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8-K - Emergent BioSolutions Inc.form8-k.htm
 
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FOR IMMEDIATE RELEASE


EMERGENT BIOSOLUTIONS REPORTS FINANCIAL RESULTS FOR SECOND QUARTER AND FIRST SIX MONTHS OF 2012
 
§
Q2 2012 total revenues of $70.4 million; YTD 2012 total revenues of $120.7 million
§
Q2 2012 net income of $7.6 million, or $0.21 per share; YTD 2012 net income of $0.8 million, or $0.02 per share
§
Q3 2012 total revenue forecast of $60 to $70 million
§
FY 2012 guidance reaffirmed: total revenues of $280 to $300 million and net income of $15 to $25 million

ROCKVILLE, MD, August 2, 2012-Emergent BioSolutions Inc. (NYSE: EBS) announced today its financial results for the second quarter and six months ended June 30, 2012.

Total revenues for Q2 and the first six months of 2012 were $70.4 million and $120.7 million, respectively.  Net income for Q2 2012 was $7.6 million, or $0.21 per basic share.  Net income for the first six months of 2012 was $0.8 million or $0.02 per share.

The company also provided a forecast for Q3 2012 revenues of $60 to $70 million and reaffirmed its full year 2012 guidance for total revenues of $280 to $300 million and net income of $15 to $25 million.

Q2 Operational Accomplishments

§
Initiated manufacture of BioThrax consistency lots in Building 55;
§
Received FDA approval for BioThrax administered intramuscularly in a three-dose primary series;
§
Secured additional BARDA funding to conduct a non-interference study to support licensure of BioThrax for post-exposure prophylaxis (PEP);
§
Completed dosing and the last subject visit in a pivotal PEP immunogenicity and safety study evaluating a three-dose vaccination schedule for BioThrax;
§
Secured a new BARDA development contract to establish a Center for Innovation in Advanced Development and Manufacturing at the company's Baltimore facility;
§
Secured NIAID grant to further advance the development of MVA85A, a candidate vaccine against tuberculosis; and
§
Announced a stock repurchase program.
 
Daniel J. Abdun-Nabi, president and chief executive officer of Emergent BioSolutions, said, "The performance of our business during the second quarter and first half of 2012 was in line with expectations.  We look forward to building on our year-to-date success and anticipate achieving key milestones in the near term, including - completing Building 55 consistency lot manufacture, reviewing preliminary efficacy data from our TB vaccine Phase IIb infant trial, concluding enrollment in our TRU-016 Phase II CLL combination study, and presenting data from our TRU-016 Phase Ib NHL combination study and Phase Ib CLL combination study."

Financial Results

Product Sales
For Q2 2012, product sales were $53.2 million, a decrease from $71.5 million for Q2 2011.  This decrease was primarily due to fewer doses of BioThrax delivered.

For the six month period of 2012, product sales were $87.5 million, an increase from $77.1 million in the comparable period of 2011.  This increase was primarily due to more doses of BioThrax delivered, partially offset by a lower sales price per dose.  Product sales revenues for the six month period of 2012 included BioThrax sales to HHS of $87.3 million.

Contracts and Grants Revenues
For Q2 2012, contracts and grants revenues were $17.2 million, an increase from $16.7 million for Q2 2011.

For the six month period of 2012, contracts and grants revenues were $33.2 million, an increase from $29.6 million in the comparable period of 2011.  This increase in both periods was primarily due to increased activity and associated revenue from the company's development contracts.

Cost of Product Sales
For Q2 2012, cost of product sales was $13.2 million, a decrease from $16.1 million for Q2 2011.  This decrease was attributable to fewer doses of BioThrax delivered.

For the six month period of 2012, cost of product sales were $20.7 million, an increase from $17.1 million in the comparable period of 2011.  This increase was primarily attributable to the increase in the number of BioThrax doses delivered.

