Core Viewpoint - DexCom reported strong quarterly earnings and revenue, exceeding analyst expectations, and reaffirmed its revenue outlook for fiscal 2026 [2]. Financial Performance - Quarterly earnings were reported at 68 cents per share, surpassing the Street estimate of 65 cents [2]. - Quarterly revenue reached $1.26 billion, slightly above the analyst estimate of $1.25 billion [2]. - U.S. revenue increased by 11% year-over-year, while international revenue grew by 18% on a reported basis [2]. Future Outlook - The company affirmed its fiscal 2026 revenue outlook, projecting a range of $5.16 billion to $5.25 billion [2]. Stock Performance - DexCom stock rose by 0.57% to $65.46 in extended trading [3].

Financial Data and Key Metrics Changes - The company reported fourth quarter revenue of $17.6 million and full-year revenue of approximately $71.6 million, representing about 11% growth over 2024 [5][11] - Full-year gross margin was 82.1%, down from 85.8% in 2024, due to inventory reserves and product mix changes [12] - Fourth quarter gross margin was 81.2%, compared to 87.6% for the same period last year [13] Business Line Data and Key Metrics Changes - The focus for 2025 was on resolving reimbursement uncertainty for the RECELL product, with six of the seven Medicare Administrative Contractors publishing payment rates for RECELL procedures [6] - Approximately 90% of revenue comes from about 200 burn and trauma centers, with a shift towards organic monthly usage patterns rather than bulk ordering [6][7] Market Data and Key Metrics Changes - The company is taking a disciplined distributor-led approach to expand its footprint in select international markets, focusing on establishing familiarity and operational readiness [9] - Initial clinical use of RECELL GO in European markets has begun, with a focus on responding to urgent needs in the burn community [9] Company Strategy and Development Direction - The strategy is centered around a single integrated platform consisting of RECELL, Cohealyx, and PermeaDerm, aimed at increasing adoption and utilization among clinicians [7] - The company expects full-year revenue for 2026 to be between $80 million and $85 million, reflecting growth of approximately 12% to 19% over 2025 [10] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of establishing a disciplined operating model and improving visibility into cash use, which are expected to support consistent execution in 2026 [4][10] - The company aims to maintain disciplined control of operating costs while supporting revenue growth with a stable and scalable cost structure [17] Other Important Information - The company refinanced its debt through a new credit facility, which is designed to reduce covenant risk and support execution rather than constrain it [16] - The fourth quarter marked the third consecutive quarter of improvement in net cash use, declining from $10.1 million in Q2 to $5.1 million in Q4 [15] Q&A Session Summary Question: Guidance on revenue covenants and growth pace - Management clarified that the $15.4 million revenue covenant is not a guidance figure and indicated that they expect growth to be progressive from Q4 to Q1 and throughout the year [20][25] Question: Reimbursement dynamics affecting 2025 - Management confirmed that they are engaged with all seven MACs and are optimistic about the seventh MAC publishing payment rates soon, with no concerns about disruptions [30][31] Question: Customer experience with Cohealyx and PermeaDerm - Management discussed the process of working with champions in accounts to facilitate the adoption of Cohealyx and PermeaDerm, noting early positive experiences [37][38] Question: Drivers of growth for 2026 guidance - Management indicated that growth will be driven by increased utilization within existing accounts and contributions from all three product lines, including RECELL, Cohealyx, and PermeaDerm [49]

