Fuad El-Hibri Organization Blog

CEO & Chairman, 10% Owner of Emergent BioSolutions Inc. (EBS) Fuad El-hibri sells 15,000 shares of EBS on 08/11/2009 at an average price of $16.78 a share.

EMERGENT BIOSULUTIONS INC. is a leading biopharmaceutical company dedicated to one simple mission – to protect life. EBS develops manufactures and commercializes vaccines and therapeutics that assist the body\’s immune system to prevent or treat disease. Their products target infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs. Their 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. Emergent BioSolutions Inc. has a market cap of $511.8 million; its shares were traded at around $16.91 with a P/E ratio of 13.1 and P/S ratio of 2.8.

Washington Business Journal reports

Emergent BioSolutions hands out bonuses

Bonus may be a bad word right now — but not for a biotech that is actually making money.

Alongside minimal pay raises, Emergent BioSolutions Inc. execs received bonuses in 2008 that increased anywhere from 5 percent to 43 percent from their 2007 bonuses. Fuad El-Hibri, chief executive officer and chairman of the Rockville company, got the lowest increase, but the highest bonus at $323,250. The highest increase was doled out to Kyle Keese, senior vice president of manufacturing operations, who took home a $96,460 bonus for 2008.

Though, at least one manager’s perk wasn’t quite so perky last year. Robert Kramer, who stepped down in January as head of Emergent’s manufacturing subsidiary and instead will manage a contract that the company hopes to nail with the federal government this year, got a 48 percent decrease in his bonus from 2007, bringing his 2008 figure to $78,815….

BioPort is the only FDA-licensed producer of the anthrax vaccine.

Fuad El-Hibri, chairman and CEO of Emergent BioSolutions Inc., speaks March 9 in Sage Hall. Kevin Stearns/University Photography

On March 9, MBA students taking International Political Risk Management, a course taught by Elena Iankova, a lecturer at the S.C. Johnson Graduate School of Management, heard Fuad El-Hibri, chairman and CEO of Bioport’s parent company, Emergent BioSolutions Inc., discuss the hurdles his firm faces in making and marketing its products abroad.

His guest lecture was titled “Managing International Risk in the Bio-Defense and Telecommunications Industries.”

Using his own company as an example, El-Hibri outlined six areas of risk in international business, among them export/import regulations, politics at home and abroad and financial issues. Much of his talk focused on political issues ranging from export regulations to how to deal with foreign governments.  Read More

ROCKVILLE, MD, May 16, 2007—Emergent BioSolutions Inc. (NYSE: EBS) announced today the consolidation of the president and chief operating officer position.  With this change, Daniel J. Abdun-Nabi, the company’s president, will also take on the role of chief operating officer. In this combined role, Mr. Abdun-Nabi will oversee all of the company’s product development, manufacturing and corporate affairs activities.  Mr. Abdun-Nabi will continue to report to Fuad El-Hibri, chairman and chief executive officer of the company.

Specifics of other management changes, which are also effective immediately, include:

• R. Don Elsey is being promoted to the position of senior vice president finance and administration.  Mr. Elsey was formerly vice president finance and administration.  Mr. Elsey will continue to retain his responsibilities as chief financial officer for the company and will now assume additional responsibility for investor relations and human resource activities.  Mr. Elsey will continue to report to Mr. El-Hibri, chairman and chief executive officer.
• Kyle W. Keese is being appointed to the position of senior vice president corporate affairs with responsibility for public affairs, marketing and sales and corporate development.  Mr. Keese was formerly senior vice president marketing and communications.
• Thomas K. Zink, M.D. is assuming the responsibility for clinical development in addition to medical affairs.  Dr. Zink, formerly senior vice president medical affairs, is now senior vice president medical and clinical development.  Dr. Zink will continue to retain his responsibilities as chief medical officer for the company and, in that capacity, will continue to report to Mr. El-Hibri, chairman and chief executive officer.
• Edward J. Arcuri, Ph.D., is resigning his position as chief operating officer.  The resignation is effective immediately.

