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    Christopher PasqualeStifel, Nicolaus & Company, Incorporated

    Christopher Pasquale's questions to Transmedics Group Inc (TMDX) leadership

    Christopher Pasquale's questions to Transmedics Group Inc (TMDX) leadership • Q1 2025

    Question

    Christopher Pasquale questioned the updated operating margin guidance, which seems conservative after a strong Q1, and asked about the key driver for improving service gross margin, which was flat sequentially.

    Answer

    Executive Waleed Hassanein explained the full-year operating margin guidance reflects significant investments planned for later in the year. CFO Gerardo Hernandez added that the primary lever for improving service gross margin is increasing the utilization of their aviation fleet. He noted they are already covering a much higher percentage of missions and are exploring initiatives like double-shifting aircraft to further boost efficiency and expand margins.

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    Christopher Pasquale's questions to Transmedics Group Inc (TMDX) leadership • Q4 2024

    Question

    Christopher Pasquale of Nephron Research asked about the operational capacity of the planned 22-aircraft fleet and how the company will balance asset utilization with the need for a maintenance cushion. He also inquired about the expected R&D spending growth relative to SG&A in 2025.

    Answer

    CEO Waleed Hassanein and CFO Gerardo Hernandez explained the focus is on optimizing the existing fleet, with 22 aircraft providing 18-20 operational planes daily, and capacity further boosted by double-shifting pilots. Gerardo Hernandez projected modest operating leverage gains in 2025, with continued strong investment in R&D for innovation while SG&A grows more moderately.

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    Christopher Pasquale's questions to AxoGen Inc (AXGN) leadership

    Christopher Pasquale's questions to AxoGen Inc (AXGN) leadership • Q1 2025

    Question

    Christopher Pasquale of Nephron Research LLC asked for clarity on the status of the ~215 high-potential accounts that were not active in Q1 and questioned the rationale and feasibility of a second comparative study of Avance versus autograft, given historical enrollment timelines.

    Answer

    An Axogen executive explained that the non-active high-potential accounts are a mix of those with sporadic ordering patterns and those where Axogen has yet to establish a presence, representing a significant growth opportunity. CEO Michael Dale clarified that the new study targets mixed and motor nerves, differing from the RECON study, and expressed confidence in completing enrollment over a year, viewing the 2-3 year program as essential for generating Level 1 evidence.

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    Christopher Pasquale's questions to AxoGen Inc (AXGN) leadership • Q4 2024

    Question

    Christopher Pasquale of Nephron Research questioned the doubling of the U.S. Total Addressable Market (TAM) to $5 billion and inquired about the balance between investing in growth initiatives and maintaining profitability and positive cash flow.

    Answer

    CEO Michael Dale confirmed the TAM was re-evaluated based on solid data, emphasizing that addressability is key. He and CFO Nir Naor affirmed the strategic plan is designed to balance growth investments with continued profitability and positive cash flow for 2025, building on recent progress. Dale noted the company is still in an early stage of market development with significant untapped potential.

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    Christopher Pasquale's questions to AxoGen Inc (AXGN) leadership • Q3 2024

    Question

    Christopher Pasquale of Stifel questioned the decision to only reiterate full-year guidance despite a strong Q3, implying a conservative Q4 outlook. He also asked new CEO Michael Dale about his initial assessment of what is needed to achieve standard-of-care status for Avance.

    Answer

    CEO Michael Dale stated that maintaining the established guidance demonstrates predictability and commitment to stakeholders while the new strategic plan is being developed. Regarding standard-of-care status, Dale explained it's a multi-year process involving evidence generation, society collaboration, and payer engagement, and that Avance's strong benefit-risk profile justifies this pursuit.

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    Christopher Pasquale's questions to Procept Biorobotics Corp (PRCT) leadership

    Christopher Pasquale's questions to Procept Biorobotics Corp (PRCT) leadership • Q1 2025

    Question

    Christopher Pasquale asked for the latest thoughts on the enrollment timeline for the WATER IV study and the practical implications of the recent positive LCD changes from Medicare contractors First Coast and Novitas.

