Management Presentation - March 2021 - Investor Relations
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March 2021 Management Presentation
Forward Looking Statements
The statements made in this presentation may include forward-looking statements regarding the treatment of smallpox and
other orthopoxvirus infections, the development and attributes of SIGA Technologies, Inc. (“SIGA”) products, and the future
operations, opportunities or financial performance of SIGA. Although we believe that the expectations contained in this
presentation are reasonable, these forward-looking statements are only estimations based upon the information available to
SIGA as of the date of this presentation. Except as required by law, we expressly disclaim any responsibility to publicly update
or revise our forward-looking statements, whether as a result of new information, future events or otherwise. Thus, the
forward-looking statements herein involve known and unknown risks and uncertainties and other important factors such that
actual future operations, opportunities or financial performance may differ materially from these forward-looking
statements.
Undue reliance should not be placed on forward looking statements, which speak only as of the date hereof. All forward-
looking statements contained herein are qualified in their entirety by the foregoing cautionary statements.
For a more detailed discussion of our risks, see the Risk Factors section in SIGA’s Annual Report on Form 10-K for the fiscal
year ended December 31, 2020 filed with the SEC and our other filings with the SEC, including our most recent Quarterly
Report, all of which are available on our website, www.siga.com.
2
Company Overview
SIGA Company Overview
Commercial stage pharmaceutical company focused on health
security and infectious disease
Lead product is an oral formulation of TPOXX®, an antiviral drug
for the treatment of smallpox (FDA approved in 2018)
TPOXX is stockpiled by the US Government for smallpox; current
$600+ million contract with BARDA primarily seeks to replenish
the U.S. Government’s stockpile of TPOXX®
TPOXX is being sold internationally through a promotion and
sales partnership with Meridian Medical Technologies (a Pfizer
company)
Completed first international sale to Canada in 2020; anticipate
Canadian deliveries of TPOXX of up to approximately $45 million
mostly over next four years
In July 2019, the Company was awarded a contract from the U.S.
Department of Defense (currently at ~ $23 mm) to pursue
development of post-exposure prophylaxis (“PEP”) indication
PEP label expansion would result in substantially higher
usage of TPOXX during an outbreak, and may require a
higher stockpile to meet demand
4
SIGA: Commercial Stage Pharmaceutical Company
Non-TPOXX Value Creation
M&A
Ongoing TPOXX Initiatives
Collaborations
Label Expansion
─ Post-Exposure Prophylaxis Oncology
(“PEP”) label provides
ST-357, Novel Mechanism of
Existing TPOXX Contracts opportunity to significantly
Action Smallpox Antiviral
expand U.S. stockpile
$600+ million U.S. International Build
Government Contract for ─ First international sale in
TPOXX (lead product) Canada in 2020
Replenish 1.7 mm course ─ EMA and Canada regulatory
SNS stockpile submissions in 2020
─ Partnership with Meridian /
$113 mm of oral TPOXX Pfizer to market
product revenues in internationally
2020 Formulation Expansion
$414 mm of ─ Anticipated NDA submission
procurement revenues for IV in April 2021
expected next 4 years ─ Liquid Formulation
Canadian contracts for up to Capital Management
$47 mm of product deliveries
issued between April 2020 –
January 2021
5
SIGA Company Overview of Key Milestones
Historical & Upcoming Milestones for TPOXX®
March 2013
Current Market for TPOXX®
September 2018
Initial delivery of Oral TPOXX® to U.S.
Executed $600+ million
Government stockpile
contract with BARDA
2020
Delivery of 363,000 courses
July 2018 of TPOXX (value of $113 mm)
May 2011 FDA approval of Oral TPOXX®
Entered into initial
contract with BARDA
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Label / Market / Formulation
July 2019 – Label Expansion 2022
Expansion Opportunities
Awarded contract from DoD to PEP Clinical Data
support work in PEP
May 2020 – Market Expansion Late 2021/early 2022
First international delivery to Canadian Department of EMA and Health Canada Approvals
National Defence
2020 – Market / Label Expansion 2021
Submission for EMA and for Canadian approval for Oral TPOXX® (including indications for Initiation of PEP Clinical Studies
monkeypox, cowpox, and vaccinia complications)
2021
Early 2021 – New Formulation Additional International Sales
Anticipated NDA submission for the IV formulation
of TPOXX®
Over time, the sources of TPOXX®-related revenue have expanded
and are expected to continue to expand. Note that TPOXX product revenue has occurred prior to regulatory
approval in US and in Canada as stockpiles are established while regulatory approval is being pursued.
