Nathan Treybeck

Nathan Treybeck asked about the launch timelines of the two electrophysiology and one neuromodulation products, whether an inventory build in 2025 contributed to sales growth, and if the two EP products were from separate customers. He also questioned if the PMA portfolio's 15-20% CAGR target remains intact given the current headwinds.

Answer

Payman Khales, President and CEO-elect, stated that the products were recently launched with strong ramps in 2025, followed by customer adjustments due to slower market adoption, primarily impacting 2026. He could not confirm if the EP products were from separate customers due to confidentiality. He reiterated that the EP market is strong, and Integer's EP business (excluding these two products) grows at market rate. He affirmed the 15-20% PMA portfolio CAGR target remains intact long-term, with new product launches expected to drive growth in 2027.

Nathan Treybeck asked about the market duration of the two electrophysiology and one neuromodulation products, inquiring if an inventory build in 2025 contributed to sales growth before end market demand softened. He also sought confirmation if the two EP products were from separate customers, and if these were novel products not tied to existing procedures, given the strong overall EP market outlook. Finally, he asked if the prior 15%-20% three-to-five-year CAGR outlook for the PMA portfolio was still intact.

Answer

Payman Khales, President and CEO-elect, explained that these products were recently launched and had strong ramps in 2025, with customers building inventory for distribution. The current changes reflect slower-than-anticipated market adoption. He could not confirm if the two EP products were from separate customers due to confidentiality. Khales reiterated the overall strength of the EP market and Integer's EP business, noting that excluding the two impacted products, the EP business still grows at the market rate. He affirmed that the 15%-20% CAGR for the PMA portfolio over the next three to five years remains intact, with expected short-term headwinds in Q4 and 2026, but a return to above-market growth in 2027 driven by new product launches.

Nathan Treybeck asked for more detail on the Cardio & Vascular (C&V) demand pull-forward into Q2, questioning if it was due to inventory building by customers and seeking to understand the expected second-half deceleration. He also asked incoming CEO Peyman Khales about his strategic priorities and focus areas for improvement.

Answer

COO Peyman Khales attributed the strong 24% reported C&V growth to new product launches, strong neurovascular demand, and some demand shifting from Q3. He emphasized looking at the 17% trailing four-quarter growth as a better indicator and confirmed the mid-teens full-year guidance is on a reported basis. On strategy, Khales stated his intention to continue and refine the existing strategy, focusing on outperforming market growth, expanding margins through manufacturing excellence, and pursuing tuck-in acquisitions while maintaining the target leverage ratio of 2.5x to 3.5x.

Nathan Treybeck from Wells Fargo sought clarification on whether the tariff estimate includes a scenario where the 90-day pause ends, asked about gross margin drivers, and questioned if customers were building inventory.

Answer

CEO Joseph Dziedzic confirmed the tariff estimate does account for the pause ending. He explained that while Q1 gross margin improved, variability should be expected due to new product launch timings, but reiterated the full-year operating margin expansion guidance. He also stated that Integer is not seeing customers pull forward orders or build inventory as a precaution against tariffs.

Nathan Treybeck asked for details on Integer's involvement in the Renal Denervation market, including the nature of its manufacturing and customer relationships. He also inquired about the expected growth sequencing for the emerging PMA customer portfolio, which is guided to a 15-20% CAGR.

Answer

President and CEO Joseph Dziedzic confirmed Renal Denervation is an exciting market that leverages Integer's core capabilities, but declined to disclose specific customer or product details. Regarding the PMA portfolio, he explained that while growth will be more predictable now that it's a $125 million business, it won't be perfectly linear due to the nature of new product launches. He highlighted the pipeline's strength, noting the number of PMA customers has grown from 27 to 39 since 2020.

Nathan Treybeck from Wells Fargo asked for an update on the hospital capital spending environment and the company's strategy for entering Ambulatory Surgery Centers (ASCs).

Answer

EVP & CFO Kevin Waters confirmed the capital environment remains stable with no signs of a slowdown, noting the robot's value proposition resonates with hospital CFOs. President & CEO Reza Zadno reiterated that the company's primary focus is the hospital market, where 90% of procedures occur, and that the ASC initiative remains a pilot program for the future.

Nathan Treybeck sought clarification on the average selling price (ASP) difference between new greenfield systems and legacy system replacements. He also asked for an update on the 2,000 procedures that were deferred from Q4.

