SEC Company Response from Emergent BioSolutions Inc. (EBS) (CIK 0001367644) (EBS) — Nov 13, 2009
Emergent BioSolutions Inc. (EBS) (CIK 0001367644)
Date: Nov. 13, 2009 · CIK: 0001367644 · Accession: 0000950123-09-062302
AI Filing Summary & Sentiment
File numbers found in text: 001-33137
Referenced dates: October 29, 2009
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CORRESP
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corresp
November 13, 2009
VIA EDGAR SUBMISSION
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, DC 20549
Attention:
Mr. Jim B. Rosenberg
Senior Assistant Chief Accountant
Re:
Emergent BioSolutions Inc.
Form 10-K for the Fiscal Year Ended December 31, 2008
Schedule 14A filed April 3, 2009
Form 10-Q for the Fiscal Quarter Ended June 30, 2009
File No. 001-33137
Ladies and Gentlemen:
We are submitting this letter in response to comments contained in a letter dated October 29, 2009
from Jim B. Rosenberg, Senior Assistant Chief Accountant, of the Staff (the “Staff”) of the
Securities and Exchange Commission (the “Commission”) to R. Don Elsey, Senior Vice President
Finance, Chief Financial Officer and Treasurer of Emergent BioSolutions Inc. (the “Company”). The
responses to these comments are set forth below and are keyed to the numbering of the comments and
the headings used in the Staff’s letter.
Form 10-K for the Fiscal Year Ended December 31, 2008
Item 1. Business
Manufacturing, page 21
1.
We note that you have entered into a Product Supply Agreement with Talecris Biotherapeutics,
whereby you have agreed to obtain all manufacturing requirements for your anthrax immune
globulin therapeutic candidate exclusively from Talecris, and have also agreed to pay Talecris
royalties on net sales on a country-by-country basis for commercial product manufactured by
Talecris under the contract. Please disclose a range of royalty rates (for example,
“low-single-digits,” “high-single-digits,” etc.) payable to Talecris. Your disclosure should
disclose any differences in the royalty range based on the country in which the sales may
occur.
Response:
In response to the Staff’s comment, the Company proposes to include disclosure of
the range of royalty rates under this agreement in its Annual Report on Form 10-K for
the fiscal year ending December 31, 2009 (the “2009 Form 10-K”).
Intellectual Property and Licenses, page 24
2.
We note your description of your license agreements with USAMRIID, OETC, and HPA. Please
expand your description of these agreements to disclose the following information:
Securities and Exchange Commission
November 13, 2009
Page 2
•
All material rights and obligations of the company and the other party;
•
The range of royalty rates (for example, “low-single-digits,” “high-single-digits,”
etc.);
•
The aggregate amount of milestone or other payments payable or receivable to each
party, and the amounts paid to date; and
•
Duration and termination provisions.
Response:
In response to the Staff’s comment, the Company proposes to include revised and
expanded disclosure substantially as set forth on Exhibit A hereto in its 2009 Form
10-K.
3.
We note your statement on page 28 that you have paid minimum contractual commitments of $1.0
million under each of the two development agreements to which you are a party with HPA. If
you have additional payment obligations to HPA, please disclose the aggregate amount of
expected payments under each development agreement.
Response:
The Company advises the Staff that there are currently no outstanding amounts due
or future required payments under either development agreement. The Company may decide
in the future to use HPA to perform additional work under one or both of the
development agreements; however, until the Company determines to perform such
additional work, it is not capable of estimating future amounts that may be paid under
either of the agreements.
4.
We note your disclosure on page 28 that you acquired a license agreement with StMUGV, under
which you are required to pay StMUGV a percentage of the net revenue or license fees that you
receive from products developed using the MVA platform technology that are used for research
or other purposes, and a percentage of the license fees that you receive from products
developed using MVA that are licensed as starting material for the production of a smallpox
vaccine. Please expand your description of this agreement to state the royalty range (for
example, “low-single-digits,” “high-single-digits,” etc.) payable to StMUGV.
Response:
In response to the Staff’s comment, the Company proposes to include disclosure of
the range of royalty rates under this agreement in its 2009 Form 10-K.
5.
We note that you have described the material terms of the license agreement with StMUGV, but
have not filed the license agreement as an exhibit. Please file the agreement as an exhibit
to your Form 10-K, or provide us with a legal analysis as to why you are not required to file
the agreement as an exhibit pursuant to Item 601(b)(l0) of Regulation S-K.