6
Key Investment Highlights
Proven platform, decade-long track record of contracting with the U.S. Government
(“USG”); USG stockpile of 1.7 million courses of smallpox antiviral; Pursuing
stockpile expansion to ensure full access to benefits of TPOXX
In partnership with the Department of Defense, pursuing a post-exposure
prophylaxis (“PEP”) indication, which has the potential to double the courses
needed in existing USG stockpile
First international delivery of TPOXX® in May 2020; significant growth opportunity
with international military and civilian government purchasers around the world
Highly scalable operating model; US based Supply Chain to ensure robust security;
end-to-end product development and commercial capabilities
COVID-19 pandemic has dramatically increased government focus on health
security preparedness; over $40B appropriated to address the coronavirus
outbreak
Uniquely positioned to navigate the increasing role of USG in pharmaceutical
industry, extensive patent portfolio with strong protections past 2030
7
Smallpox and the Health Security Market
Smallpox Outbreak Could Be Much Worse than COVID-19
Smallpox has higher mortality and morbidity rates than COVID-19 and is more easily transmitted; availability of
smallpox antiviral drug and vaccines would have tremendous value once an outbreak is recognized
Smallpox COVID-19
Mortality Rate Up to 30% of cases < 3% of U.S. cases
Average of ~5 people infected by Average of ~2 to 4 people
Transmission
each sick person infected by each sick person(1)
Permanent scarring and potential
Morbidity TBD
blindness
SIGA is Pursuing Label Expansions to ensure access to the potential uses of TPOXX,
and an Increase in the US Stockpile to Ensure Preparedness
Sources: Centers for Disease Control and Prevention, World Health Organization.
1. New York Times as of February 28, 2020.
9Smallpox Remains Widely Recognized as a Significant
Bioterrorism Threat
The Threat of Smallpox Today
and Tomorrow
“
North Korea is far more likely to “Somebody would reconstruct, say, a smallpox
virus and have that spread, and that would not
use biological weapons than only kill millions, it could potentially kill billions.”
nuclear ones. The program is
advanced, underestimated and Bill Gates on bioterrorism, 2017, PBS
highly lethal.
”
Andrew C. Weber
Pentagon official in charge of nuclear, chemical and biological “In 2014, the NIH discovered live stocks in a storage room on
defense programs under President Obama its campus in Bethesda, Maryland. If the venerable and highly
regulated NIH could lose track of smallpox, other institutions
The New York Times, 2019
could have some forgotten vials as well.”
August 2018
10Viral Outbreaks, Including Those of Orthopoxviruses, are
Becoming More Common
2014 &
2002 2009 2013 2016 2019 2020
2018
SARS H1N1 MERS ZIKA EBOLA Monkeypox COVID-19
Species of A virus that Respiratory Can trigger A virus that An The disease
coronavirus was the most syndrome paralysis causes severe orthopoxvirus causes
that infects common related (Guillain- bleeding, that causes respiratory
people, bats, cause of coronavirus Barre organ failure, mortality in illness with
and certain human which infects, Syndrome). In and can lead up to 10% of symptoms
other influenza and humans, bats, pregnant to death cases such as a
mammals is associated and camels women, it cough, fever,
with the 1918 may cause and difficulty
Spanish Flu birth defects breathing
SIGA is seeking an expanded label in the EU and Canada for TPOXX® to include treatment of
orthopoxviruses
11Product Overview
Oral TPOXX® (Tecovirimat/ST-246) FDA-approved (July 2018) novel small-molecule oral drug indicated for treatment of human smallpox disease in adults and pediatric patients ≥13 kg Exhibits antiviral activity against all orthopoxviruses tested in vitro (nanomolar concentrations) and in animal models No drug-related SAEs in clinical trials Adult Dosing: Oral capsule (200 mg/capsule)/600 mg twice a day for 14 days 84-months stability demonstrated for active pharmaceutical ingredient (tecovirimat monohydrate) and final drug product (TPOXX®) More than two million courses of treatment delivered to the U.S. Strategic National Stockpile (“SNS”) European Medicines Agency (EMA) Marketing Authorisation Application (MAA) and Canadian New Drug Submission (NDS) filed in 2020 for indications including smallpox, vaccinia complications, monkeypox and cowpox
