|
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)
|
|
·
|
costs associated with the Seattle, Washington site;
|
|
·
|
costs associated with the Berwyn, Pennsylvania site;
|
|
·
|
costs associated with research and development conducted on biosciences-related programs at the Winnipeg, Manitoba, Canada site; and
|
|
·
|
product sales revenue and associated gross margin contribution related to the biosciences commercial products.
|
|
Date: August 6, 2015
|
EMERGENT BIOSOLUTIONS INC.
|
|
|
By:
|
/s/ A.B. Cruz III
A.B. Cruz III
Executive Vice President, General Counsel and Corporate Secretary
|
|
|
·
|
Total revenues: Q2 2015 of $126.1 million, up 14% over prior year; six months 2015 of $189.7 million, up 16% over prior year;
|
|
·
|
GAAP net income/loss: Q2 2015 net income of $14.1 million, or $0.32 per diluted share; six months 2015 net loss of $7.4 million, or $0.19 per diluted share;
|
|
·
|
Adjusted net income/loss: Q2 2015 net income of $17.0 million, or $0.36 per diluted share; six months 2015 net loss of $1.8 million, or $0.05 per diluted share;
|
|
·
|
EBITDA: Q2 2015 of $29.6 million, or $0.62 per diluted share; six months 2015 of $9.6 million, or $0.25 per diluted share; and
|
|
·
|
Adjusted EBITDA: Q2 2015 of $31.0 million, or $0.65 per diluted share; six months 2015 of $12.2 million, or $0.32 per diluted share.
|
|
·
|
FDA approval of Anthrasil™
|
|
·
|
Awards to manufacture Ebola monoclonal antibodies under our CIADM arrangement with BARDA
|
|
·
|
Successful dosing of our first patient in the Phase I trial for MOR209/ES414, our immunotherapeutic treatment for prostate cancer
|
|
·
|
FDA approval and launch of IXINITY®, a recombinant factor IX treatment for Hemophilia B
|
|
·
|
Continued steady progress on Building 55 sBLA approval
|
|
·
|
Reaffirmation of previous guidance – FY 2015 total revenues of $510-$540 million, net income of $50-$60 million (GAAP) and $60-$70 million (adjusted); and
|
|
·
|
New guidance – Q3 2015 total revenues of $140 to $155 million.
|
|
Three Months Ended
June 30,
|
||||||||||||
|
(in millions)
|
2015
|
2014
|
% Change
|
|||||||||
|
Product Sales
|
||||||||||||
|
BioThrax®
|
$
|
72.2
|
$
|
67.5
|
7
|
%
|
||||||
|
Other biodefense
|
2.8
|
1.9
|
47
|
%
|
||||||||
|
Total Biodefense
|
$
|
75.0
|
$
|
69.4
|
8
|
%
|
||||||
|
Total Biosciences
|
$
|
7.0
|
$
|
8.9
|
(21
|
)%
|
||||||
|
Total Product Sales
|
$
|
82.0
|
$
|
78.3
|
5
|
%
|
||||||
|
Three Months Ended
June 30,
|
||||||||||||
|
(in millions)
|
2015
|
2014
|
% Change
|
|||||||||
|
Research and Development Expenses (Gross)
|
$
|
40.9
|
$
|
37.4
|
9
|
%
|
||||||
|
Adjustments:
|
||||||||||||
|
Contracts, grants and collaborations revenues
|
35.2
|
22.9
|
54
|
%
|
||||||||
|
Net Research and Development Expenses
|
$
|
5.7
|
$
|
14.5
|
(61
|
)%
|
||||||
|
Six Months Ended
June 30,
|
||||||||||||
|
(in millions)
|
2015
|
2014
|
% Change
|
|||||||||
|
Product Sales
|
||||||||||||
|
BioThrax®
|
$
|
72.2
|
$
|
92.0
|
(22
|
)%
|
||||||
|
Other biodefense
|
14.8
|
10.0
|
48
|
%
|
||||||||
|
Total Biodefense
|
$
|
87.0
|
$
|
102.0
|
(15
|
)%
|
||||||
|
Total Biosciences
|
$
|
13.3
|
$
|
12.0
|
11
|
%
|
||||||
|
Total Product Sales
|
$
|
100.3
|
$
|
114.0
|
(12
|
)%
|
||||||
|
Six Months Ended
June 30,
|
||||||||||||
|
(in millions)
|
2015
|
2014
|
% Change
|
|||||||||
|
Research and Development Expenses (Gross)
|
$
|
