Mike Kratky

Mike Kratky asked if the significant growth acceleration in the Cardiac Ablation Solutions (CAS) business puts the company on track to achieve its $2 billion annual sales target in fiscal 2026.

Answer

Chairman & CEO Geoff Martha confirmed the company is sticking to its near-term goal of adding an incremental $1 billion in revenue on top of its fiscal 2025 base for the CAS business. He clarified that while the goal is on track, it may extend into fiscal 2027, but reiterated confidence in the trajectory.

Sam, on behalf of Mike Kratky from Leerink Partners, requested more color on NeuroPace's ongoing dialogue with the FDA regarding the NAUTILUS trial submission. He also asked about the typical ramp-up time and learning curve for a community center in Project CARE to become a significant contributor to implant volumes.

Answer

CEO Joel Becker reported that the company's pre-submission documents for NAUTILUS were accepted by the FDA and a meeting is scheduled in the coming weeks, highlighting a collaborative relationship with the agency. Regarding Project CARE, Becker described three types of centers with varying ramp times: some are ready to start implanting quickly, others require more time to build out infrastructure or staff, and a third group prefers to focus on programming patients while partnering with Level 4 centers for the implant procedure.

An analyst on behalf of Mike Kratky of Leerink Partners asked about penetration in low-to-medium volume hospitals and the commercial impact of recent Medicare LCD updates.

Answer

EVP & CFO Kevin Waters responded that the near-term focus remains on high-volume hospitals where significant opportunity still exists. Regarding the LCD updates, he noted it is too early to see an impact as most changes become active in the fall, with any potential effect not expected until 2026.

Speaking on behalf of Mike Kratky, an analyst asked about the Q4 ASP guidance, probing for any potential discounting on legacy AquaBeam systems. He also inquired about the long-term cost of goods sold (COGS) for HYDROS compared to the legacy system.

Answer

CFO Kevin Waters confirmed the Q4 ASP guidance is for primarily greenfield accounts with no unusual discounting dynamics. On COGS, he stated that HYDROS currently costs about 10% more than AquaBeam but expects this to decrease with scale and eventually cost less. He emphasized that higher ASPs are more than offsetting this cost headwind, and the record Q3 gross margin of 63.2% serves as a new jumping-off point for future expansion.

An analyst on behalf of Mike Kratky at Leerink Partners asked about any remaining major milestones in the BLA process before the expected September approval and requested details on the specific manufacturing improvements planned post-approval.

Answer

President and CEO Michael Dale explained that the final BLA stages involve working with the FDA on labeling and finalizing quality system requirements. Post-approval, he said manufacturing improvements will focus on classic continuous improvement processes, such as reducing process steps and implementing electronic systems to decrease manual record-keeping, which can begin once the BLA is secured.

Sam on for Mike Kratky asked for the underlying cause of biopsy growth outpacing implant growth in H1 2025 and inquired about the mix of newly trained MACI Arthro surgeons between existing and new customers.

Answer

CFO Joe Mara explained that the biopsy/implant dynamic was an expected part of the MACI Arthro launch, similar to the original MACI launch, and is a positive indicator for future growth. CEO Dominick Colangelo provided a detailed breakdown of the 600 trained surgeons, noting they are evenly split between two existing MACI user segments and one segment of prior non-users, demonstrating broad appeal.

An analyst on for Mike Kratky at Leerink Partners asked about the progression of gross margin throughout the year as the Inspire V mix increases, given the significant inventory build. A follow-up question concerned the OUS performance and any foreign exchange impacts.

Answer

CFO Richard Buchholz reiterated the full-year gross margin guidance of 84% to 86% and confirmed that Inspire V is accretive to margins, excluding price changes. He explained that Inspire IV will continue to be manufactured for international markets pending approval, and many components are shared between the two systems. Regarding OUS, he noted no real FX impact in Q1 but is seeing some in Q2.

Mike Kratky asked for additional color on the commercial impact of recent CGM integrations, both for Insulet's products and in the context of competitor launches.

Answer

President and CEO Jim Hollingshead described the sensor integrations as a 'terrific' growth tailwind. He highlighted the successful U.S. launch with Dexcom's G7 and the European launches with Abbott's Libre 2 Plus as material drivers of new customer starts. CFO and Treasurer Ana Maria Chadwick added that the strong uptake of the new iOS app further boosts their confidence in providing customer choice.