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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 30, 2025

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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

Appointment of Chief Financial Officer

On May 30, 2025, the Board of Directors (the “Board”) of Outset Medical, Inc. (the “Company”) appointed Renee Gaeta as the Company’s Chief Financial Officer, Principal Financial Officer and Principal Accounting Officer, effective June 3, 2025 (the “Effective Date”).

 

Prior to joining the Company, Ms. Gaeta, age 44, served as the Chief Financial Officer of Shockwave Medical, Inc., a medical device company, from February 2024 until it was acquired by Johnson & Johnson in May 2024. Prior to that, she served as Chief Financial Officer of Eko Health, a cardiopulmonary digital health company, from July 2021 to February 2024. From July 2017 to July 2021, Ms. Gaeta was Chief Financial Officer at Establishment Labs Holdings, Inc., a global medical technology company, and from August 2014 to June 2017, she served as Vice President, Corporate Controller at Sientra, Inc., a medical aesthetics company. Earlier in her career, Ms. Gaeta spent ten years at KPMG LLP where she held various positions of increasing responsibility. Ms. Gaeta has served on the board of directors of Candel Therapeutics, Inc., a biopharmaceutical company, since August 2022. Previously, she also served on the board of directors of SeaSpine Holdings Corporation, a global medical technology company, from February 2019 to January 2023 when it merged with Orthofix Medical. Ms. Gaeta holds a B.S. from Loyola Marymount University and is a Certified Public Accountant in the State of California.

 

In connection with her appointment as the Company’s Chief Financial Officer, Principal Financial Officer and Principal Accounting Officer, and as approved by the Compensation of Committee of the Board (the “Compensation Committee”), Ms. Gaeta and the Company have entered into an offer letter agreement (the “Offer Letter”) pursuant to which Ms. Gaeta is entitled to receive the following compensation: (i) an annual base salary of $500,000, (ii) an annual bonus for 2025 under the Company’s 2025 annual cash bonus program with a target bonus opportunity of 50% of her annual base salary, prorated for the portion of the year beginning on the Effective Date, (iii) a restricted stock unit award (the “RSU Award”) to be granted to Ms. Gaeta shortly following the Effective Date, valued at $2,480,000 as of the date of grant and (iv) a performance-based restricted stock unit award (the “PSU Award”) to be granted to Ms. Gaeta shortly following the Effective Date, valued at $620,000 as of the date of grant. One-third of the shares underlying the RSU Award will vest on the one-year anniversary of the Effective Date, with the remainder vesting quarterly over the course of the following two years, subject to Ms. Gaeta’s continuous service through the applicable vesting date. Shares underlying the PSU Award will be earned and vest based on achievement against two metrics, consistent with the performance-based restricted stock unit awards to be awarded to other executive officers in 2025: (i) 70% will be earned and vest based on a financial metric to be determined by the Compensation Committee and measured over a three-year performance period ending at the end of 2027, with 100% of earned units vesting immediately after certification of the achievement level following the end of 2027 and (ii) 30% will be earned and vest based on the Company’s relative total stockholder return over a three-year performance period as compared to companies in a pre-determined index of medical device companies, with 100% of earned units vesting immediately after certification of the achievement level at the end of the three-year performance period, in each case, subject to Ms. Gaeta’s continuous service through the applicable vesting date.

 

Ms. Gaeta will also enter into the Company’s standard Change in Control and Severance Agreement for executive officers (other than the Chief Executive Officer) effective as of the Effective Date, the form of which was previously filed by the Company as Exhibit 10.12 to the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission (“SEC”) on February 21, 2024. In addition, Ms. Gaeta will enter into the Company’s standard director and officer indemnification agreement effective as of the Effective Date, the form of which was previously filed by the Company as Exhibit 10.1 to Amendment No. 1 to the Company’s Registration Statement on Form S-1/A (Registration No. 333-248225), filed with the SEC on September 9, 2020.

 

There are no arrangements or understandings between Ms. Gaeta and any other persons pursuant to which she was appointed as Chief Financial Officer, Principal Financial Officer and Principal Accounting Officer. In addition, there are no family relationships between Ms. Gaeta and any other director or executive officer of the Company, and Ms. Gaeta has no direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K.

 

The foregoing description of the Offer Letter is qualified in its entirety by reference to the full text of such letter, which the Company plans to file as an exhibit to its Quarterly Report on Form 10-Q for the quarter ended June 30, 2025.

 

Departure of Former Chief Financial Officer

 

Ms. Gaeta succeeds Nabeel Ahmed, who is leaving his role as the Company’s Financial Officer, Principal Financial Officer and Principal Accounting Officer, effective as of the Effective Date, to pursue other opportunities.

 

 


 

In connection with his departure, and subject to his execution and non-revocation of a general release of claims in favor of the Company, Mr. Ahmed will receive severance benefits of (i) a lump sum payment equal to nine months of base salary and (ii) payment of premiums for COBRA continuation coverage for nine months, pursuant to the terms of the existing Change in Control and Severance Agreement between Mr. Ahmed and the Company most recently amended and restated effective February 7, 2024 (the “Severance Agreement”). The foregoing description is qualified by reference to the full text of the Severance Agreement, a form of which was filed as Exhibit 10.12 to the Company's Annual Report on Form 10-K filed with the SEC on February 21, 2024. Mr. Ahmed’s departure is not related to any disagreement with the Company or its independent registered public accountants on any matter relating to the Company’s financial or accounting operations, policies or practices. The Company would like to thank Mr. Ahmed for his contributions to the Company and wish him continued success in his future endeavors.

 

Item 5.07. Submission of Matters to a Vote of Security Holders.

