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)
|
(Zip Code)
|
Date: November 5, 2015
|
EMERGENT BIOSOLUTIONS INC.
|
|
|
By:
|
/s/ A.B. Cruz III
A.B. Cruz III
Executive Vice President, General Counsel and Corporate Secretary
|
·
|
Total revenues: Q3 2015 of $164.9 million, +20% Y/Y; nine months 2015 of $354.7 million, +17% Y/Y;
|
·
|
GAAP net income: Q3 2015 of $36.9 million, or $0.79 per diluted share, +69% Y/Y; nine months 2015 of $29.5 million, or $0.69 per diluted share;
|
·
|
Adjusted net income: Q3 2015 of $39.8 million, or $0.83 per diluted share, +59% Y/Y; nine months 2015 of $38.0 million, or $0.81 per diluted share, +95% Y/Y;
|
·
|
EBITDA: Q3 2015 of $61.8 million, or $1.29 per diluted share, +54% Y/Y; nine months 2015 of $71.5 million, or $1.52 per diluted share, +83% Y/Y; and
|
·
|
Adjusted EBITDA: Q3 2015 of $63.2 million, or $1.32 per diluted share, +50% Y/Y; nine months 2015 of $75.6 million, or $1.61 per diluted share, +56% Y/Y.
|
·
|
Announced plan to implement tax-free spin-off of Aptevo Therapeutics (the Company's Biosciences business) into a separate publicly traded company, targeted for mid-2016;
|
·
|
Successfully launched Emergard, the Company's military-grade auto-injector device for chemical threats in Ex-US markets;
|
·
|
Received FDA approval and launched IXINITY®, a recombinant factor IX treatment for Hemophilia B;
|
·
|
Received FDA approval of Anthrasil™, an immune globulin for the treatment for inhalational anthrax;
|
·
|
Awarded $20M in multiple contracts with BARDA to manufacture Ebola monoclonal antibodies under the Center for Innovation in Advanced Development and Manufacturing program;
|
·
|
Received a $44M CDC contract to further supply the strategic national stockpile with the Company's Vaccinia Immune Globulin product; and
|
·
|
Continued steady progress on Building 55 sBLA approval.
|
·
|
Total revenues of $520-$540 million (previously $510-$540 million)
|
·
|
Net income of $50-$60 million (GAAP) and $60-$70 million (Adjusted)
|
Three Months Ended
September 30,
|
||||||||||||
(in millions)
|
2015
|
2014
|
% Change
|
|||||||||
Product Sales
|
||||||||||||
BioThrax®
|
$
|
109.8
|
$
|
66.0
|
66
|
%
|
||||||
Other biodefense
|
7.7
|
11.7
|
(34
|
)%
|
||||||||
Total Biodefense
|
$
|
117.5
|
$
|
77.7
|
51
|
%
|
||||||
Total Biosciences
|
$
|
6.5
|
$
|
6.8
|
(4
|
)%
|
||||||
Total Product Sales
|
$
|
124.0
|
$
|
84.5
|
47
|
%
|
Three Months Ended
September 30,
|
||||||||||||
(in millions)
|
2015
|
2014
|
% Change
|
|||||||||
Research and Development Expenses (Gross)
|
$
|
41.9
|
$
|
44.2
|
(5
|
)%
|
||||||
Adjustments:
|
||||||||||||
Contracts, grants and collaborations revenues
|
29.6
|
44.1
|
(33
|
)%
|
||||||||
Net Research and Development Expenses
|
$
|
12.2
|
$
|
0.1
|
NA
|
Nine Months Ended
September 30,
|
||||||||||||
(in millions)
|
2015
|
2014
|
% Change
|
|||||||||
Product Sales
|
||||||||||||
BioThrax®
|
$
|
182.0
|
$
|
158.0
|
15
|
%
|
