David Rescott

David Rescott asked about the sustainability of the accelerated plasma collection market growth, seeking metrics and visibility into the forward-looking outlook for this segment, and whether the current 'flow period' could persist for several more quarters. He also inquired about the impact of increasing PFA utilization on the VASCADE business, whether PFA headwinds are beginning to lap, and if the vascular closure market growth is expected to step higher as PFA conversion stabilizes.

Answer

Chris Simon (President and CEO, Haemonetics) linked sustained plasma growth to strong end-market demand for immunoglobulin-based therapy, noting the current 'building phase' in collections began six quarters ago with Persona's yield enhancement. He stated that guidance reflects controllable factors like share uptick and price annualization, not directly controlled volume. Regarding VASCADE, he acknowledged PFA's defining impact on electrophysiology, affecting access sites and sizing, but expects the market to regress to its underlying growth rate (at least mid-teens) as PFA effects level out, expressing optimism for VASCADE's return to growth in FY2027 through improved execution.

David Rescott asked about the forward-looking outlook for plasma collection and market growth, specifically the sustainability of the current accelerated period and why this 'flow' period might not sustain for several more quarters, given past 'ebb' periods. He also inquired about the VASCADE business, the impact of increasing PFA utilization as a headwind, and whether PFA headwinds are beginning to lap, potentially leading to higher vascular closure device market growth.

Answer

Chris Simon, President and CEO, linked plasma demand to unmet needs in immunoglobulin-based therapy, indicating a 'building phase' in collections that began six quarters ago with Persona's 10% yield enhancement. He stated that while the company guides on controllable factors like share uptick and price annualization, they are optimistic about volume. Regarding VASCADE, Simon acknowledged PFA's defining impact on electrophysiology, noting its effect on access sites and sizing (making MVP XL critical). He expects the category growth rate, currently mid-teens or better, to drive future VCD market growth as PFA disruption levels out, emphasizing the need for improved execution against competitors.

David Rescott questioned the Hospital segment's full-year guidance, noting the outperformance in Blood Management Technologies (BMT) versus underperformance in Interventional Technologies (IVT), and asked about confidence in an IVT recovery. He also requested an analysis of the drivers behind the strong Q1 gross margin performance and the outlook for the rest of the year.

Answer

CEO Christopher Simon expressed confidence in the 8-11% full-year Hospital guidance, acknowledging that BMT's strength, led by TEG, is currently offsetting IVT's softness. He expects IVT to recover but noted the growth contribution split will no longer be 50/50. On margins, Simon attributed the strength to favorable portfolio mix, price, and productivity, reaffirming the 26-27% adjusted operating margin guidance for the year. CFO James D'Arecca added that since BMT and IVT have similar gross margins, the mix shift between them does not negatively impact overall margins.

David Rescott from Baird followed up on the proposed APC reimbursement code change for epilepsy, asking if it could create an opportunity for premium pricing and if the company would re-apply for a Level 6 NPI code. He also requested a breakdown of the moving parts in the updated EPS guidance.

Answer

President of Global Epilepsy Stephanie Bolton clarified that both NPI and EOS procedures would be in Level 5 under the proposal, and the company will continue to lobby for Level 6 for NPIs, linking premium pricing to future innovation. CFO Alex Shvartsburg explained the EPS guidance reflects a strategic investment in an Essence PCBA upgrade to enable future software innovation, a decision made possible by strong first-half performance.

David Rescott questioned the magnitude of the underlying EPS guidance raise, suggesting it could have been higher, and asked for the rationale behind the new Cardiopulmonary growth outlook given strong Q1 trends and the China approval.

Answer

CFO Alex Shvartsburg explained that the bottom line is naturally hedged against foreign exchange, as top-line headwinds from a strong dollar are offset by OpEx benefits, limiting the net impact. Regarding the Cardiopulmonary guidance, he noted that while Q1 HLM growth was very strong at 30%, capital equipment sales are not linear, and that rate is not expected to continue, though a strong ramp is still assumed for the year. CEO Vladimir Makatsaria added that it is still early in the year and the team is focused on maintaining momentum.

David Rescott from Baird asked for clarity on the SNIA litigation, specifically the potential timing of a payout if the first-half 2025 decision is unfavorable. He also questioned the 2025 outlook for the epilepsy business, asking how much the weaker replacement cycle from 2019-2020 is impacting the forecast and if that headwind could extend into 2026.

Answer

CFO Alex Shvartsburg stated it's impossible to speculate on the SNIA litigation decision and confirmed it is not in the guidance. He reiterated that if the ruling is unfavorable at the previously stated amount, the estimated quarterly EPS impact would be around $0.11. Regarding epilepsy, CEO Vladimir Makatsaria emphasized the large untreated patient population as a key growth driver. Shvartsburg added that the forecast for flat replacement units in 2025 is due to lapping the down years of 2019 and 2020, and the 2026 outlook will be assessed as the year progresses.

