(Mark One)
|
|
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
For the quarterly period ended September 30, 2018
|
|
OR
|
|
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
For the transition period from
to
|
Delaware
|
14-1902018
|
(State or Other Jurisdiction of
Incorporation or Organization)
|
(I.R.S. Employer
Identification No.)
|
400 Professional Drive, Suite 400
|
|
Gaithersburg, Maryland
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20879
|
(Address of Principal Executive Offices)
|
(Zip Code)
|
Part I. Financial Information
|
|
|
|
Part II. Other Information
|
|
§ |
appropriations for the procurement of BioThrax
®
(Anthrax Vaccine Adsorbed) and our other products addressing public health threats;
|
§ |
our ability to perform under our contracts with the U.S. government related to BioThrax, our NuThrax™ product candidate, and our other public health threat products, including the timing of and specifications relating to deliveries;
|
§ |
our ability to obtain Emergency Use Authorization pre-approval for NuThrax (anthrax vaccine adsorbed with CPG 7909 adjuvant) from the U.S. Food and Drug Administration, or FDA;
|
§ |
the availability of funding for our U.S. government grants and contracts;
|
§ |
our ability to secure follow-on procurement contracts for our public health threat products that are under procurement contracts that have expired or will be expiring;
|
§ |
our ability and the ability of our collaborations to protect our intellectual property rights;
|
§ |
our ability to identify and acquire companies, businesses, products or product candidates that satisfy our selection criteria;
|
§ |
our ability to successfully integrate our acquisitions of PaxVax Holding Company Ltd. and Adapt Pharma Limited, both of which were acquired in October 2018, and realize the benefits of these acquisitions;
|
§ |
our ability to successfully identify and respond to new development contracts with the U.S. government, as well as successfully maintain, through achievement of development milestones, current development contracts with the U.S. government;
|
§ |
our ability and the ability of our contractors and suppliers to maintain compliance with current good manufacturing practices and other regulatory obligations;
|
§ |
the results of regulatory inspections;
|
§ |
the operating and financial restrictions placed on us and our subsidiaries under our senior secured credit facilities;
|
§ |
our ability to obtain and maintain regulatory approvals for our product candidates and the timing of any such approvals;
|
§ |
the procurement of products by U.S. government entities under regulatory exemptions prior to approval by the FDA and corresponding procurement by government entities outside of the United States under regulatory exemptions prior to approval by the corresponding regulatory authorities in the applicable country;
|
§ |
the success of our commercialization, marketing and manufacturing capabilities and strategy; and
|
§ |
the accuracy of our estimates regarding future revenues, expenses, capital requirements and needs for additional financing.
|
(in thousands, except share and per share data)
|
||||||||||||||||
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||||||||||
2018
|
2017
|
2018
|
2017
|
|||||||||||||
(Unaudited)
|
(Unaudited)
|
|||||||||||||||
Revenues:
|
||||||||||||||||
Product sales
|
$
|
133,269
|
$
|
114,296
|
$
|
389,115
|
$
|
259,875
|
||||||||
Contract manufacturing
|
22,172
|
18,912
|
71,963
|
52,700
|
||||||||||||
Contracts and grants
|
18,212
|
16,226
|
50,589
|
54,489
|
||||||||||||
Total revenues
|
173,653
|
149,434
|
511,667
|
367,064
|
||||||||||||
Operating expenses:
|
||||||||||||||||
Cost of product sales and contract manufacturing
|
73,232
|
44,503
|
220,449
|
125,449
|
||||||||||||
Research and development
|
37,006
|
22,659
|
90,802
|
68,886
|
||||||||||||
Selling, general and administrative
|
42,105
|
34,503
|
121,815
|
101,521
|
||||||||||||
Income from operations
|
21,310
|
47,769
|
78,601
|
71,208
|
||||||||||||
Other income (expense):
|
||||||||||||||||
Interest income
|
701
|
637
|
1,229
|
1,593
|
||||||||||||
Interest expense
|
(642
|
)
|
(1,991
|
)
|
(1,884
|
)
|
(5,734
|
)
|
||||||||
Other income (expense), net
|
190
|
(101
|
)
|
11
|
(387
|
)
|
||||||||||
Total other income (expense), net
|
249
|
(1,455
|
)
|
(644
|
)
|
(4,528
|
)
|
|||||||||
Income before provision for income taxes
|
21,559
|
46,314
|
77,957
|
66,680
|
||||||||||||
Provision for income taxes
|
614
|
12,763
|
11,776
|
18,028
|
||||||||||||
Net income
|
$
|
20,945
|
$
|
33,551
|
$
|
66,181
|
$
|
48,652
|
||||||||
Net income per share - basic
|
$
|
0.42
|
$
|
0.81
|
$
|
1.33
|
$
|
1.19
|
||||||||
Net income per share - diluted (1)
|
$
|
0.41
|
$
|