||||||
Other biodefense
|
22.5
|
21.4
|
5
|
%
|
||||||||
Total Biodefense
|
$
|
204.5
|
$
|
179.4
|
14
|
%
|
||||||
Total Biosciences
|
$
|
19.8
|
$
|
19.0
|
4
|
%
|
||||||
Total Product Sales
|
$
|
224.3
|
$
|
198.5
|
13
|
%
|
Nine Months Ended
September 30,
|
||||||||||||
(in millions)
|
2015
|
2014
|
% Change
|
|||||||||
Research and Development Expenses (Gross)
|
$
|
121.5
|
$
|
111.9
|
9
|
%
|
||||||
Adjustments:
|
||||||||||||
Contracts, grants and collaboration revenues
|
98.0
|
82.3
|
19
|
%
|
||||||||
Net loss attributable to non-controlling interest
|
--
|
--
|
--
|
|||||||||
Net Research and Development Expenses
|
$
|
23.5
|
$
|
29.6
|
(20
|
)%
|
Three Months Ended September 30,
|
|||||||||
(in millions, except per share value)
|
2015
|
2014
|
Source
|
||||||
GAAP Net Income
|
$
|
36.9
|
$
|
21.8
|
NA
|
||||
Adjustments:
|
|||||||||
Spin-off and acquisition-related costs
(transaction & integration) |
1.0
|
1.0
|
SG&A
|
||||||
Non-cash amortization charges
|
2.7
|
2.6
|
COGS, SG&A,
Other Income |
||||||
Impact of purchase accounting on inventory step-up
|
0.4
|
1.0
|
COGS
|
||||||
Tax effect
|
(1.3
|
)
|
(1.4
|
)
|
NA
|
||||
Total Adjustments
|
2.9
|
3.2
|
NA
|
||||||
Adjusted Net Income
Adjusted Net Income per Diluted Share
|
$
|
39.8
$0.83
|
$
|
25.0
$0.54
|
NA
|
Nine Months Ended September 30,
|
|||||||||
(in millions, except per share value)
|
2015
|
2014
|
Source
|
||||||
GAAP Net Income
|
$
|
29.5
|
$
|
6.6
|
NA
|
||||
Adjustments:
|
|||||||||
Spin-off and acquisition-related costs
(transaction & integration) |
3.5
|
7.4
|
SG&A
|
||||||
Non-cash amortization charges
|
8.1
|
7.2
|
COGS, SG&A,
Other Income |
||||||
Write-off of syndicated loans
|
--
|
1.8
|
Other Income
|
||||||
Impact of purchase accounting on inventory step-up
|
0.6
|
2.0
|
COGS
|
||||||
Tax effect
|
(3.6
|
)
|
(5.5
|
)
|
NA
|
||||
Total Adjustments
|
8.5
|
12.9
|
NA
|
||||||
Adjusted Net Income
Adjusted Net Income per Diluted Share
|
$
|
38.0
$0.81
|
$
|
19.5
$0.51
|
NA
|
Three Months Ended
September 30,
|
||||||||
(in millions, except per share value)
|
2015
|
2014
|
||||||
GAAP Net Income
|
$
|
36.9
|
$
|
21.8
|
||||
Adjustments:
|
||||||||
+ Depreciation & Amortization
|
8.2
|
8.6
|
||||||
+ Provision For Income Taxes
|
15.1
|
7.9
|
||||||
+ Total Interest Expense
|
1.6
|
1.8
|
||||||
Total Adjustments
|
24.9
|
18.3
|
||||||
EBITDA
EBITDA per Diluted Share
|
$
|
61.8
$1.29
|
$
|
40.1
$0.86
|
||||
Additional Adjustments:
|
||||||||
+ Spin-off and acquisition-related costs
(transaction & integration) |
1.0
|
1.0
|
||||||
+ Impact of purchase accounting on inventory step-up
|
0.4
|
1.0
|
||||||
Total Additional Adjustments
|
1.4
|
2.0
|
||||||
Adjusted EBITDA
Adjusted EBITDA per Diluted Share
|
$
|
63.2
$1.32
|
$
|
42.1
$0.90
|
Nine Months Ended
September 30,
|
||||||||
(in millions, except per share value)
|
2015
|
2014
|
||||||
GAAP Net Income
|
$
|
29.5
|
$
|
6.6
|
||||
Adjustments:
|
||||||||
