Marie Thibault

Marie Thibault asked about the assumptions underpinning Delcath Systems' 2026 guidance, specifically inquiring about the anticipated seasonality in the third quarter and its expected magnitude, as well as clarifying the pricing trends for HEPZATO KIT, particularly the $175,000 average selling price. She also sought clarification on the distinction between HEPZATO KIT REMS sites, HEPZATO KIT sites, and clinical trial centers, and how to differentiate between commercial and purely clinical sites for tracking metrics.

Answer

Gerard Michel, CEO, confirmed expectations for seasonality in the third quarter, anticipating modest growth or flat volume from Q2 to Q3, similar to 2025. Sandra Pennell, CFO, elaborated on the pricing, noting a slight list price increase and a more favorable customer mix resulting in an average 10% discount off the list price for HEPZATO, an improvement from previous 20% discount expectations. Michel further clarified that HEPZATOKITREMS.com lists actively treating or REMS-certified commercial centers, while HEPZATOKIT.com serves as a patient referral site, including centers accepting referrals but not yet actively treating. He also stated that clinical trial centers would only be listed on the REMS site if they are also commercial centers.

Marie Thibault asked about the assumptions underpinning Delcath's 2026 guidance, specifically inquiring about the expected seasonality in the third quarter, its potential magnitude, and the trends influencing the average selling price of HEPZATO KIT, which was guided at $175,000 for the year. She also sought clarification on the distinction between HEPZATO KIT REMS sites and HEPZATO KIT sites, and how to differentiate between commercial and purely clinical trial centers for tracking metrics.

Answer

Gerard Michel, CEO, confirmed expected seasonality in Q3, attributing it to REMS-certified team members taking vacation, which reduces site capacity. Sandra Pennell, CFO, elaborated that while each patient represents significant revenue, they anticipate flat to modest growth from Q2 to Q3, followed by a rebound in Q4. Regarding pricing, Ms. Pennell noted a slight list price increase and a more favorable customer mix, resulting in an approximate 10% discount from the list price, leading to the $175,000 average selling price. Mr. Michel clarified that HEPZATOKITREMS.com lists compliant sites actively treating or soon to treat MUM patients (commercial centers only), while HEPZATOKIT.com serves as a patient resource for all centers accepting referrals.

Marie Thibault of BTIG inquired about the initial impact of the National Drug Rebate Agreement (NDRA) program, asking about center awareness, potential volume tailwinds, and its influence on guidance. She also requested an update on the sales force expansion and its productivity.

Answer

CEO Gerard Michel stated it is too early to see volume tailwinds from the NDRA but noted centers are pleased with the change. He projected activating 1 to 1.5 centers per month for the remainder of the year. He also confirmed the sales force expansion to six regions is complete and the new team has "hit their stride."

Marie Thibault inquired about the new HEPZATO KIT Access 360 program, asking if it was created to address payment hurdles, and also asked about the clinical bar for success for the upcoming CHOPIN trial data.

Answer

CEO Gerard Michel explained that the patient access program was always planned as a standard service for rare diseases, primarily for co-pay assistance, and not due to any reimbursement hurdles with payers. For the CHOPIN trial, he stated that the primary endpoint is progression-free survival (PFS) and that a four-month increase in PFS would be a 'phenomenal' result, likely translating to a meaningful survival benefit for patients.

Marie Thibault of BTIG inquired about the expected impact of the commercial team expansion on SG&A expenses and sought an update on the pipeline, including necessary device modifications and site preparations for upcoming trials.

Answer

CFO Sandra Pennell projected a 30-40% increase in SG&A for 2025, with the ramp beginning in Q2. CEO Gerard Michel clarified that no device modifications are needed for new indications. CMO Vojo Vukovic added that the company will leverage existing trained sites for new trials to streamline activation.

Marie Thibault asked for clarification on the expected acceleration of account adds in 2026 and 2027, specifically whether it's an acceleration from the current low 30s or earlier mid-20s, and if it's expected to build throughout the year due to newer rep productivity. She also inquired about the process and recent implementation of selling into entire healthcare systems using an enterprise-wide approach.

Answer

Scott Blumberg, Chief Financial Officer, clarified that the acceleration refers to adding more than 118 accounts in 2026, which was the total for 2025. He noted that account adds might be lumpy due to the new health system strategy but expects a general trend of acceleration as reps age into greater productivity. Jane Chao, Co-founder and Chief Executive Officer, explained that the enterprise-wide approach, expanded this year due to success in 2025, involves senior territory managers working with regional directors and VPs to engage system-level administrators and fine-tune value propositions for entire hospital systems.

Marie Thibault inquired about the drivers behind potential 'opportunistic investments' in sales territories. She also asked for anecdotal feedback from the sales force regarding competitive activity following a recent competitor launch.

Answer

CEO Jane Chao explained that the company's strategy is to run commercial pilots and will 'pull the trigger' on further investments upon seeing strong signals from these pilots. Regarding competition, Chao stated that it has not impacted commercial performance, expressing high confidence in their superior product, extensive validation, and key differentiators like their FedRAMP cybersecurity certification, which position them to remain the dominant category leader.

Marie Thibault requested more details on the innovative channel partnerships included in the outlook, specifically inquiring about the number of partners and how many are scaling up after pilot programs.

Answer

Dan Wilson, CFO, stated that iRhythm continues to add partners in the innovative channel, noting that the distinction between this and the core business is blurring. He mentioned new partners in Q4 and early Q1 but declined to provide specific quarter-to-quarter numbers, emphasizing a thoughtful approach to guidance due to the emerging nature and varying ramp speeds of these partnerships.

Marie Thibault requested more details on the innovative channel partnerships included in the 2026 outlook, specifically regarding the number of partners and how many might be scaling up after 2025 pilots.

