Joanne Wuensch

Joanne Wuensch inquired about the impact of CMS language regarding the elimination of chart-derived diagnoses on Zio use and asked for clarification on 2026 gross and operating margin guidance.

Answer

President and CEO Quentin Blackford explained that Zio provides confirmatory diagnoses, aligning with CMS's focus and potentially acting as a tailwind by reducing care costs. CFO Dan Wilson provided formal adjusted EBITDA margin guidance of 11.5%-12.5% for 2026 (3%-4% for Q1) and projected 80-100 basis points of gross margin improvement.

Joanne Wuensch asked about the implications of CMS's language regarding the elimination of chart-derived diagnoses for Zio use and requested clarification on the 2026 gross and operating margin guidance.

Answer

Quentin Blackford, President and CEO, addressed the CMS concerns, stating that Zio provides a confirmatory diagnosis, which he believes will be a tailwind for the company by reducing the cost of care. Dan Wilson, CFO, provided 2026 Adjusted EBITDA margin guidance of 11.5%-12.5% for the full year and 3%-4% for Q1, also projecting an incremental gross margin improvement of 80-100 basis points.

Joanne Wuensch requested guidance on the progression of revenue and gross margins throughout 2026, specifically for Q1, Q2, Q3, and Q4, to help model the impact of U.S. and OUS transitions.

Answer

EVP and CFO Leigh Vosseller advised expecting a similar seasonal curve for U.S. pump shipments as in 2025, with the lowest point in Q1 and highest in Q4, which heavily influences gross margins. She projected gross margins to start around 54% in Q1 and scale linearly to 60% by Q4, driven by supply pricing benefits from the pharmacy channel and positive contributions from the scaling OUS direct business, despite pump price headwinds. She noted that while the models are not yet dissimilar from past years, pharmacy's growing role will eventually level out seasonal curves.

Joanne Wuensch asked for guidance on the progression of revenue and gross margins throughout 2026, including ratios or groundwork for modeling, given the numerous changes in both U.S. and international markets.

Answer

EVP and CFO Leigh Vosseller advised modeling U.S. pump shipments with similar seasonality to prior years (lowest in Q1, highest in Q4), as 80% will still be through DME. Gross margins are expected to follow a similar trajectory, starting at nearly 54% in Q1 and scaling linearly to 60% in Q4, driven by higher pump margins and the pricing benefit from pharmacy supplies. She noted that international direct business scaling also contributes positively, and while headwinds exist, pharmacy will eventually help level out seasonal curves.

Joanne Wuensch of Citi inquired about the outlook for the international business rolling into 2026 and the company's plans for adding more direct salespeople and expanding into more regions.

Answer

EVP, CFO & Treasurer Leigh Vosseller confirmed that investments in systems, talent, and market research are already underway in 2025 to prepare for the transition to direct operations. She stated that going direct will allow Tandem to drive growth differently with more intimacy and will also provide a structural revenue and margin benefit by eliminating the price concessions given to distributors.

Joanne Wuensch's team asked whether international (OUS) customer renewals are expected to achieve the same high rates seen in the U.S.

Answer

CFO Leigh Vosseller noted that while early OUS renewal momentum is positive, she does not expect to immediately match the U.S. rate of 70% capture within 18 months. She explained it took years to build to that level in the U.S. but expressed confidence in achieving that goal OUS long-term.

Joanne Wuensch asked if the core insulin pump market is seeing accelerated adoption globally and what factors are driving this potential shift.

Answer

President and CEO John Sheridan explained that 2023 was a "bumpy year" due to customer pausing ahead of multiple new product launches across the industry. He believes 2024 will be a year of market growth, driven by the absence of that dynamic, continued innovation, and new indications like the upcoming Type 2 label, which will expand the addressable market.

Joanne Wuensch asked what internal changes, if any, have occurred since Q3 in how Integer runs its business and communicates goals, particularly in light of activist involvement, and if this has impacted their approach to setting goals.

Answer

Payman Khales, President and CEO, stated that Integer is not changing its business operations because the management and board have strong belief in their strategy, execution, and ability to deliver sustainable shareholder value. He emphasized that the three new product headwinds are an unusual, unexpected event related to market adoption, not a reflection of a need for strategic change. Mr. Khales affirmed that while they listen to all shareholders, they remain confident in their current strategy.

Joanne Wuensch asked if the dynamic in neuromodulation, where forecasts changed in Q3 after an anticipated ramp, was similar to electrophysiology. She also questioned if having multiple customers (three in this case) simultaneously change their forecasts and ordering patterns was an aberration in Integer's business history.

Answer

Payman Khales, President and CEO-elect, confirmed a similar dynamic in neuromodulation, where a handful of customers are not seeing the anticipated market adoption, leading them to align purchases with observed market demand. He noted that this book of business is still growing at a high single-digit rate in Q4. Khales emphasized that having multiple programs with a large magnitude of change occurring simultaneously is highly unusual and an aberration for Integer's business.

Joanne Wuensch asked if the dynamic in neuromodulation, where forecasts changed in Q3, was similar to electrophysiology. She also questioned if having multiple customers (three in this case) simultaneously change their ordering patterns is an aberration in Integer's business history.

Answer

Payman Khales, President and CEO-elect, confirmed a similar dynamic for neuromodulation, where a handful of emerging customers are not seeing anticipated market adoption rates, leading to forecast adjustments. He emphasized that having multiple programs with significant magnitude changes simultaneously is 'highly unusual' and an 'aberration' for Integer.

Joanne Wuensch sought to reconcile the strong Q2 results with the narrowing of the full-year revenue guidance, asking if the 'Other' market segment was declining faster than anticipated. She also asked about the extent of customer inventory management in the second half of the year, particularly in the context of potential tariffs.

Answer

COO Peyman Khales clarified the full-year guidance math, stating the midpoint of $1.863 billion is based on strong visibility from their ~$700 million backlog. He reiterated the outlook for C&V (mid-teens), CRM & N (5%), and a ~$32.5 million decline in 'Other' markets. Regarding inventory, Khales noted that management has become more normalized over the last couple of years and that the company's guidance already accounts for any customer inventory adjustments. He also stated the potential tariff impact remains minimal, in the $1-5 million range.

Joanne Wuensch from Citigroup asked for the quantified impact of fewer shipping days in the quarter and questioned how OEM manufacturing would perform in a recessionary environment.

Answer

CEO Joseph Dziedzic quantified the impact of fewer shipping days at approximately 300 basis points of headwind in Q1. Regarding a potential recession, he stated that the medtech industry is resilient, with most of Integer's supported therapies being non-elective. He believes the trend of customers outsourcing manufacturing to partners like Integer would continue, as it allows them to focus capital on therapy development and commercialization.

Joanne Wuensch requested preliminary commentary on the outlook for 2025 and sought confirmation of the underlying market growth rate assumption Integer uses for its strategic targets.

Answer

Joseph Dziedzic, President and CEO, stated that while formal 2025 guidance will be provided in February, the company remains focused on its strategic objectives of growing sales organically 200 basis points above the market and expanding operating profit at twice the rate of sales. He noted that 2024 has been a normal market growth year and he has no reason to believe 2025 will be different.

Joanne Wuensch asked about upcoming announcements at ADA and the clinical development timeline for Omnipod 6.

Answer

Ashley McEvoy (President and CEO) discussed presenting data from the Evolution feasibility study for Insulet's fully closed loop system at ATTD (not ADA). She detailed its design for Type 2 diabetes, emphasizing no user intervention, no clinician-defined settings at start, and patient self-initiation of training. Eric Benjamin (COO) clarified that ATTD would feature Evolution data and health economic data, while ADA would include pivotal results from the Strive study supporting Omnipod 6, along with new independent third-party studies comparing AID systems.

Joanne Wuensch inquired about key announcements expected at the upcoming ADA conference and the timeline for clinical updates regarding Omnipod 6.

