>>> Emergent BioSolutions Signs $448 Million Three Year Contract with Department of Health and Human Services
Wednesday September 26, 8:00 am ET
ROCKVILLE, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE:EBS - News), 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(R) (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. <<<
