UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): November 3, 2022
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization)
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(Commission file number)
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(I.R.S. employer identification no.)
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(Address of principal executive offices)
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(Zip code)
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Registrant’s telephone number, including area code: (212 )
672-9100
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of
the following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2
of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected
not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 2.02 |
Results of Operations and Financial Condition.
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On November 3, 2022, SIGA Technologies, Inc. (the “Company”) issued a press release (the “Press Release”) announcing its financial
results for the three and nine months ended September 30, 2022.
Pursuant to General Instruction B.2 of Form 8-K, the information contained in, or incorporated into, this Item 2.02, including the
Press Release, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed
incorporated by reference into any registration statement or other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference to such filing.
The full text of the Press Release is attached as Exhibit 99.1 hereto and incorporated herein by reference.
| Item 9.01 |
Financial Statements and Exhibits.
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(d) The following exhibits are included in this report:
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Exhibit
No.
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Description
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Earnings Press Release, dated November 3, 2022.
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL document).
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be
signed on its behalf by the undersigned hereunto duly authorized.
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SIGA TECHNOLOGIES, INC.
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By:
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/s/ Daniel J. Luckshire
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Name:
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Daniel J. Luckshire
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Title:
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Chief Financial Officer
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Date: November 3, 2022
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Exhibit 99.1
SIGA Reports Financial Results for Three and Nine Months Ended September 30, 2022
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Approximately $61 Million of International Sales in the Third Quarter –
- Corporate Update Conference Call Today at 4:30 PM ET
November 3, 2022, 4:05 pm ET
NEW YORK -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company, today reported financial results for the
three and nine months ended September 30, 2022.
“With significant international sales, our third quarter financial results continue a trend of substantial financial diversification at SIGA,” said
Phil Gomez, CEO of SIGA. “In combination with the first sale of the intravenous formulation of TPOXX® (“IV TPOXX”) in the first quarter of 2022 and the first sale of oral TPOXX to the U.S. Department of Defense (“DoD”) in the second quarter of 2022,
the sale of oral TPOXX (tecovirimat) to ten new international customers in the third quarter of 2022 highlights the continuing diversification of SIGA’s revenue base. We believe the expanded number of customers is a sign that more leaders in
government are recognizing the critical importance of health security preparedness, and that by increasing both the scale and scope of TPOXX stockpiling, countries can be better prepared to address the
risks associated with smallpox, monkeypox, and other viruses in the orthopoxvirus family of viruses.”
Summary Financial Results
($ in millions, except per share amounts)
Third Quarter 2022 in comparison to Third Quarter 2021
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Three Months Ended
September 30,
2022
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Three Months
Ended September 30,
2021
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Total Revenues
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$
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72.2
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$
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4.8
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Operating Income (Loss) (1)
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$
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42.9
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$
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(2.9
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)
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Income (Loss) before Income Taxes (1)
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$
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43.1
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$
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(4.0
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)
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Net Income (Loss)
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$
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33.0
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$
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(3.1
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)
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Diluted Income (Loss) per Share
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$ 0.45 per share
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($0.04) per share
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Nine Months Ended September 30, 2022 in comparison to Nine Months Ended September 30, 2021
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Nine Months
Ended
September 30,
2022
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Nine Months
Ended
September 30,
2021 |
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Total Revenues
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$
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99.4
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$
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18.3
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Operating Income (Loss) (1)
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$
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44.5
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$
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(4.9
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)
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Income (Loss) before Income Taxes (1)
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$
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45.3
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$
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(4.6
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)
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Net Income (Loss)
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$
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34.7
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$
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(3.8
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)
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Diluted Income (Loss) per Share
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$ 0.47 per share
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($0.05) per share
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(1) Operating Income / (Loss) excludes, and Income / (Loss) before Income Taxes includes, interest income, and adjustments to the fair value of the Company’s
outstanding warrant. Both line items exclude the impact of income taxes.
Key Business and Operational Activity
| • |
This year, through October 31, SIGA has received approximately $77 million of international orders for oral TPOXX (tecovirimat) from 13 customers, of which
12 are new customers. Approximately $61 million of these orders were delivered in the third quarter of 2022, following $5 million of deliveries in the second quarter.
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| • |
On October 12, the Company provided an update on the progress in clinical trials assessing the use of TPOXX for the treatment of monkeypox, noting that in September and October
randomized, placebo-controlled clinical trials were initiated in the U.S., the U.K., and the Democratic Republic of Congo (DRC) to further assess the safety and efficacy of TPOXX in participants with monkeypox. The U.S.-based trial and the
DRC-based trial are being sponsored by the National Institute of Allergy and Infectious Disease (NIAID), and the U.K.-based trial is commissioned and funded by the National Institute for Health Care and Research.