Answer

Ashley McEvoy, President and CEO, highlighted that Insulet would share data from its Evolution feasibility study for the fully closed-loop system for Type 2 diabetes at ATTD, emphasizing its design for no user intervention, no clinician-defined settings, and patient self-initiation. Eric Benjamin, COO, added that ATTD would also feature health economic data. At ADA, Insulet plans to publish pivotal results from the Strive study, which supports Omnipod 6, and discuss independent third-party studies comparing on-market AID systems.

Joanne Wuensch asked about the new leadership team's (CEO, CFO, Investor Relations) plans to maintain momentum and implement new strategies to continue the company's strong performance.

Answer

Ashley McEvoy, President and CEO, emphasized elevating strong internal talent and welcoming new capabilities. She stated the focus is on leveraging remarkable technology, selling on science, scaling the supply chain for affordability, and investing in market development and demand generation. Flavia Pease, CFO, added that the strategic and capital allocation strategy remains intact, with a focus on understanding priorities, innovation, commercial plans, and expanding market penetration while executing with discipline.

Joanne Wuensch asked a high-level question about the new leadership team, including the CEO, CFO, and VP of Investor Relations, and their collective plans to maintain and build upon the company's current momentum.

Answer

Ashley McEvoy (President and CEO) emphasized the elevation of strong internal talent (Eric Benjamin as COO, Amit Guliani as CTO) and the addition of new capabilities (Flavia Pease as CFO, Manoj Raghunandanan as Chief Growth Officer). She highlighted a focus on selling with science, leveraging supply chain scale for affordability, and investing in market development and demand generation to build a competitive moat. Flavia Pease (CFO) added that the strategic and capital allocation strategy remains intact, with a focus on understanding priorities, innovation, commercial plans, and expanding market penetration.

Joanne Wuensch of Citigroup Inc. asked about Insulet's strategy for international expansion beyond its three core European markets.

Answer

President and CEO Ashley McEvoy detailed a multi-faceted strategy focused on: 1) increasing penetration in stronghold markets like the UK, France, and Germany; 2) realizing positive price mix from the Omnipod 5 upgrade cycle; and 3) executing a financially disciplined expansion into new markets. She noted successful recent launches in Canada, Australia, and the Netherlands, with more details on future plans to be shared at the upcoming Investor Day.

Joanne Wuensch asked about Insulet's strategy for international expansion, specifically how the company thinks about growing its footprint beyond its current key markets.

Answer

Ashley McEvoy, Director, President & CEO, outlined a balanced strategy focused on three areas: 1) driving deeper penetration in existing strongholds like the UK, France, and Germany; 2) capturing positive price mix from the Omnipod DASH to Omnipod 5 conversion; and 3) executing a financially disciplined expansion into new markets, noting that recent launches are performing well.

Joanne Wuensch asked for the long-term view on expanding gross and operating margins beyond the current planning period, and how the company balances margin goals with the necessary investments to scale the organization significantly.

Answer

President and CEO Ashley McEvoy expressed satisfaction with achieving industry-leading gross margins in the low 70s, driven by manufacturing efficiencies. She reaffirmed the 2025 adjusted operating margin guidance of 16.5% and stated that the company's disciplined investment approach remains unchanged, allowing flexibility to fund key growth opportunities in the U.S. type 2 market and international expansion.

Joanne Wuensch of Citi asked management to weigh the relative importance of U.S. Type 2 adoption versus international expansion as the primary revenue growth driver over the next 12-18 months and beyond.

Answer

President and CEO Jim Hollingshead described both as core strategic imperatives with significant growth opportunities. He deliberately avoided prioritizing one over the other, stating that the company is focused on leading growth in U.S. Type 1 and Type 2, as well as driving international rollout. He deferred a more detailed long-term outlook to the upcoming Investor Day in June.

Joanne Wuensch asked about the new patient opportunity created by the Libre and G7 integrations and sought confirmation on whether new patient starts were positive year-over-year in Q3.

Answer

President and CEO Jim Hollingshead confirmed that sensor integrations provide growth tailwinds. Regarding new patient starts, he clarified that while there was 'really clear sequential growth' in Q3, the company expects to see 'very clearly to have year-over-year growth for the second half' for the U.S., combining Q3 and Q4 performance.

Joanne Wuensch inquired about the early clinical data for the new contact lens material (Halo daily disposable) and its impact on confidence, as well as the expected progression of EBITDA expansion throughout the four quarters of 2026.

Answer

Chairman and CEO Brent Saunders and EVP and Chief Medical Officer Yehia Hashad reported positive top-line data from the first external clinical evaluation of the Halo daily disposable contact lens, noting no adverse events and good visual acuity in 98.5% of subjects, increasing confidence for the 2028 launch. Brent Saunders and CFO Sam Eldessouky reiterated the natural seasonality of the business, with Q1 being the lowest and Q4 the highest, which will be more pronounced due to dry eye growth. Sam Eldessouky detailed that Q1 revenue is expected to be around 22% of the midpoint guidance, and EBITDA around 18% (up from 14% last year), reflecting operating leverage.

Joanne Wuensch inquired about the early clinical data for the new contact lens material (Halo daily disposable), asking for more details on what increased the company's confidence. She also asked for insights into the progression of EBITDA expansion throughout the four quarters of 2026 to help model expectations.

Answer

Chairman and CEO Brent Saunders and EVP and Chief Medical Officer Yehia Hashad reported positive top-line data from the first external clinical evaluation, noting no adverse events, good visual acuity for 98.5% of subjects, and increased confidence in the platform for the planned 2028 launch. Mr. Saunders and CFO Sam Eldessouky reiterated the natural seasonality of the business, with Q1 being the weakest and Q4 the strongest, which will be more pronounced due to the growing dry eye franchise. Mr. Eldessouky provided specific Q1 2026 guidance: approximately 22% of midpoint revenue and 18% of midpoint EBITDA, indicating improved leverage compared to Q1 2025.

Joanne Wuensch asked for insights into the contact lens business, specifically regarding Bausch + Lomb's market share and overall market dynamics, referencing a recent Wall Street Journal article where the company was quoted.

Answer

Chairman and CEO Brent Saunders stated that the contact lens market is growing in the mid-single digits, with Bausch + Lomb consistently outpacing the industry due to new product innovations and strong execution. He clarified that the Cooper situation mentioned in the article is an internal matter for Cooper and its shareholders.

Joanne Wuensch inquired about the performance of the contact lens business, specifically its growth rate relative to the market, Bausch + Lomb's market share, and any additional insights regarding recent changes in the contact lens market, including comments on a Wall Street Journal article.

Answer

Chairman and CEO Brent Saunders stated that the contact lens market is growing in the mid-single digits, with Bausch + Lomb outpacing the industry due to new product innovations and strong execution, particularly with daily SIHY Infuse and Ultra daily. He clarified that the Cooper situation mentioned in the Wall Street Journal is an internal matter for Cooper, but a more scaled competitor could benefit consumers.

Joanne Wuensch of Citibank asked for an update on the company's contact lens product pipeline and what innovations could be expected in the coming years.

Answer

CEO & Chairman Brent Saunders described the contact lens R&D pipeline as the best in the company's history, marking a strategic shift from "catching up" to "leading the market." EVP of R&D Yehia Hashad provided details on the "Biomimetic" lens project, a significant material innovation. He confirmed that after approximately 10 successful internal studies, a large-scale external clinical study is set to begin around October, with a full deep-dive planned for the November Investor Day.

Joanne Wuensch requested an overview of the contact lens market, including demand trends in the U.S. and internationally and the potential impact of a recession. She also asked for details on the four new contact lens products shown in the pipeline slide.

Answer

Chairman and CEO Brenton L. Saunders described the contact lens market as resilient, with continued mid-single-digit growth and a history of muted but positive growth even during recessions. Head of R&D Yehia Hashad elaborated on the pipeline, noting the biomimetic lens is in final optimization studies, the myopia lens will have interim data by early 2026, and a new premium FRP SiHy lens program has started. Saunders added that these new lenses are designed for existing manufacturing infrastructure, avoiding large capital investments.

