|
x
|
Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
|
|
For the fiscal year ended December 31, 2018
|
|
Or
|
o
|
Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
|
|
For the transition period from ________ to ___________
|
Delaware
|
13-3864870
|
(State or other jurisdiction of
|
(IRS Employer Identification. No.)
|
incorporation or organization)
|
|
|
|
31 East 62nd Street
|
10065
|
New York, NY
|
(zip code)
|
(Address of principal executive offices)
|
|
Securities registered pursuant to Section 12(b) of the Act:
|
|
Title of each class
|
Name of each exchange on which registered
|
common stock, $.0001 par value
|
The Nasdaq Global Market
|
Document
|
Parts Into Which Incorporated
|
Proxy Statement for the Company’s 2019 Annual
|
Part III
|
Meeting of Stockholders
|
|
|
|
|
Page No.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Principal Accoun
ting Fees and Services
|
||
|
|
|
|
|
|
Exhibits, Financial Stat
ement Schedules
|
||
|
|
|
|
•
|
foreign governments, including both defense and public health agencies;
|
•
|
non-governmental organizations and multinational companies, including transportation and security companies
|
•
|
healthcare providers, including hospitals and clinics; and
|
•
|
state and local governments, which may be interested in these products to protect, among others, emergency responders, such as police, fire and emergency medical personnel.
|
Patent Number
|
Country
|
Protection Conferred
|
Issue Date
|
Expiration Date
|
US 7737168
|
United States
|
Method of treating orthopoxvirus infection with ST-246
|
June 15, 2010
|
May 3, 2027^
|
US 8039504
|
United States
|
Pharmaceutical compositions and unit dosage forms containing ST-246
|
October 18, 2011
|
July 23, 2027
|
US 7687641
|
United States
|
Method of manufacturing ST-246
|
March 30, 2010
|
September 27, 2024
|
US 8124643
|
United States
|
Composition of matter for the ST-246 compound and Pharmaceutical compositions containing ST-246
|
February 28, 2012
|
June 18, 2024^
|
US 7956197
|
United States
|
Method of manufacturing ST-246
|
June 7, 2011
|
June 18, 2024
|
US 8530509
|
United States
|
Pharmaceutical compositions containing a mixture of compounds including ST-246
|
September 10, 2013
|
June 18, 2024
|
US 8802714
|
United States
|
Method of treating orthopoxvirus infection with a mixture of compounds including ST-246
|
August 12, 2014
|
June 18, 2024
|
US 9045418
|
United States
|
Method of manufacturing ST-246
|
June 2, 2015
|
June 18, 2024
|
US 9233097
|
United States
|
Liquid Pharmaceutical formulations containing ST-246
|
January 12, 2016
|
August 2, 2031
|
US 9339466
|
United States
|
Certain polymorph of ST-246, method of preparation of the polymorph and pharmaceutical compositions containing the polymorph
|
May 17, 2016
|
March 23, 2031
|
US 9546137
|
United States
|
Methods of preparing ST-246
|
January 17, 2017
|
August 14, 2033
|
US 9744154
|
United States
|
Polymorphic forms of ST-246 and methods of preparation
|
August 29, 2017
|
March 23, 2031
|
US 9862683
|
United States
|
Methods of preparing Tecovirimat
|
January 9, 2018
|
August 14, 2033
|
US 9670158
|
United States
|
Amorphous Tecovirimat preparation
|
June 6, 2017
|
July 11, 2034
|
US 9889119
|
United States
|
Amorphous Tecovirimat preparation
|
February 13, 2018
|
July 11, 2034
|
US 9907859
|
United States
|
ST-246 liquid formulations and methods
|
March 6, 2018
|
August 2, 2031
|
US 10029985
|
United States
|
Methods of preparing Tecovirimat
|
July 24, 2018
|
August 14, 2033
|
US 10045963
|
United States
|
Amorphous Tecovirimat preparation
|
August 14, 2018
|
July 11, 2034
|
US 10045964
|
United States
|
Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs
|
August 14, 2018
|
March 23, 2031
|
US 10124071
|
United States
|
ST-246 liquid formulations and methods
|
November 13, 2018
|
August 2, 2031
|
US 10155723
|
United States
|
Methods of preparing Tecovirimat
|
December 18, 2018
|
August 14, 2033
|
SG 184201
|
Singapore
|
Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs
|
June 22, 2015
|
March 23, 2031
|
RU 2578606
|
Russia
|
Certain polymorphs of ST-246, method of preparation of the polymorphs and their use in treating orthopoxvirus
|
March 27, 2016
|
March 23, 2031
|
OA 16109
|
OAPI/Africa
|
Certain polymorphs of ST-246, method of preparation of the polymorphs and their use in treating orthopoxvirus
|
October 31, 2013
|
March 23, 2031
|
NZ 602578
|
New Zealand
|
Certain polymorphs of ST-246, method of preparation of the polymorphs and their use in treating orthopoxvirus
|
December 2, 2014
|
March 23, 2031
|
MX 326231
|
Mexico
|
Pharmaceutical compositions containing ST-246 and one or more additional ingredients and dosage unit forms containing ST-246
|
December 11, 2014
|
April 23, 2027
|
MX 348481
|
Mexico
|
Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
|
June 15, 2017
|
April 23, 2027
|
MX 347795
|
Mexico
|
ST-246 liquid formulations and methods
|
May 15, 2017
|
August 2, 2031
|
MX 361428
|
Mexico
|
Polymorphic forms of ST-246 and methods of preparation
|
December 6, 2018
|
March 23, 2031
|
KR 101868117
|
Korea
|
ST-246 liquid formulations and methods
|
June 8, 2018
|
August 2, 2031
|
JP 4884216
|
Japan
|
Therapeutic agent for treating orthopoxvirus including ST-246, pharmaceutical composition of matter for the ST-246 compound and method of manufacturing ST-246
|
December 16, 2011
|
June 18, 2024
|
JP 5657489
|
Japan
|
Method of manufacturing ST-246
|
December 5, 2014
|
June 18, 2024
|
JP 5898196
|
Japan
|
Liquid Pharmaceutical formulations containing ST-246
|
March 11, 2016
|
August 2, 2031
|
JP 6018041
|
Japan
|
Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs
|
October 7, 2016
|
March 23, 2031
|
JP 6188802
|
Japan
|
Methods of preparing Tecovirimat
|
August 10, 2017
|
August 14, 2033
|
JP 6444460
|
Japan
|
Methods of preparing Tecovirimat
|
December 7, 2018
|
August 14, 2033
|
CN 2011800245893
|
China
|
Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs
|
August 26, 2015
|
March 23, 2031
|
CN 2013800429237
|
China
|
Methods of preparing Tecovirimat
|
June 20, 2017
|
August 14, 2033
|
CA 2529761
|
Canada
|
Use of ST-246 to treat orthopoxvirus infection, pharmaceutical compositions containing ST-246 and composition of matter for the ST-246 compound
|
August 13, 2013
|
June 18, 2024
|
CA 2685153
|
Canada
|
Pharmaceutical compositions containing ST-246 and one or more additional ingredients and dosage unit forms containing ST-246
|
December 16, 2014
|
April 23, 2027
|
CA 2866037
|
Canada
|
Chemicals, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
|
May 16, 2017
|
April 23, 2027
|
CA 2807528
|
Canada
|
Liquid Pharmaceutical formulations containing ST-246
|
September 25, 2018
|
August 2, 2031
|
AU 2004249250
|
Australia
|
Method of treating orthopoxvirus infection, pharmaceutical composition containing ST-246 and composition of matter for the ST-246 compound
|
March 29, 2012
|
June 18, 2024
|
AU 2007351866
|
Australia
|
Pharmaceutical compositions containing ST-246 and one or more additional ingredients and dosage unit forms containing ST-246
|
January 10, 2013
|
June 18, 2024
|
AU 2011232551
|
Australia
|
Certain polymorphs of ST-246, method of preparation of the polymorphs and their use in treating orthopoxvirus
|
February 26, 2015
|
March 23, 2031
|
AU 2011285871
|
Australia
|
Liquid Pharmaceutical formulations containing ST-246
|
August 6, 2015
|
August 2, 2031
|
AU 2013302764
|
Australia
|
Methods of preparing Tecovirimat
|
April 5, 2018
|
August 14, 2033
|
AU 2012268859
|
Australia
|
Pharmaceutical compositions containing ST-246 and one or more additional ingredients and dosage unit forms containing ST-246
|
August 18, 2016
|
June 18, 2024
|
AU 2014290333
|
Australia
|
Amorphous Tecovirimat preparation
|
February 21, 2019
|
July 11, 2034
|
AP 3221
|
ARIPO*/Africa
|
Certain polymorphs of ST-246, method of preparation of the polymorphs and their use in treating orthopoxvirus
|
April 3, 2015
|
March 23, 2031
|
ZA 2012/07141
|
South Africa
|
Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs
|
June 29, 2016
|
March 23, 2031
|
ZA 2013/00930
|
South Africa
|
Liquid Pharmaceutical formulations containing ST-246
|
November 25, 2015
|
August 2, 2031
|
IL 201736
|
Israel
|
Pharmaceutical compositions containing ST-246 and one or more additional ingredients and dosage unit forms containing ST-246
|
October 1, 2016
|
April 23, 2027
|
IL 236944
|
Israel
|
Methods of preparing Tecovirimat
|
February 1, 2017
|
August 14, 2033
|
IL 242666
|
Israel
|
Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
|
December 1, 2018
|
April 23, 2027
|
AT 1638938
|
Austria
|
Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
|
April 12, 2017
|
June 18, 2024
|
BE 1638938
|
Belgium
|
Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
|
April 12, 2017
|
June 18, 2024
|
BE 2549871
|
Belgium
|
Polymorphic forms of ST-246
|
August 22, 2018
|
March 23, 2031
|
CH 1638938
|
Switzerland
|
Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
|
April 12, 2017
|
June 18, 2024
|
CH 2549871
|
Switzerland
|
Polymorphic forms of ST-246
|
August 22, 2018
|
March 23, 2031
|
DE 1638938
|
Germany
|
Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
|
April 12, 2017
|
June 18, 2024
|
DE 2549871
|
Germany
|
Polymorphic forms of ST-246
|
August 22, 2018
|
March 23, 2031
|
DE 2887938
|
Germany
|
Methods of preparing Tecovirimat
|
January 10, 2018
|
August 14, 2033
|
DK 1638938
|
Denmark
|
Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
|
