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8-K - Emergent BioSolutions Inc.form8-k.htm
 
 
EXHIBIT 99

 
 
EMERGENT BIOSOLUTIONS REPORTS FINANCIAL RESULTS FOR FOURTH QUARTER AND FULL YEAR 2012

ROCKVILLE, MD, March 7, 2013Emergent BioSolutions Inc. (NYSE: EBS) announced today its financial results for the fourth quarter and full year ended December 31, 2012.

Total revenues for 2012 were $281.9 million as compared to $273.4 million in 2011, and net income for 2012 was $23.5 million, or $0.65 per basic share, as compared to $23.0 million, or $0.65 per basic share, in 2011.

For the fourth quarter 2012, total revenues were $94.6 million as compared to $107.9 million in 2011, and net income was $16.1 million, or $0.45 per basic share, as compared to $28.7 million, or $0.80 per basic share, in 2011.

Robert Kramer, executive vice president and chief financial officer of Emergent BioSolutions, commented, "Our operational achievements in 2012 marked another solid year of performance for the company, highlighted by our ongoing deliveries of BioThrax to the SNS, continued advancement of our many biodefense development contracts, progress toward licensure of Building 55, and securing designation of our Baltimore facility by BARDA as one of three Centers for Innovation in Advanced Development and Manufacturing in the nation.  We look to build upon these successes in 2013 as we take definitive steps toward achieving the financial and operational goals we set out in our growth plan."

2012 Key Operational Accomplishments
 
·
Received FDA approval for BioThrax® (Anthrax Vaccine Adsorbed) administered in a three-dose primary series with booster doses at 12 and 18 months and annually thereafter;
·
Advanced toward a post-exposure prophylaxis indication for BioThrax by initiating a pivotal antibiotic non-interference study;
·
Progressed toward licensure of Building 55 by initiating manufacture of consistency lots;
·
Secured a contract option from BARDA for development of PreviThrax™ (Recombinant Protective Antigen Anthrax Vaccine, Purified);
·
Partnered with BARDA to establish a Center for Innovation in Advanced Development and Manufacturing;
·
Initiated a Phase 2 study of TRU-016 in combination with bendamustine in patients with relapsed refractory Chronic Lymphocytic Leukemia (CLL);
·
Initiated a Phase 1b study of TRU-016 in combination with rituximab in patients with previously untreated CLL; and
·
Announced a three-year plan for growth and established key financial and operational goals to be achieved by year-end 2015.

2012 Key Financial Results

Product Sales
For the full twelve months of 2012, product sales were $215.9 million, an increase of $13.5 million, or 7 percent, from $202.4 million in 2011, primarily due to a 15 percent increase in the number of doses of BioThrax delivered.

For 4Q 2012, product sales were $74.4 million, a decrease of $7.3 million, or 9 percent, from $81.7 million in 4Q 2011, primarily due to a 4 percent decrease in the number of BioThrax doses delivered and a decrease in the average sales price per dose.

Contracts and Grants Revenues
For the full twelve months of 2012, contracts and grants revenue was $66.0 million, a decrease of $5.0 million, or 7 percent, from $71.0 million in 2011.  The decrease in contracts and grants revenue was primarily due to decreased revenues from our agreements with Abbott and Pfizer.

For 4Q 2012, contracts and grants revenue was $20.3 million, a decrease of $6.0 million, or 23 percent, from $26.3 million in 4Q 2011.  The decrease in contracts and grants revenue was primarily due to decreased revenues from our agreement with Abbott.

Cost of Product Sales
For the full twelve months of 2012, cost of product sales was $46.1 million, an increase of $3.9 million, or 9 percent, from $42.2 million in 2011.  The increase in 2012 was primarily attributable to the 15 percent increase in the number of BioThrax doses delivered.

For 4Q 2012, cost of product sales was $15.1 million, an increase of $0.8 million, or 6 percent, from $14.3 million in 4Q 2011.  The increase was primarily attributable to a 4 percent decrease in the number of BioThrax doses delivered.

Research and Development
For the full twelve months of 2012, gross research and development expenses were $120.2 million, a decrease of $4.6 million, or 4 percent, from $124.8 million in 2011.  This decrease primarily reflects lower contract service costs.