Joanne Wuensch inquired about the contact lens business, asking about the sustainability of its strong double-digit growth and for more details on key pipeline products, specifically the biomimetic lens and the myopia control solution.

Answer

Chairman and CEO Brenton L. Saunders expressed pride in the contact lens performance, attributing the growth to a strong market, broad-based execution in the U.S. and China, and investments in platforms like Opal. Head of R&D Yehia Hashad added that the biomimetic lens is a new material designed to mimic the eye's natural environment and is showing promising results in internal studies, with a large external study planned for mid-year. Mr. Saunders highlighted that it was designed for existing manufacturing lines to minimize future capital expenditures.

Joanne Wuensch asked if physicians are creating a waitlist for Epioxa, implying a stronger second half once the J-code is applied. She also questioned if the 2027 growth rate would be faster than 2026, and what makes the implied iDose TR guidance of $225 million for the year the 'right number'.

Answer

Joe Gilliam, President and COO, confirmed that patients are being enrolled in the hub, creating an Epioxa 'wait list,' which is expected to be more material in Q2 (detrimental to cornea business) and beneficial to H2, especially Q4. He stopped short of 2027 guidance but noted the combined acceleration of iDose TR and Epioxa makes 2027 and beyond attractive. Regarding iDose TR guidance, he stated the implied range is in the general 'zip code' and is based on a bell curve of scenarios and multiple pathways to achieve the numbers.

Joanne Wuensch asked if physicians are creating a waitlist for Epioxa, implying a stronger second half once the J-code is in place, and if the 2027 growth rate could be faster than 2026. She also inquired about the rationale behind the implied iDose TR guidance of $225 million for the year.

Answer

Joe Gilliam, President and COO, Glaukos, confirmed that patients are being enrolled in the Epioxa hub, creating a waitlist, which is expected to be material in Q2 (detrimental to cornea business) but beneficial to the latter part of the year, especially Q4. He stated that the combination of iDose TR and Epioxa acceleration makes 2027 and beyond attractive for growth, but stopped short of giving 2027 guidance. Regarding iDose TR guidance, Mr. Gilliam explained that it's based on a bell curve of scenarios and multiple pathways to achieve sequential growth and the overall target.

Joanne Wuensch of Citigroup asked for clarification on the full-year guidance for iDose TR. She also inquired about the potential revenue ramp for Epioxa post-approval and whether a patient waitlist was beginning to form.

Answer

President & COO Joe Gilliam reiterated that the overall guidance raise implies a higher full-year expectation for iDose TR, driven by strong momentum. For Epioxa, he outlined a methodical 2026 ramp focused on securing a J-code and payer policies. He stated there is no formal patient waitlist yet but expects procedure deferrals to become a significant dynamic post-approval.

Joanne Wuensch sought confirmation on the implied increase to the iDose guidance, which she calculated at approximately $5 million, and asked for more color on the expected ramp over the subsequent quarters.

Answer

President and COO Joseph Gilliam confirmed there was a modest, implied raise to the iDose expectations for the year but declined to specify the exact amount. He reiterated that the quarterly ramp would be driven by the factors previously discussed, including expanding MAC coverage and seasonality, and advised analysts to use the provided segment commentary to build their models.

Joanne Wuensch asked for confirmation of the full-year 2024 gross margin guidance and for commentary on whether management feels comfortable with the current 2025 consensus revenue estimates.

Answer

CFO Alex Thurman confirmed the 2024 gross margin guidance has been narrowed to a range of 82% to 83%. President and COO Joseph Gilliam declined to comment on specific 2025 consensus numbers but provided macro considerations, including international competition, ongoing Corneal Health headwinds, and U.S. glaucoma momentum being gated by reimbursement progress and sales execution.

Joanne Wuensch asked for details about Medtronic's Stealth AXiS Surgical System, including its product features and the reasons for the company's excitement about it.

Answer

Chairman and CEO Geoff Martha described Stealth AXiS as a new platform with enhanced functionality, not merely an extension of Mazor. He emphasized its seamless integration into the existing 70% navigated spine procedure workflow, combining AI-powered planning, navigation, and robotics. He believes it lowers barriers to robotics adoption, will grow the market, and extends Medtronic's lead in the space.

Joanne Wuensch, a Managing Director at Citi, asked for more information about Medtronic's new Stealth Access surgical system for spinal procedures, seeking details on the product and the reasons behind the company's excitement for its potential.

Answer

Chairman and CEO Geoff Martha emphasized that Stealth Access is an underappreciated, transformative new platform, not merely an extension of Mazor. He highlighted its new functionality and seamless integration into the existing 70% navigated spine procedure workflow, unifying AI-powered planning, robotics, and navigation. This integration lowers barriers for physicians to adopt robotics, is expected to grow the market, and significantly extends Medtronic's lead over competitors in spine surgery.

Joanne Wuensch inquired about the Hugo surgical robot, asking what lessons from the European launch can be applied to the U.S. and requesting performance metrics like revenue or number of systems placed.

Answer

EVP & President of the Medical Surgical Portfolio Mike Marinaro shared that key learnings include the positive reception of Hugo's modular design and the importance of a partnership-based ecosystem approach. He provided metrics, stating Hugo is in over 30 countries with 'tens of thousands' of procedures logged and is seeing significant double-digit procedure growth in existing accounts. He also confirmed progress on FDA submissions.

Joanne Wuensch asked for more details on hospital preparations for renal denervation (RDN) reimbursement and how the revenue ramp for this new therapy might compare to the recent PFA launch.

Answer

Executive Sean Salmon explained that market development involves training physicians and helping centers establish new hypertension service lines. He clarified that the RDN revenue ramp will be longer and more gradual than PFA because it's establishing a new treatment pathway for a vast patient population, rather than replacing an existing procedure. CEO Geoffrey Martha added that health systems are proactively seeking partnerships.

Joanne Wuensch asked for more details on hospital preparations for renal denervation (RDN) and how the revenue ramp for this new therapy is expected to compare to the recent ramp of pulsed-field ablation (PFA).

Answer

EVP Sean Salmon explained that market development involves training physicians and establishing service lines. He clarified that the RDN ramp will be longer and more gradual than PFA because it's a new therapy pathway, not a replacement for an existing procedure. However, he stressed it represents a 'massive patient population' and a 'long annuity' growth driver for the company.

Joanne Wuensch asked for an update on Medtronic's pipeline programs for mitral valve replacement and repair, as well as its tricuspid valve opportunities.

Answer

Sean Salmon, EVP & President of the Cardiovascular Portfolio, provided an update on the Intrepid valve, which is being studied in the APOLLO trial for both mitral and tricuspid applications. He noted good progress, aided by a new 29 French transseptal delivery system, and highlighted excellent clinical outcomes, particularly in complex patients. He also mentioned that modifications are being made to optimize the valve for the tricuspid position.

Joanne Wuensch of Citi asked for the Stelo contribution to 2025 results, what is embedded in the 2026 guidance, and any additional color on its performance.

Answer

Jereme Sylvain, CFO of Dexcom, reported $130 million in Stelo revenue for 2025, contributing to the top end of the 2-3% growth range. For 2026, Stelo is expected to contribute about one point to overall growth. Jake Leach, President and CEO of Dexcom, highlighted excitement for new innovations like a redesigned app and enhanced smart food logging with macronutrient tracking. He noted Stelo's role in attracting Type 2 non-insulin users without coverage, with the potential to transition them to G7 as coverage expands.

Joanne Wuensch asked for the Stelo contribution to Dexcom's 2025 results, its embedded contribution in the 2026 guidance, and an update on its overall performance.

Answer

Jereme Sylvain, Chief Financial Officer, reported $130 million in Stelo revenue for 2025, at the top end of the 2-3% growth range, and projected it to contribute about one point to 2026 growth. Jake Leach, President and CEO, highlighted upcoming innovations for Stelo, including a redesigned app and enhanced smart food logging with macronutrient tracking. He noted that Stelo is attracting a diverse user base, particularly Type 2 non-insulin users over-the-counter, with an opportunity to transition them to G7 as coverage expands.

