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These terms and conditions govern your use of the website alphaminr.com and its related services.
These Terms and Conditions (“Terms”) are a binding contract between you and Alphaminr, (“Alphaminr”, “we”, “us” and “service”). You must agree to and accept the Terms. These Terms include the provisions in this document as well as those in the Privacy Policy. These terms may be modified at any time.
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You represent that you are of legal age to form a binding contract. You are responsible for any
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time.
The Services are intended for your own individual use. You shall only use the Services in a
manner that complies with all laws. You may not use any automated software, spider or system to
scrape data from Alphaminr.
Alphaminr is not a financial advisor and does not provide financial advice of any kind. The service is provided “As is”. The materials and information accessible through the Service are solely for informational purposes. While we strive to provide good information and data, we make no guarantee or warranty as to its accuracy.
TO THE EXTENT PERMITTED BY APPLICABLE LAW, UNDER NO CIRCUMSTANCES SHALL ALPHAMINR BE LIABLE TO YOU FOR DAMAGES OF ANY KIND, INCLUDING DAMAGES FOR INVESTMENT LOSSES, LOSS OF DATA, OR ACCURACY OF DATA, OR FOR ANY AMOUNT, IN THE AGGREGATE, IN EXCESS OF THE GREATER OF (1) FIFTY DOLLARS OR (2) THE AMOUNTS PAID BY YOU TO ALPHAMINR IN THE SIX MONTH PERIOD PRECEDING THIS APPLICABLE CLAIM. SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL OR CERTAIN OTHER DAMAGES, SO THE ABOVE LIMITATION AND EXCLUSIONS MAY NOT APPLY TO YOU.
If any provision of these Terms is found to be invalid under any applicable law, such provision shall not affect the validity or enforceability of the remaining provisions herein.
This privacy policy describes how we (“Alphaminr”) collect, use, share and protect your personal information when we provide our service (“Service”). This Privacy Policy explains how information is collected about you either directly or indirectly. By using our service, you acknowledge the terms of this Privacy Notice. If you do not agree to the terms of this Privacy Policy, please do not use our Service. You should contact us if you have questions about it. We may modify this Privacy Policy periodically.
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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14-1902018
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(State or Other Jurisdiction of Incorporation or Organization)
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(IRS Employer Identification No.)
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400 Professional Drive, Gaithersburg , Maryland
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20879
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(Address of Principal Executive Offices)
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(Zip Code)
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Title of Each Class
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Name of Each Exchange on Which Registered
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Common stock, $0.001 par value per share
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New York Stock Exchange
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INDEX
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PART I
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PART II
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PART III
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PART IV
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| § |
appropriations for the procurement of BioThrax
®
(Anthrax Vaccine Adsorbed) and our other countermeasure products;
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our ability to obtain a BioThrax procurement contract from BARDA under the Sole Source Notification;
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our ability to perform under our contracts with the U.S. government related to BioThrax, including the timing of deliveries;
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our ability to obtain Emergency Use Authorization pre-approval for NuThrax from the FDA;
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the availability of funding for our U.S. government grants and contracts;
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our ability to successfully execute our growth strategy and achieve our financial and operational goals;
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our ability to successfully integrate and develop the products or product candidates, programs, operations and personnel of any entities or businesses that we acquire;
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our ability to utilize the full manufacturing capacity of Building 55, our large-scale vaccine manufacturing facility in Lansing, Michigan;
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whether the operational, marketing and strategic benefits of the spin-off of our biosciences business can be achieved and the timing of any such benefits;
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our ability to identify and acquire companies or in-license products or late-stage product candidates that satisfy our selection criteria;
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our ability to realize synergies and benefits from acquisitions or in-licenses within expected time periods or at all;
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our ability to successfully identify and respond to new development contracts with the U.S. government, as well as successfully maintain, through achievement of development milestones, current development contracts with the U.S. government;
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our ability to obtain and maintain intellectual property protection for our products and product candidates;
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our ability and plans to expand our manufacturing facilities and capabilities;
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our ability and the ability of our contractors and suppliers to maintain compliance with cGMP and other regulatory obligations;
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the results of regulatory inspections;
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the operating and financial restrictions placed on us and our subsidiaries under our senior secured credit facility;
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the outcome of the purported class action lawsuit filed against us and possible other future material legal proceedings;
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the rate and degree of market acceptance and clinical utility of our products;
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the success of our ongoing and planned development programs, non-clinical activities and clinical trials of our product candidates;
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our ability to obtain and maintain regulatory approvals for our product candidates and the timing of any such approvals;
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the success of our commercialization, marketing and manufacturing capabilities and strategy; and
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| § |
the accuracy of our estimates regarding future revenues, expenses, capital requirements and needs for additional financing.
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| § |
Vaccines and Anti-infectives;
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Antibody Therapeutics;
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Devices; and
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Contract Manufacturing.
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NuThrax™ (anthrax vaccine adsorbed with CPG 7909 adjuvant), a next generation anthrax vaccine;
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UV-4B, a novel anti-viral therapeutic being developed as an oral treatment for dengue and influenza infections; and
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| § |
GC-072, the lead compound in the EV-035 series of broad-spectrum antibiotics, being developed as an oral and intravenous treatment for
Burkholderia pseudomallei
infection.
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Anthrasil
®
[
Anthrax Immune Globulin Intravenous (Human)], the only polyclonal antibody therapeutic licensed by the FDA for the treatment of inhalational anthrax;
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BAT
®
[Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine)],
the only heptavalent therapeutic licensed by the FDA and Health Canada for the treatment of botulinum disease; and
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VIGIV [Vaccinia Immune Globulin Intravenous (Human)]
the only therapeutic licensed by the FDA and Health Canada to address certain complications from smallpox vaccination.
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FLU-IG (NP025), a human polyclonal antibody therapeutic being developed to treat seasonal influenza;
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ZIKA-IG (NP024), a human polyclonal antibody therapeutic being developed as a prophylaxis and treatment for Zika infections; and
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FILOV (NP026), an equine polyclonal antibody therapeutic being developed to treat hemorrhagic fever caused by Filoviruses (Ebola, Marburg and Sudan).
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RSDL
®
(Reactive Skin Decontamination Lotion Kit), the only device cleared by the FDA to remove or neutralize chemical warfare agents and T-2 toxins
from the skin; and
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Trobigard™ (atropine sulfate, obidoxime chloride),
an auto-injector device designed for intramuscular self-injection
of atropine sulfate and obidoxime chloride, a nerve agent countermeasure. This product has not been approved by the FDA or any other regulatory agency, is not promoted or distributed in the U.S., and is only sold to non-U.S. authorized government buyers.
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expand our leadership position in the public health threats market;
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develop and manufacture innovative products in partnership with governments and non-governmental organizations;
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grow organically and through acquisition of revenue-generating and accretive products and businesses
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expand our portfolio of best in class/only in class medical countermeasures and services;
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establish dual-market international marketing and sales capabilities; and
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enhance our culture to create a sustainable competitive advantage.
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government relations and contracting;
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medical countermeasure development and commercialization;
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quality manufacturing using multiple platform technologies;
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business and product acquisitions; and
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financial discipline.
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VACCINES AND ANTI-INFECTIVES UNIT
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Product
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Indication(s)
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Regulatory Approvals
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BioThrax
®
(Anthrax Vaccine Adsorbed)
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GUP - General use prophylaxis of anthrax disease; and
PEP - Post-exposure prophylaxis of anthrax disease in combination with appropriate antibacterial drugs
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United States – GUP and PEP
Germany - GUP
Singapore - GUP
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ANTIBODY THERAPEUTICS UNIT
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Product
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Indication(s)
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Regulatory Approvals
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Anthrasil
®
[Anthrax Immune Globulin Intravenous (Human)]
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Treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs
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United States
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BAT
®
[Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine)]
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Comprised of purified polyclonal equine immune globulins indicated for the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults and pediatric patients
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United States
Canada
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VIGIV [Vaccinia Immune Globulin Intravenous (Human)]
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Treatment of complications due to vaccinia vaccination, including:
• Eczema vaccinatum
• Progressive vaccinia
• Severe generalized vaccinia
• Aberrant infections induced by vaccinia virus (except in cases of isolated keratitis)
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United States
Canada
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DEVICES UNIT
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Product
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Indication(s)
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Regulatory Approvals
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RSDL
®
(Reactive Skin Decontamination Lotion Kit)
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RSDL to remove or neutralize chemical warfare agents and T-2 toxin from the skin
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United States 510(k)
Australia
Canada
Israel
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Trobigard™ (atropine sulfate, obidoxime chloride)
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A auto-injector device designed for intramuscular self-injection of atropine sulfate and obidoxime chloride.
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This product has not been approved by the FDA or any other regulatory agency, is not promoted or distributed in the U.S., and is only sold to non-U.S. authorized government buyers.
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| § |
Camden (Baltimore, Maryland).
Primarily supporting our Contract Manufacturing business unit, our Camden facility located in Baltimore, Maryland has provided manufacturing services to more than 50 domestic and international customers and has manufactured over 20 commercial products distributed in approximately 50 countries. This facility offers customers a broad portfolio of capabilities essential to their product development and commercialization efforts.
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Winnipeg, Manitoba, Canada.
Our facility in Winnipeg is the primary location for product development and manufacturing in support of our Antibody Therapeutics business unit. This facility also supports our Contract Manufacturing business unit through product development and manufacturing support to a number of customers.
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December 31,
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||||||||||||
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in millions
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2016
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2015
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2014
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|||||||||
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Research and development expense
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$
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108.3
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$
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119.2
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$
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104.7
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||||||
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less: Contracts and grants
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(143.4
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)
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(117.4
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)
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(91.7
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)
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Net research and development expense (income)
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$
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(35.1
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)
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$
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1.8
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$
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13.0
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|||||
| § |
BioThrax and NuThrax.
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. PharmAthene, Inc., PaxVax Inc., Altimmune, Inc., Pfenex Inc., Soligenix, Inc., Immunovaccine Inc. and NanoBio Corporation are each currently developing anthrax vaccine product candidates.
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| § |
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. also has obtained FDA approval for Anthim® (obiltoxaximab) injection, indicated for the treatment and prophylaxis of inhalational anthrax.
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| § |
BAT
.
Our botulinum immune globulin product is the only heptavalent therapeutic licensed by the FDA and Health Canada for the treatment of botulinum disease and has Orphan Drug Status. Other companies may be developing therapies aimed at treating or preventing botulism infections, however, direct competition is currently limited.
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| § |
VIGIV
.
Our VIGIV product is the only therapeutic licensed by the FDA and Health Canada to address adverse events from smallpox vaccination with ACAM2000. Other companies may be developing therapies aimed at treating or preventing vaccinia infections; however, direct competition is currently limited. SIGA Technologies, Inc. is developing Tecovirimat (Arestvyr™, ST-26), an oral therapy that targets orthopox viruses such as vaccinia and potentially smallpox.
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| § |
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 procured Fullers Earth, Dutch Powder and French Powder as a preparedness countermeasure for liquid chemical weapons.
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| § |
Trobigard
. Trobigard auto-injector delivers obidoxime chloride and atropine sulfate for emergency treatment of organophosphate nerve agent or insecticide poisoning. Meridian Medical Technologies, a subsidiary of Pfizer, is currently the sole provider of FDA-approved nerve agent antidote auto-injector devices to the U.S. government and many international allied governments. Internationally, the remaining market is fragmented and served by regional or national-based defense product manufacturers.