79.6
|
$
|
67.7
|
18
|
%
|
||||||
|
Adjustments:
|
||||||||||||
|
Contracts, grants and collaboration revenues
|
68.3
|
38.3
|
78
|
%
|
||||||||
|
Net loss attributable to non-controlling interest
|
--
|
--
|
--
|
|||||||||
|
Net Research and Development Expenses
|
$
|
11.3
|
$
|
29.4
|
(62
|
)%
|
||||||
|
Three Months Ended
June 30,
|
|||||||||
|
(in millions, except per share price)
|
2015
|
2014
|
Source
|
||||||
|
GAAP Net Income
|
$
|
14.1
|
$
|
5.0
|
NA
|
||||
|
Adjustments:
|
|||||||||
|
Acquisition-related costs
(transaction & integration) |
1.4
|
2.4
|
SG&A
|
||||||
|
Non-cash amortization charges
|
2.8
|
2.9
|
COGS, SG&A,
Other Income |
||||||
|
Impact of purchase accounting on inventory step-up
|
--
|
1.0
|
COGS
|
||||||
|
Tax effect
|
(1.3
|
)
|
(1.9
|
)
|
NA
|
||||
|
Total Adjustments
|
2.9
|
4.4
|
NA
|
||||||
|
Adjusted Net Income
|
$
|
17.0
|
$
|
9.4
|
NA
|
||||
|
Adjusted Net Income Per Diluted Share
|
$
|
0.36
|
$
|
0.25
|
NA
|
||||
|
Six Months Ended
June 30,
|
|||||||||
|
(in millions, except per share price)
|
2015
|
2014
|
Source
|
||||||
|
GAAP Net Loss
|
$
|
(7.4
|
)
|
$
|
(15.2
|
)
|
NA
|
||
|
Adjustments:
|
|||||||||
|
Acquisition-related costs
(transaction & integration) |
2.5
|
6.3
|
SG&A
|
||||||
|
Non-cash amortization charges
|
5.3
|
4.5
|
COGS, SG&A,
Other Income |
||||||
|
Write-off of syndicated loans
|
--
|
1.8
|
Other Income
|
||||||
|
Impact of purchase accounting on inventory step-up
|
0.1
|
1.4
|
COGS
|
||||||
|
Tax effect
|
(2.4
|
)
|
(4.2
|
)
|
NA
|
||||
|
Total Adjustments
|
5.6
|
9.8
|
NA
|
||||||
|
Adjusted Loss
|
$
|
(1.8
|
)
|
$
|
(5.4
|
)
|
NA
|
||
|
Adjusted Net Loss Per Diluted Share
|
$
|
(0.05
|
)
|
$
|
(0.15
|
)
|
NA
|
||
|
Three Months Ended
June 30,
|
||||||||
|
(in millions, except per share price)
|
2015
|
2014
|
||||||
|
GAAP Net Income
|
$
|
14.1
|
$
|
5.0
|
||||
|
Adjustments:
|
||||||||
|
+ Depreciation & Amortization
|
8.4
|
8.0
|
||||||
|
+ Provision For Income Taxes
|
5.5
|
2.5
|
||||||
|
- Total Interest Expense
|
1.6
|
1.7
|
||||||
|
Total Adjustments
|
15.5
|
12.2
|
||||||
|
EBITDA
|
$
|
29.6
|
$
|
17.2
|
||||
|
Additional Adjustments:
|
||||||||
|
Acquisition-related costs (transaction & integration)
|
1.4
|
2.4
|
||||||
|
Impact of purchase accounting on inventory step-up
|
--
|
1.0
|
||||||
|
Total Additional Adjustments
|
1.4
|
3.4
|
||||||
|
Adjusted EBITDA
|
$
|
31.0
|
$
|
20.6
|
||||
|
Six Months Ended
June 30,
|
||||||||
|
(in millions, except per share price)
|
2015
|
2014
|
||||||
|
GAAP Net Loss
|
$
|
(7.4
|
)
|
$
|
(15.2
|
)
|
||
|
Adjustments:
|
||||||||
|
+ Depreciation & Amortization
|
16.5
|
14.6
|
||||||
|
+ Benefit From Income Taxes
|
(2.8
|
)
|
(5.7
|
)
|
||||
|
- Total Interest Expense
|
3.3
|
5.3
|
||||||
|
Total Adjustments
|
17.0
|
14.2
|
||||||
|
EBITDA
|
$
|
9.6
|
$
|
(1.0
|
)
|
|||
|
Additional Adjustments:
|
||||||||
|
Acquisition-related costs (transaction & integration)
|
2.5
|
6.3
|
||||||
|
Impact of purchase accounting on inventory step-up
|
0.1
|
1.4
|
||||||
|
Total Additional Adjustments
|
2.6
|
7.7
|
||||||
|
Adjusted EBITDA
|
$
|
12.2
|
$
|
6.7
|
||||
|
Live Teleconference Information:
Dial in number: (855) 766-6521
International dial in: (262) 912-6157
Passcode: 78708197
|
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
|
Media Contact
Tracey Schmitt
Vice President, Global Public Affairs, Corp. Resp.
