Press Release: Carlsmed(R) Reports Second Quarter 2025 Financial Results

Dow Jones
Aug 29

Q2'25 revenue of $12.1 million, 99% YOY growth

Full year revenue guidance of $45.5M - $47.5M

CARLSBAD, Calif., Aug. 28, 2025 (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 second quarter ended June 30, 2025.

"Our strong commercial performance was driven by the continued adoption of our highly differentiated AI-enabled aprevo$(R)$ technology platform and growing recognition of its ability to deliver more favorable patient outcomes than legacy devices," said Mike Cordonnier, Chairman and CEO of Carlsmed. "Building upon our momentum in personalized lumbar fusion surgery, in July we successfully completed the first personalized cervical spine surgery using our aprevo(R) technology platform, launching in 2026. We enter the second half of 2025 well positioned for continued scale as we become the new standard of care in spine fusion surgery."

Second Quarter Financial Results & Recent Highlights

   -- Revenue was $12.1 million for the second quarter of 2025; a 99% increase 
      compared to $6.1 million for the second quarter of 2024. This increase 
      was driven by the increased number of surgical procedures utilizing the 
      aprevo(R) technology platform in the second quarter of 2025, with average 
      revenue per procedure flat between these periods. 
 
   -- Gross profit for the second quarter of 2025 was $8.9 million compared to 
      $4.6 million for the second quarter of 2024, due to our increased 
      revenue. Gross margin was 73.4% for the second quarter of 2025, compared 
      with 75.0% for the second quarter of 2024; this decrease was primarily 
      driven by expedite production fees charged by our contract manufacturer 
      in the second quarter to meet customer timing requirements. 
 
   -- Operating expenses were $15.4 million for the second quarter of 2025, 
      compared with $10.9 million for the second quarter of 2024. 
 
          -- Research and development expenses were $4.2 million for the second 
             quarter of 2025, compared with $4.0 million for the second quarter 
             of 2024. This increase was primarily driven by higher personnel 
             costs to support product development and artificial intelligence 
             initiatives, partially offset by lower prototype and materials 
             costs and reduced COMPASS registry costs following enrollment 
             completion in second half of 2024. 
 
          -- Sales and marketing expenses were $7.9 million for the second 
             quarter of 2025, compared with $4.9 million for the second quarter 
             of 2024. This increase was primarily driven by personnel additions 
             and variable sales expenses associated with our revenue growth, as 
             well as an increase in marketing expenses. 
 
          -- General and administrative expenses were $3.3 million for the 
             second quarter of 2025, compared with $2.0 million for the second 
             quarter of 2024. This increase was primarily due to personnel 
             additions to support business growth and costs associated with the 
             transition to being a publicly traded company, including 
             associated legal, accounting, and other professional fees. 
   -- Net loss was $6.8 million for the second quarter of 2025, compared to a 
      $6.3 million net loss for the second quarter of 2024. 
 
   -- Adjusted EBITDA loss was $6.2 million for the second quarters of 2025 and 
      2024. 
   -- Cash and cash equivalents were $33.5 million as of June 30, 2025. The 
      Company received $93.5 million of net proceeds, after deducting 
      underwriting discounts and commissions and before other additional 
      offering expenses, from its initial public offering in July 2025. 
 
   -- The first personalized cervical spine surgery using the AI-enabled 
      aprevo(R) technology platform was performed. 
 
   -- aprevo(R) cervical procedures received CMS New Technology Add-On Payment 
      $(NTAP)$ reimbursement, in effect October 1, 2025. 

2025 Full Year Financial Outlook

   -- Revenue for the full year 2025 is expected to be in the range of $45.5 
      million to $47.5 million, representing growth of 67% to 75% over 2024. 

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 second quarter and first half of 2025 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/y7ki9icw.

