SIGA Reports Financial Results for Three Months Ended March 31, 2022
05/05/2022 - 04:05 PM
- First Sale of Intravenous (IV) TPOXX® to U.S. Government under the 19C BARDA Contract –
- Contract with a New International Jurisdiction for an Initial Order of Approximately $3 Million of Oral TPOXX -
- Corporate Update Conference Call Today at 4:30 PM ET -
NEW YORK, May 05, 2022 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company, today reported financial results for the three months ended March 31, 2022.
“SIGA’s first quarter financial results are highlighted by the first sale of the intravenous (IV) formulation of TPOXX (IV TPOXX) to the U.S. government,” said Phil Gomez, CEO of SIGA. “With the delivery in the first quarter of $7 million of IV TPOXX to the U.S. government, SIGA has expanded its TPOXX revenue base in the U.S. On the international front, the revenue base is also expanding with a new contract with a jurisdiction in the Asia Pacific region. Under the new contract, approximately $3 million of oral TPOXX has been ordered for delivery in 2022, with the timing and amount of future orders to be determined on an annual basis.”
Summary Financial Results ($ in millions, except per share amounts)
Three Months Ended March 31, 2022 in comparison to Three Months Ended March 31, 2021
Three Months Ended March 31, 2022 Three Months March 31, 2021 Total Revenues $10.5 $1.4) $1.1) $0.4) $0.01) per share $4.8 $2.0) $1.0) $0.8) $0.02) per share
Recent Key Activities:
On May 5, 2022, the Board of Directors declared a special dividend of $0.45 per share on the common stock of the Company. The special dividend is payable on June 2, 2022 to shareholders of record at the close of business on May 17, 2022. During the first quarter, the Company made a series of deliveries of IV TPOXX to the U.S. government totaling $7 million . These deliveries represent the first sales of IV TPOXX under the 19C BARDA contract. In March 2022, a country in the Asia Pacific region awarded a TPOXX contract that includes an initial order for the delivery in 2022 of approximately $3 million of oral TPOXX. This contract, which represents the first procurement contract for TPOXX for this country, is structured so that the timing and amount of future orders will be determined on an annual basis. Meridian Medical Technologies, Inc. (Meridian) is the counterparty to this contract, and SIGA will be responsible for the manufacture and delivery of product. In March 2022, the size of the oral TPOXX procurement contract with the Public Health Agency of Canada (PHAC) was increased by approximately $5 million to a total value of up to $38 million . Included in this amount is an order by PHAC for the delivery of approximately $13 million of oral TPOXX, which is targeted for 2022. In January 2022, the European Medicines Agency (EMA) approved the marketing authorisation application (MAA) for oral Tecovirimat SIGA®, the same formulation that was approved by the U.S. Food and Drug Administration (FDA) in July 2018 under the brand name TPOXX®. The approved EMA label has a broader indication for use to treat smallpox, monkeypox, cowpox, and vaccinia complications following vaccination against smallpox. The MAA was filed as part of the EMA centralized application process, which, upon approval, enables sales, including procurement for stockpiling, of oral tecovirimat in all European Union (EU) member states, as well as Norway (which separately approved the product in February 2022), Iceland, and Liechtenstein. In January 2022, SIGA announced a research collaboration with Bioarchitech, a United Kingdom-based biotech company developing immunotherapy for the treatment of cancer. This collaboration will investigate TPOXX (tecovirimat) in combination with Bioarchitech’s proprietary vaccinia-based immunotherapy platform in preclinical studies. This platform utilizes engineered antibodies and other proteins expressed within the genome of an oncolytic virus. Cancer cells infected by the vaccinia virus release these potent immunotherapy molecules into the tumor where they orchestrate the destruction of malignant cells using the patient’s own immune system. Share Repurchase Activity
During the first quarter of 2022, SIGA repurchased approximately 1.0 million shares of its common stock, for approximately $6.6 million .
Conference Call and Webcast
SIGA will host a conference call and webcast to provide a business update today, Thursday, May 5, 2022, at 4:30 P.M. ET.
Participants may access the call by dialing 1-855-327-6837 for domestic callers or 1-631-891-4304 for international callers. A live webcast of the call will also be available on the Company's website at www.siga.com under the 'Events & Presentations' tab in the Investor Relations section, or by clicking here . Please log in approximately 5-10 minutes prior to the scheduled start time.
A replay of the call will be available for two weeks by dialing 1-844-512-2921 for domestic callers or 1-412-317-6671 for international callers and using Conference ID: 10018746. The archived webcast will be available in the Events and Presentations section of the Company's website .
