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8-K

Emergent BioSolutions Inc. (EBS)

8-K 2011-08-04 For: 2011-08-03
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Added on April 04, 2026

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

____________________

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of report (Date of earliest event reported):  July 29, 2011

Emergent BioSolutions Inc.

(Exact Name of Registrant as Specified in Charter)

Delaware 001-33137 14-1902018
(State or Other Jurisdiction<br><br><br><br>of Incorporation) (Commission<br><br><br><br>File Number) (IRS Employer<br><br><br><br>Identification No.)
2273 Research Boulevard, Suite 400, Rockville, Maryland 20850
--- ---
(Address of Principal Executive Offices) (Zip Code)

Registrant’s telephone number, including area code:  (301) 795-1800

Not applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


Item 1.01. Entry into a Material Definitive Agreement.

PNC Construction Loan Agreement

On July 29, 2011, Emergent BioSolutions Inc. (the “Registrant”), entered into a Loan Agreement (the “PNC Loan Agreement”) and related agreements with PNC Bank, National Association (“PNC”) under which PNC will provide a loan of up to $30.0 million to the Registrant based on periodic requests, primarily to fund the ongoing build-out of the Registrant’s Baltimore facility. A portion of the proceeds of the initial draw on the loan under the PNC Loan Agreement was used to make final payment on a pre-existing loan between Emergent Manufacturing Operations Baltimore LLC (“Emergent Manufacturing Operations”), a wholly-owned subsidiary of the Registrant, and HSBC Realty Credit Corporation (USA) (“HSBC”) related to the initial purchase of the Baltimore facility (the “HSBC Loan Agreement”). Additional information regarding the PNC Loan Agreement is set forth below in Item 2.03 and is incorporated by reference in this Item 1.01 in its entirety.

PNC Equipment Loan Agreement

On August 3, 2011, Emergent Manufacturing Operations and the Registrant entered into a separate loan agreement with PNC to provide a loan to fund equipment purchases at the Registrant’s Baltimore facility (the “Equipment Loan Agreement”). Under the Equipment Loan Agreement, PNC will make advances to the Registrant of up to $12.0 million through August 3, 2012 based on periodic requests from the Registrant. To date, the Registrant has not requested any advances under the Equipment Loan Agreement.  Each request for advance under the Equipment Loan Agreement will be secured by the specific collateral described in such request, as well as by the Registrant’s other collateral securing the Registrant’s obligations under the PNC Loan Agreement.  The Equipment Loan Agreement contains affirmative and negative covenants that are substantially similar to those contained in the PNC Loan Agreement, as well as covenants that are customary for equipment financings of this type. Negative covenants in the Equipment Loan Agreement limit the ability of the Registrant to incur indebtedness and liens; sell assets; make loans, advances or guarantees; and enter into certain mergers or similar transactions.

Item 2.02 Results of Operations and Financial Condition.

On August 4, 2011, the Company announced financial and operating results for the quarter ended June 30, 2011. The full text of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K.

The information in Item 2.02 of this Form 8-K, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.

The information set forth in Item 1.01 above with respect to the PNC Loan Agreement is incorporated by reference in this Item 2.03 in its entirety.