David Rescott asked about the outlook for 2025 EPS and margin expansion, considering factors like trial cost drop-throughs and tax headwinds. He also sought clarity on the company's increasingly optimistic tone regarding the DTD program and the potential scenarios for its advancement.

Answer

CFO Alex Shvartsburg reiterated the company's goal to grow margins faster than revenue in 2025, inclusive of the DTD program savings and ACS wind-down benefits, while confirming a projected 24-25% tax rate. Chief Innovation Officer Ahmet Tezel explained the DTD optimism stems from the high unmet medical need, CMS's practice of reviewing the totality of data (including positive secondary endpoints), and insights from further data analysis.

David Rescott from Baird sought to clarify whether the updated EPS guidance was relative to GAAP or adjusted figures and asked for an update on the recovery progress of the various headwinds impacting the business.

Answer

CFO Rick Buchholz confirmed the EPS guidance is on a GAAP basis and that the large stock-based compensation charge was a one-time event. CEO Tim Herbert reported significant progress on the headwinds: the Medicare billing issue is now fully resolved, over 50% of centers have adopted the new SleepSync software, and surgeon training is well advanced, positioning the company for an accelerated transition in the second half of the year.

David Rescott of Robert W. Baird & Co. asked about operating expense leverage, noting that OpEx growth has been well below revenue growth. He questioned the assumptions behind the full-year EPS guidance and whether to expect an acceleration in spending to support the Inspire V launch.

Answer

CFO Richard Buchholz confirmed that while they will continue to invest to drive top-line growth, they expect annual revenue growth to outpace OpEx growth. He specified that spending on patient marketing (DTC) will increase with the Inspire V launch and R&D will continue at a mid-teens rate, ultimately resulting in a mid-single-digit operating margin for the full year.

David Rescott asked if international growth is expected to be accretive to the overall growth rate in 2025 and what the assumption is for interest income.

Answer

Chief Financial Officer Rick Buchholz stated that international (OUS) revenue is expected to remain between 3% and 4% of worldwide revenue in 2025 and therefore will not be accretive to the overall growth rate. He also confirmed the full-year 2025 assumption for interest income is approximately $20 million.

David Rescott of Baird questioned the future of DTC advertising spend, asking if the recent flat-to-down trend could continue or if it might need to reaccelerate to support growth. He also asked for an outlook on the international business for Q4 and the potential size of new markets like France in 2025.

Answer

CEO Tim Herbert stated that while they have found efficiencies, the company will continue to invest in growth and is not committed to decreasing DTC spend long-term, potentially increasing it to drive further adoption. CFO Rick Buchholz added that overall marketing includes higher investment in medical education. For international markets, Tim Herbert highlighted France and the U.K. as key future growth drivers and expects consistent growth momentum from existing European markets.

David Rescott of Robert W. Baird & Co. Incorporated asked for clarification on the 'new store growth' metric, including whether innovative channels are captured in it, and inquired about the margin profile of these new accounts relative to the 2027 long-term targets.

Answer

CFO Daniel Wilson confirmed that the new store growth metric includes both innovative channel partners and successful recent launches of large IDN customers. He noted that while it's still early, the innovative channels are expected to be very profitable due to the 'one-to-many' selling model, which aligns with the company's long-term margin accretion goals.

David Rescott asked for a breakdown of the drivers behind the raised guidance, questioning if the contribution mix from innovative channels and MCT share gains was similar to Q4.

Answer

CFO Daniel Wilson clarified that the Q1 outperformance and the subsequent guidance raise were primarily driven by sustained momentum in Zio AT. He noted that while the undiagnosed monitoring channel contributes, they are being cautious in their forecast due to its emerging and less predictable nature, ensuring they don't get ahead of themselves.

David Rescott asked about the two key drivers of Q4 strength—the innovative channel partner and MCT growth—and inquired about the level of upside that flowed through to the bottom line and its potential impact on future EBITDA.

Answer

CFO Daniel Wilson confirmed that both Zio AT strength and the new innovative channel partner drove the Q4 top- and bottom-line beat. He noted that while these channels offer operating leverage, especially the 'one-to-many' model of channel partners, the profit impact is balanced by Zio AT's slightly lower gross margin compared to Zio monitor. He concluded that the trends are positive for future profitability as these areas grow.

David Rescott of Robert W. Baird & Co. sought clarification on whether the new Zio AT 510(k) clearance changes the Q3 2025 MCT submission timeline and asked for context on the baseline for the $10 million revenue impact from the delay.

Answer

CEO Quentin Blackford confirmed the recent Zio AT clearances do not change the MCT timeline. The delay is driven by the need to proactively incorporate human factor testing related to including technicians in the product definition. Regarding the revenue impact, he agreed that thinking about 2025 growth by adjusting for the MCT delay from the current growth trajectory is the right approach, without giving specific 2025 guidance.