0.68
|
$
|
1.29
|
$
|
1.03
|
||||||||
Weighted-average number of shares - basic
|
50,071,632
|
41,222,504
|
49,851,082
|
40,989,813
|
||||||||||||
Weighted-average number of shares - diluted
|
51,486,996
|
50,467,829
|
51,189,680
|
50,090,088
|
Emergent BioSolutions Inc. and Subsidiaries
|
||||||||||||||||
(in thousands)
|
||||||||||||||||
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||||||||||
2018
|
2017
|
2018
|
2017
|
|||||||||||||
(Unaudited)
|
(Unaudited)
|
|||||||||||||||
Net income
|
$
|
20,945
|
$
|
33,551
|
$
|
66,181
|
$
|
48,652
|
||||||||
Foreign currency translations, net of tax
|
(250
|
)
|
(296
|
)
|
(968
|
)
|
516
|
|||||||||
Comprehensive income
|
$
|
20,695
|
$
|
33,255
|
$
|
65,213
|
$
|
49,168
|
(in thousands)
|
||||||||
Nine Months Ended September 30,
|
||||||||
2018
|
2017
|
|||||||
Cash flows from operating activities:
|
(Unaudited)
|
|||||||
Net income
|
$
|
66,181
|
$
|
48,652
|
||||
Adjustments to reconcile to net cash provided by (used in) operating activities:
|
||||||||
Stock-based compensation expense
|
16,664
|
11,805
|
||||||
Depreciation and amortization
|
37,106
|
29,899
|
||||||
Income taxes
|
12,761
|
18,618
|
||||||
Change in fair value of contingent consideration
|
1,917
|
1,350
|
||||||
Other
|
1,515
|
703
|
||||||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable
|
66,455
|
9,411
|
||||||
Inventories
|
17,067
|
5,113
|
||||||
Income taxes payable
|
(10,130
|
)
|
(5,515
|
)
|
||||
Prepaid expenses and other assets
|
(5,921
|
)
|
(2,157
|
)
|
||||
Accounts payable
|
(5,695
|
)
|
2,965
|
|||||
Accrued expenses and other liabilities
|
2,457
|
(2,334
|
)
|
|||||
Accrued compensation
|
3,925
|
(1,902
|
)
|
|||||
Deferred revenue
|
3,262
|
14,006
|
||||||
Net cash provided by operating activities
|
207,564
|
130,614
|
||||||
Cash flows from investing activities:
|
||||||||
Purchases of property, plant and equipment and other
|
(51,275
|
)
|
(42,381
|
)
|
||||
Proceeds from sale of assets
|
2,624
|
-
|
||||||
Net cash used in investing activities
|
(48,651
|
)
|
(42,381
|
)
|
||||
Cash flows from financing activities:
|
||||||||
Issuance of common stock upon exercise of stock options
|
11,402
|
10,799
|
||||||
Debt issuance costs
|
-
|
(1,426
|
)
|
|||||
Taxes paid on behalf of employees for equity activity
|
(6,303
|
)
|
(4,184
|
)
|
||||
Payments of notes payable to Aptevo
|
-
|
(20,000
|
)
|
|||||
Contingent consideration payments
|
(2,234
|
)
|
(2,744
|
)
|
||||
Restricted cash
|
-
|
(1,043
|
)
|
|||||
Purchase of treasury stock
|
(145
|
)
|
(83
|
)
|
||||
Net cash provided by (used in) financing activities
|
2,720
|
(18,681
|
)
|
|||||
Effect of exchange rate changes on cash, cash equivalents and restricted cash
|
(567
|
)
|
(74
|
)
|
||||
Net increase in cash, cash equivalents and restricted cash
|
161,066
|
69,478
|
||||||
Cash, cash equivalents and restricted cash at beginning of period (1)
|
179,335
|
271,513
|
||||||
Cash, cash equivalents and restricted cash at end of period (1)
|
$
|
340,401
|
$
|
340,991
|
$0.001 Par Value Common Stock
|
Additional Paid-In
|
Treasury Stock
|
Accumulated Other Comprehensive
|
Retained
|
Total Stockholders'
|
|||||||||||||||||||||||||||
Shares
|
Amount
|
Capital
|
Shares
|
Amount
|
Loss
|
Earnings
|
Equity
|
|||||||||||||||||||||||||
Balance at December 31, 2017
|
50,619,808
|
$
|
50
|
$
|
618,416
|
(1,214,443
|
)
|
$
|
(39,497
|
)
|
$
|
(3,698
|
)
|
$
|
337,074
|
$
|
912,345
|
|||||||||||||||
Adoption of new accounting standard (ASC 606), net of tax
|
-
|
-
|
-
|
-
|
-
|
-
|
(32,527
|
)
|
(32,527
|
)
|
||||||||||||||||||||||
Balance at January 1, 2018
|
50,619,808
|
50
|
618,416
|
(1,214,443
|
)
|
(39,497
|
)
|
(3,698
|
)
|
304,547
|
879,818
|
|||||||||||||||||||||
Employee equity plans activity
|
783,777
|
1
|
21,762
|
-
|
-
|
-
|
-
|
21,763
|
||||||||||||||||||||||||
Treasury stock
|
-
|
-
|
-
|
(2,843
|
)
|
(145
|
)
|
-
|
-
|
(145
|
)
|
|||||||||||||||||||||
Net income
|
-
|
-
|
-
|
-
|
-
|
-
|
66,181
|
66,181
|
||||||||||||||||||||||||
Foreign currency translation, net of tax
|
-
|
-
|
-
|
-
|
-
|
(968
|
)
|
-
|
(968
|
)
|
||||||||||||||||||||||
Balance at September 30, 2018
|
51,403,585
|
$
|
51
|
$
|
640,178
|
(1,217,286
|
)
|
$
|
(39,642
|
)
|
$
|
(4,666
|
)
|
$
|
370,728
|
$
|
966,649
|
(in thousands)
|
||||
Balance at December 31, 2017
|
$
|
30,491
|
||
Adoption of new accounting standard (ASC 606)
|
42,379
|
|||
Balance at January 1, 2018
|
72,870
|
|||
Deferral of revenue
|
18,384
|
|||
Recognition of revenue included in beginning of year contract liability
|
(15,121
|
)
|
||
Balance at September 30, 2018
|
$
|
76,133
|
(in thousands)
|
Three Months Ended September 30, 2018
|
Nine Months Ended September 30, 2018
|
||||||||||||||||||||||
U.S
|
Non-U.S.
|
U.S
|
Non-U.S.
