Emergent BioSolutions, Inc. (EBS) - 500 Beiträge pro Seite
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ISIN: US29089Q1058 · WKN: A0LC2W · Symbol: ER4
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Profile:Emergent BioSolutions, Inc., a biopharmaceutical company, together with its subsidiaries, focuses on the development, manufacture, and commercialization of immunobiotics. Immunobiotics are pharmaceutical products, such as vaccines and immune globulins that assist the body’s immune system to prevent diseases. It has two segments, Biodefense and Commercial. The Biodefense segment develops and commercializes immunobiotics for use against biological agents, which are weapons of bioterrorism. This segment’s primary product includes BioThrax, a vaccine for the prevention of anthrax infection. Its other products, which are in preclinical stage comprise Anthrax Immune Globulin, for post-exposure treatment of anthrax infection; Recombinant Bivalent Botulinum Vaccine, a prophylaxis for botulinum; and Botulinum Immune Globulin for post-exposure treatment of botulinum intoxication. The Commercial segment develops immunobiotics for use against infectious diseases with unmet or underserved medical needs. This segment’s product portfolio consists of Typhoid Vaccine, a single-dose drinkable vaccine in phase II clinical trial; Hepatitis B Therapeutic Vaccine, for treating chronic carriers of hepatitis B infection, which has completed phase I clinical trial; Group B Streptococcus Vaccine in phase I clinical trial; Meningitis B Vaccine, a recombinant protein sub-unit vaccine for babies, children, and adolescents that has completed phase I clinical trial; and Chlamydia Vaccine, for the prevention of chlamydia trachomatis in preclinical stage. Emergent BioSolutions serves primarily the department of defense and the health and human services. It operates in the United States, the United Kingdom, Germany, and Singapore. The company, formerly known as BioPort Corporation, was founded in 1998 and is based in Gaithersburg, Maryland.
http://www.emergentbiosolutions.com/
http://www.emergentbiosolutions.com/
Emergent BioSolutions Delivers over 3 Million Doses of BioThrax(R) to U.S. Department of Health and Human Services for Strategic National Stockpile
Thursday December 14, 8:57 am ET
--Delivery represents approximately $75 million of revenue for 4Q 2006; Company on track to deliver remaining 1 million doses in 1Q 2007--
GAITHERSBURG, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE:EBS - News) today announced that it has successfully completed the 4Q 2006 deliveries of over three million doses of BioThrax® (Anthrax Vaccine Adsorbed), the only FDA licensed anthrax vaccine, to the Department of Health and Human Services (HHS) for placement into the nation's strategic national stockpile (SNS). The delivery of these doses, made under a May 2006 modified contract with HHS, represents 4Q 2006 revenue of approximately $75 million.
Under the modified contract, the company is required to complete delivery of a total of five million doses of BioThrax® to HHS prior to May 31, 2007 for a fixed price of $120 million. Since the contract modification, the company has delivered approximately four million doses of BioThrax® and expects to deliver the balance during 1Q 2007. Including the 4Q 2006 deliveries, the company has now supplied over nine million doses of BioThrax® to HHS for inclusion in the SNS.
"Over the past five years, we have consistently demonstrated our ability to meet our contractual obligations to deliver critically needed countermeasures to the U.S. Government for placement into the Strategic National Stockpile," said Robert G. Kramer, president and chief executive officer of the company's biodefense operations. "Our success is directly attributable to our dedicated employees who exhibit a deep commitment to these principles every day in assuring the continued successful manufacture of the only FDA approved vaccine against anthrax."
The company's initial deliveries to HHS were pursuant to a May 2005 supply agreement under which the company agreed to supply an initial five million doses of BioThrax® for placement into the SNS for a fixed price of $123 million. The company successfully delivered all five million doses by February 2006, seven months ahead of schedule. The SNS, which is administered by the U.S. Centers for Disease Control and Prevention, comprises large quantities of medicine and medical supplies to protect the American public if there is a public health emergency (terrorist attack, flu outbreak, earthquake) severe enough to cause local supplies to run out.
"We are proud to play a vital role in the strategic defense of the United States and the protection of its citizens from the threat of an anthrax attack," said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. "We welcome the opportunity to continue to work closely with the Department of Health and Human Services to meet the strategic biodefense requirements of the Government."
