Emergent BioSolutions Reports Financial Results for First Quarter 2011

ROCKVILLE, Md., May 05, 2011 (BUSINESS WIRE) -- Emergent BioSolutionsInc. (NYSE: EBS) announced  its financial results for the first quarter ended March 31, 2011.

For 1Q 2011, total revenues were $18.5 million as compared to $46.8 million in 2010. In addition, for 1Q 2011 the company recorded a net loss of $21.4 million, or $0.61 per basic share, as compared to net income of $2.5 million, or $0.08 per basic share, in 2010.

R. Don Elsey, chief financial officer of Emergent BioSolutions, stated, "While our first quarter revenues were slightly lower than expected, we remain on track to achieve our full year guidance of total revenues of $320 to $340 million and net income of $35 to $45 million."

1Q 2011 Key Financial Results

Product Sales

For 1Q 2011, product sales were $5.6 million, a decrease of $33.3 million, or 86 percent, from $38.9 million for 1Q 2010. This decrease was primarily due to an 88 percent decrease in the number of doses of BioThrax delivered. During the first quarter, the company redeployed its potency testing capacity from BioThrax release testing to qualification of replacement reference standards and other development testing. This process, which is required to enable continued future release of BioThrax doses, has now been substantially completed. Product sales revenues for 1Q 2011 consisted of BioThrax sales to CDC of $5.0 million and aggregate international and other sales of $0.6 million.

Contracts and Grants Revenues

For 1Q 2011, contracts and grants revenues were $12.9 million, an increase of $5.0 million, or 63 percent, from $7.9 million for 1Q 2010. The increase was primarily due to revenues from the recently awarded contract from BARDA for large-scale manufacturing for BioThrax, collaborations with Abbott and Pfizer, along with increased activity and associated revenue from development contracts with BARDA and NIAID.

Cost of Product Sales

For 1Q 2011, cost of product sales was $1.1 million, a decrease of $6.4 million, or 86 percent, from $7.5 million for 1Q 2010. This decrease was primarily attributable to the 88 percent decrease in the number of BioThrax doses sold.

Research and Development

For 1Q 2011, research and development expenses were $34.8 million, an increase of $14.8 million, or 74 percent, from $19.9 million for 1Q 2010. This increase primarily reflects higher contract service and personnel costs, and includes increased expenses of $13.9 million on product candidates and technology platform development activities associated with the BioSciences segment and increased expenses of $0.9 million on product candidates associated with the BioDefense segment. Net of development contracts and grants reimbursement revenue along with the net loss attributable to noncontrolling interests, research and development expenses were $20.0 million for 1Q 2011.

Selling, General and Administrative

For 1Q 2011, selling, general and administrative expenses were $18.2 million, an increase of $2.0 million, or 12 percent, from $16.2 million for 1Q 2010. This increase is primarily due to increased personnel-related expenses and professional services to support the business. Selling, general and administrative expenses for 1Q 2011 consisted of $14.0 million associated with the BioDefense segment and $4.2 million associated with the BioSciences segment.

Financial Condition and Liquidity

Cash and cash equivalents combined with investments at March 31, 2011 was $143.3 million compared to $171.0 million at December 31, 2010. Additionally, at March 31, 2011, the accounts receivable balance was $12.0 million, which is comprised primarily of unpaid amounts under our NIAID and BARDA development contracts.

2Q 2011 Revenue Forecast

For the second quarter of 2011, the company anticipates total revenues of $80 to $90 million.

2011 Forecast

For full year 2011, the company is reaffirming its financial forecast of total revenues of $320 to $340 million and net income of $35 to $45 million.

2011 total revenue is expected to be driven by, among other things:

• the continuation of deliveries of BioThrax under the current multi-year procurement contract with CDC, which was recently modified to increase the total contracted doses to 17.9 million;


• additional deliveries of BioThrax under a follow-on, multi-year procurement contract with CDC, anticipated to begin in 4Q 2011;


• a significant increase in contracts and grants revenue based primarily on development contracts related to product development programs in the company's BioDefense segment; and


• collaboration and milestone revenues associated with achievement of clinical development milestones related to the company's oncology product candidate, which is under an existing co-development agreement with Abbott, and the company's autoimmune product candidate, which is being developed by Pfizer under a license agreement from the company.