Research and Development
For Q2 2012, research and development expenses were $30.6 million, a decrease from $31.5 million for Q2 2011.  Net of development contracts and grants revenue along with the net loss attributable to non-controlling interests, research and development expenses were $11.3 million for Q2 2012, a decrease from $13.1 million for the comparable period in 2011.

For the six month period of 2012, research and development expenses were $56.9 million, a decrease from $66.2 million in the comparable period of 2011.  This decrease primarily reflects lower contract service and personnel-related costs.  Net of development contracts and grants revenue along with the net loss attributable to non-controlling interests, research and development expenses were $20.4 million for Q2 2012, a decrease from $33.2 million for the comparable period in 2011.

Selling, General and Administrative
For Q2 2012, selling, general and administrative expenses were $17.9 million, a decrease from $20.4 million for Q2 2011.

For the six month period of 2012, selling, general and administrative expenses were $37.4 million, a decrease from $38.6 million in the comparable period of 2011.  This decrease in both periods was primarily due to charges incurred in 2011 related to the restructuring of the company's UK operations.

Financial Condition and Liquidity
Cash and cash equivalents combined with investments at June 30, 2012 was $161.8 million, compared to $150.4 million at March 31, 2012 and $145.9 million at December 31, 2011.  Additionally, at June 30, 2012, the accounts receivable balance was $46.8 million, which is comprised primarily of unpaid amounts due for shipments of BioThrax to the US government.

Forecast: Q3 2012
For Q3 2012, the company anticipates total revenues of $60 to $70 million.

Forecast: Full Year 2012
For full year 2012, the company is reaffirming its forecast of total revenues of $280 to $300 million, split between product sales of $220 to $230 million and contracts and grants revenue of $60 to $70 million.  The company also reaffirms its forecast of net income of $15 to $25 million.

Conference Call and Webcast
Company management will host a conference call at 5:00 pm Eastern on August 2, 2012 to discuss these financial results.  The conference call will be accessible by dialing 888/713-4214 or 617/213-4866 (international) and providing passcode 49184891.  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 35599950.  The replay will be available through August 16, 2012.  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.  Our marketed and investigational products target infectious diseases, oncology and autoimmune disorders.  Additional information about us may be found at www.emergentbiosolutions.com.  Follow us on twitter: @emergentbiosolu.

Forward-Looking Statements
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 our expected revenue growth and net earnings for full year 2012, and our expected revenue for Q3 2012, 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 manufacturing of BioThrax® in our large-scale vaccine manufacturing facility in Lansing, Michigan; our ability to perform under our contract with the U.S. government to establish a Center for Innovation in Advanced Development and Manufacturing; 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's existing business and whether anticipated synergies and benefits are realized within expected time periods; our ability to identify and acquire or in-license products and product candidates; 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 Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and subsequent reports filed with the SEC.  Except as required by law, the company does not undertake any obligation to update any forward-looking statements as a result of new information, events or circumstances occurring after the date of this press 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

Financial Statements Follow




Emergent BioSolutions Inc. and Subsidiaries
 
Consolidated Balance Sheets
 
(in thousands, except share and per share data)
 
 
 
   
 
 
 
June 30,
   
December 31,
 
 
 
2012
   
2011
 
ASSETS
 
(Unaudited)
   
 
Current assets:
 
   
 
Cash and cash equivalents
 
$
161,843
   
$
143,901
 
Investments
   
-
     
1,966
 
Accounts receivable
   
46,815
     
74,153
 
Inventories
   
16,008
     
14,661
 
Deferred tax assets, net
   
638
     
1,735
 
Income tax receivable, net
   
10,422
     
9,506
 
Restricted cash
   
-
     
220
 
Prepaid expenses and other current assets
   
7,489
     
8,276
 
Total current assets
   
243,215
     
254,418
 
 
               
Property, plant and equipment, net
   
224,894
     
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
   
11,016
     
13,999
 
Other assets
   
713
     
807
 
 
               
Total assets
 
$
527,140
   
$
546,864
 
 
               
LIABILITIES AND STOCKHOLDERS' EQUITY
               
Current liabilities:
               
