UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 11, 2026
Outset Medical, Inc.
(Exact name of Registrant as Specified in Its Charter)
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Delaware |
001-39513 |
20-0514392 |
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
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3052 Orchard Dr., San Jose, California |
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95134 |
(Address of Principal Executive Offices) |
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(Zip Code) |
Registrant’s Telephone Number, Including Area Code: (669) 231-8200
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common Stock, $0.001 par value per share |
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OM |
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The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Result of Operations and Financial Condition.
On February 11, 2026, Outset Medical, Inc. (the “Company”) issued a press release and will hold its fourth quarter and full year 2025 earnings conference call announcing the Company’s financial results for the quarter ended and year ended December 31, 2025, as well as a guidance for 2026 revenue and non-GAAP gross margin. A copy of the press release is furnished herewith as Exhibit 99.1 and incorporated herein by reference.
The information contained in this Item 2.02 and Exhibit 99.1 hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Forward-Looking Statements
This report and the exhibit attached hereto contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements include, but are not limited to, statements about possible or assumed future results of operations and financial position, including expectations regarding projected revenues, gross margin, operating expenses, capital expenditures, cash use, cash burn, cash position, profitability and outlook; statements about the sufficiency of the Company’s cash balances through cashflow breakeven; statements regarding the anticipated impacts and benefits of the Company’s cost reduction actions, initiatives to optimize the commercial organization and improve forecasting and order visibility, and restructurings; statements regarding anticipated customer orders or other business opportunities including the expected closing and timing thereof; statements regarding the Company’s overall business strategy, plans and objectives of management; statements regarding the anticipated launch and timing of product enhancements and new features, as well as new or expanded services, and the expected benefits, performance, and impact thereof; the Company’s expectations regarding the market sizes and growth potential for Tablo and the total addressable market opportunities for Tablo; continued execution of the Company's initiatives designed to expand gross margins; the Company’s ability to respond to and resolve any reports, observations or other actions by the Food and Drug Administration or other regulators in a timely and effective manner; as well as the Company’s expectations regarding the impact of macroeconomic factors (including changes in tariff or trade laws and policies) on the Company, its customers and suppliers. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results or other events to differ materially from those contemplated in this press release can be found in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission, including its latest annual and quarterly reports. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of their date and, except to the extent required by law, the Company undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit Number |
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Description |
99.1 |
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Press Release entitled “Outset Medical Reports Fourth Quarter and Full Year 2025 Financial Results” dated February 11, 2026 |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Outset Medical, Inc. |
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Date: February 11, 2026 |
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By: |
/s/Renee Gaeta |
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Renee Gaeta |
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Chief Financial Officer |
Outset Medical Reports Fourth Quarter and Full Year 2025 Financial Results
San Jose, CA – Feb. 11, 2026 – Outset Medical, Inc. (Nasdaq: OM), a medical technology company pioneering a first-of-its-kind technology to improve clinical outcomes in dialysis with less cost and complexity, today reported financial results for the fourth quarter and year ended December 31, 2025.
Fourth Quarter, Year-End and Recent Highlights
•Net revenue totaled $28.9 million in the fourth quarter, bringing revenue in 2025 to $119.5 million, a 5% increase over $113.7 million in 2024.
•Recurring revenue consisting of Tablo consumables and services was $22.5 million in the fourth quarter and grew 6% in 2025 to $88.7 million compared to $83.9 million in 2024.
•Gross margin expanded by nearly 600 basis points in the fourth quarter to 42.4% (42.9% on a non-GAAP basis). Gross margin for the year of 39.1% (39.6% on a non-GAAP basis) expanded more than 500 basis points from 33.9% in 2024.
•Year-end cash, including restricted cash, cash equivalents and short-term investments, totaled $173 million. Net cash used in operations in 2025 was $46 million compared to $116 million in 2024.