Financial Data and Key Metrics Changes - For the full year of 2025, total adjusted constant currency revenue growth was 13% and adjusted EBITDA growth was 26% year-over-year, resulting in positive free cash flow while investing significantly in future growth [5][15] - Total adjusted revenues for Q4 of 2025 were $118.3 million, up 18.5% compared to Q4 of 2024, with adjusted EBITDA increasing approximately 29% from $17.6 million to $22.7 million [15][16] - Adjusted EBITDA margin was 19.2% in Q4 of 2025, an improvement of approximately 110 basis points over the prior year [16] Business Line Data and Key Metrics Changes - Stent graft revenues grew 36% on a constant currency basis in Q4 compared to the same period last year, driven by AMDS in the U.S. and strong international growth [6][19] - On-X revenues increased 24% year-over-year on a constant currency basis, supported by global market share gains and new U.S. market opportunities [7][8] - Tissue processing revenue increased 6% year-over-year on a constant currency basis, while BioGlue revenues were flat compared to the same period last year [8][19] Market Data and Key Metrics Changes - Revenues in Asia Pacific increased 32%, North America increased 18%, EMEA increased 17%, and Latin America increased 9% compared to Q4 of 2024 [20] - Q4 gross margins were 63% in both 2025 and 2024, with the 2024 gross margin negatively impacted by an idle plant charge due to a cybersecurity incident [20] Company Strategy and Development Direction - The company plans to replicate its proven strategy by introducing additional stent graft products already generating revenue in Europe to the U.S. and Japan, aiming to expand the total addressable market [7] - Future growth is expected to be driven by AMDS commercialization in the U.S., On-X heart valve data, NEXUS PMA, and the ARTISAN IDE trial [32][33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in delivering sustainable double-digit revenue growth and driving EBITDA margin expansion, with expectations for constant currency growth between 10%-14% for 2026 [23][26] - The company anticipates challenges in the second and third quarters of 2026 due to tougher comparisons and recovery of the tissue backlog [25] Other Important Information - The company recorded a $2.3 million adjustment to revenue for estimated payback obligations due to Italian government legislation, which has been excluded from adjusted revenue [17][18] - Free cash flow for the full year was approximately $1 million, despite significant investments in the business [22] Q&A Session Summary Question: Impact of Italian clawback on growth - The Italian clawback was specific to the EMEA line and did not impact major product lines, thus not skewing growth rates [36][38] Question: Commentary on AMDS sell-in versus sell-through - Management does not typically break out details on AMDS revenue but noted that implantations are continuing to grow positively [40][41] Question: Progress on AMDS target accounts - The company is in the early stages of AMDS rollout, with significant opportunities to open new accounts and increase implants in existing accounts in 2026 [44][45] Question: Market opportunity for NEXUS - The NEXUS device is positioned in a nascent market with a $150 million U.S. opportunity, and the company believes it is well-positioned against competitors [46][48] Question: Pricing for AMDS and NEXUS - The company sees strong demand for AMDS and NEXUS at their current price points, supported by favorable reimbursement dynamics [54] Question: CapEx plans for 2026 - CapEx is expected to be approximately $50 million in 2026, primarily for capacity expansion and IT system improvements [71][72]

Financial Data and Key Metrics Changes - For Q4 2025, the company reported worldwide revenue of $1.26 billion, a 13% increase from $1.11 billion in Q4 2024, with organic growth at 12% [17] - U.S. revenue reached $892 million in Q4 2025, up 11% from $803 million in Q4 2024 [17] - International revenue grew 18% to $368 million in Q4 2025, with organic growth at 15% [18] - Gross profit for Q4 was $799.8 million, representing 63.5% of revenue, an increase from 59.4% in Q4 2024 [19] - Operating income was $331.5 million, or 26.3% of revenue, compared to $209.5 million, or 18.8% of revenue, in Q4 2024 [20] - Adjusted EBITDA for Q4 was $422.2 million, or 33.5% of revenue, up from $300.1 million, or 27.0% of revenue, in Q4 2024 [20] - The company closed the quarter with approximately $2 billion in cash and cash equivalents, indicating strong financial flexibility [21] Business Line Data and Key Metrics Changes - The rollout of the Dexcom G7 15-day system has received positive feedback, enhancing customer experience and potentially increasing market share [8][9] - The company is focusing on improving customer experience through new digital support systems and AI integration [9][10] - The early access launch of Dexcom Smart Basal aims to improve outcomes for Type 2 diabetes management [10] Market Data and Key Metrics Changes - International markets, particularly Germany, the UK, and France, showed strong growth, with France being one of the fastest-growing markets due to Type 2 access expansion [18] - The company plans to expand its CGM product portfolio in international markets in 2026, targeting new segments [14] Company Strategy and Development Direction - The company aims to be the premier glucose sensing solution, focusing on sensor accuracy, reliability, and connectivity [7][8] - Strategic priorities include enhancing customer experience, expanding international market share, and driving growth through product innovation [12][14] - The company is preparing for an Investor Day in May 2026 to provide further outlook details [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential in metabolic health and the impact of CGM technology on patient outcomes [28] - The company anticipates total revenue for 2026 to be between $5.16 billion and $5.25 billion, reflecting growth of 11%-13% [22] - Management highlighted the importance of maintaining strong category growth and expanding CGM access globally [23] Other Important Information - The company has successfully managed supply chain challenges, leading to improved gross margins and reduced sensor deployment issues [15] - The launch of the new patch technology is expected to enhance customer experience across the product portfolio [11] Q&A Session Summary Question: Discussion on glucose journey and market potential - Management believes the company is in the early stages of addressing metabolic health and sees significant growth opportunities, especially with potential Medicare coverage for Type 2 non-insulin users [26][28] Question: CMS proposal for Type 2 non-insulin coverage - Management is optimistic about upcoming CMS coverage decisions and expects to see positive outcomes from ongoing clinical trials [32][35] Question: Impact of the 15-day product on margins and market expansion - The 15-day product is expected to contribute to margins over time, with significant opportunities for international market expansion [38][41] Question: Operating expenses and investment in manufacturing - The increase in operating expenses is primarily due to investments in the new Ireland manufacturing facility, which will enhance production capabilities [46][48] Question: Utilization rates among different user segments - Utilization rates remain stable across various user segments, with high engagement expected to drive further growth [52][54] Question: Revenue outlook and new patient dynamics - Management provided insights into the factors influencing revenue growth, emphasizing the importance of patient retention and utilization [60][62] Question: Strengthening U.S. sensor uptake trends - Improved sensor deployment and the launch of new products have positively impacted sell-through trends, contributing to stable user retention [68][70] Question: Pricing dynamics with potential Medicare unlock - Management discussed the stable pricing environment and the impact of competitive bidding processes on future pricing strategies [75][78] Question: International growth strategy and competition - The company aims to close the revenue gap with competitors by expanding its product portfolio and increasing market penetration in international markets [82][84]