Joanne Wuensch inquired about the expansion of the 15-day sensor from its limited 'warrior community' launch to a broader group, and its expected revenue and gross margin contributions.

Answer

Jake Leach, President and Interim CEO, confirmed the 15-day sensor is in limited launch with positive feedback, with broader shipping expected in coming weeks after securing coverage and partner integrations. Jereme Sylvain, CFO, added that it will have nominal revenue and gross margin contribution this year but represents a significant opportunity in 2026 for patient acquisition and margin expansion, particularly in cash-pay or lower reimbursement markets.

Joanne Wuensch asked about the 15-Day sensor launch, what it takes to expand beyond the warrior community, and its potential revenue and gross margin contribution.

Answer

Jake Leach, President and Interim CEO, stated that the 15-Day sensor is receiving positive feedback in the warrior community and will begin broader launch with channel partners in the coming weeks, following secured coverage and insulin partner integrations. Jereme Sylvain, CFO, noted nominal revenue and margin contribution in 2025, but significant opportunity in 2026 for additional patients and margin expansion, especially in markets with lower reimbursement.

Joanne Wuensch from Citibank inquired about the development timeline and features of the G8 sensor, and also asked for Dexcom's perspective on the competitive landscape for dual-analyte sensors.

Answer

President & COO Jacob Leach described the G8 as 50% smaller with a next-gen chipset supporting multi-analyte sensing and improved performance. Regarding competition, he emphasized that Dexcom's focus is on proven clinical utility and critical safety features, like hypoglycemia alerts, over novel analytes. He confirmed a ketone sensor is in development but will be launched when appropriate.

Joanne Wuensch from Citigroup Inc. asked about the implications of the recent FDA warning letter, specifically if it restricts any activities like a potential hospital label approval, and the expected timeline for resolution.

Answer

COO Jacob Leach clarified that the warning letter does not restrict new product submissions, approvals, or distribution. He stated that the company is working diligently with the FDA to address all concerns but noted it is hard to speculate on an exact resolution timeline, though progress is being made without impacting the innovation pipeline.

Joanne Wuensch asked about the complexity of integrating the 15-day sensor with insulin pumps and requested any available details on the next-generation G8 platform.

Answer

Executive Jacob Leach explained that the 15-day pump integration is a much smaller technical lift for partners compared to the G6-to-G7 transition. Regarding G8, he described it as the next hardware platform that will be smaller with more capabilities, including multi-analyte potential and pump compatibility closer to launch. CEO Kevin Sayer added that G8 will be a series of stepwise innovations.

Joanne Wuensch inquired about the potential FDA approval timeline for the 15-day G7 sensor and its anticipated financial impact on 2025 results.

Answer

CEO Kevin Sayer declined to speculate on the FDA's timeline but expressed hope for a fast approval, similar to the 15-day Stelo. CFO Jereme Sylvain described the product as a 'big opportunity' and a 'compelling cost lever' for 2025, particularly with monthly fee contracts, while reaffirming the company's existing 2025 long-range plan targets.

Joanne Wuensch inquired about Baxter's philosophy behind constructing the 2026 guidance, specifically how the company aims to ensure deliverability and meet its stated targets.

Answer

CFO Joel Grade explained that the guidance is prudent and reflects the best available information, aiming for transparency regarding challenges and actions. He cited key assumptions including the Novum situation, rebased IV solutions, Pharma pressures, product mix impacts, manufacturing volumes, reduced pricing contribution, and EPS impacts. CEO Andrew Hider echoed the prudent market view and emphasized that the Baxter GPS system will be foundational for driving accountability and continuous improvement, ultimately enhancing the company's 'Say-Do Ratio' throughout the year.

Joanne Wuensch asked about the continued IV fluid conservation post-Hurricane Helene, questioning if it's a normalized utilization rate. She also inquired about Baxter's observations on hospital CapEx and procedures, and if changes are anticipated due to macroeconomic or political uncertainties.

Answer

EVP and CFO Joel Grade explained that market insights suggest fluid conservation remains a buying pattern, citing a similar two-year recovery post-2017, and expressed confidence in the long-term IV Solutions business. He noted no observed slowdown in hospital CapEx despite uncertainty, with robust HST order books, including a 30% year-over-year increase in capital orders.

Joanne Wuensch from Citigroup Inc. expressed confusion regarding the prolonged IV fluid conservation post-Hurricane Helene, questioning if it represents a new normalized utilization rate rather than a recovery. Wuensch also asked about Baxter's observations on the hospital environment, specifically concerning CapEx spending, procedure volumes, and any anticipated changes due to political factors.

Answer

EVP and CFO Joel Grade clarified that based on customer feedback and market insights, buying patterns still reflect fluid conservation, noting that similar past events took up to two years for recovery. He expressed confidence in the long-term strength of the IV Solutions business and highlighted active efforts to improve utilization and reinforce clinical benefits. Regarding hospital CapEx, Grade stated that Baxter has not observed a slowdown despite macroeconomic uncertainty and political factors, with the Healthcare Systems & Technologies business showing robust order growth, up 30% year-over-year in Q3.

Joanne Wuensch asked about specific mitigation strategies for tariff headwinds, the outlook for 2026, and the sustainability of the strong recovery in the Healthcare Systems and Technologies (HST) segment.

Answer

EVP & CFO Joel Grade detailed tariff mitigation efforts including supply chain optimization, targeted pricing, and seeking exemptions, noting the impact would phase in. COO Heather Knight attributed the HST strength to a healthy backlog, competitive wins in Patient Support Systems (PSS), and strong order growth, expressing confidence in the momentum while remaining cautious about the macro environment.

Joanne Wuensch asked for an update on business conditions in China, the potential impact of tariffs, and the market uptake of the new Novum IQ infusion pump.

Answer

CEO José Almeida stated that post-divestiture, China will be less than 2% of sales, minimizing country-specific risk, and noted that potential tariffs would be an industry-wide issue for raw materials. He described the Novum IQ launch as 'extremely well,' with market share gains accelerating to 2-2.5% this year. CFO Joel Grade added that infusion hardware sales are up 50% year-to-date, with strength expected to continue.

Joanne Wuensch requested an update on the SAPIEN M3 uptake in the United States and its international impacts. She also asked for more color on the European guideline changes and their anticipated effects for the remainder of the year.

Answer

Daveen Chopra, Global Head for TMTT, Surgical, and IHFM, reported that SAPIEN M3 launch in the US is scaling in line with expectations, initially focusing on centers from the ENCIRCLE pivotal study, with similar scaling in Europe. He highlighted high procedural success and positive patient outcomes, especially for those without other TEER or surgical alternatives. Regarding European guidelines, Chopra noted Class I recommendations for functional mitral regurgitation (FMR) for heart failure hospitalization reduction, increasing awareness and referrals. Dan Lippis, Global Leader of TAVR, added that TAVR guidelines reduced the age recommendation from 75 to 70 and promoted proactive disease management, shifting away from watchful waiting. He expects these changes to provide layers of durable growth rather than an immediate 'light switch' effect.

Joanne Wuensch asked for an update on the SAPIEN M3 uptake in the United States and its impact outside the U.S. She also requested more color on the recent European guideline changes and their anticipated impact for the remainder of the year.

Answer

Daveen Chopra, Global Head for TMTT, Surgical, and IHFM, reported that SAPIEN M3's U.S. launch is scaling in line with expectations, focusing on ENCIRCLE trial centers, with similar scaling in Europe. He highlighted high procedural success, great patient outcomes, and physician excitement for patients without other TEER or surgical options. Chopra also noted European FMR guidelines are now Class I for heart failure hospitalization reduction, increasing awareness and referrals. Dan Lippis, Global Leader of TAVR, detailed European TAVR guideline changes, including reducing the age recommendation from 75 to 70 and promoting proactive disease management. He expects these changes to provide durable growth momentum rather than an immediate 'light switch' effect.