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of immunobiotics. Immunobiotics are vaccines and immune globulins that induce or assist the body's immune system to prevent or treat disease. The company's biodefense business is focused on developing and commercializing immunobiotics for use against biological agents that are potential weapons of bioterrorism. The company's commercial business is focused on developing immunobiotics for use against infectious diseases with significant unmet or underserved medical needs. More information on the company is available at www.emergentbiosolutions.com.
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management and any other statements containing the words "believes", "expects", "anticipates", "plans", "estimates" and similar expressions are forward-looking statements. There are a number of important factors that could cause actual results to differ materially from those indicated by such forward-looking statements, including our plans for future sales of BioThrax®; our plans to pursue label expansions and improvements for BioThrax®; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; our ongoing and planned development programs; preclinical studies and clinical trials; our ability to identify and acquire or in license products and product candidates that satisfy our selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company's Registration Statement on Form S-1 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
Contact:
Emergent BioSolutions Inc.
Media Contact:
Robert G. Burrows, 301-944-0108
burrowsr@ebsi.com
--------------------------------------------------------------------------------
Source: Emergent BioSolutions Inc.
Thursday December 14, 8:57 am ET
--Delivery represents approximately $75 million of revenue for 4Q 2006; Company on track to deliver remaining 1 million doses in 1Q 2007--
GAITHERSBURG, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE:EBS - News) today announced that it has successfully completed the 4Q 2006 deliveries of over three million doses of BioThrax® (Anthrax Vaccine Adsorbed), the only FDA licensed anthrax vaccine, to the Department of Health and Human Services (HHS) for placement into the nation's strategic national stockpile (SNS). The delivery of these doses, made under a May 2006 modified contract with HHS, represents 4Q 2006 revenue of approximately $75 million.
Under the modified contract, the company is required to complete delivery of a total of five million doses of BioThrax® to HHS prior to May 31, 2007 for a fixed price of $120 million. Since the contract modification, the company has delivered approximately four million doses of BioThrax® and expects to deliver the balance during 1Q 2007. Including the 4Q 2006 deliveries, the company has now supplied over nine million doses of BioThrax® to HHS for inclusion in the SNS.
"Over the past five years, we have consistently demonstrated our ability to meet our contractual obligations to deliver critically needed countermeasures to the U.S. Government for placement into the Strategic National Stockpile," said Robert G. Kramer, president and chief executive officer of the company's biodefense operations. "Our success is directly attributable to our dedicated employees who exhibit a deep commitment to these principles every day in assuring the continued successful manufacture of the only FDA approved vaccine against anthrax."
The company's initial deliveries to HHS were pursuant to a May 2005 supply agreement under which the company agreed to supply an initial five million doses of BioThrax® for placement into the SNS for a fixed price of $123 million. The company successfully delivered all five million doses by February 2006, seven months ahead of schedule. The SNS, which is administered by the U.S. Centers for Disease Control and Prevention, comprises large quantities of medicine and medical supplies to protect the American public if there is a public health emergency (terrorist attack, flu outbreak, earthquake) severe enough to cause local supplies to run out.
"We are proud to play a vital role in the strategic defense of the United States and the protection of its citizens from the threat of an anthrax attack," said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. "We welcome the opportunity to continue to work closely with the Department of Health and Human Services to meet the strategic biodefense requirements of the Government."
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of immunobiotics. Immunobiotics are vaccines and immune globulins that induce or assist the body's immune system to prevent or treat disease. The company's biodefense business is focused on developing and commercializing immunobiotics for use against biological agents that are potential weapons of bioterrorism. The company's commercial business is focused on developing immunobiotics for use against infectious diseases with significant unmet or underserved medical needs. More information on the company is available at www.emergentbiosolutions.com.
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management and any other statements containing the words "believes", "expects", "anticipates", "plans", "estimates" and similar expressions are forward-looking statements. There are a number of important factors that could cause actual results to differ materially from those indicated by such forward-looking statements, including our plans for future sales of BioThrax®; our plans to pursue label expansions and improvements for BioThrax®; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; our ongoing and planned development programs; preclinical studies and clinical trials; our ability to identify and acquire or in license products and product candidates that satisfy our selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company's Registration Statement on Form S-1 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
Contact:
Emergent BioSolutions Inc.
Media Contact:
Robert G. Burrows, 301-944-0108
burrowsr@ebsi.com
--------------------------------------------------------------------------------
Source: Emergent BioSolutions Inc.
