CARL

This article first appeared on GuruFocus. Revenue: $18.9 million in Q2 2026, a 57% increase year-over-year from $12.1 million in Q2 2025. Gross Margin: 76.8% in Q2 2026, up 340 basis points from 73.4% in Q2 2025. Operating Expenses: $25.6 million in Q2 2026, compared to $15.4 million in Q2 2025. R&D Expenses: $6.0 million in Q2 2026, up from $4.2 million in Q2 2025. Sales and Marketing Expenses: $11.9 million in Q2 2026, compared to $7.9 million in Q2 2025. G&A Expenses: $7.6 million in Q2 2026, compared to $3.3 million in Q2 2025. Net Loss: GAAP net loss of $10.5 million in Q2 2026, compared to a net loss of $6.8 million in Q2 2025. Adjusted EBITDA: Negative $8.6 million in Q2 2026, compared to negative $6.2 million in Q2 2025. Cash and Investments: $89.3 million as of June 30, 2026. Cash Used in Operating Activities: $7.4 million in Q2 2026, compared to $8.2 million in Q2 2025. Revenue by Product Line: Lumbar fusion procedures represented approximately 90% of Q2 revenue; cervical fusion procedures represented approximately 10%. Full Year 2026 Revenue Guidance: Raised to between $74 million and $78 million, representing over 50% growth at the midpoint over full year 2025. Warning! GuruFocus has detected 2 Warning Sign with CARL. Is CARL fairly valued? Test your thesis with our free DCF calculator. Release Date: August 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Carlsmed Inc (NASDAQ:CARL) delivered strong Q2 2026 revenue of $18.9 million, a 57% year-over-year increase, driven by robust surgeon adoption and procedure volume growth. The company's surgeon user base grew by more than 60% year-over-year, indicating strong market traction and expanding adoption of the aprevo platform. CMS issued a favorable final rule creating three new MS-DRG codes for aprevo lumbar procedures, simplifying coding and enhancing hospital reimbursement, which is expected to expand access. Gross margins expanded by 340 basis points year-over-year to 76.8%, reflecting operational efficiencies and a capital-light, digital-first business model. The company is on track for multiple product launches in Q4 2026, including the aprevo lumbar bilateral system and CORA cervical plating system, which are expected to drive further growth. Carlsmed Inc (NASDAQ:CARL) raised its full-year 2026 revenue guidance to $74-$78 million, representing over 50% growth at the midpoint, reflecting strong first-half performance and confidence in the second half. The company reported a GAAP net loss of $10.5 million in Q2 2026, wider than the $6.8 million loss in the prior year, indicating increasing losses despite revenue growth. Total operating expenses increased significantly to $25.6 million in Q2 2026, up from $15.4 million in Q2 2025, driven by higher R&D, sales and marketing, and G&A costs. Adjusted EBITDA remained negative at -$8.6 million in Q2 2026, compared to -$6.2 million in the prior year, showing continued cash burn. The company's guidance implies a deceleration in revenue growth in the second half of 2026, with a midpoint growth rate of 45% versus the 57% achieved in Q2, suggesting potential headwinds or conservatism. The new CMS reimbursement ruling is not expected to have a material impact on second-half 2026 revenue, with benefits likely deferred to 2027, limiting near-term upside. The company faces increasing competition as competitors plan to introduce their own custom implants, which could pressure market share and pricing in the future. Q: How should we think about the second-half revenue cadence, and is the potential for procedures to be pushed into Q4 due to the new DRG reimbursement structure factored into guidance?A: Mike Cordonnier, CEO, stated that while Q3 typically has some variability in procedure volume, the company does not anticipate the recent CMS ruling to have a material impact on the strong second-half business. He views the new ruling, along with product pipeline catalysts, as being highly beneficial for 2027 and beyond as the company scales and expands hospital access. Q: What is the potential impact of the new CMS IPPS final rule that creates three new MS-DRG codes for aprevo lumbar procedures?A: Mike Cordonnier, CEO, explained that the new reimbursement structure, effective October 1, 2026, simplifies coding and enhances reimbursement for hospitals. While the company is not baking incremental revenue from this ruling into 2026 guidance, it is expected to be a significant tailwind into 2027 by accelerating the hospital Value Analysis Committee (VAC) process, expanding coverage in new hospital systems, and deepening penetration within the existing surgeon base. Q: Can you provide an update on the expected revenue mix between lumbar and cervical procedures, and the pricing dynamics for the back half of the year?A: Leo Greensbank, CFO, stated that cervical volumes are expected to see an ongoing uptick, with cervical projected to be in the low double digits (11%-12%) of revenue in the second half. He noted that the average revenue per procedure (ARP) was roughly $29,000 for lumbar and $18,000 for cervical in Q2, and these levels are expected to persist. The upcoming launch of the CORA plating system is expected to provide a modest uplift in cervical ARP. Q: What is driving the strong growth in new surgeon adds, and how might the new reimbursement benefits impact this trend?A: Mike Cordonnier, CEO, attributed the strong quarter for new surgeon adds to the launch of the aprevo Cervical platform, which has attracted both existing lumbar users and surgeons new to aprevo. He noted an acceleration in new surgeon users adopting both lumbar and cervical procedures, which provides confidence in ongoing growth for both franchises. Q: What are the plans for the upcoming launch of the CORA Cervical Plating System, and what is the expected market impact?A: Mike Cordonnier, CEO, confirmed that the CORA cervical plating system is on track for a full commercial launch in Q4, following a successful limited market evaluation. The system allows for a fully personalized ACDF procedure and is expected to provide a slight uptick in average revenue per procedure for the cervical franchise. With approximately 60% of cervical ACDF procedures utilizing fixation plates, there is significant potential for adoption. Q: How should we think about the long-term gross margin trajectory?A: Leo Greensbank, CFO, stated that over the next 24 months, the company sees opportunities to reach the higher end of the 70s and potentially into the lower end of the 80s. He highlighted that the capital-light, digital-first model is highly scalable, and the focus remains on optimizing the digital production system to sustain gross margins in the high 70s while driving operating expense leverage. Q: How is the company thinking about growth in 2027 and beyondis it more of a pricing or volume opportunity?A: Mike Cordonnier, CEO, stated that the company anticipates maintaining its average revenue per procedure largely where it is and will focus on increasing partnerships with hospitals and accelerating access. Net-net, the growth strategy is driven by procedure volume growth rather than growth through ARP. Q: How is the company responding to increased competition in the custom implant space?A: Mike Cordonnier, CEO, expressed confidence in the company's growth profile as the only pure-play AI-enabled personalized surgery company. He views the increased investment in innovation from competitors as a positive tipping point for the industry, which is ripe for innovation, and believes Carlsmed is well-positioned to maintain its leadership. Q: Can you provide an update on the aprevo Cervical Effectiveness (ACE) registry and its expected timeline?A: Mike Cordonnier, CEO, announced that the company has received IRB approval for the ACE multi-center registry, which will collect real-world evidence from patients treated with aprevo Cervical at six-month, one-year, and two-year time points. Enrollment is on track to commence in Q4, with anticipation of more than a dozen sites and over 300 total patients enrolled. Q: What is the status of the aprevo bilateral system launch, and what is the market opportunity?A: Mike Cordonnier, CEO, stated that the limited market evaluation of the aprevo bilateral system has received strong early feedback from surgeons, highlighting the benefits of preoperative 3D digital planning and seamless integration into posterior bilateral techniques. The company remains on track for a Q4 commercial launch, addressing an estimated 30,000 procedures annually in the US. