Larry Biegelsen

Larry Biegelsen asked about Stryker's confidence in its 2026 organic growth guidance of 8%-9.5%, noting it's slightly higher than the previous year's start, and whether 10% growth is still considered possible. He also inquired about the rationale behind elevating Spencer Stiles to President and COO, its implications for Stryker, and for Kevin Lobo's role.

Answer

CFO Preston Wells and Chair and CEO Kevin Lobo expressed increased confidence for 2026, citing a strong order book and Mako performance, suggesting 10% growth is certainly possible for a fifth consecutive year. Kevin Lobo explained Spencer Stiles' promotion reflects his readiness and provides a platform for him to lead the global commercial organization, enabling other promotions and allowing Kevin Lobo to focus on operations, IT, AI, and M&A.

Larry Biegelsen asked about Stryker's confidence in its 2026 organic growth guidance of 8%-9.5% compared to the prior year's start, and if 10% growth is still a possibility. He also inquired about the strategic rationale behind Spencer Stiles' promotion to President and COO, its implications for Stryker, and for CEO Kevin Lobo's future focus.

Answer

Kevin Lobo, Chair and CEO, Stryker, expressed increased confidence for 2026, citing a strong order book and Mako's performance, confirming 10% growth is possible depending on macro conditions. Regarding Spencer Stiles' promotion, Mr. Lobo explained it provides a significant leadership platform for Mr. Stiles, enables other internal promotions, and allows Mr. Lobo to dedicate more time to operations, IT, AI, and M&A.

Larry Biegelsen questioned why the full-year guidance implies slower growth after a strong Q1 and asked for clarity on the cadence of gross and operating margins for the rest of the year, considering the impact of tariffs.

Answer

CEO Kevin Lobo stated that while it's possible to exceed the current guidance, it's still early in the year. He noted that Q2 supply chain disruptions in the Medical division are factored in. CFO Preston Wells affirmed the focus remains on achieving 100 basis points of operating margin expansion for the full year, with tariffs creating a headwind to gross margin in the second half that will be balanced by other initiatives.

Larry Biegelsen inquired about the rationale and timing of the spine implant business divestiture, its financial impact, and the assumptions behind the Inari Medical acquisition, specifically regarding return on invested capital (ROIC) and accretion timeline.

Answer

CEO Kevin Lobo explained the spine sale allows Stryker to focus on higher-growth areas while partnering with the new owners on enabling technology. CFO Glenn Boehnlein stated the Inari acquisition fits their model of returning to WACC in 5-7 years, with near-term EPS dilution primarily driven by financing costs.

Larry Biegelsen inquired about the sustainability of top-line growth into 2025, the specific drivers for the 100 basis points of margin expansion, and the factors behind the strong hip growth in Q3.

Answer

VP of Finance and IR Jason Beach deferred detailed 2025 guidance but affirmed commitment to 100 bps of margin expansion. CFO Glenn Boehnlein detailed margin drivers including manufacturing efficiencies, sourcing, SG&A leverage, and pricing. CEO Kevin Lobo attributed strong hip growth to the Insignia hip stem launch, Mako hip momentum, and the successful integration of the SURF acquisition in Europe.

Larry Biegelsen inquired about Intuitive's strategy for expanding its footprint in Ambulatory Surgery Centers (ASCs), the size of this opportunity for focused procedures, key procedures moving to ASCs, and what is needed to unlock this market. He also asked about the outlook for system utilization and average selling prices (ASPs) in 2026, considering the impact of refurbished Xi systems and the shift to ASCs.

Answer

CEO Dave Rosa highlighted that ASC leaders seek repeatable, high-quality clinical outcomes, reliable technology, and efficient operating infrastructure that fits their economic structure. Key procedures include cholecystectomy, hernia repairs, and benign GYN. CFO Jamie Samath noted that ASC procedures are a small but growing proportion of US procedures, with XIR systems well-positioned for this setting. Jamie Samath stated that da Vinci utilization grew 4% in recent quarters, with existing ASC utilization being strong. For 2026 ASPs, he indicated a higher mix of da Vinci 5 and XIR (which will have lower ASPs), along with higher trade-ins, creating offsetting dynamics, and noted that ASPs only apply to purchased systems, about half of placements.

Larry Biegelsen asked for more details on Intuitive's expanding footprint in Ambulatory Surgery Centers (ASCs), the size of the ASC opportunity for focused procedures, key procedures moving to ASCs, and what is needed to unlock this opportunity. He also inquired about expectations for utilization and system Average Selling Prices (ASPs) in 2026, considering the impact of refurbished Xi systems and ASC penetration.

Answer

CEO Dave Rosa highlighted customer needs in ASCs: repeatable high-quality outcomes, reliable technology, and routine operating infrastructure, all within a viable economic structure. He noted common ASC procedures include cholecystectomy, hernia repairs, and benign GYN. CFO Jamie Samath added that ASC procedures are a small but growing proportion, with the da Vinci XIR system and instrument portfolio well-positioned. Jamie Samath stated da Vinci utilization grew 4% in recent quarters but did not predict 2026. He noted current ASC utilization is good. For ASPs, he anticipated a higher mix of da Vinci 5 and XIR systems, along with increased trade-ins, creating offsetting dynamics, and clarified ASPs apply only to purchased systems.

Larry Biegelsen asked for clarification on the tariff impact, specifically if the 1.7% estimate includes potential European reciprocal tariffs. He also questioned the company's ability and timeline for mitigating these costs. His follow-up concerned the da Vinci 5 placement trend in the U.S., asking why it might have declined as a percentage of total placements from the prior quarter.

Answer

Executive Jamie Samath confirmed the 1.7% tariff estimate assumes European retaliatory tariffs will be implemented after the 90-day pause. On mitigation, he stated the company's strategy is to let the environment stabilize before pursuing non-disruptive operational changes, after evaluating their economic returns. Regarding da Vinci 5, Samath corrected the premise, stating he believed the U.S. placement percentage was actually higher in Q1 than Q4 and characterized the overall capital performance as showing normal seasonality with no underlying concerns.

Larry Biegelsen asked about the divergence between strong U.S. system placements and lower utilization growth in late 2024, questioning if it signals future procedure growth or a digestion period. He also requested a breakdown of the drivers for the 2025 gross margin guidance, which was lower than anticipated, and the path back to the company's 70% target.

