SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage
pharmaceutical company, today reported financial results for the
three and six months ended June 30, 2023.
“SIGA’s second quarter financial results reflect
the continuation of international sales activity that began in mid
2022,” said Phil Gomez, CEO of SIGA. “Importantly, revenues for the
first half of 2023 represent only a small percentage of revenues
expected for 2023. In the second half of 2023, the Company expects
to generate approximately $113 million of revenues from deliveries
of oral TPOXX to the U.S. strategic national stockpile and to
generate between $30 million and $45 million of revenues from a
broad cross-section of domestic and international deliveries,
including deliveries of oral TPOXX to the Department of Defense, IV
TPOXX to the U.S. strategic national stockpile and oral TPOXX to
international customers. Such revenues in the second half of the
year, when combined with the financial results of the first half of
2023, are expected to generate full year 2023 pre-tax operating
income of between $90 million and $100 million. We are pleased that
we are able to consistently meet demand for oral TPOXX, which is
driving substantial and increasingly diversified global revenue
opportunities at SIGA.”
Summary Financial
Results($ in millions, except per share
amounts)
Second Quarter 2023 in comparison to Second
Quarter 2022
|
Three Months Ended June 30,
2023 |
|
Three Months Ended June 30,
2022 |
Total RevenuesOperating (Loss) Income (1)(Loss) Income before
Income Taxes (1)Net (Loss) IncomeDiluted (Loss) Income per
Share |
$5.9($4.6)($3.4)($2.9)($0.04) per share |
|
$16.7$3.1$3.2$2.0$0.03 per share |
Six Months Ended June 30, 2023 in
comparison to Six Months Ended June 30, 2022
|
Six Months Ended June 30,
2023 |
|
Six Months Ended June 30,
2022 |
Total RevenuesOperating (Loss) Income (1)(Loss) Income before
Income Taxes (1)Net (Loss) Income Diluted (Loss) Income per
Share |
$14.2($6.7)($4.7)($3.8)($0.05) per share |
|
$27.2$1.6$2.1$1.7$0.02 per share |
(1) Operating Income / (Loss) excludes, and Income
/ (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 Developments
On July 27, 2023, the Company announced that the
U.S. Department of Health and Human Services placed orders for the
delivery of approximately $113 million worth of oral TPOXX®
treatment courses and approximately $25 million worth of IV TPOXX®
treatment courses. These orders were made by the exercise of
procurement options under SIGA’s 19C contract with the U.S.
Government.
Year-to-Date Capital Management
Activity
Year to date, the Company has spent approximately
$43 million on capital management activities, including a special
cash dividend of $0.45 per share and the repurchase of
approximately 1.7 million shares of common stock.
Conference Call and Webcast
SIGA will host a conference call and webcast to
provide a business update today, Tuesday, August 8, 2023, at 4:30
P.M. ET.
Participants may access the call by dialing
1-888-304-1803 for domestic callers or 1-848-488-9277 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:
153003. 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 US maintains a
supply of TPOXX under Project BioShield. The oral formulation of
TPOXX was approved by the FDA for the treatment of smallpox in
2018, and the IV formulation was approved for the same indication
in 2022. The full label is available by clicking here. Oral
tecovirimat received approval from the European Medicines Agency
(EMA) and the Medicines and Healthcare Products Regulatory Agency
(MHRA) in the United Kingdom in 2022. The EMA and UK approvals
include labeling for oral tecovirimat indicating its use for the
treatment of smallpox, monkeypox, cowpox, and vaccinia
complications following vaccination against smallpox. The full
label is available by clicking here. In September 2018, SIGA signed
a contract with the Biomedical Advanced Research and Development
Authority (BARDA), part of the office of the Assistant Secretary
for Preparedness and Response within the U.S. Department of Health
and Human Services, for additional procurement and development
related to both oral and intravenous formulations of TPOXX. For
more information about SIGA, please visit www.siga.com.
About Smallpox
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.
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, delivering products to the Strategic
Stockpile, the enforceability of our procurement contracts,
such as the 19C BARDA Contract (the "BARDA Contract"),
with BARDA, and responding to the global outbreak of monkeypox
(“mpox”). 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, DoD Contract #2 or PEP
Label Expansion R&D Contract 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 continue 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 of disruptions to 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) risks associated
with actions or uncertainties surrounding the debt ceiling, (xv)
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
adversely affect SIGA’s business, and (xvi) risks associated with
responding to the current mpox outbreak, as well as the risks and
uncertainties included in Item 1A “Risk Factors” of our Annual
Report on Form 10-K for the year ended December 31,
2022 and SIGA's subsequent filings with the Securities and
Exchange Commission. SIGA urges investors and security holders to
read those documents free of charge at the SEC's website at
http://www.sec.gov. All such forward-looking statements are current
only as of the date on which such statements were made. SIGA does
not undertake any obligation to update publicly any forward-looking
statement to reflect events or circumstances after the date on
which any such statement is made or to reflect the occurrence of
unanticipated events.
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.
