinsic
Value
927,356 $
473,111
(422,515)
(82,156)
895,796 $
22.44 $ 25,251,904
29.61
20.60
25.10
26.85 $ 35,840,796
The weighted average remaining contractual term of options outstanding as of December 31, 2015 and 2014 was 4.4 years and 4.0 years,
respectively. The weighted average remaining contractual term of options exercisable as of December 31, 2015 and 2014 was 3.4 years and 3.2 years,
respectively.
The weighted average grant date fair value of options granted during the years ended December 31, 2015, 2014 and 2013 was $8.66, $8.84
and $5.38, respectively. The total intrinsic value of options exercised during the years ended December 31, 2015, 2014 and 2013 was $20.2 million,
$7.5 million and $6.9 million, respectively. The total fair value of awards vested during 2015, 2014 and 2013 was $14.4 million, $12.3 million and
$9.1 million, respectively. As of the year ended December 31, 2015, the total compensation cost and weighted average period over which total
compensation is expected to be recognized related to unvested equity awards was $20.0 million and 1.9 years, respectively.
Stock-based compensation expense was recorded in the following financial statement line items:
(in thousands)
Cost of product sales
Research and development
General and administrative
Total stock-based compensation expense
Years ended December 31,
2014
2015
2013
$
$
1,183 $
3,112
11,553
15,848 $
1,145 $
3,606
8,078
12,829 $
575
3,283
7,380
11,238
74
12. Income taxes
Significant components of the provisions for income taxes attributable to operations consist of the following:
(in thousands)
Current
Federal
State
International
Total current
Deferred
Federal
State
International
Total deferred
Total provision for income taxes
The Company's net deferred tax asset (liability) consists of the following:
(in thousands)
Federal losses carryforward
State losses carryforward
Research and development carryforward
Scientific research and experimental development credit carryforward
Intangible assets
Stock compensation
Foreign deferrals
Inventory reserves
Other
Deferred tax asset
Fixed assets
Intangible assets
Other
Deferred tax liability
Valuation allowance
Net deferred tax (liabilities)/ asset
Year ended December 31,
2014
2015
2013
$
$
20,664 $
1,401
1,370
23,435
7,802
185
(4,523)
3,464
26,899 $
10,412 $
479
112
11,003
7,693
128
(2,503)
5,318
16,321 $
(878)
(173)
300
(751)
12,679
1,028
152
13,859
13,108
December 31,
2015
2014
5,394 $
12,751
3,545
25,771
5,792
9,391
80,920
3,754
8,484
155,802
(31,925)
(4,760)
(17,192)
(53,877)
(90,639)
11,286 $
8,487
12,043
8,049
29,556
5,689
8,196
75,511
4,122
7,463
159,116
(34,839)
(6,538)
(10,891)
(52,268)
(92,374)
14,474
$
$
As of December 31, 2015, the Company currently has approximately $15.4 million ($5.4 million tax effected) in net operating loss
carryforwards along with $3.5 million in research and development tax credit carryforwards for U.S. federal tax purposes that will begin to expire in
2026 and 2023, respectively. The U.S. federal tax carryforwards are recorded with no valuation allowance. The Company has $237.8 million ($12.8
million tax effected) in state net operating loss carryforwards, primarily in Maryland, that will begin to expire in 2018. The U.S. state tax loss
carryforwards are recorded with a valuation allowance of $190.0 million ($10.2 million tax effected). The Company has approximately $231.1
million ($59.8 million tax effected) in net operating losses from foreign jurisdictions (excluding Canada) that will have an indefinite life unless the
foreign entities have a change in the nature or conduct of the business in the three years following a change in ownership. A valuation allowance in
respect to these foreign losses has been recorded in the amount of $59.8 million. The Company has approximately $66.9 million ($17.4 million tax
effected) in Canadian loss carryforwards which are recorded with no valuation allowance. The Company currently has approximately $5.1 million of
Canadian federal scientific research and experimental development credit carryforwards that will begin to expire in 2029. In addition, the Company
has approximately $20.6 million in Manitoba scientific research and experimental development credit carryforwards that will begin to expire in 2026.
Due to the timing of the expiry of the Manitoba credits, the Company has recorded a valuation allowance with respect to the Manitoba credits in the
amount of $20.6 million, as it is uncertain whether sufficient future taxable income will be generated in Manitoba during the carryforward period.
The use of any of these net operating losses and research and development tax credit carryforwards may be restricted due to changes in the
Company's ownership.
75
The provision for income taxes differs from the amount of taxes determined by applying the U.S. federal statutory rate to loss before
provision for income taxes as a result of the following:
(in thousands)
US
International
Earnings before taxes on income
Federal tax at statutory rates
State taxes, net of federal benefit
Impact of foreign operations
Change in valuation allowance
Tax credits
Other differences
Permanent differences
Provision for income taxes
Year ended December 31,
2014
2015
2013
$
$
$
88,525 $
1,244
89,769
31,394 $
613
(144)
(1,735)
(4,849)
748
872
26,899 $
59,764 $
(6,702)
53,062
18,572 $
257
186
1,808
(7,137)
124
2,511
16,321 $
52,749
(8,506)
44,243
15,485
538
(1,116)
1,434
(5,918)
(227)
2,912
13,108
The effective annual tax rate for the years ended December 31, 2015, 2014 and 2013 was 30%, 31% and 30%, respectively.
The Company recognizes interest in interest expense and recognizes potential penalties related to unrecognized tax benefits in selling,
general and administrative expense. Of the total unrecognized tax benefits recorded at December 31, 2015 and 2014, $0.3 million and $0.2 million,
respectively, is classified as a current liability and $1.1 million for both periods, respectively, is classified as a non-current liability on the balance
sheet.
