(Mark One)
|
|
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
For the quarterly period ended September 30, 2017
|
|
OR
|
|
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
For the transition period from to
|
Delaware
|
14-1902018
|
(State or Other Jurisdiction of
Incorporation or Organization)
|
(I.R.S. Employer
Identification No.)
|
400 Professional Drive, Suite 400
|
|
Gaithersburg, Maryland
|
20879
|
(Address of Principal Executive Offices)
|
(Zip Code)
|
Part I. Financial Information
|
|
|
|
Part II. Other Information
|
|
§ |
appropriations for the procurement of BioThrax® (Anthrax Vaccine Adsorbed) and our other public health threat products;
|
§ |
our ability to perform under our contracts with the U.S. government related to BioThrax and our other public health threat products, including the timing of and specifications relating to deliveries;
|
§ |
our ability to obtain Emergency Use Authorization pre-approval for NuThrax from the U.S. Food and Drug Administration;
|
§ |
the availability of funding for our U.S. government grants and contracts;
|
§ |
our ability to secure follow-on procurement contracts for our public health threat products that are under current contracts that will be expiring;
|
§ |
our ability to successfully execute our growth strategy and achieve our financial and operational goals;
|
§ |
our ability to successfully integrate and develop the products or product candidates, programs, operations and personnel of any entities, businesses or products that we acquire, including our recently completed acquisitions of the ACAM2000 business from Sanofi Pasteur Biologics, LLC and raxibacumab from GlaxoSmithKline LLC and the timing and receipt of required FDA approvals for actions contemplated in connection with our integration of these products;
|
§ |
our ability to identify and acquire companies or in-license products or late-stage product candidates that satisfy our selection criteria;
|
§ |
our ability to realize synergies and benefits from acquisitions or in-licenses within expected time periods or at all;
|
§ |
our ability to successfully identify and respond to new development contracts with the U.S. government, as well as successfully maintain, through achievement of development milestones, current development contracts with the U.S. government;
|
§ |
our ability to obtain and maintain intellectual property protection for our products and product candidates;
|
§ |
our ability and plans to expand our manufacturing capabilities and utilize the capacity of our manufacturing facilities;
|
§ |
our ability and the ability of our contractors and suppliers to maintain compliance with current good manufacturing practices and other regulatory obligations;
|
§ |
the results of regulatory inspections;
|
§ |
the operating and financial restrictions placed on us and our subsidiaries under our senior secured credit facility;
|
§ |
the outcome of the class action lawsuit filed against us and possible other future material legal proceedings;
|
§ |
the rate and degree of market acceptance and clinical utility of our products;
|
§ |
the success of our ongoing and planned development programs, non-clinical activities and clinical trials of our product candidates;
|
§ |
our ability to obtain and maintain regulatory approvals for our product candidates and the timing of any such approvals;
|
§ |
the success of our commercialization, marketing and manufacturing capabilities and strategy; and
|
§ |
the accuracy of our estimates regarding future revenues, expenses, capital requirements and needs for additional financing.
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||
(in thousands, except share and per share data)
|
||||||||
September 30, 2017
|
December 31, 2016
|
|||||||
ASSETS
|
(unaudited)
|
|||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
340,991
|
$
|
271,513
|
||||
Restricted cash
|
1,043
|
-
|
||||||
Accounts receivable, net
|
129,357
|
138,478
|
||||||
Inventories
|
68,889
|
74,002
|
||||||
Income tax receivable, net
|
-
|
9,996
|
||||||
Prepaid expenses and other current assets
|
15,754
|
16,229
|
||||||
Total current assets
|
556,034
|
510,218
|
||||||
Property, plant and equipment, net
|
386,457
|
376,448
|
||||||
Intangible assets, net
|
29,202
|
33,865
|
||||||
Goodwill
|
41,001
|
41,001
|
||||||
Deferred tax assets, net
|
4,864
|
6,096
|
||||||
Other assets
|
6,644
|
2,483
|
||||||
Total assets
|
$
|
1,024,202
|
$
|
970,111
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
30,111
|
$
|
34,649
|
||||
Accrued expenses and other current liabilities
|
3,918
|
6,368
|
||||||
Accrued compensation
|
32,626
|
34,537
|
||||||
Notes payable
|
-
|
20,000
|
||||||
Contingent consideration, current portion
|
2,393
|
3,266
|
||||||
Income taxes payable
|
1,875
|
-
|
||||||
Deferred revenue, current portion
|
4,509
|
7,036
|
||||||
Total current liabilities
|
75,432
|
105,856
|
||||||
Contingent consideration, net of current portion
|
9,398
|
9,919
|
||||||
Long-term indebtedness
|
248,994
|
248,094
|
||||||
Deferred revenue, net of current portion
|
24,966
|
8,433
|
||||||
Other liabilities
|
1,702
|
1,604
|
||||||
Total liabilities
|
360,492
|
373,906
|
||||||
Stockholders' equity:
|
||||||||
Preferred stock, $0.001 par value; 15,000,000 shares authorized, 0 shares issued and outstanding at both September 30, 2017 and December 31, 2016
|
-
|
-
|
||||||
Common stock, $0.001 par value; 200,000,000 shares authorized, 41,807,978 shares issued and 41,382,429 shares outstanding at September 30, 2017; 40,996,890 shares issued and 40,574,060 shares outstanding at December 31, 2016
|
41
|
41
|
||||||
Treasury stock, at cost, 425,549 and 422,830 common shares at September 30, 2017 and December 31, 2016, respectively
|
(6,503
|
)
|
(6,420
|
)
|
||||
Additional paid-in capital
|
370,855
|
352,435
|
||||||
Accumulated other comprehensive loss
|
(3,815
|
)
|
(4,331
|
)
|
||||
Retained earnings
|
303,132
|
254,480
|
||||||
Total stockholders' equity
|
663,710
|
596,205
|
||||||
Total liabilities and stockholders' equity
|
$
|
1,024,202
|
$
|
970,111
|
(in thousands, except share and per share data)
|
||||||||||||||||
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||||||||||
2017
|
2016
|
2017
|
2016
|
|||||||||||||
(Unaudited)
|
(Unaudited)
|
|||||||||||||||
Revenues:
|
||||||||||||||||
Product sales
|
$
|
114,296
|
$
|
96,698
|
$
|
259,875
|
$
|
208,785
|
||||||||
Contract manufacturing
|
18,912
|
14,712
|
52,700
|
32,455
|
||||||||||||
Contracts and grants
|
16,226
|
31,504
|
54,489
|
95,879
|
||||||||||||
Total revenues
|
149,434
|
142,914
|
367,064
|
337,119
|
||||||||||||
Operating expenses:
|
||||||||||||||||
Cost of product sales and contract manufacturing
|
44,503
|
39,560
|
125,449
|
93,025
|
||||||||||||
Research and development
|
22,659
|
27,188
|
68,886
|
81,173
|
||||||||||||
Selling, general and administrative
|
34,503
|
40,688
|
101,521
|
108,328
|
||||||||||||
Income from operations
|
47,769
|
35,478
|
71,208
|
54,593
|
||||||||||||
Other income (expense):
|
||||||||||||||||
Interest income
|
637
|
358
|
1,593
|
764
|
||||||||||||
Interest expense
|
(1,991
|
)
|
(2,049
|
)
|
(5,734
|
)
|
(5,082
|
)
|
||||||||
Other expense, net
|
(101
|
)
|
(234
|
)
|
(387
|
)
|
(176
|
)
|
||||||||
Total other expense, net
|
(1,455
|
)
|
(1,925
|
)
|
(4,528
|
)
|
(4,494
|
)
|
||||||||
Income from continuing operations before provision for income taxes
|
46,314
|
33,553
|
66,680
|
50,099
|
||||||||||||
Provision for income taxes
|
12,763
|
13,165
|
18,028
|
19,861
|
||||||||||||
Net income from continuing operations
|
33,551
|
20,388
|
48,652
|
30,238
|
||||||||||||
Net income (loss) from discontinued operations
|
-
|
952
|
-
|
(15,854
|
)
|
|||||||||||
Net income
|
$
|
33,551
|
$
|
21,340
|
$
|
48,652
|
$
|
14,384
|
||||||||
Net income per share from continuing operations - basic
|
$
|
0.81
|
$
|
0.50
|
$
|
1.19
|
$
|
0.75
|
||||||||
Net income (loss) per share from discontinued operations - basic
|
-
|
0.02
|
-
|
(0.40
|
)
|
|||||||||||
Net income per share - basic
|
$
|
0.81
|
$
|
0.52
|
$
|
1.19
|
$
|
0.35
|
||||||||
Net income per share from continuing operations - diluted
|
$
|
0.68
|
$
|
0.43
|
$
|
1.03
|
$
|
0.68
|
||||||||
Net income (loss) per share from discontinued operations - diluted
|
-
|
0.02
|
-
|
(0.32
|
)
|
|||||||||||
Net income per share - diluted (1)
|
$
|
0.68
|
$
|
0.45
|
$
|
1.03
|
$
|
0.36
|
||||||||
Weighted-average number of shares - basic
|
41,222,504
|
40,465,423
|
40,989,813
|
40,071,730
|
||||||||||||
Weighted-average number of shares - diluted
|
50,467,829
|
49,440,313
|
50,090,088
|
48,826,597
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||||||||||
(in thousands)
|
||||||||||||||||
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||||||||||
2017
|
2016
|
2017
|
2016
|
|||||||||||||
(Unaudited)
|
(Unaudited)
|
|||||||||||||||
Net income
|
$
|
33,551
|
$
|
21,340
|
$
|
48,652
|
$
|
14,384
|
||||||||
Foreign currency translations, net of tax
|
(296
|
)
|
(492
|
)
|
516
|
(859
|
)
|
|||||||||
Comprehensive income
|
$
|
33,255
|
$
|
20,848
|
$
|
49,168
|
$
|
13,525
|
(in thousands)
|
||||||||
Nine Months Ended September 30,
|
||||||||
2017
|
2016
|
|||||||
Cash flows from operating activities:
|
(Unaudited)
|
|||||||
Net income
|
$
|
48,652
|
$
|
14,384
|
||||
Adjustments to reconcile to net cash provided by (used in) operating activities:
|
||||||||
Stock-based compensation expense
|
11,805
|
14,527
|
||||||
Depreciation and amortization
|
29,899
|
28,155
|
||||||
Income taxes
|
18,618
|
4,814
|
||||||
Change in fair value of contingent consideration
|
1,350
|
(1,253
|
)
|
|||||
Debt issuance costs
|
(1,426
|
)
|
-
|
|||||
Abandonment of long-lived assets
|
-
|
3,749
|
||||||
Excess tax benefits from stock-based compensation
|
-
|
(10,825
|
)
|
|||||
Other
|
703
|
2,467
|
||||||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable
|
9,411
|
45,035
|
||||||
Inventories
|
5,113
|
(16,183
|
)
|
|||||
Income taxes
|
(5,515
|
)
|
(10,072
|
)
|
||||
Prepaid expenses and other assets
|
(2,157
|
)
|
(3,146
|
)
|
||||
Accounts payable
|
2,965
|
(1,305
|
)
|
|||||
Accrued expenses and other liabilities
|
(2,334
|
)
|
(1,699
|
)
|
||||
Accrued compensation
|
(1,902
|
)
|
(152
|
)
|
||||
Provision for chargebacks
|
-
|
103
|
||||||
Deferred revenue
|
14,006
|
(1,348
|
)
|
|||||
Net cash provided by operating activities
|
129,188
|
67,251
|
||||||
Cash flows from investing activities:
|
||||||||
Purchases of property, plant and equipment and other
|
(42,381
|
)
|
(56,243
|
)
|
||||
Net cash used in investing activities
|
(42,381
|
)
|
(56,243
|
)
|
||||
Cash flows from financing activities:
|
||||||||
Issuance of common stock upon exercise of stock options
|
10,799
|
14,981
|
||||||
Excess tax benefits from stock-based compensation
|
-
|
10,825
|
||||||
Taxes paid on behalf of employees for equity activity
|
(4,184
|
)
|
(4,590
|
)
|
||||
Payments of notes payable
|
(20,000
|
)
|
-
|
|||||
Distribution of Aptevo
|
-
|
(45,000
|
)
|
|||||
Contingent consideration payments
|
(2,744
|
)
|
(1,226
|
)
|
||||
Restricted cash
|
(1,043
|
)
|
-
|
|||||
Purchase of treasury stock
|
(83
|
)
|
-
|
|||||
Net cash used in financing activities
|
(17,255
|
)
|
(25,010
|
)
|
||||
Effect of exchange rate changes on cash and cash equivalents
|
(74
|
)
|
139
|
|||||
Net increase (decrease) in cash and cash equivalents
|
69,478
|
(13,863
|
)
|
|||||
Cash and cash equivalents at beginning of period
|
271,513
|
312,795
|
||||||
Cash and cash equivalents at end of period
|
$
|
340,991
|
$
|
298,932
|
·
|
development services for the NuThrax product candidate under the BARDA NuThrax Contract; and
|
·
|
procurement of BioThrax under the BARDA BioThrax Contract.
