|
DELAWARE
|
001-33137
|
14-1902018
|
||
|
(State or other jurisdiction
|
(Commission File Number)
|
(IRS Employer
|
||
|
of incorporation)
|
Identification No.)
|
|
Exhibit No.
|
Description
|
|
|
|
Press release issued by the company on February 22, 2018.
|
|
EMERGENT BIOSOLUTIONS INC.
|
||
|
|
|
|
|
Dated: February 22, 2018
|
By:
|
/s/ ROBERT G. KRAMER, SR.
|
|
Name: Robert G. Kramer, Sr.
Title: Executive Vice President, Administration, and Chief Financial Officer
|
||
|
-
|
Reaffirms full year 2018 forecast and 2020 goals
|
|
-
|
Revises 1Q 2018 forecast
|
|
(in millions)
|
4Q 2017
(unaudited)
|
4Q 2016 (1)
(unaudited)
|
||||||
|
Total Revenues
|
$
|
193.8
|
$
|
151.7
|
||||
|
Net Income
|
$
|
33.9
|
$
|
32.3
|
||||
|
Adjusted Net Income (2)
|
$
|
37.8
|
$
|
36.6
|
||||
|
EBITDA (1)
|
$
|
65.2
|
$
|
61.3
|
||||
|
(in millions)
|
Full Year 2017
(unaudited)
|
Full Year 2016 (1)
|
||||||
|
Total Revenues
|
$
|
560.9
|
$
|
488.8
|
||||
|
Net Income
|
$
|
82.6
|
$
|
62.5
|
||||
|
Adjusted Net Income (2)
|
$
|
95.7
|
$
|
77.5
|
||||
|
EBITDA (1)
|
$
|
166.0
|
$
|
141.7
|
||||
|
(1)
|
Financial results for 4Q 2016 and Full Year 2016 are presented on a continuing operations basis.
|
|
(2)
|
See "Reconciliation of Net Income to Adjusted Net Income and EBITDA" for a definition of terms and a reconciliation table.
|
|
·
|
Completed the acquisition of Sanofi's ACAM2000® business, including ACAM2000 (Smallpox (Vaccinia) Vaccine, Live), the only smallpox vaccine licensed by the U.S. Food and Drug Administration (FDA), related manufacturing facilities and employees, and an existing 10-year, $425 million contract with the Centers for Disease Control and Prevention (CDC) with a remaining value at acquisition of up to approximately $160 million for deliveries of ACAM2000 to the Strategic National Stockpile (SNS)
|
|
·
|
Completed the acquisition of Raxibacumab, an FDA-approved anthrax monoclonal antibody, from GSK and assumed responsibility for a multi-year contract with the Biomedical Advanced Research and Development Authority (BARDA), with a remaining value at acquisition of up to approximately $130 million, to supply Raxibacumab to the SNS
|
|
·
|
Awarded a contract valued at up to approximately $25 million by the U.S. Department of State to supply Trobigard™(3) (Atropine Sulfate [2mg]/Obidoxime Chloride [220mg]) auto-injector, a drug and device combination product for emergency use outside of the U.S. in the event of nerve agent or organophosphate poisoning
|
|
·
|
Awarded a contract by the Department of National Defence, valued at approximately $8 million, to deliver Anthrasil® (Anthrax Immune Globulin Intravenous [human]) to the Canadian government
|
|
·
|
Converted approximately $239.4 million, or 95.8%, of the $250 million 2.875% Convertible Senior Notes due 2021 (the Notes) for approximately 8.5 million shares of the company's common stock by holders of the Notes.