Joanne Wuensch requested clarification on the various upcoming TAVR catalysts, including the label expansion, potential NCD changes, and guideline updates, and asked when these factors might lead to a ramp in procedures.

Answer

Larry Wood, Group President of TAVR, distinguished between the three developments: FDA label expansion (expected Q2), CMS NCD updates (timing uncertain), and society guideline changes. He emphasized that the FDA approval is the critical first step that will allow the company to begin promotional and educational efforts for asymptomatic patients, which will then be amplified by subsequent NCD and guideline changes.

Joanne Wuensch asked for a review of the SAPIEN M3 market opportunity and its strategic importance within the portfolio, given the expected approval and data presentation timelines.

Answer

Daveen Chopra, Global Leader of TMTT, explained that SAPIEN M3 is designed for a large group of patients who are unsuitable for transcatheter edge-to-edge repair (TEER). He reiterated the mid-2025 European and 2026 U.S. approval timelines. The strategy involves a disciplined launch focused on physician training and excellent outcomes, positioning M3 as a key future growth driver to help TMTT reach its $2 billion revenue goal by 2030.

Joanne Wuensch requested quantification of the one-time impacts affecting the Q4 TAVR forecast and asked for an update on the development and launch timeline for the SAPIEN M3 mitral replacement system.

Answer

CFO Scott Ullem quantified the China distributor adjustment at approximately $5 million but did not quantify other impacts like hurricanes. Daveen Chopra, Global Leader of TMTT, reiterated that the European launch for SAPIEN M3 is anticipated in mid-2025, with a U.S. launch to follow after the completion of the one-year follow-up and standard FDA review.

Joanne Wuensch inquired about expectations for the upcoming AAOS meeting, specifically regarding the showcasing of the mBôs system, and how Zimmer Biomet anticipates integrating this system into its existing robotics portfolio and platform.

Answer

Ivan Tornos, Chairman, President, and CEO of Zimmer Biomet, stated that the AAOS meeting will feature new products, the Magnificent Seven, and next-generation S.E.T. products, with the main event being the mBôs system. He described mBôs as a fully and semi-autonomous robotic platform acquired from Monogram, expected to change the standard of care by moving towards smart robotics, offering best-in-class ease of use, rapid registration speed, a hands-free approach, streamlined workflow, high accuracy, reproducibility, and safety. Tornos noted that mBôs debuted at the Hip and Knee Society meeting to tremendous feedback. Regarding integration, he emphasized optionality, believing that since not all customers are alike, not all technology should be, and the company values category breadth (large/small footprint, CT/imageless, varying levels of autonomy) which is currently proving successful.

Joanne Wuensch inquired about expectations for the upcoming AAOS meeting, specifically regarding the showcase of the mBOS system, and how Zimmer Biomet plans to integrate mBOS into its existing robotics portfolio and platform.

Answer

Ivan Tornos, Chairman, President, and CEO, stated AAOS will feature new products, with mBOS (fully/semi-autonomous robotic platform from Monogram) as the main event, expected to change the standard of care. He highlighted mBOS's ease of use, registration speed, hands-free approach, streamlined workflow, accuracy, reproducibility, and safety. He noted the company maintains optionality for integration but currently prefers category breadth due to diverse customer needs.

Joanne Wuensch asked about the rationale for renaming the 'Other' category to 'Technology, Data, Bone Cement and Surgical' and inquired about the strategic focus for these businesses, including potential M&A.

Answer

President and CEO Ivan Tornos explained the name was changed because 'Other' was an inappropriate label for the fast-growing enabling technologies business within that segment. He noted the segment's quarterly decline was due to tough prior-year comparisons and a mix shift toward ROSA system placements over outright sales, not a change in underlying demand.

Joanne Wuensch asked about any macro trends observed in the quarter, such as nursing shortages, weather impacts, or ACA effects. She also requested more details on BD's GLP-1 contracts and any noteworthy aspects of these agreements.

Answer

Tom Polen, Chairman, CEO and President, reported steady utilization levels, solid CapEx environment, and no significant weather effects. He emphasized that over 90% of BD's revenue is from resilient consumables, with strong CapEx-driven growth in pharmacy automation. Regarding GLP-1s, he stated it's a modest but high-growth area, with over 80 novel and biosimilar molecules contracted in BD devices, and continued momentum in injectable GLP-1s, which are seen as complementary to orals.

Joanne Wuensch asked about any observed macro impacts in the quarter, such as nursing shortages, weather effects, or ACA changes. She also requested more details on the GLP-1 contracts, specifically if there was anything noteworthy to share.

Answer

Tom Polen, Chairman, CEO and President, reported steady utilization levels in line with hospital surveys, a solid CapEx environment, and no significant weather effects. He highlighted that over 90% of New BD's revenue is recurring consumables, providing resilience. Regarding GLP-1s, he stated it's a modest but high-growth area (2% of revenue), with BD supporting major molecules and having a high win rate for over 80 novel and biosimilar GLP-1s contracted in their devices. He noted continued momentum in injectable GLP-1s, with pharma companies investing billions in capacity, viewing orals as complementary.

Joanne Wuensch asked for clarification on the EPS gating for the remainder of the fiscal year, given the Q1 tax rate, and for an update on the integration of the recently acquired Critical Care business.

Answer

EVP and CFO Chris DelOrefice explained that the Q1 operational outperformance is reflected in the new guidance, and the rest of the year's phasing is impacted by translational FX and a higher tax rate after a favorable discrete item in Q1. Chairman, CEO and President Tom Polen added that the Critical Care (APM) integration is off to a fantastic start, growing high-single digits ahead of the deal model, with integration planning on or ahead of schedule and teams already working on revenue synergies and technology integration.

Joanne Wuensch inquired about the Vivisure acquisition, seeking insights into initial learnings for the PerQseal Elite product launch in 2027 and any financial details that could be shared. She also asked for clarification on the company's capital deployment strategy, specifically the phrase 'deploy capital in a balanced fashion.'

Answer

Chris Simon (President and CEO, Haemonetics) expressed excitement for Vivisure and the PerQseal Elite product, which will extend leadership in vascular closure across small, medium, and large bore procedures, including structural heart (TAVR, EVAR), with an addressable market of roughly $300 million. He noted a measured, stepwise launch approach based on past learnings, pending FDA approval. James D'Arecca (CFO, Haemonetics) explained that capital deployment is disciplined, balanced, and returns-focused, supported by strong free cash flow. Priorities include organic growth, debt reduction (convertible notes in March), and share buybacks, with M&A like Vivisure considered longer-term after IVT execution is restored.

Joanne Wuensch inquired about the Vivasure acquisition, seeking insights into initial learnings that inform the planned product launch in 2027 and any financial details that could be shared at this stage. She also asked for clarification on the company's capital deployment strategy, particularly the phrase 'deploy capital in a balanced fashion.'

Answer

Chris Simon, President and CEO, expressed excitement for Vivasure and the PerQseal Elite product, highlighting its potential to extend leadership in vascular closure across small, medium, and large bore procedures, including structural heart (TAVR, EVAR). He noted a measured, stepwise launch approach, learning from prior experiences, targeting a $300 million addressable market (2/3 in US). James D'Arecca, CFO, described capital deployment as disciplined, balanced, and returns-focused, driven by strong free cash flow (95% conversion YTD, over $200M FCF this year). Priorities include organic growth, debt reduction (convertible notes due March), and share buybacks, with M&A like Vivasure considered longer-term after IVT execution is restored.

Joanne Wuensch of Citi asked for clarification on the expected progression of revenue and EPS throughout fiscal 2026, noting the commentary on back-half weighted Plasma growth. She also requested more detail on the sources of the anticipated Plasma share gains, such as whether they stem from sales force expansion or competitor issues.

Answer

CEO Christopher Simon confirmed that both revenue and margin expansion are expected to be back-half loaded in fiscal 2026, reflecting collection volume assumptions and focused efforts in Interventional Technologies. He specified that the Plasma share gains are coming from new, extended agreements with major collectors like Grifols and BioLife Takeda, which involve converting competitor centers to Haemonetics' advanced Persona and Express Plus technology.

