El-Hibri Fuad Blog

Archive for the ‘Biothrax’ Category

Originally posted on Gazette.net

Fuad El-Hibri has started a financial consulting business. He’s started telecommunications businesses.

But his most challenging venture has been the Rockville biotech he helped launch 14 years ago.

Still, El-Hibri — CEO and board chairman of Emergent BioSolutions — says the challenges are worth it, because the rewards are so great from protecting and saving lives.

Unlike products in many other sectors, vaccines and other bioscience products can take 10 to 15 years to develop. The regulatory climate can drive up costs. The probability of commercial success is relatively low, in the neighborhood of 20 percent.

“You need to have a strong and focused will,” said El-Hibri, 54, who is retiring as CEO as of Sunday, but remaining as executive chairman. “It takes a lot of patience and persistence.”

El-Hibri co-founded Emergent — then called BioPort Corp. — in 1998, and the company has seen annual revenues more than triple in the past eight years to almost $300 million, with a decade-long track record of financial profits. The biotech focuses on several prominent disease areas, with numerous clinical stage product development programs. Its biggest money-maker is its anthrax vaccine.

 

Brian Lewis/The Gazette “For us, our central mission is to protect life,” says Fuad El-Hibri, CEO of Emergent BioSolutions. “It’s been a great honor to serve the military and protect our active military.”

 

Fuad El-Hibri
Age: 54.
Position: CEO, chairman, Emergent BioSolutions, Rockville.
Education: Master’s in public and private management, Yale University; bachelor’s in economics, Stanford University.
Community/professional activities: Board of directors, U.S. Chamber of Commerce; board of trustees, International Biomedical Research Alliance, National Health Museum; advisory board, Yale Healthcare Conference, Heifetz International Music Institute; chairman, El-Hibri Charitable Foundation.
Awards: Biotech CEO of the Year, World Vaccine Congress, 2011; International Leadership Award, World Trade Center Institute, 2010; Ernst & Young Entrepreneur of the Year for Greater Washington, 2009; Rene Moawad Foundation Distinguished Community Service and Achievement Award, 2007.
Residence: Naples, Fla.; also has home in Potomac.
Family: Wife, Nancy; three adult children; two grandchildren.
Hobbies: General aviation, equestrian sports, scuba diving.

Emergent’s success can be attributed to El-Hibri’s vision, his ability to anticipate and overcome challenges, and his unwavering commitment that has motivated others in the company, said Daniel J. Abdun-Nabi, who is taking over as CEO after holding the president and COO posts since 2008.

“Over the years, we have come to appreciate his business acumen, drive to address global unmet medical needs and dedication to creating a workplace environment and culture that is both challenging and rewarding,” Abdun-Nabi said.

El-Hibri’s contributions extend beyond Emergent to the biotech and business communities throughout the state, said Henry Bernstein, a board member of the Tech Council of Maryland and senior vice president of Rockville real estate development and management firm Scheer Partners.

“Under his leadership, Emergent BioSolutions became a growth company that has contributed to the business community, attracted top talent to the region and invested heavily into the community overall,” said Bernstein, a former COO of the Montgomery County Department of Economic Development.

Emergent did what relatively few biotechs do — turn a profit for an entire year within four years of forming. Gaithersburg biotech giant MedImmune was founded in 1988 and took a decade to see an annual profit. After launching in 1992, Rockville life sciences company Human Genome Sciences saw net income in 1993 and 1994, but has seen only one profitable year since, in 2009.

Even during the Great Recession, Emergent continued to show a profit. A key factor was acquiring a product — BioThrax, the only federally licensed anthrax vaccine — that could generate revenue almost immediately, El-Hibri said. The federal government buys the vaccine to innoculate military personnel.

“It’s been quite a ride,” he said.

Early exposure to other countries

Born in Germany the son of a Lebanese father and German mother, El-Hibri split boyhood time in both nations. Being immersed in different nations gave him an early appreciation for various cultures, he said.

“I learned how you have to get along and respect other cultures,” El-Hibri said. “That’s an important factor to having peace and having a successful business.”

At Emergent, he carried that philosophy into defining five core corporate values: respect, empowerment, commitment, communication and innovation. Having such values is key to building a top-notch company, he said.

“For us, our central mission is to protect life,” El-Hibri said. “It’s been a great honor to serve the military and protect our active military.”

His entrepreneurial career started soon after earning a master’s in public and private management from Yale University and a bachelor’s in economics from Stanford University.

Following stints in banking with Citigroup and management consulting with Booz Allen Hamilton, the latter in southeast Asia, El-Hibri started a financial consulting business, East West Resources. Then came three mobile telecommunications companies: Mobile TeleSystems, Digitel and Digicel.