The table below presents the gross unrecognized tax benefits activity for 2015, 2014 and 2013:
(in thousands)
Gross unrecognized tax benefits at December 31, 2012
Increases for tax positions for prior years
Decreases for tax positions for prior years
Increases for tax positions for current year
Settlements
Lapse of statute of limitations
Gross unrecognized tax benefits at December 31, 2013
Increases for tax positions for prior years
Decreases for tax positions for prior years
Increases for tax positions for current year
Settlements
Lapse of statute of limitations
Gross unrecognized tax benefits at December 31, 2014
Increases for tax positions for prior years
Decreases for tax positions for prior years
Increases for tax positions for current year
Settlements
Lapse of statute of limitations
Gross unrecognized tax benefits at December 31, 2015
$
$
1,016
165
-
15
-
(75)
1,121
150
-
102
-
(125)
1,248
150
-
59
-
-
1,457
When resolved, substantially all of these reserves would impact the effective tax rate.
The Company's federal and state income tax returns for the tax years 2011 to 2014 remain open to examination. The Company's tax returns
in the United Kingdom remain open to examination for the tax years 2007 to 2014, and tax returns in Germany remain open indefinitely. The
Company's tax returns for Canada remains open to examination for the tax years 2009 to 2013.
As of December 31, 2015, the Company's 2009 and 2010 federal income tax returns are in appeals with the Internal Revenue service. The
Company believes appropriate provisions have been made for any outstanding issues. As of December 31, 2015, the Company's 2011 and 2012
federal income tax returns are under audit.
76
13. Assets held for sale
The Company currently owns a manufacturing and development facility in Winnipeg, Manitoba, Canada, within the Company's
Biosciences segment, that it is actively seeking to sell. In October 2014, the Company determined that this facility, along with associated equipment,
would not be placed into service and committed to a plan to sell the facility. As a result, this facility and related equipment are classified on the
Company's balance sheet as an asset held for sale within the prepaid and other current assets line item. The Company recorded the assets held for sale
at fair market value of $2.4 million, based on factors that include recent purchase offers less estimated selling costs.
14. Purchase commitment
During 2014 the Company entered into a contract with Norwood Laboratories Inc. ("Norwood") to purchase $15.2 million of raw materials
related to the Company's RSDL product. For the years ended December 31, 2015 and 2014, the Company purchased $6.2 million and $1.5 million,
respectively, of materials under this commitment.
15. 401(k) savings plan
The Company has established a defined contribution savings plan under Section 401(k) of the Internal Revenue Code. The 401(k) Plan
covers substantially all U.S. employees. Under the 401(k) Plan, employees may make elective salary deferrals. The Company currently provides for
matching of qualified deferrals up to 50% of the first 6% of the employee's salary. During the years ended December 31, 2015, 2014, and 2013, the
Company made matching contributions of approximately $2.5 million, $2.4 million and $2.0 million, respectively.
16. Leases
The Company leases laboratory and office facilities, office equipment and vehicles under various operating lease agreements. The
Company leases office space in Washington, D.C. under an operating lease that contains a 2.5% escalation clause, which expires in May 2027. The
Company leases office and laboratory space in Seattle, Washington under a operating lease that contains a 2% escalation clause, which expires in
April 2020. For the years ended December 31, 2015, 2014, and 2013, total lease expense was $3.0 million, $4.6 million and $3.9 million,
respectively. For the years ended December 31, 2015, 2014 and 2013, the Company recorded lease income of $0.4 million, $3.1 million and $0.4
million, respectively, from the Company's office facility in Gaithersburg, Maryland.
Future minimum lease payments under operating lease obligations as of December 31, 2015 were as follows:
(in thousands)
2016
2017
2018
2019
2020
2021 and beyond
Total minimum lease payments
Minimum lease receipts
Total minimum lease payments
17. Related party transactions
$
$
2,577
2,324
2,044
1,988
924
2,137
11,994
(1,105)
10,889
In November 2015, the Company entered into a consulting arrangement with a member of the Company's Board of Directors to provide
assistance in connection with the planned spin-off of the biosciences business into a separate company, to be named Aptevo Therapeutics Inc.
("Aptevo"). The maximum compensation under the agreement is $0.1 million per year. The consulting agreement will terminate with the completion
of the spin-off, at which time the member of the Board of Directors is expected to become the CEO of Aptevo.
The Company entered into an agreement in February 2009 with an entity controlled by family members of the Company's Executive
Chairman to market and sell BioThrax. The agreement was effective as of November 2008 and requires payment based on a percentage of net sales
of biodefense products of 17.5% in Saudi Arabia and 15% in Qatar and United Arab Emirates, and reimbursement of certain expenses. No expenses
were incurred under this agreement during 2015, 2014 and 2013.
77
18. Earnings per share
The following table presents the calculation of basic and diluted net income per share:
(in thousands, except share and per share data)
Numerator:
Net income
Interest expense applicable to convertible debt, net of tax
Amortization of debt issuance costs, net of tax
Adjusted net income
Denominator:
Weighted-average number of shares—basic
Dilutive securities—equity awards
Dilutive securities—convertible debt
Weighted-average number of shares—diluted
Earnings per share-basic
Earnings per share-diluted
Years ended December 31,
2014
2015
2013
$
$
62,870 $
3,019
868
66,757 $
36,741 $
2,879
735
40,355 $
31,135
-
-
31,135
38,595,435
939,882
7,720,525
47,255,842
37,344,891
737,391
7,720,525
45,802,807
36,201,283
546,273
-
36,747,556
$
$
1.63 $
1.41 $
0.98 $
0.88 $
0.86
0.85
For the year ending December 31, 2015, substantially all of the outstanding stock options to purchase shares of common stock were
included in the calculation of diluted earnings per share. For the years ending December 31, 2014 and 2013, outstanding stock options to purchase
approximately 1.4 million and 1.5 million shares of common stock, respectively, are not considered in the diluted earnings per share calculation
because the exercise price of these options is greater than the average per share closing price during the year.
