SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage
pharmaceutical company focused on the health security market, today
reported financial results for the three and six months ended June
30, 2020.
“SIGA’s successful second quarter was highlighted
by the initial deliveries of TPOXX® to the U.S. Strategic National
Stockpile pursuant to the April option exercises and to the
Canadian Department of Defence, as part of our first international
order,” said Phil Gomez, CEO of SIGA. “In addition to our strong
financial results, we are laying the groundwork for the future; We
recently submitted a Marketing Authorisation Application for oral
tecovirimat with the European Medicines Agency in July, and are
targeting regulatory submissions within the next six months to
Health Canada for oral TPOXX, as well as a New Drug Application for
the IV formulation of TPOXX to the FDA. Furthermore, we are
preparing clinical protocols to support the potential expansion of
the oral TPOXX label in the U.S. to include Post-Exposure
Prophylaxis, a program we are developing with funding from the U.S.
Department of Defense.”
Summary Financial Results ($ in millions,
except per share amounts)
Three Months Ended June 30, 2020 in
comparison to Three Months Ended June 30, 2019
|
Three Months Ended June 30, 2020 |
|
Three Months Ended June 30,2019 |
Total Revenues Operating Income (Loss) (1) Income (Loss) before
Income Taxes (1) Net Income (Loss) Diluted Income (Loss) per
Share |
$40.3 $28.8 $27.2 $20.9 $0.26 per share |
|
$3.9 ($1.7) ($4.3) ($3.2) ($0.05) per share |
Six Months Ended June 30, 2020 in
comparison to Six Months Ended June 30, 2019
|
Six Months Ended June 30, 2020 |
|
Six Months Ended June 30, 2019 |
Total Revenues Operating Income (1) Income (Loss) before Income
Taxes (1) Net Income (Loss) Diluted Income (Loss) per Share |
$43.0 $24.8 $15.6 $12.0 $0.15 per share |
|
$14.4 $0.5 ($2.1) ($1.5) ($0.06) per share |
(1) Operating Income excludes, and Income (Loss)
before Income Taxes includes, costs in connection with the
retirement of the Company’s term loan, interest expense, interest
income and adjustments to the fair value of the Company’s
outstanding warrant. Both line items exclude the impact of
income taxes.
Recent Key Activities:
- On July 30, the Company announced that it filed a Marketing
Authorisation Application (MAA) with the European Medicines Agency
(EMA) for oral tecovirimat. SIGA is targeting approval for
the second half of 2021.
- On June 25, the Company announced that approximately 117,000
courses of oral TPOXX® were delivered to the Strategic National
Stockpile. SIGA has recognized $36.2 million of revenue in
connection with these deliveries, of which $3.6 million relates to
amounts previously received in connection with raw material
procurement and recorded as deferred revenue.
- On June 15, the Company announced that the United States
Department of Defense (“DoD”) increased research and development
funding to approximately $23 million in connection with
the DoD contract, to support work necessary to obtain a
potential label expansion from the U.S. Food and Drug
Administration (FDA) for oral TPOXX to cover Post-Exposure
Prophylaxis (PEP), in addition to the currently approved labeling
for the treatment of smallpox.
- On June 1, the Company announced its first international
delivery of TPOXX® (tecovirimat) with 2,500 courses delivered
to the Canadian Department of National
Defence (CDND). In connection with this delivery, SIGA
recognized revenue of $2.3 million. The delivery was made as
part of the contract awarded by the CDND to Meridian Medical
Technologies, Inc. (“Meridian”, a Pfizer Company) (“Canadian
Contract”), in which the CDND will purchase up to 15,325 courses of
oral TPOXX over four years for a total value of $14.3 million.
Remaining purchases of up to 12,825 courses under this contract are
at the option of the CDND and are expected to occur after
regulatory approval of oral TPOXX in Canada. Meridian is
counterparty to the Canadian Contract and SIGA is responsible for
manufacture and delivery of oral TPOXX. The contract award was
coordinated between SIGA and Meridian under the international
promotion agreement entered into by the parties on June 3,
2019.
Share Repurchase Activity
During the second quarter, SIGA repurchased
approximately 2.5 million shares of its common stock, for
approximately $15.2 million.