Mobile Telesystems, which he formed in 1993 and later sold, has grown to be a leading telecommunications company in Russia, with $12 billion in sales last year. The other two companies, which he also sold, are good-sized players in South America and Central America, respectively.

During the 1990s, El-Hibri got his first taste of biotechnology when he organized a management buyout of British life sciences company Porton and formed Speywood Holdings, a recapitalized biopharmaceutical company.

In 1998, El-Hibri was among a team that bought the rights to BioThrax, which was being manufactured in Michigan, and its production facilities.

“They only marketed it on a relatively small scale,” he said. “After we acquired the product, we renovated the facilities and increased capacity.”

About 170 Michigan state employees agreed to transition to the privately held business that year, El-Hibri said. BioPort later became Emergent, which went public in 2006 and now has more than 800 employees in 10 locations. Some 250 employees are in Maryland, within the Rockville headquarters, a research and development facility in Gaithersburg and a manufacturing plant in Baltimore.

The company has branched out into combating tuberculosis, cancer and autoimmune disorders. Since 2003, the company has acquired three biotech companies and completed other acquisitions to broaden its product pipeline.

Some reports, including one by a researcher with the Center for American Progress, say that Emergent lobbied hard against a former California biotech, VaxGen, which received a major federal contract to develop a new anthrax vaccine in 2004. VaxGen had never produced a drug before, and the government canceled the contract two years later.

Emergent’s lobbyists did not criticize VaxGen but simply stated what their own company could do, El-Hibri said.

“We lobbied using a positive message,” he said. “We did not criticize their product. … The government decided to cancel the contract. It was not because of us.”

Emergent also purchased the VaxGen vaccine through a fair process and is working to develop that as a secondary vaccine, El-Hibri said.

Building a better world

El-Hibri has his own charitable foundation, which promotes peace and social justice. In 2007, he started the annual El-Hibri Peace Education Prize, which recognizes educators who teach about peace issues. The organization also has constructed orphanages in Lebanon.

“I have a strong belief in giving back,” he said. “There are so many worthwhile projects and organizations.”

As a member of the U.S. Chamber of Commerce’s board of directors, El-Hibri has the opportunity to discuss national issues with business leaders across the country.

“It’s very interesting to meet business leaders across the nation and get their perspective,” he said. “As you can guess, there is no full agreement on every issue, but there is hope that the economy will turn around soon.”

El-Hibri also serves on the board of trustees of the International Biomedical Research Alliance, an academic venture between the National Institutes of Health in Bethesda, Oxford University and Cambridge University in the U.K., and the National Health Museum, a science institution planned to open in Atlanta in the near future.

He is on the advisory board for the Yale Healthcare Conference, which brings together professionals, academics and students to discuss health care issues, and the Heifetz International Music Institute in Staunton, Va., founded by acclaimed violinist Daniel Heifetz to teach young musicians.

Among the awards El-Hibri has garnered are Biotech CEO of the Year during the 2011 World Vaccine Congress; the International Leadership Award from the World Trade Center Institute in 2010; the Ernst and Young Entrepreneur of the Year Award in Greater Washington in 2009; and the Rene Moawad Foundation Distinguished Community Service and Achievement Award in 2007 for philanthropic work in Lebanon.

In choosing El-Hibri for the honor at the World Vaccine Congress last year, judges cited his “leadership and entrepreneurial spirit” in guiding Emergent to another profitable year, securing some key development contracts, completing an acquisition and arranging collaborations with Pfizer and Abbott, according to business conference organizing company Terrapinn Holdings.

Sometimes hands-on, sometimes not

El-Hibri said he can vary his management style depending on the situation.

“Some managers are new, and I roll up my sleeves and get deep in the weeds,” he said. “Other people are seasoned and don’t need as much supervision.”

His primary residence is now in Naples, Fla., where Emergent has an office. But he also maintains a home in Potomac. He and his wife, Nancy, have three children and two grandchildren.

El-Hibri doesn’t engage in the stereotypical executive hobbies such as golf. He likes to fly single-engine airplanes, scuba dive and participate in equestrian sports. He flies a Diamond Aircraft plane, and has scuba dived in Indonesia, the Red Sea and the Caribbean.

“I seem to like being either very high above sea level or below sea level,” he said with a laugh.

kshay@gazette.net

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Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions Inc.,(NYSE: EBS) announced that, in response to solicitation RFP-2011-N-13414, it has received an award to supply the U.S. government with 44.75 million doses of BioThrax(R) (Anthrax Vaccine Adsorbed) over a period of five years for a total value of up to $1.25 billion. BioThrax is the only vaccine licensed by the  U.S. Food and Drug Administration (FDA) to protect against anthrax infection.