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| • |
On September 29, SIGA announced that the DoD awarded a new procurement contract to the Company for the purchase of up to $10.7 million of oral TPOXX. Including a prior
contract award, DoD has awarded procurement contracts to SIGA in 2022 for the purchase of up to $18.1 million of oral TPOXX.
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On August 9, the Company announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Administration for Strategic Preparedness
and Response at the U.S. Department of Health and Human Services, exercised procurement options under the 19C contract for the purchase of approximately $26 million of IV TPOXX.
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Monkeypox Outbreak
Starting in June 2022, SIGA has received procurement orders for oral TPOXX from new international jurisdictions as well as orders under existing contracts, and continues
to receive inquiries about accessing oral TPOXX in connection with a global monkeypox outbreak. The Company believes that a portion of the courses of oral TPOXX delivered under these orders is being used for the treatment of active monkeypox cases
in countries around the world.
Monkeypox is a disease caused by infection with the monkeypox virus, which is part of the same family of viruses as smallpox. Monkeypox symptoms are similar to smallpox
but not as severe, with historical fatality rates of less than 1% to 10% reported in Africa depending on region and clade. The first human case of monkeypox was recorded in 1970. Since then, monkeypox has been reported in several central and
western African countries, with case numbers increasing in recent years. Prior to the ongoing 2022 outbreak, nearly all monkeypox cases in people outside of Africa were linked to international travel to countries where the disease commonly occurs, or
through imported animals, including two cases in the United States in 2021. Moneypox cases are now currently occurring on multiple continents. On July 23, 2022, the World Health Organization declared the monkeypox outbreak as a public health
emergency of international concern. On August 4, 2022, the U.S. government declared the monkeypox outbreak as a public health emergency.
COVID-19 Pandemic
The COVID-19 pandemic has caused significant societal and economic disruption. The continuing direct and indirect impact of the pandemic are significant and broad based,
including supply chain disruptions and labor shortages that started during the pandemic and continue to represent business and financial risks. As such, the Company is continually coordinating with service providers and vendors, in particular
Contract Manufacturing Organizations that constitute our supply chain, with respect to risks and mitigating actions.
The Company has not identified or been notified by government customers of impediments to the continued full performance of their government contracts. With regard to
day-to-day operations, the COVID-19 pandemic, and the secondary effects of the pandemic, have at times slowed the pace of execution of government contracts as well as new contract generation. Additionally, the COVID-19 pandemic, and the secondary
effects of the pandemic have increased the risk of delays in connection with a broad range of operational activities, including: supply chain procurement of raw materials and manufacturing; and certain research and development activities, such as
those that involve clinical trials. Furthermore, the pandemic and related secondary effects could result in a slower pace of future product deliveries if there are shortages or delays in the receipt by the supply chain of raw materials or supplies,
or if labor shortages become more acute. While the Company does not currently expect such delays to have a material adverse impact on the financial condition of the Company or its long-term operating performance, and while the COVID-19 pandemic has
not adversely affected the liquidity position of the Company, the Company cannot give assurances as to the full extent of the impact at this time.
Conference Call and Webcast
SIGA will host a conference call and webcast to provide a business update today, Thursday, November 3, 2022, at 4:30 P.M. ET.
Participants may access the call by dialing 1-844-826-3033 for domestic callers or 1-412-317-5185 for international callers. A live webcast of the call will also be
available on the Company's website at www.siga.com under the 'Events & Presentations' tab in the Investor Relations section, or by clicking
here. Please log in approximately 5-10 minutes prior to the scheduled start time.
A replay of the call will be available for two weeks by dialing 1-844-512-2921 for domestic callers or 1-412-317-6671 for international callers and using Conference
ID: 10171319. The archived webcast will be available in the Events and Presentations section of the Company's website.
ABOUT SIGA TECHNOLOGIES, INC. and TPOXX®
SIGA Technologies, Inc. is a commercial-stage pharmaceutical company focused on the health security market. Health security comprises
countermeasures for biological, chemical, radiological and nuclear attacks (biodefense market), vaccines and therapies for emerging infectious diseases, and health preparedness. Our lead product is TPOXX®, also known as tecovirimat and ST-246®, an
orally administered and IV formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. TPOXX is a novel small-molecule drug and the US maintains a supply of TPOXX under Project BioShield. The oral formulation of
TPOXX was approved by the FDA for the treatment of smallpox in 2018, and the IV formulation was approved for the same indication in 2022. The full label is available by clicking here.