|
|||||||||||||||||||||
Government
|
Government
|
Total
|
Government
|
Government
|
Total
|
|||||||||||||||||||
Product sales
|
$
|
127,332
|
$
|
5,937
|
$
|
133,269
|
$
|
363,254
|
$
|
25,861
|
$
|
389,115
|
||||||||||||
Contract manufacturing
|
-
|
22,172
|
22,172
|
-
|
71,963
|
71,963
|
||||||||||||||||||
Contracts and grants
|
16,656
|
1,556
|
18,212
|
46,711
|
3,878
|
50,589
|
||||||||||||||||||
Total revenues
|
$
|
143,988
|
$
|
29,665
|
$
|
173,653
|
$
|
409,965
|
$
|
101,702
|
$
|
511,667
|
(in thousands)
|
||||
Amount of cash paid to Sanofi
|
$
|
117,500
|
||
Fair value of contingent purchase consideration
|
2,200
|
|||
Total purchase price
|
$
|
119,700
|
(in thousands)
|
||||
Balance at December 31, 2017
|
$
|
12,274
|
||
Expense included in earnings
|
1,917
|
|||
Settlements
|
(2,234
|
)
|
||
Balance at September 30, 2018
|
$
|
11,957
|
September 30,
|
December 31,
|
|||||||
(in thousands)
|
2018
|
2017
|
||||||
Raw materials and supplies
|
$
|
33,845
|
$
|
36,069
|
||||
Work-in-process
|
64,825
|
76,610
|
||||||
Finished goods
|
27,075
|
30,133
|
||||||
Total inventories
|
$
|
125,745
|
$
|
142,812
|
September 30,
|
December 31,
|
|||||||
(in thousands)
|
2018
|
2017
|
||||||
Land and improvements
|
$
|
21,848
|
$
|
21,843
|
||||
Buildings, building improvements and leasehold improvements
|
161,175
|
160,005
|
||||||
Furniture and equipment
|
217,908
|
206,819
|
||||||
Software
|
53,180
|
50,829
|
||||||
Construction-in-progress
|
141,348
|
100,088
|
||||||
Property, plant and equipment, gross
|
595,459
|
539,584
|
||||||
Less: Accumulated depreciation and amortization
|
(160,384
|
)
|
(132,374
|
)
|
||||
Total property, plant and equipment, net
|
$
|
435,075
|
$
|
407,210
|
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||||||||||
(in thousands, except share and per share data)
|
2018
|
2017
|
2018
|
2017
|
||||||||||||
Numerator:
|
||||||||||||||||
Net income
|
$
|
20,945
|
$
|
33,551
|
$
|
66,181
|
$
|
48,652
|
||||||||
Interest expense on convertible debt, net of tax
|
-
|
704
|
-
|
2,445
|
||||||||||||
Amortization of convertible debt issuance costs, net of tax
|
-
|
195
|
-
|
586
|
||||||||||||
Net income, adjusted
|
$
|
20,945
|
$
|
34,450
|
$
|
66,181
|
$
|
51,683
|
||||||||
Denominator:
|
||||||||||||||||
Weighted-average number of shares—basic
|
50,071,632
|
41,222,504
|
49,851,082
|
40,989,813
|
||||||||||||
Dilutive securities—equity awards
|
1,415,364
|
1,148,857
|
1,338,598
|
1,003,794
|
||||||||||||
Dilutive securities—convertible debt
|
-
|
8,096,468
|
-
|
8,096,481
|
||||||||||||
Weighted-average number of shares—diluted
|
51,486,996
|
50,467,829
|
51,189,680
|
50,090,088
|
||||||||||||
Net income per share - basic
|
$
|
0.42
|
$
|
0.81
|
$
|
1.33
|
$
|
1.19
|
||||||||
Net income per share - diluted
|
$
|
0.41
|
$
|
0.68
|
$
|
1.29
|
$
|
1.03
|
§ |
BioThrax
®
(Anthrax Vaccine Adsorbed), the only vaccine licensed by the U.S. Food and Drug Administration, or FDA, for the general use prophylaxis and post-exposure prophylaxis of anthrax disease;
|
§ |
ACAM2000
®
(Smallpox (Vaccinia) Vaccine, Live), the only smallpox vaccine licensed by the FDA for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection (acquired from Sanofi Pasteur Biologics, LLC in October 2017);
|
§ |
Vaxchora® (Cholera Vaccine, Live, Oral), the only FDA-licensed vaccine for the prevention of cholera (acquired in October 2018); and
|
§ |
Vivotif® (Typhoid Vaccine Live Oral Ty21a), the only oral vaccine licensed by the FDA for the prevention of typhoid fever (acquired in October 2018).
|
§ |
NARCAN® (naloxone HCl) Nasal Spray, the first and only 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 (acquired in October 2018);
|
§ |
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; and
|
§ |
Tro
bigard™ (atropine sulfate, obidoxime chloride),
an auto-injector device designed for intramuscular self-injection
of atropine sulfate and obidoxime chloride, as a nerve agent countermeasure. This product is not currently approved or cleared by the FDA or any similar regulatory body, and is only distributed to authorized government buyers for use outside the United States. This product is not distributed in the United States.
|
§ |
Raxibacumab (Anthrax Monoclonal), the first fully human monoclonal antibody therapeutic licensed by the FDA for the treatment and prophylaxis of inhalational anthrax (acquired from GlaxoSmithKline LLC in October 2017);
|
§ |
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 antibody therapeutic licensed by the FDA and Health Canada to address certain complications from smallpox vaccination.
|
§ |
VLA1601, a highly purified inactivated vaccine against the Zika virus;
|
§ |
UNI-FLU, a universal influenza vaccine;
|
§ |
EBX-205, an oral therapeutic to treat acute bacterial skin and skin structure infection, including those caused by methicillin-resistant
Staphylococcus aureus
, or MRSA, as well as to treat other serious bacterial infections caused by biothreat pathogens;
|
§ |
EBI-001, a pan respiratory antiviral from our iminosugar-based discovery program;
|
§ |
GC-072, an oral and intravenous treatment for
Burkholderia pseudomallei
infection (GC-072 is the lead compound in the EV-035 series of broad-spectrum antibiotics);
|
§ |
Live Attenuated Virus, a vaccine that address adenovirus types 4 and 7 (acquired in October 2018); and
|
§ |
Chikungunya Virus Like Particle (VLP) Platform, vaccine for the prevention of disease caused by the chikungunya virus (acquired in October 2018).
|
§ |
D4, a multi-drug delivery device being developed for nerve agent antidote delivery (atropine and pralidoxime chloride in combination); and
|
§ |
SIAN (stabilized isoamyl nitrite), a stabilized form of isoamyl nitrite in an intra-nasal spray device being developed as a treatment for known or suspected acute cyanide poisoning.
|
§ |
FLU-IGIV (NP025), a human polyclonal antibody therapeutic being developed for the treatment of serious influenza A infection in hospitalized patients;
|
§ |
ZIKV-IG (NP024), a human polyclonal antibody therapeutic being developed as a prophylaxis for Zika infections in at risk populations; and
|
§ |
FILOV (NP026), an equine polyclonal antibody therapeutic being developed to treat hemorrhagic fever caused by Filoviruses (Ebola, Marburg and Sudan).
|
Development Programs
|
Funding Source
|
Award Date
|
Performance Period
|
Anthrasil
|
BARDA
|
09/2005
|
09/2005 — 04/2021
|
BARDA
|
09/2018
|
09/2018 — 09/2023
|
|
Auto-injector platform
|
DoD
|
07/2017
|
07/2017 — 06/2022
|
BAT
|
BARDA
|
05/2006
|
05/2006 — 12/2027
|
CIADM
|
BARDA
|
06/2012
|
06/2012 — 06/2027
|
GC-072
|
DTRA
|
08/2014
|
08/2014 — 08/2019
|
NuThrax
|
NIAID
|
08/2014
|
08/2014 — 01/2020
|
BARDA
|
03/2015
|
03/2015 — 03/2019
|
|
BARDA
|
09/2016
|
09/2016 — 09/2021
|
|
SIAN
|
BARDA
|
09/2017
|
09/2017 — 09/2022
|
VIGIV
|
CDC
|
02/2018
|
02/2018 — 02/2019
|
|
Three Months Ended September 30, 2018
|
|||||||||||||||
(in millions)
|
2018
|
2017
|
Change
|
% Change
|
||||||||||||
Product sales:
|
||||||||||||||||
BioThrax
|
$
|
45.9
|
$
|
83.5
|
$
|
(37.6
|
)
|
(45
|
%)
|
|||||||
Other
|
87.4
|
30.8
|
56.6
|
184
|
%
|
|||||||||||
Total Product sales
|
133.3
|
114.3
|
19.0
|
17
|
%
|
|||||||||||
Contract manufacturing
|
22.2
|
18.9
|
3.3
|
17
|
%
|
|||||||||||
Contracts and grants
|
18.2
|
16.2
|
2.0
|
12
|
%
|
|||||||||||
Total revenues
|
$
|
173.7
|
$
|
149.4
|
$
|
24.3
|
16
|
%
|
§ |
sales of ACAM2000 (which was acquired in October 2017) to the CDC;
|
§ |
sales of Raxibacumab (which was acquired in October 2017) to BARDA;
|
§ |
sales of RSDL to the DoD; and
|
§ |
sales of Trobigard to the U.S. Department of State.
