(Mark One)
|
|
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
For the quarterly period ended June 30, 2016
|
|
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 countermeasure products; |
| our ability to perform under our contracts with the U.S. government related to BioThrax, including the timing of deliveries; |
| our ability to obtain new BioThrax sales contracts or modifications to existing contracts; |
| the availability of funding for our U.S. government grants and contracts; |
| 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 or businesses that we acquire; |
| our ability to perform under our contract with the U.S. government to develop and obtain regulatory approval for the manufacturing of BioThrax in Building 55, our large-scale vaccine manufacturing facility in Lansing, Michigan; |
§ | whether the operational, marketing and strategic benefits of the spin-off of our biosciences business can be achieved and the timing of any such benefits; |
| 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 facilities and capabilities; |
| our ability and the ability of our contractors and suppliers to maintain compliance with cGMP 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 purported class action lawsuit recently 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)
|
||||||||
June 30, 2016
|
December 31, 2015
|
|||||||
ASSETS
|
(unaudited)
|
|||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
333,395
|
$
|
312,795
|
||||
Accounts receivable, net
|
66,749
|
120,767
|
||||||
Inventories
|
96,674
|
76,936
|
||||||
Income tax receivable, net
|
9,184
|
6,573
|
||||||
Prepaid expenses and other current assets
|
22,045
|
20,339
|
||||||
Total current assets
|
528,047
|
537,410
|
||||||
Property, plant and equipment, net
|
359,034
|
331,856
|
||||||
In-process research and development
|
41,800
|
42,501
|
||||||
Intangible assets, net
|
52,645
|
57,375
|
||||||
Goodwill
|
54,902
|
54,902
|
||||||
Deferred tax assets, net
|
18,192
|
11,286
|
||||||
Other assets
|
1,846
|
2,154
|
||||||
Total assets
|
$
|
1,056,466
|
$
|
1,037,484
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
58,974
|
$
|
45,966
|
||||
Accrued expenses and other current liabilities
|
2,482
|
6,229
|
||||||
Accrued compensation
|
29,778
|
34,683
|
||||||
Contingent consideration, current portion
|
2,983
|
2,553
|
||||||
Provisions for chargebacks
|
2,512
|
2,238
|
||||||
Deferred revenue, current portion
|
7,129
|
7,942
|
||||||
Total current liabilities
|
103,858
|
99,611
|
||||||
Contingent consideration, net of current portion
|
22,580
|
23,046
|
||||||
Long-term indebtedness
|
247,393
|
246,892
|
||||||
Deferred revenue, net of current portion
|
8,410
|
6,590
|
||||||
Other liabilities
|
1,553
|
1,328
|
||||||
Total liabilities
|
383,794
|
377,467
|
||||||
Stockholders' equity:
|
||||||||
Preferred stock, $0.001 par value; 15,000,000 shares authorized, 0 shares issued and outstanding at both June 30, 2016 and December 31, 2015
|
-
|
-
|
||||||
Common stock, $0.001 par value; 200,000,000 shares authorized, 40,852,511 shares issued and 40,429,681 shares outstanding at June 30, 2016; 100,000,000 shares authorized, 39,829,408 shares issued and 39,406,578 shares outstanding at December 31, 2015
|
41
|
40
|
||||||
Treasury stock, at cost, 422,830 common shares at both June 30, 2016 and December 31, 2015
|
(6,420
|
)
|
(6,420
|
)
|
||||
Additional paid-in capital
|
337,947
|
317,971
|
||||||
Accumulated other comprehensive loss
|
(3,080
|
)
|
(2,713
|
)
|
||||
Retained earnings
|
344,184
|
351,139
|
||||||
Total stockholders' equity
|
672,672
|
660,017
|
||||||
Total liabilities and stockholders' equity
|
$
|
1,056,466
|
$
|
1,037,484
|
(in thousands, except share and per share data)
|
||||||||||||||||
