SIGA Technologies, Inc. (NASDAQ:SIGA) Q4 2022 Earnings Conference Call March 2, 2023 4:30 PM ET Company Participants Phil Gomez - Chief Executive Officer Dan Luckshire - Chief Financial Officer Conference Call Participants Soo Romanoff - Edison Group Operator Ladies and gentlemen, greetings and welcome to the SIGA Technologies Fourth Quarter and Full Year 2022 Earnings Conference Call. At this time, all participants' lines are in a listen-only mode. A brief question-and-answer session will follow the formal ...

PART I [Business](index=5&type=section&id=Item%201.%20Business) SIGA Technologies focuses on TPOXX®, an antiviral for smallpox, with U.S. and international government procurement driving revenue and ongoing label expansion efforts [Overview](index=5&type=section&id=Overview) SIGA Technologies focuses on TPOXX®, an antiviral for smallpox, with both oral and IV formulations approved and label expansions underway - SIGA's primary product is TPOXX®, an antiviral drug for smallpox, with both oral and intravenous formulations approved by the FDA[17](index=17&type=chunk)[18](index=18&type=chunk) - Oral TPOXX® also holds regulatory approval in Europe (EMA), the UK (MHRA), and Canada, with the EMA and MHRA labels including treatment for smallpox, mpox, cowpox, and vaccinia complications[19](index=19&type=chunk) - The company is pursuing an FDA label expansion for TPOXX® for smallpox post-exposure prophylaxis (PEP), targeting a supplemental New Drug Application submission in early 2024[21](index=21&type=chunk) - Multiple randomized, placebo-controlled clinical trials (STOMP in the U.S., PLATINUM in the U.K., and PALM 007 in the DRC) were initiated in 2022 to evaluate TPOXX®'s efficacy for treating mpox, potentially supporting another FDA label expansion[22](index=22&type=chunk)[23](index=23&type=chunk)[24](index=24&type=chunk) [Procurement Contracts with the U.S. Government](index=8&type=section&id=Procurement%20Contracts%20with%20the%20U.S.%20Government) U.S. government contracts, primarily the $602.5 million BARDA agreement, drive TPOXX® procurement, with significant unexercised options 19C BARDA Contract Status (as of Dec 31, 2022) | Category | Value (approx.) | Description | | :--- | :--- | :--- | | **Total Contract Value** | **$602.5M** | Includes base period, exercised options, and unexercised options for oral and IV TPOXX® | | Base Period | $51.7M | Covers initial deliveries of oral TPOXX®, manufacture of IV TPOXX®, and R&D activities | | Exercised Options | $268.9M | Primarily for procurement of oral TPOXX®, raw materials, and post-marketing activities | | Unexercised Options | $281.9M | Potential future payments for oral and IV TPOXX® delivery and manufacturing, at BARDA's discretion | - The company estimates that approximately **920,000 courses of TPOXX®** need to be delivered in 2023 and 2024 to maintain historical U.S. Strategic Stockpile levels, suggesting potential for future option exercises by BARDA[33](index=33&type=chunk) - In 2022, SIGA secured two contracts with the U.S. Department of Defense (DoD). DoD Contract 1, valued at **$7.4 million**, was fully exercised and delivered. DoD Contract 2 includes a **$5.2 million** firm commitment and a **$5.5 million** option[34](index=34&type=chunk)[35](index=35&type=chunk) [International Procurement Contracts and Promotion Agreement](index=10&type=section&id=International%20Procurement%20Contracts%20and%20Promotion%20Agreement) International TPOXX® sales, totaling $71 million in 2022, are managed via Meridian Medical Technologies, with strong contribution margins - In 2022, the company received firm orders worth approximately **$77 million** from 13 international customers, of which **$71 million** was delivered and recognized as revenue[37](index=37&type=chunk) - All remaining amounts under the Public Health Agency of Canada (PHAC) contract, totaling approximately **$35 million**, were delivered and recognized as revenue in 2022[38](index=38&type=chunk) - International sales are managed through an exclusive promotion agreement with Meridian Medical Technologies, Inc., which handles marketing, sales, invoicing, and collection in all regions except the U.S.