Answer

CEO Gary Guthart explained that lower utilization growth is partly due to new, lower-volume accounts adopting robotics and the launch of da Vinci 5 creating a 'ripple' in purchasing patterns. CFO Jamie Samath detailed the gross margin drivers, citing increased depreciation from new facilities as the largest factor, followed by a product mix shift to lower-margin systems (dV5, Ion, SP) and unfavorable foreign exchange rates. He reiterated a mid-term goal of returning to 70%+ margins through operational leverage and cost improvements.

Larry Biegelsen asked for an update on the international launch of da Vinci 5, specifically regarding supply for the early Korean approval, the timing for Japan, and the expected review process length in Europe. He also inquired about the status of newer procedure categories like appendectomy, foregut, and hepatobiliary.

Answer

President David Rosa stated that Intuitive has the supply to support demand in Korea and expects the CE Mark in Europe near the end of 2025, but did not provide a specific timeline for Japan. CFO Jamie Samath clarified that foregut and HPB procedures have been growing well in the U.S. for some time, while appendectomy is a smaller, earlier-stage opportunity driven by surgeons expanding their practice into emergent care settings.

Larry Biegelsen from Wells Fargo asked about the MedTech market outlook for 2026 compared to 2025, specifically if an acceleration is expected, and the potential impact of expiring ACA subsidies. He also requested an update on the electrophysiology (EP) business, noting its growth below market.

Answer

CFO Joseph Wolk stated that the loss of ACA subsidies is not expected to materially impact MedTech performance, as clinical capacity, not coverage, is the primary constraint. He anticipates MedTech performance to accelerate in 2026 compared to 2025, driven by a strategic shift to higher innovation, growth, and margin markets. Wolk highlighted strong 2025 performance in cardiovascular (15.2% growth), vision (mid- to high-single-digit, double-digit in surgical vision), and continued improvement in orthopedics. For EP, Wolk noted accelerated growth to 9.5% in Q4, nearing double-digit growth in the U.S., driven by VARIPULSE and commitment to new catheters and CARTO updates, reinforcing J&J's leadership in integrated EP solutions.

Larry Biegelsen inquired about the MedTech market outlook for 2026 compared to 2025, including the impact of expiring ACA subsidies. He asked if Johnson & Johnson expects MedTech's adjusted operational growth to accelerate and sought an outlook for the electrophysiology (EP) business, which is currently growing below market.

Answer

Joseph Wolk (CFO, Johnson & Johnson) stated that ACA subsidy changes are not expected to materially impact MedTech performance, with clinical capacity being the primary constraint. He confirmed expectations for MedTech growth acceleration in 2026, driven by a strategic shift to higher innovation, growth, and margin markets. He detailed the EP business's acceleration, VARIPULSE success, commitment to new catheters, and the competitive advantage of the CARTO system.

Larry Biegelsen asked for clarification on whether the accelerating 5%+ sales growth projected for 2026 is on a reported or adjusted operational basis, how the extra week in 2026 factors in, and if growth would accelerate on an adjusted operational basis excluding the extra week, including for EPS.

Answer

CFO Joe Wolk confirmed that the 5%+ growth outlook for 2026 is on a reported basis, aligning with consensus models. He noted a slight foreign exchange tailwind and assumed analysts' models already incorporate FX impacts. He indicated that the projected lift in both sales and EPS is consistent with how analysts typically view these metrics.

Larry Biegelsen sought clarification on the 5%+ sales growth projection for 2026, specifically whether it refers to reported or adjusted operational basis, considering potential FX tailwinds and the impact of an extra week in the fiscal year. He also asked for similar clarification on the EPS outlook.

Answer

CFO Joe Wolk confirmed that the 5%+ sales growth and EPS commentary for 2026 are based on reported figures, aligning with how consensus models are typically structured. He noted that analysts' models usually account for FX impacts and that the projection represents a lift across the board.

Larry Biegelsen from Wells Fargo Securities inquired about the annualized impact of the $400 million in 2025 tariffs and potential mitigation strategies.

Answer

CFO Joseph Wolk clarified the $400 million is a partial-year impact based on current programs, primarily from China, and noted the company has limited ability to pass on costs. CEO Joaquin Duato added that tax policy is a more effective tool than tariffs for building U.S. manufacturing capacity, highlighting J&J's $55 billion domestic investment plan.

Larry Biegelsen asked for the outlook on the MedTech market's growth in 2025, how Johnson & Johnson expects to perform relative to the market, and what assumptions are being made for the electrophysiology (EP) business and VARIPULSE.

Answer

CFO Joseph Wolk stated that MedTech procedure volumes have largely normalized and reiterated the 5-7% market growth forecast. Regarding EP, he confirmed a temporary pause for VARIPULSE in the U.S. but emphasized no impact OUS. He expressed long-term confidence in J&J's EP leadership, citing its $5 billion business, large CARTO installed base, and a comprehensive PFA portfolio in development to address the market.

Larry Biegelsen from Wells Fargo asked for clarification on MedTech's Q3 performance, including the impact of onetime items like the ortho rationalization, the potential Q4 impact from hurricanes, and the company's confidence in delivering at the high end of its 5% to 7% growth target for the next year.

Answer

Tim Schmid, Executive VP of MedTech, acknowledged a softer Q3 in Orthopaedics due to restructuring but expects a return to better performance. He highlighted strong growth in Cardiovascular, driven by the Shockwave and Abiomed acquisitions, and noted that while hurricanes had a localized impact, a potential IV fluid shortage is a watch item. He expressed confidence in future growth, citing new product launches and enabling technologies like VELYS.

Larry Biegelsen inquired about the impact of the American Heart Association (AHA) data on the WCD market, asking if the observed low double-digit growth was primarily due to market expansion or share capture. He also asked for an update on rep productivity, sales force hiring plans, and whether commercial plans would accelerate following the recent secondary offering.

Answer

President and CEO Brian Webster clarified that market growth is indeed low double-digit and, while early, anecdotal evidence suggests clinicians are making different decisions based on the data. He noted a significant increase in medical education events. Regarding sales force, he stated Kestra is on track to double its original rep count and will evaluate accelerating hiring plans during the upcoming fiscal year planning.

Larry Biegelsen inquired about the impact of the American Heart Association (AHA) data on the WCD market, asking if the observed low double-digit growth was due to share capture, market expansion, or both. He also asked about rep productivity, sales force hiring plans, and the expected year-end rep count following the recent secondary offering.

Answer

Brian Webster, President and Chief Executive Officer, clarified that market growth is accelerating to low double-digits, with anecdotal evidence of clinicians making different decisions post-data presentation. He noted that Kestra is on track to double its rep count from the IPO (currently at 100, aiming for ~140 in 6-8 months) and will evaluate accelerating plans with the new capital.