    Answer

    Executive Kevin Waters stated the WATER IV enrollment timeline is approximately 24 months, with a goal to shorten it by 6 months through additional investment. Executive Reza Zadno explained that the LCD changes significantly streamline the patient workup by removing obstacles like age restrictions and the requirement for a transrectal ultrasound, making it easier for surgeons to adopt and schedule the procedure.

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    Christopher Pasquale's questions to Procept Biorobotics Corp (PRCT) leadership • Q4 2024

    Question

    Christopher Pasquale of Nephron Research asked about the key drivers of the strong international revenue growth seen in late 2024 and the outlook for further OUS expansion. He also asked for clarification on the patient enrollment number for the WATER IV trial.

    Answer

    CFO Kevin Waters attributed the international strength primarily to momentum in the United Kingdom for both systems and procedures. CCO Sham Shiblaq added that Japan is the next key focus for 2025 as they build out the direct team there. CEO Reza Zadno confirmed the WATER IV trial has been planned for 280 patients.

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    Christopher Pasquale's questions to Procept Biorobotics Corp (PRCT) leadership • Q3 2024

    Question

    Christopher Pasquale asked about the strategic rationale for seeking a specific prostate cancer label with the WATER IV study and inquired about the trial's protocol, particularly regarding radiation. He also sought clarification on the impact of saline shortages and hurricanes on procedures.

    Answer

    Executive Reza Zadno explained the goal is to generate Level 1 clinical data to get into treatment guidelines and expand the market by proving harm reduction. Executive Sham Shiblaq clarified the trial compares Aquablation directly to radical prostatectomy and does not involve a radiation component. CFO Kevin Waters quantified the macro impact, noting a few hundred procedures were canceled in October, which is factored into Q4 guidance. Reza Zadno added that Aquablation uses less saline than alternative procedures.

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    Christopher Pasquale's questions to Inspire Medical Systems Inc (INSP) leadership

    Christopher Pasquale's questions to Inspire Medical Systems Inc (INSP) leadership • Q1 2025

    Question

    Christopher Pasquale from Canaccord Genuity asked what the upcoming clinical data presentation on Inspire V is expected to show. He specifically inquired if the new accelerometer-based system would demonstrate tangible improvements in patient outcomes beyond the convenience of a simpler procedure.

    Answer

    CEO Tim Herbert stated that while data on reduced OR time and safety will be presented, the key focus is on patient outcomes. He expressed belief that the accelerometer provides a more stable sensing environment, which, combined with new algorithms, can improve upon the already strong outcomes of Inspire therapy. He confirmed they are tracking metrics like patient adherence and AHI, with initial data to be shared in June.

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    Christopher Pasquale's questions to Inspire Medical Systems Inc (INSP) leadership • Q3 2024

    Question

    Christopher Pasquale from Nephron Research asked how Inspire plans to execute the training and transition for the Inspire V launch for both reps and physicians without causing disruption to procedure volumes.

    Answer

    CEO Tim Herbert explained that the training for Inspire V is relatively straightforward, as the main change is the elimination of the pressure sensing lead implant step. He believes much of the training can be conducted efficiently online or on-site, which should minimize the need to pull the sales and clinical teams from the field and thus avoid significant disruption to procedures.

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    Christopher Pasquale's questions to Zimmer Biomet Holdings Inc (ZBH) leadership

    Christopher Pasquale's questions to Zimmer Biomet Holdings Inc (ZBH) leadership • Q1 2025

    Question

    Christopher Pasquale sought clarification on U.S. hip performance, asking if the 50% of Z1 users from competitive accounts were entirely new surgeons to Zimmer Biomet, and questioned when the new product impact in the knee segment would materialize.

    Answer

    President and CEO Ivan Tornos confirmed that the competitive conversions for the Z1 hip stem were indeed 'true new customers' to Zimmer Biomet's hip portfolio. Regarding the knee segment, he stated that momentum from new products should begin to be visible in Q2, with a more significant acceleration expected in the second half of the year as product availability and training expand.

