1. Nature of the business and organization

Organization and business

Emergent BioSolutions Inc. (the "Company" or "Emergent") is a global life sciences company focused on providing specialty products for civilian and military populations that address accidental, intentional and naturally occurring public health threats.

Within the category of the Company's specialty products, it is focused on developing, manufacturing and commercializing medical countermeasures ("MCMs"), that address public health and national security threats, which the Company collectively refer to as PHTs. The PHTs that the Company is addressing fall into two categories: Chemical, Biological, Radiological, Nuclear and Explosives ("CBRNE"); and emerging infectious diseases ("EID"). The Company has a portfolio of eight products through which it generates most of its revenue, a fully-integrated portfolio of contract development and manufacturing services and a research and development pipeline of various investigational-stage product candidates.

Our MCM products are:

BioThrax^® (Anthrax Vaccine Adsorbed), the only vaccine licensed by the U.S. Food and Drug Administration ("FDA"), for the general use prophylaxis and post-exposure prophylaxis of anthrax disease;

ACAM2000^® (Smallpox (Vaccinia) Vaccine, Live), the only smallpox vaccine licensed by the FDA for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection (acquired from Sanofi Pasteur Biologics, LLC in October 2017);

Raxibacumab (Anthrax Monoclonal), the first fully human monoclonal antibody therapeutic licensed by the FDA for the treatment and prophylaxis of inhalational anthrax (acquired from GlaxoSmithKline LLC in October 2017);

Anthrasil^® [Anthrax Immune Globulin Intravenous (Human)], the only polyclonal antibody therapeutic licensed by the FDA and Health Canada for the treatment of inhalational anthrax;

BAT® [Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine)], the only heptavalent antibody therapeutic licensed by the FDA and Health Canada for the treatment of botulism;

VIGIV [Vaccinia Immune Globulin Intravenous (Human)], the only therapeutic licensed by the FDA and Health Canada to address certain complications from smallpox vaccination;

RSDL^® (Reactive Skin Decontamination Lotion Kit), the only medical device cleared by the FDA to remove or neutralize the following chemical warfare agents from the skin: tabun, sarin, soman, cyclohexyl sarin, VR, VX, mustard gas and T-2 toxin; and

Trobigard™ (atropine sulfate, obidoxime chloride), an auto-injector device designed for intramuscular self-injection of atropine sulfate and obidoxime chloride, as a nerve agent countermeasure. This product is not currently approved or cleared by the FDA or any similar regulatory body, and is only distributed to authorized government buyers for use outside the United States. This product is not distributed in the United States.

Aptevo spin-off

On August 1, 2016, the Company completed the spin-off of Aptevo Therapeutics Inc. ("Aptevo") and has classified the results of operations of Aptevo as discontinued operations for the years ended December 31, 2016 and 2015. The historical financial statements and footnotes have been revised accordingly.