April 12, 2017
|
June 18, 2024
|
DK 2549871
|
Denmark
|
Polymorphic forms of ST-246
|
August 22, 2018
|
March 23, 2031
|
ES 1638938
|
Spain
|
Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
|
April 12, 2017
|
June 18, 2024
|
FI 1638938
|
Finland
|
Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
|
April 12, 2017
|
June 18, 2024
|
FR 1638938
|
France
|
Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
|
April 12, 2017
|
June 18, 2024
|
FR 2887938
|
France
|
Methods of preparing Tecovirimat
|
January 10, 2018
|
August 14, 2033
|
FR 2549871
|
France
|
Polymorphic forms of ST-246
|
August 22, 2018
|
March 23, 2031
|
GB 1638938
|
United Kingdom
|
Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
|
April 12, 2017
|
June 18, 2024
|
GB 2887938
|
United Kingdom
|
Methods of preparing Tecovirimat
|
January 10, 2018
|
August 14, 2033
|
GB 2549871
|
United Kingdom
|
Polymorphic forms of ST-246
|
August 22, 2018
|
March 23, 2031
|
IE 1638938
|
Ireland
|
Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
|
April 12, 2017
|
June 18, 2024
|
IT 502017000078377
|
Italy
|
Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
|
April 12, 2017
|
June 18, 2024
|
NL 1638938
|
Netherlands
|
Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
|
April 12, 2017
|
June 18, 2024
|
PL 1638938
|
Poland
|
Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
|
April 12, 2017
|
June 18, 2024
|
SE 1638938
|
Sweden
|
Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
|
April 12, 2017
|
June 18, 2024
|
•
|
the agent for which the countermeasure is designed can cause serious or life-threatening disease;
|
•
|
the product may reasonably be believed to be effective in detecting, diagnosing, treating or preventing the disease;
|
•
|
the known and potential benefits of the product outweigh its known and potential risks; and
|
•
|
there is no adequate alternative to a product that is approved and available.
|
•
|
Audit Committee Charter;
|
•
|
Compensation Committee Charter;
|
•
|
Nominating and Corporate Governance Committee Charter;
|
•
|
Code of Ethics and Business Conduct;
|
•
|
Procedure for Sending Communications to the Board of Directors;
|
•
|
Procedures for Security Holder Submission of Nominating Recommendations;
|
•
|
Policy on Confidentiality of Information and Securities Trading; and
|
•
|
Conflict of Interest Policy.
|
•
|
procurement integrity;
|
•
|
rates and pricing of services and goods to be reimbursed by the U.S. government;
|
•
|
export control;
|
•
|
government security regulations;
|
•
|
employment practices;
|
•
|
protection of the environment;
|
•
|
accuracy of records and the recording and reporting of costs; and
|
•
|
foreign corrupt practices.
|
•
|
terminate existing contracts or grants, in whole or in part, for any reason or no reason;
|
•
|
unilaterally reduce or modify grants, contracts or subcontracts, including through the use of equitable price adjustments;
|
•
|
cancel multi-year contracts or grants and related orders if funds for performance for any subsequent year become unavailable;
|
•
|
decline to exercise an option to renew a contract or grant;
|
•
|
exercise an option to purchase only the minimum amount specified in a contract or grant;
|
•
|
decline to exercise an option to purchase the maximum amount specified in a contract or grant;
|
•
|
claim rights to products, including intellectual property, developed under a contract or grant;
|
•
|
take actions that result in a longer development timeline or higher costs than expected;
|
•
|
suspend or debar the contractor from doing business with the government or a specific government agency due to regulatory or compliance failures;
|
•
|
pursue criminal or civil remedies under the False Claims Act and the False Statements Accountability Act; and
|
•
|
control or prohibit the export of products.
|
•
|
termination of contracts;
|
•
|
forfeiture of profits;
|
•
|
suspension of payments;
|
•
|
fines; and
|
•
|
suspension, debarment or prohibition from doing business with the U.S. government.
|
•
|
the Federal Acquisition Regulation and other agency-specific regulations supplemental to the Federal Acquisition Regulation, which comprehensively regulate the procurement, formation, administration and performance of government contracts;
|
•
|
the business ethics and public integrity obligations, which govern conflicts of interest and the hiring of
|
•
|
export and import control laws and 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.
|
•
|
regulatory approval may be withdrawn;
|
•
|
reformulation of our products, additional clinical trials or other testing or changes in labeling of our products may be required;
|
•
|
changes to or re-approvals of manufacturing facilities used by SIGA may be required;
|
•
|
sales of the affected products may drop significantly;
|
•
|
our reputation in the marketplace may suffer; and
|
•
|
lawsuits, including class action suits, may be brought against us.
|
•
|
decreased demand for any product candidate or product that we may develop;
|
•
|
injury to our reputation;
|
•
|
withdrawal of a product from the market;
|
•
|
costs and management time and focus to defend the related litigation;
|
•
|
substantial monetary awards to trial participants or patients;
|
•
|
loss of revenue;
|
•
|
harm to our reputation; and
|
•
|
the inability to commercialize any products that we may develop.
|
•
|
successful development, formulation and cGMP scale-up of drug manufacturing that meets FDA requirements;
|
•
|
successful development of animal models;
|
•
|
successful completion of non-clinical development, including studies in approved animal models;
|
•
|
our ability to pay the expense of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights;
|
•
|
successful completion of clinical trials;
|
•
|
receipt of marketing approvals from FDA for IV TPOXX® and similar foreign regulatory authorities;
|
•
|
establishing arrangements on reasonable terms with suppliers and contract manufacturers;
|
•
|
manufacturing stable commercial supplies of drug candidates, including availability of raw materials;
|
•
|
launching commercial sales of the product, whether alone or in collaboration with others; and
|
•
|
acceptance of the product by potential government customers, public health experts, physicians, patients, healthcare payors and others in the medical community.
|
•
|
regulators or institutional review boards may not authorize us to commence a clinical trial or conduct a clinical trial at a prospective trial site;
|
•
|
we may decide, or regulators may require us, to conduct additional pre-clinical testing or clinical trials, or we may abandon projects that we expect to be promising, if our pre-clinical tests, clinical trials or animal efficacy studies produce negative or inconclusive results;
|
•
|
we might have to suspend or terminate our clinical trials if the participants are being exposed to unacceptable health risks;
|
•
|
regulators or institutional review boards may require that we hold, suspend or terminate clinical development for various reasons, including noncompliance with regulatory requirements;
|
•
|
the cost of our clinical trials could escalate and become cost prohibitive;
|
•
|
our governmental regulators may impose requirements on clinical trials, pre-clinical trials or animal efficacy studies that we cannot meet or that may prohibit or limit our ability to perform or complete the necessary testing in order to obtain regulatory approval;
|
•
|
any regulatory approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the product not commercially viable;
|
•
|
we may not be successful in recruiting a sufficient number of qualifying subjects for our clinical trials; or
|
•
|
the effects of our drug candidates may not be the desired effects or may include undesirable side effects or the drug candidates may have other unexpected characteristics;
|
•
|
the costs, regulations, or challenges associated with animal studies may increase and make our studies more difficult.
|
•
|
be shown to be safe, non-toxic and effective;
|
•
|
otherwise meet applicable regulatory standards;
|
•
|
receive the necessary regulatory approvals;
|
•
|
develop into commercially viable drugs;
|
•
|
be manufactured or produced economically and on a large scale;
|
•
|
be successfully marketed;
|
•
|
be paid for by governmental procurers or be reimbursed by governmental or private insurers; or
|
•
|
achieve customer acceptance.
|
•
|
publicity regarding actual or potential clinical or animal test results relating to products under development by our competitors or us;
|
•
|
initiating, completing or analyzing, or a delay or failure in initiating, completing or analyzing, pre-clinical or clinical trials or animal trials or the design or results of these trials for products in development;
|
•
|
achievement or rejection of regulatory approvals for products in development by our competitors or us;
|
•
|
announcements of technological innovations or new commercial products by our competitors or us;
|
•
|
developments concerning our collaborations and supply chain;
|
•
|
regulatory developments in the United States and foreign countries;
|
•
|
economic or other crises and other external factors;
|
•
|
period-to-period fluctuations in our revenues and other results of operations;
|
•
|
changes in financial estimates by securities analysts; or
|
•
|
publicity or activity involving possible future acquisitions, strategic investments, partnerships or alliances.