Answer

CFO Dan Wilson stated that iRhythm continues to add partners in the innovative channel, which is blurring with the core business as it monitors both symptomatic and asymptomatic patients. He mentioned new partners were added in Q4 2025 and early Q1 2026, but declined to give specific partner numbers due to the emerging nature and varying ramp-up speeds of this business.

Marie Thibault of BTIG, LLC requested a more granular breakdown of the factors driving the Q2 revenue beat and the full-year guidance increase, specifically asking to parse the contributions from the core business, Zio AT, and innovative channels.

Answer

President and CEO Quentin Blackford clarified that the Q2 outperformance was driven primarily by the core business, with Zio AT and Innovative Channels contributing the remainder in roughly equal measure. He applied the same logic to the $30 million full-year guidance raise, attributing approximately $20 million to the core business and the remaining $10 million split evenly between Zio AT and innovative channels.

Marie Thibault of BTIG requested more detail on the remediation processes for incorporating cardiac technicians into the quality system and asked if the MCT delay allows for further product enhancements, like extended wear time.

Answer

CEO Quentin Blackford explained that incorporating technicians impacts internal processes like documentation and quality management, but not the external patient or physician experience. He noted this is becoming an industry-wide issue. Regarding the MCT product, he confirmed that a longer wear duration has been a core part of the next-generation design from the start to address a key market need.

Marie Thibault asked for help in sizing the portion of AtriCure's U.S. appendage management business that might directly compete with new entrants, specifically in concomitant valve surgeries. She also followed up on OpEx leverage, asking if R&D leverage could be expected this year given the shift in trial costs.

Answer

President and CEO Mike Carrel explained that while specific guidance on those areas isn't provided, the overall cardiac surgery market is large (300,000+ patients), with 170,000-180,000 coronary bypass patients. He noted AtriCure's strength in the valvular market, particularly mitral valve procedures where penetration is higher (60%-70% of AFib patients treated with ablation and AtriClip), leveraging its field team's expertise in AFib treatment. The CABG market was described as a greenfield opportunity where AtriCure is uniquely positioned. CFO Angie Wirick confirmed expectations for modest gross margin improvement and SG&A growth below top-line growth. She also stated that with the conclusion of LEAPS enrollment, a step down in clinical trial costs is expected, leading to 'pretty natural leverage' within R&D, with organic growth projected in the low teens.

Marie Thibault asked AtriCure to size the portion of its U.S. appendage management business directly competing with new entrants, specifically open clips used in concomitant valve surgeries. She also inquired about R&D leverage expectations for the year, given changes in trial costs.

Answer

Mike Carrel, President and CEO of AtriCure, did not provide specific sizing but discussed the overall market opportunity: 300,000 cardiac surgery patients annually, with 170,000-180,000 being coronary bypass patients. He noted AtriCure's strength in the valvular market, where penetration is higher (60%-70% of AFib patients undergoing mitral valve surgery receive treatment), often combined with ablation. He highlighted AtriCure's built-in advantage with 300+ field personnel understanding AFib treatment and the combination of AtriClip with ablation devices. The CABG market was described as a greenfield opportunity. Angie Wirick, CFO, confirmed expectations for modest gross margin improvement driven by new product launches and operational efficiencies. She also anticipated SG&A growth to be below top-line growth, showing leverage. For R&D, with LeAAPS enrollment concluded, a step-down in clinical trial costs is expected, leading to 'pretty natural leverage' despite strong BoxX-NoAF enrollment. Organic R&D growth is projected in the low teens.

Marie Thibault of BTIG inquired about the U.S. account conversion progress for CryoSphere MAX, its expected uptake in Europe, and sought confirmation that the CryoSphere XT launch represents upside to the current financial outlook.

Answer

CFO Angela Wirick stated that CryoSphere MAX was in over half of U.S. accounts and contributed over half of U.S. pain management revenue, while expressing cautious optimism for Europe due to pricing dynamics. Both Wirick and CEO Michael Carrel confirmed the CryoXT launch is not included in 2025 guidance, with a limited, learning-focused launch planned for late 2025 before a wider rollout in 2026.

Marie Thibault asked about the expected duration of growth tailwinds from recent product launches like FLEX-Mini and EnCompass, and inquired about the sales force strategy for the new cryoXT probe for amputations.

Answer

CEO Michael H. Carrel projected 'multiple years' of growth from the new products, citing significant remaining market penetration for EnCompass and future trial expansions. He also confirmed the cryoXT launch will utilize the existing sales force and hospital relationships, supplemented by additional clinical support rather than a new dedicated sales team.

Marie Thibault from BTIG, LLC asked about the expected conversion timeline for the AtriClip FLEX-Mini and requested a breakdown of volume versus price contribution within the 2025 revenue guidance.

Answer

CFO Angela Wirick responded that the FLEX-Mini conversion will be a multi-year effort, similar to the FLEX-V launch. She also clarified that the 2025 growth guidance is primarily based on volume, with potential upside from the product mix of higher-priced new devices.

Marie Thibault requested a rundown of expected product and market catalysts for 2025, including potential tailwinds and headwinds. She also asked for more details on the PFA partnership, questioning if the technology is intended for MIS or open products and if it's meant to replace existing RF ablation technology.

Answer

CFO Angela Wirick detailed 2025 catalysts, including the full-year impact of the EnCompass Clamp in Europe, the cryoSPHERE MAX probe, and the AtriClip FLEX-Mini in the U.S., while noting likely continued pressure on the Hybrid franchise. CEO Michael H. Carrel explained that the PFA strategy has been in development for over five years and aims to incorporate the technology across all epicardial ablation products (both open and MIS) to offer physicians a choice, not to replace the durable and effective RF and cryo technologies.

Marie Thibault inquired about Beyond Air's communications with the FDA regarding the Gen 2 system, the company's confidence in the timeline for clearance by the end of calendar year 2026, the post-clearance requirements for inventory building and launch, and any recent international wins or catalysts.

