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].
Carlsmed Inc(CARL) - 2025 Q3 - Quarterly Report