|
|
·
|
Repurchased 788,894 shares of its common stock in the fourth quarter of 2017 under a board-approved share repurchase program
|
|
Three Months Ended
December 31,
|
||||||||||||
|
(in millions)
(unaudited)
|
2017
|
2016
|
% Change
|
|||||||||
|
Product Sales
|
||||||||||||
|
BioThrax®
|
$
|
107.0
|
$
|
43.8
|
145
|
%
|
||||||
|
Other
|
54.6
|
43.7
|
25
|
%
|
||||||||
|
Total Product Sales
|
$
|
161.6
|
$
|
87.5
|
85
|
%
|
||||||
|
Three Months Ended
December 31,
|
||||||||||||
|
(in millions)
(unaudited)
|
2017
|
2016
|
% Change
|
|||||||||
|
Research and Development Expenses
|
$
|
28.5
|
$
|
27.1
|
5
|
%
|
||||||
|
Adjustments:
|
||||||||||||
|
- Contracts and grants revenue
|
$
|
15.9
|
$
|
47.5
|
(66
|
%)
|
||||||
|
Net Research and Development Expenses (Income)
|
$
|
12.6
|
$
|
(20.4
|
)
|
--
|
||||||
|
Three Months Ended
December 31,
|
||||||||
|
(in millions, except per share value)
(unaudited)
|
2017
|
2016
|
||||||
|
Net Income
|
$
|
33.9
|
$
|
32.3
|
||||
|
Adjustments:
|
||||||||
|
+ Interest expense, net of tax
|
0.2
|
0.9
|
||||||
|
+ Amortization of debt issuance costs, net of tax
|
0.1
|
0.2
|
||||||
|
Net Income, adjusted ("if converted")
Net Income Per Diluted Share, adjusted ("if converted")
|
$
|
34.2
0.67
|
$
|
33.4
0.67
|
||||
|
Weighted Average Diluted Shares
|
51.0
|
49.6
|
||||||
|
Twelve Months Ended
December 31,
|
||||||||||||
|
(in millions)
|
2017
(unaudited)
|
2016
|
% Change
|
|||||||||
|
Product Sales
|
||||||||||||
|
BioThrax®
|
$
|
286.6
|
$
|
237.0
|
21
|
%
|
||||||
|
Other
|
$
|
134.9
|
$
|
59.3
|
128
|
%
|
||||||
|
Total Product Sales
|
$
|
421.5
|
$
|
296.3
|
42
|
%
|
||||||
|
Twelve Months Ended
December 31,
|
||||||||||||
|
(in millions)
|
2017
(unaudited)
|
2016
|
% Change
|
|||||||||
|
Research and Development Expenses
|
$
|
97.4
|
$
|
108.3
|
(10
|
%)
|
||||||
|
Adjustments:
|
||||||||||||
|
- Contracts and grants revenue
|
$
|
70.4
|
$
|
143.4
|
(51
|
%)
|
||||||
|
Net Research and Development Expenses (Income)
|
$
|
27.0
|
$
|
(35.1
|
)
|
--
|
||||||
|
Twelve Months Ended
December 31,
|
||||||||
|
(in millions, except per share value)
|
2017
(unaudited)
|
2016
|
||||||
|
Net Income
|
$
|
82.6
|
$
|
62.5
|
||||
|
Adjustments:
|
||||||||
|
+ Interest expense, net of tax
|
2.6
|
3.3
|
||||||
|
+ Amortization of debt issuance costs, net of tax
|
0.7
|
0.8
|
||||||
|
Net Income, adjusted ("if converted")
Net Income Per Diluted Share, adjusted ("if converted")
|
$
|
85.9
1.71
|
$
|
66.6
1.35
|
||||
|
Weighted Average Diluted Shares
|
50.3
|
49.3
|
||||||
|
·
|
Total revenue of $715 to $755 million
|
|
·
|
Pre-Tax income of $120 to $140 million
|
|
·
|
Net income of $95 to $110 million
|
|
·
|
Adjusted net income of $110 to $125 million (2)
|
|
·
|
EBITDA of $175 to $190 million (2)
|
| (2) |
See "Reconciliation of Net Income to Adjusted Net Income and EBITDA" for a definition of terms and a reconciliation table.