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    Christopher Pasquale's questions to Zimmer Biomet Holdings Inc (ZBH) leadership • Q3 2024

    Question

    Christopher Pasquale of Nephron Research inquired about the Z1 triple taper hip stem launch, the market opportunity it addresses, and the expected supply situation for the product.

    Answer

    CEO Ivan Tornos confirmed the Z1 stem has already launched, with a full launch planned for the upcoming Hip and Knee Society meeting. He believes the category will become the standard of care and stated that the company will have ample supply for a full U.S. launch beginning January 1, 2025, with no expected shortages.

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    Christopher Pasquale's questions to Dexcom Inc (DXCM) leadership

    Christopher Pasquale's questions to Dexcom Inc (DXCM) leadership • Q1 2025

    Question

    Christopher Pasquale from Nephron Research requested an update on the Stelo installed base and asked why the future impact from freight costs is guided to be so high (100 bps) if channel inventory is already back to normal.

    Answer

    CFO Jereme Sylvain pointed to public data showing over 200,000 Stelo downloads. He clarified that while *channel* inventory is normal, Dexcom's *internal* inventory is very low. The company will continue using expensive, expedited freight (chartered flights) to rebuild its own stock to target levels, an impact that will persist through Q2.

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    Christopher Pasquale's questions to Dexcom Inc (DXCM) leadership • Q4 2024

    Question

    Christopher Pasquale inquired about Stelo's performance during the New Year's resolution season, user engagement and retention, and the specific role of AI in the platform.

    Answer

    CEO Kevin Sayer confirmed a 'nice spike' in sign-ups in January and reported that subscription renewal rates have been excellent, particularly among the Type 2 diabetes population. Executive Jacob Leach added that the first generative AI feature is live in Stelo's insight reports, and future development will focus on deeper, more personalized insights, enhanced by the Oura integration.

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    Christopher Pasquale's questions to Dexcom Inc (DXCM) leadership • Q3 2024

    Question

    Christopher Pasquale asked two questions about the 15-day G7 sensor: whether it has incremental costs of goods sold (COGS) and if its durability to full wear time will be similar to the current 10-day version.

    Answer

    CFO Jereme Sylvain stated that the standard cost does not change, providing a 'real opportunity' for margin improvement, though warranty costs could see a minor increase. He said durability is expected to be 'solid' and 'very well received by the community,' indicating they reached a survivability level they were comfortable with before filing.

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    Christopher Pasquale's questions to Tandem Diabetes Care Inc (TNDM) leadership

    Christopher Pasquale's questions to Tandem Diabetes Care Inc (TNDM) leadership • Q1 2025

    Question

    Christopher Pasquale questioned the decision to only reiterate guidance after a strong Q1 beat and asked if the margin guidance accounts for potential tariff impacts.

    Answer

    CFO Leigh Vosseller explained that reaffirming guidance was a prudent decision given the dynamic broader economic environment, despite high confidence in their plan. She also confirmed that the guidance continues to assume a minimal impact from tariffs.

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    Christopher Pasquale's questions to Tandem Diabetes Care Inc (TNDM) leadership • Q4 2024

    Question

    Christopher Pasquale of Nephron Research asked about the progress of the U.S. sales force expansion, the timing of potential disruption, and whether the current expansion is sufficient to capitalize on the Type 2 opportunity.

    Answer

    Mark Novara, Executive Vice President and Chief Commercial Officer, reported that the expansion was largely completed in Q4 2024 and is now over 95% staffed to minimize disruption. He explained the expansion was designed with the Type 2 opportunity in mind, initially targeting high-volume insulin prescribers, but is scalable to reach primary care physicians later if needed.

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    Christopher Pasquale's questions to Tandem Diabetes Care Inc (TNDM) leadership • Q3 2024

    Question

    Christopher Pasquale asked about the drivers behind the strong performance in supply revenue, particularly in the U.S.

    Answer

    EVP and CFO Leigh Vosseller attributed the strength in U.S. supply revenue to two main factors: a minor, non-material timing shift of sales from Q2 into Q3, and continued favorable pricing trends.