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| § |
Contract Manufacturing Services Business
. We compete for contract manufacturing service business with a number of biopharmaceutical product development organizations, contract manufacturers of biopharmaceutical products and university research laboratories, including, among others: Lonza Group Ltd., OSO BioPharmaceuticals Manufacturing, LLC, Par Pharmaceutical Companies, Inc., Jubilant Hollister-Stier Laboratories LLC (a subsidiary of Jubilant Life Sciences Limited), Patheon Inc., Hospira Inc., Ajinomoto Althea, Inc. (a subsidiary of Ajinomoto Co., Inc.) Cook Pharmica LLC (a subsidiary of Cook Group Inc.), and Albany Molecular Research, Inc. We also compete with in-house research, development and support service departments of other biopharmaceutical companies.
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| § |
the Federal Acquisition Regulation, or FAR, and agency-specific regulations supplemental to FAR, which comprehensively regulate the award, formation, administration and performance of government contracts;
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| § |
the Defense Federal Acquisition Regulations, or DFARs, and agency-specific regulations supplemental to DFARs, which comprehensively regulate the award, formation, administration and performance of DoD government contracts;
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| § |
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;
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| § |
export and import control laws and regulations, including but not limited to ITAR (International Traffic in Arms Regulations); and
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| § |
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.
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| § |
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.
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| § |
Phase 2 clinical trials involve a small number of patients with the target disease or disorder and seek to assess the efficacy of the drug for specific indications to determine dose response and the optimal dose range and to gather additional information relating to safety and potential adverse effects.
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| § |
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 candidate using a specific dosing regimen. The safety and efficacy data generated from Phase 3 clinical trials typically form the basis for FDA approval of the product candidate.
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| § |
Phase 4 clinical trials are sometimes conducted after a product has been approved. These trials can be conducted for a number of purposes, including to collect long-term safety information or to collect additional data about a specific patient population. As part of a product approval, the FDA may require that certain Phase 4 studies, which are sometimes called post-marketing commitment studies, be conducted post-approval.
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| § |
BioThrax for post-exposure prophylaxis of disease following suspected or confirmed
B. anthracis
exposure, when administered in conjunction with recommended antibacterial drugs, with exclusivity though November 2022;
|
| § |
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; and
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| § |
BAT with exclusivity through March 2020 for treatment of suspected or documented exposure to botulinum neurotoxin A, B, C, D, E, F or G.
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| § |
Class I devices are those for which safety and effectiveness can be assured by adherence to a set of general controls. These general controls include compliance with the applicable portions of the FDA's Quality System Regulation, or QSR, which sets forth requirements for manufacturing practices, record keeping, reporting of adverse medical events, labeling and promotion only for cleared or approved intended uses.
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| § |
Class II devices are also subject to these general controls and to any other special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device. Review and clearance by the FDA for these devices is typically accomplished through the 510(k) pre-market notification procedure. When 510(k) clearance is sought, a sponsor must submit a pre-market notification demonstrating that the proposed device is substantially equivalent to a device approved by the FDA after May 28, 1976. This previously-cleared device is called the predicate device. If the FDA agrees that the proposed device is substantially equivalent to the predicate device, then 510(k) clearance to market will be granted. After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, requires a new 510(k) clearance or could require pre-market approval.
If a proposed device is substantially equivalent to a predicate device that was cleared prior to May 28, 1976, the proposed device is cleared based on a pre-amendment and is cleared as an unclassified device.
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| § |
A Class III device requires approval of a pre-market application, or PMA, which is an expensive, lengthy and uncertain process requiring many years to complete. Clinical trials are almost always required to support a PMA. These trials generally require submission of an application for an investigational device exemption, or IDE. An IDE must be supported by pre-clinical data, such as animal and laboratory testing results, which show that the device is safe to test in humans and that the study protocols are scientifically sound. The IDE must be approved in advance by the FDA for a specified number of patients, unless the product is deemed a non-significant risk device and is eligible for more abbreviated investigational device exemption requirements.
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fines, injunctions, and civil penalties;
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| § |
recall or seizure of products;
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| § |
operating restrictions, partial suspension or total shutdown of production;
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| § |
refusal of requests for 510(k) clearance or PMA approval of new products;
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| § |
withdrawal of 510(k) clearance or PMA approvals already granted; and
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| § |
criminal prosecution.
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| § |
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;
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| § |
the need to accurately estimate the resources and cost structure that will be required to perform any contract that we might be awarded;
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| § |
the possibility that we may be ineligible to respond to a request for proposal issued by the government;
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| § |
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
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| § |
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.
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| § |
the Federal Acquisition Regulation, or FAR, and agency-specific regulations supplemental to FAR, which comprehensively regulate the award, formation, administration and performance of government contracts;
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| § |
the Defense Federal Acquisition Regulations, or DFARs, and agency-specific regulations supplemental to DFARs, which comprehensively regulate the award, formation, administration and performance of U.S. Department of Defense, or DoD, government contracts;
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| § |
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;
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| § |
export and import control laws and regulations, including but not limited to ITAR (International Traffic in Arms Regulations); and
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| § |
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.
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| § |
terminate existing contracts, in whole or in part, for any reason or no reason;
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| § |
unilaterally reduce or modify contracts or subcontracts, including by imposing equitable price adjustments;
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| § |
cancel multi-year contracts and related orders, if funds for contract performance for any subsequent year become unavailable;
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| § |
decline, in whole or in part, to exercise an option to purchase product under a procurement contract or to fund additional development under a development contract;
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| § |
decline to renew a procurement contract;
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| § |
claim rights to facilities or to products, including intellectual property, developed under the contract;
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| § |
require repayment of contract funds spent on construction of facilities in the event of contract default;
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| § |
take actions that result in a longer development timeline than expected;
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| § |
direct the course of a development program in a manner not chosen by the government contractor;
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| § |
suspend or debar the contractor from doing business with the government or a specific government agency;
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| § |
pursue civil or criminal remedies under acts such as the False Claims Act and False Statements Act; and
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| § |
control or prohibit the export of products.
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| § |
warning letters and other communications;
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| § |
product seizure or withdrawal of the product from the market;
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| § |
restrictions on the marketing or manufacturing of a product;
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| § |
suspension or withdrawal of regulatory approvals or refusal to approve pending applications or supplements to approved applications;
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| § |
fines or disgorgement of profits or revenue; and
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| § |
injunctions or the imposition of civil or criminal penalties.
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| § |
equipment malfunctions or failures;
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| § |
technology malfunctions;
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| § |
cyber-attacks;
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| § |
work stoppages or slow-downs;
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| § |
protests, including by animal rights activists;
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| § |
injunctions or the imposition of civil or criminal penalties.
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| § |
damage to or destruction of the facility; or
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| § |
product contamination or tampering.
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| § |
successful development, formulation and cGMP scale-up of manufacturing that meets FDA requirements;
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| § |
successful program partnering;
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| § |
successful completion of clinical or non-clinical development, including toxicology studies and studies in approved animal models;
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| § |
receipt of marketing approvals from the FDA and equivalent foreign regulatory authorities;
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| § |
establishment of commercial manufacturing processes and product supply arrangements;
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| § |
training of a commercial sales force for the product, whether alone or in collaboration with others;
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| § |
successful registration and maintenance of relevant patent and/or other proprietary protection; and
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| § |
acceptance of the product by potential government customers.
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| § |
our inability to manufacture sufficient quantities of materials for use in trials;
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| § |
the unavailability or variability in the number and types of subjects for each study;
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| § |
safety issues or inconclusive or incomplete testing, trial or study results;
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| § |
drug immunogenicity;
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| § |
lack of efficacy of product candidates during the trials;
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| § |
government or regulatory restrictions or delays; and
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| § |
greater than anticipated costs of trials.
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| § |
retaining existing customers and attracting new customers;
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| § |
retaining key employees;
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| § |
diversion of management attention and resources;
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| § |
conforming internal controls, policies and procedures, business cultures and compensation programs;
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| § |
consolidating corporate and administrative infrastructures;
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| § |
consolidating sales and marketing operations;
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| § |
identifying and eliminating redundant and underperforming operations and assets;
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| § |
assumption of known and unknown liabilities;
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| § |
coordinating geographically dispersed organizations; and
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| § |
managing tax costs or inefficiencies associated with integrating operations.
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| § |
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;
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| § |
increasing the amount of interest that we have to pay on debt with variable interest rates, if market rates of interest increase;
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| § |
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;
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| § |
requiring us to pledge our assets as collateral, which could limit our ability to obtain additional debt financing;
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| § |
limiting our flexibility in planning for, or reacting to, general adverse economic and industry conditions; and
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| § |
placing us at a competitive disadvantage compared to our competitors that have less debt, better debt servicing options or stronger debt servicing capacity.
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| § |
the level, timing and cost of product sales;
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| § |
the extent to which we acquire or invest in and integrate companies, businesses, products or technologies;
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| § |
the acquisition of new facilities and capital improvements to new or existing facilities;
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| § |
the payment obligations under our indebtedness;
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| § |
the scope, progress, results and costs of our development activities;
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| § |
our ability to obtain funding from government entities for our development programs; and
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| § |
the costs of commercialization activities, including product marketing, sales and distribution.
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| § |
decreased demand or withdrawal of a product;
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| § |
injury to our reputation;
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| § |
withdrawal of clinical trial participants;
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| § |
costs to defend the related litigation;
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| § |
substantial monetary awards to trial participants or patients;
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| § |
loss of revenue; and
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| § |
an inability to commercialize products that we may develop.
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| § |
the classification of our directors;
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| § |
limitations on changing the number of directors then in office;
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| § |
limitations on the removal of directors;
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| § |
limitations on filling vacancies on the board;
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| § |
limitations on the removal and appointment of the chairman of our Board of Directors;
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| § |
advance notice requirements for stockholder nominations of candidates for election to the Board of Directors and other proposals;
|
| § |
the inability of stockholders to act by written consent;
|
| § |
the inability of stockholders to call special meetings; and
|
| § |
the ability of our Board of Directors to designate the terms of and issue a new series of preferred stock without stockholder approval.
|
| § |
contracts, decisions and procurement policies by the U.S. government affecting BioThrax and our other biodefense products and product candidates;
|
| § |
the success of competitive products or technologies;
|
| § |
results of clinical and non-clinical trials of our product candidates;
|
| § |
announcements of acquisitions, financings or other transactions by us;
|
| § |
announcements relating to litigation or legal proceedings;
|
| § |
public concern as to the safety of our products;
|
| § |
termination or delay of a development program;
|
| § |
the recruitment or departure of key personnel;
|
| § |
variations in our product revenue and profitability; and
|
| § |
the other factors described in this "Risk Factors" section.