For 4Q 2012, gross research and development expenses were $35.9 million, an increase of $6.6 million, or 22 percent, from $29.4 million in 4Q 2011.  This increase primarily reflects higher contract service costs and an upfront payment for an exclusive license to certain rights to pandemic influenza products.

Net R&D expense is calculated as research and development expenses less development contract and grant reimbursements and the net loss attributable to non-controlling interests.  For the full twelve months of 2012 and 2011, net R&D expenses were $48.8 million and $47.0 million, respectively.  For 4Q 2012 and 2011, net R&D expenses were $14.6 million and $1.3 million, respectively.

Selling, General and Administrative
For the full twelve months of 2012, general and administrative expenses were $76.0 million, an increase of $1.7 million, or 2 percent, from $74.3 million in 2011.

For 4Q 2012, selling, general and administrative expenses were $19.5 million, an increase of $1.2 million, or 7 percent, from $18.3 million in 4Q 2011.  The twelve month and 4Q increases were primarily due to increased spending related to professional and personnel costs.

Financial Condition and Liquidity
Cash and cash equivalents combined with investments at December 31, 2012 was $141.7 million compared to $145.9 million at December 31, 2011.  Additionally, at December 31, 2012, the accounts receivable balance was $96.0 million, as compared to $74.2 million at December 31, 2011.  The accounts receivable balance for both periods is comprised primarily of unpaid amounts due related to shipments of BioThrax accepted by the US government.

2013 Forecast
For 2013, the company is reaffirming its financial forecast of total revenue of $290 to $310 million, split between product sales of $230 to $240 million and contracts and grants revenue of $60 to $70 million.  The company also forecasts 2013 net income of $20 to $30 million.

For the first quarter of 2013, the company anticipates total revenues of $40 to $50 million.

Conference Call and Webcast
Company management will host a conference call at 5:00 pm Eastern on March 7, 2013 to discuss these financial results.  The conference call will be accessible by dialing 888/679-8038 or 617/213-4850 (international) and providing passcode 76232628.  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 28122043.  The replay will be available through March 21, 2013.  The webcast will be archived on the company's website, www.emergentbiosolutions.com, under "Investors".

About Emergent BioSolutions Inc.
Emergent BioSolutions is a specialty pharmaceutical company seeking to protect and enhance life by offering specialized products to healthcare providers and governments to address medical needs and emerging health threats.  Additional information about the company may be found at www.emergentbiosolutions.com.

Follow us on twitter: @emergentbiosolu

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 our expected revenue growth and net income, and any other statements containing the words "believes", "expects", "anticipates", "intends", "plans", "estimates" and similar expressions, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.

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; our plans to pursue label expansions and improvements for BioThrax®; availability of funding for our US government grants and contracts; our ability to identify and acquire or in license products and product candidates that satisfy our selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; our ability to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; and our commercialization, marketing and manufacturing capabilities and strategy. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.

###

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)
 
 
 
   
 
 
 
December 31,
 
 
 
2012
   
2011
 
ASSETS
 
   
 
Current assets:
 
   
 
Cash and cash equivalents
 
$
141,666
   
$
143,901
 
Investments
   
-
     
1,966
 
Accounts receivable
   
96,043
     
74,153
 
Inventories
   
15,161
     
14,661
 
Deferred tax assets, net
   
1,264
     
1,735
 
Income tax receivable, net
   
-
     
9,506
 
Restricted cash
   
-
     
220
 
Prepaid expenses and other current assets
   
9,213
     
8,276
 
Total current assets
   
263,347
     
254,418
 
 
               
Property, plant and equipment, net
   
241,764
     
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
   
11,087
     
13,999
 
Other assets
   
730
     
807
 
 
               
Total assets
 
$
564,230
   
$
546,864
 
 
               
LIABILITIES AND STOCKHOLDERS' EQUITY
               
Current liabilities:
               
Accounts payable
 
$
31,297
   
$
40,530
 
Accrued expenses and other current liabilities
   
1,488
     
1,170
 
Accrued compensation
   
22,726
     
20,884
 
Contingent value rights, current portion
   
-
     
1,748
 
Income tax payable, net
   
115
     
-
 
Long-term indebtedness, current portion
   
4,470
     
5,360
 
Deferred revenue
   
1,811
     
1,362
 
Total current liabilities
   
61,907
     
71,054
 
 
               
