Financial Data and Key Metrics Changes - Revenue in Q2 2025 was $47.4 million, representing a 7% increase compared to the same period in 2024 [7][19] - Gross margin decreased to 79.7% in 2025 from 80.2% in 2024 [19] - Total operating expenses were reduced by 4% to $54.7 million in 2025 from $57.1 million in 2024 [19] - Net loss improved to $17.4 million or $0.28 per share, an 18% improvement from a net loss of $21.2 million or $0.34 per share in Q2 2024 [20] - Adjusted EBITDA loss was $3.6 million, significantly improved by 58% compared to $8.7 million in 2024 [20] - Cash usage decreased by 55.78% in Q2 2025 compared to the prior year, supporting a projected 50% reduction in cash used for the full year [21] Business Line Data and Key Metrics Changes - The company expanded its portfolio to include three new bunion correction systems, enhancing its offerings alongside the flagship lapoplasty and adductoplasty systems [7][10] - The new systems are expected to drive procedure penetration and expand market leadership [8][10] Market Data and Key Metrics Changes - The total addressable market (TAM) for the company is estimated at over $5 billion, with approximately 1.1 million annual symptomatic surgical candidates in the U.S. [10] - Current market penetration is approximately 2.8%, indicating significant untapped opportunities [10] Company Strategy and Development Direction - The company's strategy focuses on increasing procedure volumes and expanding its customer base, aiming to penetrate the remaining 70% of bunion-related cases among existing customers [11][12] - The company is also targeting new surgeons who prefer metatarsal osteotomy procedures, leveraging its expanded portfolio to attract this audience [12][13] - The company plans to launch additional products and technologies, including the next-generation Lapaplasty system, to further enhance its market position [14][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving revenue growth of 7% to 10% for the full year 2025, with expectations for sequential growth in the remaining quarters [15][21] - The company anticipates a strong performance in Q3 and Q4, traditionally the strongest quarters, driven by new product launches and increased surgeon engagement [35][41] Other Important Information - The company will host an Investor Day on September 3, 2025, to present its expanded technology portfolio [22] - A recent peer-reviewed publication highlighted successful patient outcomes from the ALIGN3D lapoplasty clinical study, further differentiating the company's offerings in the marketplace [16] Q&A Session Summary Question: Can you provide more quantitative commentary on surgeon profiles for the new systems? - Management expects increasing volumes and revenue contributions from the new systems as they penetrate the market and serve the osteotomy segment [25] Question: What feedback has been received regarding the Lapoplasty Lightning System? - The Lapoplasty Lightning System is anticipated to significantly advance the procedure, with expectations for it to drive growth in 2026 [30] Question: How is the company viewing the foot and ankle market and procedure trends? - Management noted that while some procedures have been pushed out, they do not believe any cases are lost, and they anticipate growth to be back half-weighted [34][35] Question: What is the confidence level in achieving a strong ramp in Q4? - Management expressed confidence in a substantial step-up in revenue and procedure volume in Q4, supported by a full suite of bunion products [41][58] Question: Is there interest in inorganic growth opportunities? - The company is opportunistically looking for inorganic growth opportunities to drive expansion and is also exploring international markets [53]

Financial Data and Key Metrics Changes - Revenue in Q1 2025 was $52.6 million, representing a 3% increase compared to Q1 2024, and adjusted for one less selling day, growth was 4.5% [4][9][17] - Gross margin was 79.7% in Q1 2025, down from 80.2% in Q1 2024 [18] - Net loss for Q1 2025 was $15.9 million or $0.25 per share, compared to a net loss of $18.7 million or $0.30 per share in Q1 2024 [18] - Adjusted EBITDA loss improved to $3.8 million in Q1 2025 from $8.3 million in Q1 2024, marking a 54% improvement [18][19] - Cash and cash equivalents were $76.1 million as of March 31, 2025, compared to $75.7 million as of December 31, 2024 [19] Business Line Data and Key Metrics Changes - The growth in revenue was primarily driven by an increase in bunion procedure kits sold compared to the prior year [17] - The company has established a strong customer base of over 3,100 surgeon users and treated over 130,000 patients since its inception [10] Market Data and Key Metrics Changes - The company expects to target virtually 100% of surgeon and patient preferences for bunion correction with five best-in-class systems starting in Q3 2025 [11] - The company anticipates substantial growth in Q4 2025, driven by the timing of patient deductibles and the full availability of new products [15] Company Strategy and Development Direction - The company aims to evolve from a single technology lapoplasty company to a comprehensive bunion solutions provider [10] - The upcoming commercialization of three new bunion correction systems is expected to enhance market penetration and address a broader range of surgeon preferences [11][12] - The company plans to launch several new sterile instruments and a next-generation