Short answer
Protagonist Therapeutics, Inc (PTGX) filed its fiscal 2025 10-K annual report with the SEC on Feb 25, 2026. It reported revenue of $46M (−89.4% year over year) and net income of −$130M.
- Top risk flagged: Regulatory risk: FDA approval timing and receipt of up to $400M payments plus $75M milestone under Takeda Collaboration Agreement opt-out in 2026
FY2025 key financial metrics · XBRL
- Revenue
- $46M
- −89.4% YoY
- Net income
- −$130M
- −147.3% YoY
- Operating margin
- -343.6%
- −401.8 pp YoY
- EPS (diluted)
- −$2.05
- −148.5% YoY
- ROE
- -21.2%
- −61.9 pp YoY
- Operating cash flow
- $58M
- −68.7% YoY
Source: XBRL data from the Protagonist Therapeutics, Inc (PTGX) FY2025 10-K on SEC EDGAR. USD.
Protagonist Therapeutics, Inc FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business: Development and commercialization of pharmaceutical and biological products subject to extensive U.S. and EU regulatory oversight
- New filings: July 2025 NDA by Johnson & Johnson for Icotyde; January 2026 NDA by Protagonist and Takeda for rusfertide for polycythemia vera
- Strategic focus: Emphasis on global clinical trials and international marketing with associated geopolitical and regulatory risk exposure
- Quantitative metric: Introduction of new U.S. tariffs up to 100% on branded pharmaceuticals announced September 2025, potential cost impact
- Noteworthy fact: May 2025 executive order on most-favored-nation drug pricing aiming to align U.S. prices with OECD countries affecting pricing strategy
Management Discussion & Analysis
- Revenue not explicitly disclosed; milestone payments: $165M (2025), $300M upfront (2024), $25M milestone (2025)
- Net loss $130.1M in 2025 vs net income $275.2M in 2024; no margin % figures provided
- Cash from operations $57.7M (2025) down from $184.2M (2024), driven by milestone-related cash flows
- Cash flow investing: $49.3M (2025) vs $299.5M (2024) used, mainly marketable securities transactions and capex $1.6M (2025)
- Financing cash inflows $22.9M (2025) vs $25.9M (2024) from stock issuances; $0 buybacks or dividends mentioned
- Outlook: Cash $646M sufficient for at least 12 months; potential future funding needs depend on pipeline advancement and collaborations
Risk Factors
- Regulatory risk: FDA approval timing and receipt of up to $400M payments plus $75M milestone under Takeda Collaboration Agreement opt-out in 2026
- Macroeconomic risk: exposure to geopolitical instability, high interest rates, and trade policy changes potentially impacting operations and FDA agency functioning
- Operational risk: reliance on third-party clinical trial sites and contract manufacturers with accrual variability affecting R&D expense accuracy
- Market disruption risk: competition in obesity and oral hepcidin therapy markets with development of PN-477, PN-458, and PN-8047 pipeline candidates
- Financial risk: cumulative net losses of $470.7M through 2025 with increased R&D expenses of $159.3M, pressuring liquidity and funding needs
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