Representing Larry Biegelsen of Wells Fargo, an analyst asked for an update on Kestra's plans for a randomized clinical trial and for more specific details on the financial cadence for the first quarter of fiscal 2026.

Answer

CEO Brian Webster clarified that there are no immediate plans for a new randomized trial, as the company is focused on completing its 20,000-patient post-approval study and publishing those results to influence clinical guidelines. CFO Vaseem Mahboob did not provide specific quarterly guidance but reiterated that the first half of the year would see slower growth than the second half due to the sales team's ramp-up, while expressing comfort with current consensus estimates.

Speaking on behalf of Larry Biegelsen, an analyst from Wells Fargo asked for an update on Kestra's plans for a new randomized clinical trial. He also inquired about the expected revenue cadence for fiscal Q1 2026.

Answer

President and CEO Brian Webster stated there are no announced plans for a new randomized trial, as the immediate focus is on completing the 20,000-patient post-approval study and publishing its results to influence clinical guidelines. CFO Vaseem Mahboob declined to provide specific quarterly guidance but reiterated that the first half of the year would see slower growth than the second half due to the ramp-up of new sales territories.

Simran, on behalf of Larry Biegelsen, asked about the factors driving the upside in U.S. Omnipod, particularly given the guidance raise exceeding the beat, and whether the trend of record U.S. new customer starts is sustainable moving forward.

Answer

Ashley McEvoy (President and CEO) attributed the upside to strong performance in the core U.S. Type 1 business (40% penetration, ongoing education against clinical inertia, AID standard of care guidelines) and accelerated momentum in Type 2 (low penetration, educating endocrinologists and high-prescribing PCPs on science, peer-to-peer education, and activating consumers through DTC efforts).

Larry Biegelsen noted that new customer starts grew sequentially in Q1, a historically unusual trend, and asked for confirmation and color on the drivers behind this strong performance in both U.S. and international markets.

Answer

CFO and Treasurer Ana Maria Chadwick confirmed the strong sequential and year-over-year growth in new customer starts. Chief Product and Customer Experience Officer Eric Benjamin attributed the success to the clear differentiation of the Omnipod 5 platform, including its pay-as-you-go model, wearable form factor, multiple sensor options, iOS control, and the new type 2 indication, which he stated is resonating strongly with customers.

Larry Biegelsen of Wells Fargo asked if the Type 2 mix of new starts could surpass the 35-40% level seen with Omnipod DASH and whether the focus on Type 2 could create a "halo effect" for Type 1 or risk distracting from it.

Answer

President and CEO Jim Hollingshead affirmed that continuing to lead in both Type 1 and Type 2 is a "huge strategic focus," and the commercial teams are dedicated to growing both. He expects the Type 2 mix to grow well beyond the current 30% over time, given its much larger addressable market, but emphasized the significant runway remaining in the Type 1 market as well.

Larry Biegelsen followed up on the Q4 U.S. Omnipod guidance, noting the 21% underlying growth implies a deceleration from Q3, and asked if the Type 2 launch could accelerate growth off that Q4 base in 2025.

Answer

CFO and Treasurer Ana Maria Chadwick reiterated that the annuity model means revenue from recent new customer starts will ramp into 2025. President and CEO Jim Hollingshead added that while the Type 2 launch provides confidence for the Q4 guide, its primary revenue impact will create a ramping effect into 2025. He also confirmed clear sequential new customer start growth in Q3.

Larry Biegelsen inquired about China's performance, specifically its organic growth in Q4 and full year fiscal 2025, and sought updated thoughts on the new BD strategy and its unique earnings algorithm, including the potential for double-digit EPS growth.

Answer

Tom Polen, Chairman, CEO, and President of BD, stated that China was down high single digits organically in Q4, and the guidance prudently assumes continued impact from VBP, with China becoming about 4% of revenue post-separation. He detailed the new BD strategy as a focused MedTech leader, emphasizing commercial excellence, R&D reallocation to high-growth/high-margin areas, confidence in long-term mid-single digit growth, and leveraging BD Excellence for margin expansion and compounding earnings growth through share buybacks.

Larry Biegelsen asked for clarification on China's organic growth in Q4 and full year 2025, noting the weaker-than-expected fiscal year 2026 guidance, and sought updated thoughts on the new BD strategy and its unique earnings algorithm.

Answer

Chairman, CEO, and President Tom Polen stated that China was down high single digits organically in Q4, with the FY26 guide reflecting a prudent approach to VBP, expecting 80% portfolio coverage by year-end. He outlined the new BD strategy as a focused MedTech leader, confident in mid-single-digit growth, driven by BD Excellence, cash generation for buybacks, and compounding earnings growth, aiming for a steady, durable value creation.

Larry Biegelsen asked for clarification on the fiscal 2025 tariff impact, questioning if the $0.25 EPS headwind is a net figure and how to model the impact for fiscal 2026. He also requested more detail on the drivers for the projected second-half organic growth acceleration.

Answer

EVP and CFO Christopher DelOrefice confirmed the $0.25 tariff impact is a net figure after significant mitigation efforts. He advised that while simple annualization is not perfect, it's fair to use an annualization factor since the guidance only includes about three months of impact. For H2 growth, he detailed four key drivers for the Q4 acceleration to over 5%: the APM acquisition becoming organic, continued momentum in Pharm Systems (Biologics/GLP-1s), BDI returning to high single-digit growth, and BDB cycling an easier comp while launching the FACSDiscover A8.

Larry Biegelsen inquired about the potential impact of announced and potential tariffs involving China, Mexico, and Canada on BD's operations and the company's ability to offset these costs.

Answer

Chairman, CEO and President Tom Polen responded that BD's largest manufacturing footprint is in North America, particularly the U.S., and that the company is monitoring the situation closely. He noted it was positive to see a temporary resolution and that it's too early to quantify any impact, as the final form and timing of tariffs, including potential med-tech carve-outs, are not yet confirmed.

Larry Biegelsen inquired about the Alaris infusion pump performance, asking if it met the $350 million sales goal for fiscal 2024 and what the sales outlook is for fiscal 2025.

Answer

Medical Segment President Mike Garrison confirmed that Alaris sales exceeded the $350 million goal for fiscal 2024. Chairman, CEO, and President Tom Polen added that the company exited the year at its historical revenue run rate for Alaris and expects continued strong growth in fiscal 2025, supported by a rebuilt backlog of committed contracts.

Larry Biegelsen asked Andrew Heider how his experience at ATS, a non-medical device company, would help him turn Baxter around. He also inquired about Heider's thoughts on Baxter's portfolio, specifically if all pieces fit together or if there might be a greater focus on the hospital setting.