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 (i) net interest expense and income, (ii) income tax expense (benefit), (iii) depreciation and amortization expense, (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 has limitations as an analytical tool and 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 the Carlsmed's ability to scale the impact of its aprevo(R) technology platform and advance its personalized spine surgery platform to transform patient outcomes and drive long-term growth, Carlsmed's current expectation of commercially launching aprevo(R) cervical in the United States in 2026, the number ranges presented in our 2025 Full Year 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 Registration Statement on Form S-1 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

Caroline Corner, PhD

IR@Carlsmed.com

Media

LeAnn Burton

Senior Director Brand Marketing

LBurton@Carlsmed.com

(END) Dow Jones Newswires

 
 

Q2'25 revenue of $12.1 million, 99% YOY growth

Full year revenue guidance of $45.5M - $47.5M

CARLSBAD, Calif., Aug. 28, 2025 (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 second quarter ended June 30, 2025.

"Our strong commercial performance was driven by the continued adoption of our highly differentiated AI-enabled aprevo(R) technology platform and growing recognition of its ability to deliver more favorable patient outcomes than legacy devices," said Mike Cordonnier, Chairman and CEO of Carlsmed. "Building upon our momentum in personalized lumbar fusion surgery, in July we successfully completed the first personalized cervical spine surgery using our aprevo(R) technology platform, launching in 2026. We enter the second half of 2025 well positioned for continued scale as we become the new standard of care in spine fusion surgery."

Second Quarter Financial Results & Recent Highlights

   -- Revenue was $12.1 million for the second quarter of 2025; a 99% increase 
      compared to $6.1 million for the second quarter of 2024. This increase 
      was driven by the increased number of surgical procedures utilizing the 
      aprevo(R) technology platform in the second quarter of 2025, with average 
      revenue per procedure flat between these periods. 
 
   -- Gross profit for the second quarter of 2025 was $8.9 million compared to 
      $4.6 million for the second quarter of 2024, due to our increased 
      revenue. Gross margin was 73.4% for the second quarter of 2025, compared 
      with 75.0% for the second quarter of 2024; this decrease was primarily 
      driven by expedite production fees charged by our contract manufacturer 
      in the second quarter to meet customer timing requirements. 
 
   -- Operating expenses were $15.4 million for the second quarter of 2025, 
      compared with $10.9 million for the second quarter of 2024. 
 
          -- Research and development expenses were $4.2 million for the second 
             quarter of 2025, compared with $4.0 million for the second quarter 
             of 2024. This increase was primarily driven by higher personnel 
             costs to support product development and artificial intelligence 
             initiatives, partially offset by lower prototype and materials 
             costs and reduced COMPASS registry costs following enrollment 
             completion in second half of 2024. 
 
          -- Sales and marketing expenses were $7.9 million for the second 
             quarter of 2025, compared with $4.9 million for the second quarter 
             of 2024. This increase was primarily driven by personnel additions 
             and variable sales expenses associated with our revenue growth, as 
             well as an increase in marketing expenses. 
 
          -- General and administrative expenses were $3.3 million for the 
             second quarter of 2025, compared with $2.0 million for the second 
             quarter of 2024. This increase was primarily due to personnel 
             additions to support business growth and costs associated with the 
             transition to being a publicly traded company, including 
             associated legal, accounting, and other professional fees. 
   -- Net loss was $6.8 million for the second quarter of 2025, compared to a 
      $6.3 million net loss for the second quarter of 2024. 
 
   -- Adjusted EBITDA loss was $6.2 million for the second quarters of 2025 and 
      2024. 
   -- Cash and cash equivalents were $33.5 million as of June 30, 2025. The 
      Company received $93.5 million of net proceeds, after deducting 
      underwriting discounts and commissions and before other additional 
      offering expenses, from its initial public offering in July 2025. 
 
   -- The first personalized cervical spine surgery using the AI-enabled 
      aprevo(R) technology platform was performed. 
 
   -- aprevo(R) cervical procedures received CMS New Technology Add-On Payment 
      (NTAP) reimbursement, in effect October 1, 2025. 

2025 Full Year Financial Outlook

   -- Revenue for the full year 2025 is expected to be in the range of $45.5 
      million to $47.5 million, representing growth of 67% to 75% over 2024. 

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 second quarter and first half of 2025 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/y7ki9icw.