Oral tecovirimat received approval from the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom in 2022. The EMA and UK
approvals include labeling for oral tecovirimat indicating its use for the treatment of smallpox, monkeypox, cowpox, and vaccinia complications following vaccination against smallpox. The full
label is available by clicking here. In September 2018, SIGA signed a contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant
Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, for additional procurement and development related to both oral and intravenous formulations of TPOXX. For more information about SIGA, please visit
www.siga.com.
About Smallpox
Smallpox is a contagious, disfiguring and often deadly disease that has affected humans for thousands of years. Naturally-occurring smallpox was
eradicated worldwide by 1980, the result of an unprecedented global immunization campaign. Samples of smallpox virus have been kept for research purposes. This has led to concerns that smallpox could someday be used as a biological warfare agent. A
vaccine can prevent smallpox, but the risk of the current vaccine's side effects is too high to justify routine vaccination for people at low risk of exposure to the smallpox virus.
FORWARD-LOOKING STATEMENTS
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended,
including statements relating to the progress of SIGA’s development programs and timelines for bringing products to market, delivering products to the Strategic Stockpile, the enforceability of our procurement contracts, such as the 19C BARDA
Contract (the "BARDA Contract"), with BARDA, the impact of the COVID pandemic and responding to the global outbreak of monkeypox. The words or phrases “can be,” “expects,” “may affect,” “may depend,” “believes,” “estimate,” “project” and similar
words and phrases are intended to identify such forward-looking statements. Such forward-looking statements are subject to various known and unknown risks and uncertainties, and SIGA cautions you that any forward-looking information provided by or
on behalf of SIGA is not a guarantee of future performance. SIGA’s actual results could differ materially from those anticipated by such forward-looking statements due to a number of factors, some of which are beyond SIGA’s control, including, but
not limited to, (i) the risk that BARDA elects, in its sole discretion as permitted under the BARDA Contract, not to exercise all, or any, of the remaining unexercised options under those contracts, (ii) the risk that SIGA may not complete
performance under the BARDA Contract on schedule or in accordance with contractual terms, (iii) the risk that the BARDA Contract, the current Department of Defense procurement contract or PEP Label Expansion R&D Contract (as defined in the Form
10-Q) are modified or canceled at the request or requirement of the U.S. Government, (iv) the risk that the nascent international biodefense market does not develop to a degree that allows SIGA to continue to successfully market TPOXX®
internationally, (v) the risk that potential products, including potential alternative uses or formulations of TPOXX® that appear promising to SIGA or its collaborators, cannot be shown to be efficacious or safe in subsequent pre-clinical or
clinical trials, (vi) the risk that SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market these or other potential products or uses, (vii) the risk that SIGA may not be able to secure or enforce
sufficient legal rights in its products, including intellectual property protection, (viii) the risk that any challenge to SIGA’s patent and other property rights, if adversely determined, could affect SIGA’s business and, even if determined
favorably, could be costly, (ix) the risk that regulatory requirements applicable to SIGA’s products may result in the need for further or additional testing or documentation that will delay or prevent SIGA from seeking or obtaining needed
approvals to market these products, (x) the risk that the volatile and competitive nature of the biotechnology industry may hamper SIGA’s efforts to develop or market its products, (xi) the risk that changes in domestic or foreign economic and
market conditions may affect SIGA’s ability to advance its research or may affect its products adversely, (xii) the effect of federal, state, and foreign regulation, including drug regulation and international trade regulation, on SIGA’s
businesses, (xiii) the risk of disruptions to SIGA’s supply chain for the manufacture of TPOXX®, causing delays in SIGA’s research and development activities, causing delays or the re-allocation of funding in connection with SIGA’s government
contracts, or diverting the attention of government staff overseeing SIGA’s government contracts, (xiv) the risk that the U.S. or foreign governments' responses (including inaction) to national or global economic conditions or infectious diseases,
such as COVID-19, are ineffective and may adversely affect SIGA’s business, and (xv) risks associated with responding to the current monkeypox outbreak, as well as the risks and uncertainties included in Item 1A “Risk Factors” of our Annual Report
on Form 10-K for the year ended December 31, 2021 and SIGA's subsequent filings with the Securities and Exchange Commission. SIGA urges investors and security holders to read those documents free of charge at the SEC's website at
http://www.sec.gov. All such forward-looking statements are current only as of the date on which such statements were made. SIGA does not undertake any obligation to update publicly any forward-looking statement to reflect events or circumstances
after the date on which any such statement is made or to reflect the occurrence of unanticipated events.
The information contained in this press release does not necessarily reflect the position or the policy of the Government and no
official endorsement should be inferred.
