|
Delaware
|
001-33137
|
14-1902018
|
|
(State or Other Jurisdiction
of Incorporation)
|
(Commission
File Number)
|
(IRS Employer
Identification No.)
|
|
2273 Research Boulevard, Suite 400, Rockville, Maryland
|
20850
|
|
(Address of Principal Executive Offices)
|
(Zip Code)
|
|
Date: November 1, 2012
|
EMERGENT BIOSOLUTIONS INC.
|
|
|
By:
|
/s/Jay G. Reilly
Jay G. Reilly
General Counsel
|
|
|
·
|
Q3 2012 total revenues of $66.6 million; YTD 2012 total revenues of $187.3 million
|
|
·
|
Q3 2012 net income of $6.6 million, or $0.18 per basic share
|
|
·
|
YTD 2012 net income of $7.4 million, or $0.21 per basic share
|
|
·
|
FY 2012 guidance reaffirmed: total revenues of $280 to $300 million and net income of $15 to $25 million
|
|
·
|
Completed manufacture of BioThrax® (Anthrax Vaccine Adsorbed) consistency lots in Building 55;
|
|
·
|
Secured BARDA contract option to further advance the development of PreviThrax™ (Recombinant Protective Antigen Anthrax Vaccine, Purified); and
|
|
·
|
Completed phase 1b comparative study evaluating TRU-016 in combination with bendamustine and rituximab in relapsed indolent non-Hodgkin's lymphoma.
|
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||
|
Consolidated Balance Sheets
|
||||||||
|
(in thousands, except share and per share data)
|
||||||||
|
|
||||||||
|
|
September 30,
|
December 31,
|
||||||
|
|
2012
|
2011
|
||||||
|
ASSETS
|
(Unaudited)
|
|||||||
|
Current assets:
|
||||||||
|
Cash and cash equivalents
|
$
|
197,901
|
$
|
143,901
|
||||
|
Investments
|
-
|
1,966
|
||||||
|
Accounts receivable
|
17,085
|
74,153
|
||||||
|
Inventories
|
18,245
|
14,661
|
||||||
|
Deferred tax assets, net
|
327
|
1,735
|
||||||
|
Income tax receivable, net
|
9,618
|
9,506
|
||||||
|
Restricted cash
|
-
|
220
|
||||||
|
Prepaid expenses and other current assets
|
9,759
|
8,276
|
||||||
|
Total current assets
|
252,935
|
254,418
|
||||||
|
|
||||||||
|
Property, plant and equipment, net
|
232,310
|
208,973
|
||||||
|
In-process research and development
|
41,800
|
51,400
|
||||||
|
Goodwill
|
5,502
|
5,502
|
||||||
|
Assets held for sale
|
-
|
11,765
|
||||||
|
Deferred tax assets, net
|
6,728
|
13,999
|
||||||
|
Other assets
|
750
|
807
|
||||||
|
|
||||||||
|
Total assets
|
$
|
540,025
|
$
|
546,864
|
||||
|
|
||||||||
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
|
Current liabilities:
|
||||||||
|
Accounts payable
|
$
|
27,348
|
$
|
40,530
|
||||
|
Accrued expenses and other current liabilities
|
1,332
|
1,170
|
||||||
|
Accrued compensation
|
16,170
|
20,884
|
||||||
|
Contingent value rights, current portion
|
-
|
1,748
|
||||||
|
Long-term indebtedness, current portion
|
4,148
|
5,360
|
||||||
|
Deferred revenue
|
1,574
|
1,362
|
||||||
|
Total current liabilities
|
50,572
|
71,054
|
||||||
|
|
||||||||
|
Contingent value rights, net of current portion
|
-
|
3,005
|
||||||
|
Long-term indebtedness, net of current portion
|
58,866
|
54,094
|
||||||
|
Other liabilities
|
2,175
|
1,984
|
||||||
|
Total liabilities
|
111,613
|
130,137
|
||||||
|
|
||||||||
|
Commitments and contingencies
|
||||||||
|
|
||||||||
|
Stockholders' equity:
|
||||||||
|
Preferred stock, $0.001 par value; 15,000,000 shares authorized, 0 shares issued and outstanding at September 30, 2012 and December 31, 2011, respectively
|
-
|
-
|
||||||
|
Common stock, $0.001 par value; 100,000,000 shares authorized, 36,237,537 shares issued and 36,139,937 shares outstanding at September 30, 2012; 36,002,698 shares issued and outstanding at December 31, 2011
|
36
|
36
|
||||||
|