“Today’s senior management consolidation and associated changes within our corporate organization are designed to strengthen the integration of our development and manufacturing organizations and to enhance the company’s positioning and capabilities in both the biodefense and commercial immunobiotic markets,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions Inc.

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 or 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 performance under 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 Annual Report on Form 10-K for the year ended December 31, 2006 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.

ROCKVILLE, MD, October 9, 2007—Emergent BioSolutions Inc. (NYSE: EBS) announced today that Ms. Denise Landry has joined the company as Senior Vice President, Quality with responsibility for managing and overseeing all Quality activities company-wide.  Ms. Landry has broad-based quality experience for pharmaceutical and biologics operations, including activities relating to all phases of product development, regulatory submissions, and compliance programs.  In addition, Mrs. Landry has extensive experience interacting with regulatory authorities including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA) and the Medicines and Healthcare Product Regulatory Agency (MHRA) in the United Kingdom.

Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions stated “I am pleased to welcome Ms. Denise Landry to Emergent BioSolutions as Senior Vice-President, Quality.  Her two decades of experience in the Quality programs will be a critical asset to our team.  Denise’s first-hand experience and breadth of knowledge make her uniquely qualified for such an important role in our company.”

Ms. Landry joins the company from MGI Pharma Inc. and its predecessor Guilford Pharmaceuticals, where she served as Vice President, Corporate Quality.  Prior to her 13 year tenure there, Ms. Landry was the Director Quality Assurance for Pharmaceutical Systems, Inc. and Quality Assurance Director for Smith & Nephew Solopak.  She began her career in the quality control field as a Service Quality Manager for Baxter Healthcare Corporation.

“I am very pleased to be joining the management team at Emergent BioSolutions, and I share their commitment to maintaining the highest quality standards in manufacturing and product development,” said Ms. Denise Landry.  “I have dedicated my career to this industry and look forward to leading and promoting continuous quality improvement throughout the company as it develops and manufactures products to protect life.”

Mrs. Landry holds a BA in Biology from Fisk University in Tennessee.  She is a member of the American Society of Quality Control and the Parenteral Drug Association.

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 disease.  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 any 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 the execution of our strategy by our executive team; 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 other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended June 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.

ROCKVILLE, MD, September 26, 2007—Emergent BioSolutions Inc. (NYSE: EBS), announced today that it has signed a three year contract with the U.S. Department of Health and Human Services (HHS), with a total value of up to $448 million.  Components of the contract include:

(i)           $400 million firm fixed-price for delivery of 18.75 million doses of BioThrax^® (Anthrax Vaccine Adsorbed) for inclusion in the strategic national stockpile (SNS);

(ii)          $34 million for receipt of regulatory approval of 4-year expiry dating for BioThrax payable through a combination of a lump-sum payment reflecting a price per dose increase for certain doses delivered prior to approval and an increase in the per dose price to be paid for doses delivered following approval;

(iii)         up to $11.5 million in milestone payments in connection with advancement towards a post-exposure prophylaxis (PEP) indication for BioThrax; and,

(iv)         $2.2 million for logistics services and other related support.

The Company anticipates making deliveries for approximately 6 million doses under this contract by year-end 2007.  As a result, the company reaffirms its expectation for full year total revenue growth of 10 to 15 percent, with a bias toward the upper end of the range, and full year positive net earnings.

Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions, stated, “We are honored to continue our longstanding relationship with HHS to provide BioThrax as a critical component of our nation’s biodefense stockpile.  I applaud the dedication and professionalism of the senior leadership within HHS and Biomedical Advanced Research and Development Authority in completing this important step towards enhancing our domestic biodefense infrastructure.  Emergent BioSolutions remains dedicated to working with various government agencies in their commitment to procure medical countermeasures as a primary element of establishing the highest possible levels of biopreparedness.”