Answer

President and CEO Andrew Heider highlighted his experience in driving continuous improvement cultures, now implemented with Baxter's GPS system, and his familiarity with the medical tech space. Regarding the portfolio, he stated it is strong for the future, acknowledging prior streamlining efforts, and plans frequent customer visits for further insights.

Larry Biegelsen from Wells Fargo & Company asked CEO Andrew Heider to elaborate on how his prior experience at ATS, a non-medical device company, would help him lead Baxter's turnaround. Biegelsen also sought Heider's perspective on Baxter's current portfolio, questioning if all pieces fit together or if there might be a future focus shift towards hospital settings over physician offices.

Answer

President and CEO Andrew Heider highlighted his experience in launching and driving continuous improvement cultures at several businesses, emphasizing its impact at every level and the alignment with Baxter's new GPS system. He noted his understanding of the medical tech space, including Baxter as a past customer, and the deep insight of the current leadership team. Regarding the portfolio, Heider stated that while it's early in his tenure, he believes the current portfolio is strong and has already undergone streamlining. He expressed satisfaction with customer feedback and reiterated his commitment to frequent customer visits to drive execution.

Larry Biegelsen asked for an update on the timing of the permanent CEO announcement and inquired about the potential benefits from declining oil prices.

Answer

Chair and Interim CEO Brent Shafer stated that the CEO search is active and progressing expeditiously, though no specific date was given. EVP & CFO Joel Grade explained that while lower oil prices are a positive, the impact is significantly less pronounced for the company following the divestiture of the Kidney Care business, which had higher energy consumption.

Larry Biegelsen asked about the board's perspective on an external versus internal CEO candidate and questioned how the interim CEO evaluated the 2025 guidance, given the risk that a new permanent CEO might change it.

Answer

An executive, identified as Brent, explained the board is focused on finding the "right fit" for CEO over speed, acknowledging the pros and cons of both internal and external candidates. Regarding the guidance, he expressed confidence, stating the board has reviewed the three-year plan and feels good about it, though a new leader might apply a "different filter." He emphasized that the company is now well-positioned for a new CEO to drive growth after significant strategic work has been completed.

Larry Biegelsen requested help in bridging the 2024 continuing operations margin to the 16.5% target for 2025, asking if adding back stranded costs would provide a clean underlying number. He also asked for color on how much lower non-operating expenses could be in 2025.

Answer

CFO Joel Grade reiterated that bridging from 2024 continuing ops to the 2025 target is 'really complicated' because 2024 results are distorted by stranded costs without the offsetting TSA income and cost-out measures that will benefit 2025. Executive Clare Trachtman added that while interest expense should decrease due to debt repayment from divestiture proceeds, it's premature to quantify the total non-operating expense change for next year.

Larry Biegelsen from Wells Fargo questioned the conservative 20% market outlook for the WATCHMAN LAA market provided at the investor day, given current higher growth rates and upcoming CHAMPION data. He also asked if studies like ALONE-AF and OCEAN raised concerns and for Chief Medical Officer Dr. Ken Stein's view on CLOSURE-AF's read-through to CHAMPION.

Answer

Chairman and CEO Mike Mahoney emphasized providing accurate forecasts while aiming to exceed commitments. Chief Medical Officer Dr. Ken Stein clarified that the 20% growth projection over the LRP is considered comfortable due to the significantly underpenetrated indicated population and the prospect of indication expansion. Dr. Stein stated that CLOSURE-AF is not a good read-through for CHAMPION due to population, endpoint, and follow-up differences, preferring PROG-17 and OPTION for confidence. He noted that ALONE-AF and OCEAN, if confirmatory, support FARAPULSE growth by enabling AF ablation patients to come off blood thinners, but have not materially impacted concomitant procedures as current patients are not low-risk.

Larry Biegelsen followed up on the Watchman and LAA market, questioning the 20% market outlook as potentially conservative given current higher growth and upcoming Champion data. He also asked about any concerns from Alone AF and OCEAN studies and the read-through of Closure AF at American Heart to Champion.

Answer

Chairman and CEO Mike Mahoney reiterated the company's commitment to accurate forecasts and exceeding commitments. Chief Medical Officer Dr. Ken Stein affirmed confidence in the 20% market growth projection, citing the significantly underpenetrated indicated population. He clarified that Closure AF is not a good read-through for Champion due to different populations and endpoints. Dr. Stein also noted that Alone AF and OCEAN, if confirmatory, support Therapulse growth for AF ablation patients seeking to discontinue blood thinners, but these studies do not materially impact concomitant Watchman procedures, which target higher-risk patients.

Larry Biegelsen of Wells Fargo inquired about Boston Scientific's new #2 position in the Electrophysiology (EP) market, asking about the strategy to potentially overtake the market leader and the path for international market share to match U.S. levels.

Answer

Michael Mahoney, Chairman and CEO, affirmed that the company's aim is to become #1 in EP, a goal he believes is achievable in a few years through PFA leadership and clinical evidence. He noted excellent momentum in Europe and Japan, and highlighted China as a significant, multi-year growth opportunity where the company is making substantial investments to replicate its success in other regions.

Larry Biegelsen asked a long-term question regarding the company's 2026 outlook, questioning if the projected 9% weighted average market growth rate implies Boston Scientific will grow at least 9% and if double-digit EPS growth is achievable with a rising tax rate.

Answer

CFO Dan Brennan stated that while not providing specific 2026 guidance, the company's consistent goal is to outgrow its end markets. He pointed to the company's strong track record of delivering double-digit adjusted EPS growth and affirmed this remains the objective, even if the tax rate were to increase.

Larry Biegelsen from Wells Fargo sought more details on the 'unanticipated observations' in the AVANT GUARD trial and asked what factors will ensure FARAPULSE retains customers as new PFA competitors enter the market.

Answer

CMO Dr. Ken Stein explained the temporary pause in the AVANT GUARD trial, which studies a new, drug-naive patient population, was not due to life-threatening events and the company intends to resume enrollment. He affirmed confidence in FARAPULSE's leadership due to its ease of use, extensive clinical data (including superiority in ADVENT sub-analysis), and the new FARAVIEW mapping system.

Larry Biegelsen asked about Abbott's comfort level with 2026 consensus sales and EPS, inquiring if the company still feels comfortable with these estimates given potential tailwinds.

