SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage
pharmaceutical company, today reported financial results for the
three and nine months ended September 30, 2024.
“Building on strong momentum, SIGA received $122
million in orders during the third quarter, including a significant
$112.5 million order for oral TPOXX under the 19C BARDA contract
and a $9 million order for oral TPOXX from the U.S. Department of
Defense,” said Diem Nguyen, Chief Executive Officer. “As of
September 30, 2024, the Company had approximately $146 million of
outstanding procurement orders, positioning the Company for
substantial revenue in the fourth quarter and 2025.
Deliveries related to the $112.5 million order began in late
September and continued into October. We remain committed to
diversifying and expanding our revenue base, enhancing shareholder
value, advancing our development programs, and continuing our
public health mission, while preparing to negotiate the next
contract with the U.S. Government.”Summary Financial
Results
($ in millions, exceptper share amounts) |
Three MonthsEnded September
30 |
|
Nine MonthsEnded September
30 |
|
|
2024 |
|
|
2023 |
|
|
|
2024 |
|
|
2023 |
|
Product sales(1) |
$8.9 |
|
$8.0 |
|
|
$53.5 |
|
$14.9 |
|
Total revenues |
$10.0 |
|
$9.2 |
|
|
$57.3 |
|
$23.4 |
|
Operating income (loss)(2) |
$0.5 |
|
($1.3 |
) |
|
$12.9 |
|
($8.1 |
) |
Income (loss) before income taxes(2) |
$1.9 |
|
($0.4 |
) |
|
$17.5 |
|
($5.1 |
) |
Net income (loss) |
$1.3 |
|
($0.4 |
) |
|
$13.5 |
|
($4.2 |
) |
Diluted income (loss) per share |
$0.02 |
|
($0.01 |
) |
|
$0.19 |
|
($0.06 |
) |
(1) Includes supportive services
related to product sales.
(2) Operating income (loss)
excludes, and income (loss) before income taxes includes other
income. Both line items exclude the impact of income taxes.
Recent Developments:
- In October 2024,
the Company announced that it obtained an exclusive license to a
portfolio of preclinical fully human monoclonal antibodies (mAbs)
from Vanderbilt University that have the potential to treatment a
broad range of orthopoxviruses, including smallpox and mpox. Under
the agreement, SIGA has exclusive rights to develop, manufacture,
and commercialize these mAbs globally. The U.S. Department of
Defense is currently funding the development of these mAbs as
potential orthopoxvirus treatments through Phase 1 clinical trials
under a contract awarded to a contract manufacturing organization
with proven biologics development and manufacturing expertise.
- In October 2024,
the Company announced its first sale of TPOXX (tecovirimat) in
Africa, made in response to a request from the Ministry of Health
in Morocco. This milestone sale occurred during the third
quarter.
- In August 2024,
the Company received a procurement contract and related order from
the U.S. Department of Defense for approximately $9 million of oral
TPOXX, as well as a small amount of IV TPOXX.
- In August 2024,
the Company reported that the National Institutes of Health’s (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
announced topline results from a preliminary analysis of the PALM
007 (Tecovirimat for Treatment of Monkeypox Virus) clinical trial
(NCT05559099). NIAID reported that the study did not meet its
primary endpoint of a statistically significant improvement in time
to lesion resolution within 28 days post-randomization for patients
in the Democratic Republic of the Congo with mpox who were
administered tecovirimat versus placebo. Improvement was observed,
however, in patients receiving tecovirimat whose symptoms began
seven days or fewer before randomization and in those with severe
or grave disease, defined by the World Health Organization as
having 100 or more skin lesions. The Company believes these data
are consistent to tecovirimat’s mechanism of action and support
further trials to assess its potential benefit in post exposure
prophylactic settings, or in patients who present for medical care
soon after symptoms, and in those with the most severe
disease.
- In July 2024, the Company received a
procurement order for $112.5 million of oral TPOXX from the U.S.
Government under the 19C BARDA contract, for delivery to the U.S.
Strategic National Stockpile (SNS).
Capital Management
Activity:
On April 11, 2024, a special cash dividend of $0.60
per share was paid, an increase of $0.15 per share from last year’s
special cash dividend. This dividend was declared on
March 12, 2024.
Conference Call and Webcast
SIGA will host a conference call and webcast to
provide a business update today, Thursday, November 7, 2024, at
4:30 P.M. ET.
