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: August 5, 2013
|
EMERGENT BIOSOLUTIONS INC.
|
|
By:
|
/s/Robert G. Kramer
Robert G. Kramer
Executive Vice President and Chief Financial Officer
|
·
|
Entered into and closed an asset purchase agreement to acquire the Healthcare Protective Products Division (HPPD) of Bracco Diagnostics Inc.;
|
·
|
Received Paul-Ehrlich-Institut approval to market BioThrax in Germany with a three-dose primary schedule over 6 months with triennial boosters thereafter;
|
·
|
Completed the Phase 3 clinical study evaluating the immunogenicity and safety of a three-dose BioThrax regimen for the post-exposure prophylaxis (PEP) indication;
|
·
|
Completed enrollment in the pivotal antibiotic non-interference trial in support of the PEP indication for BioThrax;
|
·
|
Expanded the ongoing phase 1b study of otlertuzumab (formerly TRU-016) to include two new cohorts: one cohort with a lower dose of otlertuzumab in front line chronic lymphocytic leukemia (CLL); one to evaluate the combination of otlertuzumab and rituximab in relapsed CLL patients;
|
·
|
Announced positive preclinical efficacy and pharmacokinetic data for ES414, a bispecific ADAPTIR™ (Modular Protein Technology) molecule in development for castration-resistant prostate cancer; and
|
·
|
Presented preclinical efficacy data on ES210, a bispecific ADAPTIR molecule in development for treating autoimmune diseases.
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||
Consolidated Balance Sheets
|
||||||||
(in thousands, except share and per share data)
|
||||||||
|
||||||||
|
June 30,
|
December 31,
|
||||||
|
2013
|
2012
|
||||||
ASSETS
|
(Unaudited)
|
|||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
156,243
|
$
|
141,666
|
||||
Accounts receivable
|
54,369
|
96,043
|
||||||
Inventories
|
18,582
|
15,161
|
||||||
Deferred tax assets, net
|
1,264
|
1,264
|
||||||
Income tax receivable, net
|
6,502
|
-
|
||||||
Prepaid expenses and other current assets
|
11,199
|
9,213
|
||||||
Total current assets
|
248,159
|
263,347
|
||||||
|
||||||||
Property, plant and equipment, net
|
248,504
|
241,764
|
||||||
In-process research and development
|
41,800
|
41,800
|
||||||
Goodwill
|
5,502
|
5,502
|
||||||
Deferred tax assets, net
|
11,087
|
11,087
|
||||||
Other assets
|
562
|
730
|
||||||
|
||||||||
Total assets
|
$
|
555,614
|
$
|
564,230
|
||||
|
||||||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
25,711
|
$
|
31,297
|
||||
Accrued expenses and other current liabilities
|
1,067
|
1,603
|
||||||
Accrued compensation
|
15,481
|
22,726
|
||||||
Long-term indebtedness, current portion
|
4,470
|
4,470
|
||||||
Deferred revenue
|
2,049
|
1,811
|
||||||
Total current liabilities
|
48,778
|
61,907
|
||||||
|
||||||||
Long-term indebtedness, net of current portion
|
56,069
|
58,304
|
||||||
Other liabilities
|
1,685
|
1,891
|
||||||
Total liabilities
|
106,532
|
122,102
|
||||||
|
||||||||
Commitments and contingencies
|
||||||||
|
||||||||
Stockholders' equity:
|
||||||||
Preferred stock, $0.001 par value; 15,000,000 shares authorized, 0 shares issued and outstanding at June 30, 2013 and December 31, 2012, respectively
|
-
|
-
|
||||||
Common stock, $0.001 par value; 100,000,000 shares authorized, 36,589,921 shares issued and 36,186,763 shares outstanding at June 30, 2013; 36,272,550 shares issued and 35,869,392 shares outstanding at December 31, 2012
|
