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SIGA Technologies(SIGA) - 2022 Q1 - Earnings Call Transcript
2022-05-08 13:23
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 ...
SIGA Technologies(SIGA) - 2022 Q1 - Quarterly Report
2022-05-05 20:55
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(SIGA) - 2021 Q4 - Earnings Call Transcript
2022-03-04 03:04
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 ...
SIGA Technologies(SIGA) - 2021 Q4 - Annual Report
2022-03-03 22:15
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)
SIGA Technologies(SIGA) - 2021 Q3 - Earnings Call Transcript
2021-11-07 16:47
Financial Data and Key Metrics Changes - For Q3 2021, SIGA's revenue was approximately $4.8 million, with $18.3 million for the nine months ended September 30, 2021, showing a significant increase in international product sales by approximately $10 million compared to the same period in 2020, representing more than a fourfold increase [31][32] - The operating loss for Q3 2021 was approximately $2.9 million, while the net loss was approximately $3.1 million, with a fully diluted loss per share of $0.04 for Q3 and $0.05 for the nine months ended September 30, 2021 [32][33] Business Line Data and Key Metrics Changes - The company delivered approximately $33 million of oral TPOXX to the U.S. government in October 2021, with a cumulative value of $113 million targeted for multiple deliveries in Q4 2021 [6][7] - SIGA delivered $2.3 million of oral TPOXX to the Canadian military during Q3 2021, ahead of schedule [17] Market Data and Key Metrics Changes - The company is actively pursuing international sales, generating approximately $13 million of revenue year-to-date from international sales initiatives, compared to $2 million in 2020 [39] - SIGA is optimistic about future sales potential as it gains EMA approval and engages in advanced discussions with customers in Europe, the Middle East, and Asia [20] Company Strategy and Development Direction - SIGA is focusing on expanding its government portfolio products and contracts through collaborations, such as with Cipla, and anticipates responding to an upcoming BARDA RFP for antibiotics [41][42] - The company is also working on broadening the U.S. customer base, potentially including the U.S. Department of Defense [42] Management's Comments on Operating Environment and Future Outlook - Management highlighted ongoing supply chain challenges but emphasized efforts to ensure timely delivery of TPOXX [7] - The company is preparing for a potential transition to a longer-term 10-year contract with the U.S. government, which could provide a more consistent product delivery timeline [9][48] Other Important Information - SIGA has approximately $93 million in cash as of September 30, 2021, and has repurchased approximately 7.7 million shares of its common stock since the inception of its share repurchase program [34] - The company is targeting regulatory approvals for IV TPOXX and EMA MAA applications in early 2022, with ongoing clinical trials for TPOXX in monkeypox patients [21][22][25] Q&A Session Summary Question: Potential contract transition to a 10-year contract - Management indicated that predicting the U.S. government's timeline is difficult, but historically, there is usually a multi-year transition after FDA approval [46][48] Question: Existing label for TPOXX and future sales - Management confirmed that the current label for TPOXX is for stockpiling only, but discussions for broader sales are ongoing as regulatory processes progress [52][54] Question: Virulence of monkeypox clades - It was confirmed that Central African monkeypox clades are more virulent, but TPOXX is expected to be effective against both Central and West African clades [56] Question: Solubility issues with ST-357 - Management acknowledged the identification of solubility issues and plans for a chemistry optimization campaign to address them [58] Question: Department of Defense's interest in TPOXX - Management expressed excitement about the DoD's notice of intent to purchase TPOXX and emphasized the importance of having a contract vehicle for future business opportunities [62][63]
SIGA Technologies(SIGA) - 2021 Q3 - Quarterly Report
2021-11-04 20:59
[PART I - FINANCIAL INFORMATION](index=4&type=section&id=PART%20I-FINANCIAL%20INFORMATION) [Condensed Consolidated Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) The unaudited condensed consolidated financial statements for the period ended September 30, 2021, show a significant decrease in revenue and a shift from net income to net loss compared to the same period in 2020, primarily due to the timing of large government contract deliveries Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | Sep 30, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $92,819,425 | $117,890,240 | | Total current assets | $128,937,547 | $143,608,091 | | Total assets | $135,563,352 | $149,831,391 | | **Liabilities & Equity** | | | | Total current liabilities | $18,942,093 | $10,483,510 | | Total liabilities | $29,007,490 | $20,038,122 | | Total stockholders' equity | $106,555,862 | $129,793,269 | Condensed Consolidated Statements of Operations Highlights (Unaudited) | Metric | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | | Total revenues | $18,313,206 | $87,229,949 | | Operating (loss)/income | ($4,932,193) | $57,697,298 | | Net and comprehensive (loss)/income | ($3,756,262) | $36,180,584 | | Diluted (loss)/income per share | ($0.05) | $0.45 | Condensed Consolidated Statements of Cash Flows Highlights (Unaudited) | Cash Flow Activity | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | | Net cash (used in)/provided by operating activities | ($4,607,926) | $25,572,850 | | Net cash used in investing activities | ($24,424) | ($15,501) | | Net cash used in financing activities | ($20,438,465) | ($107,880,757) | | **Net decrease in cash** | **($25,070,815)** | **($82,323,408)** | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's accounting policies, particularly revenue recognition for long-term contracts, and provide specifics on major procurement and research agreements - As of September 30, 2021, the aggregate amount of transaction price allocated to remaining performance obligations was **$177.2 million**, with **$112.6 million** expected to be recognized as product-related revenue within the next twelve months[19](index=19&type=chunk) - The 19C BARDA Contract, entered in 2018, contemplates up to approximately **$602.5 million** in payments for TPOXX®, including a base period of **$51.7 million**, **$239.7 million** in exercised options, and up to **$311.1 million** in unexercised options as of September 30, 2021[27](index=27&type=chunk) - On September 7, 2021, BARDA exercised an option under the 19C contract for the manufacture and delivery of approximately **$112.6 million** of oral TPOXX®[27](index=27&type=chunk) - International contracts include a deal with the Public Health Agency of Canada (PHAC) for up to **~$33 million** of oral TPOXX® over five years, and a contract with the Canadian Department of National Defence (CDND) for up to **~$14 million** over four years[33](index=33&type=chunk)[34](index=34&type=chunk) - The company's Board of Directors authorized a share repurchase program of up to **$50 million** in March 2020, under which **$48.8 million** of shares have been repurchased as of September 30, 2021, with a new **$50 million** authorization approved in August 2021 effective through December 2023[79](index=79&type=chunk)[80](index=80&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the significant year-over-year decline in revenue and profitability, attributing it to the timing of TPOXX® deliveries under the 19C BARDA contract, while highlighting ongoing government contracts, international expansion, and regulatory progress [Overview and COVID-19 Pandemic](index=22&type=section&id=Overview%20and%20COVID-19%20Pandemic) SIGA is a commercial-stage pharmaceutical company with its lead product, TPOXX®, an FDA-approved antiviral for smallpox, and while the COVID-19 pandemic has caused some operational delays, it is not currently expected to have a material adverse effect on the company's financial condition or 2021 results - The COVID-19 pandemic has slowed the daily pace of execution of government contracts and new contract generation due to the diversion of government staff time[89](index=89&type=chunk) - The company's supply chain for TPOXX® has remained operational without material disruption, and sufficient raw materials are secured for current projects[89](index=89&type=chunk) - The pandemic is not currently expected to have a material adverse effect on the 2021 financial results, though it could continue to affect the timing of international contract awards[90](index=90&type=chunk) [Lead Product-TPOXX® and Key Contracts](index=22&type=section&id=Lead%20Product-TPOXX%C2%AE%20and%20Key%20Contracts) The company's primary revenue driver is TPOXX®, supported by two major contracts with BARDA, with international sales growing and regulatory approval for TPOXX® in Europe and Canada expected by Q1 2022 - The company estimates that approximately **one million courses** of smallpox antiviral treatment need to be delivered to the U.S. Government between 2021 and 2023 to maintain stockpile levels[97](index=97&type=chunk) - International sales of oral TPOXX® are estimated to have a contribution margin of between **65% and 80%** of product sales[104](index=104&type=chunk) - The company is seeking regulatory approval for oral TPOXX® in Europe and Canada, with review processes for both expected to be completed by the **first quarter of 2022**[108](index=108&type=chunk) - An NDA for an IV formulation of TPOXX® was filed with the FDA in April 2021, with a decision targeted for the **first quarter of 2022**[107](index=107&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) The company experienced a significant decrease in revenue and a shift to a net loss for both the three and nine months ended September 30, 2021, compared to the same periods in 2020, driven by a sharp drop in product sales due to the timing of large U.S. government deliveries Comparison of Results for the Three Months Ended September 30 | Metric | 2021 | 2020 | Change | | :--- | :--- | :--- | :--- | | Product Sales Revenue | $2.3M | $41.8M | -94.5% | | Total Revenues | $4.8M | $44.3M | -89.2% | | Operating (Loss)/Income | ($2.9M) | $32.9M | - | | Pre-tax (Loss)/Income | ($4.0M) | $31.6M | - | Comparison of Results for the Nine Months Ended September 30 | Metric | 2021 | 2020 | Change | | :--- | :--- | :--- | :--- | | Product Sales Revenue | $12.8M | $80.5M | -84.1% | | Total Revenues | $18.3M | $87.2M | -79.0% | | Operating (Loss)/Income | ($4.9M) | $57.7M | - | | Pre-tax (Loss)/Income | ($4.6M) | $47.3M | - | - The decrease in product sales revenue in 2021 is primarily due to the timing of deliveries under the 19C BARDA Contract, with significant deliveries occurring in 2020 and 2021 revenue stemming from smaller international sales to Canada (PHAC and CDND)[110](index=110&type=chunk)[118](index=118&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2021, the company held **$92.8 million** in cash and cash equivalents, a decrease from **$117.9 million** at year-end 2020, primarily driven by common stock repurchases and operating activities - Cash and cash equivalents