8:58AM Emergent Biosolutions says delivers over 3 mln doses of BioThrax to US Dept of Health and Human Services for national stockpile (EBS) 9.77 : Co announces that it has successfully completed the 4Q 2006 deliveries of over 3 mln doses of BioThrax, the only FDA licensed anthrax vaccine, to the Dept of Health and Human Services for placement into the nation's strategic national stockpile. The delivery of these doses, made under a May 2006 modified contract with H.H.S, represents 4Q 2006 revenue of approximately $75 mln.
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Trading Spotlight
AP
Emergent Biosolutions Rise on Vaccine
Thursday December 14, 2:10 pm ET
Emergent Biosolutions Shares Hit New High on Shipment of $75 Million of Anthrax Vaccine
NEW YORK (AP) -- Shares of Emergent Biosolutions Inc. rose Thursday, after the biopharmaceutical company said it delivered more than three million doses of anthrax vaccine to the Department of Health and Human Services.
Shares jumped to a new high of $18.45 before falling back to $10.29, up 52 cents of 5.4 percent in the afternoon session on the New York Stock Exchange. The stock began trading Nov. 15.
The company delivered more than three million doses of BioThrax, the only U.S.-approved anthrax vaccine. The doses, ordered in May, represent $75 million in revenue that will be recognized in the fourth quarter.
It is part of a larger $120 million contract for 5 million doses that must be delivered before May 31 to HHS for a stockpile. The balance of the shipment is on track to be delivered during the first 2007 quarter, the company said.
Including the recent shipment, Emergent Biosolutions has supplied the health agency with about 9 million doses of the vaccine, partially under a prior agreement.
The stockpile is to be used in case of emergencies, if local supplies of vaccine run out.
Emergent Biosolutions Rise on Vaccine
Thursday December 14, 2:10 pm ET
Emergent Biosolutions Shares Hit New High on Shipment of $75 Million of Anthrax Vaccine
NEW YORK (AP) -- Shares of Emergent Biosolutions Inc. rose Thursday, after the biopharmaceutical company said it delivered more than three million doses of anthrax vaccine to the Department of Health and Human Services.
Shares jumped to a new high of $18.45 before falling back to $10.29, up 52 cents of 5.4 percent in the afternoon session on the New York Stock Exchange. The stock began trading Nov. 15.
The company delivered more than three million doses of BioThrax, the only U.S.-approved anthrax vaccine. The doses, ordered in May, represent $75 million in revenue that will be recognized in the fourth quarter.
It is part of a larger $120 million contract for 5 million doses that must be delivered before May 31 to HHS for a stockpile. The balance of the shipment is on track to be delivered during the first 2007 quarter, the company said.
Including the recent shipment, Emergent Biosolutions has supplied the health agency with about 9 million doses of the vaccine, partially under a prior agreement.
The stockpile is to be used in case of emergencies, if local supplies of vaccine run out.
VaxGen says U.S. cancels anthrax contract
http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn…
Emergent könnte damit zusätzliche Aufträge für BioThrax erhalten. VaxGen kommt aus seinen Schwierigkeiten nicht heraus und BioThrax ist als weltweit einziges vom Heimatschutzministerium als für den Heimatschutz zugelassenes Produkt gegen Milzbrand Erreger zertifiziert. Emergent müsste damit sowieso erste Wahl für die Auftragsvergabe der US Regierung sein.
Die Produktpipeline ist zwar noch ein paar Jahre in der Entwicklung, aber ebenfalls vielversprechend und m.E. noch überhaupt nicht in der Bewertung der Aktie drin.
http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn…
Emergent könnte damit zusätzliche Aufträge für BioThrax erhalten. VaxGen kommt aus seinen Schwierigkeiten nicht heraus und BioThrax ist als weltweit einziges vom Heimatschutzministerium als für den Heimatschutz zugelassenes Produkt gegen Milzbrand Erreger zertifiziert. Emergent müsste damit sowieso erste Wahl für die Auftragsvergabe der US Regierung sein.
Die Produktpipeline ist zwar noch ein paar Jahre in der Entwicklung, aber ebenfalls vielversprechend und m.E. noch überhaupt nicht in der Bewertung der Aktie drin.
