Danielle Antalffy

Danielle Antalffy from UBS Group asked about the go-to-market strategy for primary care physicians (PCPs), how it differs from the approach with endocrinologists, and the level of effort required to activate this channel.

Answer

President and CEO Ashley McEvoy explained that Omnipod's simplicity is a key advantage with PCPs. The combination of ease-of-use, strong clinical data, and a simple, affordable access model is driving early traction. EVP Eric Benjamin added that the conversation with PCPs focuses on selling the science and providing the necessary support for offices that may be new to prescribing automated insulin delivery systems.

Danielle Antalffy asked about the differences in the go-to-market strategy for primary care physicians (PCPs) compared to endocrinologists, and the relative effort required to activate the PCP channel.

Answer

Ashley McEvoy, Director, President & CEO, and Eric Benjamin, EVP, responded. They explained that Omnipod's simplicity is a key advantage for PCPs. The strategy combines this ease of use with strong clinical data and an accessible pharmacy model. For new prescribers, the focus is on education and support to help them and their staff manage patients on the therapy.

Danielle Antalffy questioned the Q4 U.S. Omnipod guidance, which appeared below consensus at the midpoint, seeking to understand the dynamics given the strong Q3 results and typical Q4 seasonality.

Answer

CFO and Treasurer Ana Maria Chadwick explained that the guidance reflects a tough comparison to Q4 2023, which included a $30-40 million stocking benefit. She stated that on a normalized basis, the underlying growth is approximately 21% at the midpoint. She also noted that the high end of the guidance range encompasses the consensus estimate and reflects the company's best available information.

Danielle Antalffy asked about Stryker's go-forward pricing power in MedSurg and Orthopaedics, specifically whether pricing is expected to be flat or if continued pricing power is anticipated.

Answer

Jason Beach, Vice President of Finance and Investor Relations, affirmed that Stryker expects to have opportunities for pricing power across all businesses going forward. He attributed this to overall execution, new products, and innovation, though he noted the impact would vary across different business lines.

Danielle Antalffy asked about the future outlook for pricing power, particularly in orthopaedics, given positive price trends in MedSurg and recent upticks in ortho, and whether flat pricing or continued pricing power is expected.

Answer

Jason Beach (VP of Finance and Investor Relations, Stryker) affirmed that Stryker expects continued opportunities for pricing power across all businesses, driven by execution, contracting, new products, and innovation, though the exact impact will vary by business line.

Danielle Antalffy of UBS Group asked for Stryker's current perspective on China as a growth market and whether the U.S. Mako adoption ramp is a good proxy for its international potential.

Answer

Chair & CEO Kevin Lobo described Stryker's China strategy as 'treading carefully,' maintaining its presence but being thoughtful with investments in the post-VBP era. For Mako's international ramp, he said the U.S. is a good proxy for markets like Japan and parts of Europe, but adoption will be slower in purely socialized medicine systems like France and Canada, though recent clinical data is helping drive interest globally.

Danielle Antalffy asked about the recession-proof nature of Stryker's business and whether there are any signs of hospital capital spending paralysis due to budget uncertainty.

Answer

CEO Kevin Lobo stated that the business is highly resilient, as most procedures are urgent or necessary, and the company is not seeing any signs of a slowdown. He confirmed there is no inertia in hospital capital spending, evidenced by a very strong order book and backlog, which gave management the confidence to raise full-year guidance.

Danielle Antalffy asked about Stryker's forward-looking R&D spending, productivity, and focus areas to ensure a continued cadence of new products that can sustain growth and pricing power.

Answer

CFO Glenn Boehnlein affirmed that Stryker's commitment to R&D remains strong, targeting 6-7% of sales to fuel its innovation engine. He said the strategy is unchanged, though the company will seek efficiencies by building centers of excellence for areas like software and AI. The integration of Inari's R&D is also a key focus.

Danielle Antalffy asked about the primary driver of market share gains in large joint orthopedics, questioning if it was the robot or the broad product portfolio, and also asked about the progress of procedures shifting to ASCs.

Answer

VP of Finance and IR Jason Beach stated that the success is a combination of all factors, including the large Mako installed base, rising utilization, and favorable pricing. CEO Kevin Lobo added that a key sustained advantage is Stryker's high-performing sales culture. Both deferred specific ASC procedure metrics to the year-end update but confirmed the trend is positive.