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in Carlsmed, Inc.? Here are five stocks we like better. Carlsmed’s Q2 revenue rose 57% year over year to $18.9 million, driven by higher adoption of its aprevo lumbar platform and newer cervical offering. The surgeon user base grew more than 60%. The company raised its 2026 revenue outlook to $74 million-$78 million, while noting that a new Medicare reimbursement structure is expected to support hospital access primarily from 2027 onward. Gross margin improved to 76.8%, but higher research, sales and administrative costs widened the GAAP net loss to $10.5 million. Carlsmed also expects fourth-quarter launches for its aprevo Bilateral system and Corra Cervical Plating System. Carlsmed (NASDAQ:CARL) reported second-quarter 2026 revenue of $18.9 million, up 57% from $12.1 million a year earlier, as growth in its aprevo lumbar platform and contributions from its newer cervical offering lifted procedure volumes. Chairman and Chief Executive Officer Mike Cordonnier said the company’s surgeon user base increased by more than 60% year over year. He attributed growth to new surgeon onboarding, increased utilization among existing customers and demand for aprevo in higher-acuity lumbar and cervical fusion procedures. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control “We had a really great quarter and really great year with new surgeon adds,” Cordonnier said during the company’s earnings call. He added that some surgeons were adopting both lumbar and cervical offerings for the first time, contributing to an acceleration in new users. Carlsmed raised its full-year 2026 revenue outlook to $74 million to $78 million. At the midpoint, the forecast represents growth of more than 50% over 2025, according to management. → 3 Drone Stocks That Should Soar After the Summer Slump Chief Financial Officer Leo Greenstein said the revised outlook reflects volume growth in the first half and expectations for continued growth in both aprevo lumbar and aprevo Cervical during the second half. The company said it was not incorporating incremental revenue from a recent Medicare reimbursement rule into its guidance, viewing that change primarily as a catalyst for 2027 and beyond. Greenstein described the outlook as prudent. While first-half revenue grew 57% year over year, the midpoint of the full-year guidance implies 45% growth in the second half compared with the same period of 2025, he said. → The Bitcoin Comeback May Already Be Underway—2 ETFs for Exposure Management highlighted a final rule issued by the Centers for Medicare & Medicaid Services on July 31. The FY 2027 Inpatient Prospective Payment System rule creates three new Medicare Severity Diagnosis-Related Group, or MS-DRG, codes for aprevo lumbar procedures—523, 524 and 525—replacing 11 previously applicable codes. The reimbursement structure becomes effective Oct. 1, 2026. Cordonnier said the changes simplify coding and enhance hospital reimbursement for aprevo lumbar procedures, which the company believes could broaden hospital and patient access. However, management said it does not expect the rule to have a material impact on second-half 2026 results. Cordonnier said the company sees the policy as beneficial for hospital partnerships and procedure access over the long term, while Greenstein said hospitals will need time to absorb the new rule and complete coverage processes. Carlsmed expects growth from the opportunity to be driven mainly by procedure volume rather than changes in average revenue per procedure. Greenstein said lumbar average revenue per procedure was about $29,000 in the second quarter, while cervical average revenue per procedure was about $18,000, and the company expects those levels to persist in coming quarters. Second-quarter gross margin expanded 340 basis points year over year to 76.8%, from 73.4%. Greenstein said lower contract-manufacturer costs per unit and efficiency improvements in the company’s digital production system more than offset product-mix effects. Carlsmed expects to sustain gross margins in the high 70% range during the second half. Looking further ahead, Greenstein said the company sees an opportunity to reach the higher end of the 70% range and potentially the low 80% range over the next 24 months through further production-system improvements. Operating expenses rose to $25.6 million from $15.4 million a year earlier. Research and development spending increased to $6 million, driven primarily by personnel costs related to product-development priorities and artificial-intelligence initiatives. Sales and marketing expense rose to $11.9 million as the company added sales personnel, expanded targeted marketing and paid higher variable commissions tied to revenue growth. General and administrative expense increased to $7.6 million from $3.3 million, reflecting personnel additions, professional services, legal fees and compliance costs. The company reported a GAAP net loss of $10.5 million, compared with a $6.8 million loss in the prior-year quarter. Adjusted EBITDA was negative $8.6 million, compared with negative $6.2 million a year earlier. As of June 30, Carlsmed had $89.3 million in cash and investments and total liabilities of $34 million. Its liabilities included $15.6 million of outstanding principal under a $50 million debt facility maturing in October 2030. Cash used in operating activities was $7.4 million during the quarter, compared with $8.2 million a year earlier. Lumbar procedures accounted for about 90% of second-quarter revenue, while cervical procedures represented about 10%. Management expects cervical revenue to reach roughly 11% to 12% of revenue in the second half as adoption continues to build. The company remains on track for a fourth-quarter commercial launch of its aprevo Bilateral system, a lumbar offering being evaluated in a limited market release. Cordonnier said early surgeon feedback has pointed to the system’s preoperative 3D planning and visualization capabilities, as well as integration with posterior bilateral surgical techniques. Carlsmed also plans a fourth-quarter commercial launch for its Corra Cervical Plating System. The company is currently conducting a limited market evaluation and expects the full launch to coincide with a fall medical society meeting. Cordonnier said Corra could provide a modest increase in cervical average revenue per procedure. Separately, Carlsmed received institutional review board approval for its aprevo Cervical Effectiveness, or ACE, multicenter registry. The company expects enrollment to begin in the fourth quarter, with more than a dozen sites and over 300 patients anticipated. The registry is designed to collect real-world evidence at six-month, one-year and two-year intervals. Cordonnier also cited a retrospective cohort study published in the Global Spine Journal that found a 74% reduction in reoperations among adult spinal deformity patients treated with aprevo personalized lumbar implants. We are a commercial-stage 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. We are focused on becoming the standard of care for spine fusion surgery. The aprevo Technology Platform consists of artificial intelligence (“AI”)-enabled software solutions, and interbody implants that we custom design for each patient's unique pathology and vertebral bone topography, and single-use surgical instruments (the “aprevo Technology Platform”). This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Carlsmed Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Second quarter 2026 revenue of $18.9 million, representing 57% growth year-over-year Full year 2026 revenue guidance raised to $74 million to $78 million CARLSBAD, Calif., Aug. 05, 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 second quarter ended June 30, 2026. “Our second quarter 2026 results reflect the growing momentum of aprevo® procedures and further progress on our path to profitability,” said Mike