ITEM 1. FINANCIAL STATEMENTS
Emergent BioSolutions Inc.
Condensed Consolidated Balance Sheets
(unaudited, in millions, except per share amounts)
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June 30, 2021
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December 31, 2020
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ASSETS
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Current assets:
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Cash and cash equivalents
|
$
|
447.5
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|
|
$
|
621.3
|
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Restricted cash
|
0.2
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|
|
0.2
|
|
Accounts receivable, net
|
261.9
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|
|
230.9
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|
Inventories, net
|
386.4
|
|
|
307.0
|
|
Prepaid expenses and other current assets
|
66.1
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|
36.5
|
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Total current assets
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1,162.1
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|
1,195.9
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Property, plant and equipment, net
|
743.5
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|
644.1
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Intangible assets, net
|
633.1
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|
663.1
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Goodwill
|
266.6
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|
266.7
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Other assets
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109.9
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|
113.4
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Total assets
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$
|
2,915.2
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$
|
2,883.2
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LIABILITIES AND STOCKHOLDERS' EQUITY
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Current liabilities:
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Accounts payable
|
$
|
151.8
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|
|
$
|
136.1
|
|
Accrued expenses
|
33.8
|
|
|
46.9
|
|
Accrued compensation
|
63.2
|
|
|
84.6
|
|
Debt, current portion
|
28.8
|
|
|
33.8
|
|
Other current liabilities
|
100.2
|
|
|
83.1
|
|
Total current liabilities
|
377.8
|
|
|
384.5
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|
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Contingent consideration, net of current portion
|
5.0
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|
34.2
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|
Debt, net of current portion
|
825.2
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|
|
841.0
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Deferred tax liability
|
53.2
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|
53.2
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Contract liabilities, net of current portion
|
48.9
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|
55.5
|
|
Other liabilities
|
61.4
|
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|
67.8
|
|
Total liabilities
|
1,371.5
|
|
|
1,436.2
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Stockholders' equity:
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Preferred stock, $0.001 par value; 15.0 shares authorized, no shares issued or outstanding
|
—
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—
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|
Common stock, $0.001 par value; 200.0 shares authorized, 54.9 and 54.3 shares issued; 53.7 and 53.1 shares outstanding, respectively
|
0.1
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|
|
0.1
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Additional paid-in capital
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804.4
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784.9
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Treasury stock, at cost, 1.2 common shares
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(39.6)
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(39.6)
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Accumulated other comprehensive loss, net
|
(22.4)
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(25.3)
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Retained earnings
|
801.2
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|
726.9
|
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Total stockholders' equity
|
1,543.7
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1,447.0
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Total liabilities and stockholders' equity
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$
|
2,915.2
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$
|
2,883.2
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See accompanying notes.
Emergent BioSolutions Inc.
Condensed Consolidated Statements of Operations
(unaudited, in millions, except per share amounts)
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Three Months Ended June 30,
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Six Months Ended June 30,
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2021
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2020
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|
2021
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|
2020
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Revenues:
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Product sales, net
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$
|
181.2
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|
|
$
|
298.5
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$
|
319.1
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$
|
446.7
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Contract development and manufacturing services
|
190.9
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|
|
72.6
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374.7
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|
94.3
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Contracts and grants
|
25.4
|
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|
23.6
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|
|
46.7
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|
46.2
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Total revenues
|
397.5
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|
|
394.7
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|
740.5
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587.2
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Operating expenses:
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Cost of product sales and contract development and manufacturing services
|
227.8
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129.8
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|
327.1
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|
206.7
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Research and development
|
48.9
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|
47.9
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|
101.4
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|
90.6
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Selling, general and administrative
|
91.2
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|
76.0
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172.1
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|
145.7
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Amortization of intangible assets
|
15.1
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|
|
15.0
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|
|
30.0
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|
|
29.8
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|
Total operating expenses
|
383.0
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|
268.7
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|
630.6
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|
472.8
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Income from operations
|
14.5
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|
|
126.0
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|
|
109.9
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|
114.4
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Other income (expense):
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Interest expense
|
(8.6)
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|
(6.4)
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(17.1)
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(15.0)
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Other, net
|
1.3
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|
1.1
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|
|
(0.4)
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—
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Total other income (expense), net
|
(7.3)
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|
(5.3)
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|
(17.5)
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(15.0)
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Income before income taxes
|
7.2
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|
120.7
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|
92.4
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|
99.4
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Income taxes
|
(2.6)
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|
(28.0)
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|
(18.1)
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(19.2)
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Net income
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$
|
4.6
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|
$
|
92.7
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$
|
74.3
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$
|
80.2
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Net income per common share
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Basic
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$
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0.09
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$
|
1.76
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$
|
1.40
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$
|
1.53
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Diluted
|
$
|
0.09
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|
$
|
1.73
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|
$
|
1.37
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|
$
|
1.51
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Shares used in computing income per share
|
|
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Basic
|
53.6
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|
|
52.6
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|
|
53.5
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|
|
52.3
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|
Diluted
|
54.0
|
|
|
53.5
|
|
|
54.3
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|
|
53.2
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|
See accompanying notes.
Emergent BioSolutions Inc.
Condensed Consolidated Statements of Comprehensive Income
(unaudited, in millions)
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Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
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|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
|
|
|
Net income
|
$
|
4.6
|
|
|
$
|
92.7
|
|
|
$
|
74.3
|
|
|
$
|
80.2
|
|
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|
Other comprehensive income (loss), net of tax:
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Foreign currency translation
|
0.5
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(0.3)
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(1.7)
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|
(0.4)
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Unrealized gains (losses) on hedging activities
|
1.5
|
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|
(0.7)
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|
4.6
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|
(11.9)
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Total other comprehensive income (loss)
|
2.0
|
|
|
(1.0)
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|
|
2.9
|
|
|
(12.3)
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|
|
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|
Comprehensive income
|
$
|
6.6
|
|
|
$
|
91.7
|
|
|
$
|
77.2
|
|
|
$
|
67.9
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
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|
See accompanying notes.
Emergent BioSolutions Inc.