Additional paid-in capital
|
228,080
|
220,654
|
||||||
|
Treasury stock, at cost, 97,600 common shares at September 30, 2012
|
(1,457
|
)
|
-
|
|||||
|
Accumulated other comprehensive loss
|
(3,901
|
)
|
(3,313
|
)
|
||||
|
Retained earnings
|
204,286
|
196,869
|
||||||
|
Total Emergent BioSolutions Inc. stockholders' equity
|
427,044
|
414,246
|
||||||
|
Noncontrolling interest in subsidiaries
|
1,368
|
2,481
|
||||||
|
Total stockholders' equity
|
428,412
|
416,727
|
||||||
|
Total liabilities and stockholders' equity
|
$
|
540,025
|
$
|
546,864
|
||||
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||
|
Consolidated Statements of Operations
|
||||||||
|
(in thousands, except share and per share data)
|
||||||||
|
|
||||||||
|
|
Three Months Ended
|
|||||||
|
|
September 30,
|
|||||||
|
|
2012
|
2011
|
||||||
|
|
(Unaudited)
|
|||||||
|
Revenues:
|
||||||||
|
Product sales
|
$
|
54,011
|
$
|
43,663
|
||||
|
Contracts and grants
|
12,581
|
15,099
|
||||||
|
Total revenues
|
66,592
|
58,762
|
||||||
|
|
||||||||
|
Operating expense:
|
||||||||
|
Cost of product sales
|
10,230
|
10,706
|
||||||
|
Research and development
|
27,390
|
29,216
|
||||||
|
Selling, general and administrative
|
19,155
|
17,432
|
||||||
|
Income from operations
|
9,817
|
1,408
|
||||||
|
|
||||||||
|
Other income (expense):
|
||||||||
|
Interest income
|
55
|
22
|
||||||
|
Interest expense
|
-
|
-
|
||||||
|
Other income (expense), net
|
(16
|
)
|
37
|
|||||
|
Total other income (expense)
|
39
|
59
|
||||||
|
|
||||||||
|
Income before provision for income taxes
|
9,856
|
1,467
|
||||||
|
Provision for income taxes
|
4,236
|
1,604
|
||||||
|
Net income (loss)
|
5,620
|
(137
|
)
|
|||||
|
Net loss attributable to noncontrolling interest
|
997
|
1,686
|
||||||
|
Net income attributable to Emergent BioSolutions Inc.
|
$
|
6,617
|
$
|
1,549
|
||||
|
|
||||||||
|
Income per share - basic
|
$
|
0.18
|
$
|
0.04
|
||||
|
Income per share - diluted
|
$
|
0.18
|
$
|
0.04
|
||||
|
|
||||||||
|
Weighted-average number of shares - basic
|
36,202,801
|
35,855,217
|
||||||
|
Weighted-average number of shares - diluted
|
36,670,094
|
36,447,933
|
||||||
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||
|
Consolidated Statements of Operations
|
||||||||
|
(in thousands, except share and per share data)
|
||||||||
|
|
||||||||
|
|
Nine Months Ended
|
|||||||
|
|
September 30,
|
|||||||
|
|
2012
|
2011
|
||||||
|
|
(Unaudited)
|
|||||||
|
Revenues:
|
||||||||
|
Product sales
|
$
|
141,529
|
$
|
120,739
|
||||
|
Contracts and grants
|
45,753
|
44,697
|
||||||
|
Total revenues
|
187,282
|
165,436
|
||||||
|
|
||||||||
|
Operating expense:
|
||||||||
|
Cost of product sales
|
30,927
|
27,843
|
||||||
|
Research and development
|
84,281
|
95,456
|
||||||
|
Selling, general and administrative
|
56,542
|
56,028
|
||||||
|
Impairment of in-process research and development
|
9,600
|
-
|
||||||
|
Income (loss) from operations
|
5,932
|
(13,891
|
)
|
|||||
|
|
||||||||
|
Other income (expense):
|
||||||||
|
Interest income
|
103
|
81
|
||||||
|
Interest expense
|
-
|
-
|
||||||
|
Other income (expense), net
|
1,745
|
(9
|
)
|
|||||
|
Total other income (expense)
|
1,848
|
72
|
||||||
|
|
||||||||
|
Income (loss) before provision for (benefit from) income taxes
|
7,780
|
(13,819
|
)
|
|||||
|
Provision for (benefit from) income taxes
|
4,639
|
(3,032
|
)
|
|||||
|
Net income (loss)
|
3,141
|
(10,787
|
)
|
|||||
|
Net loss attributable to noncontrolling interest
|
4,276
|
5,149
|
||||||
|
Net income (loss) attributable to Emergent BioSolutions Inc.
