Fuad El-Hibri Blog

February 3, 2012

Emergent BioSolutions to Release Fourth Quarter and Full Year 2011 Financial Results and Conduct a Conference Call on March 8, 2012

ROCKVILLE, Md.–(BUSINESS WIRE)–Jan. 30, 2012– Emergent BioSolutions Inc. (NYSE: EBS) announced today that it will report financial results for the fourth quarter and full year 2011 on Thursday, March 8, 2012, after market close.

Company management will host a conference call at 5:00 pm Eastern on March 8, 2012 to discuss the financial results for the fourth quarter and full twelve months of 2011, recent business developments, revenue guidance for the first quarter of 2012 and revenue and net income guidance for full year 2012. The conference call will be accessible by dialing 888/680-0878 or 617/213-4855 (international) and providing passcode 35663572. A webcast of the conference call will be accessible from the company’s website at www.emergentbiosolutions.com, under “Investors”.

Emergent BioSolutions is offering call participants a pre-registration option that expedites access to the call and minimizes hold times. Pre-registrants will be issued a pin number to be used when dialing into the live call which will provide quick access to the conference call by bypassing the operator upon connection. Pre-registration, while not mandatory, can be accessed using the following website:https://www.theconferencingservice.com/prereg/key.process?key=PFU8DEVX6.

A replay of the conference call will be accessible, approximately two hours following the conclusion of the call, by dialing 888/286-8010 or 617/801-6888 and using the passcode 57332722. The replay will be available through March 22, 2012. 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 about the company may be found at www.emergentbiosolutions.com.

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.

Source: Emergent BioSolutions Inc.

August 19, 2010

Emergent BioSolutions to Acquire Trubion Pharmaceuticals

  • Trubion provides promising clinical-stage therapeutic candidates in the targeted disease areas of oncology and autoimmunity
  • Trubion offers novel, protein therapeutic platforms and scientific expertise for developing innovative therapeutic candidates
  • Transaction leverages large pharma partnerships to provide sales and marketing infrastructureidates
  • Emergent reaffirms 2010 guidance for revenues and net income

ROCKVILLE, Md., Aug 12, 2010 (BUSINESS WIRE) –

Emergent BioSolutions Inc. (NYSE: EBS) announced today it has entered into a definitive agreement to acquire Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN) for upfront consideration of $96.8 million of value and up to $38.7 million of success-based milestones, resulting in a total consideration of up to $135.5 million. The acquisition will diversify Emergent’s product development pipeline with the addition of Trubion’s two clinical-stage product candidates focused on the targeted disease areas of oncology and autoimmunity. The acquisition also offers novel platforms, consisting of proprietary Small Modular Immunopharmaceutic (SMIPTM) and SCORPIONTM technologies, for developing additional innovative therapeutic candidates.
The acquisition of Trubion is expected to further Emergent’s position as a leading, fully integrated biopharmaceutical company focused on the manufacture, development and commercialization of vaccines and antibody therapeutics. Trubion’s clinical and preclinical stage programs, as well as its leading edge science, will expand Emergent’s product development pipeline and significantly broaden its antibody-based capabilities. Upon closing, the transaction is expected to provide approximately $20 million in cash, net of customary closing costs, and $70 million of net operating losses (NOLs) that are expected to be used over the next ten years.
Trubion’s development pipeline is comprised of two clinical-stage therapeutic candidates and multiple preclinical programs, including:

  • a clinical-stage CD20 directed SMIP candidate (SBI-087) for the treatment of Rheumatoid Arthritis (Phase 2) and Systemic Lupus Erythematosus (Phase 1/2) in partnership with Pfizer;
  • a clinical-stage CD37 targeted SMIP candidate (TRU-016) for the treatment of Chronic Lymphocytic Leukemia (Phase 1/2), Non-Hodgkin’s Lymphoma (Preclinical/Phase 1) in partnership with Abbott; and
  • promising preclinical candidates based on the novel, proprietary SMIP and SCORPION platforms for the treatment of selected oncology and autoimmune diseases.

Fuad El-Hibri, chairman of the board of directors and chief executive officer of Emergent BioSolutions, stated, “This acquisition strengthens Emergent’s biologics capabilities in two key aspects. First, it diversifies our product pipeline beyond infectious diseases into the two high growth areas of oncology and autoimmunity. And, second, it broadens our monoclonal antibody therapeutic capabilities. Emergent’s stable vaccine franchise, substantial capital resources, and expertise in manufacturing and product development combined with Trubion’s world-class therapeutic platform technologies and clinical-stage development programs should translate into significant value over the near and long term.”
Steven Gillis, Ph.D., executive chairman of the board of directors and acting president of Trubion, stated, “The acquisition of Trubion by Emergent should accelerate the continued development of our leading products and technologies. We believe the combination of Emergent’s strong financial position and expertise in development of biologics with Trubion’s innovative SMIP and SCORPION protein therapeutic product candidates and technologies will provide an efficient and effective development path for these promising products and technologies.”
Emergent will maintain research facilities in Seattle, Washington upon completion of the acquisition, and the location will become a therapeutics-focused product development site for the combined company. Taking this transaction into account, Emergent is reaffirming its annual 2010 forecast of $275 to $300 million in total revenues and $40 to $50 million in net income.