[40](index=40&type=chunk)[41](index=41&type=chunk) - SIGA estimates the contribution margin on international sales of oral TPOXX® to be between **65% and 80%**, depending on annual sales levels[42](index=42&type=chunk) [Manufacturing](index=11&type=section&id=Manufacturing) SIGA utilizes a capital-light model, relying entirely on third-party Contract Manufacturing Organizations (CMOs) for all TPOXX® production - SIGA does not have its own manufacturing infrastructure and relies on Contract Manufacturing Organizations (CMOs) for all TPOXX® production[45](index=45&type=chunk) Key Manufacturing Partners (CMOs) | Formulation | Process Step | Partner | | :--- | :--- | :--- | | **Oral TPOXX®** | API Manufacturing | W.R. Grace and Company | | | Micronization | Microsize | | | Encapsulation & Testing | Catalent Pharma Solutions LLC | | | Packaging | Packaging Coordinators, LLC (PCI) | | **IV TPOXX®** | Excipient Supply | Roquette America, Inc. | | | Manufacturing & Testing | Patheon Manufacturing Services LLC | | | Packaging | Packaging Coordinators, LLC (PCI) | [Intellectual Property and Proprietary Rights](index=14&type=section&id=Intellectual%20Property%20and%20Proprietary%20Rights) SIGA protects TPOXX® through a robust patent portfolio, including 29 U.S. and 101 foreign patents, with expirations up to 2039 - As of January 10, 2023, the TPOXX® patent portfolio consists of **7 patent families**, including **29 U.S. utility patents**, **101 issued foreign patents**, and **25 pending applications** worldwide[69](index=69&type=chunk)[80](index=80&type=chunk) Key U.S. Patents for TPOXX® | Patent Number | Protection Conferred | Expiration Date | | :--- | :--- | :--- | | US 8124643 | Composition of matter for the ST-246 compound | June 18, 2024 | | US 7737168 | Method of treating orthopoxvirus infection | September 4, 2031 | | US 9233097 | Liquid Pharmaceutical formulations | August 2, 2031 | | US 9546137 | Methods of preparing ST-246 | August 14, 2033 | | US 9670158 | Amorphous Tecovirimat preparation | July 11, 2034 | | US 11433051 | ST-246 suspension formulations | November 27, 2039 | [Government Regulation](index=21&type=section&id=Government%20Regulation) SIGA's operations are subject to extensive government regulation, including FDA approval processes, the Animal Rule, Project BioShield, and the PREP Act - The company's products are subject to rigorous testing and approval procedures by the FDA in the U.S. and similar authorities in foreign countries[82](index=82&type=chunk) - TPOXX® was approved for smallpox under the FDA's "Animal Rule," which allows for approval based on animal efficacy data when human trials are not ethical or feasible[87](index=87&type=chunk) - Project BioShield provides expedited procedures for the U.S. government to procure biomedical countermeasures, allowing for purchases of unapproved products for the Strategic Stockpile under certain conditions[95](index=95&type=chunk)[96](index=96&type=chunk) - The Public Readiness and Emergency Preparedness (PREP) Act provides manufacturers like SIGA with immunity from tort liability for losses arising from the use of covered countermeasures, including those for smallpox and mpox[98](index=98&type=chunk) [Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) Key risks include heavy reliance on government contracts, regulatory approval complexities, third-party dependencies, and potential patent challenges - A substantial percentage of potential revenue comes from government contracts, with over **85%** of the remaining value of the 19C BARDA Contract tied to options exercisable at BARDA's sole discretion[107](index=107&type=chunk)[110](index=110&type=chunk) - The business is highly dependent on the U.S. Government's commitment to maintaining its TPOXX® stockpile after the current BARDA contract ends[112](index=112&type=chunk) - The company relies on third-party manufacturers (CMOs) for all production of TPOXX®, exposing it to risks of performance failure, supply chain disruptions, and compliance issues[144](index=144&type=chunk)[147](index=147&type=chunk) - International revenues depend heavily on the performance of Meridian Medical Technologies under a promotion agreement, including their ability to collect and remit payments[133](index=133&type=chunk)[134](index=134&type=chunk) - The company's ability to grow may be impacted by its success in developing and commercializing new formulations or additional indications for TPOXX®, such as for post-exposure prophylaxis or mpox[151](index=151&type=chunk) [Properties](index=47&type=section&id=Item%202.%20Properties) SIGA leases its corporate headquarters in New York and R&D facilities in Corvallis, Oregon, with the latter's lease expiring in 2024 - Corporate headquarters are leased in New York, NY (**3,200 sq ft**)[188](index=188&type=chunk) - Research and development facilities are leased in Corvallis, Oregon (**10,276 sq ft**), with the lease set to expire in December 2024[189](index=189&type=chunk) [Legal Proceedings](index=47&type=section&id=Item%203.