SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage
pharmaceutical company, today reported financial results for the
three and twelve months ended December 31, 2022.
“In 2022, SIGA had approximately $111 million in
revenue including approximately $71 million of international sales.
Importantly, we generated revenue from a more diversified customer
base compared to previous years,” said Phil Gomez, CEO of SIGA.
“The year included the first sale of the intravenous formulation of
TPOXX® (“IV TPOXX”) to the U.S. Government, the first sales of oral
TPOXX to the U.S. Department of Defense (“DoD”), and the sale of
oral TPOXX (tecovirimat) to twelve new international customers. Our
focus on customer diversification played a key role in helping us
generate pre-tax operating income of approximately $43 million in
2022, a period during which the U.S. Government did not replace any
quantities of TPOXX in the Strategic National Stockpile based on
expirations.”
Summary Financial
Results($ in millions, except per share
amounts)
Three Months Ended December 31, 2022 in
comparison to Three Months Ended December 31,
2021
|
Three Months Ended
December 31,2022 |
|
Three Months EndedDecember 31,
2021 |
Total RevenuesOperating (Loss) Income (1)(Loss) Income before
Income Taxes (1)Net (Loss) Income Diluted (Loss) Income per
Share |
$11.4($1.8)($1.2)($0.8) ($.01) per share |
|
$115.4$94.0$93.9$73.2 $0.98 per share |
Year Ended December 31, 2022 in comparison
to Year Ended December 31, 2021
|
Year EndedDecember
31, 2022 |
|
Year EndedDecember
31, 2021 |
Total RevenuesOperating Income (1)Income before Income Taxes (1)Net
Income Diluted Income per Share |
$110.8$42.7$44.1$33.9$0.46 per share |
|
$133.7$89.1$89.3$69.5$0.91 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 million of international orders for oral
TPOXX (tecovirimat) from 13 customers, of which 12 were new
customers in 2022. Approximately $71 million of these orders were
delivered and recorded as international sales in 2022. In
comparison, the Company had approximately $13 million of
international sales in 2021 and approximately $3 million of
international sales in 2020.
- In September and
May of 2022, the DoD awarded procurement contracts to the Company
for the total purchase of up to approximately $18 million of oral
TPOXX, of which approximately $7 million of 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 million of IV TPOXX. These
were the first option exercises under the 19C Contract for IV
TPOXX, which followed its May 2022 FDA 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 $0.45 per share. Additionally, the Company
repurchased approximately 1.8 million shares of its common stock,
for approximately $13 million, in 2022, including $2.9 million of
repurchases in the fourth quarter. In total, the Company used cash
of approximately $46 million in 2022 for capital management
activities.
COVID-19 Pandemic
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, Thursday, March 2, 2023, 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:
13735849. 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, 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 Department of Defense procurement
contract or PEP Label Expansion R&D Contract (as defined
in the Form 10-Q) 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) 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, 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.CONSOLIDATED
BALANCE SHEETSAs of |
|
|
|
December 31, 2022 |
|
|
December 31, 2021 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
98,790,622 |
|
|
$ |
103,138,819 |
|
Accounts receivable |
|
|
45,406,960 |
|
|
|
83,650,450 |
|
Inventory |
|
|
39,273,090 |
|
|
|
19,510,379 |
|
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 |
|
Goodwill |
|
|
898,334 |
|
|
|
898,334 |
|
Other assets |
|
|
252,546 |
|
|
|
286,585 |
|
Total assets |
|
$ |
195,035,923 |
|
|
$ |
214,726,575 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
3,355,268 |
|
|
$ |
2,028,004 |
|
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 |
|
Warrant liability |
|
|
— |
|
|
|
6,521,441 |
|
Other liabilities |
|
|
3,358,160 |
|
|
|
3,402,869 |
|
Total liabilities |
|
|
24,875,881 |
|
|
|
40,412,168 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Stockholders' equity |
|
|
|
|
|
|
|
|
Common stock ($.0001 par value, 600,000,000 shares authorized,
72,675,190 and 73,543,602 issued and outstanding at December 31,
2022 and December 31, 2021, respectively) |
|
|
7,268 |
|
|
|
7,354 |
|
Additional paid-in capital |
|
|
233,957,767 |
|
|
|
226,070,308 |
|
Accumulated deficit |
|
|
(63,804,993 |
) |
|
|
(51,763,255 |
) |
Total stockholders' equity |
|
|
170,160,042 |
|
|
|
174,314,407 |
|
Total liabilities and stockholders' equity |
|
$ |
195,035,923 |
|
|
$ |
214,726,575 |
|
SIGA TECHNOLOGIES, INC.CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE INCOMEFor the Years Ended
December 31 |
|
|
|
2022 |
|
|
2021 |
|
|
2020 |
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
Total revenues |
|
|
110,775,610 |
|
|
|
133,670,454 |
|
|
|
124,959,304 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
Operating income |
|
|
42,700,166 |
|
|
|
89,092,799 |
|
|
|
84,500,630 |
|
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 |
) |
Interest expense |
|
|
— |
|
|
|
— |
|
|
|
(3,016,817 |
) |
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 |
|
Grafico Azioni SIGA Technologies (NASDAQ:SIGA)
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Da Mag 2024 a Giu 2024
Grafico Azioni SIGA Technologies (NASDAQ:SIGA)
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Da Giu 2023 a Giu 2024