John Young

John Young asked about the sales force's feedback on selling WRAPSODY with the new strategy, their focus on opening new accounts versus deepening existing ones, and if there's any stocking revenue. He also inquired about the R&D pipeline for 2026 and whether Merit plans to pursue additional PMA-type products longer term.

Answer

Martha Aronson, President and CEO, described an energized, 'small yet mighty' WRAPSODY sales team with detailed targeting plans, pursuing both the predominantly non-hospital setting and hospital accounts (despite VAC committee challenges), emphasizing WRAPSODY's role as one of many products in the portfolio. She confirmed that strategic planning in 2026 will focus on product and platform roadmaps, and there's no reason not to continue pursuing PMA-type products, leveraging technical talent and focusing on existing platforms to enhance customer offerings and sales rep effectiveness.

John Young asked about the sales force's feedback on selling WRAPSODY with the new strategy, their focus on opening new accounts versus deepening existing ones, and whether there's any stocking revenue. He also inquired about the R&D pipeline for 2026 and the longer-term strategy regarding pursuing additional PMA products.

Answer

President and CEO Martha Aronson described the WRAPSODY sales team as energized and motivated, pursuing both non-hospital and hospital settings (where NTAP provides higher pricing, despite VAC committee challenges). She confirmed the team is targeting broadly and that WRAPSODY is one of many products in the company's portfolio. Regarding R&D, she stated that 2026 will involve strategic planning for long-term product and platform roadmaps, and the company sees no reason not to continue pursuing PMA-type products, leveraging technical talent and focusing on customer needs and sales rep 'bag filling'.

John Young asked about the company's ability to raise prices to offset tariffs and for commentary on the U.S. performance of the WRAPSODY device during the quarter.

Answer

EVP and CFO Raul Parra explained that while pricing is a lever in their CGI program, they are taking a measured approach to avoid disrupting customer relationships amid tariff uncertainty. Chairman and CEO Fred Lampropoulos expressed continued enthusiasm for WRAPSODY, stating that its progress on clinical data, reimbursement, and adoption is meeting all expectations.

John Young of Canaccord Genuity asked for confirmation on the timely filing of the Wrapsody TPT application, the status of prior OEM supply chain challenges, and the company's ability to mitigate potential tariffs by moving manufacturing.

Answer

Executive Fred Lampropoulos confirmed that both the NTAP and TPT applications for Wrapsody were filed on time. Executive Raul Parra stated that previous OEM supply chain issues are now largely resolved. Regarding tariffs, both executives explained that making significant manufacturing moves is impractical given the fluid situation. They are monitoring developments closely but will not overreact, instead focusing on execution and adjusting as official policies are announced.

John Young of Canaccord Genuity inquired about the potential 'halo effect' of the Cook Medical acquisition on Merit's broader Cardiac Intervention portfolio in 2025. He also sought clarification on the WRAPSODY reimbursement strategy, specifically the timeline for the NTAP add-on payment and whether product pricing would assume its approval.

Answer

Joseph Wright, an executive, confirmed the strategic rationale is to create an anchor portfolio to build out an EP-focused sales force, driving both acquired and existing product revenue. Raul Parra, an executive, added the deal would contribute approximately $40 million in annualized revenue in fiscal 2025. Regarding WRAPSODY, Joseph Wright stated the company has submitted for NTAP and will price the product with the assumption of receiving it, noting the TPT application would be submitted post-FDA approval.

John Young asked for clarification on 'Epic Aura accounts,' specifically if the '75 of top 100 customers' refers to Epic, commentary on volume improvements from Aura, and whether this is embedded in guidance or represents potential upside.

Answer

Dan Wilson, CFO, clarified that '75 of top 100' refers to all integrated EHR systems, not exclusively Epic, though Epic is a significant component. He noted that Epic integrations are performing exceptionally well, with record numbers in Q4 2025 and Q1 2026. Data indicates a roughly 25% increase in prescribing volume six months post-integration, which is not fully factored into current guidance, representing potential upside.

John Young asked about Epic Aura accounts, clarifying if the "75 of top 100 customers" referred to Epic systems, and inquired about volume improvements from Aura and whether they are embedded in 2026 guidance or represent potential upside.