19. Segment information
For financial reporting purposes, the Company reports financial information for two business segments: Biodefense and Biosciences. The
Company's two business segments, or divisions, engage in business activities for which discrete financial information is provided to and resources
are allocated by the chief operating decision maker. The accounting policies of the reportable segments are the same as those described in the
summary of significant accounting policies. The Company's reportable segments offer different products, product candidates, manufacturing
processes and services, development processes, sales and marketing processes, and are managed separately.
The Biodefense division is a specialty biopharmaceutical business focused on countermeasures that address public health threats,
specifically Chemical, Biological, Radiological, Nuclear and Explosive threats, as well as emerging infectious diseases and consists of two business
units: vaccines and therapeutics, and medical devices. Revenues in this segment are primarily from sales of the Company's FDA-licensed product,
BioThrax® (Anthrax Vaccine Adsorbed), to the U.S. government. The Biosciences division is a specialty biopharmaceutical business focused on
therapeutics primarily in hematology/oncology with secondary areas of focus in transplantation, infectious disease and autoimmunity. The
Biosciences division consists of three business units: therapeutics, vaccines and contract manufacturing. The "All Other" segment relates to the
general operating costs of the Company and includes costs of the centralized services departments, which are not allocated to the other segments, as
well as spending on activities that are not classified as Biodefense or Biosciences. The assets in this segment consist primarily of cash. For the years
ended December 31, 2015, 2014 and 2013, the Company had total assets of $270.0 million, $242.5 million and $56.7 million, respectively, located in
foreign jurisdictions.
78
(in thousands)
Year Ended December 31, 2015
External revenue
Intersegment revenue (expense)
Research and development
Interest income
Interest expense
Depreciation and amortization
Net income (loss)
Intangible assets
In-process research and development assets
Goodwill
Total assets
Expenditures for long-lived assets
Year Ended December 31, 2014
External revenue
Intersegment revenue (expense)
Research and development
Interest income
Interest expense
Depreciation and amortization
Net income (loss)
Intangible assets
In-process research and development assets
Goodwill
Total assets
Expenditures for long-lived assets
Year Ended December 31, 2013
External revenue
Intersegment revenue (expense)
Research and development
Interest income
Interest expense
Depreciation and amortization
Net income (loss)
Intangible assets
In-process research and development assets
Goodwill
Total assets
Expenditures for long-lived assets
20. Quarterly financial data (unaudited)
Biodefense Biosciences All Other
Total
Reportable Segments
$
$
$
450,088 $
(1,877)
111,663
149
-
18,677
125,609
34,770
701
34,264
511,875
37,735
370,547 $
-
81,975
62
-
17,669
96,966
40,979
10,528
31,239
433,226
26,736
311,564 $
-
62,663
-
-
15,584
87,289
30,148
-
8,452
331,827
30,700
72,701 $
1,877
37,816
-
(41)
5,597
(55,644)
22,605
41,800
20,638
345,995
6,689
79,591 $
-
60,821
-
-
5,070
(51,300)
17,365
50,100
21,346
344,420
2,444
1,181 $
-
50,652
-
-
1,238
(50,925)
0
41,800
5,502
98,510
1,343
- $
-
4,518
423
(6,482)
227
(7,095)
-
-
-
185,722
388
- $
-
8,033
258
(8,240)
267
(8,925)
-
-
-
161,045
1,493
- $
-
6,618
139
-
186
(5,229)
0
-
-
196,293
9,978
522,789
-
153,997
572
(6,523)
24,501
62,870
57,375
42,501
54,902
1,043,592
44,812
450,138
-
150,829
320
(8,240)
23,006
36,741
58,344
60,628
52,585
938,691
30,673
312,745
-
119,933
139
-
17,008
31,135
30,148
41,800
13,954
626,630
42,021
Quarterly financial information for the years ended December 31, 2015 and 2014 is presented in the following tables:
(in thousands, except per share data)
2015:
Revenue
Income (loss) from operations
Net income (loss)
Net income (loss) per share, basic
Net income (loss) per share, diluted
2014:
Revenue
Income (loss) from operations
Net income (loss)
Net income (loss) per share, basic
Net income (loss) per share, diluted
March 31,
June 30,
September 30,
December 31,
Quarter Ended
$
$
63,633 $
(28,310)
(21,519)
(0.57)
(0.57)
53,884 $
(25,458)
(20,236)
(0.55)
(0.55)
126,112 $
21,452
14,100
0.37
0.32
110,325 $
7,862
5,029
0.13
0.13
164,940 $
53,005
36,942
0.95
0.79
137,954 $
31,032
21,832
0.58
0.49
168,104
49,892
33,347
0.85
0.71
147,975
44,620
30,116
0.80
0.66
79
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
Not applicable.
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our chief executive officer and chief financial officer, evaluated the effectiveness of our
disclosure controls and procedures as of December 31, 2015. The term "disclosure controls and procedures," as defined in Rules 13a-15(e) and 15d-
15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be
disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the
time periods specified in the SEC's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed
to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and
communicated to the company's management, including its principal executive and principal financial officers, as appropriate to allow timely
decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can
provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit
relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of December 31, 2015, our
chief executive officer and chief financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the
reasonable assurance level.
