SIGA Technologies Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>SIGA Technologies Inc. has filed its 2023 annual report (10-K) detailing its financial performance and business operations for the fiscal year ending December 31, 2023.</b>

AI Summary

SIGA TECHNOLOGIES INC (SIGA) filed a Annual Report (10-K) with the SEC on March 12, 2024. SIGA Technologies Inc. filed its 2023 Form 10-K on March 12, 2024. The filing covers the fiscal year ending December 31, 2023. The company's principal business address is 31 East 62nd Street, New York, NY 10065. SIGA Technologies Inc. was formerly known as SIGA Pharmaceuticals Inc. The SIC code for the company is 2834 (Pharmaceutical Preparations).

Why It Matters

For investors and stakeholders tracking SIGA TECHNOLOGIES INC, this filing contains several important signals. This 10-K filing provides a comprehensive overview of SIGA's financial health, operational activities, and strategic direction for the past fiscal year, crucial for investors and stakeholders to assess performance and future prospects. The detailed financial statements and risk factors within the report offer insights into the company's revenue streams, profitability, and potential challenges, enabling informed investment decisions.

Risk Assessment

Risk Level: medium — SIGA TECHNOLOGIES INC shows moderate risk based on this filing. The company operates in the pharmaceutical preparations industry, which is subject to significant regulatory oversight, lengthy development cycles, and intense competition, posing inherent risks to revenue and profitability.

Analyst Insight

Review the detailed financial statements and management's discussion and analysis in the 10-K to understand SIGA's revenue drivers, cost structure, and outlook for its pharmaceutical products.

Key Numbers

• 20231231 — Fiscal Year End (Conformed Period of Report)
• 20240312 — Filed As Of Date (Date of filing)
• 79 — Public Document Count (Number of documents in the filing)
• 0001010086 — Central Index Key (Filer's identifier)

Key Players & Entities

• SIGA TECHNOLOGIES INC (company) — Filer name
• SIGA TECHNOLOGIES INC (company) — Company name
• 0001010086 (company) — Central Index Key
• 2834 (company) — Standard Industrial Classification
• DE (company) — State of Incorporation
• 31 EAST 62ND STREET (company) — Business Address Street 1
• NEW YORK (company) — Business Address City
• NY (company) — Business Address State

FAQ

Industry Context

SIGA Technologies Inc. operates within the pharmaceutical preparations industry, focusing on the development and commercialization of therapeutics.

Regulatory Implications

Companies in the pharmaceutical sector are subject to stringent regulations from bodies like the FDA regarding drug development, approval, and marketing.

What Investors Should Do

1. Analyze the revenue and cost breakdown for Product Sales and Supportive Services and Research and Development.
2. Examine any disclosed executive compensation details.
3. Review the company's stated business strategy and any forward-looking statements.

Key Dates

• 2024-03-12: 10-K Filing — Filing of the annual report for the fiscal year ended December 31, 2023.

Year-Over-Year Comparison

This filing is the 2023 annual report, following previous filings such as the 2022 10-K.

Key Financial Figures

• $602.5 million — ract") contemplates up to approximately $602.5 million of payments, of which approximately $51
• $51.7 million — ion of payments, of which approximately $51.7 million of payments are included within the bas
• $407.1 million — se period of performance, approximately $407.1 million of payments are related to exercised op
• $143.7 million — ercised options and up to approximately $143.7 million of payments are currently specified as
• $11.1 million — g activities: payments of approximately $11.1 million for the delivery of approximately 35,70
• $8.0 million — to the Strategic Stockpile; payments of $8.0 million for the manufacture of 10,000 courses (
• $3.2 million — roduct of IV TPOXX ("IV FDP"), of which $3.2 million of payments are related to the manufact
• $32.0 million — re of IV FDP; payments of approximately $32.0 million to fund reimbursed activities; and paym
• $0.6 million — tivities; and payments of approximately $0.6 million for supportive procurement activities.
• $4.3 million — million for the manufacture of IV BDS, $4.3 million for the delivery of IV FDP to the Strat
• $22.1 million — IV FDP to the Strategic Stockpile, and $22.1 million for other base period activities. IV BD
• $337.7 million — he following activities: payments up to $337.7 million for the manufacture and delivery of up
• $51.2 million — n courses of oral TPOXX; payments up to $51.2 million for the manufacture of courses of IV FD
• $20.4 million — ufacture of courses of IV FDP, of which $20.4 million of payments relate to the manufacture o
• $3.6 million — IV FDP; payments of up to approximately $3.6 million to fund post-marketing activities for I

