SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage
pharmaceutical company, today reported financial results for the
three and six months ended June 30, 2022.
“SIGA’s second quarter financial results reflect
the first sales of oral TPOXX to a new international jurisdiction
in the Asia-Pacific region as well as the U.S. Department of
Defense (DoD),” said Phil Gomez, CEO of SIGA. “In combination with
the first sale of the intravenous formulation of TPOXX (“IV TPOXX”)
in the first quarter of 2022, the Company continues to expand and
diversify its revenue base. We expect this positive trend to
continue in the second half of 2022 as we have received year to
date, as of July 31, approximately $60 million of international
orders from ten international jurisdictions, of which nine of the
jurisdictions are first-time customers. We believe the increasing
number of international governments that are procuring oral TPOXX,
as well as the large number of inquiries regarding TPOXX
procurement, highlight the overall importance of health security
preparedness, and that by increasing both the scale and scope of
TPOXX stockpiling, countries can be better prepared for the
outbreak risks of smallpox, monkeypox, and other viruses in the
orthopoxvirus family of viruses and make sure that patients are
able to access treatment.”
Summary Financial
Results($ in millions, except per share
amounts)
Second Quarter 2022 in comparison to Second
Quarter 2021
|
Three Months Ended June
30,2022 |
|
Three MonthsEnded June
30,2021 |
Total RevenuesOperating Income (1)Income before Income Taxes (1)Net
Income Diluted Income (Loss) per Share |
$16.7$3.1$3.2$2.0$0.03 per share |
|
$8.7$0.0$0.5$0.2($0.00) per share |
Six Months Ended June 30, 2022 in
comparison to Six Months Ended June 30, 2021
|
Six Months Ended June
30,2022 |
|
Six Months Ended June
30,2021 |
Total RevenuesOperating Income (Loss) (1)Income (Loss) before
Income Taxes (1)Net Income (Loss) Diluted Income (Loss) per
Share |
$27.2$1.6$2.1$1.7$0.02 per share |
|
$13.5($2.0)($0.6)($0.6)($0.03) 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.
Key Business and Operational
Activity
- This year, through July 31, SIGA has received approximately $60
million of international orders for oral TPOXX (tecovirimat) from
ten jurisdictions, of which nine are new customers. Approximately
$5 million of these orders were delivered in the second quarter of
2022, approximately $26 million is expected to be delivered in the
third quarter of 2022, and the remaining orders are expected to be
fulfilled between October 1, 2022 and July 31, 2023.
- On July 8, the Company announced that the United Kingdom had
approved oral tecovirimat (known in the U.S. as oral TPOXX) for the
treatment of smallpox, monkeypox, cowpox, and vaccinia
complications following vaccination against smallpox in adults and
children with a body weight of at least 13kg. This regulatory
approval follows the regulatory approval by the European Medicines
Agency (EMA) in January 2022, with a similar label.
- In the second quarter of 2022, the Company made its first sales
of oral TPOXX to a jurisdiction in the Asia-Pacific region and to
the DoD, continuing a positive trend of expanding and diversifying
its revenue base. In the first quarter of 2022, the Company made
its first sale of IV TPOXX to the U.S. Government.
- On May 19, the Company announced that the U.S. Food & Drug
Administration (FDA) approved the intravenous formulation of TPOXX
(IV TPOXX).
Capital Management Activity
During the second quarter of 2022, SIGA declared
and paid a special cash dividend of $0.45 per share. Additionally,
the Company repurchased approximately 0.5 million shares of its
common stock, for approximately $3.6 million.
Monkeypox Outbreak
Starting in June 2022, procurement orders for oral
TPOXX® from new international jurisdictions, as well as orders
under existing contracts, have occurred as SIGA has received a
large and ongoing number of inquiries about accessing oral TPOXX in
connection with a global monkeypox outbreak. The Company believes
that a portion of the courses of oral TPOXX delivered under these
orders will be used for the treatment of active monkeypox cases as
part of a response to this outbreak by the global health
community.