Cordonnier, Chairman and Chief Executive Officer. "We delivered 57% revenue growth year-over-year, expanded gross margins by 340 basis points, and grew our trained surgeon user base by more than 60% over the prior year. We continue to see strong volume growth across lumbar and cervical aprevo® procedures, with continued advancements in our proprietary digital production system enabling scalability ahead of strong market demand. We believe the recent CMS ruling – which takes effect on October 1, 2026, and provides new and enhanced hospital reimbursement for the aprevo® lumbar procedure – positions us well for ongoing growth in the years to come." Recent Business Highlights Surgeon adoption grew significantly, with total trained surgeon users up over 60% year-over-year, led by strong engagement from early-career and post-fellowship surgeons CMS Inpatient Prospective Payment System (IPPS) rule for fiscal year 2027 recently finalized to include three new MS-DRG codes and favorable reimbursement for inpatient aprevo® lumbar procedures, a significant milestone towards expanding access for Medicare patients aprevo® cervical completed second full quarter of commercialization, now representing approximately 10% of quarterly revenue, with surgeon training on the platform expanding significantly since last quarter Raised full-year 2026 revenue guidance to a range of $74–$78 million, over 50% growth at the midpoint versus full-year 2025, reflecting strong volume trends and a robust pipeline Second Quarter 2026 Financial Results Revenue was $18.9 million for the second quarter of 2026, a 57% increase compared to $12.1 million in the second quarter of 2025. Gross profit for the second quarter of 2026 was $14.5 million compared to $8.9 million for the second quarter of 2025. Gross margin was 76.8% for the second quarter of 2026, compared with 73.4% in the second quarter of 2025. Operating expenses were $25.6 million for the second quarter of 2026, compared with $15.4 million for the second quarter of 2025, which consisted of: Net loss was ($10.5) million for the second quarter of 2026, compared to a ($6.8) million net loss for the second quarter of 2025. Adjusted EBITDA was ($8.6) million for the second quarter of 2026, compared to ($6.2) million for the second quarter of 2025. Cash and cash equivalents, restricted cash, short-term investments, and marketable securities were $89.3 million as of June 30, 2026. 2026 Financial Outlook Revenue for the full year 2026 is expected to be in the range of $74 to $78 million, representing growth of over 50% at the midpoint of the range over 2025. This compares to prior guidance of $72 to $77 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. A live webcast of the conference call will be available in the Events & Presentations section of the Company’s investor website at investors.carlsmed.com. A replay will be archived on the Company’s website following completion of the call. 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 Statements Any statements in this press release about future expectations, plans and prospects, including statements about Carlsmed’s growth prospects and future performance, the ability of Carlsmed to achieve profitability in the near term or at all, the scalability of Carlsmed’s business, the level of demand for Carlsmed’s products, the impact of the recent CMS ruling on Carlsmed’s business , 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 [email protected] Media [email protected] **Change not meaningful

Wall Street expects a year-over-year decline in earnings on lower revenues when 10x Genomics (TXG) reports results for the quarter ended June 2026. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on August 6. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This life science technology company is expected to post quarterly loss of $0.23 per share in its upcoming report, which represents a year-over-year change of -182.1%. Revenues are expected to be $146.96 million, down 15% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 1.73% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For 10x Genomics, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +10.93%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination indicates that 10x Genomics will most likely beat the consensus EPS estimate. Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that 10x Genomics would post a loss of$0.29 per share when it actually produced a loss of -$0.10, delivering a surprise of +65.52%. Over the last four quarters, the company has beaten consensus EPS estimates four times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. 10x Genomics appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Carlsmed, Inc. (CARL), another stock in the Zacks Medical Info Systems industry, is expected to report loss per share of $0.4 for the quarter ended June 2026. This estimate points to a year-over-year change of +72.8%. Revenues for the quarter are expected to be $18.52 million, up 53.3% from the year-ago quarter. The consensus EPS estimate for Carlsmed, Inc. has remained unchanged over the last 30 days. However, a lower Most Accurate Estimate has resulted in an Earnings ESP of -18.99%. When combined with a Zacks Rank of #3 (Hold), this Earnings ESP makes it difficult to conclusively predict that Carlsmed, Inc. will beat the consensus EPS estimate. The company beat consensus EPS estimates in each of the trailing four quarters. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report 10x Genomics (TXG) : Free Stock Analysis Report Carlsmed, Inc. (CARL) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

The market expects Carlsmed, Inc. (CARL) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on August 5. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.40 per share in its upcoming report, which represents a year-over-year change of +72.8%. Revenues are expected to be $18.52 million, up 53.3% from the year-ago quarter. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Carlsmed, Inc., the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -18.99%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination makes it difficult to conclusively predict that Carlsmed, Inc. will beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Carlsmed, Inc. would post a loss of$0.43 per share when it actually produced a loss of -$0.32, delivering a surprise of +25.58%. Over the last four quarters, the company has beaten consensus EPS estimates four times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Carlsmed, Inc. doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Hinge Health Inc. (HNGE), another stock in the Zacks Medical Info Systems industry, is expected to report earnings per share of $0.59 for the quarter ended June 2026. This estimate points to a year-over-year change of -11.9%. Revenues for the quarter are expected to be $200.51 million, up 44.2% from the year-ago quarter. The consensus EPS estimate for Hinge Health Inc. has been revised 4.4% higher over the last 30 days to the current level. However, a lower Most Accurate Estimate has resulted in an Earnings ESP of -4.78%. This Earnings ESP, combined with its Zacks Rank #1 (Strong Buy), makes it difficult to conclusively predict that Hinge Health Inc. will beat the consensus EPS estimate. The company beat consensus EPS estimates in each of the trailing four quarters. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Carlsmed, Inc. (CARL) : Free Stock Analysis Report Hinge Health Inc. (HNGE) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