|
§ |
SIAN primarily related to toxicology/safety studies and manufacturing development;
|
§ |
ACAM2000 (acquired October 2017) primarily related to development contract closeout activities with the CDC;
|
§ |
BAT primarily related to the timing of stability testing; and
|
§ |
D4 primarily related to device concept and feasibility activities.
|
§ |
CIADM program, primarily due to the adoption of a new revenue accounting standard effective January 1, 2018; and
|
§ |
NuThrax program related to the timing of clinical trial activities, partially offset by an increase in manufacturing development activities.
|
§ |
timing of manufacturing development activities for ACAM2000 (acquired in October 2017);
|
§ |
timing of a Phase 2 clinical study and related activities for our FLU-IGIV (NP025) program;
|
§ |
timing of manufacturing development activities for our NuThrax product candidate; and
|
§ |
timing of manufacturing activities and toxicology/safety studies for our SIAN product candidate.
|
|
Nine Months Ended September 30, 2018
|
|||||||||||||||
(in millions)
|
2018
|
2017
|
Change
|
% Change
|
||||||||||||
Product sales:
|
||||||||||||||||
BioThrax
|
$
|
143.7
|
$
|
179.6
|
$
|
(35.9
|
)
|
(20
|
%)
|
|||||||
Other
|
245.4
|
80.3
|
165.1
|
206
|
%
|
|||||||||||
Total Product sales
|
389.1
|
259.9
|
129.2
|
50
|
%
|
|||||||||||
Contract manufacturing
|
72.0
|
52.7
|
19.3
|
37
|
%
|
|||||||||||
Contracts and grants
|
50.6
|
54.5
|
(3.9
|
)
|
(7
|
%)
|
||||||||||
Total revenues
|
$
|
511.7
|
$
|
367.1
|
$
|
144.6
|
39
|
%
|
§ |
sales of ACAM2000 (which was acquired in October 2017) to the CDC;
|
§ |
sales of Raxibacumab (which was acquired in October 2017) to BARDA;
|
§ |
sales of Trobigard to the U.S. Department of State;
|
§ |
sales of RSDL to the DoD; and
|
§ |
sales of Anthrasil to the Canadian National Defence ministry.
|
§ |
CIADM program primarily due to adoption of a new revenue accounting standard effective January 1, 2018. The decrease also includes a decrease in funding for CIADM task orders (related to Ebola and Zika);
|
§ |
NuThrax program related to the timing of clinical trial activities, partially offset by an increase in manufacturing development activities; and
|
§ |
large-scale manufacturing of BioThrax, primarily due to the timing of contract close out activities associated with the development contract from BARDA.
|
§ |
SIAN primarily related to toxicology/safety studies and manufacturing development;
|
§ |
ACAM2000 (acquired October 2017) primarily related to development contract closeout activities with the CDC; and
|
§ |
D4 primarily related to device concept and feasibility activities.
|
§ |
technology transfer activities for Raxibacumab (acquired in October 2017), moving the manufacturing from GlaxoSmithKline's facility to our Bayview facility;
|
§ |
timing of manufacturing development activities for ACAM2000 (acquired in October 2017);
|
§ |
timing of a Phase 2 clinical study and related activities for our FLU-IGIV (NP025) program; and
|
§ |
timing of manufacturing activities and toxicology/safety studies for our SIAN product candidate.
|
|
Nine Months Ended
|
|||||||
September 30,
|
||||||||
(in millions)
|
2018
|
2017
|
||||||
Net cash provided by (used in):
|
||||||||
Operating activities(i)
|
$
|
207.0
|
$
|
130.5
|
||||
Investing activities
|
(48.7
|
)
|
(42.4
|
)
|
||||
Financing activities
|
2.7
|
(18.7
|
)
|
|||||
Net increase in cash and cash equivalents
|
$
|
161.0
|
$
|
69.4
|
§ |
existing cash and cash equivalents;
|
§ |
net proceeds from the sale of our products and contract manufacturing services;
|
§ |
development contracts and grants funding; and
|
§ |
our senior secured credit facilities and any other lines of credit we may establish from time to time.
|
§ |
the level, timing and cost of product sales and contract manufacturing services;
|
§ |
the extent to which we acquire or invest in and integrate companies, businesses, products or technologies;
|
§ |
the acquisition of new facilities and capital improvements to new or existing facilities;
|
§ |
the payment obligations under our indebtedness;
|
§ |
the scope, progress, results and costs of our development activities;
|
§ |
our ability to obtain funding from collaborative partners, government entities and non-governmental organizations for our development programs;
|
§ |
the extent to which we repurchase additional common stock under our authorized share repurchase program; and
|
§ |
the costs of commercialization activities, including product marketing, sales and distribution.
|
§ |
the possibility that we may be ineligible to respond to a request for proposal issued by the government;
|
§ |
the commitment of substantial time and attention of management and key employees to the preparation of bids and proposals for contracts that may not be awarded to us;
|
§ |
the need to accurately estimate the resources and cost structure that will be required to perform any contract that we might be awarded;
|
§ |
the submission by third parties of protests to our responses to requests for proposal that could result in delays or withdrawals of those requests for proposal; and
|
§ |
in the event our competitors protest or challenge contract or grant awards made to us pursuant to competitive bidding, the potential that we may incur expenses or delays, and that any such protest or challenge could result in the resubmission of bids based on modified specifications, or in the termination, reduction or modification of the awarded contract.