Answer

Robert Ford, Chairman and CEO, expressed strong comfort with 2026 consensus, noting it aligns with 2025 estimates and year-to-date performance despite headwinds. He highlighted three key growth drivers: underlying portfolio momentum (Aveir, TAVR, Libre, Triclip), new product launches (Volt in U.S., PactaFlex Duo, Alinity N, biosimilars), and easing diagnostics headwinds (China VBP, COVID testing decline). Ford also emphasized unwavering commitment to pipeline investment and expected gross/operating margin expansion.

Larry Biegelsen requested an update on the Electrophysiology (EP) franchise's performance and outlook, as well as the U.S. approval timeline for the Volt PFA system.

Answer

Chairman and CEO Robert Ford expressed confidence in the EP business, highlighting its strong growth even before the recent European approval of the Volt PFA system. He noted very positive initial feedback on Volt and its integration with Abbott's market-leading mapping systems. For the U.S., Ford stated they will submit data this year and anticipates a potential approval around the beginning of next year.

Larry Biegelsen inquired about the growth expectations for the continuous glucose monitoring (CGM) business in 2025, the status of Libre 3 supply, and any updates on the LINGO launch.

Answer

CEO Robert Ford confirmed that Libre 3 supply constraints have been addressed with a new manufacturing site now at full capacity. For 2025, he outlined three growth accelerators for the CGM business: continued penetration in the intensive insulin segment, expanding reimbursement coverage for basal insulin users, and new connectivity partnerships with insulin pump companies. Ford also noted the LINGO launch for non-diabetic applications is exceeding expectations, particularly in reorder rates, with plans for national expansion.

Larry Biegelsen asked for a big-picture view of the CGM market, Abbott's confidence in achieving its $10 billion Libre sales target by 2028, and for initial feedback on the new Lingo consumer biosensor.

Answer

Robert Ford, Chairman and CEO, stated he remains very bullish on the CGM market, viewing it as a mass-market opportunity with significant room for growth. He noted that Libre's 21% growth puts it ahead of the pace needed for the $10 billion target. Regarding Lingo, he reported very good early interest and surprisingly high reorder rates, indicating a successful U.S. launch.

Simran, on behalf of Larry Biegelsen of Wells Fargo, asked for more detail on the sales cadence for the second half of 2025 and the implied iDose TR exit rate. She also inquired about the national percentage of iDose TR cases performed in combination with cataract surgery.

Answer

President & COO Joe Gilliam detailed the expected sequential sales trends, noting Q3 is seasonally down but U.S. Glaucoma should still grow sequentially due to iDose TR strength, with a larger step-up in Q4. He stated that while the company cannot track it precisely, they believe the largest portion of iDose TR utilization remains in standalone procedures, though combo-use is expected to grow.

Larry Biegelsen asked if the iDose reimbursement process has met expectations, whether the product's price has been an impediment to adoption, and if the company would consider pursuing an LCD to accelerate Medicare Advantage coverage.

Answer

President and COO Joseph Gilliam responded that iDose financial results have exceeded internal forecasts, though the market access process is a methodical one. He clarified that the reimbursement timeline is a standard process for new codes and not driven by price. He also stated that pursuing an LCD is not the company's preferred strategy for unlocking Medicare Advantage coverage, as they expect to follow a path similar to other procedural pharmaceuticals.

Simran, on behalf of Larry Biegelsen, asked for more detail on the 2025 guidance, specifically the cadence of LCD headwinds and the expected ramp of iDose throughout the year. She also posed a broader question about whether iDose procedures could eventually surpass the number of traditional implantable MIGS procedures in the U.S.

Answer

President and COO Joe Gilliam projected that LCD headwinds would be most pronounced in the first half of 2025. He provided quarterly revenue contribution guidance for 2025 (Q1 ~21%, Q4 ~30%), reflecting the anticipated iDose ramp. On the broader market question, Gilliam stated "absolutely," explaining that iDose targets a much larger market of approximately 10 million actively treated glaucoma patients, compared to the 500,000-700,000 eye market historically addressed by MIGS in combination with cataract surgery.

Larry Biegelsen sought confirmation on the implied Q3 and Q4 revenue for iDose TR and questioned why the full-year 2024 guidance was raised only by the amount of the Q3 beat. He also asked for an update on the types of patients receiving iDose.

Answer

President and COO Joseph Gilliam confirmed iDose TR sales doubled from Q2, driving strong U.S. glaucoma growth. He explained the guidance raise was tempered by expected Q4 headwinds, including a peak year-over-year impact from MDRP in Corneal Health and currency/competition challenges internationally. Regarding patient types, he noted broad utilization across stand-alone and combo procedures, but confirmed the current focus remains on Medicare fee-for-service patients.

Speaking on behalf of Larry Biegelsen from Wells Fargo, an analyst asked about the outlook for 2026, specifically if the business could achieve 6-8% growth (excluding the recall impact) and return to pre-recall EBITDA margins. A follow-up question concerned the pipeline, seeking clarity on the ILIOS approval timeline and the reason for the Envista BEYOND delay.

Answer

CEO & Chairman Brent Saunders conveyed strong optimism for 2026, stating the company is now positioned to accelerate growth and margins. EVP & CFO Sam Eldessouky supported this, noting that strong second-half 2025 performance will create a high exit point into 2026. EVP of R&D Yehia Hashad explained the ILIOS filing was strategically delayed to submit a more robust file, with approval now anticipated in H2 of the following year. The Envista BEYOND timeline was pushed out slightly due to a two-month pause in clinical trial recruitment during the recall.

Larry Biegelsen questioned the 2025 revenue guidance of approximately 6.5% growth at the midpoint, asking why it was a reasonable starting point given the recent 10% organic growth momentum and which businesses were expected to slow down.

Answer

CFO Osama Eldessouky responded that the company sees no business slowing down and that market dynamics remain solid. He explained the guidance range of 5.5% to 7.5% reflects the strategy of growing faster than the mid-single-digit market growth. He noted the guidance absorbs headwinds from the Inflation Reduction Act (IRA) and market access investments for Xiidra, making it a reasonable and well-balanced starting point for the year.

Speaking for Larry Biegelsen, an analyst asked for clarification on the Q4 guidance, which seems to imply a growth deceleration, and requested quantification of the two headwinds facing Xiidra in 2025.

Answer

CFO Osama Eldessouky explained that the Q4 guidance does not imply a slowdown, as the organic growth rate remains consistent with the year's performance when lapping the Xiidra acquisition. He also reaffirmed expectations for steady margin expansion. Regarding Xiidra, he declined to provide specific 2025 guidance but confirmed the company anticipates headwinds from the Inflation Reduction Act and rebate negotiations while remaining focused on driving TRx volume.

