Caitlin Roberts

Caitlin Roberts from Canaccord Genuity asked about the expected seasonality of revenue guidance for 2026, particularly with the ramp-up in the U.S. market. She also inquired about the number of high-volume accounts in the U.S. and the average penetration within existing accounts.

Answer

Raj Denhoy, CFO at Establishment Labs, projected sequential revenue growth in Q1 (modest), followed by continued step-ups and a strong U.S. finish, aligning with normal seasonality. He noted that internationally, patterns are more normalized. Regarding accounts, Mr. Denhoy stated that while initial sign-ups included many high-volume accounts, penetration remains low in many markets due to timing. He emphasized that 2026 will focus on expanding the number of accounts and deepening penetration within existing ones. Peter Caldini, Board of Directors, added that early adopters show Motiva as a majority of their volume, and enhancing penetration is a key focus for the next phase of growth.

Caitlin Roberts asked for more color on the expected cadence of revenues throughout 2026. She also inquired about AxoGen's efforts to expand its breast reconstruction technique to address a broader part of the market, given current nerve size and technique limitations.

Answer

CEO Michael Dale stated that the revenue cadence for 2026 should be similar to the past two years, with Q1 typically being the most modest quarter and Q2/Q3 showing stronger performance due to seasonal dynamics like increased trauma. He confirmed that AxoGen is actively engaged in R&D and regulatory work to explore other permutations for breast reconstruction, including greater nerve length and different morphology representations, to make the technique easier and address a wider market, with potential new offerings within 24 months.

Caitlin Roberts asked for more color on the expected cadence of revenues throughout 2026. She also inquired about AxoGen's efforts to expand breast reconstruction techniques to address a broader market, given current nerve size and technique limitations.

Answer

Michael Dale (CEO) indicated that the revenue cadence for 2026 should be similar to the past two years, with Q1 typically being the most modest quarter and Q2 and Q3 showing stronger performance due to seasonal dynamics like increased trauma in summer. He confirmed that AxoGen is actively working on expanding breast reconstruction techniques through ongoing R&D and regulatory efforts, exploring permutations like greater nerve length and different morphology representations, with potential market availability within 24 months if successful, though nothing is expected this year.

Caitlin Roberts asked about the strategy behind the direct commercial expansion, specifically how new territories are added with a focus on growing the outpatient business. She also inquired about the business contribution from the legacy triangular iFuse implant following a patent extension.

Answer

CEO Laura Francis explained that new territories are added by identifying target opportunities across the U.S. (spine or interventional), with approximately 50% of new territory managers promoted internally and 50% hired externally. She highlighted the significant leverage gained from the hybrid sales model, which includes over 300 third-party agents. CFO and COO Anshul Maheshwari stated that the legacy classic iFuse implant now accounts for less than 0.1% of the business, with the majority of SI joint business coming from iFuse TORQ, iFuse-3D, and iFuse INTRA.

Caitlin Roberts asked about the strategic approach to SI-BONE's direct commercial expansion, specifically how new territories are added with a focus on growing the outpatient business and ASCs. She also inquired about the proportion of the business that still relies on the legacy triangular iFuse implant, given a recent patent extension.

Answer

CEO Laura Francis explained that new territories are strategically added by identifying significant opportunities across the U.S. for spine and interventional, with approximately 50% of new territory managers being internal promotions and 50% external hires. She noted that the hybrid sales model, with over 300 third-party agents, provides significant leverage, and adding 10 new territories in 2026 strikes the right balance. CFO Anshul Maheshwari clarified that the legacy classic iFuse implant accounts for less than 0.1% of the business, with the majority of SI joint business coming from iFuse TORQ, iFuse-3D, and iFuse INTRA, and INTRA Ti expected to be a significant contributor.

Caitlin Roberts asked about the specific encouraging trends observed in Europe and whether international revenue is expected to constitute a higher mix in 2026. She also inquired about the projected R&D and sales and marketing spend for 2026 compared to 2025.

Answer

Moshe Mizrahy, InMode CEO, mentioned adding international subsidiaries and bases but also emphasized efforts to streamline North American operations, aiming for growth in both regions without predicting a higher international mix. He stated that R&D spending would increase due to two significant clinical studies for women's health (each costing $2M-$4M over several years). Sales and marketing spend will be similar to 2025 but more focused, driven by market softness and new product launches.

Caitlin Roberts asked what specific factors were driving encouraging trends in Europe and if InMode expects international revenue to constitute a higher mix in 2026. She also inquired about the anticipated levels of R&D and sales & marketing spend for 2026 compared to 2025.

Answer

Moshe Mizrahy, CEO, mentioned that adding subsidiaries and bases in Europe would boost direct sales, but also highlighted efforts to streamline North American operations to drive growth there. He could not predict if international revenue would surpass North America. Mr. Mizrahy stated that R&D spending would increase due to two significant clinical studies for women's health (each costing $2M-$4M over several years). Sales and marketing spend would also increase due to market softness and new product launches, but with a more focused approach.

Caitlin Roberts asked for an update on the percentage of hips, knees, and shoulders flowing through the ASC (Ambulatory Surgical Center) channel for Stryker. She also inquired about the launch status and details of Triathlon Gold.

Answer

VP of Finance and Head of Investor Relations Jason Beach stated that hips and knees in the ASC channel are in the "high teens" and have been consistently ticking up. Chair and CEO Kevin Lobo confirmed that Triathlon Gold is in a limited launch with extremely positive feedback, noting its ability to be used both cemented and cementless, and will be showcased at AOS.

Caitlin Roberts asked for an update on the percentage of hips, knees, and shoulders procedures flowing through the Ambulatory Surgical Center (ASC) channel for Stryker. She also requested more details on the Triathlon Gold product, specifically if it has already launched.

Answer

Jason Beach, VP of Finance and Head of Investor Relations, Stryker, stated that hips and knees procedures in ASCs are in the 'high teens' and that ASC performance is strong. Kevin Lobo, Chair and CEO, Stryker, confirmed that Triathlon Gold is in limited launch with extremely positive feedback, noting its ability to be used both cemented and cementless, and that it will be displayed at AAOS.