•Received clearance from the U.S. Food and Drug Administration for the next-generation Tablo platform, designed for enterprise-level cybersecurity, reliability and connectivity, which is expected to launch in the second quarter.
“We enter 2026 standing on a strong foundation for growth, well capitalized, and with a highly differentiated platform to help healthcare providers transform their clinical, operational and financial outcomes by insourcing dialysis with Outset,” said Leslie Trigg, Chair and Chief Executive Officer.
Fourth Quarter 2025 Financial Results
Revenue for the fourth quarter was $28.9 million, a decrease of 2% compared to $29.5 million in the fourth quarter of 2024. Product revenue was $19.9 million as compared to $21.0 million in the fourth quarter of 2024. Service and other revenue of $9.0 million increased 6% compared to $8.5 million in the fourth quarter of 2024. Recurring revenue from the sale of Tablo consumables and services was $22.5 million as compared to $23.7 million in the prior year period.
Gross profit of $12.2 million increased 14% from $10.7 million in the fourth quarter of 2024. Gross margin was 42.4%, compared to 36.5% in the fourth quarter of 2024. On a non-GAAP basis, gross margin reached 42.9%, as compared to 38.6% in the fourth quarter of 2024. Product gross profit was $10.1 million, compared to $9.2 million in the fourth quarter of 2024. Product gross margin reached 50.7%, compared to 44.0% in the fourth quarter of 2024. Service and other gross profit was $2.2 million, compared to $1.5 million in the fourth quarter of 2024. Service and other gross margin was 24.0%, compared to 17.8% in the fourth quarter of 2024.
Operating expenses of $29.9 million declined 8% from the prior year period as a result of reductions in spending during the year intended to streamline operations and accelerate the company’s path to profitability. Research and development (R&D) expenses were $5.1 million, sales and marketing (S&M) expenses were $12.9 million, and general and administrative (G&A) expenses were $11.9 million. This compared to operating expenses of $32.6 million in the fourth quarter of 2024, including R&D expenses of $7.9 million, S&M expenses of $15.5 million, and G&A expenses of $9.3 million.
Excluding stock-based compensation expense, severance and related charges, and litigation charges, non-GAAP operating expenses were $25.7 million, including R&D expenses of $4.1 million, S&M expenses of $12.4 million, and G&A expenses of $9.2 million.
Net loss was $19.5 million compared to a net loss of $25.6 million for the same period in 2024. On a non-GAAP basis, net loss was $15.1 million compared to a non-GAAP net loss of $19.3 million for the same period in 2024.
Total cash, including restricted cash, cash equivalents and short-term investments, was $173 million as of December 31, 2025.
Full Year 2025 Financial Results
Revenue for 2025 was $119.5 million, an increase of 5% as compared to $113.7 million in 2024. Product revenue was $84.8 million, representing an increase of 5% compared to $81.0 million in 2024. Service and other revenue was $34.7 million, an increase of 6% compared to $32.7 million in 2024. Recurring revenue grew 6% to $88.7 million compared to
$83.9 million in 2024.
Total gross profit was $46.8 million, compared to $38.6 million for 2024. Total gross margin was 39.1%, compared to 33.9% in 2024. On a non-GAAP basis, gross margin improved 4 percentage points to 39.6% from 35.6% in 2024. Product gross profit was $41.0 million, compared to $34.5 million in 2024. Product gross margin was 48.4%, compared to 42.6% in 2024. Service and other gross profit was $5.7 million, compared to a gross profit of $4 million in 2024. Service and other gross margin was 16.5%, compared to 12.3% in 2024.
Operating expenses were $113.5 million, including R&D expenses of $21.2 million, S&M expenses of $54.4 million, and G&A expenses of $37.9 million. This compared to operating expenses of $151.9 million, including R&D expenses of $38.4 million, S&M expenses of $70.0 million, and G&A expenses of $43.5 million in 2024.
