Core Viewpoint - Carlsmed, Inc. is set to present at the 37th Annual Piper Sandler Healthcare conference, highlighting its focus on AI-enabled personalized spine surgery solutions aimed at improving healthcare outcomes and reducing costs [1]. Company Overview - Carlsmed is a medical technology company specializing in AI-enabled personalized spine surgery solutions [3]. - The company's mission is to enhance outcomes and lower healthcare costs associated with spine surgery and related areas [3]. Event Details - Mike Cordonnier, Chairman and CEO of Carlsmed, will present at the conference on December 3rd from 9:00 to 9:25 am ET in New York, NY [1]. - The company will also host one-on-one investor meetings during the conference [1]. - A live webcast of the presentation will be available for registered participants, with a replay accessible afterward [2].

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $13.1 million, a 98% increase from $6.6 million in Q3 2024, driven by the expansion of surgeon users and increased procedure volume [15][19] - Gross margins improved to 75.9% in Q3 2025 from 72.8% in Q3 2024, primarily due to lower contract manufacturing costs and reduced inventory reserve expenses [15][16] - Operating expenses increased to $19 million in Q3 2025 from $12.6 million in Q3 2024, with R&D expenses slightly rising to $4.4 million [16][17] - GAAP net loss was $8.5 million in Q3 2025 compared to a net loss of $7.8 million in Q3 2024 [17] Business Line Data and Key Metrics Changes - The surgeon user base grew by over 70% year over year, with minimal seasonal utilization headwinds in Q3 2025 [5][10] - The average revenue per procedure remained constant, indicating that revenue growth was driven by increased procedure volume rather than price changes [15] Market Data and Key Metrics Changes - The addressable market for Carlsmed's technology is estimated at $13 billion, with nearly 500,000 patients undergoing lumbar spine fusion procedures annually [6] - Recent clinical data showed an 83% reduction in reoperation rates for Aprivo procedures compared to traditional methods, enhancing the value proposition for hospitals and surgeons [11][34] Company Strategy and Development Direction - The company aims to transform spine surgery through a digital surgery platform that improves patient outcomes and reduces revision rates [6][12] - Key strategic focuses include commercial execution, surgeon education, and patient-centric innovation, with plans to launch Aprivo for cervical fusion procedures [12][13] - The company is leveraging clinical outcome data and economic value propositions to expand market access and surgeon engagement [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about ongoing durable growth, driven by surgeon enthusiasm and strategic investments in product and technology [21] - The company anticipates continued improvements in gross margins and operating leverage as it scales its business model [17][26] Other Important Information - Cash at September 30, 2025, was $115.5 million, bolstered by proceeds from the July IPO [18] - The company executed an expanded credit facility, increasing borrowing capacity to $50 million, providing financial flexibility for growth initiatives [18] Q&A Session Summary Question: Commentary on surgeon additions and utilization - Management noted strong surgeon enthusiasm in Q3, leading to higher-than-expected surgeon additions despite typical seasonal slowdowns [24] Question: Guidance on surgical ads and gross margin sustainability - Management indicated that gross margins of 76% are expected to be sustainable due to investments in supply chain efficiency [26][29] Question: Insights on the cervical launch and account characteristics - Early clinical evaluations for cervical procedures have been positive, with targeted accounts showing strong adoption [32] Question: Impact of new data on physician discussions - Recent long-term outcome data showing significant reductions in reoperation rates has positively influenced discussions with physicians [34] Question: Pipeline visibility and surgeon training time - Management expressed high confidence in pipeline visibility and ongoing investments in education to potentially shorten surgeon training time [44][46]