%20Legal%20Proceedings) Management anticipates no material adverse effect from current legal proceedings on the company's business or financial position - The company states that it does not expect any current legal proceedings to have a material adverse effect on its business or financial condition[190](index=190&type=chunk) PART II [Market For Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=48&type=section&id=Item%205.%20Market%20For%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) SIGA's common stock trades on Nasdaq, with an active share repurchase program authorized for up to $50 million through 2023 - The company's common stock is traded on The Nasdaq Global Market under the symbol "SIGA"[194](index=194&type=chunk) Issuer Purchases of Equity Securities (Q4 2022) | Period | Total Shares Purchased | Average Price Paid per Share | Dollar Value Remaining in Program | | :--- | :--- | :--- | :--- | | Oct 2022 | - | $- | $35,325,830 | | Nov 2022 | 88,705 | $9.22 | $34,507,731 | | Dec 2022 | 260,252 | $7.83 | $32,469,204 | | **Total Q4** | **348,957** | **$8.19** | **$32,469,204** | - A share repurchase program for up to **$50 million** of common stock is authorized through December 31, 2023[196](index=196&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=51&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Total revenues decreased to $110.8 million in 2022, driven by lower U.S. government sales, impacting net income despite strong international growth [Results of Operations](index=60&type=section&id=Results%20of%20Operations) Total revenues decreased to $110.8 million in 2022, primarily due to lower U.S. product sales, resulting in a net income of $33.9 million Results of Operations (in millions) | Metric | 2022 | 2021 | Change | | :--- | :--- | :--- | :--- | | Product Sales Revenue | $86.7 | $126.8 | ($40.1) | | R&D Revenue | $24.1 | $6.9 | $17.2 | | **Total Revenues** | **$110.8** | **$133.7** | **($22.9)** | | Cost of Sales | $10.4 | $16.6 | ($6.2) | | SG&A Expenses | $35.1 | $18.0 | $17.1 | | R&D Expenses | $22.5 | $9.9 | $12.6 | | **Operating Income** | **$42.7** | **$89.1** | **($46.4)** | | **Net Income** | **$33.9** | **$69.5** | **($35.6)** | - The decrease in product sales revenue was primarily due to lower deliveries to the U.S. Government under the 19C BARDA Contract, partially offset by a significant increase in international sales of oral TPOXX® to **$71.0 million**[247](index=247&type=chunk) - Selling, general and administrative (SG&A) expenses increased by **$17.1 million**, mostly reflecting higher promotion fees paid to Meridian in connection with the substantial increase in international sales[250](index=250&type=chunk) - Research and development (R&D) expenses increased by **$12.6 million**, mainly due to increased clinical trial activity for the PEP Label Expansion program[251](index=251&type=chunk) [Liquidity and Capital Resources](index=61&type=section&id=Liquidity%20and%20Capital%20Resources) SIGA maintained a strong cash position of $98.8 million at year-end 2022, with $41.6 million from operations and significant financing outflows Cash and Cash Equivalents | Date | Amount (in millions) | | :--- | :--- | | Dec 31, 2022 | $98.8 | | Dec 31, 2021 | $103.1 | Cash Flow Summary (Year Ended Dec 31, 2022, in millions) | Activity | Amount | | :--- | :--- | | Net Cash from Operations | $41.6 | | Net Cash from Investing | $0.0 | | Net Cash from Financing | ($46.0) | - Major financing activities in 2022 included the payment of a **$32.9 million** special dividend and the repurchase of **$13.0 million** of common stock[263](index=263&type=chunk) - As of December 31, 2022, the company has approximately **$33.8 million** in outstanding purchase commitments for manufacturing obligations[264](index=264&type=chunk) [Financial Statements and Supplementary Data](index=64&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the audited consolidated financial statements, including balance sheets, statements of operations, cash flows, and related notes Consolidated Balance Sheet Data (in millions) | Account | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $98.8 | $103.1 | | Total current assets | $185.8 | $208.8 | | **Total assets** | **$195.0** | **$214.7** | | Total current liabilities | $21.5 | $30.5 | | **Total liabilities** | **$24.9** | **$40.4** | | **Total stockholders' equity** | **$170.2** | **$174.3** | Consolidated Statement of Operations Data (in millions) | Account | 2022 | 2021 | | :--- | :--- | :--- | | Total revenues | $110.8 | $133.7 | | Total operating expenses | $68.1 | $44.6 | | Operating income | $42.7 | $89.1 | | **Net and comprehensive income** | **$33.9** | **$69.5** | | **Diluted earnings per share** | **$0.46** | **$0.91** | - The independent auditor, PricewaterhouseCoopers LLP, issued an unqualified opinion on the consolidated financial statements and the effectiveness of internal control over financial reporting[272](index=272&type=chunk) - A critical audit matter identified was the revenue recognition for R&D services, specifically management's significant judgments in estimating the total costs to complete performance obligations under the 19C BARDA and PEP Label Expansion R&D contracts[280](index=280&type=chunk)[281](index=281&type=chunk) [Controls and Procedures](index=92&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management and independent auditors concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2022 - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2022[404](index=404&type=chunk) - Based on an evaluation using the COSO framework, management concluded that the company's internal control over financial reporting was effective as of December 31, 2022[408](index=408&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended December 31, 2022, that materially affected, or are reasonably likely to materially affect, internal controls[405](index=405&type=chunk) PART III [Directors, Executive Compensation, Security Ownership, and Principal Accountant Fees](index=94&type=section&id=Item%2010%2C%2011%2C%2012%2C%2013%2C%2014) Information on directors, executive compensation, security ownership, and related party transactions is incorporated by reference from the 2023 Proxy Statement - Information regarding directors, executive officers, corporate governance, executive compensation, security ownership, and related transactions is incorporated by reference from the Company's 2023 Proxy Statement[414](index=414&type=chunk)[417](index=417&type=chunk)[418](index=418&type=chunk) Equity Compensation Plan Information (as of Dec 31, 2022) | Plan Category | Securities to be Issued Upon Exercise | Weighted-average Exercise Price | Securities Available for Future Issuance | | :--- | :--- | :--- | :--- | | Approved by security holders | 505,328 | $7.68 | 4,106,840 | | Not approved by security holders | — | — | — | | **Total** | **505,328** | **$7.68** | **4,106,840** | PART IV [Exhibits and Financial Statement Schedules](index=96&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section provides an index of all exhibits filed with the Form 10-K, including financial statements, material contracts, and certifications - This section provides an index of all exhibits filed with the Form 10-K, including material contracts, corporate documents, and required certifications[425](index=425&type=chunk)

SIGA Technologies, Inc. (NASDAQ:SIGA) Q3 2022 Results Conference Call November 3, 2022 4:30 PM ET Company Participants Phil Gomez - CEO Dan Luckshire - CFO Conference Call Participants Ken Mestemacher - Edison Brian Adams - Carter, Terry & Company Operator Welcome to the SIGA business update call. Before we turn the call over to SIGA management, please note that any forward-looking statements made during this call are based on management’s current expectations and observations, and are subject to risks and ...

Table of Contents SIGA Technologies, Inc. (Exact name of registrant as specified in its charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Quarterly Period Ended September 30, 2022 Or ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from ________ to ___________ Commission File No. 0-23047 Delaw ...

SIGA Technologies, Inc. (NASDAQ:SIGA) Q2 2022 Earnings Conference Call August 4, 2022 4:30 PM ET Company Participants Phillip Gomez - CEO & Director Dennis Hruby - EVP & Chief Scientific Officer Daniel Luckshire - EVP, CFO & Secretary Conference Call Participants Soo Romanoff - Edison Group Peter Imber - North Point Partners Operator Welcome to the SIGA business update call. Before we turn the call over to SIGA management, please note that any forward-looking statements made during this call are based on ma ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Quarterly Period Ended June 30, 2022 Or ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from ________ to ___________ Commission File No. 0-23047 SIGA Technologies, Inc. (Exact name of registrant as specified in its charter) Delaware 1 ...

