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: May 2, 2013
|
EMERGENT BIOSOLUTIONS INC.
|
|
By:
|
/s/Jay G. Reilly
Jay G. Reilly
General Counsel
|
·
|
M&A
|
o
|
Announced asset purchase agreement for Healthcare Protective Products Division (HPPD) of Bracco Diagnostics Inc.:
|
§
|
Adds product sales from Reactive Skin Decontamination Lotion (RSDL);
|
§
|
2010-2012 total revenues averaged approximately $20 million annually;
|
§
|
5-year (2012-2017) IDIQ procurement contract with the Department of Defense valued at up to $240 million in place; and
|
§
|
Expected to contribute to revenue and net income, exclusive of transaction costs, beginning in 2013, with further growth anticipated as business is expanded.
|
·
|
Biodefense
|
o
|
BioThrax® (Anthrax Vaccine Adsorbed):
|
§
|
Initiated Post-Exposure Prophylaxis (PEP) antibiotic non-interference clinical trial;
|
§
|
Completed pilot non-clinical studies for BioThrax produced in Building 55; and
|
§
|
Received written confirmation from FDA on the acceptability of the design and endpoints for the pivotal non-clinical study for Building 55 licensure.
|
o
|
Initiated Phase 2 clinical study to evaluate safety and immunogenicity of NuThrax™ (BioThrax with CPG 7909 Adjuvant) for a PEP indication.
|
·
|
Biosciences
|
o
|
TRU-016, an ADAPTIR™ (Modular Protein Technology) therapeutic:
|
§
|
Received orphan medicinal product designation from the European Commission;
|
§
|
Completed enrollment in Phase 2 combination study (Study 16201) in relapsed/refractory CLL; and
|
§
|
Announced intention to expand Phase 1 combination study (Study 16009) in front line CLL:
|
·
|
One cohort will examine a lower dose of TRU-016 with rituximab in front line CLL; and
|
·
|
One cohort will evaluate the combination in relapsed/refractory CLL patients.
|
o
|
Presented data at industry conferences on two preclinical programs based on the ADAPTIR platform - one for castration-resistant prostate cancer, and the second to address autoimmune disorders.
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||
Consolidated Balance Sheets
|
||||||||
(in thousands, except share and per share data)
|
||||||||
|
||||||||
|
March 31,
|
December 31,
|
||||||
|
2013
|
2012
|
||||||
ASSETS
|
(Unaudited)
|
|||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
130,238
|
$
|
141,666
|
||||
Accounts receivable
|
62,964
|
96,043
|
||||||
Inventories
|
22,148
|
15,161
|
||||||
Deferred tax assets, net
|
1,264
|
1,264
|
||||||
Income tax receivable, net
|
10,762
|
-
|
||||||
Prepaid expenses and other current assets
|
9,703
|
9,213
|
||||||
Total current assets
|
237,079
|
263,347
|
||||||
|
||||||||
Property, plant and equipment, net
|
242,344
|
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
|
573
|
730
|
||||||
|
||||||||
Total assets
|
$
|
538,385
|
$
|
564,230
|
||||
|
||||||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
23,871
|
$
|
31,297
|
||||
Accrued expenses and other current liabilities
|
1,517
|
1,603
|
||||||
Accrued compensation
|
11,675
|
22,726
|
||||||
Long-term indebtedness, current portion
|
4,470
|
4,470
|
||||||
Deferred revenue
|
2,008
|
1,811
|
||||||
Total current liabilities
|
43,541
|
61,907
|
||||||
|
||||||||
Long-term indebtedness, net of current portion
|
57,187
|
58,304
|
||||||
Other liabilities
|
1,852
|
1,891
|
||||||
Total liabilities
|
102,580
|
122,102
|
||||||
|
||||||||
Commitments and contingencies
|
||||||||
|
||||||||
Stockholders' equity:
|
||||||||
Preferred stock, $0.001 par value; 15,000,000 shares authorized, 0 shares issued and outstanding at March 31, 2013 and December 31, 2012, respectively
|
-
|
-
|
||||||
Common stock, $0.001 par value; 100,000,000 shares authorized, 36,521,011 shares issued and 36,117,853 shares outstanding at March 31, 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 March 31, 2013 and December 31, 2012
|
(5,906
|
)
|
(5,906
|
)
|
||||
Additional paid-in capital
|
232,887
|
230,964
|
||||||
Accumulated other comprehensive loss
|
(3,759
|
)
|
(4,129
|
)
|
||||
Retained earnings
|
212,330
|
220,393
|
||||||
Total Emergent BioSolutions Inc. stockholders' equity
|
435,588
|
441,358
|
||||||
Noncontrolling interest in subsidiaries
|
217
|
770
|
||||||
Total stockholders' equity
|
435,805
|
442,128
|
||||||
Total liabilities and stockholders' equity
|
$
|
538,385
|
$
|
564,230
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||
Consolidated Statements of Operations
|
||||||||
(in thousands, except share and per share data)
|
||||||||
|
||||||||
|
Three Months Ended March 31,
|
|||||||
|
2013
|
2012
|
||||||
|
(Unaudited)
|
|||||||
Revenues:
|
||||||||
Product sales
|
$
|
30,359
|
$
|
34,357
|
||||
Contracts and grants
|
12,741
|
15,954
|
||||||
Total revenues
|
43,100
|
50,311
|
||||||
|
||||||||
Operating expense:
|
||||||||
Cost of product sales
|
5,698
|
7,511
|
||||||
Research and development
|
30,724
|
26,246
|
||||||
Selling, general and administrative
|
20,028
|
19,492
|
||||||
Impairment of in-process research and development
|
-
|
9,600
|
||||||
Loss from operations
|
(13,350
|
)
|
(12,538
|
)
|
||||
|
||||||||
Other income (expense):
|
||||||||
Interest income
|
23
|
25
|
||||||
Interest expense
|
(11
|
)
|
(3
|
)
|
||||
Other income (expense), net
|
17
|
854
|
||||||
Total other income (expense)
|
29
|
876
|
||||||
|
||||||||
Loss before benefit from income taxes
|
(13,321
|
)
|
(11,662
|
)
|
||||
Benefit from income taxes
|
(4,516
|
)
|
(3,640
|
)
|
||||
Net loss
|
(8,805
|
)
|
(8,022
|
)
|
||||
Net loss attributable to noncontrolling interest
|
743
|
1,193
|
||||||
Net loss attributable to Emergent BioSolutions Inc.
