Form 8-K

8-K — CARLSMED, INC.

Accession: 0001794546-26-000010

Filed: 2026-05-05

Period: 2026-05-05

CIK: 0001794546

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — carl-20260505.htm (Primary)

EX-99.1 (carl-ex99_1.htm)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K

8-K (Primary)

Filename: carl-20260505.htm · Sequence: 1

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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 5, 2026

Carlsmed, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware

001-42756

83-1081863

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

1800 Aston Ave, Suite 100

Carlsbad, California

92008

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (760) 766-1923

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, $0.00001 par value per share

CARL

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 Results of Operations and Financial Condition.

On May 5, 2026, Carlsmed, Inc. (the "Company") issued a press release announcing its financial results for the quarter ended March 31, 2026. The full text of the press release is furnished hereto as Exhibit 99.1 and is incorporated herein by reference.

The foregoing information in this Item 2.02 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(a) Exhibits

Exhibit No.

Description

99.1*

Press Release of Carlsmed, Inc., dated May 5, 2026

104

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

* Filed herewith.

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 hereunto duly authorized.

CARLSMED, INC.

Date: May 5, 2026

By:

/s/Michael Cordonnier

Michael Cordonnier

Chief Executive Officer and President

EX-99.1

Filename: carl-ex99_1.htm · Sequence: 2

EX-99.1

Carlsmed® Reports First Quarter 2026 Financial Results

First quarter 2026 revenue of $16.1 million, representing 58% growth year-over-year

Full year 2026 revenue guidance raised to $72 million to $77 million

CARLSBAD, CALIFORNIA, MAY 5, 2026 (GLOBE NEWSWIRE) -- Carlsmed, Inc. (Nasdaq: CARL) (“Carlsmed” or the “Company”), a medical technology company pioneering AI-enabled personalized spine surgery solutions, today reported financial results for the first quarter ended March 31, 2026.

“We began 2026 with strong momentum, delivering 58% year-over-year revenue growth, publishing meaningful clinical data, and debuting new products to continue to advance our mission of improved patient outcomes and reduced cost of healthcare," said Mike Cordonnier, Chairman and Chief Executive Officer of Carlsmed. "The publication of peer-reviewed data from a retrospective cohort study in Global Spine Journal demonstrates a 74% reduction in revision rates for aprevo®, which represents one of the most significant advancements in reducing reoperations in adult spinal deformity over the past two decades. With our first full commercial quarter for aprevo® Cervical and the launch of our corra™ patient-specific fixation portfolio later this year, we believe we are well positioned for continued growth and innovation throughout 2026.”

Recent Business Highlights

•

Study published in Global Spine Journal demonstrated 74% reduction in reoperations in patients treated with aprevo® personalized lumbar implants compared to previously published results for patients treated with traditional implants, reinforcing the durability and clinical differentiation of the aprevo platform.

•

Performed first procedure using the corra™ personalized cervical plating system in February, marking the debut of the Company’s patient-specific fixation portfolio.

•

Completed first procedure utilizing aprevo® bi-lateral posterior in February, expanding the personalized lumbar platform for this additional lumbar fusion technique.

First Quarter 2026 Financial Results

•

Revenue was $16.1 million for the first quarter of 2026, a 58.2% increase compared to $10.2 million for the first quarter of 2025.

•

Gross profit for the first quarter of 2026 was $12.4 million compared to $7.6 million for the first quarter of 2025. Gross margin was 77.1% for the first quarter of 2026, compared with 74.9% for the first quarter of 2025.

•

Operating expenses were $21.7 million for the first quarter of 2026, compared with $13.4 million for the first quarter of 2025, which consisted of:

•

Research and development expenses of $5.2 million for the first quarter of 2026, compared with $3.2 million for the first quarter of 2025.

•

Sales and marketing expenses of $10.3 million for the first quarter of 2026, compared with $6.7 million for the first quarter of 2025.

•

General and administrative expenses of $6.2 million for the first quarter of 2026, compared with $3.5 million for the first quarter of 2025.

•

Net loss was ($8.7) million for the first quarter of 2026, compared to a ($5.7) million net loss for the first quarter of 2025.

•

Adjusted EBITDA was ($7.5) million for the first quarter of 2026, compared to ($5.5) million for the first quarter of 2025.

•

Cash and cash equivalents, restricted cash, and short-term investments were $97.1 million as of March 31, 2026.

2026 Financial Outlook

•

Revenue for the full year 2026 is expected to be in the range of $72 to $77 million, representing growth of 48% at the midpoint of the range over 2025. This compares to prior guidance of $70 to $75 million.

Webcast & Conference Call Details

Carlsmed will host a conference call and concurrent webcast today at 4:30 pm Eastern Time (1:30 pm Pacific Time), to review the Company’s performance. To access the webcast, please use the following link, which will provide you with dial-in details: https://edge.media-server.com/mmc/p/2j9w2c9m/

Non-GAAP Financial Measures

This press release contains certain financial information that is not presented in conformity with U.S. generally accepted accounting principles (“GAAP”), including adjusted EBITDA. The non-GAAP financial measures are provided as supplemental information to Carlsmed’s financial measures presented in this press release that are calculated and presented in accordance with GAAP.

The Company calculates adjusted EBITDA as net income (loss), as adjusted to exclude, as applicable, (i) net interest income (expense), (ii) income tax expense (benefit), (iii) depreciation expense from property and equipment (iv) amortization expense from long-lived assets, (iv) stock-based compensation expense and (v) change in fair value of warrant liabilities.