SIGA Technologies, Inc. (NASDAQ:SIGA) Q1 2022 Earnings Conference Call May 5, 2022 4:30 PM ET Company Participants Phillip Gomez - Chief Executive Officer Dan Luckshire - Chief Financial Officer Dennis Hruby - Executive Vice President & Chief Scientific Officer Conference Call Participants Ken Mestemacher - Edison Group Operator Welcome to the SIGA Business Update Call. Before we turn the call over to SIGA management, please note that any forward-looking statements made during this call are based on managem ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Quarterly Period Ended March 31, 2022 Or ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from ________ to ___________ Commission File No. 0-23047 SIGA Technologies, Inc. (Exact name of registrant as specified in its charter) Delaware ...

SIGA Technologies, Inc. (NASDAQ:SIGA) Q4 2021 Earnings Conference Call March 3, 2022 4:30 PM ET Company Participants Phillip Gomez - Chief Executive Officer Dan Luckshire - Chief Financial Officer Conference Call Participants Operator Welcome to the SIGA Business Update Call. Before we turn the call over to SIGA management, please note that any forward-looking statements made during this call are based on management's current expectations and observations and are subject to risks and uncertainties that coul ...

PART I [Business](index=5&type=section&id=Item%201.%20Business) SIGA Technologies is a commercial-stage pharmaceutical company whose lead product, TPOXX®, is an FDA-approved oral antiviral for smallpox, with revenue primarily from U.S. government contracts and expanding international sales [Lead Product-TPOXX®](index=5&type=section&id=Lead%20Product-TPOXX%C2%AE) TPOXX®, an FDA-approved oral antiviral for smallpox, has secured international approvals and an IV formulation is currently under FDA review - Oral TPOXX® was **FDA-approved on July 13, 2018**, for smallpox treatment, with U.S. sales restricted to the Strategic National Stockpile[17](index=17&type=chunk) - International approvals for TPOXX® include **Health Canada (December 2021)** and the **European Medicines Agency (January 2022)**, covering smallpox, monkeypox, cowpox, and vaccinia complications[18](index=18&type=chunk)[19](index=19&type=chunk) - An NDA for an **intravenous (IV) TPOXX® formulation** was filed with the FDA in April 2021, with a decision anticipated in the first half of 2022[21](index=21&type=chunk) [Procurement Contracts with the U.S. Government](index=7&type=section&id=Procurement%20Contracts%20with%20the%20U.S.%20Government) U.S. Government contracts, particularly the 19C BARDA Contract with **$311.1 million** in unexercised options, are SIGA's primary revenue source 19C BARDA Contract Status (as of Dec 31, 2021) | Category | Value (approx.) | | :--- | :--- | | **Total Potential Value** | **$602.5 million** | | Base Period | $51.7 million | | Exercised Options | $239.7 million | | Unexercised Options | $311.1 million | - In 2021, **$112.5 million** of oral TPOXX® was delivered to the Strategic Stockpile under the 19C BARDA contract[25](index=25&type=chunk) - The 1C BARDA Contract (2011) is largely fulfilled, with **$505.7 million** of its **$508.4 million** total value received as of December 31, 2021[31](index=31&type=chunk) [International Procurement Contracts](index=9&type=section&id=International%20Procurement%20Contracts) SIGA is expanding internationally via Meridian Medical Technologies, securing contracts with Canadian agencies for up to **$47 million** in oral TPOXX® sales with a **65-80%** contribution margin - A contract with the Public Health Agency of Canada (PHAC) is for up to **$33 million** of oral TPOXX® over five years, with **$10 million** delivered by year-end 2021[34](index=34&type=chunk) - A contract with the Canadian Department of National Defence (CDND) is for up to **$14 million** over four years, with **$4 million** in cumulative purchases by year-end 2021[35](index=35&type=chunk) - International sales are managed through an exclusive promotion agreement with Meridian Medical Technologies, with an estimated contribution margin between **65% and 80%**[36](index=36&type=chunk)[37](index=37&type=chunk) [Manufacturing](index=10&type=section&id=Manufacturing) SIGA employs a fabless manufacturing model, relying on third-party Contract Manufacturing Organizations (CMOs) for all TPOXX® production, including both oral and IV formulations - SIGA utilizes third-party Contract Manufacturing Organizations (CMOs) for all TPOXX® production, lacking its own manufacturing infrastructure[42](index=42&type=chunk) - Key CMOs for oral TPOXX® include **W.R. Grace (API)**, **Powdersize**, **Catalent**, and **PCI**[43](index=43&type=chunk) - Key CMOs for the IV formulation of TPOXX® include **Roquette**, **Patheon**, and **PCI**[48](index=48&type=chunk) [Intellectual Property and Proprietary Rights](index=13&type=section&id=Intellectual%20Property%20and%20Proprietary%20Rights) SIGA's TPOXX® patent portfolio, comprising **28 U.S.