|
|
·
|
Advance NuThrax development to enable Emergency Use Authorization filing with the FDA in 2018
|
|
·
|
Complete ACAM2000 deliveries; establish a multi-year follow-on contract with the U.S. government
|
|
·
|
Deliver Raxibacumab doses under current contract; advance tech transfer to the company's CIADM Bayview facility in Baltimore, Maryland
|
|
·
|
Progress pipeline to have at least four product candidates in advanced development
|
|
·
|
Complete an acquisition that generates revenue within 12 months of closing
|
|
·
|
Total revenue of $125 to $150 million; previous forecast was $145 to $160 million; the revision primarily reflects the timing of deliveries of BioThrax
|
|
·
|
Total Revenue: $1 billion
|
|
·
|
Revenue Mix: at least 10% of total revenue from ex-US customers
|
|
·
|
Expense Discipline: Net R&D <15% of net revenue (4); SG&A <25% of total revenue
|
|
·
|
Net Income: at least 14% of total revenue
|
|
·
|
Product Development Pipeline: Six products in clinical or advanced development (with at least three dual-market opportunities)
|
|
Live Teleconference Information:
Dial in number: (855) 766-6521
International dial in: (262) 912-6157
Conference ID: 93325042
|
|
Live Webcast Information:
Visit edge.media-server.com/m6/p/qhvnyd93 for the live webcast feed.
|
|
Investor Contact
Robert Burrows
Vice President, Investor Relations
(o) 240/631-3280; (m) 240/413-1917
|
Media Contact
Lynn Kieffer
Vice President, Corporate Communications
(o) 240/631-3391
|
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||
|
Consolidated Statements of Operations
|
||||||||
|
(in thousands, except share and per share data)
|
||||||||
|
Three Months Ended December 31,
|
||||||||
|
2017
|
2016
|
|||||||
|
(Unaudited)
|
||||||||
|
Revenues:
|
||||||||
|
Product sales
|
$
|
161,641
|
$
|
87,493
|
||||
|
Contract manufacturing
|
16,235
|
16,683
|
||||||
|
Contracts and grants
|
15,933
|
47,487
|
||||||
|
Total revenues
|
193,809
|
151,663
|
||||||
|
Operating expenses:
|
||||||||
|
Cost of product sales and contract manufacturing
|
70,258
|
38,259
|
||||||
|
Research and development
|
28,498
|
27,117
|
||||||
|
Selling, general and administrative
|
41,976
|
35,358
|
||||||
|
Income from operations
|
53,077
|
50,929
|
||||||
|
Other income (expense):
|
||||||||
|
Interest income
|
160
|
289
|
||||||
|
Interest expense
|
(856
|
)
|
(2,535
|
)
|
||||
|
Other income (expense), net
|
(428
|
)
|
439
|
|||||
|
Total other expense, net
|
(1,124
|
)
|
(1,807
|
)
|
||||
|
Income before provision for income taxes
|
51,953
|
49,122
|
||||||
|
Provision for income taxes
|
18,011
|
16,836
|
||||||
|
Net income
|
$
|
33,942
|
$
|
32,286
|
||||
|
Net income per share - basic
|
$
|
0.77
|
$
|
0.80
|
||||
|
Net income per share – diluted (5)
|
$
|
0.67
|
$
|
0.67
|
||||
|
Weighted-average number of shares - basic
|
44,269,276
|
40,519,002
|
||||||
|
Weighted-average number of shares - diluted
|
51,004,378
|
49,572,655
|
||||||
|
(5)
|
See "Net Income and Adjusted Net Income" within section "(I) Quarter Ended December 31, 2017 and 2016 (Unaudited)" for explanation of adjustments to denominator for per diluted share calculation.
