El-Hibri Fuad Blog

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Written by Staff and Wire Reports
Tuesday, 08 December 2009 01:28

Key news developments will affect shares of these two companies who help meet the critical needs of the United States and its allies by developing and commercializing medical countermeasures against biological and chemical weapons.

The two companies which waited until late after hours on Monday to announce that the Biomedical Research and Development Authority had informed them of some negative news.

After hours on Monday, PharmAthene, Inc. (NYSE Amex: PIP) a biodefense company specializing in the development and commercialization of medical countermeasures against chemical and biological threats, announced that the Department of Health and Human Services Biomedical Research and Development Authority (BARDA) has canceled its request for proposal (RFP) for Recombinant Protective Antigen Anthrax Vaccine for the Strategic National Stockpile (RFP BARDA 08-15).

PharmAthene was informed of BARDA’s decision during a meeting late Monday afternoon with BARDA representatives. BARDA issued a press release after the close of the securities markets announcing that it will cancel RFP BARDA 08-15 because it did not believe vaccine developers submitting proposals in response to the request for proposal (RFP) could have product ready for FDA licensure within 8 years.

In similar news…

Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has been advised by the Office of the Biomedical Advanced Research and Development Authority (BARDA) that the Request for Proposal (RFP) for the procurement of rPA vaccines has been cancelled in favor of a Broad Agency Announcement (BAA) for rPA vaccine development. According to BARDA officials, BARDA took this action after a technical evaluation panel determined that none of the vaccine developers submitting proposals could meet the Project BioShield statutory requirement of having a product ready for licensure within 8 years.

Simultaneously, BARDA issued an amendment to BAA 09-34 to enable companies to submit proposals to obtain development funding for rPA vaccine candidates. The due date for all proposals is February 1, 2010. During a meeting with company officials today, BARDA strongly encouraged Emergent to submit a proposal to this BAA. Emergent intends to submit its proposal by the end of this year.

While the decision by BARDA has no impact on the company’s $400 million procurement contract with the Centers for Disease Control and Prevention (CDC) for the manufacture and delivery of 14.5 million doses of BioThrax® into the Strategic National Stockpile (SNS). Investors are still likely to react negatively to the news.

After selling dies down, there may be a bounce trade opportunity for EBS followers since the company feels that “BioThrax remains a critical and long-term countermeasure for the US government,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “In addition, based upon encouragement by the USG, we believe our rPA vaccine is well-positioned to obtain a development contract under this BAA. Our anthrax franchise solidifies Emergent as a leader in the development and supply of anthrax medical countermeasures.”

Source :: http://biomedreports.com/articles/most-popular/20870-bad-news-clouds-move-in-on-these-stocks.html

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 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.

For the benefit of those who may be listening to the replay, this call is held and recorded on August 6, 2009. Since then Emergent may have made announcements relating to topics discussed during today’s call, so again, please reference our most recent press releases and SEC filings.

Emergent BioSolutions assumes no obligation to update the information in today’s press release or as presented on this call except as maybe required by applicable laws or regulations. Today’s press release may be found on our website at www.emergentbiosolutions.com under Investors/Press Release.

With that brief introduction, I would now like to turn the call over to Fuad El-Hibri, Emergent’s Chairman and CEO.

Fuad El-Hibri

Good afternoon ladies and gentlemen. We appreciate your participation on this call. Today, we announced two important items. First, we reported financial results for the second quarter and first 6 months of 2009. Let me tell you that I’m very pleased with Emergent’s overall performance year to date. We have delivered strong sales and earnings results while we continue to invest in our product pipeline. We remain on the path to achieving our financial and product development goals for the year.

Second, we announced a series of real estate transactions that expand our manufacturing and development infrastructure. In addition the strategic implication, these transactions should reduce our total debt and annual interest and operating expenses. In addition, I would like to provide a brief update on selected aspects of our business.

21 November, 2006 GAITHERSBURG, Md.–(BUSINESS WIRE)–Nov. 21, 2006–Emergent BioSolutions Inc. (NYSE:EBS), a biopharmaceutical company that develops vaccines and therapeutics for biodefense and commercial applications and manufactures the only anthrax vaccine approved by the U.S. Food and Drug Administration (FDA), today announced it will be celebrating the Company’s recently completed initial public offering with the ringing of the opening bell of the New York Stock Exchange by Fuad El-Hibri, chairman and chief executive officer, on Wednesday November 22, 2006. “Throughout the Company’s history, our people, science and technology have contributed significantly to safeguarding millions of military personnel and the general population through the delivery of a safe and effective countermeasure against the threat of anthrax infection,” said Mr. El-Hibri. “Tomorrow’s ringing of the opening bell is an opportunity to celebrate our Company and our achievements thus far, while acknowledging the commitment and support of our employees, customers and, now, investors who continue to drive our success.” Emergent BioSolutions’ common stock began trading on November 15, 2006 under the symbol EBS. Emergent is a biopharmaceutical company focused on the development, manufacture and commercialization of immunobiotics, such as vaccines and immune globulins, that induce or assist the body’s immune system to prevent or treat disease. The Company operates in two business segments: biodefense and commercial. In its biodefense business, the Company develops and commercializes immunobiotics for use against biological agents that are potential weapons of bioterrorism. In its commercial business, the Company develops immunobiotics for use against infectious diseases with significant unmet or underserved medical needs. The Company’s marketed product, BioThrax(R) (Anthrax Vaccine Adsorbed), is the only vaccine approved by the FDA for the prevention of anthrax infection. For more information about BioThrax, please review the package insert located on the Company’s website www.emergentbiosolutions.com. In addition to BioThrax(R), the Company’s biodefense product portfolio includes three biodefense product candidates in preclinical development and a next generation anthrax vaccine program with product candidates in preclinical and Phase I clinical development. The Company’s commercial product portfolio includes a typhoid vaccine candidate and a hepatitis B therapeutic vaccine candidate, both of which are in Phase II clinical development, one vaccine candidate in Phase I clinical development and two vaccine candidates in preclinical development. 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 Emergent’s actual results to differ materially from those indicated by such forward-looking statements, including 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; and 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.www.emergentbiosolutions.com