|
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 February 21, 2019.
|
|
Date: February 21, 2019
|
EMERGENT BIOSOLUTIONS INC.
|
|
|
|
By:
|
/s/ Richard S. Lindahl
Richard S. Lindahl
Executive Vice President, Chief Financial Officer and Treasurer
|
|
(in millions)
|
Q4 2018
(unaudited)
|
Q4 2017
(unaudited)
|
||||||
|
Total Revenues
|
$
|
270.7
|
$
|
193.8
|
||||
|
Pretax Income
|
$
|
3.6
|
$
|
51.9
|
||||
|
Net Income (Loss)
|
$
|
(3.4
|
)
|
$
|
33.9
|
|||
|
Adjusted Net Income (1)
|
$
|
38.3
|
$
|
37.8
|
||||
|
EBITDA (1)
|
$
|
36.1
|
$
|
65.2
|
||||
|
Adjusted EBITDA (1)
|
$
|
75.0
|
$
|
67.1
|
||||
|
(in millions)
|
Full Year 2018
(unaudited)
|
Full Year 2017
|
||||||
|
Total Revenues
|
$
|
782.4
|
$
|
560.9
|
||||
|
Pretax Income
|
$
|
81.5
|
$
|
118.6
|
||||
|
Net Income
|
$
|
62.7
|
$
|
82.6
|
||||
|
Adjusted Net Income (1)
|
$
|
119.6
|
$
|
95.7
|
||||
|
EBITDA (1)
|
$
|
152.7
|
$
|
166.0
|
||||
|
Adjusted EBITDA (1)
|
$
|
198.8
|
$
|
175.7
|
||||
|
Three Months Ended
December 31,
|
||||||||||||
|
(in millions)
(unaudited)
|
2018
|
2017
|
% Change
|
|||||||||
|
Product Sales
|
||||||||||||
|
BioThrax®
|
$
|
134.3
|
$
|
107.0
|
26
|
%
|
||||||
|
NARCAN® (naloxone HCl) nasal spray
|
41.7
|
--
|
--
|
|||||||||
|
Other
|
41.4
|
54.7
|
(24
|
%)
|
||||||||
|
Total Product Sales
|
$
|
217.4
|
$
|
161.7
|
34
|
%
|
||||||
|
Three Months Ended
December 31,
|
||||||||||||
|
(in millions)
(unaudited)
|
2018
|
2017
|
% Change
|
|||||||||
|
Research and Development Expenses
|
$
|
52.0
|
$
|
28.5
|
82
|
%
|
||||||
|
Adjustments:
|
||||||||||||
|
- Contracts and grants
revenue
|
$
|
26.4
|
$
|
15.9
|
66
|
%
|
||||||
|
Net Research and Development Expenses
|
$
|
25.6
|
$
|
12.6
|
103
|
%
|
||||||
|
Adjusted
Revenue
(Total Revenue less Contracts and Grants Revenue) |
$
|
244.3
|
$
|
177.9
|
37
|
%
|
||||||
|
Net R&D as % of Adjusted Revenue (Net R&D Margin)
|
10
|
%
|
7
|
%
|
NA
|
|||||||
|
Year Ended
December 31,
|
||||||||||||
|
(in millions)
(unaudited)
|
2018
|
2017
|
% Change
|
|||||||||
|
Product Sales
|
||||||||||||
|
BioThrax®
|
$
|
278.0
|
$
|
286.6
|
(3
|
%)
|
||||||
|
ACAM2000®
|
116.7
|
11.5
|
915
|
%
|
||||||||
|
Other
|
211.8
|
123.4
|
72
|
%
|
||||||||
|
Total Product Sales
|
$
|
606.5
|
$
|
421.5
|
44
|
%
|
||||||
|
Year Ended
December 31,
|
||||||||||||
|
(in millions)
(unaudited)
|
2018
|
2017
|
% Change
|
|||||||||
|
Research and Development Expenses
|
$
|
142.8
|
$
|
97.4
|
47
|
%
|
||||||
|
Adjustments:
|
||||||||||||
|
- Contracts and grants
revenue
|
$
|
77.0
|
$
|
70.5
|
9
|
%
|
||||||
|
Net Research and Development Expenses
|
$
|
65.8
|
$
|
26.9
|
145
|
%
|
||||||
|
Adjusted
Revenue
(Total Revenue less Contracts and Grants Revenue) |
$
|
705.4
|
$
|
490.4
|
44
|
%
|
||||||
|
Net R&D as % of Adjusted Revenue (Net R&D Margin)
|
9
|
%
|
5
|
%
|
NA
|
|||||||
|
(in millions)
|
FULL YEAR 2019
(As of 2/21/2019) |
|||
|
Total Revenues
|
$
|
1,060 -- $1,140
|
||
|
Net Income (1)
|
$
|
80 -- $110
|
||
|
Adjusted Net
Income (1)
|
$
|
150 -- $180
|
||
|
EBITDA (1)
|
$
|
255 -- $285
|
||
|
Adjusted
EBITDA (1)
|
$
|
280 -- $310
|
||
|
·
|
