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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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14-1902018
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(State or Other Jurisdiction of Incorporation or Organization)
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(IRS Employer Identification No.)
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2273 Research Boulevard, Suite 400, Rockville, Maryland
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20850
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(Address of Principal Executive Offices)
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(Zip Code)
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Title of Each Class
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Name of Each Exchange on Which Registered
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Common stock, $0.001 par value per share
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New York Stock Exchange
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Series A junior participating preferred stock purchase rights
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New York Stock Exchange
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PART I
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Item 1.
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Item 1A.
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Item 1B.
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Item 2.
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Item 3.
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Item 4.
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PART II
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Item 5.
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Item 6.
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Item 7.
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Item 7A.
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Item 8.
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Item 9.
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Item 9A.
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Item 9B.
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PART III
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Item 10.
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Item 11.
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Item 12.
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Item 13.
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Item 14.
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PART IV
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Item 15.
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our ability to perform under our contracts with the U.S. government related to BioThrax® (Anthrax Vaccine Adsorbed), our FDA-approved anthrax vaccine, including the timing of deliveries;
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our plans for future sales of BioThrax, including our ability to obtain funding for existing procurement contracts with the U.S. government;
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our plans to pursue label expansions and other improvements for BioThrax;
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our ability to perform under our development contract with the U.S. government for our product candidate PreviThrax
TM
(Recombinant Protective Antigen Anthrax Vaccine, Purified);
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our ability to perform under our contract with the U.S. government to develop and obtain regulatory approval for large-scale manufacturing of BioThrax in Building 55, our large-scale vaccine manufacturing facility in Lansing, Michigan;
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our plans to expand our manufacturing facilities and capabilities;
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the rate and degree of market acceptance of our products and product candidates;
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the success of ongoing and planned development programs, preclinical studies and clinical trials of our product candidates and post-approval clinical utility of our products;
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our ability to identify and acquire or in-license products and product candidates that satisfy our selection criteria;
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our ability to successfully integrate and develop the products or product candidates, programs, operations and personnel of any entities or businesses that we acquire;
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the timing of and our ability to obtain and maintain regulatory approvals for our products and product candidates;
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our commercialization, marketing and manufacturing capabilities and strategy;
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our intellectual property portfolio; and
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our estimates regarding expenses, future revenues, capital requirements and needs for additional financing.
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Disease
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Product or Product Candidate
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Description
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Development Stage
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Infectious Diseases:
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Anthrax
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BioThrax
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Only FDA-approved vaccine for pre-exposure prevention of anthrax disease
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Marketed
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BioThrax PEP
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BioThrax as a post-exposure prophylaxis
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Phase III
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NuThrax*
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Pre-exposure prophylactic vaccine
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Phase I
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PreviThrax*
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Pre/post-exposure prophylactic vaccine
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Phase II
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Anthrivig*
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Human immune globulin therapeutic
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Phase II
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Thravixa*
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Fully human monoclonal antibody therapeutic
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Phase I
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Tuberculosis
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MVA-85A
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Prophylactic recombinant TB vaccine
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Phase II
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AIID:
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Rheumatoid Arthritis
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SBI-087
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Humanized anti-CD20 SMIP therapeutic
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Phase II
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Systemic Lupus Erythematosus
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SBI-087
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Humanized anti-CD20 SMIP therapeutic
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Phase I
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Cancer:
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Chronic Lymphocytic Leukemia
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TRU-016
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Humanized anti-CD37 SMIP therapeutic
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Phase II
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Non-Hodgkin's Lymphoma
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TRU-016
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Humanized anti-CD37 SMIP therapeutic
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Phase I
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Peripheral T-cell Lymphoma
Cutaneous T-cell Lymphoma
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Zanolimumab
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Humanized anti-CD4 monoclonal antibody therapeutic
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Phase I
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Zanolimumab
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Humanized anti-CD4 monoclonal antibody therapeutic
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Phase II
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state and local governments, which we expect may be interested in these products to protect emergency responders, such as police, fire and emergency medical personnel;
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foreign governments, including both defense and public health agencies;
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non-governmental organizations and multinational companies, including transportation, critical infrastructure services and security companies;
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the U.S. Postal Service; and
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health care providers, including hospitals and clinics.
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Extended expiry dating
. In June 2009, we received approval from the FDA of our supplemental biologics license application, or sBLA, to extend the expiry dating of BioThrax from three years to four years, which will allow BioThrax to be stockpiled for a longer period of time. In follow up to that, in December 2010, we submitted to the FDA a new sBLA to extend the expiry dating of BioThrax from four year to five years, which would further extend the length of time BioThrax may be stockpiled. In February 2011, the FDA issued a complete response letter indicating that the submitted data are not adequate to support a five year expiry. We are currently evaluating our response to the FDA.
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Optimized dosing schedule for general use prophylaxis (GUP).
In February 2010, we submitted a BLA efficacy supplement to the FDA to change the BioThrax dosing schedule from the current 0-, 1-, 6-, 12- and 18-month schedule with annual boosters to a 0-, 1- and 6-month schedule with triennial boosters. The BLA supplement was primarily based on data from a clinical trial completed by the CDC in December 2009 to evaluate whether as few as three doses of BioThrax administered over six months, with booster doses up to three years apart, would confer an adequate immune response
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According to the statistical analysis plan of the trial, a switch in the dosing schedule would be justified by demonstrated non-inferiority of immune response of groups with a modified vaccination schedule as compared to the original approved schedule. The primary endpoints for comparison to determine non-inferiority were (1) geometric mean antibody titer, or GMT, (2) geometric mean antibody concentration, or GMC, and (3) the proportion of subjects achieving 4-fold increase in antibody titer after vaccination. Non-inferiority had to be demonstrated for all primary endpoints in order to support the use of specific regimens. In accordance with applicable regulatory guidance and the FDA’s recommendations to the CDC on trial design, all non-inferiority tests were done at the 0.025 significance level to insure that results were not due to random variation. A conclusion of non-inferiority, to be accepted by the FDA, required that the upper limits of 95% confidence intervals be less than 1.5 for GMT and GMC ratios and less than 0.1 for differences in proportions of subjects achieving 4-fold increase in antibody titer.
In this trial, the immunogenicity for groups with a modified vaccination schedule were all non-inferior to the group with the original approved schedule for all primary endpoints. Additionally, the intramuscular route of administration resulted in significantly fewer adverse events when compared to the subcutaneous route for six of the eight solicited local (injection site) adverse events: warmth, tenderness, erythema, swelling, bruising and itching. Intramuscular administration resulted in a shorter duration of the adverse event than subcutaneous administration for the same six solicited adverse events. Few statistically significant differences were detected in the occurrence of systemic adverse events between the intramuscular treatment groups and the subcutaneous treatment group.
In November 2010, the FDA sent us a complete response letter to our BLA efficacy supplement stating that it could not be approved on the basis of the BLA efficacy supplement as submitted. We had an informal meeting with the FDA in July 2011 to discuss steps necessary for approval. Based on the discussion, in November 2011, we submitted a complete response to the FDA’s letter, supporting a three dose primary vaccination series followed by boosters thereafter.
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Second label indication to include PEP.
We plan to seek approval of BioThrax as a PEP against anthrax disease, to be administered in combination with the approved course of antimicrobial therapy in persons 18 to 65 years of age.
In February 2007, the FDA granted Fast Track designation for BioThrax as PEP against anthrax disease.
In October 2007, we completed a human clinical trial of BioThrax for the PEP indication using the anticipated dosing schedule of three doses of BioThrax given two weeks apart. The data from that trial, in combination with data from our non-clinical studies, were used to design our anticipated pivotal human clinical trial. We submitted our proposal for this trial to the FDA in May 2008. Based on an initial meeting with the FDA, we conducted additional studies employing the FDA animal rule to demonstrate efficacy of BioThrax in an anthrax post-exposure setting. These additional non-clinical studies included a confirmatory study in
non-human primates
for pre-exposure general-use prophylaxis, or GUP, which we completed in September 2009. We conducted these non-clinical studies to determine the immune correlate of protection and proof-of-concept that BioThrax is protective in a post-exposure setting. Previously completed
proof-of-concept PEP model studies conducted by NIAID and the U.S. Army Medical Research Institute of Infectious Diseases, or USAMRIID, also demonstrated the efficacy of BioThrax by establishing statistically significant increases in survival rates for rabbits treated with all dose amounts of BioThrax in combination with antibiotics compared to rabbits treated with antibiotics alone.
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In November 2010, a Vaccines and Related Biological Products Advisory Committee, or VRBPAC, was convened to discuss the pathway to licensure for protective antigen-based anthrax vaccines for a PEP indication (for the prevention of disease caused by residual B.
anthracis
spores in exposed individuals who have received full course antibiotics) using the animal rule. The VRBPAC agreed with an FDA-proposed strategy for bridging animal protection data to humans for protective antigen-based anthrax vaccines for a PEP indication using appropriately designed GUP studies
. In November 2011, we initiated a pivotal immunogenicity and safety study to evaluate a three-dose vaccination schedule of BioThrax for the PEP indication.
We believe that the data from our non-clinical efficacy studies such as our
GUP studies and proof-of-concept
PEP
studies
, together with pivotal data on human immunogenicity
and noninterference of the vaccine with antimicrobials
, will be sufficient to support the filing of a BLA supplement with the FDA for marketing approval of BioThrax for the PEP indication. Our development efforts to obtain approval of BioThrax as a PEP are supported in part with funding from BARDA. In December 2011, we entered into an extension of our contract with BARDA through June 2012. BARDA is reviewing a proposal to extend the contract through PEP licensure.
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NuThrax™ (Anthrax Vaccine Adsorbed containing CPG 7909 Adjuvant).
We are developing NuThrax, a product candidate based on BioThrax combined with CPG 7909, an adjuvant that we license from Pfizer Inc., or Pfizer, in part with funding from NIAID and BARDA. We anticipate that NuThrax will, among other things, require fewer doses to produce a sufficient protective immune response, or elicit an enhanced immune response. We obtained additional U.S. government funding through a NIAID award in August 2010 to supplement the further development of NuThrax, including activities related to manufacturing and stability studies of Phase II clinical trial lots, process characterization and assay validation, and clinical trial preparation. The award also contains additional optional funding from NIAID for milestone-based activities for continued stability testing of Phase II clinical trial lots, non-clinical studies and a Phase II clinical trial to evaluate safety and immunogenicity of this product candidate, which we expect to begin in 2012.
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In collaboration with us, Coley Pharmaceuticals, the owner of CPG 7909 before its sale to Pfizer, conducted a double-blind Phase I clinical trial of BioThrax combined with CPG 7909 that was funded by DARPA. That trial, which was completed in 2005 and involved 69 healthy volunteers, was designed to evaluate the safety and immunogenicity of this product candidate compared to BioThrax alone and to CPG 7909 alone. In this Phase I trial, the product candidate was administered in three doses by intramuscular injection at two week intervals and elicited an enhanced immune response.
The immunogenicity parameters for this trial were the mean peak antibody concentration and the median time to achieve mean peak immune response in trial participants who received BioThrax combined with CPG 7909 as compared to trial participants who received BioThrax alone. In this trial, the mean peak concentration of antibodies to anthrax protective antigen in participants who received the product candidate was approximately 6.3 times higher than in participants who received BioThrax alone. This result was statistically significant, with a
p
value of less than 0.001. Participants who received BioThrax alone achieved a mean peak geometric anti-PA IgG concentration approximately 42.5 days after first injection. Participants who received BioThrax combined with CPG 7909 achieved this same mean antibody concentration 21 days after the first injection. This result was statistically significant, with a
p
value of less than 0.001. In this trial, there was a higher frequency of moderate injection site reactions and systemic adverse events in the volunteers who received the product candidate as compared to volunteers who received BioThrax alone or CPG 7909 alone. One volunteer withdrew from this trial because of an adverse event. There were no serious adverse events reported that the trial investigators considered related to the product candidate, to BioThrax or to CPG 7909.
In August 2010, we obtained additional U.S. government funding through a NIAID award to supplement the further development of NuThrax, including activities related to manufacturing and stability studies of Phase II clinical trial lots, process characterization and assay validation, and clinical trial preparation. The award also contains additional optional funding from NIAID for milestone-based activities for continued stability testing of Phase II clinical trial lots, non-clinical studies and a Phase II clinical trial to evaluate safety and immunogenicity of this product candidate, which we expect to begin in the first quarter of 2012.
In December 2010, we initiated a parallel arm dose-ranging Phase I clinical trial designed to evaluate the safety, tolerability and immunogenicity of NuThrax. The trial was conducted in multiple sites within the United States and involves 105 healthy volunteers. Preliminary data from this study confirmed previous data which indicate superiority of NuThrax over BioThrax. We are currently preparing the clinical study report.
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PreviThrax™ (Recombinant Protective Antigen Anthrax Vaccine, Purified)
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We are developing a recombinant anthrax vaccine, based on original development work at USAMRIID. This vaccine, PreviThrax, contains purified recombinant protective antigen, or rPA, formulated with an aluminum hydroxide adjuvant and is designed to induce antibodies that neutralize anthrax toxins in a manner similar to BioThrax. PreviThrax has been evaluated in one Phase II clinical trial, but this trial did not achieve statistically significant results due to product stability issues. We believe that future trials will not be adversely affected by similar stability concerns. In September 2010, BARDA awarded us a contract valued at up to approximately $187 million to fund development activities related to process characterization and assay validation, as well as formulation and stability studies, with potential milestone-based options for completion of a Phase II clinical trial and non-clinical efficacy studies, process validation and consistency lot manufacture. We have completed several formulation studies and have initiated additional studies designed to determine the optimal dose presentation for PreviThrax.
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Anthrivig™ (Human Anthrax Immune globulin).
We are developing Anthrivig, a human anthrax immune globulin, or AIG, therapeutic product candidate, which is a polyclonal antibody therapeutic, designed as a treatment for patients who have been exposed to anthrax spores and who present with symptoms of anthrax disease. We expect that, if approved, Anthrivig would be prescribed as an intravenous infusion in conjunction with a regimen of antibiotics. We are developing Anthrivig using plasma produced by healthy donors who have been immunized with BioThrax.
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NIAID has previously provided us grant and contract funding for a combination of initiatives, including studies designed to assess the tolerability, pharmacokinetics and efficacy of this product candidate in non-clinical studies, the development and validation of product assays, and a human clinical trial to evaluate safety and pharmacokinetics. In March 2009, we commenced a Phase I/II dose-escalation trial to evaluate the safety and pharmacokinetics of Anthrivig in 125 healthy human volunteers. We completed dosing in July 2010 and completed subject follow-up in October 2010. The final clinical study report was completed in April 2011 and filed with the FDA in June 2011. The study findings indicated that Anthrivig was safe and that exposure was proportional to dose. All activities under the NIAID contract have been completed. In November 2010, BARDA requested that we submit a full proposal for late-stage development of Anthrivig, including all development activities through license. We submitted our proposal in January 2011 and BARDA has since indicated that it is evaluating its funding priorities. We are currently evaluating our future development efforts for this product candidate.