|
2018
|
High
|
|
Low
|
||||
First Quarter
|
$
|
6.78
|
|
|
$
|
4.21
|
|
Second Quarter
|
7.54
|
|
|
5.72
|
|
||
Third Quarter
|
8.47
|
|
|
5.77
|
|
||
Fourth Quarter
|
7.94
|
|
|
4.68
|
|
||
|
|
|
|
||||
2017
|
High
|
|
Low
|
||||
First Quarter
|
$
|
3.40
|
|
|
$
|
2.80
|
|
Second Quarter
|
3.88
|
|
|
3.00
|
|
||
Third Quarter
|
3.39
|
|
|
2.85
|
|
||
Fourth Quarter
|
5.24
|
|
|
3.14
|
|
|
|
|||||||||||||||||||||||
|
|
2013
|
|
2014
|
|
2015
|
|
2016
|
|
2017
|
|
2018
|
||||||||||||
SIGA Technologies, Inc.
|
|
$
|
100
|
|
|
$
|
44
|
|
|
$
|
13
|
|
|
$
|
88
|
|
|
$
|
148
|
|
|
$
|
242
|
|
NASDAQ Composite Index
|
|
$
|
100
|
|
|
$
|
113
|
|
|
$
|
120
|
|
|
$
|
129
|
|
|
$
|
165
|
|
|
$
|
159
|
|
NASDAQ Biotech Composite Index
|
|
$
|
100
|
|
|
$
|
134
|
|
|
$
|
149
|
|
|
$
|
117
|
|
|
$
|
142
|
|
|
$
|
128
|
|
|
Year Ended December 31,
|
||||||||||||||||||
|
2018
|
|
2017
|
|
2016
|
|
2015
|
|
2014
|
||||||||||
|
(in thousands, except share and per share data)
|
||||||||||||||||||
Revenues
|
$
|
477,054
|
|
|
$
|
12,269
|
|
|
$
|
14,988
|
|
|
$
|
8,176
|
|
|
$
|
3,140
|
|
Cost of sales and supportive services
|
95,269
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Selling, general and administrative
|
12,880
|
|
|
12,303
|
|
|
13,714
|
|
|
10,582
|
|
|
12,647
|
|
|||||
Research and development
|
13,016
|
|
|
16,680
|
|
|
19,711
|
|
|
13,131
|
|
|
10,707
|
|
|||||
Patent expenses
|
789
|
|
|
910
|
|
|
909
|
|
|
1,009
|
|
|
988
|
|
|||||
Litigation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
14,407
|
|
|
188,465
|
|
|||||
Lease termination
|
—
|
|
|
1,225
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Interest on PharmAthene liability
|
—
|
|
|
—
|
|
|
11,669
|
|
|
—
|
|
|
—
|
|
|||||
Income (loss) from operations
|
355,100
|
|
|
(18,849
|
)
|
|
(31,015
|
)
|
|
(30,953
|
)
|
|
(209,667
|
)
|
|||||
(Increase) decrease in fair value of common stock warrants
|
(6,923
|
)
|
|
(4,739
|
)
|
|
(895
|
)
|
|
—
|
|
|
313
|
|
|||||
Interest expense, net
|
(15,478
|
)
|
|
(14,758
|
)
|
|
(2,396
|
)
|
|
(267
|
)
|
|
(456
|
)
|
|||||
Backstop fee
|
—
|
|
|
—
|
|
|
(1,764
|
)
|
|
—
|
|
|
—
|
|
|||||
Other income, net
|
78,941
|
|
|
17
|
|
|
102
|
|
|
42
|
|
|
1
|
|
|||||
Reorganization items, net
|
—
|
|
|
—
|
|
|
(3,717
|
)
|
|
(7,811
|
)
|
|
(2,127
|
)
|
|||||
Income (loss) before income taxes
|
411,640
|
|
|
(38,329
|
)
|
|
(39,685
|
)
|
|
(38,989
|
)
|
|
(211,936
|
)
|
|||||
Benefit from (provision for) income taxes
|
10,168
|
|
|
2,094
|
|
|
(14
|
)
|
|
(462
|
)
|
|
(53,528
|
)
|
|||||
Net income (loss)
|
$
|
421,808
|
|
|
$
|
(36,235
|
)
|
|
$
|
(39,699
|
)
|
|
$
|
(39,451
|
)
|
|
$
|
(265,464
|
)
|
Basic earnings (loss) per common share
|
$
|
5.28
|
|
|
$
|
(0.46
|
)
|
|
$
|
(0.69
|
)
|
|
$
|
(0.73
|
)
|
|
$
|
(4.97
|
)
|
Diluted earnings (loss) per common share
|
$
|
5.18
|
|
|
$
|
(0.46
|
)
|
|
$
|
(0.69
|
)
|
|
$
|
(0.73
|
)
|
|
$
|
(4.97
|
)
|
Weighted average common shares outstanding: basic
|
79,923,295
|
|
|
78,874,494
|
|
|
57,188,503
|
|
|
53,777,687
|
|
|
53,419,686
|
|
|||||
Weighted average common shares outstanding: diluted
|
82,708,472
|
|
|
78,874,494
|
|
|
57,188,503
|
|
|
53,777,687
|
|
|
53,419,686
|
|
|||||
Cash and cash equivalents and restricted cash
|
$
|
180,397
|
|
|
$
|
37,102
|
|
|
$
|
56,174
|
|
|
$
|
112,711
|
|
|
$
|
99,714
|
|
Total assets
|
203,444
|
|
|
144,670
|
|
|
160,982
|
|
|
185,733
|
|
|
160,729
|
|
|||||
Long-term obligations
|
76,811
|
|
|
71,891
|
|
|
66,801
|
|
|
332
|
|
|
405
|
|
|||||
Stockholders’ equity (deficiency)
|
102,915
|
|
|
(323,138
|
)
|
|
(287,418
|
)
|
|
(284,429
|
)
|
|
(246,502
|
)
|
|||||
Net cash provided by (used in) operating activities
|
$
|
68,871
|
|
|
$
|
(18,387
|
)
|
|
$
|
(116,813
|
)
|
|
$
|
11,109
|
|
|
$
|
14,177
|
|
|
Total
|
|
Less than 1 year
|
|
1 to 3 years
|
|
3 to 5 years
|
|
Greater than 5 years
|
||||||||||
Operating lease obligations (1)
|
$
|
3,019,928
|
|
|
$
|
541,376
|
|
|
$
|
608,000
|
|
|
$
|
672,774
|
|
|
$
|
1,197,778
|
|
Term loan obligations at maturity
|
84,000,000
|
|
|
—
|
|
|
84,000,000
|
|
|
—
|
|
|
—
|
|
|||||
Interest payment obligations on the Term Loan (2)
|
21,523,631
|
|
|
11,452,078
|
|
|
10,071,553
|
|
|
—
|
|
|
—
|
|
|||||
Purchase obligations (3)
|
7,224,223
|
|
|
6,679,261
|
|
|
488,530
|
|
|
56,432
|
|
|
—
|
|
|||||
Payments under Lease Termination Agreement
|
568,057
|
|
|
336,955
|
|
|
231,102
|
|
|
—
|
|
|
—
|
|
|||||
Total contractual obligations
|
$
|
116,335,839
|
|
|
$
|
19,009,670
|
|
|
$
|
95,399,185
|
|
|
$
|
729,206
|
|
|
$
|
1,197,778
|
|
(1)
|
Includes facilities and office space under two operating leases expiring in 2019 and 2027, respectively. These obligations assume non-termination of agreements and represent expected payments, which are subject to change.
|
(2)
|
Includes amounts to be paid with restricted cash. Assumes cash interest r
ate of 14.1% (the rate at December 31, 2018) t
hroughout the duration of the Term Loan.
|
(3)
|
Includes purchase orders for manufacturing and R&D activities.