Larry Biegelsen asked about the significant deceleration in the contact lens market, seeking color on distributor and consumer behavior, such as consumers buying smaller supplies. He also requested guidance on the revenue gating for Q3 versus Q4.

Answer

President & CEO Albert White confirmed that a shift in consumer behavior, such as purchasing a three-month supply instead of a year's worth, is contributing to revenue softness despite strong fitting activity. CFO Brian Andrews guided that for both divisions, Q3 organic growth would likely be below the full-year range, while Q4 would be at or above the top end of the range.

Larry Biegelsen from Wells Fargo Securities questioned why CooperVision's (CVI) Q1 growth was below peers, sought confidence in the division's expected growth acceleration, and asked about the anticipated impact of new competition on PARAGARD.

Answer

CEO Al White explained that CVI had a soft start to the quarter due to channel inventory reductions but saw a strong pickup in January and February. He expressed confidence in acceleration in Q3 and Q4 as MyDay supply increases. Regarding PARAGARD, he noted the new competitor faces hurdles like a shorter efficacy label and different material, and reiterated guidance of -2% to +2% growth for the year.

Larry Biegelsen of Wells Fargo asked for more detail on the 10% Q4 decline in Paragard, the growth assumptions for it in fiscal 2025, and any expected cadence for sales and margins throughout the upcoming year.

Answer

CEO Al White attributed the Paragard weakness to continued pressure from other birth control options. For fiscal 2025, he guided to a range of "down a little bit to up a little bit," assuming no new direct competitor launches. CFO Brian Andrews stated there was no significant change to expect in sales and margin seasonality for FY25, advising to model it similarly to past years.

Speaking for Larry Biegelsen, an analyst asked for commentary on fiscal 2025 top-line growth expectations and below-the-line items like interest and tax rates. A follow-up question concerned the timing of CooperVision's last price increase and the outlook for pricing in fiscal 2025.

Answer

CEO Al White deferred specific revenue guidance to December but expressed optimism for continued market strength. CFO Brian Andrews reiterated the goal of low double-digit constant currency OI growth, noting potential for positive FX and lower interest expense, offset by a higher effective tax rate. Al White added that they last took price in Q1 and anticipate doing so again in Q1 of next year to offset inflation.

Larry Biegelsen asked about the rationale for separating the Diabetes business, questioning why the company didn't pursue a broader breakup and why it was spinning off a business growing above the corporate average.

Answer

CEO Geoffrey Martha described the separation as a 'win-win,' enabling the Diabetes business to gain necessary focus and funding while allowing Medtronic to concentrate on its higher-margin growth drivers. He explained that Medtronic's core businesses have greater synergies and a B2B focus, unlike Diabetes' B2C model, and that the transaction is accretive to Medtronic's margins and EPS.

Larry Biegelsen asked about the strategic rationale for separating the Diabetes business, questioning why the company is spinning off a high-growth segment and why it didn't consider a more extensive breakup of its other businesses.

Answer

CEO Geoff Martha described the separation as a 'win-win.' He explained that an independent Diabetes company can better secure focused funding for its distinct B2C model. For Medtronic, the move sharpens focus on its core, high-margin B2B markets, simplifies the portfolio, and is accretive to margins and EPS. He affirmed the remaining businesses are 'better together' due to significant synergies.

Larry Biegelsen from Wells Fargo & Company inquired about the drivers for the expected acceleration in the AF Solutions business for Q4 and fiscal '26, specifically asking about the Affera ramp, supply status, and the timeline to reach the '$2 billion line of sight'.

Answer

CEO Geoff Martha described Pulsed Field Ablation (PFA) as a 'hyper growth driver,' noting strong demand for both the PulseSelect and Affera platforms and improved supply from a new factory in Galway. He clarified the $2 billion revenue target is a 'shorter term' line of sight. Sean Salmon, EVP & President of the Cardiovascular Portfolio, added that the company is aggressively expanding factory and field capacity to stay ahead of demand, leveraging the dual-platform strategy to penetrate accounts globally.

Larry Biegelsen inquired about the commercial opportunity for Medtronic's renal denervation (hypertension) therapy, asking about the expected benefit from the new TPT payment, the timeline for a national coverage decision, and the overall strategy.

Answer

Sean Salmon, EVP & President of the Cardiovascular Portfolio, explained that the new Transitional Pass-Through (TPT) payment will cover about half of the Medicare fee-for-service population, serving as an accelerator for the therapy. He noted that broader coverage is still a key goal to streamline the process, and the company is actively pursuing coverage with evidence development with CMS, though no new timeline was provided.

Larry Biegelsen asked about the quarterly cadence of the tariff impact on gross margin in 2025 and whether Alcon could still grow margins in 2026. He also questioned how the changing macro environment affects the long-term EPS growth targets set at the Capital Markets Day.

Answer

Chief Financial Officer Tim Stonesifer stated that the gross tariff impact will primarily affect Q3 and Q4 but will be fully offset by operational actions and currency tailwinds in 2025. He reaffirmed confidence in the company's 5-year goals, explaining that the fundamentals of growing faster than the market and managing costs responsibly remain intact, which will drive margin expansion and free cash flow over the long term.

Larry Biegelsen sought details on the assumptions behind the 6-8% revenue guidance, particularly the growth phasing in 2025, and asked about the expected growth cadence for the equipment business with the launch of Unity.

Answer

CFO Tim Stonesifer detailed that revenue growth is expected to be at the low end of the guidance range in the first half due to tough comps and the OcuMension deal, accelerating to the high end in the second half driven by new product launches. CEO David Endicott added that the equipment business will be very strong in 2025, with the Unity launch being a significant back-half driver after its initial rollout and training period starting in May.

Larry Biegelsen asked for the timing of the AR-15512 data publication and the launch gap between the Unity CS and VCS systems. He also inquired about Alcon's high-level view on the phakic IOL market.

Answer

CEO David Endicott stated that the AR-15512 data will likely be presented at the American Academy of Ophthalmology in October and that the Unity CS system would follow the VCS launch by approximately six months. Regarding phakic IOLs, he views them as a good option for high myopes that does not significantly impact Alcon's core LASIK business, which remains the standard for most patients.

Simran, on behalf of Larry Biegelsen at Wells Fargo, questioned the updated 2025 guidance, asking what changed the second-half outlook. She also inquired about the hospital selling cycle, the number of office sites in the launch readiness phase, and the economic models for selling into the office setting.