Answer

CFO Dan Wilson clarified that the "75 of top 100 customers" refers to all EHR-integrated systems, not just Epic, though Epic is a significant part. He noted that Epic integrations are performing incredibly well, with record numbers in Q4 2025 and Q1 2026, and a strong pipeline. He stated that post-integration, a 25% increase in prescribing volume is typically observed after six months, but this is not fully factored into 2026 guidance, suggesting it as a source of potential upside.

John Young asked if the overall MCT market is growing and if iRhythm is benefiting from post-ablation monitoring, particularly with the expansion of Pulsed Field Ablation (PFA).

Answer

CEO Quentin Blackford responded that it is difficult to isolate any benefit from PFA and believes the overall MCT market is likely to be 'slightly flat' over time due to CMS pricing pressure. He emphasized that iRhythm's growth opportunity is in taking share from competitors in existing accounts, noting every 10 points of share gain represents $80M-$100M in revenue.

John Young asked whether any revenue from the sleep apnea initiative is included in the 2025 guidance and how management is thinking about contributions from this and other adjacent market opportunities.

Answer

CEO Quentin Blackford confirmed that there is no revenue from sleep apnea included in the 2025 guidance. He expressed confidence in the company's 'right to win' in the space by leveraging its existing digital platform for primary care physicians. However, following a prudent approach, management will wait for revenue to materialize before incorporating it into financial forecasts.

John Young inquired about the BENEFIT-HF trial's initial site strategy, including the mix of new versus existing commercial sites and potential revenue generation from trial cases. He also asked about the expected trend for active account growth in 2026 following a lower sequential growth in Q4 2025.

Answer

President and CEO Kevin Hykes stated that BENEFIT-HF centers would be a mix of existing Barostim users and new sites, selected based on interest and impact in the heart failure community. CFO Jared Oasheim clarified that approximately 1,600-1,700 devices would be sold for the trial, reimbursed by Medicare/Medicare Advantage. For active accounts, Mr. Oasheim explained that Q4's low sequential growth was net, with expectations to add around 3 active territories quarterly in 2026, leading to high single-digit net account adds.

John Young asked about the BENEFIT-HF trial strategy, specifically regarding the initial sites (new vs. existing commercial sites), the overlap with the current indication, and potential revenue generation from trial cases.

Answer

Kevin Hykes (President and CEO) explained that initial sites would be a mix of existing Barostim users and new centers, selected based on interest and impact within the heart failure community. Jared Oasheim (CFO) clarified that CVRx expects to sell approximately 1,600-1,700 devices for the trial, with Medicare or Medicare Advantage plans reimbursing hospitals for these units. John Young also inquired about the sequential growth of active accounts in Q4 and the expected trend for 2026. Jared Oasheim (CFO) noted that Q4 growth was on a net basis, with some accounts sunsetted, and projected high single-digit net account additions quarterly in 2026, with each new territory managing 3-5 active implanting centers.

John Young of Canaccord Genuity asked about CVRx's narrowed revenue guidance, specifically how it accounts for the productivity ramp of the 35% of territory managers who are new since January. He also inquired about the process for identifying and targeting high-potential Tier 3 and 4 accounts and whether this could slow the commercial process.

Answer

CFO Jared Oasheim explained that the narrowed guidance reflects the pace at which the new sales team becomes productive, noting the midpoint shift was minor. He clarified that the company uses internal data to identify promising Tier 3 and 4 accounts and provides this information to reps in a playbook, ensuring the process is efficient and does not slow down commercial efforts.

Focused on the China business, asking about its contribution to OUS sales, the extent of distributor stocking in Q1, expectations for Q2 orders, and how potential tariffs are factored into guidance.

Answer

The company does not break out revenue by country but confirmed strong buying from their Chinese distributor, who likely bought about a quarter's worth of extra inventory in Q1. They expect continued purchasing in Q2. Potential future tariffs are not reflected in the current guidance, but the situation is being monitored.

Asked about the drivers of the strong Q4 OUS performance, whether Q4 is a good baseline for 2025 OUS modeling, and if the expected H2 acceleration in the U.S. could overcome typical Q3 seasonality.