Conference Call and Webcast

Company management hosted a conference call at 5:00 pm Eastern on May 5, 2011 to discuss the financial results for the first quarter of 2011, recent business developments, revenue guidance for the second quarter of 2011 and revenue and net income guidance for the full year 2011.

A replay of the conference call will be accessible by dialing 888/286-8010 or 617/801-6888 and using the passcode 12159691. The replay will be available through May 19, 2011. The webcast will be archived on the company's website, www.emergentbiosolutions.com, under "Investors".

About Emergent BioSolutions Inc.

Emergent BioSolutions, led by Chairman and CEO, Fuad El-Hibri, protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent's marketed and investigational products target infectious diseases, oncology and autoimmune disorders. Additional information may be found 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 any potential future securities offering, our estimates of preliminary results for 2010, and our expected revenue growth and net earnings for 2011, 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 appropriations for BioThrax(R) procurement; our ability to obtain new BioThrax(R) sales contracts or modifications to existing contracts; our plans to pursue label expansions and improvements for BioThrax(R); our ability to perform under our current development contracts with the U.S. government; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance of our products and product candidates; the success of preclinical studies and clinical trials of our product candidates and post-approval clinical utility of our products; the potential benefits of our existing collaborations and our ability to selectively enter into additional collaborative arrangements; ongoing and planned development programs, preclinical studies and clinical trials; and other factors identified in the company's Annual Report on Form 10-K for the year ended December 31, 2010 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.

Oxford-Emergent Tuberculosis Consortium Vaccinates Last Infant in Phase IIb Clinical Trial

• Total of 2,784 infants vaccinated in TB efficacy trial evaluating MVA85A
• Study results expected to be available as early as mid-2012

ROCKVILLE, Md., Apr 28, 2011

Emergent BioSolutions Inc. (NYSE:EBS) announced today that its joint venture with the University of Oxford (Oxford), the Oxford-Emergent Tuberculosis Consortium (OETC), has vaccinated the last of the 2,784 infants in its Phase IIb efficacy trial evaluating MVA85A, the world’s most clinically advanced tuberculosis (TB) vaccine in development. This clinical trial in Worcester, South Africa, is being conducted by the University of Cape Town’s South African Tuberculosis Vaccine Initiative (SATVI), in partnership with Aeras, the clinical sponsor of the study, and the Wellcome Trust.

“Emergent BioSolutions joined the fight against TB when it formed OETC with Oxford to further develop MVA85A,” said Daniel J. Abdun-Nabi, Chairman of the Board, OETC and President and Chief Operating Officer, Emergent BioSolutions. “We are pleased to complete the vaccination of our targeted 2,784 infants, which is the largest number of infants enrolled in any TB vaccine clinical trial. Our quest to fulfill Emergent’s corporate mission – to protect life – will come to fruition when we can bring this vaccine candidate to market and ultimately make an impact in patients’ lives.”

“We are extremely proud of this achievement and are eager to see the study results, which are expected to be available as early as mid-2012,” said Dr. Helen McShane, lead scientist and developer of MVA85A from the University of Oxford. “This milestone brings us a step closer to potentially having a new TB vaccine, from which millions of people around the world would benefit.”

This Phase IIb clinical trial was initiated in July 2009 and involves a two-year follow up on the infants vaccinated as part of the trial to evaluate whether the vaccine candidate has conferred protection against TB.

About Emergent BioSolutions Inc.