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
2016
|
2015
|
2016
|
2015
|
|||||||||||||
(Unaudited)
|
(Unaudited)
|
|||||||||||||||
Revenues:
|
||||||||||||||||
Product sales
|
$
|
58,546
|
$
|
82,023
|
$
|
130,252
|
$
|
100,314
|
||||||||
Contract manufacturing
|
10,156
|
8,859
|
17,743
|
21,102
|
||||||||||||
Contracts, grants and collaborations
|
32,785
|
35,230
|
64,494
|
68,329
|
||||||||||||
Total revenues
|
101,487
|
126,112
|
212,489
|
189,745
|
||||||||||||
Operating expense:
|
||||||||||||||||
Cost of product sales and contract manufacturing
|
35,612
|
27,266
|
64,115
|
46,014
|
||||||||||||
Research and development
|
35,347
|
40,941
|
69,501
|
79,643
|
||||||||||||
Selling, general and administrative
|
44,148
|
36,453
|
83,932
|
70,946
|
||||||||||||
Income (loss) from operations
|
(13,620
|
)
|
21,452
|
(5,059
|
)
|
(6,858
|
)
|
|||||||||
Other income (expense):
|
||||||||||||||||
Interest income
|
220
|
273
|
406
|
355
|
||||||||||||
Interest expense
|
(1,509
|
)
|
(1,628
|
)
|
(3,033
|
)
|
(3,288
|
)
|
||||||||
Other income, net
|
17
|
(497
|
)
|
133
|
(397
|
)
|
||||||||||
Total other expense, net
|
(1,272
|
)
|
(1,852
|
)
|
(2,494
|
)
|
(3,330
|
)
|
||||||||
Income (loss) before provision for (benefit from) income taxes
|
(14,892
|
)
|
19,600
|
(7,553
|
)
|
(10,188
|
)
|
|||||||||
Provision for (benefit from) income taxes
|
(3,945
|
)
|
5,500
|
(597
|
)
|
(2,769
|
)
|
|||||||||
Net income (loss)
|
$
|
(10,947
|
)
|
$
|
14,100
|
$
|
(6,956
|
)
|
$
|
(7,419
|
)
|
|||||
Net income (loss) per share - basic
|
$
|
(0.27
|
)
|
$
|
0.37
|
$
|
(0.17
|
)
|
$
|
(0.19
|
)
|
|||||
Net income (loss) per share - diluted (1)
|
$
|
(0.27
|
)
|
$
|
0.32
|
$
|
(0.17
|
)
|
$
|
(0.19
|
)
|
|||||
Weighted-average number of shares - basic
|
40,202,821
|
38,480,754
|
39,872,738
|
38,216,524
|
||||||||||||
Weighted-average number of shares - diluted
|
40,202,821
|
47,410,413
|
39,872,738
|
38,216,524
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||||||||||
(in thousands)
|
||||||||||||||||
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
2016
|
2015
|
2016
|
2015
|
|||||||||||||
(Unaudited)
|
(Unaudited)
|
|||||||||||||||
Net income (loss)
|
$
|
(10,947
|
)
|
$
|
14,100
|
$
|
(6,956
|
)
|
$
|
(7,419
|
)
|
|||||
Foreign currency translations, net of tax
|
1,072
|
(415
|
)
|
(367
|
)
|
(649
|
)
|
|||||||||
Comprehensive income (loss)
|
$
|
(9,875
|
)
|
$
|
13,685
|
$
|
(7,323
|
)
|
$
|
(8,068
|
)
|
(in thousands)
|
||||||||
Six Months Ended June 30,
|
||||||||
2016
|
2015
|
|||||||
Cash flows from operating activities:
|
(Unaudited)
|
|||||||
Net loss
|
$
|
(6,956
|
)
|
$
|
(7,419
|
)
|
||
Adjustments to reconcile to net cash provided by (used in) operating activities:
|
||||||||
Stock-based compensation expense
|
9,945
|
7,790
|
||||||
Depreciation and amortization
|
17,770
|
17,298
|
||||||
Income taxes
|
547
|
630
|
||||||
Change in fair value of contingent obligations
|
935
|
751
|
||||||
Impairment of long-lived assets
|
1,114
|
-
|
||||||
Excess tax benefits from stock-based compensation
|
(10,442
|
)
|
(7,241
|
)
|
||||
Other
|
775
|
153
|
||||||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable
|
53,933
|
(40,884
|
)
|
|||||
Inventories
|
(19,738
|
)
|
(19,034
|
)
|
||||
Income taxes
|
(14,556
|
)
|
(16,740
|
)
|
||||
Prepaid expenses and other assets
|
(1,713
|
)
|
2,465
|
|||||
Accounts payable
|
11,287
|
2,062
|
||||||
Accrued expenses and other liabilities
|
(3,533
|
)
|
157
|
|||||
Accrued compensation
|
(4,966
|
)
|
(5,473
|
)
|
||||
Provision for chargebacks
|
274
|
(253
|
)
|
|||||
Deferred revenue
|
1,007
|
2,368
|
||||||
Net cash provided by (used in) operating activities
|
35,683
|
(63,370
|
)
|
|||||
Cash flows from investing activities:
|
||||||||
Purchases of property, plant and equipment