Terms of the Agreement

The transaction has been approved by the Boards of Directors of both companies and is subject to customary closing conditions, including the approval of the acquisition by stockholders of Trubion Pharmaceuticals and the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
Under the terms of the agreement, each share of Trubion Pharmaceuticals common stock will be converted into the right to receive an upfront payment of $1.365 per share in cash and 0.1641 shares of Emergent BioSolutions common stock. The upfront payment represents a value of $4.55 per share, or approximately $96.8 million, based on Trubion’s total common shares outstanding, the net value of dilutive stock options, and the trading average of Emergent BioSolutions common stock for the five days prior to the signing of the definitive agreement. In the aggregate, Emergent will issue approximately 3,350,000 shares of its common stock as part of the upfront consideration, which after the closing of the merger will represent approximately 9.2% of Emergent’s total shares outstanding. Certain of these shares will be subject to lockup provisions. Trubion Pharmaceuticals stockholders will also receive one Contingent Value Right (CVR) per share, which will entitle the holders to receive cash payments based upon achievement of five predefined Phase 2 and Phase 3 clinical study initiation milestones and one manufacturing-related milestone. The total potential aggregate value of the CVRs is $38.7 million over a 36-month period following the closing of the merger.

Details regarding the predefined milestones are as follows:

Milestone Events Applicable Payments
Initiation of the first Phase 2 clinical study for TRU-016 $1.75 million
Release of TRU-016 manufactured for use in clinical studies $10.0 million
Initiation of dosing in the first Phase 2 clinical study for a non-CD20 target $0.75 million
Initiation of the first Phase 3 clinical study in oncology indication for TRU-016 $15.0 million
Initiation of dosing in the first Phase 3 clinical study for the first major indication for CD20 candidate $6.25 million
Initiation of dosing in the first Phase 3 clinical study for the second major indication for CD20 candidate $5.0 million

The acquisition of Trubion is expected to close in the fourth quarter of 2010.

Conference Call and Webcast

Emergent hosted a conference call to discuss the acquisition of Trubion Pharmaceuticals on August 12, 2010 at 5:00 pm Eastern.  A replay of the conference call is accessible by dialing 888/286-8010 or 617/801-6888 and using the passcode 48453582. The replay will be archived for an indefinite period on the company’s website, www.emergentbiosolutions.com, under “Investors”.

Advisors

Wedbush PacGrow Life Sciences is acting as financial advisor and Bingham McCutchen LLP is acting as legal advisor to Emergent BioSolutions for this transaction. MTS Health Partners, L.P. is acting as financial advisor and Fenwick & West LLP is acting as legal advisor to Trubion Pharmaceuticals.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body’s immune system to prevent or treat disease. Emergent’s marketed product, BioThrax(R) (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax disease. Emergent’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia. Additional information may be found at www.emergentbiosolutions.com.

Additional Information and Where to Find It

This communication is being made in connection with the proposed merger (the “Merger”) among Emergent BioSolutions Inc. (”Emergent”), Trubion Pharmaceuticals, Inc. (”Trubion”) and certain of Emergent’s direct and indirect wholly-owned subsidiaries. Emergent intends to file with the Securities and Exchange Commission (the “SEC”) a registration statement on Form S-4, which will contain a prospectus relating to the securities Emergent intends to issue in the proposed Merger. Trubion intends to file a preliminary proxy statement in connection with the proposed Merger and to mail a definitive proxy statement and other relevant documents to Trubion’s stockholders. Stockholders of Emergent and Trubion and other interested persons are advised to read, when available, the registration statement and Trubion’s preliminary proxy statement, and amendments thereto, and definitive proxy statement in connection with Trubion’s solicitation of proxies for the special meeting to be held to approve the Merger because these documents will contain important information about Trubion, Emergent and the proposed Merger. The definitive proxy statement will be mailed to stockholders as of a record date to be established for voting on the Merger. Stockholders will also be able to obtain a copy of the documents filed with the SEC, without charge, once available, at the SEC’s website at http://www.sec.gov or by directing a request to: Emergent BioSolutions Inc., Attn: Investor Relations, 2273 Research Boulevard, Suite 400, Rockville, Maryland 20850, or Trubion Pharmaceuticals, Inc., Attention: Investor Relations, 2401 4th Avenue, Suite 1050, Seattle, Washington, 98121.

