Form 8-K

8-K — Outset Medical, Inc.

Accession: 0001193125-26-211980

Filed: 2026-05-07

Period: 2026-05-07

CIK: 0001484612

SIC: 3845 (ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — om-20260507.htm (Primary)

EX-99.1 (om-ex99_1.htm)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K

8-K (Primary)

Filename: om-20260507.htm · Sequence: 1

8-K

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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): May 7, 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

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 May 7, 2026, Outset Medial, Inc. (the “Company”) issued a press release and will hold its first quarter 2026 earnings conference call announcing the Company’s financial results for the quarter ended March 31, 2026. 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.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit

Number

Description

99.1

Press Release entitled “Outset Medical Reports First-Quarter Results” dated May 7, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

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.

Outset Medical, Inc.

Date: May 7, 2026

By:

/s/Renee Gaeta

Renee Gaeta

Chief Financial Officer

EX-99.1

Filename: om-ex99_1.htm · Sequence: 2

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 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 and 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. 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 size, 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

Investors@outsetmedical.com

Outset Medical, Inc.

Condensed Statements of Operations

(in thousands, except per share amounts)

(unaudited)

Three Months Ended

March 31,

2026

2025

Revenue:

Product revenue

18,550

21,294

Service and other revenue

9,313

8,458

Total revenue

27,863

29,752

Cost of revenue:

Cost of product revenue (2)

8,833

11,002

Cost of service and other revenue

6,935

7,684

Total cost of revenue

15,768

18,686

Gross profit (1)

12,095

11,066

Gross margin (1)

43.4

37.2

Operating expenses:

Research and development (2)

5,618

5,515

Sales and marketing (2)

13,279

13,652

General and administrative (2)(3)

10,117

8,298

Total operating expenses

29,014

27,465

Loss from operations

(16,919

)

(16,399

)

Interest income and other income, net

1,527

1,976

Interest expense

(3,369

)

(3,560

)

Loss on extinguishment of term loan

—

(7,685

)

Loss before provision for income taxes

(18,761

)

(25,668

)

Provision for income taxes

217

115

Net loss

(18,978

)

(25,783

)

Net loss per share, basic and diluted

(1.03

)

(3.66

)

Shares used in computing net loss per share, basic and diluted

18,373

7,038

(1) Gross profit and gross margin by source consisted of the following:

Three Months Ended

March 31,

2026

2025

Gross profit

Product revenue

9,717

10,292

Service and other revenue

2,378

774

Total gross profit

12,095

11,066

Gross margin

Product revenue

52.4

48.3

Service and other revenue

25.5

9.2

Total gross margin

43.4

37.2

(2) Includes stock-based compensation expense as follows:

Three Months Ended

Stock-based compensation expense

March 31,

2026

2025

Cost of revenue

111

117

Research and development

820

559

Sales and marketing

458

479

General and administrative

2,064

1,822

Total stock-based compensation expense

3,453

2,977

(3) Includes non-ordinary course litigation charges related to stockholder class action and related derivative lawsuits as follows:

Three Months Ended

Litigation charges

March 31,

2026

2025

General and administrative

112

—

Total litigation charges

112

—

Outset Medical, Inc.

Condensed Balance Sheets

(in thousands, except per share amounts)

March 31,

December 31,

2026

2025

(unaudited)

Assets

Current assets:

Cash and cash equivalents

30,562

35,006

Short-term investments

126,144

133,940

Accounts receivable, net

25,322

28,329

Inventories

49,650

47,609

Prepaid expenses and other current assets

5,031

5,999

Total current assets

236,709

250,883

Restricted cash

3,829

Property and equipment, net

4,073

4,670

Operating lease right-of-use assets

4,410

4,797

Finance lease right-of-use assets

—

Other assets

353

317

Total assets

249,454

264,496

Liabilities and stockholders' equity

Current liabilities:

Accounts payable

1,440

554

Accrued compensation and related benefits

8,754

10,735

Accrued expenses and other current liabilities

11,599

9,433

Accrued warranty liability

1,352

1,374

Deferred revenue, current

12,641

13,795

Operating lease liabilities, current

1,795

1,739

Finance lease liabilities, current

—

Total current liabilities

37,607

37,630

Deferred revenue

366

406

Operating lease liabilities

2,797

3,271

Finance lease liabilities

—

Term loan

96,937

96,237

Total liabilities

137,766

137,544

Commitments and contingencies

Stockholders' equity:

Preferred Stock, $0.001 par value; 5,000 shares authorized, and no shares issued and outstanding as of March 31, 2026 and December 31, 2025

—

Common stock, $0.001 par value; 300,000 shares authorized as of March 31, 2026 and December 31, 2025; 18,529 and 18,169 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively

Additional paid-in capital

1,302,097

1,298,138

Accumulated other comprehensive income

(73

)

172

Accumulated deficit

(1,190,354

)

(1,171,376

)

Total stockholders' equity

111,688

126,952

Total liabilities and stockholders' equity

249,454

264,496

Outset Medical, Inc.

Condensed Statements of Cash Flows

(in thousands)

(unaudited)

Three Months Ended March 31,

2026

2025

Net cash used in operating activities

(12,844

)

(25,663

)

Net cash provided by (used in) investing activities

7,899

(78,079

)

Net cash provided by financing activities

501

55,656

Net decrease in cash, cash equivalents and restricted cash

(4,444

)

(48,086

)

Cash, cash equivalents and restricted cash at beginning of the period

38,835

127,343

Cash, cash equivalents and restricted cash at end of the period (1)

34,391

79,257

(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):

March 31,

2026

2025

Cash and cash equivalents

30,562

75,928

Restricted cash

3,829

3,329

Total cash, cash equivalents and restricted cash*

34,391

79,257

* The total cash, including restricted cash, cash equivalents and investment securities as of March 31, 2026 was $160.5 million; compared to $192.3 million as of March 31, 2025.

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

March 31,

2026

2025

GAAP net loss per share, diluted

(1.03

)

(3.66

)

Stock-based compensation expense

0.19

0.42

Litigation charges

0.01

—

Non-GAAP net loss per share, diluted

(0.83

)

(3.24

)

Reconciliation between GAAP and non-GAAP net loss:

Three Months Ended

March 31,

2026

2025

GAAP net loss, diluted

(18,978

)

(25,783

)

Stock-based compensation expense

3,453

2,977

Litigation charges

112

—

Non-GAAP net loss, diluted

(15,413

)

(22,806

)

Reconciliation between GAAP and non-GAAP results of operations:

Three Months Ended

March 31,

2026

2025

GAAP gross profit

12,095

11,066

Stock-based compensation expense

111

117

Non-GAAP gross profit

12,206

11,183

GAAP gross margin

43.4

37.2

Stock-based compensation expense

0.4

Non-GAAP gross margin

43.8

37.6

GAAP research and development expense

5,618

5,515

Stock-based compensation expense

(820

)

(559

)

Non-GAAP research and development expense

4,798

4,956

GAAP sales and marketing expense

13,279

13,652

Stock-based compensation expense

(458

)

(479

)

Non-GAAP sales and marketing expense

12,821

13,173

GAAP general and administrative expense

10,117

8,298

Stock-based compensation expense

(2,064

)

(1,822

)

Litigation charges

(112

)

—

Non-GAAP general and administrative expense

7,941

6,476

GAAP total operating expense

29,014

27,465

Stock-based compensation expense

(3,342

)

(2,860

)

Litigation charges

(112

)

—

Non-GAAP total operating expense

25,560

24,605

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Title of a 12(b) registered security.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Name of the Exchange on which a security is registered.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Trading symbol of an instrument as listed on an exchange.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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