Emergent BioSolutions Announces Expected 2006 Total Revenue of Approximately $150 Million
Monday January 8, 7:00 am ET
Expected 2006 Total Revenues Increase Approximately 15% From 2005
ROCKVILLE, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE: EBS - News) today announced that its total revenues for 2006 are estimated to be approximately $150 million, based on the company's preliminary, unaudited results for full year 2006. This represents an increase of approximately 15% over 2005 total revenues of $130.7 million. The company has not finalized its financial statements for 2006, and results are subject to change.
As previously announced, Fuad El-Hibri, president, chief executive officer and chairman of the board of directors of Emergent BioSolutions, will provide a company overview and outline future growth opportunities at the 25th Annual JPMorgan Healthcare Conference in San Francisco today at 3:00 pm PST at the St. Francis Hotel in San Francisco, California.
A webcast of the presentation will be available both live and by replay. To access both the live and archived webcast, please go to www.emergentbiosolutions.com, click on the "Investors" link and proceed to the "Webcasts & Presentations" section. The archived replay will be available 24 hours after the live presentation and will be accessible for 30 days.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of immunobiotics, such as vaccines and therapeutics that induce or assist the body's immune system to prevent or treat disease. The company's biodefense business is focused on developing and commercializing immunobiotics for use against biological agents that are potential weapons of bioterrorism. The company's commercial business is focused on developing immunobiotics for use against infectious diseases with significant unmet or underserved medical needs. More information on the company is available at www.emergentbiosolutions.com.
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding expected 2006 total revenues and any other statements containing the words "believes", "expects", "anticipates", "plans", "estimates" and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company's actual results to differ materially from those indicated by such forward-looking statements, including a revision to the company's preliminary, unaudited results for 2006 as a result of finalizing its audited financial statements and other factors identified in the company's Registration Statement on Form S-1 and subsequent reports filed with the Securities and Exchange Commission. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
Contact:
Emergent BioSolutions Inc.
Vice President, Corporate Communications
Robert G. Burrows, 301-795-1877
burrowsr@ebsi.com
--------------------------------------------------------------------------------
Source: Emergent BioSolutions Inc.
Monday January 8, 7:00 am ET
Expected 2006 Total Revenues Increase Approximately 15% From 2005
ROCKVILLE, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE: EBS - News) today announced that its total revenues for 2006 are estimated to be approximately $150 million, based on the company's preliminary, unaudited results for full year 2006. This represents an increase of approximately 15% over 2005 total revenues of $130.7 million. The company has not finalized its financial statements for 2006, and results are subject to change.
As previously announced, Fuad El-Hibri, president, chief executive officer and chairman of the board of directors of Emergent BioSolutions, will provide a company overview and outline future growth opportunities at the 25th Annual JPMorgan Healthcare Conference in San Francisco today at 3:00 pm PST at the St. Francis Hotel in San Francisco, California.
A webcast of the presentation will be available both live and by replay. To access both the live and archived webcast, please go to www.emergentbiosolutions.com, click on the "Investors" link and proceed to the "Webcasts & Presentations" section. The archived replay will be available 24 hours after the live presentation and will be accessible for 30 days.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of immunobiotics, such as vaccines and therapeutics that induce or assist the body's immune system to prevent or treat disease. The company's biodefense business is focused on developing and commercializing immunobiotics for use against biological agents that are potential weapons of bioterrorism. The company's commercial business is focused on developing immunobiotics for use against infectious diseases with significant unmet or underserved medical needs. More information on the company is available at www.emergentbiosolutions.com.
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding expected 2006 total revenues and any other statements containing the words "believes", "expects", "anticipates", "plans", "estimates" and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company's actual results to differ materially from those indicated by such forward-looking statements, including a revision to the company's preliminary, unaudited results for 2006 as a result of finalizing its audited financial statements and other factors identified in the company's Registration Statement on Form S-1 and subsequent reports filed with the Securities and Exchange Commission. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
Contact:
Emergent BioSolutions Inc.
Vice President, Corporate Communications
Robert G. Burrows, 301-795-1877
burrowsr@ebsi.com
--------------------------------------------------------------------------------
Source: Emergent BioSolutions Inc.
Emergent BioSolutions sees 2006 revenue above analysts' view
Jan 8 (Reuters) - Biopharmaceutical company Emergent BioSolutions Inc. (EBS.N: Quote, Profile , Research) forecast 2006 revenue above analysts' estimates.