Excluding stock-based compensation expense, severance and related charges, and litigation charges, non-GAAP operating expenses were $97.8 million, including R&D expenses of $17.8 million, S&M expenses of $51.3 million, and G&A expenses of $28.7 million.
Net loss was $81.7 million compared to a net loss of $128 million in 2024. On a non-GAAP basis, net loss was $65.4 million compared to a non-GAAP net loss of $94.8 million in 2024.
Full Year 2026 Financial Guidance
Outset provided 2026 revenue guidance of $125 million to $130 million, a 5% to 9% increase] over $119.5 million in 2025, and non-GAAP gross margin guidance in the low to mid-40% range for the year.
Webcast and Conference Call Details
Outset will host a conference call today, February 13, 2026, at 1:30 p.m. PT / 4:30 p.m. ET to discuss its fourth quarter and full year 2025 financial results. Those interested in listening to the conference call may do so by registering online. Once registered, participants will receive dial-in numbers and a unique pin to join the call. Participants are encouraged to register more than 15 minutes before the start of the call. A live webcast of the conference call will be available on the Investor Relations section of the Company's website at https://investors.outsetmedical.com. The webcast will be archived on the website following the completion of the call.
Use of Non-GAAP Financial Measures
The Company may report non-GAAP results for gross profit/loss, gross margin, operating expenses, operating margins, net income/loss, basic and diluted net income/loss per share, other income/loss, and cash flows. These non-GAAP financial measures are in addition to, and not a substitute for, or superior to, financial measures calculated in accordance with GAAP. As listed in the itemized reconciliations between GAAP and non-GAAP financial measures included in this press release, the Company’s GAAP financial measures include stock-based compensation expense, severance and related charges net of the reversal of compensation accruals for impacted employees, as well as litigation charges incurred outside of the ordinary course of business in connection with the stockholder class action and relative derivative lawsuits as disclosed in the Company’s latest annual and quarterly reports. Stock-based compensation is a non-cash expense, and severance and related charges arise outside the ordinary course of continuing operations and are not reflective of the Company's current operating performance. In addition, litigation charges related to the above-described matters are excluded because they constitute non-routine litigation costs, arise outside of the ordinary course of the Company’s business, and are not indicative of its recurring operating results or underlying performance trends. As such, management has excluded the effects of these items in non-GAAP measures to assist investors in analyzing and assessing past and future operating performance and period-to-period comparisons. There are limitations related to the use of non-GAAP financial measures because they are not prepared in accordance with GAAP, may exclude significant expenses required by GAAP to be recognized in the Company’s financial statements, and may not be comparable to non-GAAP financial measures used by other companies. The Company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Reconciliations between GAAP and non-GAAP results are presented in the Appendix A of this press release.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or
financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements include, but are not limited to, statements about the Company’s possible or assumed future results of operations and financial position, including expectations regarding projected revenues, gross margin, operating expenses, capital expenditures, cash use, cash burn, cash position, profitability and outlook; statements about the sufficiency of the Company’s cash balances through cashflow breakeven; statements regarding the anticipated impacts and benefits of the Company’s cost reduction actions, initiatives to optimize the commercial organization and improve forecasting and order visibility, and restructurings; statements regarding anticipated customer orders or other business opportunities including the expected closing and timing thereof; statements regarding the Company’s overall business strategy, plans and objectives of management; statements regarding the anticipated launch and timing of product enhancements and new features, as well as new or expanded services, and the expected benefits, performance, and impact thereof; the Company’s expectations regarding the market sizes and growth potential for Tablo and the total addressable market opportunities for Tablo; continued execution of the Company’s initiatives designed to expand gross margins; the Company’s ability to respond to and resolve any reports, observations or other actions by the Food and Drug Administration or other regulators in a timely and effective manner; as well as the Company’s expectations regarding the impact of macroeconomic factors (including changes in tariff or trade laws and policies) on the Company, its customers and suppliers. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results or other events to differ materially from those contemplated in this press release can be found in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission, including its latest annual and quarterly reports. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of their date and, except to the extent required by law, the Company undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise.