Management's Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Rules 13a-
15(f) and 15d-15(f) under the Exchange Act. Because of its inherent limitations, internal control over financial reporting may not prevent or detect
misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of
changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. Our management assessed the effectiveness
of our internal control over financial reporting as of December 31, 2015. In making this assessment, our management used the criteria set forth by the
Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework (2013 Framework). Based on this
assessment, our management concluded that, as of December 31, 2015, our internal control over financial reporting was effective based on those
criteria.
Ernst & Young LLP, the independent registered public accounting firm that has audited our consolidated financial statements included
herein, has issued an attestation report on the effectiveness of our internal control over financial reporting as of December 31, 2015, a copy of which
is included in this annual report on Form 10-K.
Changes in Internal Control Over Financial Reporting
We are in the process of implementing a new enterprise resource planning ("ERP") system, which will occur over a period of more than
one year. During the year ended December 31, 2015, we completed the implementation of this new ERP system for our Biosciences business
segment. In connection with the implementation, we updated the processes that constitute our internal control over financial reporting, as necessary,
to accommodate related changes to our business processes and accounting procedures. We expect to complete the implementation of the new ERP
system for the remainder of the company in 2016.
Although the processes that constitute our internal control over financial reporting have been materially affected by the implementation of
this new system for our Biosciences business and will require testing for effectiveness as the implementation progresses, we do not believe that the
implementation has had or will have a material adverse effect on our internal control over financial reporting.
Except as otherwise described above, there have been no other changes in our internal control over financial reporting (as defined in Rules
13a-15(f) and 15d-15(f) under the Exchange Act) during the three months ended December 31, 2015, that has materially affected, or is reasonably
likely to materially affect our internal control over financial reporting.
80
Report of Ernst & Young LLP,
Independent Registered Public Accounting Firm,
Regarding Internal Control Over Financial Reporting
The Board of Directors and Stockholders of Emergent BioSolutions Inc. and subsidiaries
We have audited Emergent BioSolutions Inc. and subsidiaries' internal control over financial reporting as of December 31, 2015, based on
criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission
(2013 framework), (the COSO criteria). Emergent BioSolutions Inc. and subsidiaries' management is responsible for maintaining effective internal
control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying
Management's Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the company's internal control
over financial reporting based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting
was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk
that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and
performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our
opinion.
A company's internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of
financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A
company's internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in
reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that
transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and
that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company;
and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company's assets
that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of
any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that
the degree of compliance with the policies or procedures may deteriorate.
In our opinion, Emergent BioSolutions Inc. and subsidiaries maintained, in all material respects, effective internal control over financial
reporting as of December 31, 2015, based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the
consolidated balance sheets of Emergent BioSolutions Inc. and subsidiaries as of December 31, 2015 and 2014, and the related consolidated
statements of operations, comprehensive income, changes in stockholders' equity and cash flows for each of the three years in the period ended
December 31, 2015 of Emergent BioSolutions Inc. and subsidiaries and our report dated February 29, 2016 expressed an unqualified opinion thereon.
McLean, Virginia
February 29, 2016
/s/ Ernst & Young LLP
81
ITEM 9B. OTHER INFORMATION
On February 24, 2016, the Compensation Committee of the Board of Directors of Emergent BioSolutions Inc. took a number of actions
with respect to the compensation of our named executive officers.
Executive Cash Compensation
The committee awarded cash bonuses to our named executive officers for their performance in 2015 in the following amounts:
Fuad El-Hibri, Executive Chairman: not bonus eligible;
Daniel J. Abdun-Nabi, President and Chief Executive Officer: $566,211;
Robert G. Kramer, Executive Vice President, Corporate Services Division, and Chief Financial Officer: $225,264;
Adam Havey, Executive Vice President and President, Biodefense Division: $195,126; and
The committee also approved base salaries and target bonus percentages for our named executive officers for 2016. The annualized base
salaries and target bonus percentages, effective as of January 1, 2016, are as follows: Fuad El-Hibri, $964,579 and 0%; Daniel J. Abdun-Nabi,
$767,374 and 85%; Robert G. Kramer, $488,467 and 60%; and Adam Havey, $427,461 and 50%.
Executive Equity Awards
The committee approved grants of stock options and restricted stock units in accordance with the terms and provisions of the company's
Third Amended and Restated 2006 Stock Incentive Plan to be made on March 1, 2016 to our named executive officers based on the following cash
values: Fuad El-Hibri, based on a value of $1,800,000; Daniel J. Abdun-Nabi, based on a value of $2,400,000; Robert Kramer, based on a value of
$1,000,000; and Adam Havey, based on a value of $525,000. Half of the value granted to each executive was in the form of stock options and the
other half was in the form of RSUs.
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Code of Ethics
We have adopted a code of business conduct and ethics that applies to our directors, officers (including our principal executive officer,
principal financial officer, principal accounting officer or controller, or persons performing similar functions), as well as our other employees. A
copy of our code of business conduct and ethics is available on our website at www.emergentbiosolutions.com. We intend to post on our website all
disclosures that are required by applicable law, the rules of the Securities and Exchange Commission or the New York Stock Exchange concerning
any amendment to, or waiver of, our code of business conduct and ethics.
The remaining information required by Item 10 is hereby incorporated by reference from our Definitive Proxy Statement relating to our
2016 Annual Meeting of Stockholders, to be filed with the SEC within 120 days following the end of our fiscal year.
ITEM 11. EXECUTIVE COMPENSATION
The information required by Item 11 is hereby incorporated by reference from our Definitive Proxy Statement relating to our 2016 annual
meeting of stockholders, to be filed with the SEC within 120 days following the end of our fiscal year.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER
MATTERS
The information required by Item 12 is hereby incorporated by reference from our Definitive Proxy Statement relating to our 2016 Annual
Meeting of Stockholders, to be filed with the SEC within 120 days following the end of our fiscal year.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information required by Item 13 is hereby incorporated by reference from our Definitive Proxy Statement relating to our 2016 Annual
Meeting of Stockholders, to be filed with the SEC within 120 days following the end of our fiscal year.