Accounts payable
 
$
23,301
   
$
40,530
 
Accrued expenses and other current liabilities
   
1,623
     
1,170
 
Accrued compensation
   
13,980
     
20,884
 
Contingent value rights, current portion
   
-
     
1,748
 
Long-term indebtedness, current portion
   
4,057
     
5,360
 
Deferred revenue
   
1,504
     
1,362
 
Total current liabilities
   
44,465
     
71,054
 
 
               
Contingent value rights, net of current portion
   
-
     
3,005
 
Long-term indebtedness, net of current portion
   
58,140
     
54,094
 
Other liabilities
   
2,013
     
1,984
 
Total liabilities
   
104,618
     
130,137
 
 
               
Commitments and contingencies
               
 
               
Stockholders' equity:
               
Preferred stock, $0.001 par value; 15,000,000 shares authorized, 0 shares issued and outstanding at June 30, 2012 and December 31, 2011, respectively
   
-
     
-
 
Common stock, $0.001 par value; 100,000,000 shares authorized, 36,203,917 and 36,002,698 shares issued and outstanding at June 30, 2012 and December 31, 2011, respectively
   
36
     
36
 
Additional paid-in capital
   
225,231
     
220,654
 
Accumulated other comprehensive loss
   
(3,249
)
   
(3,313
)
Retained earnings
   
197,670
     
196,869
 
    Total Emergent BioSolutions Inc. stockholders' equity
   
419,688
     
414,246
 
Noncontrolling interest in subsidiaries
   
2,834
     
2,481
 
Total stockholders' equity
   
422,522
     
416,727
 
Total liabilities and stockholders' equity
 
$
527,140
   
$
546,864
 



Emergent BioSolutions Inc. and Subsidiaries
 
Consolidated Statements of Operations
 
(in thousands, except share and per share data)
 
 
 
   
 
 
 
Three Months Ended June 30,
 
 
 
2012
   
2011
 
 
 
(Unaudited)
 
Revenues:
 
   
 
Product sales
 
$
53,161
   
$
71,479
 
Contracts and grants
   
17,218
     
16,662
 
Total revenues
   
70,379
     
88,141
 
 
               
Operating expense:
               
Cost of product sales
   
13,186
     
16,069
 
Research and development
   
30,645
     
31,481
 
Selling, general and administrative
   
17,895
     
20,384
 
Income from operations
   
8,653
     
20,207
 
 
               
Other income (expense):
               
Interest income
   
29
     
24
 
Interest expense
   
-
     
(6
)
Other income (expense), net
   
907
     
(39
)
Total other income (expense)
   
936
     
(21
)
 
               
Income before provision for income taxes
   
9,589
     
20,186
 
Provision for income taxes
   
4,043
     
7,663
 
Net income
   
5,546
     
12,523
 
    Net loss attributable to noncontrolling interest
   
2,086
     
1,687
 
Net income attributable to Emergent BioSolutions Inc.
 
$
7,632
   
$
14,210
 
 
               
Income per share - basic
 
$
0.21
   
$
0.40
 
Income per share - diluted
 
$
0.21
   
$
0.39
 
 
               
Weighted-average number of shares - basic
   
36,182,826
     
35,619,514
 
Weighted-average number of shares - diluted
   
36,556,697
     
36,667,452
 



Emergent BioSolutions Inc. and Subsidiaries
 
Consolidated Statements of Operations
 
(in thousands, except share and per share data)
 
 
 
   
 
 
 
Six Months Ended June 30,
 
 
 
2012
   
2011
 
 
 
(Unaudited)
 
Revenues:
 
   
 
Product sales
 
$
87,518
   
$
77,076
 
Contracts and grants
   
33,172
     
29,598
 
Total revenues
   
120,690
     
106,674
 
 
               
Operating expense:
               
Cost of product sales
   
20,697
     
17,137
 
Research and development
   
56,891
     
66,240
 
Selling, general and administrative
   
37,387
     
38,596
 
Impairment of in-process research and development
   
9,600
     
-
 
Loss from operations
   
(3,885
)
   