About Outset Medical, Inc.
Outset is a medical technology company transforming the dialysis experience across the continuum of care with a first-of-its-kind technology. The Tablo® Hemodialysis System, FDA-cleared for use from hospital to home, is trusted by more than 1,000 U.S. healthcare facilities and has enabled millions of treatments delivered by thousands of nurses. Designed to reduce the cost and complexity of dialysis, Tablo combines water purification and on-demand dialysate production into a single, integrated system that connects seamlessly with Electronic Medical Record systems and a proprietary data analytics platform. This enterprise solution empowers providers to develop an in-house dialysis program where they are in control – enabling better operational, clinical, and financial outcomes. Outset is redefining what’s possible in kidney care through innovation, scale, and a relentless commitment to improving the lives of patients and the professionals who care for them. For more information, visit www.outsetmedical.com.
Investor Contact
Jim Mazzola
jmazzola@outsetmedical.com
Outset Medical, Inc.
Condensed Statements of Operations
(in thousands, except per share amounts)
(unaudited)
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Three Months Ended |
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Years Ended |
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December 31, |
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December 31, |
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2025 |
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2024 |
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2025 |
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2024 |
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Revenue: |
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Product revenue |
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$ |
19,874 |
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$ |
21,006 |
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$ |
84,808 |
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|
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$ |
80,977 |
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Service and other revenue |
|
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9,000 |
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|
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|
8,461 |
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|
|
|
34,668 |
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|
|
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32,712 |
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Total revenue |
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28,874 |
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29,467 |
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119,476 |
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113,689 |
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Cost of revenue: |
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Cost of product revenue (2) |
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9,803 |
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11,769 |
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43,765 |
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|
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46,449 |
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Cost of service and other revenue |
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6,840 |
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|
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6,951 |
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28,957 |
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|
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28,676 |
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Total cost of revenue |
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16,643 |
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18,720 |
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72,722 |
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75,125 |
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Gross profit (1) |
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12,231 |
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10,747 |
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46,754 |
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38,564 |
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Gross margin (1) |
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42.4 |
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% |
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36.5 |
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% |
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39.1 |
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% |
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33.9 |
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% |
Operating expenses: |
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Research and development (2) |
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5,054 |
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7,889 |
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21,235 |
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38,397 |
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Sales and marketing (2) |
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12,879 |
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15,451 |
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54,361 |
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70,044 |
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General and administrative (2)(3) |
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11,926 |
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9,267 |
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37,864 |
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43,498 |
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Total operating expenses |
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29,859 |
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32,607 |
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113,460 |
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151,939 |
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Loss from operations |
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(17,628 |
) |
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(21,860 |
) |
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(66,706 |
) |
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(113,375 |
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Interest income and other income, net |
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1,673 |
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2,043 |
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7,408 |
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9,761 |
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Interest expense |
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(3,441 |
) |
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(5,825 |
) |
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(13,952 |
) |
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(23,871 |
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Loss on extinguishment of term loan |
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— |
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— |
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(7,685 |
) |
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— |
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Loss before provision for income taxes |
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(19,396 |
) |
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(25,642 |
) |