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 (i) net interest expense and income, (ii) income tax expense (benefit), (iii) depreciation and amortization expense, (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 has limitations as an analytical tool and 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 the Carlsmed's ability to scale the impact of its aprevo(R) technology platform and advance its personalized spine surgery platform to transform patient outcomes and drive long-term growth, Carlsmed's current expectation of commercially launching aprevo(R) cervical in the United States in 2026, the number ranges presented in our 2025 Full Year 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 Registration Statement on Form S-1 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

Caroline Corner, PhD

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 June    Six Months Ended June 
                                30,                       30, 
                      -----------------------   ----------------------- 
                         2025         2024         2025         2024 
                      ----------   ----------   ----------   ---------- 
Revenue               $   12,083   $    6,081   $   22,272   $   11,167 
Cost of sales              3,214        1,519        5,767        2,941 
                       ---------    ---------    ---------    --------- 
Gross profit               8,869        4,562       16,505        8,226 
                       ---------    ---------    ---------    --------- 
Operating expenses: 
    Research and 
     development           4,160        3,998        7,310        7,254 
    Sales and 
     marketing             7,869        4,873       14,608        8,470 
    General and 
     administrative        3,342        2,010        6,808        4,150 
                       ---------    ---------    ---------    --------- 
Total operating 
 expenses                 15,371       10,881       28,726       19,874 
                       ---------    ---------    ---------    --------- 
Loss from operations      (6,502)      (6,319)     (12,221)     (11,648) 
Other income 
(expense): 
    Interest expense        (363)        (325)        (720)        (541) 
    Interest income          336          428          716          526 
    Change in fair 
     value of 
     warrant 
     liabilities            (237)         (61)        (270)         (61) 
                       ---------    ---------    ---------    --------- 
      Total other 
       income 
       (expense), 
       net                  (264)          42         (274)         (76) 
                       ---------    ---------    ---------    --------- 
Net loss and 
 comprehensive loss       (6,766)      (6,277)     (12,495)     (11,724) 
                       ---------    ---------    ---------    --------- 
Deemed dividend to 
 preferred 
 stockholders                 --           --         (584)          -- 
                       ---------    ---------    ---------    --------- 
Net loss 
 attributable to 
 common 
 stockholders         $   (6,766)  $   (6,277)  $  (13,079)  $  (11,724) 
                       =========    =========    =========    ========= 
 
Net loss per share 
 attributable to 
 common 
 stockholders, basic 
 and diluted          $    (1.47)  $    (1.55)  $    (2.94)  $    (2.91) 
Weighted-average 
 number of common 
 shares used to 
 compute basic and 
 diluted net loss 
 per share             4,589,717    4,053,063    4,445,384    4,024,815 
 
 
                           CARLSMED, INC. 
                       CONDENSED BALANCE SHEETS 
        (in thousands, except for share and par value amounts) 
                             (unaudited) 
                                 June 30, 2025     December 31, 2024 
                                ---------------   ------------------- 
Assets 
Current assets: 
   Cash and cash equivalents     $       33,472     $          40,125 
   Restricted cash                          100                   100 
   Accounts receivable, net of 
    allowances of $1,576 and 
    $1,239, as of June 30, 
    2025 and December 31, 
    2024, respectively                    9,711                 6,766 
   Inventory                              1,068                   995 
   Prepaid expenses and other 
    current assets                        1,841                 1,365 
                                    -----------   ---  -------------- 
Total current assets                     46,192                49,351 
Property and equipment, net                 972                   260 
Operating lease right-of-use 
 assets                                   2,144                 1,644 
Other assets                              3,962                   569 
                                    -----------   ---  -------------- 
Total assets                     $       53,270     $          51,824 
                                    ===========   ===  ============== 
 
