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These terms and conditions govern your use of the website alphaminr.com and its related services.
These Terms and Conditions (“Terms”) are a binding contract between you and Alphaminr, (“Alphaminr”, “we”, “us” and “service”). You must agree to and accept the Terms. These Terms include the provisions in this document as well as those in the Privacy Policy. These terms may be modified at any time.
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We will provide you with advance notice of any change in fees.
You represent that you are of legal age to form a binding contract. You are responsible for any
activity associated with your account. The account can be logged in at only one computer at a
time.
The Services are intended for your own individual use. You shall only use the Services in a
manner that complies with all laws. You may not use any automated software, spider or system to
scrape data from Alphaminr.
Alphaminr is not a financial advisor and does not provide financial advice of any kind. The service is provided “As is”. The materials and information accessible through the Service are solely for informational purposes. While we strive to provide good information and data, we make no guarantee or warranty as to its accuracy.
TO THE EXTENT PERMITTED BY APPLICABLE LAW, UNDER NO CIRCUMSTANCES SHALL ALPHAMINR BE LIABLE TO YOU FOR DAMAGES OF ANY KIND, INCLUDING DAMAGES FOR INVESTMENT LOSSES, LOSS OF DATA, OR ACCURACY OF DATA, OR FOR ANY AMOUNT, IN THE AGGREGATE, IN EXCESS OF THE GREATER OF (1) FIFTY DOLLARS OR (2) THE AMOUNTS PAID BY YOU TO ALPHAMINR IN THE SIX MONTH PERIOD PRECEDING THIS APPLICABLE CLAIM. SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL OR CERTAIN OTHER DAMAGES, SO THE ABOVE LIMITATION AND EXCLUSIONS MAY NOT APPLY TO YOU.
If any provision of these Terms is found to be invalid under any applicable law, such provision shall not affect the validity or enforceability of the remaining provisions herein.
This privacy policy describes how we (“Alphaminr”) collect, use, share and protect your personal information when we provide our service (“Service”). This Privacy Policy explains how information is collected about you either directly or indirectly. By using our service, you acknowledge the terms of this Privacy Notice. If you do not agree to the terms of this Privacy Policy, please do not use our Service. You should contact us if you have questions about it. We may modify this Privacy Policy periodically.
When you register for our Service, we collect information from you such as your name, email address and credit card information.
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We use Google Analytics and we use Stripe for payment processing. We will not share the information we collect with third parties for promotional purposes. We may share personal information with law enforcement as required or permitted by law.
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| ý | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| ¨ | 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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Business
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Item 1A.
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Risk Factors
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Item 1B.
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Unresolved Staff Comments
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Item 2.
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Properties
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Item 3.
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Legal Proceedings
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Item 4.
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Mine Safety Disclosures
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PART II
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Item 5.
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Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
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Item 6.
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Selected Financial Data
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Item 7.
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Management's Discussion and Analysis of Financial Condition and Results of Operations
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Item 7A.
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Quantitative and Qualitative Disclosures About Market Risk
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Item 8.
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Financial Statements and Supplementary Data
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Item 9.
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Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
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Item 9A.
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Controls and Procedures
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Item 9B.
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Other Information
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PART III
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Item 10.
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Directors, Executive Officers and Corporate Governance
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Item 11.
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Executive Compensation
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Item 12.
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Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
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Item 13.
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Certain Relationships and Related Transactions, and Director Independence
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Item 14.
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Principal Accountant Fees and Services
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PART IV
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Item 15.
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Exhibits and Financial Statement Schedules
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Signatures
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Exhibit Index
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§
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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 ability to successfully execute our growth strategy and achieve our financial and operational goals;
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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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our ability to selectively enter into new collaborative arrangements;
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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; and
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our estimates regarding expenses, future revenues, capital requirements and needs for additional financing.
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driving organic growth through maximizing the financial contribution of BioThrax;
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acquiring revenue generating products that complement our existing operations and competencies;
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focusing our product development efforts on promising late-stage candidates that we believe satisfy well defined criteria and seeking to utilize collaborations or non-dilutive funding; and
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continuing to partner with third parties, such as governments and NGOs.
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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; 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 BLA, to extend the expiry dating of BioThrax from three years to four years, which allows BioThrax to be stockpiled for a longer period of time. In December 2010, we submitted to the FDA a new supplemental BLA to extend the expiry dating of BioThrax from four years 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 were not adequate to support a five year expiry.
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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 supplemental BLA 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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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, was 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 for pre-exposure 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.
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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 and elicit an enhanced immune response. We obtained additional U.S. government funding through an 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 including 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. We enrolled and dosed the first subject in the Phase II clinical trial in January 2013.
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PreviThrax™ (Recombinant Protective Antigen Anthrax Vaccine, Purified)
.
We are developing PreviThrax, in part with funding from NIAID and BARDA, a recombinant vaccine product candidate, designed as a pre-exposure prophylaxis against anthrax disease. PreviThrax contains purified recombinant protective antigen, or rPA, and is formulated to induce antibodies that neutralize anthrax toxins in a manner similar to BioThrax. In response to a request from BARDA, we have refocused our development plan to work toward the identification of a new adjuvant for this product and are currently evaluating this vaccine formulated with the new adjuvant.
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Anthrivig™ (Human Anthrax Immune Globulin).
We are developing Anthrivig, a human immune globulin, or AIG, a polyclonal antibody therapeutic product candidate, 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. We have submitted a response to a request for proposal, or RFP, from BARDA for the supply of anthrax antitoxins to the U.S. Government. 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, designed 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, 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 2011. Because the development of this project does not benefit from current external funding from BARDA or NIAID, we are 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 the 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, Inc., Vaxin Inc. and Pfenex Inc. are currently developing rPA based anthrax vaccines funded by BARDA.
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Anthrivig and Thravixa.
GlaxoSmithKline plc has obtained licensure for ABthrax™, as a therapeutic, which is a monoclonal antibody to
Bacillus anthracis
protective antigen. Elusys Therapeutics, Inc. is developing Anthim™, for pre-exposure and PEP and as a therapeutic against anthrax.
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Technology
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US Patents
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Foreign Patents
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US Applications
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Foreign Applications
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Earliest Expiration
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Latest Expiration
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ADAPTIR Monovalent
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-
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1
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1
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11
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January 17, 2022
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July 7, 2029
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ADAPTIR Multivalent
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-
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1
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4
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48
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June 12, 2027
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December 29, 2030
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TRU-016
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6
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56
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8
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75
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January 17, 2022
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November 1, 2029
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Thravixa
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2
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2
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-
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1
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November 14, 2023
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November 14, 2023
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PreviThrax
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2
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-
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2
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2
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November 23, 2014
1
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June 25, 2032
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MVA85A
2
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1
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52
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-
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13
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January 5, 2026
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January 5, 2026
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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 biologics license application, or BLA, in the case of a biologic, which applications contain, 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; and
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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.
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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;
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the need to accurately estimate the resources and cost structure that will be required to perform any contract that we might be awarded;
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the possibility that we may be ineligible to respond to a request for proposal issued by the government;
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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
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in the event 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 the termination, reduction or modification of the awarded contract.
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procurement integrity;
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export control;
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government security;
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employment practices;
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protection of the environment;
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accuracy of records and the recording of costs; and
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foreign corrupt practices.
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terminate existing contracts, in whole or in part, for any reason or no reason;
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unilaterally reduce or modify contracts or subcontracts, including by imposing equitable price adjustments;
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cancel multi-year contracts and related orders if funds for contract performance for any subsequent year become unavailable;
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decline to exercise an option to renew a contract;
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exercise an option to purchase only the minimum amount, if any, specified in a contract;
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decline to exercise an option to purchase the maximum amount, if any, specified in a contract;
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claim rights to facilities or to products, including intellectual property, developed under the contract;
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require repayment of contract funds spent on construction of facilities in the event of contract default;
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take actions that result in a longer development timeline than expected;
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change the course of a development program in a manner that differs from the contract's original terms or from our desired development plan, including decisions regarding our partners in the program;
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pursue civil or criminal remedies under the False Claims Act and False Statements Act; and
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control or prohibit the export of products.
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termination of contracts;
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forfeiture of profits;
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suspension of payments;
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fines; and
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suspension or prohibition from conducting business with the U.S. government.
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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;
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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 Foreign Corrupt Practices Act, or FCPA;
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export and import control laws and regulations; and
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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.