Emergent BioSolutions, led by Chairman &CEO, Fuad El-Hibri, protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent’s marketed and investigational products target infectious diseases, oncology and autoimmune disorders. Additional information about the company may be found 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 strategy, future operations, future financial position, future revenues, projected costs, future product development, 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 the actual results of the Consortium or Emergent to differ materially from those indicated by such forward-looking statements, including the timing of, and the potential for successful outcomes resulting from, future product development efforts; the ability of the Consortium or Emergent to obtain funding for product development efforts; plans of the Consortium and Emergent to expand manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of products; and other factors identified in Emergent’s Annual Report for the year ended December 31, 2010 and subsequent reports filed with the SEC. The Consortium and Emergent disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

SOURCE: Emergent BioSolutions Inc.

Emergent BioSolutions Chairman and CEO Fuad El-Hibri Named Biotech CEO of the Year at the World Vaccine Congress

ROCKVILLE, Md., Apr 12, 2011 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that Fuad El-Hibri, its chairman and chief executive officer, has been recognized as Biotech CEO of the Year during the Vaccine Industry Excellence (ViE) Awards at the World Vaccine Congress. The ViE awards showcase excellence and honor accomplishments of both individuals and companies in the global vaccine industry.

“This award is a testament to the collective efforts of the Emergent BioSolutions team, who on a daily basis and all over the world, lives out the corporate mission – to protect life,” said Mr. El-Hibri. “Our team shares a passion and commitment to make vital contributions to address unmet and underserved medical needs. It is an honor to be recognized for the work that we do.”

In selecting the winner for this category, the distinguished panel of judges evaluated the finalists based on their commitment to disease prevention and treatment, leadership, contribution to company performance, communication, and vision, industry influence, and achievements in company positioning and status.

About Emergent BioSolutions Inc.

Emergent BioSolutions protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent’s marketed and investigational products target infectious diseases, oncology and autoimmune disorders. Additional information about the company may be found at www.emergentbiosolutions.com.

Home Fuad El-Hibri Official Bio Emergent BioSolutions Reports Financial Results for Full Year 2010

• 2010 revenues of $286.2 million
• 2010 net income of $51.7 million, or $1.63 per share, representing ninth consecutive year of profitability
• 2010 cash, investments and accounts receivable balance of $210.4 million
• 2011 forecast reaffirmed: total revenues of $320 to $340 million and net income of $35 to $45 million

Emergent BioSolutions Inc. (NYSE: EBS) announced on 10 March its financial results for the full year ending December 31, 2010.

Total revenues for 2010 were $286.2 million as compared to $234.8 million in 2009, and net income was $51.7 million, or $1.63 per basic share, as compared to $31.1 million, or $1.02 per basic share, in 2009.

For the fourth quarter 2010, total revenues were $103.2 million as compared to $53.8 million in 2009, and net income was $26.2 million, or $0.78 per basic share, as compared to $4.2 million, or $0.14 per basic share, in 2009.

R. Don Elsey, chief financial officer of Emergent BioSolutions, stated, “Our 2010 financial performance reflects our continued success in growing revenue from the sale of BioThrax(R) and government development contracts, as well as from development collaborations with our large pharma partners. We achieved this revenue growth while closely managing our overall expenditures even as we continued to advance our pipeline of vaccines and therapeutics targeting key disease areas. We expect to continue our growth in 2011, as evidenced by our reaffirmed 2011 forecast of total revenues of $320 to $340 million and net income of $35 to $45 million.”

2010 Key Operational Accomplishments

• Acquired Trubion Pharmaceuticals, Inc. for a total consideration of up to $131.6 million, including $92.9 million in upfront cash and stock and up to $38.7 million of success-based milestones, payable between October 2010 and October 2013;
• Secured a BARDA development contract, valued at up to $107.0 million, to fund qualification, validation and licensure of Building 55 in order to manufacture BioThrax(R) (Anthrax Vaccine Adsorbed) at large-scale;
• Secured a BARDA development contract, valued at up to $186.6 million, to fund development of our rPA vaccine candidate PreviThraxTM (Recombinant Protective Antigen Anthrax Vaccine, Purified);
• Secured a NIAID development contract, valued at up to $28.7 million, to fund further development of NuThraxTM (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant), the second contract award for this vaccine candidate;
• Launched Singapore operations and formed EPIC Bio, Pte. Ltd., a joint venture with Temasek Life Sciences Ventures Pte. Ltd., to develop, manufacture, and commercialize pre-pandemic influenza vaccines and therapeutics;
• Obtained Fast Track designation and Orphan Drug status from FDA for ThravixaTM (Fully Human Anthrax Monoclonal Antibody);
• Initiated a Phase 1 clinical study for Thravixa;
• Initiated a Phase 1 clinical study for NuThrax; and