continued deliveries of BioThrax to the Strategic National Stockpile (SNS) under the current procurement
contract with the Centers for Disease Control and Prevention (CDC), (the contract and the SNS are now managed by the Office of the Assistant Secretary for Preparedness and Response (ASPR));
|
|
·
|
initial deliveries of NuThrax™ (anthrax vaccine adsorbed with CPG 7909 adjuvant) to the SNS following
expected Emergency Use Authorization pre-approval by the U.S. Food and Drug Administration (FDA) under the company’s current development and procurement contract with the Biomedical Advanced Research and Development Authority (BARDA);
|
|
·
|
full year sales of NARCAN Nasal Spray, Vaxchora® (Cholera Vaccine, Live, Oral), and Vivotif®
(Typhoid Vaccine Live Oral Ty21a), all of which were acquired in the fourth quarter of 2018;
|
|
·
|
|
·
|
deliveries of raxibacumab to the SNS under the current procurement contract with BARDA;
|
|
·
|
domestic and international sales of the other medical countermeasures that comprise Other Product sales;
|
|
·
|
continued CDMO services revenue;
|
|
·
|
increased Contract & Grant revenue due to anticipated increased work related to development projects
funded by third parties; and
|
|
·
|
continued investment in discretionary development projects funded by the company targeting opportunities in
medical countermeasures for existing and emerging infectious diseases, opioid overdose and other public health threats.
|
| (1) |
See “Reconciliation of Net Income (Loss) to Adjusted Net Income, EBITDA and Adjusted EBITDA” for a definition of terms and a
reconciliation table.
|
| (2) |
See “Calculation of Diluted Earnings Per Share.”
|
|
Live Teleconference Information:
Dial in: [US] (855) 766-6521; [International] (262) 912-6157
Conference ID: 2299983
|
|
|
Live Webcast Information:
Visit https://edge.media-server.com/m6/p/ow37uwh9
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 Balance Sheets
|
||||||||
|
(in millions, except per share data)
|
||||||||
|
December 31, 2018
|
December 31, 2017
|
|||||||
|
ASSETS
|
(Unaudited)
|
|||||||
|
Current assets:
|
||||||||
|
Cash and cash equivalents
|
$
|
112.2
|
$
|
178.3
|
||||
|
Restricted cash
|
0.2
|
1.0
|
||||||
|
Accounts receivable, net
|
262.5
|
143.7
|
||||||
|
Inventories
|
205.8
|
142.8
|
||||||
|
Income tax receivable, net
|
8.6
|
2.4
|
||||||
|
Prepaid expenses and other current assets
|
31.5
|
17.2
|
||||||
|
Total current assets
|
620.8
|
485.4
|
||||||
|
Property, plant and equipment, net
|
510.2
|
407.2
|
||||||
|
Intangible assets, net
|
761.6
|
119.6
|
||||||
|
In-process research and development
|
50.0
|
--
|
||||||
|
Goodwill
|
259.7
|
49.1
|
||||||
|
Deferred tax assets, net
|
13.4
|
2.8
|
||||||
|
Other assets
|
13.7
|
6.1
|
||||||
|
Total assets
|
$
|
2,229.4
|
$
|
1,070.2
|
||||
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
|
Current liabilities:
|
||||||||
|
Accounts payable
|
$
|
80.7
|
$
|
41.8
|
||||
|
Accrued expenses and other current liabilities
|
30.7
|
4.8
|
||||||
|
Accrued compensation
|
58.2
|
37.9
|
||||||
|
Long-term indebtedness, current portion
|
10.1
|
--
|
||||||