Danielle Antalffy of UBS Group AG questioned Boston Scientific's CRM business performance, noting it has grown below market while a competitor projects double-digit growth. She asked about the expected growth cadence with upcoming new product cycles, including the Denali platform, EMPOWER leadless pacemaker, and Elutia BioEnvelope assets.

Answer

Chairman and CEO Mike Mahoney highlighted strong performance in the LUX ICM device. He and CMO Dr. Ken Stein detailed the Denali platform, a complete refresh of implantable devices (Brady, high-voltage CRT, SICD) launching in late H2 2026 and throughout the LRP, expected to strengthen core CRM. They also emphasized EMPOWER's potential in the leadless pacemaker market and as an SICD enabler, alongside the Elutia BioEnvelope acquisition for preventing postoperative complications and strong growth in conduction system pacing.

Danielle Antalffy asked about the CRM business, which has been growing below market, especially with a competitor in a new product cycle. She inquired about the expected cadence of growth as Boston Scientific launches its own new product cycle.

Answer

Chairman and CEO Mike Mahoney noted satisfaction with the Lux ICM device's performance and highlighted significant investments in the new Denali platform, a complete refresh of pacemakers and defibrillators expected to launch from H2 2026 through the LRP. He also expressed enthusiasm for Empower, the company's entry into the leadless pacemaker market, combined with SICD. Mike Mahoney stated that while unit growth is at market, dollar growth has been below due to the leadless gap, but expressed confidence that the CRM business will strengthen and become a larger contributor over the LRP. Chief Medical Officer Dr. Ken Stein added that Empower is crucial for both leadless and SICD growth, and the Alucia Bioenvelope acquisition provides an important adjunctive technology to prevent complications. He emphasized Denali as a 'generational opportunity' for market-leading technology across all platforms and highlighted strong growth in conduction system pacing.

Danielle Antalffy of UBS Group AG inquired about potential capacity constraints for electrophysiologists performing both WATCHMAN and Farapulse procedures. She also asked if the Farapulse launch was expanding into lower-volume centers and if that was leading to an increase in their procedure volumes.

Answer

CEO Mike Mahoney stated that there are no significant capacity constraints, as the procedures are predictable and hospitals are investing in new labs to support the profitable service line. He noted the potential ASC rule could also ease capacity over time. Regarding the rollout, he confirmed that after initially focusing on high-volume centers, the company is now expanding the Farapulse launch into smaller centers as it scales its commercial and clinical footprint.

Danielle Antalffy of UBS inquired about the recent acquisition of SoniVie, asking about the expected timeline, key clinical and regulatory milestones, and when the renal denervation technology could become a meaningful contributor.

Answer

Michael Mahoney, Chairman and CEO, stated the deal should close in Q2 and expressed excitement about SoniVie's differentiated ultrasound technology. He noted the timing is favorable, allowing them to develop strong clinical data while the market and reimbursement landscape mature. Dr. Ken Stein, CMO, emphasized the large unmet need in hypertension and SoniVie's potential clinical advantages, including enhanced safety by not obstructing renal artery blood flow.

Danielle Antalffy asked for management's perspective on areas where Boston Scientific might be underperforming or has an underappreciated opportunity for improvement, beyond the well-known growth drivers.

Answer

CEO Mike Mahoney identified two key areas for improvement in 2025. First is Neuromodulation, where he anticipates better performance driven by a new DBS platform launch and refocused commercial efforts. Second is the U.S. CRM business, where the company aims to strengthen its position ahead of the EMPOWER leadless pacemaker launch in the second half of 2025. He also noted the need to address increasing competition from lower-cost players in certain segments.

Danielle Antalffy from UBS requested more color on sales growth drivers and headwinds for 2025, beyond the general guidance of 'above-market' growth.

Answer

CEO Michael Mahoney highlighted several tailwinds for 2025, including the full-year impact of FARAPULSE launches in Japan and China, continued penetration in the U.S., and the benefit of concomitant reimbursement for WATCHMAN. He also noted the AGENT drug-coated balloon as a potential contributor. CFO Dan Brennan added that formal 2025 guidance will be provided on the Q4 earnings call after the annual operating plan process is complete.

Danielle Antalffy asked about the structural heart business, focusing on left atrial appendage (LAA) closure, its evolution for Abbott in 2026 and beyond, and the company's benefit from concomitant procedures. She also questioned the barriers preventing faster basal CGM penetration in the U.S. diabetes market.