|
$
|
(8,062
|
)
|
$
|
(6,829
|
)
|
||
|
||||||||
Loss per share - basic
|
$
|
(0.22
|
)
|
$
|
(0.19
|
)
|
||
Loss per share - diluted
|
$
|
(0.22
|
)
|
$
|
(0.19
|
)
|
||
|
||||||||
Weighted-average number of shares - basic
|
35,968,064
|
36,045,839
|
||||||
Weighted-average number of shares - diluted
|
35,968,064
|
36,045,839
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||
Consolidated Statements of Cash Flows
|
||||||||
(in thousands)
|
||||||||
|
||||||||
|
Three Months Ended March 31,
|
|||||||
|
2013
|
2012
|
||||||
Cash flows from operating activities:
|
(Unaudited)
|
|||||||
|
||||||||
Net loss
|
$
|
(8,805
|
)
|
$
|
(8,022
|
)
|
||
Adjustments to reconcile to net cash provided by (used in) operating activities:
|
||||||||
Stock-based compensation expense
|
2,976
|
2,712
|
||||||
Depreciation and amortization
|
4,163
|
2,373
|
||||||
Deferred income taxes
|
(4,516
|
)
|
6,944
|
|||||
Non-cash development expenses from joint venture
|
190
|
1,212
|
||||||
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
|
(1,608
|
)
|
(1,118
|
)
|
||||
Other
|
6
|
(19
|
)
|
|||||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable
|
33,079
|
30,501
|
||||||
Inventories
|
(6,987
|
)
|
(2,658
|
)
|
||||
Income taxes
|
(7,918
|
)
|
(11,154
|
)
|
||||
Prepaid expenses and other assets
|
(246
|
)
|
443
|
|||||
Accounts payable
|
(4,196
|
)
|
(1,988
|
)
|
||||
Accrued expenses and other liabilities
|
21
|
(11
|
)
|
|||||
Accrued compensation
|
(10,982
|
)
|
(10,895
|
)
|
||||
Deferred revenue
|
197
|
(1,075
|
)
|
|||||
Net cash provided by (used in) operating activities
|
(4,626
|
)
|
13,840
|
|||||
Cash flows from investing activities:
|
||||||||
Purchases of property, plant and equipment
|
(7,679
|
)
|
(22,329
|
)
|
||||
Proceeds from sale of assets
|
-
|
11,765
|
||||||
Proceeds from maturity of investments
|
-
|
1,966
|
||||||
Net cash used in investing activities
|
(7,679
|
)
|
(8,598
|
)
|
||||
Cash flows from financing activities:
|
||||||||
Proceeds from borrowings on long-term indebtedness
|
-
|
9,621
|
||||||
Issuance of common stock subject to exercise of stock options
|
504
|
242
|
||||||
Excess tax benefits from stock-based compensation
|
1,608
|
1,118
|
||||||
Principal payments on long-term indebtedness
|
(1,117
|
)
|
(8,203
|
)
|
||||
Contingent value right payment
|
-
|
(1,748
|
)
|
|||||
Restricted cash
|
-
|
220
|
||||||
Net cash provided by financing activities
|
995
|
1,250
|
||||||
|
||||||||
Effect of exchange rate changes on cash and cash equivalents
|
(118
|
)
|
32
|
|||||
|
||||||||
Net increase (decrease) in cash and cash equivalents
|
(11,428
|
)
|
6,524
|
|||||
Cash and cash equivalents at beginning of period
|
141,666
|
143,901
|
||||||
Cash and cash equivalents at end of period
|
$
|
130,238
|
$
|
150,425
|