Response:
The Company advises the Staff that the license agreement with StMUGV is included
as Exhibit 10.20 to the
2008 Form 10-K.
Item 1A. Risk Factors
“If we are unable to protect the confidentiality of our proprietary information and know-how...,” page 64
6.
We note that the only intellectual property protection for BioThrax, other than the BioThrax
trademark, is confidentiality regarding your manufacturing capability and specialty know-how,
which you protect, in part, with confidentiality agreements with your employees, consultants and
Securities and Exchange Commission
November 13, 2009
Page 3
third parties. Please provide us with a supplemental copy of the standard confidentiality
agreement you enter into with your employees. We may have further comment.
Response:
Under separate cover, the Company is supplementally providing the Staff with the
Company’s standard form of confidentiality agreement with its employees.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
7.
We note that you have not provided the performance graph required by Item 201(e) of
Regulation S-K in either your Form 10-K or in your definitive proxy statement, or in your
Annual Report to Shareholders. If you have not included the performance graph in your filed
materials, please confirm that you will include this information in your Form 10-K for the
next fiscal year, or in your 2010 proxy statement.
Response:
The Company advises the Staff that the performance graph required by Item 201(e)
of Regulation S-K was set forth on page 135 of the Company’s 2008 Annual Report to
Stockholders, consistent with Instruction 7 to Item 201(e). The Company further
confirms that it will likewise include the performance graph in its 2009 Annual Report
to Stockholders. For the Staff’s convenience, the Company is supplementally providing
the Staff with a copy of the Company’s 2008 Annual Report to Stockholders under
separate cover.
Item 7.
Management’s Discussion and Analysis of Financial Condition and
Results of Operations
Financial Operations Overview
Revenues, page 80
8.
We note your disclosure that in September 2007 and September 2008, you received two
development contracts from the National Institute of Allergy and Infectious Disease, valued at
up to $9.5 million and $30 million, respectively. Please disclose when and how these amounts
will become receivable.
Response:
In response to the Staff’s comment, the Company proposes to include revised and
expanded disclosure substantially as set forth on Exhibit B hereto in the Revenue
Recognition section of Management’s Discussion and Analysis in its 2009 Form 10-K.
Additionally, the Company advises the Staff that in its Quarterly Report on
Form 10-Q for the period ended September 30, 2009, filed on November 5,
2009, the Company has included additional disclosure of period of
performance with regard to its contracts and grants, and that the Company
will continue to disclose such information.
9.
Please file the development contracts with NIAID as exhibits to your Form 10-K, or provide us
with a legal analysis as to why you are not required to file the agreements as exhibits
pursuant to Item 601(b)(l0) of Regulation S-K.
Securities and Exchange Commission
November 13, 2009
Page 4
Response:
The Company advises the Staff that in the Company’s view the development contracts
with NIAID are not material contracts that are required to be filed pursuant to Item
601(b)(10) of Regulation S-K. The Company believes that its development contracts
with NIAID are of the type that ordinarily accompany the kind of business conducted by
the Company and were entered into in the ordinary course of business. In addition, the
Company does not believe that the Company’s business is substantially dependent on
either of these agreements or that the agreements are material in light of the
substantial revenues that the Company has generated from BioThrax product sales, which
it uses to fund product development. The Company believes that in total, its contracts
and grants revenue does not represent a material source of revenue for the years ended
2006, 2007 and 2008. The Company’s average annual product sales revenue for the past
three full fiscal years is approximately $162.3 million. Total average annual contracts
and grants revenue for these same three full fiscal years is approximately $9.1
million, or 5.3% of total revenues for the three year period. Accordingly, the Company
respectfully submits that the agreements with these third parties are not required to
be filed as exhibits to its Annual Report on Form 10-K.
Liquidity and Capital Resources
Contractual Obligations, page 89
10.
You note on page 26 that you consider three existing licenses to be material to your current
product portfolio or development pipeline, and they include licenses with USAMRIID, OETC, and
HPA. Please include in the contractual obligation table the cash obligations under all
material license and collaboration agreements. Where uncertainties prevent making a
reasonable estimate of the obligations, explain the uncertainties in a note to the table
indicating aggregate license and milestone payments, their timing, events triggering their
payment and expected effects on financial position, operations and capital resources.
Additionally, disclose any significant terms in the notes to the financial statements, as
required.