36
|
36
|
||||||
Treasury stock, at cost, 403,158 common shares at June 30, 2013 and December 31, 2012
|
(5,906
|
)
|
(5,906
|
)
|
||||
Additional paid-in capital
|
236,099
|
230,964
|
||||||
Accumulated other comprehensive loss
|
(3,513
|
)
|
(4,129
|
)
|
||||
Retained earnings
|
222,814
|
220,393
|
||||||
Total Emergent BioSolutions Inc. stockholders' equity
|
449,530
|
441,358
|
||||||
Noncontrolling interest in subsidiaries
|
(448
|
)
|
770
|
|||||
Total stockholders' equity
|
449,082
|
442,128
|
||||||
Total liabilities and stockholders' equity
|
$
|
555,614
|
$
|
564,230
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||
Consolidated Statements of Operations
|
||||||||
(in thousands, except share and per share data)
|
||||||||
|
||||||||
|
Three Months Ended June 30,
|
|||||||
|
2013
|
2012
|
||||||
|
(Unaudited)
|
|||||||
Revenues:
|
||||||||
Product sales
|
$
|
65,596
|
$
|
53,161
|
||||
Contracts and grants
|
16,840
|
17,218
|
||||||
Total revenues
|
82,436
|
70,379
|
||||||
|
||||||||
Operating expense:
|
||||||||
Cost of product sales
|
16,945
|
13,186
|
||||||
Research and development
|
30,278
|
30,645
|
||||||
Selling, general and administrative
|
20,501
|
17,895
|
||||||
Income from operations
|
14,712
|
8,653
|
||||||
|
||||||||
Other income (expense):
|
||||||||
Interest income
|
10
|
29
|
||||||
Interest expense
|
(3
|
)
|
-
|
|||||
Other income (expense), net
|
18
|
907
|
||||||
Total other income (expense)
|
25
|
936
|
||||||
|
||||||||
Income before provision for income taxes
|
14,737
|
9,589
|
||||||
Provision for income taxes
|
4,381
|
4,043
|
||||||
Net income
|
10,356
|
5,546
|
||||||
Net loss attributable to noncontrolling interest
|
128
|
2,086
|
||||||
Net income attributable to Emergent BioSolutions Inc.
|
$
|
10,484
|
$
|
7,632
|
||||
|
||||||||
Income per share - basic
|
$
|
0.29
|
$
|
0.21
|
||||
Income per share - diluted
|
$
|
0.29
|
$
|
0.21
|
||||
|
||||||||
Weighted-average number of shares - basic
|
36,144,063
|
36,182,826
|
||||||
Weighted-average number of shares - diluted
|
36,527,014
|
36,556,697
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||
Consolidated Statements of Operations
|
||||||||
(in thousands, except share and per share data)
|
||||||||
|
||||||||
|
Six Months Ended June 30,
|
|||||||
|
2013
|
2012
|
||||||
|
(Unaudited)
|
|||||||
Revenues:
|
||||||||
Product sales
|
$
|
95,955
|
$
|
87,518
|
||||
Contracts and grants
|
29,581
|
33,172
|
||||||
Total revenues
|
125,536
|
120,690
|
||||||
|
||||||||
Operating expense:
|
||||||||
Cost of product sales
|
22,643
|
20,697
|
||||||
Research and development
|
61,002
|
56,891
|
||||||
Selling, general and administrative
|
40,529
|
37,387
|
||||||
Impairment of in-process research and development
|
-
|
9,600
|
||||||
Income (loss) from operations
|
1,362
|
(3,885
|
)
|
|||||
|
||||||||
Other income (expense):
|
||||||||
Interest income
|
33
|
54
|
||||||
Interest expense
|
(14
|
)
|
(6
|
)
|
||||
Other income (expense), net
|
35
|
1,761
|
||||||
Total other income (expense)
|
54
|
1,809
|
||||||
|
||||||||
Income (loss) before provision for (benefit from) income taxes
|
1,416
|
(2,076
|
)
|
|||||
Provision for (benefit from) income taxes
|
(135
|
)
|
403
|
|||||
Net income (loss)
|
1,551
|
(2,479
|
)
|
|||||
Net loss attributable to noncontrolling interest
|
871
|
3,279
|
||||||
Net income attributable to Emergent BioSolutions Inc.
