SEC Company Response from Emergent BioSolutions Inc. (EBS) (CIK 0001367644) (EBS) — Jan 11, 2019
Emergent BioSolutions Inc. (EBS) (CIK 0001367644)
Date: Jan. 11, 2019 · CIK: 0001367644 · Accession: 0001367644-19-000007
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File numbers found in text: 001-33137
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FOIA Confidential Treatment Request
Confidential Treatment Requested by Emergent BioSolutions Inc. Pursuant to 17 C.F.R. §200.83. A version of
this letter submitted via EDGAR omits confidential information. Brackets ([ ]) denote the omission of the confidential information from the EDGAR submission of this letter.
January 11, 2019
VIA EDGAR
SUBMISSION
Securities and Exchange Commission
Division of Corporation Finance
Office of Healthcare & Insurance
100 F Street, N.E.
Washington, DC 20549-3561
Re: Emergent BioSolutions Inc.
Form 10-K for the Fiscal Year Ended December 31, 2017
Filed February 23, 2018
Form 10-Q for the Quarterly Period Ended September 30, 2018
Filed November 2, 2018
Form 8-K
Filed November 1, 2018
File No. 001-33137
This letter sets forth the response of Emergent BioSolutions Inc. (“Emergent” or the “Company”) to the comments contained
in your letter, dated December 12, 2018, relating to Emergent’s Form 10-K filed with the Commission on February 23, 2018, Emergent’s Form 10-Q filed with the Commission on November 2, 2018, and Emergent’s Form 8-K filed with the Commission on
November 1, 2018. The comments of the Staff of the Commission (the “Staff”) are set forth in bold/italicized text below, and the Company’s response is set forth in plain text immediately beneath such comment.
Form 10-K for the Fiscal Year Ended December
31, 2017
Management's Discussion and Analysis of
Financial Condition and Results of Operations
Results of Operations
Year ended December 31, 2017 Compared to Year
Ended December 31, 2016
Revenue
1.
Please tell us the following regarding your discussion of the changes in revenue:
•
How much of the increase in BioThrax
product sales relates to volume versus price.
•
What is meant by "timing of BioThrax
deliveries to SNS" and how it explains the increase in BioThrax sales.
•
The amount of other product sales by
product for 2017 and 2016.
•
The amount attributable to each bullet
with regard to the increase in other product sales.
•
The amount of expense incurred in 2017 and
2016 related to contracts and grants and where they are reflected in your financial statements.
Also address the above bullets, as applicable, to your
MD&A revenue discussion for the nine months ended September 30, 2018 compared to nine months ended September 30, 2017 in your Form 10-Q for the quarterly period ended September 30, 2018.
In response to the Staff’s comment, the Company respectfully advises the Staff that substantially all of the Company’s
sales of BioThrax® during the periods in question were made to the United States government (“USG”) under two long-term procurement contracts between the Company and the Centers for Disease Control (“CDC”) and Biomedical Advanced Research
and Development Authority (“BARDA”) at a fixed price per dose. The price per dose of BioThrax® in the two contracts is identical. Therefore, the fluctuations in BioThrax® revenue are related to changes in volume depending on
the timing of when the USG requests delivery of doses to the Strategic National Stockpile (“SNS”). The SNS is a national repository of critical antibiotics, vaccines, chemical antidotes, antitoxins, and other critical medical supplies maintained by
the USG and it retains a threshold level of BioThrax® at any given time, as it deems necessary. The Company will clarify in future Exchange Act periodic reports that BioThrax® product sales fluctuations are substantially due to
changes in volume and those changes in volume are driven by the timing of deliveries and acceptance of product by the USG.