|
§ |
the Federal Acquisition Regulation, or FAR, and agency-specific regulations supplemental to FAR, which comprehensively regulate the award, formation, administration and performance of government contracts;
|
§ |
the Defense Federal Acquisition Regulations, or DFARs, and agency-specific regulations supplemental to DFARs, which comprehensively regulate the award, formation, administration and performance of U.S. Department of Defense, or DoD, government contracts;
|
§ |
the Department of State Acquisition Regulation, or DOSAR, which regulates the relationship between a Department of State organization and a contractor or potential contractor;
|
§ |
business ethics and public integrity obligations, which govern conflicts of interest and the hiring of former government employees, restrict the granting of gratuities and funding of lobbying activities and incorporate other requirements such as the Anti-Kickback Act, the Procurement Integrity Act, the False Claims Act and the Foreign Corrupt Practices Act;
|
§ |
export and import control laws and regulations, including but not limited to International Traffic in Arms Regulations; and
|
§ |
laws, regulations and executive orders restricting the use and dissemination of information classified for national security purposes and the exportation of certain products and technical data.
|
§ |
terminate existing contracts, in whole or in part, for any reason or no reason;
|
§ |
unilaterally reduce or modify contracts or subcontracts, including by imposing equitable price adjustments;
|
§ |
cancel multi-year contracts and related orders, if funds for contract performance for any subsequent year become unavailable;
|
§ |
decline, in whole or in part, to exercise an option to purchase product under a procurement contract or to fund additional development under a development contract;
|
§ |
decline to renew a procurement contract;
|
§ |
claim rights to facilities or to products, including intellectual property, developed under the contract;
|
§ |
require repayment of contract funds spent on construction of facilities in the event of contract default;
|
§ |
take actions that result in a longer development timeline than expected;
|
§ |
direct the course of a development program in a manner not chosen by the government contractor;
|
§ |
suspend or debar the contractor from doing business with the government or a specific government agency;
|
§ |
pursue civil or criminal remedies under acts such as the False Claims Act and False Statements Act; and
|
§ |
control or prohibit the export of products.
|
§ |
warning letters and other communications;
|
§ |
product seizure or withdrawal of the product from the market;
|
§ |
restrictions on the marketing or manufacturing of a product;
|
§ |
suspension or withdrawal of regulatory approvals or refusal to approve pending applications or supplements to approved applications;
|
§ |
fines or disgorgement of profits or revenue; and
|
§ |
injunctions or the imposition of civil or criminal penalties.
|
§ |
equipment malfunctions or failures;
|
§ |
technology malfunctions;
|
§ |
cyber-attacks;
|
§ |
work stoppages or slow-downs;
|
§ |
protests, including by animal rights activists;
|
§ |
injunctions;
|
§ |
damage to or destruction of the facility; and
|
§ |
product contamination or tampering.
|
§ |
retaining existing customers and attracting new customers;
|
§ |
retaining key employees;
|
§ |
diversion of management attention and resources;
|
§ |
conforming internal controls, policies and procedures, business cultures and compensation programs;
|
§ |
consolidating corporate and administrative infrastructures;
|
§ |
successfully executing technology transfers and obtaining required regulatory approvals;
|
§ |
consolidating sales and marketing operations;
|
§ |
identifying and eliminating redundant and underperforming operations and assets;
|
§ |
assumption of known and unknown liabilities;
|
§ |
coordinating geographically dispersed organizations; and
|
§ |
managing tax costs or inefficiencies associated with integrating operations.
|
§ |
successful development, formulation and cGMP scale-up of manufacturing that meets FDA or other foreign regulatory requirements;
|
§ |
successful program partnering;
|
§ |
successful completion of clinical or non-clinical development, including toxicology studies and studies in approved animal models;
|
§ |
receipt of marketing approvals from the FDA and equivalent foreign regulatory authorities;
|
§ |
establishment of commercial manufacturing processes and product supply arrangements;
|
§ |
training of a commercial sales force for the product, whether alone or in collaboration with others;
|
§ |
successful registration and maintenance of relevant patent and/or other proprietary protection; and
|
§ |
acceptance of the product by potential government and other customers.
|
§ |
our inability to manufacture sufficient quantities of materials for use in trials;
|
§ |
the unavailability or variability in the number and types of subjects for each study;
|
§ |
safety issues or inconclusive or incomplete testing, trial or study results;
|
§ |
drug immunogenicity;
|
§ |
lack of efficacy of product candidates during the trials;
|
§ |
government or regulatory restrictions or delays; and
|
§ |
greater than anticipated costs of trials.
|
§ |
requiring us to dedicate a substantial portion of any cash flow from operations to payment on our debt, which would reduce the amounts available to fund other corporate initiatives;
|
§ |
increasing the amount of interest that we have to pay on debt with variable interest rates, if market rates of interest increase;
|
§ |
subjecting us, as under our senior secured revolving credit facility, to restrictive covenants that may reduce our ability to take certain corporate actions, acquire companies, products or technology, or obtain further debt financing;
|
§ |
requiring us to pledge our assets as collateral, which could limit our ability to obtain additional debt financing;
|
§ |
limiting our flexibility in planning for, or reacting to, general adverse economic and industry conditions; and
|
§ |
placing us at a competitive disadvantage compared to our competitors that have less debt, better debt servicing options or stronger debt servicing capacity.
|
§ |
the level, timing and cost of product sales and contract manufacturing services;
|
§ |
the extent to which we acquire or invest in and integrate companies, businesses, products or technologies;
|
§ |
the acquisition of new facilities and capital improvements to new or existing facilities;
|
§ |
the payment obligations under our indebtedness;
|
§ |
the scope, progress, results and costs of our development activities;
|
§ |
our ability to obtain funding from collaborative partners, government entities and non-governmental organizations for our development programs;
|
§ |
the extent to which we repurchase additional common stock under our authorized share repurchase program; and
|
§ |
the costs of commercialization activities, including product marketing, sales and distribution.
|
§ |
decreased demand or withdrawal of a product;
|
§ |
injury to our reputation;
|
§ |
withdrawal of clinical trial participants;
|
§ |
costs to defend the related litigation;
|
§ |
substantial monetary awards to trial participants or patients;
|
§ |
loss of revenue; and
|
§ |
an inability to commercialize products that we may develop.
|
§ |
the classification of our directors;
|
§ |
limitations on changing the number of directors then in office;
|
§ |
limitations on the removal of directors;
|
§ |
limitations on filling vacancies on the board;
|
§ |
advance notice requirements for stockholder nominations of candidates for election to the Board of Directors and other proposals;
|
§ |
the inability of stockholders to act by written consent;
|
§ |
the inability of stockholders to call special meetings; and
|
§ |
the ability of our Board of Directors to designate the terms of and issue a new series of preferred stock without stockholder approval.
