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SIGA Technologies Inc. (NASDAQ: SIGA) is a commercial-stage pharmaceutical company that targets the health security market. SIGA specializes in the development of antiviral therapeutics aimed at treating some of the world's most lethal pathogens including smallpox, Ebola, dengue, and Lassa fever. The company's flagship product, TPOXX® (also known as tecovirimat and ST-246®), is an oral and intravenous formulation antiviral drug approved for the treatment of human smallpox disease caused by the variola virus.
TPOXX has received approval from multiple regulatory bodies. In 2018, the U.S. Food and Drug Administration (FDA) approved the oral formulation of TPOXX, followed by approval for the intravenous formulation in 2022. The European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom also approved oral TPOXX in 2022 for treating smallpox, monkeypox, cowpox, and complications arising from vaccinia virus infections post smallpox vaccination.
In recent developments, SIGA has expanded its reach in Europe through a joint procurement mechanism, allowing multiple EU countries to access oral TPOXX. Orders under this mechanism are anticipated to generate around $164 million in 2023, with a substantial portion of deliveries expected within the year. As such, the company projects a pre-tax operating income between $90 million and $100 million for 2023. Additionally, SIGA has recently amended its international promotion agreement with Meridian Medical Technologies, Inc., granting SIGA primary responsibility for promoting oral TPOXX in various territories, including the European Union, thereby enhancing its global reach.
SIGA also maintains a strong relationship with the Biomedical Advanced Research and Development Authority (BARDA) for the procurement and development of both oral and intravenous formulations of TPOXX under Project BioShield. This partnership underscores SIGA's commitment to enhancing global health security through its innovative antiviral treatments.
With a clear focus on health security, SIGA aims to address high-priority biological threats, providing solutions that are crucial in preparing for and mitigating the impact of infectious diseases and potential bioterrorist threats.
SIGA Technologies has filed a New Drug Application (NDA) with the FDA for an intravenous (IV) formulation of TPOXX to treat smallpox in adults and pediatric patients over 13 kg. This marks a significant step in expanding treatment options for patients unable to swallow oral capsules, particularly relevant amid the ongoing COVID-19 pandemic. The IV formulation leverages data from prior studies, eliminating the need for additional trials. TPOXX is the first approved smallpox antiviral, and SIGA aims to facilitate access for a broader patient population in emergencies.
SIGA Technologies, Inc. (SIGA) announced a webcast and conference call scheduled for May 6, 2021, at 4:30 P.M. ET to provide a business update. CEO Phil Gomez and CFO Daniel Luckshire will participate. SIGA specializes in health security, primarily focusing on countermeasures against biological threats. Its lead product, TPOXX®, is a treatment for smallpox, with the US holding a stockpile of 1.7 million treatment courses. The company signed a potentially $600 million contract with BARDA in 2018 for TPOXX® development and procurement.
On March 23, 2021, Cipla Therapeutics and SIGA Technologies announced a strategic partnership aimed at addressing antimicrobial resistance (AMR). With AMR identified as a top global health threat by the WHO, this collaboration seeks to leverage Cipla's antibiotic expertise and SIGA's drug development skills to deliver innovative solutions to the Biomedical Advanced Research and Development Authority (BARDA). The partnership will enhance U.S. health security by providing access to novel antibacterial drugs, notably Cipla's ZEMDRI®. The deal aligns with both companies' commitment to countering AMR and improving public health.
SIGA Technologies reported strong financial results for 2020, delivering approximately 363,000 courses of oral TPOXX® to the U.S. government, generating $113 million in revenue. In Q4 alone, revenues reached $37.8 million, compared to $26.8 million in Q4 2019. The company also secured international contracts worth up to $47 million, including a $33 million contract from Canada's Public Health Agency. Despite the challenges posed by the COVID-19 pandemic, SIGA's financial position remains stable. A conference call is scheduled for March 4, 2021, to discuss these developments.
SIGA Technologies, Inc. (SIGA) will host a webcast and conference call on March 4, 2021, at 4:30 PM ET to provide a business update. The call will feature CEO Dr. Phil Gomez, CFO Daniel Luckshire, and CSO Dr. Dennis Hruby. Participants can join the live webcast on SIGA's website, with a replay available for two weeks. SIGA focuses on health security, particularly through its lead product, TPOXX, an antiviral drug for smallpox. The company maintains a stockpile of 1.7 million doses in the Strategic National Stockpile.
SIGA Technologies (SIGA) announced a significant contract with the Public Health Agency of Canada for the purchase of oral TPOXX® valued at up to $33 million over five years. The initial commitment includes $3.4 million by March 31, 2021, and a cumulative $17.2 million by March 31, 2023. This contract follows a previous $14 million agreement with the Canadian Department of National Defence. SIGA expects Canadian regulatory approval for TPOXX in late 2021 or early 2022, enhancing its role in biodefense and public health preparedness.
On November 12, 2020, SIGA Technologies (SIGA) announced Dr. Dennis Hruby's participation in a panel discussion at the Non-Conventional Threats (NCT) Asia Virtual Conference. The discussion, titled “COVID-19: Insights on an Epidemic Outbreak,” is scheduled for November 13, 2020, highlighting the importance of health security amidst the ongoing pandemic. Dr. Hruby emphasized the significance of TPOXX® (tecovirimat), an antiviral drug for smallpox, as a countermeasure against potential future pandemics. SIGA maintains a stockpile of 1.7 million TPOXX® courses under Project BioShield.
In Q3 2020, SIGA Technologies (SIGA) delivered approximately 134,000 courses of TPOXX® to the U.S. government, generating revenue of $41.4 million. Total revenues for Q3 were $44.3 million, a 35% increase compared to $32.9 million in Q3 2019. The company also reported net income of $31.6 million or $0.31 per share. Additionally, Canada plans to purchase up to 33,300 courses of TPOXX® over five years. SIGA repurchased 0.9 million shares for $5.6 million, totaling 3.7 million shares repurchased in 2020.
SIGA Technologies, Inc. (SIGA) will host a business update conference call on November 5, 2020, at 4:30 PM ET. CEO Dr. Phil Gomez and CFO Daniel Luckshire will present. A live webcast will be accessible via SIGA's website, and a replay will be available for two weeks. SIGA focuses on health security, with its leading product TPOXX® for smallpox treatment, approved by the FDA in July 2018. The U.S. government maintains a stockpile of 1.7 million courses under Project BioShield. For more details, visit www.siga.com.
SIGA Technologies (SIGA) announced a potential contract with the Public Health Agency of Canada (PHAC) for up to 33,300 courses of oral TPOXX (tecovirimat) over five years. The contract includes delivery of 18,500 courses by March 31, 2023, with an optional 14,800 courses afterward. This follows a prior contract from the Department of National Defence for 15,325 courses. SIGA plans to submit a marketing authorization application to Health Canada by the end of 2020, aiming for approval in 2021.
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