|
|
|
|
|
Consolidated Statements of Operations and Comprehensive
Income (Loss)
|
|
|
|
Consolidated Statements of Changes in Stockholders’
Equity/(Deficiency)
|
|
|
|
|
|
|
December 31, 2018
|
|
December 31, 2017
|
||||
ASSETS
|
|
|
|
||||
Current assets
|
|
|
|
||||
Cash and cash equivalents
|
$
|
100,652,809
|
|
|
$
|
19,857,833
|
|
Restricted cash, short-term
|
11,452,078
|
|
|
10,701,305
|
|
||
Accounts receivable
|
1,959,133
|
|
|
1,802,107
|
|
||
Inventory
|
2,908,210
|
|
|
2,983,249
|
|
||
Prepaid expenses and other current assets
|
4,317,615
|
|
|
2,019,999
|
|
||
Total current assets
|
121,289,845
|
|
|
37,364,493
|
|
||
|
|
|
|
||||
Property, plant and equipment, net
|
171,274
|
|
|
138,640
|
|
||
Restricted cash, long-term
|
68,292,023
|
|
|
6,542,448
|
|
||
Deferred costs
|
—
|
|
|
96,592,334
|
|
||
Deferred tax asset, net
|
11,733,385
|
|
|
2,431,963
|
|
||
Goodwill
|
898,334
|
|
|
898,334
|
|
||
Other assets
|
1,058,880
|
|
|
702,167
|
|
||
Total assets
|
$
|
203,443,741
|
|
|
$
|
144,670,379
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY/(DEFICIENCY)
|
|
|
|
||||
Current liabilities
|
|
|
|
||||
Accounts payable
|
$
|
1,688,488
|
|
|
$
|
1,328,867
|
|
Accrued expenses and other current liabilities
|
9,648,917
|
|
|
5,481,579
|
|
||
Total current liabilities
|
11,337,405
|
|
|
6,810,446
|
|
||
Deferred revenue
|
—
|
|
|
377,641,485
|
|
||
Warrant liability
|
12,380,939
|
|
|
11,466,162
|
|
||
Other liabilities
|
1,263,113
|
|
|
840,253
|
|
||
Long-term debt
|
75,547,597
|
|
|
71,050,324
|
|
||
Total liabilities
|
100,529,054
|
|
|
467,808,670
|
|
||
Commitments and contingencies (Note 13)
|
|
|
|
||||
Stockholders' equity/(deficiency)
|
|
|
|
||||
Common stock ($.0001 par value, 600,000,000 shares authorized, 80,763,350 and 79,039,000 issued and outstanding at December 31, 2018, and December 31, 2017, respectively)
|
8,076
|
|
|
7,904
|
|
||
Additional paid-in capital
|
218,697,872
|
|
|
214,229,581
|
|
||
Accumulated deficit
|
(115,791,261
|
)
|
|
(537,375,776
|
)
|
||
Total stockholders' equity/(deficiency)
|
102,914,687
|
|
|
(323,138,291
|
)
|
||
Total liabilities and stockholders' equity/(deficiency)
|
$
|
203,443,741
|
|
|
$
|
144,670,379
|
|
|
2018
|
|
2017
|
|
2016
|
||||||
Revenues
|
|
|
|
|
|
||||||
Product sales and supportive services
|
$
|
468,918,468
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Research and development
|
8,135,314
|
|
|
12,268,960
|
|
|
14,987,628
|
|
|||
Total revenues
|
477,053,782
|
|
|
12,268,960
|
|
|
14,987,628
|
|
|||
|
|
|
|
|
|
||||||
Operating expenses
|
|
|
|
|
|
||||||
Cost of sales and supportive services
|
95,268,974
|
|
|
—
|
|
|
—
|
|
|||
Selling, general and administrative
|
12,879,738
|
|
|
12,303,050
|
|
|
13,713,635
|
|
|||
Research and development
|
13,016,183
|
|
|
16,679,712
|
|
|
19,710,673
|
|
|||
Patent expenses
|
789,489
|
|
|
909,946
|
|
|
909,376
|
|
|||
Lease termination
|
—
|
|
|
1,225,421
|
|
|
—
|
|
|||
Interest on PharmAthene liability
|
—
|
|
|
—
|
|
|
11,668,900
|
|
|||
Total operating expenses
|
121,954,384
|
|
|
31,118,129
|
|
|
46,002,584
|
|
|||
Operating income (loss)
|
355,099,398
|
|
|
(18,849,169
|
)
|
|
(31,014,956
|
)
|
|||
Loss from change in fair value of warrant liability
|
(6,922,624
|
)
|
|
(4,738,753
|
)
|
|
(894,785
|
)
|
|||
Interest expense
|
(15,478,203
|
)
|
|
(14,758,140
|
)
|
|
(2,395,517
|
)
|
|||
Backstop fee
|
—
|
|
|
—
|
|
|
(1,764,240
|
)
|
|||
Other income, net
|
78,940,985
|
|
|
16,788
|
|
|
102,324
|
|
|||
Reorganization items, net
|
—
|
|
|
—
|
|
|
(3,716,902
|
)
|
|||
Income (loss) before income taxes
|
411,639,556
|
|
|
(38,329,274
|
)
|
|
(39,684,076
|
)
|
|||
Benefit/(provision) for income taxes
|
10,168,272
|
|
|
2,093,790
|
|
|
(13,884
|
)
|
|||
Net and comprehensive income (loss)
|
$
|
421,807,828
|
|
|
$
|
(36,235,484
|
)
|
|
$
|
(39,697,960
|
)
|
Basic earnings (loss) per share
|
$
|
5.28
|
|
|
$
|
(0.46
|
)
|
|
$
|
(0.69
|
)
|
Diluted earnings (loss) per share
|
$
|
5.18
|
|
|
$
|
(0.46
|
)
|
|
$
|
(0.69
|
)
|
Weighted average shares outstanding: basic
|
79,923,295
|
|
|
78,874,494
|
|
|
57,188,503
|
|
|||
Weighted average shares outstanding: diluted
|
82,708,472
|
|
|
78,874,494
|
|
|
57,188,503
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|||||||||||
|
|
|
|
|
Additional
|
|
|
|
Other
|
|
Total
|
|||||||||||
|
Common Stock
|
|
Paid-In
|
|
Accumulated
|
|
Comprehensive
|
|
Stockholders’
|
|||||||||||||
|
Shares
|
|
Amount
|
|
Capital
|
|
Deficit
|
|
Income (Loss)
|
|
Equity/ (Deficiency)
|
|||||||||||
Balances, December 31, 2015
|
54,114,296
|
|
|
$
|
5,411
|
|
|
$
|
177,008,371
|
|
|
$
|
(461,442,332
|
)
|
|
$
|
—
|
|
|
$
|
(284,428,550
|
)
|
Net loss
|
|
|
|
|
|
|
(39,697,960
|
)
|
|
|
|
(39,697,960
|
)
|
|||||||||
Issuance of common stock upon exercise of RSUs
|
483,335
|
|
|
48
|
|
|
(48
|
)
|
|
|
|
|
|
—
|
|
|||||||
Stock-based compensation
|
|
|
|
|
775,541
|
|
|
|
|
|
|
775,541
|
|
|||||||||
Payment of common stock tendered for employee stock-based compensation tax obligations
|
(136,744
|
)
|
|
(13
|
)
|
|
(427,996
|
)
|
|
|
|
|
|
(428,009
|
)
|
|||||||
Issuance of common stock associated with rights offering
|
23,523,195
|
|
|
2,352
|
|
|
34,594,117
|
|
|
|
|
|
|
34,596,469
|
|
|||||||
Issuance of common stock associated with backstop agreement
|
708,530
|
|
|
71
|
|
|
1,764,169
|
|
|
|
|
|
|
1,764,240
|
|
|||||||
Balances, December 31, 2016
|
78,692,612
|
|
|
$
|
7,869
|
|
|
$
|
213,714,154
|
|
|
$
|
(501,140,292
|
)
|
|
$
|
—
|
|
|
$
|
(287,418,269
|
)
|
Net loss
|
|
|
|
|
|
|
(36,235,484
|
)
|
|
|
|
(36,235,484
|
)
|
|||||||||
Issuance of common stock upon exercise of stock options
|
33,870
|
|
|
3
|
|
|
89,495
|
|
|
|
|
|
|
89,498
|
|
|||||||
Issuance of common stock upon vesting of RSUs and exercise of stock-settled appreciation rights
|
466,328
|
|
|
47
|
|
|
(47
|
)
|
|
|
|
|
|
—
|
|
|||||||
Payment of common stock tendered for employee stock-based compensation tax obligations
|
(153,810
|
)
|
|
(15
|
)
|
|
(591,052
|
)
|
|
|
|
|
|
(591,067
|
)
|
|||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
1,101,031
|
|
|
|
|
|
|
1,101,031
|
|
|||||||
Buy-back of stock options
|
—
|
|
|
—
|
|
|
(84,000
|
)
|
|
|
|
|
|
(84,000
|
)
|
|||||||
Balances, December 31, 2017
|
79,039,000
|
|
|
$
|
7,904
|
|
|
$
|
214,229,581
|
|
|
$
|
(537,375,776
|
)
|
|
$
|
—
|
|
|
$
|
(323,138,291
|
)
|
Net income
|
|
|
|
|
|
|
421,807,828
|
|
