Emergent BioSolutions

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Emergent BioSolutions
Public company
Traded as NYSEEBS
Founded 1998
Headquarters Gaithersburg, Maryland
Key people
List
  • Fuad El-Hibri (Executive Chairman of the Board of Directors)
  • Daniel J. Abdun-Nabi (President and Chief Executive Officer)
Revenue Increase US $445-$500 million (2014)
Increase US $42.8 million (2014)
Profit Increase US $53-$55 million (2014)
Website Official website
Footnotes / references
[1][2][3][4][5][6][7][8]

Emergent BioSolutions is a multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland.[9] It develops vaccines and antibody therapeutics for infectious diseases, oncology and autoimmune disorders, and provides medical devices for biodefense purposes.

Among the company’s notable products is BioThrax (Anthrax Vaccine Adsorbed), the only anthrax vaccine licensed by the U.S. Food and Drug Administration (FDA). The company also manufactures pharmaceuticals for adults and children with acute blood disorders, people undergoing certain liver transplants, palliative care for chemo or radiation therapy patients, hemophilia B and a varicella (Chickenpox) vaccine for high risk patients.

The company has two divisions: a Biodefense division for medical countermeasures and a Biosciences division to treat infectious disease, autoimmune diseases, and cancer.[10]

Fuad El-Hibri, the founder of the company and former CEO,[11] led the company since its founding as BioPort Inc.[10][12] until his retirement on April 1, 2012.[13][14] He continues to serve as the executive chairman of Emergent BioSolutions’ board of directors.[15] The current CEO is Daniel Abdun-Nabi.

Anthrax vaccine

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Anthrax Vaccine Adsorbed

BioThrax

According to the U.S. National Library of Medicine, BioThrax was first made available in 1970.[16] BioThrax (Anthrax Vaccine Adsorbed), a vaccine licensed by the U.S. Food and Drug Administration.[17] Following a study by scientists from the Centers for Disease Control and Prevention,[18] on December 19, 2008, Emergent received final FDA licensing for use of BioThrax five doses for intramuscular injection.[19] Later in 2009, Emergent received approval from the FDA to extend the shelf life of its anthrax vaccine from three to four years. BioThrax was approved for distribution in the United States.[20][not in citation given] BioThrax has received marketing approval in India, Singapore, and Germany.[21][22][23]

The FDA gave BioThrax an "orphan drug" designation in April 2014.[24] The FDA gives that status to drugs that are used to treat rare diseases.[24] BioThrax is the only anthrax vaccine licensed by the FDA.[24]

As of April 2014, Emergent has sold over 66 million doses of BioThrax to the U.S. government.[25] Three million U.S. military personnel have received the BioThrax vaccine.[25]

The main buyer of BioThrax is the U.S. Centers for Disease Control and Prevention (CDC).[26] The CDC buys BioThrax for the Strategic National Stockpile (SNS).[26] The government uses the SNS to protect the public in the event of a national emergency like a terrorist attack.[26]

Company history

Acquisition history
  • 2003 (2003): Antex Biologics, Inc.[27]
  • 2005 (2005): Microscience Ltd.[28]
  • 2006 (2006): Vivacs GmbH[29]
  • 2008 (2008): A group of anthrax monoclonal antibodies from Avanir Pharmaceuticals[30]
  • 2008 (2008): Anthrax vaccine program, patents and processes from VaxGen[31][32]
  • 2010 (2010): Trubion Pharmaceuticals[33]
  • 2013 (2013): Healthcare Protective Products Division of Bracco Diagnostics Inc., which includes RSDL decontamination lotion[34][35]
  • 2014 (2014): Cangene Corporation[36][37]

Founding

Emergent BioSolutions was founded on September 5, 1998, under the name BioPort. At the time, the Michigan Department of Public Health, though its Michigan Biologics Products Institute, owned an anthrax vaccine manufacturing facility in Lansing, Michigan. BioPort purchased the facility and the rights to manufacture the vaccine for the U.S. military.[38][39]

2001 anthrax attacks

After the September 11, 2001, and the anthrax attacks that followed, Emergent worked with the U.S. government to supply anthrax countermeasures.[40]

Emergent BioSolutions and acquisitions

BioPort was renamed Emergent BioSolutions in 2004.[41] Between 2003 and 2014, Emergent acquired several companies and product lines. See Acquisition history box to the right.

Initial public offering (IPO)

Emergent became a publicly traded company in 2006, with its stock trading on the New York Stock Exchange under the symbol EBS.[40]

Centers for Innovation in Advanced Development and Manufacturing

In June 2012, Emergent, along with Novartis and the Texas A&M University System was selected by the U.S. Department of Health and Human Services as one of the three Centers for Innovation in Advanced Development and Manufacturing. The public-private partnership granted Emergent $163 million over eight years to assist in the development of countermeasures for health, nuclear and radiological epidemics.[42] The point of the sites is to produce medical countermeasures in the event of a national pandemic.[43] Emergent's site is located in Maryland. The company expects the site to be operational by the year 2020.[43]