David Rescott of Baird questioned the low end of the updated EPS guidance, which maintains a significant tariff headwind despite a strong first half. He also asked for the updated full-year revenue contribution from Rhapsody and how the sales force is responding to the reimbursement delay.

Answer

CFO Raul Parra provided a bridge for the EPS guidance, noting the Q1/Q2 beats were partially offset by higher interest expense and taxes. He justified keeping the large tariff impact at the low end due to high uncertainty. He reiterated the updated Rhapsody revenue guidance is $2-4 million. CEO Fred Lampropoulos asserted that the RTG sales force remains highly motivated or 'on fire,' as they have a broad portfolio of strong products to sell.

David Rescott asked how the company makes investment decisions for tariff mitigation given the volatility and questioned if the recent strong gross margin performance reflects the true underlying trajectory of the business.

Answer

EVP and CFO Raul Parra stated that the company is executing on a pre-existing list of CGI initiatives rather than making reactive, long-term decisions based on volatile tariff news. He affirmed that the strong gross margin is a result of the compounding effects of these long-term initiatives in pricing, mix, and operational efficiency, reflecting the business's positive trajectory.

David Rescott of Baird sought clarification on whether Wrapsody revenue was incremental to the 2025 guidance. He also asked why the 2025 guidance for the Endoscopy segment seemed conservative, questioning if it was related to the underlying business or the EGS integration.

Answer

Executive Raul Parra clarified that the guided $7-9 million in Wrapsody revenue is included in the overall 2025 forecast, not incremental to it. Regarding the Endoscopy guidance, he explained it is a measured and realistic forecast that accounts for the complexities of integrating the Merit and acquired EGS sales forces, which were combined on January 1st. Executive Fred Lampropoulos added that the EGS manufacturing integration was completed ahead of schedule.

David Rescott of R.W. Baird asked about the WRAPSODY market opportunity, questioning whether the initial target is the existing stent graft market or if the PTA market is equally accessible. He also asked if WRAPSODY's margin profile is expected to align with the company's long-term CGI margin expansion goals.

Answer

Executive Fred Lampropoulos deferred answering the market opportunity question, stating that the company is focused on launch preparations and will discuss commercial strategy in a future virtual meeting. Executive Joseph Wright also deferred on the margin question, reiterating the company's focus on achieving PMA approval and delivering on the overall CGI target of at least 20% operating margins, with financial modeling details to come post-approval.

David Rescott asked for confirmation that July's seasonality trends are consistent with prior years and questioned if clinical trials contribute to the raised full-year operating margin guidance.

Answer

CEO Waleed Hassanein confirmed July seasonality is "par for the course" but cautioned against relying on third-party flight data. CFO Gerardo Hernandez Omana added that the improved operating margin guidance is driven by operating expense leverage, not trial contributions, and is subject to the timing of planned investments.

David Rescott asked about the likelihood of historical seasonality patterns (stronger Q2, weaker Q3) repeating this year and questioned whether revenue from the new heart trial would be incremental or cannibalize existing procedures.

Answer

Executive Waleed Hassanein acknowledged that historical trends suggest a Q3 slowdown is more probable due to summer vacations but noted the current environment is volatile. Regarding the heart trial, he explained that the largest portion of the trial (750 patients) is for a new indication not currently approved in the U.S., meaning it cannot be cannibalistic. He views the trial as additive, expanding the market and showcasing next-generation technology.

David Rescott from Baird sought clarification on the 2025 margin outlook, asking if the Q4 service gross margin was a sustainable baseline. He also inquired about the operational expense scaling associated with adding new aircraft to the fleet.

Answer

CFO Gerardo Hernandez guided for modest overall gross margin improvement in 2025, noting that gains would be moderated by the growing mix of service revenue. CEO Waleed Hassanein added that unexpected aircraft maintenance could create variability. Hassanein also clarified that operational scaling is not linear; new planes require pilot crews, but the broader clinical support staff is part of a larger network and not tied to individual aircraft.

David Rescott from Robert W. Baird & Co. asked if the market share level exiting Q3 should be the baseline expectation for Q4. He also requested more details on aircraft maintenance, including the number of planes affected and potential for future headwinds.

Answer

CEO Waleed Hassanein stated that maintaining the Q3 exit share is the 'low-hanging fruit' and that the team is focused on ending the year strong. He explained that while having 1-2 aircraft in maintenance is normal, Q3 saw a higher-than-average number down for scheduled and unscheduled work. The company is now working to minimize the impact of these events.

David Rescott asked about the Genio 2.1 software rollout, specifically how the company will avoid implant delays in the U.S. during future updates. He also inquired about the back-end support planned to ensure smooth reimbursement under the targeted CPT code.

