OM at a glance
Outset Medical, Inc. (OM, SEC CIK 1484612) filed its latest 10-K annual report on February 13, 2026, a 10-Q quarterly report on August 6, 2026, an 8-K current report on August 28, 2026 and Form 4 insider filings as recently as October 5, 2026. SignalX summarizes each filing with AI and tracks the company's insider trades and institutional holders.
- For the fiscal year ended December 31, 2025 (FY2025), Outset Medical, Inc. (OM) reported revenue of $119.5 million (up 5.1% from FY2024) and a net loss of $81.7 million. Diluted EPS was -$5.37.
- As of December 31, 2024, 11 institutional investment managers tracked by SignalX reported holding Outset Medical, Inc. (OM) shares worth $10.3 million in 13F-HR filings.
- The most recent insider open-market purchase reported on Form 4 was by Leonard Braden Michael on October 2, 2026 of 16,575 shares at $3.88 per share.
- In the last 90 days, OM insiders reported 2 open-market purchases ($870K) and 3 open-market sales ($47K) on Form 4, a net purchase of $824K.
Source: SEC EDGAR (XBRL financial data, 13F-HR and Form 4 filings).
- Revenue · FY2025
- $119.5M
- +5.1% vs prior year
- Insiders · 90 days
- 2 buys · 3 sells
- Net +$824K
- 13F holders
- 11 funds
- $10.3M · −1 vs prior quarter
- Latest 8-K
- Aug 28, 2026
- Item 5.02
AI 10-K Annual Report Analysis
Latest 10-K, fiscal year ended Dec 31, 2025
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
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
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
AI summary of the OM 10-K filed . Generated from the filing text; verify against the original.View on SEC EDGARHow to read a 10-K
AI 10-Q Quarterly Report Analysis
Latest 10-Q, quarter ended Jun 30, 2026
Management Discussion & Analysis
- Q2 revenue $31.635M, up 1% YoY from $31.419M
- Service revenue $9.727M, up 17% YoY; product revenue $21.908M, down 5%
- Gross margin 42.0% vs 37.8% YoY; operating loss $15.676M vs $16.865M
- Cash, equivalents, restricted cash and short-term investments $151.0M at June 30, 2026
- Six-month operating cash outflow $22.479M vs $30.486M; management expects operating losses near term
Risk Factors
- Newly triggered regulatory risk: Q3 2026 FDA inspection of San Jose facility produced a Form FDA-483 with inspectional observations
- Most materially updated risk: potential follow-on FDA communications or actions, with costly remediation and possible operating restrictions
- Compliance risk: QMSR or supplier noncompliance could cause recalls, clearance withdrawals, production shutdowns, or penalties
- Operational risk: supplier regulatory failures could delay Tablo production or prevent required quantities
- Financial risk: August 5, 2026 credit amendment changed trailing-twelve-month net-revenue covenants and reset warrant exercise price to $4.838
AI summary of the OM 10-Q filed . Generated from the filing text; verify against the original.View on SEC EDGAR10-K vs 10-Q vs 8-K
AI 8-K Current Report Analysis
The most recent material events, by 8-K item
Item 5.02: Departure/Appointment of Directors or Principal Officers
- General Counsel John Brottem departing effective September 11, 2026
- Departure attributed to pursuing other professional opportunities
Item 2.02: Results of Operations and Financial Condition
- Q2 2026 earnings release covers the quarter ended June 30, 2026
- Press release furnished as Exhibit 99.1 contains the financial results and management commentary
Item EX-99.1: Item EX-99.1
- Q2 revenue $31.6M, up 1% YoY and 14% sequentially, indicating modest growth acceleration
- Gross margin expanded to 42.0% from 37.8%; service margin surged to 32.6% from 6.9%
Item 1.01: Entry into a Material Definitive Agreement
- Outset Medical reiterated previously issued 2026 guidance
- Amendment’s 2026 financial impact remains uncertain pending implementation timing and ramp
Item 2.02: Results of Operations and Financial Condition
- Forward-looking statements cover projected revenue, gross margin, expenses, capital expenditures, cash use, profitability, and outlook
- Customer orders, device refreshes, expansions, timing, and expected benefits remain subject to execution risk
AI summaries of OM 8-K current reports filed with the SEC. What 8-K item codes mean
SignalX for OM
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Recent Insider Transactions (Form 4)
Latest reported trades by officers, directors and 10% owners
| Insider | Type | Date | Shares | Price |
|---|---|---|---|---|
| Leonard Braden Michael | Buy | Oct 2, 2026 | 16,575 | $3.88 |
| Leonard Braden Michael | Buy | Oct 1, 2026 | 228,334 | $3.53 |
| Brottem John L. | Sell | Aug 17, 2026 | 2,632 | $4.39 |
| Trigg Leslie | Sell | Aug 17, 2026 | 3,437 | $4.39 |
| Gaeta Renee | Sell | Aug 17, 2026 | 4,543 | $4.39 |
| Gaeta Renee | A | Jun 26, 2026 | 71,630 | - |
| Trigg Leslie | A | Jun 26, 2026 | 99,160 | - |
| Brottem John L. | A | Jun 26, 2026 | 59,830 | - |
Financial SummaryXBRL
| Metric | FY2023 | FY2024 | FY2025 |
|---|---|---|---|
| Profitability | |||
| Revenue | $130.4M | $113.7M | $119.5M |
| Gross Profit | - | $38.6M | $46.8M |
| Operating Income | - | -$113.4M | -$66.7M |
| Net Income | - | -$128.0M | -$81.7M |
| Gross Margin | - | 33.9% | 39.1% |
| Op. Margin | - | -99.7% | -55.8% |
| Net Margin | - | -112.6% | -68.3% |
| Balance Sheet | |||
| Total Assets | $313.8M | $275.8M | $264.5M |
| Equity | - | $26.8M | $127.0M |
| ROE | - | -477.2% | -64.3% |
| Per Share | |||
| EPS | - | $-2.46 | $-5.37 |
| Cash Flow | |||
| Operating CF | - | -$116.3M | -$46.3M |
| CapEx | - | $912K | $798K |
Source: XBRL data in Outset Medical, Inc. (OM)'s 10-K filings on SEC EDGAR, in USD. Compare across companies →
13F Fund Holdings: Quarterly Trend
Latest: Q4 2024Aggregate OM share value held by 13F filers tracked by SignalX, by quarter.