An analyst on behalf of Joanne Wuensch asked about the steps being taken to improve performance of the OpSens and Attune businesses and inquired about the financial impact and timeline of the Japanese Red Cross win.

Answer

CEO Christopher Simon explained that the main challenge for Attune's Enzo ETM is market disruption from PFA, and the strategy is to focus on the remaining RF ablation market. For the Japanese Red Cross win, he clarified there is no current financial impact, as implementation will take several years, with commercial benefits expected in FY '27 and beyond. He positioned the win as a key proof point for the NexSys platform.

Joanne Wuensch requested a 'state of the union' on medical technology, specifically asking about the hospital CapEx environment and any anticipated impacts from changes to the Affordable Care Act (ACA).

Answer

Jay Saccaro (VP and CFO) and Peter Arduini (President and CEO) described a solid U.S. capital backdrop, supported by customer surveys indicating robust investment in an aging installed base and strong procedure trends. They noted improving European markets and solid trends in emerging markets. They have not observed concerning impacts on the capital environment related to ACA changes, emphasizing GE HealthCare's equipment as a priority investment for institutions due to its role in enabling profit growth and breakthrough technologies.

Joanne Wuensch requested a 'state of the union' on the medical technology landscape, specifically asking about the hospital CapEx environment and any anticipated impacts from changes to the Affordable Care Act (ACA).

Answer

Jay Saccaro (VP and CFO) and Peter Arduini (President and CEO) described a solid US capital backdrop, driven by customer investment in an aging installed base and strong procedure trends, with a recent survey indicating anticipated investment increases. They noted improving European markets and solid trends in emerging markets. They reported no concerning impacts from ACA changes on the capital environment, emphasizing that GE HealthCare's equipment, as an enabler of breakthrough technologies and institutional profit growth, often remains a high priority for customers.

Joanne Wuensch asked for an update on the timing and ramping expectations for photon counting technology. She also questioned how the Patient Care Solutions (PCS) franchise plans to reaccelerate growth in upcoming quarters after a high single-digit decline in Q3.

Answer

President and CEO Peter Arduini confirmed photon counting is on track for plans, with more details expected at RSNA, emphasizing GE HealthCare's unique deep silicone approach. VP and CFO Jay Saccaro explained PCS's Q3 decline was due to a product hold, now resolved, and anticipated meaningful sequential improvement in Q4 and into next year under new leadership.

Joanne Wuensch asked for an update on the timing and expected ramp-up of GE HealthCare's photon counting technology and how the Patient Care Solutions (PCS) franchise plans to reaccelerate after a high single-digit decline in the quarter.

Answer

President and CEO Peter Arduini confirmed that photon counting remains on track for upcoming announcements, highlighting its unique deep silicone approach for significant impact on CT usage and spectral imaging. VP and CFO Jay Saccaro explained that the PCS decline was primarily due to a resolved product hold, which impacted 5% of sales and half of the segment's margin decline. He anticipates meaningful sequential improvement in Q4 2025 and continued dividends into 2026 under new leadership.

Joanne Wuensch of Citi inquired about the apparent deceleration in order growth from Q1 to Q2, asking if there were any pull-forwards or if a longer-term view is more appropriate.

Answer

VP & CFO James Saccaro explained that some moderation was expected after a very strong Q1, which included a large customer order. He emphasized looking at a more extended period, noting that first-half orders grew 7% and the last twelve months saw mid-single-digit growth, aligning with their mid-term goals. President & CEO Peter Arduini added that large enterprise deals naturally create quarterly lumpiness.

Joanne Wuensch asked for an update on the hospital capital expenditure (CapEx) environment in the United States and internationally. She also inquired about the potential for the Photon Counting CT system to accelerate revenue post-launch.

Answer

CEO Peter Arduini noted robust demand in the U.S. and Europe, reflected in 10% orders growth, stating that imaging remains a priority for hospitals as it drives productivity. Regarding Photon Counting CT, he confirmed it's on track for its planned submission and launch, highlighting its differentiating technology as a key investment the company is protecting.

Joanne Wuensch asked for more detail on the expected headwinds for Q1 operating margins and requested a broad overview of the current competitive landscape across GE HealthCare's global markets.

Answer

CFO Jay Saccaro reiterated that the flat Q1 margin outlook is due to a deliberate increase in R&D and SG&A investments to support critical new product launches, which will offset gross margin expansion. CEO Peter Arduini addressed the competitive landscape by noting that while they compete with several companies, no competitor has the same business mix, particularly with their unique position in radiopharmaceuticals. He stated they are performing well, especially in the U.S., and are driving growth by converting their installed base with high-value innovations.

Joanne Wuensch of Citigroup Inc. asked about the necessary infrastructure improvements—such as structural changes or human resources—required for hospitals to adopt Flyrcado and enable it to reach its $500 million revenue potential. She also requested an update on the commercial performance of Vizamyl.

Answer

CEO Peter Arduini explained that Flyrcado adoption will require some customers to acquire new PET systems, particularly in cardiology departments, which represents a capital equipment opportunity for GE HealthCare. CFO Jay Saccaro reported encouraging progress for Vizamyl, with U.S. sales nearly doubling quarter-over-quarter, and noted that expected CMS reimbursement changes should further accelerate adoption.

Joanne Wuensch asked for commentary on how changes in the competitive landscape, such as The Number being acquired by Boston Scientific and J&J's announced spinout of its ortho business, might impact Stryker. She also raised concerns about patient volumes, particularly with potential changes in Affordable Care Act coverage, and what Stryker is observing or expecting for patient volumes throughout the year.

Answer

VP of Finance and Head of Investor Relations Jason Beach stated that Stryker's strategy and go-to-market approach remain unchanged despite competitive shifts. Regarding patient volumes, Jason Beach noted that volumes remained robust at the end of 2025 and into 2026, with orthopedic markets expected to grow mid-single digits, and Stryker anticipating outperforming these markets.

Joanne Wuensch asked for Stryker's perspective on the evolving competitive landscape, specifically mentioning recent industry moves like The Number's acquisition by Boston Scientific and Johnson & Johnson's orthopedic business spin-out. She also inquired about any observed or expected impacts on patient volumes due to changes in Affordable Care Act coverage.

Answer

Jason Beach, VP of Finance and Head of Investor Relations, Stryker, stated that competitive landscape changes have no impact on Stryker's strategy or go-to-market approach. Regarding patient volumes, Mr. Beach noted that volumes remained robust at the end of 2025 and into 2026, with expectations for mid-single-digit growth in orthopedic markets and Stryker outperforming.

Joanne Wuensch asked about the future of margin expansion beyond the current achievement of pre-pandemic levels, acknowledging it might be covered at Investor Day. She then asked for an update on the trauma and extremities business segment.

Answer

Kevin Lobo (Chair and CEO, Stryker) deferred the margin expansion question to the upcoming Investor Day. Regarding trauma and extremities, he highlighted the 'on fire' performance, particularly the shoulder business with market-leading growth, even before the full launch of Mako Shoulder. He also noted strong core trauma performance with Pangea and new product innovations, while acknowledging some softness in foot and ankle with expected improvements next year.

Joanne Wuensch asked for an update on the performance and dynamics of the trauma and extremities business segment.

Answer

Kevin Lobo, Chair and Chief Executive Officer, highlighted the trauma and extremities business as performing exceptionally well, with phenomenal market-leading growth in the shoulder business (even before full MEKO launch). He noted strong core trauma performance driven by products like Pangea and volar plates, while acknowledging that foot and ankle was softer but expected to improve next year.

Joanne Wuensch of Citibank asked for the resolution timeline for the MedSurg supply issue and for an update on the launch of the new Mako Gen 4 system, including progress on its shoulder and spine applications.

Answer

VP of Finance & IR Jason Beach stated the supply issue, largely in the Medical division, is expected to linger through year-end but that the division's growth will still accelerate. Chair & CEO Kevin Lobo reported the Mako 4 launch is going well, with spine and revision hip applications exclusive to it. The shoulder application is migrating to Mako 4 for a full launch next year, with a significant sales impact expected in 2026.