Answer

Robert Ford, Chairman and CEO, identified LAA closure as a crucial growth area, acknowledging Abbott needs to improve its share in concomitant procedures. He highlighted positive physician feedback for the next-generation Amulet device, with trial enrollment complete and filing expected in H1 2026 for a potential 2026/2027 launch, which will differentiate Abbott's full portfolio. Regarding basal CGM, Ford noted U.S. penetration is around 20%, attributing the slower pace to the large universe of primary care physicians, awareness building, and the need for better execution, including Epic integration and promoting ambulatory glucose profiles.

Danielle Antalffy of UBS Group AG asked about the Structural Heart business, specifically the Amulet franchise, and the potential for a competitor's upcoming trial data to expand the market and accelerate Amulet's growth.

Answer

Chairman and CEO Robert Ford concurred that positive trial data from both Abbott and its competitor would be a "rising tide" that expands the market. He noted Abbott's own trial enrollment will complete this year. He also highlighted significant R&D progress on a second-generation Amulet device, which has received "spectacular" physician feedback for its improved deployment and delivery.

Danielle Antalffy inquired about the strategy for accelerating growth in historically slower-growing businesses like Rhythm Management (CRM) and Vascular.

Answer

CEO Robert Ford detailed a deliberate strategy to elevate these businesses from flat to mid-single-digit growth, thereby lifting the entire medtech portfolio's growth rate. For CRM, the focus has been on establishing leadership in leadless pacing with the Aveir system, which has driven 7% growth over the last two years. For Vascular, the strategy involves increasing participation in higher-growth peripheral segments. Ford called Aveir one of the most underappreciated opportunities in Abbott's portfolio.

Danielle Antalffy asked for a deeper look into the Structural Heart business for 2025, focusing on the puts and takes between potential LAA closure indication expansion and upcoming competitive data in the tricuspid space.

Answer

Robert Ford, Chairman and CEO, expressed excitement for both areas. He noted strong growth and pipeline progress for Amulet (LAA), with a new trial for Amulet 2.0 starting soon. For tricuspid, he views the emergence of more clinical data as a positive for the new category and highlighted the NCD process for TriClip as a key opportunity. He believes tricuspid repair can become a billion-dollar business for Abbott over time.

Danielle Antalffy of UBS Group AG inquired about the drivers behind the stronger-than-expected surgical glaucoma results and the implications for the standalone market opportunity. She also asked for an updated timeline on TearCare reimbursement, questioning if positive decisions are now more likely in 2026.

Answer

Chief Commercial Officer Matt Link attributed the surgical glaucoma strength to stable market conditions and strong team execution, noting early but positive traction in the standalone market. CEO Paul Badawi added that the OMNI device is highly competitive in a single-MIGS environment. Regarding TearCare, CFO Ali Bauerlein and CEO Paul Badawi confirmed their conviction for reimbursement is growing with new clinical data, and while timing is uncertain, they are still working towards payer wins in 2025.

Speaking on behalf of Danielle Antalffy, an analyst from UBS asked about the reimbursement mechanics for OMNI versus competitive devices in the new single-MIGS environment. The follow-up question requested an update on TearCare reimbursement progress, including any trackable metrics like the number of covered lives or successful MAC enrollments.

Answer

CFO Alison Bauerlein explained that reimbursement dynamics are largely unchanged for the majority of the market, as most procedures were already single-MIGS. Regarding TearCare, she confirmed there are no covered lives yet but noted that individual claims are being paid. Bauerlein reiterated that the company is having productive conversations with payers and still expects positive coverage or payment decisions to begin in 2025.

Danielle Antalffy inquired about the market development progress for the standalone MIGS opportunity with OMNI and its long-term trajectory. She also asked for an update on TearCare reimbursement, seeking details on the percentage of claims being paid and key milestones for future adoption.

Answer

Executive Matthew Link and CEO Paul Badawi described strong momentum in fostering an 'interventional mindset' for standalone MIGS, supported by compelling 3-year clinical data, but noted that driving a paradigm shift takes time. CFO Alison Bauerlein addressed TearCare, stating that while specific claim numbers are not disclosed, there is an increasing volume of paid claims and growing payer acceptance. She highlighted that achieving formal policy coverage in 2025 is expected to be a major growth catalyst.