|
|
Location
|
Use
|
Approximate square feet
Owned/leased
|
Owned/leased
|
|
Lansing, Michigan
|
Manufacturing operations facilities, office space and laboratory space
|
336,000
|
Owned
|
|
Winnipeg, Manitoba, Canada
|
Manufacturing operations facilities, office space and laboratory space
|
315,000
|
Owned
|
|
Gaithersburg, Maryland
|
Office space/rental real estate
|
130,000
|
Owned
|
|
Baltimore, Maryland (Camden)
|
Manufacturing facilities and office and laboratory space
|
70,000
|
Owned
|
|
Baltimore, Maryland (Bayview)
|
Manufacturing facilities and office and laboratory space
|
56,000
|
Owned
|
|
Gaithersburg, Maryland
|
Office and laboratory space
|
48,000
|
Owned
|
|
Hattiesburg, Mississippi
|
Manufacturing facilities
|
9,000
|
Lease expires 2026
|
|
First Quarter
|
Second Quarter
|
Third Quarter
|
Fourth Quarter
|
|||||||||||||
|
Year Ended December 31, 2016
|
||||||||||||||||
|
High
|
$
|
39.29
|
$
|
44.38
|
$
|
34.10
|
$
|
36.64
|
||||||||
|
Low
|
$
|
31.26
|
$
|
27.01
|
$
|
26.12
|
$
|
24.47
|
||||||||
|
Year Ended December 31, 2015
|
||||||||||||||||
|
High
|
$
|
30.96
|
$
|
33.84
|
$
|
36.20
|
$
|
40.49
|
||||||||
|
Low
|
$
|
25.97
|
$
|
28.33
|
$
|
27.82
|
$
|
27.68
|
||||||||
|
Year Ended December 31,
|
||||||||||||||||||||
|
(in thousands, except share and per share data)
|
2016
|
2015
|
2014
|
2013
|
2012
|
|||||||||||||||
|
Statements of operations data:
|
||||||||||||||||||||
|
Revenues:
|
||||||||||||||||||||
|
Product sales
|
$
|
296,278
|
$
|
328,969
|
$
|
281,845
|
$
|
257,922
|
$
|
215,879
|
||||||||||
|
Contract manufacturing
|
49,138
|
42,968
|
30,944
|
-
|
-
|
|||||||||||||||
|
Contracts and grants
|
143,366
|
117,394
|
91,677
|
54,823
|
62,083
|
|||||||||||||||
|
Total revenues
|
488,782
|
489,331
|
404,466
|
312,745
|
277,962
|
|||||||||||||||
|
Operating expenses:
|
||||||||||||||||||||
|
Cost of product sales and contract manufacturing
|
131,284
|
107,486
|
101,963
|
62,127
|
46,077
|
|||||||||||||||
|
Research and development
|
108,290
|
119,186
|
104,721
|
81,759
|
96,442
|
|||||||||||||||
|
Selling, general & administrative
|
143,686
|
121,145
|
108,594
|
86,844
|
74,883
|
|||||||||||||||
|
Total operating expenses
|
383,260
|
347,817
|
315,278
|
230,730
|
217,402
|
|||||||||||||||
|
Income from operations
|
105,522
|
141,514
|
89,188
|
82,015
|
60,560
|
|||||||||||||||
|
Other income (expense):
|
||||||||||||||||||||
|
Interest income
|
1,053
|
572
|
320
|
139
|
133
|
|||||||||||||||
|
Interest expense
|
(7,617
|
)
|
(6,523
|
)
|
(8,240
|
)
|
-
|
(6
|
)
|
|||||||||||
|
Other income (expense), net
|
263
|
153
|
2,926
|
409
|
1,943
|
|||||||||||||||
|
Total other income (expense)
|
(6,301
|
)
|
(5,798
|
)
|
(4,994
|
)
|
548
|
2,070
|
||||||||||||
|
Income from continuing operations before provision for income taxes
|
99,221
|
135,716
|
84,194
|
82,563
|
62,630
|
|||||||||||||||
|
Provision for income taxes
|
36,697
|
44,300
|
29,928
|
12,270
|
9,834
|
|||||||||||||||
|
Net income from continuing operations
|
62,524
|
91,416
|
54,266
|
70,293
|
52,796
|
|||||||||||||||
|
Net loss attributable to noncontrolling interest
|
-
|
-
|
-
|
876
|
5,381
|
|||||||||||||||
|
Net income attributable to Emergent BioSolutions Inc. from continuing operations
|
62,524
|
91,416
|
54,266
|
71,169
|
58,177
|
|||||||||||||||
|
Net loss from discontinued operations
|
(10,748
|
)
|
(28,546
|
)
|
(17,525
|
)
|
(40,034
|
)
|
(34,653
|
)
|
||||||||||
|
Net income
|
$
|
51,776
|
$
|
62,870
|
$
|
36,741
|
$
|
31,135
|
$
|
23,524
|
||||||||||
|
Net income per share from continuing operations-basic
|
$
|
1.56
|
$
|
2.37
|
$
|
1.45
|
$
|
1.97
|
$
|
1.61
|
||||||||||
|
Net loss per share from discontinued operations-basic
|
(0.27
|
)
|
(0.74
|
)
|
(0.47
|
)
|
(1.11
|
)
|
(0.96
|
)
|
||||||||||
|
Net income per share-basic
|
$
|
1.29
|
$
|
1.63
|
$
|
0.98
|
$
|
0.86
|
$
|
0.65
|
||||||||||
|
Net income per share from continuing operations-diluted
|
$
|
1.35
|
$
|
2.02
|
$
|
1.26
|
$
|
1.94
|
$
|
1.60
|
||||||||||
|
Net loss per share from discontinued operations-diluted
|
(0.22
|
)
|
(0.61
|
)
|
(0.38
|
)
|
(1.09
|
)
|
(0.95
|
)
|
||||||||||
|
Net income per share-diluted (1)
|
$
|
1.13
|
$
|
1.41
|
$
|
0.88
|
$
|
0.85
|
$
|
0.65
|
||||||||||
|
Weighted average number of shares — basic
|
40,184,159
|
38,595,435
|
37,344,891
|
36,201,283
|
36,080,495
|
|||||||||||||||
|
Weighted average number of shares — diluted
|
49,335,112
|
47,255,842
|
45,802,807
|
36,747,556
|
36,420,662
|
|||||||||||||||
|
As of December 31,
|
||||||||||||||||||||
|
(in thousands)
|
2016
|
2015
|
2014
|
2013
|
2012
|
|||||||||||||||
|
Balance Sheet Data:
|
||||||||||||||||||||
|
Cash and cash equivalents
|
$
|
271,513
|
$
|
308,304
|
$
|
276,786
|
$
|
179,338
|
$
|
141,666
|
||||||||||
|
Working capital
|
404,362
|
425,865
|
312,767
|
284,652
|
250,962
|
|||||||||||||||
|
Total assets
|
970,111
|
931,836
|
815,611
|
521,898
|
486,509
|
|||||||||||||||
|
Total long-term liabilities
|
268,050
|
274,622
|
281,472
|
83,853
|
59,324
|
|||||||||||||||
|
Total stockholders' equity
|
596,205
|
574,951
|
454,495
|
482,395
|
406,512
|
|||||||||||||||
| § |
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. BioThrax is also licensed by the Paul-Ehrlich-Institut of the German Federal Ministry of Health for general use 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 and Health Canada for the treatment of botulinum disease;
|
| § |
VIGIV [Vaccinia Immune Globulin Intravenous (Human)], the only therapeutic licensed by the FDA to address certain complications from smallpox vaccination;
|
| § |
RSDL
®
(Reactive Skin Decontamination Lotion Kit), the only device cleared by the FDA intended to remove or neutralize chemical warfare agents and T-2 toxin from the skin; and
|
| § |
Tro
bigard™ (atropine sulfate, obidoxime chloride),
an auto-injector device designed for intramuscular self-injection
of atropine sulfate and obidoxime chloride, a nerve agent countermeasure. This product has not been approved by the FDA or any other regulatory agency, is not promoted or distributed in the U.S., and is only sold to non-U.S. authorized government buyers.
|
| § |
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 for
Burkholderia pseudomallei
;
|
| § |
FLU-IG (NP025), a human polyclonal antibody therapeutic being developed to treat seasonal influenza;
|
| § |
ZIKA-IG (NP024), a human polyclonal antibody therapeutic being developed as a prophylaxis for Zika infections; and
|
| § |
FILOV (NP026), an equine polyclonal antibody therapeutic being developed to treat Ebola infections.
|
| |
there is persuasive evidence of an arrangement;
|
| |
delivery has occurred or title has passed to our customer based on contract terms;
|
| |
the fee is fixed or determinable; and
|
| |
collectability is reasonably assured.
|
|
Development Programs
|
Funding Source
|
Award Date
|
Performance Period
|
|
Anthrasil
|
BARDA
|
Sep-05
|
9/2005 — 4/2021
|
|
BARDA
|
Sep-13
|
9/2013 — 9/2018
|
|
|
BAT
|
BARDA
|
May-06
|
5/2006 — 5/2026
|
|
CIADM
|
BARDA
|
Jun-12
|
6/2012 — 6/2037
|
|
GC-072
|
DTRA
|
Aug-14
|
8/2014 — 8/2017
|
|
Large-scale manufacturing for BioThrax
|
BARDA
|
Jul-10
|
7/2010 — 7/2017
|
|
NuThrax
|
NIAID
|
Aug-14
|
8/2014 — 10/2019
|
|
BARDA
|
Mar-15
|
3/2015 — 8/2017
|
|
|
BARDA
|
Sep-16
|
9/2016 — 9/2021
|
|
|
UV-4B
|
NIAID
|
Sep-11
|
9/2011 — 9/2017
|
|
VIGIV
|
CDC
|
Aug-12
|
8/2012 — 8/2017
|
|
Zika
|
BARDA
|
Jun-16
|
6/2016 — 12/2018
|
| § |
personnel-related expenses;
|
| § |
fees to professional service providers for, among other things, analytical testing, independent monitoring or other administration of our clinical trials and obtaining and evaluating data from our clinical trials and non-clinical studies;
|
| § |
costs of contract manufacturing services for clinical trial material; and
|
| § |
costs of materials used in clinical trials and research and development.