Contingent value rights, net of current portion
   
-
     
3,005
 
Long-term indebtedness, net of current portion
   
58,304
     
54,094
 
Other liabilities
   
1,891
     
1,984
 
Total liabilities
   
122,102
     
130,137
 
 
               
Commitments and contingencies
               
 
               
Stockholders' equity:
               
Preferred stock, $0.001 par value; 15,000,000 shares authorized, 0 shares issued and outstanding at December 31, 2012 and December 31, 2011, respectively
   
-
     
-
 
Common stock, $0.001 par value; 100,000,000 shares authorized, 36,272,550 shares issued and 35,869,392 shares outstanding at December 31, 2012; 36,002,698 shares issued and outstanding at December 31, 2011
   
36
     
36
 
Treasury stock, at cost, 403,158 and 0 common shares at December 31, 2012 and 2011, respectively
   
(5,906
)
   
-
 
Additional paid-in capital
   
230,964
     
220,654
 
Accumulated other comprehensive loss
   
(4,129
)
   
(3,313
)
Retained earnings
   
220,393
     
196,869
 
    Total Emergent BioSolutions Inc. stockholders' equity
   
441,358
     
414,246
 
Noncontrolling interest in subsidiaries
   
770
     
2,481
 
Total stockholders' equity
   
442,128
     
416,727
 
Total liabilities and stockholders' equity
 
$
564,230
   
$
546,864
 




 
Emergent BioSolutions Inc. and Subsidiaries
 
Consolidated Statements of Operations
 
(in thousands, except share and per share data)
 
 
 
   
 
 
 
Year Ended December 31,
 
 
 
2012
   
2011
 
Revenues:
 
   
 
Product sales
 
$
215,879
   
$
202,409
 
Contracts and grants
   
66,009
     
70,975
 
Total revenues
   
281,888
     
273,384
 
 
               
Operating expense:
               
Cost of product sales
   
46,077
     
42,171
 
Research and development
   
120,226
     
124,832
 
Selling, general and administrative
   
76,018
     
74,282
 
Impairment of in-process research and development
   
9,600
     
-
 
Income from operations
   
29,967
     
32,099
 
 
               
Other income (expense):
               
Interest income
   
134
     
105
 
Interest expense
   
(6
)
   
-
 
Other income (expense), net
   
1,970
     
(261
)
Total other income (expense)
   
2,098
     
(156
)
 
               
Income before provision for income taxes
   
32,065
     
31,943
 
Provision for income taxes
   
13,922
     
15,830
 
Net income
   
18,143
     
16,113
 
    Net loss attributable to noncontrolling interest
   
5,381
     
6,906
 
Net income attributable to Emergent BioSolutions Inc.
 
$
23,524
   
$
23,019
 
 
               
Earnings per share - basic
 
$
0.65
   
$
0.65
 
Earnings per share - diluted
 
$
0.65
   
$
0.64
 
 
               
Weighted-average number of shares - basic
   
36,080,495
     
35,658,907
 
Weighted-average number of shares - diluted
   
36,420,662
     
36,206,052
 

 
Emergent BioSolutions Inc. and Subsidiaries
 
Consolidated Statements of Operations
 
(in thousands, except share and per share data)
 
 
 
   
 
 
 
Three Months Ended December 31,
 
 
 
2012
   
2011
 
 
 
(Unaudited)
 
Revenues:
 
   
 
Product sales
 
$
74,350
   
$
81,670
 
Contracts and grants
   
20,256
     
26,278
 
Total revenues
   
94,606
     
107,948
 
 
               
Operating expense:
               
Cost of product sales
   
15,150
     
14,328
 
Research and development
   
35,945
     
29,376
 
Selling, general and administrative
   
19,476
     
18,254
 
Income from operations
   
24,035
     
45,990
 
 
               
Other income (expense):
               
Interest income
   
31
     
24
 
Interest expense
   
(6
)
   
-
 
Other income (expense), net
   
222
     
(252
)
Total other income (expense)
   
247
     
(228
)
 
               
Income before provision for income taxes
   
24,282
     
45,762
 
Provision for income taxes
   
9,283
     
18,862
 
Net income
   
14,999
     
26,900
 
    Net loss attributable to noncontrolling interest
   
1,105
     
1,757
 
Net income attributable to Emergent BioSolutions Inc.
 