Answer

The company confirmed Q4 OUS strength was broad-based across Europe and China with recurring orders, not one-time stocking. They expect continued, predictable OUS growth in 2025 but not at the same rate as 2024. For the U.S., they believe new initiatives might help normalize some Q3 seasonality but still expect H2 acceleration driven by a range of growth drivers including marketing, R&D (LungTrax), and sales force changes.

Representing John Young of Canaccord Genuity, an analyst asked about the growth outlook for the OUS (Outside the U.S.) business in 2025 and beyond, given its strong recent performance.

Answer

CEO Steven Williamson expressed a bullish outlook for OUS markets, citing the successful implementation of the U.S. sales process, stronger-than-expected adoption in China, and positive developments like the UK's targeted lung health check program. He expects continued growth but will provide formal 2025 guidance on the Q4 call.

John Young of Canaccord Genuity asked if AngioVac's strong $6.8 million revenue represents a new sustainable baseline and requested details on NanoKnife's prostate revenue, marketing KPIs, and the CPT-1 code reimbursement timeline.

Answer

EVP & CFO Stephen Trowbridge confirmed that the mid-$6 million level for AngioVac is a solid new base for future growth, highlighting the synergistic benefits with the AlphaVac portfolio. CEO James Clemmer noted that prostate procedures now account for over half of NanoKnife treatments, with strong organic interest from patients and physicians. Trowbridge added that the key inflection point remains reimbursement, with an initial CPT-1 code readout expected in July and full effect in January.

John Young from Canaccord Genuity inquired about the drivers behind the strong growth in AngioDynamics' thrombectomy business, specifically the acceleration in AngioVac and the commercial execution strategy for AlphaVac. He also asked about the impact of recent sector M&A on commercial plans and followed up on Auryon's growth dynamics, the potential ceiling for the OBL market, and reimbursement in Europe.

Answer

Executive James Clemmer and CFO Stephen Trowbridge explained that the thrombectomy growth is driven by strong commercial synergies, where the fully trained sales force is leveraging the comprehensive portfolio of both AngioVac and AlphaVac to open new doors. Trowbridge noted that the publication of APEX trial data is a key catalyst for AlphaVac adoption. Regarding Auryon, Clemmer highlighted the successful strategic shift to hospitals, which now account for over 35% of its revenue, without abandoning the OBL market. He described the European launch as a targeted effort.

John Young of Canaccord Genuity asked about the NanoKnife CPT code pathway, including the timeline beyond the October committee decision and whether the company would commercialize without the code. He also questioned the significant Q1 cash burn and the path to cash flow positivity, and inquired if the OUS Med Device revenue shortfall was due to order timing that would shift to Q2.

Answer

Executive Vice President and CFO Stephen Trowbridge explained that the NanoKnife FDA indication and reimbursement processes are on parallel paths and that commercialization is already underway due to its existing general indication. Regarding the Q1 cash burn, Trowbridge confirmed it was in line with expectations due to seasonal payments like incentive compensation and insurance premiums, and he reiterated the company's target to be cash flow positive in fiscal 2026. He also affirmed that the international Med Device performance was impacted by order timing and a tough prior-year comparison, with an expectation for improvement in Q2.

John Young of Canaccord asked for feedback from STAAR's on-the-ground sales force in China and how their incentives are being adjusted to manage the distributor dynamics. He also inquired about the current number of U.S. 'Fast Lane' accounts and any updates on U.S. growth initiatives given the company's new cost-saving measures.

Answer

CEO Tom Frinzi stated that the China team's incentives are being shifted to focus on driving sell-through procedure volume rather than just sell-in to distributors. CFO Patrick Williams reported strong U.S. performance, with approximately 13 'Fast Lane' accounts now established. Both executives emphasized a continued focus on U.S. growth, including initiatives to educate optometrists and conduct a head-to-head clinical study to grow the overall refractive market, not just take share from a declining laser vision correction market.

John Young of Canaccord Genuity asked for an update on the 'fast lane' accounts mentioned last quarter, inquiring how many new ones were identified and about plans for signing more strategic alliances in the second half of the year.

Answer

Executive Thomas G. Frinzi reported that the company has now signed 9 new strategic agreements in the U.S. this year, up from 6 reported last quarter, against a target list of 15. Executive Patrick Williams added that they are experiencing a 'halo effect,' with other accounts now proactively approaching them to partner.