|
|
|
Year ended December 31,
|
|||||||||||||||
|
(in thousands)
|
2016
|
2015
|
Change
|
% Change
|
||||||||||||
|
Product sales:
|
||||||||||||||||
|
BioThrax
|
$
|
237,030
|
$
|
293,921
|
$
|
(56,891
|
)
|
(19
|
%)
|
|||||||
|
Other
|
59,248
|
35,048
|
24,200
|
69
|
%
|
|||||||||||
|
Total product sales
|
296,278
|
328,969
|
(32,691
|
)
|
(10
|
%)
|
||||||||||
|
Contract manufacturing
|
49,138
|
42,968
|
6,170
|
14
|
%
|
|||||||||||
|
Contracts and grants
|
143,366
|
117,394
|
25,972
|
22
|
%
|
|||||||||||
|
Total revenues
|
$
|
488,782
|
$
|
489,331
|
$
|
(549
|
)
|
0
|
%
|
|||||||
|
Year ended December 31,
|
||||||||||||||||
|
(in thousands)
|
2016
|
2015
|
Change
|
% Change
|
||||||||||||
|
Large-scale manufacturing for BioThrax
|
$
|
6,104
|
$
|
9,911
|
$
|
(3,807
|
)
|
(38
|
%)
|
|||||||
|
BioThrax related programs
|
3,069
|
3,511
|
(442
|
)
|
(13
|
%)
|
||||||||||
|
PreviThrax
|
1,324
|
7,152
|
(5,828
|
)
|
(81
|
%)
|
||||||||||
|
NuThrax
|
22,478
|
12,560
|
9,918
|
79
|
%
|
|||||||||||
|
Pandemic influenza
|
1,710
|
6,583
|
(4,873
|
)
|
(74
|
%)
|
||||||||||
|
Anthrasil
|
1,279
|
25,986
|
(24,707
|
)
|
(95
|
%)
|
||||||||||
|
BAT
|
3,904
|
4,867
|
(963
|
)
|
(20
|
%)
|
||||||||||
|
EV-035 series of molecules
|
326
|
6,801
|
(6,475
|
)
|
(95
|
%)
|
||||||||||
|
CIADM task orders
|
13,955
|
2,957
|
10,998
|
372
|
%
|
|||||||||||
|
VIGIV
|
12,019
|
3,060
|
8,959
|
293
|
%
|
|||||||||||
|
Emergard
|
9,000
|
4,643
|
4,357
|
94
|
%
|
|||||||||||
|
Other
|
33,122
|
31,155
|
1,967
|
6
|
%
|
|||||||||||
|
Total
|
$
|
108,290
|
$
|
119,186
|
$
|
(10,896
|
)
|
(9
|
%)
|
|||||||
|
|
Year ended December 31,
|
|||||||||||||||
|
(in thousands)
|
2015
|
2014
|
Change
|
% Change
|
||||||||||||
|
Product sales:
|
||||||||||||||||
|
BioThrax
|
$
|
293,921
|
$
|
245,905
|
$
|
48,016
|
20
|
%
|
||||||||
|
Other
|
35,048
|
35,940
|
(892
|
)
|
(2
|
%)
|
||||||||||
|
Total product sales
|
328,969
|
281,845
|
47,124
|
17
|
%
|
|||||||||||
|
Contract manufacturing
|
42,968
|
30,944
|
12,024
|
39
|
%
|
|||||||||||
|
Contracts and grants
|
117,394
|
91,677
|
25,717
|
28
|
%
|
|||||||||||
|
Total revenues
|
$
|
489,331
|
$
|
404,466
|
$
|
84,865
|
21
|
%
|
||||||||
|
Year ended December 31,
|
||||||||||||||||
|
(in thousands)
|
2015
|
2014
|
Change
|
% Change
|
||||||||||||
|
Large-scale manufacturing for BioThrax
|
$
|
9,911
|
$
|
13,625
|
$
|
(3,714
|
)
|
(27
|
%)
|
|||||||
|
BioThrax related programs
|
3,511
|
7,157
|
(3,646
|
)
|
(51
|
%)
|
||||||||||
|
PreviThrax
|
7,152
|
10,737
|
(3,585
|
)
|
(33
|
%)
|
||||||||||
|
NuThrax
|
12,560
|
9,428
|
3,132
|
33
|
%
|
|||||||||||
|
Pandemic influenza
|
6,583
|
469
|
6,114
|
1,304
|
%
|
|||||||||||
|
Anthrasil
|
25,986
|
19,513
|
6,473
|
33
|
%
|
|||||||||||
|
BAT
|
4,867
|
7,351
|
(2,484
|
)
|
(34
|
%)
|
||||||||||
|
EV-035 series of molecules
|
6,801
|
-
|
6,801
|
N/A
|
||||||||||||
|
CIADM task orders
|
2,957
|
-
|
2,957
|
N/A
|
||||||||||||
|
VIGIV
|
3,060
|
737
|
2,323
|
315
|
%
|
|||||||||||
|
Emergard
|
4,643
|
-
|
4,643
|
N/A
|
||||||||||||
|
Other
|
31,155
|
35,704
|
(4,549
|
)
|
(13
|
%)
|
||||||||||
|
Total
|
$
|
119,186
|
$
|
104,721
|
$
|
14,465
|
14
|
%
|
||||||||
|
|
Year ended December 31,
|
|||||||||||
|
(in thousands)
|
2016
|
2015
|
2014
|
|||||||||
|
Net cash provided by (used in):
|
||||||||||||
|
Operating activities(1)
|
$
|
53,616
|
$
|
44,309
|
$
|
112,339
|
||||||
|
Investing activities
|
(76,257
|
)
|
(45,462
|
)
|
(210,052
|
)
|
||||||
|
Financing activities
|
(18,641
|
)
|
33,449
|
198,874
|
||||||||
|
Net (decrease) increase in cash and cash equivalents
|
$
|
(41,282
|
)
|
$
|
32,296
|
$
|
101,161
|
|||||
|
Payments due by period
|
||||||||||||||||||||
|
Less than
|
1 to 3
|
3 to 5
|
More than
|
|||||||||||||||||
|
(in thousands)
|
Total
|
1 year
|
Years
|
Years
|
5 years
|
|||||||||||||||
|
Contractual obligations:
|
||||||||||||||||||||
|
2.875% Convertible Senior Notes due 2021 (Notes)
|
$
|
250,000
|
$
|
-
|
$
|
-
|
$
|
250,000
|
$
|
-
|
||||||||||
|
Contractual interest due on Notes
|
29,048
|
7,188
|
14,376
|
7,484
|
-
|
|||||||||||||||
|
Long-term indebtedness (excluding Notes)
|
3,000
|
-
|
-
|
-
|
3,000
|
|||||||||||||||
|
Purchase commitments
|
3,000
|
3,000
|
-
|
-
|
-
|
|||||||||||||||
|
Total contractual obligations
|
$
|
285,048
|
$
|
10,188
|
$
|
14,376
|
$
|
257,484
|
$
|
3,000
|
||||||||||
| § |
our ability to deliver doses under our new BioThrax procurement contract;
|
| § |
the level, timing and cost of product sales;
|
| § |
the extent to which we acquire or invest in and integrate companies, businesses, products or technologies;
|
| § |
the acquisition of new facilities and capital improvements to new or existing facilities;
|
| § |
the payment obligations under our indebtedness;
|
| § |
the scope, progress, results and costs of our development activities;
|
| § |
our ability to obtain funding from collaborative partners, government entities and non-governmental organizations for our development programs;
|
| § |
the extent to which we repurchase our common stock under our share repurchase program; and
|
| § |
the costs of commercialization activities, including product marketing, sales and distribution.
|
|
December 31,
|
||||||||
|
2016
|
2015
|
|||||||
|
ASSETS
|
||||||||
|
Current assets:
|
||||||||
|
Cash and cash equivalents
|
$
|
271,513
|
$
|
308,304
|
||||
|
Accounts receivable, net
|
138,478
|
113,906
|
||||||
|
Inventories
|
74,002
|
60,887
|
||||||
|
Income tax receivable, net
|
9,996
|
6,573
|
||||||
|
Prepaid expenses and other current assets
|
16,229
|
18,458
|
||||||
|
Current assets of discontinued operations
|
-
|
29,282
|
||||||
|
Total current assets
|
510,218
|
537,410
|
||||||
|
Property, plant and equipment, net
|
376,448
|
327,808
|
||||||
|
In-process research and development
|
-
|
701
|
||||||
|
Intangible assets, net
|
33,865
|
40,758
|
||||||
|
Goodwill
|
41,001
|
41,001
|
||||||
|
Deferred tax assets, net
|
6,096
|
11,286
|
||||||
|
Other assets
|
2,483
|
2,155
|
||||||
|
Non-current assets of discontinued operations
|
-
|
76,365
|
||||||
|
Total assets
|
$
|
970,111
|
$
|
1,037,484
|
||||
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
|
Current liabilities:
|
||||||||
|
Accounts payable
|
$
|
34,649
|
$
|
37,970
|
||||
|
Accrued expenses and other current liabilities
|
6,368
|
6,207
|
||||||
|
Accrued compensation
|
34,537
|
31,998
|
||||||
|
Notes payable
|
20,000
|
-
|
||||||
|
Contingent consideration, current portion
|
3,266
|
2,109
|
||||||
|
Deferred revenue, current portion
|
7,036
|
3,979
|
||||||
|
Current liabilities of discontinued operations
|
-
|
17,348
|
||||||
|
Total current liabilities
|
105,856
|
99,611
|
||||||
|
Contingent consideration, net of current portion
|
9,919
|
23,046
|
||||||
|
Long-term indebtedness
|
248,094
|
246,892
|
||||||
|
Deferred revenue, net of current portion
|
8,433
|
3,426
|
||||||
|
Other liabilities
|
1,604
|
1,258
|
||||||
|
Non-current liabilities of discontinued operations
|
-
|
3,234
|
||||||
|
Total liabilities
|
373,906
|
377,467
|
||||||
|
Commitments and contingencies
|
||||||||
|
Stockholders' equity:
|
||||||||
|
Preferred stock, $0.001 par value; 15,000,000 shares authorized, 0 shares issued and outstanding at both December 31, 2016 and December 31, 2015
|
-
|
-
|
||||||
|
Common stock, $0.001 par value; 200,000,000 shares authorized, 40,996,890 shares issued and 40,574,060 shares outstanding at December 31, 2016; 100,000,000 shares authorized, 39,829,408 shares issued and 39,406,578 shares outstanding at December 31, 2015
|
41
|
40
|
||||||
|
Treasury stock, at cost, 422,830 common shares at both December 31, 2016 and 2015
|
(6,420
|
)
|
(6,420
|
)
|
||||
|
Additional paid-in capital
|
352,435
|
317,971
|
||||||
|
Accumulated other comprehensive loss
|
(4,331
|
)
|
(2,713
|
)
|
||||
|
Retained earnings
|
254,480
|
351,139
|
||||||
|
Total stockholders' equity
|
596,205
|
660,017
|
||||||
|
Total liabilities and stockholders' equity
|
$
|
970,111
|
$
|
1,037,484
|
||||
|
Year Ended December 31,
|
||||||||||||
|
2016
|
2015
|
2014
|
||||||||||
|
Revenues:
|
||||||||||||
|
Product sales
|
$
|
296,278
|
$
|
328,969
|
$
|
281,845
|
||||||
|
Contract manufacturing
|
49,138
|
42,968
|
30,944
|
|||||||||
|
Contracts and grants
|
143,366
|
117,394
|
91,677
|
|||||||||
|
Total revenues
|
488,782
|
489,331
|
404,466
|
|||||||||
|
Operating expenses:
|
||||||||||||
|
Cost of product sales and contract manufacturing
|
131,284
|
107,486
|
101,963
|
|||||||||
|
Research and development
|
108,290
|
119,186
|
104,721
|
|||||||||
|
Selling, general and administrative
|
143,686
|
121,145
|
108,594
|
|||||||||
|
Income from operations
|
105,522
|
141,514
|
89,188
|
|||||||||
|
Other income (expense):
|
||||||||||||
|
Interest income
|
1,053
|
572
|
320
|
|||||||||
|
Interest expense
|
(7,617
|
)
|
(6,523
|
)
|
(8,240
|
)
|
||||||
|
Other income (expense), net
|
263
|
153
|
2,926
|
|||||||||
|
Total other expense, net
|
(6,301
|
)
|
(5,798
|
)
|
(4,994
|
)
|
||||||
|
Income from continuing operations before provision for income taxes
|
99,221
|
135,716
|
84,194
|
|||||||||
|
Provision for income taxes
|
36,697
|
44,300
|
29,928
|
|||||||||
|
Net income from continuing operations
|
62,524
|
91,416
|
54,266
|
|||||||||
|
Net loss from discontinued operations
|
(10,748
|
)
|
(28,546
|
)
|
(17,525
|
)
|
||||||
|
Net income
|
$
|
51,776
|
$
|
62,870
|
$
|
36,741
|
||||||
|
Net income per share from continuing operations-basic
|
$
|
1.56
|
$
|
2.37
|
$
|
1.45
|
||||||
|
Net loss per share from discontinued operations-basic
|
(0.27
|
)
|
(0.74
|
)
|
(0.47
|
)
|
||||||
|
Net income per share-basic
|
$
|
1.29
|
$
|
1.63
|
$
|
0.98
|
||||||
|
Net income per share from continuing operations-diluted
|
$
|
1.35
|
$
|
2.02
|
$
|
1.26
|
||||||
|
Net loss per share from discontinued operations-diluted
|
(0.22
|
)
|
(0.61
|
)
|
(0.38
|
)
|
||||||
|
Net income per share-diluted (1)
|
$
|
1.13
|
$
|
1.41
|
$
|
0.88
|
||||||
|
Weighted-average number of shares - basic
|
40,184,159
|
38,595,435
|
37,344,891
|
|||||||||
|
Weighted-average number of shares - diluted
|
49,335,112
|
47,255,842
|
45,802,807
|
|||||||||
|
December 31,
|
||||||||||||
|
2016
|
2015
|
2014
|
||||||||||
|
Net income
|
$
|
51,776
|
$
|
62,870
|
$
|
36,741