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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 would reduce the amounts available to fund working capital, capital expenditures, product development efforts and other general corporate purposes;
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increasing the amount of interest that we have to pay on debt with variable interest rates if market rates of interest increase;
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increasing our vulnerability to general adverse economic and industry conditions;
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obligating us to restrictive covenants that may reduce our ability to take certain corporate actions or obtain further debt or equity financing;
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limiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we compete; and
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placing us at a competitive disadvantage compared to our competitors that have less debt, better debt servicing options or stronger debt servicing capacity.
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the level and timing of BioThrax product sales and cost of product sales;
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our acquisition of companies, products or product candidates;
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our ability to obtain funding from government entities and non-government and philanthropic organizations for our development programs;
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the acquisition of new facilities and capital improvements to new or existing facilities;
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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 future plans for our manufacturing facility in Baltimore, Maryland, and any other new facilities;
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our ability to meet balloon payments upon maturity of our current borrowings
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the scope, progress, results and costs of our preclinical and clinical development activities;
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the extent to which we invest in companies, businesses, products or technologies;
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the costs, timing and outcome of regulatory review of our product candidates;
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the number of, and development requirements for, other product candidates that we may pursue;
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the costs of commercialization activities, including product marketing, sales and distribution;
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the market acceptance and sales growth of any of our products and product candidates upon regulatory approval;
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the extent to which our growth generates increased administrative costs;
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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;
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the extent to which we repurchase our common stock under our share repurchase program; and
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the effect of competing technological and market developments.
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equipment malfunctions or failures;
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technology malfunctions;
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cyber attacks;
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work stoppages or slow-downs;
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protests, including by animal rights activists;
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damage to or destruction of the facility;
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natural disasters;
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regional power shortages; or
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product tampering.
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limitations on our ability to schedule production with contract suppliers when needed to supply clinical trials;
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reliance on contract suppliers for legal and regulatory compliance and quality assurance;
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potential rejection by a contract supplier of a purchase order;
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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;
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breach of agreements by contract suppliers; and
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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.
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fines, injunctions and civil penalties;
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refusal by regulatory authorities to grant marketing approval of our product candidates;
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delays, suspension or withdrawal of regulatory approvals, including license revocation;
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seizures or recalls of product candidates or products;
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temporary or permanent shut-down of manufacturing facilities;
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operating restrictions; and
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criminal prosecutions.
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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 toxicology and efficacy 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.
|
|
§
|
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.
|
|
§
|
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.
|
|
§
|
warning letters;
|
|
§
|
restrictions on the marketing or manufacturing of a product;
|
|
§
|
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 collaborators may prefer regulatory strategies that differ from those we prefer, complicating the process of obtaining marketing approvals and releasing products;
|
|
§
|
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, result in impairment charges or write offs 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 of candidates for election as 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), or delay in achievement of milestones;
|
|
§
|
announcements of technological innovations or new therapeutic products or methods by us or others;
|
|
§
|
acts or omissions of our licensees, suppliers, or any collaborators;
|
|
§
|
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.
|
|
|
|
|
Amount
|
|
|
Location
|
Use
|
Segment
|
Approximate square feet
|
Owned/leased
|
|
Lansing, Michigan
|
Manufacturing operations facilities, office space and laboratory space
|
Biodefense
|
214,000
|
Owned
|
|
Baltimore, Maryland
|
Manufacturing facilities and office and laboratory space
|
Biodefense
|
56,000
|
Owned
|
|
Gaithersburg, Maryland
|
Office and laboratory space
|
Biodefense
|
48,000
|
Owned
|
|
Seattle, Washington
|
Office and laboratory space
|
Biosciences
|
51,000
|
Leases expire 2015
|
|
Rockville, Maryland
|
Office space
|
Biodefense/Biosciences
|
41,000
|
Lease expires 2016
|
|
Munich, Germany
|
Office and laboratory space
|
Biosciences
|
16,000
|
Lease expires 2015
|
| ITEM 5. | MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES |
|
First
|
Second
|
Third
|
Fourth
|
|||||||||||||
|
|
Quarter
|
Quarter
|
Quarter
|
Quarter
|
||||||||||||
|
Year Ended December 31, 2012
|
|
|
|
|
||||||||||||
|
High
|
$
|
18.34
|
$
|
16.32
|
$
|
15.87
|
$
|
16.15
|
||||||||
|
Low
|
$
|
14.22
|
$
|
13.30
|
$
|
13.49
|
$
|
12.50
|
||||||||
|
|
||||||||||||||||
|
Year Ended December 31, 2011
|
||||||||||||||||
|
High
|
$
|
25.07
|
$
|
26.41
|
$
|
22.84
|
$
|
19.77
|
||||||||
|
Low
|
$
|
18.32
|
$
|
20.44
|
$
|
14.90
|
$
|
15.14
|
||||||||
|
Issuer Purchases of Equity Securities
|
||||||||||||||||
|
Period
|
|
|
|
|
||||||||||||
|
Total number of shares (or units) purchased
|
Average price paid per share (or unit)
|
Total number of shares (or units) purchased as part of publicly announced plans or programs
|
Maximum number (or approximate dollar value) of shares (or units) that may yet be purchased under the plans or programs
|
|||||||||||||
|
September 1 to September 30, 2012
(1)
|
97,600
|
$
|
14.93
|
97,600
|
$
|
33,542,832
|
||||||||||
|
October 1 to October 31, 2012
(1)
|
300,881
|
14.54
|
300,881
|
$
|
29,168,022
|
|||||||||||
|
December 1 to December 31, 2012
(2)
|
4,677
|
15.81
|
-
|
$
|
29,168,022
|
|||||||||||
|
Total
|
403,158
|
$
|
14.64
|
398,481
|
$
|
29,168,022
|
||||||||||
|
(1)
|
On May 21, 2012, we publicly announced that our board of directors authorized the repurchase of up to $35.0 million of our common stock through a share repurchase program. The repurchase program was authorized on May 17, 2012 and terminates on December 31, 2013. We did not repurchase any shares of our common stock under this repurchase program prior to September 2012.
|
|
(2)
|
In December 2012, in a form of stock option transaction provided for under the terms of our stock incentive plan and the stock option agreement, we engaged in a transaction with our chief executive officer in which we acquired 4,677 shares of common stock as payment of the exercise price for 7,300 stock options.
|
|
|
Year Ended December 31,
|
|||||||||||||||||||
|
(in thousands, except share and per share data)
|
2012
|
2011
|
2010
|
2009
|
2008
|
|||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||
|
Statements of operations data:
|
|
|
|
|
|
|||||||||||||||
|
Revenues:
|
|
|
|
|
|
|||||||||||||||
|
Product sales
|
$
|
215,879
|
$
|
202,409
|
$
|
251,381
|
$
|
217,172
|
$
|
169,124
|
||||||||||
|
Contracts and grants
|
66,009
|
70,975
|
34,790
|
17,614
|
9,430
|
|||||||||||||||
|
Total revenues
|
281,888
|
273,384
|
286,171
|
234,786
|
178,554
|
|||||||||||||||
|
Operating expenses:
|
||||||||||||||||||||
|
Cost of product sales
|
46,077
|
42,171
|
47,114
|
46,262
|
34,081
|
|||||||||||||||
|
Research and development
|
120,226
|
124,832
|
89,295
|
74,588
|
59,470
|
|||||||||||||||
|
Selling, general & administrative
|
76,018
|
74,282
|
76,205
|
73,786
|
55,076
|
|||||||||||||||
|
Impairment of in-process research and development
|
9,600
|
-
|
-
|
-
|
-
|
|||||||||||||||
|
Total operating expenses
|
251,921
|
241,285
|
212,614
|
194,636
|
148,627
|
|||||||||||||||
|
Income from operations
|
29,967
|
32,099
|
73,557
|
40,150
|
29,927
|
|||||||||||||||
|
Other income (expense):
|
||||||||||||||||||||
|
Interest income
|
134
|
105
|
832
|
1,418
|
1,999
|
|||||||||||||||
|
Interest expense
|
(6
|
)
|
-
|
-
|
(7
|
)
|
(47
|
)
|
||||||||||||
|
Other income (expense), net
|
1,970
|
(261
|
)
|
(1,023
|
)
|
(50
|
)
|
134
|
||||||||||||
|
Total other income (expense)
|
2,098
|
(156
|
)
|
(191
|
)
|
1,361
|
2,086
|
|||||||||||||
|
|
||||||||||||||||||||
|
Income before provision for income taxes
|
32,065
|
31,943
|
73,366
|
41,511
|
32,013
|
|||||||||||||||
|
Provision for income taxes
|
13,922
|
15,830
|
26,182
|
14,966
|
12,055
|
|||||||||||||||
|
Net income
|
$
|
18,143
|
$
|
16,113
|
$
|
47,184
|
$
|
26,545
|
$
|
19,958
|
||||||||||
|
Net loss attributable to noncontrolling interest
|
5,381
|
6,906
|
4,514
|
4,599
|
724
|
|||||||||||||||
|
Net income attributable to Emergent BioSolutions Inc.
