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Emergent BioSolutions Inc., Q2 2009 Earnings Call Transcript

Emergent BioSolutions Inc., (EBS)

Q2 2009 Earnings Call

August 6, 2009 5:00 pm ET

Executives

Robert G. Burrows – Vice President, Investor Relations

Fuad El-Hibri - Chairman of the Board, Chief Executive Officer

R. Don Elsey – Chief Financial Officer

Daniel J. Abdun-Nabi – President, Chief Operating Officer

W. James Jackson, Ph.D. – Senior Vice President and Chief Scientific Officer

Analysts

Eric Schmidt – Cowen & Company

David Moskowitz – Caris & Company

Mona Ashiya – J.P. Morgan

Sean Long – Kennedy Capital Management

Presentation

Operator

Welcome to the Emergent BioSolutions Incorporated second quarter 2009 financial results conference call. (Operator Instructions) I would now like to turn the call over to Mr. Robert Burrows.

Robert Burrows

Good afternoon ladies and gentlemen. My name is Robert Burrows, Vice President of Investor Relations for Emergent. Thank you for joining us today as we discuss Emergent BioSolutions financial results for the second quarter and first six months of 2009. As is customary, our call today is open to all participants. In addition, the call is being recorded and is copyrighted by Emergent BioSolutions.

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Emergent BioSolutions Announces Management Promotions

ROCKVILLE, Md.–(BUSINESS WIRE)–Emergent BioSolutions Inc. (NYSE: EBS) announced today the promotion of a number of key executives to positions of expanded responsibility to support the company’s global business development strategies and manufacturing initiatives.

“I am very pleased to announce today’s senior management promotions,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions Inc. “These promotions mark an important step in our continuing growth plans, and I am confident that the industry expertise, commitment to success and leadership skills of these executives will contribute greatly to the strategic and global development of our company.”

Specifics of the management changes, which will become effective on April 1, 2007, include:

Daniel J. Abdun-Nabi is being promoted to president of Emergent BioSolutions, overseeing a majority of the company’s corporate functions. Mr. Abdun-Nabi was formerly senior vice president and general counsel for the company.

Robert G. Kramer, Sr., is being promoted to executive vice president manufacturing operations, with responsibility for global manufacturing, reporting directly to Edward J. Arcuri, Ph.D., the company’s chief operating officer. Mr. Kramer will also continue as president of Emergent Biodefense Operations Lansing.

Denise Esposito is being promoted to senior vice president and general counsel. Ms. Esposito was formerly vice president and deputy general counsel for the company.
Mauro Gibellini is being promoted to senior vice president corporate development. Mr. Gibellini was formerly vice president corporate development for the company.
In addition, the company announced that Steven N. Chatfield will be joining the Health Protection Agency (HPA) in the UK in the Fall of 2007.

Dr. Chatfield, who will remain with Emergent BioSolutions on a full time basis through August 2007, has held dual roles as chief scientific officer and president, Emergent Product Development UK, since June 2004. The company is recruiting for a new chief scientific officer.

“It is with regret that I leave Emergent BioSolutions but it is a great privilege to be offered the opportunity to join the HPA, an organization that is central to protecting the public health in the UK,” said Dr. Steven N. Chatfield. “I have spent my career developing products and strategies to improve public health and this will give me the opportunity to continue my work in the context of public health protection in the UK. I have had an incredibly rich set of experiences during my tenure at Emergent BioSolutions and have benefited immensely from my time working with Fuad and the entire management team. I look forward to spending the next few months ensuring a smooth transition and will be leaving the company with the utmost confidence in its continued development success.”

“Steve Chatfield’s contributions to our company’s success have been substantial,” Mr. El-Hibri said. “Under Steve’s leadership, significant strides have been made in the development of our commercial product portfolio. He has built a seasoned team of highly skilled professionals with both management and product development expertise. We look forward to working with Steve over the coming months to ensure a smooth transition and wish him continued success upon joining HPA later this year.”

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of immunobiotics, consisting of 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 immunobiotics for use against biological agents that are potential weapons of bioterrorism. The company’s commercial business is focused on development, manufacture and commercialization of immunobiotics for use against infectious diseases. These immunobiotics are designed to address 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, 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 company’s actual results to differ materially from those indicated by such forward-looking statements, including our performance under existing BioThrax® sales contracts with the U.S. government, including the timing of deliveries under these contracts; 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 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.

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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES REMAINS COMMITTED TO PROCUREMENT OF BIOTHRAX® UNDER CURRENT CONTRACT

ROCKVILLE, MD, November 19, 2007 —Emergent BioSolutions Inc. (NYSE: EBS) 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.

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