|
||||||
|
Foreign currency translations, net of tax
|
(1,618
|
)
|
295
|
457
|
||||||||
|
Comprehensive income
|
$
|
50,158
|
$
|
63,165
|
$
|
37,198
|
||||||
|
Year Ended December 31,
|
||||||||||||
|
2016
|
2015
|
2014
|
||||||||||
|
Cash flows from operating activities:
|
||||||||||||
|
Net income
|
$
|
51,776
|
$
|
62,870
|
$
|
36,741
|
||||||
|
Adjustments to reconcile to net cash provided by (used in) operating activities:
|
||||||||||||
|
Stock-based compensation expense
|
18,477
|
15,848
|
12,829
|
|||||||||
|
Depreciation and amortization
|
38,229
|
35,335
|
32,453
|
|||||||||
|
Income taxes
|
5,190
|
3,464
|
16,493
|
|||||||||
|
Change in fair value of contingent obligations
|
(10,838
|
)
|
(10,599
|
)
|
3,133
|
|||||||
|
Write off of debt issuance costs
|
-
|
-
|
1,831
|
|||||||||
|
Impairment of intangible assets (including IPR&D)
|
701
|
9,827
|
-
|
|||||||||
|
Impairment and abandonment of long-lived assets
|
5,569
|
1,147
|
-
|
|||||||||
|
Bad debt expense
|
-
|
3,481
|
-
|
|||||||||
|
Excess tax benefits from stock-based compensation
|
(10,619
|
)
|
(11,281
|
)
|
(5,987
|
)
|
||||||
|
Other
|
452
|
271
|
1,284
|
|||||||||
|
Changes in operating assets and liabilities:
|
||||||||||||
|
Accounts receivable
|
(22,446
|
)
|
(64,351
|
)
|
21,405
|
|||||||
|
Inventories
|
(9,026
|
)
|
(11,262
|
)
|
4,229
|
|||||||
|
Income taxes
|
(4,560
|
)
|
(3,550
|
)
|
(4,711
|
)
|
||||||
|
Prepaid expenses and other assets
|
(2,089
|
)
|
2,319
|
(8,472
|
)
|
|||||||
|
Accounts payable
|
(14,791
|
)
|
4,749
|
(9,279
|
)
|
|||||||
|
Accrued expenses and other liabilities
|
624
|
45
|
2,685
|
|||||||||
|
Accrued compensation
|
2,236
|
2,680
|
4,539
|
|||||||||
|
Provision for chargebacks
|
-
|
(8
|
)
|
299
|
||||||||
|
Deferred revenue
|
4,602
|
3,474
|
2,846
|
|||||||||
|
Net cash provided by operating activities
|
53,487
|
44,459
|
112,318
|
|||||||||
|
Cash flows from investing activities:
|
||||||||||||
|
Purchases of property, plant and equipment
|
(76,257
|
)
|
(44,812
|
)
|
(30,673
|
)
|
||||||
|
Acquisitions, net of acquired cash
|
-
|
(650
|
)
|
(179,379
|
)
|
|||||||
|
Net cash used in investing activities
|
(76,257
|
)
|
(45,462
|
)
|
(210,052
|
)
|
||||||
|
Cash flows from financing activities:
|
||||||||||||
|
Proceeds from convertible debenture, net of bank fees
|
-
|
-
|
241,588
|
|||||||||
|
Proceeds from long-term debt obligations
|
-
|
2,000
|
1,000
|
|||||||||
|
Issuance of common stock upon exercise of stock options
|
17,125
|
25,961
|
14,078
|
|||||||||
|
Excess tax benefits from stock-based compensation
|
10,619
|
11,281
|
5,987
|
|||||||||
|
Principal payments on long-term indebtedness
|
-
|
-
|
(62,000
|
)
|
||||||||
|
Distribution to Aptevo
|
(45,000
|
)
|
-
|
-
|
||||||||
|
Contingent obligation payments
|
(1,385
|
)
|
(5,693
|
)
|
(1,579
|
)
|
||||||
|
Purchase of treasury stock
|
-
|
(100
|
)
|
(200
|
)
|
|||||||
|
Net cash (used in) provided by financing activities
|
(18,641
|
)
|
33,449
|
198,874
|
||||||||
|
Effect of exchange rate changes on cash and cash equivalents
|
129
|
(150
|
)
|
21
|
||||||||
|
Net (decrease) increase in cash and cash equivalents
|
(41,282
|
)
|
32,296
|
101,161
|
||||||||
|
Cash and cash equivalents at beginning of year
|
312,795
|
280,499
|
179,338
|
|||||||||
|
Cash and cash equivalents at end of year
|
$
|
271,513
|
$
|
312,795
|
$
|
280,499
|
||||||
|
Supplemental disclosure of cash flow information:
|
||||||||||||
|
Cash paid during the year for interest
|
$
|
8,210
|
$
|
7,751
|
$
|
3,761
|
||||||
|
Cash paid during the year for income taxes
|
$
|
10,081
|
$
|
28,271
|
$
|
4,711
|
||||||
|
Supplemental information on non-cash investing and financing activities:
|
||||||||||||
|
Purchases of property, plant and equipment unpaid at year end
|
$
|
13,459
|
$
|
4,379
|
$
|
5,394
|
||||||
|
$0.001 Par Value Common Stock
|
Additional Paid-In
|
Treasury Stock
|
Accumulated Other Comprehensive
|
Noncontrolling Interest
|
Retained
|
Total Stockholders'
|
||||||||||||||||||||||||||||||
|
Shares
|
Amount
|
Capital
|
Shares
|
Amount
|
Loss
|
in Subsidiary
|
Earnings
|
Equity
|
||||||||||||||||||||||||||||
|
Balance at December 31, 2013
|
37,036,996
|
$
|
37
|
$
|
247,637
|
(412,953
|
)
|
$
|
(6,119
|
)
|
$
|
(3,465
|
)
|
$
|
(453
|
)
|
$
|
251,528
|
$
|
489,165
|
||||||||||||||||
|
Employee equity award plans activity
|
1,092,876
|
1
|
26,585
|
-
|
-
|
-
|
-
|
-
|
26,586
|
|||||||||||||||||||||||||||
|
Non-cash development expenses from joint venture
|
-
|
-
|
-
|
-
|
-
|
-
|
453
|
-
|
453
|
|||||||||||||||||||||||||||
|
Treasury stock
|
-
|
-
|
-
|
(7,236
|
)
|
(201
|
)
|
-
|
-
|
(201
|
)
|
|||||||||||||||||||||||||
|
Net income
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
36,741
|
36,741
|
|||||||||||||||||||||||||||
|
Foreign currency translation, net of tax
|
-
|
-
|
-
|
-
|
-
|
457
|
-
|
-
|
457
|
|||||||||||||||||||||||||||
|
Balance at December 31, 2014
|
38,129,872
|
$
|
38
|
$
|
274,222
|
(420,189
|
)
|
$
|
(6,320
|
)
|
$
|
(3,008
|
)
|
$
|
-
|
$
|
288,269
|
$
|
553,201
|
|||||||||||||||||
|
Employee equity award plans activity
|
1,699,536
|
2
|
43,749
|
-
|
-
|
-
|
43,751
|
|||||||||||||||||||||||||||||
|
Treasury stock
|
-
|
-
|
-
|
(2,641
|
)
|
(100
|
)
|
-
|
-
|
(100
|
)
|
|||||||||||||||||||||||||
|
Net income
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
62,870
|
62,870
|
|||||||||||||||||||||||||||
|
Foreign currency translation, net of tax
|
-
|
-
|
-
|
-
|
-
|
295
|
-
|
-
|
295
|
|||||||||||||||||||||||||||
|
Balance at December 31, 2015
|
39,829,408
|
$
|
40
|
$
|
317,971
|
(422,830
|
)
|
$
|
(6,420
|
)
|
$
|
(2,713
|
)
|
$
|
-
|
$
|
351,139
|
$
|
660,017
|
|||||||||||||||||
|
Employee equity award plans activity
|
1,167,482
|
1
|
34,464
|
-
|
-
|
-
|
-
|
-
|
34,465
|
|||||||||||||||||||||||||||
|
Separation of Aptevo
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(148,435
|
)
|
(148,435
|
)
|
|||||||||||||||||||||||||
|
Treasury stock
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
||||||||||||||||||||||||||||
|
Net income
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
51,776
|
51,776
|
|||||||||||||||||||||||||||
|
Foreign currency translation, net of tax
|
-
|
-
|
-
|
-
|
-
|
(1,618
|
)
|
-
|
-
|
(1,618
|
)
|
|||||||||||||||||||||||||
|
Balance at December 31, 2016
|
40,996,890
|
$
|
41
|
$
|
352,435
|
(422,830
|
)
|
$
|
(6,420
|
)
|
$
|
(4,331
|
)
|
$
|
-
|
$
|
254,480
|
$
|
596,205
|
|||||||||||||||||
| § |
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 in combination with appropriate anti-bacterial drugs. BioThrax is also licensed in Singapore and by the Paul-Ehrlich-Institut of the German Federal Ministry of Health for general use 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 and Health Canada for the treatment of botulinum disease;
|
| § |
VIGIV [Vaccinia Immune Globulin Intravenous (Human)], the only therapeutic licensed by the FDA to address certain complications from smallpox vaccination;
|
| § |
RSDL
®
(Reactive Skin Decontamination Lotion Kit), the only device cleared by the FDA to remove or neutralize chemical warfare agents and T-2 toxins from the skin; and
|
| § |
Tro
bigard™ (atropine sulfate, obidoxime chloride),
an auto-injector device designed for intramuscular self-injection
of atropine sulfate and obidoxime chloride, a nerve agent countermeasure. This product has not been approved by the FDA or any other regulatory agency, is not promoted or distributed in the U.S., and is only sold to non-U.S. authorized government buyers.
|
| Level 1 — |
Observable inputs for identical assets or liabilities such as quoted prices in active markets;
|
| Level 2 — |
Inputs other than quoted prices in active markets that are either directly or indirectly observable; and
|
| Level 3 — |
Unobservable inputs in which little or no market data exists, which are therefore developed by the Company using estimates and assumptions that reflect those that a market participant would use.
|
|
Buildings
|
31-39 years
|
|
Building improvements
|
10-39 years
|
|
Furniture and equipment
|
3-15 years
|
|
Software
|
3-7 years or product life
|
|
Leasehold improvements
|
Lesser of the asset life or lease term
|
| |
there is persuasive evidence of an arrangement;
|
| |
delivery has occurred or title has passed to the Company's customer;
|
| |
the fee is fixed or determinable; and
|
| |
collectability is reasonably assured.
|
| § |
BAT product sales upon delivery to the SNS;
|
| § |
stability testing based on the required testing schedule of the product;
|
| § |
extended product expiry based on achievement of the extension;
|
| § |
horse maintenance based on a per horse basis; and
|
| § |
plasma collection on a per liter basis.
|
| § |
VIGIV and Anthrasil product sales upon delivery to the CDC;
|
| § |
stability testing based on the required testing schedule of the product;
|
| § |
extended product expiry based on achievement of the extension; and
|
| § |
plasma collection on a per liter basis.
|
| § |
personnel-related expenses;
|
| § |
fees to professional service providers for, among other things, analytical testing, independent monitoring or other administration of our clinical trials and obtaining and evaluating data from our clinical trials and non-clinical studies;
|
| § |
costs of contract manufacturing services for clinical trial material; and
|
| § |
costs of materials used in clinical trials and research and development.
|
|
Year Ended December 31,
|
||||||
|
|
2016
|
|
2015
|
|
2014
|
|
|
Expected dividend yield
|
0%
|
0%
|
0%
|
|||
|
Expected volatility
|
31-33%
|
34-35%
|
35-38%
|
|||
|
Risk-free interest rate
|
0.93-1.22%
|
1.27-1.61%
|
1.14-1.65%
|
|||
|
Expected average life of options
|
4.3 years
|
4.3 years
|
4.5 years
|
|||
| |
Expected dividend yield — the Company does not pay regular dividends on its common stock and does not anticipate paying any dividends in the foreseeable future.
|
| |
Expected volatility — a measure of the amount by which a financial variable, such as share price, has fluctuated (historical volatility) or is expected to fluctuate (implied volatility) during a period. The Company analyzed its own historical volatility to estimate expected volatility over the same period as the expected average life of the options.