|
$
|
23,524
|
$
|
23,019
|
$
|
51,698
|
$
|
31,144
|
$
|
20,682
|
||||||||||
|
|
||||||||||||||||||||
|
Earnings per share — basic
|
$
|
0.65
|
$
|
0.65
|
$
|
1.63
|
$
|
1.02
|
$
|
0.69
|
||||||||||
|
Earnings per share — diluted
|
$
|
0.65
|
$
|
0.64
|
$
|
1.59
|
$
|
0.99
|
$
|
0.68
|
||||||||||
|
Weighted average number of shares — basic
|
36,080,495
|
35,658,907
|
31,782,286
|
30,444,485
|
29,835,134
|
|||||||||||||||
|
Weighted average number of shares — diluted
|
36,420,662
|
36,206,052
|
32,539,500
|
31,375,305
|
30,458,098
|
|||||||||||||||
|
|
||||||||||||||||||||
|
|
As of December 31,
|
|||||||||||||||||||
|
(in thousands)
|
2012
|
2011
|
2010
|
2009
|
2008
|
|||||||||||||||
|
|
||||||||||||||||||||
|
Balance Sheet Data:
|
||||||||||||||||||||
|
Cash and cash equivalents
|
$
|
141,666
|
$
|
143,901
|
$
|
169,019
|
$
|
102,924
|
$
|
91,473
|
||||||||||
|
Working capital
|
201,440
|
183,364
|
167,774
|
139,113
|
98,866
|
|||||||||||||||
|
Total assets
|
564,230
|
546,864
|
500,319
|
344,689
|
290,788
|
|||||||||||||||
|
Total long-term liabilities
|
60,195
|
59,083
|
51,039
|
46,173
|
37,418
|
|||||||||||||||
|
Total stockholders' equity
|
442,128
|
416,727
|
373,561
|
243,815
|
199,349
|
|||||||||||||||
|
§
|
Anthrivig;
|
|
§
|
BioThrax as a post-exposure prophylaxis, or PEP;
|
|
§
|
NuThrax;
|
|
§
|
Large-scale manufacturing for BioThrax;
|
|
§
|
PreviThrax;
|
|
§
|
Thravixa; and
|
|
§
|
Tuberculosis 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 the likelihood and timing of 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. |
|
Development Programs
|
Funding Source
|
Award Date
|
Performance Period
|
|
Post-Exposure Prophylaxis indication for BioThrax
|
BARDA
|
9/2007
|
9/2007 — 3/2016
|
|
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
|
|
Tuberculosis vaccine
|
NIAID
|
3/2012
|
3/2012 — 2/2017
|
| § | personnel-related expenses; |
| § | fees to professional service providers for, among other things, 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)
|
2012
|
2011
|
||||||
|
Biodefense:
|
|
|
||||||
|
Large-scale manufacturing for BioThrax
|
$
|
18,908
|
$
|
13,138
|
||||
|
BioThrax related programs
|
10,934
|
6,961
|
||||||
|
PreviThrax
|
19,805
|
14,404
|
||||||
|
NuThrax
|
8,591
|
11,632
|
||||||
|
Pandemic influenza
(1)
|
2,500
|
-
|
||||||
|
Thravixa
|
1,362
|
3,460
|
||||||
|
Anthrivig
|
257
|
2,608
|
||||||
|
Other Biodefense
|
6,222
|
5,630
|
||||||
|
Total biodefense
|
68,579
|
57,833
|
||||||
|
Biosciences:
|
||||||||
|
Tuberculosis vaccine
|
15,736
|
19,032
|
||||||
|
TRU-016
|
13,585
|
13,503
|
||||||
|
T-Scorp
|
4,673
|
-
|
||||||
|
ES-301 (formerly DRACO)
|
2,047
|
7,165
|
||||||
|
Zanolimumab
|
1,057
|
4,821
|
||||||
|
Influenza vaccine
|
391
|
2,520
|
||||||
|
Typhella
|
295
|
1,271
|
||||||
|
Other biosciences
|
6,804
|
13,254
|
||||||
|
Total biosciences
|
44,588
|
61,566
|
||||||
|
Other
|
7,059
|
5,433
|
||||||
|
Total
|
$
|
120,226
|
$
|
124,832
|
||||
|
(1)
|
Represents an upfront payment for an exclusive license and the rights to manufacture and sell pandemic influenza products in support of our contract with BARDA to establish a CIADM.
|
|
|
Year ended
|
|||||||
|
|
December 31,
|
|||||||
|
(in thousands)
|
2011
|
2010
|
||||||
|
Biodefense:
|
|
|
||||||
|
Large-scale manufacturing for BioThrax
|
$
|
13,138
|
$
|
9,099
|
||||
|
BioThrax related programs
|
6,961
|
7,201
|
||||||
|
PreviThrax
|
14,404
|
3,767
|
||||||
|
NuThrax
|
11,632
|
9,876
|
||||||
|
Thravixa
|
3,460
|
8,148
|
||||||
|
Anthrivig
|
2,608
|
5,937
|
||||||
|
Other Biodefense
|
5,630
|
8,163
|
||||||
|
Total Biodefense
|
57,833
|
52,191
|
||||||
|
Biosciences:
|
||||||||
|
Tuberculosis vaccine
|
19,032
|
13,690
|
||||||
|
TRU-016
|
13,503
|
2,205
|
||||||
|
ES-301 (formerly DRACO)
|
7,165
|
693
|
||||||
|
Zanolimumab
|
4,821
|
-
|
||||||
|
Influenza vaccine
|
2,520
|
4,088
|
||||||
|
Typhella
|
1,271
|
3,398
|
||||||
|
Other Biosciences
|
13,254
|
8,821
|
||||||
|
Total Biosciences
|
61,566
|
32,895
|
||||||
|
Other
|
5,433
|
4,209
|
||||||
|
Total
|
$
|
124,832
|
$
|
89,295
|
||||
|
|
Year ended December 31,
|
|||||||||||
|
(in thousands)
|
2012
|
2011
|
2010
|
|||||||||
|
Net cash provided by (used in):
|
|
|
|
|||||||||
|
Operating activities(1)
|
$
|
39,644
|
$
|
12,186
|
$
|
98,000
|
||||||
|
Investing activities
|
(40,114
|
)
|
(53,963
|
)
|
(23,456
|
)
|
||||||
|
Financing activities
|
(1,765
|
)
|
16,659
|
(8,449
|
)
|
|||||||
|
Total net cash provided by (used in)
|
$
|
(2,235
|
)
|
$
|
(25,118
|
)
|
$
|
66,095
|
||||
|
|
Payments due by period
|
|||||||||||||||||||||||
|
(in thousands)
|
Total
|
2013
|
2014
|
2015
|
2016
|
After 2016
|
||||||||||||||||||
|
Contractual obligations:
|
|
|
|
|
|
|
||||||||||||||||||
|
Long-term indebtedness including current portion
|
$
|
62,774
|
$
|
4,470
|
$
|
23,075
|
$
|
2,607
|
$
|
2,607
|
$
|
30,015
|
||||||||||||
|
Operating lease obligations
|
10,652
|
3,447
|
3,497
|
2,331
|
1,377
|
-
|
||||||||||||||||||
|
Total contractual obligations
|
$
|
73,426
|
$
|
7,917
|
$
|
26,572
|
$
|
4,938
|
$
|
3,984
|
$
|
30,015
|
||||||||||||
|
§
|
$18.2 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;
|
|
§
|
$4.1 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;
|
|
§
|
$29.4 million outstanding under a construction loan from PNC Bank used to
fund the ongoing renovation of our Baltimore, Maryland facility
; and
|
|
§
|
$11.1 million outstanding under an equipment loan from PNC Bank used to fund equipment purchases at our Baltimore, Maryland facility.
