Financial Data and Key Metrics Changes - For the second quarter of 2023, the company reported a net loss of approximately $3 million, with a fully diluted loss per share of $0.04. For the six months ended June 30, the net loss was approximately $4 million, with a fully diluted loss per share of $0.05 [8][22][37] - The company expects to generate full-year 2023 pre-tax operating income between $90 million and $100 million, reflecting strong growth over the prior year [3][23] Business Line Data and Key Metrics Changes - Revenue for the three months ended June 30, 2023, was approximately $6 million, with $1 million from international sales of oral TPOXX and $5 million from research and development activities. For the six months ended June 30, total revenue was approximately $14 million [22][52] - The company anticipates approximately $113 million in revenue from deliveries of oral TPOXX to the US Strategic National Stockpile in the second half of 2023, along with an additional $30 million to $45 million from various domestic and international deliveries [17][52] Market Data and Key Metrics Changes - The company is seeing increased interest in international sales, with follow-on orders from countries and discussions about smallpox stockpiling [13][39] - The ongoing international sales growth initiative is progressing positively, indicating a meaningful international market is developing [24] Company Strategy and Development Direction - The company is focused on transitioning its US government contract to a long-term SNS contract, which will enhance supply chain planning and financial predictability [9] - The PEP-based development program is viewed as a growth initiative that may support stockpile expansion, emphasizing the need for proactive government measures in response to viral outbreaks [39][54] Management's Comments on Operating Environment and Future Outlook - Management highlighted the importance of TPOXX in treating orthopoxviruses, noting that the current stockpile may not be sufficient for future needs [53] - The company is investigating lower-than-expected immune response rates in clinical trials, which may affect the timing of regulatory submissions [19][49] Other Important Information - The company declared and paid a special cash dividend of $0.45 per share, totaling approximately $32 million [52] - The CEO search is ongoing, with a focus on ensuring a smooth transition for the next CEO [54] Q&A Session Summary Question: Incremental orders or stockpiling after 2024 under the 19C BARDA contract - Management indicated that discussions with the government are progressing, and they anticipate recognizing sales in the second half of the year [40][41] Question: Plans for stock buybacks - The company has $21 million remaining in its stock buyback authorization and will discuss next steps with the Board once this is used or expires [33] Question: International orders for smallpox and monkeypox stockpiling - Management confirmed that there is increased interest from international jurisdictions regarding stockpiling for smallpox and monkeypox [57]

PART I - FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) The unaudited statements show financial position, operations, and cash flows as of June 30, 2023 [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets and stockholders' equity decreased to $146.5 million and $124.1 million respectively Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | June 30, 2023 ($) | December 31, 2022 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | 76,213,484 | 98,790,622 | | Accounts receivable | 6,026,887 | 45,406,960 | | Inventory | 50,497,103 | 39,273,090 | | Total current assets | 134,298,100 | 185,786,344 | | **Total assets** | **146,510,759** | **195,035,923** | | **Liabilities & Equity** | | | | Total current liabilities | 18,988,145 | 21,517,721 | | **Total liabilities** | **22,436,703** | **24,875,881** | | **Total stockholders' equity** | **124,074,056** | **170,160,042** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company shifted to a net loss of $3.8 million in H1 2023 from a net income in H1 2022 due to lower revenues Condensed Consolidated Statements of Operations Highlights (Unaudited) | Metric | Three Months Ended June 30, 2023 ($) | Three Months Ended June 30, 2022 ($) | Six Months Ended June 30, 2023 ($) | Six Months Ended June 30, 2022 ($) | | :--- | :--- | :--- | :--- | :--- | | Total revenues | 5,878,166 | 16,667,045 | 14,201,190 | 27,206,345 | | Operating (loss)/income | (4,638,367) | 3,070,711 | (6,746,675) | 1,631,830 | | Net and comprehensive (loss)/income | (2,875,476) | 