Condensed Consolidated Statements of Cash Flows
(unaudited, in millions)
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Six Months Ended June 30,
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|
2021
|
|
2020
|
Cash flows (used in) provided by operating activities:
|
|
|
|
Net income
|
$
|
74.3
|
|
|
$
|
80.2
|
|
Adjustments to reconcile to net income to net cash (used in) provided by operating activities:
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|
|
|
Share-based compensation expense
|
21.9
|
|
|
31.0
|
|
Depreciation and amortization
|
61.9
|
|
|
56.8
|
|
Change in fair value of contingent consideration, net
|
1.7
|
|
|
1.1
|
|
Amortization of deferred financing costs
|
2.0
|
|
|
1.5
|
|
Deferred income taxes
|
(3.2)
|
|
|
(3.7)
|
|
Other
|
2.0
|
|
|
1.1
|
|
Changes in operating assets and liabilities:
|
|
|
|
Accounts receivable
|
(34.7)
|
|
|
12.1
|
|
Inventories
|
(79.7)
|
|
|
(13.7)
|
|
Prepaid expenses and other assets
|
(2.4)
|
|
|
(16.9)
|
|
Accounts payable
|
8.0
|
|
|
(14.5)
|
|
Accrued expenses and other liabilities
|
(55.4)
|
|
|
25.0
|
|
Accrued compensation
|
(21.4)
|
|
|
(3.4)
|
|
Contract liabilities
|
0.4
|
|
|
29.1
|
|
Net cash (used in) provided by operating activities:
|
(24.6)
|
|
|
185.7
|
|
Cash flows used in investing activities:
|
|
|
|
Purchases of property, plant and equipment
|
(123.1)
|
|
|
(59.3)
|
|
Milestone payment from prior asset acquisition
|
—
|
|
|
(10.0)
|
|
Net cash used in investing activities:
|
(123.1)
|
|
|
(69.3)
|
|
Cash flows used in financing activities:
|
|
|
|
Principal payments on revolving credit facility
|
—
|
|
|
(20.0)
|
|
Principal payments on term loan facility
|
(11.3)
|
|
|
(5.6)
|
|
Principal payments on convertible senior notes
|
(10.6)
|
|
|
—
|
|
Proceeds from share-based compensation activity
|
10.0
|
|
|
23.1
|
|
Taxes paid for share-based compensation activity
|
(13.0)
|
|
|
(11.7)
|
|
Contingent consideration payments
|
(1.1)
|
|
|
(1.1)
|
|
Net cash used in financing activities:
|
(26.0)
|
|
|
(15.3)
|
|
Effect of exchange rate changes on cash, cash equivalents and restricted cash
|
(0.1)
|
|
|
(0.1)
|
|
Net change in cash, cash equivalents and restricted cash
|
(173.8)
|
|
|
101.0
|
|
Cash, cash equivalents and restricted cash at beginning of period
|
621.5
|
|
|
168.0
|
|
Cash, cash equivalents and restricted cash at end of period
|
$
|
447.7
|
|
|
$
|
269.0
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
Cash paid during the period for interest
|
$
|
15.5
|
|
|
$
|
11.6
|
|
Cash paid during the period for income taxes
|
$
|
50.3
|
|
|
$
|
12.2
|
|
Supplemental information on non-cash investing and financing activities:
|
|
|
|
Purchases of property, plant and equipment unpaid at period end
|
$
|
31.7
|
|
|
$
|
16.8
|
|
Reconciliation of cash and cash equivalent and restricted cash at June 30, 2021 and December 31, 2020:
|
|
|
|
Cash and cash equivalents
|
$
|
447.5
|
|
|
$
|
621.3
|
|
Restricted cash
|
0.2
|
|
|
0.2
|
|
Total
|
$
|
447.7
|
|
|
$
|
621.5
|
|
See accompanying notes.
Emergent BioSolutions Inc.
Condensed Consolidated Statements of Changes in Stockholders' Equity
(unaudited, in millions)
|
|
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|
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|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$0.001 Par Value Common Stock
|
|
Additional Paid-In Capital
|
|
Treasury Stock
|
|
Accumulated Other Comprehensive Loss
|
|
Retained Earnings
|
|
Total Stockholders' Equity
|
|
|
Shares
|
|
Amount
|
|
|
Shares
|
|
Amount
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2020
|
|
54.3
|
|
|
$
|
0.1
|
|
|
$
|
784.9
|
|
|
(1.2)
|
|
|
$
|
(39.6)
|
|
|
$
|
(25.3)
|
|
|
$
|
726.9
|
|
|
$
|
1,447.0
|
|
Share-based compensation activity
|
|
0.6
|
|
|
—
|
|
|
19.5
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
19.5
|
|
Net income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
74.3
|
|
|
74.3
|
|
Other comprehensive income (loss)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2.9
|
|
|
—
|
|
|
2.9
|
|
Balance at June 30, 2021
|
|
54.9
|
|
|
$
|
0.1
|
|
|
$
|
804.4
|
|
|
(1.2)
|
|
|
$
|
(39.6)
|
|
|
$
|
(22.4)
|
|
|
$
|
801.2
|
|
|
$
|
1,543.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2021
|
|
54.8
|
|
|
$
|
0.1
|
|
|
$
|
790.1
|
|
|
(1.2)
|
|
|
$
|
(39.6)
|
|
|
$
|
(24.4)
|
|
|
$
|
796.6
|
|
|
$
|
1,522.8
|
|
Share-based compensation activity
|
|
0.1
|
|
|
—
|
|
|
14.3
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
14.3
|
|
Net income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4.6
|
|
|
4.6
|
|
Other comprehensive income (loss)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2.0
|
|
|
—
|
|
|
2.0
|
|
Balance at June 30, 2021
|
|
54.9
|
|
|
$
|
0.1
|
|
|
$
|
804.4
|
|
|
(1.2)
|
|
|
$
|
(39.6)
|
|
|
$
|
(22.4)
|
|
|
$
|
801.2
|
|
|
$
|
1,543.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2019
|
|
53.0
|
|
|
$
|
0.1
|
|
|
$
|
716.1
|
|
|
(1.2)
|
|
|
$
|
(39.6)
|
|
|
$
|
(9.9)
|
|
|
$
|
421.8
|
|
|
$
|
1,088.5
|
|
Share-based compensation activity
|
|
1.1
|
|
|
—
|
|
|
42.4
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
42.4
|
|
Net income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
80.2
|
|
|
80.2
|
|
Other comprehensive income (loss)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(12.3)
|
|
|
—
|
|
|
(12.3)
|
|
Balance at June 30, 2020
|
|
54.1
|
|
|
$
|
0.1
|
|
|
$
|
758.5
|
|
|
(1.2)
|
|
|
$
|
(39.6)
|
|
|
$
|
(22.2)
|
|
|
$
|
502.0
|
|
|
$
|
1,198.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2020
|
|
53.5
|
|
|
$
|
0.1
|
|
|
$
|
726.2
|
|
|
(1.2)
|
|
|
$
|
(39.6)
|
|
|
$
|
(21.2)
|
|
|
$
|
409.3
|
|
|
$
|
1,074.8
|
|
Share-based compensation activity
|
|
0.6
|
|
|
—
|
|
|
32.3
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
32.3
|
|
Net income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
92.7
|
|
|
92.7
|
|
Other comprehensive income (loss)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1.0)
|
|
|
—
|
|
|
(1.0)
|
|
Balance at June 30, 2020
|
|
54.1
|
|
|
$
|
0.1
|
|
|
$
|
758.5
|
|
|
(1.2)
|
|
|
$
|
(39.6)
|
|
|
$
|
(22.2)
|
|
|
$
|
502.0
|
|
|
$
|
1,198.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
EMERGENT BIOSOLUTIONS INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited, in millions, except share and per share amounts)
1. Business
Organization and business
Emergent BioSolutions Inc. (the "Company" or "Emergent") is a global life sciences company focused on providing civilian and military populations with a portfolio of innovative preparedness and response products and solutions that address accidental, deliberate and naturally occurring public health threats ("PHTs," each a “PHT”).
The Company is focused on the following five distinct PHT categories: Chemical, Biological, Radiological, Nuclear and Explosives ("CBRNE"); emerging infectious diseases ("EID"); travel health; emerging health crises; acute/emergency care; and contract development and manufacturing ("CDMO"). The Company has a product portfolio of ten products (vaccines, therapeutics, and drug-device combination products) that contribute a substantial portion of our revenue. The Company has two product candidates that are procured under special circumstances by certain government agencies, although they are not approved by the U.S. Food and Drug Administration ("FDA"). The U.S. government (the "USG") is the Company's largest customer and provides the Company with substantial funding for the development of a number of its product candidates.