Under the PNC Loan Agreement, PNC will make advances to of up to $30.0 million through July 28, 2012 based on periodic requests from the Registrant.  The Registrant has drawn $17.8 million on the loan to date, of which $6.2 million was used to repay the HSBC Loan Agreement.  The Registrant is required to make monthly payments under the PNC Loan Agreement based on the amounts then outstanding, including interest based on certain options made available to the Registrant with respect to each draw on the loan.  With respect to the initial draw on the loan, the Registrant’s interest rate is a one-month option of LIBOR plus 3.18725%. The Registrant’s payment obligations are secured by the accounts receivable of Emergent BioDefense Operations Lansing LLC that relate to BioThrax supply contracts with the U.S. government.  Payment obligations relating to the PNC Loan Agreement may be accelerated upon the occurrence of an event of default under the PNC Loan Agreement or the Equipment Loan Agreement. Such events of default include, subject in some cases to specified cure periods, payment defaults; inaccuracy of representations and warranties in any material respect; defaults in the observance or performance of covenants; bankruptcy and insolvency related defaults; the entry of one or more final judgments for the payment of more than $500,000 million that are not satisfied within 30 days; uninsured loss or destruction of a material portion of the collateral; invalidity of loan documents relating to the PNC Loan Agreement; and the occurrence of a material adverse change in financial condition.  The PNC Loan Agreement contains affirmative and negative covenants customary for financings of this type. Negative covenants in the PNC Loan Agreement limit the ability of the Registrant to incur indebtedness and liens; sell assets; make loans, advances or guarantees; and enter into certain mergers or similar transactions. The PNC Loan Agreement also contains financial covenants that require the Registrant and its consolidated subsidiaries to maintain a balance of unencumbered cash or liquid investments of $50,000,000; maintain on a quarterly basis, on a rolling four quarters basis, a ratio of all indebtedness for borrowed money to earnings before interest, taxes, depreciation and amortization for the most recent four quarters of less than 2.00 to 1.00; and maintain, on a quarterly basis, on a rolling four quarters basis, a ratio of earnings before interest, taxes, depreciation and amortization less cash taxes to the total current obligations and interest expense of indebtedness for borrowed money of at least 1.25 to 1.00.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

99.1 Press Release dated August 4, 2011.


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

EMERGENT BIOSOLUTIONS INC.

By: /s/R. Don Elsey

R. Don Elsey

Chief Financial Officer


exhibit99.htm

EXHIBIT 99.1

FOR IMMEDIATE RELEASE

Investor Contact

Robert G. Burrows

Vice President, Investor Relations

301-795-1877

BurrowsR@ebsi.com

Media Contact:

Tracey Schmitt

Vice President, Corporate Communications

301-795-1800

SchmittT@ebsi.com

EMERGENT BIOSOLUTIONS REPORTS FINANCIAL RESULTS FOR SECOND QUARTER AND FIRST SIX MONTHS OF 2011

· 2Q and six month 2011 revenues of $88.1 and $106.7 million, respectively
· 2Q net income of $14.2 million or $0.40 per share; six month net loss of
--- ---
$7.2 million or $0.20 per share
---
· 2011 revised forecast: total revenues of $270 to $290 million and net income
--- ---
of $15 to $25 million
---

ROCKVILLE, MD, August 4, 2011—Emergent BioSolutions Inc. (NYSE: EBS) announced today its financial results for the second quarter and six months ended June 30, 2011.

Total revenues for the second quarter and first six months of 2011 were $88.1 million and $106.7 million, respectively.  Net income for the second quarter was $14.2 million, or $0.40 per basic share, and for the first six months of 2011 the company recorded a net loss of $7.2 million, or $0.20 per basic share.  The second quarter 2011 performance was primarily driven by sales of BioThrax® (Anthrax Vaccine Adsorbed) based on scheduled deliveries to the Strategic National Stockpile (SNS), revenues from US government development contracts and grants, and revenues from our collaborations with Abbott Laboratories (Abbott) and Pfizer Inc. (Pfizer).

R. Don Elsey, chief financial officer of Emergent BioSolutions, stated, “Our second quarter financial performance reflects the continued deliveries of BioThrax to the SNS under the modified current contract for 17.9 million doses and our ongoing commitment to control expenditures while investing in the development of our pipeline programs.”

2Q and First Six Months of 2011 Key Financial Results

Product Sales

For 2Q 2011, product sales were $71.5 million, an increase of $15.6 million, or 28 percent, from $55.9 million in 2Q 2010, primarily due to a 25% increase in the number of doses of BioThrax delivered.  Product sales revenues for 2Q 2011 consisted of BioThrax sales to HHS of $70.7 million and aggregate international and other sales of $0.7 million.

For the six month period of 2011, product sales were $77.1 million, a decrease of $17.7 million, or 19 percent, from $94.7 million in the comparable period of 2010, primarily due to a 22% decrease in the number of doses of BioThrax delivered due to the company redeploying its potency testing capacity from BioThrax release testing to qualification of replacement reference standards and other development testing during the first quarter of 2011.  Product sales revenues for the six months ended June 30, 2011 consisted of BioThrax sales to HHS of $75.8 million and aggregate international and other sales of $1.3 million.