Danielle Antalffy questioned the company's confidence in returning to sustainable double-digit growth in 2026 and inquired about any interest in inorganic growth through tuck-in acquisitions.

Answer

CFO Mark Hair noted that the current guidance implies double-digit growth in the back half of 2025, driven by new products and commercial team additions, but deferred specific 2026 commentary. CEO John Treace added that the company is always opportunistically evaluating inorganic growth opportunities and is also increasing its focus on markets outside the U.S.

Danielle Antalffy from UBS asked management to frame the opportunity to attract new surgeons with the broader product portfolio and inquired about the company's long-term view on expanding into other areas of the foot and ankle market.

Answer

CEO John Treace stated that adding approximately 200 new surgeons in the year is a reasonable target and framed the market opportunity as penetrating the large 70% segment of the market that uses osteotomies. Regarding market expansion, he explained that for the near-to-moderate term, the company's R&D is focused on its core bunion and midfoot markets, with little need to explore other foot and ankle areas given the significant runway ahead.

Danielle Antalffy asked for the rationale behind the updated 2024 guidance, which implies a step-down in Q4 growth, and inquired about potential headwinds like hurricane impacts. She also pressed for conceptual thoughts on 2025 growth, questioning if a deceleration was likely given the strong new product pipeline.

Answer

CFO Mark Hair explained that Q3 had an easier year-over-year comparison and that the current guidance prudently accounts for known headwinds and some new variables like IV bag rationing and hurricanes. Regarding 2025, he stated that while the product pipeline is strong, the company wants to observe the market adoption of its new MIS systems before providing guidance, reiterating the primary focus on achieving adjusted EBITDA breakeven.

Danielle Antalffy of UBS Group asked how the Monogram and ROSA robotic platforms are expected to coexist within the portfolio and what unique value Monogram brings to the market.

Answer

Chairman, President & CEO Ivan Tornos emphasized that the strategy is to offer the most flexible and comprehensive suite of solutions to meet diverse surgeon preferences. He noted that 80% of U.S. surgeons and 90% internationally do not use a robot, and Monogram's autonomous capabilities will expand the market by appealing to surgeons seeking efficiency and reproducibility.

Danielle Antalffy of UBS requested more details on the Ambulatory Surgery Center (ASC) opportunity, including the current revenue contribution and how the Paragon 28 portfolio enhances ZBH's position.

Answer

President and CEO Ivan Tornos highlighted that ASC-related revenue has grown from 2-3% in 2019 to nearly 20% today, with ZBH holding the #1 position in Hips and Knees in that setting. He noted that the Paragon 28 portfolio presents a significant, though not fully modeled, synergy opportunity in ASCs due to favorable reimbursement for procedures like bunions. He projects 40-60% of core orthopedic cases will migrate to ASCs in the next 3-5 years.

Danielle Antalffy from UBS asked about the competitive dynamics in the shoulder market and Enovis's strategy to maintain its leadership position. She also inquired about the current stage of the turnaround in the P&R business and its future growth potential.

Answer

CEO Damien McDonald outlined a multi-pronged shoulder strategy focused on surgeon relationships, commercial execution (especially cross-selling), and innovation like the ARG system and next-gen ARVIS. CFO Ben Berry added that the Lima acquisition was critical for market access. On P&R, McDonald praised the team's execution and new products like Manifuse, while Berry noted the business has stabilized to consistent low-single-digit growth, with a focus on continued shaping and improvement.

Danielle Antalffy asked how recession-proof the business is and whether the current tariff situation alters the company's long-term annual margin expansion goals.

Answer

CEO Matthew Trerotola asserted that their markets are highly resilient, with historically limited impact from recessions. CFO Phillip Berry confirmed the company remains committed to its long-term margin expansion goals, viewing the 2025 tariff impact as a temporary delay and expecting to resume momentum toward those goals in 2026, driven by favorable mix, scale, and synergies.

Danielle Antalffy asked how much of the expected sales synergies and new product launch benefits are already factored into the 2025 guidance versus representing potential upside. She also inquired about the medium-term (3-5 year) capital deployment strategy.

Answer

CFO Phillip Berry characterized the guidance as thoughtful and slightly conservative, noting it contemplates new products and cross-selling but that upside opportunity exists. CEO Matthew Trerotola reiterated that acquisitions remain a key long-term strategy, with a near-term focus on smaller deals and deleveraging before pursuing larger opportunities in ortho and adjacent medtech spaces.