The company said it expects total revenue for 2006 to be about $150 million. Analysts, on average, expect revenue of $144.5 million for the year, according to Reuters Estimates. (Reporting by Dhanya Skariachan in Bangalore)
Jan 8 (Reuters) - Biopharmaceutical company Emergent BioSolutions Inc. (EBS.N: Quote, Profile , Research) forecast 2006 revenue above analysts' estimates.
The company said it expects total revenue for 2006 to be about $150 million. Analysts, on average, expect revenue of $144.5 million for the year, according to Reuters Estimates. (Reporting by Dhanya Skariachan in Bangalore)
mmhh wo ist der boden?
U.S. Department of Health and Human Services Remains Committed to Procurement of BioThrax(R) Under Current Contract
Monday November 19, 9:22 am ET
ROCKVILLE, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE:EBS - News) announced today that the Department of Health and Human Services (HHS) has reaffirmed its commitment to continue to purchase BioThrax® (Anthrax Vaccine Adsorbed) under the current contract for 18.75 million doses that provides for a firm fixed price of $400 million plus an additional $34 million upon receipt of regulatory approval of four year dating. In a recent notification, HHS stated the following:
HHS plans to continue purchasing BioThrax under the contract, which is for 18.75 million doses; and
HHS is diligently working with the Department of Defense (DOD) and other federal partners, as required by Homeland Security Presidential Directive 21 and recommended by a recent Government Accountability Office report, to address effective stockpile management to meet collective requirements.
“We are pleased that HHS has reaffirmed its commitment to the continued procurement of BioThrax under our recent contract, and we are confident that BioThrax will remain a critical component of our nation’s preparedness efforts,” said Fuad El-Hibri, Chief Executive Officer and Chairman of Emergent BioSolutions. “Emergent BioSolutions looks forward to continuing our long standing relationship with the U.S. government to protect our military men and women as well as Americans at home.”
In the last few months, the company announced significant progress in achieving its business objectives including:
the upward revision to its revenue guidance to reflect 2007 full-year revenue growth of between 16% and 18%, and a continued commitment to profitability in 2007, which will represent the sixth consecutive year of full year profitability;
the signing of a $448 million three-year contract with the HHS that included $400 million for delivery of 18.75 million doses of BioThrax, $34 million upon receipt of regulatory approval of four year dating, and $11.5 million in connection with a post-exposure indication for BioThrax;
the completion of the first delivery of BioThrax to HHS under the new contract, which generated revenue of approximately $42 million;
the completion of a clinical study in support of the post exposure prophylaxis indication for BioThrax, which triggered an $8.8 million milestone payment from HHS;
the receipt of a $9.5 million award from HHS to fund the continued development of the company’s anthrax immune globulin therapeutic candidate; and
the positive completion of a double-blind, placebo-controlled Phase II clinical trial of its single-dose, oral typhoid vaccine candidate in a pediatric population, with the vaccine being well-tolerated and immunogenic.
“These developments demonstrate consistent progress during 2007 towards expanding our business and achieving long-term growth,” he continued. “The HHS contract provides us with a baseline of revenue sufficient to support the growth and profitability of our company in 2008 and 2009, and we intend to expand our revenue sources, including with the Department of Defense, other domestic customers, and internationally with foreign governments based on projects we have been actively pursuing while remaining fiscally responsible in the management of our operations. Emergent BioSolutions remains focused on building upon our past success and further expanding our presence as an innovative biopharmaceutical company with a simple mission – to protect life.”
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company dedicated to one simple mission – to protect life. We develop, manufacture and commercialize immunobiotics, consisting of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease. Our biodefense business focuses on immunobiotics for use against biological agents that are potential weapons of bioterrorism and biowarfare. Our marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Our commercial business focuses on immunobiotics for use against infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs. More information on the company is available at www.emergentbiosolutions.com.
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including our expected revenue growth and net earnings for 2007, and any other statements containing the words "believes", "expects", "anticipates", "plans", "estimates" and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company's actual results to differ materially from those indicated by such forward-looking statements, including our ability to obtain new BioThrax® sales contracts with the U.S. government; our plans for future sales of BioThrax; our plans to pursue label expansions and improvements for BioThrax; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; our ongoing and planned development programs, preclinical studies and clinical trials; our ability to identify and acquire or in license products and product candidates that satisfy our selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2007 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
Contact:
Emergent BioSolutions Inc.
