Financial Data and Key Metrics Changes - The company reported third quarter revenues of $50.2 million, representing an 11% growth over the third quarter of 2024 and a 49% improvement in adjusted EBITDA compared to the prior year [4][17] - Gross margin decreased to 79.1% in Q3 2025 from 80.1% in Q3 2024 [17] - The net loss for the third quarter was $16.3 million, or $0.26 per share, which is a 6% increase in net loss compared to $15.4 million, or $0.25 per share, in Q3 2024 [18] - Year-to-date net loss decreased by 10% to $49.6 million compared to $55.2 million for the same period in 2024 [18] - Total liquidity as of September 30, 2025, was $80.6 million, down from $90.7 million at the end of Q2 [19] Business Line Data and Key Metrics Changes - The company has expanded its product portfolio to include three new bunion correction systems, aiming to address nearly 100% of surgeon preferences for bunion correction [5][6] - Case volume growth was mid-single digits compared to the prior year, but below original expectations, largely driven by new bunion systems with lower average selling prices (ASPs) [10] - Sales to a limited number of stocking distributors contributed approximately $6 million in the third quarter, which is not expected to recur at the same levels in future quarters [12] Market Data and Key Metrics Changes - A survey indicated that surgeon customers reported a 7% decrease in bunion surgical volumes year-to-date through October compared to the same period last year [11] - Broader economic conditions and softer consumer sentiment have led to deferrals of elective bunion procedures, impacting case volumes [8][11] Company Strategy and Development Direction - The company is transitioning from a single technology focus to a comprehensive bunion solutions provider, with plans to capture market share in minimally invasive osteotomies and MTP fusion markets [5][9] - The strategy includes enhancing the sales team's capabilities and expanding the product portfolio to drive market share gains and improve profitability [13][15] Management's Comments on Operating Environment and Future Outlook - Management expressed disappointment in the current growth trajectory and revised the full-year revenue outlook to $211 million-$213 million, reflecting only 1%-2% growth compared to 2024 [8][20] - The company plans to continue focusing on training existing customers and onboarding new surgeons to drive adoption of new products [13][22] Other Important Information - The company is taking actions to control costs and improve profitability, with a focus on reducing cash burn in 2026 [16][20] - The company has appointed a new Chief Commercial Officer and expanded its sales team to enhance market presence [6] Q&A Session Summary Question: Can you talk about the softness in the core Lapiplasty business? - Management acknowledged a trend towards minimally invasive osteotomies but emphasized the importance of Lapiplasty for significant bunion deformities, stating efforts to capture market share in this area [24][25] Question: What does the guidance imply for Q4 and 2026? - Management refrained from providing specific guidance for 2026 but expressed optimism about case volume growth and the reception of new products [26][27] Question: Has there been an acceleration in the shift away from Lapiplasty? - Management confirmed a trend towards minimally invasive procedures but highlighted ongoing efforts to capture market share with new technologies [30][31] Question: How will the company recoup deferred procedures next year? - Management indicated that improved consumer sentiment and enhanced engagement with new products would help capture a larger share of patients returning for surgery [38]

Financial Data and Key Metrics Changes - Fourth quarter revenue was $68.7 million, representing a 10.4% growth over the fourth quarter of 2023, at the top-end of previously announced preliminary results [22][27] - Full-year 2024 revenue was $209.4 million, a 12% increase over 2023, also at the top-end of prior guidance [28] - Gross margin for the fourth quarter was 80.7%, down from 81.6% in the fourth quarter of 2023, while full-year gross margin was 80.4%, compared to 81.2% in 2023 [28][29] - Fourth quarter net loss was $0.5 million or $0.01 per share, compared to a net loss of $6.3 million or $0.10 per share in the fourth quarter of 2023 [30] - Adjusted EBITDA for the fourth quarter was $11.1 million, an improvement of 322% compared to the fourth quarter of 2023 [30] Business Line Data and Key Metrics Changes - The growth was driven by a product mix shift, increased adoption of newer technologies such as Adductoplasty and SpeedPlate, and an increase in active surgeon users [22][28] - The company aims to capture a larger share of the remaining 75% of bunion procedures performed by its surgeon customers [20] Market Data and Key Metrics Changes - The company has a growing base of over 3,100 surgeon customers, representing a ready audience for its expanding suite of technologies [10] - The company estimates that around 10% to 15% of all metatarsal osteotomies today are being performed with minimally invasive approaches, indicating a significant growth opportunity [14] Company Strategy and Development Direction - The company focuses on expanding its portfolio of innovative solutions to address all four classes of bunions, aiming to maximize market share [20][26] - The strategy includes making procedures less invasive, which is expected to appeal to a larger portion of the 4.4 million Americans seeking medical attention for bunions each year [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the setup for 2025, expecting revenue guidance of $224 million to $230 million, reflecting a 7% to 10% increase over 2024 [24][32] - The company anticipates break-even adjusted EBITDA for full-year 2025 and a 50% decrease in cash burn compared to 2024 [32] Other Important Information - The company has introduced new technologies such as Mini-Adductoplasty and SpeedMTP, which are expected to ramp availability and revenue impact in the back half of 2025 [21][19] - The company is monitoring reimbursement trends following significant increases in material reimbursement for CPT code 28297, associated with Lapiplasty procedures [23] Q&A Session Summary Question: Thoughts on revenue pacing through 2025 - Management acknowledged that Q1 will be a tougher comp but expects higher growth rates in Q2, Q3, and Q4 [38] Question: Impact of new products on ASPs and unit volumes - Management indicated that the focus will be on procedure volume rather than significant shifts in blended ASP [44] Question: Profitability and leverage components - Management highlighted natural leverage from a more experienced sales force and reduced aggressive hiring [52][54] Question: Early feedback on new products and competitive dynamics - Early feedback on new products has been positive, with some surgeons returning to Lapiplasty after trying competitors [58] Question: Thoughts on the Zimmer-Paragon deal - Management stated they are focused on growing their product line and will observe the market effects of the acquisition [66] Question: Clinical outcomes of new osteotomy solutions - Management emphasized the importance of three-plane correction in their osteotomy approach, which they believe will lead to better long-term outcomes [72] Question: Q1 revenue expectations - Management confirmed that Q1 is expected to show low-single digit growth rates year-over-year [76] Question: Targeting new surgeons with broader product offerings - Management aims to add approximately 200 new surgeons to their customer base in 2025 [84] Question: Future opportunities in foot and ankle market - Management indicated a robust pipeline of products and a focus on penetrating the bunion and midfoot markets [90][92] Question: Utilization of new osteotomy offerings - Initial adopters of the new osteotomy systems are high utilizers of minimally invasive techniques [98] Question: Update on SpeedPlate attach rates - SpeedPlate has grown to over 50% of the overall fixation mix, with expectations for continued growth [108]