The paragraph is from the Boston Scientific Third Quarter 2024 Earnings Call, where participants are informed that the call will be in a listen-only mode initially, with an opportunity for questions afterward. The call is being recorded and involves key executives, including Mike Mahoney, the CEO, and Dan Brennan, the CFO, who are joined by other leaders during the Q&A session. The company announced their Q3 results, highlighting non-GAAP measures, operational revenue excluding foreign currency impacts, and organic revenue considerations excluding recent acquisitions and divestitures. Guidance excludes the pending acquisition of Axonics. The call includes forward-looking statements about financial performance and business plans. More details are available on their website's Investor Relations section.

The paragraph discusses Boston Scientific's financial performance and future outlook. It begins with a disclaimer that forward-looking statements are based on current beliefs and available information, and actual results may differ due to various factors. CEO Michael Mahoney highlights that the company's Q3 2024 results exceeded expectations, with operational sales growing 19% and organic sales 18%. The company achieved a Q3 adjusted EPS of $0.63, surpassing the guidance range. For Q4 and the full year 2024, Boston Scientific projects organic growth of 14% to 16% and raises full-year guidance to around 15%, noting strong performance in its AF solutions. The adjusted EPS forecast for Q4 is $0.64 to $0.66, with full-year growth expected between 20% to 21%.

The paragraph provides an overview of Boston Scientific's third-quarter regional and operational performance. The US saw a 24% growth, driven by the EP business and products like FARAPULSE. The EMEA region experienced a 14% growth, with notable advancements in PFA, complex PCI, and structural heart sectors, and a successful TAVI launch. The company announced that Eric Thepaut will retire, with Xavier Bertrand succeeding him as President of EMEA. Asia-Pacific grew by 12%, rebounding despite VBP implementations, and achieved a significant milestone in Japan with FARAPULSE approval. In the Urology segment, sales rose by 10%, supported by growth in Stone Management and Prostate Health, and the company anticipates closing the Axonics acquisition in the fourth quarter.

The paragraph details various segments of a company's medical products sales performance. Endoscopy sales increased, driven by products like AXIOS and Exalt D, with future growth expected from a new procedure code. Neuromodulation sales also rose, with strong growth in the brains franchise and a modest increase in the pain franchise. Peripheral Intervention saw significant growth, boosted by their acquisition of Silk Road Medical. Interventional oncology and embolization experienced double-digit growth, propelled by new product launches. Cardiology sales saw remarkable growth, driven by Interventional and Coronary Therapies. Overall, the paragraph highlights strong operational growth across diverse medical product lines.

In the recent quarter, the US AGENT launch has exceeded expectations with significant new account openings and reorder rates. The company has also begun enrollment in the IDE long lesion substudy related to aging and completed the Vitalist early feasibility study for high-risk PCI patients. Their structural heart valves franchise experienced double-digit growth, particularly with the ACURATE Neo2 in Europe. In the US, they are collaborating with the FDA and will present data from the ACURATE IDE at TCT on October 30. WATCHMAN grew by 18%, with over 500,000 patients treated globally, supported by innovation and clinical evidence. Upcoming catalysts for WATCHMAN include the new DRG for LAAC and AF ablation and the OPTION trial data presentation. Enrollment for the SIMPLIFY trial, examining a less intensive drug regimen post-procedure with WATCHMAN FLX Pro, has begun, and results from the CHAMPION trial are expected in early 2026. Cardiac Rhythm Management sales grew by 2%, and Diagnostics saw high-single-digit growth, driven by LUX-Dx implantable cardiac monitors receiving CE Mark. Strong international growth in Core CRM was offset by below-market growth in the US.

The paragraph highlights the company's excitement about new product launches and innovations in its electrophysiology business. It mentions the FDA approval of the INGEVITY lead for conduction system pacing and the submission of the EMPOWUR leadless pacemaker for approval. Electrophysiology sales have surged by 177%, driven by successful commercial execution and the adoption of FARAPULSE technology, which is rapidly converting procedures from RF and cryo to PFA. The company anticipates PFA will dominate global AF ablations by 2026. Notable developments include FARAPULSE approvals in Japan and China, the U.S. approval of the FARAWAVE NAV Catheter, and progress in clinical trials, particularly the ADVANTAGE AF trial, which is evaluating FARAPULSE for drug-refractory persistent AF. The AVANT GUARD trial for a new patient population has been temporarily paused for assessments but is expected to resume soon.