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Thravixa™ (Fully Human Anthrax Monoclonal Antibody).
We are developing Thravixa, a human monoclonal antibody therapeutic product candidate as an intravenous treatment for patients who present with symptoms of inhalational anthrax disease. Thravixa's development has been funded in part by BARDA and NIAID to support efficacy testing in non-clinical studies, the establishment of a current good manufacturing practices, or cGMP, manufacturing process and initial clinical evaluation. In August 2010, we commenced a randomized, double-blind, placebo-controlled, dose escalation Phase I clinical trial involving 50 healthy volunteers, designed to evaluate the safety and pharmacokinetics of Thravixa. Dosing was completed in the first quarter of 2011 and subject follow-up was completed in the second quarter of 2011. We are currently preparing the final clinical study report. We are currently evaluating our future development efforts for this product candidate.
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BioThrax.
Although BioThrax is the only product approved by the FDA for human use for the prevention of anthrax infection, we face potential future competition for the supply of anthrax vaccines to the U.S. government. Various agencies of the U.S. government are providing funding to our competitors for development of anthrax vaccines. In addition, the United Kingdom Health Protection Agency, or HPA, manufactures an anthrax vaccine for use by the government of the United Kingdom. Other countries may also have anthrax vaccines for use by or in development for their own internal purposes.
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PreviThrax and NuThrax.
PharmAthene, Vaxin and Pfenex are currently developing rPA based anthrax vaccines funded by BARDA.
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Anthrivig and Thravixa.
Cangene is currently developing an anthrax immune globulin therapeutic based on plasma collected from military personnel who have been vaccinated with BioThrax. In addition, three companies, Human Genome Sciences, Elusys Therapeutics and PharmAthene, are developing monoclonal antibodies to
B. anthracis
protective antigen. Human Genome Sciences is developing ABthrax™ as a therapeutic for anthrax. Elusys is developing Anthim™, for pre-exposure and PEP and as a therapeutic against anthrax. PharmAthene is developing Valortim™ as a PEP and as a therapeutic against anthrax. The FDA has granted Fast Track designation and orphan drug status for ABthrax and Valortim. HHS awarded development and procurement contracts to Human Genome Sciences and development contracts to Elusys and PharmAthene.
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Tuberculosis vaccine.
The Aeras Global Tuberculosis Vaccine Foundation is developing or supporting the development of five tuberculosis vaccine product candidates, two of which are in a Phase II clinical trial, and the rest of which are either in Phase I clinical trials or close to commencing Phase I clinical trials. The Aeras Global Tuberculosis Vaccine Foundation is also the sponsor of the Phase IIb clinical trial of our tuberculosis vaccine product candidate.
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SBI-087.
If approved for the treatment of RA, we anticipate that SBI-087 would compete with other marketed protein therapeutics for the treatment of RA including: Rituxan® (Genentech, Roche and Biogen Idec), Enbrel® (Amgen and Pfizer), Remicade® (Johnson & Johnson and Schering-Plough), Humira® (Abbott), Orencia® (Bristol-Myers Squibb), Cimzia® (Union Chimique Belge), Simponi® (Johnson & Johnson and Schering-Plough) and Actemra® (Roche and Chugai). In addition, Pfizer is currently developing a small molecule Janus kinase inhibitor for the treatment of RA. If approved for the treatment of SLE, we anticipate that SBI-087 would compete with Benlysta® (Human Genome Sciences and GlaxoSmithKline) and other B-cell depleting therapies, including CD20-directed therapeutics.
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TRU-016
. If approved for the treatment of CLL, NHL, or other B-cell malignancies, we anticipate that TRU-016 would compete with other B-cell depleting therapies. Non-CD37-directed therapeutics marketed for the treatment of NHL or CLL or both include Rituxan® (Genentech), Zevalin® (Spectrum Pharmaceuticals, Inc. and Bayer Schering AG), Bexxar® (GlaxoSmithKline), Campath® (Genzyme and Bayer Schering AG), Treanda® (Cephalon Oncology) and Arzerra® (GlaxoSmithKline and Genmab). In addition, Boehringer Ingelheim and Immunogen recently announced their development of monoclonal antibodies directed to CD37 and Abbott is developing ABT-263, a Bcl-2 inhibitor, for treatment of CLL in collaboration with Genentech.
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Zanolimumab
. If approved for the treatment of CTCL and PTCL, we anticipate that zanolimumab would compete with other T-cell therapies and related therapeutics. Therapeutics marketed for the treatment of CTCL or PTCL include Ontak and Targretin (Eisai), Istodax ® (Celgene), Zolinza ® (Merck), Folotyn ® (Allos Therapeutics) and Campath ® (Bayer Schering AG). In addition, GlaxoSmithKline, Roche, Bristol-Myers Squibb, AstraZeneca and Spectrum Pharmaceuticals are developing therapies directed to CTCL or PTCL.
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laboratory and preclinical tests, including animal testing;
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submission to the FDA of an IND which must become effective before clinical trials may begin;
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completion of human clinical trials and other studies evaluating the safety and efficacy of the proposed product for each intended use;
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FDA inspection of facilities in which the product is manufactured, processed, filled, packed and held to determine compliance with cGMP; and
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submission to the FDA and approval of a new drug application, or NDA, in the case of a drug, or a BLA containing, among other things, preclinical, nonclinical and clinical data; proposed labeling; and information to demonstrate that the product will be safe and effective (in the case of an NDA) or safe, pure and potent (in the case of a BLA), and manufactured to appropriate standards of identity, purity and quality.
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In a Phase I clinical trial, the drug or biologic is initially administered into healthy human subjects or subjects with the target condition and tested for safety, dosage tolerance, absorption, distribution, metabolism and excretion.
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In a Phase II clinical trial, the drug or biologic is administered to a limited subject population to identify possible adverse effects and safety risks, and preliminary information related to the efficacy of the product for specific targeted diseases, dosage tolerance and optimal dosage.
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A Phase III clinical trial is undertaken if a Phase II clinical trial demonstrates that a dosage range of the drug has the potential to be effective and appears to potentially have an acceptable safety profile. In a Phase III clinical trial, the drug or biologic is administered to an expanded population, often at geographically dispersed clinical trial sites, to further evaluate the dosage amount(s), clinical efficacy, and safety. Prior to commencing Phase III clinical trials, many sponsors elect to meet with FDA officials to discuss the conduct and design of the proposed trial or trials.
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recordkeeping requirements;
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periodic reporting requirements;
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cGMP requirements related to all stages of manufacturing, testing, storage, packaging, labeling and distribution of finished dosage forms of the product;
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labeling;
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distribution of samples;
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import and export;
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reporting of adverse experiences with the product; and
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advertising and promotion restrictions.
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restrictions on the marketing or manufacturing of a product;
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Warning Letters or Untitled Letters from the FDA asking us, our collaborators or third party contractors to take or refrain from taking certain actions;
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withdrawal of the product from the market;
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FDA’s refusal to approve pending applications or supplements to approved applications;
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voluntary or mandatory product recall;
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fines or disgorgement of profits or revenue;
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suspension or withdrawal of regulatory approvals;
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refusal to permit the import or export of products;
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product seizure; and
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injunctions or the imposition of civil or criminal penalties.
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the agent for which the countermeasure is designed can cause serious or life-threatening disease;
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the product may reasonably be believed to be effective in detecting, diagnosing, treating or preventing the disease;
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the known and potential benefits of the product outweigh its known and potential risks; and
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there is no adequate alternative to the product that is approved and available.
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develop and implement biosafety, security and emergency response plans;
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restrict access to select agents and toxins;
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provide appropriate training to our employees for safety, security and emergency response;
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comply with strict requirements governing transfer of select agents and toxins;
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provide timely notice to the government of any theft, loss or release of a select agent or toxin; and
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maintain detailed records of information necessary to give a complete accounting of all activities related to select agents and toxins.
|
|
§
|
the commitment of substantial time and attention of management and key employees to the preparation of bids and proposals for contracts that may not be awarded to us;
|
|
§
|
the need to accurately estimate the resources and cost structure that will be required to perform any contract that we might be awarded;
|
|
§
|
the possibility that we may be ineligible to respond to a request for proposal issued by the government;
|
|
§
|
the submission by third parties of protests to our responses to requests for proposal that could result in delays or withdrawals of those requests for proposal; and
|
|
§
|
if our competitors protest or challenge contract awards made to us pursuant to competitive bidding, the potential that we may incur expenses or delays, and that any such protest or challenge would result in the resubmission of bids based on modified specifications, or in termination, reduction or modification of the awarded contract.
|
|
§
|
procurement integrity;
|
|
§
|
export control;
|
|
§
|
government security;
|
|
§
|
employment practices;
|
|
§
|
protection of the environment;
|
|
§
|
accuracy of records and the recording of costs; and
|
|
§
|
foreign corrupt practices.
|
|
§
|
terminate existing contracts, in whole or in part, for any reason or no reason;
|
|
§
|
unilaterally reduce or modify contracts or subcontracts, including by imposing equitable price adjustments;
|
|
§
|
cancel multi-year contracts and related orders if funds for contract performance for any subsequent year become unavailable;
|
|
§
|
decline to exercise an option to renew a contract;
|
|
§
|
exercise an option to purchase only the minimum amount, if any, specified in a contract;
|
|
§
|
decline to exercise an option to purchase the maximum amount, if any, specified in a contract;
|
|
§
|
claim rights to products, including intellectual property, developed under the contract;
|
|
§
|
take actions that result in a longer development timeline than expected;
|
|
§
|
direct the course of a development program in a manner not chosen by the government contractor;
|
|
§
|
suspend or debar the contractor from doing business with the government or a specific government agency;
|
|
§
|
pursue criminal or civil remedies under the False Claims Act and False Statements Act; and
|
|
§
|
control or prohibit the export of products.
|
|
§
|
termination of contracts;
|
|
§
|
forfeiture of profits;
|
|
§
|
suspension of payments;
|
|
§
|
fines; and
|
|
§
|
suspension or prohibition from conducting business with the U.S. government.
|
|
§
|
the Federal Acquisition Regulations, and agency-specific regulations supplemental to the Federal Acquisition Regulations, which comprehensively regulate the procurement, formation, administration and performance of government contracts;
|
|
§
|
the business ethics and public integrity obligations, which govern conflicts of interest and the hiring of former government employees, restrict the granting of gratuities and funding of lobbying activities and incorporate other requirements such as the Anti-Kickback Act and the FCPA;
|
|
§
|
export and import control laws and regulations; and
|
|
§
|
laws, regulations and executive orders restricting the use and dissemination of information classified for national security purposes and the exportation of certain products and technical data.
|
|
§
|
requiring us to dedicate a substantial portion of any cash flow from operations to the payment of interest on, and principal of, our debt, which will reduce the amounts available to fund working capital, capital expenditures, product development efforts and other general corporate purposes;
|
|
§
|
increasing the amount of interest that we have to pay on debt with variable interest rates if market rates of interest increase;
|
|
§
|
increasing our vulnerability to general adverse economic and industry conditions;
|
|
§
|
obligating us to restrictive covenants that may reduce our ability to take certain corporate actions or obtain further debt or equity financing;
|
|
§
|
limiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we compete; and
|
|
§
|
placing us at a competitive disadvantage compared to our competitors that have less debt or better debt servicing options.
|
|
§
|
the level and timing of BioThrax product sales and cost of product sales;
|
|
§
|
our ability to obtain funding from government entities and non-government and philanthropic organizations for our development programs;
|
|
§
|
the acquisition of new facilities and capital improvements to new or existing facilities;
|
|
§
|
the timing of, and the costs involved in, completion of qualification and validation activities related to Building 55, our large-scale manufacturing facility in Lansing, Michigan, the build out of our facility in Baltimore, Maryland, and any other new facilities;
|
|
§
|
the scope, progress, results and costs of our preclinical and clinical development activities;
|
|
§
|
the costs, timing and outcome of regulatory review of our product candidates;
|
|
§
|
the number of, and development requirements for, other product candidates that we may pursue;
|
|
§
|
the costs of commercialization activities, including product marketing, sales and distribution;
|
|
§
|
the market acceptance and sales growth of any of our products or product candidates upon regulatory approval;
|
|
§
|
the extent to which our growth generates increased administrative costs;
|
|
§
|
the costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims and other patent-related costs, including litigation costs and the results of such litigation;
|
|
§
|
the extent to which we acquire or invest in companies, businesses, products or technologies; and
|
|
§
|
the effect of competing technological and market developments.
|
|
§
|
equipment malfunctions or failures;
|
|
§
|
technology malfunctions;
|
|
§
|
cyberattacks;
|
|
§
|
work stoppages or slow-downs;
|
|
§
|
protests, including by animal rights activists;
|
|
§
|
damage to or destruction of the facility;
|
|
§
|
natural disasters;
|
|
§
|
regional power shortages; or
|
|
§
|
product tampering.
|
|
§
|
limitations on our ability to schedule production with contract suppliers when needed to supply clinical trials;
|
|
§
|
reliance on contract suppliers for legal and regulatory compliance and quality assurance;
|
|
§
|
potential rejection by a contract supplier of a purchase order;
|
|
§
|
contract supplier’s insistence on exclusivity, minimum or maximum levels of supply and related restrictions on our ability to increase or decrease supply, including provisions whereby we pay a penalty if we fail to order a minimum amount;
|
|
§
|
breach of agreements by contract suppliers; and
|
|
§
|
termination, price increases, or non-renewal of agreements by contract suppliers, based on other business priorities, at times that are costly or inconvenient for us.
|
|
§
|
fines, injunctions and civil penalties;
|
|
§
|
refusal by regulatory authorities to grant marketing approval of our product candidates;
|
|
§
|
delays, suspension or withdrawal of regulatory approvals, including license revocation;
|
|
§
|
seizures or recalls of product candidates or products;
|
|
§
|
temporary or permanent shut-down of manufacturing facilities;
|
|
§
|
operating restrictions; and
|
|
§
|
criminal prosecutions.
|
|
§
|
successful development, formulation and cGMP scale-up of biological manufacturing that meets FDA requirements;
|
|
§
|
successful development of animal models;
|
|
§
|
successful completion of non-clinical development, including toxicology studies and studies in approved animal models;
|
|
§
|
the expense of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;
|
|
§
|
successful completion of clinical trials;
|
|
§
|
receipt of marketing approvals from the FDA and equivalent foreign regulatory authorities;
|
|
§
|
procurement of our biodefense product candidates prior to FDA approval;
|
|
§
|
establishing commercial manufacturing processes of our own or arrangements with contract manufacturers;
|
|
§
|
manufacturing stable commercial supplies of product candidates, including materials based on recombinant technology;
|
|
§
|
launching commercial sales of the product candidate, whether alone or in collaboration with others; and
|
|
§
|
acceptance of the product candidate by potential government customers, physicians, patients, healthcare payors and others in the medical community.