|
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||
|
Consolidated Statements of Operations
|
||||||||
|
(in thousands, except share and per share data)
|
||||||||
|
Twelve Months Ended December 31,
|
||||||||
|
2017
|
2016
|
|||||||
|
(Unaudited)
|
||||||||
|
Revenues:
|
||||||||
|
Product sales
|
$
|
421,516
|
$
|
296,278
|
||||
|
Contract manufacturing
|
68,935
|
49,138
|
||||||
|
Contracts and grants
|
70,422
|
143,366
|
||||||
|
Total revenues
|
560,873
|
488,782
|
||||||
|
Operating expenses:
|
||||||||
|
Cost of product sales and contract manufacturing
|
195,707
|
131,284
|
||||||
|
Research and development
|
97,384
|
108,290
|
||||||
|
Selling, general and administrative
|
143,497
|
143,686
|
||||||
|
Income from operations
|
124,285
|
105,522
|
||||||
|
Other income (expense):
|
||||||||
|
Interest income
|
1,753
|
1,053
|
||||||
|
Interest expense
|
(6,590
|
)
|
(7,617
|
)
|
||||
|
Other income (expense), net
|
(815
|
)
|
263
|
|||||
|
Total other expense, net
|
(5,652
|
)
|
(6,301
|
)
|
||||
|
Income from continuing operations before provision for income taxes
|
118,633
|
99,221
|
||||||
|
Provision for income taxes
|
36,039
|
36,697
|
||||||
|
Net income from continuing operations
|
82,594
|
62,524
|
||||||
|
Net loss from discontinued operations
|
-
|
(10,748
|
)
|
|||||
|
Net income
|
$
|
82,594
|
$
|
51,776
|
||||
|
Net income per share from continuing operations - basic
|
$
|
1.98
|
$
|
1.56
|
||||
|
Net loss per share from discontinued operations - basic
|
-
|
(0.27
|
)
|
|||||
|
Net income per share - basic
|
$
|
1.98
|
$
|
1.29
|
||||
|
Net income per share from continuing operations - diluted
|
$
|
1.71
|
$
|
1.35
|
||||
|
Net loss per share from discontinued operations - diluted
|
-
|
(0.22
|
)
|
|||||
|
Net income per share - diluted (5)
|
$
|
1.71
|
$
|
1.13
|
||||
|
Weighted-average number of shares - basic
|
41,816,431
|
40,184,159
|
||||||
|
Weighted-average number of shares - diluted
|
50,327,937
|
49,335,112
|
||||||
|
(5)
|
See "Net Income and Adjusted Net Income" within section "(II) Year Ended December 31, 2017
(Unaudited)" for explanation of adjustments to denominator for per diluted share calculation. |
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||
|
Consolidated Balance Sheets
|
||||||||
|
(in thousands, except share and per share data)
|
||||||||
|
December 31, 2017
|
December 31, 2016
|
|||||||
|
ASSETS
|
(Unaudited)
|
|||||||
|
Current assets:
|
||||||||
|
Cash and cash equivalents
|
$
|
178,292
|
$
|
271,513
|
||||
|
Restricted cash
|
1,043
|
-
|
||||||
|
Accounts receivable, net
|
143,653
|
138,478
|
||||||
|
Inventories
|
142,812
|
74,002
|
||||||
|
Income tax receivable, net
|
2,432
|
9,996
|
||||||
|
Prepaid expenses and other current assets
|
17,157
|
16,229
|
||||||
|
Total current assets
|
485,389
|
510,218
|
||||||
|