As you might know, Carlsmed, Inc. (NASDAQ:CARL) just kicked off its latest quarterly results with some very strong numbers. Revenues beat expectations coming in atUS$16m, ahead of estimates by 7.8%. Statutory losses were somewhat smaller thanthe analysts expected, coming in at US$0.32 per share. The analysts typically update their forecasts at each earnings report, and we can judge from their estimates whether their view of the company has changed or if there are any new concerns to be aware of. With this in mind, we've gathered the latest statutory forecasts to see what the analysts are expecting for next year. AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. Taking into account the latest results, the consensus forecast from Carlsmed's five analysts is for revenues of US$74.5m in 2026. This reflects a huge 32% improvement in revenue compared to the last 12 months. Losses are expected to increase substantially, hitting US$1.49 per share. Before this latest report, the consensus had been expecting revenues of US$72.8m and US$1.58 per share in losses. So there seems to have been a moderate uplift in analyst sentiment with the latest consensus release, given the upgrades to both revenue and loss per share forecasts for this year. Check out our latest analysis for Carlsmed Despite these upgrades,the analysts have not made any major changes to their price target of US$18.40, implying that their latest estimates don't have a long term impact on what they think the stock is worth. Fixating on a single price target can be unwise though, since the consensus target is effectively the average of analyst price targets. As a result, some investors like to look at the range of estimates to see if there are any diverging opinions on the company's valuation. There are some variant perceptions on Carlsmed, with the most bullish analyst valuing it at US$23.00 and the most bearish at US$16.00 per share. There are definitely some different views on the stock, but the range of estimates is not wide enough as to imply that the situation is unforecastable, in our view. Another way we can view these estimates is in the context of the bigger picture, such as how the forecasts stack up against past performance, and whether forecasts are more or less bullish relative to other companies in the industry. It's pretty clear that there is an expectation that Carlsmed's revenue growth will slow down substantially, with revenues to the end of 2026 expected to display 45% growth on an annualised basis. This is compared to a historical growth rate of 75% over the past year. By way of comparison, the other companies in this industry with analyst coverage are forecast to grow their revenue at 8.0% annually. Even after the forecast slowdown in growth, it seems obvious that Carlsmed is also expected to grow faster than the wider industry. The most important thing to take away is that the analysts reconfirmed their loss per share estimates for next year. Pleasantly, they also upgraded their revenue estimates, and their forecasts suggest the business is expected to grow faster than the wider industry. There was no real change to the consensus price target, suggesting that the intrinsic value of the business has not undergone any major changes with the latest estimates. With that said, the long-term trajectory of the company's earnings is a lot more important than next year. We have estimates - from multiple Carlsmed analysts - going out to 2028, and you can see them free on our platform here. It is also worth noting that we have found 1 warning sign for Carlsmed that you need to take into consideration. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Revenue and outlook: Q1 revenue was $16.1 million, up 58% year‑over‑year, and management raised full‑year 2026 guidance to $72–$77 million (about 48% growth at the midpoint); gross margin was ~77% while GAAP net loss widened to $8.7 million, with $97.1 million in cash and $15.6 million drawn on a $50 million facility. Commercial momentum and operating efficiency: Surgeon users grew >60% YoY and utilization is accelerating, while production lead time fell >30% to six business days, driving more than 200 basis points of margin expansion; aprevo cervical is in its first full commercial quarter and cervical is expected to contribute a high single‑digit to low double‑digit share of revenue in 2026. Clinical and reimbursement developments: Peer‑reviewed data reported a 74% reduction in two‑year revision rates for aprevo versus historical stock implants (mechanical complication revisions 4.3% vs 16.6%), and CMS proposals would map aprevo lumbar to three new MS‑DRG codes potentially at a premium while aprevo cervical retains a NTAP of up to $21,125 (renewed preliminarily for FY2027). Interested in Carlsmed, Inc.? Here are five stocks we like better. Carlsmed (NASDAQ:CARL) reported first-quarter 2026 revenue of $16.1 million, up 58% from $10.2 million in the prior-year period, as the company highlighted continued surgeon adoption of its patient-specific “aprevo” spine fusion procedures and ongoing efficiency gains in its digital production system. Chairman and CEO Mike Cordonnier said the company saw “strong adoption” across its lumbar and cervical personalized surgery offerings in the quarter and believes the aprevo platform is positioned to “transform spine surgery.” Cordonnier attributed growth to medical education efforts, clinical outcomes data, and expansion in the company’s surgeon base. → Roblox Stock Slides to New Low as Safety Changes Weigh on Outlook Operationally, Cordonnier said Carlsmed reduced production lead time “by more than 30% to six business days” and delivered “more than 200 basis points of margin expansion year-over-year.” He also said the company’s surgeon user base grew more than 60% year-over-year, with notable engagement from early-career and post-fellowship surgeons. In response to a question on utilization trends, Cordonnier said surgeon enthusiasm continued to “accelerate into the year” following strong new surgeon additions exiting 2025. He added that utilization has increased, particularly among surgeons who have moved beyond the initial trial phase and into broader adoption. → The Real SpaceX Play: 5 Chip Stocks Powering the IPO Before It Launches Cordonnier pointed to peer-reviewed data published in January in Global Spine Journal that he said demonstrated a 74% reduction in surgery revision rates at two years for complex adult spinal deformity patients receiving Carlsmed’s aprevo personalized interbody implants compared with previously published revision data for a similar cohort using conventional stock implants. According to Cordonnier, the revision rate due to mechanical complications was 4.3% for aprevo-treated patients versus 16.6% for patients with stock devices. He said the reductions were driven by decreases in complications such as rod fractures and proximal junctional kyphosis. → 3 Emerging Markets ETFs to Maximize Exposure to High-Potential Countries Carlsmed also discussed pipeline progress. Cordonnier said the company completed the first aprevo bilateral lumbar fusion procedure in February and is conducting a limited market evaluation, with a full commercial launch targeted for the fourth quarter of 2026. On the cervical side, Cordonnier said the first quarter marked Carlsmed’s first full quarter commercially in the market for aprevo cervical fusion, which launched in December 2025. He said the company has trained more than 20% of its surgeon users on the cervical platform. In Q&A, Cordonnier said the cervical business is tracking with expectations for a “high single digit, low double digit percent contribution of revenue” for the year. The company also announced its CORRA cervical plating system, which Cordonnier described as the debut of Carlsmed’s patient-specific fixation portfolio for anterior cervical discectomy and fusion procedures. He said the first procedure using CORRA was performed in February 2026 at the University of California, San Francisco, and the company remains on track for a Q4 launch following a limited market evaluation. Cordonnier highlighted reimbursement developments for both lumbar and cervical procedures. He said the aprevo lumbar platform is currently covered under 11 different MS-DRG codes, and “the majority” of procedures are reassigned to the three elevated major complication or comorbidity MS-DRG codes. He also discussed the Centers for Medicare & Medicaid Services’ FY 2027 proposed inpatient prospective payment system rule published April 10. Under the proposal, Cordonnier said all aprevo lumbar spine fusion procedures would map to one of three new MS-DRG codes—523, 524, or 525—“at a premium to traditional spine fusion procedures,” if finalized as proposed. He noted the rule is preliminary and said the final rule is expected ahead of an effective date of Oct. 1, 2026. In Q&A, Cordonnier described the benefit primarily as improved access and simplified