Contracts and Grants Revenues

For 2Q 2011, contracts and grants revenue was $16.7 million, an increase of $10.4 million, or 166 percent, from $6.3 million in 2Q 2010.  For the six month period of 2011, contracts and grants revenue was $29.6 million, an increase of $15.4 million, or 108 percent, from $14.2 million in the comparable period of 2010.  The increase in contracts and grants revenue was primarily due to revenues from our contract from BARDA for large-scale manufacturing for BioThrax and our collaborations with Abbott and Pfizer, along with increased activity and associated revenue from our other development contracts with NIAID and BARDA.

Cost of Product Sales

For 2Q 2011, cost of product sales was $16.1 million, an increase of $5.0 million, or 45 percent, from $11.1 million in 2Q 2010.  This increase was primarily attributable to the 25% increase in the number of BioThrax doses sold coupled with an increase in the cost per dose sold associated with decreased production yield in the period in which the doses were produced.

For the six month period of 2011, cost of product sales was $17.1 million, a decrease of $1.4 million, or 8 percent, from $18.6 million in the comparable period of 2010.  This decrease was attributable to a 22% decrease in the number of doses of BioThrax delivered partially offset by an increase in the cost per dose sold associated with decreased production yield in the period in which the doses were produced.

Research and Development

For 2Q 2011, research and development expenses were $31.5 million, an increase of $12.9 million, or 69 percent, from $18.6 million in 2Q 2010.  This increase primarily reflects higher contract service and personnel-related costs, and includes increased expenses of $12.4 million for product candidates and technology platform development activities that are categorized in the biosciences segment, increased expenses of $0.2 million for product candidates categorized in the biodefense segment, and increased expenses of $0.3 million in other research and development.

For the six month period of 2011, research and development expenses were $66.2 million, an increase of $27.7 million, or 72 percent, from $38.5 million in the comparable period of 2010.  This increase primarily reflects higher contract service and personnel-related costs, and includes increased expenses of $26.0 million for product candidates and technology platform development activities that are categorized in the biosciences segment, increased expenses of $1.1 million categorized in the biodefense segment, and increased expenses of $0.7 million in other research and development.

Selling, General and Administrative

For 2Q 2011, selling, general and administrative expenses were $20.4 million, an increase of $2.7 million, or 15 percent, from $17.6 million in 2Q 2010.  This increase is primarily due to approximately $2.2 million in restructuring charges related to our UK operations.

For the six month period of 2011, general and administrative expenses were $38.6 million, an increase of $4.8 million, or 14 percent, from $33.8 million in the comparable period of 2010.  This increase is primarily due the UK restructuring charges and increased personnel and professional services to support growth of the business.

Financial Condition and Liquidity

Cash and cash equivalents combined with investments at June 30, 2011 was $127.1 million compared to $171.0 million at December 31, 2010.  Additionally, at June 30, 2011, the accounts receivable balance was $47.3 million, which is comprised primarily of unpaid amounts due related to shipments of BioThrax received and accepted by the US government in the second quarter of 2011.

2011 Forecast

For the full year 2011, the Company is revising its financial forecast of total revenues and net income.  The Company anticipates total revenues of $270 to $290 million and net income of $15 to $25 million.  The reduction of 2011 expected total revenue is primarily driven by lower than expected fermentation yields during the six month period of 2011, which, in turn, is expected to result in an annual output this year of approximately 7 million doses.

For the third quarter of 2011, the Company anticipates total revenues of $50 to $60 million.

Conference Call and Webcast

Company management will host a conference call at 5:00 pm Eastern on August 4, 2011 to discuss the financial results for the second quarter and first six months of 2011, recent business developments, revenue guidance for the third quarter of 2011 and revenue and net income guidance for full year 2011.  The conference call will be accessible by dialing 888/713-4214 or 617/213-4866 (international) and providing passcode 23117164.  A webcast of the conference call will be accessible from the company’s website at www.emergentbiosolutions.com, under “Investors”.

A replay of the conference call will be accessible, approximately two hours following the conclusion of the call, by dialing 888/286-8010 or 617/801-6888 and using passcode 93267041.  The replay will be available through August 18, 2011.  The webcast will be archived on the company’s website, www.emergentbiosolutions.com, under “Investors”.