Answer

CEO Steve Lisi confirmed constant and positive communication with the FDA, expressing high confidence in the Gen 2 timeline, pending contract manufacturer inspection. Chief Commercial Officer Bob Goodman highlighted recent international wins, noting that distributors are now deploying products and seeing reorders for accessories, indicating growing adoption and stickiness.

Marie Thibault inquired about communications with the FDA regarding the Gen 2 process and confidence in the timeline for clearance by the end of the calendar year, as well as the post-clearance timeline for inventory building and formal launch. She also asked about recent wins or catalysts on the international side.

Answer

Steve Lisi, CEO, confirmed constant and positive communication with the FDA, seeing no major hurdles, with the gating factor being the contract manufacturer's inspection. He expressed high confidence in the provided timelines. Bob Goodman, Chief Commercial Officer, added that there have been recent international wins, with distributors now deploying demo devices and hospitals reordering filters, indicating product deployment and stickiness.

Marie Thibault inquired about the key growth drivers supporting the fiscal 2026 revenue guidance and asked for more details on the international (OUS) commercialization strategy, including the timing of tender wins and key countries to monitor.

Answer

CEO Steve Lisi explained that while the full guidance range is not yet secured, they are confident in hitting it by winning a percentage of open opportunities. He noted the Premier GPO agreement's impact will be more significant next fiscal year. For international markets, Lisi clarified that initial revenues are from selling demonstration and training devices to partners, with hospital contract wins expected to materialize toward the end of the current fiscal year and into fiscal 2027.

Marie Thibault from BTIG requested qualitative details on the specific commercial strategies implemented by the new Chief Commercial Officer that are proving successful. She also asked for guidance on how gross margins might be impacted by higher volumes, label expansions, the new transport system, and international sales.

Answer

Executive Steven Lisi highlighted new partnerships with firms like BAC for international distribution and Healthcare Links for GPOs/IDNs as key wins driven by the new CCO, noting their impact will become more visible in the coming months. CFO Douglas Larson explained that gross margins, expected to turn positive in the March 2025 quarter, were recently impacted by one-time upgrade costs and non-cash depreciation. He noted that deploying existing inventory will boost margins, while international sales will have a different, lower-margin profile that will gradually impact the overall rate.

Marie Thibault of BTIG questioned Dexcom's pricing strategy, specifically the "couple points of pricing" from commercial Type 2 non-insulin coverage, and asked about potential pricing headwinds from the anticipated Medicare unlock (CMS coverage) within the next 12 months.

Answer

Jereme Sylvain, CFO of Dexcom, explained that annual negotiations involve volume-price conversations, which have been stable. Regarding CMS, he noted that pricing is typically handled separately from policy approval, with competitive bidding processes determining fair value, expected to kick in more in 2028. He reiterated Dexcom's bullish stance on CMS coverage and readiness for its implementation.

Marie Thibault asked about pricing dynamics, specifically the "couple points of pricing" from commercial Type 2 non-insulin coverage, and potential pricing headwinds from the anticipated Medicare unlock for this population.

Answer

Jereme Sylvain, Chief Financial Officer, explained that annual volume-price negotiations have been stable. For CMS, pricing is typically handled separately from policy approval, with the competitive bidding process (expected to kick in more in 2028) determining fair value. He noted that Dexcom is bullish on CMS coverage and is building capacity in anticipation.

Marie Thibault asked for clarification on the scrap rate issue, its connection to deployment materials (inserter), and the timing for resolving it, particularly for the 15-Day rollout and 2026.

Answer

Jereme Sylvain, CFO, confirmed the scrap rate issue relates to how the needle drops the sensor into the skin. He expects it to dissipate into Q4 2025 and largely be behind them by 2026, returning to more normalized margin rates. He noted that the impact from scrap and expedited freight was roughly 50/50, and the goal for 2026 is to move the majority of product via ocean freight.

Marie Thibault sought clarification on the G7 scrap rate issue, specifically if it relates to the inserter, and the timing for resolving it to be 'in the rearview' by 2026, especially with the 15-day rollout.

Answer

Jereme Sylvain, CFO, confirmed the scrap rate issue relates to how the needle deploys the sensor. He expects the issue to dissipate in Q4 and largely be resolved by 2026, leading to more normalized margin rates. He noted that the impact from freight and scrapping was roughly 50/50 and anticipates benefits from increased ocean freight and reduced out-of-box failures.

Marie Thibault from BTIG asked for an update on the clinical trial work aimed at securing reimbursement for the entire Type 2 non-insulin population, including trial progress and expected readouts.

Answer

President & COO Jacob Leach confirmed that the randomized controlled trial for the broad Type 2 non-insulin population is on track to read out early next year. CEO Kevin Sayer added that Dexcom is continuously building a body of evidence to support expanded access, similar to its successful past efforts to secure Medicare and basal coverage.

Marie Thibault of BTIG asked about the OpEx control that allows Dexcom to reaffirm its operating and EBITDA margin guidance despite a lower gross margin forecast.

Answer

CFO Jereme Sylvain and COO Jacob Leach explained that the company is leveraging prior investments, such as the sales force expansion, and driving efficiencies through AI, robotics, and location strategies. Leach noted that teams, particularly in software, are becoming more efficient, allowing them to protect the innovation pipeline while managing costs.

Speaking on behalf of Marie Thibault, an analyst asked about the sustainability of international growth and the expected contribution from various levers like new market entry and coverage expansion.

Answer

CEO Kevin Sayer explained that the primary international growth driver will be expanding access and penetration in large, established markets where CGM is already a proven technology, similar to the U.S. strategy. He highlighted significant remaining opportunity in Type 2 intensive and basal populations in many OUS countries, such as Japan and France, which will be the main focus over entering smaller, new geographies.