+ Depreciation & Amortization
|
24.7
|
23.2
|
||||||
+ Provision Income Taxes
|
12.4
|
2.1
|
||||||
+ Total Interest Expense
|
4.9
|
7.1
|
||||||
Total Adjustments
|
42.0
|
32.4
|
||||||
EBITDA
EBITDA per Diluted Share
|
$
|
71.5
$1.52
|
$
|
39.0
$1.03
|
||||
Additional Adjustments:
|
||||||||
+ Spin-off and acquisition-related costs
(transaction & integration) |
3.5
|
7.4
|
||||||
+ Impact of purchase accounting on inventory step-up
|
0.6
|
2.0
|
||||||
Total Additional Adjustments
|
4.1
|
9.4
|
||||||
Adjusted EBITDA
Adjusted EBITDA per Diluted Share
|
$
|
75.6
$1.61
|
$
|
48.4
$1.28
|
Live Teleconference Information:
Dial in number: (855) 766-6521
International dial in: (262) 912-6157
Passcode: 48261059
|
Live Webcast Information:
Visit www.emergentbiosolutions.com
and select the "Investors" section
|
Investor Contact
Robert Burrows
Vice President, Investor Relations
(o) 240/631-3280; (m) 240/413-1917
burrowsr@ebsi.com
|
Media Contact
Tracey Schmitt Lintott
Vice President, Global Public Affairs, Corp. Resp.
(o) 240/631-3394
schmittt@ebsi.com
|
Consolidated Balance Sheets
|
||||||||
(in thousands, except share and per share data)
|
||||||||
September 30, 2015
|
December 31, 2014
|
|||||||
ASSETS
|
(Unaudited)
|
|||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
308,718
|
$
|
280,499
|
||||
Accounts receivable
|
57,037
|
58,834
|
||||||
Inventories
|
80,070
|
65,674
|
||||||
Deferred taxes, current portion, net
|
1,483
|
1,710
|
||||||
Income tax receivable, net
|
3,433
|
1,357
|
||||||
Prepaid expenses and other current assets
|
22,749
|
24,101
|
||||||
Total current assets
|
473,490
|
432,175
|
||||||
Property, plant and equipment, net
|
327,643
|
313,979
|
||||||
In-process research and development
|
42,501
|
60,628
|
||||||
Intangible assets, net
|
59,738
|
58,344
|
||||||
Goodwill
|
52,585
|
52,585
|
||||||
Deferred tax assets, long-term, net
|
13,747
|
12,764
|
||||||
Other assets
|
6,844
|
8,216
|
||||||
Total assets
|
$
|
976,548
|
$
|
938,691
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
41,248
|
$
|
40,930
|
||||
Accrued expenses and other current liabilities
|
4,214
|
6,274
|
||||||
Accrued compensation
|
30,089
|
31,654
|
||||||
Contingent consideration, current portion
|
2,490
|
6,487
|
||||||
Provisions for chargebacks
|
1,950
|
2,246
|
||||||
Deferred revenue, current portion
|
8,734
|
5,345
|
||||||
Total current liabilities
|
88,725
|
92,936
|
||||||
Contingent consideration, net of current portion
|
22,271
|
34,599
|
||||||
Long-term indebtedness
|
253,000
|
251,000
|
||||||
Deferred revenue, net of current portion
|
5,987
|
5,713
|
||||||
Other liabilities
|
1,253
|
1,242
|
||||||
Total liabilities
|
371,236
|
385,490
|
||||||
Commitments and contingencies
|
||||||||
Stockholders' equity:
|
||||||||
Preferred stock, $0.001 par value; 15,000,000 shares authorized, 0 shares issued and outstanding at both September 30, 2015 and December 31, 2014
|
-
|
-
|
||||||