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(80,935 |
) |
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(127,485 |
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Provision for income taxes |
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|
95 |
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(4 |
) |
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718 |
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|
491 |
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Net loss |
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$ |
(19,491 |
) |
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|
$ |
(25,638 |
) |
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$ |
(81,653 |
) |
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|
$ |
(127,976 |
) |
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Net loss per share, basic and diluted |
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$ |
(1.09 |
) |
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|
$ |
(7.29 |
) |
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$ |
(5.37 |
) |
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$ |
(36.96 |
) |
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Shares used in computing net loss per share, basic and diluted |
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17,817 |
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3,516 |
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15,211 |
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|
3,463 |
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(1) Gross profit and gross margin by source consisted of the following: |
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Three Months Ended |
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Years Ended |
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December 31, |
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December 31, |
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2025 |
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2024 |
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2025 |
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2024 |
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Gross profit |
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Product revenue |
|
$ |
10,071 |
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|
|
$ |
9,237 |
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|
|
$ |
41,043 |
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|
|
$ |
34,528 |
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Service and other revenue |
|
|
2,160 |
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|
|
|
1,510 |
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|
|
|
5,711 |
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|
|
|
4,036 |
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Total gross profit |
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$ |
12,231 |
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$ |
10,747 |
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|
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$ |
46,754 |
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|
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$ |
38,564 |
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Gross margin |
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Product revenue |
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50.7 |
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% |
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44.0 |
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% |
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48.4 |
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% |
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42.6 |
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% |
Service and other revenue |
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24.0 |
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% |
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17.8 |
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% |
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16.5 |
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% |
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12.3 |
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% |
Total gross margin |
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42.4 |
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% |
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36.5 |
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% |
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39.1 |
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% |
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33.9 |
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% |
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(2) Includes stock-based compensation expense and severance and related charges, net as follows: |
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Three Months Ended |
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Years Ended |
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Stock-based compensation expense |
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December 31, |
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December 31, |
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2025 |
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2024 |
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2025 |
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|
|
2024 |
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Cost of revenue |
|
$ |
145 |
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|
$ |
280 |
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|
$ |
583 |
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|
|
$ |
1,372 |
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Research and development |
|
|
940 |
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|
|
1,266 |
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|
|
|
3,366 |
|
|
|
|
7,291 |
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Sales and marketing |
|
|
497 |
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|
|
|
1,224 |
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|
|
|
3,083 |
|
|
|
|
6,122 |
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General and administrative |
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|
2,481 |
|
|
|
|
2,175 |
|
|
|
|
8,584 |
|
|
|
|
14,571 |
|
|
Total stock-based compensation expense |
|
$ |
4,063 |
|
|
|
$ |
4,945 |
|
|
|
$ |
15,616 |
|
|
|
$ |
29,356 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
Years Ended |
|
|
Severance and related charges, net |
|
December 31, |
|
|
|
December 31, |
|
|
|
|
2025 |
|
|
|
2024* |
|
|
|
2025 |
|
|
|
2024* |
|
|
Cost of revenue |
|
$ |
— |
|
|
|
|
317 |
|
|
|
$ |
— |
|
|
|
|
518 |
|
|
Research and development |
|
|
— |
|
|
|
|
161 |
|
|
|
|
34 |
|
|
|
|
1,124 |
|
|
Sales and marketing |
|
|
— |
|
|
|
|
873 |
|
|
|
|
— |
|
|
|
|
1,765 |
|
|
General and administrative |
|
|
— |
|
|
|
|
20 |
|
|
|
|
(42 |
) |
|
|
|
390 |
|
|
Total severance and related charges, net |
|
$ |
— |
|
|
|
|
1,371 |
|
|
|
$ |
(8 |
) |
|
|
|
3,797 |
|
|
* Net of adjustments to compensation accrual |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3) Includes non-ordinary course litigation charges related to stockholder class action and related derivative lawsuits as follows: |
|
|
|
|
Three Months Ended |
|
|
|
Years Ended |
|
|
Litigation charges |
|
December 31, |
|
|
|
December 31, |
|
|
|
|
2025 |
|
|
|
2024 |
|
|
|
2025 |
|
|
|
2024 |
|
|
General and administrative |
|
$ |
284 |
|
|
|
$ |
— |
|
|
|
$ |
626 |
|
|
|
$ |
— |
|
|
Total litigation charges |
|
$ |
284 |
|
|
|
$ |
— |
|
|
|
$ |
626 |
|
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outset Medical, Inc.