Revenue Growth - For the three months ended September 30, 2025, Carlsmed recognized revenue of $13.1 million, a 98.4% increase from $6.6 million in the same period of 2024[134]. - For the nine months ended September 30, 2025, revenue reached $35.3 million, up 99.1% from $17.8 million in the prior year[134]. - Revenue for the three months ended September 30, 2025, was $13.1 million, a 98.4% increase from $6.6 million in the same period of 2024, driven by increased volume of surgical procedures with the aprevo Technology Platform[163]. - Revenue for the nine months ended September 30, 2025, was $35.3 million, a 99.1% increase from $17.8 million in the same period of 2024, also driven by increased volume of surgical procedures with the aprevo Technology Platform[164]. Product Development and Innovation - The aprevo Technology Platform has been used to treat over 2,600 patients since its commercial launch in October 2021[140]. - The FDA granted Breakthrough Device Designation for the aprevo cervical spine fusion in September 2023, with commercialization expected by early 2026[138]. - The company launched a digital production system in November 2024, reducing delivery time for interbody implants to eight business days[135]. - The company plans to expand its commercial infrastructure and market access initiatives to grow the base of surgeons using the aprevo Technology Platform[141]. - Research and development expenses are expected to increase as Carlsmed accelerates product and software innovation[154]. Financial Performance - Cost of sales for the three months ended September 30, 2025, was $3.1 million, a 75.6% increase from $1.8 million in the same period of 2024, primarily due to increased sales of aprevo interbody implants[165]. - Gross margin improved to 75.9% for the three months ended September 30, 2025, compared to 72.8% in the same period of 2024, attributed to reduced production fees and decreased inventory reserve expenses[166]. - Total operating expenses for the three months ended September 30, 2025, were $19.0 million, a 50.8% increase from $12.6 million in the same period of 2024[169]. - Research and development expenses for the three months ended September 30, 2025, were $4.4 million, a 10.2% increase from $4.0 million in the same period of 2024, mainly due to higher personnel costs[169]. - Sales and marketing expenses for the three months ended September 30, 2025, were $9.6 million, a 45.1% increase from $6.6 million in the same period of 2024, driven by increased personnel-related costs and commissions[171]. - General and administrative expenses for the three months ended September 30, 2025, were $4.9 million, a 155.8% increase from $1.9 million in the same period of 2024, primarily due to increased professional service and legal fees[173]. - Interest income for the three months ended September 30, 2025, was $1.0 million, a 142.1% increase from $0.4 million in the same period of 2024, due to higher daily average cash balances from IPO proceeds[176]. - Net loss for the three months ended September 30, 2025, was $8.5 million, a 9.1% increase from $7.8 million in the same period of 2024[162]. - Adjusted EBITDA for the nine months ended September 30, 2025, was $(19.9) million, reflecting a 4.0% increase from $(19.2) million in 2024[182]. Cash Flow and Financing - Cash and cash equivalents as of September 30, 2025, totaled $115.4 million, with an accumulated deficit of $92.2 million[183]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $23.7 million, compared to $21.3 million in 2024[192]. - Proceeds from the initial public offering (IPO) amounted to $93.5 million, net of underwriting discounts and commissions, contributing to net cash provided by financing activities of $100.2 million for the nine months ended September 30, 2025[197]. - The Customers Loan Agreement was amended to increase borrowing capacity, with a term loan of up to $50 million, contingent upon revenue milestones[186]. - The maturity date of the Term Loan was extended to October 15, 2030, with an interest-only period through October 15, 2027[187]. - Cash payments to vendors during the nine months ended September 30, 2025, totaled $34.4 million, while payroll-related cash payments were $19.8 million[193]. - The company expects existing cash and cash equivalents, along with anticipated sales from aprevo interbody implants, to fund operations for at least the next 12 months[188]. - Total principal amount outstanding under the Customers Loan Agreement as of September 30, 2025, was $15.6 million, maturing on October 31, 2029[199]. Company Classification - The company may take advantage of exemptions for up to five years as an emerging growth company, ceasing to be one when total annual gross revenues reach $1.235 billion or more[205]. - The company is classified as a "smaller reporting company" with a market value of shares held by non-affiliates less than $700 million and annual revenue below $100 million[206]. - The company can continue to rely on exemptions from certain disclosure requirements if it remains a smaller reporting company after ceasing to be an emerging growth company[206].