|
§ |
contracts, decisions and procurement policies by the U.S. government affecting BioThrax and our other products and product candidates;
|
§ |
the success of competitive products or technologies;
|
§ |
results of clinical and non-clinical trials of our product candidates;
|
§ |
announcements of acquisitions, financings or other transactions by us;
|
§ |
litigation or legal proceedings;
|
§ |
public concern as to the safety of our products;
|
§ |
termination or delay of a development program;
|
§ |
the recruitment or departure of key personnel;
|
§ |
variations in our product revenue and profitability; and
|
§ |
the other factors described in this "Risk Factors" section.
|
Exhibit
Number
|
Description
|
2.1
†
|
Share Purchase Agreement, dated August 28, 2018, by and among Emergent BioSolutions Inc., the Sellers identified therein, Seamus Mulligan and Adapt Pharma Limited (incorporated by reference to Exhibit 2 to the Company's Current Report on Form 8-K, filed on October 15, 2018).
|
2.2
†
|
Merger Agreement, dated August 8, 2018, by and among Emergent BioSolutions Inc., PaxVax Holding Company Ltd., Panama Merger Sub Ltd., and PaxVax SH Representative LLC (incorporated by reference to Exhibit 2 to the Company's Current Report on Form 8-K, filed on October 5, 2018).
|
Amended and Restated Credit Agreement, dated October 15, 2018, by and among Emergent BioSolutions Inc., the lenders party thereto from time to time, and Wells Fargo Bank, National Association, as the Administrative Agent (incorporated by reference to Exhibit 10 to the Company's Current Report on Form 8-K, filed on October 15, 2018).
|
|
10.2
#
†
|
Modification No. 13, effective September 21, 2018, to the
Solicitation/Contract/Order for Commercial Items
, effective December 8, 2016, from the Centers for Disease Control and Prevention to Emergent Biodefense Operations Lansing LLC.
|
10.3
#
†
|
Modification No. 2, effective August 29, 2018 to the Award/Contract, effective September 30, 2016, from the BioMedical Advanced Research and Development Authority to Emergent Product Development Gaithersburg, Inc.
|
12
#
|
Ratio of Earnings to Fixed Charges.
|
31.1
#
|
Certification of the Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a).
|
31.2
#
|
Certification of the Chief Financial Officer pursuant to Exchange Act Rule 13a-14(a).
|
32.1
#
|
Certification of the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
32.2
#
|
Certification of the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
101. INS
|
XBRL Instance Document.
|
101.SCH
|
XBRL Taxonomy Extension Schema Document.
|
101.CAL
|
XBRL Taxonomy Calculation Linksbase Document.
|
101.DEF
|
XBRL Taxonomy Definition Linksbase Document.
|
101.LAB
|
XBRL Taxonomy Label Linksbase Document.
|
101.PRE
|
XBRL Taxonomy Presentation Linksbase Document.
|
† |
Confidential treatment requested with the Securities and Exchange Commission as to certain portions. Confidential materials omitted and filed separately with the Securities and Exchange Commission.
|
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
|
1. CONTRACT ID CODE
|
PAGE OF PAGES
1
5
|
|||||||||||
2. AMENDMENT/MODIFICATION NO.
0002
|
3. EFFECTIVE DATE
See Block 16C
|
4. REQUISITION/PURCHASE REQ. NO.
OS226613
|
5. PROJECT NO.
(If applicable)
|
||||||||||
6. ISSUED BY
|
CODE
|
ASPR-BARDA
|
7. ADMINISTERED BY
(If other than Item 6)
|
CODE
|
ASPR-BARDA
|
||||||||
ASPR-BARDA
200 Independence Ave., S.W.
Room 640-G
Washington DC 20201
|
ASPR-BARDA
200 Independence Ave., S.W.
Room 638-G
Washington DC 20201
|
||||||||||||
8. NAME AND ADDRESS OF CONTRACTOR
(No., street, county, State and ZIP Code)
EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.
EMERGENT PRODUCT DEVLOPMENT GAITHE
300 PROFESSIONAL DR # 100
GAITHERSBURG MD 208793419
|
X
X
|
9A. AMENDMENT OF SOLICITATION NO.
9B. DATED
(See Item 11)
10A. MODIFICATION OF CONTRACT/ORDER NO.
HHSO100201600030C
10B. DATED
(See Item 13)
|
|||||||||||
CODE
1365869
|
FACILITY CODE
|
09/30/2016
|
|||||||||||
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
|
|||||||||||||
The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended.
Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:
(a) By completing Items 8 and 15, and returning
copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer
submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEGMENT
TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT
IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter,
provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.
|
|||||||||||||
12. ACCOUNTING AND APPROPRIATION DATA
(If required)
Net Increase:
$[***]
2018.199TWNP.25106
|
|||||||||||||
13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,
IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.
|
|||||||||||||
CHECK ONE
|
A.
THIS CHANGE ORDER IS ISSUED PURSUANT TO:
(Specify authority)
THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.
|
||||||||||||
B.
THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES
(such as changes in paying office, appropriation date, etc.)
SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).
|
|||||||||||||
X
|
C.
THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
FAR 52.243-2 – Changes - Cost Reimbursement
|
||||||||||||
D.
OTHER
(Specify type of modification and authority)
|
|||||||||||||
E. IMPORTANT: Contractor
is not,
x
is required to sign this document and return
2
copies to the issuing office.
|
|||||||||||||
14. DESCRIPTION OF AMENDMENT/MODIFICATION
(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
Tax ID Number: [***]
DUNS Number: [***]
The purpose of this modification is to modify ARTICLES B.3. OPTION PRICES, B.5. ADVANCE UNDERSTANDINGS, C.1. STATEMENT OF WORK, G.3. KEY PERSONNEL, and SECTION J – LIST OF
ATTACHMENTS.
