Delaware
|
001-33137
|
14-1902018
|
(State or Other Jurisdiction
of Incorporation)
|
(Commission
File Number)
|
(IRS Employer
Identification No.)
|
400 Professional Drive, Suite 400
Gaithersburg, Maryland 20879
|
|
(Address of Principal Executive Offices)
|
|
Exhibit No.
|
Description
|
|
|
Press release issued by the company on August 2, 2018.
|
Date: August 2, 2018
|
EMERGENT BIOSOLUTIONS INC.
|
|
|
By:
|
/s/ Richard S. Lindahl
Richard S. Lindahl
Executive Vice President, Chief Financial Officer and Treasurer
|
-
|
Q2 2018 total revenues of $220 million, net income of $50 million
|
-
|
Reaffirms full year 2018 financial forecast and operational goals
|
(in millions, except per share value)
|
Q2 2018
(unaudited)
|
Q2 2017
(unaudited)
|
||||||
Total Revenues
|
$
|
220.2
|
$
|
100.8
|
||||
Net Income
Net Income Per Diluted Share (1)
|
$
|
50.1
0.98
|
$
|
4.6
0.11
|
||||
Adjusted Net Income (2)
Adjusted Net Income Per Diluted Share (2)
|
$
|
54.7
1.07
|
$
|
6.6
0.13
|
||||
EBITDA (2)
EBITDA Per Diluted Share (2)
|
$
|
79.0
1.54
|
$
|
18.0
0.36
|
(in millions, except per share value)
|
6 Months 2018
(unaudited)
|
6 Months 2017
(unaudited)
|
||||||
Total Revenues
|
$
|
338.0
|
$
|
217.6
|
||||
Net Income
Net Income Per Diluted Share (1)
|
$
|
45.2
$0.89
|
$
|
15.1
0.35
|
||||
Adjusted Net Income (2)
Adjusted Net Income Per Diluted Share (2)
|
$
|
53.1
1.04
|
$
|
20.8
0.42
|
||||
EBITDA (2)
EBITDA Per Diluted Share (2)
|
$
|
82.1
1.61
|
$
|
43.4
0.87
|
·
|
Completed Mutual Recognition Procedure for market authorization of BioThrax® (Anthrax Vaccine Adsorbed) in five Concerned Member States within the European Union – Italy, the Netherlands, Poland, the U.K. and France; to date, BioThrax has received market authorization in four of the five countries.
|
·
|
Initiated an investment of up to $50 million over the next three years in the Camden fill/finish facility located in Baltimore, an expansion project that will significantly enhance the capabilities of this key site within the Company's CDMO Business Unit.
|
·
|
Announced Framework Partnering Agreement under which the Company will provide technical and manufacturing support for the development and manufacture of a vaccine against Nipah virus in collaboration with Profectus BioSciences, Inc. and CEPI (Coalition for Epidemic Preparedness Innovations); under a separate agreement with Profectus, Emergent will retain the exclusive option to license and assume control of development activities for the Nipah virus vaccine from Profectus.
|
·
|
Initiated a Phase 1 clinical study of ZIKV-IG, the Company's anti-Zika virus immune globulin being developed as a therapeutic intervention against Zika virus disease; the candidate was granted Fast Track designation by the U.S. Food and Drug Administration in December 2017.