Product Delivery Expectations in
Connection with the 19C BARDA Contract
Pursuant to options already exercised under the 19C
BARDA Contract, SIGA expects to deliver approximately 246,000
courses of oral TPOXX to the SNS (in addition to those courses
recently delivered) by April 2021, and such deliveries may occur in
their entirety in 2020. These deliveries are expected to
generate revenues of approximately $76 million. In addition to the
above-mentioned expectations, the 19C BARDA Contract has up to $414
million of procurement-related options remaining for future
exercise by BARDA.
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 future
course of the COVID-19 pandemic, and the uncertain scale and scope
of its future impact, the Company is continually reviewing business
and financial risks related to the pandemic and is continually
seeking coordination with its government partners with respect to
the performance of current and future government contracts.
Additionally, the Company is continually coordinating with service
providers and vendors, in particular contract manufacturing
organizations (“CMOs”) that constitute our supply chain, to review
actions and risks caused by the COVID-19 pandemic.
The COVID-19 pandemic has not adversely affected
the liquidity position of the Company, nor is it currently expected
to have a material adverse effect on the financial condition or
annual financial results of the Company, although the Company
cannot provide assurances as to the ultimate impact of the pandemic
upon the macro environment or the Company’s industry.
Conference Call and Webcast
SIGA will host a conference call and webcast to
provide a business update today, Thursday, August 6, 2020, at 4:30
P.M. ET.
Participants may access the call by dialing
877-407-6184 for domestic callers or 201-389-0877 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 877-660-6853 for domestic callers or 201-612-7415
for international callers and using Conference ID: 13706604. 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
stockpile of 1.7 million courses in the Strategic National
Stockpile under Project BioShield. The oral formulation of TPOXX®
was approved by the FDA for the treatment of smallpox in 2018. The
full label is here:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fce826ab-4d6a-4139-a2ee-a304a913a253.
In September 2018, SIGA signed a contract potentially worth more
than $600 million with BARDA 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 Smallpox1
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 certain
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended. 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. More
detailed information about SIGA and risk factors that may
affect the realization of forward-looking statements, including the
forward-looking statements in this press release, is set forth
in SIGA's filings with the Securities and Exchange
Commission, including SIGA's Annual Report on Form 10-K
for the year ended December 31, 2019, and in other documents
that SIGA has filed with
the SEC. SIGA urges investors and security holders
to read those documents free of charge at the SEC's web
site at http://www.sec.gov. Interested parties may also obtain
those documents free of charge from SIGA. Forward-looking
statements are current only as of the date on which such statements
were made, and except for our ongoing obligations under the
United States of America federal securities laws, we undertake
no obligation to update publicly any forward-looking statements
whether as a result of new information, future events, or
otherwise.
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:InvestorsDavid Carey
212-867-1768david.carey@finnpartners.com
MediaStephanie
Seiler206-713-0124stephanie.seiler@finnpartners.com
1
http://www.mayoclinic.org/diseases-conditions/smallpox/basics/definition/con-20022769
SIGA TECHNOLOGIES,
INC.CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
|
|
June 30, 2020 |
|
|
December 31, 2019 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
53,065,833 |
|
|