82
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The information required by Item 14 is hereby incorporated by reference from our Definitive Proxy Statement relating to our 2016 Annual
Meeting of Stockholders, to be filed with the SEC within 120 days following the end of our fiscal year.
PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
Financial Statements
The following financial statements and supplementary data are filed as a part of this annual report on Form 10-K in Part I, Item 8.
Report of Independent Registered Public Accounting Firm
Consolidated Balance Sheets at December 31, 2015 and 2014
Consolidated Statements of Operations for the years ended December 31, 2015, 2014 and 2013
Consolidated Statements of Comprehensive Income for the years ended December 31, 2015, 2014 and 2013
Consolidated Statements of Cash Flows for the years ended December 31, 2015, 2014 and 2013
Consolidated Statement of Changes in Stockholders' Equity for the years ended December 31, 2015, 2014 and 2013
Notes to Consolidated Financial Statements
Financial Statement Schedules
Schedule II - Valuation and Qualifying Accounts for the years ended December 31, 2015, 2014 and 2013 has been filed as part of this
annual report on Form 10-K. All other financial statement schedules are omitted because they are not applicable or the required information is
included in the financial statements or notes thereto.
Exhibits
Those exhibits required to be filed by Item 601 of Regulation S-K are listed in the Exhibit Index immediately preceding the exhibits hereto
and such listing is incorporated herein by reference.
SCHEDULE II - VALUATION AND QUALIFYING ACCOUNTS
(in thousands)
Year ended December 31, 2015
Inventory allowance
Prepaid expenses and other current assets allowance
Year ended December 31, 2014
Inventory allowance
Prepaid expenses and other current assets allowance
Year ended December 31, 2013
Inventory allowance
Prepaid expenses and other current assets allowance
Beginning
Balance
Charged to
costs and
expenses
Deductions
Ending
Balance
1,314 $
1,885
6,258 $
96
(5,935) $
-
1,637
1,981
963 $
1,446
3,185 $
439
(2,834) $
-
1,314
1,885
923 $
1,166
2,383 $
280
(2,343) $
-
963
1,446
$
$
$
83
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be
signed on its behalf by the undersigned, thereunto duly authorized.
SIGNATURES
EMERGENT BIOSOLUTIONS INC.
By: /s/ Daniel J. Abdun-Nabi
Daniel J. Abdun-Nabi
President and Chief Executive Officer
Date: February 29, 2016
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf
of the registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/Daniel J. Abdun-Nabi
Daniel J. Abdun-Nabi
President, Chief Executive Officer and Director
(Principal Executive Officer)
Executive Vice President, Chief Financial Officer and Treasurer
(Principal Financial and Accounting Officer)
February 29, 2016
February 29, 2016
Executive Chairman of the Board of Directors
February 29, 2016
Director
Director
Director
Director
Director
Director
Director
Director
February 29, 2016
February 29, 2016
February 29, 2016
February 29, 2016
February 29, 2016
February 29, 2016
February 29, 2016
February 29, 2016
/s/Robert G. Kramer
Robert G. Kramer
/s/Fuad El-Hibri
Fuad El-Hibri
/s/Zsolt Harsanyi
Zsolt Harsanyi, Ph.D.
/s/Dr. John Niederhuber
Dr. John Niederhuber
/s/Ronald B. Richard
Ronald B. Richard
/s/Louis W. Sullivan, M.D.
Louis W. Sullivan, M.D.
/s/Marvin White
Marvin White
/s/Dr. Sue Bailey
Dr. Sue Bailey
/s/George Joulwan
George Joulwan
/s/Jerome Hauer
Jerome Hauer
84
All documents referenced below were filed pursuant to the Securities Exchange Act of 1934 by the Company, (File No. 001-33137), unless otherwise
indicated.
Exhibit Index
Exhibit
Number
3.1
3.2
4.1
4.2
4.3
4.4
9.1
10.1
10.2
10.3
10.4
10.5
10.6
10.7
10.8
10.9
10.10
10.11
10.12
10.13
10.14
10.15
10.16
10.17
10.18
Description
Restated Certificate of Incorporation of the Company (incorporated by reference to Exhibit 4.1 to the Company's Registration
Statement on Form S-8 filed on December 8, 2006) (Registration No. 333-139190).
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).
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).
Rights Agreement, dated as of November 14, 2006, between the Company and American Stock Transfer & Trust Company
(incorporated by reference to Exhibit 4.3 to the Company's Registration Statement on Form S-8 filed on December 8, 2006)
(Registration No. 333-139190).
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).
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).
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).
Credit Agreement, dated as of December 11, 2013, among the Company, as borrower, certain of its subsidiaries party thereto,
as guarantors, Bank of America, N.A., as administrative agent, and certain financial institutions party thereto as lenders
(incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed on December 12, 2013).
First Amendment to Credit Agreement, dated as of January 17, 2014, among the Company, as borrower, certain of its
subsidiaries party thereto, as guarantors, Bank of America, N.A., as administrative agent, and certain financial institutions
party thereto as lenders (incorporated by reference to Exhibit 10.2 to the Company's Annual Report on Form 10-K filed on
March 10, 2014).
Second Amendment to Credit Agreement, dated as of March 21, 2014, among the Company, as borrower, certain of its
subsidiaries party thereto, as guarantors, Bank of America, N.A., as administrative agent, and certain financial institutions
party thereto as lenders (incorporated by reference to Exhibit 10 to the Company's Quarterly Report on Form 10-Q filed on
May 12, 2014).