$
16,104
   
$
28,657
 
 
               
 
               
Earnings per share - basic
 
$
0.45
   
$
0.80
 
Earnings per share - diluted
 
$
0.44
   
$
0.78
 
 
               
 
               
Weighted-average number of shares - basic
   
35,890,640
     
35,972,320
 
Weighted-average number of shares - diluted
   
36,410,143
     
36,520,245
 



 
Emergent BioSolutions Inc. and Subsidiaries
 
Consolidated Statements of Cash Flows
 
(in thousands)
 
 
 
   
   
 
 
 
Year Ended December 31,
 
 
 
2012
   
2011
   
2010
 
Cash flows from operating activities:
 
   
   
 
Net income
 
$
18,143
   
$
16,113
   
$
47,184
 
Adjustments to reconcile to net cash provided by operating activities:
                       
Stock-based compensation expense
   
11,115
     
10,739
     
7,063
 
Depreciation and amortization
   
11,197
     
9,355
     
5,990
 
Deferred income taxes
   
3,383
     
20,188
     
9,229
 
     Non-cash development expenses from joint venture
   
3,670
     
5,290
     
5,995
 
Change in fair value of contingent value rights
   
(3,005
)
   
221
     
-
 
Impairment of in-process research and development
   
9,600
     
-
     
-
 
Impairment of long-lived assets
   
-
     
976
     
1,218
 
Provision for impairment of accrued interest on note receivable
   
-
     
-
     
1,032
 
Excess tax benefits from stock-based compensation
   
(1,588
)
   
(4,608
)
   
(2,609
)
Other
   
(40
)
   
392
     
(38
)
Changes in operating assets and liabilities:
                       
Accounts receivable
   
(21,890
)
   
(34,873
)
   
19,094
 
Inventories
   
(500
)
   
(1,939
)
   
799
 
Income taxes
   
8,055
     
1,422
     
(4,454
)
Prepaid expenses and other assets
   
(1,038
)
   
660
     
(764
)
Accounts payable
   
274
     
2,510
     
3,392
 
Accrued expenses and other liabilities
   
169
     
(95
)
   
(447
)
Accrued compensation
   
1,649
     
(3,303
)
   
6,175
 
Deferred revenue
   
449
     
(10,863
)
   
(838
)
Net cash provided by operating activities
   
39,643
     
12,185
     
98,021
 
Cash flows from investing activities:
                       
Purchases of property, plant and equipment
   
(53,845
)
   
(54,026
)
   
(22,101
)
Proceeds from sale of assets
   
11,765
     
-
     
-
 
Proceeds from maturity of investments
   
1,966
     
4,250
     
6,518
 
Purchase of investments
   
-
     
(4,187
)
   
-
 
Acquisition of Trubion Pharmaceuticals, Inc., net of cash acquired
   
-
     
-
     
(17,873
)
Repayment of note receivable
   
-
     
-
     
10,000
 
Net cash used in investing activities
   
(40,114
)
   
(53,963
)
   
(23,456
)
Cash flows from financing activities:
                       
Proceeds from borrowings on long-term indebtedness
   
13,547
     
27,522
     
15,000
 
Issuance of common stock subject to exercise of stock options
   
761
     
10,026
     
7,235
 
Excess tax benefits from stock-based compensation
   
1,588
     
4,608
     
2,609
 
Principal payments on long-term indebtedness and line of credit
   
(10,227
)
   
(15,494
)
   
(33,291
)
Contingent value right payment
   
(1,748
)
   
(10,000
)
   
-
 
Purchase of treasury stock
   
(5,906
)
   
-
     
-
 
Restricted cash deposit
   
220
     
(3
)
   
(2
)
Net cash provided by (used in) financing activities
   
(1,765
)
   
16,659
     
(8,449
)
 
                       
Effect of exchange rate changes on cash and cash equivalents
   
1
     
1
     
(21
)
 
                       
Net increase (decrease) in cash and cash equivalents
   
(2,235
)
   
(25,118
)
   
66,095
 
Cash and cash equivalents at beginning of year
   
143,901
     
169,019
     
102,924
 
Cash and cash equivalents at end of year
 
$
141,666
   
$
143,901
   
$
169,019