Initial deliveries under this award are expected to begin in 2011 with 8.5 million doses scheduled to be delivered during the first year of a five-year contract. The company may modify the timing of deliveries depending on manufacturing yields and other factors.

“Emergent is proud to be able to contribute to the U.S. government’s program of protecting the nation from the threat of anthrax,” said  Fuad El-Hibri. “This 5-year award provides for uninterrupted supply of this critical biodefense countermeasure while addressing the government’s mandate to reduce spending across all programs. In coming to agreement, Emergent and the  Centers for Disease Control and Prevention worked diligently to establish business terms that incorporate substantial price concessions.”

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.

About BioThrax

BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. It is indicated for the active immunization of adults who are at high risk of exposure to anthrax. BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis. To date, Emergent has delivered over 55 million doses of BioThrax to the U.S. government and continues to deliver additional doses under active procurement contracts. Since 1998, over 10 million doses have been administered to more than 2.6 million military personnel. For full prescribing information, please visit  www.biothrax.com/prescribinginformation_biothrax_us.pdf.

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 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 plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance of our products; the success of preclinical studies and clinical trials of our product candidates and post-approval clinical utility of our products; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2011 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.

SOURCE: Emergent BioSolutions Inc.

ROCKVILLE, Md., — Emergent BioSolutions Inc. (NYSE:EBS) announced on June 23rdthat the Singapore Health Sciences Authority (HSA) has approved Emergent’s product license application for the marketing and sale of BioThrax(R) (Anthrax Vaccine Adsorbed) in Singapore. BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration (FDA) to protect against anthrax infection.

“Emergent is pleased with this development as it continues to grow its presence in the Pacific Rim,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. “With HSA approval of BioThrax, we look forward to initiating discussions with the government of Singapore, as well as other allied governments that recognize HSA registered products such as Brunei, to help protect their constituents against the threat of anthrax as a biological weapon.”

HSA is the statutory board of the Singapore Ministry of Health that administers the country’s regulatory framework for pharmaceuticals, complementary medicines, medical devices and other health products. Its vision is to be the leading innovative authority that protects and advances national health and safety in Singapore.

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 http://www.emergentbiosolutions.com.

About BioThrax

BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. It is indicated for the active immunization of adults who are at high risk of exposure to anthrax. BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis. To date, Emergent has delivered over 42 million doses of BioThrax to the U.S. government and continues to deliver additional doses under active procurement contracts. Since 1998, over 10 million doses have been administered to more than 2.5 million military personnel. For full prescribing information, please visit http://www.biothrax.com/prescribinginformation_biothrax_us.pdf.

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 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 plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance of our products; the success of preclinical studies and clinical trials of our product candidates and post-approval clinical utility of our products; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2011 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.

SOURCE: Emergent BioSolutions Inc.

ROCKVILLE, Md., May 31, 2011 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that eight lots of BioThrax(R) (Anthrax Vaccine Adsorbed) have received regulatory release for delivery to the U.S. government under the company’s contract (200-2009-30162) originally written to supply 14.5 million doses of BioThrax to the Strategic National Stockpile. This marks the largest single-week regulatory release of product for delivery in the company’s history. The company expects to complete delivery of the 14.5 million doses as early as June, approximately three months ahead of the schedule originally set forth in the contract. BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration (FDA) to protect against anthrax infection.

“Emergent is pleased with its progress towards early completion of its original procurement contract to supply 14.5 million doses of BioThrax,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. “Upon completion of this delivery, anticipated to occur as early as June, the company will focus on delivering the additional 3.42 million doses under the modified procurement contract. With the recent request for proposal issued by the U.S. government, Emergent is also advancing discussions to supply 44.75 million doses of BioThrax over the next five years.”

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.

About BioThrax

BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. It is indicated for the active immunization of adults who are at high risk of exposure to anthrax. BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis. To date, Emergent has delivered over 42 million doses of BioThrax to the U.S. government and continues to deliver additional doses under active procurement contracts. Since 1998, over 10 million doses have been administered to more than 2.5 million military personnel. For full prescribing information, please visit www.biothrax.com/prescribinginformation_biothrax_us.pdf.

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 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 plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance of our products; the success of preclinical studies and clinical trials of our product candidates and post-approval clinical utility of our products; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2011 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.

SOURCE: Emergent BioSolutions Inc.

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.