|
|
§
|
regulators or institutional review boards may not authorize us, or our collaborators, to commence a clinical trial or conduct a clinical trial at a prospective trial site;
|
|
§
|
we may decide, or regulators may require us, to conduct additional preclinical testing or clinical trials, or we may abandon projects that we expect to be promising, if our preclinical tests, clinical trials or animal efficacy studies produce negative or inconclusive results;
|
|
§
|
we might have to suspend or terminate our clinical trials if the participants are being exposed to unacceptable health risks;
|
|
§
|
regulators or institutional review boards may require that we hold, suspend or terminate clinical development for various reasons, including noncompliance with regulatory requirements;
|
|
§
|
regulators may determine that service providers we use in the conduct of a clinical trial are precluded from providing such services;
|
|
§
|
we or our collaborative partners may experience delay in beginning the clinical trial;
|
|
§
|
we may experience competition in recruiting clinical investigators;
|
|
§
|
the cost of our clinical trials could escalate and become cost prohibitive;
|
|
§
|
any regulatory approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the product not commercially viable;
|
|
§
|
regulatory requirements, policy and guidelines could change;
|
|
§
|
we may experience limitations in our ability to manufacture or obtain from third parties materials sufficient for use in preclinical studies and clinical trials;
|
|
§
|
we or our collaborators may fail to adequately manage the increasing number, size and complexity of our clinical trials;
|
|
§
|
any or all of our collaborators, the FDA and foreign regulatory agencies may interpret data differently;
|
|
§
|
third parties conducting and overseeing the operations of our clinical trials may fail to perform their contractual or regulatory obligations in a timely fashion;
|
|
§
|
we may not be successful in recruiting a sufficient number of qualifying subjects for our clinical trials or may experience delays in patient enrollment and variability in the number and types of patients available for clinical trials; and
|
|
§
|
the effects of our product candidates may not be the desired effects or may include undesirable side effects or the product candidates may have other unexpected characteristics.
|
|
§
|
be delayed in obtaining marketing approval for our product candidates;
|
|
§
|
obtain approval for indications that are not as broad as intended; or
|
|
§
|
not be able to obtain marketing approval.
|
|
§
|
our ability to provide acceptable evidence of safety and efficacy;
|
|
§
|
the prevalence and severity of any side effects;
|
|
§
|
availability, relative cost and relative efficacy of alternative and competing treatments;
|
|
§
|
the ability to offer our product candidates for sale at competitive prices;
|
|
§
|
the relative convenience and ease of administration;
|
|
§
|
the willingness of the target patient population to try new products and of physicians to prescribe these products;
|
|
§
|
the strength of marketing and distribution support;
|
|
§
|
publicity concerning our products or competing products and treatments; and
|
|
§
|
the sufficiency of coverage or reimbursement by third parties.
|
|
§
|
potential difficulties in recruiting, training and retaining adequate numbers of effective sales and marketing personnel;
|
|
§
|
the potential that the commercial launch of a product candidate for which we recruit a sales force and establish marketing capabilities could be delayed, resulting in us incurring related expenses too early relative to the product launch and causing personnel retention issues;
|
|
§
|
our limited experience in the commercialization of pharmaceutical products other than BioThrax;
|
|
§
|
difficulties in establishing an effective distribution network, including entering into marketing and distribution agreements with third parties on acceptable terms;
|
|
§
|
the inability of sales personnel to obtain access to or persuade adequate numbers of potential government customers to purchase our products and physicians to prescribe our products;
|
|
§
|
the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and
|
|
§
|
unforeseen costs and expenses associated with creating and maintaining a sales and marketing organization.
|
|
§
|
decreased demand for any product candidates or products that we may develop;
|
|
§
|
injury to our reputation;
|
|
§
|
withdrawal of clinical trial participants;
|
|
§
|
withdrawal of a product from the market;
|
|
§
|
costs to defend the related litigation;
|
|
§
|
substantial monetary awards to trial participants or patients;
|
|
§
|
loss of revenue; and
|
|
§
|
the inability to commercialize any products that we may develop.
|
|
§
|
a covered benefit under its health plan;
|
|
§
|
safe, effective and medically necessary;
|
|
§
|
appropriate for the specific patient;
|
|
§
|
cost-effective; and
|
|
§
|
neither experimental nor investigational.
|
|
§
|
use of cash resources;
|
|
§
|
higher than anticipated acquisition costs and expenses;
|
|
§
|
potentially dilutive issuances of equity securities;
|
|
§
|
the incurrence of debt and contingent liabilities, impairment losses or restructuring charges; and
|
|
§
|
amortization expenses related to intangible assets.
|
|
§
|
challenges associated with managing an increasingly diversified business;
|
|
§
|
prioritization of product portfolios and related changes in resources available to each product portfolio;
|
|
§
|
disruption of our pre-acquisition business;
|
|
§
|
greater administrative burdens and operating costs;
|
|
§
|
difficulty and expense in assimilating and integrating the operations, products, technology, information systems, culture or personnel of the acquired entities or businesses;
|
|
§
|
potential loss of key collaborators;
|
|
§
|
difficulty in entering markets in which we have limited or no direct experience;
|
|
§
|
diversion of management’s time and attention from other business concerns;
|
|
§
|
difficulty in implementing uniform standards, controls, procedures and policies;
|
|
§
|
the assumption of known and unknown liabilities of the acquired entities or businesses;
|
|
§
|
increased exposure to uncertainties inherent in developing and commercializing new products;
|
|
§
|
impairment of acquired intangible assets as a result of technological advances or worse-than-expected clinical results or performance of the acquired company or the partnered assets;
|
|
§
|
challenges and costs associated with reductions in work force; and
|
|
§
|
potential loss of key personnel.
|
|
§
|
we may be unable to license or acquire the relevant technology on terms that would allow us to make an appropriate return on the investment;
|
|
§
|
companies that perceive us to be their competitor may be unwilling to assign or license their product rights to us; or
|
|
§
|
we may be unable to identify suitable products or product candidates within our areas of expertise.
|
|
§
|
restrictions on the marketing or manufacturing of a product;
|
|
§
|
warning letters;
|
|
§
|
withdrawal of the product from the market;
|
|
§
|
refusal to approve pending applications or supplements to approved applications;
|
|
§
|
voluntary or mandatory product recall;
|
|
§
|
fines or disgorgement of profits or revenue;
|
|
§
|
suspension or withdrawal of regulatory approvals, including license revocation;
|
|
§
|
shut down, or substantial limitations of the operations in, manufacturing facilities;
|
|
§
|
refusal to permit the import or export of products;
|
|
§
|
product seizure; and
|
|
§
|
injunctions or the imposition of civil or criminal penalties.
|
|
§
|
we may not be able to control the amount and timing of resources that our collaborators devote to the development or commercialization of product candidates;
|
|
§
|
our collaborators may delay clinical trials, design clinical trials in a manner with which we do not agree, provide insufficient funding, terminate a clinical trial or abandon a product candidate, repeat or conduct new clinical trials, or require a new version of a product candidate for clinical testing;
|
|
§
|
our collaboration agreements are likely to be for fixed terms and may be subject to termination by our collaborators;
|
|
§
|
our collaborators may have the first right to maintain or defend our intellectual property rights and, although we may have the right to assume the maintenance and defense of our intellectual property rights if our collaborators do not do so, our ability to maintain and defend our intellectual property rights may be compromised by our collaborators’ acts or omissions;
|
|
§
|
our collaborators may utilize our intellectual property rights in such a way as to invite litigation that could jeopardize or invalidate our intellectual property rights or expose us to potential liability;
|
|
§
|
our collaborators may decide not to pursue further development and commercialization of products and product candidates resulting from the collaboration, or may elect to discontinue research and development programs, which could delay development and increase the cost of developing our product candidates;
|
|
§
|
our collaborators may not commit adequate resources to the marketing and distribution of any future products, limiting our potential revenues from these products;
|
|
§
|
we may experience difficulties in the day-to-day activities required by collaboration including close and frequent communications between several different teams, technology transfer and a collaborative sharing of responsibilities;
|
|
§
|
disputes may arise between us and our collaborators that result in the delay or termination of the research, development or commercialization of our product candidates or that result in costly litigation or arbitration that diverts management’s attention and consumes resources;
|
|
§
|
our collaborators may experience financial difficulties;
|
|
§
|
business combinations or significant changes in a collaborator’s business strategy may adversely affect a collaborator’s willingness or ability to complete its obligations; and
|
|
§
|
our collaborators could independently move forward with a competing product candidate developed either independently or in collaboration with others, including our competitors.
|
|
§
|
the classification of our directors;
|
|
§
|
limitations on changing the number of directors then in office;
|
|
§
|
limitations on the removal of directors;
|
|
§
|
limitations on filling vacancies on the board;
|
|
§
|
limitations on the removal and appointment of the chairman of our Board of Directors;
|
|
§
|
advance notice requirements for stockholder nominations for election of directors and other proposals;
|
|
§
|
the inability of stockholders to act by written consent;
|
|
§
|
the inability of stockholders to call special meetings; and
|
|
§
|
the ability of our Board of Directors to designate the terms of and issue new series of preferred stock without stockholder approval.
|
|
§
|
the success of competitive products or technologies;
|
|
§
|
results of clinical trials of our product candidates or those of our competitors and success in our research and development programs;
|
|
§
|
decisions and procurement policies by the U.S. government affecting BioThrax and our biodefense product candidates;
|
|
§
|
regulatory developments in the U.S. and foreign countries;
|
|
§
|
public concern as to the safety of drugs developed by us or others;
|
|
§
|
announcements of issuances of common stock or acquisitions by us;
|
|
§
|
the announcement and timing of new product introductions by us or others;
|
|
§
|
termination or delay of development program(s) by our collaborative partners, or delay in achievement of collaboration milestones;
|
|
§
|
announcements of technological innovations or new therapeutic products or methods by us or others;
|
|
§
|
acts or omissions of our licensees, collaborators and suppliers;
|
|
§
|
developments or disputes concerning patents or other proprietary rights;
|
|
§
|
the recruitment or departure of key personnel;
|
|
§
|
variations in our financial results or those of companies that are perceived to be similar to us;
|
|
§
|
market conditions in the pharmaceutical and biotechnology sectors and issuance of new or changed securities analysts’ reports or recommendations;
|
|
§
|
general economic, industry and market conditions or other external factors, such as disaster or crisis; and
|
|
§
|
the other factors described in this “Risk Factors” section.
|
|
|
|||||||
|
Location
|
Use
|
Segment
|
Approximate square feet
|
Owned/leased
|
|||
|
Lansing, Michigan
|
Manufacturing operations facilities, office space and laboratory space
|
Biodefense
|
214,000 |
Owned
|
|||
|
Baltimore, Maryland
|
Future manufacturing facilities and office and laboratory space
|
Biosciences
|
56,000 |
Owned
|
|||
|
Gaithersburg, Maryland
|
Office and laboratory space
|
Biodefense
|
48,000 |
Owned
|
|||
|
Seattle, Washington
|
Office and laboratory space
|
Biosciences
|
51,000 |
Lease expires 2013
|
|||
|
Rockville, Maryland
|
Office space
|
Biodefense/Biosciences
|
41,000 |
Lease expires 2016
|
|||
|
Munich, Germany
|
Office and laboratory space
|
Biosciences
|
16,000 |
Lease expires 2015
|
|||
|
Wokingham, England
|
Office and laboratory space
|
Biosciences
|
8,000 |
Lease expires 2016
|
|||
|
Frederick, Maryland
|
Held for sale
|
Biosciences
|
290,000 |
Owned
|
|||
|
First
|
Second
|
Third
|
Fourth
|
|||||||||||||
|
Quarter
|
Quarter
|
Quarter
|
Quarter
|
|||||||||||||
|
Year Ended December 31, 2011
|
||||||||||||||||
|
High
|
$ | 25.07 | $ | 26.41 | $ | 22.84 | $ | 19.77 | ||||||||
|
Low
|
$ | 18.32 | $ | 20.44 | $ | 14.90 | $ | 15.14 | ||||||||
|
Year Ended December 31, 2010
|
||||||||||||||||
|
High
|
$ | 17.24 | $ | 17.30 | $ | 19.98 | $ | 23.93 | ||||||||
|
Low
|
$ | 13.22 | $ | 14.11 | $ | 14.86 | $ | 17.10 | ||||||||
|
Year Ended December 31,
|
||||||||||||||||||||
|
(in thousands, except share and per share data)
|
2011
|
2010
|
2009
|
2008
|
2007
|
|||||||||||||||
|
Statements of operations data:
|
||||||||||||||||||||
|
Revenues:
|
||||||||||||||||||||
|
Product sales
|
$ | 202,409 | $ | 251,381 | $ | 217,172 | $ | 169,124 | $ | 169,799 | ||||||||||
|
Contracts and grants
|
70,975 | 34,790 | 17,614 | 9,430 | 13,116 | |||||||||||||||
|
Total revenues
|
273,384 | 286,171 | 234,786 | 178,554 | 182,915 | |||||||||||||||
|
Operating expenses:
|
||||||||||||||||||||
|
Cost of product sales
|
42,171 | 47,114 | 46,262 | 34,081 | 40,309 | |||||||||||||||
|
Research and development
|
124,832 | 89,295 | 74,588 | 59,470 | 53,958 | |||||||||||||||
|
Selling, general & administrative
|
74,282 | 76,205 | 73,786 | 55,076 | 55,555 | |||||||||||||||
|
Total operating expenses
|
241,285 | 212,614 | 194,636 | 148,627 | 149,822 | |||||||||||||||
|
Income from operations
|
32,099 | 73,557 | 40,150 | 29,927 | 33,093 | |||||||||||||||
|
Other income (expense):
|
||||||||||||||||||||
|
Interest income
|
105 | 832 | 1,418 | 1,999 | 2,809 | |||||||||||||||
|
Interest expense
|
- | - | (7 | ) | (47 | ) | (71 | ) | ||||||||||||
|
Other income (expense), net
|
(261 | ) | (1,023 | ) | (50 | ) | 134 | 156 | ||||||||||||
|
Total other income (expense)
|
(156 | ) | (191 | ) | 1,361 | 2,086 | 2,894 | |||||||||||||
|
Income before provision for income taxes
|
31,943 | 73,366 | 41,511 | 32,013 | 35,987 | |||||||||||||||
|
Provision for income taxes
|
15,830 | 26,182 | 14,966 | 12,055 | 13,051 | |||||||||||||||
|
Net income
|
$ | 16,113 | $ | 47,184 | $ | 26,545 | $ | 19,958 | $ | 22,936 | ||||||||||
|
Net loss attributable to noncontrolling interest
|
6,906 | 4,514 | 4,599 | 724 | - | |||||||||||||||
|
Net income attributable to Emergent BioSolutions Inc.