Condensed Balance Sheets
(in thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2025 |
|
|
2024 |
|
|
|
(unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
35,006 |
|
|
$ |
124,014 |
|
Short-term investments |
|
|
133,940 |
|
|
|
34,671 |
|
Accounts receivable, net |
|
|
28,329 |
|
|
|
35,619 |
|
Inventories |
|
|
47,609 |
|
|
|
59,387 |
|
Prepaid expenses and other current assets |
|
|
5,999 |
|
|
|
4,530 |
|
Total current assets |
|
|
250,883 |
|
|
|
258,221 |
|
Restricted cash |
|
|
3,829 |
|
|
|
3,329 |
|
Property and equipment, net |
|
|
4,670 |
|
|
|
8,133 |
|
Operating lease right-of-use assets |
|
|
4,797 |
|
|
|
3,940 |
|
Other assets |
|
|
317 |
|
|
|
2,172 |
|
Total assets |
|
$ |
264,496 |
|
|
$ |
275,795 |
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
554 |
|
|
$ |
3,862 |
|
Accrued compensation and related benefits |
|
|
10,735 |
|
|
|
16,821 |
|
Accrued expenses and other current liabilities |
|
|
9,433 |
|
|
|
8,205 |
|
Accrued warranty liability |
|
|
1,374 |
|
|
|
1,938 |
|
Deferred revenue, current |
|
|
13,795 |
|
|
|
12,753 |
|
Operating lease liabilities, current |
|
|
1,739 |
|
|
|
1,799 |
|
Total current liabilities |
|
|
37,630 |
|
|
|
45,378 |
|
Accrued interest |
|
|
— |
|
|
|
2,695 |
|
Deferred revenue |
|
|
406 |
|
|
|
844 |
|
Operating lease liabilities |
|
|
3,271 |
|
|
|
2,684 |
|
Term loans |
|
|
96,237 |
|
|
|
197,375 |
|
Total liabilities |
|
|
137,544 |
|
|
|
248,976 |
|
Commitments and contingencies |
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
Preferred Stock, $0.001 par value; 5,000 shares authorized, and no shares issued and outstanding as of December 31, 2025 and 2024 |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 300,000 shares authorized as of December 31, 2025 and 2024; 18,169 and 3,530 shares issued and outstanding as of December 31, 2025 and 2024, respectively |
|
|
18 |
|
|
|
4 |
|
Additional paid-in capital |
|
|
1,298,138 |
|
|
|
1,116,496 |
|
Accumulated other comprehensive income |
|
|
172 |
|
|
|
42 |
|
Accumulated deficit |
|
|
(1,171,376 |
) |
|
|
(1,089,723 |
) |
Total stockholders' equity |
|
|
126,952 |
|
|
|
26,819 |
|
Total liabilities and stockholders' equity |
|
$ |
264,496 |
|
|
$ |
275,795 |
|
Outset Medical, Inc.
Condensed Statements of Cash Flows
(in thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2025 |
|
|
2024 |
|
Net cash used in operating activities |
|
$ |
(46,327 |
) |
|
$ |
(116,303 |
) |
Net cash (used in) provided by investing activities |
|
|
(97,684 |
) |
|
|
103,938 |
|
Net cash provided by financing activities |
|
|
55,503 |
|
|
|
67,870 |
|
Net (decrease) increase in cash, cash equivalents and restricted cash |
|
|
(88,508 |
) |
|
|
55,505 |
|
Cash, cash equivalents and restricted cash at beginning of the period |
|
|
127,343 |
|
|
|
71,838 |
|
Cash, cash equivalents and restricted cash at end of the period (1) |
|
$ |
38,835 |
|
|
$ |
127,343 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the accompanying condensed balance sheets that sum to the total of the amounts shown in the accompanying condensed statements of cash flows (in thousands): |
|
|
|
|
|
December 31, |
|
|
|
2025 |
|
|
2024 |
|
Cash and cash equivalents |
|
$ |
35,006 |
|
|
$ |
124,014 |
|
Restricted cash |
|
|
3,829 |
|
|
|
3,329 |
|
Total cash, cash equivalents and restricted cash* |
|
$ |
38,835 |
|
|
$ |
127,343 |
|
|
|
|
|
|
|
|
* The total cash, including restricted cash, cash equivalents and investment securities as of December 31, 2025 was $172.8 million; compared to $162.0 million as of December 31, 2024. |
|
|
|
Appendix A
Outset Medical, Inc.