(o) 240/631-3394
|
|
Consolidated Balance Sheets
|
||||||||
|
(in thousands, except share and per share data)
|
||||||||
|
June 30, 2015
|
December 31, 2014
|
|||||||
|
ASSETS
|
(Unaudited)
|
|||||||
|
Current assets:
|
||||||||
|
Cash and cash equivalents
|
$
|
214,841
|
$
|
280,499
|
||||
|
Accounts receivable
|
99,718
|
58,834
|
||||||
|
Inventories
|
84,708
|
65,674
|
||||||
|
Deferred taxes, current portion, net
|
1,483
|
1,710
|
||||||
|
Income tax receivable, net
|
13,142
|
1,357
|
||||||
|
Prepaid expenses and other current assets
|
21,596
|
24,101
|
||||||
|
Total current assets
|
435,488
|
432,175
|
||||||
|
Property, plant and equipment, net
|
320,084
|
313,979
|
||||||
|
In-process research and development
|
52,328
|
60,628
|
||||||
|
Intangible assets, net
|
62,110
|
58,344
|
||||||
|
Goodwill
|
52,585
|
52,585
|
||||||
|
Deferred tax assets, long-term, net
|
13,481
|
12,764
|
||||||
|
Other assets
|
7,247
|
8,216
|
||||||
|
Total assets
|
$
|
943,323
|
$
|
938,691
|
||||
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
|
Current liabilities:
|
||||||||
|
Accounts payable
|
$
|
41,824
|
$
|
40,930
|
||||
|
Accrued expenses and other current liabilities
|
6,442
|
6,274
|
||||||
|
Accrued compensation
|
26,320
|
31,654
|
||||||
|
Contingent consideration, current portion
|
3,040
|
6,487
|
||||||
|
Provisions for chargebacks
|
1,993
|
2,246
|
||||||
|
Deferred revenue, current portion
|
7,343
|
5,345
|
||||||
|
Total current liabilities
|
86,962
|
92,936
|
||||||
|
Contingent consideration, net of current portion
|
33,795
|
34,599
|
||||||
|
Long-term indebtedness
|
253,000
|
251,000
|
||||||
|
Deferred revenue, net of current portion
|
6,083
|
5,713
|
||||||
|
Other liabilities
|
1,232
|
1,242
|
||||||
|
Total liabilities
|
381,072
|
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 June 30, 2015 and December 31, 2014
|
-
|
-
|
||||||
|
Common stock, $0.001 par value; 100,000,000 shares authorized, 39,162,799 shares issued and 38,742,610 shares outstanding at June 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 both June 30, 2015 and December 31, 2014
|
(6,320
|
)
|
(6,320
|
)
|
||||
|
Additional paid-in capital
|
291,339
|
274,222
|
||||||
|
Accumulated other comprehensive loss
|
(3,657
|
)
|
(3,008
|
)
|
||||
|
Retained earnings
|
280,850
|
288,269
|
||||||
|
Total stockholders' equity
|
562,251
|
553,201
|
||||||
|
Total liabilities and stockholders' equity
|
$
|
943,323
|
$
|
938,691
|
||||
|
Consolidated Statements of Operations
|
||||||||
|
(in thousands, except share and per share data)
|
||||||||
|
Three Months Ended June 30,
|
||||||||
|
2015
|
2014
|
|||||||
|
(Unaudited)
|
||||||||
|
Revenues:
|
||||||||
|
Product sales
|
$
|
82,023
|
$
|
78,269
|
||||
|
Contract manufacturing
|
8,859
|
9,187
|
||||||
|
Contracts, grants and collaborations
|
35,230
|
22,869
|
||||||
|
Total revenues
|
126,112
|
110,325
|
||||||
|
Operating expense:
|
||||||||
|
Cost of product sales and contract manufacturing
|
27,266
|
34,507
|
||||||
|
Research and development
|
40,941
|
37,401
|
||||||
|
Selling, general and administrative
|
36,453
|
30,555
|
||||||
|
Income from operations
|
21,452
|
7,862
|
||||||
|
Other income (expense):
|
||||||||
|
Interest income
|
273
|
31
|
||||||
|
Interest expense
|
(1,628
|
)
|
(1,721
|
)
|
||||
|
Other income, net
|
(497
|
)
|
1,322
|
|||||
|
Total other expense, net
|
(1,852
|
)
|
(368
|
)
|