$ |
65,249,072 |
|
Restricted cash and cash equivalents, short-term |
|
|
- |
|
|
|
95,737,862 |
|
Accounts receivable |
|
|
36,611,661 |
|
|
|
4,167,996 |
|
Inventory |
|
|
14,006,986 |
|
|
|
9,652,855 |
|
Prepaid expenses and other current assets |
|
|
1,382,499 |
|
|
|
5,234,000 |
|
Total current assets |
|
|
105,066,979 |
|
|
|
180,041,785 |
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net |
|
|
2,366,135 |
|
|
|
2,618,303 |
|
Deferred tax assets, net |
|
|
11,183,600 |
|
|
|
14,151,002 |
|
Goodwill |
|
|
898,334 |
|
|
|
898,334 |
|
Other assets |
|
|
901,906 |
|
|
|
856,766 |
|
Total assets |
|
$ |
120,416,954 |
|
|
$ |
198,566,190 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
630,165 |
|
|
$ |
3,054,032 |
|
Accrued expenses and other current liabilities |
|
|
14,931,370 |
|
|
|
8,636,911 |
|
Total debt, current |
|
|
- |
|
|
|
80,044,866 |
|
Total current liabilities |
|
|
15,561,535 |
|
|
|
91,735,809 |
|
Warrant liability |
|
|
7,752,534 |
|
|
|
6,116,882 |
|
Other liabilities |
|
|
2,969,867 |
|
|
|
2,929,743 |
|
Total liabilities |
|
|
26,283,936 |
|
|
|
100,782,434 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
|
|
Common stock ($.0001 par value, 600,000,000 shares authorized,
78,618,743 and 81,269,868 issued and outstanding at June 30, 2020,
and December 31, 2019, respectively) |
|
|
7,862 |
|
|
|
8,127 |
|
Additional paid-in capital |
|
|
221,380,828 |
|
|
|
220,808,037 |
|
Accumulated deficit |
|
|
(127,255,672 |
) |
|
|
(123,032,408 |
) |
Total stockholders’ equity |
|
|
94,133,018 |
|
|
|
97,783,756 |
|
Total liabilities and stockholders’ equity |
|
$ |
120,416,954 |
|
|
$ |
198,566,190 |
|
SIGA TECHNOLOGIES,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (UNAUDITED)
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales and supportive services |
|
$ |
38,624,450 |
|
|
$ |
- |
|
|
$ |
38,737,459 |
|
|
$ |
7,142,400 |
|
Research and development |
|
|
1,724,327 |
|
|
|
3,907,611 |
|
|
|
4,231,083 |
|
|
|
7,224,295 |
|
Total revenues |
|
|
40,348,777 |
|
|
|
3,907,611 |
|
|
|
42,968,542 |
|
|
|
14,366,695 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales and supportive services |
|
|
4,796,768 |
|
|
|
- |
|
|
|
4,905,863 |
|
|
|
915,367 |
|
Selling, general and administrative |
|
|
3,870,927 |
|
|
|
3,392,228 |
|
|
|
7,046,952 |
|
|
|
6,558,794 |
|
Research and development |
|
|
2,709,743 |
|
|
|
2,038,323 |
|
|
|
5,859,847 |
|
|
|
6,035,604 |
|
Patent expenses |
|
|
174,203 |
|
|
|
182,310 |
|
|
|
356,800 |
|
|
|
370,226 |
|
Total operating expenses |
|
|
11,551,641 |
|
|
|
5,612,861 |
|
|
|
18,169,462 |
|
|
|
13,879,991 |
|
Operating income (loss) |
|
|
28,797,136 |
|
|
|
(1,705,250 |
) |
|
|
24,799,080 |
|
|
|
486,704 |
|
(Loss) gain from change in fair value of warrant liability |
|
|
(1,619,587 |
) |
|
|
656,523 |
|
|
|
(1,635,652 |
) |
|
|
3,792,788 |
|
Loss on extinguishment of Term Loan |
|
|
- |
|
|
|
- |
|
|
|
(4,981,461 |
) |
|
|
- |
|
Interest expense |
|
|
- |
|
|
|
(3,971,031 |
) |
|
|
(3,016,817 |
) |
|
|
(7,899,449 |
) |
Other income, net |
|
|
31,931 |
|
|
|
737,577 |
|
|
|
444,295 |
|
|
|
1,473,706 |
|
Income (loss) before income taxes |
|
|
27,209,480 |
|
|
|
(4,282,181 |
) |
|
|
15,609,445 |
|
|
|
(2,146,251 |
) |
(Provision) benefit for income taxes |
|
|
(6,319,322 |
) |
|
|
1,119,689 |
|
|
|
(3,616,816 |
) |
|
|
613,536 |
|
Net and comprehensive income (loss) |
|
$ |
20,890,158 |
|
|
$ |
(3,162,492 |
) |
|
$ |
11,992,629 |
|
|
$ |
(1,532,715 |
) |
Basic income (loss) per share |
|
$ |
0.26 |
|
|
$ |
(0.04 |
) |
|
$ |
0.15 |
|
|
$ |
(0.02 |
) |
Diluted income (loss) per share |
|
$ |
0.26 |
|
|
$ |
(0.05 |
) |
|
$ |
0.15 |
|
|
$ |
(0.06 |
) |
Weighted average shares outstanding: basic |
|
|
80,340,695 |
|
|
|
80,986,524 |
|
|
|
80,790,400 |
|
|
|
80,950,124 |
|
Weighted average shares outstanding: diluted |
|
|
80,516,863 |
|
|
|
82,114,661 |
|
|
|
80,959,812 |
|
|
|
82,129,601 |
|
SIGA Technologies (NASDAQ:SIGA)
Historical Stock Chart
From Mar 2024 to Apr 2024
SIGA Technologies (NASDAQ:SIGA)
Historical Stock Chart
From Apr 2023 to Apr 2024