(15,299
)
 
               
Other income (expense):
               
Interest income
   
54
     
59
 
Interest expense
   
(6
)
   
(6
)
Other income (expense), net
   
1,761
     
(40
)
Total other income (expense)
   
1,809
     
13
 
 
               
Loss before provision for (benefit from) income taxes
   
(2,076
)
   
(15,286
)
Provision for (benefit from) income taxes
   
403
     
(4,636
)
Net loss
   
(2,479
)
   
(10,650
)
    Net loss attributable to noncontrolling interest
   
3,279
     
3,463
 
Net income (loss) attributable to Emergent BioSolutions Inc.
 
$
800
   
$
(7,187
)
 
               
Income (loss) per share - basic
 
$
0.02
   
$
(0.20
)
Income (loss) per share - diluted
 
$
0.02
   
$
(0.20
)
 
               
Weighted-average number of shares - basic
   
36,114,400
     
35,400,906
 
Weighted-average number of shares - diluted
   
36,301,335
     
35,400,906
 



Emergent BioSolutions Inc. and Subsidiaries
 
Consolidated Statements of Cash Flows
 
(in thousands)
 
 
 
   
 
 
 
Six Months Ended June 30,
 
 
 
2012
   
2011
 
Cash flows from operating activities:
 
(Unaudited)
 
 
 
   
 
Net loss
 
$
(2,479
)
 
$
(10,650
)
Adjustments to reconcile to net cash provided by (used in) operating activities:
               
Stock-based compensation expense
   
5,425
     
5,150
 
Depreciation and amortization
   
4,909
     
4,514
 
Deferred income taxes
   
4,080
     
3,129
 
     Non-cash development expenses from joint ventures
   
3,632
     
3,348
 
Change in fair value of contingent value rights
   
(3,005
)
   
1,408
 
Impairment of in-process research and development
   
9,600
     
-
 
Impairment of long-lived assets
   
-
     
193
 
Excess tax benefits from stock-based compensation
   
1,247
     
(1,786
)
Other
   
(55
)
   
43
 
Changes in operating assets and liabilities:
               
Accounts receivable
   
27,338
     
(7,937
)
Inventories
   
(1,347
)
   
(4,540
)
Income taxes
   
(2,163
)
   
(8,408
)
Prepaid expenses and other assets
   
888
     
1,401
 
Accounts payable
   
(7,068
)
   
(1,143
)
Accrued expenses and other liabilities
   
488
     
3
 
Accrued compensation
   
(6,900
)
   
(10,160
)
Deferred revenue
   
142
     
(3,973
)
Net cash provided by (used in) operating activities
   
34,732
     
(29,408
)
Cash flows from investing activities:
               
Purchases of property, plant and equipment
   
(30,921
)
   
(16,795
)
Proceeds from sale of assets
   
11,765
     
-
 
Proceeds from maturity of investments
   
1,966
     
2,250
 
Purchase of investments
   
-
     
(5,269
)
Net cash used in investing activities
   
(17,190
)
   
(19,814
)
Cash flows from financing activities:
               
Proceeds from borrowings on long-term indebtedness
   
11,413
     
-
 
Issuance of common stock subject to exercise of stock options
   
401
     
8,695
 
Excess tax benefits from stock-based compensation
   
(1,247
)
   
1,786
 
Principal payments on long-term indebtedness
   
(8,670
)
   
(8,123
)
Contingent value right payment
   
(1,748
)
   
-
 
Release of restricted cash deposit
   
220
     
-
 
Net cash provided by financing activities
   
369
     
2,358
 
 
               
Effect of exchange rate changes on cash and cash equivalents
   
31
     
(61
)
 
               
Net increase (decrease) in cash and cash equivalents
   
17,942
     
(46,925
)
Cash and cash equivalents at beginning of period
   
143,901
     
169,019
 
Cash and cash equivalents at end of period
 
$
161,843
     
122,094