SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage
pharmaceutical company, today reported financial results for the
three months ended March 31, 2023.
“First quarter product revenues primarily reflect
the sale of oral TPOXX to the U.S. Department of Defense (“DoD”),
which marks the third product delivery to the DoD within the past
twelve months,” said Phil Gomez, CEO of SIGA. “Including the $5
million of deliveries in the first quarter, we are targeting a
total of approximately $11 million of oral TPOXX deliveries to the
DoD in 2023. In addition, based on the anticipated expiration this
year of significant quantities of TPOXX held within the U.S.
Government’s Strategic National Stockpile (“SNS”), we are targeting
for this year approximately $113 million of oral TPOXX deliveries
to the SNS. We will continue to work to build and meet demand for
oral TPOXX across geographic regions around the world as well as
continue to work toward deliveries this year of IV TPOXX to the
SNS.”
Summary Financial
Results($ in millions, except per share
amounts)
Three Months Ended March 31, 2023 in
comparison to Three Months Ended March 31,
2022
|
Three Months Ended March
31,2023 |
|
Three MonthsEndedMarch
31,2022 |
Total RevenuesOperating Loss (1)Loss before Income Taxes (1)Net
LossDiluted Loss per Share |
$8.3($2.1)($1.2)($0.9)($0.01) per share |
|
$10.5($1.4)($1.1)($0.4)($0.01) 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.
Capital Management Activity
Earlier today the Company announced a special cash
dividend of $0.45 per share. The cash dividend is payable on June
1, 2023 to shareholders of record at the close of business on May
16, 2023.
During the first quarter of 2023, SIGA repurchased
approximately 1.1 million shares for approximately $7.5 million
(excluding excise taxes of $0.1 million).
Conference Call and Webcast
SIGA will host a conference call and webcast to
provide a business update today, Thursday, May 4, 2023, at 4:30
P.M. ET.
Participants may access the call by dialing
1-888-999-3182 for domestic callers or 1-848-280-6330 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:
151824. 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, 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.CONSOLIDATED BALANCE SHEETS
(UNAUDITED)As of
|
|
March 31, 2023 |
|
|
December 31, 2022 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
115,680,683 |
|
|
$ |
98,790,622 |
|
Accounts receivable |
|
|
12,316,704 |
|
|
|
45,406,960 |
|
Inventory |
|
|
42,577,787 |
|
|
|
39,273,090 |
|
Prepaid expenses and other current assets |
|
|
1,958,508 |
|
|
|
2,315,672 |
|
Total current assets |
|
|
172,533,682 |
|
|
|
185,786,344 |
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net |
|
|
1,717,193 |
|
|
|
1,848,314 |
|
Deferred tax asset, net |
|
|
6,733,810 |
|
|
|
6,250,385 |
|
Goodwill |
|
|
898,334 |
|
|
|
898,334 |
|
Other assets |
|
|
2,041,240 |
|
|
|
252,546 |
|
Total assets |
|
$ |
183,924,259 |
|
|
$ |
195,035,923 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,139,853 |
|
|
$ |
3,355,268 |
|
Accrued expenses and other current liabilities |
|
|
16,001,327 |
|
|
|
16,852,781 |
|
Income tax payable |
|
|
1,335,311 |
|
|
|
1,309,672 |
|
Total current liabilities |
|
|
18,476,491 |
|
|
|
21,517,721 |
|
|
|
|
|
|
|
|
|
|
Other liabilities |
|
|
3,354,308 |
|
|
|
3,358,160 |
|
Total liabilities |
|
|
21,830,799 |
|
|
|
24,875,881 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
|
|
Common stock ($.0001 par value, 600,000,000 shares authorized,
71,535,268 and 72,675,190, issued and outstanding at March 31, 2023
and December 31, 2022, respectively) |
|
|
7,154 |
|
|
|
7,268 |
|
Additional paid-in capital |
|
|
234,366,497 |
|
|
|
233,957,767 |
|
Accumulated deficit |
|
|
(72,280,191 |
) |
|
|
(63,804,993 |
) |
Total stockholders’ equity |
|
|
162,093,460 |
|
|
|
170,160,042 |
|
Total liabilities and stockholders’ equity |
|
$ |
183,924,259 |
|
|
$ |
195,035,923 |
|
|
|
|
|
|
|
|
|
|
SIGA TECHNOLOGIES,
INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS (UNAUDITED)
|
|
Three Months Ended March 31, |
|
|
|
2023 |
|
|
2022 |
|
Revenues |
|
|
|
|
|
|
|
|
Product sales and supportive services |
|
$ |
5,702,515 |
|
|
$ |
7,320,872 |
|
Research and development |
|
|
2,620,510 |
|
|
|
3,218,427 |
|
Total revenues |
|
|
8,323,025 |
|
|
|
10,539,299 |
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
Cost of sales and supportive services |
|
|
1,150,187 |
|
|
|
4,720,116 |
|
Selling, general and administrative |
|
|
4,235,108 |
|
|
|
3,711,288 |
|
Research and development |
|
|
5,046,036 |
|
|
|
3,546,776 |
|
Total operating expenses |
|
|
10,431,331 |
|
|
|
11,978,180 |
|
Operating loss |
|
|
(2,108,306 |
) |
|
|
(1,438,881 |
) |
Gain from change in fair value of warrant liability |
|
|
— |
|
|
|
351,104 |
|
Other income, net |
|
|
890,629 |
|
|
|
23,322 |
|
Loss before income taxes |
|
|
(1,217,677 |
) |
|
|
(1,064,455 |
) |
Benefit for income taxes |
|
|
299,422 |
|
|
|
703,406 |
|
Net and comprehensive loss |
|
$ |
(918,255 |
) |
|
$ |
(361,049 |
) |
Basic loss per share |
|
$ |
(0.01 |
) |
|
$ |
(0.00 |
) |
Diluted loss per share |
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
Weighted average shares outstanding: basic |
|
|
72,197,038 |
|
|
|
73,070,565 |
|
Weighted average shares outstanding: diluted |
|
|
72,197,038 |
|
|
|
73,883,058 |
|
|
|
|
|
|
|
|
|
|
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