** and **97 foreign patents**, is crucial for commercial success, with key U.S. patents expiring between **2024 and 2034** - As of January 10, 2022, the TPOXX® patent portfolio includes **28 U.S. utility patents**, **97 issued foreign patents**, and **26 pending applications** globally[68](index=68&type=chunk)[80](index=80&type=chunk) Key U.S. Patents for TPOXX® | Patent Number | Protection Conferred | Expiration Date | | :--- | :--- | :--- | | US 8124643 | Composition of matter for the ST-246 compound | June 18, 2024 | | US 7687641 | Method of manufacturing ST-246 | September 27, 2024 | | US 7737168 | Method of treating orthopoxvirus infection | May 3, 2027 | | US 9233097 | Liquid Pharmaceutical formulations | August 2, 2031 | | US 9670158 | Amorphous Tecovirimat preparation | July 11, 2034 | - Patent Term Extension Applications are pending for two key patents, potentially extending their expiration dates to **2031 and 2027** respectively[77](index=77&type=chunk) [Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including heavy dependence on U.S. government contracts, regulatory approval challenges, reliance on third-party manufacturers, and intellectual property protection - A substantial percentage of potential revenue from the **19C BARDA Contract** is tied to unexercised options, which BARDA may or may not exercise at its sole discretion[101](index=101&type=chunk)[104](index=104&type=chunk) - Reliance on third-party manufacturers (CMOs) for TPOXX® production poses a significant risk, as their failure to perform could impair contractual obligations[140](index=140&type=chunk) - Failure to obtain regulatory approvals for additional TPOXX® formulations or indications could limit commercialization and future revenue[117](index=117&type=chunk) - International revenue heavily depends on the success of the promotion agreement with Meridian Medical Technologies, which may not be successful[128](index=128&type=chunk) - The COVID-19 pandemic poses risks of supply chain disruption, R&D delays, and diversion of government attention and funding[169](index=169&type=chunk)[170](index=170&type=chunk) [Unresolved Staff Comments](index=43&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments - None[184](index=184&type=chunk) [Properties](index=43&type=section&id=Item%202.%20Properties) The company leases corporate headquarters in New York, NY, and research and development facilities in Corvallis, Oregon - Corporate headquarters are leased in **New York, NY (3,200 sq. ft.)**[185](index=185&type=chunk) - Research and development facilities are leased in **Corvallis, Oregon (10,276 sq. ft.)**, with the lease expiring in **December 2024**[186](index=186&type=chunk) [Legal Proceedings](index=43&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to have a material adverse effect on its business or financial condition - The company is not currently involved in any legal proceedings expected to have a material adverse effect on its business, financial position, or cash flow[188](index=188&type=chunk) [Mine Safety Disclosures](index=44&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[189](index=189&type=chunk) PART II [Market For Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=45&type=section&id=Item%205.%20Market%20For%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) SIGA's common stock trades on Nasdaq, with an active **$50 million** share repurchase program authorized through **December 2023**, under which **762,993 shares** were repurchased in Q4 2021 - The company's common stock trades on **The Nasdaq Global Market** under the symbol 'SIGA'[191](index=191&type=chunk) - A share repurchase program for up to **$50 million** was authorized in August 2021, extending through **December 31, 2023**[193](index=193&type=chunk) Issuer Purchases of Equity Securities (Q4 2021) | Period | Total Number of Shares Purchased | Average Price Paid per Share | Dollar Value Remaining Under Program | | :--- | :--- | :--- | :--- | | Oct 2021 | 286,059 | $7.26 | $49,156,221 | | Nov 2021 | 199,697 | $7.73 | $47,612,331 | | Dec 2021 | 277,237 | $7.71 | $45,475,535 | | **Total Q4** | **762,993** | **$7.55** | **$45,475,535** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=48&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) In 2021, total revenue increased to **$133.7 million** and net income grew to **$69.5 million**, driven by TPOXX® deliveries, maintaining a strong financial position with **$103.1 million** in cash and no debt [Results of