|
(39,246
|
)
|
(19,681
|
)
|
||||
Net cash used in investing activities
|
(39,246
|
)
|
(19,681
|
)
|
||||
Cash flows from financing activities:
|
||||||||
Proceeds from long-term debt obligations
|
-
|
2,000
|
||||||
Issuance of common stock upon exercise of stock options
|
14,524
|
13,162
|
||||||
Excess tax benefits from stock-based compensation
|
10,442
|
7,241
|
||||||
Contingent obligation payments
|
(971
|
)
|
(5,002
|
)
|
||||
Net cash provided by financing activities
|
23,995
|
17,401
|
||||||
Effect of exchange rate changes on cash and cash equivalents
|
168
|
(8
|
)
|
|||||
Net increase (decrease) in cash and cash equivalents
|
20,600
|
(65,658
|
)
|
|||||
Cash and cash equivalents at beginning of period
|
312,795
|
280,499
|
||||||
Cash and cash equivalents at end of period
|
$
|
333,395
|
$
|
214,841
|
June 30, 2016
|
||||||||||||||||
(in thousands)
|
Level 1
|
Level 2
|
Level 3
|
Total
|
||||||||||||
Assets:
|
||||||||||||||||
Investment in money market funds (1)
|
$
|
92
|
$
|
-
|
$
|
-
|
$
|
92
|
||||||||
Total assets
|
$
|
92
|
$
|
-
|
$
|
-
|
$
|
92
|
||||||||
Liabilities:
|
||||||||||||||||
Contingent consideration
|
$
|
-
|
$
|
-
|
$
|
25,563
|
$
|
25,563
|
||||||||
Total liabilities
|
$
|
-
|
$
|
-
|
$
|
25,563
|
$
|
25,563
|
||||||||
December 31, 2015
|
||||||||||||||||
(in thousands)
|
Level 1
|
Level 2
|
Level 3
|
Total
|
||||||||||||
Assets:
|
||||||||||||||||
Investment in money market funds (1)
|
$
|
3,323
|
$
|
-
|
$
|
-
|
$
|
3,323
|
||||||||
Total assets
|
$
|
3,323
|
$
|
-
|
$
|
-
|
$
|
3,323
|
||||||||
Liabilities:
|
||||||||||||||||
Contingent consideration
|
$
|
-
|
$
|
-
|
$
|
25,599
|
$
|
25,599
|
||||||||
Total liabilities
|
$
|
-
|
$
|
-
|
$
|
25,599
|
$
|
25,599
|
(in thousands)
|
||||
Balance at December 31, 2015
|
$
|
25,599
|
||
Expense included in earnings
|
935
|
|||
Settlements
|
(971
|
)
|
||
Purchases, sales and issuances
|
-
|
|||
Transfers in/(out) of Level 3
|
-
|
|||
Balance at June 30, 2016
|
$
|
25,563
|
June 30,
|
December 31,
|
|||||||
(in thousands)
|
2016
|
2015
|
||||||
Raw materials and supplies
|
$
|
27,875
|
$
|
23,099
|
||||
Work-in-process
|
41,281
|
37,209
|
||||||
Finished goods
|
27,518
|
16,628
|
||||||
Total inventories
|
$
|
96,674
|
$
|
76,936
|
June 30,
|
December 31,
|
|||||||
(in thousands)
|
2016
|
2015
|
||||||
Land and improvements
|
$
|
17,208
|
$
|
16,520
|
||||
Buildings, building improvements and leasehold improvements
|
142,687
|
111,060
|
||||||
Furniture and equipment
|
201,455
|
136,528
|
||||||
Software
|
56,716
|
39,784
|
||||||
Construction-in-progress
|
51,097
|
127,489
|
||||||
Property, plant and equipment, gross
|
469,163
|
431,381
|
||||||
Less: Accumulated depreciation and amortization
|
(110,129
|
)
|
(99,525
|
)
|
||||
Total property, plant and equipment, net
|
$
|
359,034
|
$
|
331,856
|
Biodefense
|
Aptevo
|
|||||||||||
(in thousands)
|
Segment
|
Segment
|
Total
|
|||||||||
Cost basis
|
||||||||||||
Balance at December 31, 2015
|
$
|
55,790
|
$
|
20,809
|
$
|
76,599
|
||||||
Additions
|
-
|
-
|
-
|
|||||||||
Balance at June 30, 2016
|
$
|
55,790
|
$
|
20,809
|
$
|
76,599
|
||||||
Accumulated amortization
|
||||||||||||
Balance at December 31, 2015
|
$
|
(15,857
|
)
|
$
|
(3,368
|
)
|
$
|
(19,225
|
)
|
|||
Amortization
|
(3,557
|
)
|
(1,172
|
)
|
(4,729
|
)
|
||||||
Balance at June 30, 2016
|
$
|
(19,414
|
)
|
$
|
(4,540
|
)
|
$
|
(23,954
|
)
|
|||
Net balance at June 30, 2016
|
$
|
36,376
|
$
|
16,269
|
$
|
52,645
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
(in thousands)
|
2016
|
2015
|
2016
|
2015
|
||||||||||||
Biodefense segment
|
$
|
1,778
|
$
|
2,014
|
$
|
3,557
|
$
|
3,777
|
||||||||
Aptevo segment
|
587
|
378
|
1,172
|
757
|
||||||||||||
Total amortization expense
|
$
|
2,365
|
$
|
2,392
|
$
|