Common stock, $0.001 par value; 100,000,000 shares authorized, 39,305,269 shares issued and 38,885,080 shares outstanding at September 30, 2015; 38,129,872 shares issued and 37,709,683 shares outstanding at December 31, 2014
|
39
|
38
|
||||||
Treasury stock, at cost, 420,189 common shares at September 30, 2015 and December 31, 2014
|
(6,320
|
)
|
(6,320
|
)
|
||||
Additional paid-in capital
|
297,953
|
274,222
|
||||||
Accumulated other comprehensive loss
|
(4,152
|
)
|
(3,008
|
)
|
||||
Retained earnings
|
317,792
|
288,269
|
||||||
Total stockholders' equity
|
605,312
|
553,201
|
||||||
Total liabilities and stockholders' equity
|
$
|
976,548
|
$
|
938,691
|
Consolidated Statements of Operations
|
||||||||
(in thousands, except share and per share data)
|
||||||||
Three Months Ended September 30,
|
||||||||
2015
|
2014
|
|||||||
(Unaudited)
|
||||||||
Revenues:
|
||||||||
Product sales
|
$
|
123,953
|
$
|
84,457
|
||||
Contract manufacturing
|
11,341
|
9,433
|
||||||
Contracts, grants and collaborations
|
29,646
|
44,064
|
||||||
Total revenues
|
164,940
|
137,954
|
||||||
Operating expense:
|
||||||||
Cost of product sales and contract manufacturing
|
38,511
|
32,423
|
||||||
Research and development
|
41,868
|
44,207
|
||||||
Selling, general and administrative
|
31,556
|
30,292
|
||||||
Income from operations
|
53,005
|
31,032
|
||||||
Other income (expense):
|
||||||||
Interest income
|
104
|
59
|
||||||
Interest expense
|
(1,635
|
)
|
(1,810
|
)
|
||||
Other income, net
|
602
|
420
|
||||||
Total other expense, net
|
(929
|
)
|
(1,331
|
)
|
||||
Income before provision for income taxes
|
52,076
|
29,701
|
||||||
Provision for income taxes
|
15,134
|
7,869
|
||||||
Net income
|
$
|
36,942
|
$
|
21,832
|
||||
Net income per share - basic
|
$
|
0.95
|
$
|
0.58
|
||||
Net income per share - diluted
|
$
|
0.79
|
$
|
0.49
|
||||
Weighted-average number of shares - basic
|
38,831,341
|
37,507,220
|
||||||
Weighted-average number of shares - diluted
|
47,784,550
|
46,557,163
|
Consolidated Statements of Operations
|
||||||||
(in thousands, except share and per share data)
|
||||||||
Nine Months Ended September 30,
|
||||||||
2015
|
2014
|
|||||||
(Unaudited)
|
||||||||
Revenues:
|
||||||||
Product sales
|
$
|
224,267
|
$
|
198,493
|
||||
Contract manufacturing
|
32,443
|
21,346
|
||||||
Contracts, grants and collaborations
|
97,975
|
82,324
|
||||||
Total revenues
|
354,685
|
302,163
|
||||||
Operating expense:
|
||||||||
Cost of product sales and contract manufacturing
|
84,525
|
85,927
|
||||||
Research and development
|
121,511
|
111,864
|
||||||
Selling, general and administrative
|
102,502
|
90,936
|
||||||
Income from operations
|
46,147
|
13,436
|
||||||
Other income (expense):
|
||||||||
Interest income
|
459
|
130
|
||||||
Interest expense
|
(4,923
|
)
|
(7,066
|
)
|
||||
Other income, net
|
205
|
2,254
|
||||||
Total other expense, net
|
(4,259
|
)
|
(4,682
|
)
|
||||