|
| |
Risk-free interest rate — the range of U.S. Treasury rates with a term that most closely resembles the expected life of the option as of the date on which the option is granted.
|
| |
Expected average life of options — the period of time that options granted are expected to remain outstanding, based primarily on the Company's expectation of optionee exercise behavior subsequent to vesting of options.
|
|
(in thousands)
|
August 1, 2016
|
|||
|
Assets:
|
||||
|
Cash and cash equivalents
|
$
|
45,000
|
||
|
Accounts receivable, net
|
4,465
|
|||
|
Inventories
|
11,959
|
|||
|
Note receivable
|
20,000
|
|||
|
Other current assets
|
4,870
|
|||
|
Current assets of discontinued operations
|
86,294
|
|||
|
Property, plant and equipment, net
|
6,128
|
|||
|
In-process research and development
|
41,800
|
|||
|
Intangible assets, net
|
15,402
|
|||
|
Goodwill
|
13,902
|
|||
|
Non-current assets of discontinued operations
|
77,232
|
|||
|
Total assets of discontinued operations
|
$
|
163,526
|
||
|
Liabilities:
|
||||
|
Accounts payable
|
$
|
6,285
|
||
|
Accrued expenses and other current liabilities
|
64
|
|||
|
Accrued compensation
|
2,456
|
|||
|
Contingent consideration
|
191
|
|||
|
Provisions for chargebacks
|
2,341
|
|||
|
Deferred revenue, current portion
|
433
|
|||
|
Current liabilities of discontinued operations
|
11,770
|
|||
|
Deferred revenue, net of current portion
|
3,232
|
|||
|
Other liabilities
|
91
|
|||
|
Non-current liabilities of discontinued operations
|
3,323
|
|||
|
Total liabilities of discontinued operations
|
$
|
15,093
|
||
|
(in thousands)
|
December 31, 2015
|
|||
|
Assets:
|
||||
|
Cash and cash equivalents
|
$
|
4,492
|
||
|
Accounts receivable, net
|
6,861
|
|||
|
Inventories
|
16,049
|
|||
|
Prepaid expenses and other current assets
|
1,880
|
|||
|
Current assets of discontinued operations
|
29,282
|
|||
|
Property, plant and equipment, net
|
4,046
|
|||
|
In-process research and development
|
41,800
|
|||
|
Intangible assets, net
|
16,617
|
|||
|
Goodwill
|
13,902
|
|||
|
Non-current assets of discontinued operations
|
76,365
|
|||
|
Total assets of discontinued operations
|
$
|
105,647
|
||
|
Liabilities:
|
||||
|
Accounts payable
|
$
|
8,134
|
||
|
Accrued expenses and other current liabilities
|
22
|
|||
|
Accrued compensation
|
2,684
|
|||
|
Contingent consideration, current portion
|
306
|
|||
|
Provisions for chargebacks
|
2,238
|
|||
|
Deferred revenue, current portion
|
3,964
|
|||
|
Current liabilities of discontinued operations
|
17,348
|
|||
|
Deferred revenue, net of current portion
|
3,163
|
|||
|
Other liabilities
|
71
|
|||
|
Non-current liabilities of discontinued operations
|
3,234
|
|||
|
Total liabilities of discontinued operations
|
$
|
20,582
|
||
|
(in thousands)
|
2016
|
2015
|
2014
|
|||||||||
|
Revenues:
|
||||||||||||
|
Product sales
|
$
|
21,183
|
$
|
27,947
|
$
|
30,036
|
||||||
|
Collaborations
|
187
|
5,511
|
15,636
|
|||||||||
|
Total revenues
|
21,370
|
33,458
|
45,672
|
|||||||||
|
Operating expense:
|
||||||||||||
|
Cost of product sales
|
11,556
|
16,809
|
16,449
|
|||||||||
|
Research and development
|
18,024
|
34,811
|
46,108
|
|||||||||
|
Selling, general and administrative
|
23,792
|
27,313
|
14,248
|
|||||||||
|
Loss from operations
|
(32,002
|
)
|
(45,475
|
)
|
(31,133
|
)
|
||||||
|
Other income (expense), net:
|
(41
|
)
|
(472
|
)
|
-
|
|||||||
|
Loss from discontinued operations before benefit from income taxes
|
(32,043
|
)
|
(45,947
|
)
|
(31,133
|
)
|
||||||
|
Benefit from income taxes
|
(21,295
|
)
|
(17,401
|
)
|
(13,608
|
)
|
||||||
|
Net loss from discontinued operations
|
$
|
(10,748
|
)
|
$
|
(28,546
|
)
|
$
|
(17,525
|
)
|
|||
|
Years ended December 31,
|
||||||||||||
|
(in thousands)
|
2016
|
2015
|
2014
|
|||||||||
|
Net cash (used in) provided by operating activities
|
$
|
(10,299
|
)
|
$
|
(12,716
|
)
|
$
|
(14,683
|
)
|
|||
|
Net cash used in investing activities
|
(1,926
|
)
|
(1,518
|
)
|
(48,822
|
)
|
||||||
|
Net cash provided by (used in) financing activities
|
7,733
|
15,012
|
67,219
|
|||||||||
|
Net increase (decrease) in cash and cash equivalents
|
$
|
(4,492
|
)
|
$
|
778
|
$
|
3,714
|
|||||
|
December 31, 2016
|
||||||||||||||||
|
(in thousands)
|
Level 1
|
Level 2
|
Level 3
|
Total
|
||||||||||||
|
Assets:
|
||||||||||||||||
|
Investment in money market funds (1)
|
$
|
10
|
$
|
-
|
$
|
-
|
$
|
10
|
||||||||
|
Total assets
|
$
|
10
|
$
|
-
|
$
|
-
|
$
|
10
|
||||||||
|
Liabilities:
|
||||||||||||||||
|
Contingent consideration
|
$
|
-
|
$
|
-
|
$
|
13,185
|
$
|
13,185
|
||||||||
|
Total liabilities
|
$
|
-
|
$
|
-
|
$
|
13,185
|
$
|
13,185
|
||||||||
|
December 31, 2015
|
||||||||||||||||
|
(in thousands)
|
Level 1
|
Level 2
|
Level 3
|
Total
|
||||||||||||
|
Assets:
|
||||||||||||||||
|
Investment in money market funds (1)
|
$
|
3,323
|
$
|
-
|
$
|
-
|
$
|
3,323
|
||||||||
|
Total assets
|
$
|
3,323
|
$
|
-
|
$
|
-
|
$
|
3,323
|
||||||||
|
Liabilities:
|
||||||||||||||||
|
Contingent price consideration
|
$
|
-
|
$
|
-
|
$
|
25,155
|
$
|
25,155
|
||||||||
|
Total liabilities
|
$
|
-
|
$
|
-
|
$
|
25,155
|
$
|
25,155
|
||||||||
|
(in thousands)
|
||||
|
Balance at December 31, 2014
|
$
|
40,037
|
||
|
(Income) expense included in earnings
|
(10,884
|
)
|
||
|
Settlements
|
(4,803
|
)
|
||
|
Purchases, sales and issuances
|
805
|
|||
|
Transfers in/(out) of Level 3
|
-
|
|||
|
Balance at December 31, 2015
|
$
|
25,155
|
||
|
(Income) expense included in earnings
|
(10,857
|
)
|
||
|
Settlements
|
(1,113
|
)
|
||
|
Purchases, sales and issuances
|
-
|
|||
|
Transfers in/(out) of Level 3
|
-
|
|||
|
Balance at December 31, 2016
|
$
|
13,185
|
||
|
December 31,
|
||||||||
|
(in thousands)
|
2016
|
2015
|
||||||
|
Billed
|
$
|
90,439
|
$
|
95,735
|
||||
|
Unbilled
|
48,039
|
18,171
|
||||||
|
Total
|
$
|
138,478
|
$
|
113,906
|
||||
|
December 31,
|
||||||||
|
(in thousands)
|
2016
|
2015
|
||||||
|
Raw materials and supplies
|
$
|
30,687
|
$
|
21,275
|
||||
|
Work-in-process
|
19,821
|
32,709
|
||||||
|
Finished goods
|
23,494
|
6,903
|
||||||
|
Total inventories
|
$
|
74,002
|
$
|
60,887
|
||||
|
December 31,
|
||||||||
|
(in thousands)
|
2016
|
2015
|
||||||
|
Land and improvements
|
$
|
20,340
|
$
|
16,520
|
||||
|
Buildings, building improvements and leasehold improvements
|
147,130
|
108,908
|
||||||
|
Furniture and equipment
|
190,157
|
129,933
|
||||||
|
Software
|
52,564
|
39,683
|
||||||
|
Construction-in-progress
|
77,813
|
126,531
|
||||||
|
488,004
|
421,575
|
|||||||
|
Less: Accumulated depreciation and amortization
|
(111,556
|
)
|
(93,767
|
)
|
||||
|
Total property, plant and equipment, net
|
$
|
376,448
|
$
|
327,808
|
||||
|
(in thousands)
|
Total
|
|||
|
Cost basis
|
||||
|
Balance at December 31, 2015
|
$
|
57,099
|
||
|
Additions
|
-
|
|||
|
Balance at December 31, 2016
|
$
|
57,099
|
||
|
Accumulated amortization
|
||||
|
Balance at December 31, 2015
|
$
|
(16,341
|
)
|
|
|
Amortization
|
(6,893
|
)
|
||
|
Balance at December 31, 2016
|
$
|
(23,234
|
)
|
|
|
Net book value at December 31, 2016
|
$
|
33,865
|
||
|
(in thousands)
|
||||
|
2017
|
$
|
6,217
|
||
|
2018
|
6,217
|
|||
|
2019
|
5,738
|
|||
|
2020
|
5,657
|
|||
|
2021 and beyond
|
10,036
|
|||
|
Total remaining amortization
|
$
|
33,865
|
||
|
(in thousands)
|
Therapeutics and vaccines
|
Contract manufacturing
|
Medical devices
|
Total
|
||||||||||||
|
Cost Basis
|
||||||||||||||||
|
Balance at December 31, 2015
|
$
|
24,349
|
$
|
6,736
|
$
|
9,916
|
$
|
41,001
|
||||||||
|
Additions
|
-
|
-
|
-
|
-
|
||||||||||||
|
Balance at December 31, 2016
|
$
|
24,349
|
$
|
6,736
|
$
|
9,916
|
$
|
41,001
|
||||||||
|
2006 Plan
|
2004 Plan
|
|||||||||||||||||||
|
Number of Shares
|
Weighted-Average Exercise Price
|
Number of Shares
|
Weighted-Average Exercise Price
|
Aggregate Intrinsic Value
|
||||||||||||||||
|
Outstanding at December 31, 2015
|
2,964,237
|
$
|
22.73
|
29,699
|
$
|
10.28
|
$
|
52,119,607
|
||||||||||||
|
Granted
|
411,698
|
33.61
|
-
|
-
|
||||||||||||||||
|
Exercised
|
(809,638
|
)
|
19.41
|
(29,699
|
)
|
10.28
|
||||||||||||||
|
Forfeited
|
(96,293
|
)
|
26.67
|
-
|
-
|
|||||||||||||||
|
Cancelled
|
(146,986
|
)
|
28.33
|
-
|
-
|
|||||||||||||||
|
Equitable adjustment
|
236,313
|
22.90
|
-
|
-
|
||||||||||||||||
|
Outstanding at December 31, 2016
|
2,559,331
|
$
|
22.94
|
-
|
$
|
-
|
$
|
25,348,245
|
||||||||||||
|
Exercisable at December 31, 2016
|
1,504,855
|
$
|
19.59
|
-
|
$
|
-
|
$
|
19,938,451
|
||||||||||||
|
Options expected to vest at December 31, 2016
|
849,184
|
$
|
27.46
|
-
|
$
|
-
|
$
|
4,565,548
|
||||||||||||
|
Number of Shares
|
Weighted-Average Grant Price
|
Aggregate Intrinsic Value
|
||||||||||
|
Outstanding at December 31, 2015
|
889,004
|
$
|
26.86
|
$
|
35,569,048
|
|||||||
|
Granted
|
515,782
|
34.00
|
||||||||||
|
Vested
|
(420,599
|
)
|
24.68
|
|||||||||
|
Forfeited
|
(80,428
|
)
|
29.40
|
|||||||||
|
Cancelled
|
(107,514
|
)
|
30.90
|
|||||||||
|
Equitable adjustment
|
79,339
|
28.86
|
||||||||||
|
Outstanding at December 31, 2016
|
875,584
|
$
|
28.94
|
$
|
28,754,179
|
|||||||
|
Years ended December 31,
|
||||||||||||
|
(in thousands)
|
2016
|
2015
|
2014
|
|||||||||
|
Cost of product sales
|
$
|
997
|
$
|
1,183
|
$
|
1,145
|
||||||
|
Research and development