|
|
§
|
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; and
|
|
§
|
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 acquisition of companies, products or product candidates;
|
|
§
|
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 future plans for our manufacturing facility in Baltimore, Maryland, and any other new facilities;
|
|
§
|
our ability to meet balloon payments upon maturity of our current borrowings;
|
|
§
|
the scope, progress, results and costs of our preclinical and clinical development activities;
|
|
§
|
the extent to which we invest in companies, businesses, products or technologies;
|
|
§
|
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 repurchase our common stock under our share repurchase program; and
|
|
§
|
the effect of competing technological and market developments.
|
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||
|
Consolidated Balance Sheets
|
||||||||
|
(in thousands, except share and per share data)
|
||||||||
|
|
|
|
||||||
|
|
December 31,
|
|||||||
|
|
2012
|
2011
|
||||||
|
ASSETS
|
|
|
||||||
|
Current assets:
|
|
|
||||||
|
Cash and cash equivalents
|
$
|
141,666
|
$
|
143,901
|
||||
|
Investments
|
-
|
1,966
|
||||||
|
Accounts receivable
|
96,043
|
74,153
|
||||||
|
Inventories
|
15,161
|
14,661
|
||||||
|
Deferred tax assets, net
|
1,264
|
1,735
|
||||||
|
Income tax receivable, net
|
-
|
9,506
|
||||||
|
Restricted cash
|
-
|
220
|
||||||
|
Prepaid expenses and other current assets
|
9,213
|
8,276
|
||||||
|
Total current assets
|
263,347
|
254,418
|
||||||
|
|
||||||||
|
Property, plant and equipment, net
|
241,764
|
208,973
|
||||||
|
In-process research and development
|
41,800
|
51,400
|
||||||
|
Goodwill
|
5,502
|
5,502
|
||||||
|
Assets held for sale
|
-
|
11,765
|
||||||
|
Deferred tax assets, net
|
11,087
|
13,999
|
||||||
|
Other assets
|
730
|
807
|
||||||
|
|
||||||||
|
Total assets
|
$
|
564,230
|
$
|
546,864
|
||||
|
|
||||||||
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
|
Current liabilities:
|
||||||||
|
Accounts payable
|
$
|
31,297
|
$
|
40,530
|
||||
|
Accrued expenses and other current liabilities
|
1,488
|
1,170
|
||||||
|
Accrued compensation
|
22,726
|
20,884
|
||||||
|
Contingent value rights, current portion
|
-
|
1,748
|
||||||
|
Income tax payable, net
|
115
|
-
|
||||||
|
Long-term indebtedness, current portion
|
4,470
|
5,360
|
||||||
|
Deferred revenue
|
1,811
|
1,362
|
||||||
|
Total current liabilities
|
61,907
|
71,054
|
||||||
|
|
||||||||
|
Contingent value rights, net of current portion
|
-
|
3,005
|
||||||
|
Long-term indebtedness, net of current portion
|
58,304
|
54,094
|
||||||
|
Other liabilities
|
1,891
|
1,984
|
||||||
|
Total liabilities
|
122,102
|
130,137
|
||||||
|
|
||||||||
|
Commitments and contingencies
|
||||||||
|
|
||||||||
|
Stockholders' equity:
|
||||||||
|
Preferred stock, $0.001 par value; 15,000,000 shares authorized, 0 shares issued and outstanding at December 31, 2012 and December 31, 2011, respectively
|
-
|
-
|
||||||
|
Common stock, $0.001 par value; 100,000,000 shares authorized, 36,272,550 shares issued and 35,869,392 shares outstanding at December 31, 2012; 36,002,698 shares issued and outstanding at December 31, 2011
|
36
|
36
|
||||||
|
Treasury stock, at cost, 403,158 and 0 common shares at December 31, 2012 and 2011, respectively
|
(5,906
|
)
|
-
|
|||||
|
Additional paid-in capital
|
230,964
|
220,654
|
||||||
|
Accumulated other comprehensive loss
|
(4,129
|
)
|
(3,313
|
)
|
||||
|
Retained earnings
|
220,393
|
196,869
|
||||||
|
Total Emergent BioSolutions Inc. stockholders' equity
|
441,358
|
414,246
|
||||||
|
Noncontrolling interest in subsidiaries
|
770
|
2,481
|
||||||
|
Total stockholders' equity
|
442,128
|
416,727
|
||||||
|
Total liabilities and stockholders' equity
|
$
|
564,230
|
$
|
546,864
|
||||
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||||||
|
Consolidated Statements of Operations
|
||||||||||||
|
(in thousands, except share and per share data)
|
||||||||||||
|
|
|
|
|
|||||||||
|
|
Year Ended December 31,
|
|||||||||||
|
|
2012
|
2011
|
2010
|
|||||||||
|
Revenues:
|
|
|
|
|||||||||
|
Product sales
|
$
|
215,879
|
$
|
202,409
|
$
|
251,381
|
||||||
|
Contracts and grants
|
66,009
|
70,975
|
34,790
|
|||||||||
|
Total revenues
|
281,888
|
273,384
|
286,171
|
|||||||||
|
|
||||||||||||
|
Operating expense:
|
||||||||||||
|
Cost of product sales
|
46,077
|
42,171
|
47,114
|
|||||||||
|
Research and development
|
120,226
|
124,832
|
89,295
|
|||||||||
|
Selling, general and administrative
|
76,018
|
74,282
|
76,205
|
|||||||||
|
Impairment of in-process research and development
|
9,600
|
-
|
-
|
|||||||||
|
Income from operations
|
29,967
|
32,099
|
73,557
|
|||||||||
|
|
||||||||||||
|
Other income (expense):
|
||||||||||||
|
Interest income
|
134
|
105
|
832
|
|||||||||
|
Interest expense
|
(6
|
)
|
-
|
-
|
||||||||
|
Other income (expense), net
|
1,970
|
(261
|
)
|
(1,023
|
)
|
|||||||
|
Total other income (expense)
|
2,098
|
(156
|
)
|
(191
|
)
|
|||||||
|
|
||||||||||||
|
Income before provision for income taxes
|
32,065
|
31,943
|
73,366
|
|||||||||
|
Provision for income taxes
|
13,922
|
15,830
|
26,182
|
|||||||||
|
Net income
|
18,143
|
16,113
|
47,184
|
|||||||||
|
Net loss attributable to noncontrolling interest
|
5,381
|
6,906
|
4,514
|
|||||||||
|
Net income attributable to Emergent BioSolutions Inc.
|
$
|
23,524
|
$
|
23,019
|
$
|
51,698
|
||||||
|
|
||||||||||||
|
Earnings per share - basic
|
$
|
0.65
|
$
|
0.65
|
$
|
1.63
|
||||||
|
Earnings per share - diluted
|
$
|
0.65
|
$
|
0.64
|
$
|
1.59
|
||||||
|
|
||||||||||||
|
Weighted-average number of shares - basic
|
36,080,495
|
35,658,907
|
31,782,286
|
|||||||||
|
Weighted-average number of shares - diluted
|
36,420,662
|
36,206,052
|
32,539,500
|
|||||||||
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||||||
|
Consolidated Statements of Comprehensive Income
|
||||||||||||
|
(in thousands)
|
||||||||||||
|
|
|
|
|
|||||||||
|
|
December 31,
|
|||||||||||
|
|
2012
|
2011
|
2010
|
|||||||||
|
|
|
|
|
|||||||||
|
Net income attributable to Emergent BioSolutions Inc.