The paragraph discusses the financial performance of the company in the third quarter of 2024. Consolidated revenue reached $4,209 million, marking a 19.4% growth compared to the same period in 2023, with a slight negative impact from foreign exchange. Excluding this impact, operational revenue growth was 19.5%. Acquisitions contributed 130 basis points, resulting in an 18.2% organic revenue growth, surpassing the guidance range. Adjusted earnings per share grew by 27% to $0.63, exceeding expectations. The adjusted gross margin was 70.4%, slightly lower due to foreign exchange effects, but the company anticipates improvement in the second half of the year. The adjusted operating margin for the quarter was 27.2%, which improved by 110 basis points from the previous year. The company expects the full-year adjusted operating margin to be around 27%. On a GAAP basis, the operating margin was 17.4%.

In the third quarter, the company reported adjusted interest and other expenses of $65 million, benefiting from higher interest income. The adjusted tax rate was 13.2%, aided by favorable tax items, while the operational tax rate was 13.5%. Fully diluted shares ended at 1,487 million, and free cash flow reached $822 million. They anticipate full-year 2024 free cash flow to exceed $2 billion, with significant payments for special items. As of September 30th, 2024, cash on hand was $2.5 billion, and the gross debt leverage ratio was 2.4. Their capital allocation focus is on strategic acquisitions and share repurchases. Legal reserves stood at $250 million, with $53 million funded. For 2024, they project revenue growth of 16.5%, with 17% operational growth excluding foreign exchange impact, and 15% organic growth excluding acquisitions. Q4 2024 revenue growth is expected to range from 16.5% to 18.5% compared to Q4 2023.

In the paragraph, the company outlines its financial expectations for the fourth quarter of 2024 and the full year 2024, anticipating an operational revenue growth of 16% to 18% and organic revenue growth of 14% to 16%. They project full-year adjusted below-the-line expenses to be around $300 million, with an operational tax rate of approximately 13.5% and an adjusted tax rate of 12.5%. Adjusted earnings per share for the year are expected to grow by 20% to 21% to reach $2.45 to $2.47, despite a $0.04 foreign exchange headwind. For Q4 2024, EPS is predicted to be between $0.64 and $0.66. In 2025, there will be one less business day in Q1 compared to 2024, which has two extra business days. The company expects an increase in net interest expense in 2025 due to nonrecurring interest income from 2024 and plans to refinance about $1.6 billion of bonds likely at higher rates.

The paragraph is from a Q&A session during an investor conference where Robert Marcus from JPMorgan congratulates the company on a successful quarter and asks about the upcoming OPTION trial at AHA. He inquires about the impact of this trial combined with the new reimbursement for concomitant WATCHMAN and PF ablation that began on October 1st. Marcus asks for insights on how a positive outcome from the OPTION trial could influence usage patterns before the CHAMPION trial in 2026 and its importance for the company's franchises in both the short and long term. Michael Mahoney and the team are asked to respond to these considerations.

In the paragraph, Michael Mahoney and Dr. Kenneth Stein discuss the success and safety of both the WATCHMAN and FARAPULSE platforms, noting their positive impact on healthcare economics and patient outcomes. They highlight the benefits of concomitant procedures under the new CMS DRG system, which supports reimbursement and efficiency in treating atrial fibrillation and stroke-risk patients. Stein emphasizes the importance of upcoming OPTION data in potentially demonstrating further benefits of WATCHMAN, considering the high number of annual ablations and stroke risks among patients.

The paragraph discusses the successful launch and high demand for FARAPULSE, a medical product for treating atrial fibrillation (AF), with positive results and rapid adoption by physicians. Michael Mahoney highlights the strong performance of the operational and clinical teams, the product's excellent momentum, and the anticipated shift of 40% to 60% of global AF procedures to FARAPULSE by 2026. This transition is driven by favorable outcomes and efficiency compared to traditional methods, supported by studies like ADVENT.

The paragraph discusses the competitive position and future plans for FARAPULSE. Joanne Wuensch of the operator introduces a question from Lawrence Biegelsen from Wells Fargo, who asks Dr. Kenneth Stein about the AVANT GUARD trial and competitions in the PFA market. Dr. Stein explains that the AVANT GUARD trial, which investigates a new population of drug-naive patients with persistent AF not currently indicated for FARAPULSE, has temporarily paused enrollment due to unforeseen observations, although no life-threatening issues were noted. He assures that this does not affect the performance confidence of FARAPULSE in its current uses and other trials. They plan to resume the trial soon and aim to expand indications based on data from the ADVANTAGE Phase I trial, which they expect to submit to the FDA later in the quarter.