The Company's product and services portfolio includes:
Vaccines
▪ACAM2000® (Smallpox (Vaccinia) Vaccine, Live), the only single-dose smallpox vaccine licensed by the FDA for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection;
▪BioThrax® (Anthrax Vaccine Adsorbed), the only vaccine licensed by the FDA, for the general use prophylaxis and post-exposure prophylaxis of anthrax disease;
▪Vaxchora® (Cholera Vaccine, Live, Oral), the only single-dose oral vaccine licensed by the FDA and the European Medicines Agency (EMA) for the prevention of cholera; and
▪Vivotif® (Typhoid Vaccine Live Oral Ty21a), the only oral vaccine licensed by the FDA for the prevention of typhoid fever.
Devices
▪NARCAN® (naloxone HCl) Nasal Spray, the first needle-free formulation of naloxone approved by the FDA and Health Canada, for the emergency treatment of known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression; and
▪RSDL® (Reactive Skin Decontamination Lotion Kit), the only medical device cleared by the FDA to remove or neutralize the following chemical warfare agents from the skin: tabun, sarin, soman, cyclohexyl sarin, VR, VX, mustard gas and T-2 toxin.
Therapeutics
▪raxibacumab (Anthrax Monoclonal), a fully human monoclonal antibody therapeutic licensed by the FDA for the treatment and prophylaxis of inhalational anthrax;
▪Anthrasil® (Anthrax Immune Globulin Intravenous (Human)), the only polyclonal antibody therapeutic licensed by the FDA and Health Canada for the treatment of inhalational anthrax;
▪BAT® (Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine)), the only heptavalent antibody therapeutic licensed by the FDA and Health Canada for the treatment of botulism; and;
▪VIGIV (Vaccinia Immune Globulin Intravenous (Human)), the only polyclonal antibody therapeutic licensed by the FDA and Health Canada to address certain complications from smallpox vaccination.
Procured Product Candidates
•AV7909® (Anthrax Vaccine Absorbed with Adjuvant), is a procured product candidate being developed as a next generation anthrax vaccine for post-exposure prophylaxis of disease resulting from suspected or confirmed Bacillus anthracis exposure. The USG has started procuring AV7909 for the Strategic National Stockpile ("SNS") prior to its approval by the FDA and has reduced its purchases of BioThrax as a result; and
EMERGENT BIOSOLUTIONS INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited, in millions, except share and per share amounts)
•Trobigard® is a combination drug-device auto-injector procured product candidate that contains atropine sulfate and obidoxime chloride. It has not been approved by the FDA, but it is procured by certain authorized government buyers under special circumstances for potential use as a nerve agent countermeasure.
Contract Development and Manufacturing Services
The Company's contract development and manufacturing service offerings cover development services, drug substance manufacturing and drug product manufacturing across the pharmaceutical and biotechnology industries as well as the USG and non-governmental organizations. The Company's technology platforms include mammalian, microbial, viral, plasma and advanced therapies utilizing our core capabilities for manufacturing to third parties on a clinical and commercial (small and large) scale. Additional services include fill/finish formulation and analytical development services for injectable and other sterile products, inclusive of process design, technical transfer, manufacturing validations, aseptic filling, lyophilization, final packaging and stability studies, as well as manufacturing of vial and pre-filled syringe formats on multiple platforms.
The Company operates as one operating segment.
2. Basis of Presentation and Principles of Consolidation
Basis of presentation
The accompanying unaudited condensed consolidated financial statements include the accounts of Emergent and its wholly-owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation. The unaudited condensed consolidated financial statements included herein have been prepared in accordance with U.S. generally accepted accounting principles ("GAAP") for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X issued by the SEC. Certain information and footnote disclosures normally included in consolidated financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the SEC.
All adjustments contained in the accompanying unaudited condensed consolidated financial statements are of a normal recurring nature and are necessary to present fairly the financial position of the Company as of June 30, 2021. Interim results are not necessarily indicative of results that may be expected for any other interim period or for an entire year.
Significant accounting policies
During the six months ended June 30, 2021, there have been no significant changes to the Company's summary of significant accounting policies contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the SEC.
Fair value measurements
Separate disclosure is required for assets and liabilities measured at fair value on a recurring basis from those measured at fair value on a non-recurring basis. The Company has cash held in money market accounts (level 1) and time deposits (level 2), contingent purchase consideration (level 3) and interest rate swaps arrangements (level 2) that are measured at fair value on a recurring basis (Note 7 and Note 8).
EMERGENT BIOSOLUTIONS INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited, in millions, except share and per share amounts)
On a non-recurring basis, the Company measures its long-lived assets as part of impairment evaluations using fair value measurements. Goodwill is allocated to the Company's reporting units, which are one level below its operating segment. The Company evaluates goodwill and other indefinite-lived intangible assets for impairment annually as of October 1 and earlier if an event or other circumstance indicates that the carrying value of the asset may not be recoverable. If the Company believes that as a result of its qualitative assessment it is more likely than not that the fair value of a reporting unit or other indefinite-lived intangible asset is greater than its carrying amount, the quantitative impairment test is not required. If however it is determined that it is not more likely than not that the fair value of a reporting unit or other indefinite-lived intangible asset is greater than its carrying amount, a quantitative test is required. Long-lived assets such as intangible assets and property, plant and equipment are not required to be tested for impairment annually. Instead, long-lived assets are tested for impairment whenever circumstances indicate that the carrying amount of the asset may not be recoverable, such as when there is an adverse change in the market relating to those related assets. The impairment test first requires a comparison of undiscounted future cash flows to the carrying value of the asset. Determining the need for a detailed impairment analysis requires the exercise of judgment about several business factors, including the timing of expected future cash flows and assumptions about the economic environment.
As of June 30, 2021 and December 31, 2020, the Company had no other significant assets or liabilities that were measured at fair value.
Recently issued accounting standards
Recently Adopted
ASU 2019-12, Simplifications to Accounting for Income Taxes ("ASU 2019-12")
In December 2019, the FASB issued ASU 2019-12. ASU 2019-12 removes certain exceptions for recognizing deferred taxes for investments, performing intra-period allocation and calculating income taxes in interim periods. The ASU also adds guidance to reduce complexity in certain areas, including deferred taxes for goodwill and allocating taxes for members of a consolidated group. ASU 2019-12 is effective for all entities for fiscal years beginning after December 15, 2020, and earlier adoption is permitted. As of January 1, 2021, the Company adopted the standard, which did not have a material impact on the Company's consolidated financial statements.
Not Yet Adopted
ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting
In March 2020, the FASB issued Topic 848, which was further amended in January 2021. Topic 848 provides relief for impacted areas as it relates to impending reference rate reform. ASC 848 contains optional expedients and exceptions to debt arrangements, contracts, hedging relationships, and other areas or transactions that are impacted by reference rate reform. This guidance is effective upon issuance for all entities and elections of certain optional expedients are required to apply the provisions of the guidance. The Company continues to assess all potential impacts of the standard and will disclose the nature and reason for any elections that the Company makes.
3. Inventories, net
The components of inventory are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2021
|
|
December 31, 2020
|
Raw materials and supplies
|
$
|
174.3
|
|
|
$
|
160.6
|
|
Work-in-process
|
141.7
|
|
|
102.5
|
|
Finished goods
|
70.4
|
|
|
43.9
|
|
Total inventories, net
|
$
|
386.4
|
|
|
$
|
307.0
|
|
Inventories, net is stated at the lower of cost or net realizable value. During the three and six months ended June 30, 2021, the Company recorded inventory write-offs at its Bayview facility of $41.5 million. The inventory write-off was due to raw materials and in-process batches at the Bayview facility that the Company plans to discard as they were deemed unusable. The charge was reflected as a component of cost of product sales and contract development and manufacturing services.