Marie Thibault followed up on the rebate issue, asking for the assumed headwind to growth in the Q4 guidance, following the 6-point impact reported for Q3.

Answer

CFO Jereme Sylvain confirmed the impact in Q4 will be less than the 6 points seen in Q3, as the headwind peaked in the third quarter. While not providing a specific figure, he noted that average selling prices should be consistent from Q3 to Q4 since the rebate rate is now at 100%.

Marie Thibault asked about the next-generation Tablo platform, specifically how its advantages, including FDA clearance under 2025 cybersecurity requirements, might expand market reach, alter sales cycle timelines, and impact average selling price (ASP). She also inquired about sales force stability, attrition post-leadership changes, the search for a new sales leader, and the current visibility and diversification of the deal pipeline, especially given the Q1 flat guidance.

Answer

Chair and CEO Leslie Trigg highlighted the next-gen Tablo's secure-by-design architecture as a significant competitive advantage, expecting it to generate incremental attention from hospitals of all sizes due to heightened cybersecurity concerns. She deferred specific ASP lift details until closer to the Q2 launch. Trigg affirmed the sales leadership team's stability and focus, noting an ongoing, deliberate search for a new sales leader. She reported pipeline growth across key metrics (size, average deal size, deals over $1 million) and good diversification between new and existing customers, as well as across hospital sizes, including critical access hospitals. CFO Renee Gaeta added that recurring revenue growth for 2026 is expected to align with the overall 5-9% top-line growth.

Marie Thibault inquired about the market impact, sales cycle changes, and potential ASP lift from the launch of the Next-Gen Tablo platform, specifically how its advanced cybersecurity features might attract new hospital segments.

Answer

Leslie Trigg, Chair and CEO, highlighted the Next-Gen Tablo's FDA-cleared cybersecurity as a significant competitive advantage, expecting it to generate incremental customer interest across all hospital sizes due to patient safety concerns. She noted that ASP lift specifics would be provided closer to the Q2 launch. Thibault also asked about sales force stability and pipeline visibility. Trigg confirmed an experienced sales leadership team, ongoing search for a new leader, and robust pipeline growth in 2025 across various metrics, including new customers, expansion sites, and critical access hospitals.

Marie Thibault of BTIG questioned the sustainability of recent deal strength and higher console ASPs, asking about the role of new product attachments. She also inquired about the strategic focus for the newly appointed Chief Nursing Officer.

Answer

Chair and CEO Leslie Trigg attributed strong ASPs to high attach rates for Tableau Cart and Tableau Pro Plus software, alongside sales team discipline. She affirmed the pipeline's durability, citing a new enterprise agreement with potential for hundreds of consoles. Trigg explained the new Chief Nursing Officer will focus on partnering with the sales team to engage customer CNOs, sharing her experience to ease the transition from outsourced to insourced dialysis.

Marie Thibault inquired about the progress of the console selling process transformation, whether commercial team disruption is now in the past, and the drivers behind the console revenue beat, specifically volume versus pricing. She also asked for details on the selling process into the subacute care space.

Answer

Leslie Trigg, Chair and CEO, confirmed the sales transformation has made remarkable progress, with growing team tenure and improved forecast accuracy, and is on track for completion in the first half of 2025. She noted strong customer demand and brand awareness are key drivers. Nabeel Ahmed, CFO, added that the 23% sequential growth in console revenue was primarily driven by higher volume, with pricing discipline remaining strong. Leslie Trigg then explained that the selling process for subacute facilities is very similar to the acute setting, focusing on the value proposition of cost reduction and improved clinical care through insourcing.

Marie Thibault of BTIG inquired about the qualitative and quantitative outlook for console sales, seeking confidence in the turnaround given Q4 results and guidance. She also asked about the drivers behind the strong performance in treatment and consumables revenue.

Answer

Chair and CEO Leslie Trigg explained that confidence in the console sales rebound for 2025 stems from the completion of sales team changes, a newly tenured sales force, and a strong, diversified pipeline where 70% of top opportunities are already in late stages. CFO Nabeel Ahmed added that the strong recurring revenue was driven by high console utilization across the growing installed base, along with some minor, typical Q4 stocking.

Marie Thibault of BTIG inquired about the drivers behind the 18% year-over-year increase in console ASP, particularly the role of TabloCart, and asked about the expected timeline for gross margin dynamics to normalize.

Answer

CFO Nabeel Ahmed attributed the strong ASP to disciplined pricing, high attach rates for the Tablo Pro Plus software, and the re-availability of TabloCart with prefiltration, which helped close deals in Q3. Regarding gross margin, he stated that despite short-term fluctuations from lower overhead absorption, the company remains on a relatively linear path to its 50% gross margin target.

Marie Thibault (via Sam) inquired about the U.S. business dynamics, specifically distributor ordering, pricing impact, and volumes, as well as the expected recovery in China during the second half of the fiscal year. She also asked for clarification on the continued relevance and market position of injectable GLP-1s amidst the rollout of new oral GLP-1 therapies.

Answer

CEO Devdatt Kurdikar explained that the U.S. decline was due to lower pricing from customer/product mix and lower volumes from channel dynamics, partially offset by advanced purchases. He noted China's Q1 performance was in line with expectations, with recovery anticipated in the second half due to sales force reorganization and new pen needle introductions. CFO Jake Elguicze added that Q1 revenue was largely as expected, with international volume strength exceeding expectations, and pricing dynamics being a slight incremental headwind. Kurdikar also affirmed confidence in the GLP-1 opportunity, citing injectables' better weight loss profiles, oral GLP-1s expanding the market, and the prevalence of injectables in pharma pipelines, including the recent FDA approval for Zepbound's KwikPen.

Marie Thibault asked about the dynamics impacting Embecta's U.S. business, including distributor ordering, pricing, and volumes, as well as the expected recovery trajectory for the China market in the latter half of fiscal year 2026. She also inquired about the continued relevance and market position of injectable GLP-1 therapies amidst the emergence of new oral GLP-1 options.