Results of Operations – Non-GAAP
(in thousands, except per share amounts)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation between GAAP and non-GAAP net loss per share: |
|
|
|
|
Three Months Ended |
|
|
|
Years Ended |
|
|
|
|
December 31, |
|
|
|
December 31, |
|
|
|
|
2025 |
|
|
|
2024 |
|
|
|
2025 |
|
|
|
2024 |
|
|
GAAP net loss per share, diluted |
|
$ |
(1.09 |
) |
|
|
$ |
(7.29 |
) |
|
|
$ |
(5.37 |
) |
|
|
$ |
(36.96 |
) |
|
Stock-based compensation expense |
|
|
0.23 |
|
|
|
|
1.41 |
|
|
|
|
1.03 |
|
|
|
|
8.48 |
|
|
Severance and related charges, net |
|
|
— |
|
|
|
|
0.39 |
|
|
|
|
— |
|
|
|
|
1.10 |
|
|
Litigation charges |
|
|
0.02 |
|
|
|
|
— |
|
|
|
|
0.04 |
|
|
|
|
— |
|
|
Non-GAAP net loss per share, diluted |
|
$ |
(0.84 |
) |
|
|
$ |
(5.49 |
) |
|
|
$ |
(4.30 |
) |
|
|
$ |
(27.38 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation between GAAP and non-GAAP net loss: |
|
|
|
|
Three Months Ended |
|
|
|
Years Ended |
|
|
|
|
December 31, |
|
|
|
December 31, |
|
|
|
|
2025 |
|
|
|
2024 |
|
|
|
2025 |
|
|
|
2024 |
|
|
GAAP net loss, diluted |
|
$ |
(19,491 |
) |
|
|
$ |
(25,638 |
) |
|
|
$ |
(81,653 |
) |
|
|
$ |
(127,976 |
) |
|
Stock-based compensation expense |
|
|
4,063 |
|
|
|
|
4,945 |
|
|
|
|
15,616 |
|
|
|
|
29,356 |
|
|
Severance and related charges, net |
|
|
— |
|
|
|
|
1,371 |
|
|
|
|
(8 |
) |
|
|
|
3,797 |
|
|
Litigation charges |
|
|
284 |
|
|
|
|
— |
|
|
|
|
626 |
|
|
|
|
— |
|
|
Non-GAAP net loss, diluted |
|
$ |
(15,144 |
) |
|
|
$ |
(19,322 |
) |
|
|
$ |
(65,419 |
) |
|
|
$ |
(94,823 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation between GAAP and non-GAAP results of operations: |
|
|
Three Months Ended |
|
|
|
Years Ended |
|
|
|
|
December 31, |
|
|
|
December 31, |
|
|
|
|
2025 |
|
|
|
2024 |
|
|
|
2025 |
|
|
|
2024 |
|
|
GAAP gross profit |
|
$ |
12,231 |
|
|
|
$ |
10,747 |
|
|
|
$ |
46,754 |
|
|
|
$ |
38,564 |
|
|
Stock-based compensation expense |
|
|
145 |
|
|
|
|
280 |
|
|
|
|
583 |
|
|
|
|
1,372 |
|
|
Severance and related charges, net |
|
|
— |
|
|
|
|
317 |
|
|
|
|
— |
|
|
|
|
518 |
|
|
Non-GAAP gross profit |
|
$ |
12,376 |
|
|
|
$ |
11,344 |
|
|
|
$ |
47,337 |
|
|
|
$ |
40,454 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP gross margin |
|
|
42.4 |
|
% |
|
|
36.5 |
|
% |
|
|
39.1 |
|
% |
|
|
33.9 |
|
% |