coding rather than new coverage. “We have full coverage today,” he said, adding that the proposal could remove ambiguity for hospitals and allow them to code procedures “as they normally would” with more certainty around MS-DRG mapping. For cervical procedures, Cordonnier said CMS granted a new technology add-on payment in October 2025 of up to $21,125 in incremental hospital reimbursement for aprevo cervical for a three-year period. He added that CMS renewed the payment for FY 2027 in the preliminary rule. Chief Financial Officer Leo Greenstein said first-quarter revenue growth was driven by expansion in surgeon users and increased unit volume, with average revenue per procedure “substantially consistent” year-over-year. Gross margin was 77.1%, up from 74.9% in Q1 2025, which Greenstein attributed to stable average revenue per procedure and efficiency improvements in the digital production system. Operating expenses rose to $21.7 million from $13.4 million a year earlier. Greenstein broke out the increases across functions: R&D increased to $5.2 million from $3.2 million, primarily from higher personnel costs tied to product development priorities and AI-enabled initiatives for digital surgical planning. Sales and marketing increased to $10.3 million from $6.7 million, driven by increased sales headcount, higher variable commissions with revenue growth, and increased marketing spending. General and administrative increased to $6.2 million from $3.5 million, reflecting personnel additions and higher professional services and legal fees, including compliance and public company-related costs. Carlsmed reported a GAAP net loss of $8.7 million, compared with a $5.7 million net loss in the prior-year quarter. Adjusted EBITDA, excluding stock-based compensation, was negative $7.5 million versus negative $5.5 million in Q1 2025. Greenstein said the company anticipates improvement in adjusted EBITDA “over the coming years” as revenue grows and operating leverage improves. Greenstein said cash and investments totaled $97.1 million as of March 31, 2026. The company had $15.6 million outstanding under a $50 million debt facility that matures in October 2030, and Greenstein said there are “no current plans” to make additional draws, though he described the facility as low-cost, non-dilutive standby capital. Total liabilities were $26.5 million, including the debt balance. Cash used in operating activities was $13.0 million in the quarter, compared with $8.2 million in the first quarter of 2025. For full-year 2026, Greenstein said Carlsmed is raising its revenue guidance to $72 million to $77 million, which he said represents 48% growth at the midpoint over full-year 2025. He reiterated expectations for gross margins in the mid-to-high 70s and said the company anticipates operating expense leverage in coming quarters with an expected revenue ramp in aprevo lumbar and aprevo cervical. On product mix and pricing, Greenstein told analysts the average revenue per procedure was consistent year-over-year, but he expects average revenue per procedure to be in the “mid to high 20s” over time as cervical becomes a larger portion of revenue, noting cervical carries lower average revenue per procedure than lumbar. He also said the company expects gross margins to remain in the mid-to-high 70s even as cervical grows to a high single-digit to low double-digit mix, with lower cervical gross margin headwinds offset by production efficiencies in lumbar. We are a commercial-stage 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. We are focused on becoming the standard of care for spine fusion surgery. The aprevo Technology Platform consists of artificial intelligence (“AI”)-enabled software solutions, and interbody implants that we custom design for each patient's unique pathology and vertebral bone topography, and single-use surgical instruments (the “aprevo Technology Platform”). The article "Carlsmed Q1 Earnings Call Highlights" was originally published by MarketBeat.

Image source: The Motley Fool. Tuesday, May 5, 2026 at 4:30 p.m. ET Chairman & Chief Executive Officer — Michael Cordonnier Chief Financial Officer — Leonard Greenstein Vice President, Investor Relations — Stephanie Vadkovich Need a quote from a Motley Fool analyst? Email [email protected] Stephanie Vadkovich: Thank you, operator. Welcome to Carlsmed, Inc.'s first quarter 2026 earnings call. Joining me on today's call are Michael Cordonnier, chairman and chief executive officer, and Leonard Greenstein, chief financial officer. Before we begin, I would like to caution that comments made during this call will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements made on this call that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the market in which Carlsmed, Inc. operates, trends, expectations and demand for Carlsmed, Inc. products, expectations with respect to reimbursement, statements about the company's clinical data, surgeon adoption and utilization, and Carlsmed, Inc.'s expected financial performance and position in the market. Any forward-looking statements made during this call, including projections for future performance, are based on management's expectations as of today. Carlsmed, Inc. undertakes no obligation to update these statements except as required by applicable law. These statements are neither promises nor guarantees and are subject to known and unknown risks and uncertainties that could cause actual results, performance, or achievements to differ materially from those expressed or implied by the forward-looking statements. For more detailed information, please review the cautionary notes on the earnings materials accompanying today's presentation as well as Carlsmed, Inc.'s filings with the SEC, particularly the risk factors described in Carlsmed, Inc.'s Annual Report on Form 10-K for the year ended 12/31/2025. I encourage you to review all Carlsmed, Inc.'s filings with the SEC concerning these and other matters. Additionally, during today's call, management will discuss certain non-GAAP financial measures, including adjusted EBITDA. A reconciliation of these non-GAAP financial measures to the most directly comparable GAAP financial measures is included in today's earnings press release. These filings, along with Carlsmed, Inc.'s press release for the first quarter 2026 results, are available on carlsmed.com under the investor section, and include additional information about Carlsmed, Inc.'s financial results. A recording of today's call will also be available on Carlsmed, Inc.'s website by 5:00 p.m. Pacific time today. Now I would like to turn the call over to Michael to go over Carlsmed, Inc.'s business highlights. Michael Cordonnier: Thank you, Stephanie, and welcome to the team. I would like to welcome everyone on our call today. At Carlsmed, Inc., our mission is to improve outcomes and decrease the cost of health care for spine surgery and beyond. To achieve this mission, we have pioneered patient-specific digital surgery for lumbar and cervical spine fusion procedures. Our vision is to make personalized surgery at scale the standard of care for spine surgery. Our AI-enabled digital surgery empowers surgeons to partner closely with patients to seamlessly create three-dimensional surgical plans and 3D-printed spine fusion devices designed to achieve predictable patient outcomes while supporting the surgeon's preferred surgical approach. We then provide postoperative outcome analytics to our surgeon users for each procedure through our Aprivile Insights as part of the MyAprivile ecosystem. We believe this personalized, outcome-driven, AI-enabled ecosystem approach represents the future standard in medical technology, one that is better for patients, surgeons, hospitals, and payers. Importantly, our model is built to scale efficiently. By manufacturing only what is needed for each specific procedure, we avoid the traditional prebuilt inventory trays of implants and instruments that have long burdened the legacy spine and orthopedics businesses. Instead, we are able to provide patient-specific, sterile-packed implants and instruments specific to each patient just in time for their surgery. This capital-light, demand-driven approach enables us to scale rapidly while