2,037,062 | (3,793,733) | 1,676,012 | | Diluted (loss)/income per share | (0.04) | 0.03 | (0.05) | 0.02 | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash decreased by $22.6 million in H1 2023, driven by significant financing outflows Six Months Ended June 30 - Cash Flow Summary (Unaudited) | Cash Flow Activity | 2023 ($) | 2022 ($) | | :--- | :--- | :--- | | Net cash provided by operating activities | 20,866,971 | 54,498,658 | | Cash used in investing activities | (21,686) | — | | Cash used in financing activities | (43,422,423) | (43,106,551) | | Net (decrease)/increase in cash | (22,577,138) | 11,392,107 | | Cash and cash equivalents at end of period | 76,213,484 | 114,530,926 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail revenue recognition policies, major government contracts, and significant equity transactions - As of June 30, 2023, the aggregate amount of transaction price allocated to remaining performance obligations was **$59.0 million**, with an additional **$138.2 million** added in July from new U.S. government orders[16](index=16&type=chunk) - The 19C BARDA Contract has a total potential value of approximately **$602.5 million**, with about **$407.1 million** in exercised options and **$143.7 million** in unexercised options as of July 31, 2023[22](index=22&type=chunk) - As of June 30, 2023, the company had approximately **$24.6 million** of purchase commitments associated with manufacturing obligations[54](index=54&type=chunk) Revenues by Geographic Region (Six Months Ended June 30) | Region | 2023 ($) | 2022 ($) | | :--- | :--- | :--- | | United States | 12,970,007 | 22,254,602 | | International | 1,231,183 | 4,951,743 | | **Total revenues** | **14,201,190** | **27,206,345** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses lower H1 2023 revenue due to order timing, TPOXX® developments, and capital allocation - SIGA is a commercial-stage pharmaceutical company whose lead product, **TPOXX®**, is approved for smallpox in the U.S. and for smallpox, mpox, and cowpox in Europe and the UK[78](index=78&type=chunk)[79](index=79&type=chunk)[80](index=80&type=chunk) - The company is pursuing a potential FDA label expansion for TPOXX® to include **post-exposure prophylaxis (PEP)** for smallpox and is also assessing its use for the treatment of mpox through various clinical trials[82](index=82&type=chunk)[83](index=83&type=chunk)[84](index=84&type=chunk) - The company estimates that approximately **920,000 courses of TPOXX®** would need to be delivered to the U.S. Strategic Stockpile in 2023 and 2024 to maintain historical levels of unexpired treatment[91](index=91&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) H1 2023 revenues fell to $14.2 million, resulting in a pre-tax loss of $4.7 million Comparison of Results (Three Months Ended June 30) | Metric | 2023 ($M) | 2022 ($M) | Change ($M) | | :--- | :--- | :--- | :--- | | Product Sales Revenue | 1.3 | 8.6 | (7.3) | | R&D Revenue | 4.6 | 8.1 | (3.5) | | SG&A Expenses | 4.4 | 5.9 | (1.5) | | R&D Expenses | 5.1 | 6.8 | (1.7) | | Pre-tax (Loss)/Income | (3.4) | 3.2 | (6.6) | Comparison of Results (Six Months Ended June 30) | Metric | 2023 ($M) | 2022 ($M) | Change ($M) | | :--- | :--- | :--- | :--- | | Product Sales Revenue | 7.0 | 15.9 | (8.9) | | R&D Revenue | 7.2 | 11.3 | (4.1) | | Cost of Sales | 2.1 | 5.6 | (3.5) | | Pre-tax (Loss)/Income | (4.7) | 2.1 | (6.8) | [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) Cash decreased to $76.2 million due to a $32.1 million dividend and $11.0 million in share repurchases - Cash and cash equivalents decreased to **$76.2 million** as of June 30, 2023, from **$98.8 million** at December 31, 2022[120](index=120&type=chunk) - For the six months ended June 30, 2023, cash used in financing activities was **$43.4 million**, primarily due to a **$32.1 million special cash dividend** and **$11.0 million in common stock repurchases**[124](index=124&type=chunk) - As of June 30, 2023, the company had outstanding purchase orders for manufacturing obligations totaling approximately **$24.6 million**[125](index=125&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risk is interest rate changes affecting its cash and equivalents - The company's main market risk exposure is from **changes in U.S. interest rates** affecting its cash and cash equivalents[129](index=129&type=chunk) - SIGA **does not use derivative financial instruments** to manage interest rate exposure[129](index=129&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2023 - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were **effective** as of June 30, 2023[131](index=131&type=chunk) - **No material changes** were made to the internal control over financial reporting during the quarter ended June 30, 2023[132](index=132&type=chunk) PART II - OTHER INFORMATION [Item 1. Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) Current legal proceedings are not expected to have a material adverse effect on the business - The company is not involved in any legal proceedings that are expected to have a **material adverse effect** on its business[133](index=133&type=chunk) [Item 1A. Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors were reported since the 2022 Annual Report on Form 10-K - **No material changes** to risk factors were reported since the 2022 Annual Report on Form 10-K[134](index=134&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company repurchased 596,900 shares in Q2 2023, with $21.5 million remaining in its buyback program Issuer Purchases of Equity Securities (Q2 2023) | Period | Total Shares Purchased | Average Price Paid per Share ($) | Dollar Value Remaining for Purchase ($) | | :--- | :--- | :--- | :--- | | April 2023 | 431,700 | 5.87 | 22,450,884 | | May 2023 | 165,200 | 5.77 | 21,498,370 | | June 2023 | - | - | 21,498,370 | | **Total** | **596,900** | **5.84** | **21,498,370** | - The company has a share repurchase program authorized for up to **$50 million**, running through December 31, 2023[137](index=137&type=chunk) [Item 3. Defaults upon Senior Securities](index=30&type=section&id=Item%203.%20Defaults%20upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[138](index=138&type=chunk) [Item 4. Mine Safety Disclosures](index=30&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - No disclosure is required pursuant to this item[139](index=139&type=chunk) [Item 5. Other Information](index=30&type=section&id=Item%205.%20Other%20Information) The company reports no other material information for this period - No disclosure is required pursuant to this item[140](index=140&type=chunk) [Item 6. Exhibits](index=31&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including key contract modifications - Exhibits filed include a modification to the **BARDA contract (10.2)**, an amended transition agreement with the former CEO (10.3), and **CEO/CFO certifications** (31.1, 31.2, 32.1, 32.2)[141](index=141&type=chunk)

SIGA Technologies, Inc. (NASDAQ:SIGA) Q1 2023 Earnings Conference Call May 4, 2023 4:30 PM ET Company Participants Phil Gomez - CEO Dennis Hruby - Chief Scientific Officer Dan Luckshire - CFO Conference Call Participants Adam McCarter - Edison Group Ralph Weil - R. Weil Investments 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 observat ...

[PART I - FINANCIAL INFORMATION](index=4&type=section&id=PART%20I-FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) This section presents SIGA Technologies, Inc.'s unaudited interim financial statements as of March 31, 2023, including balance sheets, statements of operations, and cash flows, with notes on accounting policies and contract details [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $115,680,683 | $98,790,622 | | Accounts receivable | $12,316,704 | $45,406,960 | | Inventory | $42,577,787 | $39,273,090 | | **Total Assets** | **$183,924,259** | **$195,035,923** | | **Liabilities & Equity** | | | | Total current liabilities | $18,476,491 | $21,517,721 | | **Total Liabilities** | **$21,830,799** | **$24,875,881** | | **Total Stockholders' Equity** | **$162,093,460** | **$170,160,042** | - Total assets decreased from **$195.0 million** at year-end 2022 to **$183.9 million**, primarily due to a decrease in accounts receivable[12](index=12&type=chunk) - Cash and cash equivalents increased to **$115.7 million** from **$98.8 million**[12](index=12&type=chunk) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Condensed Consolidated Statements of Operations (Unaudited, Three Months Ended March 31) | Metric | 2023 | 2022 | | :--- | :--- | :--- | | Total Revenues | $8,323,025 | $10,539,299 | | Total Operating Expenses | $10,431,331 | $11,978,180 | | Operating Loss | ($2,108,306) | ($1,438,881) | | Net and Comprehensive Loss | ($918,255) | ($361,049) | | Basic Loss Per Share | ($0.01) | ($0.00) | | Diluted Loss Per Share | ($0.01) | ($0.01) | - Total revenues decreased to **$8.3 million** in Q1 2023 from **$10.5 million** in Q1 2022[14](index=14&type=chunk) - The company reported a net loss of **$0.9 million**, compared to a net loss of **$0.4 million** in the prior-year period[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Condensed Consolidated Statements of Cash Flows (Unaudited, Three