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    Christopher Pasquale's questions to Edwards Lifesciences Corp (EW) leadership

    Christopher Pasquale's questions to Edwards Lifesciences Corp (EW) leadership • Q1 2025

    Question

    Chris Pasquale questioned the slow growth in the Surgical business this quarter and the company's confidence in sustaining mid-single-digit growth. He also asked for an update on the regulatory pathway for the JenaValve product.

    Answer

    CFO Scott Ullem attributed the slow Q1 Surgical growth to a challenging prior-year comparison and expressed confidence in the full-year mid-single-digit guidance, citing catalysts like the MITRIS launch in China. Larry Wood, Group President of TAVR, stated that the company could not comment on the JenaValve regulatory pathway until the acquisition closes, as they have no direct knowledge at this time.

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    Christopher Pasquale's questions to Cooper Companies Inc (COO) leadership

    Christopher Pasquale's questions to Cooper Companies Inc (COO) leadership • Q1 2025

    Question

    Christopher Pasquale from Nephron Research asked for clarification on the interest rate assumptions in guidance and whether the 40% growth target for MiSight this year depends on the launch of MyDay MiSight.

    Answer

    CFO Brian Andrews clarified that the guidance does not assume any Fed rate moves and that a 0.25 point move has a minimal impact of about $0.5 million per quarter. CEO Al White confirmed that the launch of MyDay MiSight is a fiscal '26 story and is not included in the fiscal '25 forecast; the 40% growth target for MiSight will be achieved with the existing product platform.

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    Christopher Pasquale's questions to Cooper Companies Inc (COO) leadership • Q4 2024

    Question

    Christopher Pasquale from Nephron Research asked about the sustainability of the current contact lens pricing environment. He also inquired about the annualized revenue contribution from recent acquisitions and the outlook for M&A in fiscal 2025.

    Answer

    CEO Al White stated his belief that the contact lens industry is now in a position to pass on inflationary pressures, expecting pricing to offset inflation of around 2.5-3.0% in FY25. He confirmed the annualized revenue from recent deals (obp Surgical, ZyMot) is around $25 million and described the current M&A environment as "really quiet," with the company focused on integrating recent acquisitions.

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    Christopher Pasquale's questions to Cooper Companies Inc (COO) leadership • Q3 2024

    Question

    Christopher Pasquale requested the specific revenue figure for PARAGARD in the third quarter. He also asked about the strong growth in frequent replacement lenses (Biofinity and Avaira) and the current stage of the market's transition to daily lenses in the U.S. and Europe.

    Answer

    CEO Al White provided the PARAGARD revenue figure as $48 million. He explained that while frequent replacement lens growth was strong, it can fluctuate and that the industry still has a "long runway" for converting wearers to daily lenses, as less than half of new fits are in dailies. He sees this trend continuing, driven by product innovation in daily torics and multifocals.

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    Christopher Pasquale's questions to Alcon AG (ALC) leadership

    Christopher Pasquale's questions to Alcon AG (ALC) leadership • Q4 2024

    Question

    Christopher Pasquale questioned if moderating price would lead to slower contact lens market growth and asked why the price tailwind was expected to moderate now.

    Answer

    CEO David Endicott clarified that he still expects normal mid-single-digit (4-6%) market growth, consistent with historical trends. He attributed the moderation in pricing power to two factors: an increase in competitive pricing and discounting in the U.S. market, and the fact that recent price hikes were largely a one-time catch-up to inflation, which has now been absorbed by the market.

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    Christopher Pasquale's questions to Insulet Corp (PODD) leadership

    Christopher Pasquale's questions to Insulet Corp (PODD) leadership • Q4 2024

    Question

    Christopher Pasquale of Nephron Research pressed on the 2025 gross margin guidance, noting it appears relatively flat year-over-year when adjusted for a prior charge, despite positive drivers like the Malaysia facility ramp. He also asked about the long-term potential for gross margin.