|
$
|
23,524
|
$
|
23,019
|
$
|
51,698
|
||||||
|
Foreign currency translations, net of tax
|
(816
|
)
|
(1,203
|
)
|
(634
|
)
|
||||||
|
Comprehensive income
|
$
|
22,708
|
$
|
21,816
|
$
|
51,064
|
||||||
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||||||
|
Consolidated Statements of Cash Flows
|
||||||||||||
|
(in thousands)
|
||||||||||||
|
|
|
|
|
|||||||||
|
|
Year Ended December 31,
|
|||||||||||
|
|
2012
|
2011
|
2010
|
|||||||||
|
Cash flows from operating activities:
|
|
|
|
|||||||||
|
Net income
|
$
|
18,143
|
$
|
16,113
|
$
|
47,184
|
||||||
|
Adjustments to reconcile to net cash provided by operating activities:
|
||||||||||||
|
Stock-based compensation expense
|
11,115
|
10,739
|
7,063
|
|||||||||
|
Depreciation and amortization
|
11,197
|
9,355
|
5,990
|
|||||||||
|
Deferred income taxes
|
3,383
|
20,188
|
9,229
|
|||||||||
|
Non-cash development expenses from joint venture
|
3,670
|
5,290
|
5,995
|
|||||||||
|
Change in fair value of contingent value rights
|
(3,005
|
)
|
221
|
-
|
||||||||
|
Impairment of in-process research and development
|
9,600
|
-
|
-
|
|||||||||
|
Impairment of long-lived assets
|
-
|
976
|
1,218
|
|||||||||
|
Provision for impairment of accrued interest on note receivable
|
-
|
-
|
1,032
|
|||||||||
|
Excess tax benefits from stock-based compensation
|
(1,588
|
)
|
(4,608
|
)
|
(2,609
|
)
|
||||||
|
Other
|
(40
|
)
|
392
|
(38
|
)
|
|||||||
|
Changes in operating assets and liabilities:
|
||||||||||||
|
Accounts receivable
|
(21,890
|
)
|
(34,873
|
)
|
19,094
|
|||||||
|
Inventories
|
(500
|
)
|
(1,939
|
)
|
799
|
|||||||
|
Income taxes
|
8,055
|
1,422
|
(4,454
|
)
|
||||||||
|
Prepaid expenses and other assets
|
(1,038
|
)
|
660
|
(764
|
)
|
|||||||
|
Accounts payable
|
274
|
2,510
|
3,392
|
|||||||||
|
Accrued expenses and other liabilities
|
169
|
(95
|
)
|
(447
|
)
|
|||||||
|
Accrued compensation
|
1,649
|
(3,303
|
)
|
6,175
|
||||||||
|
Deferred revenue
|
449
|
(10,863
|
)
|
(838
|
)
|
|||||||
|
Net cash provided by operating activities
|
39,643
|
12,185
|
98,021
|
|||||||||
|
Cash flows from investing activities:
|
||||||||||||
|
Purchases of property, plant and equipment
|
(53,845
|
)
|
(54,026
|
)
|
(22,101
|
)
|
||||||
|
Proceeds from sale of assets
|
11,765
|
-
|
-
|
|||||||||
|
Proceeds from maturity of investments
|
1,966
|
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
|
(40,114
|
)
|
(53,963
|
)
|
(23,456
|
)
|
||||||
|
Cash flows from financing activities:
|
||||||||||||
|
Proceeds from borrowings on long-term indebtedness
|
13,547
|
27,522
|
15,000
|
|||||||||
|
Issuance of common stock subject to exercise of stock options
|
761
|
10,026
|
7,235
|
|||||||||
|
Excess tax benefits from stock-based compensation
|
1,588
|
4,608
|
2,609
|
|||||||||
|
Principal payments on long-term indebtedness and line of credit
|
(10,227
|
)
|
(15,494
|
)
|
(33,291
|
)
|
||||||
|
Contingent value right payment
|
(1,748
|
)
|
(10,000
|
)
|
-
|
|||||||
|
Purchase of treasury stock
|
(5,906
|
)
|
-
|
-
|
||||||||
|
Restricted cash deposit
|
220
|
(3
|
)
|
(2
|
)
|
|||||||
|
Net cash provided by (used in) financing activities
|
(1,765
|
)
|
16,659
|
(8,449
|
)
|
|||||||
|
|
||||||||||||
|
Effect of exchange rate changes on cash and cash equivalents
|
1
|
1
|
(21
|
)
|
||||||||
|
|
||||||||||||
|
Net increase (decrease) in cash and cash equivalents
|
(2,235
|
)
|
(25,118
|
)
|
66,095
|
|||||||
|
Cash and cash equivalents at beginning of year
|
143,901
|
169,019
|
102,924
|
|||||||||
|
Cash and cash equivalents at end of year
|
$
|
141,666
|
$
|
143,901
|
$
|
169,019
|
||||||
|
|
||||||||||||
|
Supplemental disclosure of cash flow information:
|
||||||||||||
|
Cash paid during the year for interest
|
$
|
2,137
|
$
|
1,740
|
$
|
2,176
|
||||||
|
Cash paid during the year for income taxes
|
$
|
6,537
|
$
|
4,280
|
$
|
22,440
|
||||||
|
Supplemental information on non-cash investing and financing activities:
|
||||||||||||
|
Issuance of common stock to acquire Trubion Pharmaceuticals, Inc.
|
$
|
-
|
$
|
-
|
$
|
61,203
|
||||||
|
Purchases of property, plant and equipment unpaid at year end
|
$
|
5,612
|
$
|
15,509
|
$
|
3,519
|
||||||
|
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
|
Treasury Stock
|
Accumulated Other
|
Noncontrolling Interest
|
Retained
|
Total
|
|||||||||||||||||||||||||||||
|
Paid-In
|
Comprehensive
|
Stockholders'
|
||||||||||||||||||||||||||||||||||
|
|
Shares
|
Amount
|
Capital
|
Shares
|
Amount
|
Loss
|
in Subsidiary
|
Earnings
|
Equity
|
|||||||||||||||||||||||||||
|
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
|
|||||||||||||||||||||||||||
|
Employee equity award plans activity
|
828,246
|
1
|
15,997
|
-
|
-
|
-
|
-
|
-
|
15,998
|
|||||||||||||||||||||||||||
|
Non-cash development expenses from joint venture
|
-
|
-
|
-
|
-
|
-
|
-
|
5,995
|
-
|
5,995
|
|||||||||||||||||||||||||||
|
Net loss attributable to noncontrolling interest
|
-
|
-
|
-
|
-
|
-
|
-
|
(4,514
|
)
|
-
|
(4,514
|
)
|
|||||||||||||||||||||||||
|
Net income
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
51,698
|
51,698
|
|||||||||||||||||||||||||||
|
Foreign currency translation, net of tax
|
-
|
-
|
-
|
-
|
-
|
(634
|
)
|
-
|
-
|
(634
|
)
|
|||||||||||||||||||||||||
|
|
||||||||||||||||||||||||||||||||||||
|
Balance at December 31, 2010
|
35,011,423
|
$
|
35
|
$
|
197,689
|
-
|
$
|
-
|
$
|
(2,110
|
)
|
$
|
4,097
|
$
|
173,850
|
$
|
373,561
|
|||||||||||||||||||
|
|
||||||||||||||||||||||||||||||||||||
|
Employee equity award plans activity
|
991,275
|
1
|
22,965
|
-
|
-
|
-
|
-
|
-
|
22,966
|
|||||||||||||||||||||||||||
|
Non-cash development expenses from joint venture
|
-
|
-
|
-
|
-
|
-
|
-
|
5,290
|
-
|
5,290
|
|||||||||||||||||||||||||||
|
Net loss attributable to noncontrolling interest
|
-
|
-
|
-
|
-
|
-
|
-
|
(6,906
|
)
|
-
|
(6,906
|
)
|
|||||||||||||||||||||||||
|
Net income
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
23,019
|
23,019
|
|||||||||||||||||||||||||||
|
Foreign currency translation, net of tax
|
-
|
-
|
-
|
-
|
-
|
(1,203
|
)
|
-
|
-
|
(1,203
|
)
|
|||||||||||||||||||||||||
|
|
||||||||||||||||||||||||||||||||||||
|
Balance at December 31, 2011
|
36,002,698
|
$
|
36
|
$
|
220,654
|
-
|
$
|
-
|
$
|
(3,313
|
)
|
$
|
2,481
|
$
|
196,869
|
$
|
416,727
|
|||||||||||||||||||
|
|
||||||||||||||||||||||||||||||||||||
|
Employee equity award plans activity
|
269,852
|
-
|
10,310
|
-
|
-
|
-
|
10,310
|
|||||||||||||||||||||||||||||
|
Non-cash development expenses from joint venture
|
-
|
-
|
-
|
-
|
-
|
-
|
3,670
|
-
|
3,670
|
|||||||||||||||||||||||||||
|
Net loss attributable to noncontrolling interest
|
-
|
-
|
-
|
-
|
-
|
-
|
(5,381
|
)
|
-
|
(5,381
|
)
|
|||||||||||||||||||||||||
|
Treasury stock
|
-
|
-
|
-
|
(403,158
|
)
|
(5,906
|
)
|
-
|
-
|
(5,906
|
)
|
|||||||||||||||||||||||||
|
Net income
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
23,524
|
23,524
|
|||||||||||||||||||||||||||
|
Foreign currency translation, net of tax
|
-
|
-
|
-
|
-
|
-
|
(816
|
)
|
-
|
-
|
(816
|
)
|
|||||||||||||||||||||||||
|
|
||||||||||||||||||||||||||||||||||||
|
Balance at December 31, 2012
|
36,272,550
|
$
|
36
|
$
|
230,964
|
(403,158
|
)
|
$
|
(5,906
|
)
|
$
|
(4,129
|
)
|
$
|
770
|
$
|
220,393
|
$
|
442,128
|
|||||||||||||||||
|
Buildings
|
31-39 years
|
|
Building improvements
|
10-39 years
|
|
Furniture and equipment
|
3-15 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 |
| § | collectability is reasonably assured. |
| § | estimating the timing of and expected costs to complete the in-process projects; |
| § | projecting the likelihood and timing of 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,
|
|
|||||||||
|
|
|
2012
|
|
|
2011
|
|
|
2010
|
|
|||
|
Expected dividend yield
|
|
|
0
|
%
|
|
|
0
|
%
|
|
|
0
|
%
|
|
Expected volatility
|
|
|
41-52
|
%
|
|
|
60
|
%
|
|
|
55
|
%
|
|
Risk-free interest rate
|
|
|
0.36-0.54
|
%
|
|
|
0.35-1.04
|
%
|
|
|
0.49-1.46
|
%
|
|
Expected average life of options
|
|
3.4 years
|
|
|
3.4 years
|
|
|
3.4 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.