Participants may access the call by dialing
1-800-717-1738 for domestic callers or 1-646-307-1865 for
international callers. A live webcast of the call will also be
available on the Company's website at www.siga.com in the
Investor Relations section of the website, 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:
1146096. The archived webcast will be available in the Investor
Relations section of the Company's website.ABOUT
SIGA
SIGA is a commercial-stage pharmaceutical company
and leader in global health focused on the development of
innovative medicines to treat and prevent infectious diseases. With
a primary focus on orthopoxviruses, we are dedicated to protecting
humanity against the world’s most severe infectious diseases,
including those that occur naturally, accidentally, or
intentionally. Through partnerships with governments and public
health agencies, we work to build a healthier and safer world by
providing essential countermeasures against these global health
threats. Our flagship product, TPOXX® (tecovirimat), is an
antiviral medicine approved in
the U.S. and Canada for the treatment of
smallpox and authorized in Europe and
the UK for the treatment of smallpox, mpox (monkeypox),
cowpox, and vaccinia complications. For more information about
SIGA, visit www.siga.com.
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
SIGA’s future business development and plans including with respect
to securing new contracts and the timing of delivery of ordered
oral TPOXX courses. Forward-looking statements include statements
regarding our future financial position, business strategy,
budgets, projected costs, plans and objectives of management for
future operations. The words “may,” “continue,” “estimate,”
“intend,” “plan,” “will,” “believe,” “project,” “expect,” “seek,”
“anticipate,” “could,” “should,” “target,” “goal,” “potential” and
similar expressions may identify forward-looking statements, but
the absence of these words does not necessarily mean that a
statement is not forward-looking. 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 75A50118C00019 BARDA
Contract (the “BARDA Contract”), not to exercise the remaining
unexercised option under the BARDA Contract, (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 or U.S. Department of
Defense contracts are modified or canceled at the request or
requirement of, or SIGA is not able to enter into new contracts to
supply TPOXX to, 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 target timing for deliveries of product to
customers, and the recognition of related revenues, are delayed or
adversely impacted by the actions, or inaction, of contract
manufacturing organizations, or other vendors, within the supply
chain, or due to coordination activities between the customer and
supply chain vendors, (vii) the risk that SIGA or its collaborators
will not obtain appropriate or necessary governmental approvals to
market these or other potential products or uses, (viii) the risk
that SIGA may not be able to secure or enforce sufficient legal
rights in its products, including intellectual property protection,
(ix) 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, (x)
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, (xi) the risk
that the volatile and competitive nature of the biotechnology
industry may hamper SIGA’s efforts to develop or market its
products, (xii) 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, (xiii) the
effect of federal, state, and foreign regulation, including drug
regulation and international trade regulation, on SIGA’s
businesses, (xiv) 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, (xv) risks associated with
actions or uncertainties surrounding the debt ceiling, (xvi)
the risk that the U.S. or foreign governments'
responses (including inaction) to national or global economic
conditions or infectious diseases, are ineffective and may
adversely affect SIGA’s business, and (xvii) risks associated with
responding to an 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,
2023 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.