|
$
|
2,422
|
$
|
800
|
||||
|
||||||||
Income per share - basic
|
$
|
0.07
|
$
|
0.02
|
||||
Income per share - diluted
|
$
|
0.07
|
$
|
0.02
|
||||
|
||||||||
Weighted-average number of shares - basic
|
36,056,297
|
36,114,400
|
||||||
Weighted-average number of shares - diluted
|
36,247,773
|
36,301,335
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||
Consolidated Statements of Cash Flows
|
||||||||
(in thousands)
|
||||||||
|
||||||||
|
Six Months Ended June 30,
|
|||||||
|
2013
|
2012
|
||||||
Cash flows from operating activities:
|
(Unaudited)
|
|||||||
|
||||||||
Net income (loss)
|
$
|
1,551
|
$
|
(2,479
|
)
|
|||
Adjustments to reconcile to net cash provided by (used in) operating activities:
|
||||||||
Stock-based compensation expense
|
5,718
|
5,425
|
||||||
Depreciation and amortization
|
8,372
|
4,909
|
||||||
Current and deferred income taxes
|
(135
|
)
|
4,080
|
|||||
Non-cash development expenses from joint venture
|
(347
|
)
|
3,632
|
|||||
Change in fair value of contingent value rights
|
-
|
(3,005
|
)
|
|||||
Impairment of in-process research and development
|
-
|
9,600
|
||||||
Excess tax benefits from stock-based compensation
|
(1,757
|
)
|
(1,307
|
)
|
||||
Other
|
(10
|
)
|
(55
|
)
|
||||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable
|
41,674
|
27,338
|
||||||
Inventories
|
(3,421
|
)
|
(1,347
|
)
|
||||
Income taxes
|
(7,999
|
)
|
(2,163
|
)
|
||||
Prepaid expenses and other assets
|
(1,734
|
)
|
888
|
|||||
Accounts payable
|
(6,199
|
)
|
(7,068
|
)
|
||||
Accrued expenses and other liabilities
|
(619
|
)
|
488
|
|||||
Accrued compensation
|
(7,130
|
)
|
(6,900
|
)
|
||||
Deferred revenue
|
238
|
142
|
||||||
Net cash provided by operating activities
|
28,202
|
32,178
|
||||||
Cash flows from investing activities:
|
||||||||
Purchases of property, plant and equipment
|
(14,123
|
)
|
(30,921
|
)
|
||||
Proceeds from sale of assets
|
-
|
11,765
|
||||||
Proceeds from maturity of investments
|
-
|
1,966
|
||||||
Net cash used in investing activities
|
(14,123
|
)
|
(17,190
|
)
|
||||
Cash flows from financing activities:
|
||||||||
Proceeds from borrowings on long-term indebtedness
|
-
|
11,413
|
||||||
Issuance of common stock subject to employee equity plans
|
933
|
401
|
||||||
Excess tax benefits from stock-based compensation
|
1,757
|
1,307
|
||||||
Principal payments on long-term indebtedness
|
(2,235
|
)
|
(8,670
|
)
|
||||
Contingent value right payment
|
-
|
(1,748
|
)
|
|||||
Restricted cash
|
-
|
220
|
||||||
Net cash provided by financing activities
|
455
|
2,923
|
||||||
|
||||||||
Effect of exchange rate changes on cash and cash equivalents
|
43
|
31
|
||||||
|
||||||||
Net increase (decrease) in cash and cash equivalents
|
14,577
|
17,942
|
||||||
Cash and cash equivalents at beginning of period
|
141,666
|
143,901
|
||||||
Cash and cash equivalents at end of period
|
$
|
156,243
|
$
|
161,843
|