Joanne Wuensch asked for an update on the capital equipment spending environment and the progress of the Inari Medical acquisition since its close.

Answer

VP of Finance and Investor Relations Jason Beach confirmed the capital environment remains strong with no signs of a slowdown, evidenced by double-digit growth in capital businesses. CEO Kevin Lobo added that the Inari integration is proceeding very well, with strong top-line performance and a culture consistent with Stryker's.

Joanne Wuensch asked management to address investor concerns about the sustainability of high growth in the orthopedics market and requested early feedback on the Mako Spine launch.

Answer

CEO Kevin Lobo stated that the elevated ortho market feels like a 'new normal' driven by strong underlying fundamentals, not just temporary pent-up demand. CFO Glenn Boehnlein added that pricing pressures in ortho are lessening. Regarding Mako Spine, Kevin Lobo reported that it is very early but the launch is proceeding as expected, emphasizing a deliberate, slow rollout to ensure proper training and execution.

Joanne Wuensch asked about the sustained high single-digit growth in EPD despite a complicated macro landscape, seeking insights into potential challenges over the next 12-18 months. She also inquired about the drivers of growth in structural heart, highlighting multiple products, and any upcoming medical meeting highlights.

Answer

CEO Robert Ford praised the EPD team's resilience in navigating macro challenges, expressing confidence in their ability to drive 7-9% growth, supported by the launch of a biosimilar portfolio. For structural heart, he noted heavy investment and a best-in-class portfolio across three valves. Key growth catalysts include Navitor, TriClip, and Amulet, with MitraClip seeing double-digit growth due to guideline changes. He highlighted the upcoming launch of TriClip in Japan, next-generation repair technologies, and bolt-on M&A like Lower Lab for AI-powered imaging. The pipeline includes a next-gen Amulet (early 2027), a balloon TAVR IDE trial (H2 2026), and a femoral transseptal mitral valve replacement IDE trial.

Joanne Wuensch asked for an update on the NEC litigation and addressed pockets of softness in the nutrition business, specifically in U.S. pediatric nutrition, and the outlook for this segment.

Answer

Robert Ford, Chairman and CEO, stated Abbott won summary judgments in recent federal NEC cases, reaffirming confidence in its products and label, and committed to defending them in ongoing cases. He acknowledged that the 4% nutrition growth was in line with historical rates, but U.S. pediatric nutrition was softer due to competitive impacts, including giving back share gained during a competitor's supply disruption and losing a large WIC contract. Ford expects this impact for a couple of quarters but is confident in regaining share through two new WIC contracts (effective Q1/Q2 2026) and new product launches.

Joanne Wuensch asked for an update on the NEC litigation impacting Abbott's nutrition business and sought clarification on pockets of weakness in nutrition during Q3, specifically addressing U.S. pediatric performance and WIC contracts.

Answer

Chairman and CEO Robert Ford declined to comment on specific NEC cases but affirmed Abbott's defense of its products, noting recent federal summary judgment wins. He explained that Q3 nutrition softness was due to U.S. pediatric, where Abbott lost some share gained during a competitor's supply disruption and a large WIC contract moved to a competitor. He expects this impact for a few quarters but is confident in regaining share with new WIC contracts (effective Q1/Q2 2026) and new product launches.

Joanne Wuensch asked for an update on the new coronary intravascular lithotripsy (IVL) trial and the drivers behind the sustained double-digit growth in the Structural Heart business.

Answer

Chairman and CEO Robert Ford stated that for the coronary IVL system, Abbott expects to complete trial enrollment and file for FDA approval next year, noting positive early feedback on the system's deliverability. He attributed the 15% growth in Structural Heart to a broad portfolio strategy, with strong performance from the Navitor TAVR system and the TriClip device, which is gaining momentum from strong clinical data and upcoming CMS coverage.

Joanne Wuensch asked for a high-level perspective on the overall health of the medtech market, seeking commentary on procedure volumes and the pricing environment.

Answer

CEO Robert Ford described the medtech market as robust, with utilization growth driven by favorable demographics and continuous innovation rather than temporary pent-up demand. He noted that less invasive and faster procedures are attracting more patients. On pricing, Ford stated that the environment has been "pretty stable" over the last couple of years, and this stability, combined with strong utilization, is driving the sector's growth.

Joanne Wuensch asked for an overview of the electrophysiology market, specifically regarding the uptake of Pulsed Field Ablation (PFA) and how it is impacting Abbott's mapping and navigation systems.

Answer

Robert Ford, Chairman and CEO, explained that the arrival of PFA has been a net positive, with Abbott's EP business growing faster now than before. This is driven by a significant increase in the use of Abbott's cardiac mapping systems, which are used in over 90% of PFA cases. He noted that RF ablation catheters also continue to see double-digit growth, underscoring the strength of Abbott's full-portfolio approach in the space.

Joanne Wuensch from Citibank asked for insights into Johnson & Johnson's vision care business, specifically addressing the surgical business's slower performance in the U.S. versus outside the U.S. during the quarter, and the overall health of the contact lens market.

Answer

VP of Investor Relations Darren Snellgrove confirmed vision as a priority MedTech area, reporting strong Q4 growth of just under 7%. He noted robust underlying demand in contact lenses, with 5.3% growth and share gains from the Acuvue Oasys 1-Day family, including new multifocal astigmatism products. Surgical vision grew close to 11% in the quarter, driven by premium intraocular lenses like Tecnis Odyssey and PureSee. Snellgrove acknowledged some U.S. market declines in legacy categories but expressed confidence in continued double-digit growth for surgical vision, emphasizing global market share expansion and increased capital allocation post-ortho separation.

Joanne Wuensch focused on Johnson & Johnson's Vision Care segment, specifically asking about the slower growth in Surgical Vision in the U.S. compared to outside the U.S. in Q4. She also sought insights into the health of the contact lens market.

Answer

Darren Snellgrove (VP of Investor Relations, Johnson & Johnson) confirmed Vision as a priority area, noting strong Q4 growth (just under 7%). He highlighted robust underlying demand in contact lenses, driven by the Acuvue Oasys 1-Day family, despite some softness in Asia-Pacific. Surgical Vision grew nearly 11%, propelled by premium intraocular lenses (Tecnis Odyssey, PureSee). He acknowledged U.S. Surgical Vision was partially offset by declines in legacy categories but expressed confidence in continued double-digit growth, global market share expansion, and capital allocation post-ortho separation.

Joanne Wuensch of Citibank asked for a breakdown of the factors impacting the weak orthopedic sales and the outlook for recovery in the second half of the year.

Answer

EVP, MedTech, Tim Schmid explained that one-time events negatively impacted worldwide Orthopedics growth by approximately 480 basis points. These included lapping a prior-year revenue recognition change, fewer selling days, and disruption from the ongoing ortho transformation. He expressed confidence in a back-half acceleration driven by new product launches in trauma, spine, and hips.

Joanne Wuensch of Citibank asked for Boston Scientific's perspective on two macro trends: the performance of its China business amidst market dynamics and any observed procedural pull-forward in the U.S. due to anticipated Affordable Care Act and Medicare cuts.

Answer

Chairman and CEO Mike Mahoney stated that Boston Scientific observed no signals of procedural pull-forward in Q3 2025, noting consistent procedural demand. Regarding China, Mahoney affirmed the business's strong performance, achieving mid-teens growth in the quarter. He expressed confidence in sustained double-digit growth over the long-range plan, attributing it to innovation, new product launches (like WATCHMAN FLX Pro), and expanded customer coverage, which effectively offset VBP price pressures across ICTx, EP, and WATCHMAN segments.

Joanne Wuensch from Citibank shifted focus to the MedSurg business, noting its solid high single-digit growth and asking management to highlight key drivers and any overlooked positive aspects within the segment.

