Key Developments: Emergent BioSolutions Inc (EBS.N)

EBS.N on New York Stock Exchange

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1 Aug 2013
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Latest Key Developments (Source: Significant Developments)

Emergent Biosolutions Inc Closes On Its Acquisition Of Healthcare Protective Products Division From Bracco Diagnostics Inc
7:00am EDT 

Emergent Biosolutions Inc announced that it has closed on its acquisition of Bracco Diagnostics Inc.'s Healthcare Protective Products Division. This acquisition, which includes the RSDL (decontamination lotion) product that is cleared for marketing by the U.S. Food and Drug Administration (FDA) for removal or neutralization of chemical warfare agents from the skin, diversifies and broadens Emergent's biodefense franchise into the chemical countermeasure market. The closing on this acquisition contemplates that certain additional assets will be transferred to the company by year end. The company will discuss the impact of this acquisition to Emergent's anticipated revenue and net income for full year 2013 during the company's 2Q 2013 financial results call scheduled for August 5, 2013.  Full Article

Emergent BioSolutions Inc Issues Q2 2013 Revenue Guidance In Line With Analysts' Estimates; Reaffirms FY 2013 Guidance
Thursday, 2 May 2013 04:01pm EDT 

Emergent BioSolutions Inc announced that for second quarter of 2013, it expects total revenues of $70 to $80 million. The Company reaffirmed fiscal 2013 guidance and expects total revenues of $290 to $310 million, split between product sales of $230 to $240 million and contracts and grants revenue of $60 to $70 million. The company is also reaffirming its fiscal 2013 net income forecast of $20 to $30 million. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $76 million for second quarter of 2013; revenue of $298 million and net income of $30 million for fiscal 2013.  Full Article

Emergent BioSolutions Inc Reaffirms FY 2013 Guidance; Reaffirms Q1 2013 Revenue Guidance-Conference Call
Monday, 29 Apr 2013 07:00am EDT 

Emergent BioSolutions Inc announced that it is reaffirming its fiscal 2013 guidance of $290 to $310 million in total revenues and $20 to $30 million in net income. The company also reaffirms its first quarter 2013 revenue guidance of $40 to $50 million.  Full Article

Emergent BioSolutions Inc Reaffirms FY 2013; Issues Q1 2013 Revenue Guidance Below Analysts' Estimates
Thursday, 7 Mar 2013 04:01pm EST 

Emergent BioSolutions Inc reaffirmed it fiscal 2013 guidance and expects total revenue of $290 to $310 million. For first quarter of 2013, it expects total revenues of $40 to $50 million. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $301 million for fiscal 2013; revenue of $60 million for first quarter of 2013.  Full Article

Emergent BioSolutions Inc Announces Initiation Of Phase 2 Study In Pursuit Of Post-Exposure Prophylaxis Indication For BioThrax
Tuesday, 22 Jan 2013 07:00am EST 

Emergent BioSolutions Inc announced the initiation of a Phase 2 study designed to evaluate non-interference of BioThrax (Anthrax Vaccine Adsorbed) when administered in conjunction with antibiotics. This non-interference study will be used to support a supplemental Biologics License Application seeking licensure of a Post-Exposure Prophylaxis (PEP) indication for BioThrax to be used in combination with antibiotics in people suspected to have been exposed to anthrax spores. Currently, BioThrax is licensed for a pre-exposure prophylaxis indication only. The primary objective of this Phase 2, randomized, open label study is to evaluate any impact of the vaccine on ciprofloxacin by administering the antibiotic prior to and following the administration of a 3-dose series of BioThrax. The study, which will enroll 120 healthy adult volunteers and is being conducted in multiple sites within the U.S., will also provide additional safety data on the concurrent administration of ciprofloxacin and BioThrax. Preliminary data from this study are expected in the fourth quarter of 2013.  Full Article

Emergent BioSolutions Inc Initiates Phase 2 Clinical Trial for Anthrax Vaccine NuThrax
Thursday, 17 Jan 2013 07:00am EST 