Stock-based compensation expense |
|
|
0.5 |
|
|
|
|
1.0 |
|
|
|
|
0.5 |
|
|
|
|
1.2 |
|
|
Severance and related charges, net |
|
|
— |
|
|
|
|
1.1 |
|
|
|
|
— |
|
|
|
|
0.5 |
|
|
Non-GAAP gross margin |
|
|
42.9 |
|
% |
|
|
38.6 |
|
% |
|
|
39.6 |
|
% |
|
|
35.6 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP research and development expense |
|
$ |
5,054 |
|
|
|
$ |
7,889 |
|
|
|
$ |
21,235 |
|
|
|
$ |
38,397 |
|
|
Stock-based compensation expense |
|
|
(940 |
) |
|
|
|
(1,266 |
) |
|
|
|
(3,366 |
) |
|
|
|
(7,291 |
) |
|
Severance and related charges, net |
|
|
— |
|
|
|
|
(161 |
) |
|
|
|
(34 |
) |
|
|
|
(1,124 |
) |
|
Non-GAAP research and development expense |
|
$ |
4,114 |
|
|
|
$ |
6,462 |
|
|
|
$ |
17,835 |
|
|
|
$ |
29,982 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP sales and marketing expense |
|
$ |
12,879 |
|
|
|
$ |
15,451 |
|
|
|
$ |
54,361 |
|
|
|
$ |
70,044 |
|
|
Stock-based compensation expense |
|
|
(497 |
) |
|
|
|
(1,224 |
) |
|
|
|
(3,083 |
) |
|
|
|
(6,122 |
) |
|
Severance and related charges, net |
|
|
— |
|
|
|
|
(873 |
) |
|
|
|
— |
|
|
|
|
(1,765 |
) |
|
Non-GAAP sales and marketing expense |
|
$ |
12,382 |
|
|
|
$ |
13,354 |
|
|
|
$ |
51,278 |
|
|
|
$ |
62,157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP general and administrative expense |
|
$ |
11,926 |
|
|
|
$ |
9,267 |
|
|
|
$ |
37,864 |
|
|
|
$ |
43,498 |
|
|
Stock-based compensation expense |
|
|
(2,481 |
) |
|
|
|
(2,175 |
) |
|
|
|
(8,584 |
) |
|
|
|
(14,571 |
) |
|
Severance and related charges, net |
|
|
— |
|
|
|
|
(20 |
) |
|
|
|
42 |
|
|
|
|
(390 |
) |
|
Litigation charges |
|
|
(284 |
) |
|
|
|
— |
|
|
|
|
(626 |
) |
|
|
|
— |
|
|
Non-GAAP general and administrative expense |
|
$ |
9,161 |
|
|
|
$ |
7,072 |
|
|
|
$ |
28,696 |
|
|
|
$ |
28,537 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP total operating expense |
|
$ |
29,859 |
|
|
|
$ |
32,607 |
|
|
|
$ |
113,460 |
|
|
|
$ |
151,939 |
|
|
Stock-based compensation expense |
|
|
(3,918 |
) |
|
|
|
(4,665 |
) |
|
|
|
(15,033 |
) |
|
|
|
(27,984 |
) |
|
Severance and related charges, net |
|
|
— |
|
|
|
|
(1,054 |
) |
|
|
|
8 |
|
|
|
|
(3,279 |
) |
|
Litigation charges |
|
|
(284 |
) |
|
|
|
— |
|
|
|
|
(626 |
) |
|
|
|
— |
|
|
Non-GAAP total operating expense |
|
$ |
25,657 |
|
|
|
$ |
26,888 |
|
|
|
$ |
97,809 |
|
|
|
$ |
120,676 |
|
|