Monkeypox is a disease caused by infection with the
monkeypox virus. Monkeypox virus is part of the same family of
viruses as smallpox. Monkeypox symptoms are similar to smallpox,
but not as severe and with historical fatality in Africa of less
than 1% to 10% depending on region and clade. The first human case
of monkeypox was recorded in 1970. Since then, monkeypox has been
reported in several central and western African countries, with
case numbers greatly increasing in recent years. Prior to the
ongoing 2022 outbreak, nearly all monkeypox cases in people outside
of Africa were linked to international travel to countries where
the disease commonly occurs, or through imported animals, including
two cases in the United States in 2021. These cases are currently
occurring on multiple continents. On July 23, 2022, the
World Health Organization (WHO) declared the monkeypox outbreak as
a public health emergency of international concern.
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 scale,
scope, and current and future impact of the pandemic, the Company
is regularly reviewing business and financial risks, and seeking
coordination with its government partners with respect to the
performance of current and future contract timing and
execution. Additionally, the Company is coordinating closely
with service providers and vendors, in particular contract
manufacturing organizations that constitute our supply chain, with
respect to direct and indirect actions and risks caused by the
COVID-19 pandemic.
The COVID-19 pandemic has not adversely affected
the liquidity position of the Company. 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 have
been 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.
Conference Call and Webcast
SIGA will host a conference call and webcast to
provide a business update today, Thursday, August 4, 2022, at 4:30
P.M. ET.
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:
13730372. 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.
About Monkeypox
Monkeypox is a disease caused by infection with the
monkeypox virus. Monkeypox virus is part of the same family of
viruses as smallpox. Monkeypox symptoms are similar to smallpox,
but not as severe and with historical fatality in Africa of less
than 1% to 10% depending on region and clade. The first human
case of monkeypox was recorded in 1970. Since then, monkeypox has
been reported in several central and western African countries,
with case numbers greatly increasing in recent years. Prior to the
ongoing 2022 outbreak, nearly all monkeypox cases in people outside
of Africa were linked to international travel to countries where
the disease commonly occurs, or through imported animals, including
two cases in the United States in 2021. These cases are currently
occurring on multiple continents.
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 Contracts"),
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 Contracts, 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 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 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) 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 (xv) risks associated with responding to the current monkeypox
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, 2021 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
Michael Crawford, Edison
Groupmcrawford@edisongroup.com
Public RelationsDoug Haslam, Berry &
Companydhaslam@berrypr.com
SIGA TECHNOLOGIES,
INC.CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)As of
|
|
|
|
|
|
|
June 30, 2022 |
|
|
December 31, 2021 |
|
ASSETS |
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
114,530,926 |