Property, plant and equipment, net
|
407,210
|
376,448
|
||||||
|
Intangible assets, net
|
119,597
|
33,865
|
||||||
|
Goodwill
|
49,130
|
41,001
|
||||||
|
Deferred tax assets, long-term, net
|
2,834
|
6,096
|
||||||
|
Other assets
|
6,046
|
2,483
|
||||||
|
Total assets
|
$
|
1,070,206
|
$
|
970,111
|
||||
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
|
Current liabilities:
|
||||||||
|
Accounts payable
|
$
|
41,751
|
$
|
34,649
|
||||
|
Accrued expenses and other current liabilities
|
4,831
|
6,368
|
||||||
|
Accrued compensation
|
37,882
|
34,537
|
||||||
|
Notes payable
|
-
|
20,000
|
||||||
|
Contingent consideration, current portion
|
2,372
|
3,266
|
||||||
|
Deferred revenue, current portion
|
13,232
|
7,036
|
||||||
|
Total current liabilities
|
100,068
|
105,856
|
||||||
|
Contingent consideration, net of current portion
|
9,902
|
9,919
|
||||||
|
Long-term indebtedness
|
13,457
|
248,094
|
||||||
|
Income taxes payable, net of current
|
12,500
|
-
|
||||||
|
Deferred revenue, net of current portion
|
17,259
|
8,433
|
||||||
|
Other liabilities
|
4,675
|
1,604
|
||||||
|
Total liabilities
|
157,861
|
373,906
|
||||||
|
Stockholders' equity:
|
||||||||
|
Preferred stock, $0.001 par value; 15,000,000 shares authorized, 0 shares issued and outstanding at both December 31, 2017 and December 31, 2016
|
-
|
-
|
||||||
|
Common stock, $0.001 par value; 200,000,000 shares authorized, 50,619,808 shares issued and 49,405,365 shares outstanding at December 31, 2017; 40,996,890 shares issued and 40,574,060 shares outstanding at December 31, 2016
|
50
|
41
|
||||||
|
Treasury stock, at cost, 1,214,443 and 422,830 common shares at December 31, 2017 and December 31, 2016, respectively
|
(39,497
|
)
|
(6,420
|
)
|
||||
|
Additional paid-in capital
|
618,416
|
352,435
|
||||||
|
Accumulated other comprehensive loss
|
(3,698
|
)
|
(4,331
|
)
|
||||
|
Retained earnings
|
337,074
|
254,480
|
||||||
|
Total stockholders' equity
|
912,345
|
596,205
|
||||||
|
Total liabilities and stockholders' equity
|
$
|
1,070,206
|
$
|
970,111
|
||||
|
Three Months Ended
December 31, |
||||||||||||
|
(in millions, except per share value)
|
2017
|
2016
|
Source
|
|||||||||
|
Net Income
|
$
|
33.9
|
$
|
32.3
|
N/A
|
|||||||
|
Adjustments:
|
||||||||||||
|
+ Acquisition-related costs (transaction & integration)
|
1.5
|
1.0
|
SG&A
|
|||||||||
|
+ Non-cash amortization charges
|
4.1
|
1.9
|
COGS, SG&A, Other Income
|
|||||||||
|
+ Exit and disposal costs
|
--
|
2.6
|
SG&A
|
|||||||||
|
+ Impact of purchase accounting on inventory step-up
|
0.4
|
1.1
|
SG&A
|
|||||||||
|
Tax effect
|
(2.1
|
)
|
(2.3
|
)
|
N/A
|
|||||||
|
Total Adjustments:
|
3.9
|
4.3
|
N/A
|
|||||||||
|
Adjusted Net Income
Adjusted Net Income Per Diluted Share
|
$
|
37.8
0.74
|
$
|
36.6
0.74
|
N/A
|
|||||||
|
Twelve Months Ended
December 31,
|
||||||||||||