|
|
|
At December 31, 2012
|
|||||||||||||||
|
(in thousands)
|
Level 1
|
Level 2
|
Level 3
|
Total
|
||||||||||||
|
Assets:
|
|
|
|
|
||||||||||||
|
Investment in money market funds (1)
|
$
|
42,720
|
$
|
-
|
$
|
-
|
$
|
42,720
|
||||||||
|
Total assets
|
$
|
42,720
|
$
|
-
|
$
|
-
|
$
|
42,720
|
||||||||
|
|
||||||||||||||||
|
|
||||||||||||||||
|
|
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
|
||||||||
|
(in thousands)
|
|
|||
|
Balance at January 1, 2011
|
$
|
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
|
||
|
Expense (income) included in earnings
|
(3,005
|
)
|
||
|
Settlements
|
(1,748
|
)
|
||
|
Purchases, sales and issuances
|
-
|
|||
|
Transfers in/(out) of Level 3
|
-
|
|||
|
Balance at December 31, 2012
|
$
|
-
|
||
|
|
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
|
||||||||
|
|
December 31,
|
|||||||
|
(in thousands)
|
2012
|
2011
|
||||||
|
Billed
|
$
|
76,155
|
$
|
55,188
|
||||
|
Unbilled
|
19,888
|
18,965
|
||||||
|
Total
|
$
|
96,043
|
$
|
74,153
|
||||
|
|
December 31,
|
|||||||
|
(in thousands)
|
2012
|
2011
|
||||||
|
Raw materials and supplies
|
$
|
2,733
|
$
|
2,313
|
||||
|
Work-in-process
|
9,813
|
10,149
|
||||||
|
Finished goods
|
2,615
|
2,199
|
||||||
|
Total inventories
|
$
|
15,161
|
$
|
14,661
|
||||
|
|
December 31,
|
|||||||
|
(in thousands)
|
2012
|
2011
|
||||||
|
Land and improvements
|
$
|
4,839
|
$
|
4,115
|
||||
|
Buildings, building improvements and leasehold improvements
|
66,953
|
26,122
|
||||||
|
Furniture and equipment
|
91,772
|
42,135
|
||||||
|
Software
|
15,691
|
11,854
|
||||||
|
Construction-in-progress
|
105,452
|
157,206
|
||||||
|
|
284,707
|
241,432
|
||||||
|
Less: Accumulated depreciation and amortization
|
(42,943
|
)
|
(32,459
|
)
|
||||
|
Total Property, plant and equipment, net
|
$
|
241,764
|
$
|
208,973
|
||||
| 8. | In-process research and development and goodwill |
|
|
December 31,
|
|||||||
|
(in thousands)
|
2012
|
2011
|
||||||
|
Construction loan dated July 2011; one month LIBOR plus 3%, due July 2017
|
$
|
29,375
|
$
|
26,095
|
||||
|
Equipment loan dated August 2011; one month LIBOR plus 3%, due December 2017
|
11,068
|
1,426
|
||||||
|
Term loan dated December 2009; three month LIBOR plus 3.25%, due December 2014
|
18,200
|
19,717
|
||||||
|
Term loan dated November 2009; three month LIBOR plus 3.25%, due November 2014
|
4,131
|
4,478
|
||||||
|
Loan dated October 2004; 3.0%, repaid in March 2012
|
-
|
2,500
|
||||||
|
Term loan dated October 2004; 3.48%, repaid in March 2012
|
-
|
5,238
|
||||||
|
Total long-term indebtedness
|
62,774
|
59,454
|
||||||
|
Less current portion of long-term indebtedness
|
(4,470
|
)
|
(5,360
|
)
|
||||
|
Noncurrent portion of long-term indebtedness
|
$
|
58,304
|
$
|
54,094
|
||||
|
(in thousands)
|
|
|||
|
2013
|
$
|
4,470
|
||
|
2014
|
23,075
|
|||
|
2015
|
2,607
|
|||
|
2016
|
2,607
|
|||
|
2017
|
30,015
|
|||
|
|
$
|
62,774
|
||
|
|
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, 2011
|
3,090,909
|
$
|
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
|
||||||||||||
|
Granted
|
785,941
|
15.65
|
-
|
-
|
||||||||||||||||
|
Exercised
|
(89,125
|
)
|
8.53
|
-
|
-
|
|||||||||||||||
|
Forfeited
|
(221,328
|
)
|
19.24
|
-
|
-
|
|||||||||||||||
|
Outstanding at December 31, 2012
|
3,566,397
|
$
|
17.08
|
53,156
|
$
|
8.86
|
$
|
4,802,547
|
||||||||||||
|
Exercisable at December 31, 2012
|
2,151,700
|
$
|
16.26
|
53,156
|
$
|
8.86
|
$
|
4,477,056
|
||||||||||||
|
Options expected to vest at December 31, 2012
|
1,056,036
|
$
|
18.15
|
-
|
$
|
-
|
$
|
245,395
|
||||||||||||
|
|
Number of Shares
|
Weighted-Average Grant Price
|
Aggregate Intrinsic Value
|
|||||||||
|
Outstanding at December 31, 2011
|
635,500
|
$
|
20.89
|
$
|
10,714,450
|
|||||||
|
Granted
|
413,022
|
15.61
|
||||||||||
|
Vested
|
(260,738
|
)
|
15.22
|
|||||||||
|
Forfeited
|
(67,716
|
)
|
19.36
|
|||||||||
|
Outstanding at December 31, 2012
|
720,068
|
$
|
20.89
|
$
|
11,549,891
|
|||||||
|
|
December 31,
|
|||||||||||
|
(in thousands)
|
2012
|
2011
|
2010
|
|||||||||
|
Cost of product sales
|
$
|
513
|
$
|
466
|
$
|
324
|
||||||
|
Research and development
|
3,451
|
3,203
|
1,635
|
|||||||||
|
Selling, general and administrative
|
7,151
|
7,070
|
5,104
|
|||||||||
|
Total stock-based compensation expense
|
$
|
11,115
|
$
|
10,739
|
$
|
7,063
|
||||||
|
|
Year ended December 31,
|
|||||||||||
|
(in thousands)
|
2012
|
2011
|
2010
|
|||||||||
|
Current
|
|
|
|
|||||||||
|
Federal
|
$
|
11,481
|
$
|
(3,795
|
)
|
$
|
16,664
|
|||||
|
State
|
(1,045
|
)
|
(1,110
|
)
|
187
|
|||||||
|
International
|
103
|
74
|
102
|
|||||||||
|
Total current
|
10,539
|
(4,831
|
)
|
16,953
|
||||||||
|
Deferred
|
||||||||||||
|
Federal
|
3,758
|
19,055
|
10,003
|
|||||||||
|
State
|
(375
|
)
|
1,606
|
(774
|
)
|
|||||||
|
Total deferred
|
3,383
|
20,661
|
9,229
|
|||||||||
|
Total provision for income taxes
|
$
|
13,922
|
$
|
15,830
|
$
|
26,182
|
||||||
|
|
December 31,
|
|||||||
|
(in thousands)
|
2012
|
2011
|
||||||
|
Net operating loss carryforward
|
$
|
26,102
|
$
|
28,621
|
||||
|
Research and development carryforward
|
3,556
|
3,556
|
||||||
|
Stock compensation
|
5,289
|
3,666
|
||||||
|
Foreign deferrals
|
64,009
|
61,255
|
||||||
|
Deferred revenue
|
-
|
485
|
||||||
|
Other
|
9,005
|
9,596
|
||||||
|
Deferred tax asset
|
107,961
|
107,179
|
||||||
|
Fixed assets
|
(22,040
|
)
|
(21,760
|
)
|
||||
|
Other
|
(6,158
|
)
|
(6,902
|
)
|
||||
|
Deferred tax liability
|
(28,198
|
)
|
(28,662
|
)
|
||||
|
Valuation allowance
|
(67,412
|
)
|
(62,783
|
)
|
||||
|
Net deferred tax asset
|
$
|
12,351
|
$
|
15,734
|
||||
|
|
Year ended December 31,
|
|||||||||||
|
(in thousands)
|
2012
|
2011
|
2010
|
|||||||||
|
US
|
$
|
52,391
|
$
|
66,756
|
$
|
111,775
|
||||||
|
International
|
(14,945
|
)
|
(27,907
|
)
|
(33,895
|
)
|
||||||
|
Earnings before taxes on income
|
37,446
|
38,849
|
77,880
|
|||||||||
|
|
||||||||||||
|
Federal tax at statutory rates
|
$
|
13,106
|
$
|
13,597
|
$
|
27,258