maintaining a relentless focus on patient outcomes. With this vision as our guide, 2026 is off to a great start with solid execution across our business. In the first quarter, we saw strong adoption of our lumbar and cervical personalized surgery procedures, reinforcing our view that Aprivo as a platform technology is positioned to transform spine surgery. Our clinical outcome data continues to be robust, and our investments in technology continue to drive the scale and productivity needed to make personalized surgery the standard of care for spine fusion procedures. With the peer-reviewed data published on reduced reoperations with the Prevost personalized surgery procedures, we continue to execute on our mission to improve outcomes and decrease the cost of health care for spine surgery. Turning to the first quarter, we delivered strong revenue of $16.1 million, representing growth of 58% over the prior year. Our growth was driven by the continued focus on medical education and compelling clinical outcome data, driving expansion of our surgeon base and increasing procedure volumes. Operationally, we continue to leverage our investments in technology to further drive production efficiencies, reducing lead time by more than 30% to six business days in the quarter and delivering more than 200 basis points of margin expansion year over year. Our fully integrated digital system allows us to partner with hospitals, surgeons, and patients to seamlessly integrate into clinic and operating room workflows preoperatively, intraoperatively, and postoperatively for nearly all indicated patients. Our commercial growth continues to be driven by a surgeon-led adoption model and expanding utilization. I am proud to report that we grew our total surgeon user base by more than 60% year over year, reflective of the rapid clinical adoption of personalized surgery procedures. We continue to drive particularly strong engagement from early career and post-fellowship surgeons who are eager to adopt new technology to differentiate their practices and improve outcomes. With our rapidly growing base of surgeon users, we are still in the early innings of market penetration and have a long runway ahead of us. The Opdivo lumbar procedure represents the majority of our business today, where we continue to gain traction within the estimated 445 thousand lumbar spine fusion procedures performed annually in the U.S. Clinical evidence generation continues to support the early adoption of Aprivo by consistently demonstrating improved outcomes for patients compared to stock implants. In January, data published in the Global Spine Journal further validated our personalized spine surgery approach, including evidence demonstrating a 74% reduction in surgery revision rates at two years compared to stock devices. This peer-reviewed study compared two-year revision rates among complex adult spinal deformity patients receiving Carlsmed, Inc.'s Aprivo personalized interbody implants with previously published revision data from a similar patient cohort receiving conventional stock implants. Patients treated with Aprivo experienced significantly fewer revisions due to mechanical complications, showing a revision rate of 4.3% in patients treated with Aprivo compared to a revision rate of 16.6% in patients who had stock devices. To put this into perspective, over the past 25 years, lumbar fusion technologies have not published data to demonstrate significant reduction in reoperation rates at the standard two-year benchmark. In contrast, Aprivo’s patient-specific lumbar procedures have demonstrated clinically meaningful reduction in reoperations driven by significant decreases in key complications like rod fractures and proximal junction kyphosis. Importantly, this improvement is measured against procedures with traditional stock fusion devices used by the most experienced and skilled surgeons. As a further expansion of our Prevel lumbar procedure, we have announced successful completion of the first Aprivo bilateral lumbar fusion procedure in February. We are seeing great data in our limited market evaluation and are on track for our full commercial launch in the fourth quarter of this year. Carlsmed, Inc.'s Suprivo Lumbar Fusion has strong hospital reimbursement from CMS with all Aprivile lumbar fusion procedures covered by one of 11 different MS-DRG codes. The majority of Aprivo lumbar procedures are reassigned to the three elevated major complication or comorbidity MS-DRG codes. This provides hospitals with superior economic and clinical value to provide access to the Aprivile procedure for patients. On 04/10/2026, CMS published the FY 2027 proposed rule for the inpatient prospective payment system. Under this proposed rule, all Aprivile lumbar spine fusion procedures would be reimbursed by one of three new MS-DRG codes—523, 524, or 525—at a premium to traditional spine fusion procedures. If finalized as proposed, we see this development as very positive for patients, surgeons, and hospitals to establish and maintain long-term access to the Prevost lumbar spine fusion procedure. This published rule is preliminary. We anticipate the final rule to be published prior to becoming effective on 10/01/2026. Shifting to cervical, the first quarter 2026 represented our first full quarter in market commercially with the Aprivo cervical fusion procedure, which we launched in December 2025. With an estimated 370 thousand cervical fusion procedures performed annually in the U.S., we believe that this additional growth lever can provide additional momentum in our business as a further extension of the Aprivo platform. Cervical and lumbar spine fusion procedures are performed by spine surgery trained neurosurgeons and orthopedic surgeons alike. Many of the spine surgeons perform both lumbar spine fusion and cervical spine fusion procedures, demonstrating a substantial procedural overlap across spine surgeons. We believe that we can leverage our team to train and onboard many of the surgeons already familiar with the lumbar Privo technology platform on the Privo cervical platform. In the early days of launch, we have already trained more than 20% of our surgeon users on the cervical platform. The Aprivo cervical procedure is designed to address common causes of variable outcomes associated with anterior cervical discectomy and fusion (ACDF) failure, including subsidence, malalignment, and reoperations. The procedure is designed to optimize bone contact surface area to improve load distribution, bone graft loading, preserve end plate strength, reduce subsidence risk, and restore or maintain alignment. To complement Aprivo cervical and achieve progress against some of these challenges in cervical fusions, our newly announced Cora cervical plating system marks the debut of Carlsmed, Inc.'s patient-specific fixation portfolio and represents a fully personalized solution for ACDF procedures. The first procedure was performed in February 2026 at the University of California, San Francisco. We are progressing well with the limited market evaluation and are on track for the launch of Cora cervical personalized plating system in Q4. Much like the lumbar Aprivo procedure, the cervical Aprivo procedure has a strong inpatient reimbursement profile. In October 2025, the Aprivo cervical procedure received a new technology add-on payment up to an incremental $21 thousand 125 hospital reimbursement. This reimbursement program is for a three-year period, and CMS renewed the NTAP payment for FY 2027 as anticipated in the publication of the preliminary rule. Looking ahead, our strategic focus remains consistent and positions us to continue the durable, high-quality growth we have demonstrated to date. Within our first area of focus, patient-centric innovation, we continue to advance our proprietary personalized surgery platform, including AI-enabled 3D surgical planning, workflow automation, patient- and surgeon-specific devices, and single-use sterile-packed surgical instruments, and further procedural integration in the clinic and operating room. As discussed previously, we have demonstrated great early traction with the recent launch of Aprivo cervical, and we are collecting early clinical experience with the bilateral posterior