|
|
$ |
103,138,819 |
|
Accounts receivable |
|
19,598,122 |
|
|
|
83,650,450 |
|
Inventory |
|
16,431,382 |
|
|
|
19,510,379 |
|
Prepaid expenses and other current assets |
|
3,083,027 |
|
|
|
2,453,444 |
|
Total current assets |
|
153,643,457 |
|
|
|
208,753,092 |
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net |
|
2,109,720 |
|
|
|
2,365,957 |
|
Deferred income taxes, net |
|
3,039,814 |
|
|
|
2,422,607 |
|
Goodwill |
|
898,334 |
|
|
|
898,334 |
|
Other assets |
|
249,170 |
|
|
|
286,585 |
|
Total assets |
$ |
159,940,495 |
|
|
$ |
214,726,575 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
Accounts payable |
$ |
1,214,617 |
|
|
$ |
2,028,004 |
|
Accrued expenses and other current liabilities |
|
14,844,830 |
|
|
|
9,252,812 |
|
Income tax payable |
|
634,619 |
|
|
|
19,207,042 |
|
Total current liabilities |
|
16,694,066 |
|
|
|
30,487,858 |
|
|
|
|
|
|
|
|
|
Warrant liability |
|
— |
|
|
|
6,521,441 |
|
Other liabilities |
|
3,477,575 |
|
|
|
3,402,869 |
|
Total liabilities |
|
20,171,641 |
|
|
|
40,412,168 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
|
Common stock ($.0001 par value, 600,000,000 shares authorized,
73,024,147 and 73,543,602, issued and outstanding at June 30, 2022
and December 31, 2021, respectively) |
|
7,302 |
|
|
|
7,354 |
|
Additional paid-in capital |
|
232,942,666 |
|
|
|
226,070,308 |
|
Accumulated deficit |
|
(93,181,114 |
) |
|
|
(51,763,255 |
) |
Total stockholders’ equity |
|
139,768,854 |
|
|
|
174,314,407 |
|
Total liabilities and stockholders’ equity |
$ |
159,940,495 |
|
|
$ |
214,726,575 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SIGA TECHNOLOGIES,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (UNAUDITED)
|
|
|
|
|
|
|
Three Months EndedJune 30, |
|
|
Six Months Ended June 30, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales and supportive services |
$ |
8,615,765 |
|
|
$ |
6,924,162 |
|
|
$ |
15,936,637 |
|
|
$ |
10,447,505 |
|
Research and development |
|
8,051,280 |
|
|
|
1,729,127 |
|
|
|
11,269,708 |
|
|
|
3,019,528 |
|
Total revenues |
|
16,667,045 |
|
|
|
8,653,289 |
|
|
|
27,206,345 |
|
|
|
13,467,033 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales and supportive services |
|
882,096 |
|
|
|
995,990 |
|
|
|
5,602,212 |
|
|
|
1,246,838 |
|
Selling, general and administrative |
|
5,874,139 |
|
|
|
5,392,226 |
|
|
|
9,585,427 |
|
|
|
9,641,744 |
|
Research and development |
|
6,840,099 |
|
|
|
2,263,971 |
|
|
|
10,386,876 |
|
|
|
4,566,756 |
|
Total operating expenses |
|
13,596,334 |
|
|
|
8,652,187 |
|
|
|
25,574,515 |
|
|
|
15,455,338 |
|
Operating income/(loss) |
|
3,070,711 |
|
|
|
1,102 |
|
|
|
1,631,830 |
|
|
|
(1,988,305 |
) |
Gain from change in fair value of warrant liability |
|
49,559 |
|
|
|
442,269 |
|
|
|
400,663 |
|
|
|
1,361,070 |
|
Other income, net |
|
72,373 |
|
|
|
24,235 |
|
|
|
95,694 |
|
|
|
49,803 |
|
Income/(loss) before income taxes |
|
3,192,643 |
|
|
|
467,606 |
|
|
|
2,128,187 |
|
|
|
(577,432 |
) |
Provision for income taxes |
|
(1,155,581 |
) |
|
|
(298,406 |
) |
|
|
(452,175 |
) |
|
|
(65,473 |
) |
Net and comprehensive income/(loss) |
$ |
2,037,062 |
|
|
$ |
169,200 |
|
|
$ |
1,676,012 |
|
|
$ |
(642,905 |
) |
Basic income/(loss) per share |
$ |
0.03 |
|
|
$ |
0.00 |
|
|
$ |
0.02 |
|
|
$ |
(0.01 |
) |
Diluted income/(loss) per share |
$ |
0.03 |
|
|
$ |
(0.00 |
) |
|
$ |
0.02 |
|
|
$ |
(0.03 |
) |
Weighted average shares outstanding: basic |
|
72,678,333 |
|
|
|
75,810,641 |
|
|
|
72,873,366 |
|
|
|
76,281,211 |
|
Weighted average shares outstanding: diluted |
|
73,332,888 |
|
|
|
76,660,054 |
|
|
|
73,699,226 |
|
|
|
77,128,973 |
|
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