|
|
|
421,807,828
|
|
|||||||||
Issuance of common stock upon exercise of stock options
|
426,366
|
|
|
42
|
|
|
261,837
|
|
|
|
|
|
|
261,879
|
|
|||||||
Issuance of common stock upon vesting of RSUs and exercise of stock-settled appreciation rights
|
1,184,283
|
|
|
118
|
|
|
(118
|
)
|
|
|
|
|
|
—
|
|
|||||||
Issuance of common stock upon exercise of warrants
|
760,626
|
|
|
77
|
|
|
6,007,770
|
|
|
|
|
|
|
6,007,847
|
|
|||||||
Payment of common stock tendered for employee stock-based compensation tax obligations
|
(646,925
|
)
|
|
(65
|
)
|
|
(4,074,375
|
)
|
|
|
|
|
|
(4,074,440
|
)
|
|||||||
Cumulative effect of accounting change
|
|
|
|
|
|
|
(223,313
|
)
|
|
|
|
(223,313
|
)
|
|||||||||
Stock-based compensation
|
|
|
|
|
2,273,177
|
|
|
|
|
|
|
2,273,177
|
|
|||||||||
Balances, December 31, 2018
|
80,763,350
|
|
|
$
|
8,076
|
|
|
$
|
218,697,872
|
|
|
$
|
(115,791,261
|
)
|
|
$
|
—
|
|
|
$
|
102,914,687
|
|
|
2018
|
|
2017
|
|
2016
|
||||||
Cash flows from operating activities:
|
|
|
|
|
|
||||||
Net income (loss)
|
$
|
421,807,828
|
|
|
$
|
(36,235,484
|
)
|
|
$
|
(39,697,960
|
)
|
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
|
|
|
|
|
|
||||||
Depreciation and other amortization
|
69,630
|
|
|
132,189
|
|
|
174,275
|
|
|||
Loss on change in fair value of warrant liability
|
6,922,624
|
|
|
4,738,753
|
|
|
894,785
|
|
|||
Lease termination
|
—
|
|
|
1,225,421
|
|
|
—
|
|
|||
Stock-based compensation
|
2,273,177
|
|
|
1,101,031
|
|
|
775,541
|
|
|||
Net realization of deferred revenue and costs due to FDA approval
|
(281,950,853
|
)
|
|
—
|
|
|
—
|
|
|||
Deferred income taxes (benefit)/provision
|
(9,301,422
|
)
|
|
(2,718,029
|
)
|
|
20,423
|
|
|||
Write down of inventory, net
|
—
|
|
|
536,000
|
|
|
—
|
|
|||
Non-cash backstop fee
|
—
|
|
|
—
|
|
|
1,764,240
|
|
|||
Non-cash interest expense
|
4,497,273
|
|
|
4,497,271
|
|
|
566,779
|
|
|||
Gain on sale of priority review voucher
|
(78,338,826
|
)
|
|
—
|
|
|
—
|
|
|||
Changes in assets and liabilities:
|
|
|
|
|
|
||||||
Accounts receivable
|
(49,723
|
)
|
|
1,352,263
|
|
|
522,360
|
|
|||
Inventory
|
39
|
|
|
22,690,715
|
|
|
(13,762,876
|
)
|
|||
Deferred costs
|
—
|
|
|
(23,943,057
|
)
|
|
(19,712,849
|
)
|
|||
Prepaid expenses and other current assets
|
(2,222,616
|
)
|
|
(1,065,573
|
)
|
|
(330,443
|
)
|
|||
Other assets
|
(356,713
|
)
|
|
(60,084
|
)
|
|
80,928
|
|
|||
Accounts payable, accrued expenses and other current liabilities
|
1,622,331
|
|
|
(1,847,427
|
)
|
|
(177,342
|
)
|
|||
Liabilities subject to compromise
|
—
|
|
|
—
|
|
|
(160,072,170
|
)
|
|||
Deferred revenue
|
3,475,714
|
|
|
11,412,898
|
|
|
112,225,534
|
|
|||
Other liabilities
|
422,860
|
|
|
(203,654
|
)
|
|
(84,228
|
)
|
|||
Net cash provided by (used in) operating activities
|
68,871,323
|
|
|
(18,386,767
|
)
|
|
(116,813,003
|
)
|
|||
Cash flows from investing activities:
|
|
|
|
|
|
||||||
Capital expenditures
|
(102,264
|
)
|
|
(100,124
|
)
|
|
(23,927
|
)
|
|||
Net proceeds from sale of priority review voucher
|
78,338,826
|
|
|
—
|
|
|
—
|
|
|||
Return of collateral for surety bond
|
—
|
|
|
—
|
|
|
1,212,591
|
|
|||
Net cash provided by (used in) investing activities
|
78,236,562
|
|
|
(100,124
|
)
|
|
1,188,664
|
|
|||
Cash flows from financing activities:
|
|
|
|
|
|
||||||
Net proceeds from exercise of stock options
|
261,879
|
|
|
89,498
|
|
|
—
|
|
|||
Net proceeds from equity rights offering - net of offering costs
|
—
|
|
|
—
|
|
|
34,596,468
|
|
|||
Proceeds from Term Loan escrow release
|
—
|
|
|
—
|
|
|
28,694,444
|
|
|||
Buy back of stock options
|
—
|
|
|
(84,000
|
)
|
|
—
|
|
|||
Payment of employee tax obligations for common stock tendered
|
(4,074,440
|
)
|
|
(591,067
|
)
|
|
(428,009
|
)
|
|||
Debt issue costs
|
—
|
|
|
—
|
|
|
(3,775,546
|
)
|
|||
Net cash (used in) provided by financing activities
|
(3,812,561
|
)
|
|
(585,569
|
)
|
|
59,087,357
|
|
|||
Net increase (decrease) in cash and cash equivalents
|
143,295,324
|
|
|
(19,072,460
|
)
|
|
(56,536,982
|
)
|
|||
Cash, cash equivalents and restricted cash at the beginning of period
|
37,101,586
|
|
|
56,174,046
|
|
|
112,711,028
|
|
|||
Cash, cash equivalents and restricted cash at end of period
|
$
|
180,396,910
|
|
|
$
|
37,101,586
|
|
|
$
|
56,174,046
|
|
|
|
|
|
|
|
||||||
Supplemental disclosure of cash inflows information:
|
|
|
|
|
|
||||||
Conversion of warrants to common stock
|
$
|
6,007,847
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Issuance of common stock upon cashless exercise
|
$
|
1,681,426
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Portion of Term Loan paid directly to PharmAthene by the Lender in satisfaction of the PharmAthene claim; such liability is part of the Liabilities Subject to Compromise line item
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
46,900,000
|
|
Cash interest paid on PharmAthene liability
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
11,668,900
|
|
Cash income taxes paid (refund)
|
$
|
251,961
|
|
|
$
|
325,000
|
|
|
$
|
500,975
|
|
Fair value of warrant, at issuance date, in connection with loan agreement and recorded as warrant liability
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
5,832,624
|
|
|
As of December 31,
|
||||||||||||||
|
2018
|
|
2017
|
|
2016
|
|
2015
|
||||||||
Cash and cash equivalents
|
$
|
100,652,809
|
|
|
$
|
19,857,833
|
|
|
$
|
28,701,824
|
|
|
$
|
112,711,028
|
|
Restricted cash - short-term
|
11,452,078
|
|
|
10,701,305
|
|
|
10,138,890
|
|
|
—
|
|
||||
Restricted cash - long-term
|
68,292,023
|
|
|
6,542,448
|
|
|
17,333,332
|
|
|
—
|
|
||||
Cash, cash equivalents and restricted cash
|
$
|
180,396,910
|
|
|
$
|
37,101,586
|
|
|
$
|
56,174,046
|
|
|
$
|
112,711,028
|
|
|
For the year ended December 31, 2018
|
||
Balance at December 31, 2017
|
$
|
378,896,803
|
|
Cumulative effect of accounting change
|
(1,780,050
|
)
|
|
Billings in advance of revenue recognized
|
3,399,630
|
|
|
Revenue recognized
|
(376,356,437
|
)
|
|
Balance at December 31, 2018, included in Accrued expenses and other current liabilities
|
$
|
4,159,946
|
|
•
|
Level 1 – Quoted prices for identical instruments in active markets.
|
•
|
Level 2 – Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations where inputs are observable or where significant value drivers are observable.
|
•
|
Level 3 – Instruments where significant value drivers are unobservable to third parties.