Answer

Devdatt Kurdikar, CEO of Embecta Corp, attributed the U.S. decline to lower pricing from customer/product mix and lower volumes due to channel dynamics, partially offset by pre-price increase purchases. He noted China's Q1 performance met expectations, with H2 recovery anticipated from sales force reorganization and new product launches. Jake Elguicze, CFO, confirmed Q1 revenue was largely as expected, with strong international volumes offsetting U.S. pricing headwinds. Kurdikar further explained that oral GLP-1s were factored into their $100M+ opportunity, emphasizing injectables' superior weight loss profiles, market expansion by orals, and the continued focus on injectables in pharma pipelines, citing Lilly's Zepbound KwikPen approval as a positive for pen needle demand.

Marie Thibault asked for more details on Embecta's GLP-1 partnerships, including the number of partners with signed purchase orders, timing of orders ahead of approvals, and the potential impact on Fiscal Year 2026 revenue guidance. She also inquired about the on-the-ground dynamics in China regarding consumer willingness to purchase non-Chinese brands amidst geopolitical tensions.

Answer

Dev Kurdikar (President and CEO) explained that Embecta is in discussions with over 30 potential GLP-1 entrants, with a handful already providing orders and product shipped in 2025 for development. He noted that generic GLP-1s could launch in Canada, Brazil, India, and China in Calendar Year 2026, reiterating confidence in the $100 million opportunity by 2033. Jake Elguicze (CFO) clarified that 2026 guidance assumes negligible GLP-1 impact at the low end and a 1% positive contribution at the high end. Regarding China, Dev Kurdikar stated Q4 2025 performance was in line with expectations, incorporating a significant year-over-year decline. He mentioned steps taken to stabilize the situation, including reorganizing the sales team and introducing a more price-competitive pen needle, expecting less headwind in 2026 compared to 2025, and emphasized China's long-term market importance.

Marie Thibault inquired about Embecta's GLP-1 partnerships, seeking details on the number of signed purchase orders, product shipment timing, and the anticipated impact on fiscal year 2026 revenue guidance. She also asked for an update on the competitive landscape in China, specifically regarding consumer preferences for local brands amidst geopolitical tensions, and Embecta's strategies to stabilize its business in the region.

Answer

Dev Kurdikar (President and CEO, Embecta Corp) reported discussions with over 30 potential GLP-1 entrants, with several having signed orders and shipped product in 2025 for development. He noted potential generic GLP-1 launches in Canada, Brazil, India, and China in calendar year 2026, reiterating confidence in the $100 million opportunity by 2033. Jake Elguicze (CFO, Embecta Corp) clarified that FY2026 guidance's low end assumes negligible GLP-1 impact, while the high end factors in a 1% positive contribution. For China, Dev Kurdikar stated Q4 2025 performance met expectations, and Embecta is stabilizing the situation through sales team reorganization and a new price-competitive pen needle, anticipating reduced headwinds in 2026 and emphasizing China's long-term market importance.

Marie Thibault from BTIG inquired about the drivers for Embecta's fiscal fourth-quarter guidance, specifically the expected reversal of Q3's timing and pricing benefits. She also asked for clarification on the anticipated sharp decline in Q4 margins and questioned the company's stance on capital allocation, particularly the potential for share repurchases.

Answer

SVP & CFO Jake Elguicze explained that the sequential Q4 revenue decline is driven by the non-recurrence of Q3's favorable distributor order timing and rebate adjustments, coupled with FX headwinds and softness in China. He attributed the margin step-down to lower revenue, a negative profit-in-inventory impact, and seasonally higher SG&A and R&D spending. CEO Devdatt Kurdikar added that Q4 margin profiles are historically consistent. Regarding capital allocation, Kurdikar reiterated that debt paydown and investments for growth remain the primary focus over share buybacks.

Marie Thibault asked for more detail on the 25 basis point gross margin impact from tariffs, its annualized effect, and the significance of receiving purchase orders (POs) from generic GLP-1 manufacturers.

Answer

CFO Jake Elguicze quantified the tariff impact at approximately $3 million for the second half of 2025, primarily from U.S.-China dynamics, with a potential annualized gross impact of $8-9 million in fiscal 2026 before mitigation. CEO Devdatt Kurdikar described the GLP-1 POs as a 'substantive step forward' and a 'tangible milestone,' confirming they are for bulk pen needles to be used by generic partners for internal testing and regulatory submissions.

Marie Thibault asked about Embecta's capital allocation priorities, such as M&A, dividends, or share repurchases, following the discontinuation of the patch pump program. She also inquired about macro-level impacts from potential tariffs, foreign exchange rates, and the Pillar 2 tax framework.

Answer

CEO Devdatt Kurdikar stated that the primary capital allocation priority is aggressive debt paydown to create financial flexibility for future M&A, with no current plans to change the dividend. He noted minimal U.S. exposure to China tariffs but is monitoring the Canada/Mexico situation. CFO Jake Elguicze added that cash savings from lower separation costs will be repurposed for debt paydown, targeting a net leverage ratio of around 3x by year-end 2025. He also quantified the FX headwind and explained that the 2025 tax rate increase to ~25% is driven by Pillar 2 and other factors.

Marie Thibault asked for more details on the Interventional Technologies (IVT) business, specifically the anticipated return to growth in fiscal year 2027, the current competitive landscape regarding pricing and free products, the sales team's progress, and the expected timing for the MVP XL label expansion.

Answer

Chris Simon, President and CEO, clarified that 70% of the 12% IVT decline in the quarter was due to esophageal cooling (PFA disruption) and OEM agreement leveling. He expressed confidence in the vascular closure team, strategy, and funding to return to growth in FY2027. Simon noted that competition has intensified but affirmed the MVP XL product's superiority. He mentioned the MVP XL label expansion is with the FDA, with constructive dialogue, and is expected to broaden product promotion and contract opportunities with IDNs and ASCs.