|
Three Months Ended
June 30,
|
||||||||||||
(in millions)
(unaudited)
|
2018
|
2017
|
% Change
|
|||||||||
Product Sales
|
||||||||||||
BioThrax®
|
$
|
77.6
|
$
|
52.3
|
48
|
%
|
||||||
Other
|
102.5
|
11.3
|
807
|
%
|
||||||||
Total Product Sales
|
$
|
180.1
|
$
|
63.6
|
183
|
%
|
Three Months Ended
June 30,
|
||||||||||||
(in millions)
(unaudited)
|
2018
|
2017
|
% Change
|
|||||||||
Research and Development Expenses
|
$
|
24.7
|
$
|
25.8
|
(4
|
%)
|
||||||
Adjustments:
|
||||||||||||
- Contracts and grants revenue
|
$
|
16.5
|
$
|
21.0
|
(21
|
%)
|
||||||
Net Research and Development Expenses
|
$
|
8.2
|
$
|
4.8
|
71
|
%
|
Six Months Ended
June 30,
|
||||||||||||
(in millions)
(unaudited)
|
2018
|
2017
|
% Change
|
|||||||||
Product Sales
|
||||||||||||
BioThrax®
|
$
|
97.8
|
$
|
96.1
|
2
|
%
|
||||||
Other
|
158.0
|
49.4
|
220
|
%
|
||||||||
Total Product Sales
|
$
|
255.8
|
$
|
145.5
|
76
|
%
|
Six Months Ended
June 30,
|
||||||||||||
(in millions)
(unaudited)
|
2018
|
2017
|
% Change
|
|||||||||
Research and Development Expenses
|
$
|
53.8
|
$
|
46.2
|
16
|
%
|
||||||
Adjustments:
|
||||||||||||
- Contracts and grants revenue
|
$
|
32.4
|
$
|
38.3
|
(15
|
%)
|
||||||
Net Research and Development Expenses
|
$
|
21.4
|
$
|
7.9
|
171
|
%
|
· Total Revenue
|
$715 million to $755 million
|
· Pre-Tax Income
|
$120 million to $140 million
|
· Net Income (3)
|
$95 million to $110 million
|
· Adjusted Net Income (2) (3)
|
$110 million to $125 million
|
· EBITDA (2) (3)
|
$175 million to $190 million
|
·
|
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 technology transfer to the Company's 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
|
(1) |
See "Calculation of Diluted Earnings Per Share."
|
(2) |
See "Reconciliation of Net Income to Adjusted Net Income and EBITDA" for a definition of terms and a reconciliation table.
|
(3) |
Reflects an estimated tax rate that includes the expected effects of the United States Tax Cuts and Jobs Act of 2017 on the Company's 2018 income tax provision.
|
Live Teleconference Information:
Dial in: [US] (855) 766-6521; [International] (262) 912-6157
Conference ID: 93342423
|
|
Live Webcast Information:
Visit https://edge.media-server.com/m6/p/qdyuod7s for the live webcast feed.
|
Investor Contact
Robert Burrows
Vice President, Investor Relations
(o) 240/631-3280; (m) 240/413-1917
burrowsr@ebsi.com
|
Media Contact
Lynn Kieffer
Vice President, Corporate Communications
(o) 240/631-3391
kiefferl@ebsi.com
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||
Consolidated Balance Sheets
|
||||||||
(in thousands, except share and per share data)
|
||||||||
June 30, 2018
|
December 31, 2017
|
|||||||
ASSETS
|
(Unaudited)
|
|||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
190,237
|
$
|
178,292
|
||||
Restricted cash
|
1,043
|
1,043
|
||||||
Accounts receivable, net
|
189,489
|
143,653
|
||||||
Inventories
|
139,373
|
142,812
|
||||||
Income tax receivable, net
|
-
|
2,432
|
||||||
Prepaid expenses and other current assets
|
21,166
|
17,157
|
||||||
Total current assets
|
541,308
|
485,389
|
||||||
Property, plant and equipment, net
|
419,157
|
407,210
|
||||||
Intangible assets, net
|
111,773
|
119,597
|
||||||
Goodwill
|
49,130
|
49,130
|
||||||
Deferred tax assets, net
|
12,654
|
2,834
|
||||||
Other assets
|
4,869
|
6,046
|
||||||
Total assets
|
$
|
1,138,891
|
$
|
1,070,206
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
41,629
|
$
|
41,751
|
||||
Accrued expenses and other current liabilities
|
10,552
|
4,831
|
||||||
Accrued compensation
|
29,259
|
37,882
|
||||||
Contingent consideration, current portion