|
|
Fair Value Measurements of Level 3 liability classified warrant
|
||
Warrant liability at December 31, 2017
|
$
|
11,466,162
|
|
Increase in fair value of warrant liability
|
6,922,624
|
|
|
Exercise of warrants
|
(6,007,847
|
)
|
|
Warrant liability at December 31, 2018
|
$
|
12,380,939
|
|
|
As of
|
||||||
|
December 31, 2018
|
|
December 31, 2017
|
||||
Work in-process
|
$
|
1,950,445
|
|
|
$
|
2,025,445
|
|
Finished goods
|
957,765
|
|
|
957,804
|
|
||
Inventory
|
$
|
2,908,210
|
|
|
$
|
2,983,249
|
|
|
As of
|
||||||
|
December 31, 2018
|
|
December 31, 2017
|
||||
Leasehold improvements
|
$
|
2,420,028
|
|
|
$
|
2,420,028
|
|
Computer equipment
|
618,248
|
|
|
701,762
|
|
||
Furniture and fixtures
|
377,859
|
|
|
363,588
|
|
||
|
3,416,135
|
|
|
3,485,378
|
|
||
Less-accumulated depreciation
|
(3,244,861
|
)
|
|
(3,346,738
|
)
|
||
Property, plant and equipment, net
|
$
|
171,274
|
|
|
$
|
138,640
|
|
|
As of
|
||||||
|
December 31, 2018
|
|
December 31, 2017
|
||||
Bonus
|
$
|
2,600,839
|
|
|
$
|
2,538,340
|
|
Deferred revenue
|
4,159,946
|
|
|
1,255,318
|
|
||
Research and development vendor costs
|
1,446,410
|
|
|
183,856
|
|
||
Professional fees
|
242,043
|
|
|
381,980
|
|
||
Vacation
|
294,794
|
|
|
328,588
|
|
||
Other
|
904,885
|
|
|
793,497
|
|
||
Accrued expenses and other current liabilities
|
$
|
9,648,917
|
|
|
$
|
5,481,579
|
|
|
Year Ended December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Net income (loss) for basic earnings per share
|
$
|
421,807,828
|
|
|
$
|
(36,235,484
|
)
|
|
$
|
(39,697,960
|
)
|
Less: Change in fair value of warrants
|
(6,922,624
|
)
|
|
—
|
|
|
—
|
|
|||
Net income (loss), adjusted for change in fair value of warrants for diluted earnings per share
|
$
|
428,730,452
|
|
|
$
|
(36,235,484
|
)
|
|
$
|
(39,697,960
|
)
|
Weighted-average shares
|
79,923,295
|
|
|
78,874,494
|
|
|
57,188,503
|
|
|||
Effect of potential common shares
|
2,785,177
|
|
|
—
|
|
|
—
|
|
|||
Weighted-average shares: diluted
|
82,708,472
|
|
|
78,874,494
|
|
|
57,188,503
|
|
|||
Earnings (loss) per share: basic
|
$
|
5.28
|
|
|
$
|
(0.46
|
)
|
|
$
|
(0.69
|
)
|
Earnings (loss) per share: diluted
|
$
|
5.18
|
|
|
$
|
(0.46
|
)
|
|
$
|
(0.69
|
)
|
|
Year Ended December 31,
|
|||||
|
|
2017
|
|
2016
|
||
Stock Options
|
|
1,386,176
|
|
|
1,789,751
|
|
Stock-Settled Stock Appreciation Rights
|
|
333,252
|
|
|
360,031
|
|
Restricted Stock Units
|
|
1,396,730
|
|
|
705,850
|
|
Warrants
|
|
2,690,950
|
|
|
877,303
|
|
|
Number of
Options
|
|
Weighted
Average Exercise
Price
|
|
Weighted
Average
Remaining Life
(in years)
|
|
Aggregate
Intrinsic Value
(in thousands)
|
|||||
Outstanding at January 1, 2018
|
1,062,467
|
|
|
$
|
5.42
|
|
|
|
|
|
||
Granted
|
—
|
|
|
—
|
|
|
|
|
|
|||
Exercised
|
(635,067
|
)
|
|
3.06
|
|
|
|
|
|
|||
Canceled/Expired
|
(25,000
|
)
|
|
7.13
|
|
|
|
|
|
|||
Outstanding at December 31, 2018
|
402,400
|
|
|
$
|
9.03
|
|
|
2.04
|
|
$
|
421,250
|
|
Vested at December 31, 2018
|
402,400
|
|
|
$
|
9.03
|
|
|
2.04
|
|
$
|
421,050
|
|
Exercisable at December 31, 2018
|
402,400
|
|
|
$
|
9.03
|
|
|
2.04
|
|
$
|
421,050
|
|
|
Number of
SSARs
|
|
Weighted
Average Exercise
Price
|
|
Weighted
Average
Remaining Life
(in years)
|
|
Aggregate
Intrinsic Value
(in thousands)
|
|||||
Outstanding at January 1, 2018
|
266,150
|
|
|
$
|
3.53
|
|
|
|
|
|
||
Granted
|
—
|
|
|
—
|
|
|
|
|
|
|||
Exercised
|
(232,050
|
)
|
|
3.53
|
|
|
|
|
|
|||
Canceled/Expired
|
—
|
|
|
—
|
|
|
|
|
|
|||
Outstanding at December 31, 2018
|
34,100
|
|
|
3.53
|
|
|
0.09
|
|
149,017
|
|
||
Vested at December 31, 2018
|
34,100
|
|
|
$
|
3.53
|
|
|
0.09
|
|
$
|
149,017
|
|
Exercisable at December 31, 2018
|
34,100
|
|
|
$
|
3.53
|
|
|
0.09
|
|
$
|
149,017
|
|
|
Number of
RSUs
|
|
Weighted
Average Grant-Date Fair Value
|
|||
Outstanding at January 1, 2018
|
1,472,000
|
|
|
$
|
2.61
|
|
Granted
|
105,000
|
|
|
6.53
|
|
|
Vested and released
|
(1,077,884
|
)
|
|
2.69
|
|
|
Canceled/Expired
|
—
|
|
|
—
|
|
|
Outstanding at December 31, 2018
|
499,116
|
|
|
$
|
3.26
|
|
|
For the year ended December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Current:
|
|
|
|
|
|
||||||
Federal
|
$
|
(1,326,022
|
)
|
|
$
|
623,060
|
|
|
$
|
(5,093
|
)
|
State and local
|
459,172
|
|
|
1,179
|
|
|
(1,446
|
)
|
|||
Total current provision (benefit)
|
(866,850
|
)
|
|
624,239
|
|
|
(6,539
|
)
|
|||
Deferred:
|
|
|
|
|
|
||||||
Federal
|
(9,256,661
|
)
|
|
(2,724,371
|
)
|
|
21,252
|
|
|||
State and local
|
(44,761
|
)
|
|
6,342
|
|
|
(829
|
)
|
|||
Total deferred (benefit) provision
|
(9,301,422
|
)
|
|
(2,718,029
|
)
|
|
20,423
|
|
|||
Total (benefit) provision
|
$
|
(10,168,272
|
)
|
|
$
|
(2,093,790
|
)
|
|
$
|
13,884
|
|
|
As of December 31,
|
||||||
|
2018
|
|
2017
|
||||
Deferred income tax assets:
|
|
|
|
||||
Net operating losses
|
9,798,319
|
|
|
$
|
38,087,782
|
|
|
Deferred research and development costs
|
60,535
|
|
|
205,527
|
|
||
Amortization of intangible assets
|
171,044
|
|
|
282,213
|
|
||
Share-based compensation
|
508,089
|
|
|
1,001,662
|
|
||
Fixed assets
|
371,804
|
|
|
417,085
|
|
||
Deferred revenue
|
—
|
|
|
84,130,212
|
|
||
Alternative minimum tax credits
|
1,326,228
|
|
|
2,652,250
|
|
||
Other
|
1,028,083
|
|
|
1,024,082
|
|
||
Deferred income tax assets
|
13,264,102
|
|
|
127,800,813
|
|
||
Less: valuation allowance
|
(1,051,307
|
)
|
|
(102,556,657
|
)
|
||
Deferred income tax assets, net of valuation allowance
|
$
|
12,212,795
|
|
|
$
|
25,244,156
|
|
Deferred income tax liabilities:
|
|
|
|
||||
Amortization of goodwill
|
(192,146
|
)
|
|
(193,458
|
)
|
||
Capitalized contract costs
|
—
|
|
|
(21,518,646
|
)
|
||
Other
|
(287,264
|
)
|
|
(1,100,089
|
)
|
||
Deferred income tax asset (liability), net
|
$
|
11,733,385
|
|
|
$
|
2,431,963
|
|
|
For the year ended
|
||
|
December 31, 2018
|
||
Balance at beginning of year
|
$
|
—
|
|
Tax positions related to the current and prior years:
|
|
||
Additions
|
5,738,964
|
|
|
Reductions
|
—
|
|
|
Settlements
|
—
|
|
|
Lapses in applicable statutes of limitation
|
—
|
|
|
Balance at the end of the year
|
$
|
5,738,964
|
|
2019
|
$
|
541,376
|
|
2020
|
304,000
|
|
|
2021
|
304,000
|
|
|
2022
|
320,774
|
|
|
2023
|
352,000
|
|
|
Thereafter
|
1,197,778
|
|
|
Total
|
$
|
3,019,928
|
|
|
For the years ended December 31,
|
||||||
|
2018
|
|
2017
|
||||
Beginning Balance
|
$
|
814,622
|
|
|
$
|
—
|
|
Charges
|
35,861
|
|
|
1,096,648
|
|
||
Cash Payments
|
(340,546
|
)
|
|
(282,026
|
)
|
||
Lease Termination Liability
|
$
|
509,937
|
|
|
$
|
814,622
|
|
Legal fees
|
$
|
1,951,381
|
|
Professional fees
|
1,732,521
|
|
|
Trustee fees
|
33,000
|
|
|
Total
|
$
|
3,716,902
|
|
|
Three Months Ended
|
|
||||||||||||||
2018
|
March 31
|
|
June 30
|
|
September 30
|
|
December 31
|
|
||||||||
|
(in thousands, except for per share data)
|
|
||||||||||||||
Revenues
|
$
|
1,748
|
|
|
$
|
2,661
|
|
|
$
|
471,075
|
|
|
$
|
1,569
|
|
|
Cost of sales and supportive services
|
—
|
|
|
—
|
|
|
95,166
|
|
|
103
|
|
|
||||
Selling, general & administrative
|
3,057
|
|
|
2,880
|
|
|
3,115
|
|
|
3,828
|
|
|
||||
Research and development
|
3,008
|
|
|
3,312
|
|
|
3,723
|
|
|
2,973
|
|
|
||||
Patent preparation fees
|
218
|
|
|
178
|
|
|
186
|
|
|
207
|
|
|
||||
Operating income (loss)
|
(4,535
|
)
|
|
(3,710
|
)
|
|
368,885
|
|
|
(5,541
|
)
|
|
||||
Net income (loss)
|
(11,582
|
)
|
|
(7,051
|
)
|
|
388,050
|
|
|
52,391
|
|
A
|
||||
Net loss per share: basic
|
$
|
(0.15
|
)
|
|
$
|
(0.09
|
)
|
|
$
|
4.85
|
|
|
$
|
0.65
|
|
|
Net loss per share: diluted
|
$
|
(0.15
|
)
|
|
$
|
(0.09
|
)
|
|
$
|
4.71
|
|
|
$
|
0.65
|
|
|
|
Three Months Ended
|
||||||||||||||
2017
|
March 31
|
|
June 30
|
|
September 30
|
|
December 31
|
||||||||
|
(in thousands, except for per share data)
|
||||||||||||||
Revenues
|
$
|
5,202
|
|
|
$
|
4,265
|
|
|
$
|
1,390
|
|
|
$
|
1,412
|
|
Selling, general and administrative
|
2,870
|
|
|
3,058
|
|
|
3,094
|
|
|
3,281
|
|
||||
Research and development
|
6,360
|
|
|
5,068
|
|
|
2,471
|
|
|
2,781
|
|
||||
Patent expenses
|
241
|
|
|
197
|
|
|
251
|
|
|
221
|
|
||||
Lease termination
|
—
|
|
|
—
|
|
|
1,225
|
|
|
—
|
|
||||
Operating loss
|
(4,269
|
)
|
|
(4,059
|
)
|
|
(5,651
|
)
|
|
(4,871
|
)
|
||||
Net loss
|
(8,615
|
)
|
|
(7,501
|
)
|
|
(9,816
|
)
|
|
(10,303
|
)
|
||||
Loss per common share: basic and diluted
|
$
|
(0.11
|
)
|
|
$
|
(0.10
|
)
|
|
$
|
(0.12
|
)
|
|
$
|
(0.13
|
)
|
a.