4,729
|
$
|
4,534
|
2006 Plan
|
2004 Plan
|
|||||||||||||||||||
Number of Shares
|
Weighted-Average Exercise Price
|
Number of Shares
|
Weighted-Average Exercise Price
|
Aggregate Intrinsic Value
|
||||||||||||||||
Outstanding at December 31, 2015
|
2,964,237
|
$
|
22.73
|
29,699
|
$
|
10.28
|
$
|
52,119,607
|
||||||||||||
Granted
|
391,158
|
$
|
33.83
|
-
|
$
|
-
|
||||||||||||||
Exercised
|
(700,605
|
)
|
$
|
19.32
|
(29,699
|
)
|
$
|
10.28
|
||||||||||||
Forfeited
|
(24,467
|
)
|
$
|
26.76
|
-
|
$
|
-
|
|||||||||||||
Outstanding at June 30, 2016
|
2,630,323
|
$
|
25.25
|
-
|
$
|
-
|
$
|
10,318,273
|
||||||||||||
Exercisable at June 30, 2016
|
1,479,516
|
$
|
21.55
|
-
|
$
|
-
|
$
|
9,850,228
|
Number of Shares
|
Weighted-Average Grant Price
|
Aggregate Intrinsic Value
|
||||||||||
Outstanding at December 31, 2015
|
889,004
|
$
|
26.86
|
$
|
35,569,048
|
|||||||
Granted
|
470,911
|
$
|
34.53
|
|||||||||
Vested
|
(404,585
|
)
|
$
|
24.77
|
||||||||
Forfeited
|
(26,103
|
)
|
$
|
30.95
|
||||||||
Outstanding at June 30, 2016
|
929,227
|
$
|
31.53
|
$
|
26,129,863
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
(in thousands, except share and per share data)
|
2016
|
2015
|
2016
|
2015
|
||||||||||||
Numerator:
|
||||||||||||||||
Net income (loss)
|
$
|
(10,947
|
)
|
$
|
14,100
|
$
|
(6,956
|
)
|
$
|
(7,419
|
)
|
|||||
Interest expense, net of tax
|
-
|
809
|
-
|
-
|
||||||||||||
Amortization of debt issuance costs, net of tax
|
-
|
219
|
-
|
-
|
||||||||||||
Net income (loss), adjusted
|
$
|
(10,947
|
)
|
$
|
15,128
|
$
|
(6,956
|
)
|
$
|
(7,419
|
)
|
|||||
Denominator:
|
||||||||||||||||
Weighted-average number of shares—basic
|
40,202,821
|
38,480,754
|
39,872,738
|
38,216,524
|
||||||||||||
Dilutive securities—equity awards
|
-
|
1,209,134
|
-
|
-
|
||||||||||||
Dilutive securities—convertible debt
|
-
|
7,720,525
|
-
|
-
|
||||||||||||
Weighted-average number of shares—diluted
|
40,202,821
|
47,410,413
|
39,872,738
|
38,216,524
|
||||||||||||
Net income (loss) per share-basic
|
$
|
(0.27
|
)
|
$
|
0.37
|
$
|
(0.17
|
)
|
$
|
(0.19
|
)
|
|||||
Net income (loss) per share-diluted
|
$
|
(0.27
|
)
|
$
|
0.32
|
$
|
(0.17
|
)
|
$
|
(0.19
|
)
|
Reportable Segments
|
||||||||||||
(in thousands)
|
Biodefense
|
Aptevo
|
Total
|
|||||||||
Three Months Ended June 30, 2016
|
||||||||||||
External revenue
|
$
|
91,254
|
$
|
10,233
|
$
|
101,487
|
||||||
Intersegment revenue (expense)
|
1,844
|
(1,844
|
)
|
-
|
||||||||
Income (loss) from operations
|
(1,323
|
)
|
(12,297
|
)
|
(13,620
|
)
|
||||||
Three Months Ended June 30, 2015
|
||||||||||||
External revenue
|
$
|
119,022
|
$
|
7,090
|
$
|
126,112
|
||||||
Intersegment revenue (expense)
|
2,130
|
(2,130
|
)
|
-
|
||||||||
Income (loss) from operations
|
41,694
|
(20,242
|
)
|
21,452
|
||||||||
Six Months Ended June 30, 2016
|
||||||||||||
External revenue
|
$
|
194,223
|
$
|
18,266
|
$
|
212,489
|
||||||
Intersegment revenue (expense)
|
2,418
|
(2,418
|
)
|
-
|
||||||||
Income (loss) from operations
|
21,693
|
(26,752
|
)
|
(5,059
|
)
|
|||||||
Total assets
|
945,058
|
111,408
|
1,056,466
|
|||||||||
Six Months Ended June 30, 2015
|
||||||||||||
External revenue
|
$
|
171,169
|
$
|
18,576
|
$
|
189,745
|
||||||
Intersegment revenue (expense)
|
2,234
|
(2,234
|
)
|
-
|
||||||||
Income (loss) from operations
|
23,198
|
(30,056
|
)
|
(6,858
|
)
|
|||||||
Total assets
|
820,503
|
122,820
|
943,323
|
| 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; |
| 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 for the treatment of botulinum disease; |
| VIGIV (Vaccinia Immune Globulin Intravenous (Human)), the only therapeutic licensed by the FDA to address adverse events from smallpox vaccination; and |