Marie Thibault asked for more details on the Interventional Technologies (IVT) business's anticipated return to growth in fiscal year 2027, specifically regarding the competitive landscape, the effectiveness of the sales team, and the timing of the MVP XL label expansion.

Answer

Chris Simon (President and CEO, Haemonetics) clarified that 70% of the 12% IVT decline was due to esophageal cooling (PFA disruption) and OEM agreement leveling. He expressed confidence in the vascular closure team, strategy, and funding to return to growth in FY2027, asserting the product's superiority despite competitive aggression. He noted that the MVP XL label expansion is with the FDA, with constructive dialogue, and expects it to broaden product promotion and access in IDNs and ASCs.

Marie Thibault inquired about the commercial progress of the Opsens SavvyWire portfolio within Interventional Technologies. She also requested more detail on Vascade's performance, asking for a U.S. versus international growth breakdown for the MVP and XL products and the magnitude of the decline in the legacy Vascade line.

Answer

CEO Christopher Simon reported seeing 'green shoots' with SavvyWire, but noted its progress is currently masked by OEM destocking issues. He emphasized that the company's primary focus within Interventional Technologies is winning with the Vascade portfolio. For Vascade, Simon stated that growth was 'disproportionately, by far' in the U.S., driven by the strong adoption of the XL product alongside PFA procedures. He did not provide a specific magnitude for the legacy Vascade decline.

Marie Thibault of BTIG inquired about the Vascular Closure portfolio, seeking details on share gains and new account penetration for MVP and XL, and the specific strategies to improve the legacy PCI-side business. She also asked about the recent leadership changes in the Hospital division and requested quantification of the segment's margin expansion.

Answer

CEO Christopher Simon highlighted the high-20s growth for VASCADE MVP/XL and noted that a newly realigned U.S. sales force is now providing dedicated focus to drive growth in the legacy coronary and peripheral business. Regarding leadership, he stated the changes support the plan for both Blood Management and Interventional Technologies to become $1 billion franchises. He confirmed the Hospital business has a gross margin profile exceeding 70%, contributing significantly to the company's overall margin expansion toward the high 20s.

Marie Thibault asked for more detail on the Blood Management Technologies segment, including the sustainability of growth from a new assay and the timeline for weakness in China. She also requested details on new long-term agreements with BioLife and Grifols.

Answer

CEO Christopher Simon expressed confidence in Blood Management, noting a new assay is driving U.S. growth and is planned for Europe. He stated that weakness in China is specific to hemostasis management due to reimbursement cuts and is not expected to improve. Regarding the new plasma contracts, Simon described them as long-duration (5-7+ years) agreements focused on technology adoption, positioning Haemonetics for majority share in those accounts.

Marie Thibault asked for clarification on the significant adjusted operating margin improvement, the decision to maintain full-year guidance despite the beat, and the expected cadence of investments. She also questioned the performance of recently acquired products.

Answer

CEO Christopher Simon attributed the margin expansion to the growing mix of the high-margin Hospital business and technology upgrades in Plasma. CFO James D'Arecca added that Q3 operating margin would likely be flat sequentially due to planned investments in commercial and clinical teams, with an increase expected in Q4. Regarding acquisitions, Simon explained the slower start for EnsoETM (Attune) was due to the market shift to PFA, while the OpSens launch is a more deliberate, foundational build in the structural heart market.

Marie Thibault with BTIG inquired about the rationale behind Accuray's revised fiscal 2026 revenue guidance, specifically asking what factors in the second half of the year, beyond the usual 40/60 revenue split, led to increased caution, particularly concerning China. She also asked for expectations on future product gross margins given the recent quarter's performance and China JV timing.

Answer

Steve La Neve, President and CEO of Accuray, clarified the typical revenue split is closer to 45/55 and attributed the guidance adjustment primarily to ongoing tariffs and an unstable geopolitical environment in China, which has slowed the quota, license, tender, and funding process. Ali Pervaiz, CFO, explained that product gross margins were impacted by lower China JV releases, higher tariffs, and product mix, stating future margins are expected to be between 20%-30%, dependent on mix and China-centric releases.

Marie Thibault inquired about the rationale behind Accuray's revised revenue guidance, specifically questioning the shift from the historical 40/60 revenue split and seeking details on factors impacting the second half of the fiscal year. She also asked about future expectations for product gross margins, given the light performance in the current quarter and the new revenue guidance.

Answer

CEO Steve La Neve clarified the historical revenue split is closer to 45/55 and attributed the guidance adjustment primarily to ongoing tariffs and an unstable geopolitical environment in China, which has slowed demand patterns and commercial activity due to protracted processes for quota, license, tender, and funding. CFO Ali Pervaiz explained that product gross margins are impacted by tariffs and inflation. He detailed Q2's decline was due to lower China JV margin releases (8.2 points), higher tariffs (6 points), and product mix (5.4 points from fewer CyberKnife shipments). He anticipates future product gross margins to be in the 20-30% range, dependent on product mix and China releases.

Marie Thibault of BTIG inquired about the current market conditions in China, asking if customer demand and shipments have normalized following tariff reductions. She also sought clarification on whether the fiscal 2026 guidance already incorporates the potential benefits of establishing a foreign trade zone.

Answer

President and CEO Suzanne Winter explained that while the situation in China has improved, it has not fully returned to normal, and this cautious outlook is factored into the guidance. She noted strong underlying customer demand but slower government funding for licenses. CFO Ali Pervaiz added that the 90-day tariff extension creates ongoing uncertainty. Regarding the foreign trade zone, Suzanne Winter confirmed that its expected implementation in the second half of fiscal 2026 is already assumed in the provided guidance.

