SIGA Reports Financial Results for Three Months Ended March 31, 2022
- First Sale of Intravenous (IV) TPOXX® to
- Contract with a New International Jurisdiction for an Initial Order of Approximately
- Corporate Update Conference Call Today at
“SIGA’s first quarter financial results are highlighted by the first sale of the intravenous (IV) formulation of TPOXX (IV TPOXX) to the
Summary Financial Results
($ in millions, except per share amounts)
Three Months Ended
Operating Loss (1)
Loss before Income Taxes (1)
Diluted Loss per Share
(1) Operating Loss excludes, and Loss before Income Taxes includes, interest income and adjustments to the fair value of the Company’s outstanding warrant. Both line items exclude the impact of income taxes.
Recent Key Activities:
May 5, 2022, the Board of Directors declared a special dividend of $0.45per share on the common stock of the Company. The special dividend is payable on June 2, 2022to 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.
March 2022, a country in the Asia Pacificregion awarded a TPOXX contract that includes an initial order for the delivery in 2022 of approximately $3 millionof 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.
March 2022, the size of the oral TPOXX procurement contract with the Public Health Agency of Canada(PHAC) was increased by approximately $5 millionto a total value of up to $38 million. Included in this amount is an order by PHAC for the delivery of approximately $13 millionof oral TPOXX, which is targeted for 2022.
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.
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
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 1-855-327-6837 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.
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 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
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
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
|Cash and cash equivalents||$||153,259,914||$||103,138,819|
|Prepaid expenses and other current assets||2,232,989||2,453,444|
|Total current assets||177,109,304||208,753,092|
|Property, plant and equipment, net||2,238,431||2,365,957|
|Deferred income taxes, net||4,035,141||2,422,607|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued expenses and other current liabilities||4,653,420||9,252,812|
|Income tax payable||808,771||19,207,042|
|Total current liabilities||7,240,550||30,487,858|
|Commitments and contingencies|
|Common stock (
|Additional paid-in capital||226,426,529||226,070,308|
|Total stockholders’ equity||167,736,796||174,314,407|
|Total liabilities and stockholders’ equity||$||184,546,643||$||214,726,575|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (UNAUDITED)
|Three Months Ended
|Product sales and supportive services||$||7,320,872||$||3,523,343|
|Research and development||3,218,427||1,290,401|
|Cost of sales and supportive services||4,720,116||250,848|
|Selling, general and administrative||3,518,030||4,056,184|
|Research and development||3,546,776||2,302,785|
|Total operating expenses||11,978,180||6,803,151|
|Gain from change in fair value of warrant liability||351,104||918,801|
|Other income, net||23,322||25,568|
|Loss before income taxes||(1,064,455||)||(1,045,038||)|
|Benefit for income taxes||703,406||232,933|
|Net and comprehensive loss||$||(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|
Source: SIGA Technologies Inc.