Response:
In response to the Staff’s comment, the Company proposes to include revised and
expanded disclosure substantially as set forth on Exhibit C hereto in the footnote to
the contractual obligation table in its 2009 Form 10-K. The Company also
advises the Staff that the Company has evaluated its prior disclosure with
respect to the terms of its three material licenses, and believes that no
additional disclosure of significant terms is required in the notes to the
financial statements.
Exhibit Index
11.
We note that you have described the material terms of the following related party agreements,
but have not filed the agreements as exhibits:
•
2009 Marketing Arrangement with an entity controlled by family members of the Chief
Executive Officer to market and sell BioThrax; and
•
Consulting Arrangement with a member of the Company’s Board of Directors.
Securities and Exchange Commission
November 13, 2009
Page 5
Please file these agreements as exhibits to your Form 10-K, or provide us with a legal
analysis as to why you are not required to file the agreements as exhibits pursuant to Item
601(b)(10)(ii)(A) of Regulation S-K.
Response:
The Company advises the Staff that the Marketing Agreement is included as Exhibit
10.27 and the Consulting Services Agreements are included as Exhibits 10.24 and 10.25
to the Company’s 2008 Form 10-K.
12.
Please identify the member of the company’s Board of Directors with whom the company entered
into a consulting arrangement, as disclosed on page 118. Please refer to Item 404(a)(l) of
Regulation S-K. It does not appear that you are describing the related party consulting
agreement with The Hauer Group, as you indicate on page 118 that the company paid
approximately $218,000 under the unnamed consulting arrangement at issue during the year ended
December 31, 2008, while you disclose on page 11 of the definitive proxy statement that the
company paid The Hauer Group approximately $180,000 in 2008 in connection with the Consulting
Agreement to which it is a party.
Response:
The Company advises the Staff that the reference on page 118 of the Company’s 2008
Form 10-K is a reference to the Consulting Services Agreement with The Hauer Group.
The $218,000 amount in the 2008 Form 10-K inadvertently included $38,000 in fees paid
to Jerome Hauer for his services as a director. The $180,000 amount disclosed in the
definitive proxy statement is the actual amount paid to the Hauer Group in 2008
pursuant to the consulting arrangement.
Schedule 14A filed April 3, 2009
Information About Executive And Director Compensation
Compensation Discussion and Analysis
Elements of Executive Compensation, page 17
13.
We note your disclosure on page 17 that adjustments to base salary are based in part upon
each executive officer’s individual performance. We further note that the base salaries of
your named executive officers increased in 2008. Please confirm that you will expand your disclosure
to discuss the material factors that the Compensation Committee considered in adjusting base
salaries in next year’s Compensation Discussion and Analysis.
Response:
The Company confirms that it will expand its disclosure in next year’s
Compensation Discussion and Analysis with respect to the material factors that the
Compensation Committee considers in adjusting base salaries.
Employment Agreements, page 23
14.
We note that you have described the material terms of the company’s employment agreement with
Dr. Lockhart, but have not filed the employment agreement as an exhibit. Please file the
agreement as an exhibit to your Form 10-K.
Response:
The Company advises the Staff that the agreement with Dr. Lockhart described in
the Company’s definitive proxy statement was not executed by the parties at
Securities and Exchange Commission
November 13, 2009
Page 6
the time the definitive proxy statement was filed and did not constitute a
definitive agreement. The agreement currently remains unexecuted. The Company further
advises the Staff that notwithstanding that the agreement has not been executed, the
Company has paid Dr. Lockhart compensation to date as summarized in the Company’s
public disclosure. The Company proposes to either (i) include a written description of
the draft agreement, containing substantially the same information as previously disclosed in
the definitive proxy statement, as an exhibit to the Company’s 2009 Form 10-K, or (ii)
if the agreement is executed by the parties, file the definitive written contract as an
exhibit to the Company’s 2009 Form 10-K.
Information Relating to Option Exercises, page 25
15.
We note your disclosure on page 25 regarding the exercise of stock options during the fiscal
year ended December 31,2009 for each named executive officer. However, your disclosure does
not address any vesting of stock during the last completed fiscal year. Please advise whether
the company had any vesting of stock.
Response:
The Company advises the Staff that there was no vesting of stock awards during the
fiscal year ended December 31, 2008, nor does the Company have outstanding any stock
awards with respect to which Item 402(g)(2)(iv) or
(v) of
Regulation S-K would apply.
Form 10-Q for the Fiscal Quarter Ended June 30, 2009
Notes to Consolidated Financial Statements
1. Summary of significant accounting policies
Note receivable, page 7
16.
Please tell us how you concluded that your note receivable with PS