Contacts:
Investor Contact
Laine Yonker, Edison Group
lyonker@edisongroup.com
Michael Crawford, Edison Group
mcrawford@edisongroup.com
Public Relations
Holly Stevens, Berry & Company
hstevens@berrypr.com
SIGA TECHNOLOGIES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
As of
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September
30, 2022
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December
31, 2021
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|||||||
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ASSETS
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||||||||
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Current assets
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||||||||
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Cash and cash equivalents
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$
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109,749,555
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$
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103,138,819
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||||
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Accounts receivable
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54,925,558
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83,650,450
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||||||
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Inventory
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31,261,346
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19,510,379
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Prepaid expenses and other current assets
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964,065
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2,453,444
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Total current assets
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196,900,524
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208,753,092
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Property, plant and equipment, net
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1,979,517
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2,365,957
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Deferred income taxes, net
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4,183,886
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2,422,607
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Goodwill
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898,334
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898,334
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Other assets
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261,814
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286,585
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Total assets
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$
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204,224,075
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$
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214,726,575
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LIABILITIES AND STOCKHOLDERS’ EQUITY
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Current liabilities
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Accounts payable
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$
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2,445,390
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$
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2,028,004
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||||
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Accrued expenses and other current liabilities
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15,887,359
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9,252,812
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Income tax payable
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9,123,153
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19,207,042
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Total current liabilities
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27,455,902
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30,487,858
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Warrant liability
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—
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6,521,441
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Other liabilities
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3,630,046
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3,402,869
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Total liabilities
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31,085,948
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40,412,168
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Commitments and contingencies
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Stockholders’ equity
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||||||||
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Common stock ($.0001 par value, 600,000,000 shares authorized, 73,024,147 and 73,543,602, issued and outstanding at
September 30, 2022 and December 31, 2021, respectively)
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7,302
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7,354
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Additional paid-in capital
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233,271,351
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226,070,308
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Accumulated deficit
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(60,140,526
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)
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(51,763,255
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)
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Total stockholders’ equity
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173,138,127
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174,314,407
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Total liabilities and stockholders’ equity
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$
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204,224,075
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$
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214,726,575
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||||
SIGA TECHNOLOGIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
INCOME (LOSS) (UNAUDITED)
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Three Months Ended
September 30,
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Nine Months Ended
September 30,
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|||||||||||||||
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2022
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2021
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2022
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2021
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|||||||||||||
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Revenues
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||||||||||||||||
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Product sales and supportive services
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$
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65,621,511
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$
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2,346,110
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$
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81,558,148
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$
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12,793,615
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||||||||
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Research and development
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6,589,616
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2,500,062
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17,859,323
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5,519,591
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||||||||||||
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Total revenues
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72,211,127
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4,846,172
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99,417,471
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18,313,206
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||||||||||||
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Operating expenses
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||||||||||||||||
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Cost of sales and supportive services
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3,948,974
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83,276
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9,551,186
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1,330,114
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||||||||||||
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Selling, general and administrative
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19,656,138
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4,471,640
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29,241,565
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14,113,384
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||||||||||||
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Research and development
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5,732,982
|
3,235,145
|
16,119,858
|
7,801,901
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||||||||||||
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Total operating expenses
|
29,338,094
|
7,790,061
|
54,912,609
|
23,245,399
|
||||||||||||
|
Operating income/(loss)
|
42,873,033
|
(2,943,889
|
)
|
44,504,862
|
(4,932,193
|
)
|
||||||||||
|
Gain/(loss) from change in fair value of warrant liability
|
—
|
(1,066,522
|
)
|
400,663
|
294,548
|
|||||||||||
|
Other income, net
|
258,975
|
26,252
|
354,670
|
76,055
|
||||||||||||
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Income/(loss) before income taxes
|
43,132,008
|
(3,984,159
|
)
|
45,260,195
|
(4,561,590
|
)
|
||||||||||
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(Provision)/benefit for income taxes
|
(10,091,420
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)
|
870,801
|
(10,543,595
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)
|
805,328
|
||||||||||
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Net and comprehensive income/(loss)
|
$
|
33,040,588
|
$
|
(3,113,358
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)
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$
|
34,716,600
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$
|
(3,756,262
|
)
|
||||||
|
Basic income/(loss) per share
|
$
|
0.45
|
$
|
(0.04
|
)
|
$
|
0.48
|
$
|
(0.05
|
)
|
||||||
|
Diluted income/(loss) per share
|
$
|
0.45
|
$
|
(0.04
|
)
|
$
|
0.47
|
$
|
(0.05
|
)
|
||||||
|
Weighted average shares outstanding: basic
|
73,024,147
|
74,840,846
|
72,924,178
|
75,822,713
|
||||||||||||
|
Weighted average shares outstanding: diluted
|
73,259,272
|
74,840,846
|
73,616,837
|
76,634,963
|
||||||||||||