Michael Kratky • Leerink Partners

Answer

Executive Joel Becker and CFO Rebecca Kuhn attributed the strong gross margin primarily to the RNS business, driven by higher production volumes, manufacturing efficiencies, and successful price increases, rather than product mix. They noted that while margins can fluctuate quarterly, the underlying operational drivers like volume and pricing are durable levers.

Ask Fintool Equity Research AI

Answer

Executive Joel Becker confirmed that they are seeing accounts with multiple implants and referrals through Project CARE, which is an encouraging sign of adoption. He and CFO Rebecca Kuhn affirmed the economic viability of RNS procedures outside Level 4 centers, noting that while reimbursement rates and payer mix vary, the value proposition for centers and payers is attractive given the high costs associated with uncontrolled seizures.

Ask Fintool Equity Research AI

Answer

Executive Joel Becker clarified that Project CARE's Q3 contribution came from both direct implants in new centers and patient referrals back to Level 4 centers for implantation or advanced testing. Regarding guidance, Becker emphasized that the updated forecast implies over 20% growth for the full year, despite tougher comps from the NAUTILUS trial in the second half, reflecting strong business fundamentals and a focus on balancing growth with disciplined spending.

Ask Fintool Equity Research AI

Answer

Executive Reza Zadno confirmed that the prostate size distribution has remained consistent, with most cases being under 100ml. Executive Sham Shiblaq added that a key value proposition is the technology's ability to treat all prostate sizes with consistent and efficient outcomes, which is a major benefit for surgeons, especially for larger prostates they may have previously referred out.

Ask Fintool Equity Research AI

Answer

CFO Kevin Waters did not comment on 2026 but affirmed that sequential EBITDA improvements in 2025 will demonstrate a clear path to sustained profitability. Regarding the handpiece ASP, he stated it was too early to quantify the specific price difference as customer negotiations for the new HYDROS system are ongoing.

Ask Fintool Equity Research AI

Answer

CEO Kevin Sayer stated that the Type 1 business is performing exactly as anticipated. He affirmed that the company continues to do 'incredibly well' in the Type 1 market, saw nice growth in the quarter in line with expectations, and maintains outstanding retention and utilization in that population.

Ask Fintool Equity Research AI

Answer

CFO Jereme Sylvain noted a strong Q4 with record new patients and good share performance across the board. He highlighted the non-insulin space as a key opportunity for 2025, as this is an area where DexCom historically had less share due to lack of coverage. He expects the expanded sales force and product innovation to drive strong performance in this newly accessible market.

Ask Fintool Equity Research AI

Answer

CFO Jereme Sylvain downplayed any significant impact from competitor issues. He attributed the company's positive momentum to its own sales force's effectiveness in bringing in new physicians and communicating the value of G7 and Stelo, rather than capturing share from competitor supply disruptions.

Ask Fintool Equity Research AI

Answer

CFO Leigh Vosseller confirmed the mid-single-digit growth assumption for new starts remains in the guidance. She highlighted that MDI conversions grew at a double-digit rate for the fourth consecutive quarter and now represent approximately two-thirds of all new patient starts.

Ask Fintool Equity Research AI

Answer

Mark Novara, Executive Vice President and Chief Commercial Officer, reiterated that while seasonality was muted, December was still the largest shipment month of the year with sizable year-over-year growth. He cited macro factors like out-of-pocket costs as a continuing challenge and confirmed the sales force realignment did not impact Q4 as teams remained focused on selling.

Ask Fintool Equity Research AI

Answer

EVP and CFO Leigh Vosseller noted it's too early to quantify volume from the single contract but highlighted that numerous other conversations are underway. CEO John Sheridan added they are "aggressively" working on many more opportunities. They reiterated it's a multiyear strategy for Tandem Mobi that requires building out payer pull-through.

Ask Fintool Equity Research AI

Answer

CEO Dominick Colangelo attributed the higher conversion rate to a maturing surgeon base but clarified that a significant increase is not built into 2025 guidance, representing potential upside. He added that while it's early, leading indicators for MACI Arthro are positive, with biopsy growth from trained surgeons outpacing others and cases being scheduled across all surgeon segments.

Ask Fintool Equity Research AI

Answer

CEO Nick Colangelo stated that the main impact of MACI Arthro is expected in 2025 due to the typical biopsy-to-procedure timeline. CFO Joe Mara clarified the Q4 MACI guidance of ~$68M is based on core business momentum, not a significant Arthro contribution. Mr. Colangelo confirmed that NexoBrid's launch has driven meaningful and durable Epicel pull-through from new and dormant accounts, a trend expected to continue.

Ask Fintool Equity Research AI

Answer

CEO Michael Dale detailed plans to double the breast commercial team from 12 to 24 people, supplemented by about 10 market development and education staff. CMO Jens Schroeder Kemp explained that the 600 'high potential accounts' are typically Level 1 trauma centers or academic hospitals with a high volume of nerve repair procedures and existing microsurgeons.

Ask Fintool Equity Research AI

Answer

CEO Michael Dale explained that BLA approval is strategically crucial as it formally affirms Avance's safety and efficacy, removing any 'experimental' perception for payers and enabling the pursuit of standard-of-care status. Regarding business development, Dale stated that anything necessary to achieve that status is 'within scope,' without signaling specific targets.

Ask Fintool Equity Research AI

Answer

President and CEO Jim Hollingshead expressed high confidence in Insulet's position. He argued that Omnipod 5's inherent advantages in simplicity and ease of use, which allowed it to overtake incumbents in the Type 1 market, are even more critical for the Type 2 population. He emphasized that being first-to-market with a product proven to be a "winning offer" gives them a clear right to win, even if competitors eventually follow with their own indications.

Ask Fintool Equity Research AI

Answer

CEO Adam Elsesser responded that it was premature to provide that level of detail on the U.S. business, as multiple verticals have significant growth drivers. Regarding Europe, he noted that while full reimbursement is not yet available in all countries, adoption trends where products are launched mirror the U.S. experience, driven by the technology's ability to remove clots faster and safer.

Ask Fintool Equity Research AI

Answer

CEO Adam Elsesser reported that the U.S. arterial business grew in the "high teens" in Q3, a strong result against challenging prior-year comparisons. He described the BTK opportunity as bringing the benefits of CAVT technology to smaller vessels where the company already competes with non-CAVT products, framing it as a technology upgrade and part of a broader innovation strategy.

Ask Fintool Equity Research AI

Answer

CEO Tim Herbert confirmed that he expects it to have an impact. He noted that some payers already have policies that don't explicitly require a DISE, and the algorithm presented from the PREDICTOR study provides a clear method for physicians to identify suitable candidates without it. He added that they are already working with physicians to submit patients to payers using this new algorithm, which should streamline the patient journey.

Ask Fintool Equity Research AI