EMERGENT BIOSOLUTIONS INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited, in millions, except share and per share amounts)
4. Property, plant and equipment
Property, plant and equipment consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2021
|
|
December 31, 2020
|
Land and improvements
|
$
|
51.7
|
|
|
$
|
52.7
|
|
Buildings, building improvements and leasehold improvements
|
287.3
|
|
|
246.3
|
|
Furniture and equipment
|
437.0
|
|
|
362.1
|
|
Software
|
60.9
|
|
|
58.7
|
|
Construction-in-progress
|
194.3
|
|
|
183.4
|
|
Property, plant and equipment, gross
|
1,031.2
|
|
|
903.2
|
|
Accumulated depreciation
|
(287.7)
|
|
|
(259.1)
|
|
Total property, plant and equipment, net
|
$
|
743.5
|
|
|
$
|
644.1
|
|
5. Leases
The Company has operating leases for corporate offices, research and development facilities and manufacturing facilities. We determine if an arrangement is a lease at inception. Operating leases are included in right-of-use ("ROU") assets and liabilities.
The components of lease expense were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Operating lease cost:
|
|
|
|
|
|
|
|
Amortization of right-of-use assets
|
$
|
1.5
|
|
|
$
|
1.0
|
|
|
$
|
2.8
|
|
|
$
|
2.1
|
|
Interest on lease liabilities
|
0.3
|
|
|
0.3
|
|
|
0.7
|
|
|
0.6
|
|
Total operating lease cost
|
$
|
1.8
|
|
|
$
|
1.3
|
|
|
$
|
3.5
|
|
|
$
|
2.7
|
|
Operating lease costs are reflected as components of cost of product sales and contract development and manufacturing services, research and development expense and selling, general and administrative expense.
Supplemental balance sheet information related to leases was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In millions, except lease term and discount rate)
|
Balance Sheet location
|
|
June 30, 2021
|
|
December 31, 2020
|
Operating lease right-of-use assets
|
Other assets
|
|
$
|
29.6
|
|
$
|
31.0
|
|
|
|
|
|
|
Operating lease liabilities, current portion
|
Other current liabilities
|
|
5.7
|
|
5.4
|
Operating lease liabilities
|
Other liabilities
|
|
25.9
|
|
27.8
|
Total operating lease liabilities
|
|
|
$
|
31.6
|
|
$
|
33.2
|
|
|
|
|
|
|
Operating leases:
|
|
|
|
|
|
Weighted average remaining lease term (years)
|
|
|
7.2
|
|
7.7
|
Weighted average discount rate
|
|
|
4.0
|
%
|
|
4.1
|
%
|
EMERGENT BIOSOLUTIONS INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited, in millions, except share and per share amounts)
6. Intangible assets
The Company's intangible assets consist of products acquired via business combinations or asset acquisitions. The following tables summarize the Company's intangible assets for the periods ended June 30, 2021 and December 31, 2020:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2021
|
|
December 31, 2020
|
Asset Type
|
Estimated Life
|
|
Cost
|
Accumulated Amortization
|
Net
|
|
Cost
|
Accumulated Amortization
|
Net
|
Products
|
9-22 years
|
|
$
|
798.0
|
|
$
|
165.6
|
|
$
|
632.4
|
|
|
$
|
798.0
|
|
$
|
137.8
|
|
$
|
660.2
|
|
Customer relationships
|
8 years
|
|
28.6
|
|
28.3
|
|
0.3
|
|
|
28.6
|
|
26.5
|
|
2.1
|
|
CDMO
|
8 years
|
|
5.5
|
|
5.1
|
|
0.4
|
|
|
5.5
|
|
4.7
|
|
0.8
|
|
Total intangible assets
|
|
$
|
832.1
|
|
$
|
199.0
|
|
$
|
633.1
|
|
|
$
|
832.1
|
|
$
|
169.0
|
|
$
|
663.1
|
|
During the six months ended June 30, 2021 and 2020, the Company recorded amortization expense for intangible assets of $30.0 million and $29.8 million, respectively. During the three months ended June 30, 2021 and 2020, the Company recorded amortization expense for intangible assets of $15.1 million and $15.0 million, respectively. As of June 30, 2021, the weighted average amortization period remaining for intangible assets was 12.3 years.
The following table provides a roll forward of changes in our goodwill balance:
|
|
|
|
|
|
|
|
Goodwill, December 31, 2020
|
$
|
266.7
|
|
Foreign currency translation
|
(0.1)
|
|
Goodwill, June 30, 2021
|
$
|
266.6
|
|
7. Fair Value Measurements
The table below presents information about our assets and liabilities that are regularly measured and carried at fair value and indicate the level within the fair value hierarchy of the valuation techniques we utilized to determine fair value:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2021
|
December 31, 2020
|
|
Total
|
Level1
|
Level 2
|
Level 3
|
Total
|
Level1
|
Level 2
|
Level 3
|
Assets:
|
|
|
|
|
|
|
|
|
Money market accounts
|
82.4
|
|
82.4
|
|
—
|
|
—
|
|
352.2
|
|
352.2
|
|
—
|
|
—
|
|
Time deposits
|
240.1
|
|
—
|
|
240.1
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
Total
|
322.5
|
|
82.4
|
|
240.1
|
|
—
|
|
352.2
|
|
352.2
|
|
—
|
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
Contingent consideration
|
38.1
|
|
—
|
|
—
|
|
38.1
|
|
58.1
|
|
—
|
|
—
|
|
58.1
|
|
Derivative instruments
|
11.4
|
|
—
|
|
11.4
|
|
—
|
|
15.0
|
|
—
|
|
15.0
|
|
—
|
|
Total
|
49.5
|
|
—
|
|
11.4
|
|
38.1
|
|
73.1
|
|
—
|
|
15.0
|
|
58.1
|
|
Contingent Consideration
Contingent consideration liabilities associated with business combinations are measured at fair value. These liabilities represent an obligation of the Company to transfer additional assets to the selling shareholders and owners if future events occur or conditions are met. These liabilities associated with business combinations are measured at fair value at inception and at each subsequent reporting date. The changes in the fair value are primarily due to the expected amount and timing of future net sales, which are inputs that have no observable market. Any changes in fair value for the contingent consideration liabilities related to the Company’s products are classified in the Company's statement of operations as cost of product sales and CDMO services. Any changes in fair value for the contingent consideration liabilities related to the Company’s product candidates are recorded in research and development expense for regulatory and development milestones.
EMERGENT BIOSOLUTIONS INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited, in millions, except share and per share amounts)
The following table is a reconciliation of the beginning and ending balance of contingent considerations.
|
|
|
|
|
|
|
|
Balance at December 31, 2020
|
$
|
58.1
|
|
Change in fair value
|
1.7
|
|
Settlements
|
(21.7)
|
|
Balance at June 30, 2021
|
$
|
38.1
|
|
As of June 30, 2021 and December 31, 2020, the current portion of the contingent consideration liability was $33.1 million and $23.9 million, respectively, and was included in other current liabilities on the condensed consolidated balance sheets.
The recurring Level 3 fair value measurements for the Company's contingent consideration liability include the following significant unobservable inputs:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent Consideration Liability
|
Fair Value as of June 30, 2021
|
Valuation Technique
|
Unobservable Input
|
Range
|
Weighted Average
|
Revenue milestone and royalty based
|
$38.1 million
|
Discounted cash flow
|
Discount rate
|
—% - 7.3%
|
1.7%
|
Probability of payment
|
25% - 100%
|
86%
|
Projected year of payment
|
2021 - 2028
|
2022
|
Derivative Instruments
Refer to Note 8, Derivatives, to these condensed consolidated financial statements.