|
$
|
7,417
|
$
|
(5,638
|
)
|
|||
|
|
||||||||
|
Income (loss) per share - basic
|
$
|
0.21
|
$
|
(0.16
|
)
|
|||
|
Income (loss) per share - diluted
|
$
|
0.20
|
$
|
(0.16
|
)
|
|||
|
|
||||||||
|
Weighted-average number of shares - basic
|
36,144,242
|
35,552,900
|
||||||
|
Weighted-average number of shares - diluted
|
36,424,630
|
35,552,900
|
||||||
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||
|
Consolidated Statements of Cash Flows
|
||||||||
|
(in thousands)
|
||||||||
|
|
Nine Months Ended
|
|||||||
|
|
September 30,
|
|||||||
|
|
2012
|
2011
|
||||||
|
|
(Unaudited)
|
|||||||
|
Cash flows from operating activities:
|
||||||||
|
Net income (loss)
|
$
|
3,141
|
$
|
(10,787
|
)
|
|||
|
Adjustments to reconcile to net cash provided by (used in) operating activities:
|
||||||||
|
Stock-based compensation expense
|
8,417
|
7,911
|
||||||
|
Depreciation and amortization
|
7,679
|
6,926
|
||||||
|
Deferred income taxes
|
8,679
|
11,937
|
||||||
|
Non-cash development expenses from joint ventures
|
3,163
|
4,263
|
||||||
|
Change in fair value of contingent value rights
|
(3,005
|
)
|
1,325
|
|||||
|
Impairment of in-process research and development
|
9,600
|
-
|
||||||
|
Impairment of long-lived assets
|
-
|
676
|
||||||
|
Excess tax benefits from stock-based compensation
|
1,485
|
(1,502
|
)
|
|||||
|
Other
|
(39
|
)
|
60
|
|||||
|
Changes in operating assets and liabilities:
|
||||||||
|
Accounts receivable
|
57,006
|
(9,705
|
)
|
|||||
|
Inventories
|
(3,584
|
)
|
(5,257
|
)
|
||||
|
Income taxes
|
(1,597
|
)
|
(15,760
|
)
|
||||
|
Prepaid expenses and other assets
|
(1,544
|
)
|
132
|
|||||
|
Accounts payable
|
(3,495
|
)
|
(278
|
)
|
||||
|
Accrued expenses and other liabilities
|
301
|
(194
|
)
|
|||||
|
Accrued compensation
|
(4,790
|
)
|
(9,350
|
)
|
||||
|
Deferred revenue
|
212
|
(5,143
|
)
|
|||||
|
Net cash provided by (used in) operating activities
|
81,629
|
(24,746
|
)
|
|||||
|
Cash flows from investing activities:
|
||||||||
|
Purchases of property, plant and equipment
|
(40,943
|
)
|
(34,153
|
)
|
||||
|
Proceeds from sale of assets
|
11,765
|
-
|
||||||
|
Proceeds from maturity of investments
|
1,966
|
3,750
|
||||||
|
Purchase of investments
|
-
|
(5,220
|
)
|
|||||
|
Net cash used in investing activities
|
(27,212
|
)
|
(35,623
|
)
|
||||
|
Cash flows from financing activities:
|
||||||||
|
Proceeds from borrowings on long-term indebtedness
|
12,946
|
21,298
|
||||||
|
Issuance of common stock subject to exercise of stock options
|
495
|
8,836
|
||||||
|
Excess tax benefits from stock-based compensation
|
(1,485
|
)
|
1,502
|
|||||
|
Principal payments on long-term indebtedness
|
(9,386
|
)
|
(14,931
|
)
|
||||
|
Contingent value right payment
|
(1,748
|
)
|
-
|
|||||
|
Purchase of treasury stock
|
(1,457
|
)
|
-
|
|||||
|
Release of restricted cash deposit
|
220
|
-
|
||||||
|
Net cash provided by (used in) financing activities
|
(415
|
)
|
16,705
|
|||||
|
|
||||||||
|
Effect of exchange rate changes on cash and cash equivalents
|
(2
|
)
|
(9
|
)
|
||||
|
|
||||||||
|
Net increase (decrease) in cash and cash equivalents
|
54,000
|
(43,673
|
)
|
|||||
|
Cash and cash equivalents at beginning of period
|
143,901
|
169,019
|
||||||
|
Cash and cash equivalents at end of period
|
$
|
197,901
|
125,346
|
|||||
|
·
|
Generate annual product revenue of greater than $500 million;
|
|
·
|
Achieve a three-year (2012-2015) compound net income growth rate of greater than 15%; and
|
|
·
|
Secure diversified revenues from at least three marketed specialty products.
|
|
·
|
The company's recognized leadership position in the biodefense field, which can be leveraged to advance its existing pipeline and to acquire new products for this specialty market;
|
|
·
|
The company's breadth and depth of resources and expertise in biologics manufacturing and advanced-stage product development;
|
|
·
|
The company's expertise and capabilities in government and NGO contracting and partnering; and
|
|
·
|
The company's experience and expertise in structuring and closing acquisition transactions.
|
|
1)
|
Acquire synergistic revenue generating products in biodefense and other specialty markets. This approach is designed to advance the company towards the achievement of the 2015 goals by:
|
|
·
|
increasing revenue through product acquisitions addressing specialty markets where existing capabilities can improve product performance and financial returns;
|
|
·
|
enhancing contributions to net income growth; and
|
|
·
|
providing product revenue diversification.
|
|
2)
|
Focus product development efforts on promising late-stage candidates. This approach is designed to advance the company towards the achievement of the 2015 goals by:
|
|
·
|
advancing only those programs that have achieved clinically important milestones that justify further research and development investments;
|
|
·
|
enhancing the value of development expenditures by focusing on products that have the potential for nearer term regulatory approval; and
|
|
·
|
minimizing early stage research and development costs that are not funded by third parties.
|
|
3)
|
Expand collaborations with third parties such as governments and NGOs. This approach is designed to advance the company toward the achievement of the 2015 goals by:
|
|
·
|
mitigating operational risk through the knowledge, capabilities and expertise provided by partners and collaborators; and
|
|
·
|
offsetting development expenditures through non-dilutive funding.
|