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8-K - Emergent BioSolutions Inc.form8-k.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 FULL YEAR 2010

·  
2010 revenues of $286.2 million
·  
2010 net income of $51.7 million, or $1.63 per share, representing ninth consecutive year of profitability
·  
2010 cash, investments and accounts receivable balance of $210.4 million
·  
2011 forecast reaffirmed: total revenues of $320 to $340 million and net income of
 
$35 to $45 million

ROCKVILLE, MD, March 10, 2011—Emergent BioSolutions Inc. (NYSE: EBS) announced today its financial results for the full year ended December 31, 2010.

Total revenues for 2010 were $286.2 million as compared to $234.8 million in 2009, and net income was $51.7 million, or $1.63 per basic share, as compared to $31.1 million, or $1.02 per basic share, in 2009.

For the fourth quarter 2010, total revenues were $103.2 million as compared to $53.8 million in 2009, and net income was $26.2 million, or $0.78 per basic share, as compared to $4.2 million, or $0.14 per basic share, in 2009.

R. Don Elsey, chief financial officer of Emergent BioSolutions, stated, “Our 2010 financial performance reflects our continued success in growing revenue from the sale of BioThrax® and government development contracts, as well as from development collaborations with our large pharma partners.  We achieved this revenue growth while closely managing our overall expenditures even as we continued to advance our pipeline of vaccines and therapeutics targeting key disease areas.  We expect to continue our growth in 2011, as evidenced by our reaffirmed 2011 forecast of total revenues of $320 to $340 million and net income of $35 to $45 million.”

2010 Key Operational Accomplishments

·  
Acquired Trubion Pharmaceuticals, Inc. for a total consideration of up to $131.6 million, including  $92.9 million in upfront cash and stock and up to $38.7 million of success-based milestones, payable between October 2010 and October 2013;
 
·  
Secured a BARDA development contract, valued at up to $107.0 million, to fund qualification, validation and licensure of Building 55 in order to manufacture BioThrax® (Anthrax Vaccine Adsorbed) at large-scale;
 
·  
Secured a BARDA development contract, valued at up to $186.6 million, to fund development of our rPA vaccine candidate PreviThraxTM (Recombinant Protective Antigen Anthrax Vaccine, Purified);
 
·  
Secured a NIAID development contract, valued at up to $28.7 million, to fund further development of NuThraxTM (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant), the second contract award for this vaccine candidate;
 
·  
Launched Singapore operations and formed EPIC Bio, Pte. Ltd., a joint venture with Temasek Life Sciences Ventures Pte. Ltd., to develop, manufacture, and commercialize pre-pandemic influenza vaccines and therapeutics;
 
·  
Obtained Fast Track designation and Orphan Drug status from FDA for ThravixaTM (Fully Human Anthrax Monoclonal Antibody);
 
·  
Initiated a Phase 1 clinical study for Thravixa;
 
·  
Initiated a Phase 1 clinical study for NuThrax; and
 
·  
Expanded the Board of Directors with the appointment of John E. Niederhuber, M.D., former Director, The National Cancer Institute (NCI), and Marvin White, Chief Financial Officer, St. Vincent Health and former Chief Financial Officer, LillyUSA.
 
 
 

 

2010 Key Financial Results

Product Sales
For 2010, product sales were $251.4 million, an increase of $34.2 million, or 16 percent, from $217.2 million for 2009.  This increase was primarily due to a 15 percent increase in the number of doses of BioThrax delivered.  Product sales revenues for 2010 consisted of BioThrax sales to CDC of $248.5 million and aggregate international and other sales of $2.9 million.

Contracts and Grants Revenues
For 2010, contracts and grants revenues were $34.8 million, an increase of $17.2 million, or 98 percent, from $17.6 million for 2009.  The increase was primarily due to revenues from our recently awarded contracts with BARDA and NIAID and our collaboration with Abbott Laboratories.

Cost of Product Sales
For 2010, cost of product sales was $47.1 million, an increase of $0.9 million, or 2 percent, from $46.3 million for 2009.  This increase was primarily attributable to the 15 percent increase in BioThrax doses sold, substantially offset by a decrease in cost per dose sold associated with increased production yield in the period during which the doses sold were produced.

Research and Development
For 2010, research and development expenses were $89.3 million, an increase of $14.7 million, or 20 percent, from $74.6 million for 2009.  This increase reflects higher contract service and personnel costs, and includes increased expenses of $7.7 million on product candidates associated with our BioDefense Division and increased expenses of $6.9 million on product candidates and technology platform development activities associated with our BioSciences Division.

Selling, General and Administrative
For 2010, selling, general and administrative expenses were $76.2 million, an increase of $2.4 million, or 3 percent, from $73.8 million for 2009.  This increase is primarily due to increased personnel and professional services to support the business.