Filing Documents

• siga20231231_10k.htm (10-K) — 1565KB
• ex_598879.htm (EX-10.MMM) — 95KB
• ex_625610.htm (EX-10.NNN) — 39KB
• ex_585431.htm (EX-23.1) — 2KB
• ex_585432.htm (EX-31.1) — 14KB
• ex_585433.htm (EX-31.2) — 14KB
• ex_585434.htm (EX-32.1) — 6KB
• ex_585435.htm (EX-32.2) — 6KB
• ex_598878.htm (EX-97.1) — 34KB
• image01.jpg (GRAPHIC) — 44KB
• 0001437749-24-007487.txt (&nbsp;) — 7252KB
• siga-20231231.xsd (EX-101.SCH) — 63KB
• siga-20231231_cal.xml (EX-101.CAL) — 48KB
• siga-20231231_def.xml (EX-101.DEF) — 436KB
• siga-20231231_lab.xml (EX-101.LAB) — 420KB
• siga-20231231_pre.xml (EX-101.PRE) — 468KB
• siga20231231_10k_htm.xml (XML) — 927KB

Business

Business 2 Item 1A.

Risk Factors

Risk Factors 17 Item 1B. Unresolved Staff Comments 29 Item 1C. Cybersecurity 29 Item 2.

Properties

Properties 29 Item 3.

Legal Proceedings

Legal Proceedings 29 Item 4. Mine Safety Disclosures 29 PART II Item 5. Market For Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 30 Item 6. [Reserved] 32 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 33 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 42 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 43 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 67 Item 9A.

Controls and Procedures

Controls and Procedures 67 Item 9B. Other Information 68 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 68 PART III Item 10. Directors, Executive Officers and Corporate Governance 69 Item 11.

Executive Compensation

Executive Compensation 69 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 69 Item 13. Certain Relationships and Related Transactions, and Director Independence 69 Item 14. Principal Accounting Fees and Services 69 PART IV Item 15. Exhibits, Financial Statement Schedules 70 Item 16. Form 10-K Summary 76

SIGNATURES

SIGNATURES 77 Table of Contents Part I

Forward-Looking Statements

Forward-Looking Statements Certain statements in this Annual Report on Form 10-K, including certain statements contained in "Business" and "Management's Discussion and Analysis of Financial Condition and Results of Operations," constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), including statements relating to the progress of SIGA's development programs and timelines for bringing products to market, delivering products to domestic and international customers, the enforceability of our procurement contracts, such as the 19C BARDA Contract (the "BARDA Contract"), with the U.S. Biomedical Advanced Research and Development Authority ("BARDA"), and responding to the global outbreak of monkeypox ("mpox"). The words or phrases "can be," "expects," "may affect," "may depend," "believes," "estimate," "targeting," "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, DoD Contract #2 (defined below) or PEP Label Expansion R&D Contract (defined below) are modified or canceled at the

Business

Item 1. Business Overview SIGA Technologies, Inc. is referred to throughout this report as "SIGA," "the Company," "we" or "us." We are a commercial-stage pharmaceutical company. The Company sells its lead product, TPOXX ("oral TPOXX," also known as "tecovirimat" in certain international markets), to the U.S. Government and international governments (including government affiliated entities). Additionally, the Company sells the intravenous formulation of TPOXX ("IV TPOXX") to the U.S. Government. TPOXX is an oral formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. On July 13, 2018, the United States Food & Drug Administration ("FDA") approved oral TPOXX for the treatment of smallpox. The Company has been delivering oral TPOXX to the U.S. Strategic National Stockpile ("Strategic Stockpile") since 2013. In connection with IV TPOXX, SIGA announced on May 19, 2022 that the FDA approved this formulation for the treatment of smallpox. In addition to being approved by the FDA, oral TPOXX (tecovirimat) has regulatory approval with the European Medicines Agency ("EMA"), Health Canada and the Medicines and Healthcare Products Regulatory Agency ("MHRA") of the United Kingdom. The EMA and MHRA approved label indication covers the treatment of smallpox, monkeypox ("mpox"), cowpox, and vaccinia complications following vaccination against smallpox. The Health Canada approved label indication covers the treatment of smallpox. With respect to the regulatory approvals by the EMA, MHRA and Health Canada, oral tecovirimat represents the same formulation that was approved by the FDA in July 2018 under the brand name TPOXX. 2 Table of Contents In connection with a potential FDA label expansion of oral TPOXX for an indication covering smallpox post-exposure prophylaxis ("PEP"), the Company completed an immunogenicity trial and an expanded safety trial in early 2023. The nature and timing of a submission of a supplemental New Drug Ap

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View this 10-K filing on SEC EDGAR