|
2,297
|
2,324
|
2,779
|
|||||||||
|
Selling, general and administrative
|
14,062
|
11,234
|
7,830
|
|||||||||
|
Continuing operations
|
17,356
|
14,741
|
11,754
|
|||||||||
|
Discontinued operations
|
1,121
|
1,107
|
1,075
|
|||||||||
|
Total stock-based compensation expense
|
$
|
18,477
|
$
|
15,848
|
$
|
12,829
|
||||||
|
Year ended December 31,
|
||||||||||||
|
(in thousands)
|
2016
|
2015
|
2014
|
|||||||||
|
Current
|
||||||||||||
|
Federal
|
$
|
29,244
|
$
|
38,957
|
$
|
22,988
|
||||||
|
State
|
2,331
|
2,221
|
959
|
|||||||||
|
International
|
1,002
|
2,029
|
828
|
|||||||||
|
Total current
|
32,577
|
43,207
|
24,775
|
|||||||||
|
Deferred
|
||||||||||||
|
Federal
|
9,979
|
(119
|
)
|
3,332
|
||||||||
|
State
|
(272
|
)
|
(111
|
)
|
209
|
|||||||
|
International
|
(5,587
|
)
|
1,323
|
1,612
|
||||||||
|
Total deferred
|
4,120
|
1,093
|
5,153
|
|||||||||
|
Total provision for income taxes
|
$
|
36,697
|
$
|
44,300
|
$
|
29,928
|
||||||
|
December 31,
|
||||||||
|
(in thousands)
|
2016
|
2015
|
||||||
|
Federal losses carryforward
|
$
|
4,130
|
$
|
5,394
|
||||
|
State losses carryforward
|
13,682
|
12,751
|
||||||
|
Research and development carryforward
|
3,647
|
3,545
|
||||||
|
Scientific research and experimental development credit carryforward
|
16,594
|
25,771
|
||||||
|
Intangible assets
|
-
|
5,792
|
||||||
|
Stock compensation
|
8,389
|
9,391
|
||||||
|
Foreign deferrals
|
58,647
|
80,920
|
||||||
|
Inventory reserves
|
2,273
|
3,754
|
||||||
|
Other
|
5,569
|
8,484
|
||||||
|
Deferred tax asset
|
112,931
|
155,802
|
||||||
|
Fixed assets
|
(30,728
|
)
|
(31,925
|
)
|
||||
|
Intangible assets
|
(5,882
|
)
|
(4,760
|
)
|
||||
|
Other
|
(16,047
|
)
|
(17,192
|
)
|
||||
|
Deferred tax liability
|
(52,657
|
)
|
(53,877
|
)
|
||||
|
Valuation allowance
|
(54,178
|
)
|
(90,639
|
)
|
||||
|
Net deferred tax (liabilities)/ asset
|
$
|
6,096
|
$
|
11,286
|
||||
|
Year ended December 31,
|
||||||||||||
|
(in thousands)
|
2016
|
2015
|
2014
|
|||||||||
|
US
|
$
|
63,330
|
$
|
117,385
|
$
|
76,909
|
||||||
|
International
|
35,891
|
18,331
|
7,285
|
|||||||||
|
Earnings before taxes on income
|
99,221
|
135,716
|
84,194
|
|||||||||
|
Federal tax at statutory rates
|
$
|
34,738
|
$
|
47,475
|
$
|
29,468
|
||||||
|
State taxes, net of federal benefit
|
529
|
852
|
650
|
|||||||||
|
Impact of foreign operations
|
(9,937
|
)
|
(1,640
|
)
|
(1,176
|
)
|
||||||
|
Change in valuation allowance
|
10,458
|
(950
|
)
|
1,091
|
||||||||
|
Effect of foreign rates
|
(720
|
)
|
-
|
-
|
||||||||
|
Tax credits
|
(1,572
|
)
|
(2,088
|
)
|
(1,743
|
)
|
||||||
|
Other differences
|
1,823
|
733
|
126
|
|||||||||
|
Permanent differences
|
1,378
|
(82
|
)
|
1,512
|
||||||||
|
Provision for income taxes
|
$
|
36,697
|
$
|
44,300
|
$
|
29,928
|
||||||
|
(in thousands)
|
||||
|
Gross unrecognized tax benefits at December 31, 2013
|
$
|
1,121
|
||
|
Increases for tax positions for prior years
|
150
|
|||
|
Decreases for tax positions for prior years
|
-
|
|||
|
Increases for tax positions for current year
|
102
|
|||
|
Settlements
|
-
|
|||
|
Lapse of statute of limitations
|
(125
|
)
|
||
|
Gross unrecognized tax benefits at December 31, 2014
|
1,248
|
|||
|
Increases for tax positions for prior years
|
150
|
|||
|
Decreases for tax positions for prior years
|
-
|
|||
|
Increases for tax positions for current year
|
59
|
|||
|
Settlements
|
-
|
|||
|
Lapse of statute of limitations
|
-
|
|||
|
Gross unrecognized tax benefits at December 31, 2015
|
1,457
|
|||
|
Increases for tax positions for prior years
|
5
|
|||
|
Decreases for tax positions for prior years
|
-
|
|||
|
Increases for tax positions for current year
|
299
|
|||
|
Settlements
|
-
|
|||
|
Lapse of statute of limitations
|
-
|
|||
|
Gross unrecognized tax benefits at December 31, 2016
|
$
|
1,761
|
||
|
Years ended December 31,
|
||||||||||||
|
(in thousands, except share and per share data)
|
2016
|
2015
|
2014
|
|||||||||
|
Numerator:
|
||||||||||||
|
Net income from continuing operations
|
$
|
62,524
|
$
|
91,416
|
$
|
54,266
|
||||||
|
Interest expense, net of tax
|
3,255
|
3,019
|
2,879
|
|||||||||
|
Amortization of debt issuance costs, net of tax
|
781
|
868
|
735
|
|||||||||
|
Net income, adjusted from continuing operations
|
66,560
|
95,303
|
57,880
|
|||||||||
|
Net loss from discontinued operations
|
(10,748
|
)
|
(28,546
|
)
|
(17,525
|
)
|
||||||
|
Net income, adjusted
|
$
|
55,812
|
$
|
66,757
|
$
|
40,355
|
||||||
|
Denominator:
|
||||||||||||
|
Weighted-average number of shares-basic
|
40,184,159
|
38,595,435
|
37,344,891
|
|||||||||
|
Dilutive securities-equity awards
|
1,054,453
|
939,882
|
737,391
|
|||||||||
|
Dilutive securities-convertible debt
|
8,096,500
|
7,720,525
|
7,720,525
|
|||||||||
|
Weighted-average number of shares-diluted
|
49,335,112
|
47,255,842
|
45,802,807
|
|||||||||
|
Net income per share-basic from continuing operations
|
$
|
1.56
|
$
|
2.37
|
$
|
1.45
|
||||||
|
Net loss per share-basic from discontinued operations
|
(0.27
|
)
|
(0.74
|
)
|
(0.47
|
)
|
||||||
|
Net income per share-basic
|
$
|
1.29
|
$
|
1.63
|
$
|
0.98
|
||||||
|
Net income per share-diluted from continuing operations
|
$
|
1.35
|
$
|
2.02
|
$
|
1.26
|
||||||
|
Net loss per share-diluted from discontinued operations
|
(0.22
|
)
|
(0.61
|
)
|
(0.38
|
)
|
||||||
|
Net income per share-diluted
|
$
|
1.13
|
$
|
1.41
|
$
|
0.88
|
||||||
|
Incurred in
|
Inception to Date
|
Total Expected
|
||||||||||
|
(in thousands)
|
2016
|
Costs Incurred
|
to be Incurred
|
|||||||||
|
Termination benefits
|
$
|
5,246
|
$
|
5,246
|
$
|
5,287
|
||||||
|
Abandonment of equipment
|
3,749
|
3,749
|
3,749
|
|||||||||
|
Other costs
|
691
|
691
|
691
|
|||||||||
|
Total
|
$
|
9,686
|
$
|
9,686
|
$
|
9,727
|
||||||
|
Termination
|
||||
|
(in thousands)
|
Benefits
|
|||
|
Balance at December 31, 2015
|
$
|
-
|
||
|
Expenses incurred
|
5,246
|
|||
|
Amount paid
|
(889
|
)
|
||
|
Other adjustments
|
-
|
|||
|
Balance at December 31, 2016
|
$
|
4,357
|
||
|
Quarter Ended
|
||||||||||||||||
|
(in thousands, except per share data)
|
March 31,
|
June 30,
|
September 30,
|
December 31,
|
||||||||||||
|
2016:
|
||||||||||||||||
|
Revenue
|
$
|
102,964
|
$
|
91,241
|
$
|
142,914
|
$
|
151,663
|
||||||||
|
Income (loss) from operations
|
21,157
|
(2,042
|
)
|
35,478
|
50,929
|
|||||||||||
|
Net income (loss) from continuing operations
|
11,889
|
(2,042
|
)
|
20,388
|
32,289
|
|||||||||||
|
Net income (loss) from discontinued operations (1)
|
(7,898
|
)
|
(8,905
|
)
|
952
|
5,103
|
||||||||||
|
Net income (loss)
|
3,991
|
(10,947
|
)
|
21,340
|
37,392
|
|||||||||||
|
Net income (loss) per share from continuing operations-basic
|
$
|
0.30
|
$
|
(0.05
|
)
|
$
|
0.50
|
$
|
0.80
|
|||||||
|
Net income (loss) per share from discontinued operations-basic
|
(0.20
|
)
|
(0.22
|
)
|
0.02
|
0.13
|
||||||||||
|
Net income (loss) per share-basic
|
$
|
0.10
|
$
|
(0.27
|
)
|
$
|
0.52
|
$
|
0.93
|
|||||||
|
Net income (loss) per share from continuing operations-diluted
|
$
|
0.26
|
$
|
(0.05
|
)
|
$
|
0.43
|
$
|
0.67
|
|||||||
|
Net income (loss) per share from discontinued operations-diluted
|
(0.16
|
)
|
(0.22
|
)
|
0.02
|
0.10
|
||||||||||
|
Net income (loss) per share-diluted
|
$
|
0.10
|
$
|
(0.27
|
)
|
$
|
0.45
|
$
|
0.77
|
|||||||
|
2015
|
||||||||||||||||
|
Revenue
|
$
|
52,147
|
$
|
119,022
|
$
|
158,378
|
$
|
159,784
|
||||||||
|
Income (loss) from operations
|
(21,895
|
)
|
35,104
|
63,159
|
65,146
|
|||||||||||
|
Net income (loss) from continuing operations
|
(15,728
|
)
|
22,565
|
42,088
|
42,491
|
|||||||||||
|
Net loss from discontinued operations
|
(5,792
|
)
|
(8,465
|
)
|
(5,145
|
)
|
(9,144
|
)
|
||||||||
|
Net income (loss)
|
(21,520
|
)
|
14,100
|
36,943
|
33,347
|
|||||||||||
|
Net income (loss) per share from continuing operations-basic
|
$
|
(0.42
|
)
|
$
|
0.59
|
$
|
1.08
|
$
|
1.08
|
|||||||
|
Net loss per share from discontinued operations-basic
|
(0.15
|
)
|
(0.22
|
)
|
(0.14
|
)
|
(0.23
|
)
|
||||||||
|
Net income (loss) per share-basic
|
$
|
(0.57
|
)
|
$
|
0.37
|
$
|
0.94
|
$
|
0.85
|
|||||||
|
Net income (loss) per share from continuing operations-diluted
|
$
|
(0.42
|
)
|
$
|
0.50
|
$
|
0.90
|
$
|
0.90
|
|||||||
|
Net loss per share from discontinued operations-diluted
|
(0.15
|
)
|
(0.18
|
)
|
(0.11
|
)
|
(0.19
|
)
|
||||||||
|
Net income (loss) per share-diluted
|
$
|
(0.57
|
)
|
$
|
0.32
|
$
|
0.79
|
$
|
0.71
|
|||||||
|
(in thousands)
|
Beginning Balance
|
Charged to costs and expenses
|
Deductions
|
Ending Balance
|
||||||||||||
|
Year ended December 31, 2016
|
||||||||||||||||
|
Inventory allowance
|
$
|
1,637
|
$
|
9,950
|
$
|
(8,052
|
)
|
$
|
3,535
|
|||||||
|
Prepaid expenses and other current assets allowance
|
1,981
|
2,887
|
-
|
4,868
|
||||||||||||
|
Year ended December 31, 2015
|
||||||||||||||||
|
Inventory allowance
|
$
|
1,314
|
$
|
6,258
|
$
|
(5,935
|
)
|
$
|
1,637
|
|||||||
|
Prepaid expenses and other current assets allowance
|
1,885
|
96
|
-
|
1,981
|
||||||||||||
|
Year ended December 31, 2014
|
||||||||||||||||
|
Inventory allowance
|
$
|
963
|
$
|
3,185
|
$
|
(2,834
|
)
|
$
|
1,314
|
|||||||
|
Prepaid expenses and other current assets allowance
|
1,446
|
439
|
-
|
1,885
|
||||||||||||
|
EMERGENT BIOSOLUTIONS INC.
