Financial Data and Key Metrics Changes - Revenue in Q4 2025 was $62.5 million, a decrease of 9% compared to the prior year period, primarily due to a shift in revenue mix towards lower-priced products [21] - Gross margin was 80.6% in Q4 2025, slightly down from 80.7% in Q4 2024 [21] - Total operating expenses increased to $56.3 million in Q4 2025 from $55.7 million in Q4 2024, reflecting restructuring charges and increased litigation expenses [21] - The net loss for Q4 2025 was $9.4 million, or $0.15 per share, compared to a net loss of $0.5 million, or $0.01 per share, in Q4 2024 [22] - Adjusted EBITDA for Q4 was $6.2 million, down from $11.1 million in Q4 2024, while the full year 2025 Adjusted EBITDA loss was $3.9 million, a 64% improvement over the prior year [22][23] - Cash usage for the full year 2025 was $27.3 million, a 46% reduction compared to $50.5 million in 2024 [23] Business Line Data and Key Metrics Changes - The company has expanded its bunion procedure offerings, now addressing virtually 100% of surgeons' technique preferences for bunion correction [5] - New bunion systems launched in 2025 are expected to significantly increase market penetration and procedure volume growth [10][19] - Over 25% of the surgeon base has incorporated one or more of the new bunion systems into their practice, with Q4 procedure volume growth exceeding mid-single-digit rates [13][19] Market Data and Key Metrics Changes - The overall foot and ankle market was reported to be soft in 2025, with deferrals of elective procedures impacting case volumes [27] - The company anticipates that case volume growth will continue to be offset by product ASP mix-related headwinds in the first half of 2026 [28] - The company expects to capture a larger share of the market with new product launches and improved sales strategies [19][28] Company Strategy and Development Direction - The company is focused on leveraging its existing customer base to drive adoption of new products and expand its serviceable total addressable market (TAM) [10] - Plans for 2026 include launching new products that are expected to enhance market share and profitability [16][19] - The company aims to continue improving its profitability and reducing cash burn, with a target of a 50% reduction in cash usage for 2026 compared to 2025 [23][24] Management's Comments on Operating Environment and Future Outlook - Management noted that broader economic conditions and softer consumer sentiment continue to impact the business environment [7] - The outlook for full year 2026 revenue is projected to be in the range of $200 million to $212 million, representing a decline of 6% to 0% compared to 2025 [8][23] - Management expressed confidence in the strategies in place to restore top-line revenue growth and improve profitability [6][19] Other Important Information - The company has expanded its active surgeon base from nearly 1,300 users in 2020 to over 3,300 users in 2025 [18] - The company has entered the biologics market with new offerings, which are expected to enhance revenue without negatively impacting margins [31] Q&A Session Summary Question: Market conditions and growth outlook - Management acknowledged that the foot and ankle market was soft in 2025, with case deferrals impacting overall surgical volume, but noted an increase in Q4 case volumes [27][28] Question: Impact of biologics on operating margins - Management indicated that the expansion into biologics is expected to provide additional revenue without negatively impacting margins [31] Question: Product development timelines and surgeon feedback - Management confirmed that new products like SuperBite and SpeedXM have been in development for about 18 months and received positive feedback from surgeons [36][38] Question: Balancing sales force focus with new product offerings - Management emphasized that the sales force remains focused on bunion-related products while also addressing adjacent procedures to meet surgeon demand [54][55] Question: Cash flow outlook and cost management - Management detailed initiatives to reduce cash burn and improve profitability, including lower operating expenses and capital expenditures in 2026 [64][66]