For competitive and other reasons described herein, the Company has elected not to present revenue for each of its
products on an individual basis. Additionally, certain of the Company’s products are procured by the USG and other customers on an infrequent or periodic basis and therefore period to period fluctuations in sales may not be meaningful to the
long-term financial profile of a product. Furthermore, for fiscal years 2017, 2016, and 2015, no products other than BioThrax® had sales representing more than 10% of our total revenues. BioThrax® product sales represented
51%, 48%, and 60% of our total revenues for the fiscal years ended December 31, 2017, 2016, and 2015, respectively. For the nine months ended September 30, 2018, BioThrax® product sales represented 28% of our total revenues and ACAM2000®
product sales represented 23% of our total revenues. For the nine months ended September 30, 2017, BioThrax® product sales represented 49% of our total revenues. The Company has presented the table below for the purpose of responding to
the Staff’s comment; however, the Company does not intend to present the below product sales revenue breakout in its future filings for the reasons mentioned above. The Company believes that presenting information in MD&A in a manner similar to
the below could give investors a false impression, either favorably or unfavorably, about the Company’s results of operations and the financial profile of its products on an individual basis, particularly given the fact that many of its products are
purchased on an irregular basis and therefore fluctuations period over period are not necessarily indicative of a product’s expected long-term performance.
[INFORMATION REDACTED]
In response to the Staff’s comments requesting quantification of movement in other product sales, the Company has
re-presented such text with quantification included below for the year ended December 31, 2017 compared to the year ended December 31, 2016:
“The increase in other product sales relates primarily to:
•
the timing of BAT® deliveries to the SNS ($28.4 million);
•
international sales for VIGIV and Trobigard™ ($25.3 million); and
•
sales of ACAM2000® and Raxibacumab, both acquired in October 2017 ($20.5 million).”
Additionally, the Company has quantified the corresponding disclosure for the nine months ended September 30, 2018 and
2017:
“The increase in other product sales relates primarily to:
•
sales of ACAM2000® (which was acquired in October 2017) to the CDC ($116.7 million);
•
sales of Raxibacumab (which was acquired in October 2017) to BARDA ($39.6 million);
•
sales of Trobigard™ to the U.S. Department of State ($17.5 million);
•
sales of RSDL® to the DoD ($7.4 million); and
•
sales of Anthrasil® to the Canadian Defence Ministry ($7.0 million).
These increases in other Products sales were partially offset by a decrease in BAT® sales
($18.9 million) primarily due to the timing of deliveries to the SNS.”
In future filings under the Exchange Act, the Company confirms that it will include quantification of changes in Results
of Operations similar to the above presentation.
The revenues within our contracts and grants revenues primarily related to our cost-plus fixed fee contracts with the USG.
The Company’s expenses associated with contracts and grants are primarily recorded within research and development expenses and represented 43% and 67% of total research and development expenses for the years ended December 31, 2017 and 2016,
respectively. Additionally, for the nine months ended September 30, 2018 and 2017 expenses associated with contracts and grants represented 34% and 46% of total research and development expenses, respectively.
Cost of Product Sales and Contract
Manufacturing
2.
Please tell us the amount attributable to each bullet with regard to the increase in cost of product sales and
manufacturing.
In response to the Staff’s comments requesting quantification of the increase in cost of product sales and manufacturing,
the Company has re-presented such text with quantification included below for the year ended December 31, 2017 compared to the year ended December 31, 2016:
“Cost of product sales and contract manufacturing increased by $64.4 million, or 49%, to $195.7 million
for 2017 from $131.3 million for 2016. The increase was primarily attributable to:
•
the timing of non-cash fair value adjustments to the contingent consideration liability (year over year increase of $8.2 million);
•
timing of BAT® sales to the SNS ($7.2 million);
•
timing of international sales for VIGIV and Trobigard™ ($13.7 million);
•
sales of the newly acquired ACAM2000® and Raxibacumab products ($18.5 million) (both acquired October 2017); and
•
increased costs associated with the expansion of our contract manufacturing business ($18.8 million).”
In future filings under the Exchange Act, the Company confirms that it will include quantification of changes in Results
of Operations similar to the above presentation.
Consolidated Financial Statements
Consolidated Statements of Operations
3.
Regarding the line item cost of product sales and contract manufacturing, please provide us the amounts included for
fiscal years December 31, 2016 and 2017 and the nine months ended September 30, 2018 for cost of product sales versus cost of contract manufacturing. Tell us how your current presentation that combines those items into one line item
complies with rule 5-03(b)2 of Regulation S-X.