Non-Variable Rate Debt
As of June 30, 2021 and December 31, 2020, the fair value of the Company's 3.875% Senior Unsecured Notes is $443.3 million and $466.0 million. The fair value was determined through market sources, which are level 1 inputs, observable and corroborated. The carrying amounts of the Company’s other long-term variable interest rate debt arrangements approximate their fair values. For additional information related to the Company's debt, please refer to Note 9, Debt, to these condensed consolidated financial statements.
8. Derivative instruments and hedging activities
Risk management objective of using derivatives
The Company is exposed to certain risks arising from both its business operations and economic conditions. The Company principally manages its exposures to a wide variety of business and operational risks through management of its core business activities. The Company manages economic risks, including interest rate, liquidity, and credit risk primarily by managing the amount, sources, and duration of its assets and liabilities and the use of derivative financial instruments. Specifically, the Company has entered into interest rate swaps to manage exposures that arise from the Company's senior secured credit agreement's payments of variable interest rate debt.
If current fair values of designated interest rate swaps remained static over the next twelve months, the Company would reclassify $5.7 million of net deferred losses from accumulated other comprehensive loss to the statement of operations over the next twelve month period. All outstanding cash flow hedges mature in October 2023.
As of June 30, 2021, the Company had the following outstanding interest rate derivatives that were designated as cash flow hedges of interest rate risk:
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Instruments
|
|
Notional
|
Interest rate swaps
|
7
|
|
$
|
350.0
|
|
EMERGENT BIOSOLUTIONS INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited, in millions, except share and per share amounts)
The table below presents the fair value of the Company’s derivative financial instruments designated as hedges as well as their classification on the balance sheet.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liability Derivatives
|
|
June 30, 2021
|
December 31, 2020
|
|
Balance Sheet Location
|
Fair Value
|
Balance Sheet Location
|
Fair Value
|
Interest Rate Swaps
|
Other Current Liabilities
|
$
|
5.7
|
|
Other Current Liabilities
|
$
|
5.7
|
|
Other Liabilities
|
$
|
5.7
|
|
Other Liabilities
|
$
|
9.3
|
|
The valuation of the interest rate swaps is determined using widely accepted valuation techniques, including discounted cash flow analysis on the expected cash flows of each interest rate swap. This analysis reflects the contractual terms of the interest rate swaps, including the period to maturity, and uses observable market-based inputs, including interest rate curves and implied volatilities. The fair values of interest rate swaps are determined using the market standard methodology of netting the discounted future fixed cash payments (or receipts) and the discounted expected variable cash receipts (or payments). The variable cash payments (or receipts) are based on an expectation of future interest rates (forward curves) derived from observable market interest rate curves. We incorporate credit valuation adjustments in the fair value measurements to appropriately reflect both our own nonperformance risk and the respective counterparty’s nonperformance risk. These credit valuation adjustments were not significant inputs for the fair value calculations for the periods presented. In adjusting the fair value of our derivative contracts for the effect of nonperformance risk, we have considered the impact of netting and any applicable credit enhancements, such as the posting of collateral, thresholds, mutual puts and guarantees. The valuation of interest rate swaps fall into Level 2 in the fair value hierarchy.
The table below presents the effect of cash flow hedge accounting on accumulated other comprehensive income.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hedging derivatives
|
Cumulative Amount of Gain/(Loss) Recognized in OCI on Derivative
|
Location of Gain or (Loss) Reclassified from Accumulated OCI into Income
|
Amount of Gain/(Loss) Reclassified from Accumulated OCI into Income
|
June 30,
|
December 31,
|
Six Months Ended June 30,
|
2021
|
2020
|
2021
|
2020
|
Interest Rate Swaps
|
$
|
(11.4)
|
|
$
|
(15.0)
|
|
Interest expense
|
$
|
(3.0)
|
|
$
|
(1.1)
|
|
9. Debt
The components of debt are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2021
|
|
December 31, 2020
|
Senior secured credit agreement - Term loan due 2023
|
$
|
410.6
|
|
|
$
|
421.9
|
|
|
|
|
|
3.875% Senior Unsecured Notes due 2028
|
450.0
|
|
|
450.0
|
|
2.875% Convertible Senior Notes due 2021
|
—
|
|
|
10.6
|
|
Other
|
3.0
|
|
|
3.0
|
|
Total debt
|
863.6
|
|
|
885.5
|
|
|
|
|
|
Current portion of long-term debt, net of debt issuance costs
|
(28.8)
|
|
|
(33.8)
|
|
Unamortized debt issuance costs
|
(9.6)
|
|
|
(10.7)
|
|
Non-current portion of debt
|
$
|
825.2
|
|
|
$
|
841.0
|
|
|
|
|
|
|
As of June 30, 2021 and December 31, 2020, debt issuance costs associated with the revolver loan were classified as other current assets and other assets on the Company's consolidated balance sheets because there was no outstanding revolver balance at period end. As of June 30, 2021, the Company had $2.0 million and $2.6 million of debt issuance costs associated with the revolver loan classified as other current assets and other assets, respectively. As of December 31, 2020, the Company had approximately $2.0 million and $3.5 million of debt issuance costs associated with the revolver loan that were classified as other current assets and other assets, respectively.
EMERGENT BIOSOLUTIONS INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited, in millions, except share and per share amounts)
3.875% Senior Unsecured Notes due 2028
On August 7, 2020, the Company completed its offering of $450 million aggregate principal amount of 3.875% Senior Unsecured Notes due 2028 (the “2028 Notes”) of which the majority of the net proceeds were used to pay down the Revolving Credit Facility (as defined below). Interest on the 2028 Notes is payable on February 15th and August 15th of each year until maturity, beginning on February 15, 2021. The 2028 Notes will mature on August 15, 2028.
On or after August 15, 2023, the Company may redeem the 2028 Notes, in whole or in part, at the redemption prices set forth in the related Indenture, plus accrued and unpaid interest. Prior to August 15, 2023 the Company may redeem all or a portion of the 2028 Notes at a redemption price equal to 100% of the principal amount of the 2028 Notes plus a “make-whole” premium and accrued and unpaid interest. Prior to August 15, 2023, the Company may redeem up to 40% of the aggregate principal amount of the 2028 Notes using the net cash proceeds of certain equity offerings at the redemption price set forth in the related Indenture. Upon the occurrence of a change of control, the Company must offer to repurchase the 2028 Notes at a purchase price of 101% of the principal amount of such 2028 Notes plus accrued and unpaid interest.
Negative covenants in the Indenture governing the 2028 Notes, among other things, limit the ability of the Company to incur indebtedness and liens, dispose of assets, make investments, enter into certain merger or consolidation transactions and make restricted payments.
Senior secured credit agreement
Also on August 7, 2020, the Company entered into a Second Amendment (the “Credit Agreement Amendment”) to its senior secured credit agreement, dated October 15, 2018, with multiple lending institutions relating to the Company’s senior secured credit facilities (the “Credit Agreement,” and as amended, the “Amended Credit Agreement”), consisting of a senior revolving credit facility (the “Revolving Credit Facility”) and senior term loan facility (the “Term Loan Facility,” and together with the Revolving Credit Facility, the “Senior Secured Credit Facilities”). The Credit Agreement Amendment amended, among other things, the definition of incremental facilities limit, the consolidated net leverage ratio financial covenant by increasing the maximum level, increased the permissible applicable margins based on the Company’s consolidated net leverage ratio and increased the commitment fee that the Company is required to pay in respect of the average daily unused commitments under the Revolving Credit Facility, depending on the Company’s consolidated net leverage ratio.
