Short answer
Innoviva, Inc. (INVA) filed its fiscal 2025 10-K annual report with the SEC on Feb 25, 2026. It reported revenue of $411M (+14.7% year over year) and net income of $271M.
- Top risk flagged: FDA approval of NUZOLVENCE® in Dec 2025, with commercialization planned in H2 2026, regulatory risk around market launch and adoption timing
FY2025 key financial metrics · XBRL
- Revenue
- $411M
- +14.7% YoY
- Net income
- $271M
- +1059.2% YoY
- Operating margin
- 39.8%
- −6.7 pp YoY
- Gross margin
- 74.8%
- −7.8 pp YoY
- EPS (diluted)
- $3.30
- +816.7% YoY
- ROE
- 23.1%
- +19.7 pp YoY
- Operating cash flow
- $197M
- +4.4% YoY
Source: XBRL data from the Innoviva, Inc. (INVA) FY2025 10-K on SEC EDGAR. USD.
Innoviva, Inc. FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business: diversified biopharmaceutical company with royalties portfolio plus critical care and infectious disease operating platform (Innoviva Specialty Therapeutics)
- New products launched: XACDURO® (2023), ZEVTERA® (Q3 2025), and FDA approval of NUZOLVENCE® (Dec 2025) for infectious diseases
- Strategic shift: transformation from pure-play royalty business to diversified biopharma with fast-growing, differentiated operating platform
- Notable metric: XACDURO® Phase 3 ATTACK trial showed 19.0% mortality vs 32.3% for colistin; approved in US (2023) and China (2024)
- Unusual fact: XACDURO® named preferred treatment for carbapenem-resistant Acinetobacter baumannii in 2024 IDSA guidelines
Management Discussion & Analysis
- Revenue details and YoY change not disclosed in provided MD&A excerpt
- Cash flow, buybacks, dividends, capex information not provided
- Forward-looking statements referenced with risks, no specific guidance or outlook given
Risk Factors
- FDA approval of NUZOLVENCE® in Dec 2025, with commercialization planned in H2 2026, regulatory risk around market launch and adoption timing
- Pricing pressures in U.S. caused 2% decline in royalty revenue to $236.5M in 2025, signaling macroeconomic risk on revenue from GSK royalty portfolio
- Supply vulnerability from Zai Lab interim supply agreement for XACDURO® ex-U.S. sales, accounting for significant 218% YoY increase to $40.9M
- Competition risk from established respiratory products RELVAR®/BREO® and ANORO® ELLIPTA® partnered with GSK, with royalties tiered 15% up to $3B sales then 5%
- $300M capital locked in ISP Fund with Sarissa Capital as advisor and withdrawal restrictions, creating financial liquidity and concentration risk until April 2026 distributions
Generated from the filing text; verify against the original. How to read a 10-K
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