Operations](index=55&type=section&id=Results%20of%20Operations) In 2021, total revenues increased to **$133.7 million** and net income rose to **$69.5 million**, or **$0.91** per diluted share, driven by international product sales Financial Performance Comparison (Years ended Dec 31) | Metric | 2021 | 2020 | | :--- | :--- | :--- | | **Total Revenues** | **$133.7 million** | **$125.0 million** | | Product Sales Revenue | $126.8 million | $115.5 million | | R&D Revenue | $6.9 million | $9.5 million | | **Total Operating Expenses** | **$44.6 million** | **$40.5 million** | | Cost of Sales | $16.6 million | $14.8 million | | SG&A | $17.3 million | $14.0 million | | R&D Expenses | $9.9 million | $10.9 million | | **Net Income** | **$69.5 million** | **$56.3 million** | | **Diluted EPS** | **$0.91** | **$0.71** | - 2021 product sales revenue comprised **$112.5 million** from the U.S. Government and **$12.7 million** from international sales[239](index=239&type=chunk) - The increase in Selling, General and Administrative (SG&A) expenses to **$17.3 million** was primarily driven by promotion fees for international sales[242](index=242&type=chunk) [Liquidity and Capital Resources](index=56&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2021, cash and cash equivalents were **$103.1 million**, a decrease primarily due to **$26.2 million** in share repurchases, with **$11.5 million** net cash from operations and no outstanding debt Cash and Liquidity (as of Dec 31) | Metric | 2021 | 2020 | | :--- | :--- | :--- | | Cash and Cash Equivalents | $103.1 million | $117.9 million | | Accounts Receivable | $83.7 million | $3.3 million | | Restricted Cash | $0 | $0 | - Net cash provided by operations was **$11.5 million** in 2021, compared to **$71.5 million** in 2020[253](index=253&type=chunk) - Cash used in financing activities totaled **$26.2 million** in 2021, primarily for the repurchase of **3.8 million** shares of common stock[257](index=257&type=chunk) - The company had outstanding purchase commitments of approximately **$20.1 million** related to manufacturing obligations as of December 31, 2021[258](index=258&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=58&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks stem from interest rate changes affecting cash and stock price fluctuations impacting its liability-classified warrant, with a **$1** stock price increase raising warrant value by **$1.0 million** - The company's interest income is sensitive to changes in U.S. interest rates[260](index=260&type=chunk) - The company faces market risk from common stock price fluctuations due to a liability-classified warrant, where a **$1** stock price increase raises the warrant's intrinsic value by approximately **$1.0 million**[260](index=260&type=chunk) [Financial Statements and Supplementary Data](index=59&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the company's audited consolidated financial statements for 2021, including balance sheets, statements of operations, changes in equity, cash flows, and accompanying notes [Consolidated Balance Sheets](index=63&type=section&id=Consolidated%20Balance%20Sheets) As of December 31, 2021, total assets increased to **$214.7 million**, total liabilities to **$40.4 million**, and total stockholders' equity to **$174.3 million** Consolidated Balance Sheet Highlights (as of Dec 31) | Account | 2021 | 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $103.1 million | $117.9 million | | Accounts receivable | $83.7 million | $3.3 million | | Inventory | $19.5 million | $20.3 million | | **Total Assets** | **$214.7 million** | **$149.8 million** | | Total current liabilities | $30.5 million | $10.5 million | | Warrant liability | $6.5 million | $6.6 million | | **Total Liabilities** | **$40.4 million** | **$20.0 million** | | **Total Stockholders' Equity** | **$174.3 million** | **$129.8 million** | [Consolidated Statements of Operations](index=64&type=section&id=Consolidated%20Statements%20of%20Operations) For 2021, total revenues were **$133.7 million** and net income was **$69.5 million**, resulting in diluted EPS of **$0.91** Consolidated Statement of Operations Highlights (Year ended Dec 31) | Metric | 2021 | 2020 | | :--- | :--- | :--- | | Total Revenues | $133,670,454 | $124,959,304 | | Operating Income | $89,092,799 | $84,500,630 | | Income Before Taxes | $89,311,741 | $73,508,591 | | Net Income | $69,450,766 | $56,342,010 | | Diluted EPS | $0.91 | $0.71 | [Notes to Consolidated Financial Statements](index=67&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes detail accounting policies and financial activities, including revenue recognition, inventory, debt, warrant liability, stock compensation, and income taxes - **Revenue Recognition (Note 