|
·
|
$137.1 million was allocated to the development services for the NuThrax product candidate under the BARDA NuThrax Contract; and
|
·
|
$93.6 million was allocated to the procurement of BioThrax under the BARDA BioThrax Contract.
|
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||
(in thousands)
|
2016
|
2016
|
||||||
Revenues:
|
||||||||
Product sales
|
$
|
3,019
|
$
|
21,183
|
||||
Collaborations
|
68
|
187
|
||||||
Total revenues
|
3,087
|
21,370
|
||||||
Operating expense:
|
||||||||
Cost of product sales
|
907
|
11,556
|
||||||
Research and development
|
2,509
|
18,024
|
||||||
Selling, general and administrative
|
7,499
|
23,792
|
||||||
Loss from operations
|
(7,828
|
)
|
(32,002
|
)
|
||||
Other expense, net:
|
(116
|
)
|
(41
|
)
|
||||
Loss from discontinued operations before benefit from income taxes
|
(7,944
|
)
|
(32,043
|
)
|
||||
Benefit from income taxes
|
(8,896
|
)
|
(16,189
|
)
|
||||
Net income (loss) from discontinued operations
|
$
|
952
|
$
|
(15,854
|
)
|
Nine Months Ended September 30,
|
||||
(in thousands)
|
2016
|
|||
Net cash used in operating activities
|
$
|
(10,299
|
)
|
|
Net cash used in investing activities
|
(1,926
|
)
|
||
Net cash provided by financing activities
|
7,733
|
|||
Net decrease in cash and cash equivalents
|
$
|
(4,492
|
)
|
(in thousands)
|
||||
Balance at December 31, 2016
|
$
|
13,185
|
||
Expense included in earnings
|
1,350
|
|||
Settlements
|
(2,744
|
)
|
||
Balance at September 30, 2017
|
$
|
11,791
|
September 30,
|
December 31,
|
|||||||
(in thousands)
|
2017
|
2016
|
||||||
Raw materials and supplies
|
$
|
34,075
|
$
|
30,687
|
||||
Work-in-process
|
14,776
|
19,821
|
||||||
Finished goods
|
20,038
|
23,494
|
||||||
Total inventories
|
$
|
68,889
|
$
|
74,002
|
September 30,
|
December 31,
|
|||||||
(in thousands)
|
2017
|
2016
|
||||||
Land and improvements
|
$
|
20,333
|
$
|
20,340
|
||||
Buildings, building improvements and leasehold improvements
|
152,064
|
147,130
|
||||||
Furniture and equipment
|
194,385
|
190,157
|
||||||
Software
|
52,613
|
52,564
|
||||||
Construction-in-progress
|
100,328
|
77,813
|
||||||
Property, plant and equipment, gross
|
519,723
|
488,004
|
||||||
Less: Accumulated depreciation and amortization
|
(133,266
|
)
|
(111,556
|
)
|
||||
Total property, plant and equipment, net
|
$
|
386,457
|
$
|
376,448
|
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||||||||||
(in thousands)
|
2017
|
2016
|
2017
|
2016
|
||||||||||||
Operating expenses:
|
||||||||||||||||
Cost of product sales and contract manufacturing
|
$
|
1,067
|
$
|
1,163
|
$
|
3,199
|
$
|
3,873
|
||||||||
Research and development
|
348
|
348
|
1,044
|
1,044
|
||||||||||||
Selling, general and administrative
|
140
|
140
|
420
|
420
|
||||||||||||
Total amortization expense
|
$
|
1,555
|
$
|
1,651
|
$
|
4,663
|
$
|
5,337
|
Number of Shares
|
Weighted-Average Exercise Price
|
Aggregate Intrinsic Value
|
||||||||||
Outstanding at December 31, 2016
|
2,559,331
|
$
|
22.94
|
$
|
25,348,245
|
|||||||
Granted
|
418,141
|
30.85
|
||||||||||
Exercised
|
(512,542
|
)
|
19.90
|
|||||||||
Forfeited
|
(24,625
|
)
|
27.81
|
|||||||||
Outstanding at September 30, 2017
|
2,440,305
|
$
|
24.88
|
$
|
37,991,459
|
Number of Shares
|
Weighted-Average Grant Price
|
Aggregate Intrinsic Value
|
||||||||||
Outstanding at December 31, 2016
|
875,584
|
$
|
28.94
|
$
|
28,754,179
|
|||||||
Granted
|
454,513
|
30.86
|
||||||||||
Vested
|
(413,752
|
)
|
20.66
|
|||||||||
Forfeited
|
(34,355
|
)
|
28.87
|
|||||||||
Outstanding at September 30, 2017
|
881,990
|
$
|
30.39
|
$
|
35,676,496
|
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||||||||||
(in thousands, except share and per share data)
|
2017
|
2016
|
2017
|
2016
|
||||||||||||
Numerator:
|
||||||||||||||||
Net income from continuing operations
|
$
|
33,551
|
$
|
20,388
|
$
|
48,652
|
$
|
30,238
|
||||||||
Interest expense, net of tax
|
704
|
934
|
2,445
|
2,234
|
||||||||||||
Amortization of debt issuance costs, net of tax
|
195
|
183
|
586
|
569
|
||||||||||||
Net income, adjusted from continuing operations
|
34,450
|
21,505
|
51,683
|
33,041
|
||||||||||||
Net income (loss) from discontinued operations
|
-
|
952
|
-
|
(15,854
|
)
|
|||||||||||
Net income, adjusted
|
$
|
34,450
|
$
|
22,457
|
$
|
51,683
|
$
|
17,187
|
||||||||
Denominator:
|
||||||||||||||||
Weighted-average number of shares—basic
|
41,222,504
|
40,465,423
|
40,989,813
|
40,071,730
|
||||||||||||
Dilutive securities—equity awards
|
1,148,857
|
878,390
|
1,003,794
|
658,367
|
||||||||||||
Dilutive securities—convertible debt
|
8,096,468
|
8,096,500
|
8,096,481
|
8,096,500
|
||||||||||||
Weighted-average number of shares—diluted
|
50,467,829
|
49,440,313
|
50,090,088
|
48,826,597
|
||||||||||||
Net income per share from continuing operations - basic
|
$
|
0.81
|
$
|
0.50
|
$
|
1.19
|
$
|
0.75
|
||||||||
Net income (loss) per share from discontinued operations - basic
|
-
|
0.02
|
-
|
(0.40
|
)
|
|||||||||||
Net income per share - basic
|
$
|
0.81
|
$
|
0.52
|
$
|
1.19
|
$
|
0.35
|
||||||||
Net income per share from continuing operations - diluted
|
$
|
0.68
|
$
|
0.43
|
$
|
1.03
|
$
|
0.68
|
||||||||
Net income (loss) per share from discontinued operations - diluted
|
-
|
0.02
|
-
|
(0.32
|
)
|
|||||||||||
Net income per share - diluted
|
$
|
0.68
|
$
|
0.45
|
$
|
1.03
|
$
|
0.36
|
Incurred in
|
Inception
|
|||||||
(in thousands)
|
2017
|
to Date
|
||||||
Termination benefits
|
$
|
40
|
$
|
5,286
|
||||
Abandonment of equipment
|
-
|
3,749
|
||||||
Other costs
|
-
|
691
|
||||||
Total
|
$
|
40
|
$
|
9,726
|
Termination
|
||||
(in thousands)
|
Benefits
|
|||
Balance at December 31, 2016
|
$
|
4,357
|
||
Expenses incurred
|
40
|
|||
Amount paid
|
(4,298
|
)
|
||
Balance at September 30, 2017
|
$
|
99
|
§ |
BioThrax® (Anthrax Vaccine Adsorbed), the only vaccine licensed by the U.S. Food and Drug Administration, or the FDA, for the general use prophylaxis and post-exposure prophylaxis of anthrax disease. BioThrax is also licensed by the Paul-Ehrlich-Institut of the German Federal Ministry of Health for general use prophylaxis of anthrax disease;
|
§ |
Anthrasil® [Anthrax Immune Globulin Intravenous (Human)], the only polyclonal antibody therapeutic licensed by the FDA for the treatment of inhalational anthrax;
|
§ |
BAT® [Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)- (Equine)], the only heptavalent therapeutic licensed by the FDA and Health Canada for the treatment of botulinum disease;
|
§ |
VIGIV [Vaccinia Immune Globulin Intravenous (Human)], the only therapeutic licensed by the FDA to address certain complications from smallpox vaccination;
|
§ |
RSDL® (Reactive Skin Decontamination Lotion Kit), the only device cleared by the FDA intended to remove or neutralize chemical warfare agents and T-2 toxin from the skin;
|
§ |
Trobigard™ (atropine sulfate, obidoxime chloride), an auto-injector drug-device combination product designed for intramuscular self-injection of atropine sulfate and obidoxime chloride, a nerve agent countermeasure. This product is not currently approved or cleared by the FDA or any other similar regulatory body, and is only distributed to authorized government buyers for use outside the U.S. The product is not distributed in the U.S.;
|
§ |
ACAM2000® (Smallpox (Vaccinia) Vaccine, Live), the only smallpox vaccine licensed in the U.S. by the FDA for active immunization against smallpox disease for persons determined to be at high risk for smallpox (acquired from Sanofi Pasteur Biologics, LLC in October 2017); and
|
§ |
raxibacumab, a fully human monoclonal antibody approved by the FDA for the treatment and prophylaxis of inhalational anthrax (acquired from GlaxoSmithKline LLC in October 2017).
|
§ |
NuThrax™ (anthrax vaccine adsorbed with CPG 7909 adjuvant), a next generation anthrax vaccine;
|
§ |
UV-4B, a novel antiviral being developed for dengue and influenza infections;
|
§ |
GC-072, the lead compound in the EV-035 series of broad spectrum antibiotics, being developed for Burkholderia pseudomallei;
|
§ |
FLU-IG (NP025), a human polyclonal antibody therapeutic being developed to treat seasonal influenza;
|
§ |
ZIKA-IG (NP024), a human polyclonal antibody therapeutic being developed as a prophylaxis for Zika infections;
|
§ |
FILOV (NP026), an equine polyclonal antibody therapeutic being developed to treat Ebola infections;
|
§ |
ZIKV-VLA1601, a highly purified inactivated vaccine candidate against the Zika virus; and
|
§ |
SIAN, a stabilized form of isoamyl nitrite in a spray device for the treatment of known or suspected acute cyanide poisoning.
|
Development Programs
|
Funding Source
|
Award Date
|
Performance Period
|
Anthrasil
|
BARDA
|
09/2005
|
9/2005 — 4/2021
|
BARDA
|
09/2013
|
9/2013 — 9/2018
|
|
Auto-injector platform
|
DoD
|
07/2017
|
7/2017 — 6/2022
|
BAT
|
BARDA
|
05/2006
|
5/2006 — 12/2027
|
CIADM
|
BARDA
|
06/2012
|
6/2012 — 6/2037
|
GC-072
|
DTRA
|
08/2014
|
8/2014 — 3/2018
|
Large-scale manufacturing for BioThrax
|
BARDA
|
07/2010
|
7/2010 — 7/2017
|
NuThrax
|
NIAID
|
08/2014
|
8/2014 — 1/2019
|
BARDA
|
03/2015
|
3/2015 — 12/2017
|
|
BARDA
|
09/2016
|
9/2016 — 9/2021
|
|
SIAN
|
BARDA
|
09/2017
|
9/2017 — 9/2022
|
UV-4B
|
NIAID
|
09/2011
|
9/2011 — 9/2018
|
VIGIV
|
CDC
|
08/2012
|
8/2012 — 8/2017
|
|
Three Months Ended September 30,
|
|||||||||||||||
(in thousands)
|
2017
|
2016
|
Change
|
% Change
|
||||||||||||
Product sales:
|
||||||||||||||||
BioThrax
|
$
|
83,485
|
$
|
94,116
|
$
|
(10,631
|
)
|
(11
|
%)
|
|||||||
Other
|
30,811
|
2,582
|
28,229
|
1,093
|
%
|
|||||||||||
Total Product sales
|
114,296
|
96,698
|
17,598
|
18
|
%
|
|||||||||||
Contract manufacturing
|
18,912
|
14,712
|
4,200
|
29
|
%
|
|||||||||||
Contracts and grants
|
16,226
|
31,504
|
(15,278
|
)
|
(48
|
%)
|
||||||||||
Total revenues
|
$
|
149,434
|
$
|
142,914
|
$
|
6,520
|
5
|
%
|
§ |
decreased development funding of $10.1 million related to our CIADM program, which includes a decrease of $5.2 million for CIADM task orders primarily related to Ebola and Zika;
|
§ |
decreased development funding of $3.2 million for VIGIV related to the timing of plasma collection; and
|
§ |
decreased development funding of $1.8 million for large scale manufacturing of BioThrax primarily due to the successful completion of the Building 55 development program in 2016 that did not recur in 2017.