ABOUT SIGA TECHNOLOGIES, INC. and TPOXX
SIGA Technologies, Inc. is a commercial-stage pharmaceutical company focused on the health security market. Health security comprises countermeasures for biological, chemical, radiological and nuclear attacks (biodefense market), vaccines and therapies for emerging infectious diseases, and health preparedness. Our lead product is TPOXX, also known as tecovirimat and ST-246, an orally administered and IV formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. TPOXX is a novel small-molecule drug and the U.S. government maintains a stockpile of TPOXX for treatment of smallpox. Over the past decade, the U.S. government has procured, or has current orders for, approximately $705 million of TPOXX for national preparedness. The oral formulation of TPOXX was approved by the FDA for the treatment of smallpox in 2018. The full label is here: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fce826ab-4d6a-4139-a2ee-a304a913a253 . In September 2018, SIGA signed a contract potentially worth more than $600 million with BARDA for procurement and development related to both oral and intravenous formulations of TPOXX. The same oral formulation was approved by the EMA in January 2022, and Health Canada in December 2021. For more information about SIGA, please visit www.siga.com .
About Smallpox 1
Smallpox is a contagious, disfiguring and often deadly disease that has affected humans for thousands of years. Naturally occurring smallpox was eradicated worldwide by 1980, the result of an unprecedented global immunization campaign. Samples of smallpox virus have been kept for research purposes. This has led to concerns that smallpox could someday be used as a biological warfare agent. A vaccine can prevent smallpox, but the risk of the current vaccine's side effects is too high to justify routine vaccination for people at low risk of exposure to the smallpox virus.
COVID-19 Pandemic
The COVID-19 pandemic has caused significant societal and economic disruption. Such disruption, and the associated risks and costs, are expected to continue for an indeterminate period of time. Given the uncertain future course of the COVID-19 pandemic, and the uncertain scale and scope of its future direct and indirect impact, the Company is continually reviewing business and financial risks related to the pandemic and seeking coordination with its government partners with respect to the performance of current and future government contracts. Additionally, the Company is continually coordinating with service providers and vendors, in particular Contract Manufacturing Organizations ("CMOs") that constitute our supply chain, with respect to actions and risks caused by the COVID-19 pandemic.
The Company has not currently identified or been notified by government customers of impediments to the continued full performance of their government contracts. With regard to day-to-day operations, the COVID-19 pandemic, and the secondary effects of the pandemic, have at times slowed the daily pace of execution of government contracts as well as new contract generation. For example, U.S. and foreign government staffs overseeing health security preparedness have been involved directly or indirectly in governmental responses to the pandemic, which has diverted government staff time that might normally be directed toward contract matters involving SIGA. Additionally, the COVID-19 pandemic, and the secondary effects of the pandemic have increased the risk of delays in connection with a broad range of operational activities, including: supply chain procurement of raw materials and manufacturing; and certain research and development activities, such as those that involve clinical trials. While the Company does not currently expect any pandemic-related delays in such operational activities to have a material adverse impact on the financial condition of the Company, or its long-term performance, the Company cannot give assurances as to the full extent of the impact at this time.
Overall, while the COVID-19 pandemic has not adversely affected the liquidity position of the Company, the pandemic has diverted foreign government staff time normally directed toward contract matters involving SIGA and has affected and could continue to affect the timing of international contract awards for oral TPOXX. Additionally, although SIGA has completed delivery of TPOXX courses covered by the procurement option exercised in 2021, the pandemic could result in a slower pace of future product deliveries if the pandemic results in shortages or delays in the receipt by the supply chain of raw materials or supplies. Furthermore, Executive Order 14042 by the President of the United States, which subjects federal prime contractors and subcontractors to certain vaccination requirements and other COVID-19 related safety measures, could have a material impact on the availability and/or timing of services provided to SIGA by certain vendors for supply chain activities and research and development activities if such Executive Order survives any legal challenges that are currently pending, one of which involves at least one case in which a preliminary nationwide injunction has barred enforcement of the mandate while the cases are being pursued. If the general negative effect of the COVID-19 pandemic becomes more acute, including due to resurgences in infections or lack of vaccination, there could be material adverse effects to our business and cash flows.
