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Carlsmed Inc(CARL) - 2025 Q2 - Earnings Call Transcript
2025-08-28 21:30
Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $12.1 million, representing a year-over-year growth of 99% compared to $6.1 million in Q2 2024 [5][11] - Gross margin decreased to 73.4% in Q2 2025 from 75% in Q2 2024, primarily due to expedite production fees and material costs [11][12] - Operating expenses increased to $15.4 million in Q2 2025 from $10.9 million in Q2 2024, with R&D expenses slightly rising to $4.2 million [12][13] - GAAP net loss was $6.8 million in Q2 2025 compared to a net loss of $6.3 million in Q2 2024 [13] Business Line Data and Key Metrics Changes - The company reported 199 surgeon users who completed more than one procedure using the Aprivo technology platform, a 72% increase from the previous year [6] - The average revenue per procedure remained constant at approximately $30,000 [16][39] Market Data and Key Metrics Changes - The total addressable market for Aprivo lumbar spine fusions is estimated to exceed $13 billion, with nearly 4,000 spine surgeons in the U.S. [6] - Recent CMS decisions have enhanced hospital reimbursement for Aprivo procedures, translating to an incremental reimbursement of $20,000 to $50,000 depending on procedure complexity [8] Company Strategy and Development Direction - The company aims to establish a new architecture of surgery to improve patient outcomes and reduce healthcare costs [5] - Plans for a commercial launch of the personalized cervical fusion technology using the Aprivo platform are set for 2026 [10][42] - The company is focused on innovation, including a digital production system that reduces turnaround time for implants from over four weeks to ten business days [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about growth due to strong surgeon adoption and compelling clinical data supporting the Aprivo technology [11][16] - The company expects to achieve full-year 2025 revenue guidance of $45.5 million to $47.5 million, representing a growth of 67% to 75% over 2024 [16][51] Other Important Information - The company raised $100.5 million in gross proceeds from its IPO, providing sufficient capital to execute its business strategy [14][15] - Cash used in operating activities for the first half of 2025 was $15.2 million, with a monthly average cash burn of $2.5 million [15] Q&A Session Summary Question: Utilization trends in the quarter - Management noted strong uptake in utilization and new surgeon adoption, exceeding internal plans [20][21] Question: Guidance as a new public company - Management highlighted key growth drivers including recent CMS decisions and ongoing innovation [22][23] Question: Procedure adoption and segmentation - The company has seen growth in short construct fusion procedures, expanding from initial targeting of complex procedures [26][27] Question: Seasonality in revenue guidance - Management acknowledged seasonality in procedure volume but did not provide specific Q3 guidance [29][32] Question: Surgeon training and productivity - The company added 47 new surgeons, reaching a total of 199, and plans to continue investing in education programs [34][35] Question: Pricing and revenue guidance - Average revenue per procedure is expected to remain constant, with growth driven by procedure volume [38][39] Question: Cervical launch preparations - The company is preparing for the cervical launch with recent Medicare announcements and technology advancements [42][43] Question: Artificial intelligence costs - Investments in AI are expected to enhance scalability without disproportionately affecting the P&L [44][45] Question: Revenue outlook and surgeon adds - New surgeon additions are expected to drive revenue growth in subsequent quarters [58][60]