Emergent BioSolutions Inc announced the initiation of a Phase 2 clinical trial for NuThrax (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant), also known as AV7909, with the dosing of the first subject. NuThrax, a next generation vaccine being developed as part of Emergent's anthrax franchise, consists of Anthrax Vaccine Adsorbed in combination with a immunostimulatory adjuvant, CPG 7909. The Phase 2 clinical trial, a randomized, parallel-group, active-controlled, double-blind study, is designed to evaluate the safety and immunogenicity of NuThrax for post-exposure prophylaxis of anthrax infection using two and three dose immunization schedules and two dose levels. The study is being conducted in multiple sites within the U.S. and plans to enroll 168 healthy adult volunteers. Preliminary data from this study are expected in the fourth quarter of 2013.  Full Article

Emergent BioSolutions Inc Lowers High End Of FY 2012 Revenue Guidance To A Range Below Analysts' Estimates; Narrows FY 2012 Net Income Guidance
Monday, 7 Jan 2013 07:00am EST 

Emergent BioSolutions Inc announced that for fiscal 2012, it expects total revenues of $280 to $284 million, which includes approximately $216 million of product sales and $64 to $68 million of contracts and grants revenue. The company also expects fiscal 2012 net income of $21 to $24 million, which includes a one-time, non-cash charge of $9.6 million related to impairment of in-process research and development associated with the SBI-087 product candidate, which was being developed by Pfizer; the impairment charge was incurred in first quarter of 2012. According to I/B/E/S Estimates, analysts on an average are expecting the Company to report revenue of $285 million and net income of $25 million for fiscal 2012.  Full Article

Emergent BioSolutions Inc Announces CFO Change-Form 8-K
Monday, 19 Nov 2012 12:44pm EST 

Emergent BioSolutions Inc reported in its Form 8-K that on November 15, 2012, R. Don Elsey, the Chief Financial Officer (CFO) of Emergent BioSolutions Inc. (Company) resigned from the Company effective December 3, 2012. On November 16, 2012, the Company appointed Robert G. Kramer, who is currently the Executive Vice President of the corporate services division of the Company, to the additional roles of Chief Financial Officer, principal financial and accounting officer, and treasurer, also effective December 3, 2012.  Full Article

Emergent BioSolutions Inc Reaffirms FY 2012 Guidance
Thursday, 1 Nov 2012 07:00am EDT 

Emergent BioSolutions Inc reaffirmed its guidance of total revenues of $280 million to $300 million and net income of $15 million to $25 million for fiscal 2012. According to I/B/E/S Estimates, analysts on an average are expecting the Company to report revenue of $286 million and net income of $24 million for fiscal 2012.  Full Article

Emergent BioSolutions Inc Initiates Phase 1b Study Of TRU-016 In Combination With Rituximab In Patients With Previously Untreated Chronic Lymphocytic Leukemia
Wednesday, 31 Oct 2012 07:00am EDT 

Emergent BioSolutions Inc announced the initiation of a Phase 1b study (Protocol 16009) of TRU-016 in combination with rituximab for patients with previously untreated chronic lymphocytic leukemia (CLL). TRU-016 is a humanized anti-CD37 mono-specific protein therapeutic in development for the treatment of B-cell malignancies. The Phase 1b, single-arm, open label study is enrolling approximately 24 previously untreated CLL patients and will evaluate the safety and efficacy of TRU-016 (an anti-CD37 biologic) in combination with rituximab (an anti-CD20 biologic). The primary outcome measurement for this study is overall response rate. Patients will receive TRU-016 and rituximab intravenously for six months. The Company expects to complete enrollment in this study in 2013 and present data in the second half of 2013. TRU-016 is also being evaluated in an ongoing Phase 2 study (protocol 16201) in combination with bendamustine for patients with relapsed CLL. This study is designed to evaluate the safety and efficacy of TRU-016 in combination with bendamustine compared with bendamustine alone. The primary endpoint for the Phase 2 study is an overall response rate as defined by 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria. Secondary endpoints include complete and partial response rates as defined by the 1996 National Cancer Institute (NCI) criteria, progression-free survival, duration of response, and improvement in quality of life and disease symptoms.  Full Article

RPT-BRIEF-Emergent Biosolutions to expand clinical trial of TRU-016 and rituximab

April 5 - April 5 - Emergent Biosolutions Inc : * To expand front line CLL clinical trial of TRU-016 and rituximab based on strong patient enrollment and encouraging early clinical data * Source text for Eikon * Further company coverage

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