About Emergent BioSolutions Inc.

Emergent BioSolutions protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease.  Emergent’s marketed and investigational products target infectious diseases, oncology and autoimmune disorders.  Additional information about the company may be found at www.emergentbiosolutions.com.

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including any potential future securities offering, our expected revenue and net earnings for 2011, and any other statements containing the words "believes", "expects", "anticipates", "plans", "estimates" and similar expressions, are forward-looking statements. Such statements are based upon the current beliefs and expectations of management that are subject to risks, uncertainties and other important factors that could cause the company's actual results to differ materially from those indicated by such forward-looking statements, including appropriations for BioThrax® procurement; our ability to obtain new BioThrax® sales contracts or modifications to existing contracts; our plans to pursue label expansions and improvements for BioThrax®; our ability to perform under our current development contracts with the U.S. government; our plans to expand our manufacturing facilities and capabilities, including our ability to develop and obtain regulatory approval for large-scale manufacturing of BioThrax® in our large-scale vaccine manufacturing facility in Lansing, Michigan; the rate and degree of market acceptance of our products and product candidates; the success of preclinical studies and clinical trials of our product candidates and post-approval clinical utility of our products; the potential benefits of our existing collaborations and our ability to selectively enter into additional collaborative arrangements; the extent to which our licensing and acquisition activities are complementary to the company or whether anticipated synergies and benefits are realized within expected time periods; our ability to identify and acquire or in-license products and product candidates that satisfy our selection criteria; ongoing and planned development programs, preclinical studies and clinical trials; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2011 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

Financial Statements Follow


Emergent BioSolutions Inc. and Subsidiaries
Consolidated Balance Sheets
(in thousands, except share and per share data)
December 31,
2010
ASSETS
Current assets:
Cash and cash equivalents 122,094 $ 169,019
Investments 5,048 2,029
Accounts receivable 47,263 39,326
Inventories 17,262 12,722
Deferred tax assets, net 7,082 2,638
Income tax receivable, net 17,136 8,728
Restricted cash 217 217
Prepaid expenses and other current assets 7,742 8,814
Total current assets 223,844 243,493
Property, plant and equipment, net 172,481 152,701
In-process research and development 51,400 51,400
Goodwill 5,029 5,029
Assets held for sale 12,548 12,741
Deferred tax assets, net 27,970 33,757
Other assets 712 1,198
Total assets 493,984 $ 500,319
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable 32,182 $ 25,409
Accrued expenses and other current liabilities 1,200 1,309
Accrued compensation 13,823 23,975
Contingent value rights, current portion 9,734 -
Long-term indebtedness, current portion 10,229 17,187
Deferred revenue, current portion 5,336 7,839
Total current liabilities 72,504 75,719
Long-term indebtedness, net of current portion 29,074 30,239
Deferred revenue, net of current portion 2,953 4,386
Contingent value rights, net of current portion 6,206 14,532
Other liabilities 2,017 1,882
Total liabilities 112,754 126,758
Commitments and contingencies - -
Stockholders’ equity:
Preferred stock, 0.001 par value; 15,000,000 shares authorized, 0 shares issued and outstanding at June 30, 2011 and December 31, 2010, respectively - -
Common stock, 0.001 par value; 100,000,000 shares authorized, 35,850,658 and 35,011,423 shares issued and outstanding at June 30, 2011 and  December 31, 2010, respectively 36 35
Additional paid-in capital 213,320 197,689
Accumulated other comprehensive loss (2,771 ) (2,110 )
Retained earnings 166,663 173,850
Total Emergent BioSolutions Inc. stockholders' equity 377,248 369,464
Noncontrolling interest in subsidiary 3,982 4,097
Total stockholders’ equity 381,230 373,561
Total liabilities and stockholders’ equity 493,984 $ 500,319

All values are in US Dollars.