Financial Condition and Liquidity
Cash and cash equivalents combined with investments at December 31, 2010 was $171.0 million compared to $102.9 million at December 31, 2009.  Additionally, at December 31, 2010, the accounts receivable balance was $39.3 million, which is comprised primarily of unpaid amounts due related to shipments of BioThrax received and accepted by the US government in the fourth quarter of 2010.

2011 Forecast
For 2011, the company is reaffirming its financial forecast of total revenues of $320 to $340 million and net income of $35 to $45 million.

2011 total revenue is expected to be driven by, among other things:

·  
the continuation of deliveries of BioThrax under the current multi-year procurement contract with CDC;
 
·  
additional deliveries of BioThrax under a follow-on, multi-year procurement contract with CDC, anticipated to begin deliveries in 4Q 2011;
 
·  
a significant increase in contracts and grants revenue based primarily on development contracts already in place that are funding the validation and qualification of manufacturing of BioThrax in the company’s large-scale facility and the further development of our rPA vaccine candidate PreviThrax; and
 
·  
collaboration and milestone revenues associated with achievement of clinical development milestones related to the company’s oncology product candidate, which is under an existing co-development agreement with Abbott, and the company’s autoimmune product candidate, which is being developed by Pfizer under a license agreement from the company.
 
Conference Call and Webcast
Company management will host a conference call at 5:00 pm Eastern on March 10, 2011 to discuss the financial results for the fourth quarter and full twelve months of 2010, recent business developments and the forecast for 2011.  The conference call will be accessible by dialing 888/713-4205 or 617/213-4862 (international) and providing passcode 91804244.  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 the passcode 77289976.  The replay will be available through March 24, 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 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 estimates of preliminary results for 2010, and our expected revenue growth and net earnings for 2011, and any other statements containing the words "believes", "expects", "anticipates", "plans", "estimates" and similar expressions, are forward-looking statements. There are a number of 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; 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; ongoing and planned development programs, preclinical studies and clinical trials; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2010 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,
   
December 31,
 
   
2010
   
2009
 
ASSETS
     
Current assets:
           
Cash and cash equivalents
  $ 169,019     $ 102,924  
Investments
    2,029       -  
Accounts receivable
    39,326       54,872  
Inventories
    12,722       13,521  
Note receivable
    -       10,000  
Deferred tax assets, net
    2,638       1,870  
Income tax receivable, net
    8,728       2,574  
Restricted cash
    217       215  
Prepaid expenses and other current assets
    8,814       7,838  
Total current assets
    243,493       193,814  
                 
Property, plant and equipment, net
    152,701       131,834  
In-process research and development
    51,400       -  
Goodwill
    5,029       -  
Assets held for sale
    12,741       13,960  
Deferred tax assets, net
    33,757       3,894  
Other assets
    1,198       1,187  
                 
Total assets
  $ 500,319     $ 344,689  
                 
LIABILITIES AND STOCKHOLDERS' EQUITY
               
Current liabilities:
               
Accounts payable
  $ 25,409     $ 17,159  
Accrued expenses and other current liabilities
    1,309       1,570  
Accrued compensation
    23,975       14,926  
Indebtedness under line of credit
    -       15,000  
Long-term indebtedness, current portion
    17,187       5,791  
Deferred revenue, current portion
    7,839       255  
Total current liabilities
    75,719       54,701  
                 
Long-term indebtedness, net of current portion
    30,239       44,927  
Deferred revenue, net of current portion
    4,386       -  
Contingent value right
    14,532       -  
Other liabilities
    1,882       1,246  
Total liabilities
    126,758       100,874  
                 
Commitments and contingencies
    -       -  
                 
Stockholders’ equity:
               
Preferred stock, $0.001 par value; 15,000,000 shares authorized, 0 shares issued and outstanding at December 31, 2010 and 2009, respectively
    -       -  
Common stock, $0.001 par value; 100,000,000 shares authorized, 35,011,423 and 30,831,360 shares issued and outstanding at December 31, 2010 and December 31, 2009, respectively
    35       31  
Additional paid-in capital
    197,689       120,492  
Accumulated other comprehensive loss
    (2,110 )     (1,476 )
Retained earnings
    173,850       122,152  
Total Emergent BioSolutions Inc. stockholders’ equity
    369,464       241,199  
Noncontrolling interest in subsidiary
    4,097       2,616  
Total stockholders’ equity
    373,561       243,815  
Total liabilities and stockholders’ equity
  $ 500,319     $ 344,689  

 
 

 


Emergent BioSolutions Inc. and Subsidiaries
 
Consolidated Statements of Operations
 
(in thousands, except per share data)
 
             
   
Three Months Ended
 
   
December 31,
 
   
2010
   
2009
 
   
(Unaudited)
 
Revenues:
           
Product sales
  $ 89,390     $ 47,160  
Contracts and grants
    13,857       6,644  
Total revenues
    103,247       53,804  
                 
Operating expenses:
               