Financial Performance - Third quarter revenue reached $13.1 million, representing a 98% year-over-year growth compared to $6.6 million in Q3 2024[6] - Gross profit for Q3 2025 was $9.9 million, with a gross margin of 75.9%, up from 72.8% in Q3 2024[6] - The company raised its full-year 2025 revenue guidance to between $49 million and $50 million, indicating an expected growth of 80% to 84% over 2024[7] - Operating expenses for Q3 2025 were $19.0 million, compared to $12.6 million in Q3 2024, with significant increases in sales and marketing expenses[6] - The net loss for Q3 2025 was ($8.5) million, compared to a net loss of ($7.8) million in Q3 2024[6] - Adjusted EBITDA for the three months ended September 30, 2025, was $(8,249,000), reflecting a 7.4% decline from $(7,678,000) in the prior year[23] - EBITDA for the three months ended September 30, 2025, was $(9,018,000), a 16.0% increase in loss compared to $(7,772,000) in the same period of 2024[23] User Adoption and Market Expansion - The number of surgeon users increased by over 70% year-over-year, demonstrating significant user adoption[3] - The CMS New Technology Add-On Payment (NTAP) for cervical procedures became effective on October 1, 2025, with a commercial launch expected in early 2026[6] - Over 50 cervical aprevo procedures have been successfully completed as part of the clinical evaluation program[6] Assets and Liabilities - Cash and equivalents stood at $115.5 million as of September 30, 2025[14] - Total current assets increased to $131,465,000 as of September 30, 2025, compared to $49,351,000 as of December 31, 2024, representing a growth of 167.5%[21] - Total liabilities increased to $28,203,000 as of September 30, 2025, compared to $26,228,000 as of December 31, 2024, marking a rise of 7.5%[21] - Total assets reached $134,863,000 as of September 30, 2025, compared to $51,824,000 as of December 31, 2024, indicating a growth of 160.1%[21] - The accumulated deficit as of September 30, 2025, was $(92,192,000), an increase from $(71,171,000) as of December 31, 2024, indicating a deterioration of 29.6%[21] Inventory and Compensation - Inventory levels rose to $1,340,000 as of September 30, 2025, up from $995,000 as of December 31, 2024, representing a 34.7% increase[21] - Stock-based compensation for the three months ended September 30, 2025, surged to $704,000, a significant increase of 966.7% from $66,000 in the same period of 2024[23] Lead Times - Lead times for aprevo® interbody implants have been reduced to within eight business days, down from 10 business days in Q2 2025[6]

Core Insights - Carlsmed, Inc. reported a third quarter revenue of $13.1 million, reflecting a 98% year-over-year growth [1][6] - The company raised its full year 2025 revenue guidance to a range of $49 million to $50 million, indicating an expected growth of 80% to 84% over 2024 [5][6] Financial Performance - Revenue for Q3 2025 was $13.1 million, up from $6.6 million in Q3 2024, marking a 98% increase [6][17] - Gross profit for Q3 2025 was $9.9 million, compared to $4.8 million in Q3 2024, with a gross margin of 75.9% [6][17] - Operating expenses for Q3 2025 totaled $19.0 million, an increase from $12.6 million in Q3 2024, with specific expenses as follows: - Research and development: $4.4 million [6][17] - Sales and marketing: $9.6 million [6][17] - General and administrative: $4.9 million [6][17] - The net loss for Q3 2025 was ($8.5) million, compared to a net loss of ($7.8) million in Q3 2024 [6][17] - Adjusted EBITDA loss for Q3 2025 was ($8.2) million, compared to ($7.7) million in Q3 2024 [6][17] Business Highlights - The company expanded gross margins to 76% and increased surgeon users by over 70% year-over-year [2] - Lead times for surgical plan approval were reduced to within 8 business days, down from 10 business days in Q2 2025 [6] - The CMS New Technology Add-On Payment (NTAP) for cervical procedures became effective on October 1, 2025, with a commercial launch expected in early 2026 [6] - Over 50 cervical aprevo procedures have been successfully completed as part of the clinical evaluation program [6] - Data presented at the Scoliosis Research Society Annual Meeting indicated a 75% reduction in revision surgery at a two-year time point for aprevo compared to a matched cohort [6] Leadership Changes - Jennifer Kamocsay was appointed as Chief Legal Officer and Secretary, bringing over a decade of corporate legal experience [6]

Core Insights - Carlsmed, Inc. is set to report its third quarter 2025 financial results on November 6, 2025, after market close [1] - A conference call and webcast will be held on the same day at 1:30 PM Pacific Time to discuss the financial results [2] Company Overview - Carlsmed is a medical technology company focused on AI-enabled personalized spine surgery solutions, aiming to enhance healthcare outcomes and reduce costs associated with spine surgery [3]