|
||||||
|
State taxes, net of federal benefit
|
(2,079
|
)
|
46
|
666
|
||||||||
|
Impact of foreign operations
|
(3,604
|
)
|
(2,371
|
)
|
(7,713
|
)
|
||||||
|
Change in valuation allowance
|
4,629
|
3,193
|
6,394
|
|||||||||
|
Effect of foreign rates
|
(22
|
)
|
(12
|
)
|
(30
|
)
|
||||||
|
Tax credits
|
(2,904
|
)
|
(1,405
|
)
|
(1,754
|
)
|
||||||
|
Other differences
|
139
|
556
|
398
|
|||||||||
|
Permanent differences
|
4,657
|
2,226
|
963
|
|||||||||
|
Provision for income taxes
|
$
|
13,922
|
$
|
15,830
|
$
|
26,182
|
||||||
|
(in thousands)
|
|
|||
|
Gross unrecognized tax benefits at January 1, 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 statute 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 statute of limitations
|
-
|
|||
|
Gross unrecognized tax benefits at December 31, 2011
|
1,056
|
|||
|
Increases for tax positions for prior years
|
25
|
|||
|
Decreases for tax positions for prior years
|
(65
|
)
|
||
|
Increases for tax positions for current year
|
-
|
|||
|
Settlements
|
-
|
|||
|
Lapse of statute of limitations
|
-
|
|||
|
Gross unrecognized tax benefits at December 31, 2012
|
$
|
1,016
|
||
| 15. | Restructuring |
|
|
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)
|
|
|||
|
2013
|
$
|
3,447
|
||
|
2014
|
3,497
|
|||
|
2015
|
2,331
|
|||
|
2016
|
1,377
|
|||
|
2017
|
-
|
|||
|
Total minimum lease payments
|
$
|
10,652
|
||
|
|
Year Ended December 31,
|
|||||||||||
|
(in thousands, except share and per share data)
|
2012
|
2011
|
2010
|
|||||||||
|
Numerator:
|
|
|
|
|||||||||
|
Net income
|
$
|
23,524
|
$
|
23,019
|
$
|
51,698
|
||||||
|
|
||||||||||||
|
Denominator:
|
||||||||||||
|
Weighted-average number of shares—basic
|
36,080,495
|
35,658,907
|
31,782,286
|
|||||||||
|
Dilutive securities—equity awards
|
340,167
|
547,145
|
757,214
|
|||||||||
|
Weighted-average number of shares—diluted
|
36,420,662
|
36,206,052
|
32,539,500
|
|||||||||
|
|
||||||||||||
|
Earnings per share-basic
|
$
|
0.65
|
$
|
0.65
|
$
|
1.63
|
||||||
|
Earnings per share-diluted
|
$
|
0.65
|
$
|
0.64
|
$
|
1.59
|
||||||
| 21. | Segment information |
|
|
Reportable Segments
|
|||||||||||||||
|
(in thousands)
|
Biodefense
|
Biosciences
|
All Other
|
Total
|
||||||||||||
|
Year Ended December 31, 2012
|
|
|
|
|
||||||||||||
|
External revenue
|
$
|
276,469
|
$
|
5,419
|
$
|
-
|
$
|
281,888
|
||||||||
|
Intersegment revenue (expense)
|
-
|
-
|
-
|
-
|
||||||||||||
|
Research and development
|
68,579
|
44,588
|
7,059
|
120,226
|
||||||||||||
|
Interest revenue
|
-
|
-
|
134
|
134
|
||||||||||||
|
Interest expense
|
-
|
-
|
(6
|
)
|
(6
|
)
|
||||||||||
|
Depreciation and amortization
|
8,951
|
2,147
|
99
|
11,197
|
||||||||||||
|
Net income (loss)
|
94,865
|
(63,928
|
)
|
(7,413
|
)
|
23,524
|
||||||||||
|
In-process research and development assets
|
-
|
41,800
|
-
|
41,800
|
||||||||||||
|
Goodwill
|
-
|
5,502
|
-
|
5,502
|
||||||||||||
|
Total assets
|
354,010
|
56,148
|
154,072
|
564,230
|
||||||||||||
|
Expenditures for long-lived assets
|
52,957
|
810
|
78
|
53,845
|
||||||||||||
|
Year Ended December 31, 2011
|
||||||||||||||||
|
External revenue
|
$
|
251,037
|
$
|
22,347
|
$
|
- |
$
|
273,384
|
||||||||
|
Intersegment revenue (expense)
|
-
|
-
|
-
|
-
|
||||||||||||
|
Research and development
|
57,833
|
61,566
|
5,433
|
124,832
|
||||||||||||
|
Interest revenue
|
-
|
-
|
105
|
105
|
||||||||||||
|
Interest expense
|
-
|
-
|
-
|
-
|
||||||||||||
|
Depreciation and amortization
|
6,213
|
3,070
|
72
|
9,355
|
||||||||||||
|
Net income (loss)
|
86,836
|
(56,438
|
)
|
(7,379
|
)
|
23,019
|
||||||||||
|
In-process research and development assets
|
-
|
51,400
|
-
|
51,400
|
||||||||||||
|
Goodwill
|
-
|
5,502
|
-
|
5,502
|
||||||||||||
|
Total assets
|
290,302
|
92,321
|
164,241
|
546,864
|
||||||||||||
|
Expenditures for long-lived assets
|
52,326
|
1,608
|
92
|
54,026
|
||||||||||||
|
Year Ended December 31, 2010
|
||||||||||||||||
|
External revenue
|
$
|
282,727
|
$
|
3,444
|
$
|
-
|
$
|
286,171
|
||||||||
|
Intersegment revenue (expense)
|
-
|
-
|
-
|
-
|
||||||||||||
|
Research and development
|
52,191
|
32,895
|
4,209
|
89,295
|
||||||||||||
|
Interest revenue
|
-
|
-
|
832
|
832
|
||||||||||||
|
Interest expense
|
-
|
-
|
-
|
-
|
||||||||||||
|
Depreciation and amortization
|
4,584
|
1,333
|
73
|
5,990
|
||||||||||||
|
Net income (loss)
|
113,249
|
(53,676
|
)
|
(7,875
|
)
|
51,698
|
||||||||||
|
In-process research and development assets
|
-
|
51,400
|
-
|
51,400
|
||||||||||||
|
Goodwill
|
-
|
5,502
|
-
|
5,502
|
||||||||||||
|
Total assets
|
216,529
|
99,754
|
184,036
|
500,319
|
||||||||||||
|
Expenditures for long-lived assets
|
21,728
|
373
|
-
|
22,101
|
||||||||||||
|
|
Three months ended
|
|||||||||||||||
|
(in thousands)
|
March 31,
|
June 30,
|
September 30,
|
December 31,
|
||||||||||||
|
Fiscal year 2012
|
|
|
|
|
||||||||||||
|
Revenue
|
$
|
50,311
|
$
|
70,379
|
$
|
66,592
|
$
|
94,606
|
||||||||
|
Income (loss) from operations
|
(12,538
|
)
|
8,653
|
9,817
|
24,035
|
|||||||||||
|
Net income (loss)
|
(6,829
|
)
|
7,632
|
6,617
|
16,104
|
|||||||||||
|
Net income (loss) per share, basic
|
(0.19
|
)
|
0.21
|
0.18
|
0.45
|
|||||||||||
|
Net income (loss) per share, diluted
|
(0.19
|
)
|
0.21
|
0.18
|
0.44
|
|||||||||||
|
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
|
|||||||||||
| ITEM 9. | CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE |
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
|
|
|
|
|
|
|
|
/s/Daniel J. Abdun-Nabi
Daniel J. Abdun-Nabi
|
|
President and Chief Executive Officer
(Principal Executive Officer)
|
|
March 8, 2013
|
|
|
|
|
|
|
|
/s/Robert G. Kramer
Robert G. Kramer
|
|
Executive Vice President Corporate Services Division, Chief Financial Officer and Treasurer
(Principal Financial and Accounting Officer)
|
|
March 8, 2013
|
|
|
|
|
|
|
|
/s/Fuad El-Hibri
Fuad El-Hibri
|
|
Executive Chairman of the Board of Directors
|
|
March 8, 2013
|
|
|
|
|
|
|
|
__________________
Zsolt Harsanyi, Ph.D.