Under terms of the contract, HHS will purchase from the company an aggregate of 18.75 million doses of BioThrax through September 2010, for a firm, fixed-price of $400 million.  In the event the company receives U.S. Food and Drug Administration (FDA) approval of the company’s pending supplement to its biologics license application (BLA) to extend the shelf life of BioThrax from three years to four years, the company will receive a lump sum payment reflecting a price per dose increase for certain doses delivered prior to approval and an increase in the price per dose to be paid for doses delivered following the date of approval, with a total value of approximately $34 million.  If FDA approval of 4-year expiry dating is not received during the term of the contract, the company will not be entitled to receive any of the $34 million.  The company submitted its supplement for 4-year expiry dating to the FDA in December 2006 and has been providing additional information to the agency in support of its application.

Under the contract, HHS will also provide up to $11.5 million in connection with advancing the company’s program to obtain a PEP indication for BioThrax.  The PEP indication, which would expand the use of BioThrax beyond the current pre-exposure prophylaxis indication, is designed to permit the administration of BioThrax in combination with antibiotics following exposure to anthrax.  These funds are payable upon the company’s achievement of specific program milestones.  The company anticipates that it will receive $8.8 million of this amount in the fourth quarter of 2007.

In addition, under the contract the company has agreed to provide all shipping services related to delivery of doses into the SNS over the contract term, and will receive payment of an additional $2.2 million.

The contract has been funded with Federal funding through the Project BioShield Special Reserve Fund, which was created by an act of Congress in May 2004.

Previously, Emergent BioSolutions has provided 10 million doses of BioThrax to HHS for inclusion in the SNS under a May 2005 supply agreement for 5 million doses valued at $123 million and a May 2006 contract modification for an additional 5 million doses valued at $120 million.

Conference Call & Webcast

Company management will host a conference call at 9:00 am Eastern today, September 26, 2007 to discuss this announcement.  Interested parties may participate in the live teleconference by dialing 866/383-8008 or 617/597-5341 or via a webcast accessible at www.emergentbiosolutions.com, under “Investors”.  A replay of the teleconference will be available on the company website or by dialing 888/286-8010 or 617/801-6888 and using the passcode 61817264, approximately one hour after the teleconference concludes.  The replay will be available through October 10, 2007.

About BioThrax® (Anthrax Vaccine Adsorbed)

BioThrax is the only FDA-approved vaccine for the prevention of anthrax infection.  It is approved by the FDA as a pre-exposure prophylaxis for use in adults who are at high risk of exposure to anthrax spores.  BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Baccillus anthracis and contains no dead or live bacteria.  BioThrax is administered by subcutaneous injection in three initial doses followed by three additional doses, with an annual booster dose recommended thereafter.  Since 1998, approximately 20 million doses of BioThrax have been procured by the U.S. government.  During that time period, over 6.5 million doses have been administered to over 1.6 million military personnel.  BioThrax cannot cause anthrax infection.

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 performance under our contract with HHS and future payments from HHS to us under the contract, 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 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 June 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.

ROCKVILLE, MD, June 14, 2007—Emergent BioSolutions Inc. (NYSE: EBS), a biopharmaceutical company, announced today the results of the company’s 2007 annual meeting of stockholders, which took place today at the Hyatt Regency Bethesda at 10:00 am Eastern.

There were present, in person or represented by proxy, the holders of more than a majority of the shares of the outstanding common stock of the company, thus constituting a quorum.

Proposal 1—Election of Directors

The following individuals were elected Class I directors of the company to serve for a three-year term expiring 2010: Fuad El-Hibri, Jerome M. Hauer and Ronald B. Richard.

Proposal 2—Ratify Selection of Ernst & Young LLP as the Company’s Independent Registered Public Accounting Firm

The proposal to select Ernst & Young LLP as the company’s independent registered public accounting firm for the fiscal year ending December 31, 2007 successfully passed.

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.

Emergent BioSolutions has inked a deal to acquire the Protein Sciences Corporation assets for up to $75 million. The move is part of Emergent’s strategy to expand its product portfolio with a drug candidate focused on infectious disease. Currently, most of Emergent’s business comes from government contracts for biodefense. Emergent will acquire PSC’s ongoing operations, including FluBlok, a Phase III recombinant influenza vaccine candidate, and certain other assets. “The acquisition of FluBlok is consistent with Emergent’s strategy of expanding its product portfolio with a vaccine candidate focused on a major infectious disease,” said Fuad El-Hibri, Emergent’s CEO. The company recently bought rival VaxGen’s anthrax vaccine business.