Quarterly totals table
| Quarter | Funds | Total value |
|---|---|---|
| Q4 2024 | 11 | $10.3M |
| Q3 2024 | 12 | $3.4M |
- Renaissance Technologies LLC+632.6K (+1168%)
- Two Sigma Investments+129.3K (+36%)
- Northern Trust+2 (+0%)
- Millennium Management−495.2K (-26%)
- Citadel Advisors LLC−30.2K (-33%)
- U.S. Bancorp−5.2K (-99%)
- State Street Corp−4.7K (-2%)
- Invesco Ltd−600 (-1%)
- FMR LLC (Fidelity)+3.67M
- Vanguard Group Inc+2.61M
- Ameriprise Financial−1.81M
- D.E. Shaw & Co−428.6K
- Wells Fargo & Co−11
Source: 13F-HR filings on SEC EDGAR (aggregated from 23 fund-quarter rows). Reflects only 13F filers tracked by SignalX, not the full institutional ownership universe. How 13F filings work
OM filing archive
AI analysis pages for each 10-K, 10-Q and 8-K
10-K annual reports
10-Q quarterly reports
Latest 2026 SEC Filings: 10-K, 10-Q, 8-K & Form 4
| Form | Filing date | Period | Analysis | SEC |
|---|---|---|---|---|
| 4 | Oct 5, 2026 | - | - | - |
| 8-K | Aug 28, 2026 | - | Analysis | - |
| 4 | Aug 18, 2026 | - | - | - |
| 4 | Aug 18, 2026 | - | - | - |
| 4 | Aug 18, 2026 | - | - | - |
| SC 13G | Aug 12, 2026 | - | - | |
| 10-Q | Aug 6, 2026 | Jun 30, 2026 | Analysis | |
| 8-K | Aug 6, 2026 | - | Analysis | - |
| 4 | Jun 29, 2026 | - | - | - |
| 4 | Jun 29, 2026 | - | - | - |
| 4 | Jun 29, 2026 | - | - | - |
| 8-K | Jun 17, 2026 | - | Analysis | - |
| 4 | Jun 5, 2026 | - | - | |
| 4 | Jun 5, 2026 | - | - | |
| 4 | Jun 5, 2026 | - | - | |
| 4 | Jun 5, 2026 | - | - | |
| 4 | Jun 5, 2026 | - | - | |
| 8-K | Jun 5, 2026 | - | Analysis | |
| 4 | Jun 5, 2026 | - | - | |
| 4 | Jun 5, 2026 | - | - | |
| 8-K | May 29, 2026 | - | Analysis | |
| 4 | May 19, 2026 | - | - | |
| 4 | May 19, 2026 | - | - | |
| 4 | May 19, 2026 | - | - | |
| 4 | May 18, 2026 | - | - |
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OM SEC filings: frequently asked questions
Are OM insiders buying or selling?
In the last 90 days, Outset Medical, Inc. (OM) officers, directors and 10% owners reported 2 open-market purchases worth $870,260 by 1 insider and 3 open-market sales worth $46,587 by 3 insiders on Form 4, a net purchase of $823,674. Many insider sales are pre-planned or for taxes, so purchases usually carry more information.
Which institutions hold OM stock?
As of December 31, 2024, the largest Outset Medical, Inc. (OM) holders among the 13F filers tracked by SignalX were FMR LLC (Fidelity) ($4.1 million), Vanguard Group Inc ($2.9 million), Millennium Management ($1.5 million), Renaissance Technologies LLC ($762,000), Two Sigma Investments ($542,000). 13F-HR reports are filed up to 45 days after each quarter ends.
What was OM's revenue in fiscal year 2025?
For the fiscal year ended December 31, 2025 (FY2025), Outset Medical, Inc. (OM) reported revenue of $119.5 million (up 5.1% from FY2024) and a net loss of $81.7 million. Diluted EPS was -$5.37. The figures come from the XBRL data in the 10-K.
What are the main risks in OM's latest 10-K?
In the 10-K filed February 13, 2026, Outset Medical, Inc. (OM) flagged: 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. (AI summary of the Risk Factors section.)
What did OM report in its latest 8-K?
Outset Medical, Inc. (OM) filed an 8-K on August 28, 2026 reporting Item 5.02 (Departure/Appointment of Directors or Principal Officers). General Counsel John Brottem departing effective September 11, 2026.
What are the latest OM SEC filings?
Outset Medical, Inc. (OM) filed its latest 10-K annual report on February 13, 2026, a 10-Q quarterly report on August 6, 2026, an 8-K current report on August 28, 2026 and a Form 4 insider filing on October 5, 2026.
What is OM's SEC CIK number?
Outset Medical, Inc. (OM)'s SEC Central Index Key (CIK) is 1484612. EDGAR lists every OM filing under that number.
Ask anything about OM
The research agent reads OM's filings, financials, insider trades and 13F holders, then answers with sources.