Investors Contact:
Robert G. Burrows
Vice President, Investor Relations
301-795-1877
BurrowsR@ebsi.com
or
Media Contact:
Tracey Schmitt
Director, Corporate Communications
301-795-1800
SchmittT@ebsi.com
--------------------------------------------------------------------------------
Source: Emergent BioSolutions Inc.
Monday November 19, 9:22 am ET
ROCKVILLE, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE:EBS - News) announced today that the Department of Health and Human Services (HHS) has reaffirmed its commitment to continue to purchase BioThrax® (Anthrax Vaccine Adsorbed) under the current contract for 18.75 million doses that provides for a firm fixed price of $400 million plus an additional $34 million upon receipt of regulatory approval of four year dating. In a recent notification, HHS stated the following:
HHS plans to continue purchasing BioThrax under the contract, which is for 18.75 million doses; and
HHS is diligently working with the Department of Defense (DOD) and other federal partners, as required by Homeland Security Presidential Directive 21 and recommended by a recent Government Accountability Office report, to address effective stockpile management to meet collective requirements.
“We are pleased that HHS has reaffirmed its commitment to the continued procurement of BioThrax under our recent contract, and we are confident that BioThrax will remain a critical component of our nation’s preparedness efforts,” said Fuad El-Hibri, Chief Executive Officer and Chairman of Emergent BioSolutions. “Emergent BioSolutions looks forward to continuing our long standing relationship with the U.S. government to protect our military men and women as well as Americans at home.”
In the last few months, the company announced significant progress in achieving its business objectives including:
the upward revision to its revenue guidance to reflect 2007 full-year revenue growth of between 16% and 18%, and a continued commitment to profitability in 2007, which will represent the sixth consecutive year of full year profitability;
the signing of a $448 million three-year contract with the HHS that included $400 million for delivery of 18.75 million doses of BioThrax, $34 million upon receipt of regulatory approval of four year dating, and $11.5 million in connection with a post-exposure indication for BioThrax;
the completion of the first delivery of BioThrax to HHS under the new contract, which generated revenue of approximately $42 million;
the completion of a clinical study in support of the post exposure prophylaxis indication for BioThrax, which triggered an $8.8 million milestone payment from HHS;
the receipt of a $9.5 million award from HHS to fund the continued development of the company’s anthrax immune globulin therapeutic candidate; and
the positive completion of a double-blind, placebo-controlled Phase II clinical trial of its single-dose, oral typhoid vaccine candidate in a pediatric population, with the vaccine being well-tolerated and immunogenic.
“These developments demonstrate consistent progress during 2007 towards expanding our business and achieving long-term growth,” he continued. “The HHS contract provides us with a baseline of revenue sufficient to support the growth and profitability of our company in 2008 and 2009, and we intend to expand our revenue sources, including with the Department of Defense, other domestic customers, and internationally with foreign governments based on projects we have been actively pursuing while remaining fiscally responsible in the management of our operations. Emergent BioSolutions remains focused on building upon our past success and further expanding our presence as an innovative biopharmaceutical company with a simple mission – to protect life.”
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company dedicated to one simple mission – to protect life. We develop, manufacture and commercialize immunobiotics, consisting of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease. Our biodefense business focuses on immunobiotics for use against biological agents that are potential weapons of bioterrorism and biowarfare. Our marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Our commercial business focuses on immunobiotics for use against infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs. More information on the company is available at www.emergentbiosolutions.com.
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including our expected revenue growth and net earnings for 2007, and any other statements containing the words "believes", "expects", "anticipates", "plans", "estimates" and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company's actual results to differ materially from those indicated by such forward-looking statements, including our ability to obtain new BioThrax® sales contracts with the U.S. government; our plans for future sales of BioThrax; our plans to pursue label expansions and improvements for BioThrax; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; our ongoing and planned development programs, preclinical studies and clinical trials; our ability to identify and acquire or in license products and product candidates that satisfy our selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2007 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
Contact:
Emergent BioSolutions Inc.
Investors Contact:
Robert G. Burrows
Vice President, Investor Relations
301-795-1877
BurrowsR@ebsi.com
or
Media Contact:
Tracey Schmitt
Director, Corporate Communications
301-795-1800
SchmittT@ebsi.com
--------------------------------------------------------------------------------
Source: Emergent BioSolutions Inc.
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Emergent BioSolutions, Inc. (EBS)
