Core Insights - Treace Medical Concepts, Inc. is enhancing its market position with new bunion technologies showcased at the 2025 ACFAS Annual Scientific Conference [1][2] - The company aims to improve surgical outcomes for bunion patients through innovative technologies and clinical evidence [2] Company Overview - Treace Medical Concepts focuses on advancing surgical management for bunions and related midfoot deformities, affecting approximately 67 million Americans, with an estimated 1.1 million surgical candidates annually [4] - The company has developed the patented Lapiplasty® 3D Bunion Correction® System, addressing the root cause of bunions through a comprehensive surgical approach [4] New Innovations - The company introduced next-generation technologies including Micro-Lapiplasty™ and Mini-Adductoplasty™, supported by the new SpeedPlate™ MicroQuad™ implant for stable fixation [5] - New minimally invasive osteotomy systems, Nanoplasty™ and Percuplasty™, are designed to enhance surgeon access and reproducibility in procedures [5] - The SpeedMTP™ implant offers a unique fusion option for patients with arthritic great toe joints, combining advanced fixation technology for early weight bearing [5] Personalized Solutions - The IntelliGuide™ PSI platform provides personalized surgical solutions with patient-specific 3D-printed cut guides and anatomic foot models based on CT scans, leading to a new era in bunion and midfoot deformity corrections [5]

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][28] - 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 Q4 2024 was 80.7%, down from 81.6% in Q4 2023; 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 Q4 2023 [30] - Adjusted EBITDA for Q4 was $11.1 million, an improvement of 322% compared to Q4 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 significant audience for its technologies [10] - The U.S. sees approximately 450,000 bunion cases performed annually, indicating a substantial market opportunity [10] Company Strategy and Development Direction - The company focuses on expanding its portfolio of innovative bunion solutions, including less invasive procedures to attract a larger patient base [11][12] - The introduction of new technologies such as Mini-Adductoplasty and 3D MIS osteotomy systems aims to broaden the appeal to surgeons and patients [13][15] - The company is targeting all four classes of bunions with specialized solutions to maximize market share [20][26] 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 2025 and a 50% decrease in cash burn compared to 2024 [32] Other Important Information - CMS has significantly increased material reimbursement for procedures associated with Lapiplasty, which is expected to positively impact the company [23] - The company has a strong balance sheet with cash, cash equivalents, and marketable securities totaling approximately $102 million as of December 31, 2024 [31] Q&A Session Summary Question: Thoughts on revenue pacing through 2025 - Management acknowledged Q1 as a tough comp but expects higher growth rates in subsequent quarters [38] Question: Impact of new products on ASPs and unit volumes - Management believes there will be more of a procedure volume play rather than a significant shift in blended ASP [44] Question: Profitability and leverage components - Management indicated 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 refrained from commenting extensively, focusing on their own growth strategies [66] Question: Clinical outcomes of new osteotomy solutions - Management emphasized the importance of three-plane correction in their osteotomy approach for better long-term outcomes [72] Question: Utilization of new osteotomy offerings - Initial users of the new osteotomy systems are high utilizers of minimally invasive techniques, with plans to expand the customer base [99] Question: Update on SpeedPlate attach rates - SpeedPlate's attach rate has increased to over 50% of the overall fixation mix [108]