The paragraph discusses the anticipated timeline for presenting new data on the FARAPULSE system, expected in early 2025, with indication expansion in the latter half of the year. It emphasizes the unique patient population studied, which has not been previously investigated, and highlights FARAPULSE's global usage in over 125,000 patients in 65 countries, supported by extensive clinical data. The paragraph elaborates on FARAPULSE's ease of use, clinical experience, and positive outcomes, maintaining its leadership in Pulsed Field Ablation. It mentions favorable sub-analysis data from ADVENT and its strong market position in Europe, supported by data from approximately 20,000 patients.

The paragraph discusses the launch and advantages of the FARAWAVE NAV Catheter and FARAVIEW mapping system, highlighting its design specifically around Pulsed Field Ablation (PFA) technology for atrial fibrillation (AFib). Rick Wise asks about the pricing strategy and market positioning, given its first-to-market status and integration. Kenneth Stein responds, emphasizing that while the FARAWAVE is an AF ablation catheter, the OPAL HDx platform, which it integrates with, is approved for mapping navigation across various cardiac arrhythmias. Stein credits the success to the catheter’s bespoke design for effectively treating AFib.

The paragraph discusses the development and use of different catheters and software for treating arrhythmias. It highlights the current and future capabilities of the tools in their pipeline, specifically the FARAPOINT and FARAFLEX catheters and the FARAVIEW mapping and navigation software. The FARAPOINT catheter is initially intended for treating atrial flutter and potentially other arrhythmias, while the FARAFLEX catheter will help address a wide range of arrhythmias in clinical practice. The FARAVIEW software is noted for its dynamic visualization and field tagging features, aiding in precise pulsed field ablation procedures. The paragraph concludes with Frederick Wise seeking information on pricing.

The paragraph features a discussion led by Michael Mahoney about the company's strategic focus on various business units outside of EP and WATCHMAN, acknowledging a slowdown but emphasizing ongoing growth. Each division's leaders are dedicated to their specific areas like peripheral interventions and neuromodulation. Mahoney mentions substantial investment in innovation, manufacturing ramp-up of PFA, R&D, and commercial capabilities. He also highlights recent and upcoming acquisitions, like Silk Road and Axonics, to bolster their portfolio and drive category leadership.

The paragraph discusses the company's ongoing investments in various business units, which form its foundation, while maintaining an improved margin profile. Despite a slowdown in procedure volumes during the summer months, there was a recovery in September, aligning with growth trends from the past eight quarters. The company remains committed to its diverse business sectors, including PFA, without compromising other areas. The conversation then shifts to a question from Patrick Wood of Morgan Stanley about capacity constraints in the system due to high demands on EPs and structural heart procedures, and how the company plans to manage growth amid these constraints. Michael Mahoney responds, noting that the launch of FARAPULSE in the US is still in its early stages, with many new accounts yet to utilize it.

The paragraph discusses the early stages of the FARAPULSE system launch by Boston Scientific in significant markets like Japan and China. The company is seeing increasing utilization in existing accounts, with many moving to multiple systems and improving workflow efficiency, leading to a 25%-30% increase in daily procedure volume. This benefits hospitals economically and enhances procedural efficiency, especially when used alongside the WATCHMAN system. The focus is on operational efficiency, hospital economics, and patient and physician benefits. Following this update, Patrick Wood expresses approval, and the conversation shifts to a question from Travis Steed regarding the pause and expected restart of the AVANT GUARD trial.

The paragraph involves a discussion around the FARAPULSE system, focusing primarily on its use for treating patients with newly diagnosed persistent atrial fibrillation. Kenneth Stein explains that the standard of care involves trying antiarrhythmic drug therapy first and resorting to ablation only if the drug therapy fails. Despite a pause in trial enrollment, Stein reassures that nothing observed in the trials was life-threatening, emphasizing confidence in the system's safety, efficacy, and efficiency based on its extensive use and clinical data. The conversation then shifts to a new question from Danielle Antalffy of UBS, who acknowledges the limitations on what can be disclosed about future sales but notes the impressive performance and growth achievements reported in the current quarter.

Michael Mahoney discusses the company's optimistic outlook for sales growth in 2024 and 2025, highlighting an expected 15% growth in 2024 over 2023's 12% increase. He mentions several business segments like PI, ICTx, and neurology, as well as products like FARAPULSE and WATCHMAN as key growth drivers. The company anticipates growth from market expansions in Japan and China, and from new and existing U.S. accounts. Despite some slowdown in summer months, procedure volumes are expected to remain strong. Mahoney acknowledges upcoming competitive challenges but remains confident, citing strong performance in Europe and upcoming reimbursement decisions for the AGENT product.