    Answer

    CFO and Treasurer Ana Maria Chadwick acknowledged the strong 72.1% gross margin in Q4 and the achievement of the 70.5% full-year guide. She explained that a key headwind is the faster growth of the lower-margin international business. While manufacturing efficiencies and the Malaysia facility becoming accretive in H2 2025 will provide a lift, she indicated future gross margin expansion would be at a "much more moderate pace" now that they have reached industry-leading levels.

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    Christopher Pasquale's questions to Insulet Corp (PODD) leadership • Q3 2024

    Question

    Christopher Pasquale requested an update on Insulet's development of fully closed-loop algorithms, its potential applicability, and the timeline for commercialization.

    Answer

    President and CEO Jim Hollingshead praised the performance of the current Omnipod 5 algorithm before confirming two parallel development programs are underway, one of which is closer to a fully closed-loop system. He noted that extensive real-world data has accelerated these programs into early clinical trials, but did not provide a specific commercialization timeline.

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    Christopher Pasquale's questions to Boston Scientific Corp (BSX) leadership

    Christopher Pasquale's questions to Boston Scientific Corp (BSX) leadership • Q4 2024

    Question

    Christopher Pasquale questioned why concomitant procedures are viewed as a growth sustainer rather than an accelerant for the LAA market and asked for clarification on the portion of the AF population suitable for both ablation and LAA closure.

    Answer

    CEO Mike Mahoney explained that they are currently comfortable with the 20% market CAGR forecast, which is already a top-tier growth rate, and will monitor for any acceleration. CMO Dr. Ken Stein added that the OPTION trial proved WATCHMAN is safe and effective post-ablation and that performing the procedures concomitantly adds no risk, which is facilitated by FARAPULSE's efficiency. He noted that about two-thirds of U.S. ablation patients are at high stroke risk, making them potential candidates.

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    Christopher Pasquale's questions to Medtronic PLC (MDT) leadership

    Christopher Pasquale's questions to Medtronic PLC (MDT) leadership • Q2 2025

    Question

    Christopher Pasquale inquired about the Diabetes segment, focusing on the upcoming FDA submission for a Type 2 indication, the current mix of Type 2 patients in the U.S., and the competitive opportunity in that segment without a patch pump.

    Answer

    Que Dallara, EVP & President of the Diabetes business, confirmed that enrollment for the Type 2 indication is complete, with an FDA submission planned for the first half of calendar 2025. She noted that while the current business is predominantly Type 1, the company is optimistic about the large Type 2 opportunity, supported by strong clinical data.

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    Christopher Pasquale's questions to Penumbra Inc (PEN) leadership

    Christopher Pasquale's questions to Penumbra Inc (PEN) leadership • Q3 2024

    Question

    Christopher Pasquale asked for an estimate of the percentage of clots that occur in vessels too small for the primary Flash and Bolt 7 catheters and whether Penumbra currently treats these cases. He also questioned if reimbursement constraints in Europe could be addressed with new clinical data.

    Answer

    CEO Adam Elsesser confirmed that Penumbra is already active in these smaller vessel cases with its legacy, non-CAVT products. The new, smaller CAVT catheters (Bolt 6X, Bolt 12) will allow the company to bring the benefits of its advanced technology to these patients. He clarified that the issue in Europe is a need to work through processes to secure appropriate reimbursement for the more advanced, higher-cost CAVT technology, which will involve generating new data.

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    Christopher Pasquale's questions to Stryker Corp (SYK) leadership

    Christopher Pasquale's questions to Stryker Corp (SYK) leadership • Q3 2024

    Question

    Christopher Pasquale asked about the strategy behind the Vertos Medical acquisition, including plans for its MILD procedure and whether it represents a platform to build a larger interventional pain business.

    Answer

    CEO Kevin Lobo confirmed the acquisition is 'definitely not a one-off,' emphasizing the strength and high performance of Stryker's existing Interventional Spine (IBS) business. He stated that the company is excited about the acquisition and intends to continue building out this platform to solve patient problems in the pain space, indicating further activity in the future.

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