||||
|
Income before provision for income taxes
|
19,600
|
7,494
|
||||||
|
Provision for income taxes
|
5,500
|
2,465
|
||||||
|
Net income
|
$
|
14,100
|
$
|
5,029
|
||||
|
Income per share - basic
|
$
|
0.37
|
$
|
0.13
|
||||
|
Income per share – diluted (1)
|
$
|
0.32
|
$
|
0.13
|
||||
|
Weighted-average number of shares - basic
|
38,480,754
|
37,416,554
|
||||||
|
Weighted-average number of shares - diluted
|
47,410,413
|
38,333,425
|
||||||
|
(1)
|
Due to the if-converted method of accounting for dilutive earnings per share for the three months ended June 30, 2015, the calculation of diluted earnings per share includes adjustments to net income of $809,000 and $219,000, respectively, for interest expense and amortization of debt issuance costs associated with our 2.875% Convertible Senior Notes due 2021.
|
|
Consolidated Statements of Operations
|
||||||||
|
(in thousands, except share and per share data)
|
||||||||
|
Six Months Ended June 30,
|
||||||||
|
2015
|
2014
|
|||||||
|
(Unaudited)
|
||||||||
|
Revenues:
|
||||||||
|
Product sales
|
$
|
100,314
|
$
|
114,036
|
||||
|
Contract manufacturing
|
21,102
|
11,913
|
||||||
|
Contracts, grants and collaborations
|
68,329
|
38,260
|
||||||
|
Total revenues
|
189,745
|
164,209
|
||||||
|
Operating expense:
|
||||||||
|
Cost of product sales and contract manufacturing
|
46,014
|
53,504
|
||||||
|
Research and development
|
79,643
|
67,657
|
||||||
|
Selling, general and administrative
|
70,946
|
60,644
|
||||||
|
Income from operations
|
(6,858
|
)
|
(17,596
|
)
|
||||
|
Other income (expense):
|
||||||||
|
Interest income
|
355
|
71
|
||||||
|
Interest expense
|
(3,288
|
)
|
(5,256
|
)
|
||||
|
Other income, net
|
(397
|
)
|
1,834
|
|||||
|
Total other expense, net
|
(3,330
|
)
|
(3,351
|
)
|
||||
|
Loss before benefit from income taxes
|
(10,188
|
)
|
(20,947
|
)
|
||||
|
Benefit from income taxes
|
(2,769
|
)
|
(5,740
|
)
|
||||
|
Net loss
|
$
|
(7,419
|
)
|
$
|
(15,207
|
)
|
||
|
Loss per share - basic
|
$
|
(0.19
|
)
|
$
|
(0.41
|
)
|
||
|
Loss per share - diluted
|
$
|
(0.19
|
)
|
$
|
(0.41
|
)
|
||
|
Weighted-average number of shares - basic
|
38,216,524
|
37,137,015
|
||||||
|
Weighted-average number of shares - diluted
|
38,216,524
|
37,137,015
|
||||||
|
Consolidated Statements of Cash Flows
|
||||||||
|
(in thousands)
|
||||||||
|
Six Months Ended June 30,
|
||||||||
|
2015
|
2014
|
|||||||
|
Cash flows from operating activities:
|
(Unaudited)
|
|||||||
|
Net loss
|
$
|
(7,419
|
)
|
$
|
(15,207
|
)
|
||
|
Adjustments to reconcile to net cash provided by (used in) operating activities:
|
||||||||
|
Stock-based compensation expense
|
7,790
|
6,015
|
||||||
|
Depreciation and amortization
|
17,298
|
15,294
|
||||||
|
Incomes taxes
|
630
|
(5,199
|
)
|
|||||
|
Change in fair value of contingent consideration
|
751
|
1,630
|
||||||
|
Write off of debt issuance costs
|
-
|
1,831
|
||||||
|
Excess tax benefits from stock-based compensation
|
(7,241
|
)
|
(5,179
|
)
|
||||
|
Other
|
153
|
499
|
||||||
|
Changes in operating assets and liabilities:
|
||||||||
|
Accounts receivable
|
(40,884
|
)
|
2,274
|
|||||
|
Inventories
|
(19,034
|
)
|
1,232
|
|||||
|
Income taxes
|
(16,740
|
)
|
(5,184
|
)
|
||||
|
Prepaid expenses and other assets
|
2,465
|
(567
|
)
|
|||||
|
Accounts payable
|
2,062
|
(10,357
|
)
|
|||||
|
Accrued expenses and other liabilities
|
157
|
(644
|
)
|
|||||
|
Accrued compensation