Company Performance - Treace Medical Concepts reported a quarterly loss of $0.01 per share, better than the Zacks Consensus Estimate of a loss of $0.03, and an improvement from a loss of $0.10 per share a year ago, representing an earnings surprise of 66.67% [1] - The company posted revenues of $68.71 million for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 0.16% and showing an increase from $62.21 million in the same quarter last year [2] - Over the last four quarters, Treace Medical Concepts has exceeded consensus EPS estimates two times and topped consensus revenue estimates four times [2] Stock Movement and Outlook - Treace Medical Concepts shares have increased approximately 30.4% since the beginning of the year, significantly outperforming the S&P 500's gain of 1.3% [3] - The company's earnings outlook will be crucial for future stock performance, with current consensus EPS estimates at -$0.25 for the coming quarter and -$0.77 for the current fiscal year [4][7] - The estimate revisions trend for Treace Medical Concepts is currently mixed, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market in the near future [6] Industry Context - The Medical - Instruments industry, to which Treace Medical Concepts belongs, is currently ranked in the top 33% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Performance - The company incurred net losses of $55.7 million and $49.5 million for the years 2024 and 2023, respectively, with an accumulated deficit of $190.0 million as of December 31, 2024[152]. - Future revenue growth is uncertain and may be constrained by competition, market acceptance, and operational challenges[153]. - The company has significant debt obligations, with $54.0 million outstanding under loan agreements, which could restrict operational flexibility[152]. - The company has experienced seasonal fluctuations in revenue, with higher sales volumes in Q4 and lower volumes in Q1 due to factors like patient insurance deductibles and adverse weather[168]. - The company may face significant costs and risks associated with future international expansion, which could adversely affect its financial condition[200]. Market Dependency and Competition - The company is highly dependent on the Lapiplasty System for revenue generation, which poses a risk if market acceptance does not grow[152]. - Sales of the Lapiplasty System accounted for substantially all of the company's revenues in prior years, indicating a high dependency on this product for financial success[169]. - The competitive landscape includes major players like Stryker Corporation and emerging companies, which intensifies the need for effective marketing and product differentiation[160]. - The company faces significant competition from larger firms with greater sales and financial resources, which may impact its market share and profitability[161]. - Approximately 70% of bunion surgeries in the U.S. continue to use metatarsal osteotomies, highlighting the competitive landscape and the need for the company to innovate[165]. Growth Strategy and Operational Challenges - The company plans to continue investing in research and development, product offerings, and marketing initiatives to drive future growth[158]. - The company must effectively manage its rapid growth to avoid operational strains and ensure continued success[156]. - The company may seek growth through acquisitions or strategic alliances, but failure to manage these effectively could adversely affect operations[151]. - The company is investing significantly in recruiting and training sales representatives to enhance its direct sales force, which is crucial for revenue generation[164]. - The company anticipates launching new products in the second half of 2025, which will be essential for diversifying its revenue streams beyond the Lapiplasty System[169]. Regulatory and Compliance Risks - The company faces risks related to the approval and reimbursement of its products by healthcare facilities and third-party payors, which could impact sales[151]. - Approval from hospitals and healthcare facilities is critical for product usage; delays in obtaining these approvals could negatively impact sales and operating costs[181]. - The company must comply with the Health Insurance Portability and Accountability Act (HIPAA), which includes civil and criminal statutes against schemes to defraud health care benefit programs[231]. - Regulatory compliance costs are increasing, which may impact the company's profitability[232]. - The FDA's 510(k) clearance process typically takes from three to 12 months, while the PMA process can take one to three years or longer, affecting product introduction timelines[236]. Intellectual Property and Legal Risks - The company is involved in litigation against Stryker Corporation for alleged infringement of 9 patents related to its Lapiplasty technologies[212]. - The company has a patent portfolio that includes 68 owned U.S. patents, one licensed U.S. patent, 83 pending U.S. patent applications, 26 granted foreign patents, and 21 pending international PCT patent applications as of December 31, 2024[203]. - The company may face significant product liability exposure due to potential design or manufacturing failures, which could adversely affect its reputation and customer retention[175]. - Current product liability insurance may not be adequate to cover future claims, exposing the company to substantial liabilities[176]. - The company may face claims of misappropriation of intellectual property from former employees, which could lead to costly litigation[227]. Employee and Operational Management - The number of full-time employees increased from 32 in 2017 to 477 in 2024, indicating significant growth and increased operational demands[155]. - The company’s ability to attract and retain skilled employees is critical for its commercial, quality, and research and development programs[197]. - The company faces challenges in training podiatrists and orthopaedic surgeons, which may affect sales growth and profitability if not addressed[194]. - Maintaining relationships with healthcare professionals is essential for research and development; loss of these relationships could hinder product innovation[192]. - The company relies on independent sales agencies for product sales, posing a risk to anticipated revenue growth if relationships cannot be maintained[178]. Market and Economic Conditions - Unfavorable global economic conditions, including inflation and political disruptions, could adversely affect demand for the company's products and its ability to raise capital[290]. - The stock market for medical device companies has experienced significant volatility, influenced by factors such as inflation and supply chain disruptions, which may impact the company's stock price[273]. - If the company's financial performance does not meet public guidance, it may lead to a decline in the stock price, reflecting market expectations[275]. - The company may face potential limitations on product pricing and reimbursement due to government proposals aimed at controlling healthcare costs, which may adversely affect profits and operational results[245]. - Changes in tax laws could adversely affect the company's business and financial performance, impacting both domestic and international operations[302].