|
$ | 23,019 | $ | 51,698 | $ | 31,144 | $ | 20,682 | $ | 22,936 | ||||||||||
|
Earnings per share — basic
|
$ | 0.65 | $ | 1.63 | $ | 1.02 | $ | 0.69 | $ | 0.79 | ||||||||||
|
Earnings per share — diluted
|
$ | 0.64 | $ | 1.59 | $ | 0.99 | $ | 0.68 | $ | 0.77 | ||||||||||
|
Weighted average number of shares — basic
|
35,658,907 | 31,782,286 | 30,444,485 | 29,835,134 | 28,995,667 | |||||||||||||||
|
Weighted average number of shares — diluted
|
36,206,052 | 32,539,500 | 31,375,305 | 30,458,098 | 29,663,127 | |||||||||||||||
|
As of December 31,
|
||||||||||||||||||||
|
(in thousands)
|
2011 | 2010 | 2009 | 2008 | 2007 | |||||||||||||||
|
Balance Sheet Data:
|
||||||||||||||||||||
|
Cash and cash equivalents
|
$ | 143,901 | $ | 169,019 | $ | 102,924 | $ | 91,473 | $ | 105,730 | ||||||||||
|
Working capital
|
190,285 | 167,774 | 139,113 | 98,866 | 88,649 | |||||||||||||||
|
Total assets
|
546,864 | 500,319 | 344,689 | 290,788 | 273,508 | |||||||||||||||
|
Total long-term liabilities
|
59,083 | 51,039 | 46,173 | 37,418 | 46,688 | |||||||||||||||
|
Total stockholders’ equity
|
416,727 | 373,561 | 243,815 | 199,349 | 171,159 | |||||||||||||||
|
§
|
BioThrax as a post-exposure prophylaxis, or PEP;
|
|
§
|
NuThrax;
|
|
§
|
Large-scale manufacturing for BioThrax;
|
|
§
|
PreviThrax;
|
|
§
|
Anthrivig;
|
|
§
|
Thravixa;
|
|
§
|
Double mutant recombinant protective antigen anthrax vaccine; and
|
|
§
|
Recombinant botulinum vaccine.
|
|
|
§
|
there is persuasive evidence of an arrangement;
|
|
|
§
|
delivery has occurred or title has passed to our customer based on contract terms;
|
|
|
§
|
the fee is fixed or determinable; and
|
|
|
§
|
collectibility is reasonably assured.
|
|
|
§
|
estimating the timing of and expected costs to complete the in-process projects;
|
|
|
§
|
projecting regulatory approvals;
|
|
|
§
|
estimating future cash flows from product sales resulting from completed products and in-process projects; and
|
|
|
§
|
developing appropriate discount rates and probability rates by project.
|
|
Product Candidate/Manufacturing
|
Funding Source
|
Award Date
|
Performance Period
|
|||
|
Anthrivig
|
NIAID
|
8/2006 |
8/2006 — 12/2011
|
|||
|
Anthrivig
|
NIAID
|
9/2007 |
9/2007 — 12/2011
|
|||
|
Recombinant botulinum vaccine
|
NIAID
|
6/2008 |
6/2008 — 5/2012
|
|||
|
NuThrax
|
NIAID
|
7/2008 |
7/2008 — 6/2013
|
|||
|
Thravixa
|
NIAID/BARDA
|
9/2008 |
9/2008 — 8/2012
|
|||
|
NuThrax
|
NIAID/BARDA
|
9/2008 |
9/2008 — 7/2012
|
|||
|
Double mutant recombinant protective antigen anthrax vaccine
|
NIAID
|
9/2009 |
9/2009 — 8/2012
|
|||
|
Large-scale manufacturing for BioThrax
|
BARDA
|
7/2010 |
7/2010 — 7/2015
|
|||
|
NuThrax
|
NIAID
|
7/2010 |
8/2010 — 8/2014
|
|||
|
PreviThrax
|
BARDA
|
9/2010 |
9/2010 — 9/2015
|
|||
|
|
§
|
personnel-related expenses;
|
|
|
§
|
fees to professional service providers for, among other things, preclinical and analytical testing, independent monitoring or other administration of our clinical trials and acquiring and evaluating data from our clinical trials and non-clinical studies;
|
|
|
§
|
costs of contract manufacturing services for clinical trial material;
|
|
|
§
|
costs of materials used in clinical trials and research and development;
|
|
|
§
|
depreciation of capital assets used to develop our products; and
|
|
|
§
|
operating costs, such as the operating costs of facilities and the legal costs of pursuing patent protection of our intellectual property.
|
|
Year ended
|
||||||||
|
December 31,
|
||||||||
|
(in thousands)
|
2011
|
2010
|
||||||
|
Biodefense:
|
||||||||
|
NuThrax
|
$ | 11,632 | $ | 9,876 | ||||
|
Large-scale manufacturing for BioThrax
|
13,138 | 9,099 | ||||||
|
BioThrax related programs
|
6,961 | 7,201 | ||||||
|
PreviThrax
|
14,404 | 3,767 | ||||||
|
Anthrivig
|
2,608 | 5,937 | ||||||
|
Thravixa
|
3,460 | 8,148 | ||||||
|
Other Biodefense
|
2,363 | 6,585 | ||||||
|
Total Biodefense
|
54,566 | 50,613 | ||||||
|
Biosciences:
|
||||||||
|
Tuberculosis vaccine
|
19,025 | 13,690 | ||||||
|
TRU-016
|
13,500 | 2,205 | ||||||
|
ES-301 (formerly DRACO)
|
7,172 | 693 | ||||||
|
X1
|
3,376 | - | ||||||
|
Zanolimumab
|
4,820 | - | ||||||
|
Influenza vaccine
|
2,520 | 4,088 | ||||||
|
Typhella
|
1,271 | 3,398 | ||||||
|
Other Biosciences
|
12,723 | 10,338 | ||||||
|
Total Biosciences
|
64,407 | 34,412 | ||||||
|
Other
|
5,859 | 4,270 | ||||||
|
Total
|
$ | 124,832 | $ | 89,295 | ||||
|
Year ended
|
||||||||
|
December 31,
|
||||||||
|
(in thousands)
|
2010
|
2009
|
||||||
|
Biodefense:
|
||||||||
|
NuThrax
|
$ | 9,876 | $ | 5,543 | ||||
|
Large-scale manufacturing for BioThrax
|
9,099 | 1,881 | ||||||
|
BioThrax related programs
|
7,201 | 8,324 | ||||||
|
PreviThrax
|
3,767 | 8,450 | ||||||
|
Anthrivig
|
5,937 | 6,890 | ||||||
|
Thravixa
|
8,148 | 7,215 | ||||||
|
Double mutant recombinant protective antigen
|
5,938 | 560 | ||||||
|
Botulinum vaccines
|
647 | 4,027 | ||||||
|
Total Biodefense
|
50,613 | 42,890 | ||||||
|
Biosciences:
|
||||||||
|
Tuberculosis vaccine
|
13,690 | 11,710 | ||||||
|
TRU-016
|
2,205 | - | ||||||
|
ES-301 (formerly DRACO)
|
693 | - | ||||||
|
Influenza vaccine
|
4,088 | 3,653 | ||||||
|
Typhella
|
3,398 | 5,083 | ||||||
|
Other Biosciences
|
10,338 | 6,765 | ||||||
|
Total Biosciences
|
34,412 | 27,211 | ||||||
|
Other
|
4,270 | 4,487 | ||||||
|
Total
|
$ | 89,295 | $ | 74,588 | ||||
|
Year ended December 31,
|
||||||||||||
|
(in thousands)
|
2011
|
2010
|
2009
|
|||||||||
|
Net cash provided by (used in):
|
||||||||||||
|
Operating activities(1)
|
$ | 14,594 | $ | 98,909 | $ | 29,894 | ||||||
|
Investing activities
|
(53,963 | ) | (23,456 | ) | (33,287 | ) | ||||||
|
Financing activities
|
14,251 | (9,358 | ) | 14,844 | ||||||||
|
Total net cash provided by (used in)
|
$ | (25,118 | ) | $ | 66,095 | $ | 11,451 | |||||
|
Payments due by period
|
||||||||||||||||||||||||||||
|
(in thousands)
|
Total
|
2012
|
2013
|
2014
|
2015
|
2016
|
After 2016
|
|||||||||||||||||||||
|
Contractual obligations:
|
||||||||||||||||||||||||||||
|
Long-term indebtedness including current portion
|
$ | 59,454 | $ | 5,360 | $ | 7,518 | $ | 21,505 | $ | 1,072 | $ | 1,108 | $ | 22,891 | ||||||||||||||
|
Operating lease obligations
|
9,913 | 3,188 | 2,233 | 1,773 | 1,583 | 1,136 | - | |||||||||||||||||||||
|
Total contractual obligations
|
$ | 69,367 | $ | 8,548 | $ | 9,751 | $ | 23,278 | $ | 2,655 | $ | 2,244 | $ | 22,891 | ||||||||||||||
|
§
|
$2.5 million outstanding under a loan from the Department of Business and Economic Development of the State of Maryland used to finance eligible costs incurred to purchase our first facility in Frederick, Maryland;
|
|
§
|
$5.3 million outstanding under a mortgage loan from PNC Bank used to finance the remaining portion of the purchase price for our first Frederick facility;
|
|
§
|
$19.7 million outstanding under a term loan from HSBC Realty Credit Corporation used to finance a portion of the costs of our facility expansion in Lansing, Michigan;
|
|
§
|
$4.5 million outstanding under a mortgage loan from HSBC Realty Credit Corporation used to finance a portion of the purchase price of our facility in Gaithersburg, Maryland;
|
|
§
|
$26.1 million outstanding under a construction loan from PNC Bank used to fund the ongoing renovation of our Baltimore, Maryland facility; and
|
|
§
|
$1.4 million outstanding under an equipment loan from PNC Bank used to fund equipment purchases at our Baltimore, Maryland facility.
|
|
§
|
Under our loan from the State of Maryland, we were not required to repay the principal amount of the loan if we maintained a specified number of employees at the Frederick site, if we invested at least $42.9 million in total funds toward financing the purchase of the buildings on the site and for related improvements and operation of the facility, and if we occupied the facility through 2012. Our plans for this facility have changed, and we currently plan to sell both Frederick buildings. As such we have not met the requirements for the loan to be forgivable. We have reached an agreement with the State of Maryland to repay the loan in full by March 31, 2012, with an earlier repayment due upon sale of the building.
|
|
§
|
Under our mortgage loan from PNC Bank for our Frederick facility, we are required to maintain at all times a minimum tangible net worth of not less than $5.0 million. In addition, we are required to maintain at all times a ratio of earnings before interest, taxes, depreciation and amortization to the sum of current obligations under capital leases and principal obligations and interest expenses for borrowed money, in each case due and payable within the following 12 months, of not less than 1.1 to 1.0.
|
|
§
|
Under our term loan with HSBC Realty Credit Corporation to finance a portion of the costs of our facility expansion in Lansing, Michigan, we are required to maintain on an annual basis a book leverage ratio of less than 1.00. In addition, we are required to maintain on a quarterly basis a debt coverage ratio of not less than 1.25 to 1.00.
|
|
§
|
Under our mortgage loan with HSBC Realty Credit Corporation for our Gaithersburg facility, we are required to maintain on an annual basis a book leverage ratio of less than 1.00. In addition, we are required to maintain on a quarterly basis a debt coverage ratio of not less than 1.25 to 1.00.
|
|
§
|
Under our mortgage loan with HSBC Realty Credit Corporation for our Baltimore facility, we are required to maintain on an annual basis a book leverage ratio of less than 1.00. In addition, we are required to maintain on a quarterly basis a debt coverage ratio of not less than 1.25 to 1.00.
|
|
§
|
Under our construction and equipment loans with PNC Bank to finance a portion of the construction costs and equipment purchases of our facility expansion in Baltimore, Maryland, we are required to maintain on a rolling four-quarter basis a leverage ratio of less than 2.00 and a debt coverage ratio of not less than 1.25 to 1.00. In addition, we are required to maintain at all times a minimum cash balance of $50.0 million.
|
|
§
|
the level and timing of BioThrax product sales and cost of product sales;
|
|
§
|
our ability to obtain funding from government entities and non-government and philanthropic organizations for our development programs;
|
|
§
|
the acquisition of new facilities and capital improvements to new or existing facilities;
|
|
§
|
the timing of, and the costs involved in, completion of qualification and validation activities related to Building 55, our large-scale manufacturing facility in Lansing, Michigan, the build out of our facility in Baltimore, Maryland, and any other new facilities;
|
|
§
|
the scope, progress, results and costs of our preclinical and clinical development activities;
|
|
§
|
the costs, timing and outcome of regulatory review of our product candidates;
|
|
§
|
the number of, and development requirements for, other product candidates that we may pursue;
|
|
§
|
the costs of commercialization activities, including product marketing, sales and distribution;
|
|
§
|
the market acceptance and sales growth of any of our products and product candidates upon regulatory approval;
|
|
§
|
the extent to which our growth generates increased administrative costs;
|
|
§
|
the costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims and other patent-related costs, including litigation costs and the results of such litigation;
|
|
§
|
the extent to which we acquire or invest in companies, businesses, products or technologies; and
|
|
§
|
the effect of technological and market developments.