|
2,852
|
2,372
|
||||||
Income taxes payable, net
|
2,771
|
2,372
|
||||||
Deferred revenue, current portion
|
9,750
|
13,232
|
||||||
Total current liabilities
|
96,813
|
100,068
|
||||||
Contingent consideration, net of current portion
|
9,839
|
9,902
|
||||||
Long-term indebtedness
|
13,482
|
13,457
|
||||||
Income taxes payable
|
12,500
|
12,500
|
||||||
Deferred revenue, net of current portion
|
63,255
|
17,259
|
||||||
Other liabilities
|
4,656
|
4,675
|
||||||
Total liabilities
|
200,545
|
157,861
|
||||||
Stockholders' equity:
|
||||||||
Preferred stock, $0.001 par value; 15,000,000 shares authorized, 0 shares issued and outstanding at both June 30, 2018 and December 31, 2017
|
-
|
-
|
||||||
Common stock, $0.001 par value; 200,000,000 shares authorized, 51,231,814 shares issued and 50,014,528 shares outstanding at June 30, 2018; 50,619,808 shares issued and 49,405,365 shares outstanding at December 31, 2017
|
51
|
50
|
||||||
Treasury stock, at cost, 1,217,286 and 1,214,443 common shares at June 30, 2018 and December 31, 2017, respectively
|
(39,642
|
)
|
(39,497
|
)
|
||||
Additional paid-in capital
|
632,569
|
618,416
|
||||||
Accumulated other comprehensive loss
|
(4,415
|
)
|
(3,698
|
)
|
||||
Retained earnings
|
349,783
|
337,074
|
||||||
Total stockholders' equity
|
938,346
|
912,345
|
||||||
Total liabilities and stockholders' equity
|
$
|
1,138,891
|
$
|
1,070,206
|
||||
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||
Consolidated Statements of Operations
|
||||||||
(in thousands, except share and per share data)
|
||||||||
Three Months Ended June 30,
|
||||||||
2018
|
2017
|
|||||||
(Unaudited)
|
||||||||
Revenues:
|
||||||||
Product sales
|
$
|
180,075
|
$
|
63,610
|
||||
Contract manufacturing
|
23,613
|
16,160
|
||||||
Contracts and grants
|
16,512
|
21,002
|
||||||
Total revenues
|
220,200
|
100,772
|
||||||
Operating expenses:
|
||||||||
Cost of product sales and contract manufacturing
|
89,173
|
34,624
|
||||||
Research and development
|
24,745
|
25,751
|
||||||
Selling, general and administrative
|
39,506
|
31,868
|
||||||
Income from operations
|
66,776
|
8,529
|
||||||
Other income (expense):
|
||||||||
Interest income
|
306
|
583
|
||||||
Interest expense
|
(1,008
|
)
|
(1,805
|
)
|
||||
Other expense, net
|
(253
|
)
|
(586
|
)
|
||||
Total other expense, net
|
(955
|
)
|
(1,808
|
)
|
||||
Income before provision for income taxes
|
65,821
|
6,721
|
||||||
Provision for income taxes
|
15,677
|
2,105
|
||||||
Net income
|
$
|
50,144
|
$
|
4,616
|
||||
Net income per share - basic
|
$
|
1.00
|
$
|
0.11
|
||||
Net income per share - diluted (1)
|
$
|
0.98
|
$
|
0.11
|
||||
Weighted-average number of shares - basic
|
49,896,124
|
41,013,764
|
||||||
Weighted-average number of shares - diluted
|
51,162,909
|
50,078,594
|
||||||
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||
Consolidated Statements of Operations
|
||||||||
(in thousands, except share and per share data)
|
||||||||
Six Months Ended June 30,
|
||||||||
2018
|
2017
|
|||||||
(Unaudited)
|
||||||||
Revenues:
|
||||||||
Product sales
|
$
|
255,846
|
$
|
145,579
|
||||
Contract manufacturing
|
49,791
|
33,788
|
||||||
Contracts and grants
|
32,377
|
38,263
|
||||||
Total revenues
|
338,014
|
217,630
|
||||||
Operating expenses:
|
||||||||
Cost of product sales and contract manufacturing
|
147,217
|
80,946
|
||||||
Research and development
|
53,796
|
46,227
|
||||||
Selling, general and administrative
|
79,710
|
67,018
|
||||||
Income from operations
|
57,291
|
23,439
|
||||||
Other income (expense):
|
||||||||
Interest income
|
528
|
956
|
||||||
Interest expense