Answer

Executive Kevin Waters explained that the replacement ASP varies by the age of the system being traded in, but noted that for the single replacement in Q1, the price was not materially different from a new system. Regarding deferred procedures, he stated they are expected to filter back in throughout the year and that the net impact in Q1 was negligible due to offsetting headwinds.

Nathan Treybeck of Wells Fargo inquired about the gross margin impact from system replacements, the expected gross margin cadence throughout 2025, and the company's timeline for potentially moving away from having a sales representative present at every procedure.

Answer

CFO Kevin Waters stated that the replacement opportunity is already factored into the full-year 2025 gross margin guidance of ~64.5%, which implies a Q4 exit rate of 65-66%. CCO Sham Shiblaq explained that having a rep in every case remains a valuable sales and efficiency tool, but they plan to pilot some independent HYDROS accounts in 2025 to evaluate a potential transition over time.

Nathan Treybeck of Wells Fargo asked for a breakdown of the $2 million OUS ArteGraft sales guidance between Europe and other regions, and inquired about the potential market size and ramp for RestoreFlow upon its launch in Germany or Ireland.

Answer

Chairman & CEO George LeMaitre noted most of the $2 million in ArteGraft sales would be European. President & Director Dave Roberts added that LeMaitre is effectively creating the OUS biologic dialysis access market. For RestoreFlow, Roberts estimated the mature European market could be $80-$100 million but cautioned that growth will be gradual due to country-by-country approvals and supply constraints.

Nathan Treybeck of Wells Fargo Securities inquired about the underlying pricing and volume assumptions within the 2025 guidance, particularly how much of the 8% U.S. list price increase is expected to translate into actual price realization. He also asked for data on how many U.S. and European accounts have already been repriced.

Answer

EVP, CFO & Treasurer Joseph Pellegrino explained that while historical data is available, a reasonable assumption for 2025 could be approximately 6% price and 4% unit growth. He noted that many factors influence the final realized price. CEO George LeMaitre added that all accounts, excluding Japan, were repriced effective January 1.

Nathan Treybeck from Wells Fargo & Company asked to identify the key innovative partnerships underpinning the growth outlook and inquired about the reorder rates and sustainability of monitoring within these new channels.

Answer

President and CEO Quentin Blackford identified Signify Health, the newly launched CenterWell, and the long-standing partner Oak Street Health as significant contributors. He noted an encouraging trend toward repeat monitoring, with partners expecting to retest patient populations annually or continuously monitor new members to proactively manage asymptomatic and comorbid patients, suggesting a sustainable prescribing pattern.

Nathan Treybeck asked about conversations with the FDA regarding the planned Q3 submission for Zio MCT and whether a facility reinspection would be part of the approval process.

Answer

CEO Quentin Blackford expressed high confidence in the Q3 submission timeline, stating that interactions with the FDA have not raised any concerns. Regarding the warning letter, he reiterated that remediation efforts are on track for completion by mid-year but could not provide a timeline for a potential FDA reinspection. He stressed that these activities are not impeding innovation or new product submissions.

Nathan Treybeck asked for an update on the Zio MCT submission timeline and whether the company would need to wait for the full remediation of the 483 observations before filing for approval.

Answer

CEO Quentin Blackford confirmed that the timeline for the Zio MCT submission remains on track for Q3 2025. He clarified that the company does not need to have the 483s fully remediated or receive clearance from the FDA to proceed with the submission, as they have already prioritized key remediation activities to demonstrate their commitment to the agency.

Asked for details on the newly announced strategic review process and the reasons behind the full-year guidance reduction, specifically questioning the performance of the PDN business.

Answer

The company is in the early stages of a strategic review to accelerate its diversification strategy, with no set timeline. The guidance reduction is due to competitive and market headwinds in the core SCS market, not the PDN business, which continues to grow.

Inquired about the differentiation strategy for the newly acquired Vyrsa in a crowded SI Fusion market, plans for clinical data development, and the expected impact of new SCS competition in 2024.

Answer

Nevro plans to differentiate Vyrsa by offering a comprehensive product portfolio and leveraging its large, existing salesforce and physician relationships. Regarding competition, Nevro believes its unique high-frequency 10-kilohertz therapy and superior clinical data will continue to set it apart from new low-frequency competitors, and this competition is already factored into the 2024 guidance.