The Amended Credit Agreement includes (i) a Revolving Credit Facility of $600 million and (ii) a Term Loan Facility with a principal amount of $450 million. The Company may request incremental term loan facilities or increases in the Revolving Credit Facility (each an "Incremental Loan") as long as certain requirements involving our net leverage ratio will be maintained on a pro forma basis. Borrowings under the Revolving Credit Facility and the Term Loan Facility bear interest at a rate per annum equal to (a) a eurocurrency rate plus a margin ranging from 1.25% to 2.25% per annum, depending on the Company's consolidated net leverage ratio or (b) a base rate (which is the highest of the prime rate, the federal funds rate plus 0.50%, and a eurocurrency rate for an interest period of one month plus 1% plus a margin ranging from 0.25% to 1.25%, depending on the Company's consolidated net leverage ratio. The Company is required to make quarterly payments on the last business day of each calendar quarter under the Amended Credit Agreement for accrued and unpaid interest on the outstanding principal balance, based on the above interest rates. In addition, the Company is required to pay commitment fees ranging from 0.15% to 0.35% per annum, depending on the Company's consolidated net leverage ratio, for the average daily unused commitments under the Revolving Credit Facility. The Company is to repay the outstanding principal amount of the Term Loan Facility in quarterly installments on the last business day of each calendar quarter based on an annual percentage equal to 2.5% of the original principal amount of the Term Loan Facility during each of the first two years of the Term Loan Facility, 5% of the original principal amount of the Term Loan Facility during the third year of the Term Loan Facility and 7.5% of the original principal amount of the Term Loan Facility during each year of the remainder of the term of the Term Loan Facility until the maturity date of the Term Loan Facility, at which time the entire unpaid principal balance of the Term Loan Facility will be due and payable. The Company has the right to prepay the Term Loan Facility without premium or penalty. The Revolving Credit Facility and the Term Loan Facility mature on October 13, 2023.
EMERGENT BIOSOLUTIONS INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited, in millions, except share and per share amounts)
The Amended Credit Agreement also requires mandatory prepayments of the Term Loan Facility in the event the Company or its Subsidiaries (a) incur indebtedness not otherwise permitted under the Amended Credit Agreement or (b) receive cash proceeds in excess of $100 million during the term of the Credit Agreement from certain dispositions of property or from casualty events involving their property, subject to certain reinvestment rights. The financial covenants under the Amended Credit Agreement currently require the quarterly presentation of a minimum consolidated 12-month rolling debt service coverage ratio of 2.50 to 1.00, and a maximum consolidated net leverage ratio of 4.50 to 1.00 (subject to an increase to 5.00 to 1.00 for an applicable four quarter period, at the election of the Company, in connection with a permitted acquisition having an aggregate consideration in excess of $75.0 million). Negative covenants in the Amended Credit Agreement, among other things, limit the ability of the Company to incur indebtedness and liens, dispose of assets, make investments, enter into certain merger or consolidation transactions and make restricted payments. As of the date of these financial statements, the Company is in compliance with all affirmative and negative covenants.
2.875% Convertible senior notes due 2021
On January 29, 2014, the Company issued 2.875% convertible senior notes due 2021 (the "Notes"). The Notes bore interest at a rate of 2.875% per year, payable semi-annually in arrears on January 15 and July 15 of each year. The Notes matured and were paid in full on January 15, 2021.
10. Revenue recognition
The Company operates as one operating segment. Therefore, results of its operations are reported on a consolidated basis for purposes of segment reporting, consistent with internal management reporting. The Company's revenues disaggregated by the major sources were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2021
|
|
Three Months Ended June 30, 2020
|
|
U.S.
Government
|
|
Non-U.S.
Government
|
|
Total
|
|
U.S.
Government
|
|
Non-U.S.
Government
|
|
Total
|
Product sales, net
|
$
|
66.3
|
|
|
$
|
114.9
|
|
|
$
|
181.2
|
|
|
$
|
224.2
|
|
|
$
|
74.3
|
|
|
$
|
298.5
|
|
CDMO services
|
70.4
|
|
|
120.5
|
|
|
190.9
|
|
|
44.6
|
|
|
28.0
|
|
|
72.6
|
|
Contracts and grants
|
24.4
|
|
|
1.0
|
|
|
25.4
|
|
|
20.7
|
|
|
2.9
|
|
|
23.6
|
|
Total revenues
|
$
|
161.1
|
|
|
$
|
236.4
|
|
|
$
|
397.5
|
|
|
$
|
289.5
|
|
|
$
|
105.2
|
|
|
$
|
394.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2021
|
|
Six Months Ended June 30, 2020
|
|
U.S.
Government
|
|
Non-U.S.
Government
|
|
Total
|
|
U.S.
Government
|
|
Non-U.S.
Government
|
|
Total
|
Product sales, net
|
$
|
122.7
|
|
|
$
|
196.4
|
|
|
$
|
319.1
|
|
|
$
|
288.1
|
|
|
$
|
158.6
|
|
|
$
|
446.7
|
|
CDMO services
|
167.9
|
|
|
206.8
|
|
|
374.7
|
|
|
44.6
|
|
|
49.7
|
|
|
94.3
|
|
Contracts and grants
|
44.4
|
|
|
2.3
|
|
|
46.7
|
|
|
42.7
|
|
|
3.5
|
|
|
46.2
|
|
Total revenues
|
$
|
335.0
|
|
|
$
|
405.5
|
|
|
$
|
740.5
|
|
|
$
|
375.4
|
|
|
$
|
211.8
|
|
|
$
|
587.2
|
|
EMERGENT BIOSOLUTIONS INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited, in millions, except share and per share amounts)
Contract liabilities
When performance obligations are not transferred to a customer at the end of a reporting period, cash received associated with amounts allocated to those performance obligations is reflected as contract liabilities on the consolidated balance sheets and is deferred until control of these performance obligations is transferred to the customer. The following table presents the roll forward of the contract liability balances:
|
|
|
|
|
|
|
|
December 31, 2020
|
$
|
100.1
|
|
Deferral of revenue
|
194.7
|
|
Revenue recognized
|
(191.4)
|
|
June 30, 2021
|
$
|
103.4
|
|
As of June 30, 2021 and December 31, 2020, the current portion of contract liabilities was $54.5 million and $44.6 million, respectively, and was included in other current liabilities on the balance sheet.