lapoplasty platform later in the year [13][14] Management's Comments on Operating Environment and Future Outlook - Management reiterated revenue guidance for 2025, expecting revenue between $224 million and $230 million, representing a growth of 7% to 10% over 2024 [15][20] - The company is focused on achieving breakeven adjusted EBITDA for the full year 2025 and expects cash burn to decrease by approximately 50% compared to 2024 [21][62] Other Important Information - The company has limited tariff exposure, with most inventory manufactured in the U.S., and expects this to remain at immaterial levels in 2026 [21] Q&A Session Summary Question: How does the company feel about its positioning in the overall market today? - Management noted that competition remains, but the company believes lapoplasty is the superior option backed by clinical outcomes data [25][26] Question: Are there changes in how quickly new surgeon users are being trained? - Management reported strong interest and oversold attendance at training events, indicating excitement among surgeons [28] Question: What explains the expected sales for Q2 being below street estimates? - Management explained that elective procedures have been pushed out, but they expect these cases to be completed later in the year, benefiting from the expanded product portfolio [34][39] Question: How will the new products impact lapoplasty volumes? - Management indicated minimal cannibalization, as new products will primarily attract surgeons who prefer osteotomy procedures [40][44] Question: How might outpatient ASC reimbursement impact performance? - Management stated it is too early to quantify the impact but noted positive anecdotal feedback from surgeons regarding access to newer technologies [48][50] Question: What are the assumptions for the revenue guidance? - Management emphasized comfort with the midpoint of the revenue range, with potential upside from faster adoption of new products [56][58] Question: What are the drivers of positive leverage for EBITDA? - Management highlighted operational efficiencies and expense management as key drivers for improved profitability [59][62]

Financial Data and Key Metrics Changes - Revenue in Q1 2025 was $52.6 million, representing a 3% growth compared to Q1 2024, and adjusted for one less selling day, growth was 4.5% [4][8][16] - Gross margin was 79.7% in Q1 2025, down from 80.2% in Q1 2024 [17] - Net loss for Q1 2025 was $15.9 million or $0.25 per share, an improvement from a net loss of $18.7 million or $0.30 per share in Q1 2024 [17] - Adjusted EBITDA loss for Q1 2025 was $3.8 million, compared to $8.3 million in Q1 2024, marking a 54% improvement [17][18] - Cash and cash equivalents were $76.1 million as of March 31, 2025, compared to $75.7 million as of December 31, 2024 [18] Business Line Data and Key Metrics Changes - The company has established a strong customer base of over 3,100 surgeon users and treated over 130,000 patients, leading to over $200 million in revenue [9] - The upcoming commercialization of three new bunion correction systems is expected to target the remaining 75% of surgeon cases [10] Market Data and Key Metrics Changes - The company anticipates substantial growth in Q4 2025, driven by new product availability and seasonal strength from patient deductibles [14][19] - The company expects revenue for 2025 to be between $224 million and $230 million, reflecting a growth of 7% to 10% over 2024 [14][19] Company Strategy and Development Direction - The company aims to evolve from a single technology lapoplasty company to a comprehensive bunion solutions provider [9] - The introduction of new technologies, including the IntelliGuide PSI and SpeedPlate MicroQuad implant, is part of the strategy to enhance product offerings [11][12] - The company plans to launch a next-generation lapoplasty platform, the Lightning system, later in the year [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the impact of new systems on business growth starting in the second half of the year [11] - The company is focused on improving operational efficiencies and reducing cash burn by approximately 50% in 2025 [20][59] Other Important Information - The company has limited tariff exposure, with most inventory manufactured in the U.S., and expects this to remain immaterial in 2026 [20] Q&A Session Summary Question: How does the company feel about its positioning in the bunion market with increased competition? - Management believes lapoplasty remains the superior option and is well-positioned to drive growth with new innovative technologies [24][25] Question: Are there changes in how quickly new surgeon users are being trained? - There has been strong interest in training programs, indicating excitement among surgeons about the new systems [27][28] Question: What explains the expected sales for Q2 being below market expectations? - Management noted that elective procedures have been pushed out, but they expect surgeries to occur later in the year, benefiting from new product launches [36][37] Question: What is the expectation for lapoplasty volumes versus new MIS osteotomy products? - Management anticipates minimal cannibalization and believes the new systems will fill gaps in the current offerings [41][42] Question: How might the step-up in hospital outpatient ASC reimbursement impact performance? - While it's early to quantify the impact, management views it positively and expects it to benefit the business [46][47]