|
(5,473
|
)
|
(3,902
|
)
|
||||
|
Provision for chargebacks
|
(253
|
)
|
284
|
|||||
|
Deferred revenue
|
2,368
|
(1,246
|
)
|
|||||
|
Net cash used in operating activities
|
(63,370
|
)
|
(18,426
|
)
|
||||
|
Cash flows from investing activities:
|
||||||||
|
Purchases of property, plant and equipment
|
(19,681
|
)
|
(9,400
|
)
|
||||
|
Acquisition of Cangene Corporation, net of acquired cash
|
-
|
(178,167
|
)
|
|||||
|
Net cash used in investing activities
|
(19,681
|
)
|
(187,567
|
)
|
||||
|
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
|
13,162
|
9,969
|
||||||
|
Excess tax benefits from stock-based compensation
|
7,241
|
5,179
|
||||||
|
Principal payments on long-term indebtedness
|
-
|
(62,000
|
)
|
|||||
|
Contingent obligation payments
|
(5,002
|
)
|
(1,019
|
)
|
||||
|
Net cash provided by financing activities
|
17,401
|
194,783
|
||||||
|
Effect of exchange rate changes on cash and cash equivalents
|
(8
|
)
|
2
|
|||||
|
Net decrease in cash and cash equivalents
|
(65,658
|
)
|
(11,208
|
)
|
||||
|
Cash and cash equivalents at beginning of period
|
280,499
|
179,338
|
||||||
|
Cash and cash equivalents at end of period
|
$
|
214,841
|
$
|
168,130
|
||||
|
·
|
tailor business strategies to best address opportunities within its target market,
|
|
·
|
enhance business focus and better align resources to achieve strategic priorities,
|
|
·
|
pursue distinct capital structures and capital allocation strategies, and
|
|
·
|
target investors attracted to its business profile.
|
|
·
|
the ADAPTIR™ (modular protein technology) platform including bi-specific therapeutics based on Redirected T-cell Cytotoxicity (RTCC), a promising approach within immuno-oncology,
|
|
·
|
MOR209/ES414, a bi-specific therapeutic for metastatic castration resistant prostate cancer currently in Phase 1 clinical development in partnership with MorphoSys AG, and
|
|
·
|
a commercial product portfolio consisting of IXINITY, WinRho, HepaGam B, and VARIZIG.
|
|
·
|
establish itself as a "pure play" biopharmaceutical company in the highly attractive immuno-oncology field,
|
|
·
|
target investments and operations in the development of bi-specific therapeutics using the proprietary ADAPTIR platform technology,
|
|
·
|
increase awareness of ADAPTIR's RTCC mechanism of action, and
|
|
·
|
provide greater visibility into its innovative platform technology and product candidates for potential collaborators.
|
|
·
|
establish itself as a "pure play" company, recognized as a leader in the biodefense and emerging infectious diseases fields,
|
|
·
|
enhance its financial returns and operating margins through the elimination of biosciences related R&D, sales, marketing and G&A costs, and
|
|
·
|
allow greater flexibility in its capital allocation decisions.
|
|
Live Teleconference Information:
Dial in number: 855-766-6521 International dial in: 262-912-6157 Passcode: 78708197 |
Live Webcast Information:
Visit www.emergentbiosolutions.com and select the "Investors" section |
|
Teleconference Replay:
Dial in number: 855-859-2056 International dial in: 404-537-3406 Passcode: 78708197 Available through August 20, 2015 |
Webcast Archive:
Visit www.emergentbiosolutions.com and select the "Investors" section |
|
The company has posted a presentation regarding the transaction that is accessible via the following link: www.emergentbiosolutions.com/investors
|
|