FORWARD-LOOKING STATEMENTS
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements relating to the progress of SIGA’s development programs and timelines for bringing products to market, as well as the impact of COVID-19 on SIGA’s business. Forward-looking statements may be identified by words or phrases such as “believes,” “estimates,” “expects,” “may,” “will,” “would,” “can,” “could,” and similar words and phrases. Such forward-looking statements are based on current expectations and assumptions and subject to various known and unknown risks and uncertainties, and SIGA cautions you that any forward-looking information provided by or on behalf of SIGA is not a guarantee of future performance. SIGA’s actual results could differ materially from those anticipated by such forward-looking statements due to a number of factors, some of which are beyond SIGA’s control, including, but not limited to, (i) the risk that the U.S. Biomedical Advanced Research and Development Authority (“BARDA”) elects, in its sole discretion as permitted under the BARDA Contracts (as defined below), not to exercise all, or any, of the remaining unexercised options under those contracts, (ii) the risk that SIGA may not complete performance under its contracts with BARDA (the “BARDA Contracts”) on schedule or in accordance with contractual terms, (iii) the risk that the BARDA Contracts are modified or canceled at the request or requirement of the U.S. government, (iv) the risk that the nascent international biodefense market does not develop to a degree that allows SIGA to successfully market TPOXX internationally, (v) the risk that potential products, including potential alternative uses or formulations of TPOXX that appear promising to SIGA or its collaborators, cannot be shown to be efficacious or safe in subsequent pre-clinical or clinical trials, (vi) the risk that SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market these or other potential products or uses, (vii) the risk that SIGA may not be able to secure or enforce sufficient legal rights in its products, including intellectual property protection, (viii) the risk that any challenge to SIGA’s patent and other property rights, if adversely determined, could affect SIGA’s business and, even if determined favorably, could be costly, (ix) the risk that regulatory requirements applicable to SIGA’s products may result in the need for further or additional testing or documentation that will delay or prevent SIGA from seeking or obtaining needed approvals to market these products, (x) the risk that the volatile and competitive nature of the biotechnology industry may hamper SIGA’s efforts to develop or market its products, (xi) the risk that changes in domestic or foreign economic and market conditions may affect SIGA’s ability to advance its research or may affect its products adversely, (xii) the effect of federal, state, and foreign regulation, including drug regulation and international trade regulation, on SIGA’s businesses, (xiii) the risk that the COVID-19 pandemic could impact SIGA’s operations by disrupting SIGA’s supply chain for the manufacture of TPOXX, causing delays in SIGA’s research and development activities, causing delays or the re-allocation of funding in connection with SIGA’s government contracts, or diverting the attention of government staff overseeing SIGA’s government contracts, (xiv) the risk that the U.S. or foreign governments’ responses (including inaction) to national or global economic conditions or infectious diseases such as COVID-19 are ineffective and may affect SIGA’s business adversely, and (xv) other risk factors discussed in Item 1A. “Risk Factors” of SIGA’s Annual Report on Form 10-K for the year ended December 31, 2021, and in SIGA’s subsequent filings with the U.S. Securities and Exchange Commission. These documents are publicly available at the SEC’s website at http://www.sec.gov and SIGA’s website at https://investor.siga.com. Forward-looking statements are current only as of the date on which such statements were made, and except as may be otherwise required by law, we undertake no obligation to update publicly any forward-looking statements whether as a result of new information, future events, or otherwise.
The information contained in this press release does not necessarily reflect the position or the policy of the U.S. government and no official endorsement should be inferred. The information contained on the websites referenced herein is not incorporated by reference into this press release.
Investor Contacts: Laine Yonker, Edison Group lyonker@edisongroup.com
Michael Crawford, Edison Group mcrawford@edisongroup.com
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1 http://www.mayoclinic.org/diseases-conditions/smallpox/basics/definition/con-20022769
SIGA TECHNOLOGIES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) As of March 31, 2022 December 31, ASSETS Current assets Cash and cash equivalents $ 153,259,914 $ 103,138,819 Accounts receivable 5,338,900 83,650,450 Inventory 16,277,501 19,510,379 Prepaid expenses and other current assets 2,232,989 2,453,444 Total current assets 177,109,304 208,753,092 Property, plant and equipment, net 2,238,431 2,365,957 Deferred income taxes, net 4,035,141 2,422,607 Goodwill 898,334 898,334 Other assets 265,433 286,585 Total assets $ 184,546,643 $ 214,726,575 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities Accounts payable $ 1,778,359 $ 2,028,004 Accrued expenses and other current liabilities 4,653,420 9,252,812 Income tax payable 808,771 19,207,042 Total current liabilities 7,240,550 30,487,858 Warrant liability 6,170,337 6,521,441 Other liabilities 3,398,960 3,402,869 Total liabilities 16,809,847 40,412,168 Commitments and contingencies Stockholders’ equity Common stock ($.0001 par value, 600,000,000 shares authorized, 72,566,367 and 73,543,602, issued and outstanding at March 31, 2022 and December 31, 2021, respectively) 7,256 7,354 Additional paid-in capital 226,426,529 226,070,308 Accumulated deficit (58,696,989 ) (51,763,255 ) Total stockholders’ equity 167,736,796 174,314,407 Total liabilities and stockholders’ equity $ 184,546,643 $ 214,726,575
SIGA TECHNOLOGIES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (UNAUDITED) Three Months Ended March 31, 2022 2021 Revenues Product sales and supportive services $ 7,320,872 $ 3,523,343 Research and development 3,218,427 1,290,401 Total revenues 10,539,299 4,813,744 Operating expenses Cost of sales and supportive services 4,720,116 250,848 Selling, general and administrative 3,518,030 4,056,184 Research and development 3,546,776 2,302,785 Patent expenses 193,258 193,334 Total operating expenses 11,978,180 6,803,151 Operating loss (1,438,881 ) (1,989,407 ) Gain from change in fair value of warrant liability 351,104 918,801 Other income, net 23,322 25,568 Loss before income taxes (1,064,455 ) (1,045,038 ) Benefit for income taxes 703,406 232,933 Net and comprehensive loss $ (361,049 ) $ (812,105 ) Basic loss per share $ (0.00 ) $ (0.01 ) Diluted loss per share $ (0.01 ) $ (0.02 ) Weighted average shares outstanding: basic 73,070,565 76,757,010 Weighted average shares outstanding: diluted 73,883,058 77,572,587