CVRx (NasdaqGS:CVRX) Q4 2025 Earnings call February 12, 2026 04:30 PM ET Company ParticipantsJared Oasheim - CFOKevin Hykes - President and CEOMike Vallie - Healthcare Investor Relations Managing DirectorConference Call ParticipantsChase Knickerbocker - Senior Equity Research AnalystFrank Takkinen - Senior Research AnalystJohn Young - Research AnalystLily Lozada - Research AnalystMax Smock - Equity Research AnalystNone - AnalystOperatorWelcome to the CVRx Q4 2025 Earnings Call. At this time, all participant ...

Financial Data and Key Metrics Changes - For Q4 2025, the company reported worldwide revenue of $1.26 billion, a 13% increase from $1.11 billion in Q4 2024, with organic growth at 12% [17] - U.S. revenue reached $892 million in Q4 2025, up 11% from $803 million in Q4 2024 [17] - International revenue grew 18% to $368 million in Q4 2025, with organic growth at 15% [18] - Gross profit for Q4 was $799.8 million, representing 63.5% of revenue, an increase from 59.4% in Q4 2024 [19] - Operating income was $331.5 million, or 26.3% of revenue, compared to $209.5 million, or 18.8% of revenue in Q4 2024 [20] - Adjusted EBITDA for Q4 was $422.2 million, or 33.5% of revenue, up from $300.1 million, or 27.0% of revenue in Q4 2024 [20] - The company closed the quarter with approximately $2 billion in cash and cash equivalents, indicating strong financial flexibility [21] Business Line Data and Key Metrics Changes - The rollout of the Dexcom G7 15-Day system has received positive feedback, enhancing customer experience and potentially increasing market share [8][9] - The company is focusing on expanding its product portfolio, including the introduction of Stelo and a new CGM system in international markets by 2026 [14] Market Data and Key Metrics Changes - The international business showed particular strength in Germany, the United Kingdom, and France, with France being one of the fastest-growing markets due to Type 2 access expansion [18] - The company anticipates that international market opportunities could surpass the U.S. market in the future [14] Company Strategy and Development Direction - The company aims to be the premier glucose sensing solution, focusing on improving sensor accuracy, reliability, and connectivity [8] - A strategic priority is to enhance customer experience across all stakeholders, including prescribers and caregivers, through new digital support systems and AI integration [9] - The company plans to expand its international market share by increasing awareness and access to CGM technology globally [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential in metabolic health management, particularly with upcoming Medicare coverage for Type 2 non-insulin users, which could provide access to approximately 12 million people [28] - The company expects total revenue for 2026 to be in the range of $5.16 billion to $5.25 billion, reflecting growth of 11%-13% [22] - Management highlighted the importance of maintaining gross margin improvements and operational efficiencies while investing in new product launches and manufacturing capabilities [23] Other Important Information - The company has surpassed $1 billion in free cash flow for the first time in 2025, indicating strong cash generation capabilities [22] - An Investor Day is planned for May 2026 to provide further details on the company's outlook [16] Q&A Session Summary Question: Discussion on the glucose journey and potential coverage - Management believes the company is in the early stages of addressing metabolic health issues, with significant growth opportunities as coverage expands for Type 2 non-insulin users [26][28] Question: CMS proposal for Type 2 non-insulin coverage - Management is optimistic about upcoming CMS coverage decisions and expects to see results from a randomized control trial in mid-2026 [32][35] Question: Impact of the 15-Day product on margins and new markets - The 15-Day product is expected to contribute to margins over time, with significant opportunities for international expansion [38][41] Question: Operating expenses and investment in manufacturing - The increase in operating expenses is primarily due to investments in the new Ireland manufacturing facility, which will enhance future production capabilities [46][49] Question: Utilization rates among different user segments - Utilization rates remain stable across various user segments, with high rates observed in Type 1 and Type 2 insulin users [52][54] Question: 2026 revenue outlook and new patient dynamics - Revenue growth will depend on patient retention, utilization, and pricing, with expectations for continued strong performance in new patient additions [60][62] Question: International growth strategy and competition - The company aims to close the revenue gap with competitors by expanding coverage and product offerings in international markets [82][84]