Financial Data and Key Metrics Changes - Revenue in Q4 2025 was $62.5 million, a decrease of 9% compared to the prior year period, primarily due to a shift in revenue mix towards lower-priced products [21] - Gross margin was 80.6% in Q4 2025, slightly down from 80.7% in Q4 2024 [21] - The net loss for Q4 2025 was $9.4 million, or $0.15 per share, compared to a net loss of $0.5 million, or $0.01 per share, in Q4 2024 [22] - Full year 2025 adjusted EBITDA loss was $3.9 million, a 64% improvement over the prior year [22] - Cash usage for the full year 2025 was $27.3 million, a 46% reduction compared to $50.5 million in 2024 [23] Business Line Data and Key Metrics Changes - The company has expanded its bunion procedure offerings, now addressing virtually 100% of surgeons' technique preferences with five best-in-class instrumented systems [5] - The new bunion systems launched in 2025 have already been adopted by over 25% of the surgeon base, contributing to increased procedure volume growth [13] - The company expects to continue to reduce cash burn by approximately 50% in 2026 compared to 2025 [9] Market Data and Key Metrics Changes - The overall foot and ankle market was reported to be unusually soft in 2025, with elective procedures experiencing declines [27] - The company anticipates that case volume growth will improve in 2026, particularly in the fourth quarter, driven by new product launches and an increase in case volumes [8][19] Company Strategy and Development Direction - The company is focused on leveraging its existing customer base to drive adoption of new bunion products and expanding its product offerings to grow wallet share [10] - The introduction of new technologies, such as the Lapiplasty Lightning and SpeedTMT, is expected to attract new surgeons and enhance the company's competitive position [15][19] - The company plans to continue its emphasis on medical education and training for surgeons to ensure successful integration of new products [18] Management's Comments on Operating Environment and Future Outlook - Management noted that while there are ongoing headwinds related to economic conditions and consumer sentiment, they remain confident in their strategies to restore revenue growth [7] - The outlook for full year 2026 revenue is projected to be in the range of $200 million to $212 million, reflecting a decline of 6% to 0% compared to 2025 [8][23] - Management expressed optimism about the potential for market share gains and improved profitability through disciplined investments and strategic initiatives [19] Other Important Information - The company has expanded its active surgeon base from nearly 1,300 users in 2020 to over 3,300 users in 2025, indicating strong growth in customer engagement [18] - The company has entered the biologics market with new offerings, which are expected to enhance revenue without negatively impacting margins [16] Q&A Session Summary Question: Insights on the softness in the foot and ankle market - Management acknowledged that 2025 was a softer year for elective procedures, but noted an increase in Q4 case volumes, indicating market share gains despite the overall market conditions [27] Question: Impact of the biologics portfolio on operating margins - Management expressed confidence that the expansion into biologics would provide additional revenue without negatively impacting margins [30] Question: Development timeline and surgeon feedback on new products - Management confirmed that new products like SuperBite screws and SpeedXM have been in development for about 18 months and received positive feedback from surgeons during testing [35] Question: Guidance assumptions for 2026 - Management indicated that guidance includes assumptions for the uptake of new products and the performance of existing offerings, with a focus on achieving reasonable and achievable targets [82] Question: Strategy for penetrating the market - Management emphasized the strategy of deepening engagement with the existing surgeon base while also attracting new surgeons through innovative product offerings [88]

Financial Data and Key Metrics Changes - Revenue in Q4 2025 was $62.5 million, a decrease of 9% compared to the prior year period, primarily due to a shift in revenue mix towards lower-priced products [19] - Gross margin was 80.6% in Q4 2025, slightly down from 80.7% in Q4 2024 [19] - Total operating expenses increased to $56.3 million in Q4 2025 from $55.7 million in Q4 2024, reflecting restructuring charges and increased litigation expenses [19] - Net loss for Q4 2025 was $9.4 million, or $0.15 per share, compared to a net loss of $0.5 million, or $0.01 per share, in Q4 2024 [20] - Full year 2025 Adjusted EBITDA loss was $3.9 million, a 64% improvement over the prior year [20] - Cash usage for the full year 2025 was $27.3 million, a 46% reduction compared to $50.5 million in 2024 [21] Business Line Data and Key Metrics Changes - The company has transitioned from a Lapiplasty-focused company to a comprehensive bunion solutions provider, launching multiple new bunion procedure innovations [4] - The new bunion systems are expected to effectively double the accessible market, targeting a significant portion of the 450,000 annual bunion procedures in the U.S. [9] - Over 25% of the surgeon base has incorporated one or more of the new bunion systems into their practice, with Q4 procedure volume growth increasing over mid-single-digit rates achieved in Q3 [11][18] Market Data and Key Metrics Changes - The foot and ankle market was reported to be unusually soft in 2025, with deferrals of cases impacting overall bunion surgical volume [26] - The company expects to capture market share despite the softness, with an anticipated increase in case volume in 2026 [26] - The outlook for full year 2026 revenue is projected to be in the range of $200 million-$212 million, representing a decline of 6%-0% compared to full year 2025 [21] Company Strategy and Development Direction - The company aims to leverage its existing customer base to drive adoption of new bunion product launches and expand its product offerings to grow wallet share [8] - The strategy includes advancing the Lapiplasty technology and introducing new products like the Lapiplasty Lightning and SpeedTMT implants [12][14] - The company plans to expand its biologics market presence with new offerings, which are expected to enhance revenue without negatively impacting margins [15][30] Management's Comments on Operating Environment and Future Outlook - Management acknowledged ongoing headwinds related to broader economic conditions and softer consumer sentiment, which are expected to persist into 2026 [5] - The company anticipates a reduction in cash usage of approximately 50% for full year 2026 compared to 2025, supported by a strong balance sheet [22] - Management expressed confidence in the strategies in place to drive market share gains and improve profitability [18] Other Important Information - The company has expanded its active surgeon base from nearly 1,300 users in 2020 to over 3,300 users in 2025, indicating strong growth in customer engagement [17] - The company plans to launch additional products in 2026 that are expected to expand its total addressable market by an estimated $300 million [16] Q&A Session Summary Question: Thoughts on the softness in the foot and ankle market - Management noted that 2025 was a softer year due to case deferrals, but they are seeing an increase in Q4 case volumes, indicating market share gains [26] Question: Impact of biologics portfolio on operating margins - Management expressed optimism that the expansion of the biologics portfolio would provide additional revenue without negatively impacting margins [30] Question: Details on new products and their development - The SuperBite screws and SpeedXM midfoot plating system have been in development for about 18 months and are expected to enhance the product offering significantly [35][36] Question: How to balance the focus of the sales force with new products - Management emphasized that the sales force is trained to focus on the bunion segment while also addressing adjacent procedures, ensuring they meet customer demands [54] Question: Long-term growth expectations - Management believes that with the expanded product portfolio and focus on the bunion market, they can achieve at least mid-single-digit growth, potentially higher with market share gains [73]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission File Number 001-40355 TREACE MEDICAL CONCEPTS, INC. (Exact name of Registrant as specified in its Charter) Securities regis ...