Funds Obligated Prior to this Modification: $198,705,042
Funds Obligated with Mod #2: $[***]
Total Funds Obligated to Date: $[***]
Continued ...
|
|||||||||||||
Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.
|
|||||||||||||
15A. NAME AND TITLE OF SIGNER
(Type or print)
Abigail Jenkins SVP BU HEAD VAI
|
16A. NAME OF CONTRACTING OFFICER
CHRISTOPHER SCOTT
|
||||||||||||
15B. CONTRACTOR/OFFEROR
/s/ Abigail Jenkins
(Signature of person authorized to sign)
|
15C. DATE SIGNED
Aug 28, 2018
|
16B. UNITED STATES OF AMERICA
BY
/s/ Christopher Scott
(Signature of Contracting Officer)
|
16C. DATE SIGNED
08/29/2018
|
CLIN
|
Period of Performance
|
Supplies/ Services
|
Total Est. Cost
|
Fixed Fee
|
Total Cost
Plus Fixed
Fee ($)
|
COST REIMBURSEMENT
|
|||||
0001A (Option)
|
[***]
|
Phase II [**] Study or studies required by the FDA [**]
|
[***]
|
[***]
|
[***]
|
0012
|
08/29/18-
09/29/21
|
Doxycycline Arm & Redundant Contract Filler
|
[***]
|
[***]
|
[***]
|
CLIN
|
Period of Performance
|
Supplies/ Services
|
Total Est. Cost
|
Fixed Fee
|
Total Cost
Plus Fixed
Fee ($)
|
FIXED PRICE
|
|||||
0003 (Option)
|
[***]
|
Phase IV post marketing commitments /Requirements (This is an option that may or may not be exercised during the base period as determined by the need and as established by the FDA)
|
N/A
|
N/A
|
[***]
|
CLIN
|
Period of Performance
|
Supplies/ Services
|
Units (# of
Product)
|
FY 2018 Unit Price
($)
|
Total ($)
|
0004 (Option)
|
[***]
|
Additional Surge Capacity (EUA)
|
7,500,000 to [***]
|
[***]
|
[***]
|
0005 (Option)
|
[***]
|
Additional Surge Capacity (Licensure)
|
7,500,000 to [***]
|
[***]
|
[***]
|
0006 (Option)
|
[***]
|
Additional Surge Capacity (EUA)
|
[***]
|
[***]
|
[***]
|
0007 (Option)
|
[***]
|
Additional Surge Capacity (Licensure)
|
[***]
|
[***]
|
[***]
|
0008 (Option)
|
[***]
|
Additional Surge Capacity (EUA)
|
[***]
|
[***]
|
[***]
|
0009 (Option)
|
[***]
|
Additional Surge Capacity (Licensure)
|
[***]
|
[***]
|
[***]
|
0010 (Option)
|
[***]
|
Additional Surge Capacity (EUA)
|
[***]
|
[***]
|
[***]
|
0011 (Option)
|
[***]
|
Additional Surge Capacity (Licensure)
|
[***]
|
[***]
|
[***]
|
Units (# of Doses)
|
FY 2019 Unit Price ($)
|
FY 2020 Unit Price ($)
|
FY 2021 Unit Price ($)
|
7,500,000 to [***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
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[***]
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[***]
|
[***]
|
[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
|
[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
|
[***]
|
[***]
|
Name
|
Position
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
·
|
CLIN 0001 - Approval of Emergency Use Authorization (EUA), licensure, approval, and clearance of product through the FDA (Base)
|
·
|
CLIN 0001A - Conduct of a Phase 2 clinical [***] study or other studies required by the FDA [***] (Option)
|
·
|
CLIN 0002 - Initial purchase, storage, and delivery of product (Base)
|
·
|
CLIN 0003 - Phase 4 post marketing requirements (Option)
|
·
|
CLIN 0004 - Surge Capacity - Additional procurement of product (Option)
|
·
|
Identification of and management to, distinct stages of the product development pathway that are gates for Go/No Go decisions for advancing to the next stage of the Integrated Product Development Plan.
|
·
|
Establishment of and tracking of milestones and timelines for the initiation conduct, and completion of product development activities for each stage with a budget (in direct costs) linked to each stage.
|
·
|
Ongoing evaluation of qualitative and quantitative criteria and accompanying data used to assess the scientific merit and technical feasibility of proceeding to the next stage of product development.
|
·
|
Maintaining and managing staff (in-house and contracted) to assure the necessary expertise and dedicated effort to perform the work.
|
·
|
Directing and overseeing subcontractors and consultants to assure successful performance of planned activities within the cost and schedule constraints of the contract.
|
·
|
Conducting performance measurement that shall include establishing an initial plan; defining measurable parameters; defining how these parameters relate to cost and schedule impacts; their approach in providing a detailed schedule that generates a critical path for the project; and a description of the cost-accounting system used or intended to be used based on budget estimates to monitor all costs related to the contract award for both Emergent and subcontractors on a real time basis.
|
·
|
Manage contract activities in accordance with Earned Value Management. In this regard, Emergent shall:
|
o
|
Provide an Integrated Master Project Plan (including tabular and Gantt forms) to BARDA that clearly indicates the critical path to support product approval. The Integrated Master Project Plan shall outline key, critical path milestones, with "Go/No-Go" decision criteria and a contract Work Breakdown Structure (due within 90 days of contract award with updates as requested by the Contracting Officer's Representative (COR).
|
o
|
Submit an updated Integrated Master Schedule in an approved format.
|
o
|
Use principles of Earned Value Management System (EVMS) in the management of this contract.
|
o
|
Submit a plan for a Performance Measurement Baseline Review (PMBR) electronically via email to the Contracting Officer (CO) and COR for a PBMR to occur within 90 days of contract award.
|
·
|
Develop and maintain a risk management plan.
|
·
|
Participate in regular meetings to coordinate and oversee the contracting effort.
|
·
|
Identification of and management to, distinct stages of the product development pathway that are gates for Go/No Go decisions for advancing to the next stage of the Integrated Product Development Plan.
|
·
|
Establishment of and tracking of milestones and timelines for the initiation conduct, and completion of product development activities for each stage with a budget (in direct costs) linked to each stage.
|
·
|
Ongoing evaluation of qualitative and quantitative criteria and accompanying data used to assess the scientific merit and technical feasibility of proceeding to the next stage of product development.
|
·
|
Maintaining and managing staff (in-house and contracted) to assure the necessary expertise and dedicated effort to perform the work.
|
·
|
Directing and overseeing subcontractors and consultants to assure successful performance of planned activities within the cost and schedule constraints of the contract.
|
·
|
Conducting performance measurement that shall include establishing an initial plan; defining measurable parameters; defining how these parameters relate to cost and schedule impacts; their approach in providing a detailed schedule that generates a critical path for the project; and a description of the cost-accounting system used or intended to be used based on budget estimates to monitor all costs related to the contract award for both Emergent and subcontractors on a real time basis.
|
·
|
Manage contract activities in accordance with Earned Value Management. In this regard, Emergent shall:
|
o
|
Provide an Integrated Master Project Plan (including tabular and Gantt forms) to BARDA that clearly indicates the critical path to support product approval. The Integrated Master Project Plan shall outline key, critical path milestones, with "Go/ No Go" decision criteria and a contract Work Breakdown Structure (due within 90 days of contract award with updates as requested by the Contracting Officer's Representative (COR).
