Last close As at 05/08/2026
USD3.15
▲ −0.09 (−2.78%)
Market capitalisation
USD226m
Research: Healthcare
SIGA Technologies announced the FDA approval for its intravenous (IV) formulation of tecovirimat (TPOXX), an antiviral drug for the treatment of smallpox. We had already anticipated that approval was very likely to occur, and the formal decision expands the company’s addressable market to those who are unable to take the oral formulation (which was approved by the FDA in 2018). This follows on the heels of strong Q122 results and recent milestones, including EMA approval for oral TPOXX, the first contract for TPOXX in the Asia-Pacific region and increases in the Canadian oral TPOXX contract. We expect this new delivery medium, international expansion and the ongoing clinical study (on post-exposure prophylactic, PEP) to remain the key upcoming catalysts for SIGA shares. We maintain our $666m ($9.17 per share) equity valuation.
Written by
SIGA Technologies |
IV TPOXX receives FDA approval |
Update |
Pharma and biotech |
20 May 2022 |
Share price performance
Business description
Analysts
SIGA Technologies is a research client of Edison Investment Research Limited |
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SIGA Technologies announced the FDA approval for its intravenous (IV) formulation of tecovirimat (TPOXX), an antiviral drug for the treatment of smallpox. We had already anticipated that approval was very likely to occur, and the formal decision expands the company’s addressable market to those who are unable to take the oral formulation (which was approved by the FDA in 2018). This follows on the heels of strong Q122 results and recent milestones, including EMA approval for oral TPOXX, the first contract for TPOXX in the Asia-Pacific region and increases in the Canadian oral TPOXX contract. We expect this new delivery medium, international expansion and the ongoing clinical study (on post-exposure prophylactic, PEP) to remain the key upcoming catalysts for SIGA shares. We maintain our $666m ($9.17 per share) equity valuation.
Year end |
Revenue ($m) |
EBITDA* ($m) |
PBT* |
EPS* |
P/E |
Net debt/(cash)** |
12/20 |
125.0 |
88.6 |
81.5 |
0.81 |
11.4 |
(117.9) |
12/21 |
133.7 |
89.7 |
89.1 |
0.91 |
10.1 |
(103.1) |
12/22e |
125.0 |
63.5 |
63.0 |
0.66 |
14.0 |
(71.9) |
12/23e |
121.3 |
60.5 |
60.0 |
0.66 |
13.9 |
(94.9) |
Note: *EBITDA, PBT and EPS (diluted) are normalized, excluding exceptional items and other revenue and expenses. **Adjusted for special dividend in Q222e.
IV TPOXX is based on the same antiviral drug as the oral TPOXX formulation that was approved by the FDA in July 2018 for treating human smallpox in adults and pediatric patients (weighting 13kg or more). The IV TPOXX would treat those who are either too sick or unable to swallow capsules, which expands TPOXX to a new patient population. Roughly $7m worth of IV TPOXX deliveries were already made under the 19c BARDA contract. The 19c BARDA contract allocates about $85m for the procurement of 212,000 doses of IV TPOXX.
Recent news of monkeypox cases could be another catalyst for SIGA’s business, as the European Medicines Agency has approved oral TPOXX for treating orthopoxvirus pathogens like monkeypox. There are confirmed or suspected cases detected in the United States and Europe. Monkeypox is a viral disease that is spread typically by direct contact and is mostly found in West and Central Africa. According to the WHO, the disease can present with rash, fever and swollen lymph nodes, and unfortunately typically up to 6% of those ill with monkeypox may die, especially those in younger age groups. Note that the EMA-approved oral TPOXX has a broader indication for use to treat human orthopoxvirus pathogens, including monkeypox, and management has been focusing on generating European sales.
As we had already modelled this approval and future IV sales to BARDA for FY22 and the following years, we maintain our current forecasts. We currently value the IV business at a risk-adjusted NPV of $33m, or about 5% of our valuation for the company (of $666m, or $9.17 per basic share).
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Research: Investment Companies
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