Prevo procedure and personalized Cora cervical plate fixation. Our product innovation portfolio includes further advancement to drive ease of integration in the surgical workflow and further personalization of spine surgery. Our second area of strategic focus is surgeon education and includes further investments in our medical education team and programs to meet accelerating demand for Aprivo personalized surgery. We continue training new surgeons every month by leveraging success in academic centers to drive peer-to-peer surgeon education with the thought leaders in personalized spine surgery. We also continue to support education initiatives with upcoming resident and fellow courses in partnership with leading academic institutions. As previously mentioned, we have seen strong uptake with early and mid-career surgeons who are adopting digital surgical planning into their practice in their efforts to streamline workflow and improve patient outcomes. These surgeon users will continue to shape the future of spine surgery, and this is an ongoing growth driver for Carlsmed, Inc. that we believe will continue to drive adoption and utilization. Our third area of strategic focus, commercial execution, continues to center on surgeon onboarding, increasing surgeon utilization, and expanding within hospital systems. As we continue to scale, we have expanded our strategic and national accounts efforts to enable local and national access across large hospital systems. Across both lumbar and cervical platforms, hospitals are recognizing the clinical workflow benefits enabled by the Aprivoo ecosystem. By providing deeper integration within a surgeon's preoperative and postoperative clinical workflow, we believe that our platform solution can simplify the surgeon's pre-op planning, reduce time and complexity of the spine fusion procedure in the OR, and enhance surgeons' ability to provide predictable outcomes to spine fusion patients. Lastly, we will continue to generate clinical data to support medical education and market adoption of our transformative personalized surgery technology platform. We believe that personalized surgery at scale is a new standard of care for spine fusion and are committed to providing solutions to patients, surgeons, and hospitals that reduce revision surgeries, improve outcomes, and reduce the cost of health care. We are just getting started and look forward to providing further updates on our rapid market adoption. With that, I will turn it over to Leonard, who will review our financial performance. Leonard Greenstein: Thank you, Michael, and good afternoon, everyone. I will begin today with first quarter 2026 P&L highlights. Revenue for Q1 2026 was $16.1 million compared to $10.2 million in Q1 2025, representing 58% growth year over year. This growth was driven by the continued expansion of our total surgeon user base and increased unit volume sales of Aprivile, as our average revenue per procedure remains substantially consistent between periods. Gross margins were 77.1% in Q1 2026 compared to 74.9% in Q1 2025. This 220 basis point increase was driven by our stable average revenue per Aprivo procedure combined with efficiency improvements in our digital production system with investments made over the past few quarters. This now allows us to deliver the Aprivoo kit to the operating room within six business days of surgeon approval of the digital surgical plan. This lead time and the associated production capacity it enables will support our continued scale. Total operating expenses were $21.7 million in Q1 2026 compared to $13.4 million in Q1 2025. Of this amount, R&D expenses were $5.2 million this quarter, compared with $3.2 million in Q1 2025. This increase was primarily due to higher personnel cost to advance our patient-centric product development priorities and AI-enabled initiatives for our digital surgical planning processes. Sales and marketing expenses were $10.3 million this quarter compared with $6.7 million in Q1 2025. This was substantially driven by increased sales headcount to drive our commercial execution strategy and variable commissions to our sales team and independent sales agents with our revenue growth, as well as increased marketing spend. General and administrative expenses were $6.2 million this quarter, compared with $3.5 million in Q1 2025. The increase was driven by personnel additions and professional services costs and legal fees for customary corporate and intellectual property matters, as well as compliance and other public company related costs. Our GAAP net loss was $8.7 million this quarter compared to a net loss of $5.7 million in Q1 2025. EBITDA adjusted for stock-based compensation was negative $7.5 million this quarter, compared to negative $5.5 million during Q1 2025. We anticipate continued improvement in adjusted EBITDA over the coming years driven by expected revenue growth and leverage across our expense base. As we scale, expanding contribution margin dollars enabled by our capital-light, digital-first business model provide a clearly modeled pathway towards cash flow breakeven. Moving to our balance sheet, our cash and investments as of 03/31/2026 totaled $97.1 million. The outstanding principal under our $50 million debt facility remains at $15.6 million. While we have no current plans to make additional draws ahead of its October 2030 maturity, this facility provides low-cost, nondilutive standby capital and supports general corporate flexibility. Total liabilities as of 03/31/2026 were $26.5 million, of which $15.6 million relates to this debt facility. Our cash used in operating activities was $13.0 million during the quarter, compared to $8.2 million in Q1 2025. Unlike traditional medtech businesses that require capital investments and stock implant and instrument sets, our business scales without these barriers to profitability. As a pure-play personalized surgery company, our working capital can be more strategically deployed towards continued commercial investments to drive significant growth, delivery of our operational excellence priorities in digital production, and continued R&D pipeline development for our business value and growth. Turning to guidance, we are raising our full-year 2026 revenue range to be between $72 million and $77 million, representing 48% growth at the midpoint over full-year 2025. As we progress towards profitability, we continue to expect gross margins to remain in the mid to high 70s, and anticipate driving operating expense leverage in the coming quarters with expected revenue ramp in Aprivo lumbar and cervical. With that, I will turn the call over to the operator for questions. Operator: As a reminder, to ask a question, you will need to press 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press 1-1 again. Our first question comes from David Roman of Goldman Sachs. The line is now open. Analyst: Thank you. Good afternoon, everybody. I wanted to start a little bit on what you are seeing from a surgeon utilization perspective. We did see strong surgeon adds exiting 2025. Can you maybe give us some perspective on what you are seeing year to date qualitatively, and then how you are seeing utilization across both new and existing surgeons trend in the quarter? And how you are thinking about the balance of the year? And I think, Leonard, in your prepared remarks, you mentioned that average selling prices for Aprivo were roughly flat year over year. If I remember correctly, cervical procedures do come with lower ASP than lumbar. Can you corroborate that point? Is it just that cervical is not big enough as a percentage of total to move average ASPs, and how should we think about the weighted average selling price as cervical becomes a larger percentage of total going forward? Michael Cordonnier: We feel really good about our surgeon enthusiasm for the Aprivile platform. As we exited Q4 with really strong new surgeon adds, we saw that continue to accelerate into the year. As we discussed on the call, year over year, we have added about a 60% increase to our surgeon users. With that, we continue to see ongoing increases in utilization, particularly among those surgeon users that have gone through the initial trial process and continued through