Financial Data and Key Metrics Changes - The company reported fourth quarter revenue of $17.6 million and full-year revenue of approximately $71.6 million, representing about 11% growth over 2024 [5][11] - Full year gross margin was 82.1%, down from 85.8% in 2024, reflecting inventory reserves and product mix changes [12] - Fourth quarter gross margin was 81.2%, compared to 87.6% for the same period last year [13] Business Line Data and Key Metrics Changes - Approximately 90% of revenue comes from about 200 burn and trauma centers, with a focus on increasing adoption and utilization of products like RECELL, Cohealyx, and PermeaDerm [6][7] - The Cohealyx I post-market study is fully enrolled, and the PermeaDerm I study is nearing full enrollment, with data expected later in 2026 [8] Market Data and Key Metrics Changes - Six of the seven Medicare administrative contractors have published payment rates for RECELL procedures, which is expected to restore confidence among clinicians [6] - The company is taking a disciplined distributor-led approach in select international markets, focusing on establishing operational readiness [9] Company Strategy and Development Direction - The company aims to drive disciplined execution, refine commercial focus, and position for growth in 2026, with a strategy centered around an integrated platform of products [4][10] - The company expects full year revenue of $80 million to $85 million in 2026, representing growth of approximately 12% to 19% over 2025 [10] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of predictable reimbursement for products and the need for increased adoption and utilization by clinicians [6][18] - The company is focused on maintaining disciplined control of operating costs and supporting revenue growth with a stable cost structure [17] Other Important Information - The company refinanced its debt through a new credit facility, which provides more flexibility and reduces covenant risk [15][16] - The fourth quarter marked the third consecutive quarter of improvement in net cash use, declining from $10.1 million in Q2 to $5.1 million in Q4 [15] Q&A Session Summary Question: Guidance on revenue covenants and growth pace - Management clarified that the $15.4 million covenant is not a guidance figure and that they expect growth to continue from Q4 into Q1 and throughout the year [20][21] Question: Reimbursement dynamics affecting 2025 - Management confirmed engagement with all seven MACs and expressed optimism about the seventh MAC publishing payment rates soon [30][31] Question: Customer experience with Cohealyx and PermeaDerm - Management discussed the process of working with champions in accounts to facilitate the adoption of Cohealyx and PermeaDerm, noting early positive experiences [37][38] Question: Drivers of growth for 2026 guidance - Management indicated that growth will come from increased utilization within existing accounts and contributions from Cohealyx and PermeaDerm [49]