|
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||
|
|
||||||||
|
(in thousands, except share and per share data)
|
||||||||
|
December 31,
|
December 31,
|
|||||||
|
2011
|
2010
|
|||||||
|
ASSETS
|
||||||||
|
Current assets:
|
||||||||
|
Cash and cash equivalents
|
$ | 143,901 | $ | 169,019 | ||||
|
Investments
|
1,966 | 2,029 | ||||||
|
Accounts receivable
|
74,153 | 39,326 | ||||||
|
Inventories
|
14,661 | 12,722 | ||||||
|
Deferred tax assets, net
|
1,735 | 2,638 | ||||||
|
Income tax receivable, net
|
9,506 | 8,728 | ||||||
|
Restricted cash
|
220 | 217 | ||||||
|
Prepaid expenses and other current assets
|
8,276 | 8,814 | ||||||
|
Total current assets
|
254,418 | 243,493 | ||||||
|
Property, plant and equipment, net
|
208,973 | 152,701 | ||||||
|
In-process research and development
|
51,400 | 51,400 | ||||||
|
Goodwill
|
5,502 | 5,029 | ||||||
|
Assets held for sale
|
11,765 | 12,741 | ||||||
|
Deferred tax assets, net
|
13,999 | 33,757 | ||||||
|
Other assets
|
807 | 1,198 | ||||||
|
Total assets
|
$ | 546,864 | $ | 500,319 | ||||
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
|
Current liabilities:
|
||||||||
|
Accounts payable
|
$ | 40,530 | $ | 25,409 | ||||
|
Accrued expenses and other current liabilities
|
1,170 | 1,309 | ||||||
|
Accrued compensation
|
20,884 | 23,975 | ||||||
|
Contingent value rights, current portion
|
1,748 | - | ||||||
|
Long-term indebtedness, current portion
|
5,360 | 17,187 | ||||||
|
Deferred revenue, current portion
|
1,362 | 7,839 | ||||||
|
Total current liabilities
|
71,054 | 75,719 | ||||||
|
Contingent value rights, net of current portion
|
3,005 | 14,532 | ||||||
|
Long-term indebtedness, net of current portion
|
54,094 | 30,239 | ||||||
|
Deferred revenue, net of current portion
|
- | 4,386 | ||||||
|
Other liabilities
|
1,984 | 1,882 | ||||||
|
Total liabilities
|
130,137 | 126,758 | ||||||
|
Commitments and contingencies
|
||||||||
|
Stockholders’ equity:
|
||||||||
|
Preferred stock, $0.001 par value; 15,000,000 shares authorized, 0 shares issued and outstanding at December 31, 2011 and 2010, respectively
|
- | - | ||||||
|
Common stock, $0.001 par value; 100,000,000 shares authorized, 36,002,698 and 35,011,423 shares issued and outstanding at December 31, 2011 and 2010, respectively
|
36 | 35 | ||||||
|
Additional paid-in capital
|
220,654 | 197,689 | ||||||
|
Accumulated other comprehensive loss
|
(3,313 | ) | (2,110 | ) | ||||
|
Retained earnings
|
196,869 | 173,850 | ||||||
|
Total Emergent BioSolutions Inc. stockholders' equity
|
414,246 | 369,464 | ||||||
|
Noncontrolling interest in subsidiaries
|
2,481 | 4,097 | ||||||
|
Total stockholders’ equity
|
416,727 | 373,561 | ||||||
|
Total liabilities and stockholders’ equity
|
$ | 546,864 | $ | 500,319 | ||||
|
|
||||||||||||
|
(in thousands, except share and per share data)
|
||||||||||||
|
Year Ended December 31,
|
||||||||||||
|
2011
|
2010
|
2009
|
||||||||||
|
Revenues:
|
||||||||||||
|
Product sales
|
$ | 202,409 | $ | 251,381 | $ | 217,172 | ||||||
|
Contracts and grants
|
70,975 | 34,790 | 17,614 | |||||||||
|
Total revenues
|
273,384 | 286,171 | 234,786 | |||||||||
|
Operating expense:
|
||||||||||||
|
Cost of product sales
|
42,171 | 47,114 | 46,262 | |||||||||
|
Research and development
|
124,832 | 89,295 | 74,588 | |||||||||
|
Selling, general and administrative
|
74,282 | 76,205 | 73,786 | |||||||||
|
Income from operations
|
32,099 | 73,557 | 40,150 | |||||||||
|
Other income (expense):
|
||||||||||||
|
Interest income
|
105 | 832 | 1,418 | |||||||||
|
Interest expense
|
- | - | (7 | ) | ||||||||
|
Other income (expense), net
|
(261 | ) | (1,023 | ) | (50 | ) | ||||||
|
Total other income (expense)
|
(156 | ) | (191 | ) | 1,361 | |||||||
|
Income before provision for income taxes
|
31,943 | 73,366 | 41,511 | |||||||||
|
Provision for income taxes
|
15,830 | 26,182 | 14,966 | |||||||||
|
Net income
|
16,113 | 47,184 | 26,545 | |||||||||
|
Net loss attributable to noncontrolling interest
|
6,906 | 4,514 | 4,599 | |||||||||
|
Net income attributable to Emergent BioSolutions Inc.
|
$ | 23,019 | $ | 51,698 | $ | 31,144 | ||||||
|
Earnings per share - basic
|
$ | 0.65 | $ | 1.63 | $ | 1.02 | ||||||
|
Earnings per share - diluted
|
$ | 0.64 | $ | 1.59 | $ | 0.99 | ||||||
|
Weighted-average number of shares - basic
|
35,658,907 | 31,782,286 | 30,444,485 | |||||||||
|
Weighted-average number of shares - diluted
|
36,206,052 | 32,539,500 | 31,375,305 | |||||||||
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||||||
|
|
||||||||||||
|
(in thousands)
|
||||||||||||
|
Year Ended December 31,
|
||||||||||||
|
2011
|
2010
|
2009
|
||||||||||
|
Cash flows from operating activities:
|
||||||||||||
|
Net income
|
$ | 16,113 | $ | 47,184 | $ | 26,545 | ||||||
|
Adjustments to reconcile to net cash provided by operating activities:
|
||||||||||||
|
Stock-based compensation expense
|
10,739 | 7,063 | 5,007 | |||||||||
|
Depreciation and amortization
|
9,355 | 5,990 | 4,999 | |||||||||
|
Deferred income taxes
|
20,188 | 9,229 | 5,752 | |||||||||
|
Non-cash development expenses from joint venture
|
5,290 | 5,995 | 7,215 | |||||||||
|
Impairment of long-lived assets
|
976 | 1,218 | 7,328 | |||||||||
|
Change in fair value of contingent value rights
|
221 | - | - | |||||||||
|
Provision for impairment of accrued interest on note receivable
|
- | 1,032 | - | |||||||||
|
Excess tax benefits from stock-based compensation
|
(2,200 | ) | (1,700 | ) | (1,852 | ) | ||||||
|
Other
|
392 | (38 | ) | 61 | ||||||||
|
Changes in operating assets and liabilities:
|
||||||||||||
|
Accounts receivable
|
(34,873 | ) | 19,094 | (30,017 | ) | |||||||
|
Inventories
|
(1,939 | ) | 799 | 6,207 | ||||||||
|
Income taxes
|
1,422 | (4,454 | ) | (1,673 | ) | |||||||
|
Prepaid expenses and other assets
|
660 | (764 | ) | (1,435 | ) | |||||||
|
Accounts payable
|
2,510 | 3,392 | (1,547 | ) | ||||||||
|
Accrued expenses and other liabilities
|
(95 | ) | (447 | ) | (109 | ) | ||||||
|
Accrued compensation
|
(3,303 | ) | 6,175 | 3,395 | ||||||||
|
Deferred revenue
|
(10,863 | ) | (838 | ) | (6 | ) | ||||||
|
Net cash provided by operating activities
|
14,593 | 98,930 | 29,870 | |||||||||
|
Cash flows from investing activities:
|
||||||||||||
|
Purchases of property, plant and equipment
|
(54,026 | ) | (22,101 | ) | (33,287 | ) | ||||||
|
Proceeds from maturity of investments
|
4,250 | 6,518 | - | |||||||||
|
Purchase of investments
|
(4,187 | ) | - | - | ||||||||
|
Acquisition of Trubion Pharmaceuticals, Inc., net of cash acquired
|
- | (17,873 | ) | - | ||||||||
|
Repayment of note receivable
|
- | 10,000 | - | |||||||||
|
Net cash used in investing activities
|
(53,963 | ) | (23,456 | ) | (33,287 | ) | ||||||
|
Cash flows from financing activities:
|
||||||||||||
|
Proceeds from borrowings on long-term indebtedness and line of credit
|
27,522 | 15,000 | 57,183 | |||||||||
|
Issuance of common stock subject to exercise of stock options
|
10,026 | 7,235 | 4,464 | |||||||||
|
Excess tax benefits from stock-based compensation
|
2,200 | 1,700 | 1,852 | |||||||||
|
Principal payments on long-term indebtedness and line of credit
|
(15,494 | ) | (33,291 | ) | (48,648 | ) | ||||||
|
Contingent value right payment
|
(10,000 | ) | - | - | ||||||||
|
Restricted cash deposit
|
(3 | ) | (2 | ) | (7 | ) | ||||||
|
Net cash provided by (used in) financing activities
|
14,251 | (9,358 | ) | 14,844 | ||||||||
|
Effect of exchange rate changes on cash and cash equivalents
|
1 | (21 | ) | 24 | ||||||||
|
Net increase (decrease) in cash and cash equivalents
|
(25,118 | ) | 66,095 | 11,451 | ||||||||
|
Cash and cash equivalents at beginning of year
|
169,019 | 102,924 | 91,473 | |||||||||
|
Cash and cash equivalents at end of year
|
143,901 | 169,019 | 102,924 | |||||||||
|
Supplemental disclosure of cash flow information:
|
||||||||||||
|
Cash paid during the year for interest
|
$ | 1,740 | $ | 2,176 | $ | 1,627 | ||||||
|
Cash paid during the year for income taxes
|
$ | 4,280 | $ | 22,440 | $ | 15,155 | ||||||
|
Supplemental information on non-cash investing and financing activities:
|
||||||||||||
|
Issuance of common stock to acquire Trubion Pharmaceuticals, Inc.
|
$ | - | $ | 61,204 | $ | - | ||||||
|
Purchases of property, plant and equipment unpaid at year end
|
$ | 15,509 | $ | 3,519 | $ | 2,749 | ||||||
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||||||||||||||||||||||
|
Consolidated Statement of Changes in Stockholders' Equity
|
||||||||||||||||||||||||||||
|
(in thousands, except share and per share data)
|
||||||||||||||||||||||||||||
|
$0.001 Par Value Common Stock
|
Additional
|
Accumulated Other
|
Noncontrolling Interest
|
Retained
|
Total
|
|||||||||||||||||||||||
|
Paid-In
|
Comprehensive
|
Stockholders'
|
||||||||||||||||||||||||||
|
Shares
|
Amount
|
Capital
|
Loss
|
in Subsidiary
|
Earnings
|
Equity
|
||||||||||||||||||||||
|
Balance at December 31, 2008
|
30,159,546 | $ | 30 | $ | 109,170 | $ | (859 | ) | $ | - | $ | 91,008 | $ | 199,349 | ||||||||||||||
|
Exercise of stock options
|
671,814 | 1 | 4,463 | - | - | - | 4,464 | |||||||||||||||||||||
|
Stock-based compensation expense
|
- | - | 5,007 | - | - | - | 5,007 | |||||||||||||||||||||
|
Excess tax benefits from exercises of stock options
|
- | - | 1,852 | - | - | - | 1,852 | |||||||||||||||||||||
|
Non-cash development expenses from joint ventures
|
- | - | - | - | 7,215 | - | 7,215 | |||||||||||||||||||||
|
Net loss attributable to noncontrolling interest
|
- | - | - | - | (4,599 | ) | - | (4,599 | ) | |||||||||||||||||||
|
Net income
|
- | - | - | - | - | 31,144 | 31,144 | |||||||||||||||||||||
|
Foreign currency translation
|
- | - | - | (617 | ) | - | - | (617 | ) | |||||||||||||||||||
|
Comprehensive income
|
- | - | - | - | - | - | 30,527 | |||||||||||||||||||||
|
Balance at December 31, 2009
|
30,831,360 | $ | 31 | $ | 120,492 | $ | (1,476 | ) | $ | 2,616 | $ | 122,152 | $ | 243,815 | ||||||||||||||
|
Issuance of stock for Trubion
|
||||||||||||||||||||||||||||
|
Pharmaceuticals, Inc. acquisition
|
3,351,817 | 3 | 61,200 | - | - | - | 61,203 | |||||||||||||||||||||
|
Exercise of stock options
|
828,246 | 1 | 7,234 | - | - | - | 7,235 | |||||||||||||||||||||
|
Stock-based compensation expense
|
- | - | 7,063 | - | - | - | 7,063 | |||||||||||||||||||||
|
Excess tax benefits from exercises of stock options
|
- | - | 1,700 | - | - | - | 1,700 | |||||||||||||||||||||
|
Non-cash development expenses from joint ventures
|
- | - | - | - | 5,995 | - | 5,995 | |||||||||||||||||||||
|
Net loss attributable to noncontrolling interest
|
- | - | - | - | (4,514 | ) | - | (4,514 | ) | |||||||||||||||||||
|
Net income
|
- | - | - | - | - | 51,698 | 51,698 | |||||||||||||||||||||
|
Foreign currency translation
|
- | - | - | (634 | ) | - | - | (634 | ) | |||||||||||||||||||
|
Comprehensive income
|
- | - | - | - | - | - | 51,064 | |||||||||||||||||||||
|
Balance at December 31, 2010
|
35,011,423 | $ | 35 | $ | 197,689 | $ | (2,110 | ) | $ | 4,097 | $ | 173,850 | $ | 373,561 | ||||||||||||||
|
Exercise of stock options
|
991,275 | 1 | 10,025 | - | - | - | 10,026 | |||||||||||||||||||||
|
Stock-based compensation expense
|
- | - | 10,740 | - | - | - | 10,740 | |||||||||||||||||||||
|
Excess tax benefits from exercises of stock options
|
- | - | 2,200 | - | - | - | 2,200 | |||||||||||||||||||||
|
Non-cash development expenses from joint ventures
|
- | - | - | - | 5,290 | - | 5,290 | |||||||||||||||||||||
|
Net loss attributable to noncontrolling interest
|
- | - | - | - | (6,906 | ) | - | (6,906 | ) | |||||||||||||||||||
|
Net income
|
- | - | - | - | - | 23,019 | 23,019 | |||||||||||||||||||||
|
Foreign currency translation
|
- | - | - | (1,203 | ) | - | - | (1,203 | ) | |||||||||||||||||||
|
Comprehensive income
|
- | - | - | - | - | - | 21,816 | |||||||||||||||||||||
|
Balance at December 31, 2011
|
36,002,698 | $ | 36 | $ | 220,654 | $ | (3,313 | ) | $ | 2,481 | $ | 196,869 | $ | 416,727 | ||||||||||||||
|
|
Level 1 — Observable inputs for identical assets or liabilities such as quoted prices in active markets;
|
|
|
Level 2 — Inputs other than quoted prices in active markets that are either directly or indirectly observable; and
|
|
|
Level 3 —Unobservable inputs in which little or no market data exists, which are therefore developed by the Company using estimates and assumptions that reflect those that a market participant would use.
|
|
Buildings
|
31-39 years
|
|
Building improvements
|
10-39 years
|
|
Furniture and equipment
|
3-7 years
|
|
Software
|
Lesser of 3-5 years or product life
|
|
Leasehold improvements
|
Lesser of the asset life or lease term
|
|
|
§
|
there is persuasive evidence of an arrangement;
|
|
|
§
|
delivery has occurred or title has passed to the Company’s customer;
|
|
|
§
|
the fee is fixed or determinable; and
|
|
|
§
|
collectibility is reasonably assured.
|
|
|
§
|
estimating the timing of and expected costs to complete the in-process projects;
|
|
|
§
|
projecting regulatory approvals;
|
|
|
§
|
estimating future cash flows from product sales resulting from completed products and in-process projects; and
|
|
|
§
|
developing appropriate discount rates and probability rates by project.
|
|
Year Ended December 31,
|
||||||||||||
|
2011
|
2010
|
2009
|
||||||||||
|
Expected dividend yield
|
0 | % | 0 | % | 0 | % | ||||||
|
Expected volatility
|
60 | % | 55 | % | 55 | % | ||||||
|
Risk-free interest rate
|
0.35-1.04 | % | 0.49-1.46 | % | 1.32-1.72 | % | ||||||
|
Expected average life of options
|
3.4 years
|
3.4 years
|
3.3 years
|
|||||||||
|
§
|
Expected dividend yield — the Company does not pay regular dividends on its common stock and does not anticipate paying any dividends in the foreseeable future.