|
|
|
By:
/s/ Daniel J. Abdun-Nabi
|
|
|
Daniel J. Abdun-Nabi
|
|
|
President and Chief Executive Officer
|
|
|
Date: February 27, 2017
|
|
Signature
|
Title
|
Date
|
|||
|
/s/Daniel J. Abdun-Nabi
Daniel J. Abdun-Nabi
|
President, Chief Executive Officer and Director
(Principal Executive Officer)
|
February 27, 2017
|
|||
|
/s/Robert G. Kramer
Robert G. Kramer
|
Executive Vice President, Chief Financial Officer and Treasurer
(Principal Financial and Accounting Officer)
|
February 27, 2017
|
|||
|
/s/Fuad El-Hibri
Fuad El-Hibri
|
Executive Chairman of the Board of Directors
|
February 27, 2017
|
|||
|
/s/Zsolt Harsanyi
Zsolt Harsanyi, Ph.D.
|
Director
|
February 27, 2017
|
|||
|
/s/Dr. Kathryn Zoon
|
|||||
|
Dr. Kathryn Zoon
|
Director
|
February 27, 2017
|
|||
|
/s/Ronald B. Richard
Ronald B. Richard
|
Director
|
February 27, 2017
|
|||
|
/s/Louis W. Sullivan, M.D.
Louis W. Sullivan, M.D.
|
Director
|
February 27, 2017
|
|||
|
/s/Dr. Sue Bailey
Dr. Sue Bailey
|
Director
|
February 27, 2017
|
|||
|
/s/George Joulwan
George Joulwan
|
Director
|
February 27, 2017
|
|||
|
/s/Jerome Hauer
Jerome Hauer, Ph.D.
|
Director
|
February 27, 2017
|
|||
|
Exhibit
|
|
|
|
Number
|
|
Description
|
|
2.1
|
Contribution Agreement, dated July 29, 2016, by and among Emergent BioSolutions Inc., Aptevo Therapeutics Inc., Aptevo Research and Development LLC and Aptevo BioTherapeutics LLC (incorporated by reference to Exhibit 2.1 to the Company's Current Report on Form 8-K, filed on August 4, 2016).
|
|
|
2.2
|
||
|
3.1
|
|
Third Restated Certificate of Incorporation of the Company (incorporated by reference to Exhibit 3 to the Company's Quarterly Report on Form 10-Q filed on August 5, 2016).
|
|
3.2
|
|
Amended and Restated By-laws of the Company (incorporated by reference to Exhibit 3 to the Company's Current Report on Form 8-K filed on August 16, 2012).
|
|
4.1
|
|
Specimen Common Stock Certificate (incorporated by reference to Exhibit 4.1 to Amendment No. 3 to the Company's Registration Statement on Form S-1 filed on October 20, 2006) (Registration No. 333-136622).
|
|
4.2
|
|
Registration Rights Agreement, dated as of September 22, 2006, among the Company and the stockholders listed on Schedule 1 thereto (incorporated by reference to Exhibit 4.3 to Amendment No. 1 to the Company's Registration Statement on Form S-1 filed on September 25, 2006) (Registration No. 333-136622).
|
|
4.3
|
|
Indenture, dated as of January 29, 2014, between the Company and Wells Fargo Bank, National Association, including the form of 2.875% Convertible Senior Notes due 2021 (incorporated by reference to Exhibit 4.1 to the Company's Current Report on Form 8-K filed on January 29, 2014).
|
|
9.1
|
|
Voting and Right of First Refusal Agreement, dated as of October 21, 2005, between the William J. Crowe, Jr. Revocable Living Trust and Fuad El-Hibri (incorporated by reference to Exhibit 9.1 to the Company's Registration Statement on Form S-1 filed on August 14, 2006) (Registration No. 333-136622).
|
|
10.1
|
|
Credit Agreement, dated 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).
|
|
10.2
|
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).
|
|
|
10.3
|
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).
|
|
|
10.4
|
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).
|
|
|
10.5
|
#
|
Fourth Amendment to Credit Agreement, dated as of August 5, 2016, 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.
|
|
10.6
|
#
|
Fifth Amendment to Credit Agreement, dated as of November 30, 2016, 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.
|
|
10.7
|
*
|
Emergent BioSolutions Inc. Employee Stock Option Plan, as amended and restated on January 26, 2005 (incorporated by reference to Exhibit 10.1 to the Company's Registration Statement on Form S-1 filed on August 14, 2006) (Registration No. 333-136622).
|
|
10.8
|
*
|
Emergent BioSolutions Inc. 2006 Stock Incentive Plan (incorporated by reference to Exhibit 10.3 to Amendment No. 5 to the Company's Registration Statement on Form S-1 filed on October 30, 2006) (Registration No. 001-33137).
|
|
10.9
|
*
|
Amended and Restated Emergent BioSolutions Inc. 2006 Stock Incentive Plan (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q filed on August 7, 2009).
|
|
10.10
|
*
|
Second Amended and Restated Emergent BioSolutions Inc. 2006 Stock Incentive Plan (incorporated by reference to Appendix A to the Company's definitive proxy statement on Schedule 14A filed on April 6, 2012).
|
|
10.11
|
*
|
Third Amended and Restated Emergent BioSolutions Inc. 2006 Stock Incentive Plan (incorporated by reference to Appendix A to the Company's definitive proxy statement on Schedule 14A filed on April 7, 2014).
|
|
10.12
|
*
|
Fourth Amended and Restated Emergent BioSolutions Inc. 2006 Stock Incentive Plan (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q filed on August 5, 2016)..
|
|
10.13
|
*
|
Form of Director Nonstatutory Stock Option Agreement (incorporated by reference to Exhibit 10.5 to the Company's Annual Report on Form 10-K filed on March 8, 2013).
|
|
10.14
|
*
|
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).
|
|
10.15
|
*
|
Form of Non-Qualified Stock Option Agreement (incorporated by reference to Exhibit 10.7 to the Company's Annual Report on Form 10-K filed on March 8, 2013).
|
|
10.16
|
*
|
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).
|
|
10.17
|
*
|
Form of Performance-Based Stock Unit Award Agreement (incorporated by reference to Exhibit 10 to the Company's Current Report on Form 8-K filed on February 21, 2017).
|
|
10.18
|
*
|
Form of Indemnity Agreement for directors and senior officers (incorporated by reference to Exhibit 10 to the Company's Current Report on Form 8-K filed on January 18, 2013).
|
|
10.19
|
*
|
Director Compensation Program (incorporated by reference to Exhibit 10.10 to the Company's Annual Report on Form 10-K filed on March 8, 2013).
|
|
10.20
|
*
|
Annual Bonus Plan for Executive Officers (incorporated by reference to Exhibit 10.7 to the Company's Annual Report on Form 10-K filed on March 5, 2010).
|
|
10.21
|
*
|
Amended and Restated Senior Management Severance Plan (incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed on December 22, 2011).
|
|
10.22
|
*
|
Second Amended and Restated Senior Management Severance Plan (incorporated by reference to Exhibit 10 to the Company's Current Report on Form 8-K filed on July 16, 2015).
|
|
10.23
|
|
Amended and Restated Marketing Agreement, dated as of November 5, 2008, between Emergent Biodefense Operations Lansing LLC (formerly known as Emergent Biodefense Operations Lansing Inc.) and Intergen N.V. (incorporated by reference to Exhibit 10.27 to the Company's Annual Report on Form 10-K filed on March 6, 2009).
|
|
10.24
|
#††
|
Solicitation/Contract/Order for Commercial Items (the "CDC BioThrax Procurement Contract"), effective December 8, 2016, from the Centers for Disease Control and Prevention to Emergent Biodefense Operations Lansing LLC.
|
|
10.25
|
†
|
Award/Contract (the "BARDA NuThrax Contract"), effective September 30, 2016, from the BioMedical Advanced Research and Development Authority to Emergent Product Development Gaithersburg Inc. (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q filed on November 9, 2016).
|
|
12
|
#
|
Ratio of Earnings to Fixed Charges.
|
|
21
|
#
|
Subsidiaries of the Company.
|
|
23
|
#
|
Consent of Independent Registered Public Accounting Firm.
|
|
31.1
|
#
|
Certification of the Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a).
|
|
31.2
|
#
|
Certification of the Chief Financial Officer pursuant to Exchange Act Rule 13a-14(a).
|
|
32.1
|
#
|
Certification of the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
32.2
|
#
|
Certification of the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
101.INS
|
|
XBRL Instance Document
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
101.CAL
|
|
XBRL Taxonomy Calculation Linksbase Document
|
|
101.DEF
|
|
XBRL Taxonomy Definition Linksbase Document
|
|
101.LAB
|
|
XBRL Taxonomy Label Linksbase Document
|
|
101.PRE
|
|
XBRL Taxonomy Presentation Linksbase Document
|
|
|
#
|
Filed herewith
|
|
|
†
|
Confidential treatment granted by the Securities and Exchange Commission as to certain portions. Confidential materials omitted and filed separately with the Securities and Exchange Commission.
|
|
|
††
|
Confidential treatment requested by the Securities and Exchange Commission as to certain portions. Confidential materials omitted and filed separately with the Securities and Exchange Commission.
|
|
|
*
|
Management contract or compensatory plan or arrangement filed herewith in response to Item 15(a) of Form 10-K.
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|