Financial Results - Treace Medical Concepts, Inc. reported preliminary unaudited financial results for the quarter and year ended December 31, 2025[5]. Upcoming Events - The company plans to present at the J.P. Morgan Healthcare Conference on January 14, 2026, at 7:30 am Pacific Time[7]. - The investor presentation will be available on the company's investor relations website, providing insights for analysts and investors[7].

Core Insights - Treace Medical Concepts, Inc. reported financial results for Q4 and full-year 2025, highlighting a shift in product sales and expectations for future growth [1][3][4]. Financial Performance - Q4 2025 revenue was $62.5 million, a 9% decrease from $68.7 million in Q4 2024, primarily due to a shift towards lower-priced bunion kits [4]. - Gross profit for Q4 2025 was $50.4 million, with a gross margin of 80.6%, slightly down from 80.7% in Q4 2024 [4]. - Total operating expenses in Q4 2025 were $56.3 million, up 1% from $55.7 million in Q4 2024 [5]. - The net loss for Q4 2025 was $(9.4) million, or $(0.15) per share, compared to a net loss of $(0.5) million, or $(0.01) per share, in Q4 2024 [5]. - Adjusted EBITDA for Q4 2025 was $6.2 million, down from $11.1 million in Q4 2024 [5]. Full-Year Results - Full-year 2025 revenue was $212.7 million, a 2% increase from $209.4 million in 2024 [6]. - Gross profit for the full year was $169.8 million, with a gross margin of 79.8%, down from 80.4% in 2024 [6]. - Total operating expenses for 2025 were $223.9 million, slightly down from $224.0 million in 2024 [6]. - The full-year net loss was $(59.0) million, or $(0.93) per share, compared to $(55.7) million, or $(0.90) per share, in 2024 [7]. - Adjusted EBITDA loss for 2025 was $(3.9) million, significantly improved from $(11.0) million in 2024 [7]. Operational Highlights - The company increased its active surgeon base by 202, ending 2025 with 3,337 active surgeons, a 6% increase year-over-year [8]. - The company broadened its global patent portfolio to 135 granted patents and 199 pending applications [8]. Cash Flow and Liquidity - Cash, cash equivalents, and marketable securities totaled $48.4 million as of December 31, 2025 [9]. - The company reduced cash usage by 46% to $27.3 million in 2025 compared to $50.5 million in 2024 [8][9]. 2026 Financial Outlook - The company projects full-year 2026 revenue guidance of $200 million to $212 million, indicating a decline of 6% to 0% compared to 2025 [10]. - Expected Adjusted EBITDA loss for 2026 is projected to be between $(4.0) million and $(6.0) million [10]. - Anticipated reduction in cash usage for 2026 is approximately 50% compared to 2025 [10].