Newly formed company to focus on creating critical R&D and manufacturing infrastructure and supplying biodefense countermeasures within Asia and other territories.
January 24, 2008 – Emergent BioSolutions (NYSE: EBS) and Ninebio Sdn. Bhd. (“9Bio”) today announced the formation of a joint venture in Malaysia that will focus on creating critical biologics infrastructure and supplying biodefense countermeasures, including BioThrax® (Anthrax Vaccine Adsorbed), and other medical and complementary products and services to the Government of Malaysia. It is anticipated that the joint venture will also supply such products and services to certain member countries of the Organisation of the Islamic Conference (“OIC”) and other countries within Asia. 9Bio is a Malaysian Government owned company and one of the National Institutes of Health under the Ministry of Health. 9Bio is fully funded by the Government of Malaysia. The Government of Malaysia, through 9Bio, has selected Emergent BioSolutions as one of its principal partners to assist, as a contract service provider, in building vaccine development and manufacturing infrastructure. The joint venture will be majority owned by Emergent BioSolutions.

“This joint venture is a step towards our objective to obtain vaccine development and manufacturing capabilities as well as bio-terrorism preparedness. I am very proud that 9Bio has been entrusted to serve as an extension of the Malaysian Government’s implementation of these critical objectives. Emergent BioSolutions is the most appropriate partner for 9Bio for this venture and I am confident that the new company will exemplify both expertise and experience in this area,” said chief executive officer of 9Bio, Datuk Dr. Nor Shahidah Khairullah. “We are looking forward to working very closely with the Ministry of Health and other agencies in Malaysia in developing and implementing this plan.”

“We are honored to partner with 9Bio for this important joint venture and to have been selected by the Government of Malaysia to provide these important services. It is our belief that this joint venture will not only expand the use of our anthrax vaccine in this market, but will also serve as a platform for joint product development and manufacturing activities,” said Fuad El–Hibri, chairman and chief executive officer of Emergent BioSolutions. “Emergent BioSolutions applauds the Malaysian Government’s support of a public-private partnership approach to growing the Malaysia biotechnology sector and we welcome the opportunity to play a pivotal role in the implementation of its plan.”

Witnessing the signing ceremony, Director General of the Malaysian Ministry of Health, Tan Sri Datuk Dr Haji Ismail Merican affirmed that through 9Bio, one of the National Institutes of Health in Malaysia, the Ministry of Health would be able to focus on developing and manufacturing biologics, biosecurity and bioterrorism countermeasures for Malaysia.

About Ninebio
Ninebio Sdn. Bhd. is a Malaysian Government owned company, and as one of the National Institutes of Health, under the Ministry of Health, is focused on the research and development of vaccines, natural products and biologics. Its vision is to “drive innovation solutions for a healthier world.” One of the focus areas of development is in biosecurity and bioterrorism counter-measures. 9Bio is currently cementing strategic alliances with companies that meet its needs. 9Bio is constructing its research and development and secondary manufacturing facility in Bandar Enstek, Negeri Sembilan, Malaysia. It is expected to be completed by 2010. Pending the completion of its facilities, 9Bio intends to procure and distribute vaccines, natural products and biologicals to customers in the ASEAN region thereby building its brand name. 9Bio is primarily funded by the Government of Malaysia.

About Emergent BioSolutions Inc
Emergent BioSolutions Inc is a profitable, multinational 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 and other medical conditions that have resulted in significant unmet or under deserved public health needs. Our marketed product, BioThrax® (Anthrax Vaccine Absorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection.
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, prospects, plans and objectives of management, including development plans, 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 the rate and degree of market acceptance and clinical utility of products; ability to identify and acquire or in license products and product candidates that satisfy 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 Emergent’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2007 and subsequent reports filed with the SEC. Emergent disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.