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.

Joining me on the call this afternoon will be Fuad El-Hibri, Chairman and Chief Executive Officer, and Don Elsey, Chief Financial Officer. Additional members of our senior management team will be present on the call for purposes of the Q&A session.

Before we begin, however, I am compelled to remind everyone that during the all management may make projections and other forward-looking statements regarding future events and the company’s prospects or future performance. These forward-looking statements reflect Emergent’s current perspective on existing trends and information. Any such forward-looking statements are not guarantees of future performance and involve substantial risks and uncertainties. Actual results may differ materially from those projected in any forward-looking statements.

You are encouraged to review Emergent’s filings with the SEC on Forms 10-K, 10-Q, and 8-K for more information on the risks and uncertainties that could cause actual results to differ.

Emergent BioSolutions Inc. (EBS) CEO & Chairman, 10% Owner Fuad El-hibri sells 15,000 Shares

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.

Emergent Biosolutions Acquires Monoclonal Anthrax Product Candidate

Acquisition represents important addition to company’s portfolio of anthrax countermeasures

ROCKVILLE, MD., March 6, 2008—Emergent BioSolutions Inc. (NYSE: EBS) announced that today it completed the acquisition of a group of anthrax monoclonal antibodies from AVANIR Pharmaceuticals (NASDAQ:AVNR), including Avanir’s lead product candidate, AVP-21D9.

AVP-21D9 is a human monoclonal antibody product candidate that is being developed as an intravenous treatment for patients who present with symptoms of anthrax disease following exposure to Bacillus anthracis. In non-clinical studies, this candidate demonstrated an ability to protect animals challenged with a lethal dose of inhaled anthrax spores. AVP-21D9 is being developed with funding support from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (NIAID), including a grant to establish a cGMP manufacturing process and to test efficacy in additional inhalation studies.

“The acquisition of Avanir’s monoclonal anthrax antibodies rounds out our anthrax countermeasure program nicely. In addition to our FDA-approved product, BioThrax? (Anthrax Vaccine Adsorbed), which is indicated for pre-exposure prevention of anthrax in individuals at high risk of exposure to anthrax spores, we are developing a polyclonal anthrax immune globulin therapeutic, which is a human plasma-derived product candidate. Now, as a result of this acquisition, we have another anthrax therapeutic in our product portfolio – a new monoclonal anthrax antibody product candidate that has performed well in proof-of-concept studies,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “This transaction reflects our ongoing commitment to develop a full portfolio of countermeasures to strengthen our country’s preparedness in the event of future anthrax attacks.”

Fuad El-Hibri on Brightkite

Name: Fuad El-Hibri

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About: Just another Brightkite user

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Website: http://www.emergentbiosolutions....

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Age: 51

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Tags: academia, acquisitions, banking, family, health, management, mergers, music, polo, science, technology, telecom, telecommunications

Maker of anthrax vaccine discusses challenges of marketing overseas

By Courtney Potts '06

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.

One hurdle: when BioPort sought to export its anthrax vaccine, BioThrax, the U.S. Department of Defense claimed the vaccine was primarily of military importance and should therefore fall under International Traffic in Arms Regulations (ITAR). Under ITAR, export of the vaccine is controlled by the Department of State and a license is required for each sale. BioPort succeeded in arguing that its product was non-military in nature and therefore belonged under Export Administration Regulations (EAR). Exportation under EAR is controlled by the Department of Commerce and has far fewer restrictions.

El-Hibri seemed to take such challenges in stride. "Obviously," he said, "the U.S. government is interested in vaccines, especially bio-defense vaccines." It controls which countries vaccines can be exported to and may use them as a bargaining chip in its own deals with foreign ministries of defense, he commented. "They like to throw our vaccine into the mix and say, 'Listen, if you buy one more tank or one more fighter jet ... we'll throw in 10,000 doses of anthrax vaccine,'" he said. But such giveaways create problems for companies like BioPort by reducing demand for its products in foreign countries.

Some uncontrollable variables that affect the demand for vaccines are: Politics within the foreign country, the country's relationship with the United States, its finances, its fears about external threats and regional geopolitics, noted El-Hibri.

He also repeatedly mentioned the importance of having local connections. "It is critical that you appoint or partner up with a local distributor," he stressed. A local partner can help businesses stay abreast of the political situation and provide valuable insight into local culture and customs, he said, noting that acceptable business practices often vary widely between countries.

For example, in many countries it is common practice for businesses to offer bribes or gifts to government officials in return for their assistance, he commented. But under U.S. law, it is illegal for American companies to do so, with stiff penalties for violations. While the restriction can be circumvented by giving small gifts, under $25 in value, a better policy is to avoid gifts altogether, said El-Hibri, and instead get close to decision makers by developing relationships with them, helping them solve some of their problems.

R. Scott Kennedy Awarded the 2008 El-Hibri Peace Education Prize

At a glittering event at the El-Hibri Charitable Foundation on October 4th, a few blocks north of the White House, the Honorable R. Scott Kennedy received the 2008 El-Hibri Peace Education Prize. This prize, a joint effort between Nonviolence International, American University, and the El-Hibri family, was held in front of a large crowd in the renovated historic mansion that now serves as the headquarters of the El-Hibri Charitable Foundation.

Ms. Nancy El-Hibri, co-creator of the Prize, presented Mr. Kennedy a check for $10,000 which honored his service as a “peace educator and activist of extraordinary impact.” The award presentation ceremony highlighted his central role in “helping establish and promote the now widespread practice of educational delegations for peace particularly to Central America and the Middle East.”

The Honorable Sam Farr of California entered a congratulatory statement in the Congressional Record which paid tribute to Mr. Kennedy and compared his work to that of Mohandas Gandhi, Martin Luther King, Jr. and Nelson Mandela as a “…true man of peace…”

“His devotion to adult education has changed the lives of thousands of Americans,” said Dr. Mubarak Awad, Chairperson of the Prize Organizing Committee.

The first recipient of the prize in 2007, Professor Abdul Aziz Said of American University, shared his appreciation for peace educators who are doing so much to, “expand the moral imagination of our society.”

“Peace education in the classroom is valuable, yet needs to be complemented with pragmatic hands-on efforts in our communities to make peace and justice a living reality,” said Kennedy at the award ceremony. He expressed deep appreciation for the many colleagues at the Resource Center for Nonviolence as well as the citizens of Santa Cruz for their tremendous support and inspiration over 30 years.

Mr. Fuad El-Hibri, who established the El-Hibri Peace Education Prize, noted that he and the El-Hibri Charitable Foundation will continue to support the prize and its growth each year in an effort to highlight the importance of peace education and to support people who are working for a just, peaceful and healthy planet.

Mr. R. Scott Kennedy is a co-founder of Witness for Peace, the Resource Center for Nonviolence and Interfaith Peacebuilders, which have sent educational delegations to countries around the world to those countries whose people suffer from conflict, lack of educational opportunities, and social injustice.

It sure is wonderful when adult peace education is so strongly honored, and that peace educators have incorporated nonviolent action as a central theme in their work.

Fuad El-Hibri on Peoplepond

Mr. Fuad El-Hibri is the Chairman and Chief Executive Officer of Emergent BioSolutions Inc. (Emergent).

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