0001794546-26-000010 | 8-K | iXBRL Viewer | Carlsmed INC
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)) |
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.
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
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.
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.
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.
RECONCILIATION OF GAAP NET LOSS
TO ADJUSTED EBITDA
(unaudited)
| Net loss | $ | (8,696 | ) | $ | (5,729 | ) | $ | (2,967 | ) | 51.8 | % | |||||||||
| Interest (income) expense | (580 | ) | (23 | ) | (557 | ) | 2,421.7 | % | ||||||||||||
| Depreciation and amortization | 99 | 40 | 59 | 147.5 | % | |||||||||||||||
| Adjusted EBITDA | $ | (7,548 | ) | $ | (5,504 | ) | $ | (2,044 | ) | 37.1 | % |
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 | ||||||
| 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 | 100 | ||||||
| Short-term investments | 24,000 | 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 | ||||||
| Total assets | $ | 118,769 | $ | 130,120 | ||||
| Total liabilities and stockholders’ equity | $ | 118,769 | $ | 130,120 |