|
Contingent consideration, current portion
|
5.6
|
2.4
|
||||||
|
Income taxes payable, net
|
4.5
|
--
|
||||||
|
Deferred revenue, current portion
|
10.6
|
13.2
|
||||||
|
Total current liabilities
|
200.4
|
100.1
|
||||||
|
Contingent consideration, net of current portion
|
54.4
|
9.9
|
||||||
|
Long-term indebtedness, net of current portion
|
784.5
|
13.5
|
||||||
|
Deferred tax liability, net
|
67.5
|
--
|
||||||
|
Income taxes payable
|
11.2
|
12.5
|
||||||
|
Deferred revenue, net of current portion
|
62.5
|
17.3
|
||||||
|
Other liabilities
|
38.0
|
4.6
|
||||||
|
Total liabilities
|
1,218.5
|
157.9
|
||||||
|
Stockholders’ equity:
|
||||||||
|
Preferred stock, $0.001 par value; 15.0 shares authorized, 0 shares issued and outstanding at
both December 31, 2018 and 2017
|
--
|
--
|
||||||
|
Common stock, $0.001 par value; 200.0 shares authorized, 52.4 shares issued and 51.2 shares
outstanding at December 31, 2018; 50.6 shares issued and 49.4 shares outstanding at December 31, 2017
|
0.1
|
0.1
|
||||||
|
Treasury stock, at cost, 1.2 common shares at both December 31, 2018 and 2017
|
(39.6
|
)
|
(39.5
|
)
|
||||
|
Additional paid-in capital
|
688.6
|
618.3
|
||||||
|
Accumulated other comprehensive loss
|
(5.5
|
)
|
(3.7
|
)
|
||||
|
Retained earnings
|
367.3
|
337.1
|
||||||
|
Total stockholders’ equity
|
1,010.9
|
912.3
|
||||||
|
Total liabilities and stockholders’ equity
|
$
|
2,229.4
|
$
|
1,070.2
|
||||
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||
|
Consolidated Statements of Operations
|
||||||||
|
(in millions, except per share data)
|
||||||||
|
Three Months Ended December 31,
|
||||||||
|
2018
|
2017
|
|||||||
|
(Unaudited)
|
||||||||
|
Revenues:
|
||||||||
|
Product sales
|
$
|
217.4
|
$
|
161.7
|
||||
|
Contract manufacturing
|
26.9
|
16.2
|
||||||
|
Contracts and grants
|
26.4
|
15.9
|
||||||
|
Total revenues
|
270.7
|
193.8
|
||||||
|
Operating expenses:
|
||||||||
|
Cost of product sales and contract manufacturing
|
113.2
|
66.5
|
||||||
|
Research and development
|
52.0
|
28.5
|
||||||
|
Selling, general and administrative
|
81.0
|
41.8
|
||||||
|
Amortization of intangible assets
|
13.3
|
3.9
|
||||||
|
Total operating expenses
|
259.5
|
140.7
|
||||||
|
Income from operations
|
11.2
|
53.1
|
||||||
|
Other income (expense):
|
||||||||
|
Interest expense
|
(8.0
|
)
|
(0.9
|
)
|
||||
|
Other income (expense), net
|
0.4
|
(0.3
|
)
|
|||||
|
Total other expense, net
|
(7.6
|
)
|
(1.2
|
)
|
||||
|
Income before provision for income taxes
|
3.6
|
51.9
|
||||||
|
Provision for income taxes
|
7.0
|
18.0
|
||||||
|
Net income (loss)
|
$
|
(3.4
|
)
|
$
|
33.9
|
|||
|
Net income (loss) per share - basic
|
$
|
(0.07
|
)
|
$
|
0.77
|
|||
|
Net income (loss) per share - diluted (1)
|
$
|
(0.07
|
)
|
$
|
0.67
|
|||
|
Weighted-average number of shares - basic
|
50.9
|
44.3
|
||||||
|
Weighted-average number of shares - diluted
|
50.9
|
51.0
|
||||||
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||
|
Consolidated Statements of Operations
|
||||||||
|
(in millions, except per share data)
|
||||||||
|
Year Ended December 31,
|
||||||||
|
2018