Marie Thibault asked for more detail on the China tariff situation, including the potential for a medical device exemption, how quickly shipments could resume if an exemption were granted, and whether the estimated $10 million to $15 million quarterly revenue impact is a reliable run-rate.

Answer

President and CEO Suzanne Winter described the situation as 'murky' but confirmed Accuray is actively working with its China JV partner to secure a medical device exemption. She indicated that if an exemption were granted, the company could resume shipments 'relatively quickly' but refrained from providing further clarity on the probability or timing of such an event.

Marie Thibault inquired about the sustainability of Accuray's strong revenue growth in China, asking for a specific revenue figure and details on market catalysts. She also asked about the macroeconomic outlook, including confidence in a U.S. market recovery, the potential impact of tariffs, and foreign exchange headwinds.

Answer

CEO Suzanne Winter attributed the 54% year-over-year growth in China to strong execution by their joint venture partner and a differentiated product portfolio, including the Tomo C and newly cleared premium systems. She noted that while the first half was expected to be seasonally strong, Accuray gained significant market share. For the U.S., she expressed confidence in a gradual second-half recovery based on backlog visibility. CFO Ali Pervaiz added that tariff risk is considered minimal for the second half but is being monitored, while inflation remains a factor being managed. He identified the Japanese yen as the primary foreign exchange concern.

Marie Thibault inquired about the long-term growth trajectory and market impact of the Tomo C system rollout in China, and also asked for details on the drivers of service contract revenue growth outpacing the installed base.

Answer

President and CEO Suzanne Winter explained that the Tomo C launch in China is addressing significant pent-up demand in the large Type B market, which will drive market share gains and allow for the release of deferred margin through fiscal 2025. Regarding service revenue, she stated that growth is fueled by new system installations in high-growth markets and the sale of enhanced, higher-priced service contracts for more advanced system configurations, supplemented by new value-added offerings like CyberComm.

Marie Thibault asked about the sustainability of the prescription volume strength, which has been above 50%, and whether any unusual factors contributed to it. She also inquired if alternate prescribers like physician assistants and nurse practitioners are increasingly joining as prescribers. Additionally, she asked about OpEx spending plans and the expected cadence for the fiscal year.

Answer

Brian Webster, President and Chief Executive Officer, expects sustained growth, noting no unusual factors and continued success in penetrating existing accounts and adding new hospitals. He confirmed that alternate prescribers are targeted in medical education efforts. Vaseem Mahboob, Chief Financial Officer, stated that OpEx reflects investments in team expansion and revenue cycle management capabilities, supporting service levels and conversion, with the current run rate expected to accelerate growth into FY27.

Marie Thibault asked about the sustainability of Kestra's prescription volume strength, which has been above 50%, and whether any unusual factors contributed to the recent quarter's performance. She also inquired if alternate prescribers like physician assistants and nurse practitioners are increasingly contributing to prescriptions. Her follow-up question focused on OpEx spending plans, asking if the recent tick-up represents a new sustained level and for guidance on its cadence for the fiscal year.

Answer

President and CEO Brian Webster confirmed expectations for sustained high prescription rates due to continued account penetration and new account additions, noting that Q2 strength was organic and not influenced by ACE-PASS data. He also stated that medical education efforts target APPs and other clinicians. CFO Vaseem Mahboob explained that OpEx investments are strategically deployed into team expansion and revenue cycle management capabilities to support growth, indicating the current run rate is expected to continue accelerating growth.

Marie Thibault of BTIG inquired about the key inputs for the updated financial guidance, including hospital census and capital equipment trends, and asked for an update on the progress and expected impact timeline of the recent sales force realignment.

Answer

CFO Micah Young stated that the guidance reflects normal seasonality and in-line performance, with full-year assumptions for consumable and capital growth remaining unchanged. CEO Katie Szyman added that while feedback on the sales force changes is positive, a quantifiable impact on growth is not expected until 2026 due to the nature of long-term contracts.

Marie Thibault asked for details on the drivers behind the increased 2025 operating margin guidance and inquired about the underlying assumptions for hospital census, flu activity, and market share gains in the forecast.

Answer

CFO Micah Young attributed the higher margin guidance to cost-saving initiatives taking hold earlier than expected, strong Q4 results, and completed R&D project rationalization. He specified the improvement comes from project rationalization, corporate cost reductions, and lower consumer health marketing spend. For 2025 guidance, he noted it assumes low single-digit growth in hospital census and that recent strong contracting provides confidence for continued market share gains.

Marie Thibault inquired about the progress of realizing gross margin benefits from the manufacturing move to Malaysia and asked for an overview of the current healthcare environment, including hospital census and OEM ordering activity.

Answer

CFO Micah Young reported significant progress on gross margin, with the full-year healthcare guidance raised to 62.7% due to savings from the Malaysia facility. He noted Q4 margins are implied around 63% and expects continued expansion in 2025. On the market environment, Young described hospital census as stable, contributing to growth, with ordering patterns becoming more predictable. COO Bilal Muhsin added that it was too early to predict the impact of the flu season.

Marie Thibault of BTIG inquired about Abbott's biosimilars strategy, asking for details on the products' reach, necessary investments in areas like SG&A, and the size of the target emerging markets.

Answer

Chairman and CEO Robert Ford explained the strategy is to leverage Abbott's extensive existing infrastructure in emerging markets for a capital-efficient rollout. While some SG&A investment will be needed for market education, the plan primarily utilizes the current sales and regulatory teams. The portfolio, targeting areas like autoimmune disease, oncology, and GLP-1s, is expected to be a nice contributor to growth in the coming years.

Marie Thibault asked for an update on the strong performance in Rhythm Management, specifically concerning the commercial rollout and adoption of the Aveir leadless pacemaker.

