SIGA Reports Financial Results for Three and Twelve Months Ended December 31, 2021
- Corporate Update Conference Call Today at
“SIGA’s fourth quarter and annual financial results are highlighted by approximately
Summary Financial Results
($ in millions, except per share amounts)
Three Months Ended
Operating Income (1)
Income before Income Taxes (1)
Diluted Income per Share
Operating Income (1)
Income before Income Taxes (1)
Diluted Income per Share
(1) Operating Income excludes, and Income before Income Taxes includes, costs in connection with the retirement of the Company’s term loan, interest expense, interest income and adjustments to the fair value of the Company’s outstanding warrant. Both line items exclude the impact of income taxes.
Recent Activities and Recap for 2021:
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. Earlier in December 2021, Health Canadaapproved oral TPOXX (tecovirimat) as an extraordinary use drug for the treatment of human smallpox disease. 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.
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.
- In the fourth quarter of 2021, the Company delivered approximately
$113 millionof oral TPOXX to the U.S.government.
- For 2021, the Company had approximately
$13 millionof international sales. In comparison, international sales were approximately $2 millionin 2020.
Share Repurchase Activity
During the fourth quarter of 2021, SIGA repurchased approximately 0.8 million shares of its common stock, for approximately
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: 13725422. 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.
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 would 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 or annual financial results 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
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
The information contained in this press release does not necessarily reflect the position or the policy of the
CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||103,138,819||$||117,890,240|
|Prepaid expenses and other current assets||2,453,444||2,112,069|
|Total current assets||208,753,092||143,608,091|
|Property, plant and equipment, net||2,365,957||2,103,990|
|Deferred tax asset, net||2,422,607||2,544,053|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued expenses and other current liabilities||9,252,812||8,285,738|
|Income tax payable||19,207,042||919,555|
|Total current liabilities||30,487,858||10,483,510|
|Commitments and contingencies (Note 13)|
|Common stock (
|Additional paid-in capital||226,070,308||224,978,430|
|Total stockholders' equity||174,314,407||129,793,269|
|Total liabilities and stockholders' equity||$||214,726,575||$||149,831,391|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
For the Years Ended
|Product sales and supportive services||$||126,802,536||$||115,471,071||$||11,190,064|
|Research and development||6,867,918||9,488,233||15,552,021|
|Cost of sales and supportive services||16,601,880||14,797,419||1,782,838|
|Selling, general and administrative||17,323,429||14,003,184||13,252,136|
|Research and development||9,942,194||10,938,930||13,303,149|
|Total operating expenses||44,577,655||40,458,674||29,064,228|
|Operating income (loss)||89,092,799||84,500,630||(2,322,143||)|
|Gain (loss) from change in fair value of warrant liability||117,770||(3,525,846||)||5,091,256|
|Loss on extinguishment of Term Loan||—||(4,981,461||)||—|
|Other income, net||101,172||532,085||2,822,232|
|Income (loss) before income taxes||89,311,741||73,508,591||(10,178,423||)|
|(Provision) benefit for income taxes||(19,860,975||)||(17,166,581||)||2,937,276|
|Net and comprehensive income (loss)||$||69,450,766||$||56,342,010||$||(7,241,147||)|
|Basic earnings (loss) per share||$||0.92||$||0.71||$||(0.09||)|
|Diluted earnings (loss) per share||$||0.91||$||0.71||$||(0.15||)|
|Weighted average shares outstanding: basic||75,322,194||79,259,000||81,031,254|
|Weighted average shares outstanding: diluted||76,402,716||79,437,306||82,175,023|
Source: SIGA Technologies Inc.