Financial Data and Key Metrics Changes - Revenues for Q4 2025 were $4.9 million, a significant decrease from $31 million in Q4 2024, primarily due to lower unit sales [13] - Gross profit for Q4 2025 was $1.9 million, or 38.8% of revenues, down from $7.1 million, or 54.2% in Q4 2024, driven by lower sales and higher servicing costs [14] - For the full year 2025, revenues were $27.5 million, compared to $41.8 million in 2024, reflecting a decrease in unit sales [15] - The net loss for 2025 was $7.7 million, or a loss of $0.47 per share, compared to a net income of $6.6 million, or $0.41 per diluted share in 2024 [18] Business Line Data and Key Metrics Changes - The company shipped 14 units in Q4 2025, with 8 in the U.S. and 6 internationally, but did not include sales to its largest customer [24] - The Fair Deal Agreement program saw substantial year-over-year utilization increases, with treatments up more than eightfold and the number of patients treated increasing by over 250% in 2025 [7] Market Data and Key Metrics Changes - International sales were strong in Q4 2025, with shipments to China and a growing demand in Asia, particularly in Taiwan and South Korea [8][28] - The company expects international markets to remain a significant part of its growth strategy, with Brazil and the Middle East also showing potential [29] Company Strategy and Development Direction - The introduction of new CPT codes for SRT and IG-SRT technologies is expected to enhance physician reimbursement and support broader adoption of non-invasive treatments [4] - The company aims to achieve full-year profitability in 2026, supported by a diversified customer base and expanding international opportunities [9] - A disciplined approach to scaling the sales organization is being implemented, with plans to hire additional sales representatives to enhance market education and lead conversions [11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about entering 2026 with improved clarity and control over the business, emphasizing the positive impact of new reimbursement codes [20] - The company is focused on converting interest into system placements as the year progresses, with expectations for Q1 revenues to exceed Q4 levels [19] Other Important Information - The company ended 2025 with $22.1 million in cash and cash equivalents, with no outstanding debt, indicating a strong balance sheet [18] - Research and development expenses for 2025 increased to $7.8 million, reflecting higher costs related to billing and reimbursement efforts [17] Q&A Session Summary Question: Does the revenue growth guidance for Q1 assume no contribution from the largest customer? - Management confirmed that projections for 2026 exclude expectations from the largest customer, and any contribution from them would be considered upside [24] Question: What is the status of the TDI program and expected FDA approval? - Management indicated ongoing efforts with the FDA but could not provide a timeline for approval [26] Question: What is the demand outlook internationally for 2026? - Management highlighted strong demand in China and growth in Taiwan, with expectations for expansion in South Korea, Japan, and potential entry into Brazil and the Middle East [28][29] Question: How has the reaction to reimbursement affected system mix and financing options? - Management noted a shift towards outright purchases and leasing options due to guaranteed reimbursements, with a stronger focus on SRT products [38][40] Question: What is the outlook for service revenue? - Service revenue remains consistent at about 10% of total revenue, with no expected changes [48]

Financial Data and Key Metrics Changes - The company reported fourth quarter revenue of $17.6 million and full-year revenue of approximately $71.6 million, representing about 11% growth over 2024 [5][12] - Full year gross margin was 82.1%, down from 85.8% in 2024, reflecting inventory reserves and product mix changes [12] - Fourth quarter gross margin was 81.2%, compared to 87.6% for the same period last year [13] - Total operating expenses in the fourth quarter were $24.7 million, down 5% year-over-year, primarily due to lower sales and marketing expenses [14] Business Line Data and Key Metrics Changes - The company focused on increasing adoption and utilization of its products, with approximately 90% of revenue coming from about 200 burn and trauma centers [6][8] - The Cohealyx I post-market study is fully enrolled, and the PermeaDerm I study is nearing full enrollment, with data expected later in 2026 [9] Market Data and Key Metrics Changes - Six of the seven Medicare administrative contractors have published payment rates for RECELL procedures, which has begun to restore confidence for clinicians [6] - The company is taking a disciplined distributor-led approach to build its footprint in select international markets [10] Company Strategy and Development Direction - The company aims to drive disciplined execution, refine commercial focus, and position itself for growth in 2026 [4] - The strategy is built around a single integrated platform of RECELL, Cohealyx, and PermeaDerm, used repeatedly by the same clinicians [8] - The company expects full year revenue of $80 million-$85 million in 2026, representing growth of approximately 12%-19% over 2025 [11] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of predictable reimbursement for products and clinicians to drive routine use of RECELL [6] - The company is focused on establishing the right operating cadence and executing fundamentals well to ensure consistent progress [8] - Management expressed confidence in the normalization of RECELL utilization and the expansion of portfolio use within core accounts [11] Other Important Information - The company refinanced its debt through a new credit facility, which provides more flexibility and reduces covenant risk [15][16] - The fourth quarter marked the third consecutive quarter of improvement in net cash use, declining to $5.1 million [15] Q&A Session Summary Question: Guidance on revenue growth pace - Management clarified that the $15.4 million revenue covenant is not a guidance figure and that they expect progressive growth from Q4 to Q1 and throughout the year [22][26] Question: Reimbursement dynamics affecting 2025 - Management confirmed that they are engaged with all seven MACs and are hopeful for the seventh MAC to publish payment rates soon [30][31] Question: Customer experience with Cohealyx and PermeaDerm - Management indicated that champions in accounts are helping to push Cohealyx and PermeaDerm through the VAC process, with early signs of uptake [37][38] Question: Drivers of growth for 2026 guidance - Management expects growth from all three product lines, primarily driven by increased utilization within existing accounts [48]

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].