Answer

CEO Mike Mahoney highlighted several areas of strength. He pointed to Endoscopy's double-digit growth in the U.S. and Neuromodulation's strong performance in Deep Brain Stimulation (DBS). He noted the Urology franchise performance was slightly below typical levels due to temporary supply constraints and that the Axonics integration is progressing well after working through initial commercial disruption, with a strong 2026 anticipated.

Joanne Wuensch of Citi asked for more detail on the WATCHMAN franchise's strong performance, particularly the drivers behind its 24% growth, the role of concomitant procedures, and upcoming data catalysts.

Answer

Michael Mahoney, Chairman and CEO, attributed the excellent growth to strong market adoption of concomitant procedures, noting that Boston Scientific gained market share in the quarter. Dr. Ken Stein, Chief Medical Officer, added that uptake has been faster than expected, driven by strong OPTION trial data, streamlined workflows with FARAPULSE, and clear economic advantages for both hospitals and physicians.

Joanne Wuensch inquired about margin management, specifically the commentary on gross margin contributing to operating margin expansion, and also asked about the company's capital deployment strategy given its strong cash flow generation.

Answer

CFO Dan Brennan explained that the 2025 operating margin expansion of 50-75 basis points will be driven by an optimal mix of improving gross margin, SG&A leverage, and a potential slight uptick in R&D spending as a percentage of sales. He reiterated that the capital allocation strategy remains unchanged: the top priority is strategic tuck-in M&A, followed by annual share repurchases.

Joanne Wuensch from Citi asked for clarification on the updated forecast for Pulsed Field Ablation (PFA) to exceed 40-60% of global AF procedures by 2026, driven by FARAPULSE.

Answer

CEO Michael Mahoney confirmed the company's increased confidence, stating that physicians are adopting FARAPULSE more quickly than anticipated a year ago. He attributed this to excellent clinical outcomes, procedural efficiencies, and the successful manufacturing scale-up, noting that FARAPULSE has maintained market leadership even against competitors in Europe.

Joanne Wuensch from Citi pressed for more clarity on how the CooperVision (CVI) segment, which has slowed, is expected to reaccelerate to meet or exceed market growth, noting that the recovery seems entirely dependent on the MyDay lens family.

Answer

President and CEO Al White confirmed the reacceleration is indeed heavily tied to MyDay. He detailed that historical growth was constrained by manufacturing capacity, which is now resolved. He expressed high confidence in future growth, citing over 30 new MyDay private label contracts, a 50% year-over-year increase in fitting sets, and a 300% increase in trial lenses, all of which signal strong future demand and sales conversion.

Joanne Wuensch asked for a breakdown of the rationale behind the new guidance, questioning the weight of internal observations, competitor reports, and conservatism. She also inquired about the impact of foreign exchange and operational efficiencies on OpEx.

Answer

President & CEO Albert White confirmed the guidance reflects a mix of all three factors: competitor results, tightening channel inventory, and a prudent, conservative approach. Both he and CFO Brian Andrews highlighted that significant, under-appreciated operational efficiencies in manufacturing and distribution are driving leverage through the P&L, helping to offset other pressures.

Joanne Wuensch of Citigroup inquired about the potential impact of U.S. tariff discussions on the business and asked about the apparent mismatch between competitors' results and Cooper's 5-7% contact lens market growth forecast.

Answer

CEO Al White stated that current tariff discussions do not significantly impact the company. Regarding market growth, he acknowledged the market grew 7% last year and that the underlying drivers (trade-up to dailies, growth in torics/multifocals) remain strong. While he hopes the market reaches 7% again, he believes a 5-7% range is a reasonable expectation for the year.

Joanne Wuensch asked for an update on the myopia management business, inquiring about its revenue run rate, position on the adoption curve, and progress in marketing and physician education.

Answer

CEO Al White reported that the myopia management portfolio generated approximately $37 million in the quarter, with MiSight growing 50%. He characterized the business as being in the "early innings" of adoption but gaining significant traction and moving closer to becoming the standard of care in pediatric optometry. He expressed strong optimism for the market's long-term potential, supported by the MiSight and SightGlass products.

Joanne Wuensch of Citigroup Inc. asked about the primary obstacles to broader physician adoption of standalone MIGS procedures and what strategies Sight Sciences is using to help overcome them.

Answer

Chief Commercial Officer Matt Link explained that the main challenge is the different patient workflow compared to combo-cataract cases. He detailed Sight Sciences' prescriptive strategy, which focuses on identifying and creating a treatment pathway for the underserved pseudophakic patient population (those with uncontrolled glaucoma years after cataract surgery). This involves working with targeted practices to integrate this new workflow, aligning with a broader industry shift to interventional glaucoma.

Speaking for Joanne Wuensch, an analyst from Citi inquired about the SION device, asking if it was seeing a tailwind from the new LCDs and requesting its revenue contribution. The second question concerned the full-year tariff impact of $3.5 million to $4.5 million and how to think about that cost annualizing into 2026 with mitigation strategies.

Answer

CFO Alison Bauerlein stated that SION represents a modest portion of Surgical Glaucoma revenue and has not seen a material shift in its mix, serving as a complementary product to OMNI. Regarding tariffs, she explained that the impact in 2026 should be relatively minor, as the company expects new manufacturing facilities outside of China to be operational within 9 to 12 months, which will mitigate these costs.

Joanne Wuensch of Citi inquired about the timeline from the presentation of STORM PE data to its commercial impact, following the completion of trial enrollment.

Answer

CEO Adam Elsesser clarified that since the product is already cleared for use in PE, no new regulatory approval is needed. He explained the data is intended to influence the broader medical community and standard of care. If positive, he expects a significant impact on a large, underpenetrated market that lacks the logistical hurdles of stroke treatment.

Joanne Wuensch inquired about the specific steps Penumbra will take to achieve its long-term gross margin target of over 70%. She also asked about the key milestones for the commercialization of Thunderbolt following the completion of its clinical trial.

Answer

CEO Adam Elsesser corrected the gross margin target to over 70% and identified the primary driver as the product mix shift towards higher-margin CAVT products, supplemented by manufacturing efficiencies. Regarding Thunderbolt, he stated that the immediate next step is completing the patient follow-up by year-end, after which the company will submit for approval and provide further updates on commercialization plans.

Joanne Wuensch asked for a detailed outlook on gross margin progression for 2025 and into 2026, considering the tariff environment. She also inquired about the peak market share or penetration level being achieved within highly engaged U.S. accounts that are displacing competitor products.

Answer

Executive Rajbir Denhoy explained that gross margin will improve as higher-priced U.S. sales become a larger part of the mix, reiterating the 200-300 basis point improvement target for 2025 and noting that tariffs have a minimal impact. CEO Peter Caldini added that the company expects to achieve close to 100% share within converted clinics over time.

Joanne Wuensch inquired about the profile of physicians and patients adopting Motiva in the U.S. and asked about the company's plans for expanding its sales force beyond the initial 40 reps during 2025.

Answer

CEO Juan Jose Quiros explained that early adopters are innovation-focused surgeons and that patients are drawn to the technology's safety and natural results, amplified by strong organic social media buzz. He stated that the current team of 40 sales reps is sufficient and the company will only add more reps selectively in large metro areas as the year progresses.

Joanne Wuensch asked about the recovery path for the private label business and requested management to level-set expectations for the steep revenue ramp implied for the year after a low Q1 guidance.

Answer

CFO Lea Knight advised focusing on absolute sequential revenue growth rather than noisy year-over-year comparisons. She projected a step-up in revenue from Q1 to Q2, driven by ship hold remediation and higher Integra Skin production, followed by a typical seasonal lift in Q4. She reiterated that the private label issue is a temporary component delay.

Joanne Wuensch asked for an overview of the positives and negatives of the master compliance plan and inquired about its duration, confirming if it's a multi-year effort.

Answer

CEO Jan De Witte described the plan as a structured program to enhance resiliency and predictability, with the 'flip side' being that it can uncover issues leading to temporary quality holds. He confirmed it is an 18-month process that began in the summer of 2024 and will continue through 2025.