Third Amendment to Credit Agreement, dated as of September 3, 2015, among the Company, as borrower, certain of its
subsidiaries party thereto, as guarantors, Bank of America, N.A., as administrative agent, and certain financial institutions
party thereto as lenders (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q filed on
November 6, 2015).
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).
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).
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).
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).
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).
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).
Form of Director Restricted Stock Unit Agreement (incorporated by reference to Exhibit 10.6 to the Company's Annual Report
on Form 10-K filed on March 8, 2013).
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).
Form of Restricted Stock Unit Agreement (incorporated by reference to Exhibit 10.8 to the Company's Annual Report on Form
10-K filed on March 8, 2013).
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).
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).
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).
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).
Second Amended and Restated Senior Management Severance Plan (incorporated by reference to Exhibit 10 to the Company's
85
*
*
*
*
*
*
*
*
*
*
*
*
*
*
10.19
10.20
10.21
10.22
*
*#
*#
10.23
†
Current Report on Form 8-K filed on July 16, 2015).
Executive Retention and Separation Agreement, dated as of November 24, 2015, by and between the Company and Barry
Labinger (incorporated by reference to Exhibit 10 to the Company's Current Report on Form 8-K filed on December 1, 2015).
Consulting Agreement, dated as of November 11, 2015, by and between the Company and Marvin L. White.
Consulting Agreement, dated as of January 4, 2016, by and between the Company and Barry Labinger.
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).
Solicitation, Offer and Award (the "CDC BioThrax Procurement Contract"), effective September 30, 2011, from the Centers
for Disease Control and Prevention to Emergent Biodefense Operations Lansing LLC (incorporated by reference to Exhibit
10.4 to the Company's Quarterly Report on Form 10-Q filed on May 4, 2012).
10.24
† Modification No. 1 to the CDC BioThrax Procurement Contract, effective March 21, 2012, between Emergent Biodefense
10.25
10.26
Operations Lansing LLC and the Centers for Disease Control and Prevention (incorporated by reference to Exhibit 10.2 to the
Company's Quarterly Report on Form 10-Q filed on November 1, 2012).
† Modification No. 2 to the CDC BioThrax Procurement Contract, effective September 1, 2012, between Emergent Biodefense
Operations Lansing LLC and the Centers for Disease Control and Prevention (incorporated by reference to Exhibit 10.3 to the
Company's Quarterly Report on Form 10-Q filed on November 1, 2012).
Modification No. 3 to the CDC BioThrax Procurement Contract, effective April 5, 2013, between Emergent Biodefense
Operations Lansing LLC and the Centers for Disease Control and Prevention (incorporated by reference to Exhibit 10.1 to the
Company's Quarterly Report on Form 10-Q filed on August 6, 2013).
10.27
† Modification No. 4 to the CDC BioThrax Procurement Contract, effective June 1, 2013, between Emergent Biodefense
Operations Lansing LLC and the Centers for Disease Control and Prevention (incorporated by reference to Exhibit 10.2 to the
Company's Quarterly Report on Form 10-Q filed on August 6, 2013).
10.28
† Modification No. 5 to the CDC BioThrax Procurement Contract, effective June 1, 2013, between Emergent Biodefense
Operations Lansing LLC and the Centers for Disease Control and Prevention (incorporated by reference to Exhibit 10.3 to the
Company's Quarterly Report on Form 10-Q filed on August 6, 2013).
10.29
† Modification No. 6 to the CDC BioThrax Procurement Contract, effective June 1, 2013, between Emergent Biodefense
10.30
10.31
Operations Lansing LLC and the Centers for Disease Control and Prevention (incorporated by reference to Exhibit 10.4 to the
Company's Quarterly Report on Form 10-Q filed on August 6, 2013).
† Modification No. 7 to the CDC BioThrax Procurement Contract, effective September 26, 2013, between Emergent Biodefense
Operations Lansing LLC and the Centers for Disease Control and Prevention (incorporated by reference to Exhibit 10.1 to the
Company's Quarterly Report on Form 10-Q filed on November 8, 2013).
† Modification No. 8 to the CDC BioThrax Procurement Contract, effective September 30, 2013, between Emergent Biodefense
Operations Lansing LLC and the Centers for Disease Control and Prevention (incorporated by reference to Exhibit 10.2 to the
Company's Quarterly Report on Form 10-Q filed on November 8, 2013).
10.32
† Modification No. 9 to the CDC BioThrax Procurement Contract, effective January 13, 2014, between Emergent Biodefense
Operations Lansing LLC and the Centers for Disease Control and Prevention (incorporated by reference to Exhibit 10.26 to the
Company's Annual Report on Form 10-K filed on March 10, 2014).
10.33
† Modification No. 10 to the CDC BioThrax Procurement Contract, effective January 22, 2014, between Emergent Biodefense
Operations Lansing LLC and the Centers for Disease Control and Prevention (incorporated by reference to Exhibit 10.27 to the
Company's Annual Report on Form 10-K filed on March 10, 2014).
10.34
† Modification No. 11 to the CDC BioThrax Procurement Contract, effective September 18, 2014, between Emergent
Biodefense Operations Lansing LLC and the Centers for Disease Control and Prevention (incorporated by reference to Exhibit
10 to the Company's Quarterly Report on Form 10-Q/A filed on January 23, 2015).
#†† Modification No. 12 to the CDC BioThrax Procurement Contract, effective September 30, 2014, between Emergent
Biodefense Operations Lansing LLC and the Centers for Disease Control and Prevention.
#†† Modification No. 13 to the CDC BioThrax Procurement Contract, effective October 23, 2014, between Emergent Biodefense
Operations Lansing LLC and the Centers for Disease Control and Prevention.