Emergent BioSolutions Inc. and Subsidiaries
Consolidated Statements of Operations
(in thousands, except share and per share data)
Three Months Ended
June 30,
2011 2010
(Unaudited)
Revenues:
Product sales $ 71,479 $ 55,872
Contracts and grants 16,662 6,266
Total revenues 88,141 62,138
Operating expenses:
Cost of product sales 16,069 11,076
Research and development 31,481 18,602
Selling, general and administrative 20,384 17,649
Income from operations 20,207 14,811
Other income (expense):
Interest income 24 376
Interest expense (6 ) (2 )
Other income (expense), net (39 ) 6
Total other income (expense) (21 ) 380
Income before provision for income taxes 20,186 15,191
Provision for income taxes 7,663 5,757
Net income 12,523 9,434
Net loss attributable to noncontrolling interest 1,687 374
Net income attributable to Emergent BioSolutions Inc. $ 14,210 $ 9,808
Earnings per share - basic $ 0.40 $ 0.32
Earnings per share - diluted $ 0.39 $ 0.31
Weighted-average number of shares - basic 35,619,514 31,097,445
Weighted-average number of shares - diluted 36,667,452 31,900,000

Emergent BioSolutions Inc. and Subsidiaries
Consolidated Statements of Operations
(in thousands, except share and per share data)
Six Months Ended
June 30,
2011 2010
(Unaudited)
Revenues:
Product sales $ 77,076 $ 94,725
Contracts and grants 29,598 14,213
Total revenues 106,674 108,938
Operating expenses:
Cost of product sales 17,137 18,584
Research and development 66,240 38,524
Selling, general and administrative 38,596 33,841
Income (loss) from operations (15,299 ) 17,989
Other income (expense):
Interest income 59 764
Interest expense (6 ) (7 )
Other income (expense), net (40 ) (2 )
Total other income (expense) 13 755
Income (loss) before provision for (benefit from) income taxes (15,286 ) 18,744
Provision for (benefit from) income taxes (4,636 ) 7,392
Net income (loss) (10,650 ) 11,352
Net loss attributable to noncontrolling interest 3,463 979
Net income (loss) attributable to Emergent BioSolutions Inc. $ (7,187 ) $ 12,331
Earnings per share - basic $ (0.20 ) $ 0.40
Earnings per share - diluted $ (0.20 ) $ 0.39
Weighted-average number of shares - basic 35,400,906 30,989,308
Weighted-average number of shares - diluted 35,400,906 31,666,976

Emergent BioSolutions Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(in thousands)
Six Months Ended
June 30,
2011 2010
(Unaudited)
Cash flows from operating activities:
Net income (loss) $ (10,650 ) $ 11,352
Adjustments to reconcile to net cash provided by (used in) operating activities:
Stock-based compensation expense 5,150 3,363
Depreciation and amortization 4,514 2,646
Deferred income taxes 3,129 3,437
Non-cash development expenses from variable interest entities 3,348 185
Impairment of long-lived assets 193 1,029
Change in fair value of contingent value rights 1,408 -
Excess tax benefits from stock-based compensation (1,786 ) (709 )
Other 43 (29 )
Changes in operating assets and liabilities:
Accounts receivable (7,937 ) 9,107
Inventories (4,540 ) (3,595 )
Income taxes (8,408 ) (6,214 )
Prepaid expenses and other assets 1,557 159
Accounts payable (766 ) 4,151
Accrued expenses and other liabilities 26 (329 )
Accrued compensation (10,152 ) (3,346 )
Deferred revenue (3,936 ) (14 )
Net cash (used in) provided by operating activities (28,807 ) 21,193
Cash flows from investing activities:
Purchases of property, plant and equipment (16,795 ) (8,631 )
Proceeds from maturity of investments 2,250 -
Purchase of investments (5,269 ) -
Net cash used in investing activities (19,814 ) (8,631 )
Cash flows from financing activities:
Proceeds from borrowings on line of credit - 15,000
Issuance of common stock subject to exercise of stock options 8,695 2,784
Principal payments on long-term indebtedness and line of credit (8,123 ) (31,621 )
Excess tax benefits from stock-based compensation 1,786 709
Net cash provided by (used in)  financing activities 2,358 (13,128 )
Effect of exchange rate changes on cash and cash equivalents (662 ) (165 )
Net increase (decrease) in cash and cash equivalents (46,925 ) (731 )
Cash and cash equivalents at beginning of period 169,019 102,924
Cash and cash equivalents at end of period $ 122,094 $ 102,193