This non-GAAP measure is presented because management believes it allows investors to view the Company’s performance in a manner similar to the method used by management to evaluate financial performance for both strategic and annual operating planning. Management believes that to properly understand short-term and long-term financial trends, it is helpful for investors to understand the impact of the items excluded from the calculation of adjusted EBITDA, in addition to considering the Company’s GAAP financial measures. The excluded items vary in frequency and/or impact on our results of operations and management believes that the excluded items are not reflective of the Company’s ongoing core business operations and financial condition. Excluding such items allows investors and analysts to compare our operating performance to other companies in our industry and to compare the Company’s period-over-period results.

The non-GAAP financial measures used by Carlsmed may not be the same or calculated in the same manner as those used and calculated by other companies. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for

Carlsmed’s financial results prepared and reported in accordance with GAAP. This non-GAAP measure should not be construed as an inference that the Company’s future results will be unaffected by unusual or non-recurring items. We urge investors to review the reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures included in this press release, and not to rely on any single financial measure to evaluate our business. A reconciliation of adjusted EBITDA reported in this press release to the most comparable GAAP measure for the respective periods appears in the table captioned “Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA” later in this release. Within the accompanying financial tables presented, certain columns and rows may not add due to the use of rounded numbers.

About Carlsmed

Carlsmed is a medical technology company pioneering AI-enabled personalized spine surgery solutions with a mission to improve outcomes and decrease the cost of healthcare for spine surgery and beyond.

Forward Looking Statement

Any statements in this press release about future expectations, plans and prospects, including statements about Carlsmed’s growth prospects, the potential of its products to improve patient outcomes, anticipated product launch dates, the revenue ranges presented in our 2026 Financial Outlook, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including such important factors as are set forth under the caption “Risk Factors” in the Carlsmed’s Annual Report on Form 10-K on file with the U.S. Securities and Exchange Commission. The forward-looking statements included in this press release represent Carlsmed’s views as of the date of this press release. Carlsmed anticipates that subsequent events and developments will cause its views to change. However, while Carlsmed may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Carlsmed’s views as of any date subsequent to the date of this press release.

Investor Relations

Stephanie Zhadkevich, Vice President, Head of Investor Relations

IR@Carlsmed.com

Media

LeAnn Burton, Senior Director Brand Marketing

LBurton@Carlsmed.com

CARLSMED, INC.

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except share and per share amounts)

(unaudited)

Three Months Ended March 31,

2026

2025

Revenue

16,116

10,189

Cost of sales

3,691

2,553

Gross profit

12,425

7,636

Operating expenses:

Research and development

5,178

3,150

Sales and marketing

10,297

6,739

General and administrative

6,226

3,466

Total operating expenses

21,701

13,355

Loss from operations

(9,276

)

(5,719

)

Other income (expense):

Interest expense

(311

)

(357

)

Interest income

891

380

Change in fair value of warrant liabilities

—

(33

)

Total other income (expense), net

580

(10

)

Net loss and comprehensive loss

(8,696

)

(5,729

)

Deemed dividend to preferred stockholders

—

(584

)

Net loss attributable to common stockholders

(8,696

)

(6,313

)

Net loss per share attributable to common stockholders, basic

and diluted

(0.32

)

(1.47

)

Weighted-average number of common shares used to compute

basic and diluted net loss per share

26,835,841

4,299,492

CARLSMED, INC.

CONDENSED BALANCE SHEETS

(in thousands, except for share and par value amounts)

(unaudited)

March 31, 2026

December 31, 2025

Assets

Current assets:

Cash and cash equivalents

73,016

85,793

Restricted cash

100

Short-term investments

24,000

Accounts receivable, net of allowances of $2,055 and $1,653, as of March 31, 2026 and

December 31, 2025, respectively

12,268

11,362

Inventory

2,063

1,845

Prepaid expenses and other current assets

3,959

3,573

Total current assets

115,406

126,673

Property and equipment, net

1,597

1,487

Operating lease right-of-use assets

1,663

1,826

Other assets

103

134

Total assets

118,769

130,120

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable

2,952

4,481

Accrued liabilities

3,202

3,287

Accrued compensation

2,785

5,760

Short-term operating lease liabilities

776

752

Total current liabilities

9,715

14,280

Long-term portion of term loan, net

15,364

15,346

Long-term operating lease liabilities

1,115

1,316

Other long-term liabilities

327

309

Total liabilities

26,521

31,251

Commitments and contingencies

Stockholders’ equity:

Preferred stock, $0.00001 par value; 10,000,000 shares authorized and zero shares issued and outstanding as of March 31, 2026 and December 31, 2025

—

Common stock, $0.00001 par value; 600,000,000 shares authorized, 27,232,278 shares issued, and 27,181,501 shares outstanding as of March 31, 2026; 600,000,000 shares authorized, 26,664,243 shares issued, and 26,604,505 shares outstanding as of December 31, 2025

—

Additional paid-in capital

201,749

199,674

Accumulated deficit

(109,501

)

(100,805

)

Total stockholders’ equity

92,248

98,869

Total liabilities and stockholders’ equity

118,769

130,120

RECONCILIATION OF GAAP NET LOSS

TO ADJUSTED EBITDA

(unaudited)

Three Months Ended March 31,

2026

2025

Change

(in thousands, except percentages)

Net loss

(8,696

)

(5,729

)

(2,967

)

51.8

Interest (income) expense

(580

)

(23

)

(557

)

2,421.7

Income taxes

—

Depreciation and amortization

147.5

EBITDA

(9,177

)

(5,712

)

(3,465

)

60.7

Stock-based compensation

1,629

175

1,454

830.9

Change in fair value of warrant liabilities

—

(33

)

(100.0

)

Adjusted EBITDA

(7,548

)

(5,504

)

(2,044

)

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