Contacts:Suzanne
Harnettsharnett@siga.com
and
Investors |
Media |
Jennifer Drew-Bear, Edison GroupJdrew-bear@edisongroup.com |
Holly Stevens, Berry & Companyhstevens@berrypr.com |
SIGA TECHNOLOGIES, INC.CONDENSED
CONSOLIDATED BALANCE SHEETS (UNAUDITED)As
of |
|
|
|
September 30, 2024 |
|
|
December 31, 2023 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
99,269,756 |
|
|
$ |
150,145,844 |
|
Accounts receivable |
|
|
12,089,010 |
|
|
|
21,130,951 |
|
Inventory |
|
|
62,024,473 |
|
|
|
64,218,337 |
|
Prepaid expenses and other current assets |
|
|
7,302,979 |
|
|
|
3,496,028 |
|
Total current assets |
|
|
180,686,218 |
|
|
|
238,991,160 |
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net |
|
|
1,411,315 |
|
|
|
1,331,708 |
|
Deferred tax asset, net |
|
|
12,104,765 |
|
|
|
11,048,118 |
|
Goodwill |
|
|
898,334 |
|
|
|
898,334 |
|
Other assets |
|
|
253,605 |
|
|
|
2,083,535 |
|
Total assets |
|
$ |
195,354,237 |
|
|
$ |
254,352,855 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,260,762 |
|
|
$ |
1,456,316 |
|
Accrued expenses and other current liabilities |
|
|
7,184,514 |
|
|
|
10,181,810 |
|
Deferred IV TPOXX® revenue |
|
|
13,729,440 |
|
|
|
20,788,720 |
|
Income tax payable |
|
|
127,815 |
|
|
|
21,690,899 |
|
Total current liabilities |
|
|
22,302,531 |
|
|
|
54,117,745 |
|
|
|
|
|
|
|
|
|
|
Other liabilities |
|
|
3,609,572 |
|
|
|
3,376,203 |
|
Total liabilities |
|
|
25,912,103 |
|
|
|
57,493,948 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
|
|
Common stock ($.0001 par value, 600,000,000 shares authorized,
71,369,274 and 71,091,616, issued and outstanding at September 30,
2024 and December 31, 2023, respectively) |
|
|
7,137 |
|
|
|
7,109 |
|
Additional paid-in capital |
|
|
238,033,324 |
|
|
|
235,795,420 |
|
Accumulated deficit |
|
|
(68,598,327 |
) |
|
|
(38,943,622 |
) |
Total stockholders’ equity |
|
|
169,442,134 |
|
|
|
196,858,907 |
|
Total liabilities and stockholders’ equity |
|
$ |
195,354,237 |
|
|
$ |
254,352,855 |
|
SIGA TECHNOLOGIES, INC.CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
INCOME/(LOSS) (UNAUDITED) |
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales and supportive services |
|
$ |
8,942,875 |
|
|
$ |
7,958,289 |
|
|
$ |
53,496,869 |
|
|
$ |
14,924,058 |
|
Research and development |
|
|
1,066,906 |
|
|
|
1,276,882 |
|
|
|
3,753,658 |
|
|
|
8,512,303 |
|
Total revenues |
|
|
10,009,781 |
|
|
|
9,235,171 |
|
|
|
57,250,527 |
|
|
|
23,436,361 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales and supportive services |
|
|
1,620,510 |
|
|
|
896,537 |
|
|
|
17,157,508 |
|
|
|
3,021,145 |
|
Selling, general and administrative |
|
|
4,822,591 |
|
|
|
5,999,761 |
|
|
|
18,228,786 |
|
|
|
14,660,828 |
|
Research and development |
|
|
3,024,593 |
|
|
|
3,648,117 |
|
|
|
8,966,905 |
|
|
|
13,810,307 |
|
Total operating expenses |
|
|
9,467,694 |
|
|
|
10,544,415 |
|
|
|
44,353,199 |
|
|
|
31,492,280 |
|
Operating income/(loss) |
|
|
542,087 |
|
|
|
(1,309,244 |
) |
|
|
12,897,328 |
|
|
|
(8,055,919 |
) |
Other income, net |
|
|
1,330,505 |
|
|
|
883,148 |
|
|
|
4,590,935 |
|
|
|
2,964,482 |
|
Income/(Loss) before income taxes |
|
|
1,872,592 |
|
|
|
(426,096 |
) |
|
|
17,488,263 |
|
|
|
(5,091,437 |
) |
(Provision)/Benefit for income taxes |
|
|
(528,647 |
) |
|
|
33,030 |
|
|
|
(4,034,362 |
) |
|
|
904,638 |
|
Net and comprehensive income/(loss) |
|
$ |
1,343,945 |
|
|
$ |
(393,066 |
) |
|
$ |
13,453,901 |
|
|
$ |
(4,186,799 |
) |
Basic income/(loss) per share |
|
$ |
0.02 |
|
|
$ |
(0.01 |
) |
|
$ |
0.19 |
|
|
$ |
(0.06 |
) |
Diluted income/(loss) per share |
|
$ |
0.02 |
|
|
$ |
(0.01 |
) |
|
$ |
0.19 |
|
|
$ |
(0.06 |
) |
Weighted average shares outstanding: basic |
|
|
71,368,585 |
|
|
|
71,084,735 |
|
|
|
71,191,019 |
|
|
|
71,453,397 |
|
Weighted average shares outstanding: diluted |
|
|
71,766,503 |
|
|
|
71,084,735 |
|
|
|
71,853,341 |
|
|
|
71,453,397 |
|
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