|
Three Months Ended
|
||||||||||||||||
September 30,
|
||||||||||||||||
(in thousands)
|
2017
|
2016
|
Change
|
% Change
|
||||||||||||
NuThrax
|
$
|
7,384
|
$
|
6,182
|
$
|
1,202
|
19
|
%
|
||||||||
FLU-IG (NP025)
|
1,832
|
-
|
1,832
|
N/A
|
||||||||||||
UV-4B
|
1,407
|
2,147
|
(740
|
)
|
(34
|
%)
|
||||||||||
BAT
|
838
|
814
|
24
|
3
|
%
|
|||||||||||
Auto-injector platform
|
1,107
|
2,475
|
(1,368
|
)
|
(55
|
%)
|
||||||||||
CIADM task orders
|
330
|
2,600
|
(2,270
|
)
|
(87
|
%)
|
||||||||||
EV-035 series of molecules
|
772
|
1,331
|
(559
|
)
|
42
|
%
|
||||||||||
VIGIV
|
374
|
1,474
|
(1,100
|
)
|
(75
|
%)
|
||||||||||
Large-scale manufacturing for BioThrax
|
64
|
1,491
|
(1,427
|
)
|
(96
|
%)
|
||||||||||
Anthrasil
|
247
|
178
|
69
|
(39
|
%)
|
|||||||||||
BioThrax related programs
|
238
|
1,012
|
(774
|
)
|
(76
|
%)
|
||||||||||
Other
|
8,066
|
7,484
|
582
|
8
|
%
|
|||||||||||
Total
|
$
|
22,659
|
$
|
27,188
|
$
|
(4,529
|
)
|
(17
|
%)
|
|
Nine Months Ended September 30,
|
|||||||||||||||
(in thousands)
|
2017
|
2016
|
Change
|
% Change
|
||||||||||||
Product sales:
|
||||||||||||||||
BioThrax
|
$
|
179,620
|
$
|
193,255
|
$
|
(13,635
|
)
|
(7
|
%)
|
|||||||
Other
|
80,255
|
15,530
|
64,725
|
417
|
%
|
|||||||||||
Total Product sales
|
259,875
|
208,785
|
51,090
|
24
|
%
|
|||||||||||
Contract manufacturing
|
52,700
|
32,455
|
20,245
|
62
|
%
|
|||||||||||
Contracts and grants
|
54,489
|
95,879
|
(41,390
|
)
|
(43
|
%)
|
||||||||||
Total revenues
|
$
|
367,064
|
$
|
337,119
|
$
|
29,945
|
9
|
%
|
§ |
decreased development funding of $20.3 million related to our CIADM program, which includes a decrease of $10.5 million for CIADM task orders primarily related to Ebola and Zika;
|
§ |
decreased development funding of $18.8 million for VIGIV due to the timing of plasma collection; and
|
§ |
decreased development funding of $3.7 million for large scale manufacturing of BioThrax primarily due to the successful completion of the Building 55 development program in 2016 that did not recur in 2017.
|
Nine Months Ended
|
||||||||||||||||
September 30,
|
||||||||||||||||
(in thousands)
|
2017
|
2016
|
Change
|
% Change
|
||||||||||||
NuThrax
|
$
|
23,964
|
$
|
15,847
|
$
|
8,117
|
51
|
%
|
||||||||
FLU-IG (NP025)
|
5,189
|
-
|
5,189
|
N/A
|
||||||||||||
UV-4B
|
4,663
|
4,179
|
484
|
12
|
%
|
|||||||||||
BAT
|
2,509
|
2,964
|
(455
|
)
|
(15
|
%)
|
||||||||||
Auto-injector platform
|
2,551
|
7,646
|
(5,095
|
)
|
(67
|
%)
|
||||||||||
CIADM task orders
|
2,511
|
7,899
|
(5,388
|
)
|
(68
|
%)
|
||||||||||
EV-035 series of molecules
|
1,856
|
2,972
|
(1,116
|
)
|
(38
|
%)
|
||||||||||
VIGIV
|
1,211
|
7,428
|
(6,217
|
)
|
84
|
%
|
||||||||||
Large-scale manufacturing for BioThrax
|
885
|
4,870
|
(3,985
|
)
|
(82
|
%)
|
||||||||||
Anthrasil
|
737
|
626
|
111
|
18
|
%
|
|||||||||||
BioThrax related programs
|
594
|
2,701
|
(2,107
|
)
|
(78
|
%)
|
||||||||||
Other
|
22,216
|
24,041
|
(1,825
|
)
|
(8
|
%)
|
||||||||||
Total
|
$
|
68,886
|
$
|
81,173
|
$
|
(12,287
|
)
|
(15
|
%)
|
|
Nine Months Ended
|
|||||||
September 30,
|
||||||||
(in thousands)
|
2017
|
2016
|
||||||
Net cash provided by (used in):
|
||||||||
Operating activities(i)
|
$
|
129,114
|
$
|
67,390
|
||||
Investing activities
|
(42,381
|
)
|
(56,243
|
)
|
||||
Financing activities
|
(17,255
|
)
|
(25,010
|
)
|
||||
Net increase (decrease) in cash and cash equivalents
|
$
|
69,478
|
$
|
(13,863
|
)
|
|
our ability to secure a new BioThrax procurement contract on favorable terms;
|
§ |
the level, timing and cost of product sales;
|
|
the extent to which we acquire or invest in and integrate companies, businesses, products or technologies;
|
|
the acquisition of new facilities and capital improvements to new or existing facilities;
|
|
the payment obligations under our indebtedness;
|
|
the scope, progress, results and costs of our development activities;
|
|
our ability to obtain funding from collaborative partners, government entities and non-governmental organizations for our development programs;
|
§ |
the extent to which we repurchase our common stock under our share repurchase program; and
|
|
the costs of commercialization activities, including product marketing, sales and distribution.
|
§ |
the possibility that we may be ineligible to respond to a request for proposal issued by the government;
|
§ |
the commitment of substantial time and attention of management and key employees to the preparation of bids and proposals for contracts that may not be awarded to us;
|
§ |
the need to accurately estimate the resources and cost structure that will be required to perform any contract that we might be awarded;
|
§ |
the submission by third parties of protests to our responses to requests for proposal that could result in delays or withdrawals of those requests for proposal; and
|
§ |
in the event our competitors protest or challenge contract or grant awards made to us pursuant to competitive bidding, the potential that we may incur expenses or delays, and that any such protest or challenge could result in the resubmission of bids based on modified specifications, or in the termination, reduction or modification of the awarded contract.
|
§ |
the Federal Acquisition Regulation, or FAR, and agency-specific regulations supplemental to FAR, which comprehensively regulate the award, formation, administration and performance of government contracts;
|
§ |
the Defense Federal Acquisition Regulations, or DFARs, and agency-specific regulations supplemental to DFARs, which comprehensively regulate the award, formation, administration and performance of U.S. Department of Defense, or DoD, government contracts;
|
§ |
business ethics and public integrity obligations, which govern conflicts of interest and the hiring of former government employees, restrict the granting of gratuities and funding of lobbying activities and incorporate other requirements such as the Anti-Kickback Act, the Procurement Integrity Act, the False Claims Act and the Foreign Corrupt Practices Act;
|
§ |
export and import control laws and regulations, including but not limited to International Traffic in Arms Regulations; and
|
§ |
laws, regulations and executive orders restricting the use and dissemination of information classified for national security purposes and the exportation of certain products and technical data.
|
§ |
terminate existing contracts, in whole or in part, for any reason or no reason;
|
§ |
unilaterally reduce or modify contracts or subcontracts, including by imposing equitable price adjustments;
|
§ |
cancel multi-year contracts and related orders, if funds for contract performance for any subsequent year become unavailable;
|
§ |
decline, in whole or in part, to exercise an option to purchase product under a procurement contract or to fund additional development under a development contract;
|
§ |
decline to renew a procurement contract;
|
§ |
claim rights to facilities or to products, including intellectual property, developed under the contract;
|
§ |
require repayment of contract funds spent on construction of facilities in the event of contract default;
|
§ |
take actions that result in a longer development timeline than expected;
|
§ |
direct the course of a development program in a manner not chosen by the government contractor;
|
§ |
suspend or debar the contractor from doing business with the government or a specific government agency;
|
§ |
pursue civil or criminal remedies under acts such as the False Claims Act and False Statements Act; and
|
§ |
control or prohibit the export of products.
|
§ |
warning letters and other communications;
|
§ |
product seizure or withdrawal of the product from the market;
|
§ |
restrictions on the marketing or manufacturing of a product;
|
§ |
suspension or withdrawal of regulatory approvals or refusal to approve pending applications or supplements to approved applications;
|
§ |
fines or disgorgement of profits or revenue; and
|
§ |
injunctions or the imposition of civil or criminal penalties.
|
§ |
equipment malfunctions or failures;
|
§ |
technology malfunctions;
|
§ |
cyber-attacks;
|
§ |
work stoppages or slow-downs;
|
§ |
protests, including by animal rights activists;
|
§ |
injunctions;
|
§ |
damage to or destruction of the facility; and
|
§ |
product contamination or tampering.
|
§ |
retaining existing customers and attracting new customers;
|
§ |
retaining key employees;
|
§ |
diversion of management attention and resources;
|
§ |
conforming internal controls, policies and procedures, business cultures and compensation programs;
|
§ |
consolidating corporate and administrative infrastructures;
|
§ |
successfully executing technology transfers and obtaining required regulatory approvals;
|
§ |
consolidating sales and marketing operations;
|
§ |
identifying and eliminating redundant and underperforming operations and assets;
|
§ |
assumption of known and unknown liabilities;
|
§ |
coordinating geographically dispersed organizations; and
|
§ |
managing tax costs or inefficiencies associated with integrating operations.
|
§ |
successful development, formulation and cGMP scale-up of manufacturing that meets FDA or other foreign regulatory requirements;
|
§ |
successful program partnering;
|
§ |
successful completion of clinical or non-clinical development, including toxicology studies and studies in approved animal models;
|
§ |
receipt of marketing approvals from the FDA and equivalent foreign regulatory authorities;
|
§ |
establishment of commercial manufacturing processes and product supply arrangements;
|
§ |
training of a commercial sales force for the product, whether alone or in collaboration with others;
|
§ |
successful registration and maintenance of relevant patent and/or other proprietary protection; and
|
§ |
acceptance of the product by potential government and other customers.
|
§ |
our inability to manufacture sufficient quantities of materials for use in trials;
|
§ |
the unavailability or variability in the number and types of subjects for each study;
|
§ |
safety issues or inconclusive or incomplete testing, trial or study results;
|
§ |
drug immunogenicity;
|
§ |
lack of efficacy of product candidates during the trials;
|
§ |
government or regulatory restrictions or delays; and
|
§ |
greater than anticipated costs of trials.
|
§ |
requiring us to dedicate a substantial portion of any cash flow from operations to payment on our debt, which would reduce the amounts available to fund other corporate initiatives;
|
§ |
increasing the amount of interest that we have to pay on debt with variable interest rates, if market rates of interest increase;
|
§ |
subjecting us, as under our senior secured revolving credit facility, to restrictive covenants that may reduce our ability to take certain corporate actions, acquire companies, products or technology, or obtain further debt financing;
|
§ |
requiring us to pledge our assets as collateral, which could limit our ability to obtain additional debt financing;
|
§ |
limiting our flexibility in planning for, or reacting to, general adverse economic and industry conditions; and
|
§ |
placing us at a competitive disadvantage compared to our competitors that have less debt, better debt servicing options or stronger debt servicing capacity.
|
§ |
the level, timing and cost of product sales;
|
§ |
the extent to which we acquire or invest in and integrate companies, businesses, products or technologies;
|
§ |
the acquisition of new facilities and capital improvements to new or existing facilities;
|
§ |
the payment obligations under our indebtedness;
|
§ |
the scope, progress, results and costs of our development activities;
|
§ |
our ability to obtain funding from collaborative partners, government entities and non-governmental organizations for our development programs;
|
§ |
the extent to which we repurchase our common stock under our share repurchase program; and
|
§ |
the costs of commercialization activities, including product marketing, sales and distribution.
|
§ |
decreased demand or withdrawal of a product;
|
§ |
injury to our reputation;
|
§ |
withdrawal of clinical trial participants;
|
§ |
costs to defend the related litigation;
|
§ |
substantial monetary awards to trial participants or patients;
|
§ |
loss of revenue; and
|
§ |
an inability to commercialize products that we may develop.
|
§ |
the classification of our directors;
|
§ |
limitations on changing the number of directors then in office;
|
§ |
limitations on the removal of directors;
|
§ |
limitations on filling vacancies on the board;
|
§ |
advance notice requirements for stockholder nominations of candidates for election to the Board of Directors and other proposals;
|
§ |
the inability of stockholders to act by written consent;
|
§ |
the inability of stockholders to call special meetings; and
|
§ |
the ability of our Board of Directors to designate the terms of and issue a new series of preferred stock without stockholder approval.