|
pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and disposition of the Company’s assets;
|
b.
|
provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and the directors of the Company; and
|
c.
|
provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements.
|
Plan Category
|
Number of Securities to be
Issued Upon Exercise of
Outstanding Options, Warrants and Restricted Stock Units (1)
|
|
Weighted-average
Exercise Price of
Outstanding Options, Warrants and Restricted Stock Units
|
|
Number of Securities
Available for Future
Issuance under Equity Compensation Plans (2)
|
||||
Equity compensation plans approved by security holders
|
924,674
|
|
|
$
|
5.78
|
|
|
4,862,804
|
|
Equity compensation plans not approved by security holders
|
—
|
|
|
—
|
|
|
—
|
|
|
Total
|
924,674
|
|
|
$
|
5.78
|
|
|
4,862,804
|
|
(1)
|
Consists of the 1996 Incentive and Non-Qualified Stock Option Plan and the 2010 Stock Incentive Plan.
|
(2)
|
Consists of the 2010 Stock Incentive Plan.
|
Exhibit
No.
|
|
Description
|
|||
|
Asset Purchase Agreement, dated October 31, 2018, by and between Eli Lilly and Company and SIGA Technologies, Inc. (incorporated by referenced to the Current Report on Form 8-K of the Company filed on November 1, 2018).
|
|
|||
|
|
|
|
||
|
Amended and Restated Certificate of Incorporation of SIGA Technologies, Inc. (incorporated by reference to the Current Report on Form 8-K of the Company filed on April 14, 2016).
|
|
|||
|
|
|
|
||
|
Amended and Restated Bylaws of SIGA Technologies, Inc. (incorporated by reference to the Current Report on Form 8-K of the Company filed on April 14, 2016).
|
|
|||
|
|
|
|
||
|
Amendment to Amended and Restated Bylaws of SIGA Technologies, Inc. (incorporated by reference to the Current Report on Form 8-K of the Company filed on December 13, 2016).
|
|
|||
|
|
|
|
||
4(a)
|
|
Form of Common Stock Certificate (incorporated by reference to the Form SB-2 Registration Statement of the Company dated March 10, 1997 (No. 333-23037)).
|
|
||
|
|
|
|
||
|
Contract dated as of May 13, 2011, between SIGA and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services (portions of this exhibit have been omitted and separately filed with the Securities and Exchange Commission with a request for confidential treatment) (incorporated by reference to the Current Report on Form 8-K of the Company filed on May 17, 2011).
|
|
|||
|
|
|
|
||
|
Amendment of Solicitation/Modification of Contract dated as of June 24, 2011, to Agreement dated as of May 13, 2011, between SIGA and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services (portions of this exhibit have been omitted and separately filed with the Securities and Exchange Commission with a request for confidential treatment) (incorporated by reference to the Current Report on Form 8-K of the Company filed on June 28, 2011).
|
|
|||
|
|
|
|
||
|
Director Compensation Program, effective January 1, 2012 (incorporated by reference to the Definitive Proxy Statement on Form DEF 14A of the Company filed on April 27, 2012).
|
|
|||
|
|
|
|
||
|
Amendment of Solicitation/Modification of Contract dated as of September 28, 2011, to Agreement dated as of May 13, 2011, between SIGA and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services (portions of this exhibit have been omitted and separately filed with the Securities and Exchange Commission with a request for confidential treatment) (incorporated by reference to the Quarterly Report on Form 10-Q of the Company filed on May 7, 2012).
|
|
|||
|
|
|
|
|
Amendment of Solicitation/Modification of Contract dated as of October 7, 2011, to Agreement dated as of May 13, 2011, between SIGA and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services (portions of this exhibit have been omitted and separately filed with the Securities and Exchange Commission with a request for confidential treatment) (incorporated by reference to the Quarterly Report on Form 10-Q of the Company filed on May 7, 2012).
|
|
|||
|
|
|
|
||
|
Amendment of Solicitation/Modification of Contract dated as of January 25, 2012 to Agreement, dated as of May 13, 2011, between SIGA and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services (portions of this exhibit have been omitted and separately filed with the Securities and Exchange Commission with a request for confidential treatment) (incorporated by reference to the Quarterly Report on Form 10-Q of the Company filed on May 7, 2012).
|
|
|||
|
|
|
|
||
|
Amendment of Solicitation/Modification of Contract dated as of February 7, 2012, to Agreement, dated as of May 13, 2011, between SIGA and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services (incorporated by reference to the Quarterly Report on Form 10-Q of the Company filed on May 7, 2012).
|
|
|||
|
|
|
|
||
|
Amendment of Solicitation/Modification of Contract dated as of December 19, 2012, to Agreement, dated as of May 13, 2011, between SIGA and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services (portions of this exhibit have been omitted and separately filed with the Securities and Exchange Commission with a request for confidential treatment) (incorporated by reference to the Annual Report on Form 10-K of the Company filed on March 6, 2013).
|
|
|||
|
|
|
|
||
|
Amendment of Solicitation/Modification of Contract dated as of February 28, 2013, to Agreement, dated as of May 13, 2011, between SIGA and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services (incorporated by reference to the Annual Report on Form 10-K of the Company filed on March 10, 2014).
|
|
|||
|
|
|
|
||
|
Amendment of Solicitation/Modification of Contract dated as of April 9, 2013, to Agreement, dated as of May 13, 2011, between SIGA and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services (incorporated by reference to the Annual Report on Form 10-K of the Company filed on March 10, 2014).
|
|
|||
|
|
|
|
||
|
Amendment of Solicitation/Modification of Contract 0009, dated April 29, 2015, to Agreement, dated May 13, 2011 by and between SIGA and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services (portions of this exhibit have been omitted and separately filed with the Securities and Exchange Commission with a request for confidential treatment) (incorporated by reference to the Quarterly Report on Form 10-Q of the Company filed on May 6, 2015).
|
|
|||
|
|
|
|
||
|
Amendment of Solicitation/Modification of Contract 0010, dated July 1, 2015, to Agreement, dated May 13, 2011 by and between SIGA and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services (portions of this exhibit have been omitted and separately filed with the Securities and Exchange Commission with a request for confidential treatment) (incorporated by reference to the Annual Report on Form 10-K of the Company filed on March 4, 2016).
|
|
|||
|
|
|
|
||
|
Amendment of Solicitation/Modification of Contract 0011, dated December 9, 2015, to Agreement, dated May 13, 2011 by and between SIGA and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services (portions of this exhibit have been omitted and separately filed with the Securities and Exchange Commission with a request for confidential treatment)(incorporated by reference to the Annual Report on Form 10-K of the Company filed on March 4, 2016).
|
|
|||
|
|
|
|
||
|
Amended and Restated Employment Agreement, dated April 12, 2016, between SIGA Technologies, Inc. and Daniel J. Luckshire (incorporated by reference to the Current Report on Form 8-K of the Company filed on April 14, 2016).
|
|
|||
|
|
|
|
|
Amended and Restated Employment Agreement, dated April 12, 2016, between SIGA Technologies, Inc. and Dennis E. Hruby (incorporated by reference to the Current Report on Form 8-K of the Company filed on April 14, 2016).
|
|
|||
|
|
|
|
||
|
Amendment of Solicitation/Modification of Contract 0013, dated June 28, 2016, to Agreement, dated May 13, 2011, between the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services and SIGA (portions of this exhibit have been omitted and separately filed with the Securities and Exchange Commission with a request for confidential treatment) (incorporated by reference to the Current Report on Form 8-K of the Company filed on July 5, 2016).
|
|
|
Loan and Security Agreement, dated as of September 2, 2016, by and among SIGA Technologies, Inc., OCM Strategic Credit SIGTEC Holdings, LLC, Cortland Capital Market Services LLC, in its capacity as administrative agent and collateral agent, OCM Strategic Credit SIGTEC Holdings, LLC, as sole lead arranger, and each of the other persons who are or thereafter become parties to the Loan Agreement as guarantors (incorporated by reference to the Current Report on Form 8-K of the Company filed on September 7, 2016).
|
|
||
|
|
|
|
|
|
Warrant, dated as of September 2, 2016, by the Company in favor of OCM Strategic Credit SIGTEC Holdings, LLC or its registered assigns (incorporated by reference to the Current Report on Form 8-K of the Company filed on September 7, 2016).