|
o
|
Submit an updated Integrated Master Schedule in an approved format.
|
o
|
Use principles of Earned Value Management System (EVMS) in the management of this contract.
|
o
|
Submit a plan for a Performance Measurement Baseline Review (PMBR) electronically via email to the Contracting Officer (CO) and COR for a PBMR to occur within 90 days of contract award.
|
·
|
Develop and maintain a risk management plan.
|
·
|
Participate in regular meetings to coordinate and oversee the contracting effort.
|
·
|
[***] - AVA.214 Phase 2 [***] Study
|
·
|
Identification of and management to, distinct stages of the product development pathway that are gates for Go/No Go decisions for advancing to the next stage of the Integrated Product Development Plan.
|
·
|
Establishment of and tracking of milestones and timelines for the initiation conduct, and completion of product development activities for each stage with a budget (in direct costs) linked to each stage.
|
·
|
Ongoing evaluation of qualitative and quantitative criteria and accompanying data used to assess the scientific merit and technical feasibility of proceeding to the next stage of product development.
|
·
|
Maintaining and managing staff (in-house and contracted) to assure the necessary expertise and dedicated effort to perform the work.
|
·
|
Directing and overseeing subcontractors and consultants to assure successful performance of planned activities within the cost and schedule constraints of the contract.
|
·
|
Conducting performance measurement that shall include establishing an initial plan; defining measurable parameters; defining how these parameters relate to cost and schedule impacts; their approach in providing a detailed schedule that generates a critical path for the project; and a description of the cost-accounting system used or intended to be used based on budget estimates to monitor all costs related to the contract award for both Emergent and subcontractors on a real time basis.
|
·
|
Manage contract activities in accordance with Earned Value Management. In this regard, Emergent shall:
|
o
|
Provide an Integrated Master Project Plan (including tabular and Gantt forms) to BARDA that clearly indicates the critical path to support product approval. The Integrated Master Project Plan shall outline key, critical path milestones, with "Go/No Go" decision criteria and a contract Work Breakdown Structure (due within 90 days of contract award with updates as requested by the Contracting Officer's Representative (COR).
|
o
|
Submit an updated Integrated Master Schedule in an approved format.
|
o
|
Use principles of Earned Value Management System (EVMS) in the management of this contract.
|
o
|
Submit a plan for a Performance Measurement Baseline Review (PMBR) electronically via email to the Contracting Officer (CO) and COR for a PBMR to occur within 90 days of contract award.
|
·
|
Develop and maintain a risk management plan.
|
·
|
Participate in regular meetings to coordinate and oversee the contracting effort.
|
·
|
Forward the initial draft minutes to BARDA within five business days of any formal meeting with the FDA or other regulatory agency, and forward the final minutes when available.
|
·
|
Forward the initial draft minutes to BARDA within five business days of any informal meeting with the FDA or other regulatory agency, and forward the final minutes when available and if applicable.
|
·
|
Forward the dates and times of any meeting with the FDA and other regulatory agencies to BARDA as soon as the meeting times are known and make arrangements for appropriate BARDA staff to attend the meetings.
|
·
|
Provide BARDA the opportunity to review and comment upon any documents to be submitted to the FDA or other regulatory agency. Emergent will provide BARDA with five (5) business days in which to review and provide comments prior to Emergent's submission to the FDA.
|
Milestone #
|
WBS #
|
Milestone
|
Deliverables Summary (Details as specified in the Deliverables)
|
Quantity
|
Estimated Completion Date
|
|
CLIN 0001
|
1
|
[***]
|
[***]
|
[***]
|
1 Electronic Copy to Contract Officer Representative (COR);
1 Electronic Copy to Contracting Officer (CO) |
[***]
|
2
|
[***]
|
[***]
|
[***]
|
See Above
|
[***]
|
|
3
|
[***]
|
[***]
|
[***]
|
See Above
|
[***]
|
|
4
|
[***]
|
[***]
|
[***]
|
See Above
|
[***]
|
|
5
|
[***]
|
[***]
|
[***]
|
See Above
|
[***]
|
|
6
|
[***]
|
[***]
|
[***]
|
See Above
|
[***]
|
|
7
|
[***]
|
[***]
|
[***]
|
See Above
|
[***]
|
|
8
|
[***]
|
[***]
|
[***]
|
See Above
|
[***]
|
|
9
|
[***]
|
[***]
|
[***]
|
See Above
|
[***]
|
|
10
|
[***]
|
[***]
|
[***]
|
See Above
|
[***]
|
|
11
|
[***]
|
[***]
|
[***]
|
See Above
|
[***]
|
|
12
|
[***]
|
[***]
|
[***]
|
See Above
|
[***]
|
|
CLIN 0002
|
16
|
[***]
|
[***]
|
[***]
|
See Above
|
[***]
|
Ratio of Earnings to Fixed Charges
|
|||||||||||||||||||||||
Year to Date
|
|||||||||||||||||||||||
|
September 30,
|
Year Ended December 31,
|
|||||||||||||||||||||
(in thousands)
|
2018
|
2017
|
2016
|
2015
|
2014
|
2013
|
|||||||||||||||||
|
|||||||||||||||||||||||
Pretax income from continuing operations (1)
|
$
|
77,957
|
|
$
|
118,633
|
$
|
99,221
|
$
|
135,716
|
$
|
84,194
|
$
|
83,439
|
||||||||||
Fixed charges
|
|||||||||||||||||||||||
Interest expense
|
1,824
|
6,987
|
8,270
|
7,834
|
7,480
|
1,973
|
|||||||||||||||||
Debt issuance cost
|
285
|
1,759
|
1,526
|
1,564
|
3,290
|
319
|
|||||||||||||||||
Total fixed charges (2)
|
2,109
|
8,746
|
9,796
|
9,398
|
10,770
|
2,292
|
|||||||||||||||||
Noncontrolling interest in pretax income (3)
|
-
|
-
|
-
|
-
|
-
|
876
|
|||||||||||||||||
Capitalized interest (4)
|
225
|
2,156
|
2,179
|
2,875
|
2,530
|
1,973
|
|||||||||||||||||
Earnings ((1) + (2) -(3) -(4))
|
79,841
|
|
125,223
|
106,838
|
142,239
|
92,434
|
82,882
|
||||||||||||||||
Fixed charges
|
2,109
|
8,746
|
9,796
|
9,398
|
10,770
|
2,292
|
|||||||||||||||||
Ratio of earnings to fixed charges
|
37.9
|
14.3
|
10.9
|
15.1
|
8.6
|
36.2
|
|||||||||||||||||
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|