3):** Product delivery revenue is recognized at a point in time, while R&D services revenue is recognized over time; in 2021, **$112.5 million** from 19C BARDA and **$12.7 million** from international contracts were recognized[339](index=339&type=chunk)[350](index=350&type=chunk) - **Debt (Note 7):** The company fully prepaid its Term Loan in March 2020 for approximately **$87.2 million**, resulting in no outstanding debt as of December 31, 2021[357](index=357&type=chunk) - **Financial Instruments (Note 9):** A 2016 warrant is classified as a liability and re-measured to fair value, representing approximately **1.0 million shares** at a **$1.50** exercise price with a **$6.5 million** fair value as of December 31, 2021[366](index=366&type=chunk)[369](index=369&type=chunk) - **Stockholders' Equity (Note 10):** The company completed a **$50 million** share repurchase program from March 2020 and authorized a new **$50 million** program in August 2021, repurchasing **$4.5 million** of stock in 2021[372](index=372&type=chunk)[373](index=373&type=chunk) [Controls and Procedures](index=87&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2021, with no material changes in Q4 2021 - Management concluded that disclosure controls and procedures were effective as of **December 31, 2021**[401](index=401&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of **December 31, 2021**[405](index=405&type=chunk) - There were no material changes to internal controls over financial reporting in the quarter ended **December 31, 2021**[402](index=402&type=chunk) PART III [Directors, Executive Officers, and Corporate Governance](index=89&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%2C%20and%20Corporate%20Governance) Information on directors, executive officers, and corporate governance is incorporated by reference from the company's 2022 Proxy Statement - Information regarding directors, executive officers, and corporate governance is incorporated by reference from the Company's **2022 Annual Meeting of Stockholders Proxy Statement**[411](index=411&type=chunk)[412](index=412&type=chunk)[413](index=413&type=chunk) [Executive Compensation](index=89&type=section&id=Item%2011.%20Executive%20Compensation) Information on executive compensation is incorporated by reference from the company's 2022 Proxy Statement - Information regarding executive compensation is incorporated by reference from the Company's **2022 Proxy Statement**[414](index=414&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=89&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Security ownership information is incorporated by reference from the 2022 Proxy Statement, with **4,318,050** securities available for future issuance under equity compensation plans as of December 31, 2021 - Information regarding security ownership is incorporated by reference from the Company's **2022 Proxy Statement**[415](index=415&type=chunk) Equity Compensation Plan Information (as of Dec 31, 2021) | Plan Category | Securities to be Issued Upon Exercise | Weighted-average Exercise Price | Securities Available for Future Issuance | | :--- | :--- | :--- | :--- | | Approved by security holders | 479,333 | $6.62 | 4,318,050 | | Not approved by security holders | — | — | — | | **Total** | **479,333** | **$6.62** | **4,318,050** | [Certain Relationships and Related Transactions, and Director Independence](index=89&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information on related party transactions and director independence is incorporated by reference from the company's 2022 Proxy Statement - Information regarding related party transactions and director independence is incorporated by reference from the Company's **2022 Proxy Statement**[418](index=418&type=chunk) [Principal Accounting Fees and Services](index=89&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information detailing fees billed by the principal accountant is incorporated by reference from the company's 2022 Proxy Statement - Information regarding principal accounting fees and services is incorporated by reference from the Company's **2022 Proxy Statement**[419](index=419&type=chunk) PART IV [Exhibits, Financial Statement Schedules](index=91&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists financial statements from Item 8 and provides a comprehensive list of all exhibits filed with the Form 10-K, including material contracts and certifications - This section provides a list of all exhibits filed with the Form 10-K, including material contracts and required certifications[422](index=422&type=chunk) [Form 10-K Summary](index=99&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company has not provided a summary for its Form 10-K - None[431](index=431&type=chunk)