Financial information

2014-2015 activity and financial figures

According to ZACKs, Emergent's acquisition of Cangene made both of Emergent's divisions (Biosciences and Biodefense) stronger. In addition to the Cangene acquisition, Emergent and the German human antibody developer MorphySys AG in 2014 began collaborating on a prostate cancer drug called ES414. As of January 2015, the drug is in the pre-clinical stage.[44]

In early January 2015, Emergent publicly released its preliminary financial totals for the 2014 year. The company saw an increase in revenue, GAAP net income,[lower-alpha 1] and adjusted net income. Revenue amounted to between $445–$450 million, which is 43% higher than revenue earned in 2013. GAAP net income was between $36 and $38 million (a 19% increase). Adjusted net income increased by 49 percent to between $53 and $55 million.[45]

Also in January, the company gave what is known as "guidance" (an accounting term meaning a company tells the public what it expects to earn in the future[46]) for 2015. Emergent expects $90–105 million in sales in the first three months of 2015; and between $510–540 million for the full year.[44] Emergent sold more BioThrax in 2014 than in the previous year (BioThrax sales amounted to approximately $246 million). According to company statements, Emergent believes that the growth in BioThrax sales along with stronger sales of other products from its Biodefense division will drive growth in 2015.[45] The Motley Fool, an investment information company characterized in its Yahoo! Finance profile as "the king of personal investing tips",[47] believes that Emergent's drug to treat hemophilia B, called Ixinity, will also drive growth in 2015. As of January 21, 2015, the FDA was reviewing Emergent's application for Ixinity approval.[48]

Key financial figures, current as of January 21, 2015, are listed in the table:[49]

Measure Header
Market capitalization $1,040,000,000
Enterprise value $1,070,000,000
Profit margin 5.46%
Operating margin 12.19%
Cash on hand $242,250,000
Debt $251,000,000
Debt/equity ratio 43.92

R&D and manufacturing operations

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In addition to the anthrax vaccine, Emergent BioSolutions develops and manufactures vaccines and therapeutics for the prevention or treatment of several diseases.[50]

The following table shows the company's marketed products, as of May 2014:[2][51][52]

Name Disease/Therapeutic Area Treats Stage Type
Anthrasil (Anthrax Immune Globulin Intravenous) Anthrax Inhalational anthrax Marketed Therapeutic[53]
BAT (Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-Equine) Botulism Exposure to botulinum neurotoxin Marketed Therapeutic
BioThrax (Anthrax Vaccine Adsorbed) Anthrax Anthrax Marketed Vaccine
episil (Oral Liquid) Oral wound dressing Pain associated with oral mucositis Marketed Medical device
HepaGam B [Hepatitis B Immune Globulin Intravenous] Hepatitis B Hepatitis B reinfection after liver transplantation Marketed Therapeutic
IXINITY [coagulation factor IX (recombinant)] Hemophilia B Inherited bleeding disorder that prevents clotting Marketed Therapeutic[54]
RSDL Chemical decontamination Skin exposure to chemical warfare agents Marketed Medical device
VIGIV [Vaccinia Immune Globulin Intravenous (Human)] Smallpox Smallpox vaccine complications Marketed Therapeutic
VARIZIG [Varicella Zoster Immune Globulin (Human)] Chickenpox Post-exposure prophylaxis of chickenpox Marketed Therapeutic
WinRho SDF [Rho(D) Immune Globulin Intravenous (Human)] Blood disorder Immune thrombocytopenic purpura (autoimmune platelet disorder) Marketed Therapeutic

Corporate social responsibility

Emergent runs a charitable giving program called Give Corporate Social Responsibility. The company has given money to the Lansing, Michigan school district. Prominent donations and scholarships include:

  • April 2014 - $15,000 to Lansing J. W. Sexton High School for the purchase of equipment for the AP Biology program.[55]
  • October 2014 - $25,000 to Sexton High School for engineering equipment[56]
  • October 2014 - $25,000 to the Lansing Promise scholarship fund[56]

Emergent is also a donor to the "Relentless Tour", an anti-bullying program that tries to raise awareness of autism and the problem of autistic children being bullied.[57]

See also

References

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  19. "Emergent BioSolutions Gets FDA Nod For Anthrax Vaccine supplemental BLA - Update", RTT News, December 19, 2008. Retrieved August 13, 2013.
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  21. "Emergent BioSolutions Receives Paul-Ehrlich-Institut Approval to Market BioThrax in Germany", Yahoo Finance press release, July 1, 2013. Retrieved August 13, 2013.
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  36. "Cangene Receives Court Approval of Plan of Arrangement for Acquisition by Emergent BioSolutions". Wall Street Journal. 2014-02-18 (Retrieved 2014-02-21)
  37. Overly, Steven. "Emergent BioSolutions pays $222M to acquire life sciences firm Cangene Corp." The Washington Post. 2013-12-11 (Retrieved 2014-02-21)
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Notes

  1. The NASDAQ source includes a statement regarding the "reconciliation of GAAP to Non-GAAP Net Income" and cites Securities and Exchange Commission rules. The full statement appears under the header "(III) Reconciliation of GAAP to Non-GAAP Net Income" in the source text ([2])

External links