adoption. So we feel really good about the utilization and surgeon user adds that we have had. Leonard Greenstein: Yes, David. Our Q1 average revenue per procedures were consistent over the prior year quarter and in Q4 as well as Q1. As we think about the future and the combination of cervical and lumbar, we are projecting our average revenue per procedure to be in the mid to high $20 thousands as cervical takes a greater proportion of revenue over time. The average revenue per procedure for cervical is less than lumbar. To answer your question directly, the contribution margin and the ability for us to further scale our business on a single Aprivile platform that serves both the lumbar and cervical indications with largely the same ballpoint provides the operating leverage in our business to continue to scale efficiently. Operator: Thank you. One moment for our next question. Our next question comes from Travis Steed from Bank of America. Your line is now open. Analyst: Hi. This is Aden on for Travis. So first quarter, first full quarter of the cervical launch, can you talk about the puts and takes and how that is progressing? I think you said 20% of your surgeon users are trained on that. What are you seeing from those accounts that have been trained so far? And are we still expecting high single-digit to low double-digit revenue contribution from cervical for the year? And then I have a follow-up. Michael Cordonnier: Thank you. We feel really good about the traction that cervical has received here in the first quarter of launch. As reported, about 20% of our total lumbar users are now trained on cervical and going through the ramp. As we see this progression, high single-digit to low double-digit percent contribution of revenue from cervical in the total plan for the company looks about right. Analyst: Great. Thank you. And then in the Q, I see a callout of cost improvements and production fees charged by your contract manufacturer. Can you double click on that and talk about if that is a one-time item, or is that something we can expect to continue going forward? Thank you. Leonard Greenstein: Yes. We have made investments in our digital production system holistically that have allowed us to hit that six-day lead time. That really provided efficiencies in our production process inclusive of those with our contract manufacturer. The investments made in earlier quarters going back to 2025 now allow us to cut out costs and time—importantly—out of the system. What we are currently reporting in that high-70s gross margin we see to be sustainable. Operator: Thank you. As a reminder, to ask a question, you will need to press 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press 1-1 again. Our next question comes from Richard Newitter from Truist Securities. Richard, your line is now open. Analyst: Hi. Thank you for taking the questions, and congrats on the quarter. I wanted to go to the CMS proposal that just came out. You mentioned a premium and also broader coverage. I think in the past those are two things that could be pretty significant tailwinds for you in 2027, assuming everything goes as proposed into the final rule. First, what percentage of your procedures currently are getting reimbursed and covered consistently, and how much would this broaden that coverage or access? Then on the premium, we did some calculations and are estimating it could be an incremental $50 thousand reimbursement for stock implant on average—there is a big range in there—somewhere around $25 thousand to $30 thousand on average today above and beyond the premium to traditional stock implants. Is that ballpark kind of the math that you have worked out? Thanks. Michael Cordonnier: Hi, Rich. Thanks for the questions. I will talk about this in two parts. First, the current state of reimbursement for the Opdivo lumbar platform. As reported in the script, we currently have 11 different MS-DRGs that cover the Aprivo lumbar platform, all with existing coverage and reimbursement. As noted, a portion of those elevate to a higher-paying DRG today. With the proposed IPPS rule, it really simplifies the coding and reimbursement such that all Aprivo procedures would map to one of three different MS-DRGs. Based on your calculations, that seems about in line with the national average, and we agree. We think this is a really great solution that CMS is proposing to give significant reimbursement to these procedures. Analyst: That is great. In terms of where you are potentially meeting resistance or there is just not great coverage currently, what could this do for you from that standpoint? Is it 50% currently? Is it 80%? Give us a sense as to how this could broaden your coverage and access. Michael Cordonnier: We really look at this as access versus coverage because we have full coverage today. Where we really think this will provide value to hospitals in particular is to remove the ambiguity and actually simplify coding for the Aprivo procedure. We see this as very beneficial to hospitals to simplify the process so that they can code procedures as they normally would and know that they will map to the right MS-DRG. Analyst: Okay. That is really helpful. If I could squeeze one more in, just following up to David's question earlier. As cervical increases as a percentage of the mix moving through the year, Leonard, how should we think of the gross margin impact if revenue per procedure gets impacted? Leonard Greenstein: As we mentioned during our prepared remarks earlier, we see gross margins being in the mid to high 70s over the coming quarters. That factors in, as Michael covered earlier, a high single-digit to low double-digit mix between lumbar and cervical. The headwinds with the lower gross margin profile of cervical—notwithstanding the tremendous contribution margin it provides and the leverage it provides in our business—are going to be offset, as we see it, with our efficiencies in digital production for lumbar. Operator: Thank you. Our last question comes from Ryan Zimmerman from BTIG. Ryan, your line is now open. Analyst: Hi. This is Izzy on for Ryan. Thank you for taking the question. Michael, I heard your comments and the discussion around the IPPS proposal for 2027. I was just curious what you have heard in terms of feedback from your hospital customers and surgeons in reaction to the proposal. I know it is going to simplify coverage, but do you expect that there could be some benefit in terms of volumes if it is finalized as written? Michael Cordonnier: Thanks for the question. It is early days, and it is a preliminary rule. We are really holding off on those discussions until the final rule goes into place. However, this is something that, as mentioned, simplifies coding and reimbursement and makes a permanent change to the Aprivo procedure at a higher reimbursement level. Net-net, we think this is better for all stakeholders. Analyst: Appreciate it. Thank you. And then, Leonard, I have heard your commentary on guidance, but as we consider contributions layering in the back half of the year from those new product launches, is there anything that we need to keep in mind in terms of cadence on the top line? Thanks for taking the question. Leonard Greenstein: We see, over the coming quarters, Aprivo lumbar carrying the majority of our revenue and overall contribution. Certainly, we are very pleased with the early days here at cervical and the clinical results our surgeons are seeing with that indication, and how neatly it tucks into the Aprivile platform and ecosystem. We will provide additional color as we progress into the subsequent quarters with how we see additional things shaping up in the company's favor to further drive revenue beyond what we previously guided. Operator: This concludes the question-and-answer session. Thank you for your participation in today's conference. This does conclude the program, and you may now disconnect. 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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, Calif., May 05, 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 anticipated 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 [email protected] Media LeAnn Burton Senior Director, Brand Marketing [email protected]