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8-K

0001484612false00014846122026-06-142026-06-14

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): June 14, 2026

Outset Medical, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware

001-39513

20-0514392

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

3052 Orchard Dr.,

San Jose, California

95134

(Address of Principal Executive Offices)

(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:

☐

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:

Title of each class

Trading

Symbol(s)

Name of each exchange on which registered

Common Stock, $0.001 par value per share

OM

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 1.01 Entry into a Material Definitive Agreement.

On June 14, 2026, Outset Medical, Inc., (the “Company”) entered into the Refresh Amendment (the “Amendment”) to the Purchasing Agreement with HCA Management Services, L.P. (“HCA”), dated May 1, 2020, as amended (collectively, the “Agreement”).

Under the terms of the Amendment, the parties have agreed, among other things, for HCA to refresh its existing fleet of Tablo Hemodialysis Systems by purchasing new Tablo Hemodialysis Systems commencing in 2026 through the end of 2028, for an aggregate contract value, net of rebates and allowances, of approximately $40 million. This committed capital purchase agreement also provides a console and consumables purchase framework that supports potential future growth beyond the HCA hospitals that have already adopted the hemodialysis in-sourcing model with Tablo.

The foregoing summary of the Amendment does not purport to be complete and is qualified in its entirety by reference to the Amendment, a copy of which is filed herewith as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 1.01.

Item 2.02 Results of Operations and Financial Condition.

The Company is reiterating previously issued guidance for 2026, and plans to provide additional detail regarding the 2026 financial impact of the Amendment later in the year once it has visibility to the timing and ramp of the implementation.

The information contained in this Item 2.02 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 (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Forward-Looking Statements

This Current on Form 8-K contains 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 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 regarding anticipated customer orders

EX-99.1

2 om-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Outset Medical Reports First-Quarter Results

San Jose, CA – May 7, 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 first quarter ended March 31, 2026.

First Quarter and Recent Highlights

• Net revenue totaled $27.9 million, a decrease of 6% compared to $29.8 million in the first quarter of 2025.

• Recurring revenue consisting of Tablo consumables and services was $22.5 million, roughly even with the prior-year period.

• Gross margin expanded by more than 600 basis points over the prior-year period to 43.4% (43.8% on a non-GAAP basis). Product gross margin of 52.4% and service and other gross margin of 26.7% were record highs.

• Net cash used during the quarter of $12 million was less than previously forecasted, resulting in a strong cash position, including restricted cash, cash equivalents and short-term investments, of $161 million at quarter-end.

“We delivered a solid first quarter and continued to make meaningful progress on our path to profitability, driven by disciplined execution and another quarter of record gross margin performance,” said Leslie Trigg, Chair and Chief Executive Officer. “With utilization strong and service margins expanding, we remain focused on driving broader adoption of Tablo across care settings and confident in our full-year outlook.”

First Quarter 2026 Financial Results

Revenue for the first quarter was $27.9 million, a decrease of 6% compared to $29.8 million in the first quarter of 2025. Product revenue of $18.6 million decreased 13% from $21.3 million in the first quarter of 2025. Service and other revenue of $9.3 million increased 10% compared to $8.5 million in the first quarter of 2025. Recurring revenue from the sale of Tablo cartridges and service was $22.5 million as compared to $22.7 million in the prior-year period.

Gross profit of $12.1 million increased 9% from $11.1 million for the first quarter of 2025. Gross margin was 43.4%, compared to 37.2% in the first quarter of 2025. On a non-GAAP basis, gross margin reached 43.8% as compared to 37.6% in the first quarter of 2025. Product gross profit was $9.7 million, compared to $10.3 million in the first quarter of 2025. Product gross margin was 52.4%, compared to 48.3% in the first quarter of 2025. Service and other gross profit was $2.4 million, compared to $0.8 million in the first quarter of 2025. Service and other gross margin was 25.5%, compared to 9.2% in the first quarter of 2025.

Operating expenses of $29.0 million increased 6% from the prior-year period, driven by investments in systems and people. Research and development (R&D) expenses were $5.6 million, sales and marketing (S&M) expenses were $13.3 million, and general and administrative (G&A) expenses were $10.1 million. This compared to operating expenses of $27.5 million in the first quarter of 2025, including R&D expenses of $5.5 million, S&M expenses of $14 million, and G&A expenses of $8.3 million.

Excluding stock-based compensation expense and litigation charges, non-GAAP operating expenses were $25.6 million, including R&D expenses of $4.8 million, S&M expenses of $12.8 million, and G&A expenses of $7.9 million.

Net loss was $19.0 million compared to net loss of $25.8 million for the same period in 2025. On a non-GAAP basis, net loss was $15.4 million compared to non-GAAP net loss of $22.8 million for the same period in 2025.

Total cash, including restricted cash, cash equivalents and short-term investments, was $161 million as of March 31, 2026.

2026 Financial Guidance

Outset reiterated its 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, May 7, 2026, at 1:30 p.m. PT / 4:30 p.m. ET to discuss its first quarter 2026 financial results. Those interested in joining the conference call may do so by dialing (646) 307-1963 or toll-free (800) 715-9871 and referencing conference ID 1632568. 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 G