Expanded TPOXX® Label Indications - Regulatory Strategies
Current indication: smallpox Proposed indication for Proposed indication: all human
therapeutic only tecovirimat: all human pathogenic orthopoxviruses
─ NDA submitted on pathogenic orthopoxviruses (smallpox, monkeypox,
December 8, 2017 (smallpox, monkeypox, cowpox, vaccinia)
(accepted for review in cowpox, vaccinia)
─ Pre-Submission Meeting:
February 2018) ─ Centralized Procedure 1Q20
─ Advisory Committee on May Acceptability filed in ─ NDS Submission
1, 2018 (voted 17-0 in favor November 2018 December 2020
of treatment based upon ─ Letter of Intent filed in
risk-benefit profile) November 2018
─ FDA marketing approval on ─ Pre-Submission Meeting
July 13, 2018 held in April 2019
Planned Label Expansion ─ Rapporteur Meeting:
─ Post-Exposure Prophylaxis 1Q20
─ Other Orthopoxviruses ─ MAA Submission July
2020
IV Formulation
Pediatric Liquid Formulation
14TPOXX® Positioned for Broad Penetration into International
Markets
A Robust TPOXX®
SIGA SIGA International Market
Strategy
Government contracting 50 years experience in Focused marketing program
expertise selling Medical with global reach
Proven scientific and Countermeasures Proven sales model
commercial track record
Full ownership of asset & IP
Responsible for: +
Global reach; sales in over
30 countries worldwide
Responsible for international
= (military, civilian)
Diverse target market
− Each international
marketing of oral TPOXX® government has unique
− TPOXX® manufacture
(excluding U.S.) geopolitical
− Regulatory requirements
considerations and
− Marketing support under internal dynamics
the direction of Meridian
− Intellectual Property
First TPOXX international contract in May 2020; Two TPOXX International
Contracts to Date
15TPOXX Additional Formulations
Formulation Target Indication Procurement Status
Intravenous (IV) Treatment of smallpox 19C BARDA Contract has NDA filing targeted for
disease in individuals $85 million in April 2021
too sick or unable to procurement options
swallow oral TPOXX®
capsules
Pediatric Liquid Treatment of individuals None today, Development fully
Suspension < 13 kg approximately 4% of US funded by BARDA
population isST-357 – Potential Second Smallpox Antiviral
ST-357 has a unique target and mechanism of action that is distinct from TPOXX®; BARDA has a long-
standing goal to stockpile two smallpox antiviral drugs with different mechanisms of action
Target conserved in all chordopox family viruses (orthopox, molluscum contagiosum,
cervidpox)
Potential
Broad Potent antiviral activity demonstrated in vitro against numerous poxviruses
Application
Proof-of-concept in vivo efficacy demonstrated in mouse models with three
orthopoxviruses (ECTV, VACV and CPXV)
NIAID currently supporting initial medicinal chemistry campaign
Collaborations CDC has requested approval to test promising analogs versus variola virus
& Progress
SIGA is pursuing support from US Government for development
17Pursuing TPOXX Label
Expansions: PEP,
Monkeypox, Cowpox,
VacciniaTPOXX for PEP is Important in Filling the Remaining Gap in
Smallpox Preparedness
Antiviral Post-Exposure Prophylaxis
Antiviral Treatment (FDA Approved)
(Developing Label Expansion)
VACCINE (HEALTH SECURITY GAP) TPOXX®
INCUBATION (ASYMPTOMATIC STAGE) FEVER RASH
DAY 1 DAY 4 DAY 14 DAY 17 DAY 20
INFECTION INFECTIOUS
START STAGE
“The reality is that [smallpox] is so highly infectious, that post-exposure prophylaxis is
going to be a knee-jerk reaction to anybody at any time if you've got anybody who's
been diagnosed. So anybody who's within eyeball shot of somebody who's got a
diagnosed case of smallpox is going to be getting [TPOXX®]...”