Danielle Antalffy asked a high-level, long-term question about the company's strategic direction, capital deployment priorities, and portfolio evolution now that the Lima integration is progressing.

Answer

CEO Matthew Trerotola outlined the company's transformation into a $2B+ dedicated medtech firm. He stated the future strategy is to grow the Recon segment well above market, improve the P&R business to a mid-single-digit grower, and pursue bolt-on M&A. He sees a clear path to $3B in revenue driven by organic and inorganic growth, margin expansion, and improved cash flow.

Danielle Antalffy of UBS Group AG asked for commentary on market growth versus market share dynamics for new patient starts and whether competitive pressures have increased in the U.S.

Answer

EVP, CFO & Treasurer Leigh Vosseller stated that Tandem has been a leader in durable pump starts and expects to maintain that position. She affirmed the market is still growing and underpenetrated, with room for multiple companies to grow. She believes Tandem can drive its own growth through its product portfolio and pharmacy channel expansion, which can attract more patients to durable pump therapy.

Danielle Antalffy asked for a bridge to the company's goal of reaching 60% gross margins by 2026, questioning how potential headwinds like a shift to pharmacy would be overcome.

Answer

CFO Leigh Vosseller clarified that the pharmacy channel is a tailwind, not a headwind, due to favorable pricing. She outlined three key drivers to 60% gross margin: 1) cost efficiencies from the Mobi pump and cartridges, 2) meaningful price improvement from pharmacy contracts, and 3) margin benefits from going direct in select OUS markets.

Danielle Antalffy of UBS inquired about the key priorities for a Type 2 diabetes patient, such as simplicity and cost, and asked how their pump utilization patterns might differ from those of Type 1 patients.

Answer

CEO John Sheridan and CCO Mark Novara identified simplicity, discretion, and affordability as key for Type 2 patients. Sheridan noted Mobi and the pharmacy channel address these needs. Novara added that Tandem's portfolio offers choice for different patient preferences and that their experience with 30,000 existing Type 2 users informs their training and support.

Danielle Antalffy asked about Tandem's growth relative to the overall market and if the company is positioned to grow above market rates in 2025.

Answer

President and CEO John Sheridan stated that while it's difficult to assess market share without competitor data, he believes Tandem is "holding our own." He expressed optimism for 2025, noting that previous headwinds like pharmacy access are now becoming tailwinds, alongside new products and the Type 2 indication, which should drive future growth.

Danielle Antalffy of UBS Group sought more confidence regarding underlying volume trends, questioning whether the current pressures are temporary execution issues or indicative of a structural market change, such as the impact of GLP-1 drugs.

Answer

CEO Tim Herbert asserted that the issues are temporary, stemming from the delayed Inspire V transition which also limited footprint expansion in the first half. He expressed strong confidence in the company's ability to overcome these headwinds, highlighting the positive early performance of Inspire V and corrective actions already underway. He maintained that GLP-1s represent a long-term tailwind for the business by helping more patients become eligible for therapy.

Danielle Antalffy of UBS followed up on the sales cadence for the year, asking about the company's visibility into existing Inspire IV inventory levels. She questioned the level of confidence in being able to make up for the Q2 slowdown in the second half, noting that back-half loaded guidance can make investors nervous.

Answer

CEO Tim Herbert stated that Inspire has close visibility into field inventory, noting that most centers hold only a few units. He explained that while high-volume centers hold more, they also have high implant rates and are expected to work through their Inspire IV stock quickly during Q2. Herbert expressed confidence in the back-half ramp as they replace the old inventory with the new Inspire V system.

Danielle Antalffy inquired about the impact of the digital scheduling tool at 300 centers on patient volumes and sought an update on physician sentiment regarding reimbursement for the new Inspire V device.

Answer

Chairman and CEO Tim Herbert explained that a successful pilot program showing significant advantages in patient appointment setting led to the expansion of digital scheduling to 300 centers. Regarding Inspire V reimbursement, he stated it is not expected to be a barrier, as the reduced surgical time should result in a comparable time-adjusted reimbursement rate for surgeons, potentially allowing them to perform more cases. He also noted that reimbursement for Ambulatory Surgical Centers (ASCs) is actually higher with the new CPT code.