Liabilities, Convertible 
Preferred Stock, and 
Stockholders' Deficit 
Current liabilities: 
   Accounts payable              $        2,581     $           2,412 
   Accrued liabilities                    3,219                 2,687 
   Accrued compensation                   3,113                 3,270 
   Short-term operating lease 
    liabilities                             571                   449 
                                    -----------   ---  -------------- 
Total current liabilities                 9,484                 8,818 
   Long-term portion of term 
    loan, net                            15,431                15,414 
   Long-term operating lease 
    liabilities                           1,705                 1,317 
   Warrant liabilities                      727                   457 
   Other long-term liabilities              267                   222 
                                    -----------   ---  -------------- 
Total liabilities                        27,614                26,228 
                                    -----------   ---  -------------- 
Commitments and contingencies 
(Note 9) 
Series A convertible preferred 
 stock, $0.00001 par value; 
 4,902,814 shares authorized, 
 issued, and outstanding, and 
 $13,767 liquidation 
 preference as of June 30, 
 2025 and December 31, 2024              13,578                13,578 
Series B convertible preferred 
 stock, $0.00001 par value; 
 4,393,481 shares authorized, 
 4,335,051 shares issued and 
 outstanding, and $30,000 
 liquidation preference as of 
 June 30, 2025 and December 
 31, 2024                                29,801                29,801 
Series C convertible preferred 
 stock, $0.00001 par value; 
 6,028,243 and 4,910,500 
 shares authorized, 6,007,866 
 and 4,890,123 shares issued 
 and outstanding, and $64,500 
 and $52,500 liquidation 
 preference as of June 30, 
 2025 and December 31, 2024, 
 respectively                            65,350                52,847 
 
Stockholders' deficit: 
   Common stock, $0.00001 par 
   value; 23,679,694 and 
   21,835,801 shares 
   authorized, 4,681,414 and 
   4,234,798 shares issued, 
   and 4,603,756 and 
   4,139,219 shares 
   outstanding as of June 30, 
   2025 and December 31, 
   2024, respectively                        --                    -- 
   Additional paid-in capital               593                   541 
   Accumulated deficit                  (83,666)              (71,171) 
                                    -----------   ---  -------------- 
Total stockholders' deficit             (83,073)              (70,630) 
                                    -----------   ---  -------------- 
Total liabilities, convertible 
 preferred stock, and 
 stockholders' deficit           $       53,270     $          51,824 
                                    ===========   ===  ============== 
 
 
    RECONCILIATION OF GAAP NET LOSS TO ADJUSTED EBITDA 
                        (unaudited) 
                    Three Months 
                   Ended June 30,        $        % 
                  ----------------- 
                    2025      2024     Change   Change 
                   ------    ------    ------   ------ 
(in thousands, 
except 
percentages) 
Net loss          $(6,766)  $(6,277)  $  (489)     7.8    % 
Interest 
 (income) 
 expense               27      (103)      130   (126.2)   % 
Income taxes           --        --        --       -- 
Depreciation and 
 amortization          61        35        26     74.3    % 
                   ------    ------    ------ 
EBITDA             (6,678)   (6,345)     (333)     5.2    % 
Stock-based 
 compensation         258        52       206    396.2    % 
Change in fair 
 value of 
 warrant 
 liabilities          237        61       176    288.5    % 
                   ------    ------    ------ 
Adjusted EBITDA   $(6,183)  $(6,232)  $    49     (0.8)   % 
                   ======    ======    ====== 
 
 
                   Six Months Ended 
                       June 30,            $         % 
                  ------------------- 
                    2025       2024      Change    Change 
                  --------   --------   --------   ------ 
(in thousands, 
except 
percentages) 
Net loss          $(12,495)  $(11,724)   $  (771)     6.6    % 
Interest 
 (income) 
 expense                 4         15        (11)   (73.3)   % 
Income taxes            --         --         --       -- 
Depreciation and 
 amortization          101         75         26     34.7    % 
                   -------    -------       ---- 
EBITDA             (12,390)   (11,634)      (756)     6.5    % 
Stock-based 
 compensation          433         87        346    397.7    % 
Change in fair 
 value of 
 warrant 
 liabilities           270         61        209    342.6    % 
                   -------    -------       ---- 
Adjusted EBITDA   $(11,687)  $(11,486)   $  (201)     1.7    % 
                   =======    =======       ==== 
 

(END) Dow Jones Newswires

August 28, 2025 18:09 ET (22:09 GMT)

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