Contacts:
Investor ContactLaine Yonker, Edison
Grouplyonker@edisongroup.com
Public RelationsHolly Stevens, Berry &
Companyhstevens@berrypr.com
SIGA TECHNOLOGIES, INC.CONDENSED
CONSOLIDATED BALANCE SHEETS (UNAUDITED)As
of |
|
|
June 30, 2023 |
|
|
December 31, 2022 |
|
ASSETS |
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
76,213,484 |
|
|
$ |
98,790,622 |
|
Accounts receivable |
|
6,026,887 |
|
|
|
45,406,960 |
|
Inventory |
|
50,497,103 |
|
|
|
39,273,090 |
|
Prepaid expenses and other current assets |
|
1,560,626 |
|
|
|
2,315,672 |
|
Total current assets |
|
134,298,100 |
|
|
|
185,786,344 |
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net |
|
1,605,222 |
|
|
|
1,848,314 |
|
Deferred tax asset, net |
|
7,591,743 |
|
|
|
6,250,385 |
|
Goodwill |
|
898,334 |
|
|
|
898,334 |
|
Other assets |
|
2,117,360 |
|
|
|
252,546 |
|
Total assets |
$ |
146,510,759 |
|
|
$ |
195,035,923 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
Accounts payable |
$ |
1,081,337 |
|
|
$ |
3,355,268 |
|
Accrued expenses and other current liabilities |
|
17,894,986 |
|
|
|
16,852,781 |
|
Income tax payable |
|
11,822 |
|
|
|
1,309,672 |
|
Total current liabilities |
|
18,988,145 |
|
|
|
21,517,721 |
|
|
|
|
|
|
|
|
|
Other liabilities |
|
3,448,558 |
|
|
|
3,358,160 |
|
Total liabilities |
|
22,436,703 |
|
|
|
24,875,881 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
|
Common stock ($.0001 par value, 600,000,000 shares authorized,
71,082,944 and 72,675,190, issued and outstanding at June 30, 2023
and December 31, 2022, respectively) |
|
7,109 |
|
|
|
7,268 |
|
Additional paid-in capital |
|
234,873,128 |
|
|
|
233,957,767 |
|
Accumulated deficit |
|
(110,806,181 |
) |
|
|
(63,804,993 |
) |
Total stockholders’ equity |
|
124,074,056 |
|
|
|
170,160,042 |
|
Total liabilities and stockholders’ equity |
$ |
146,510,759 |
|
|
$ |
195,035,923 |
|
SIGA TECHNOLOGIES, INC.CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
(LOSS)/INCOME (UNAUDITED) |
|
|
Three Months EndedJune 30, |
|
|
Six Months EndedJune 30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales and supportive services |
$ |
1,263,255 |
|
|
$ |
8,615,765 |
|
|
$ |
6,965,769 |
|
|
$ |
15,936,637 |
|
Research and development |
|
4,614,911 |
|
|
|
8,051,280 |
|
|
|
7,235,421 |
|
|
|
11,269,708 |
|
Total revenues |
|
5,878,166 |
|
|
|
16,667,045 |
|
|
|
14,201,190 |
|
|
|
27,206,345 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales and supportive services |
|
974,420 |
|
|
|
882,096 |
|
|
|
2,124,608 |
|
|
|
5,602,212 |
|
Selling, general and administrative |
|
4,425,959 |
|
|
|
5,874,139 |
|
|
|
8,661,068 |
|
|
|
9,585,427 |
|
Research and development |
|
5,116,154 |
|
|
|
6,840,099 |
|
|
|
10,162,189 |
|
|
|
10,386,876 |
|
Total operating expenses |
|
10,516,533 |
|
|
|
13,596,334 |
|
|
|
20,947,865 |
|
|
|
25,574,515 |
|
Operating (loss)/income |
|
(4,638,367 |
) |
|
|
3,070,711 |
|
|
|
(6,746,675 |
) |
|
|
1,631,830 |
|
Gain from change in fair value of warrant liability |
|
— |
|
|
|
49,559 |
|
|
|
— |
|
|
|
400,663 |
|
Other income, net |
|
1,190,705 |
|
|
|
72,373 |
|
|
|
2,081,334 |
|
|
|
95,694 |
|
(Loss)/income before income taxes |
|
(3,447,662 |
) |
|
|
3,192,643 |
|
|
|
(4,665,341 |
) |
|
|
2,128,187 |
|
Benefit/(Provision) for income taxes |
|
572,186 |
|
|
|
(1,155,581 |
) |
|
|
871,608 |
|
|
|
(452,175 |
) |
Net and comprehensive (loss)/income |
$ |
(2,875,476 |
) |
|
$ |
2,037,062 |
|
|
$ |
(3,793,733 |
) |
|
$ |
1,676,012 |
|
Basic (loss)/income per share |
$ |
(0.04 |
) |
|
$ |
0.03 |
|
|
$ |
(0.05 |
) |
|
$ |
0.02 |
|
Diluted (loss)/income per share |
$ |
(0.04 |
) |
|
$ |
0.03 |
|
|
$ |
(0.05 |
) |
|
$ |
0.02 |
|
Weighted average shares outstanding: basic |
|
71,090,642 |
|
|
|
72,678,333 |
|
|
|
71,640,784 |
|
|
|
72,873,366 |
|
Weighted average shares outstanding: diluted |
|
71,090,642 |
|
|
|
73,332,888 |
|
|
|
71,640,784 |
|
|
|
73,699,226 |
|
SIGA Technologies (NASDAQ:SIGA)
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SIGA Technologies (NASDAQ:SIGA)
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