Danielle Antalffy from UBS asked for quantification of the revenue headwinds from hurricanes and IV fluid shortages mentioned in the Q4 guidance. She also inquired about the top of the patient funnel, asking about the potential tailwind from new sleep apnea awareness drivers like wearable tech and GLP-1 drugs in 2025.

Answer

CEO Tim Herbert explained that it is difficult to quantify the Q4 headwinds at this time but acknowledged they are monitoring the impact of regional center closures and a national IV solution shortage. He agreed that increased awareness from various sources, including new diagnostic technologies and GLP-1s, will serve as a tailwind by expanding the pool of diagnosed patients, and that Inspire is focused on improving the efficiency of connecting these patients to providers.

Danielle Antalffy of UBS Group AG asked how physicians are currently balancing the use of iDose TR versus iStent products and what the decision-making pathway looks like, seeking a snapshot of how the product lines might coexist in the future.

Answer

President & COO Joe Gilliam explained that for early adopters, iDose TR is becoming the foundational, first-line therapy due to its broad label. Physicians then increasingly use iStent Infinite, sometimes in combination with iDose TR, for patients who are progressing or require further intervention to avoid more invasive surgeries. This positions iStent as a tool for more advanced disease management.

Danielle Antalffy asked about the long-term growth outlook for the legacy iStent franchise in an environment with a rapidly ramping iDose, and for an update on the market development for iStent Infinite in standalone procedures.

Answer

President and COO Joseph Gilliam and Chairman and CEO Thomas Burns both responded. Gilliam expressed strong conviction that the shift to an "Interventional Glaucoma" paradigm creates a long-term growth runway for both iDose and stents. Burns added that he expects surgeons will increasingly combine iDose with iStent Infinite, driving growth for both products in tandem rather than at each other's expense. Gilliam noted they are well ahead of schedule in driving standalone adoption compared to the early days of combo-cataract MIGS.

Danielle Antalffy asked a high-level question comparing the current iDose launch to the original iStent launch from 2012-2015. She inquired about the key differences and gating factors that might influence the speed of the iDose revenue ramp compared to the historical precedent.

Answer

President and COO Joe Gilliam detailed the similarities and differences. A key advantage for iDose is that many more surgeons are now trained in angle-based surgery. However, he noted two significant new challenges: the complexity of reimbursement for a premium-priced procedural pharmaceutical, and the much larger prevalence of Medicare Advantage plans today, which present additional coverage hurdles compared to traditional Medicare. He concluded that while there are parallels, the different market dynamics make a direct comparison difficult.

Danielle Antalffy from UBS Group AG asked about Dexcom's strategy to protect its competitive moat in the Type 1 patient population as a key competitor prepares to integrate with insulin pumps.

Answer

CEO Kevin Sayer highlighted Dexcom's extensive experience, with over 2 million patient-years on automated insulin delivery (AID) systems built on its technology. President & COO Jacob Leach added that the comprehensive Dexcom ecosystem, including features like Share/Follow and AI meal logging, provides a superior overall user experience beyond just the sensor integration.

Danielle Antalffy from UBS asked about Dexcom's potential exposure or protection in the event of a macroeconomic recession, considering its business model and product value.

Answer

CFO Jereme Sylvain and CEO Kevin Sayer both expressed confidence in the company's resilience. They stated that because Dexcom's CGM provides significant cost savings to the healthcare system and offers tremendous informational value, they believe the business would hold up very well in an economic downturn.

Danielle Antalffy asked about the long-term impact of increasing coverage for non-insulin Type 2 patients on the relationship between volume and revenue growth.

Answer

CFO Jereme Sylvain clarified that the unit economics per sensor are similar across patient populations, so there is no direct impact on profitability per sale. However, he noted that modeling should account for potentially lower utilization on a per-patient, per-year basis. CEO Kevin Sayer added that for reimbursed patients, retention and utilization rates are quite high.

Danielle Antalffy asked for more color on Dexcom's progress throughout Q3, the revenue run rate exiting the quarter, and its current market share position within the DME channel, noting that U.S. revenue came in below consensus.

Answer

CEO Kevin Sayer acknowledged the quarter was challenging but noted they hit the high end of their guidance. He highlighted positive momentum exiting the quarter, including record new patient adds in late August and September, the addition of 35,000 new prescribers, and stabilization of DME channel share in September. He expressed confidence in achieving higher sequential growth in the U.S. for Q4.