|
|
Director
|
|
|
|
|
|
|
|
|
|
/s/Dr. John Niederhuber
|
|
|
|
|
|
Dr. John Niederhuber
|
|
Director
|
|
March 8, 2013
|
|
|
|
|
|
|
|
/s/Ronald B. Richard
Ronald B. Richard
|
|
Director
|
|
March 8, 2013
|
|
|
|
|
|
|
|
/s/Louis W. Sullivan, M.D.
Louis W. Sullivan, M.D.
|
|
Director
|
|
March 8, 2013
|
|
|
|
|
|
|
|
/s/Marvin White
|
|
|
|
|
|
Marvin White
|
|
Director
|
|
March 8, 2013
|
|
|
|
|
|
|
|
____________
Dr. Sue Bailey
|
|
Director
|
|
|
|
|
|
|
|
|
|
All documents referenced below were filed pursuant to the Securities Exchange Act of 1934 by the Company, (File No. 001-33137), unless otherwise indicated.
|
||
|
|
|
|
|
Exhibit
|
|
|
|
Number
|
|
Description
|
|
3.1
|
|
Restated Certificate of Incorporation of the Company (incorporated by reference to Exhibit 4.1 to the Company's Registration Statement on Form S-8 filed on December 8, 2006) (File No. 333-139190).
|
|
3.2
|
|
Amended and Restated By-laws of the Company (incorporated by reference to Exhibit 3 to the Company's Current Report on Form 8-K filed on August 16, 2012).
|
|
4.1
|
|
Specimen Common Stock Certificate (incorporated by reference to Exhibit 4.1 to Amendment No. 3 to the Company's Registration Statement on Form S-1 filed on October 20, 2006) (File No. 333-136622).
|
|
4.2
|
|
Rights Agreement, dated as of November 14, 2006, between the Company and American Stock Transfer & Trust Company (incorporated by reference to Exhibit 4.3 to the Company's Registration Statement on Form S-8 filed on December 8, 2006) (File No. 333-139190).
|
|
4.3
|
|
Registration Rights Agreement, dated as of September 22, 2006, among the Company and the stockholders listed on Schedule 1 thereto (incorporated by reference to Exhibit 4.3 to Amendment No. 1 to the Company's Registration Statement on Form S-1 filed on September 25, 2006) (File No. 333-136622).
|
|
9.1
|
|
Voting and Right of First Refusal Agreement, dated as of 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 Company's Registration Statement on Form S-1 filed on August 14, 2006) (File No. 333-136622).
|
|
10.1
|
*
|
Emergent BioSolutions Inc. Employee Stock Option Plan, as amended and restated on January 26, 2005 (incorporated by reference to Exhibit 10.1 to the Company's Registration Statement on Form S-1 filed on August 14, 2006) (File No. 333-136622).
|
|
10.2
|
*
|
Emergent BioSolutions Inc. 2006 Stock Incentive Plan (incorporated by reference to Exhibit 10.3 to Amendment No. 5 to the Company's Registration Statement on Form S-1 filed on October 30, 2006) (File No. 001-33137).
|
|
10.3
|
*
|
Amended and Restated Emergent BioSolutions Inc. 2006 Stock Incentive Plan (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q filed on August 7, 2009).
|
|
10.4
|
*
|
Second Amended and Restated Emergent BioSolutions Inc. 2006 Stock Incentive Plan (incorporated by reference to Appendix A to the Company's definitive proxy statement on Schedule 14A filed on April 6, 2012).
|
|
10.5
|
#*
|
Form of Director Nonstatutory Stock Option Agreement.
|
|
10.6
|
#*
|
Form of Director Restricted Stock Unit Agreement.
|
|
10.7
|
#*
|
Form of Non-Qualified Stock Option Agreement.
|
|
10.8
|
#*
|
Form of Restricted Stock Unit Agreement.
|
|
10.9
|
*
|
Form of Indemnity Agreement for directors and senior officers (incorporated by reference to Exhibit 10 to the Company's Current Report on Form 8-K filed on January 18, 2013).
|
|
10.10
|
#*
|
Director Compensation Program.
|
|
10.11
|
*
|
Employment Agreement, effective January 1, 2012, between Emergent Product Development UK Ltd and Dr. Steven Chatfield (incorporated by reference to Exhibit 10.11 to the Company's Annual Report on Form 10-K filed on March 9, 2012).
|
|
10.12
|
*
|
Annual Bonus Plan for Executive Officers (incorporated by reference to Exhibit 10.7 to the Company's Annual Report on Form 10-K filed on March 5, 2010).
|
|
10.13
|
*
|
Amended and Restated Senior Management Severance Plan (incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed on December 22, 2011).
|
|
10.14
|
|
Amended and Restated Marketing Agreement, dated as of November 5, 2008, between Emergent Biodefense Operations Lansing LLC (formerly known as Emergent Biodefense Operations Lansing Inc.) and Intergen N.V. (incorporated by reference to Exhibit 10.27 to the Company's Annual Report on Form 10-K filed on March 6, 2009).
|
|
10.15
|
†
|
Solicitation, Offer and Award (the "CDC BioThrax Procurement Contract"), effective September 30, 2011, from the Centers for Disease Control and Prevention to Emergent BioDefense Operations Lansing LLC (incorporated by reference to Exhibit 10.4 to the Company's Quarterly Report on Form 10-Q filed on May 4, 2012).
|
|
10.16
|
†
|
Modification No. 1 to the CDC BioThrax Procurement Contract, effective March 21, 2012, between Emergent BioDefense Operations Lansing LLC and the Centers for Disease Control and Prevention (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q filed on November 1, 2012).
|
|
10.17
|
†
|
Modification No. 2 to the CDC BioThrax Procurement Contract, effective September 1, 2012, between Emergent BioDefense Operations Lansing LLC and the Centers for Disease Control and Prevention (incorporated by reference to Exhibit 10.3 to the Company's Quarterly Report on Form 10-Q filed on November 1, 2012).
|
|
10.18
|
|
Lease Agreement, dated June 27, 2006, between Brandywine Research LLC and the Company (the "Rockville Lease") (incorporated by reference to Exhibit 10.24 to Amendment No. 1 to the Registrant's Registration Statement on Form S-1 filed on September 25, 2006) (File No. 333-136622).
|
|
10.19
|
|
First Amendment to the Rockville Lease, dated November 13, 2007, between Brandywine Research LLC and the Company (incorporated by reference to Exhibit 10.45 to the Registrant's Annual Report on Form 10-K for the year ended December 31, 2011 filed on March 9, 2012).
|
|
10.20
|
|
Second Amendment to the Rockville Lease, dated December 13, 2010, between Brandywine Research LLC and the Company (incorporated by reference to Exhibit 10.46 to the Registrant's Annual Report on Form 10-K for the year ended December 31, 2011 filed on March 9, 2012).
|
|
10.21
|
|
Third Amendment to the Rockville Lease, dated effective February 27, 2012, between Brandywine Research LLC and the Company (incorporated by reference to Exhibit 10.47 to the Registrant's Annual Report on Form 10-K for the year ended December 31, 2011 filed on March 9, 2012).
|
|
12
|
#
|
Ratio of Earnings to Fixed Charges.
|
|
21
|
#
|
Subsidiaries of the Company.
|
|
23
|
#
|
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.
|
|
|
|
|
|
|
#
|
Filed herewith
|
|
|
†
|
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 |
|---|