| RSDL ® (Reactive Skin Decontamination Lotion Kit), the only device cleared by the FDA for the removal or neutralization of chemical agents, T-2 toxin and many pesticide-related chemicals from the skin. |
| 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 ; |
| VAX161C, a recombinant pandemic influenza vaccine candidate being developed by VaxInnate, Inc. and for which we have an exclusive license agreement to manufacture and sell in the event of a surge order from the Biomedical Advanced Research and Development Authority, or BARDA; and |
| Other Biodefense product candidates focused on public health threats and emerging infectious diseases. |
| WinRho ® SDF [Rh o (D) Immune Globulin Intravenous (Human)], for treatment of autoimmune platelet disorder, also called immune thrombocytopenic purpura or ITP, and, separately, for the treatment of hemolytic disease of the newborn, or HDN; |
| HepaGam B ® [Hepatitis B Immune Globulin Intravenous (Human)], for post-exposure prophylactic treatment of hepatitis-B; and for prevention of hepatitis-B recurrence following liver transplantation in HBsAg-positive liver transplant patients, and for post-exposure prophylactic treatment of hepatitis-B; |
| VARIZIG ® [Varicella Zoster Immune Globulin (Human)], for post-exposure prophylactic treatment of varicella zoster virus, which causes chickenpox, in high risk individuals; and |
| IXINITY ® [coagulation factor IX (recombinant)], indicated in adults and children 12 years of age and older with hemophilia B for control and prevention of bleeding episodes, and for perioperative management. |
| MOR209/ES414, a protein therapeutic being developed for metastatic castration-resistant prostate cancer under Aptevo's collaboration with MorphoSys AG; |
| ES210, a protein therapeutic being developed for Ulcerative Colitis and other autoimmune and inflammatory diseases; |
| otlertuzumab, a protein therapeutic being developed for Chronic Lymphocytic Leukemia; |
| 5E3, a monoclonal antibody therapeutic being developed for Alzheimer's disease; and |
| Other protein therapeutic product candidates primarily targeting immuno-oncology. |
| personnel-related expenses; |
| fees to professional service providers for, among other things, analytical testing, independent monitoring or other administration of our clinical trials and obtaining and evaluating data from our clinical trials and non-clinical studies; |
| costs of contract manufacturing services for clinical trial material; and |
| costs of materials used in clinical trials and research and development. |
|
Three Months Ended June 30,
|
|||||||||||||||
(in thousands)
|
2016
|
2015
|
Change
|
% Change
|
||||||||||||
Product sales:
|
||||||||||||||||
BioThrax
|
$
|
40,038
|
$
|
72,236
|
$
|
(32,198
|
)
|
(45
|
%)
|
|||||||
Other Biodefense
|
8,309
|
2,845
|
5,464
|
192
|
%
|
|||||||||||
Total Biodefense
|
48,347
|
75,081
|
(26,734
|
)
|
(36
|
%)
|
||||||||||
Aptevo products
|
10,199
|
6,942
|
3,257
|
47
|
%
|
|||||||||||
Total product sales
|
58,546
|
82,023
|
(23,477
|
)
|
(29
|
%)
|
||||||||||
Contract manufacturing
|
10,156
|
8,859
|
1,297
|
15
|
%
|
|||||||||||
Contracts, grants and collaborations
|
32,785
|
35,230
|
(2,445
|
)
|
(7
|
%)
|
||||||||||
Total revenues
|
$
|
101,487
|
$
|
126,112
|
$
|
(24,625
|
)
|
(20
|
%)
|
| decreased development funding of $16.1 million for Anthrasil related to plasma collection; |
§ | decreased development funding of $5.0 million for PreviThrax due to reduced interest by the U.S. government for the product candidate; |
| increased development funding of $10.9 million related to our CIADM program, including $4.7 million from new CIADM task orders, and |
§ | increased development funding of $6.9 million for VIGIV related to plasma collection. |
Three Months Ended
|
||||||||||||||||
June 30,
|
||||||||||||||||
(in thousands)
