SIGA Reports Financial Results for Three and Twelve Months Ended December 31, 2022
- Corporate Update Conference Call Today at
“In 2022, SIGA had approximately
Summary Financial Results
($ in millions, except per share amounts)
Three Months Ended
Operating (Loss) Income (1)
(Loss) Income before Income Taxes (1)
Net (Loss) Income
Diluted (Loss) Income per Share
Operating Income (1)
Income before Income Taxes (1)
Diluted Income per Share
(1) Operating Income (Loss) excludes, and Income (Loss) before Income Taxes includes, other income and adjustments to the fair value of the Company’s outstanding warrant. Both line items exclude the impact of income taxes.
Key Business and Operational Activity for 2022:
- In 2022, SIGA received approximately
$77 millionof international orders for oral TPOXX (tecovirimat) from 13 customers, of which 12 were new customers in 2022. Approximately $71 millionof these orders were delivered and recorded as international sales in 2022. In comparison, the Company had approximately $13 millionof international sales in 2021 and approximately $3 millionof international sales in 2020.
- In September and May of 2022, the
DoDawarded procurement contracts to the Company for the total purchase of up to approximately $18 millionof oral TPOXX, of which approximately $7 millionof oral TPOXX was delivered in 2022. These contracts represent the first procurement contracts awarded to the Company by the DoD.
- In August of 2022, the
Biomedical Advanced Research and Development Authority(BARDA), part of the office of the Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services, exercised procurement options under the 19C Contract for the purchase of approximately $26 millionof IV TPOXX. These were the first option exercises under the 19C Contract for IV TPOXX, which followed its May 2022FDA approval.
- Starting in the third quarter of 2022, in connection with the global response to a mpox (monkeypox) outbreak, a series of randomized, placebo-controlled clinical trials were initiated in the
U.S., the U.K., and the Democratic Republic of Congo(DRC) to further assess the safety and efficacy of TPOXX in participants with mpox. The U.S.-based trial and the DRC-based trial are being sponsored by the National Institute of Allergy and Infectious Disease(NIAID), and the U.K.-based trial is commissioned and funded by the National Institute for Health Care and Research.
- In 2022, the European Medicines Agency (EMA) and the United Kingdom’s
Medicines and Healthcare Products Regulatory Agency(MHRA) approved 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 and MHRA labels have a broader indication for use to treat smallpox, mpox, cowpox, and vaccinia complications following vaccination against smallpox.
Capital Management Activity for 2022:
In May of 2022, SIGA declared and paid a special cash dividend of
The COVID-19 pandemic has caused significant societal and economic disruption. The continuing direct and indirect impacts of the pandemic are significant and broad based, including supply chain disruptions and labor shortages that started during the pandemic and continue to represent business and financial risks. As such, the Company is continually coordinating with service providers and vendors, in particular Contract Manufacturing Organizations that constitute our supply chain, with respect to risks and mitigating actions.
The Company has not 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 pace of execution of government contracts as well as new contract generation. 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. Furthermore, the pandemic and related secondary effects could result in a slower pace of future product deliveries if there are shortages or delays in the receipt by the supply chain of raw materials or supplies, or if labor shortages become more acute. While the Company does not currently expect such delays to have a material adverse impact on the financial condition of the Company or its long-term operating performance, and while the COVID-19 pandemic has not adversely affected the liquidity position of the Company, the Company cannot give assurances as to the full extent of the impact at this time.
Conference Call and Webcast
SIGA will host a conference call and webcast to provide a business update today,
Participants may access the call by dialing 1-877-425-9470 for domestic callers or 1-201-389-0878 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: 13735849. The archived webcast will be available in the Events and Presentations section of the Company's website.
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.
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, delivering products to the Strategic Stockpile, the enforceability of our procurement contracts, such as the 19C BARDA Contract (the "BARDA Contract"), with BARDA, the impact of the COVID pandemic and responding to the global outbreak of monkeypox. The words or phrases “can be,” “expects,” “may affect,” “may depend,” “believes,” “estimate,” “project” and similar words and phrases are intended to identify such forward-looking statements. Such forward-looking statements are subject to various known and unknown risks and uncertainties, and SIGA cautions you that any forward-looking information provided by or on behalf of SIGA is not a guarantee of future performance. SIGA’s actual results could differ materially from those anticipated by such forward-looking statements due to a number of factors, some of which are beyond SIGA’s control, including, but not limited to, (i) the risk that BARDA elects, in its sole discretion as permitted under the BARDA Contract, not to exercise all, or any, of the remaining unexercised options under those contracts, (ii) the risk that SIGA may not complete performance under the BARDA Contract on schedule or in accordance with contractual terms, (iii) the risk that the BARDA Contract, the current
The information contained in this press release does not necessarily reflect the position or the policy of the Government and no official endorsement should be inferred.
CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||98,790,622||$||103,138,819|
|Prepaid expenses and other current assets||2,315,672||2,453,444|
|Total current assets||185,786,344||208,753,092|
|Property, plant and equipment, net||1,848,314||2,365,957|
|Deferred tax asset, net||6,250,385||2,422,607|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued expenses and other current liabilities||16,852,781||9,252,812|
|Income tax payable||1,309,672||19,207,042|
|Total current liabilities||21,517,721||30,487,858|
|Commitments and contingencies|
|Common stock (
|Additional paid-in capital||233,957,767||226,070,308|
|Total stockholders' equity||170,160,042||174,314,407|
|Total liabilities and stockholders' equity||$||195,035,923||$||214,726,575|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME
For the Years Ended
|Product sales and supportive services||$||86,661,583||$||126,802,536||$||115,471,071|
|Research and development||24,114,027||6,867,918||9,488,233|
|Cost of sales and supportive services||10,432,561||16,601,880||14,797,419|
|Selling, general and administrative||35,117,241||18,033,581||14,722,325|
|Research and development||22,525,642||9,942,194||10,938,930|
|Total operating expenses||68,075,444||44,577,655||40,458,674|
|Gain (loss) from change in fair value of warrant liability||400,663||117,770||(3,525,846||)|
|Loss on extinguishment of Term Loan||—||—||(4,981,461||)|
|Other income, net||1,031,903||101,172||532,085|
|Income before income taxes||44,132,732||89,311,741||73,508,591|
|Provision for income taxes||(10,227,926||)||(19,860,975||)||(17,166,581||)|
|Net and comprehensive income||$||33,904,806||$||69,450,766||$||56,342,010|
|Basic earnings per share||$||0.46||$||0.92||$||0.71|
|Diluted earnings per share||$||0.46||$||0.91||$||0.71|
|Weighted average shares outstanding: basic||72,929,550||75,322,194||79,259,000|
|Weighted average shares outstanding: diluted||73,546,501||76,402,716||79,437,306|
Source: SIGA Technologies Inc.