|
|
||
|
|
|
|
|
|
Employment Agreement, dated as of October 13, 2016, between SIGA and Phillip Louis Gomez, III (incorporated by reference to the Current Report on Form 8-K of the Company filed on October 13, 2016).
|
|
||
|
|
|
|
|
|
Investment Agreement, dated October 13, 2016, by and among SIGA Technologies, Inc., ST Holdings One LLC, Blackwell Partners LLC-Series A, Nantahala Capital Partners Limited Partnership, Nantahala Capital Partners II Limited Partnership, Silver Creek CS SAV, L.L.C. and Nantahala Capital Partners SI, LP (incorporated by reference to the Current Report on Form 8-K of the Company filed on October 19, 2016).
|
|
||
|
|
|
|
|
|
Amendment of Solicitation/Modification of Contract 0012, dated April 22, 2016, to Agreement, dated May 13, 2011, between the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services and SIGA (incorporated by reference to the Quarterly Report on Form 10-Q of the Company filed on May 4, 2017).
|
|
||
|
|
|
|
|
|
Amendment of Solicitation/Modification of Contract 0014, dated September 21, 2016, to Agreement, dated May 13, 2011, between the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services and SIGA (incorporated by reference to the Quarterly Report on Form 10-Q of the Company filed on May 4, 2017).
|
|
||
|
|
|
|
|
|
Office Lease, dated as of May 26, 2017, by and between SIGA Technologies, Inc. and MacAndrews & Forbes Incorporated (portions of this exhibit have been omitted and separately filed with the Securities and Exchange Commission with a request for confidential treatment) (incorporated by reference to the Current Report on Form 8-K of the Company filed on May 30, 2017).
|
|
||
|
|
|
|
|
|
Termination of Sublease, dated as of July 31, 2017 (incorporated by reference to the Quarterly Report on Form 10-Q of the Company filed on August 3, 2017).
|
|
||
|
|
|
|
|
|
Amendment, dated August 29, 2017, to that certain Loan and Security Agreement, dated as of September 2, 2016, by and among SIGA Technologies, Inc., OCM Strategic Credit SIGTEC Holdings, LLC, Cortland Capital Market Services LLC, in its capacity as administrative agent and collateral agent, OCM Strategic Credit SIGTEC Holdings, LLC, as sole lead arranger, and each of the other persons who are or thereafter become parties to the Loan Agreement as guarantors (incorporated by reference to the Quarterly Report on Form 10-Q of the Company filed on November 7, 2017).
|
|
||
|
|
|
|
|
|
Commercial Lease Agreement for Corvallis, Oregon dated November 3, 2017 (incorporated by reference to the Quarterly Report on Form 10-Q of the Company filed on November 7, 2017).
|
|
Certification pursuant to Rules 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002-Chief Financial Officer.
|
||||
|
|
|||
Certification Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002-Chief Executive Officer.
|
||||
|
|
|||
Certification Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002-Chief Financial Officer.
|
101.INS
|
XBRL Instance Document
|
|
|
|
|
101.SCH
|
|
Taxonomy Extension Schema Document
|
|
|
|
101.CAL
|
|
Taxonomy Extension Calculation Linkbase Document
|
|
|
|
101.DEF
|
|
Taxonomy Extension Definition Linkbase Document
|
|
|
|
101.LAB
|
|
Taxonomy Extension Labels Linkbase Document
|
|
|
|
101.PRE
|
|
Taxonomy Extension Presentation Linkbase Document
|
|
|
SIGA TECHNOLOGIES, INC.
|
||
|
|
(Registrant)
|
||
|
|
|
||
Date:
|
March 5, 2019
|
By:
|
/s/ Phillip L. Gomez
|
|
|
|
|
Phillip L. Gomez
|
|
|
|
|
Chief Executive Officer
|
Signature
|
|
Title of Capacities
|
|
Date
|
/s/ Phillip L. Gomez
|
|
|
March 5, 2019
|
|
Phillip L. Gomez
|
|
Chief Executive Officer and Director
|
|
|
|
|
|
|
|
/s/ Daniel J. Luckshire
|
|
|
|
|
Daniel J. Luckshire
|
|
Executive Vice President and
|
|
March 5, 2019
|
|
|
Chief Financial Officer
|
|
|
|
|
(Principal Financial Officer and
|
|
|
|
|
Principal Accounting Officer)
|
|
|
|
|
|
|
|
/s/ Eric A. Rose
|
|
|
|
|
Eric A. Rose, M.D.
|
|
Chairman
|
|
March 5, 2019
|
|
|
|
|
|
/s/ James J. Antal
|
|
|
|
|
James J. Antal
|
|
Director
|
|
March 5, 2019
|
|
|
|
|
|
/s/ Michael J. Bayer
|
|
|
|
|
Michael J. Bayer
|
|
Director
|
|
March 5, 2019
|
|
|
|
|
|
/s/ Thomas E. Constance
|
|
|
|
|
Thomas E. Constance
|
|
Director
|
|
March 5, 2019
|
|
|
|
|
|
/s/ Jeffrey Kindler
|
|
|
|
|
Jeffrey Kindler
|
|
Director
|
|
March 5, 2019
|
|
|
|
|
|
/s/ Joseph Marshall
|
|
|
|
|
Joseph Marshall
|
|
Director
|
|
March 5, 2019
|
|
|
|
|
|
/s/ Michael Plansky
|
|
|
|
|
Michael Plansky
|
|
Director
|
|
March 5, 2019
|
|
|
|
|
|
/s/ Paul G. Savas
|
|
|
|
|
Paul G. Savas
|
|
Director
|
|
March 5, 2019
|
CLIN
|
Period of Performance
|
Supplies/ Services
|
Total Est.
Cost |
Fixed Fee
|
Total Cost Plus
Fixed Fee ($) |
0007 (Option - Exercised)
|
01/01/19 –
12/31/2023
|
Phase IV post marketing commitments (
nonparenteral (oral)
formulation) including relabeling of approved drug in the SNS (this is an option that may or may not be exercised as required by the FDA)
|
$11,497,147
|
$689,828
|
$12,186,975
|
(i)
|
Albemarle will promptly provide a replacement batch of conforming Product to Customer at no additional cost and on a schedule mutually agreed upon by Albemarle and Customer based upon lead time requirements for raw materials and reimburse Customer for the shipping and micronization costs, if any, incurred by Customer for the non-conforming batch, or
|
(ii)
|
refund within 10 business days to the Customer the full aggregate Price for such batch of Product containing non-conforming Product, plus shipping and micronization costs, if any, incurred by the Customer with respect to such non-conforming batch of Product.
|
6.1
|
Indemnity
.
|
6.
|
LIABILITY AND LIMITATIONS
|
8.
|
TERM AND TERMINATION
|
9.
|
WARRANTY
|
10.
|
REGULATORY
|
6.
|
FLOW DOWN PROVISIONS
|
7.
|
GENERAL PROVISIONS
|
Test
|
Method
|
Acceptance Criteria
|
Test
|
Method
|
Acceptance Criteria
|
Test
|
Method
|
Acceptance Criteria
|
Test
|
Method
|
Acceptance Criteria
|
1)
|
The [redacted]* Stability Testing activities as per established protocols would be undertaken for the micronized Product from [redacted]* batch of the micronized Product produced each calendar year. Customer has responsibility to provide Albemarle with micronized Product. The responsibilities of Albemarle would include:
|
a.
|
Protocol writing, with corresponding Customer approval in accordance with the Quality Agreement;
|
b.
|
Sample preparation/staging in stability chamber ovens, with corresponding Customer approval in accordance with the Quality Agreement;
|
c.
|
Analysis per the stability protocols within time period in accordance with the Albemarle SOPs and the Quality Agreement;
|
d.
|
Report writing using format mutually agreed upon with the Customer.
|
2)
|
The [redacted]* Stability Testing activities as per established protocols would be undertaken for the unmicronized Product from [redacted]* batch of the unmicronized Product produced each calendar year. The responsibilities of Albemarle would include:
|
a.
|
Protocol writing, with corresponding Customer approval in accordance with the Quality Agreement;
|
b.
|
Sample preparation/staging in stability chamber ovens, with corresponding Customer approval in accordance with the Quality Agreement;
|
c.
|
Analysis per the stability protocols within time period in accordance with the Albemarle SOPs and the Quality Agreement;
|
d.
|
Report writing using format mutually agreed upon with the Customer.
|
Raw Material
|
Approved Vendor
|
1.
|
I have reviewed this annual report on Form 10-K of SIGA Technologies, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: March 5, 2019
|
|
/s/ Phillip L. Gomez
|
Phillip L. Gomez
|
Chairman and Chief Executive Officer
|
1.
|
I have reviewed this annual report on Form 10-K of SIGA Technologies, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: March 5, 2019
|
|
/s/ Daniel J. Luckshire
|
Daniel J. Luckshire
|
Executive Vice President and
Chief Financial Officer
|
(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.
|
/s/ Phillip L. Gomez
|
Phillip L. Gomez
|
Chairman and Chief Executive Officer
|
March 5, 2019
|
(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.
|
/s/ Daniel J. Luckshire
|
Daniel J. Luckshire
|
Executive Vice President and Chief Financial Officer
|
March 5, 2019
|