Answer

CEO Olivier Taelman highlighted the patient-centric benefits of the 2.1 software upgrade. CFO John Landry assured that the U.S. launch will start with Genio 2.1, preventing any initial transition issues. On reimbursement, Landry confirmed a dedicated market access team is in place, and Taelman noted they will leverage the well-established CPT code 64568, which is already recognized by payers.

David Rescott sought to clarify the confidence in the March FDA approval timeline, asking what might cause a delay if it slips into April. He also asked about the size of the Medicare patient opportunity and the company's confidence in CMS accepting the proposed CPT code from day one.

Answer

CEO Olivier Taelman reiterated strong confidence in a pre-April approval, noting that while a 10-day FDA grace period exists, there is no indication it will be used. He estimated that Medicare patients represent 20-30% of the opportunity and expressed confidence that CMS and commercial payers will accept the established CPT code for the OSA indication, supported by their engagement through the FDA's early payer program and work with the AAO.

David Rescott sought clarification on the U.S. go-to-market strategy, asking to reconcile the mention of 31 sites with previous discussions of 75-100 centers and the goal of targeting 85% of U.S. volume. He also asked about the long-term financial model and the revenue level needed to achieve breakeven.

Answer

CEO Olivier Taelman clarified that the 31 sites were the high-volume centers that participated in the usability study. The broader strategy is to target the 200-250 Tier 1 accounts representing 85% of U.S. volume, starting with 15 sales reps covering 50-75 accounts at launch and scaling up quarterly. CFO Loic Moreau stated that with this scalable approach, the company anticipates achieving profitability at around $250 million in U.S. sales. Taelman also emphasized the strength of the balance sheet, which provides a cash runway into mid-2026.

David Rescott inquired about the strategic focus and investments aimed at returning the embolization business to more stable growth. He also asked for updated thoughts on the medium vessel occlusion (MVO) stroke market following recent data.

Answer

CEO Adam Elsesser detailed a two-part strategy for embolization: product innovation, such as Ruby XL, and ensuring the commercial team has the capacity and focus to sell the entire portfolio. Regarding MVOs, he noted that recent trial data supports using aspiration, positioning Penumbra's RED 43 and the upcoming Thunderbolt with RED 62 favorably for this segment.

David Rescott from Robert W. Baird & Co. asked about Medtronic's ability to more actively manage foreign exchange (FX) risk, the potential magnitude of this control, and the timeline for mitigating FX headwinds.

Answer

Interim CFO Gary Corona explained that proactive measures are already underway and the FX headwind in FY26 will be 'meaningfully less' than in FY25. Key actions include changing incentive structures to USD in emerging markets to drive dynamic pricing. CEO Geoff Martha added that the company is also creating natural hedges within its global supply chain to further mitigate currency risk.

Asked about the replicability of the promising early clinical results for AdaptiveAI as it is rolled out more broadly. Also questioned if this new technology could finally address the historical pain point of high reprogramming rates, thereby improving margins and rep efficiency.

Answer

Executives expressed high confidence that the positive results will be replicable, noting the limited launch was sufficiently large and included software upgrades to existing patients which showed similar benefits. They confirmed that AdaptiveAI is expected to significantly reduce the burden of reprogramming, which is a major cost driver. The technology's ability to automate adjustments and proactively flag issues should improve efficiency and be more cost-effective.

Asked about the current growth rate of the overall SCS market and long-term growth drivers, and requested more details on the new SCS product slated for 2026.

Answer

The SCS market growth has slowed to low single digits. A key long-term driver is the underpenetrated PDN market, where a second successful RCT could lead to inclusion in clinical guidelines and boost growth. The new 2026 SCS product will be based on 10-kilohertz therapy but will offer unique clinical benefits, though further details were withheld for competitive reasons.

Asked for clarification on the expected acceleration in the second half of the year, specifically if U.S. VTE growth would hold steady or if growth would be driven more by other segments. Also asked if the recent 2-year CLOUT data is sufficient to drive physician conversion and if the benefits are specific to ClotTriever.

Answer

The company expects continued strong growth in global VTE, with additional catalysts from emerging therapies (VenaCore, Artic) and international expansion contributing to back-half strength. They believe the CLOUT data results are specific to the ClotTriever system's unique mechanism of action and that the superior safety and efficacy data will help convert physicians from both conservative therapy and alternative devices.

Asked about the revenue contribution from the Emerging Therapies segment, inquiring about a reasonable run-rate and which products were the biggest contributors, and whether one product was a clear winner.

Answer

The growth in Emerging Therapies reflects new product launches like RevCore and InThrill. The company expects this portfolio to grow faster than VTE, but growth may be 'lumpy' due to new product introductions and hospital VAC approval timelines. All four segments are expected to contribute to growth going forward, with no single product identified as a 'clear winner' as they are all in early stages.