Simran Kaur

Simran Kaur asked about the market reaction to the FDA Biologics License Application (BLA) approval for Avance since December 2025, particularly regarding payer engagement. She also inquired about the rationale behind the planned sales force additions for 2026 (12 reps) compared to 2025 (22 reps), and how the productivity ramp of the sales force is currently tracking.

Answer

CEO Michael Dale reported positive feedback on Avance's product characteristics, noting the BLA provides a new vehicle to engage non-adopters and address payer objections regarding the device being experimental. He stated that while there's no fixed schedule for payer responses, the company expects to see some in 2026 and aims to overcome negative coverage decisions by 2028. Regarding sales force expansion, Michael Dale clarified that the company is far from reaching 'critical mass' in extremities (needs 400-600 reps) and breast (1,200 sites), and the incremental additions through 2028 reflect a strategic decision for disciplined growth.

Simran Kaur asked about the market and payer reaction to the FDA Biologics License Application (BLA) approval for Avance since December 2025. She also questioned the rationale behind the planned sales force additions for 2026, specifically why 12 new reps, given the perceived critical mass in segments like extremities, and how productivity ramp-up compares to historical trends.

Answer

Michael Dale (CEO) stated that the BLA approval has been positive, providing a new vehicle to engage payers who previously cited the device as experimental. He noted that while it's a formal process with no guaranteed feedback schedule, the company expects responses from these entities in 2026 and aims to overcome negative coverage decisions by 2028. Regarding the sales force, Michael Dale (CEO) clarified that current rep numbers are far from providing full coverage in extremities (130 reps vs. 400-600 needed) and breast (21 reps vs. 1,200 sites), indicating a strategic decision for incremental additions through 2028 rather than a single-year expansion.

Simran Kaur of Wells Fargo inquired about the drivers for the high and low ends of the 2025 revenue guidance, the cadence of the next-gen SWOOP system launch, and the commercial traction seen in the neurology office setting.

Answer

CFO Brett Hale clarified that Q3 revenue growth is expected to be 50% greater than the dollar increase from Q1 to Q2. CEO Maria Sainz added that confidence in the second-half ramp comes from multiple new revenue layers, including the accelerated US hospital business with the new system, the full launch into the office setting, and international expansion. Sainz noted the primary focus is on new system sales at a higher ASP, with potential for market segmentation. She also highlighted the success of the office pilot program and the rapid enrollment in the NeuroPMR study, which validates the strong clinical enthusiasm.

Simran Kaur of Wells Fargo inquired about business trends exiting Q2 and into Q3 2025, referencing prior commentary on a lack of volume acceleration in June, and asked if analyst models for Q3 are now properly calibrated.

Answer

CFO Shelley Thunen stated that while it is still early in Q3, the company is mindful of the trends from Q2 and typical third-quarter seasonality. Thunen confirmed that consensus estimates are currently in the middle of the full-year revenue guidance of $120 million to $130 million and reiterated that H2 revenue is expected to be significantly lower than H1.

Simran Kaur, on for Larry Biegelsen, asked for clarity on the implied Q4 U.S. growth range, questioning what factors would lead to the high versus low end, and sought perspective on whether 20% is a sustainable growth rate for the U.S. business into 2026.

Answer

EVP & CFO Ana Maria Chadwick clarified that underlying business trends remain very stable. She explained that after normalizing for prior-year stocking and current-quarter rebate timing, the U.S. business grew 24% in the first half. She stated the back-half guidance is strong in that context and that the company's momentum is expected to continue.

Simran Kaur from Wells Fargo questioned the wide implied Q4 growth range for the U.S. business and asked whether 20% growth remains a reasonable expectation for the U.S. segment going forward.

Answer

EVP & CFO Ana Maria Chadwick clarified that underlying business trends are very stable. She explained that after normalizing for prior-year stocking and current-year rebate timing, the U.S. business grew 24% in the first half. In this context, she described the back-half guidance as very strong and expressed confidence in continued momentum, deferring comments on 2026.