Income before provision for income taxes
|
41,888
|
8,754
|
||||||
Provision for income taxes
|
12,365
|
2,129
|
||||||
Net income
|
$
|
29,523
|
$
|
6,625
|
||||
Net income per share - basic
|
$
|
0.77
|
$
|
0.18
|
||||
Net income per share - diluted
|
$
|
0.69
|
$
|
0.17
|
||||
Weighted-average number of shares - basic
|
38,423,715
|
37,261,357
|
||||||
Weighted-average number of shares - diluted
|
46,958,179
|
37,885,194
|
Consolidated Statements of Cash Flows
|
||||||||
(in thousands)
|
||||||||
Nine Months Ended September 30,
|
||||||||
2015
|
2014
|
|||||||
Cash flows from operating activities:
|
(Unaudited)
|
|||||||
Net income
|
$
|
29,523
|
$
|
6,625
|
||||
Adjustments to reconcile to net cash provided by (used in) operating activities:
|
||||||||
Stock-based compensation expense
|
11,802
|
9,454
|
||||||
Depreciation and amortization
|
25,859
|
24,286
|
||||||
Incomes taxes
|
15,904
|
1,817
|
||||||
Change in fair value of contingent consideration
|
(10,898
|
)
|
3,216
|
|||||
Write off of debt issuance costs
|
-
|
1,831
|
||||||
Impairment of in-process research and development
|
9,827
|
-
|
||||||
Excess tax benefits from stock-based compensation
|
(8,002
|
)
|
(5,566
|
)
|
||||
Other
|
197
|
541
|
||||||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable
|
1,749
|
36,106
|
||||||
Inventories
|
(14,396
|
)
|
4,729
|
|||||
Income taxes
|
(22,707
|
)
|
(4,447
|
)
|
||||
Prepaid expenses and other assets
|
1,010
|
(10,845
|
)
|
|||||
Accounts payable
|
1,902
|
(11,176
|
)
|
|||||
Accrued expenses and other liabilities
|
(2,060
|
)
|
1,026
|
|||||
Accrued compensation
|
(1,688
|
)
|
(208
|
)
|
||||
Provision for chargebacks
|
(296
|
)
|
(308
|
)
|
||||
Deferred revenue
|
3,663
|
3,416
|
||||||
Net cash provided by operating activities
|
41,389
|
60,497
|
||||||
Cash flows from investing activities:
|
||||||||
Purchases of property, plant and equipment
|
(33,631
|
)
|
(14,621
|
)
|
||||
Acquisition of Cangene Corporation, net of acquired cash
|
-
|
(178,167
|
)
|
|||||
Net cash used in investing activities
|
(33,631
|
)
|
(192,788
|
)
|
||||
Cash flows from financing activities:
|
||||||||
Proceeds from convertible debenture, net of bank fees
|
-
|
241,654
|
||||||
Proceeds from long-term debt obligations
|
2,000
|
1,000
|
||||||
Issuance of common stock upon exercise of stock options
|
15,902
|
10,656
|
||||||
Excess tax benefits from stock-based compensation
|
8,002
|
5,566
|
||||||
Principal payments on long-term indebtedness
|
-
|
(62,000
|
)
|
|||||
Contingent obligation payments
|
(5,427
|
)
|
(1,691
|
)
|
||||
Net cash provided by financing activities
|
20,477
|
195,185
|
||||||
Effect of exchange rate changes on cash and cash equivalents
|
(16
|
)
|
17
|
|||||
Net increase in cash and cash equivalents
|
28,219
|
62,911
|
||||||
Cash and cash equivalents at beginning of period
|
280,499
|
179,338
|
||||||
Cash and cash equivalents at end of period
|
$
|
308,718
|
$
|
242,249
|