|
2016
|
2015
|
Change
|
% Change
|
||||||||||||
Biodefense:
|
||||||||||||||||
Large-scale manufacturing for BioThrax
|
$
|
998
|
$
|
2,201
|
$
|
(1,203
|
)
|
(55
|
%)
|
|||||||
BioThrax related programs
|
898
|
592
|
306
|
52
|
%
|
|||||||||||
PreviThrax
|
176
|
2,036
|
(1,860
|
)
|
(91
|
%)
|
||||||||||
NuThrax
|
5,280
|
2,505
|
2,775
|
111
|
%
|
|||||||||||
Pandemic influenza
|
146
|
109
|
37
|
34
|
%
|
|||||||||||
Anthrasil
|
166
|
10,993
|
(10,827
|
)
|
(98
|
%)
|
||||||||||
Botulinum antitoxin
|
1,095
|
2,260
|
(1,165
|
)
|
(52
|
%)
|
||||||||||
EV-035 series of molecules
|
839
|
955
|
(116
|
)
|
(12
|
%)
|
||||||||||
CIADM task orders
|
4,877
|
-
|
4,877
|
N/A
|
||||||||||||
VIGIV
|
3,368
|
421
|
2,947
|
700
|
%
|
|||||||||||
Emergard
|
2,498
|
791
|
1,707
|
216
|
%
|
|||||||||||
Other Biodefense
|
6,074
|
6,673
|
(599
|
)
|
(9
|
%)
|
||||||||||
Total Biodefense
|
26,415
|
29,536
|
(3,121
|
)
|
(11
|
%)
|
||||||||||
Aptevo:
|
||||||||||||||||
MOR209/ES414
|
1,677
|
1,893
|
(216
|
)
|
(11
|
%)
|
||||||||||
IXINITY
|
881
|
5,242
|
(4,361
|
)
|
(83
|
%)
|
||||||||||
otlertuzumab
|
928
|
799
|
129
|
16
|
%
|
|||||||||||
5E3 (formerly Alzheimer's)
|
120
|
585
|
(465
|
)
|
(79
|
%)
|
||||||||||
Other ADAPTIR related programs
|
3,886
|
1,934
|
1,952
|
101
|
%
|
|||||||||||
Other Aptevo
|
1,440
|
952
|
488
|
51
|
%
|
|||||||||||
Total Aptevo
|
8,932
|
11,405
|
(2,473
|
)
|
(22
|
%)
|
||||||||||
Total
|
$
|
35,347
|
$
|
40,941
|
$
|
(5,594
|
)
|
(14
|
%)
|
|
Three Months Ended June 30,
|
|||||||||||||||
(in thousands)
|
2016
|
2015
|
Change
|
% Change
|
||||||||||||
Biodefense
|
$
|
35,626
|
$
|
25,969
|
$
|
9,657
|
37
|
%
|
||||||||
Aptevo
|
8,522
|
10,484
|
(1,962
|
)
|
(19
|
%)
|
||||||||||
Total selling, general and administrative expenses
|
$
|
44,148
|
$
|
36,453
|
$
|
7,695
|
21
|
%
|
|
Six Months Ended June 30,
|
|||||||||||||||
(in thousands)
|
2016
|
2015
|
Change
|
% Change
|
||||||||||||
Product sales:
|
||||||||||||||||
BioThrax
|
$
|
99,139
|
$
|
72,241
|
$
|
26,898
|
37
|
%
|
||||||||
Other Biodefense
|
12,966
|
14,810
|
(1,844
|
)
|
(12
|
%)
|
||||||||||
Total Biodefense
|
112,105
|
87,051
|
25,054
|
29
|
%
|
|||||||||||
Aptevo products
|
18,147
|
13,263
|
4,884
|
37
|
%
|
|||||||||||
Total product sales
|
130,252
|
100,314
|
29,938
|
30
|
%
|
|||||||||||
Contract manufacturing
|
17,743
|
21,102
|
(3,359
|
)
|
(16
|
%)
|
||||||||||
Contracts, grants and collaborations
|
64,494
|
68,329
|
(3,835
|
)
|
(6
|
%)
|
||||||||||
Total revenues
|
$
|
212,489
|
$
|
189,745
|
$
|
22,744
|
12
|
%
|
§ | decreased development funding of $31.2 million for Anthrasil related to the timing of plasma collection during 2015; |
§ | decreased development funding of $5.6 million for PreviThrax due to reduced interest by the U.S. government for the product candidate; |
§ | increased development funding of $18.6 million related to our CIADM program, including $8.0 million from new CIADM task orders; and |
§ | increased development funding of $15.5 million for VIGIV related to plasma collection. |
Six Months Ended
|
||||||||||||||||
June 30,
|
||||||||||||||||
(in thousands)
|
2016
|
2015
|
Change
|
% Change
|
||||||||||||
Biodefense:
|
||||||||||||||||
Large-scale manufacturing for BioThrax
|
$
|
3,379
|
$
|
4,949
|
$
|
(1,570
|
)
|
(32
|
%)
|
|||||||
BioThrax related programs
|
1,690
|
1,283
|
407
|
32
|
%
|
|||||||||||
PreviThrax
|
1,076
|
3,801
|
(2,725
|
)
|
(72
|
%)
|
||||||||||
NuThrax
|
9,666
|
5,334
|
4,332
|
81
|
%
|
|||||||||||
Pandemic influenza
|
887
|
1,226
|
(339
|
)
|
(28
|
%)
|
||||||||||
Anthrasil
|
448
|
21,607
|
(21,159
|
)
|
(98
|
%)
|
||||||||||
Botulinum antitoxin
|
2,151
|
3,699
|
(1,548
|
)
|
(42
|
%)
|
||||||||||
EV-035 series of molecules
|
1,641
|
1,719
|
(78
|
)
|
(5
|
%)
|
||||||||||