|
§ |
contracts, decisions and procurement policies by the U.S. government affecting BioThrax and our other products and product candidates;
|
§ |
the success of competitive products or technologies;
|
§ |
results of clinical and non-clinical trials of our product candidates;
|
§ |
announcements of acquisitions, financings or other transactions by us;
|
§ |
litigation or legal proceedings;
|
§ |
public concern as to the safety of our products;
|
§ |
termination or delay of a development program;
|
§ |
the recruitment or departure of key personnel;
|
§ |
variations in our product revenue and profitability; and
|
§ |
the other factors described in this "Risk Factors" section.
|
Exhibit
Number
|
Description
|
2.1††
|
Asset Purchase Agreement, dated July 14, 2017, among Sanofi Pasteur Biologics, LLC, Acambis Research Ltd. and Emergent BioSolutions Inc. (incorporated by reference to Exhibit 2 to the Company's Current Report on Form 8-K, filed on July 14, 2017).
|
2.2††
|
Asset Purchase Agreement, dated July 19, 2017, among GlaxoSmithKline LLC, Human Genome Sciences, Inc., and Emergent BioSolutions Inc. (incorporated by reference to Exhibit 2 to the Company's Current Report on Form 8-K, filed on October 3, 2017).
|
Credit Agreement, dated September 29, 2017, among Emergent BioSolutions Inc., the lenders party thereto from time to time, and Wells Fargo Bank, National Association, as the Administrative Agent (incorporated by reference to Exhibit 10 to the Company's Current Report on Form 8-K, filed on October 2, 2017).
|
|
10.2# ††
|
Modification No. 5, effective September 8, 2017, to the Solicitation/Contract/Order for Commercial Items (the "CDC BioThrax Procurement Contract"), effective December 8, 2016, from the Centers for Disease Control and Prevention to Emergent Biodefense Operations Lansing LLC.
|
12#
|
Ratio of Earnings to Fixed Charges.
|
31.1#
|
Certification of the Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a).
|
31.2#
|
Certification of the Chief Financial Officer pursuant to Exchange Act Rule 13a-14(a).
|
32.1#
|
Certification of the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
32.2#
|
Certification of the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
101. INS
|
XBRL Instance Document.
|
101.SCH
|
XBRL Taxonomy Extension Schema Document.
|
101.CAL
|
XBRL Taxonomy Calculation Linksbase Document.
|
101.DEF
|
XBRL Taxonomy Definition Linksbase Document.
|
101.LAB
|
XBRL Taxonomy Label Linksbase Document.
|
101.PRE
|
XBRL Taxonomy Presentation Linksbase Document.
|
Ratio of Earnings to Fixed Charges
|
|||||||||||||||||||||||
Year to Date
|
|||||||||||||||||||||||
|
September 30,
|
Year Ended December 31,
|
|||||||||||||||||||||
(in thousands)
|
2017
|
2016
|
2015
|
2014
|
2013
|
2012
|
|||||||||||||||||
|
|||||||||||||||||||||||
Pretax income from continuing operations (1)
|
$
|
66,680
|
|
$
|
99,221
|
$
|
135,716
|
$
|
84,194
|
$
|
83,439
|
$
|
68,011
|
||||||||||
Fixed charges
|
|||||||||||||||||||||||
Interest expense
|
5,760
|
8,270
|
7,834
|
7,480
|
1,973
|
2,177
|
|||||||||||||||||
Debt issuance cost
|
1,523
|
1,526
|
1,564
|
3,290
|
319
|
67
|
|||||||||||||||||
Total fixed charges (2)
|
7,283
|
9,796
|
9,398
|
10,770
|
2,292
|
2,244
|
|||||||||||||||||
Noncontrolling interest in pretax income (3)
|
-
|
-
|
-
|
-
|
876
|
5,381
|
|||||||||||||||||
Capitalized interest (4)
|
1,549
|
2,179
|
2,875
|
2,530
|
1,973
|
2,177
|
|||||||||||||||||
Earnings ((1) + (2) -(3) -(4))
|
72,414
|
|
106,838
|
142,239
|
92,434
|
82,882
|
62,697
|
||||||||||||||||
Fixed charges
|
7,283
|
9,796
|
9,398
|
10,770
|
2,292
|
2,244
|
|||||||||||||||||
Ratio of earnings to fixed charges
|
9.9
|
10.9
|
15.1
|
8.6
|
36.2
|
27.9
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
|
1. CONTRACT ID CODE
|
PAGE OF PAGES
|
||||||
1
|
2
|
|||||||
2. AMENDMENT/MODIFICATION NO.
00005
|
3. EFFECTIVE DATE
09/08/2017
|
4. REQUISITION/PURCHASE REQ. NO.
0000HCGE-2017-12762
|
5. PROJECT NO. (If applicable)
|
|||||
6. ISSUED BY CODE
|
2543
|
7. ADMINISTERED BY (If other than Item 6) CODE
|
2543
|
|||||
Centers for Disease Control and Prevention
Office of Acquisition Services (OAS)
2920 Brandywine Rd, RM 3000
Atlanta, GA 30341-5539
|
Centers for Disease Control and Prevention
Office of Acquisition Services (OAS)
2920 Brandywine Rd, RM 3000
Atlanta, GA 30341-5539
|
|||||||
8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)
EMERGENT BIODEFENSE OPERATIONS LANSING LLC
3500 N MARTIN LUTHER KING JR BLVD # 1
LANSING, MI 48906-2933
|
(Ö)
|
9A. AMENDMENT OF SOLICITATION NO.
|
||||||
9B. DATED (See Item 11)
|
||||||||
X
|
10A. MODIFICATION OF CONTRACT/ORDER NO.
200-2017-92634
|
|||||||
10B. DATED (See Item 13)
12/08/2016
|
||||||||
CODE 026489018
|
FACILITY CODE
|
(Ö)
|
A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.
|
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).
|
|
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
|
|
X
|
D. OTHER (Specify type of modification and authority)
52.217-7 Option for Increased Quantity—Separately Priced Line Item.
|
E.
|
IMPORTANT: Contractor X is not,is required to sign this document and returncopies to the issuing office.
|
1.
|
Exercise alternate SubCLIN 1005 from Optional CLIN 0001
|
2.
|
Increase and fund [**] doses on CLIN 1005 in the amount of $[**]
|
3.
|
Total fundng for this contract has increased by $[**] from [**] to $[**]
|
15A. NAME AND TITLE OF SIGNER (Type or print)
|
16A. NAME OF CONTRACTING OFFICER
Christine N Godfrey
|
||
15B. CONTRACTOR/OFFEROR
(Signature of person authorized to sign)
|
15C. DATE SIGNED
|
16B. UNITED STATES OF AMERICA
BY: /s/CHRISTINE N. GODFREY
(Signature of Contracting Officer)
|
16C. DATE SIGNED
9/8/2017
|
ITEM
|
SUPPLIES / SERVICES
|
QTY / UNIT
|
UNIT PRICE
|
NOT TO EXCEED
|
||||||||
0001
|
BioThrax [**] product
[**] upon date of delivery:
[**] product at a unit price of $[**] estimated per the [**] unit price.
Delivery Address: Contractor's Facility
Delivery to occur within [**] of exercise of option
|
[**] Doses
|
$
|
[
|
**]
|
$
|
[
|
**]
|
ITEM
|
SUPPLIES / SERVICES
|
QTY / UNIT
|
UNIT PRICE
|
NOT TO EXCEED
|
||||||||
1005
|
BioThrax [**] product
[**] upon date of delivery:
[**] product at a unit price of $[**] estimated per the [**] unit price.
Delivery Address: Contractor's Facility
Delivery to occur NLT [**]
|
[**] Doses
|
$
|
[
|
**]
|
$
|
[
|
**]
|
||||
Line(s) Of Accounting:
93904ZU 2642 2017 75-X-0956
5664711101 $[**]
93907PY 2642 2017 75-X-0956
5664711101 $[**]
93907WF 2642 2017 75-X-0943
5664311101 $[**]
939ZWUX 2642 2017 75-X-0956
5664711101 $[**]
|
Document and Entity Information |
9 Months Ended |
---|---|
Sep. 30, 2017
shares
| |
Document and Entity Information [Abstract] | |
Entity Registrant Name | Emergent BioSolutions Inc. |
Entity Central Index Key | 0001367644 |
Current Fiscal Year End Date | --12-31 |
Entity Well-known Seasoned Issuer | Yes |
Entity Voluntary Filers | No |
Entity Current Reporting Status | Yes |
Entity Filer Category | Large Accelerated Filer |
Entity Common Stock, Shares Outstanding | 41,395,398 |
Document Fiscal Year Focus | 2017 |
Document Fiscal Period Focus | Q3 |
Document Type | 10-Q |
Amendment Flag | false |
Document Period End Date | Sep. 30, 2017 |
Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares |
Sep. 30, 2017 |
Dec. 31, 2016 |
---|---|---|
Stockholders' equity: | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 15,000,000 | 15,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, shares issued (in shares) | 41,807,978 | 40,996,890 |
Common stock, shares outstanding (in shares) | 41,382,429 | 40,574,060 |
Treasury stock ( in shares) | 425,549 | 422,830 |
Consolidated Statements of Comprehensive Income (Unaudited) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2017 |
Sep. 30, 2016 |
Sep. 30, 2017 |
Sep. 30, 2016 |
|
Consolidated Statements of Comprehensive Income [Abstract] | ||||
Net income | $ 33,551 | $ 21,340 | $ 48,652 | $ 14,384 |
Foreign currency translations, net of tax | (296) | (492) | 516 | (859) |
Comprehensive income | $ 33,255 | $ 20,848 | $ 49,168 | $ 13,525 |
Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
9 Months Ended | |
---|---|---|
Sep. 30, 2017 |
Sep. 30, 2016 |
|
Cash flows from operating activities: | ||
Net income | $ 48,652 | $ 14,384 |
Adjustments to reconcile to net cash provided by (used in) operating activities: | ||
Stock-based compensation expense | 11,805 | 14,527 |
Depreciation and amortization | 29,899 | 28,155 |
Deferred income taxes | 18,618 | 4,814 |
Change in fair value of contingent obligations | 1,350 | (1,253) |
Debt issuance costs | (1,426) | 0 |
Abandonment of long-lived assets | 0 | 3,749 |
Excess tax benefits from stock-based compensation | 0 | (10,825) |
Other | 703 | 2,467 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 9,411 | 45,035 |
Inventories | 5,113 | (16,183) |
Income taxes | (5,515) | (10,072) |
Prepaid expenses and other assets | (2,157) | (3,146) |
Accounts payable | 2,965 | (1,305) |
Accrued expenses and other liabilities | (2,334) | (1,699) |
Accrued compensation | (1,902) | (152) |
Provision for chargebacks | 0 | 103 |
Deferred revenue | 14,006 | (1,348) |
Net cash provided by operating activities | 129,188 | 67,251 |
Cash flows from investing activities: | ||
Purchases of property, plant and equipment and other | (42,381) | (56,243) |
Net cash used in investing activities | (42,381) | (56,243) |
Cash flows from financing activities: | ||
Issuance of common stock upon exercise of stock options | 10,799 | 14,981 |
Excess tax benefits from stock-based compensation | 0 | 10,825 |
Taxes paid on behalf of employees for equity activity | (4,184) | (4,590) |
Payments of notes payable | (20,000) | 0 |
Distribution to Aptevo | 0 | (45,000) |
Contingent obligation payments | (2,744) | (1,226) |
Restricted cash | (1,043) | 0 |
Purchase of treasury stock | (83) | 0 |
Net cash used in financing activities | (17,255) | (25,010) |
Effect of exchange rate changes on cash and cash equivalents | (74) | 139 |
Net increase (decrease) in cash and cash equivalents | 69,478 | (13,863) |
Cash and cash equivalents at beginning of period | 271,513 | 312,795 |
Cash and cash equivalents at end of period | $ 340,991 | $ 298,932 |
Summary of significant accounting policies |
9 Months Ended | ||||||||
---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||
Summary of significant accounting policies [Abstract] | |||||||||
Summary of significant accounting policies | 1. Summary of significant accounting policies Basis of presentation and consolidation The accompanying unaudited consolidated financial statements include the accounts of Emergent BioSolutions Inc. ("Emergent" or the "Company") and its wholly owned and majority owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation. The unaudited consolidated financial statements included herein have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X issued by the Securities and Exchange Commission ("SEC"). Certain information and footnote disclosures normally included in consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles have been condensed or omitted pursuant to such rules and regulations. These consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the SEC. On August 1, 2016, the Company completed the spin-off of Aptevo Therapeutics Inc. ("Aptevo") and has classified the results of operations of Aptevo as discontinued operations for the three and nine months ended September 30, 2016. The historical financial statements and footnotes have been revised accordingly. See Note 2 "Discontinued operations" for further details regarding the spin-off. For financial reporting purposes, in the periods following the spin-off, the Company operates as one operating segment and therefore has a single reportable segment. In the opinion of the Company's management, any adjustments contained in the accompanying unaudited consolidated financial statements are of a normal recurring nature and are necessary to present fairly the financial position of the Company as of September 30, 2017. Interim results are not necessarily indicative of results that may be expected for any other interim period or for an entire year. Revenue recognition During the three and nine months ended September 30, 2017, there have been no significant changes to the Company's summary of significant accounting policies contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the SEC, except for revenue recognition associated with the Biomedical Advanced Research and Development Authority ("BARDA") procurement contract for BioThrax (the "BARDA BioThrax Contract") and the modification of the BARDA development and procurement contract for the NuThrax product candidate (the "BARDA NuThrax Contract"). The BARDA NuThrax Contract was entered into on September 30, 2016. This contract is a service arrangement that includes multiple elements. The deliverables under the BARDA NuThrax Contract are the completion of development for NuThrax and the procurement of NuThrax for the Strategic National Stockpile ("SNS"). The Company has determined that the procurement of NuThrax under the BARDA NuThrax Contract is a contingent deliverable, as it is dependent upon successful completion of development; therefore the Company has excluded this from the allocation of the contract consideration. The Company allocated the value of the contract to the development for the NuThrax product candidate based on an approach using the best estimate of selling price ("BESP methodology"). The BESP methodology for the development deliverable takes into account a cost build-up for internal and external costs, plus a specified mark-up. The Company has allocated $147.5 million to the development services deliverable and will recognize revenue as the services are provided. On March 16, 2017, the Company entered into a contract with BARDA, valued at $100 million, for the delivery of BioThrax to the SNS over a two-year period of performance. In conjunction with the signing of this contract, the Company entered into a modification to its BARDA NuThrax Contract that increases the number of doses of NuThrax to be delivered under the base period from two million to three million doses with a commensurate reduction in dose price for the initial deliveries. The modification also provides for a discount on the sales price for doses to be procured during the option period up to $100 million. As a result of the modification of the BARDA NuThrax Contract in conjunction with execution of the BARDA BioThrax Contract, the Company has determined that the two agreements are linked under the revenue recognition requirements of the Financial Accounting Standards Board ("FASB") Topic 605, Revenue Recognition. The Company analyzed these agreements and determined that the units of accounting under the linked agreements are:
The Company's allocation of contract consideration for the development services was updated based on the services provided prior to March 17, 2017. The allocation of contract consideration for the BioThrax doses to be sold under the BARDA BioThrax Contract was determined based on similar pricing provided to other customers. The Company's determination of the amount of contract consideration to be allocated to the discounts was based on an undiscounted probability adjusted model, which factored in the expected timing of regulatory approval for the NuThrax product candidate, expected levels of procurement of the NuThrax product candidate upon regulatory approval and the market conditions for these types of medical countermeasures. The Company allocated the contract consideration to the two units of accounting as follows:
The Company will defer a portion of the consideration received for doses delivered under the BARDA BioThrax Contract and the development services for the NuThrax product candidate. The Company will recognize the deferred revenue upon the delivery of NuThrax doses under the BARDA NuThrax Contract, or upon the future extinguishment of the Company's obligation to deliver NuThrax doses to which the discount applies. Recently issued accounting standards In May 2014, the FASB issued Accounting Standards Update ("ASU") No. 2014-09, Revenue from Contracts with Customers (Topic 606) ("ASU No. 2014-09"). ASU No. 2014-09 supersedes the revenue recognition requirements in Topic 605, Revenue Recognition, as well as most industry-specific guidance, and significantly enhances comparability of revenue recognition practices across entities and industries by providing a principles-based, comprehensive framework for addressing revenue recognition issues. In order for a provider of promised goods or services to recognize as revenue the consideration that it expects to receive in exchange for the promised goods or services, the provider should apply the following five steps: (1) identify the contract with a customer(s); (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation. ASU No. 2014-09 also specifies the accounting for some costs to obtain or fulfill a contract with a customer and provides enhanced disclosure requirements. The standard will be effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period. The Company will adopt the requirements of the new standard in the first quarter of 2018 using the modified retrospective method. The modified retrospective method requires companies to recognize the cumulative effect of initially applying the new standard as an adjustment to opening retained earnings. The Company is finalizing its review of its revenue contract portfolio and has made an initial determination of its revenue streams. The Company is completing the detailed analysis of its multiple deliverable and procurement contracts with the U.S. government and believes there will be changes to the revenue recognition for its multiple deliverable contracts. The Company is in the process of finalizing its accounting policy and designing and implementing the necessary changes to processes and controls in order to account for revenue under the new standard beginning on the adoption date. Based on the Company's timeline and planned resources, the Company anticipates completing its implementation by the adoption date. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) ("ASU No. 2016-02"). ASU No. 2016-02 increases transparency and comparability among organizations by requiring the recognition of lease assets and lease liabilities on the balance sheet and disclosure of key information about leasing arrangements for both lessees and lessors. The standard will be effective January 1, 2019 for the Company, with early adoption permitted. The standard will be applied using a modified retrospective approach to the beginning of the earliest period presented in the financial statements. The Company is currently evaluating when it will adopt the standard and the expected impact to its consolidated financial statements and related disclosures. In March 2016, the FASB issued ASU No. 2016-09, Compensation - Stock Compensation (Topic 718) ("ASU No. 2016-09"). ASU No. 2016-09 simplifies several aspects of the accounting for share-based payment award transactions, including: (1) the income tax consequences, (2) classification of awards as either equity or liabilities, and (3) classification on the statement of cash flows. As of January 1, 2017, the Company adopted and performed the evaluation required by the standard and did not identify any conditions or events that would have a material impact on the current disclosures in the financial statements. The Company has retrospectively adjusted the operating and financing sections within the statement of cash flows for the classification of employee taxes paid associated with equity award activities for the nine months ended September 30, 2016. In addition, the Company prospectively adopted the provisions related to the excess tax benefits, and as a result prior periods were not adjusted. If the Company had adopted this provision retrospectively, there would have been no change to the estimated effective annual tax rate for the three and nine months ended September 30, 2016, but for the nine months ended September 30, 2016, there would have been a tax benefit associated with stock option activity of $3.5 million recorded in the provision for income taxes on the Company's statement of operations. In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business ("ASU No. 2017-01"). ASU No. 2017-01 provides clarification for the definition of a business with the objective of adding guidance and providing a more robust framework to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. The new standard will be effective for all annual periods beginning after December 15, 2017. The Company has early adopted ASU 2017-01 and determined the acquisition of raxibacumab, acquired on October 2, 2017, is an asset acquisition. See Note 12 "Subsequent events" for further details regarding this acquisition. In January 2017, the FASB issued ASU No. 2017-04, Intangibles - Goodwill and Other (Topic 250): Simplifying the Test for Goodwill Impairment ("ASU No. 2017-04"). The standard eliminates the second step in the goodwill impairment test, which requires an entity to determine the implied fair value of the reporting unit's goodwill. Instead, an entity should recognize an impairment loss if the carrying value of the net assets assigned to the reporting unit exceeds the fair value of the reporting unit, with the impairment loss not to exceed the amount of goodwill allocated to the reporting unit. The standard is effective for annual and interim goodwill impairment tests conducted in fiscal years beginning after December 15, 2019. Early adoption is permitted. The Company does not believe that the new standard will have a material impact on its financial statements. There are no other recently issued accounting pronouncements that are expected to have a material impact on the Company's financial position, results of operations or cash flows. |
Discontinued Operations |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Discontinued Operations [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Discontinued operations | 2. Discontinued operations On August 1, 2016, the Company completed the spin-off of Aptevo through the distribution of 100% of the outstanding shares of common stock of Aptevo to the Company's shareholders (the "Distribution"). The Distribution was made to the Company's shareholders of record as of the close of business on July 22, 2016 (the "Record Date"), and provided for such shareholders to receive one share of Aptevo common stock for every two shares of Emergent common stock held as of the Record Date. The Distribution was intended to qualify as a tax-free distribution for federal income tax purposes in the United States. In the aggregate, approximately 20.2 million shares of Aptevo common stock were distributed to the Company's shareholders of record as of the Record Date in the Distribution. After the Distribution, the Company no longer holds shares of Aptevo's common stock. In addition, on August 1, 2016, the Company entered into a non-negotiable, unsecured promissory note with Aptevo to provide an additional $20 million in funding, which the Company paid in January 2017. The historical statements of operations of Aptevo have been presented as discontinued operations in the consolidated financial statements and the prior period has been restated. Discontinued operations include results of Aptevo's business except for certain allocated corporate overhead costs and certain costs associated with transition services provided by the Company to Aptevo. These allocated costs remain part of continuing operations. Due to differences between the basis of presentation for discontinued operations and the basis of presentation as a stand-alone company, the financial results of Aptevo included within discontinued operations for the Company may not be indicative of actual financial results of Aptevo. The following table summarizes results from discontinued operations of Aptevo included in the consolidated statements of operations for the three and nine months ended September 30, 2016:
The following table summarizes the cash flows of Aptevo included in the September 30, 2016 consolidated statements of cash flows:
|
Fair value measurements |
9 Months Ended | |||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | ||||||||||||||||||||||||||
Fair value measurements [Abstract] | ||||||||||||||||||||||||||
Fair value measurements | 3. Fair value measurements Contingent consideration are liabilities measured at fair value on a recurring basis. For the three months ended September 30, 2017, the contingent consideration obligation associated with the EV-035 series of molecules and the broad spectrum antiviral platform program increased by a nominal amount. For the three months ended September 30, 2016, the contingent consideration obligation associated with the EV-035 series of molecules and the broad spectrum antiviral platform program increased by $0.1 million. For the nine months ended September 30, 2017 and 2016, the contingent consideration obligation associated with the EV-035 series and platform program decreased by $0.1 million and $0.3 million, respectively. The changes are primarily due to the estimated timing and probability of success for certain development and regulatory milestones of the program, which are inputs that have no observable market (Level 3). These changes are classified in the Company's statement of operations as both selling, general and administrative expense and research and development expense. For the three and nine months ended September 30, 2017, the contingent purchase consideration obligations associated with RSDL increased by $0.9 million and $1.4 million, respectively. For the three and nine months ended September 30, 2016, the contingent purchase consideration obligations associated with RSDL decreased by $2.3 million and $1.0 million, respectively. The changes in the fair value of the RSDL contingent consideration obligations are primarily due to the expected amount and timing of future net sales, which are inputs that have no observable market (Level 3). These changes are classified in the Company's statement of operations as cost of product sales and contract manufacturing. The following table is a reconciliation of the beginning and ending balance of the liabilities, consisting only of contingent consideration, measured at fair value, using significant unobservable inputs (Level 3) during the nine months ended September 30, 2017.
