|
Delaware
|
001-33137
|
14-1902018
|
|
(State or Other Jurisdiction
of Incorporation)
|
(Commission
File Number)
|
(IRS Employer
Identification No.)
|
|
2273 Research Boulevard, Suite 400, Rockville, Maryland
|
20850
|
|
(Address of Principal Executive Offices)
|
(Zip Code)
|
|
Date: March 7, 2013
|
EMERGENT BIOSOLUTIONS INC.
|
|
|
By:
|
/s/Jay G. Reilly
Jay G. Reilly
General Counsel
|
|
|
·
|
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.
|
|
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
|
||||||