Answer

CFO Brett Hale clarified that the full-year guidance was adjusted to reflect the Q1 loss of grant-funded deals, which are not expected to be recovered, but that core second-half growth driver expectations remain unchanged. President and CEO Maria Sainz added that hospital sales cycles have lengthened to 12-18 months. Regarding the office launch, Sainz described a "handful" of pilot sites and detailed the flexible economic models being offered, including payment-over-time options, to accommodate different practice sizes and preferences.

Larry Biegelsen from Wells Fargo & Company pressed for details on how 'derisked' the updated guidance is, asking for color on business trends in March and April relative to the implied forecast for the rest of the year.

Answer

CFO Shelley Thunen explained that March lacked the typical seasonal ramp-up and that April saw a recovery in the latter half of the month. She framed the guidance by stating the low end assumes stagnant same-store sales, with growth driven by new customers. The high end of the guidance assumes a recovery in consumer confidence and an abatement of intense competitive trialing.

Larry Biegelsen of Wells Fargo asked when the full transition to Inspire V would be complete, noting a prior Q4 timeline. He questioned why the transition factors affecting Q2 wouldn't also impact Q3 and inquired about potential slowdowns related to linking the new CPT code to ICD-10 codes.

Answer

CEO Tim Herbert stated they will work to accelerate the transition now that the launch is underway but reiterated that they expect a strong Q4, implying the full transition will still take time. He noted the administrative steps are simple and they will work hard in Q2. Regarding the CPT/ICD-10 issue, he confirmed they addressed it upfront with payers and have already secured coverage for 80% of lives, including Medicare.

Larry Biegelsen asked about the logistics of transitioning back to the older CPT code for Inspire V and what the guidance assumes for competition and potential patient warehousing.

Answer

Chairman and CEO Tim Herbert explained the company is experienced with the CPT code transition and is working with all payers to ensure systems accept both the old and new codes during the changeover. He confirmed that the annual guidance accounts for potential experimentation by competitors upon approval and for a limited number of patients who may choose to wait for the full Inspire V launch.

Larry Biegelsen from Wells Fargo asked how surgeons participating in the Inspire V soft launch will be instructed to bill for the procedure if the formal coding strategy is not disclosed until next year. He also questioned if there was any concern about patients 'warehousing' or delaying procedures in anticipation of the new device.

Answer

CEO Tim Herbert assured that physicians involved in the soft launch will receive specific billing instructions to use with their payers. He also stated that the company does not anticipate a significant delay or 'warehousing' of patients, particularly as many with high-deductible plans are motivated to complete procedures before the end of the year.

Larry Biegelsen asked for clarity on the net tariff impact for 2026 and questioned how Zimmer Biomet plans to make its ROSA system more competitive against systems like Mako, which he suggested is driving competitor growth.

Answer

President and CEO Ivan Tornos addressed the ROSA question, highlighting its #2 market position and an upcoming 'ROSA V15' software update to enhance accuracy and efficiency. CFO and EVP Suketu Upadhyay reiterated that the 2026 tariff impact is expected to be higher than 2025 due to annualization and inventory effects, but that the company continues to explore mitigation strategies.

An analyst on behalf of Larry Biegelsen from Wells Fargo questioned why full-year guidance was maintained despite strong Q1 organic growth and asked if the 15-day sensor launch was factored into the gross margin guidance.

Answer

CFO Jereme Sylvain stated that while the company is bullish, it is only one quarter into the year, making it prudent to reaffirm guidance and see how the year unfolds. He confirmed that a small, unchanged contribution from the 15-day sensor launch in the second half of the year is included in the guidance.

Larry Biegelsen inquired about the progress on the sales force productivity and DME channel issues that were identified on the Q2 2024 earnings call.

Answer

Kevin Sayer, Chairman, President and CEO, stated that DexCom has made significant progress on both fronts. He noted that partnerships with DME providers have improved and the expanded sales force has become more productive, evidenced by adding 50,000 new prescribers and achieving record new customer starts in the past two quarters.

Larry Biegelsen noted that combined results from Dexcom and its main competitor suggest the U.S. CGM market growth slowed to about 10% in Q3. He asked if this is the new market growth rate or if one-time factors were at play.

Answer

CEO Kevin Sayer stated that Dexcom's own results were impacted by previously disclosed execution issues, such as channel mix shifts. He affirmed that the company remains 'very bullish on the category,' believing the market can grow faster than 10% due to untapped opportunities in basal and intensive insulin populations.

Larry Biegelsen's team asked about the current U.S. competitive landscape, specifically regarding Beta Bionics and the anticipated approval of Medtronic's Simplera Sync.

Answer

CEO John Sheridan stated that the market is not a zero-sum game and the competitive environment has been stable. He noted Tandem is prepared for new entrants and highlighted the company's own upcoming sensor integrations, like FreeStyle Libre 3 and the 15-day Dexcom G7, as key competitive advantages.

Larry Biegelsen from Wells Fargo asked about the U.S. Type 2 launch, questioning its contribution to the new start growth guidance, the pilot's duration, and whether Tandem's mix of new starts from Type 2 could reach levels similar to competitors.

Answer

President and CEO John Sheridan and CCO Mark Novara expressed excitement about the large, underpenetrated Type 2 market. Novara stated a pilot will begin in March and scale based on KPIs, initially targeting high-insulin prescribers. They emphasized the focus on market development and believe they can significantly increase market penetration over the next few years.

Larry Biegelsen questioned the potential for growth to slow in 2025 to the consensus 12% from 2024's 17-18%, given multiple growth drivers.

Answer

EVP and CFO Leigh Vosseller clarified that her comments pertained to their guidance philosophy, not their business aspirations. She explained that initial 2025 guidance will be conservative, based on predictable revenue from supplies and renewals. Benefits from new growth drivers like Mobi and the Type 2 indication will be factored in only after sustainable trends emerge.

Larry Biegelsen asked for details on the cadence and mitigation of the $0.85 per share tariff impact in 2025 and 2026, and for an update on the business environment in China, including the potential impact of value-based purchasing (VBP).

Answer

CFO James Saccaro detailed the tariff impact cadence, noting it would be minimal in Q1 but grow to around $200 million by Q3/Q4. He explained that 2026 impact would be lower than $0.85 due to mitigation efforts like localizing manufacturing and multi-sourcing. CEO Peter Arduini added that the outlook for China remains cautious, with an expected decline in the first half followed by sequential improvement, and that VBP impacts are aligned with their current assumptions.

Larry Biegelsen inquired about the $1 billion, 7-year Sutter Health deal, asking about the timing of its financial impact and if similar large enterprise deals are anticipated. He also asked about the company's M&A outlook for 2025.