|
(in millions, except per share value)
|
2017
|
2016
|
Source
|
|||||||||
|
Net Income
|
$
|
82.6
|
$
|
62.5
|
N/A
|
|||||||
|
Adjustments:
|
||||||||||||
|
+ Acquisition-related costs (transaction & integration)
|
5.6
|
1.7
|
SG&A
|
|||||||||
|
+ Non-cash amortization charges
|
10.3
|
8.4
|
COGS, SG&A, Other Income
|
|||||||||
|
+ Exit and disposal costs
|
1.5
|
11.7
|
SG&A
|
|||||||||
|
+ Impact of purchase accounting on inventory step-up
|
2.6
|
1.1
|
SG&A
|
|||||||||
|
Tax effect
|
(7.0
|
)
|
(8.0
|
)
|
N/A
|
|||||||
|
Total Adjustments:
|
13.1
|
15.0
|
N/A
|
|||||||||
|
Adjusted Net Income
Adjusted Net Income Per Diluted Share
|
$
|
95.7
1.90
|
$
|
77.5
1.57
|
N/A
|
|||||||
|
Three Months Ended
December 31,
|
||||||||
|
(in millions, except per share value)
|
2017
|
2016
|
||||||
|
Net Income
|
$
|
33.9
|
$
|
32.3
|
||||
|
Adjustments:
|
||||||||
|
+ Depreciation & Amortization
|
12.4
|
9.7
|
||||||
|
+ Provision for Income Taxes
|
18.0
|
16.8
|
||||||
|
+ Total Interest Expense
|
0.9
|
2.5
|
||||||
|
Total Adjustments
|
31.3
|
29.0
|
||||||
|
EBITDA
EBITDA per Diluted Share
|
$
|
65.2
1.28
|
$
|
61.3
1.24
|
||||
|
Twelve Months Ended
December 31,
|
||||||||
|
(in millions, except per share value)
|
2017
|
2016
|
||||||
|
Net Income
|
$
|
82.6
|
62.5
|
|||||
|
Adjustments:
|
||||||||
|
+ Depreciation & Amortization
|
40.8
|
34.9
|
||||||
|
+ Provision for Income Taxes
|
36.0
|
36.7
|
||||||
|
+ Total Interest Expense
|
6.6
|
7.6
|
||||||
|
Total Adjustments
|
83.4
|
79.2
|
||||||
|
EBITDA
EBITDA per Diluted Share
|
$
|
166.0
3.30
|
$
|
141.7
2.87
|
||||
|
(in millions)
|
||||||||||||
|
Twelve Months Ended December 31, 2016
|
||||||||||||
|
Continuing Operations
|
Discontinuing Operations
|
Combined
|
||||||||||
|
Revenues:
|
||||||||||||
|
Product sales
|
$
|
296.3
|
$
|
21.2
|
$
|
317.5
|
||||||
|
Contract manufacturing
|
49.1
|
-
|
49.1
|
|||||||||
|
Contracts and grants
|
143.4
|
0.2
|
143.6
|
|||||||||
|
Total revenues
|
488.8
|
21.4
|
510.2
|
|||||||||
|
Operating expenses:
|
||||||||||||
|
Cost of product sales and contract manufacturing
|
131.3
|
11.6
|
142.9
|
|||||||||
|
Research and development
|
108.3
|
18.0
|
126.3
|
|||||||||
|
Selling, general and administrative
|
143.7
|
23.8
|
167.5
|
|||||||||
|
Income (loss) from operations
|
105.5
|
(32.0
|
)
|
73.5
|
||||||||
|
Other income (expense):
|
||||||||||||
|
Interest income
|
1.1
|
-
|
1.1
|
|||||||||
|
Interest expense
|
(7.6
|
)
|
-
|
(7.6
|
)
|
|||||||
|
Other expense, net
|
0.2
|
(0.0
|
)
|
0.2
|
||||||||
|
Total other expense, net
|
(6.3
|
)
|
(0.0
|
)
|
(6.3
|
)
|
||||||
|
Income (loss) before provision for (benefit) from income taxes
|
99.2
|
(32.0
|
)
|
67.2
|
||||||||
|
Provision for (benefit from) income taxes
|
36.7
|
(21.3
|
)
|
15.4
|
||||||||
|
Net income (loss)
|
$
|
62.5
|
$
|
(10.7
|
)
|
$
|
51.8
|
|||||