Short answer
Outset Medical, Inc. (OM) filed its fiscal 2025 10-K annual report with the SEC on Feb 13, 2026. It reported revenue of $119M (+5.1% year over year) and net income of −$82M.
- Top risk flagged: FDA warning letter in 2023 and ongoing compliance risks with medical device regulations impacting Tablo production and approval processes
FY2025 key financial metrics · XBRL
- Revenue
- $119M
- +5.1% YoY
- Net income
- −$82M
- +36.2% YoY
- Operating margin
- -55.8%
- +43.9 pp YoY
- Gross margin
- 39.1%
- +5.2 pp YoY
- EPS (diluted)
- −$5.37
- −118.3% YoY
- ROE
- -64.3%
- +412.9 pp YoY
- Operating cash flow
- −$46M
- +60.2% YoY
Source: XBRL data from the Outset Medical, Inc. (OM) FY2025 10-K on SEC EDGAR. USD.
Outset Medical, Inc. FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business model not detailed; focus on corporate governance and compliance policies
- No new products, services, or segments introduced or emphasized this year
- No strategic shift or changed competitive positioning disclosed in this filing
- Independent registered public accounting firm named as KPMG LLP, Auditor ID: 185
- Business section mainly references governance codes and proxy statement disclosures for fiscal 2026
Management Discussion & Analysis
- Revenue $119.5M, up 5% YoY from $113.7M; product revenue $84.8M (+5%), service revenue $34.7M (+6%)
- Gross margin 39.1% vs 33.9%, gross profit $46.8M, up 21%, driven by higher console and consumable margins
- Best segment: Consumables revenue up $2.9M, console revenue up $0.9M; worst: overall sales down from 2023, console sales portion declined
- Operating expenses down 25% to $113.5M from $151.9M, driven by cuts in R&D (-45%), sales and marketing (-22%), general and admin (-13%)
- No explicit cash flow, buyback or dividend data disclosed; noted cost reduction and efficiency efforts ongoing
- Forward outlook risks: macroeconomic pressure, tariffs, rising costs, cautious customer capital spending delaying sales; focus on expanding acute and home dialysis markets
Risk Factors
- FDA warning letter in 2023 and ongoing compliance risks with medical device regulations impacting Tablo production and approval processes
- Dependence on Mexico manufacturing exposed to U.S. tariffs risk from Section 232 Trade Expansion Act investigation started September 2025
- Reliance on third-party suppliers and insourced Mexican manufacturing with potential supply chain disruption from labor disputes or public health crises
- Competition from dominant home dialysis providers DaVita and Fresenius challenging Tablo's market penetration in home and post-acute care
- Revenue concentrated in Tablo product with customer financial pressures from rising interest rates and budget constraints elongating sales cycles since 2023
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