Cost of product sales
    16,998       11,782  
Research and development
    29,615       19,226  
Selling, general and administrative
    21,671       18,671  
Income from operations
    34,963       4,125  
                 
Other income (expense):
               
Interest income
    31       387  
Interest expense
    -       7  
Other income (expense), net
    (12 )     (22 )
Total other income (expense)
    19       372  
                 
Income before provision for income taxes
    34,982       4,497  
Provision for income taxes
    11,094       836  
Net income
    23,888       3,661  
    Net loss attributable to noncontrolling interest
    2,359       573  
Net income attributable to Emergent BioSolutions Inc.
  $ 26,247     $ 4,234  
                 
Earnings per share - basic
  $ 0.78     $ 0.14  
Earnings per share - diluted
  $ 0.76     $ 0.13  
                 
Weighted-average number of shares - basic
    33,823       30,808  
Weighted-average number of shares - diluted
    34,685       31,555  

 
 

 


Emergent BioSolutions Inc. and Subsidiaries
 
Consolidated Statements of Operations
 
(in thousands, except per share data)
 
             
   
Twelve Months Ended
 
   
December 31,
 
   
2010
   
2009
 
       
Revenues:
           
Product sales
  $ 251,381     $ 217,172  
Contracts and grants
    34,790       17,614  
Total revenues
    286,171       234,786  
                 
Operating expenses:
               
Cost of product sales
    47,114       46,262  
Research and development
    89,295       74,588  
Selling, general and administrative
    76,205       73,786  
Income from operations
    73,557       40,150  
                 
Other income (expense):
               
Interest income
    832       1,418  
Interest expense
    -       (7 )
Other income (expense), net
    (1,023 )     (50 )
Total other income (expense)
    (191 )     1,361  
                 
Income before provision for income taxes
    73,366       41,511  
Provision for income taxes
    26,182       14,966  
Net income
    47,184       26,545  
    Net loss attributable to noncontrolling interest
    4,514       4,599  
Net income attributable to Emergent BioSolutions Inc.
  $ 51,698     $ 31,144  
                 
Earnings per share - basic
  $ 1.63     $ 1.02  
Earnings per share - diluted
  $ 1.59     $ 0.99  
                 
Weighted-average number of shares - basic
    31,782       30,444  
Weighted-average number of shares - diluted
    32,540       31,375  


 
 

 


Emergent BioSolutions Inc. and Subsidiaries
 
Consolidated Statements of Cash Flows
 
(in thousands)
 
   
Twelve Months Ended
 
   
December 31,
 
   
2010
   
2009
 
       
Cash flows from operating activities:
           
Net income
  $ 47,184     $ 26,545  
   Adjustments to reconcile to net cash provided by operating activities:
               
Stock-based compensation expense
    7,063       5,007  
Depreciation and amortization
    5,990       4,999  
Deferred income taxes
    10,929       7,604  
Non-cash development expenses from joint venture
    5,995       7,215  
(Gain) Loss on disposal of property and equipment
    (38 )     61  
Provision for impairment of long-lived assets
    1,218       7,328  
Provision for impairment of accrued interest on note receivable
    1,032       -  
Excess tax benefits from stock-based compensation
    (1,700 )     (1,852 )
Changes in operating assets and liabilities:
               
Accounts receivable
    19,094       (30,017 )
Inventories
    799       6,207  
Income taxes
    (6,154 )     (3,525 )
Prepaid expenses and other assets
    (653 )     (1,230 )
Accounts payable
    3,623       (1,334 )
Accrued compensation
    6,207       3,546  
Accrued expenses and other liabilities
    (223 )     (66 )
Deferred revenue
    (823 )     23  
Net cash provided by operating activities
    99,543       30,511  
Cash flows from investing activities:
               
Purchases of property, plant and equipment
    (22,101 )     (33,287 )
Acquisition of Trubion Pharmaceuticals, Inc., net of cash acquired
    (17,873 )     -  
Proceed from the sale of investments
    6,518       -  
Repayment of note receivable
    10,000       -  
Net cash used in investing activities
    (23,456 )     (33,287 )
Cash flows from financing activities:
               
Restricted cash deposit
    (2 )     (7 )
Proceeds from borrowings on long-term indebtedness and line of credit
    15,000       57,183  
Issuance of common stock subject to exercise of stock options
    7,235       4,464  
Principal payments on long-term indebtedness and line of credit
    (33,291 )     (48,648 )
Excess tax benefits from stock-based compensation
    1,700       1,852  
Net cash provided by (used in) financing activities
    (9,358 )     14,844  
                 
Effect of exchange rate changes on cash and cash equivalents
    (634 )     (617 )
                 
Net increase in cash and cash equivalents
    66,095       11,451  
Cash and cash equivalents at beginning of period
    102,924       91,473  
Cash and cash equivalents at end of period
  $ 169,019     $ 102,924