-- Colonel Peter Weina, MD, the Chief of Research at Walter Reed Military Medical Center
US FDA Antimicrobial Drugs Advisory Committee, May 1, 2018 (https://www.fda.gov/media/114205/download)
Pursuing PEP Under $26M Contract with US Department of Defense
19TPOXX PEP Market Opportunity to Expand Stockpile
Opportunity:
1.7 Million PEP Courses
(3.4 Million Treatment Courses)
Consistent with current requirements while
ensuring full access to PEP therapy (PEP is a 28-day
course vs 14-day course for treatment of
symptomatic disease)
Current:
1.7 Million Treatment Courses
Only treatment of patients showing
symptoms of smallpox and no PEP treatment
Current $600+ million contract
20Seeking Additional Indications for TPOXX
Orthopoxvirus infections can Vaccinia virus
cause a spectrum of febrile rash
Vaccinia virus is used as the smallpox vaccine and some cancer
illnesses in humans, from fairly therapies in development. It causes sporadic disease in those
benign, localized skin infections immunized/treated, contacts of those immunized/treated, and
laboratory workers. Infection can be lethal in immunocompromised
to severe systemic infections. individuals.
Cowpox virus
There are four orthopoxvirus Human cowpox virus infection is classically associated with
occupational exposure to cattle; however, other animals, including
species known to cause human rats, pet cats, and zoo and circus elephants, have been implicated.
disease Infection can be lethal in immunocompromised individuals.
Monkeypox virus
SIGA filed in 2020 with the Monkeypox virus causes intermittent human infections, primarily in
European Medicines Agency and Central and West Africa, although isolated outbreaks have been
identified in the United States and Sudan. The disease is very similar to
Health Canada for the broader smallpox. Case fatality rates range from 10% depending on
indication for the treatment of virus clade.
orthopoxvirus disease. Variola virus
FDA approval for treatment in 2018 (smallpox)TPOXX as Treatment of Vaccinia Complications
(Compassionate Use)
2007
28-month old child1-3
Diagnosed with eczema vaccinatum after contact with his father, an active
U.S. military service member who had recently received smallpox vaccination 1
2009
20-year old active U.S. military service member4,5
Presented with progressive vaccinia after receiving smallpox vaccination
35-year old female6 4.5
Developed a vaccinia infection after exposure to a recombinant vaccinia-
based rabies vaccine
2011
25-year old female
Developed a vaccinia infection after changing a bandage covering a smallpox
vaccination site for her boyfriend, a U.S. military contractor
2015
Active U.S. military male service member
Developed vaccine complications due to a concomitant undiagnosed cancer
1) Science. 2007;316:1418-1419. 2) CDC MMWR. 2007;56:478-481. 3) Vora S et a. Clin. Infect Dis. 2008;46: 4) CDC MMWR. 2009;58:532-536.
5) J Infect Dis.2012;206:1372-1385. 6) CDC MMWR. 2009;58:1204-1207.
22TPOXX® May Support Adoption of Vaccinia-based Cancer
Therapies
Barriers to Vaccinia Market Growth
Concern for Burdensome local Dosing limits efficacy:
complications: Fear administration: Even modest
associated with the Limited efficacy via improvement in efficacy
potential for serious systemic delivery will may impact broader use
adverse events may limit limit adoption in the given the competitive
use clinic landscape
Potential value proposition
TPOXX® may improve the safety profile TPOXX® may allow for more
of vaccinia therapy and increase aggressive treatment strategies thus
confidence with patients, regulators and improving therapeutic benefit
physicians
23Financial Overview
Target Procurement Revenue Sources for SIGA
2021 – 2024 Targets
2020
Total 4-year Average
Product Revenues -
2018 BARDA $113M $414M $104M
Contract
Ramping
International $2 M
Up
SNS Expansion for
Building
PEP indication
The Foundation
Other Platform
Revenues Scanning
252020 Financial Results
2020 Amount
Product Revenues $115 mm
Other Revenues $10 mm
Total Revenues $125 mm
Operating Income (1) $85 million
Net Income $56 mm
Diluted EPS $0.71 / share
‘(1) Operating income excludes taxes, costs in connection with the retirement of the Company’s Term Loan in March 2020,
interest expense, interest income and adjustments to the fair value of the Company’s outstanding warrant.
26Corporate Focus: 2021 / 2022
Execute on 2018 BARDA Procurement Contract
Pursue International Sales with Meridian Medical Technologies
Secure Label Expansions for PEP and Other Orthopoxvirus Indications
Expand and Support Oncology Collaborations for TPOXX
Leverage Proven Networked Capabilities
Maximize Corporate Value
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