|
|
§
|
Expected volatility — a measure of the amount by which a financial variable, such as share price, has fluctuated (historical volatility) or is expected to fluctuate (implied volatility) during a period. The Company analyzed its own historical volatility to estimate expected volatility over the same period as the expected average life of the options.
|
|
§
|
Risk-free interest rate — the range of U.S. Treasury rates with a term that most closely resembles the expected life of the option as of the date on which the option is granted.
|
|
§
|
Expected average life of options — the period of time that options granted are expected to remain outstanding, based primarily on the Company’s expectation of optionee exercise behavior subsequent to vesting of options.
|
|
|
§
|
$1.365 in cash, without interest;
|
|
|
§
|
0.1641 of a share of Emergent common stock; and
|
|
|
§
|
one CVR issued by Emergent.
|
|
|
§
|
a cash payment equal to the difference between $4.55 and the exercise price of the stock option, as applicable; and
|
|
|
§
|
one CVR issued by Emergent.
|
|
|
§
|
$6.25 million upon initiation of dosing in the first Phase III clinical study for the first major indication for a CD20 candidate;
|
|
|
§
|
$5.0 million upon initiation of dosing in the first Phase III clinical study for the second major indication for a CD20 candidate;
|
|
|
§
|
$750,000 upon initiation of dosing in the first Phase II clinical study for a product candidate directed towards a non-CD 20 target;
|
|
|
§
|
$1.7 million upon initiation of the first Phase II clinical study for TRU-016;
|
|
|
§
|
$15.0 million upon initiation of the first Phase III clinical study in an oncology indication for TRU-016; and
|
|
|
§
|
$10.0 million upon release of TRU-016 manufactured material for use in clinical studies.
|
|
(in thousands)
|
||||
|
Amount of cash received by Trubion stockholders and stock option holders
|
$ | 31,743 | ||
|
Value of shares of Emergent common stock issued
|
61,204 | |||
|
Fair value of CVRs
|
14,532 | |||
|
Total estimated purchase price
|
$ | 107,479 | ||
|
(in thousands)
|
||||
|
Cash
|
$ | 13,870 | ||
|
Investments
|
8,547 | |||
|
Accounts receivable
|
3,548 | |||
|
Prepaid expenses and other assets
|
1,366 | |||
|
Property, plant and equipment
|
3,948 | |||
|
Deferred taxes
|
39,387 | |||
|
Acquired research and development assets
|
51,400 | |||
|
Goodwill
|
5,502 | |||
|
Accounts payable and accrued liabilities
|
(3,857 | ) | ||
|
Accrued compensation
|
(2,842 | ) | ||
|
Deferred revenue
|
(12,792 | ) | ||
|
Other long-term liabilities
|
(598 | ) | ||
|
Total purchase price
|
$ | 107,479 | ||
|
December 31,
|
||||||||
|
(in thousands, except per share data)
|
2010
|
2009
|
||||||
|
Pro forma revenue
|
$ | 303,317 | $ | 252,789 | ||||
|
Pro forma net income
|
$ | 36,973 | $ | 12,522 | ||||
|
Pro forma earnings per share-basic
|
$ | 1.16 | $ | 0.37 | ||||
|
Pro forma earnings per share-diluted
|
$ | 1.14 | $ | 0.36 | ||||
|
At December 31, 2011
|
||||||||||||||||
|
(in thousands)
|
Level 1
|
Level 2
|
Level 3
|
Total
|
||||||||||||
|
Assets:
|
||||||||||||||||
|
Investment in money market funds (1)
|
$ | 73,005 | $ | - | $ | - | $ | 73,005 | ||||||||
|
U.S. Treasury securities (2)
|
- | 1,966 | - | 1,966 | ||||||||||||
|
Total assets
|
$ | 73,005 | $ | 1,966 | $ | - | $ | 74,971 | ||||||||
|
Liabilities:
|
||||||||||||||||
|
Contingent value rights
|
$ | - | $ | - | $ | 4,753 | $ | 4,753 | ||||||||
|
Total liabilities
|
$ | - | $ | - | $ | 4,753 | $ | 4,753 | ||||||||
|
At December 31, 2010
|
||||||||||||||||
|
(in thousands)
|
Level 1
|
Level 2
|
Level 3
|
Total
|
||||||||||||
|
Assets:
|
||||||||||||||||
|
Investment in money market funds (1)
|
$ | 102,360 | $ | - | $ | - | $ | 102,360 | ||||||||
|
U.S. Treasury securities (2)
|
- | 2,029 | - | 2,029 | ||||||||||||
|
Total assets
|
$ | 102,360 | $ | 2,029 | $ | - | $ | 104,389 | ||||||||
|
Liabilities:
|
||||||||||||||||
|
Contingent value rights
|
$ | - | $ | - | $ | 14,532 | $ | 14,532 | ||||||||
|
Total liabilities
|
$ | - | $ | - | $ | 14,532 | $ | 14,532 | ||||||||
|
(in thousands)
|
||||
|
Balance at January 1, 2010
|
$ | - | ||
|
Fair value of CVRs issued
|
14,532 | |||
|
Expense (income) included in earnings
|
- | |||
|
Purchases, sales, issuances and settlements
|
- | |||
|
Transfers in/(out) of Level 3
|
- | |||
|
Balance at December 31, 2010
|
$ | 14,532 | ||
|
Expense (income) included in earnings
|
221 | |||
|
Settlements
|
(10,000 | ) | ||
|
Purchases, sales and issuances
|
- | |||
|
Transfers in/(out) of Level 3
|
- | |||
|
Balance at December 31, 2011
|
$ | 4,753 | ||
|
At December 31, 2011
|
||||||||||||||||
|
(in thousands)
|
Amortized Costs
|
Gross Unrealized Gains
|
Gross Unrealized Losses
|
Estimated Fair Market Value
|
||||||||||||
|
U.S. Treasury securities
|
$ | 1,966 | $ | - | $ | - | $ | 1,966 | ||||||||
|
At December 31, 2010
|
||||||||||||||||
|
(in thousands)
|
Amortized Costs
|
Gross Unrealized Gains
|
Gross Unrealized Losses
|
Estimated Fair Market Value
|
||||||||||||
|
U.S. Treasury securities
|
$ | 2,030 | $ | - | $ | 1 | $ | 2,029 | ||||||||
|
December 31,
|
||||||||
|
(in thousands)
|
2011
|
2010
|
||||||
|
Billed
|
$ | 55,188 | $ | 25,751 | ||||
|
Unbilled
|
18,965 | 13,575 | ||||||
|
Total
|
$ | 74,153 | $ | 39,326 | ||||
|
December 31,
|
||||||||
|
(in thousands)
|
2011
|
2010
|
||||||
|
Raw materials and supplies
|
$ | 2,313 | $ | 2,311 | ||||
|
Work-in-process
|
10,149 | 7,917 | ||||||
|
Finished goods
|
2,199 | 2,494 | ||||||
|
Total inventories
|
$ | 14,661 | $ | 12,722 | ||||
|
December 31,
|
||||||||
|
(in thousands)
|
2011
|
2010
|
||||||
|
Land and improvements
|
$ | 4,115 | $ | 3,506 | ||||
|
Buildings, building improvements and leasehold improvements
|
26,122 | 21,455 | ||||||
|
Furniture and equipment
|
42,135 | 34,797 | ||||||
|
Software
|
11,854 | 10,071 | ||||||
|
Construction-in-progress
|
157,206 | 109,567 | ||||||
| 241,432 | 179,396 | |||||||
|
Less: Accumulated depreciation and amortization
|
(32,459 | ) | (26,695 | ) | ||||
|
Total Property, plant and equipment, net
|
$ | 208,973 | $ | 152,701 | ||||
|
December 31,
|
December 31,
|
|||||||
|
(in thousands)
|
2011
|
2010
|
||||||
|
Construction loan dated July 2011; LIBOR plus 3%
|
$ | 26,095 | $ | - | ||||
|
Equipment loan dated August 2011; variable
|
1,426 | $ | - | |||||
|
Term loan dated December 2009; three month LIBOR plus 3.25%, due December 2014
|
19,717 | 21,233 | ||||||
|
Term loan dated November 2009; three month LIBOR plus 3.25%, repaid in July 2011
|
- | 6,513 | ||||||
|
Term loan dated November 2009; three month LIBOR plus 3.25%, due November 2014
|
4,478 | 4,825 | ||||||
|
Term loan dated April 2006; three month LIBOR plus 3.0%, repaid in April 2011
|
- | 6,686 | ||||||
|
Loan dated October 2004; 3.0%, due March 2012
|
2,500 | 2,500 | ||||||
|
Term loan dated October 2004; 3.48%, due October 2013
|
5,238 | 5,669 | ||||||
|
Total long-term indebtedness
|
59,454 | 47,426 | ||||||
|
Less current portion of long-term indebtedness
|
(5,360 | ) | (17,187 | ) | ||||
|
Noncurrent portion of long-term indebtedness
|
$ | 54,094 | $ | 30,239 | ||||
|
2006 Plan
|
2004 Plan
|
|||||||||||||||||||
|
Number of Shares
|
Weighted-Average Exercise Price
|
Number of Shares
|
Weighted-Average Exercise Price
|
Aggregate Intrinsic Value
|
||||||||||||||||
|
Outstanding at December 31, 2010
|
3,397,915 | $ | 14.31 | 67,541 | $ | 9.80 | $ | 32,023,466 | ||||||||||||
|
Exercisable at December 31, 2010
|
1,249,749 | $ | 12.42 | 67,541 | $ | 9.80 | $ | 14,725,004 | ||||||||||||
|
Granted
|
841,727 | 23.65 | - | - | ||||||||||||||||
|
Exercised
|
(881,368 | ) | 11.29 | (14,385 | ) | 13.26 | ||||||||||||||
|
Forfeited
|
(276,565 | ) | 18.80 | - | - | |||||||||||||||
|
Outstanding at December 31, 2011
|
3,081,709 | $ | 17.35 | 53,156 | $ | 8.86 | $ | 6,238,427 | ||||||||||||
|
Exercisable at December 31, 2011
|
1,459,049 | $ | 14.19 | 53,156 | $ | 8.86 | $ | 5,650,832 | ||||||||||||
|
Options expected to vest at December 31, 2011
|
1,138,328 | $ | 19.84 | - | $ | - | $ | 448,355 | ||||||||||||
|
Number of Shares
|
Weighted-Average Grant Price
|
Aggregate Intrinsic Value
|
||||||||||
|
Outstanding at December 31, 2010
|
395,555 | $ | 16.09 | $ | 9,279,720 | |||||||
|
Granted
|
440,873 | 23.59 | ||||||||||
|
Vested
|
(134,516 | ) | 16.29 | |||||||||
|
Forfeited
|
(66,412 | ) | 19.66 | |||||||||
|
Outstanding at December 31, 2011
|
635,500 | $ | 20.89 | $ | 10,714,450 | |||||||
|
December 31,
|
||||||||||||
|
(in thousands)
|
2011
|
2010
|
2009
|
|||||||||
|
Cost of sales
|
$ | 466 | $ | 324 | $ | 200 | ||||||
|
Research and development
|
3,203 | 1,635 | 1,103 | |||||||||
|
General and administrative
|
7,070 | 5,104 | 3,704 | |||||||||
|
Total stock-based compensation expense
|
$ | 10,739 | $ | 7,063 | $ | 5,007 | ||||||
|
Year Ended December 31,
|
||||||||||||
|
(in thousands, except share and per share data)
|
2011
|
2010
|
2009
|
|||||||||
|
Numerator:
|
||||||||||||
|
Net income
|
$ | 23,019 | $ | 51,698 | $ | 31,144 | ||||||
|
Denominator:
|
||||||||||||
|
Weighted-average number of shares—basic
|
35,658,907 | 31,782,286 | 30,444,485 | |||||||||
|
Dilutive securities—equity awards
|
547,145 | 757,214 | 930,820 | |||||||||
|
Weighted-average number of shares—diluted
|
36,206,052 | 32,539,500 | 31,375,305 | |||||||||
|
Earnings per share-basic
|
$ | 0.65 | $ | 1.63 | $ | 1.02 | ||||||
|
Earnings per share-diluted
|
$ | 0.64 | $ | 1.59 | $ | 0.99 | ||||||
|
Year ended December 31,
|
||||||||||||
|
(in thousands)
|
2011
|
2010
|
2009
|
|||||||||
|
Current
|
||||||||||||
|
Federal
|
$ | (3,795 | ) | $ | 16,664 | $ | 8,254 | |||||
|
State
|
(1,110 | ) | 187 | 902 | ||||||||
|
International
|
74 | 102 | 58 | |||||||||
|
Total current
|
(4,831 | ) | 16,953 | 9,214 | ||||||||
|
Deferred
|
||||||||||||
|
Federal
|
19,055 | 10,003 | 5,799 | |||||||||
|
State
|
1,606 | (774 | ) | (47 | ) | |||||||
|
Total deferred
|
20,661 | 9,229 | 5,752 | |||||||||
|
Total provision for income taxes
|
$ | 15,830 | $ | 26,182 | $ | 14,966 | ||||||
|
December 31,
|
||||||||
|
(in thousands)
|
2011
|
2010
|
||||||
|
Net operating loss carryforward
|
$ | 28,621 | $ | 30,852 | ||||
|
Research and development carryforward
|
3,556 | 2,991 | ||||||
|
Stock compensation
|
3,666 | 2,623 | ||||||
|
Foreign deferred tax assets
|
61,255 | 60,754 | ||||||
|
Deferred revenue
|
485 | 4,183 | ||||||
|
Other
|
9,596 | 15,703 | ||||||
|
Deferred tax asset
|
107,179 | 117,106 | ||||||
|
Fixed assets
|
(21,760 | ) | (9,150 | ) | ||||
|
Other
|
(6,902 | ) | (11,971 | ) | ||||
|
Deferred tax liability
|
(28,662 | ) | (21,121 | ) | ||||
|
Valuation allowance
|
(62,783 | ) | (59,590 | ) | ||||
|
Net deferred tax asset
|
$ | 15,734 | $ | 36,395 | ||||
|
Year ended December 31,
|
||||||||||||
|
(in thousands)
|
2011
|
2010
|
2009
|
|||||||||
|
US
|
$ | 66,756 | $ | 111,775 | $ | 74,758 | ||||||
|
International
|
(27,907 | ) | (33,895 | ) | (28,648 | ) | ||||||
|
Earnings before taxes on income
|
38,849 | 77,880 | 46,110 | |||||||||
|
Federal tax at statutory rates
|
$ | 13,597 | $ | 27,258 | $ | 16,138 | ||||||
|
State taxes, net of federal benefit
|
46 | 666 | (1,172 | ) | ||||||||
|
Impact of foreign operations
|
(2,371 | ) | (7,713 | ) | (7,156 | ) | ||||||
|
Change in valuation allowance
|
3,193 | 6,394 | 9,025 | |||||||||
|
Effect of foreign rates
|
(12 | ) | (30 | ) | (17 | ) | ||||||
|
Tax credits
|
(1,405 | ) | (1,754 | ) | (835 | ) | ||||||
|
Other differences
|
556 | 398 | (2,056 | ) | ||||||||
|
Permanent differences
|
2,226 | 963 | 1,039 | |||||||||
|
Provision for income taxes
|
$ | 15,830 | $ | 26,182 | $ | 14,966 | ||||||
|
(in thousands)
|
||||
|
Gross unrecognized tax benefits at January 1, 2009
|
$ | 270 | ||
|
Increases for tax positions for prior years
|
15 | |||
|
Decreases for tax positions for prior years
|
(80 | ) | ||
|
Increases for tax positions for current year
|
55 | |||
|
Settlements
|
- | |||
|
Lapse of statue of limitations
|
- | |||
|
Gross unrecognized tax benefits at December 31, 2010
|
260 | |||
|
Increases for tax positions for prior years
|
16 | |||
|
Decreases for tax positions for prior years
|
(175 | ) | ||
|
Increases for tax positions for current year
|
849 | |||
|
Settlements
|
- | |||
|
Lapse of statue of limitations
|
- | |||
|
Gross unrecognized tax benefits at December 31, 2010
|
950 | |||
|
Increases for tax positions for prior years
|
167 | |||
|
Decreases for tax positions for prior years
|
(61 | ) | ||
|
Increases for tax positions for current year
|
- | |||
|
Settlements
|
- | |||
|
Lapse of statue of limitations
|
- | |||
|
Gross unrecognized tax benefits at December 31, 2011
|
$ | 1,056 | ||
|
Incurred in
|
Inception to Date
|
Total
|
||||||||||
|
(in thousands)
|
2011
|
Costs Incurred
|
Incurred
|
|||||||||
|
Termination benefits
|
$ | 475 | $ | 2,893 | $ | 2,893 | ||||||
|
Contract termination costs
|
1,923 | 2,295 | 2,295 | |||||||||
|
Other costs
|
90 | 350 | 350 | |||||||||
|
Total
|
$ | 2,488 | $ | 5,538 | $ | 5,538 | ||||||
|
Lease
|
||||||||||||
|
Termination
|
Termination
|
|||||||||||
|
(in thousands)
|
Benefits
|