Months Ended March 31) | Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash provided by operating activities | $24,447,118 | $56,706,411 | | Cash used in investing activities | $0 | $0 | | Cash used in financing activities | ($7,557,057) | ($6,585,316) | | **Net increase in cash and cash equivalents** | **$16,890,061** | **$50,121,095** | - Cash from operating activities was **$24.4 million**, a decrease from **$56.7 million** in the prior year, primarily due to lower collections on accounts receivable[16](index=16&type=chunk)[114](index=114&type=chunk) - Cash used in financing activities was **$7.6 million**, mainly for common stock repurchases[16](index=16&type=chunk)[116](index=116&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - As of March 31, 2023, the aggregate transaction price allocated to remaining performance obligations was **$64.9 million**, expected to be recognized as revenue within the next three years[19](index=19&type=chunk) - The company's 19C BARDA contract contemplates up to approximately **$602.5 million** in payments, with about **$281.9 million** in unexercised options remaining as of March 31, 2023[25](index=25&type=chunk) - In March 2023, the company fulfilled a **$5.1 million** firm commitment to the DoD for oral TPOXX®, and the DoD exercised a subsequent **$5.5 million** option[34](index=34&type=chunk) - As of March 31, 2023, the company had approximately **$29.3 million** of purchase commitments associated with manufacturing obligations[56](index=56&type=chunk) - On May 4, 2023, the Board of Directors declared a special dividend of **$0.45 per share**, payable on June 1, 2023[74](index=74&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's Q1 2023 financial performance, business overview, and key government contracts, highlighting decreased revenues, TPOXX® product developments, and liquidity management including a special dividend [Overview](index=21&type=section&id=Overview) - SIGA's lead product, **TPOXX®**, is an antiviral drug for smallpox, approved by the FDA in both oral and intravenous formulations, and also approved in Europe, the UK, and Canada for treating smallpox, mpox, cowpox, and vaccinia complications[76](index=76&type=chunk)[77](index=77&type=chunk)[78](index=78&type=chunk) - The company is pursuing a potential FDA label expansion for oral TPOXX® to include post-exposure prophylaxis (PEP) for smallpox, targeting a supplemental New Drug Application (sNDA) submission in early 2024[80](index=80&type=chunk) - Several randomized, placebo-controlled clinical trials (STOMP, PLATINUM, and PALM 007) are underway to assess the safety and efficacy of TPOXX® for treating mpox, which could support a future FDA label expansion[81](index=81&type=chunk)[82](index=82&type=chunk)[83](index=83&type=chunk) [Procurement Contracts](index=23&type=section&id=Procurement%20Contracts) - The 19C BARDA Contract has a total potential value of approximately **$602.5 million**, with **$281.9 million** in unexercised options remaining for oral and IV TPOXX®[87](index=87&type=chunk)[90](index=90&type=chunk) - The company estimates that approximately **920,000 courses** of TPOXX® need to be delivered to the U.S. Strategic Stockpile in 2023 and 2024 to maintain historical levels of unexpired treatment[92](index=92&type=chunk) - In March 2023, the company fulfilled a **$5.1 million** order from the DoD and the DoD exercised an additional **$5.5 million** option under DoD Contract 2[95](index=95&type=chunk) - As of March 31, 2023, the company had firm commitments with two European countries for approximately **$8 million** of oral TPOXX®[97](index=97&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) Q1 2023 vs Q1 2022 Performance | Metric | Q1 2023 | Q1 2022 | Change | | :--- | :--- | :--- | :--- | | Product Sales Revenue | $5.7M | $7.3M | ($1.6M) | | R&D Revenue | $2.6M | $3.2M | ($0.6M) | | Cost of Sales | $1.2M | $4.7M | ($3.5M) | | SG&A Expenses | $4.2M | $3.7M | $0.5M | | R&D Expenses | $5.0M | $3.5M | $1.5M | - Q1 2023 product sales of **$5.7 million** were primarily from oral TPOXX® sales to the DoD, whereas Q1 2022 sales of **$7.3 million** were mainly from IV TPOXX® sales to the U.S. Government under the BARDA contract[104](index=104&type=chunk) - R&D expenses increased by **$1.5 million** year-over-year, primarily due to a **$0.6 million** increase in EMA regulatory fees and higher vendor costs for the PEP Label Expansion and BARDA contracts[108](index=108&type=chunk) [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) - Cash and cash equivalents increased to **$115.7 million** as of March 31, 2023, from **$98.8 million** at December 31, 2022[112](index=112&type=chunk) - Net cash provided by operating activities was **$24.4 million** for Q1 2023, primarily from the receipt of approximately **$35 million** for 2022 product deliveries[114](index=114&type=chunk) - The company used **$7.6 million** in financing activities during Q1 2023 to repurchase approximately **1.1 million shares** of common stock[116](index=116&type=chunk) - Future cash requirements include approximately **$29.3 million** in manufacturing purchase commitments and a special dividend of **$0.45 per share** declared on May 4, 2023[117](index=117&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's investment portfolio consists of cash and cash equivalents, with a primary objective of capital preservation, and its main market risk is sensitivity to changes in U.S. interest rates - The company maintains a conservative investment policy focused on capital preservation for its cash and cash equivalents[121](index=121&type=chunk) - The company does not use derivative financial instruments and its primary market risk exposure is to changes in U.S. interest rates affecting interest income[121](index=121&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of March 31, 2023, with no material changes in internal control over financial reporting during the quarter - Based on an evaluation as of March 31, 2023, the CEO and CFO concluded that the company's disclosure controls and procedures were effective[123](index=123&type=chunk) - No changes occurred during the quarter ended March 31, 2023, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[124](index=124&type=chunk) [PART II - OTHER INFORMATION](index=30&type=section&id=PART%20II-OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company may be involved in various claims and proceedings in the ordinary course of business but does not believe any current pending matters will have a material adverse effect on its financial position or results - The company states that while it may be involved in ordinary course legal claims, it does not expect the resolution of any current matters to have a material adverse effect on its business[125](index=125&type=chunk) [Item 1A. Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors disclosed in the 2022 Annual Report on Form 10-K, with the exception of a newly added risk concerning the potential loss of or delayed access to uninsured funds held in deposit or investment accounts at financial institutions - A new risk factor was added regarding cash and cash equivalents held at four financial institutions, where balances regularly exceed FDIC insurance limits, indicating that a failure of one of these institutions could result in a loss of or delay in accessing uninsured funds[126](index=126&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details the company's stock repurchase activity under its **$50 million** share repurchase program authorized through December 31, 2023, with **1,139,922 shares** repurchased for approximately **$7.5 million** during Q1 2023 Issuer Purchases of Equity Securities (Q1 2023) | Period | Total Shares Purchased | Average Price Paid per Share | Dollar Value Remaining in Program | | :--- | :--- | :--- | :--- | | Jan 2023 | 291,071 | $7.50 | $30,284,999 | | Feb 2023 | 319,519 | $7.00 | $28,049,642 | | Mar 2023 | 529,332 | $5.79 | $24,986,971 | | **Total Q1** | **1,139,922** | **$6.56** | **$24,986,971** | - The company has a share repurchase program authorized for up to **$50 million**, valid through December 31, 2023[129](index=129&type=chunk) [Item 3. Defaults upon Senior Securities](index=30&type=section&id=Item%203.%20Defaults%20upon%20Senior%20Securities) None reported - The company reports no defaults upon senior securities[130](index=130&type=chunk) [Item 4. Mine Safety Disclosures](index=30&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable - No mine safety disclosures are required[131](index=131&type=chunk) [Item 5. Other Information](index=31&type=section&id=Item%205.%20Other%20Information) No other information is required to be disclosed - No disclosure is required under this item[132](index=132&type=chunk) [Item 6. Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, a transition agreement, and certifications by the CEO and CFO as required by the Sarbanes-Oxley Act - The report includes exhibits such as the Certificate of Incorporation, By-laws, CEO/CFO certifications (Sections 302 and 906), and XBRL data files[133](index=133&type=chunk) [Signatures](index=33&type=section&id=SIGNATURES)

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 ...