#†† Modification No. 14 to the CDC BioThrax Procurement Contract, effective December 16, 2014, between Emergent Biodefense
Operations Lansing LLC and the Centers for Disease Control and Prevention.
† Modification No. 15 to the CDC BioThrax Procurement Contract, effective September 22, 2015, between Emergent
Biodefense Operations Lansing LLC and the Centers for Disease Control and Prevention (incorporated by reference to Exhibit
10.2 to the Company's Quarterly Report on Form 10-Q filed on November 6, 2015).
#
#
#
#
#
#
#
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.
XBRL Instance Document
XBRL Taxonomy Extension Schema Document
XBRL Taxonomy Calculation Linksbase Document
XBRL Taxonomy Definition Linksbase Document
XBRL Taxonomy Label Linksbase Document
10.35
10.36
10.37
10.38
12
21
23
31.1
31.2
32.1
32.2
101.INS
101.SCH
101.CAL
101.DEF
101.LAB
86
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.
Attached as Exhibit 101 to this Annual Report on Form 10-K are the following formatted in XBRL (Extensible Business Reporting
Language): (i) Consolidated Balance Sheets as of December 31, 2015 and 2014, (ii) Consolidated Statements of Operations for the Years Ended
December 31, 2015, 2014 and 2013, (iii) Consolidated Statements of Comprehensive Income for the Years Ended December 31, 2015, 2014 and
2013 (iv) Consolidated Statements of Cash Flows for the Years Ended December 31, 2015, 2014 and 2013, (v) Consolidated Statements of Changes
in Stockholders' Equity for the Years ended December 31, 2015, 2014 and 2013, and (vi) Notes to Consolidated Financial Statements.
87
The graph below matches Emergent BioSolutions, Inc.'s cumulative 5-Year total shareholder return on common stock with the cumulative total
returns of the S&P 500 index, the S&P Biotechnology index, and the S&P Pharmaceuticals index. The graph tracks the performance of a $100
investment in our common stock and in each index (with the reinvestment of all dividends) from 12/31/2010 to 12/31/2015.
COMPARISON OF 5 YEAR CUMULATIVE TOTAL RETURN*
Among Emergent BioSolutions, Inc., the S&P 500 Index,
the S&P Biotechnology Index and the S&P Pharmaceuticals Index
$500
$450
$400
$350
$300
$250
$200
$150
$100
$50
$0
12/10 3/11
6/11
9/11 12/11 3/12
6/12
9/12 12/12 3/13
6/13
9/13 12/13 3/14
6/14
9/14 12/14 3/15
6/15
9/15 12/15
Emergent BioSolutions, Inc.
S&P 500
S&P Biotechnology
S&P Pharmaceuticals
*$100 invested on 12/31/10 in stock or index, including reinvestment of dividends.
Fiscal year ending December 31.
Copyright© 2016 S&P, a division of McGraw Hill Financial. All rights reserved.
12/10
1/11
2/11
3/11
4/11
5/11
6/11
7/11
8/11
9/11
10/11
11/11
Emergent BioSolutions, Inc.
S&P 500
S&P Biotechnology
S&P Pharmaceuticals
12/11
1/12
2/12
100.00
100.00
100.00
100.00
3/12
90.54
102.37
98.86
98.01
4/12
89.68
105.88
97.99
101.30
5/12
102.98
105.92
104.57
102.60
6/12
99.23
109.06
109.88
110.12
7/12
106.48
107.82
114.79
113.11
8/12
96.12
106.03
115.09
111.60
9/12
88.02
103.87
111.69
107.83
10/12
77.02
98.23
109.54
108.14
11/12
65.77
91.32
109.22
104.92
12/12
80.39
101.30
118.35
109.28
1/13
72.63
101.08
116.90
112.10
2/13
59.93
114.24
142.66
123.40
7/13
75.40
141.69
258.06
169.16
10/14
96.42
174.06
411.34
217.69
61.47
107.38
137.59
119.99
8/13
74.94
137.59
251.20
162.20
11/14
105.97
178.74
404.50
228.09
64.58
111.80
143.14
128.39
9/13
81.20
141.90
271.23
166.02
12/14
116.07
178.29
397.13
222.70
62.28
113.35
153.66
132.05
10/13
83.25
148.42
280.45
174.30
1/15
119.48
172.93
416.82
222.39
62.79
115.91
158.55
130.56
11/13
95.69
152.95
296.54
181.31
2/15
127.75
182.87
425.07
231.17
60.57
118.90
167.26
135.76
12/13
98.00
156.82
298.20
182.22
3/15
122.59
179.98
419.39
232.64
56.65
116.71
162.19
136.29
1/14
102.00
151.40
313.03
181.74
4/15
126.56
181.71
408.72
233.51
64.02
117.38
173.50
135.89
2/14
105.46
158.32
331.75
195.72
5/15
135.81
184.04
432.56
242.00
68.37
118.45
170.22
134.75
3/14
107.72
159.65
297.99
196.76
6/15
140.45
180.48
440.48
237.38
68.41
124.59
181.91
145.02
4/14
112.36
160.83
299.31
200.73
7/15
139.94
184.26
456.04
246.30
66.03
126.28
192.29
147.23
5/14
92.46
164.61
315.20
200.31
8/15
141.90
173.15
410.78
226.32
72.34
106.69
134.46
116.50
4/13
65.39
133.54
227.33
161.75
7/14
93.78
165.69
344.88
199.22
10/15
137.04
183.11
420.67
233.11
65.09
111.30
132.43
117.30
5/13
60.53
136.67
236.76
159.64
8/14
106.14
172.32
380.90
206.64
11/15
160.57
183.65
412.32
233.59
68.20
114.97
138.41
122.46
6/13
61.47
134.83
223.66
159.67
9/14
90.84
169.91
381.29
211.03
12/15
170.55
180.75
420.66
235.59
The stock price performance included in this graph is not necessarily indicative of future stock price performance.