|
(1,242
|
)
|
(3,743
|
)
|
||||
Other expense, net
|
(179
|
)
|
(286
|
)
|
||||
Total other expense, net
|
(893
|
)
|
(3,073
|
)
|
||||
Income before provision for income taxes
|
56,398
|
20,366
|
||||||
Provision for income taxes
|
11,162
|
5,265
|
||||||
Net income
|
$
|
45,236
|
$
|
15,101
|
||||
Net income per share - basic
|
$
|
0.91
|
$
|
0.37
|
||||
Net income per share - diluted (1)
|
$
|
0.89
|
$
|
0.35
|
||||
Weighted-average number of shares - basic
|
49,738,980
|
40,871,540
|
||||||
Weighted-average number of shares - diluted
|
51,039,195
|
49,899,291
|
||||||
Three Months Ended
June 30, |
||||||||
(in millions, except per share value)
|
2018
|
2017
|
||||||
Net Income
|
$
|
50.1
|
$
|
4.6
|
||||
Adjustments:
|
||||||||
+ Interest expense, net of tax
|
--
|
0.8
|
||||||
+ Amortization of debt issuance costs, net of tax
|
--
|
0.2
|
||||||
Net Income, adjusted ("if converted")
Net Income Per Diluted Share, adjusted ("if converted")
|
$
|
50.1
0.98
|
$
|
5.6
0.11
|
||||
Weighted Average Diluted Shares
|
51.2
|
50.1
|
Six Months Ended
June 30, |
||||||||
(in millions, except per share value)
|
2018
|
2017
|
||||||
Net Income
|
$
|
45.2
|
$
|
15.1
|
||||
Adjustments:
|
||||||||
+ Interest expense, net of tax
|
--
|
1.7
|
||||||
+ Amortization of debt issuance costs, net of tax
|
--
|
0.4
|
||||||
Net Income, adjusted ("if converted")
Net Income Per Diluted Share, adjusted ("if converted")
|
$
|
45.2
0.89
|
$
|
17.2
0.35
|
||||
Weighted Average Diluted Shares
|
51.0
|
49.9
|
Three Months Ended
June 30, |
||||||||||||
(in millions, except per share value)
|
2018
|
2017
|
Source
|
|||||||||
Net Income
|
$
|
50.1
|
$
|
4.6
|
N/A
|
|||||||
Adjustments:
|
||||||||||||
+ Acquisition-related costs (transaction & integration)
|
1.4
|
1.1
|
SG&A
|
|||||||||
+ Non-cash amortization charges
|
4.0
|
1.9
|
COGS, SG&A, Other Income
|
|||||||||
+ Exit and disposal costs
|
0.4
|
0.1
|
SG&A
|
|||||||||
Tax effect
|
(1.2
|
)
|
(1.1
|
)
|
||||||||
Total Adjustments:
|
4.6
|
2.0
|
||||||||||
Adjusted Net Income
Adjusted Net Income Per Diluted Share
|
$
|
54.7
1.07
|
$
|
6.6
0.13
|
Six Months Ended
June 30, |
||||||||||||
(in millions, except per share value)
|
2018
|
2017
|
Source
|
|||||||||
Net Income
|
$
|
45.2
|
$
|
15.1
|
N/A
|
|||||||
Adjustments:
|
||||||||||||
+ Acquisition-related costs (transaction & integration)
|
1.6
|
1.7
|
SG&A
|
|||||||||
+ Non-cash amortization charges
|
8.0
|
3.9
|
COGS, SG&A, Other Income
|
|||||||||
+ Exit and disposal costs
|
0.4
|
1.5
|
SG&A
|
|||||||||
+ Impact of purchase accounting on inventory step-up
|
--
|
1.8
|
COGS
|
|||||||||
Tax effect
|
(2.1
|
)
|
(3.1
|
)
|
||||||||
Total Adjustments:
|
7.9
|
5.7
|
||||||||||
Adjusted Net Income
Adjusted Net Income Per Diluted Share
|
$
|
53.1
1.04
|
$
|
20.8
0.42
|
Three Months Ended
June 30,
|
||||||||
(in millions, except per share value)
|
2018
|
2017
|
||||||
Net Income
|
$
|
50.1
|
$
|
4.6
|
||||
Adjustments:
|
||||||||
+ Depreciation & Amortization
|
12.2
|
9.5
|
||||||
+ Provision for Income Taxes
|
15.7
|
2.1
|
||||||
+ Total Interest Expense
|
1.0
|
1.8
|
||||||
Total Adjustments
|
28.9
|
13.4
|
||||||
EBITDA
EBITDA per Diluted Share
|
$
|
79.0
1.54
|
$
|
18.0
0.36
|
Six Months Ended
June 30,
|
||||||||
(in millions, except per share value)
|
2018
|
2017
|
||||||
Net Income
|
$
|
45.2
|
$
|
15.1
|
||||
Adjustments:
|
||||||||
+ Depreciation & Amortization
|
24.5
|
19.3
|
||||||
+ Provision for Income Taxes
|
11.2
|
5.3
|
||||||
+ Total Interest Expense
|
1.2
|
3.7
|
||||||
Total Adjustments
|
36.9
|
28.3
|
||||||
EBITDA
EBITDA per Diluted Share
|
$
|
82.1
1.61
|
$
|
43.4
0.87
|