Participants in Solicitation

Emergent, Trubion and their respective directors and officers may be deemed participants in the solicitation of proxies from Trubion’s stockholders. Information regarding Emergent’s directors and officers is available in Emergent’s proxy statement for its 2010 annual meeting of stockholders and its 2009 annual report on Form 10-K, which were filed with the SEC and are available at the SEC’s website at http://www.sec.gov. Information regarding Trubion’s directors and officers is available in Trubion’s proxy statement for its 2010 annual meeting of stockholders and its 2009 annual report on Form 10-K, which were filed with the SEC and are available at the SEC’s website at http://www.sec.gov. Information regarding Trubion’s directors and officers will also be contained in Trubion’s proxy statement in connection with the Merger when it becomes available. Emergent’s and Trubion’s stockholders may obtain additional information about the interests of Trubion’s directors and officers in the Merger by reading Trubion’s proxy statement when it becomes available.

Emergent BioSolutions Forward-Looking 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 and how the acquisition of Trubion will impact that strategy, the financial impact of the merger on Emergent’s 2010 forecast, the provision of expected cash and NOLs, the anticipated timing for the transaction and anticipated future operations, 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 the parties’ ability to consummate the transaction; the conditions to the completion of the transaction, including the effectiveness of Emergent’s registration statement on Form S-4 or the regulatory approvals required for the transaction may not be obtained on the terms expected or on the anticipated schedule; and the parties’ ability to meet expectations regarding the timing, completion and financial and tax treatments of the merger; the possibility that the parties may be unable to achieve expected synergies and operating efficiencies in the merger within the expected time-frames or at all and to successfully integrate Trubion’s operations into those of Emergent; such integration may be more difficult, time-consuming or costly than expected; operating costs, partner loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees, partners, licensors and others) may be greater than expected following the transaction; the retention of certain key employees of Trubion may be difficult; the parties are subject to intense competition and increased competition is expected in the future; the failure to protect either party’s intellectual property rights may weaken its competitive position; third parties may claim that either party’s products infringe their intellectual property rights; the rate and degree of market acceptance and clinical utility of the parties’ products; the success of ongoing and planned development programs, preclinical studies and clinical trials; the ability to identify and acquire or in license products and product candidates that satisfy Emergent’s selection criteria; the potential benefits of the parties existing collaboration agreements and the ability to enter into selective additional collaboration arrangements; the timing of and ability to obtain and maintain regulatory approvals for other product candidates; commercialization, marketing and manufacturing capabilities and strategy; and other factors identified in Emergent’s Quarterly Report on Form 10-Q for the quarter ended June 30, 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.

SOURCE: Emergent BioSolutions Inc.

December 10, 2009

Emergent BioSolutions reacts to BARDA’s Request for Proposal cancellation

by Nick Rees on December 8, 2009

El-hibri_fuad

Fuad El-Hibri

The Office of the Biomedical Advanced Research and Development Authority has advised Emergent BioSolutions that while BARDA’s Request for Proposal has been canceled, Emergent is encouraged to submit a proposal for the office’s Broad Agency Announcement.

BARDA canceled the RFP for the procurement for rPA vaccines after a technical evaluation panel determined that no proposals submitted by vaccine developers could meet the ProjectBioShield statutory requirement of having the product ready for licensure within eight years.

An amendment issued by BARDA to BAA 09-34 at the same time, however, enable companies to submit proposals to obtain development funding for rPA vaccine candidates, which Emergent has been strongly encouraged to do by BARDA.

Emergent plans to submit its proposal to the BAA by the end of this year, in front of the due date of February 1, 2010 for the proposals.

This announcement also does not impact Emergent’s $400 million procurement with the Centers for Disease Control and Prevention to manufacture and deliver 14.5 million doses of BioThrax for the Strategic National Stockpile.

“With this action, BioThrax remains a critical and long-term countermeasure for the US government,” Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions, said. “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.”

BioThrax is currently being delivered under this contract with an expected completion of deliveries by September 2011. BioThrax is the only FDA licensed vaccine for the prevention of anthrax diseases.

“We believe that BioThrax will remain a premier product based on its recent enhancements, such as four-year dating, a reduced vaccination schedule and intramuscular route of administration, together with the potential for a further reduction in the vaccination schedule to a 3-dose primary series with a 3-year boost,” Daniel J.Abdun-Nabi, president and chief operating officer of Emergent BioSolutions, said. “BioThrax continues to be the product of choice for the USG and other customers seeking to address the anthrax threat.”

BARDA and Emergent are also in separate talks for a contract that would see BARDAA fund scale-up and related activities to obtain FDA licensure for large-scale production of BioThrax at Emergent’s new 50,000-square-foot Lansing, Mich., manufacturing facility.

“I am proud that Lansing remains home to America’s first line of defense against what experts say is the single biggest bioterror threat, anthrax,” U.S. Rep. Mike Rogers, MI-08, said. “The good news about the cancellation of this particular proposal is HHS recommitted itself to the Lansing-made anthrax vaccine and has opened a new proposal for a next-generation anthrax vaccine for which Emergent has indicated it will compete.

“Rest assured, I will continue working to strengthen our nation’s existing bioterror preparedness measures and protect national security jobs in Lansing.”

August 14, 2009

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.

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