Core Insights - Carlsmed, Inc. has appointed Jenifer Kamocsay as Chief Legal Officer and Secretary, effective immediately, to enhance its leadership team post-IPO [1][3] - Ms. Kamocsay has over 20 years of corporate legal experience in the life sciences and technology sectors, previously serving in significant legal roles at Akoya Biosciences, Rubius Therapeutics, and Progress Software [2][3] - The company aims to strengthen its corporate governance and legal strategy as it prepares for the launch of its cervical commercial product in 2026 [3][5] Company Overview - Carlsmed is a medical technology company focused on AI-enabled personalized spine surgery solutions, with a mission to improve healthcare outcomes and reduce costs associated with spine surgery [4]

Core Insights - Carlsmed, Inc. has been added to the Russell 2000 Index, effective after market close on September 22, 2025, marking a significant milestone following its IPO in July 2025 [1][2] - The inclusion in the Russell 2000 Index is seen as validation of Carlsmed's differentiated business model and growth potential, enhancing its visibility among investors [2] Company Overview - Carlsmed is a medical technology company focused on AI-enabled personalized spine surgery solutions, aiming to improve healthcare outcomes and reduce costs associated with spine surgery [3] Industry Context - The Russell 2000 Index represents approximately 10 percent of the total market capitalization of the broader Russell 3000 Index, which is widely utilized by investment managers and institutional investors for benchmarking [2] - Approximately $9 trillion in assets are benchmarked against Russell's U.S. indexes, indicating the significance of the Russell 2000 Index in the investment landscape [2]

Group 1: Market Overview - The stock market has rebounded strongly from the sharp decline in April, reaching a historical high, with the S&P 500 index up 11% and the Nasdaq index up 13.5% year-to-date, reflecting sustained market optimism [1] - Goldman Sachs' Chief U.S. Equity Strategist David Kostin predicts that the upcoming Federal Reserve interest rate cuts and a projected acceleration in economic growth in 2026 will support further gains in U.S. equities [1] - Kostin's forecast includes three expected interest rate cuts by the Federal Reserve this year and a prediction that the U.S. economy will avoid recession, with the S&P 500 index expected to rise by 2% by year-end and 6% by mid-2026 [1] Group 2: Braze (BRZE.US) - Braze operates a customer engagement platform for multi-channel marketing optimization, focusing on conversation rather than sales, and aims to provide a clear path from information acquisition to comfortable purchasing [2] - The platform is data-driven and AI-enabled, allowing enterprise clients to interact with users and convert sales funnels into information journeys, processing over 3.9 trillion messages last year [2] - For the second quarter of fiscal year 2026, Braze reported revenue of $180.1 million, a 24% year-over-year increase, exceeding expectations by nearly $8.5 million, with a non-GAAP EPS of $0.15, surpassing estimates by $0.12 [3] - Goldman Sachs analysts view Braze as a preferred stock with a target price of $52, indicating a potential upside of 73% over the next year [3] Group 3: Carlsmed (CARL.US) - Carlsmed focuses on AI-driven personalized spinal surgery, aiming to reduce surgical costs while improving patient outcomes, with its aprevo platform supporting precise surgical planning [4] - The company went public on July 22, pricing its IPO at $15 per share and raising approximately $100.5 million [4] - For the second quarter of fiscal year 2025, Carlsmed reported revenue of $12.1 million, a significant 99% increase year-over-year, with guidance for full-year revenue between $45.5 million and $47.5 million [5] - Goldman Sachs analysts highlight Carlsmed's growth potential driven by expected sales team expansion and the launch of cervical indications in 2026, projecting a target price of $19, indicating a 40% upside [5]

Company Overview - Braze utilizes AI technology to enhance its customer engagement platform, creating personalized content and recommendations for optimal marketing results [1][2] - The platform is designed for multi-channel marketing, focusing on customer conversations rather than just sales, facilitating a smoother transition from information to purchase [3] Financial Performance - In fiscal Q2 2026, Braze reported revenues of $180.1 million, a 24% year-over-year increase, exceeding estimates by approximately $8.5 million [8] - The company achieved a non-GAAP EPS of 15 cents, which was 12 cents higher than expected [8] Market Position and Growth Potential - Braze serves 2,422 enterprise customers, reaching 7.4 billion daily active users, and processed over 3.9 trillion messages last year [7] - Analysts view Braze as a strong buying opportunity, with a price target of $52 indicating a 73% upside potential [9] - The stock currently trades at $30.08, with an average price target of $43.07 suggesting a one-year gain of 43% [9]