Transaction price allocated to remaining performance obligations
The Company has certain performance obligations that are considered an operating lease as the customer obtains substantially all of the economic benefits of the identified asset and has the right to direct its use. The associated revenue is recognized on a straight-line basis over the term of the lease. The remaining term on the Company's operating lease performance obligations approximates 2.0 years. The Company utilizes a cost-plus model to determine the stand-alone selling price of the lease component to allocate contract consideration between the lease and non-lease components. During the three and six months ended June 30, 2021, the Company's lease revenues were $16.9 million and $35.6 million, respectively, which is included within contract development and manufacturing services in the condensed consolidated statement of operations. During the three and six months ended June 30, 2020 the Company's lease revenues were de minimis. The Company has allocated contracted operating lease revenues due under our long-term CDMO service arrangements as follows:
|
|
|
|
|
|
|
|
Year ended December 31,
|
|
2021 (1)
|
$
|
33.8
|
|
|
2022
|
67.7
|
|
|
2023
|
28.2
|
|
|
|
$
|
129.7
|
|
|
|
|
|
(1) As of June 30, 2021, amount represents the six months ending December 31, 2021.
|
As of June 30, 2021, the Company expects future revenues on unsatisfied performance obligations of approximately $1.4 billion associated with all arrangements entered into by the Company. The Company expects to recognize a majority of these revenues within the next 24 months. However, the amount and timing of revenue recognition for unsatisfied performance obligations can materially change due to timing of manufacturing activities, funding appropriations from the USG and the overall success of the Company's development activities associated with its PHT procured product candidates that are then receiving development funding support from the USG under development contracts. In addition, the amount of future revenues associated with unsatisfied performance obligations excludes the value associated with unexercised option periods in the Company's contracts.
Contract assets
The Company considers unbilled accounts receivables and deferred costs associated with revenue generating contracts, which are not included in inventory or property, plant and equipment, as contract assets. As of June 30, 2021 and December 31, 2020, the Company had contract assets associated with deferred costs of $39.7 million and $41.1 million, respectively, which is reflected as a component of other assets on the Company's consolidated balance sheets. During the three and six months ended June 30, 2021, the Company recorded amortization expense of contract assets of $1.6 million, which has been included as a component of research and development expense. The Company did not record amortization expense associated with its contract assets during 2020.
EMERGENT BIOSOLUTIONS INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited, in millions, except share and per share amounts)
Accounts receivable
Accounts receivable, including unbilled accounts receivable contract assets, consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2021
|
|
December 31, 2020
|
Billed, net
|
|
$
|
210.3
|
|
|
$
|
172.7
|
|
Unbilled
|
|
51.6
|
|
|
58.2
|
|
Total, net
|
|
$
|
261.9
|
|
|
$
|
230.9
|
|
As of June 30, 2021 and December 31, 2020, the allowances for doubtful accounts was $3.4 million and $3.1 million, respectively.
11. Income taxes
The estimated effective annual tax rate for the years ended December 31, 2021 and 2020, excluding the impact of discrete adjustments, was 26%. For the six months ended June 30, 2021 and 2020, the Company recorded discrete tax benefits of $5.5 million and $6.6 million, respectively. For the three months ended June 30, 2021 and 2020, the Company recorded a discrete tax (expense) benefits of $(1.1) million and $3.4 million, respectively. The discrete tax benefits in 2021 and 2020 were primarily due to share-based compensation activity.
12. Net income per share
The following table presents the calculation of basic and diluted net income per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
2021
|
|
2020
|
2021
|
|
2020
|
Numerator:
|
|
|
|
|
|
|
Net income
|
$
|
4.6
|
|
|
$
|
92.7
|
|
$
|
74.3
|
|
|
$
|
80.2
|
|
|
|
|
|
|
|
|
Denominator:
|
|
|
|
|
|
|
Weighted-average number of shares—basic
|
53.6
|
|
|
52.6
|
|
53.5
|
|
|
52.3
|
|
Dilutive securities—equity awards
|
0.4
|
|
|
0.9
|
|
0.8
|
|
|
0.9
|
|
Weighted-average number of shares—diluted
|
54.0
|
|
|
53.5
|
|
54.3
|
|
|
53.2
|
|
|
|
|
|
|
|
|
Net income per share - basic
|
$
|
0.09
|
|
|
$
|
1.76
|
|
$
|
1.40
|
|
|
$
|
1.53
|
|
Net income per share - diluted
|
$
|
0.09
|
|
|
$
|
1.73
|
|
$
|
1.37
|
|
|
$
|
1.51
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per share is computed by dividing net income by the weighted average number of shares of common stock outstanding during the period. Diluted income per share is computed using the treasury method by dividing net income by the weighted average number of shares of common stock outstanding during the period, adjusted for the potential dilutive effect of other securities if such securities were converted or exercised and are not anti-dilutive.
The following table presents the share-based awards that are not considered in the diluted net income per share calculation because the exercise price of the awards was greater than the average per share closing price during the three and six months ended June 30, 2021 and 2020.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|
2021
|
|
2020
|
2021
|
|
2020
|
Anti-dilutive stock awards
|
1.4
|
|
|
0.4
|
|
0.5
|
|
|
0.6
|
|
EMERGENT BIOSOLUTIONS INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited, in millions, except share and per share amounts)
13. Equity
Share-based compensation
During the six months ended June 30, 2021, the Company granted stock options to purchase 0.3 million shares of common stock and 0.5 million restricted and performance stock units under the Emergent BioSolutions Inc. Stock Incentive Plan. Typically, the stock option and restricted stock unit grants vest over three equal annual installments beginning on the day prior to the anniversary of the grant date. The performance stock units settle in stock at the end of the three-year performance period based on the Company's results compared to the performance criteria.
Share-based compensation expense was recorded in the following financial statement line items:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|
2021
|
|
2020
|
2021
|
|
2020
|
Cost of product sales and contract development and manufacturing services
|
$
|
2.0
|
|
|
$
|
8.1
|
|
$
|
3.7
|
|
|
$
|
8.8
|
|
Research and development
|
1.7
|
|
|
5.4
|
|
3.1
|
|
|
6.3
|
|
Selling, general and administrative
|
7.7
|
|
|
10.9
|
|
15.1
|
|
|
15.9
|
|
Total share-based compensation expense
|
$
|
11.4
|
|
|
$
|
24.4
|
|
$
|
21.9
|
|
|
$
|
31.0
|
|
Accumulated other comprehensive income (loss)
The following table includes changes in accumulated other comprehensive (loss) income by component, net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In Millions)
|
|
Defined Benefit Pension Plan
|
|
Derivative Instruments
|
|
Foreign Currency Translation Losses
|
|
Total
|
|
Balance, December 31, 2020
|
|
(7.7)
|
|
|
(11.0)
|
|
|
(6.6)
|
|
|
(25.3)
|
|
Other comprehensive (loss) income before reclassifications
|
|
—
|
|
|
1.6
|
|
|
(1.7)
|
|
|
(0.1)
|
|
Amounts reclassified from accumulated other comprehensive income
|
|
—
|
|
|
3.0
|
|
|
—
|
|
|
3.0
|
|
Balance, June 30, 2021
|
|
$
|
(7.7)
|
|
|
$
|
(6.4)
|
|
|
$
|
(8.3)
|
|
|
$
|
(22.4)
|
|
|
|
|
|
|
|
|
|
|
Balance, March 31, 2021
|
|
(7.7)
|
|
|
(7.9)
|
|
|
(8.8)
|
|
|
(24.4)
|
|
Other comprehensive (loss) income before reclassifications
|
|
—
|
|
|
(0.1)
|
|
|
0.5
|
|
|
0.4
|
|
Amounts reclassified from accumulated other comprehensive income
|
|
—
|
|
|
1.6
|
|
|
—
|
|
|
1.6
|
|
Balance, June 30, 2021
|
|
$
|
(7.7)
|
|
|
$
|
(6.4)
|
|
|
$
|
(8.3)
|
|
|
$
|
(22.4)
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2019
|
|
(3.4)
|
|
|
(1.6)
|
|
|
(4.9)
|
|
|
(9.9)
|
|
Other comprehensive (loss) income before reclassifications
|
|
—
|
|
|
(10.8)
|
|
|
(0.4)
|
|
|
(11.2)
|
|
Amounts reclassified from accumulated other comprehensive income
|
|
—
|
|
|
(1.1)
|
|
|
—
|
|
|
(1.1)
|
|
Balance, June 30, 2020
|
|
$
|
(3.4)
|
|
|
$
|
(13.5)
|
|
|
$
|
(5.3)
|
|
|
$
|
(22.2)
|
|
|
|
|
|
|
|
|
|
|
Balance, March 31, 2020
|
|
(3.4)
|
|
|
(12.8)
|
|
|
(5.0)
|
|
|
(21.2)
|
|
Other comprehensive (loss) income before reclassifications
|
|
—
|
|
|
0.4
|
|
|
(0.3)
|
|
|
0.1
|
|
Amounts reclassified from accumulated other comprehensive income
|
|
—
|
|
|
(1.1)
|
|
|
—
|
|
|
(1.1)
|
|
Balance, June 30, 2020
|
|
$
|
(3.4)
|
|
|
$
|
(13.5)
|
|
|
$
|
(5.3)
|
|
|
$
|
(22.2)
|
|
EMERGENT BIOSOLUTIONS INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited, in millions, except share and per share amounts)
During the three and six months ended June 30, 2021, the tax impact related to unrealized gains (losses) on hedging activities was an expense of $0.3 million and $1.0 million, respectively; the tax effects of the defined benefit pension plan and foreign currency translation losses were de minimis. During the three and six ended June 30, 2020 there were tax benefits related to unrealized losses on hedging activities of $0.8 million and $3.6 million, respectively; the tax effects of the defined benefit pension plan and foreign currency translation losses were de minimis.