Expanded the Board of Directors with the appointment of John E. Niederhuber, M.D., former Director, The National Cancer Institute (NCI), and Marvin White, Chief Financial Officer, St. Vincent Health and former Chief Financial Officer, LillyUSA.

About Emergent BioSolutions Inc.

Emergent BioSolutions, led by Chairman and CEOFuad El-Hibri, protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent’s marketed and investigational products target infectious diseases, oncology and autoimmune disorders. Additional information may be found at http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.emergentbiosolutions.com&esheet=6643305&lan=en-US&anchor=www.emergentbiosolutions.com&index=3&md5=974c9d419f86092b960b6d8622d54f18.

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 any potential future securities offering, our estimates of preliminary results for 2010, and our expected revenue growth and net earnings for 2011, 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 appropriations for BioThrax(R) procurement; our ability to obtain new BioThrax(R) sales contracts or modifications to existing contracts; our plans to pursue label expansions and improvements for BioThrax(R); our ability to perform under our current development contracts with the U.S. government; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance of our products and product candidates; the success of preclinical studies and clinical trials of our product candidates and post-approval clinical utility of our products; the potential benefits of our existing collaborations and our ability to selectively enter into additional collaborative arrangements; ongoing and planned development programs, preclinical studies and clinical trials; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2010 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.

Emergent BioSolutions to Present Today at Needham & Company Healthcare Conference

Emergent BioSolutions Inc. (NYSE: EBS) will be webcasting its presentation at the 10^th Annual Needham & Company Healthcare Conference in New York on Tuesday, April 5, 2011 at 8:00 AM Eastern. During the presentation, a member of the company’s senior management team will provide a corporate overview, which may include a discussion of recent business developments, 2010 financial results and financial guidance for 2011.

A webcast of this presentation will be available both live and by replay, accessible from the Emergent website www.emergentbiosolutions.com under “Investors”.

About Emergent BioSolutions Inc.

Emergent BioSolutions, led by Chairman and CEO, Fuad El-Hibri, protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent’s marketed and investigational products target infectious diseases, oncology and autoimmune disorders. Additional information about the company may be found at www.emergentbiosolutions.com.

Emergent BioSolutions Observes World TB Day Launches “OETC: Endeavor to End Tuberculosis,” a video to raise public awareness of TB

ROCKVILLE, Md., Mar 24, 2011 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today released the following statement in observance of World TB Day.

The World TB Day 2011 campaign, “On the move against TB: Transforming the fight towards elimination,” challenges us to undertake the fight against TB with the end goal of eliminating this highly infectious and lethal disease. Two billion people or one-third of the world’s population is infected with TB bacilli, the microbes that cause TB. The World Health Organization estimates that there are over 9 million new TB cases and 1.7 million deaths from TB annually.

“One of the barriers identified towards eliminating TB is the lack of a fully effective vaccine in the market,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “As a collaborator in the Oxford-Emergent Tuberculosis Consortium (OETC), Emergent’s joint venture with the University of Oxford, to develop what could be the first new TB vaccine in 90 years, we are pleased to be working toward a solution to address this global health emergency.”

A Phase IIb clinical trial involving 2,784 infants is currently underway in Worcester, South Africa to evaluate the efficacy of MVA85A, the world’s most clinically advanced tuberculosis vaccine in development. The trial entails administering MVA85A as a booster to the BCG vaccine and is being conducted by the University of Cape Town’s South African Tuberculosis Vaccine Initiative, in partnership with OETC and Aeras Global TB Foundation.