CIADM task orders
|
7,700
|
-
|
7,700
|
N/A
|
||||||||||||
VIGIV
|
5,955
|
722
|
5,233
|
725
|
%
|
|||||||||||
Emergard
|
5,170
|
1,199
|
3,971
|
331
|
%
|
|||||||||||
Other Biodefense
|
12,385
|
12,622
|
(237
|
)
|
(2
|
%)
|
||||||||||
Total Biodefense
|
52,148
|
58,161
|
(6,013
|
)
|
(10
|
%)
|
||||||||||
Aptevo:
|
||||||||||||||||
MOR209/ES414
|
3,474
|
2,552
|
922
|
36
|
%
|
|||||||||||
IXINITY
|
3,106
|
10,603
|
(7,497
|
)
|
(71
|
%)
|
||||||||||
otlertuzumab
|
1,450
|
1,994
|
(544
|
)
|
(27
|
%)
|
||||||||||
5E3 (formerly Alzheimer's)
|
480
|
1,145
|
(665
|
)
|
(58
|
%)
|
||||||||||
Other ADAPTIR related programs
|
6,957
|
3,733
|
3,224
|
86
|
%
|
|||||||||||
Other Aptevo
|
1,886
|
1,455
|
431
|
30
|
%
|
|||||||||||
Total Aptevo
|
17,353
|
21,482
|
(4,129
|
)
|
(19
|
%)
|
||||||||||
Total
|
$
|
69,501
|
$
|
79,643
|
$
|
(10,142
|
)
|
(13
|
%)
|
|
Six Months Ended June 30,
|
|||||||||||||||
(in thousands)
|
2016
|
2015
|
Change
|
% Change
|
||||||||||||
Biodefense
|
$
|
65,712
|
$
|
51,579
|
$
|
14,133
|
27
|
%
|
||||||||
Aptevo
|
18,220
|
19,367
|
(1,147
|
)
|
(6
|
%)
|
||||||||||
Total selling, general and administrative expenses
|
$
|
83,932
|
$
|
70,946
|
$
|
12,986
|
18
|
%
|
|
Six Months Ended
|
|||||||
June 30,
|
||||||||
(in thousands)
|
2016
|
2015
|
||||||
Net cash provided by (used in):
|
||||||||
Operating activities(i)
|
$
|
35,851
|
$
|
(63,378
|
)
|
|||
Investing activities
|
(39,246
|
)
|
(19,681
|
)
|
||||
Financing activities
|
23,995
|
17,401
|
||||||
Net increase (decrease) in cash and cash equivalents
|
$
|
20,600
|
$
|
(65,658
|
)
|
| 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; |
§ | to 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 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 possibility that we may be ineligible to respond to a request for proposal issued by the government; |
| 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 would 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 ITAR (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 or the imposition of civil or criminal penalties. |
§ | damage to or destruction of the facility; or |
§ | product contamination or tampering. |
| successful development, formulation and cGMP scale-up of manufacturing that meets FDA 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 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. |
| 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; |
| 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. |
| 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 government entities for our development programs; 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; |
| limitations on the removal and appointment of the chairman of our Board of Directors; |
| 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 biodefense 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; |
§ | announcements relating to 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
|
Contribution Agreement, dated July 29, 2016, by and among Emergent BioSolutions Inc., Aptevo Therapeutics Inc., Aptevo Research and Development LLC and Aptevo BioTherapeutics LLC (incorporated by reference to Exhibit 2.1 to the Company's Current Report on Form 8-K, filed on August 4, 2016).
|
2.2
|
Separation and Distribution Agreement, dated July 29, 2016, by and between Emergent BioSolutions Inc. and Aptevo Therapeutics Inc. (incorporated by reference to Exhibit 2.2 to the Company's Current Report on Form 8-K, filed on August 4, 2016).
|
3#
|
Third Restated Certificate of Incorporation of the Company.
|
10.2#
|
Fourth Amended and Restated Emergent BioSolutions Inc. 2006 Stock Incentive Plan.
|
10.3#
|
Consulting Agreement, dated as of May 18, 2016, by and between the Company and John E. Niederhuber, M.D.