71.78
102.11
122.87
117.76
3/13
59.59
131.02
217.36
156.48
6/14
95.74
168.01
324.43
204.25
9/15
121.44
168.86
378.03
216.13
88
Directors, Officers and Senior Management
BOARD OF DIRECTORS
Fuad El-Hibri (5*)
Executive Chairman,
Emergent BioSolutions Inc.
Daniel J. Abdun-Nabi (5)
President and Chief Executive Officer,
Emergent BioSolutions Inc.
Dr. Sue Bailey (2,3,4)
Former Advisor to the Director of the
National Cancer Institute;
Former Assistant Secretary of Defense
(Health Affairs)
Zsolt Harsanyi, Ph.D. (1*,4,5)
Chairman of the Board, N-Gene
Research Laboratories, Inc.
Dr. Jerome Hauer (4,5)
Principal, The Chertoff Group; Former
New York Commissioner, Division of
Homeland Security; Chairman of the
Executive Committee on Counterter-
rorism
General George A. Joulwan (1,2,3)
U.S. Army (retired);
President, One Team, Inc.
John E. Niederhuber, M.D. (2,4*)
Executive Vice President, Inova Health
System and Chief Executive Officer,
Inova Translational Medicine Institute
Ronald B. Richard (1,3*,5,6)
President and Chief Executive Officer,
The Cleveland Foundation
Louis W. Sullivan, M.D. (1,2*,3)
President Emeritus, Morehouse School of
Medicine; Former Secretary, Department
of Health and Human Services
Marvin L. White (4,5)
President and Chief Executive Officer,
The MLW Advisory Group, LLC; Former
Vice President and Chief Financial
Officer, St. Vincent Health
1 Audit Committee
2 Compensation Committee
3 Nominating & Corporate
Governance Committee
4 Scientific Review Committee
5 Strategic Operations Committee
6 Lead Independent Director
* Chairperson of Committee
CORPORATE OFFICERS AND SENIOR MANAGEMENT
Fuad El-Hibri*
Executive Chairman of the
Board of Directors
Daniel J. Abdun-Nabi*
President, Chief Executive Officer
and Director
A.B. Cruz III
Executive Vice President,
Legal Affairs and Compliance Division,
General Counsel and Secretary
Adam R. Havey*
Executive Vice President and
President, Biodefense Division
W. James Jackson, Ph.D.
Senior Vice President,
Chief Scientific Officer
Robert G. Kramer*
Executive Vice President and President,
Corporate Services Division,
Chief Financial Officer and Treasurer
Tracey Schmitt Lintott
Senior Vice President,
Global Public Affairs
Allen M. Shofe
Executive Vice President and President,
Corporate Affairs Division
Katy Strei
Senior Vice President,
Chief Human Resources Officer
* Executive Officer
Corporate Information
CORPORATE HEADQUARTERS
400 Professional Drive, Suite 400
Gaithersburg, MD 20879
Tel: 240-631-3200
Fax: 240-631-3203
GAITHERSBURG, MD
HEADQUARTERS AND PRODUCT DEVELOPMENT SITES
BALTIMORE, MD
CAMDEN AND BAYVIEW SITES
LONDON, UK
MUNICH, GERMANY
WINNIPEG, CANADA
PHILADELPHIA, PA
SEATTLE, WA
LANSING, MI
HATTIESBURG, MS
WASHINGTON, DC
SINGAPORE
Additional copies of the company’s Form 10-K for the year ended December 31,
2015, filed with the Securities and Exchange Commission, and copies of the
exhibits thereto, are available without charge upon written request to Investor
Relations, Emergent BioSolutions, 400 Professional Drive, Suite 400,
Gaithersburg, MD 20879, by calling (240) 631-3200 or by accessing the
company’s website at www.emergentbiosolutions.com.
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Ernst & Young LLP, McLean, VA, United States
STOCK TRANSFER AGENT AND REGISTRAR
Investors with questions concerning account information, new certificate
issuances, lost or stolen certificate replacement, securities transfers, or the
processing of a change of address should contact:
American Stock Transfer & Trust Company
6201 15th Avenue, Brooklyn, NY 11219, United States
Tel: 800-937-5449 or 718-921-8124
www.amstock.com
INVESTOR RELATIONS
Robert G. Burrows, Vice President, Investor Relations
E-mail: burrowsr@ebsi.com Tel: 240-631-3280 Fax: 240-631-3203
MARKET INFORMATION
Emergent BioSolutions Inc. common stock trades on the
New York Stock Exchange under the trading symbol EBS.
ANNUAL MEETING
Thursday, May 19, 2016, 9 a.m., Eastern Time
Bethesda Marriott
5151 Pooks Hill Road, Bethesda, MD 20814
CORPORATE GOVERNANCE
Our Chief Executive Officer intends to submit his annual chief
executive officer certification to the New York Stock Exchange
within 30 days of the date of our Annual Meeting of Stockholders in
accordance with the New York Stock Exchange listing requirements.
Emergent BioSolutions Inc. is strongly committed to the highest
standards of ethical conduct and corporate governance. Our Board
of Directors has adopted Corporate Governance Guidelines, along
with the charters of the Board Committees and a Code of Conduct and
Business Ethics for directors, officers and employees, all of which are
available on the company’s website at www.emergentbiosolutions.com.
400 Professional Drive, Suite 400, Gaithersburg, Maryland 20879 USA
www.emergentbiosolutions.com