Core Viewpoint - Treace Medical Concepts, Inc. is set to showcase new product innovations and present interim data from its clinical studies at the ACFAS Annual Scientific Conference, emphasizing advancements in surgical treatments for bunions and related midfoot deformities [1][2]. Product Innovations - The company will highlight next-generation Lapiplasty instrumentation and fixation technology platforms, including SpeedTMT, Lapiplasty Lightning System, Nanoplasty, Percuplasty, SpeedMTP, and IntelliGuide PSI, aimed at enhancing surgical outcomes and market penetration [2][4]. - SpeedTMT is a new Lapiplasty fixation option utilizing hybrid technology, expected to be fully commercialized in the second half of 2026 [4]. - The Lapiplasty Lightning System is designed for greater accuracy and control in 3D correction, with full commercialization anticipated in late 2026 [4]. - Nanoplasty and Percuplasty are minimally invasive systems designed for efficient access to 3D osteotomies, with unique features to enhance surgical precision and recovery [4]. Clinical Study Presentations - The ALIGN3D clinical study will present interim data showing early return to weight bearing at an average of 8.4 days and low recurrence rates of 8.4% at 48 months [5][6]. - The MTA3D clinical study will present interim analysis demonstrating significant improvements in radiographic measures and patient-reported outcomes through 24 months [12]. - A retrospective study on the SpeedMTP system will show early return to weight bearing at an average of 3.7 days, with full radiographic union achieved in all patients at 6 months [8]. Company Overview - Treace Medical Concepts aims to advance the standard of care for bunion and midfoot deformities, addressing a significant market with approximately 67 million affected Americans, of which 1.1 million are surgical candidates annually [14]. - The company has developed the Lapiplasty 3D Bunion Correction System, which corrects bunion deformities in all three planes and secures the unstable joint, facilitating patient recovery [14].

Core Viewpoint - Treace Medical Concepts, Inc. is set to release its financial results for Q4 and the full year of 2025 on February 27, 2026, with a conference call scheduled for 8:00 am ET to discuss these results [1]. Company Overview - Treace Medical Concepts is a medical technology company focused on improving surgical treatments for bunions and related midfoot deformities, which affect approximately 67 million Americans, with an estimated 1.1 million being surgical candidates annually [4]. - The company has developed the patented Lapiplasty 3D Bunion Correction System, which aims to correct bunion deformities in three dimensions and stabilize the affected joint, addressing the root cause of the condition [4]. - Treace also offers additional systems such as the Adductoplasty Midfoot Correction System and minimally invasive options like the Nanoplasty 3D and Percuplasty™ systems, along with the SpeedMTP System [4]. - The company is expanding its market presence by extending its SpeedPlate rapid compression implant platform and providing advanced digital solutions for pre-operative planning [4].

Company Overview - Treace Medical Concepts, Inc. (NASDAQ:TMCI) is a medical technology company founded in 2014 and headquartered in Ponte Vedra, Florida, focused on advancing surgical treatment standards for bunion and related midfoot deformities [4] Financial Performance - In the third quarter of 2025, Treace reported revenue of $50.2 million, reflecting an 11% year-over-year growth [3] - The company is in a transition phase compared to larger peers, but continues to show steady growth [3][4] Strategic Focus - Management is concentrating on expanding the product portfolio, enhancing surgeon education and training, and strengthening the sales organization to drive market share gains and improve profitability as procedure volumes normalize [3] - Despite cautious near-term investor sentiment, the company's strategic investments position it to benefit from an improving MedTech demand backdrop as 2026 approaches [4] Market Sentiment - Stifel recently lowered its price target for Treace Medical from $5 to $3 while maintaining a Hold rating, indicating a broader recalibration in the MedTech sector due to pressures anticipated in 2025 [1] - The firm remains optimistic about the sector's outlook heading into 2026, particularly for large-cap MedTech, despite Treace's transitional status [1]

Company Overview - Treace Medical is a medical device company focused on improving surgical outcomes for bunion patients [3] - The company pioneered the Lapiplasty 3D bunion correction procedure in 2015, establishing itself as a leader in the bunion market [4] Financial Performance - Since its IPO in 2021, Treace Medical has executed strategic plans leading to strong market share gains and positive adjusted EBITDA progress [3] - The company has become the largest dollar share player in the U.S. bunion market [4] Market Position - Treace Medical's innovative 3D bunion solutions are supported by strong intellectual property and marketed through the industry's only bunion-focused direct sales channel [4]