Danielle Antalffy of UBS Group asked about capital allocation priorities, given the company's significant cash balance, and sought to understand the drivers behind the strong growth observed in the non-invasive product category.

Answer

CEO Moshe Mizrahy stated that all capital allocation options, including buybacks and dividends, remain under consideration, though he noted potential tax implications and confirmed no acquisitions are in the pipeline. He explained that the trend toward non-invasive products is driven by their lower cost for patients compared to more expensive minimally invasive procedures. He also credited the success of the new Optimus Max platform for boosting non-invasive sales.

Danielle Antalffy of UBS asked about the macroeconomic assumptions baked into the reiterated guidance, particularly concerning a potential recession, and inquired about the company's strategy for keeping its sales force engaged during the downturn, drawing parallels to the COVID-19 period.

Answer

CEO Moshe Mizrahy explained that the guidance is based on historical seasonality and they are waiting for Q2 performance before making adjustments. He differentiated the current slowdown from the COVID era, noting that while sales have decreased significantly and profit is down 50%, the company is strategically retaining its entire workforce. He emphasized that InMode is a 'people-intensive company' and believes this investment will position them to lead when the market rebounds, even at the cost of short-term profitability.

Danielle Antalffy inquired about InMode's capital deployment strategy, questioning if M&A was still a priority alongside the new share repurchase program. She also asked for qualitative insights on any potential economic turnaround in 2025.

Answer

CEO Moshe Mizrahy explained that while InMode is always exploring M&A, no synergistic targets have been identified, leading to the decision to expand the share buyback program. Regarding the economy, he stated that the company currently sees no signs of a turnaround and will refrain from making predictions after their previous estimates for a 2024 recovery did not materialize.

Danielle Antalffy of UBS Group questioned the long-term growth runway for the open ablation business, given its sustained high growth rate, and asked if this was driven by adding new surgeons or deeper penetration.

Answer

Michael Carrel, President, Director & CEO, affirmed a long growth runway, noting that penetration in AFib-only patients is still only around 35-40%, far below the 100% guideline recommendation. He confirmed they are adding new surgeons "every day," especially CABG surgeons who are now adopting the Encompass clamp, and pointed to the future market expansion opportunity from the BOX No AF trial.

Danielle Antalffy asked about the competitive moat around the AtriClip business and the remaining growth runway for the EnCompass clamp in the open ablation business.

Answer

CEO Michael H. Carrel stated that AtriCure's moat is built on continuous innovation like the FLEX-Mini and will be solidified by the unique stroke-reduction label expected from the LeAAPS trial. He added that the EnCompass clamp has a long runway, with only ~40% penetration in its current market and a significant future market expansion opportunity from the BoxX-NoAF trial.

Danielle Antalffy from UBS asked for framing of the remaining growth runway in the open ablation business and inquired about the drivers of success for the MIS business in Europe and its applicability to the U.S. market.

Answer

CEO Michael H. Carrel detailed a significant growth runway, noting U.S. penetration in treating pre-op Afib is only ~35% and the post-op Afib market is three times larger. He explained that Europe's MIS success is driven by a growing funnel of patients who have failed PFA therapy, a dynamic he expects will be replicated in the U.S. over time.

Danielle Antalffy of UBS Group AG asked whether the MedTech business could achieve high-single-digit growth by 2026-2027, considering its current momentum and strong pipeline despite underperformance in some areas.

Answer

EVP Tim Schmid identified Cardiovascular and Surgery (with the upcoming Ottava launch) as the two primary future growth drivers for MedTech. While expressing confidence in achieving the previously stated 5-7% operational growth target through 2027, he declined to speculate on performance beyond that range, but noted efforts to improve the Orthopedics business.

Danielle Antalffy of UBS asked about the recession-proof nature of Johnson & Johnson's business and which areas might be most at risk in an economic downturn.

Answer

CFO Joseph Wolk stated that while not immune, healthcare is generally recession-proof, though elective procedures in orthopedics could see delays. CEO Joaquin Duato affirmed that overall healthcare demand remains solid. EVP, MedTech, Tim Schmid noted that the advanced IOLs business, a good economic indicator, has shown no negative impact and is performing well.