14. Commitments and contingencies
Securities Litigation
On April 20, 2021, May 14, 2021 and June 2, 2021 class action lawsuits were filed against the Company and certain of its current and former senior officers in the United States District Court for the District of Maryland on behalf of purchasers of the Company's common stock, seeking to pursue remedies under the Securities Exchange Act of 1934 (the “Exchange Act”). These complaints were filed by Plaintiff Palm Tran, Inc. – Amalgamated Transit Union Local 1577 Pension Plan; Plaintiff Alan I. Roth; and Plaintiff Stephen M. Weiss, respectively. The complaints allege, among other things, that the defendants disseminated materially false and misleading information about its capabilities to manufacture COVID-19 vaccine bulk drug substance in violation of Sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder. The defendants believe that the allegations in the complaints are false and intend to defend the matters vigorously.
It is expected that all three of these cases will be consolidated into a single action. Given the uncertainty of litigation, the preliminary stage of the cases, and the legal standards that must be met for, among other things, class certification and success on the merits, the Company cannot reasonably estimate the possible loss or range of loss, if any, that may result from these actions.
On June 29, 2021, Lincolnshire Police Pension Fund filed a stockholder derivative lawsuit in the United States District Court for the District of Maryland on behalf of the Company against certain of its current and former officers and directors for breach of fiduciary duties, waste of corporate assets, and unjust enrichment, each allegation related to the Company’s capabilities to manufacture COVID-19 vaccine bulk drug substance. In addition to monetary damages, the complaint seeks the implementation of multiple corporate governance and internal policy changes. The defendants believe that the allegations in the complaint are false and intend to defend the matter vigorously.
In addition to the above actions, the Company has received preliminary inquiries and subpoenas to produce documents related to these matters from Representative Maloney and Representative Clyburn, members of the Oversight Committee and the Select Subcommittee on the Coronavirus Crisis, Senator Murray of the Committee on Health, Education, Labor and Pensions, the Financial Industry Regulatory Authority (FINRA), the Department of Justice, the Securities and Exchange Commission (SEC), the Maryland Attorney General’s Office, and the New York Attorney General’s Office. The Company is producing and has produced documents as required in response and will continue to cooperate with these government inquiries.
Intellectual Property
Emergent BioSolutions’ Adapt Pharma subsidiaries (“Emergent”) are as follows: Emergent Devices Inc. (“EBPA”), formerly known as Adapt Pharma Inc.; Emergent Operations Ireland Limited (“EIRE”), formerly known as Adapt Pharma Operations Limited; and Emergent BioSolutions Ireland Limited (“EIR2”), formerly known as Adapt Pharma Limited.
ANDA Litigation - Teva 4mg
On or about September 13, 2016, Emergent BioSolutions’ Adapt Pharma subsidiaries EBPA and EIRE, and Opiant received a notice letter from Teva Pharmaceuticals Industries Limited and Teva Pharmaceuticals USA (collectively, “Teva”) that Teva had filed an ANDA with the FDA seeking regulatory approval to market a generic version of NARCAN® (naloxone hydrochloride) Nasal Spray 4 mg/spray before the expiration of U.S. Patent No. 9,211,253, (the “‘253 Patent”). Emergent and Opiant received additional notice letters from Teva relating to U.S. Patent Nos. 9,468,747 (the “‘747 Patent”), 9,561,177, (the “‘177 Patent”), 9,629,965, (the “‘965 Patent”) and 9,775,838 (the “‘838 Patent”) and 10,085,937 (the “‘937 Patent”). Teva’s notice letters asserted that the commercial manufacture, use or sale of its generic drug product described in its ANDA would not infringe the ‘253, the ‘747, the ‘177, the ‘965, the ‘838, or the ‘937 Patent, or that the ‘253, the ‘747, the ‘177, the ‘965, the ‘838, and the ‘937 Patents were invalid or
EMERGENT BIOSOLUTIONS INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited, in millions, except share and per share amounts)
unenforceable. Emergent and Opiant filed a complaint for patent infringement against Teva in the U.S. District Court for the District of New Jersey with respect to the ‘253 Patent. Emergent and Opiant also filed complaints for patent infringement against Teva in the U.S. District Court for the District of New Jersey with respect to the ‘747, the ‘177, the ‘965, and the ‘838 Patents. All five proceedings were consolidated. On June 5, 2020, the U.S. District Court for the District of New Jersey ruled in favor of Teva. Emergent filed its Notice of Appeal on July 23, 2020 with the Court of Appeals for the Federal Circuit. Briefs in the appeal have been filed. The appeal hearing has been scheduled for August 2, 2021.
Emergent has also filed suit in the Federal Court in Canada against Teva Pharmaceuticals (on July 23, 2020). The litigation in Canada is related to Teva Pharmaceuticals’ recent filing of an abbreviated new drug submission (“ANDS”) in Canada seeking to manufacture and sell a generic form of NARCAN® Nasal Spray ahead of the expiry of the Canadian patent covering our product.
ANDA Litigation - Teva 2mg
On or about February 27, 2018, Emergent BioSolutions’ Adapt Pharma subsidiaries EBPA and EIRE, and Opiant received a notice letter from Teva that Teva had filed an ANDA with the FDA seeking regulatory approval to market a generic version of NARCAN® (naloxone hydrochloride) Nasal Spray 2 mg/spray before the expiration of U.S. Patent No. 9,480,644, (the “‘644 Patent”) and U.S. Patent No. 9,707,226, (the “‘226 Patent”). Teva’s notice letter asserted that the commercial manufacture, use or sale of its generic drug product described in its ANDA would not infringe the ‘644 Patent or the ‘226 Patent, or that the ‘644 Patent and ‘226 Patent were invalid or unenforceable. Emergent and Opiant filed a complaint for patent infringement against Teva in the U.S. District Court for the District of New Jersey. This case is currently stayed pending the outcome of the appeal of the NARCAN® Nasal Spray 4 mg/spray case.