On World TB Day and beyond, Emergent hopes to raise public awareness of TB and the importance of new vaccines to help curtail the global health problem of tuberculosis. For more information, visit www.emergentbiosolutions.com/tbvaccine and view “OETC: Endeavor to End Tuberculosis,” a video that focuses on the efforts of OETC to further develop MVA85A.

About Emergent BioSolutions Inc.

Emergent BioSolutions protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent’s marketed and investigational products target infectious diseases, oncology and autoimmune disorders. Additional information about the company may be found 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 the actual results of the Consortium or Emergent to differ materially from those indicated by such forward-looking statements, including the timing of, and the potential for successful outcomes resulting from, future product development efforts; the ability of the Consortium or Emergent to obtain additional funding for product development efforts; plans of the Consortium and Emergent to expand manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of products; and other factors identified in Emergent’s Annual Report for the year ended December 31, 2010 and subsequent reports filed with the SEC. The Consortium and Emergent disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

SOURCE: Emergent BioSolutions Inc.

Delegates from European Parliament Express Support for Rapid Development of New TB Vaccine

Comments expressed during tour of South African clinical trial site where Emergent’s TB vaccine candidate is expected to complete enrollment in April for its Phase IIb efficacy study

ROCKVILLE, Md., Feb 25, 2011 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced that a joint delegation of Members of the European Parliament (MEPs) and representatives from the Oxford-Emergent Tuberculosis Consortium (OETC) today visited the trial site where MVA85A, the world’s most clinically advanced tuberculosis (TB) vaccine candidate in development, is being studied in a Phase IIb infant efficacy clinical trial. This clinical trial in Worcester, South Africa is being conducted by the University of Cape Town’s South African Tuberculosis Vaccine Initiative (SATVI), in partnership with OETC and Aeras.

“I am very anxious to see a new TB vaccine licensed and I am delighted that this trial of this promising new vaccine candidate is taking place,” said MEP Michael Cashman, Chairman of the South Africa Delegation of the European Parliament. “It is vital for South Africa that a new vaccine is developed as soon as possible, especially for infants and those with HIV. If this trial is successful, South Africa will benefit and so will the rest of the world. Too many lives are lost to tuberculosis and I am pleased to see so many public and private bodies coming together to deliver what could be the first new TB vaccine in 90 years.”

“Emergent BioSolutions is proud to be part of OETC, a joint venture established with the University of Oxford in 2008, to further develop the most clinically advanced investigational TB vaccine,” said Allen Shofe, OETC Board Member and Senior Vice President Corporate Affairs of Emergent BioSolutions. “This collaboration is an integral part of a multi-pronged approach to alleviating the global burden of tuberculosis. Through our involvement in OETC, Emergent is given an opportunity to touch the lives of many in fulfillment of our company mission – to protect life.”

The MEPs learned firsthand about the TB vaccine candidate and progress of the clinical trial from lead scientist and developer Dr. Helen McShane from the University of Oxford. “We are extremely pleased with the progress of the trial,” said Dr. McShane. “We anticipate that the trial, which involves administering MVA85A as a booster to the BCG vaccine, will reach the enrollment target of 2,784 infants by the end of April 2011. The follow-up period and study results are expected to be completed in 2012.”

The delegation also observed the vaccination of infants as part of the trial and visited the hospital facilities with Dr. Hassan Mahomed, SATVI’s Principal Investigator on the study.

About Emergent BioSolutions Inc.

Emergent BioSolutions, led by Chairman and CEO Fuad El-Hibri, protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent’s marketed and investigational products target infectious diseases, oncology and autoimmune disorders. Additional information about the company may be found 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 the actual results of the Consortium or Emergent to differ materially from those indicated by such forward-looking statements, including the timing of, and the potential for successful outcomes resulting from, future product development efforts; the ability of the Consortium or Emergent to obtain additional funding for product development efforts; plans of the Consortium and Emergent to expand manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of products; and other factors identified in Emergent’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2011 and subsequent reports filed with the SEC. The Consortium and Emergent disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

SOURCE: Emergent BioSolutions Inc.