|
2017
|
|||||||
|
(Unaudited)
|
||||||||
|
Revenues:
|
||||||||
|
Product sales
|
$
|
606.5
|
$
|
421.5
|
||||
|
Contract manufacturing
|
98.9
|
68.9
|
||||||
|
Contracts and grants
|
77.0
|
70.5
|
||||||
|
Total revenues
|
782.4
|
560.9
|
||||||
|
Operating expenses:
|
||||||||
|
Cost of product sales and contract manufacturing
|
322.3
|
187.7
|
||||||
|
Research and development
|
142.8
|
97.4
|
||||||
|
Selling, general and administrative
|
202.5
|
142.9
|
||||||
|
Amortization of intangible assets
|
25.0
|
8.6
|
||||||
|
Total operating expenses
|
692.6
|
436.6
|
||||||
|
Income from operations
|
89.8
|
124.3
|
||||||
|
Other income (expense):
|
||||||||
|
Interest expense
|
(9.9
|
)
|
(6.6
|
)
|
||||
|
Other income (expense), net
|
1.6
|
0.9
|
||||||
|
Total other expense, net
|
(8.3
|
)
|
(5.7
|
)
|
||||
|
Income before provision for income taxes
|
81.5
|
118.6
|
||||||
|
Provision for income taxes
|
18.8
|
36.0
|
||||||
|
Net income
|
$
|
62.7
|
$
|
82.6
|
||||
|
Net income per share - basic
|
$
|
1.25
|
$
|
1.98
|
||||
|
Net income per share - diluted (1)
|
$
|
1.22
|
$
|
1.71
|
||||
|
Weighted-average number of shares - basic
|
50.1
|
41.8
|
||||||
|
Weighted-average number of shares - diluted
|
51.4
|
50.3
|
||||||
|
Three Months Ended
December 31, |
||||||||
|
(in millions, except per share value)
|
2018
|
2017
|
||||||
|
Net Income (Loss)
|
$
|
(3.4
|
)
|
$
|
33.9
|
|||
|
Adjustments:
|
||||||||
|
+ Interest expense, net of tax
|
--
|
0.2
|
||||||
|
+ Amortization of debt issuance costs, net of tax
|
--
|
0.1
|
||||||
|
Net Income (Loss), adjusted (“if converted”)
Net Income (Loss) Per Diluted Share, adjusted (“if converted”)
|
$
|
(3.4
($0.07
|
)
)
|
$
|
34.2
$0.67
|
|||
|
Weighted Average Diluted Shares
|
50.9
|
51.0
|
||||||
|
Year Ended
December 31, |
||||||||
|
(in millions, except per share value)
|
2018
|
2017
|
||||||
|
Net Income
|
$
|
62.7
|
$
|
82.6
|
||||
|
Adjustments:
|
||||||||
|
+ Interest expense, net of tax
|
--
|
2.6
|
||||||
|
+ Amortization of debt issuance costs, net of tax
|
--
|
0.7
|
||||||
|
Net Income, adjusted (“if converted”)
Net Income Per Diluted Share, adjusted (“if converted”)
|
$
|
62.7
$1.22
|
$
|
85.9
$1.71
|
||||
|
Weighted Average Diluted Shares
|
51.4
|
50.3
|
||||||
|
Three Months Ended
December 31, |
|||||||||
|
(in millions, except per share value)
|
2018
|
2017
|
Source
|
||||||
|
Net Income (Loss)
|
$
|
(3.4
|
)
|
$
|
33.9
|
||||
|
Adjustments:
|
|||||||||
|
+ Acquisition-related costs (transaction & integration)
|
20.5
|
1.5
|
SG&A
|
||||||
|
+ Non-cash amortization charges
|
13.9
|
4.1
|
IA Amort., Other Income
|
||||||
|
+ Exit and disposal costs
|
--
|
--
|
SG&A
|
||||||
|
+ Impact of purchase accounting on inventory step-up
|
18.4
|
0.4
|
COGS
|
||||||
|
Tax effect
|
(11.1
|
)
|
(2.1
|
)
|
|||||
|
Total Adjustments:
|
41.7
|
3.9
|
|||||||
|
Adjusted Net Income
Adjusted Net Income Per Diluted Share
|
$
|
38.3
$0.75
|
$
|
37.8
$0.74
|
|||||
|
Year Ended
December 31, |
|||||||||
|
(in millions, except per share value)
|
2018
|
2017
|
Source
|
||||||
|
Net Income
|
$
|
62.7
|
$
|
82.6
|
|||||
|
Adjustments:
|
|||||||||
|
+ Acquisition-related costs (transaction & integration)
|
27.3
|
5.6
|
SG&A
|
||||||
|
+ Non-cash amortization charges
|
25.9
|
10.3
|
IA Amort., Other Income
|
||||||
|
+ Exit and disposal costs
|
0.4
|
1.5
|
SG&A
|
||||||
|
+ Impact of purchase accounting on inventory step-up
|
18.4
|
2.6
|
COGS
|
||||||
|
Tax effect
|
(15.1
|
)
|
(7.0
|
)
|
|||||
|
Total Adjustments:
|
56.9
|
13.1
|
|||||||
|
Adjusted Net Income
Adjusted Net Income Per Diluted Share
|
$
|
119.6
$2.33
|
$
|
95.7
$1.90
|
|||||
|
Full Year
Forecast
|
|||||
|
(in millions)
|
2019F
|
Source
|
|||
|
Net Income
|
$
|
80 - $110
|
|||
|
Adjustments:
|
|||||
|
+ Acquisition-related costs (transaction & integration)
|
14
|
SG&A
|
|||
|
+ Non-cash amortization charges
|
64
|
IA Amort., Other Income
|
|||
|
+ Exit and disposal costs
|
4
|
SG&A
|
|||
|
+ Impact of purchase accounting on inventory step-up
|
7
|
COGS
|
|||
|
Tax effect
|
(19
|
)
|
|||
|
Total Adjustments:
|
70
|
||||
|
Adjusted Net Income
|
$
|
150 - $180
|
|||
|
Three Months Ended
December 31,
|
||||||||
|
(in millions, except per share value)
|
2018
|
2017
|
||||||
|
Net Income (Loss)
|
$
|
(3.4
|
)
|
$
|
33.9
|
|||
|
Adjustments:
|
||||||||
|
+ Depreciation & amortization
|
24.5
|
12.4
|
||||||
|
+ Provision for income taxes
|
7.0
|
18.0
|
||||||
|
+ Total interest expense
|
8.0
|
0.9
|
||||||
|
Total Adjustments
|
39.5
|
31.3
|
||||||
|
EBITDA
|
$
|
36.1
|
$
|
65.2
|
||||
|
Additional Adjustments:
|
||||||||
|
+ Acquisition-related costs (transaction & integration)
|
20.5
|
1.5
|
||||||
|
+ Exit and disposal costs
|
--
|
--
|
||||||
|
+ Impact of purchase accounting on inventory step-up
|
18.4
|
0.4
|
||||||
|
Total Additional Adjustments
|
38.9
|
1.9
|
||||||
|
Adjusted EBITDA
|
$
|
75.0
|
$
|
67.1
|
||||
|
Year Ended
December 31,
|
||||||||
|
(in millions, except per share value)
|
2018
|
2017
|
||||||
|
Net Income
|
$
|
62.7
|
$
|
82.6
|
||||
|
Adjustments:
|
||||||||
|
+ Depreciation & Amortization
|
61.3
|
40.8
|
||||||
|
+ Provision for Income Taxes
|
18.8
|
36.0
|
||||||
|
+ Total Interest Expense
|
9.9
|
6.6
|
||||||
|
Total Adjustments
|
90.0
|
83.4
|
||||||
|
EBITDA
|
$
|
152.7
|
$
|
166.0
|
||||
|
Additional Adjustments:
|
||||||||
|
+ Acquisition-related costs (transaction & integration)
|
27.3
|
5.6
|
||||||
|
+ Exit and disposal costs
|
0.4
|
1.5
|
||||||
|
+ Impact of purchase accounting on inventory step-up
|
18.4
|
2.6
|
||||||
|
Total Additional Adjustments
|
46.1
|
9.7
|
||||||
|
Adjusted EBITDA
|
$
|
198.8
|
$
|
175.7
|
||||
|
Full Year
Forecast
|
||||
|
(in millions)
|
2019F
|
|
||
|
Net Income
|
$
|
80 - $110
|
||
|
Adjustments:
|
||||
|
+ Depreciation & amortization
|
106
|
|||
|
+ Provision for income taxes
|
30
|
|||
|
+ Total interest expense
|
39
|
|||
|
Total Adjustments
|
175
|
|||
|
EBITDA
|
$
|
255 - $285
|
||
|
Additional Adjustments:
|
||||
|
+ Acquisition-related costs (transaction & integration)
|
14
|
|||
|
+ Exit and disposal costs
|
4
|
|||
|
+ Impact of purchase accounting on inventory step-up
|
7
|
|||
|
Total Additional Adjustments
|
25
|
|||
|
Adjusted EBITDA
|
$
|
280 - $310
|
||