Separate disclosure is required for assets and liabilities measured at fair value on a recurring basis from those measured at fair value on a non-recurring basis. As of September 30, 2017 and 2016, the Company had no significant assets or liabilities that were measured at fair value on a non-recurring basis. On January 29, 2014, the Company issued $250.0 million aggregate principal amount of 2.875% Convertible Senior Notes due 2021 (the "Notes"). The Notes mature on January 15, 2021, unless earlier purchased by the Company or converted. The Notes are subject to the fair value disclosure requirements. The estimated fair value of the Notes at September 30, 2017 was $359.5 million. The fair value of the Notes was determined via broker quote. |
Inventories |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventories [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventories | 4. Inventories Inventories consisted of the following:
|
Property, plant and equipment |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, plant and equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, plant and equipment | 5. Property, plant and equipment Property, plant and equipment consisted of the following:
As of September 30, 2017 and December 31, 2016, construction-in-progress primarily includes costs related to the build out of the Company's Center for Innovation in Advanced Development and Manufacturing ("CIADM") facility. |
Intangible assets |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Intangible assets and in-process research and development [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Intangible assets, in-process research and development | 6. Intangible assets The Company recorded amortization expense as follows:
As of September 30, 2017, the weighted average amortization period remaining for intangible assets was 68 months. |
Long-term debt |
9 Months Ended |
---|---|
Sep. 30, 2017 | |
Long-term debt [Abstract] | |
Long-term debt | 7. Long-term debt On September 29, 2017, the Company entered into a senior secured credit agreement (the "2017 Credit Agreement") with four lending financial institutions, which replaced the Company's prior senior secured credit agreement (the "2013 Credit Agreement"). The 2017 Credit Agreement provides for a senior secured credit facility of up to $200 million through September 29, 2022. The 2017 Credit Agreement also includes a $100 million accordion feature, which could provide an additional $100 million in revolver or incremental term loans, at the option of the Company, resulting in a potential aggregate commitment of up to $300 million, subject to certain conditions and requirements set forth in the 2017 Credit Agreement. As of September 30, 2017, no amounts were drawn under the 2017 Credit Agreement. The Company's payment obligations under the 2017 Credit Agreement are secured by a lien on substantially all of the Company's assets, including the stock of all of the Company's domestic subsidiaries, and the assets of the subsidiary guarantors. Borrowings under the 2017 Credit Agreement will bear interest at a rate per annum equal to (a) a eurocurrency rate plus a margin ranging from 1.50% to 2.50% per annum, depending on the Company's consolidated net leverage ratio or (b) a base rate (which is the highest of the prime rate, the federal funds rate plus 0.50% and a eurocurrency rate for an interest period of one month plus 1%) plus a margin ranging from 0.50% to 1.50%, depending on the Company's consolidated net leverage ratio. The Company is required to make quarterly payments under the 2017 Credit Agreement of accrued and unpaid interest on the outstanding principal balance, based on the above interest rates. In addition, the Company is required to pay commitment fees ranging from 0.25% to 0.40% per annum, depending on the Company's consolidated net leverage ratio, in respect of daily unused commitments under the 2017 Credit Agreement. The 2017 Credit Agreement contains affirmative and negative covenants customary for financings of this type. Negative covenants in the 2017 Credit Agreement, among other things, limit the Company's ability to incur indebtedness and liens; dispose of assets; make investments including loans, advances, guarantees, or acquisitions (subject to compliance with the financial covenants and certain other conditions); and enter into certain mergers or consolidation transactions. The 2017 Credit Agreement also contains financial covenants, tested quarterly and in connection with any triggering events under the 2017 Credit Agreement: (1) a minimum consolidated debt service coverage ratio of 2.50 to 1.00, and (2) a maximum consolidated net leverage ratio of 3.50 to 1.00, which may be adjusted to 4.00 to 1.00 for a four quarter period in connection with a permitted acquisition, subject to the terms and conditions of the 2017 Credit Agreement. Each of the ratios referred to in the foregoing clauses (1) and (2) is calculated on a consolidated basis for each consecutive four fiscal quarter periods. The Company recorded a loss on extinguishment of debt of $0.4 million for the three and nine months ended September 30, 2017 associated with termination of the 2013 Credit Agreement. Loss on extinguishment of debt consisted of expensing unamortized debt issuance costs. The Company entered into a standby letter of credit and guarantee arrangement with a bank in the amount of $1.0 million that is fully collateralized by cash, which is classified as restricted cash in the Company's consolidated balance sheet. |
Equity |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity awards [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity awards | 8. Equity As of September 30, 2017, the Company had one equity award plan, the Fourth Amended and Restated Emergent BioSolutions Inc. 2006 Stock Incentive Plan (the "2006 Plan"), which includes both stock options and restricted stock units. The following is a summary of stock option award activity under the 2006 Plan:
The following is a summary of restricted stock unit award activity under the 2006 Plan:
|
Earnings per share |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings per share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings per share | 9. Earnings per share The following table presents the calculation of basic and diluted net income per share:
For the three and nine months ended September 30, 2017 and 2016, basic earnings per share is computed by dividing net income by the weighted average number of shares of common stock outstanding during the period. For the three and nine months ended September 30, 2017 and 2016, diluted earnings per share is computed using the "if-converted" method by dividing the net income adjusted for interest expense and amortization of debt issuance cost, both net of tax, associated with the Notes by the weighted average number of shares of common stock outstanding during the period. The weighted average number of shares is adjusted for the potential dilutive effect of the exercise of stock options and the vesting of restricted stock units along with the assumption of the conversion of the Notes, at the beginning of the period. For the three and nine months ended September 30, 2017, along with the nine months ended September 30, 2016, substantially all of the outstanding stock options to purchase shares of common stock were included in the calculation of diluted earnings per share. For the three months ended September 30, 2016, approximately 0.4 million stock options were excluded from the calculation of diluted earnings per share due to the fact that the exercise prices were in excess of the average per share closing price during the period. |
Restructuring |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Abandonment of equipment | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Restructuring | 10. Restructuring In August 2016, the Company adopted a plan to restructure and reprioritize the operations at the Emergent BioDefense Operations Lansing LLC ("EBOL") site. This plan was initiated as a result of the Company's large-scale manufacturing facility at the EBOL site commencing manufacturing operations. Severance and other related costs and asset-related charges are reflected within the Company's consolidated statement of operations as a component of selling, general and administrative expense. The Company has completed the EBOL restructuring. The costs of the restructuring as of September 30, 2017 are detailed below:
During the year ended December 31, 2016, the Company abandoned certain equipment and associated assets at its EBOL facility related to the manufacturing process at Building 12 ("manufacturing process") asset group. During the third quarter of 2016, the Company recorded a charge for the manufacturing process asset group of $3.7 million. The additional expense is classified in the Company's statements of operations as selling, general and administrative expense. The following is a summary of the activity for the liabilities related to the restructuring:
|
Litigation |
9 Months Ended |
---|---|
Sep. 30, 2017 | |
Litigation [Abstract] | |
Litigation | 11. Litigation On July 19, 2016, Plaintiff William Sponn, or Sponn, filed a putative class action complaint in the United States District Court for the District of Maryland on behalf of purchasers of the Company's common stock between January 11, 2016 and June 21, 2016, inclusive, or the Class Period, seeking to pursue remedies under the Securities Exchange Act of 1934 against the Company and certain of its senior officers and directors, collectively, the Defendants. The complaint alleges, among other things, that the Company made materially false and misleading statements about the government's demand for BioThrax and expectations that the Company's five-year exclusive procurement contract with the U.S. Department of Health and Human Services would be renewed and omitted certain material facts. Sponn is seeking unspecified damages, including legal costs. On October 25, 2016, the Court added City of Cape Coral Municipal Firefighters' Retirement Plan and City of Sunrise Police Officers' Retirement Plan as plaintiffs and appointed them Lead Plaintiffs and Robins Geller Rudman & Dowd LLP as Lead Counsel. On December 27, 2016, the Plaintiffs filed an amended complaint that cites the same class period, names the same defendants and makes similar allegations to the original complaint. The Company filed a Motion to Dismiss on February 27, 2017. The Plaintiffs filed an opposition brief on April 28, 2017. The Company's Motion to Dismiss was heard and denied on July 6, 2017. The Company filed its answer on July 28, 2017. The parties are currently in the process of exchanging discovery, and Plaintiffs' class certification motion is due by November 29, 2017. The Defendants believe that the allegations in the complaint are without merit and intend to defend themselves vigorously against those claims. As of the date of this filing, the range of potential loss cannot be determined or estimated. |
Subsequent events |
9 Months Ended |
---|---|
Sep. 30, 2017 | |
Subsequent events [Abstract] | |
Subsequent events | 12. Subsequent events Acquisition of raxibacumab On October 2, 2017, the Company completed the acquisition of raxibacumab, a fully human monoclonal antibody product approved by the U.S. Food and Drug Administration ("FDA") for the treatment and prophylaxis of inhalational anthrax, from Human Genome Sciences, Inc. and GlaxoSmithKline LLC (collectively referred to as "GSK"). The all-cash transaction consists of a $76 million upfront payment and up to $20 million in product sale and manufacturing-related milestone payments. With the acquisition, the Company assumed responsibility for a multi-year contract with BARDA, with a remaining value of up to approximately $130 million, to supply the product to the SNS through November 2019. The Company has determined that substantially all of the value of raxibacumab is attributed to the raxibacumab asset and therefore the raxibacumab acquisition is considered an asset acquisition. Acquisition of ACAM2000 On October 6, 2017, the Company completed the acquisition of the ACAM2000® (Smallpox (Vaccinia) Vaccine, Live) business of Sanofi Pasteur Biologics, LLC ("Sanofi"). This acquisition includes ACAM2000, the only smallpox vaccine approved by the FDA, a current good manufacturing practices ("cGMP") live viral manufacturing facility and office and warehouse space, both in Canton, Massachusetts, and a cGMP viral fill/finish facility in Rockville, Maryland. With this acquisition, the Company also assumed responsibility for an existing 10-year contract with the Centers for Disease Control and Prevention ("CDC"), which will expire and be up for renewal or extension in March 2018. This contract was originally valued at up to $425 million, with a remaining value of up to approximately $160 million, for the delivery of ACAM2000 to the SNS and establishing U.S.-based manufacturing of ACAM2000. At the closing, the Company paid $97.5 million in an upfront payment and $20 million in milestone payments earned as of the closing date tied to the achievement of certain regulatory and manufacturing-related milestones, for a total payment in cash of $117.5 million. The agreement includes a potential additional milestone payment of up to $7.5 million. This transaction will be accounted for by the Company under the acquisition method of accounting, with the Company as the acquirer. Under the acquisition method of accounting, the assets and liabilities of the ACAM2000 business will be recorded as of October 6, 2017, the acquisition date, at their respective fair values, and combined with those of the Company. As of the date of this filing, the valuation of acquired intangible assets, inventory, deferred taxes, property plant and equipment, contingent purchase consideration and other fair value adjustments are not complete, and as such the purchase price allocation is subject to change. |
Summary of significant accounting policies (Policies) |
9 Months Ended | ||||||||
---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||
Summary of significant accounting policies [Abstract] | |||||||||