Answer

Chairman and CEO Robert Ford described Aveir as an "underappreciated opportunity" that he predicts will help make leadless technology the standard of care in pacing within five years. He detailed strong adoption metrics, including a 50% increase in both accounts and trained physicians, and a 30% rise in implant volume at early-adopter sites. He also highlighted pipeline investments, including a next-generation Aveir with longer battery life and a leadless conduction system pacing product.

Sam, on behalf of Marie Thibault, asked about the integration of Eversense with Sequel's twiist pump, specifically the remaining work needed to meet the Q3 launch timeline and which company would lead the commercial effort. A follow-up question addressed the conversion progress of commercial payers to the 365-day sensor and any year-end targets.

Answer

Executive Tim Goodnow described the twiist integration as a joint commercial effort, highlighting strong collaboration between the Senseonics/Ascensia and Sequel teams. He confirmed the project is on schedule for a Q3 launch, with remaining work focused on verification and validation. Regarding reimbursement, Goodnow stated they are over halfway through converting commercial payers to the 365-day product and expect to reach the 90% range within the next quarter.

Marie Thibault of BTIG asked for an update on Medicare reimbursement efforts for the Eversense 365 system and inquired about the expected cadence of operating expenses throughout 2025, considering R&D and marketing initiatives.

Answer

Executive Tim Goodnow reported that while reimbursement codes for Medicare are in place, the company is actively working with MACs on pricing levels, expecting a resolution within the next quarter. Executive Frederick Sullivan added that SG&A spending will be relatively linear, while R&D expenses will see a slight increase later in the year with the start of the Gemini pivotal trial.

Marie Thibault asked about the retention trends observed in the early cohort of type 2 users, questioning if there was any risk to the full-year guidance assumption of stable retention given the introduction of this new patient group.

Answer

Chief Product and Customer Experience Officer Eric Benjamin clarified that while the guidance assumes stable retention on a total portfolio basis, they are closely monitoring the new type 2 cohort. He reported that utilization for type 2 users is very similar to type 1, while retention is slightly lower but still strong and fully consistent with their internal expectations and models.

Marie Thibault from BTIG questioned the 2025 operating margin guidance, asking why the projected 160 basis points of expansion isn't higher, given the strong and seemingly sustainable margin drivers seen in Q4.

Answer

CFO and Treasurer Ana Maria Chadwick expressed excitement for the guided expansion to 16.5%. She explained that while the company will see leverage from G&A and gross margin improvement, it is also deliberately investing in growth. These investments include increased R&D spending (projected at 10-12% of revenue) and sales and marketing to capitalize on the Type 2 and international launch opportunities, which tempers the overall margin expansion.

Marie Thibault inquired about the outlook for Establishment Labs' business outside the U.S. (OUS), asking for confirmation of guidance and a breakdown of consumer sentiment in Brazil, Southeast Asia, and China. She also asked about the new Preserve product, its target patient population, and the U.S. launch timelines for both Mia and Preserve.

Answer

CEO Peter Caldini confirmed that the OUS business has not seen any impact on demand and that regional performance is stable, with Asia and Europe showing growth while Latin America remains challenging. Founder Juan Jose Quiros added that the U.S. launch of tools for Mia and Preserve is dependent on pending regulatory supplements for the core Motiva implant line.

Marie Thibault sought clarification on the OUS revenue guidance, specifically how the new $8-10 million Mia forecast impacts the underlying growth assumption and the expected revenue cadence from China. She also asked about the 2026 cash flow target and the quarterly EBITDA trajectory for 2025.

Answer

CEO Juan Jose Quiros noted the Mia forecast is new and that China's distributor ordering pattern will result in minimal revenue in H1 2025, with a recovery in H2. Executive Rajbir Denhoy confirmed the goal is to be cash flow positive in 2026. He added that Q1 cash use and EBITDA loss will be similar to Q4, with significant improvement expected through the year, leading to positive EBITDA in H2 2025.

Marie Thibault of BTIG asked for clarification on what management means by a 'more normalized business profile' going forward and requested more detail on the performance of the Venus Hair business.

Answer

Executive Rajiv Kanishka De Silva explained that 'normalized' refers to the completion of major structural changes, suggesting that the magnitude of year-over-year revenue declines seen in 2024 should not repeat, though macroeconomic uncertainty remains. Regarding Venus Hair, he stated that the company is pleased with its performance, particularly the ARTAS Robot, is pursuing R&D innovations, and has received strategic interest in the business.

Marie Thibault highlighted the strong performance of the Interventional Oncology and embolization business and asked how the recent acquisition of Intera Oncology fits into this segment and can help accelerate its growth.

Answer

CEO Mike Mahoney attributed the division's mid-teens growth to its category leadership strategy, driven by a successful organic robotics launch and the strong performance of TheraSphere (Y-90). He explained that the Intera Oncology acquisition is a strategic extension into an adjacent area with its pump portfolio, which broadens their offerings and brings them closer to oncologists. He also mentioned forthcoming software enhancements to improve the Y-90 workflow.

Requested an update on the enrollment progress and timelines for the PEERLESS II and Defiance clinical trials. Also asked for more details on the upcoming market entry into China and Japan, specifically regarding the go-to-market strategy.

Answer

Enrollment for PEERLESS II and Defiance is on schedule, but the immediate focus is on the PEERLESS I data readout later this year. For China and Japan, the company remains on track to treat patients in Q4. Both are large market opportunities, and more details on the commercial strategy will be provided closer to the launch.

Asked for clarification on whether Emerging Therapies revenue is primarily from the U.S., and inquired about the expected sales cadence for 2024 and the operational path to achieving profitability in the first half of 2025.

Answer

Emerging Therapies revenue is currently primarily from the U.S. as international approvals are still being pursued. For 2024 cadence, the company expects about 4% sequential growth in Q1 with revenue accelerating in the second half of the year. The path to profitability involves continued operating leverage, with operating losses expected to decrease through 2024, leading to sustained GAAP operating profitability in the first half of 2025.