decreased to **$92.8 million** as of September 30, 2021, from **$117.9 million** at December 31, 2020[129](index=129&type=chunk) - For the nine months ended September 30, 2021, net cash used in operating activities was **$4.6 million**, while net cash used in financing activities was **$20.4 million**, almost entirely for stock repurchases[131](index=131&type=chunk)[133](index=133&type=chunk) - The company had outstanding purchase commitments of approximately **$4.9 million** related to manufacturing obligations as of September 30, 2021[134](index=134&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's market risk is primarily related to interest rate changes affecting its cash and cash equivalents and stock price fluctuations impacting the fair value of its liability-classified warrant - The company is subject to market risk from its liability-classified warrant, where **1.0 million shares** can be purchased at **$1.50 per share**, and for every **$1 increase** in SIGA's stock price, the intrinsic value of this warrant liability increases by about **$1.0 million**[139](index=139&type=chunk) [Controls and Procedures](index=30&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 September 30, 2021, with no material changes in internal control over financial reporting during the quarter - Based on an evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of September 30, 2021[142](index=142&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended September 30, 2021, that materially affected, or are reasonably likely to materially affect, internal controls[143](index=143&type=chunk) [PART II - OTHER INFORMATION](index=32&type=section&id=PART%20II-OTHER%20INFORMATION) [Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company may be involved in various claims and proceedings in the ordinary course of business, but management believes that the resolution of any current pending matters will not have a material adverse effect on the company's business or financial position - The company states that it does not expect any currently pending legal matters to have a material adverse effect on its business, financial position, or cash flow[145](index=145&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors disclosed in the 2020 Annual Report on Form 10-K, except for an update regarding the COVID-19 pandemic, specifically the potential impact of President Biden's Executive Order on government contractors - A new risk factor has been identified related to the COVID-19 pandemic, specifically the U.S. President's Executive Order requiring mandatory employee vaccination for government contractors and subcontractors[147](index=147&type=chunk) - The company notes that these vaccination requirements could lead to employee attrition at its subcontractors, impacting the supply chain and research activities, which in turn could affect performance under government contracts and future profits[147](index=147&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During the third quarter of 2021, the company repurchased **1,110,763 shares** of its common stock for approximately **$7.1 million** under its March 2020 share repurchase program, and an additional **$50 million** program was authorized in August 2021 Issuer Purchases of Equity Securities (Q3 2021) | Period | Total Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | July 2021 | 399,366 | $6.06 | | August 2021 | 382,000 | $6.43 | | September 2021 | 329,397 | $6.86 | | **Total** | **1,110,763** | **$6.42** | - On August 2, 2021, the Board authorized a new share repurchase program for up to **$50 million** of common stock through December 31, 2023[150](index=150&type=chunk) [Exhibits](index=34&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, a modification to the 19C BARDA contract, and certifications by the CEO and CFO as required by the Sarbanes-Oxley Act - Key exhibits filed include an amendment to the 19C BARDA Contract (Exhibit 10.1) and CEO/CFO certifications pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[156](index=156&type=chunk)
SIGA Technologies(SIGA) - 2021 Q2 - Earnings Call Transcript
2021-08-08 23:43
SIGA Technologies, Inc. (NASDAQ:SIGA) Q2 2021 Earnings Conference Call August 5, 2021 4:30 PM ET Company Participants Phil Gomez - Chief Executive Officer Dan Luckshire - Chief Financial Officer Conference Call Participants Maxim Jacobs - Edison Group Teddy Green - Private Investor Paul Saunders - Hutch Capital Operator Welcome to the SIGA Business Update Call. During the presentation, all participants will be in a listen-only mode. Afterwards we will conduct a question-and-answer session. [Operator Instruc ...
SIGA Technologies(SIGA) - 2021 Q2 - Quarterly Report
2021-08-05 21:03
Table of Contents 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, 2021 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) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Delaware 1 ...
SIGA Technologies(SIGA) - 2021 Q1 - Earnings Call Transcript
2021-05-09 05:57
SIGA Technologies, Inc. (NASDAQ:SIGA) Q1 2021 Earnings Conference Call May 6, 2021 4:30 PM ET Company Participants Phil Gomez - Chief Executive Officer Dan Luckshire - Chief Financial Officer Conference Call Participants Maxim Jacobs - Edison Group Andrew Sole - Esopus Creek Advisors Operator Welcome to the SIGA Business Update Call. During the presentation, all participants will be in a listen-only mode. Afterwards we will conduct a question-and-answer session. [Operator Instructions] As a reminder, this c ...
SIGA Technologies(SIGA) - 2021 Q1 - Quarterly Report
2021-05-06 21:05
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, 2021 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 ...