SIGA Technologies, Inc. — FY2022 Form 10-K
Reporting period: Fiscal year ended December 31, 2022. This is an annual filing; it does not provide standalone fourth-quarter results. SIGA is a commercial-stage pharmaceutical company whose business is centered on TPOXX (tecovirimat), sold primarily to government customers.
Financial performance and liquidity
| Metric | FY2022 | FY2021 |
|---|---|---|
| Total revenue | $110.8 million | $133.7 million |
| Product sales and supportive services | $86.7 million | $126.8 million |
| Research and development contract revenue | $24.1 million | $6.9 million |
| Operating income | $42.7 million | $89.1 million |
| Net income | $33.9 million | $69.5 million |
| Diluted earnings per share | $0.46 | $0.91 |
| Cash provided by operating activities | $41.6 million | $11.5 million |
| Cash and cash equivalents at year-end | $98.8 million | $103.1 million |
- Total revenue fell about 17% year over year; product sales declined about 32%, while R&D contract revenue rose substantially.
- Operating margin was approximately 38.5%, versus 66.6% in FY2021. The filing attributes higher selling, general and administrative expense largely to Meridian promotion fees on increased international sales, and higher R&D expense to expanded PEP and BARDA activities.
- International TPOXX sales were $71.0 million, compared with $12.7 million in FY2021. U.S. revenue was $39.8 million, versus $120.7 million.
- Current assets were $185.8 million and current liabilities $21.5 million at year-end. Accounts receivable was $45.4 million, including $40.9 million of unbilled receivables; inventory was $39.3 million.
- SIGA reported no outstanding debt at year-end. Its term loan was repaid in 2020. FY2022 financing cash outflows included a $32.9 million special dividend and $13.0 million of share repurchases.
Material developments and outlook
- The FDA approved IV TPOXX for smallpox treatment in May 2022. Oral TPOXX was already FDA-approved for smallpox; EMA and UK approvals also cover mpox, cowpox and vaccinia complications, while Health Canada approval covers smallpox.
- FY2022 international orders totaled approximately $77 million from 13 customers; about $71 million was delivered and recognized as revenue in 2022. The remainder was expected to be fulfilled by July 31, 2023.
- The 19C BARDA contract contemplates up to approximately $602.5 million in payments. About $281.9 million remained in unexercised options at year-end, exercisable solely at BARDA’s discretion. SIGA estimated roughly 920,000 oral courses would need delivery in 2023–2024 to maintain historical U.S. stockpile levels; this is an estimate, not guaranteed procurement.
- DoD Contract #2 included a $5.2 million firm commitment and a $5.5 million option. The Canadian Department of National Defence also had remaining options under its contract.
- SIGA was pursuing a potential smallpox post-exposure prophylaxis label expansion. Subject to supportive trial results, management expected to prepare a supplemental NDA in 2023, targeting submission in early 2024. Mpox trials were enrolling; a possible FDA submission depends on case patterns, enrollment and trial results. No revenue or earnings guidance is provided.
- Management cited reliance on government procurement and discretionary contract options, third-party manufacturers, clinical and regulatory uncertainty, and supply-chain disruption as key risks. Meridian collects international customer payments and remits SIGA’s share. The filing estimates international contribution margins of 65%–80% before costs not directly related to manufacturing or Meridian; IV sales under the BARDA contract are estimated to have gross margins below 40% if related options are exercised.
- CEO Phillip Gomez announced plans to retire in 2023; the board had begun a successor search. The company reported effective internal control over financial reporting, and the auditor issued an unqualified opinion. Revenue recognition estimates for long-term R&D contracts were identified as a critical audit matter.
Key facts for investors to verify
- Whether BARDA exercises remaining options, and the timing and economics of any stockpile replenishment orders.
- Collection of year-end international receivables, including the approximately $35 million reported received in February 2023, and timely remittance through Meridian.
- Delivery of remaining 2022 international orders and the profitability of sales after Meridian fees and manufacturing costs.
- Results and timelines for PEP and mpox studies, and any resulting regulatory submissions or approvals.
- Manufacturing capacity, inventory quality and shelf life, and the impact of outstanding $33.8 million manufacturing purchase commitments.