Core Insights - Treace Medical Concepts, Inc. reported a 10% increase in revenue for Q4 2024, reaching $68.7 million, compared to $62.2 million in Q4 2023, driven by product mix shift and increased adoption of newer technologies [4][10] - The company achieved a gross profit of $55.5 million in Q4 2024, with a gross margin of 80.7%, slightly down from 81.6% in Q4 2023 [5][10] - For the full year 2024, revenue was $209.4 million, a 12% increase from $187.1 million in 2023, with a gross profit of $168.3 million [8][10] - The net loss for Q4 2024 was reduced to $0.5 million, or $0.01 per share, compared to a net loss of $6.3 million, or $0.10 per share, in Q4 2023 [7][10] - The company expects full-year 2025 revenue to be between $224 million and $230 million, indicating growth of 7% to 10% compared to 2024 [13] Financial Performance - Q4 2024 operating expenses decreased to $55.7 million from $57.5 million in Q4 2023, reflecting improved leverage in Sales & Marketing [6][10] - Adjusted EBITDA for Q4 2024 was $11.1 million, a significant increase of 322% from $2.6 million in Q4 2023 [7][10] - Full-year 2024 net loss was $55.7 million, or $0.90 per share, compared to a net loss of $49.5 million, or $0.81 per share, in 2023 [9][10] Strategic Developments - The company announced its entry into the high-volume osteotomy market with the introduction of Nanoplasty™ and Percuplasty™ Minimally Invasive 3D Bunion Systems [10] - Treace added 280 new active surgeons in 2024, bringing the total to 3,135, a 10% increase year-over-year [10] - The global patent portfolio expanded to 97 granted patents and 88 pending applications, enhancing the company's competitive position [10] Cash Position - As of December 31, 2024, cash, cash equivalents, and marketable securities totaled $75.7 million, with access to an additional $26 million through an existing revolver, bringing the total to approximately $102 million [12]

Financial Results - Treace Medical Concepts, Inc. reported preliminary unaudited financial results for the quarter and year ended December 31, 2024[7]. Upcoming Events - The company plans to present at the J.P. Morgan Healthcare Conference on January 14, 2025, at 9:00 am Pacific Time[9]. - An investor presentation was posted on the company's investor relations website on January 13, 2025[9].

Core Insights - Treace Medical Concepts, Inc. will release its financial results for Q4 and full year 2024 on February 27, 2025, after market close [1] - A conference call will be held at 4:30 pm ET to discuss these results [1] Company Overview - Treace Medical Concepts is focused on advancing surgical treatment for bunions and midfoot deformities through its Lapiplasty® and Adductoplasty® procedures [4] - Approximately 67 million Americans are affected by bunions, with an estimated 1.1 million being surgical candidates annually [4] - The company has developed the Lapiplasty® 3D Bunion Correction® System, which addresses the root cause of bunions by correcting deformities in three planes [4] - Treace has also introduced the Adductoplasty® Midfoot Correction System for midfoot deformities and the SpeedPlate™ Rapid Compression Implants for various foot procedures [4]

Core Insights - Treace Medical Concepts, Inc. has successfully completed the first cases utilizing its SpeedAkin™ Anatomic Compression Implant, enhancing its surgical treatment offerings for bunions and related midfoot deformities [1][2]. Company Overview - Treace Medical Concepts is focused on advancing the standard of care for surgical management of bunions and midfoot deformities, which affect approximately 67 million Americans, with an estimated 1.1 million being annual surgical candidates [6]. - The company has pioneered the Lapiplasty® 3D Bunion Correction® System, which addresses the root cause of bunions by correcting all three planes of the deformity [6]. Product Development - The SpeedAkin™ implant enhances the procedural versatility of the SpeedPlate™ fixation platform, which is designed to set a new standard in bone fusion fixation [2]. - The SpeedAkin™ implant provides dynamic titanium compression to stabilize Akin osteotomies during healing, which are corrective procedures often performed alongside bunion surgeries [2][3]. Surgeon Feedback - Surgeons, such as Amber Shane, have noted that the SpeedAkin™ titanium compression implant offers anatomically contoured fixation and eliminates the risk of nickel allergy associated with nitinol staples, marking a significant advancement for Lapiplasty® and Adductoplasty® procedures [4].

Core Viewpoint - Treace Medical Concepts, Inc. (TMCI) shareholders may have been impacted by potential fraudulent activities, prompting an investigation by Levi & Korsinsky [1] Group 1: Company Overview - Treace Medical Concepts, Inc. is under scrutiny for possible fraud that could affect its shareholders [1] - The investigation is being conducted by the law firm Levi & Korsinsky, which specializes in shareholder rights [1] Group 2: Investigation Details - The investigation aims to determine if TMCI misled investors regarding its business practices and financial performance [1] - Shareholders are encouraged to reach out to the law firm to discuss their rights and potential claims [1]

The Schall Law Firm Invites Shareholders With Losses To Join An Inquiry Into Treace Medical Concepts, Inc. For Securities Law Violations ...