Basis of presentation and consolidation | Basis of presentation and consolidation The accompanying unaudited consolidated financial statements include the accounts of Emergent BioSolutions Inc. ("Emergent" or the "Company") and its wholly owned and majority owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation. The unaudited consolidated financial statements included herein have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X issued by the Securities and Exchange Commission ("SEC"). Certain information and footnote disclosures normally included in consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles have been condensed or omitted pursuant to such rules and regulations. These consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the SEC. On August 1, 2016, the Company completed the spin-off of Aptevo Therapeutics Inc. ("Aptevo") and has classified the results of operations of Aptevo as discontinued operations for the three and nine months ended September 30, 2016. The historical financial statements and footnotes have been revised accordingly. See Note 2 "Discontinued operations" for further details regarding the spin-off. For financial reporting purposes, in the periods following the spin-off, the Company operates as one operating segment and therefore has a single reportable segment. In the opinion of the Company's management, any adjustments contained in the accompanying unaudited consolidated financial statements are of a normal recurring nature and are necessary to present fairly the financial position of the Company as of September 30, 2017. Interim results are not necessarily indicative of results that may be expected for any other interim period or for an entire year. Revenue recognition During the three and nine months ended September 30, 2017, there have been no significant changes to the Company's summary of significant accounting policies contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the SEC, except for revenue recognition associated with the Biomedical Advanced Research and Development Authority ("BARDA") procurement contract for BioThrax (the "BARDA BioThrax Contract") and the modification of the BARDA development and procurement contract for the NuThrax product candidate (the "BARDA NuThrax Contract"). The BARDA NuThrax Contract was entered into on September 30, 2016. This contract is a service arrangement that includes multiple elements. The deliverables under the BARDA NuThrax Contract are the completion of development for NuThrax and the procurement of NuThrax for the Strategic National Stockpile ("SNS"). The Company has determined that the procurement of NuThrax under the BARDA NuThrax Contract is a contingent deliverable, as it is dependent upon successful completion of development; therefore the Company has excluded this from the allocation of the contract consideration. The Company allocated the value of the contract to the development for the NuThrax product candidate based on an approach using the best estimate of selling price ("BESP methodology"). The BESP methodology for the development deliverable takes into account a cost build-up for internal and external costs, plus a specified mark-up. The Company has allocated $147.5 million to the development services deliverable and will recognize revenue as the services are provided. On March 16, 2017, the Company entered into a contract with BARDA, valued at $100 million, for the delivery of BioThrax to the SNS over a two-year period of performance. In conjunction with the signing of this contract, the Company entered into a modification to its BARDA NuThrax Contract that increases the number of doses of NuThrax to be delivered under the base period from two million to three million doses with a commensurate reduction in dose price for the initial deliveries. The modification also provides for a discount on the sales price for doses to be procured during the option period up to $100 million. As a result of the modification of the BARDA NuThrax Contract in conjunction with execution of the BARDA BioThrax Contract, the Company has determined that the two agreements are linked under the revenue recognition requirements of the Financial Accounting Standards Board ("FASB") Topic 605, Revenue Recognition. The Company analyzed these agreements and determined that the units of accounting under the linked agreements are:
The Company's allocation of contract consideration for the development services was updated based on the services provided prior to March 17, 2017. The allocation of contract consideration for the BioThrax doses to be sold under the BARDA BioThrax Contract was determined based on similar pricing provided to other customers. The Company's determination of the amount of contract consideration to be allocated to the discounts was based on an undiscounted probability adjusted model, which factored in the expected timing of regulatory approval for the NuThrax product candidate, expected levels of procurement of the NuThrax product candidate upon regulatory approval and the market conditions for these types of medical countermeasures. The Company allocated the contract consideration to the two units of accounting as follows:
The Company will defer a portion of the consideration received for doses delivered under the BARDA BioThrax Contract and the development services for the NuThrax product candidate. The Company will recognize the deferred revenue upon the delivery of NuThrax doses under the BARDA NuThrax Contract, or upon the future extinguishment of the Company's obligation to deliver NuThrax doses to which the discount applies. Recently issued accounting standards In May 2014, the FASB issued Accounting Standards Update ("ASU") No. 2014-09, Revenue from Contracts with Customers (Topic 606) ("ASU No. 2014-09"). ASU No. 2014-09 supersedes the revenue recognition requirements in Topic 605, Revenue Recognition, as well as most industry-specific guidance, and significantly enhances comparability of revenue recognition practices across entities and industries by providing a principles-based, comprehensive framework for addressing revenue recognition issues. In order for a provider of promised goods or services to recognize as revenue the consideration that it expects to receive in exchange for the promised goods or services, the provider should apply the following five steps: (1) identify the contract with a customer(s); (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation. ASU No. 2014-09 also specifies the accounting for some costs to obtain or fulfill a contract with a customer and provides enhanced disclosure requirements. The standard will be effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period. The Company will adopt the requirements of the new standard in the first quarter of 2018 using the modified retrospective method. The modified retrospective method requires companies to recognize the cumulative effect of initially applying the new standard as an adjustment to opening retained earnings. The Company is finalizing its review of its revenue contract portfolio and has made an initial determination of its revenue streams. The Company is completing the detailed analysis of its multiple deliverable and procurement contracts with the U.S. government and believes there will be changes to the revenue recognition for its multiple deliverable contracts. The Company is in the process of finalizing its accounting policy and designing and implementing the necessary changes to processes and controls in order to account for revenue under the new standard beginning on the adoption date. Based on the Company's timeline and planned resources, the Company anticipates completing its implementation by the adoption date. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) ("ASU No. 2016-02"). ASU No. 2016-02 increases transparency and comparability among organizations by requiring the recognition of lease assets and lease liabilities on the balance sheet and disclosure of key information about leasing arrangements for both lessees and lessors. The standard will be effective January 1, 2019 for the Company, with early adoption permitted. The standard will be applied using a modified retrospective approach to the beginning of the earliest period presented in the financial statements. The Company is currently evaluating when it will adopt the standard and the expected impact to its consolidated financial statements and related disclosures. In March 2016, the FASB issued ASU No. 2016-09, Compensation - Stock Compensation (Topic 718) ("ASU No. 2016-09"). ASU No. 2016-09 simplifies several aspects of the accounting for share-based payment award transactions, including: (1) the income tax consequences, (2) classification of awards as either equity or liabilities, and (3) classification on the statement of cash flows. As of January 1, 2017, the Company adopted and performed the evaluation required by the standard and did not identify any conditions or events that would have a material impact on the current disclosures in the financial statements. The Company has retrospectively adjusted the operating and financing sections within the statement of cash flows for the classification of employee taxes paid associated with equity award activities for the nine months ended September 30, 2016. In addition, the Company prospectively adopted the provisions related to the excess tax benefits, and as a result prior periods were not adjusted. If the Company had adopted this provision retrospectively, there would have been no change to the estimated effective annual tax rate for the three and nine months ended September 30, 2016, but for the nine months ended September 30, 2016, there would have been a tax benefit associated with stock option activity of $3.5 million recorded in the provision for income taxes on the Company's statement of operations. In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business ("ASU No. 2017-01"). ASU No. 2017-01 provides clarification for the definition of a business with the objective of adding guidance and providing a more robust framework to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. The new standard will be effective for all annual periods beginning after December 15, 2017. The Company has early adopted ASU 2017-01 and determined the acquisition of raxibacumab, acquired on October 2, 2017, is an asset acquisition. See Note 12 "Subsequent events" for further details regarding this acquisition. In January 2017, the FASB issued ASU No. 2017-04, Intangibles - Goodwill and Other (Topic 250): Simplifying the Test for Goodwill Impairment ("ASU No. 2017-04"). The standard eliminates the second step in the goodwill impairment test, which requires an entity to determine the implied fair value of the reporting unit's goodwill. Instead, an entity should recognize an impairment loss if the carrying value of the net assets assigned to the reporting unit exceeds the fair value of the reporting unit, with the impairment loss not to exceed the amount of goodwill allocated to the reporting unit. The standard is effective for annual and interim goodwill impairment tests conducted in fiscal years beginning after December 15, 2019. Early adoption is permitted. The Company does not believe that the new standard will have a material impact on its financial statements. There are no other recently issued accounting pronouncements that are expected to have a material impact on the Company's financial position, results of operations or cash flows. |
Discontinued Operations (Tables) |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Discontinued Operations [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summarized results of discontinued operations included in consolidated statements of income | The following table summarizes results from discontinued operations of Aptevo included in the consolidated statements of operations for the three and nine months ended September 30, 2016:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of disposal groups including discontinued operations cash flows | The following table summarizes the cash flows of Aptevo included in the September 30, 2016 consolidated statements of cash flows:
|
Fair value measurements (Tables) |
9 Months Ended | |||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | ||||||||||||||||||||||||||
Fair value measurements [Abstract] | ||||||||||||||||||||||||||
Reconciliation of Liabilities Measured at Fair Value Using Significant Unobservable Inputs (Level 3) | The following table is a reconciliation of the beginning and ending balance of the liabilities, consisting only of contingent consideration, measured at fair value, using significant unobservable inputs (Level 3) during the nine months ended September 30, 2017.
|
Inventories (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventories [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventories | Inventories consisted of the following:
|
Property, plant and equipment (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, plant and equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, plant and equipment | Property, plant and equipment consisted of the following:
|
Intangible assets (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Intangible assets and in-process research and development [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Intangible Assets | The Company recorded amortization expense as follows:
|
Equity (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity awards [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Option Award Activity | The following is a summary of stock option award activity under the 2006 Plan:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Restricted Stock Units Activity | The following is a summary of restricted stock unit award activity under the 2006 Plan:
|
Earnings per share (Tables) |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings per share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Basic and Diluted Net Income (Loss) per Share | The following table presents the calculation of basic and diluted net income per share:
|
Restructuring (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Abandonment of equipment | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Costs of the restructuring | The Company has completed the EBOL restructuring. The costs of the restructuring as of September 30, 2017 are detailed below:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of the activity for liabilities related to EBOL restructuring | The following is a summary of the activity for the liabilities related to the restructuring:
|
Summary of significant accounting policies (Details) $ in Thousands, Dose in Millions |
3 Months Ended | 9 Months Ended | |||
---|---|---|---|---|---|
Mar. 16, 2017
USD ($)
Dose
|
Sep. 30, 2017
USD ($)
Segment
|
Sep. 30, 2016
USD ($)
|
Sep. 30, 2017
USD ($)
|
Sep. 30, 2016
USD ($)
|
|
Summary of significant accounting policies [Abstract] | |||||
Number of business segments | Segment | 1 | ||||
Product Information [Line Items] | |||||
Billed revenue amount | $ 114,296 | $ 96,698 | $ 259,875 | $ 208,785 | |
BioThrax [Member] | BARDA [Member] | |||||
Product Information [Line Items] | |||||
Amount of contract | $ 100,000 | ||||
Period of performance | 2 years | ||||
Consideration allocated to procurement | $ 93,600 | ||||