Answer

CEO Peter Arduini explained that large deals like Sutter are not always linear in revenue recognition due to factors like site renovations, but orders will begin booking in the first half of 2025. He confirmed they see more opportunities for such partnerships. Regarding M&A, he affirmed that GEHC expects to be active with tuck-in acquisitions of various sizes that have a strong strategic fit and meet financial return criteria, highlighting the NMP acquisition as an example of bolstering strategic capabilities.

Larry Biegelsen of Wells Fargo & Company sought clarity on the company's message for 2025, given the commentary about a limited China recovery in the first half, and how that impacts the mid-single-digit growth outlook. He also asked for confirmation of the implied Q4 organic growth rate and the drivers of the sequential revenue ramp.

Answer

CFO Jay Saccaro stated that while the company feels very good about its mid-term mid-single-digit growth target, it would stop short of giving 2025 guidance due to market volatility, particularly in China. For Q4, he confirmed an implied growth rate of around 2%, driven by strength in PDx and services, continued U.S. market health, and a high percentage of secured revenue from backlog, consistent with historical conversion rates.

Larry Biegelsen asked for a comparison of the non-small cell lung cancer (NSCLC) launch ramp to the initial glioblastoma (GBM) launch and inquired about expectations for the PANOVA-3 data presentation at ASCO, including key data points and potential clinical pushback.

Answer

CEO Ashley Cordova explained that the NSCLC launch is difficult to compare to GBM due to a different prescriber base and existing therapy awareness. She highlighted the 30,000 eligible patient market and early prescriber adoption. Regarding PANOVA-3, she noted the prime ASCO presentation slot and confirmed the full dataset would be shared, expressing confidence that the clinical community is eager for a new, effective therapy in pancreatic cancer.

Larry Biegelsen asked for a breakdown of the EPS headwinds from tariffs and the JenaValve acquisition, and how the National Coverage Determination (NCD) for EVOQUE will impact its commercial ramp.

Answer

CFO Scott Ullem quantified the EPS headwinds, estimating tariffs at ~$0.05 and the JenaValve acquisition at ~$0.05-$0.10 for 2025. He noted that a hedging program mutes FX impact. Daveen Chopra, Global Leader of TMTT, added that the EVOQUE NCD was in line with expectations, is already factored into guidance, and expands access for Medicare patients, supporting a multiyear growth opportunity.

Larry Biegelsen asked about the market impact of the EVOQUE NTAP that began in October and the expected effect of the final NCD. He also inquired about field feedback following the EARLY TAVR trial and what catalysts are needed to positively impact procedure volumes.

Answer

Daveen Chopra, Global Leader of TMTT, explained that strong patient and physician demand for EVOQUE is driving growth, and the guidance already assumes a positive NCD, which will ensure continued access. Larry Wood, Global Group President of TAVR, noted that the EARLY TAVR impact will be a multi-year catalyst driven by education, the official FDA indication, and eventual guideline changes, all balanced by the pace of hospital capacity expansion.

Larry Biegelsen asked for a bridge from prior full-year EPS guidance to the new implied Q4 run-rate, questioning the impact of the Critical Care divestiture versus other factors, and sought clarity on how to model 2025 EPS.

Answer

CFO Scott Ullem explained the guidance change was due to the Critical Care divestiture (approx. $0.35/share impact), plus added Q4 expenses from three recent acquisitions. CEO Bernard Zovighian added that 2025 will see benefits from rightsizing actions and top-line growth, with full guidance to be provided in December.

Larry Biegelsen asked for specific U.S. commercialization plans for Biotronik's Pantera Lux and Free cell products, and requested details on the current operating margins of the proposed RemainCo and NewCo, as well as any stranded costs.

Answer

CEO Liam Kelly indicated that Pantera would require development for broad U.S. use and that U.S. plans for Free cell would be updated in 2026 after progress on the European trial. He declined to provide specific current operating margins for the separate entities, directing investors to the future Form 10 filing, and suggested using recent industry precedents as a benchmark for stranded costs.

Larry Biegelsen posed a financial question about the potential for debt paydown and interest expense reduction in the upcoming year. He also asked about the competitive dynamics in the intraosseous product market following a competitor's new device approval.

Answer

Thomas Powell, EVP and CFO, responded that free cash flow will be balanced between organic/inorganic investments, share repurchases, and debt paydown. Liam Kelly, Chairman, President and CEO, addressed the competitive question, stating that Teleflex has successfully competed against this rival before and is confident in its product's loyalty and recent innovations, such as a new disposable tray format, to maintain its market position.

Questioned why the 2025 revenue growth guidance is below the long-term 20% target and when they expect to reach it. Also asked about the lack of operating leverage given OpEx guidance.

Answer

The company stated the 17% guidance for 2025 is credible as it takes time for new programs to generate results, with acceleration expected in H2 2025. They expect to reach 20%+ growth from 2026 onwards, aided by these programs and new product launches. Regarding OpEx, they clarified that revenue growth (17%) is still guided to be faster than OpEx growth (12%), thus showing leverage, with investments being directed at clinical trials (R&D) and other growth initiatives.

Larry Biegelsen asked why Penumbra's 2025 revenue guidance of 12-14% doesn't reflect acceleration from 2024, given prior year headwinds. He also inquired about the timeline for the THUNDER trial data, regulatory filing, and clearance, and the implications of recent negative distal vessel trials.

Answer

CEO Adam Elsesser explained that the guidance reflects a philosophy of not getting ahead of themselves, particularly on factors they don't fully control, like the Thunderbolt approval timeline. He stated it's premature to provide a timeline for Thunderbolt but noted that the negative distal trials, which primarily used stentrievers, were not surprising and reinforce the move toward aspiration as a primary mechanism.

Asked about the current growth expectations for the core U.S. VTE market in 2024 and what revenue contributions are assumed in the guidance for the Artix system, Japan, and China.

Answer

The company still views the VTE market as a massive, robustly growing market in the early stages of penetration and sees no change in that trend for 2024. For new products and markets, the revenue contributions assumed in the 2024 guidance for the Artix relaunch and for initial sales in China and Japan are modest due to uncertainties around timing and initial ramp-up.

Asked about the key drivers for Axonics to achieve market leadership in the U.S. and whether a 25% SNM revenue growth rate is achievable for the next year.

Answer

The company reaffirmed its confidence in achieving its growth targets, which include approximately 25% year-over-year SNM revenue growth for Axonics and 15% overall market growth. They believe that by continuing to execute their current game plan, they will achieve market leadership, potentially by the end of 2025.