Costs
|
Total
|
|||||||||
|
Balance at December 31, 2010
|
$ | 2,418 | $ | 650 | $ | 3,068 | ||||||
|
Expenses incurred
|
475 | 1,923 | 2,398 | |||||||||
|
Amount paid
|
(2,893 | ) | (2,295 | ) | (5,188 | ) | ||||||
|
Other adjustments
|
- | (278 | ) | (278 | ) | |||||||
|
Balance at December 31, 2011
|
$ | - | $ | - | $ | - | ||||||
|
(in thousands)
|
||||
|
2012
|
$ | 3,261 | ||
|
2013
|
2,457 | |||
|
2014
|
2,003 | |||
|
2015
|
1,820 | |||
|
2016
|
1,379 | |||
|
2017 and beyond
|
- | |||
|
Total minimum lease payments
|
$ | 10,919 | ||
|
Reportable Segments
|
||||||||||||||||
|
(in thousands)
|
Biodefense
|
Biosciences
|
All Other
|
Total
|
||||||||||||
|
Year Ended December 31, 2011
|
||||||||||||||||
|
External revenue
|
$ | 251,037 | $ | 22,347 | $ | $ | 273,384 | |||||||||
|
Intersegment revenue (expense)
|
- | - | - | - | ||||||||||||
|
Research and development
|
54,566 | 64,406 | 5,860 | 124,832 | ||||||||||||
|
Interest revenue
|
- | - | 105 | 105 | ||||||||||||
|
Interest expense
|
- | - | - | - | ||||||||||||
|
Depreciation and amortization
|
6,169 | 3,067 | 119 | 9,355 | ||||||||||||
|
Net income (loss)
|
90,102 | (59,705 | ) | (7,378 | ) | 23,019 | ||||||||||
|
In-process research and development assets
|
- | 51,400 | - | 51,400 | ||||||||||||
|
Goodwill
|
- | 5,502 | - | 5,502 | ||||||||||||
|
Total assets
|
301,757 | 120,190 | 124,917 | 546,864 | ||||||||||||
|
Expenditures for long-lived assets
|
23,857 | 30,077 | 92 | 54,026 | ||||||||||||
|
Year Ended December 31, 2010
|
||||||||||||||||
|
External revenue
|
$ | 282,727 | $ | 3,444 | $ | - | $ | 286,171 | ||||||||
|
Intersegment revenue (expense)
|
- | - | - | - | ||||||||||||
|
Research and development
|
50,613 | 32,835 | 5,847 | 89,295 | ||||||||||||
|
Interest revenue
|
- | - | 832 | 832 | ||||||||||||
|
Interest expense
|
- | - | - | - | ||||||||||||
|
Depreciation and amortization
|
4,549 | 1,368 | 73 | 5,990 | ||||||||||||
|
Net income (loss)
|
114,826 | (55,253 | ) | (7,875 | ) | 51,698 | ||||||||||
|
In-process research and development assets
|
- | 51,400 | - | 51,400 | ||||||||||||
|
Goodwill
|
- | 5,029 | - | 5,029 | ||||||||||||
|
Total assets
|
203,318 | 112,492 | 184,509 | 500,319 | ||||||||||||
|
Expenditures for long-lived assets
|
18,168 | 3,933 | - | 22,101 | ||||||||||||
|
Year Ended December 31, 2009
|
||||||||||||||||
|
External revenue
|
$ | 234,574 | $ | 212 | $ | - | $ | 234,786 | ||||||||
|
Intersegment revenue (expense)
|
- | - | - | - | ||||||||||||
|
Research and development
|
42,890 | 27,211 | 4,487 | 74,588 | ||||||||||||
|
Interest revenue
|
- | - | 1,418 | 1,418 | ||||||||||||
|
Interest expense
|
- | - | (7 | ) | (7 | ) | ||||||||||
|
Depreciation and amortization
|
3,867 | 1,074 | 58 | 4,999 | ||||||||||||
|
Net income (loss)
|
88,036 | (50,560 | ) | (6,332 | ) | 31,144 | ||||||||||
|
Three months ended
|
||||||||||||||||
|
(in thousands)
|
March 31,
|
June 30,
|
September 30,
|
December 31,
|
||||||||||||
|
Fiscal year 2011
|
||||||||||||||||
|
Revenue
|
$ | 18,533 | $ | 88,141 | $ | 58,762 | $ | 107,948 | ||||||||
|
Income (loss) from operations
|
(35,506 | ) | 20,207 | 1,408 | 45,990 | |||||||||||
|
Net income (loss)
|
(21,397 | ) | 14,210 | 1,549 | 28,657 | |||||||||||
|
Net income (loss) per share, basic
|
(0.61 | ) | 0.40 | 0.04 | 0.80 | |||||||||||
|
Net income (loss) per share, diluted
|
(0.61 | ) | 0.39 | 0.04 | 0.78 | |||||||||||
|
Fiscal year 2010
|
||||||||||||||||
|
Revenue
|
$ | 46,800 | $ | 62,138 | $ | 73,986 | $ | 103,247 | ||||||||
|
Income from operations
|
3,178 | 14,811 | 20,605 | 34,963 | ||||||||||||
|
Net income
|
2,523 | 9,808 | 13,120 | 26,247 | ||||||||||||
|
Net income per share, basic
|
0.08 | 0.32 | 0.42 | 0.78 | ||||||||||||
|
Net income per share, diluted
|
0.08 | 0.31 | 0.41 | 0.76 | ||||||||||||
|
Report of Independent Registered Public Accounting Firm
on Internal Controls Over Financial Reporting
|
|
Signature
|
Title
|
Date
|
||
|
/s/Fuad El-Hibri
Fuad El-Hibri
|
Chief Executive Officer and Chairman of the Board of Directors
(Principal Executive Officer)
|
March 6, 2012
|
||
|
/s/R. Don Elsey
R. Don Elsey
|
Senior Vice President Finance, Chief Financial Officer and Treasurer
(Principal Financial and Accounting Officer)
|
March 9, 2012
|
||
|
/s/Daniel Abdun-Nabi
Daniel Abdun-Nabi
|
Director
|
March 9, 2012
|
||
|
/s/Zsolt Harsanyi, Ph.D.
Zsolt Harsanyi, Ph.D.
|
Director
|
March 9, 2012
|
||
|
/s/Dr. John Niederhuber
|
||||
|
John E. Niederhuber, M.D.
|
Director
|
March 9, 2012
|
||
|
/s/Ronald B. Richard
Ronald B. Richard
|
Director
|
March 6, 2012
|
||
|
/s/Louis W. Sullivan, M.D.
Louis W. Sullivan, M.D.
|
Director
|
March 9, 2012
|
||
|
/s/Marvin White
|
||||
|
Marvin L. White
|
Director
|
March 9, 2012
|
||
|
/s/Dr. Sue Bailey
Dr. Sue Bailey
|
Director
|
March 9, 2012
|
||
|
Exhibit
|
|||
|
Number
|
Description
|
||
| 2.1 |
Agreement and Plan of Merger, dated August 12, 2010, among the Registrant, Emergent Product Development Seattle, LLC (as successor-in-interest to Trubion Pharmaceuticals, Inc.), 35406 LLC, and 30333 Inc. (Incorporated by reference to Exhibit 2.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on August 13, 2010) (File No. 001-33137)
|
||
| 2.2 |
Amendment No. 1 to Agreement and Plan of Merger, dated September 29, 2010, among the Registrant, Emergent Product Development Seattle, LLC (as successor-in-interest to Trubion Pharmaceuticals, Inc.), 35406 LLC, and 30333 Inc. (Incorporated by reference to Exhibit 99.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on September 30, 2010)(File No. 001-33137)
|
||
| 3.1 |
Restated Certificate of Incorporation of the Registrant (Incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-8 filed with the SEC on December 8, 2006) (File No. 333-139190)
|
||
| 3.2 |
Amended and Restated By-laws of the Registrant, as amended (Incorporated by reference to Exhibit 3.2 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2007 filed with the SEC on March 10, 2008) (File No. 001-33137)
|
||
| 4.1 |
Specimen Certificate Evidencing Shares of Common Stock (Incorporated by reference to Exhibit 4.1 to Amendment No. 3 to the Registrant’s Registration Statement on Form S-1 filed with the SEC on October 20, 2006) (File No. 333-136622)
|
||
| 4.2 |
Registration Rights Agreement, dated September 22, 2006, among the Registrant and the entities listed on Schedule 1 thereto (Incorporated by reference to Exhibit 4.3 to Amendment No. 1 to the Registrant’s Registration Statement on Form S-1 filed with the SEC on September 25, 2006) (File No. 333-136622)
|
||
| 4.3 |
Rights Agreement, dated November 14, 2006, between the Registrant and American Stock Transfer & Trust Company (Incorporated by reference to Exhibit 4.3 to the Registrant’s Registration Statement on Form S-8 filed with the SEC on December 8, 2006) (File No. 333-139190)
|
||
| 4.4 |
Contingent Value Rights Agreement, dated August 12, 2010, among the Registrant, Emergent Product Development Seattle, LLC (as successor-in-interest to Trubion Pharmaceuticals, Inc.) and Mellon Investor Services LLC, as rights agent (Incorporated by reference to Exhibit 10.1 to the Registrant's Current Report on Form 8-K filed with the SEC on August 13, 2010) (File No. 001-33137)
|
||
| 9.1 |
Voting and Right of First Refusal Agreement, dated October 21, 2005, between the William J. Crowe, Jr. Revocable Living Trust and Fuad El-Hibri (Incorporated by reference to Exhibit 9.1 to the Registrant’s Registration Statement on Form S-1 filed with the SEC on August 14, 2006) (File No. 333-136622)
|
||
| 10.1 | * |
Employee Stock Option Plan, as amended and restated (Incorporated by reference to Exhibit 10.1 to the Registrant’s Registration Statement on Form S-1 filed with the SEC on August 14, 2006) (File No. 333-136622)
|
|
| 10.2 | * |
Form of Director Stock Option Agreement (Incorporated by reference to Exhibit 10.2 to the Registrant’s Registration Statement on Form S-1 filed with the SEC on August 14, 2006) (File No. 333-136622)
|
|
| 10.3 | * |
Amended and Restated 2006 Stock Incentive Plan (Incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2009 filed with the SEC on August 7, 2009) (File No. 001-33137)
|
|
| 10.4 | * |
Form of Incentive Stock Option Agreement under 2006 Stock Incentive Plan (Incorporated by reference to Exhibit 10.4 to Amendment No. 5 to the Registrant’s Registration Statement on Form S-1 filed with the SEC on October 30, 2006)(File No. 333-136622)
|
|
| 10.5 | * |
Form of Nonstatutory Stock Option Agreement under 2006 Stock Incentive Plan (Incorporated by reference to Exhibit 10.5 to Amendment No. 5 to the Registrant’s Registration Statement on Form S-1 filed with the SEC on October 30, 2006) (File No. 333-136622)
|
|
| 10.6 | * |
Form of Restricted Stock Unit Agreement under Amended and Restated 2006 Stock Incentive Plan (Incorporated by reference to Exhibit 10.6 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2009 filed with the SEC on March 5, 2010) (File No. 001-33137)
|
|
| 10.7 | * |
Annual Bonus Plan for Executive Officers (Incorporated by reference to Exhibit 10.7 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2009 filed with the SEC on March 5, 2010) (File No. 001-33137)
|
|
| 10.8 | * |
Director Compensation Program (Incorporated by reference to Exhibit 10.6 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2007 filed with the SEC on March 10, 2008) (File No. 001-33137)
|
|
| 10.9 | * |
Amended and Restated Senior Management Severance Plan (Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on December 22, 2011) (File No. 001-33137)
|
|
| 10.10 | * |
Election of Fuad El-Hibri to participate in the Severance Plan and Termination Protection Program (Incorporated by reference to Exhibit 10.35 to Amendment No. 1 to the Registrant's Registration Statement on Form S-1 (File No. 333-136622) filed with the SEC on September 25, 2006
|
|
| 10.11 | *# |
Employment Agreement, effective January 1, 2012, between Emergent Product Development UK Ltd and Dr. Steven Chatfield
|
|
| 10.12 |
Form of Indemnity Agreement (Incorporated by reference to Exhibit 10.7 to the Registrant’s Registration Statement on Form S-1 filed with the SEC on August 14, 2006) (File No. 333-136622)
|
||
| 10.13 | † |
Contract No. HHSO100200700037C, dated September 25, 2007, between Emergent Biodefense Operations Lansing Inc., and the Department of Health and Human Services (Incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2007 filed with the SEC on November 5, 2007) (File No. 001-33137)
|
|
| 10.14 |
Modification No. 7 to Contract No. HHSO100200700037C, dated September 22, 2010, between Emergent Biodefense Operations Lansing LLC, formerly known as Emergent Biodefense Operations Lansing Inc., and the Department of Health and Human Services (Incorporated by reference to Exhibit 10.7 to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2010 filed with the SEC on November 5, 2010) (File No. 001-33137)
|
||
| 10.15 |
Modification No. 9 to Contract No. HHSO100200700037C, effective February 2, 2011, between Emergent BioDefense Operations Lansing LLC, formerly known as Emergent BioDefense Operations Lansing Inc., and the Department of Health and Human Services (Incorporated by reference to Exhibit 10.5 to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2011 filed with the SEC on August 5, 2011) (File No. 001-33137)
|
||
| 10.16 |
Modification No. 12 to Contract No. HHS0100200700037C, dated August 24, 2011, between Emergent BioDefense Operations Lansing LLC, formerly known as Emergent BioDefense Operations Lansing Inc., and the Department of Health and Human Services (Incorporated by reference to Exhibit 10.5 to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2011 filed with the SEC on November 4, 2011) (File No. 001-33137)
|
||
| 10.17# |
Modification No. 13 to Contract No. HHS0100200700037C, dated October 21, 2011, between Emergent BioDefense Operations Lansing LLC, formerly known as Emergent BioDefense Operations Lansing Inc., and the Department of Health and Human Services
|
||
| 10.18# |
Modification No. 14 to Contract No. HHS0100200700037C, effective January 3, 2012, between Emergent BioDefense Operations Lansing LLC, formerly known as Emergent BioDefense Operations Lansing Inc., and the Department of Health and Human Services
|
||
| 10.19 | † |
Contract No. HHS0100200800091C between the Department of Health and Human Services and Emergent Biodefense Operations Lansing Inc. dated September 30, 2008 (Incorporated by reference to Exhibit 10.6 to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2008 filed with the SEC on November 7, 2008) (File No. 001-33137)
|
|
| 10.20 | † |
Contract No. HHSO100201000034C, dated July 13, 2010, between Emergent Biodefense Operations Lansing LLC, formerly known as Emergent Biodefense Operations Lansing Inc., and the Department of Health and Human Services (Incorporated by reference to Exhibit 10.4 to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2010 filed with the SEC on November 5, 2010) (File No. 001-33137)
|
|
| 10.21 |