The Company respectfully advises the Staff that it uses the same manufacturing facilities and methods of production for
its own products as well as for fulfillment of its contract manufacturing contracts. Prior to completing two recent acquisitions in October 2018, the Company operated seven manufacturing facilities, five of which are multi-purpose as they perform
manufacturing activities for its own marketed products as well as contract manufacturing customers. The inputs and outputs in the manufacturing process are similar regardless of whether the Company is producing material for itself or external
customers. As a result, management views expenses associated with its manufacturing operations on an aggregate basis when analyzing the financial performance of its manufacturing facilities. The Company’s contract manufacturing business includes
performing “fill-finish” work for biologics products as well as producing bulk material for certain customers. For “fill-finish” customers, the Company receives work in process inventory from its client and brings the product to filled and finished
state and incurs costs to complete the manufacturing process. Additionally, when producing bulk material for customers, the Company procures raw materials and produces the contract manufacturing customer’s product from scratch and retains title and
risk of loss to the product until it is delivered to the customer upon completion of the manufacturing process and the product being approved by the Company’s quality control review process. The Company performs similar production activities for its
own products and therefore does not view the costs associated with performing these activities for third-party customers should be viewed separately from the costs incurred to produce its own products. Furthermore, the Company has historically
communicated its gross margin goals to its investors on an aggregated basis as it believes viewing overall gross margin is most useful to investors as the Company looks to optimize the profitability of its manufacturing facilities by producing its
own products and utilizing excess capacity for contract manufacturing customers where possible. As the Company expands its product portfolio, particularly with the recent acquisition of three marketed products during the fourth quarter of 2018, the
Company expects that the contract manufacturing business will be less than 10% of total revenues in future periods and it is forecasted to be less than 10% of total revenues in fiscal year 2019. As a result of these facts, the Company does not
believe that expenses related to its contract manufacturing business represent “cost of services” per Rule 5-03(b)2 of Regulation S-X and believes its presentation of expenses to be in compliance with Regulation S-X as well as the most useful
presentation of this expense to users of the financial statements.
Notes to Consolidated Financial Statements
2. Summary of Significant Accounting Policies
Revenue Recognition
4.
Please provide us an accounting analysis that describes your accounting treatment (i.e. separation, measurement,
recognition and classification) for the March 16, 2017 contract and modification that you entered with BARDA. Provide reference to authoritative literature supporting your treatment.
On September 30, 2016, the Company and BARDA entered into an agreement for the advanced development and delivery of
NuThrax™ (“BARDA NuThrax™ Contract”). The BARDA NuThrax™ Contract consisted of a five-year base period of performance to develop NuThrax™ (contract value of [ ]) and to manufacture and deliver an initial 2.0 million NuThrax™ doses into the SNS
after receiving Emergency Use Authorization (“EUA”) pre-authorization approval by US Food and Drug Administration (“FDA”) (contract value of [ ]). The BARDA NuThrax™ Contract also included procurement options (exercisable by BARDA) for the delivery
of an additional 7.5 million to 50 million doses of NuThrax™ to the SNS, with a contract value of approximately $255 million up to approximately $1.3 billion, and options (also exercisable by BARDA) for an additional clinical study and post-marketing
commitments with a contract value of $48 million.
On March 16, 2017, the Company and
BARDA entered into a new agreement for the delivery of BioThrax® to the SNS in exchange for $99.9 million (“BARDA BioThrax® Contract”). In connection with the signing of this agreement, the Company and BARDA
also entered into a modification of the BARDA NuThrax™ Contract (“Modification
to the BARDA NuThrax™ Contract”). The Modification to the BARDA NuThrax™ Contract increased the number of doses of NuThrax™ to be delivered under the base period from 2.0 million to 3.0 million, with no additional consideration to be
provided to the Company, resulting in an implied discount on the initial doses
to be delivered. Additionally, the Modification to the BARDA NuThrax™ Contract included a discount on the sales price for doses to be procured during the option period of up to $100 million.
Accounting Standards Codification (“ASC”)
605-25-25-3 states “…separate contracts with the same entity or related parties that are entered into at or near the same time are presumed to have been negotiated as a package and shall, therefore, be evaluated as a single arrangement in
considering whether there are one or more units of accounting.” As the BARDA BioThrax® Contract and the Modification to the BARDA NuThrax™ Contract were entered into at the same time and the related terms of the agreements were negotiated as a package, the Company concl