Vik Chopra

Vik Chopra from Wells Fargo & Company questioned whether the preliminary data from the NAUTILUS trial had created any negative commercial impact or tainted physicians' views of the RNS System. He also asked the new CFO, Patrick Williams, for his perspective on the achievability of the company's long-range plan (LRP) targets.

Answer

CEO Joel Becker stated there has been "absolutely no" negative commercial impact from the NAUTILUS data. He noted that investigators close to the trial are enthusiastic, as they recognize the primary endpoint miss was due to a statistical analysis method and that the secondary endpoints show highly statistically significant and clinically meaningful seizure reduction. CFO Patrick Williams expressed high conviction in achieving the LRP's target of 20%+ CAGR for the core RNS business, even without new indications. Becker added that the business is already delivering this growth and has the potential to do more.

Vik Chopra from Wells Fargo asked new CEO Dan Scavilla about applicable lessons from his time at Globus Medical. He also requested more color on the double-digit decline in the implants and prosthetics business and its outlook.

Answer

CEO Dan Scavilla emphasized the importance of a 'hands-on' leadership approach, getting into the field with sales reps and taking direct accountability for execution. CFO Matt Garth reiterated the implant performance drivers: a slight decline in premium due to product transitions, a low-double-digit decline in value from Middle East volatility, and a double-digit decline in the lab business.

Vik Chopra from Wells Fargo asked new CEO Damien McDonald about key lessons from his prior roles that he can apply at Enovis. He also inquired about the company's M&A strategy and the balance between debt paydown and potential tuck-in deals.

Answer

CEO Damien McDonald explained he will apply discipline to customer segmentation, account acquisition, and innovation. He emphasized expanding the EGX business system across the entire enterprise to improve capital efficiency and cash generation. Regarding capital allocation, McDonald was unequivocal that the immediate priority is debt reduction, with M&A or share buybacks only to be considered once the company's financial foundation is stronger.

Vik Chopra of Wells Fargo requested an update on the progress and launch timeline for Masimo's new hemodynamic monitoring technology and asked if there was any lingering impact from the recent cybersecurity incident.

Answer

CEO Katie Szyman confirmed that a next-generation monitor with enhanced hemodynamics technology is planned for launch in the second half of 2026, with pilots of current technology ongoing. CFO Micah Young and Szyman both stated the company is fully operational after the cyber attack with no material impact expected, adding that systems were fortified during the recovery process.

Vik Chopra asked for an explanation of the variables driving the 2025 guidance range and what specific factors would push results toward the low or high end.

Answer

CFO Eric Hammes explained that the high end of the guidance would be driven by continued outperformance in Spark, new product traction, and a stronger macro environment. Conversely, the low end would be defined by a deterioration in the stable dental market or an inability to fully mitigate tariff impacts. He stated that the midpoint of the guidance is a reasonable expectation given current conditions.

Vik Chopra asked for guidance on modeling Q3 and the remainder of the year following the strong quarter, and requested an update on the robot launch timeline, including whether it would be showcased at NASS.

Answer

CFO Todd Koning advised that a normal sequential revenue step-down from Q2 to Q3 is typical, but the full-year guidance was raised by $10 million since the start of the year. Chairman & CEO Pat Miles confirmed the robot is on track for a 2026 market influence, with combined navigation/robotic cases starting by year-end 2025, and affirmed it will be seen at NASS.

Vik Chopra of Wells Fargo inquired about the potential impact of the CMS's proposed 2026 reimbursement changes for skin substitutes and sought clarification on the drivers behind the significant Q4 EPS step-up implied by the full-year guidance.

Answer

President and CEO Mojdeh Poul stated that while most of Integra's business is in the acute care setting and not immediately impacted, the company is encouraged by the proposed changes long-term as they favor products with strong clinical evidence. EVP & CFO Lea Daniels Knight explained the Q4 revenue and EPS step-up is driven by normal seasonality (60%) and supply recovery from previous ship holds (40%), noting the revenue lift will also improve gross margin and overall EPS.

Vik Chopra of Wells Fargo asked what gives management confidence that the planned restructuring actions will successfully achieve their goals and help counter the soft macroeconomic environment.

Answer

CFO John Morici explained that confidence stems from the actions' dual benefits of driving productivity and moving closer to customers. Regionalizing manufacturing reduces freight costs and cycle times, while new equipment boosts efficiency. He stated that the resulting cost savings will be reinvested to help doctors improve case conversion at the practice level.

An analyst on behalf of Vik Chopra from Wells Fargo asked for an update on the recent FDA warning letter, including its resolution timeline and commercial impact, and for the outlook on the capital equipment environment for Q4 and 2025.

Answer

President & CEO Dan Scavilla stated the warning letter concerned internal complaint handling processes, not product safety, and that they have submitted corrective actions to the FDA, aiming for a resolution faster than the typical year-plus timeline. COO & CFO Keith Pfeil added that the capital environment remains healthy with a strong pipeline for Q4, and the company is focused on its best-in-class technology to compete in 2025.

Analysts on behalf of Vik Chopra asked incoming CEO Pat Beyer about his top priorities for 2025 and inquired about the impact of hurricane-related IV fluid shortages on surgical procedures.

Answer

Incoming CEO Pat Beyer stated his immediate priorities are engaging with customers, employees, and shareholders to continue the company's growth trajectory. EVP and CFO Todd Garner confirmed that procedure deferrals from IV shortages were seen in October and are factored into the Q4 guidance, which assumes a continuation of the October status quo.