The paragraph discusses the go-to-market strategy for 2025, specifically concerning the FARAWAVE NAV Catheter and its integration with the OPAL mapping system. Although the OPAL platform offers a streamlined user experience when used with FARAPULSE, the company is not restricting the FARAPULSE system to only work with OPAL. Customers can continue using FARAPULSE with competitive mapping systems, ensuring flexibility and openness in the market. The conversation highlights the company's strategy to enhance user experience while allowing for continued compatibility with other systems. Michael Mahoney and Ken provide insights into maintaining an open system approach despite upcoming competitors offering bundled solutions.

The paragraph discusses the confidence in the user experience and economic value of the OPAL integration with FARAPULSE, emphasizing that there's no need to force users to adopt their products since the advantages of using FARAWAVE are compelling. Kenneth Stein highlights that FARAWAVE can be used with or without a mapping and navigation system, and they will continue offering the original FARAWAVE Catheter for those preferring competitive systems. He describes the FARAWAVE NAV, integrated with the OPAL HDx system, as offering distinct advantages without coercion. Following this, a new speaker, Vijay Kumar, asks about the regulatory strategy and anticipated US launch of the ACURATE Neo2, to which Michael Mahoney responds, indicating the trial results will be presented soon.

The paragraph discusses an upcoming investor meeting on October 30th, led by Joe Fitzgerald and Lance Bates, focusing on the cardiology portfolio and future plans for ACCURATE following clinical trial data. The company has been successful in Europe, with momentum from the launch of the updated ACURATE Neo2. There's a question about filing with the FDA and what constitutes a successful launch. Michael Mahoney responds that they aim to grow the business but don't provide specific market share goals. An upcoming presentation at TCT will offer more details. Matt Miksic from Barclays congratulates the company on its growth and asks about gross margin dynamics and leveraging operating investments into 2025. Daniel Brennan indicates that the third quarter's financial story is straightforward.

In Q3, the company's gross margin was 70.4%, slightly below expectations due to foreign exchange impacts. While the full-year adjusted gross margin is expected to be lower than the previous year's 70.7%, the company is focused on expanding its adjusted operating margin by 70 basis points. Despite not relying on gross margin for 2024, strategic elements like SG&A are being used to drive margin growth. Moving into 2025 and beyond, all P&L lines, including gross margin, are expected to contribute to margin expansion, with product mix and items like the FARAPULSE single-use catheter playing crucial roles. FARAPULSE, as it gains traction in new markets like Japan and China, is anticipated to positively impact margins. WATCHMAN is also seen as a positive influence on gross margins, reinforcing the company's successful operating margin strategy.

The paragraph is an exchange between analysts and executives from Boston Scientific during a Q&A session. Josh Jennings from TD Cowen congratulates the company on their strong quarterly performance and inquires about potential manufacturing capacity issues for the FARAPULSE product line if demand continues to exceed expectations. Michael Mahoney, the company's CEO, assures there are no anticipated supply shortages due to effective management by their operations and supply chain teams. Kenneth Stein adds that the FARAWAVE NAV Catheter is a single-use device currently indicated for pulmonary vein isolation (PVI) procedures for patients with paroxysmal atrial fibrillation.

The paragraph discusses the ADVANTAGE clinical trial aimed at expanding the use of the FARAWAVE Catheter family for treating patients with drug-refractory persistent atrial fibrillation. It highlights the unique features of the FARAVIEW system, such as dynamic visualization and field tagging, which aid in planning ablation procedures. Joshua Jennings inquires about a high-density mapping catheter, and Kenneth Stein confirms the presence of the ORION catheter and mentions the development of additional catheters in the FARAPULSE family, including the FARAFLEX catheter, which combines high-density mapping and PFA ablation capabilities. Michael Mahoney adds that although their focus is on ablation and mapping, there are still areas within the EP procedure they aim to expand into, particularly in China and Japan, following recent approvals.

The paragraph discusses expectations for the launch of a product in China, which is anticipated to be slower than in the US and Japan due to approval and registry processes. Despite challenges from VBP (Volume-Based Procurement) affecting their IVUS franchise, the company is performing well in China, unlike some competitors. The conversation then shifts to a question from Matt O'Brien regarding a stock drop following commentary on the AVANT GUARD. He inquires about potential safety concerns and risks with FARAPULSE, which is crucial for the business. Dr. Kenneth Stein assures confidence in the system's safety, citing extensive commercial use data from over 125,000 patients.

The paragraph discusses Boston Scientific's confidence in the safety, efficiency, and efficacy of the FARAPULSE system, citing extensive clinical trial data. Michael Mahoney mentions plans to re-launch a related trial soon. Jonathan Monson thanks the team and the participants, inviting any follow-up questions to be directed to the Investor Relations team. Participants are informed that a replay of the conference will be available until October 30th, 2024, and provided with details on how to access it. The conference then concludes.

This summary was generated with AI and may contain some inaccuracies.