Danielle Antalffy of UBS inquired about the Electrophysiology (EP) business, asking about the impact of PFA competition, underlying market growth, and how the upcoming launch of VARIPULSE is expected to alter market dynamics for J&J.

Answer

Tim Schmid, Executive VP of MedTech, stated that the $5 billion EP business grew 11% in Q3. While facing PFA competition, he emphasized that J&J's CARTO system is still used for mapping in over 50% of competitive cases. He expressed excitement for the VARIPULSE launch, expected late Q4 or early Q1, which will leverage J&J's large installed base and position the company to compete directly in the PFA space with a full portfolio of catheters to follow.

Danielle Antalffy asked for more clarity on the timeline for the Cardiac Ablation Solutions (CAS) business to double its revenue from approximately $1 billion to $2 billion.

Answer

CEO Geoffrey Martha expressed high confidence in achieving this goal, citing 'incredible demand' for the Affera PFA system and a now-scaled manufacturing process. While he did not provide a specific date, he characterized the timeline as 'not far off' and 'more near term,' suggesting it is achievable in the ballpark of the next fiscal year.

Danielle Antalffy asked for more clarity on the timeline to double the Cardiac Ablation Solutions (CAS) business to $2 billion, noting that management's commentary suggested it could be a near-term achievement.

Answer

CEO Geoff Martha confirmed the goal is 'not far off' and 'more near term.' He cited 'incredible demand' for the Affera PFA system, a rapid manufacturing scale-up, and a strong follow-on pipeline with the Sphere360 catheter. He indicated that while a specific date wasn't given, achieving it within the 'ballpark' of the next fiscal year was a reasonable interpretation.

Danielle Antalffy requested a 'state of the nation' on the TAVR market, asking about growth drivers in light of recent clinical data and the impact of a competitor's delayed entry into the U.S. market.

Answer

Sean Salmon, EVP & President of the Cardiovascular Portfolio, described the TAVR market as healthy, with growth in the high single-digit range. He identified future growth from treating asymptomatic patients and, more significantly, moderate aortic stenosis. He highlighted the strength of Medtronic's data, particularly from the SMART trial, and the benefits of the new Evolut FX+ valve in addressing coronary access concerns.

Danielle Antalffy asked about the company's evolving approach to capital allocation, specifically regarding organic versus inorganic investments, now that the business is stabilizing and the Kidney Care sale is complete.

Answer

EVP & CFO Joel Grade reiterated the company's focus on targeted investments to accelerate growth, including both organic R&D and inorganic tuck-in acquisitions. He confirmed Baxter is on track to achieve its net debt-to-EBITDA target of 3x by year-end, after which the company will have the flexibility to pursue these inorganic opportunities and potentially reinstate a share buyback program.

Danielle Antalffy requested more specific details on the key pipeline drivers for 2025 and 2026, asking for potential sizing of the approximately 10 new pharma product launches and other innovations.

Answer

Executive Joel Grade outlined key 2025 drivers including a full year of the Nova IQ pump launch, mid-single-digit growth in Advanced Surgery, and momentum in HFC capital sales. Executive Heather added excitement for the pump platform's ecosystem, new HST product launches in 2025-26, and a cadence of 10-12 complex molecule launches per year in Pharma. Executive Brent concluded by stating a new key focus is on accelerating the entire innovation cycle to bring solutions to market faster.

Danielle Antalffy asked about the gross margin cadence for 2025 and the long-term upside potential, and also sought clarification on the 'noble business models' mentioned in the prepared remarks and their replicability.

Answer

CFO Shelley Thunen guided to a consistent cadence of gross margin improvement driven by mix, stating the company could reach 80%+ gross margin at maturity. CEO Dr. Ron Kurtz clarified that the business models refer to LDD-focused treatment centers, a trend he sees growing and analogous to the historical development of LASIK centers, which positively expands access for doctors and patients.

Danielle Antalffy asked about the competitive dynamics in the U.S. TAVR market, including share stability, the potential impact of a fourth market entrant, and the current pricing environment.

Answer

Larry Wood, Group President of TAVR, stated that Edwards charges a premium for its SAPIEN 3 Ultra RESILIA platform, which he believes is justified by best-in-class technology and a strong body of clinical evidence. CEO Bernard Zovighian added that the company's strategy across all segments is to lead with premium, breakthrough technologies that deliver value, and that they are confident in this strategy despite growing competition.