|
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
|
|||||||||||||||||||||||
|
June 30,
|
Year Ended December 31,
|
|||||||||||||||||||||
(in thousands)
|
2016
|
2015
|
2014
|
2013
|
2012
|
2011
|
|||||||||||||||||
|
|||||||||||||||||||||||
Pretax income (loss) from continuing operations (1)
|
$
|
(7,553)
|
|
$
|
89,769
|
$
|
53,062
|
$
|
44,243
|
$
|
37,446
|
$
|
38,849
|
||||||||||
Fixed charges
|
|||||||||||||||||||||||
Interest expense
|
3,860
|
7,834
|
7,480
|
1,973
|
2,177
|
1,719
|
|||||||||||||||||
Debt issuance cost
|
763
|
1,564
|
3,290
|
319
|
67
|
135
|
|||||||||||||||||
Total fixed charges (2)
|
4,623
|
9,398
|
10,770
|
2,292
|
2,244
|
1,854
|
|||||||||||||||||
Noncontrolling interest in pretax income (3)
|
-
|
-
|
-
|
876
|
5,381
|
6,906
|
|||||||||||||||||
Capitalized interest (4)
|
1,590
|
2,875
|
2,530
|
1,973
|
2,177
|
1,713
|
|||||||||||||||||
Earnings ((1) + (2) -(3) -(4))
|
(4,520)
|
|
96,292
|
61,302
|
43,686
|
32,132
|
32,084
|
||||||||||||||||
Fixed charges
|
4,623
|
9,398
|
10,770
|
2,292
|
2,244
|
1,854
|
|||||||||||||||||
Ratio of earnings to fixed charges
|
-
|
10.2
|
5.7
|
19.1
|
14.3
|
17.3
|
|||||||||||||||||
Coverage deficiency | (7,553) | - | - | - | - | - |
(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.
|
A
|
COMMON STOCK
.
|
B
|
PREFERRED STOCK
.
|
Title: | President and Chief Executive Officer |
1.
|
Purpose
|
2.
|
Eligibility
|
3.
|
Administration and Delegation
|
4.
|
Stock Available for Awards
.
|
5.
|
Stock Options
|
6.
|
Stock Appreciation Rights
|
7.
|
Restricted Stock; Restricted Stock Units
|
8.
|
Other Stock-Unit Awards
|
9.
|
Adjustments for Changes in Common Stock and Certain Other Events
|
10.
|
General Provisions Applicable to Awards
|
11.
|
Miscellaneous
|
EMERGENT BIOSOLUTIONS INC.
By:
/s/ Daniel J. Abdun-Nabi
Name: Daniel J. Abdun-Nabi
Title: President and Chief Executive Officer
Date:
17 May 2016
|
JOHN E. NIEDERHUBER, M.D.
/s/ John E. Niederhuber, M.D.
Date:
May 12, 2016
|
1.
|
Description of Services
: To provide evaluative services, expert advice and guidance, general strategy recommendations, and other similar assistance regarding industry products, technology platforms, and research and development programs as may be reasonably requested from time to time by the Scientific Review Committee of the Emergent Board of Directors.
|
2. | Period of Performance : Effective Date – Termination Date (as defined in Section 9 of the Agreement) |
4. | Reports : Consultant shall provide Emergent with such reports as may be requested by Emergent or its representative(s) from time to time. |
Ø
|
Fees: $2,000 per calendar quarter.
|
Ø
|
Equity Compensation:
|
o
|
Consultant will be granted 2,000 Restricted Stock Units ("RSUs") under the Third Amended and Restated Emergent BioSolutions Inc. 2006 Stock Incentive Plan on the Effective Date;
|
o
|
Consultant will be granted 2,000 additional RSUs on the first anniversary of the Effective Date; and
|
o
|
All RSUs shall vest on the first anniversary of the date of grant.
|
Ø
|
Maximum Compensation: $2,000 per calendar quarter, provided that the reimbursement of reasonable and customary business expenses shall be excluded from this maximum compensation amount.
|
Ø
|
Expenses: Reimbursable in accordance with the terms of the Agreement
|
6. | Invoicing and Payment : Invoices shall be sent and payments made in accordance with the terms of the Agreement, and the following shall apply: |
Ø
|
Manner/Location for Payments: First-class mail to primary business address
|
Ø
|
Accounting Codes (Must be noted on invoices for payment to be processed):
|
Ø
|
Emergent Address for Invoices:
Emergent BioSolutions Inc.
|
EMERGENT BIOSOLUTIONS INC.
By:
/s/ Daniel J. Abdun-Nabi
Name: Daniel J. Abdun-Nabi
Title: President and Chief Executive Officer
Date:
17 May 2016
|
JOHN E. NIEDERHUBER, M.D.
/s/ John E. Niederhuber, M.D.
Date:
May 12, 2016
|