NuThrax [Member] | BARDA [Member] | |||||
Product Information [Line Items] | |||||
Consideration allocated to development activities | $ 137,100 | $ 147,500 | 147,500 | ||
NuThrax [Member] | BARDA [Member] | Minimum [Member] | |||||
Product Information [Line Items] | |||||
Number of doses to be delivered | Dose | 2 | ||||
NuThrax [Member] | BARDA [Member] | Maximum [Member] | |||||
Product Information [Line Items] | |||||
Number of doses to be delivered | Dose | 3 | ||||
Discount on purchase price for doses to be procured | $ 100,000 | ||||
Accounting Standards Update 2016-09 [Member] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Tax benefit associated with stock option activity | $ 3,500 |
Discontinued Operations (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | |
---|---|---|---|
Aug. 01, 2016 |
Sep. 30, 2016 |
Sep. 30, 2016 |
|
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Percentage of outstanding shares distributed | 100.00% | ||
Record date for distribution | Jul. 22, 2016 | ||
Number of common stock distributed (in shares) | 20,230,000 | ||
Aptevo [Member] | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Unsecured debt | $ 20,000 | ||
Term of manufacturing services contract | 10 years | ||
Term of transition services agreement | 2 years | ||
Revenues [Abstract] | |||
Product sales | $ 3,019 | $ 21,183 | |
Contracts, grants and collaborations | 68 | 187 | |
Total revenues | 3,087 | 21,370 | |
Operating expense [Abstract] | |||
Cost of product sales | 907 | 11,556 | |
Research and development | 2,509 | 18,024 | |
Selling, general and administrative | 7,499 | 23,792 | |
Income (loss) from operations | (7,828) | (32,002) | |
Other income (expense), net [Abstract] | |||
Other income (expense), net | (116) | (41) | |
Income (loss) from discontinued operations before provision for (benefit from) income taxes | (7,944) | (32,043) | |
Provision for (benefit from) income taxes | (8,896) | (16,189) | |
Net Income (loss) from discontinued operations | $ 952 | (15,854) | |
Net Cash Provided by (Used in) Discontinued Operations [Abstract] | |||
Net cash used in operating activities | (10,299) | ||
Net cash used in investing activities | (1,926) | ||
Net cash provided by financing activities | 7,733 | ||
Net decrease in cash and cash equivalents | $ (4,492) |
Fair value measurements (Details) - USD ($) $ in Thousands |
1 Months Ended | 3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|---|
Jan. 29, 2014 |
Sep. 30, 2017 |
Sep. 30, 2016 |
Sep. 30, 2017 |
Sep. 30, 2016 |
|
Unobservable Input Reconciliation [Roll Forward] | |||||
Balance, beginning of period | $ 13,185 | ||||
Expense included in earnings | 1,350 | ||||
Settlements | (2,744) | ||||
Balance, end of period | $ 11,791 | 11,791 | |||
Convertible Senior Notes Due 2021 [Member] | |||||
Unobservable Input Reconciliation [Roll Forward] | |||||
Face amount of debt instrument | $ 250,000 | ||||
Interest rate, stated percentage | 2.875% | ||||
Maturity date | Jan. 15, 2021 | ||||
Fair value of the notes | 359,500 | 359,500 | |||
Evolva Holding SA 035 & Broad Spectrum Antiviral Platform [Member] | |||||
Unobservable Input Reconciliation [Roll Forward] | |||||
Change in fair value of contingent obligations | $ 100 | (100) | $ (300) | ||
RSDL [Member] | |||||
Unobservable Input Reconciliation [Roll Forward] | |||||
Change in fair value of contingent obligations | $ 900 | $ (2,300) | $ 1,400 | $ (1,000) |
Inventories (Details) - USD ($) $ in Thousands |
Sep. 30, 2017 |
Dec. 31, 2016 |
---|---|---|
Inventories [Abstract] | ||
Raw materials and supplies | $ 34,075 | $ 30,687 |
Work-in-process | 14,776 | 19,821 |
Finished goods | 20,038 | 23,494 |
Total inventories | $ 68,889 | $ 74,002 |
Property, plant and equipment (Details) - USD ($) $ in Thousands |
9 Months Ended | ||
---|---|---|---|
Sep. 30, 2017 |
Sep. 30, 2016 |
Dec. 31, 2016 |
|
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment | $ 519,723 | $ 488,004 | |
Less: Accumulated depreciation and amortization | (133,266) | (111,556) | |
Total Property, plant and equipment, net | 386,457 | 376,448 | |
Depreciation and amortization | 29,899 | $ 28,155 | |
Land and Improvements [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment | 20,333 | 20,340 | |
Buildings, Building Improvements and Leasehold Improvements [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment | 152,064 | 147,130 | |
Furniture and Equipment [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment | 194,385 | 190,157 | |
Software [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment | 52,613 | 52,564 | |
Construction-in-progress [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment | $ 100,328 | $ 77,813 |
Intangible assets (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2017 |
Sep. 30, 2016 |
Sep. 30, 2017 |
Sep. 30, 2016 |
|
Accumulated Amortization [Abstract] | ||||
Amortization | $ 1,555 | $ 1,651 | $ 4,663 | $ 5,337 |
Intangible assets, weighted average useful life | 68 months | |||
Cost of product sales and contract manufacturing [Member] | ||||
Accumulated Amortization [Abstract] | ||||
Amortization | 1,067 | 1,163 | $ 3,199 | 3,873 |
Research and development [Member] | ||||
Accumulated Amortization [Abstract] | ||||
Amortization | 348 | 348 | 1,044 | 1,044 |
Selling, general and administrative [Member] | ||||
Accumulated Amortization [Abstract] | ||||
Amortization | $ 140 | $ 140 | $ 420 | $ 420 |
Long-term debt (Details) $ in Millions |
3 Months Ended | 9 Months Ended |
---|---|---|
Sep. 30, 2017
USD ($)
|
Sep. 30, 2017
USD ($)
Institution
|
|
Line of Credit Facility [Line Items] | ||
Current borrowing capacity | $ 200.0 | $ 200.0 |
Loss on extinguishment of debt | 0.4 | 0.4 |
Letter of credit, outstanding amount | 1.0 | $ 1.0 |
Eurocurrency [Member] | ||
Line of Credit Facility [Line Items] | ||
Debt instrument, basis spread on variable rate | 1.00% | |
Eurocurrency [Member] | Minimum [Member] | ||
Line of Credit Facility [Line Items] | ||
Debt instrument, basis spread on variable rate | 1.50% | |
Eurocurrency [Member] | Maximum [Member] | ||
Line of Credit Facility [Line Items] | ||
Debt instrument, basis spread on variable rate | 2.50% | |
Base Rate [Member] | Minimum [Member] | ||
Line of Credit Facility [Line Items] | ||
Debt instrument, basis spread on variable rate | 0.50% | |
Base Rate [Member] | Maximum [Member] | ||
Line of Credit Facility [Line Items] | ||
Debt instrument, basis spread on variable rate | 1.50% | |
Federal Funds Rate [Member] | ||
Line of Credit Facility [Line Items] | ||
Debt instrument, basis spread on variable rate | 0.50% | |
Credit Agreement [Member] | ||
Line of Credit Facility [Line Items] | ||
Number of lending institutions | Institution | 4 | |
Maturity date | Sep. 29, 2022 | |
Borrowing capacity with accordion feature | 100.0 | $ 100.0 |
Maximum borrowing capacity | 300.0 | $ 300.0 |
Debt covenant, consolidated debt service coverage ratio, minimum | 2.50 | |
Debt covenant, leverage ratio, maximum | 3.50 | |
Credit Agreement [Member] | Minimum [Member] | ||
Line of Credit Facility [Line Items] | ||
Commitment fee percentage | 0.25% | |
Credit Agreement [Member] | Maximum [Member] | ||
Line of Credit Facility [Line Items] | ||
Commitment fee percentage | 0.40% | |
Debt covenant, leverage ratio, maximum | 4.00 | |
Revolving Credit Facility [Member] | ||
Line of Credit Facility [Line Items] | ||
Outstanding credit facility | $ 0.0 | $ 0.0 |
Equity (Details) |
9 Months Ended |
---|---|
Sep. 30, 2017
USD ($)
Plan
$ / shares
shares
| |
Equity awards [Abstract] | |
Number of stock-based employee compensation plans | Plan | 1 |
2006 Plan [Member] | Restricted Stock Units (RSUs) [Member] | |
Restricted stock unit award activity [Roll Forward] | |
Outstanding, beginning of period (in shares) | shares | 875,584 |
Granted (in shares) | shares | 454,513 |
Vested (in shares) | shares | (413,752) |
Forfeited (in shares) | shares | (34,355) |
Outstanding, end of period (in shares) | shares | 881,990 |
Weighted-Average Grant Price [Roll Forward] | |
Outstanding, beginning of period (in dollars per share) | $ / shares | $ 28.94 |
Granted (in dollars per share) | $ / shares | 30.86 |
Vested (in dollars per share) | $ / shares | 20.66 |
Forfeited (in dollars per share) | $ / shares | 28.87 |
Outstanding, end of period (in dollars per share) | $ / shares | $ 30.39 |
Aggregate intrinsic value [Abstract] | |
Outstanding, beginning of period | $ | $ 28,754,179 |
Outstanding, end of period | $ | $ 35,676,496 |
2006 Plan [Member] | Stock Options Member [Member] | |
Options outstanding [Roll Forward] | |
Outstanding, beginning of period (in shares) | shares | 2,559,331 |
Granted (in shares) | shares | 418,141 |
Exercised (in shares) | shares | (512,542) |
Forfeited (in shares) | shares | (24,625) |
Outstanding, end of period (in shares) | shares | 2,440,305 |
Weighted-Average Exercise Price [Roll Forward] | |
Outstanding, beginning of period (in dollars per share) | $ / shares | $ 22.94 |
Granted (in dollars per share) | $ / shares | 30.85 |
Exercised (in dollars per share) | $ / shares | 19.90 |
Forfeited (in dollars per share) | $ / shares | 27.81 |
Outstanding, end of period (in dollars per share) | $ / shares | $ 24.88 |
Aggregate Intrinsic Value [Abstract] | |
Outstanding, beginning of period | $ | $ 25,348,245 |
Outstanding, end of period | $ | $ 37,991,459 |
Earnings per share (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | 9 Months Ended | ||||||
---|---|---|---|---|---|---|---|---|
Sep. 30, 2017 |
Sep. 30, 2016 |
Sep. 30, 2017 |
Sep. 30, 2016 |
|||||
Numerator [Abstract] | ||||||||
Net Income from continuing operations | $ 33,551 | $ 20,388 | $ 48,652 | $ 30,238 | ||||
Interest expense, net of tax | 704 | 934 | 2,445 | 2,234 | ||||
Amortization of debt issuance costs, net of tax | 195 | 183 | 586 | 569 | ||||
Net income (loss), adjusted from continuing operations | 34,450 | 21,505 | 51,683 | 33,041 | ||||
Net Loss from discontinued operations | 0 | 952 | 0 | (15,854) | ||||
Net income (loss), adjusted | $ 34,450 | $ 22,457 | $ 51,683 | $ 17,187 | ||||
Denominator [Abstract] | ||||||||
Weighted-average number of shares-basic (in shares) | 41,222,504 | 40,465,423 | 40,989,813 | 40,071,730 | ||||
Dilutive securities-equity awards (in shares) | 1,148,857 | 878,390 | 1,003,794 | 658,367 | ||||
Dilutive securities-convertible debt | 8,096,468 | 8,096,500 | 8,096,481 | 8,096,500 | ||||
Weighted-average number of shares-diluted (in shares) | 50,467,829 | 49,440,313 | 50,090,088 | 48,826,597 | ||||
Net income (loss) per share from continuing operations-basic (in dollars per share) | $ 0.81 | $ 0.50 | $ 1.19 | $ 0.75 | ||||
Net loss per share from discontinued operations-basic (in dollars per share) | 0 | 0.02 | 0 | (0.40) | ||||
Net income (loss) per share - basic (in dollars per share) | 0.81 | 0.52 | 1.19 | 0.35 | ||||
Net income (loss) from continuing operations - diluted (in dollars per share) | 0.68 | [1] | 0.43 | [1] | 1.03 | 0.68 | ||
Net loss per share from discontinued operations-diluted (in dollars per share) | 0 | 0.02 | 0 | (0.32) | ||||
Net income (loss) per share - diluted (in dollars per share) | $ 0.68 | [1] | $ 0.45 | [1] | $ 1.03 | $ 0.36 | ||
Stock Options [Member] | ||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||||
Antidilutive shares excluded from calculation (in shares) | 400,000 | |||||||
|
Restructuring (Details) $ in Thousands |
9 Months Ended |
---|---|
Sep. 30, 2017
USD ($)
| |
Selling, General and Administrative Expenses [Member] | |
Summary of activity for liabilities [Roll Forward] | |
Abandonment of equipment charge | $ 3,700 |
EBOL Restructuring Plan [Member] | |
Restructuring Cost and Reserve [Line Items] | |
Incurred in 2017 | 40 |
Inception to Date Costs Incurred | 9,726 |
Termination Benefits [Member] | EBOL Restructuring Plan [Member] | |
Restructuring Cost and Reserve [Line Items] | |
Incurred in 2017 | 40 |
Inception to Date Costs Incurred | 5,286 |
Summary of activity for liabilities [Roll Forward] | |
Balance, beginning of period | 4,357 |
Expenses incurred | 40 |
Amount paid | (4,298) |
Balance, end of period | 99 |
Other Costs [Member] | EBOL Restructuring Plan [Member] | |
Restructuring Cost and Reserve [Line Items] | |
Incurred in 2017 | 0 |
Inception to Date Costs Incurred | 691 |
Abandonment of Equipment [Member] | EBOL Restructuring Plan [Member] | |
Restructuring Cost and Reserve [Line Items] | |
Incurred in 2017 | 0 |
Inception to Date Costs Incurred | $ 3,749 |
Subsequent events (Details) - Subsequent Event [Member] - USD ($) $ in Millions |
Oct. 06, 2017 |
Oct. 02, 2017 |
---|---|---|
Sanofi [Member] | ||
Business Acquisition [Line Items] | ||
Total value of transaction | $ 117.5 | |
Upfront cash payment | 97.5 | |
Amount of payment for manufacturing related milestones | $ 20.0 | |
Term of contract under acquisition | 10 years | |
Value of contract | $ 425.0 | |
Amount for deliveries of product to the SNS | 160.0 | |
Amount of payment for regulatory related milestones | $ 7.5 | |
GSK [Member] | ||
Business Acquisition [Line Items] | ||
Upfront cash payment | $ 76.0 | |
Amount of payment for manufacturing related milestones | 20.0 | |
Amount for deliveries of product to the SNS | $ 130.0 |
"GO\'' I!1:=2L[?^6C;V
M>AST3S28@ <"/A,PO4H@ X&\$_*KA&0@).\$=)5 !P+]*"$="*E#B/K%LJO_
MP!1;S*0X!K)_@5IFWE-TF^K]79E)NYWVF=Z 3L\>%AC'L^A@A ;,78_!(PP:
M8^XA#!YC'B ,&6.^0IADC%E>UXETO>>B,5@TM@+D0@!1# L04(!8@624 756
MI,=0BVGZ('"(! R1>#EBG,("%!2@0(Z9DV./R2YS1 DN4F?C?%B1ID7N;)V/
MPK3(,V==E@ LSK. ^CZ!N$$!,ZCG. -N/4"LY^TI;CU OF-N
M3UWK^51PWP'F.Z>G.?*Y3.<'-9J,,0T31SO R6#'SZV='B>[XY#X '8,^@?O
M)\QO5!RK5@9;KO0P94>> ^>*Z63B.UWL20^UXZ)F!V5N"WTO^LFN7RC>#5-K
M-([.Z[]02P,$% @ .V-C2V.7Z=56 @ $P@ !D !X;"]W;W)K YM4[0C#E052%;MOXL!W#/
M(G]T*L5B)]*=[ B,VS\B&D ')U[+M=] 0)FGA800J;WF,?$G99
MWH+2SG1+8V)2'&..2\!O\VV47*1KDKU"*B+VLF#+@7NL-/,0/TE. 5*/K6+0
MW.#@RV& >LI8,"'#**_&A!XMUK->:W&7@2%)& 1\L8WP;(K%6^&,B> /=R#7
M@3]A'D3K?BA*-ZD+]+XHEU28H:LW?@0N#]-C#)4-V,FU&UAATZ[+C%119=L"
M[04T2@VC/=Q/ ZQ,9Z$ &6]3T/<\11-"[B$J8M#&F@/5MT\ @U2/.@ WU-*<
MWVHEDAH0'&-8X"\@&8DS#UX-^$HW&$TAA.EQ2R9+C%@CE6
MHP..*7K56!(A;NV(D"$J!&M7U$SSI86>,R+6& *]H=L71U$MB[L _T7N.5=,YQ[>Z6_BJ.>R?E.RO3++5*]%.YRT&\6;;O *^NEO
M]0]02P,$% @ .V-C2_LII!^0 P GQ$ !D !X;"]W;W)KP?3+,HK#BW);&0B)C!3R;_(_Y!E$KTY)AP5$A-">@,U^A9XV
M=57X//5'T]Z8;2)8E_!?-*&49R^O@8O38[:
H;3N?B@:>ACX'T)6V)8:MAQH%,395(#6^
M '_7EGCH/-#CK$ORCX"B"<131OF=>2@JIF%$M&"GY.2-B>$'<99-QH#')2:-
M :0/#(T^$)GH7-%LKH786U0>'Y'3CH2 16FF>CC%WI>ML%I/+A=?0.R]3WO4
M^Z(_KP0?*4=57B')^2O%']F9$I63
8^]
M"M!5'(32-(DH94T$F.K$RY6/L2" P82643)/RA6@J!2!Y6,"$#!#T0(*_(
M:J+D'8?'F^9"OS;YF*7*E[5S6! ]"7Q>28N"8 DR4\U*.Z"HRP+;1^ZU17 R
M$:^G+!$K:Z\6):ERV?=LUA%S;PF_-)L->JREY2\.@H'EG9:W=\TH4U[+QW.&
MNFIQ9XQ.4)Y7:_A+
FHE+F%SLM;AV@J*N<',P:ZNB5I
'>+LHN
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M))5OMG'ZR$79%'WI#-48)&L