Modification No. 2 of Contract No. HHSO100201000034C, effective December 1, 2010, between Emergent Biodefense Operations Lansing LLC, formerly known as Emergent Biodefense Operations Lansing Inc., and Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services (Incorporated by reference to Exhibit 10.50 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2010 filed with the SEC on March 11, 2011) (File No. 001-33137)
|
||
| 10.22 | † |
Modification No. 9 to Contract No. 200-2009-30162, effective July 6, 2010, between Emergent Biodefense Operations Lansing LLC, formerly known as Emergent Biodefense Operations Lansing Inc., and the Centers for Disease Control and Prevention (Incorporated by reference to Exhibit 10.5 to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2010 filed with the SEC on November 5, 2010) (File No. 001-33137)
|
|
| 10.23 |
Modification No. 12 to Contract No. 200-2009-30162, effective April 26, 2011, between Emergent BioDefense Operations Lansing LLC, formerly known as Emergent BioDefense Operations Lansing Inc., and the Centers for Disease Control and Prevention (Incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2011 filed with the SEC on August 5, 2011) (File No. 001-33137)
|
||
| 10.24 |
Modification No. 14 to Contract No. 200-2009-30162, effective September 27, 2011, between Emergent BioDefense Operations Lansing LLC, formerly known as Emergent BioDefense Operations Lansing Inc., and the Centers for Disease Control and Prevention (Incorporated by reference to Exhibit 10.4 to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2011 filed with the SEC on November 4, 2011) (File No. 001-33137)
|
||
| 10.25 | † |
Contract No. HHSO100201000059C, dated September 17, 2010, between Emergent Product Development Gaithersburg Inc. and the Department of Health and Human Services (Incorporated by reference to Exhibit 10.6 to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2010 filed with the SEC on November 5, 2010) (File No. 001-33137)
|
|
| 10.26 | † |
Notice of Award Letter, dated September 30, 2011, from the Centers for Disease Control and Prevention to Emergent BioDefense Operations Lansing LLC awarding Solicitation 2011-N-13414 for Acquiring Doses of Anthrax Vaccine Adsorbed (AVA) (Incorporated by reference to Exhibit 10.6 to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2011 filed with the SEC on November 4, 2011) (File No. 001-33137)
|
|
| 10.27 | † |
Exclusive Commercial License of Technology by and among Oxford-Emergent Tuberculosis Consortium Limited, Emergent Product Development UK Limited, Emergent BioSolutions Inc. and Isis Innovation Limited dated July 18, 2008 (Incorporated by reference to Exhibit 10.5 to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2008 filed with the SEC on November 7, 2008) (File No. 001-33137)
|
|
| 10.28 | † |
Product Supply Agreement, dated June 12, 2006, between Emergent Product Development Gaithersburg Inc. and Talecris Biotherapeutics, Inc. (Incorporated by reference to Exhibit 10.34 to Amendment No. 3 to the Registrant’s Registration Statement on Form S-1 filed with the SEC on October 20, 2006) (File No. 333-136622)
|
|
| 10.29 | † |
Amendment No. 1 to Product Supply Agreement, effective December 19, 2006, between Emergent Product Development Gaithersburg Inc. and Talecris Biotherapeutics Inc. (Incorporated by reference to Exhibit 10.18 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2009 filed with the SEC on March 5, 2010) (File No. 001-33137)
|
|
| 10.30 |
Amendment No. 2 to Product Supply Agreement, effective June 25, 2007, between Emergent Product Development Gaithersburg Inc. and Talecris Biotherapeutics Inc. (Incorporated by reference to Exhibit 10.19 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2009 filed with the SEC on March 5, 2010) (File No. 001-33137)
|
||
| 10.31 | † |
Amendment No. 3 to Product Supply Agreement, effective August 29, 2007, between Emergent Product Development Gaithersburg Inc. and Talecris Biotherapeutics Inc. (Incorporated by reference to Exhibit 10.20 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2009 filed with the SEC on March 5, 2010) (File No. 001-33137)
|
|
| 10.32 |
Amendment No. 4 to Product Supply Agreement, effective November 17, 2009, between Emergent Product Development Gaithersburg Inc. and Talecris Biotherapeutics Inc. (Incorporated by reference to Exhibit 10.21 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2009 filed with the SEC on March 5, 2010) (File No. 001-33137)
|
||
| 10.33 |
Amendment No. 5 to Product Supply Agreement, dated November 3, 2010, between Emergent Product Development Gaithersburg Inc. and Talecris Biotherapeutics, Inc. (Incorporated by reference to Exhibit 10.8 to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2010 filed with the SEC on November 5, 2010) (File No. 001-33137)
|
||
| 10.34 | † |
First Addendum to Product Supply Agreement, effective September 1, 2009, between Emergent Product Development Gaithersburg Inc. and Talecris Biotherapeutics Inc. (Incorporated by reference to Exhibit 10.22 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2009 filed with the SEC on March 5, 2010) (File No. 001-33137)
|
|
| 10.35 | † |
Agreement, dated June 16, 2005, between the Free State of Bavaria and Emergent Product Development UK Limited, formerly ViVacs GmbH (Incorporated by reference to Exhibit 10.43 to Amendment No. 3 to the Registrant’s Registration Statement on Form S-1 filed with the SEC on October 20, 2006) (File No. 333-136622)
|
|
| 10.36 | † |
License Agreement between U.S. Army Medical Research Institute of Infectious Diseases and the Registrant dated October 7, 2003 (Incorporated by reference to Exhibit 10.21 of the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2008 filed with the SEC on March 6, 2009) (File No. 001-33137)
|
|
| 10.37 |
Amended and Restated Marketing Agreement entered into on February 10, 2009 between Emergent Biodefense Operations Lansing Inc. and Intergen N.V. (Incorporated by reference to Exhibit 10.27 to the Registrant's Annual Report on Form 10-K for the year ended December 31, 2008 filed with the SEC on March 6, 2009) (File No. 001-33137)
|
||
| 10.38 | † |
Collaboration and License Agreement between Emergent Product Development Seattle, LLC (as successor-in-interest to Trubion Pharmaceuticals, Inc.) and Wyeth, acting through Wyeth Pharmaceuticals Division, dated December 19, 2005 (Incorporated by reference to Exhibit 10.11 to Trubion Pharmaceuticals, Inc. Registration Statement on Form S-1 filed with the SEC on October 5, 2006) (File No. 333-134709)
|
|
| 10.39 | † |
Amendment No. 1 to the Collaboration and License Agreement between Emergent Product Development Seattle, LLC (as successor-in-interest to Trubion Pharmaceuticals, Inc.) and Wyeth, acting through Wyeth Pharmaceuticals Division, dated November 30, 2006 (Incorporated by reference to Exhibit 10.12 to Trubion Pharmaceuticals, Inc. Annual Report on Form 10-K filed with the SEC on March 26, 2007) (File No. 001-33054)
|
|
| 10.40 | † |
Amendment No. 2 to the Collaboration and License Agreement between Emergent Product Development Seattle, LLC (as successor-in-interest to Trubion Pharmaceuticals, Inc.) and Wyeth, acting through Wyeth Pharmaceuticals Division, dated April 14, 2010 (Incorporated by reference to Exhibit 10.1 to Trubion Pharmaceuticals, Inc. Quarterly Report on Form 10-Q for the quarter ended June 30, 2010 filed with the SEC on August 16, 2010) (File No. 001-33054)
|
|
| 10.41 | † |
Amendment No. 3 to the Collaboration and License Agreement, dated May 26, 2011, between Emergent Product Development Seattle, LLC and Pfizer Inc. (Incorporated by reference to Exhibit 10.3 to Trubion Pharmaceuticals, Inc. Quarterly Report on Form 10-Q for the quarter ended June 30, 3011) (File No. 001-33054)
|
|
| 10.42 | † |
Collaboration and License Agreement between Emergent Product Development Seattle, LLC (as successor-in-interest to Trubion Pharmaceuticals, Inc.) and Facet Biotech Corporation, dated August 27, 2009 (Incorporated by reference to Exhibit 10.1 to Trubion Pharmaceuticals, Inc. Quarterly Report on Form 10-Q filed with the SEC on November 5, 2009)(File No. 001-33054)
|
|
| 10.43 |
Letter Agreement, dated February 17, 2011, between the Registrant and East West Resources Corporation (Incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on February 23, 2011)(File No. 001-33137)
|
||
| 10.44 |
Lease Agreement, dated June 27, 2006, between Brandywine Research LLC and the Registrant (Incorporated by reference to Exhibit 10.24 to Amendment No. 1 to the Registrant’s Registration Statement on Form S-1 filed with the SEC on September 25, 2006) (File No. 333-136622)
|
||
| 10.45# |
First Amendment to Lease Agreement, dated November 13, 2007, between Brandywine Research LLC and the Registrant
|
||
| 10.46# |
Second Amendment to Lease Agreement, dated December 13, 2010, between Brandywine Research LLC and the Registrant
|
||
| 10.47# |
Third Amendment to Lease Agreement, dated effective February 27, 2012, between Brandywine Research LLC and the Registrant
|
||
| 10.48 |
Lease Agreement between Emergent Product Development Seattle, LLC (as successor-in-interest to Trubion Pharmaceuticals, Inc.) and Selig Real Estate Holdings Eight, dated April 28, 2003 (Incorporated by reference to Exhibit 10.8 to Trubion Pharmaceuticals, Inc. Registration Statement on Form S-1 filed with the SEC on June 2, 2006) (File No. 333-134709)
|
||
| 10.49 |
Amendment to Lease Agreement between Emergent Product Development Seattle, LLC (as successor-in-interest to Trubion Pharmaceuticals, Inc.) and Selig Real Estate Holdings Eight, dated December 8, 2004 (Incorporated by reference to Exhibit 10.9 to Trubion Pharmaceuticals, Inc. Registration Statement on Form S-1 filed with the SEC on June 2, 2006) (File No. 333-134709)
|
||
| 10.50 |
Amendment to Lease Agreement between Emergent Product Development Seattle, LLC (as successor-in-interest to Trubion Pharmaceuticals, Inc.) and Selig Real Estate Holdings Eight, dated February 1, 2006 (Incorporated by reference to Exhibit 10.10 to Trubion Pharmaceuticals, Inc. Registration Statement on Form S-1 filed with the SEC on June 2, 2006) (File No. 333-134709)
|
||
| 10.50 |
Amendment to Lease Agreement between Emergent Product Development Seattle, LLC (as successor-in-interest to Trubion Pharmaceuticals, Inc.) and Selig Real Estate Holdings Eight, L.L.C, dated February 2, 2007 (Incorporated by reference to Exhibit 10.1 to Trubion Pharmaceuticals, Inc. Quarterly Report on Form 10-Q filed with the SEC on August 7, 2008) (File No. 001-33054)
|
||
| 10.52 |
Loan Agreement, dated December 30, 2009, among the Registrant, Emergent Biodefense Operations Lansing Inc., and HSBC Realty Credit Corporation (USA)(Incorporated by reference to Exhibit 10.40 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2009 filed with the SEC on March 5, 2010) (File No. 001-33137)
|
||
| 10.53 |
Promissory Note, dated December 30, 2009, from Emergent Biodefense Operations Lansing Inc. to HSBC Realty Credit Corporation (USA) (Incorporated by reference to Exhibit 10.41 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2009 filed with the SEC on March 5, 2010) (File No. 001-33137)
|
||
| 10.54 |
Construction Loan Agreement, dated July 28, 2011, among Emergent BioSolutions Inc., Emergent Manufacturing Operations Baltimore LLC and PNC Bank, National Association (Incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2011 filed with the SEC on November 4, 2011) (File No. 001-33137)
|
||
| 10.55 |
Promissory Note, dated July 28, 2011, from Emergent BioSolutions Inc. to PNC Bank, National Association (Incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2011 filed with the SEC on November 4, 2011) (File No. 001-33137)
|
||
| 10.56 |
Loan and Security Agreement, dated August 3, 2011, among Emergent Manufacturing Operations Baltimore LLC, Emergent BioSolutions Inc. and PNC Equipment Finance, LLC (Incorporated by reference to Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2011 filed with the SEC on November 4, 2011) (File No. 001-33137)
|
||
| 21.1# |
Subsidiaries of the Registrant
|
||
| 23.1# |
Consent of Independent Registered Public Accounting Firm
|
||
| 31.1# |
Certification of the Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a)
|
||
| 31.2# |
Certification of the Chief Financial Officer pursuant to Exchange Act Rule 13a-14(a)
|
||
| 32.1# |
Certification of the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
||
| 32.2# |
Certification of the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
||
|
†
|
Confidential treatment granted by the Securities and Exchange Commission as to certain portions. Confidential materials omitted and filed separately with the Securities and Exchange Commission.
|
|
††
|
Confidential treatment requested by the Securities and Exchange Commission as to certain portions. Confidential materials omitted and filed separately with the Securities and Exchange Commission.
|
|
*
|
Management contract or compensatory plan or arrangement filed herewith in response to Item 15(a) of Form 10-K.
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|