On June 2, 2025, the Company held its Annual Meeting of Stockholders at 10:30 a.m. Pacific Time in a virtual format via live audio webcast (the “Annual Meeting”). As of April 3, 2025, the Company’s record date, there were a total of 17,722,035 shares of common stock outstanding and entitled to vote at the Annual Meeting. At the beginning of the Annual Meeting, 15,334,998 shares of common stock were present virtually in person or by proxy, and, therefore, a quorum was present. Five items of business were acted upon by the stockholders at the Annual Meeting. The final results for the votes regarding each proposal are set forth below.

Proposal One: Election of Class II Directors

Each of D. Keith Grossman and Patrick T. Hackett was elected to serve as a class II director to hold office until the Company’s 2028 annual meeting of stockholders and until the election and qualification of his successor. Votes were cast as follows:

For

Withheld

Broker Non-Votes

D. Keith Grossman

13,775,602

146,871

1,412,525

Patrick T. Hackett

13,827,416

95,057

1,412,525

Since the Board is divided into three classes with one class elected each year to hold office for a three-year term, the following directors continued to serve as directors of the Company immediately after the Annual Meeting: Karen Drexler, Brent D. Lang, Kevin O’Boyle, Andrea L. Saia and Leslie Trigg.

Proposal Two: Advisory Vote on Named Executive Officer Compensation

The proposal to approve the 2024 compensation of the Company’s named executive officers as disclosed in its 2024 proxy statement on a non-binding advisory basis was approved by the following vote:

For

Against

Abstain

Broker Non-Votes

13,574,133

342,501

5,839

1,412,525

Proposal Three: Amendment to 2020 Equity Incentive Plan

The proposal to approve an amendment to the Company’s 2020 Equity Incentive Plan to increase the number of shares of common stock available for issuance under the plan by 1,950,000 shares was approved by the following vote:

For

Against

Abstain

Broker Non-Votes

10,989,378

2,932,488

607

1,412,525

Proposal Four: Amendment to Employee Stock Purchase Plan

The proposal to approve an amendment to the Company’s Employee Stock Purchase Plan to increase the number of shares of common stock available for issuance under the plan by 255,000 shares was approved by the following vote:

For

Against

Abstain

Broker Non-Votes

13,661,326

259,632

1,515

1,412,525

Proposal Five: Ratification of Appointment of Independent Registered Public Accounting Firm

The stockholders ratified the appointment of KPMG LLP as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2025 by the following vote:

 


 

For

Against

Abstain

Broker Non-Votes

15,318,214

12,527

4,257

 

Item 7.01. Regulation FD Disclosure.

On June 3, 2025, the Company issued a press release announcing the appointment of Ms. Gaeta and the departure of Mr. Ahmed. A copy of the Company’s press release is furnished herewith as Exhibit 99.1.

The information contained in this Item 7.01 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 Appoints Renee Gaeta as Chief Financial Officer” dated June 3, 2025

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: June 3, 2025

By:

/s/ John Brottem

John Brottem

General Counsel

 

 


EX-99.1 2 om-ex99_1.htm EX-99.1 EX-99.1

Exhibit 99.1

img201318599_0.jpg

 

 

Outset Medical Appoints Renee Gaeta as Chief Financial Officer

 

San Jose, CA June 3, 2025 -- Outset Medical, Inc. (Nasdaq: OM) (“Outset”), a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis, today announced the appointment of Renee Gaeta as Chief Financial Officer (CFO), effective immediately. In addition to leading Finance, Ms. Gaeta will have responsibility for Outset’s Information Technology and Human Resources organizations. She succeeds Nabeel Ahmed who is leaving the company to pursue other opportunities.

 

“Renee brings deep financial and leadership experience to Outset with a proven track record from her roles at publicly traded medical-device growth companies as both a CFO and board member,” said Leslie Trigg, Chair and CEO. “She is the ideal fit for Outset as we drive our next phase of growth and our goal to achieve near-term profitability. I want to thank Nabeel for his contributions to Outset and wish him well in his future endeavors.”

 

With today’s announcement, Outset also reiterated its 2025 financial guidance, including expected revenue of $115 million to $125 million and non-GAAP gross margin in the high-30% range.

Ms. Gaeta most recently served as CFO of Shockwave Medical until its $13 billion acquisition by Johnson and Johnson in May 2024. She was previously CFO at Eko Health, where she also led both finance and human resources, and Establishment Labs, where she played a key role in the company’s initial public offering and growing the global business. She has served as a member of the board of directors and the audit committee of Candel Therapeutics since August 2022 and was previously audit committee chair and a board director of SeaSpine Holdings from 2019 until its acquisition in 2023 by Orthofix Medical. She received her Bachelor of Science, cum laude, in accounting from Loyola Marymount University and is a Certified Public Accountant in California.

“Outset is transforming dialysis care, and I am honored to join the company as its next CFO,” said Ms. Gaeta. “Tablo offers clear and compelling clinical, financial and operational value to acute, post-acute and home dialysis providers. I look forward to playing an important role in helping drive Outset to achieve its growth and profitability goals.”

 

About Outset Medical, Inc.

Outset is a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis. The Tablo® Hemodialysis System, FDA cleared for use from the hospital to the home, represents a significant technological advancement that transforms the dialysis experience for patients and operationally simplifies it for providers. Tablo serves as a single enterprise solution that can be utilized across the continuum of care, allowing dialysis to be delivered anytime, anywhere and by anyone. The integration of water purification and on-demand dialysate production enables Tablo to serve as a dialysis clinic on wheels, with 2-way wireless data transmission and a proprietary data analytics platform powering a new holistic approach to dialysis care. Tablo is a registered trademark of Outset Medical, Inc.

 

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 and non-GAAP gross margin. 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 filings with the Securities and Exchange Commission, including its most recent 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.

 

 

Contact

Jim Mazzola

Investor Relations

jmazzola@outsetmedical.com