BSX Investor Alert: BOSTON SCIENTIFIC CORPORATION Securities Fraud Lawsuit - Investors With Losses May Seek to Lead the Class Action After Claims Executives Misrepresented U.S. Electrophysiology Volumes: Levi & Korsinsky Accessibility StatementSkip NavigationAlert: Claims Focus on Alleged Misrepresentations About U.S. Electrophysiology Procedure GrowthNEW YORK, March 25, 2026 /PRNewswire/ -- Levi & Korsinsky, LLP reminds purchasers of Boston Scientific Corporation (NYSE: BSX) securities of a pending securit ...

Core Viewpoint - Boston Scientific Corporation is facing a class action lawsuit due to alleged misleading projections regarding the growth of the electrophysiology (EP) market, which led to inflated investor expectations and a significant drop in stock price following disappointing market performance [1][2][3]. Group 1: Allegations of Misleading Projections - The lawsuit claims that Boston Scientific projected a long-term growth rate of 15% for the EP market while knowing that the growth was unsustainable and approaching a tipping point earlier than anticipated [3]. - Management characterized the adoption of pulse field ablation (PFA) technology as accelerating, with expectations of reaching 80% global penetration by 2028, despite being aware of decelerating growth in the U.S. [3][5]. - The company allegedly elevated its full-year 2025 revenue guidance multiple times, increasing expectations from 18%-19% in July to approximately 20% by October, based on unreliable EP growth assumptions [4]. Group 2: Impact on Financials and Market Perception - The lawsuit asserts that management misrepresented the EP market as the "largest, fastest-growing market in med tech," while being aware of decelerating procedure volume growth in the U.S. [5]. - Despite reporting significant EP sales growth of 94% in Q2 2025 and 63% in Q3 2025, the company allegedly failed to disclose that these growth rates were not sustainable [5]. - The filing indicates that guidance for fiscal 2026 fell "well below expectations" due to adverse trends in the EP market that management had concealed during the class period [5]. Group 3: Competitive Landscape and Disclosure Obligations - The case raises important questions about the disclosure obligations of companies in the medical device sector, particularly when they elevate guidance while being aware of material headwinds [6]. - Management reportedly dismissed competitive concerns by emphasizing FARAPULSE's first-mover advantage, yet later disclosures attributed disappointing results to increased competition, contradicting prior assurances [7].

Summary of Conference Call Company Overview - The conference call involved Boston Scientific, with key speakers including Chairman, President, and CEO Mike Mahoney, and Chief Medical Officer Dr. Kenneth Stein [1][2] Industry and Market Guidance - Boston Scientific issued a growth guidance of 10%-11% for the upcoming year, similar to the previous year's guidance of 10%-12% [2][4] - The company expressed confidence in maintaining high double-digit growth rates despite challenging comparisons from the previous two to three years [2][4] - The company aims to exceed its Weighted Average Market Growth Rate (WAMGR) and has consistently outperformed peers in sales performance and operating margins [3][4][8] Business Segments and Performance - The Electrophysiology (EP) segment accounts for approximately 17% of revenue, with the remaining 83% of the business also performing well [5] - Upcoming milestones include the CHAMPION-AF readout in March and several acquisitions, including Nalu Medical and Penumbra [5][6] - The company is focused on improving operating margins, targeting an increase of 50-70 basis points for the year [9] Competitive Landscape - Boston Scientific expects to maintain its leadership in the PFA (Pulmonary Vein Ablation) market despite increasing competition, projecting a market growth of around 15% for 2026 [15][16] - The FARAPULSE product is positioned in a high-growth segment, with expectations of utilization increasing [16][28] - The company is enhancing its product portfolio with new offerings like FARAPOINT and FARAWAVE Ultra, which are expected to launch in the near future [18][19] Acquisitions and Strategic Fit - The acquisition of Penumbra is seen as a strategic move to enhance Boston Scientific's capabilities in neurovascular and thrombectomy markets [60][62] - The integration aims to leverage Boston Scientific's existing relationships and supply chain capabilities to help Penumbra expand internationally [62][63] - The acquisition is expected to create synergies between the two companies, enhancing their combined portfolio [64] Market Dynamics and Future Outlook - The company acknowledges potential disruptions from geopolitical events, noting that approximately 1% of its revenue is at risk due to current conflicts [10] - Boston Scientific is optimistic about the future, with expectations of sustained growth driven by product innovation and market expansion [6][57] - The upcoming CHAMPION-AF trial results are anticipated to significantly impact the market, potentially expanding the patient base for the WATCHMAN device [39][57] Key Takeaways - Boston Scientific is committed to long-term growth, with a focus on innovation and market leadership in the EP and PFA segments [3][8] - The company is strategically positioned to capitalize on market opportunities through acquisitions and product enhancements [60][64] - The management remains confident in achieving its growth targets despite external challenges and competitive pressures [2][9][10]

Core Insights - Boston Scientific achieved over $20 billion in sales for 2025, marking a mid-teens growth for the second consecutive year, driven by innovation and execution across business units [6][30] - The company reported a Q4 operational sales growth of 14% and organic sales growth of 13%, exceeding guidance [6][29] - Full year 2025 adjusted EPS grew 22% to $3.06, surpassing guidance, with operational sales growth of 19% and organic sales growth of 16% [7][30] Financial Performance - Q4 consolidated revenue reached $5.286 billion, representing a 15.9% reported growth, with operational revenue growth of 14.3% [29] - Full year 2025 consolidated revenue was $20.74 billion, a 19.9% increase, with operational revenue growth of 19.2% [30] - Adjusted gross margin for Q4 was 70.7%, with a full year adjusted gross margin of 70.6%, reflecting a 30 basis point expansion [31] Business Unit Highlights - The U.S. market saw a 17% growth in Q4 and 26% for the full year, particularly strong in EP, WATCHMAN, and ICTx [8] - The Cardiovascular segment delivered 16% operational growth in Q4 and 22% operational growth for the full year [14] - WATCHMAN business grew 29% in Q4, with strong adoption of concomitant procedures [22] Regional Performance - Europe, Middle East, and Africa (EMEA) grew 5% in Q4 and 3% for the full year, with high single-digit growth expected excluding the impact of product discontinuation [9] - Asia Pacific region grew 15% operationally in Q4 and 14% for the full year, driven by strong performance in Japan and China [10][11] Future Outlook - For Q1 2026, the company expects organic growth of 8.5% to 10% and for the full year, guidance is set at 10% to 11% [8][36] - Adjusted EPS for 2026 is projected to be between $3.43 and $3.49, indicating a growth of 12% to 14% [38] - The company anticipates continued momentum in EP and WATCHMAN, with expectations for the market to grow approximately 15% in 2026 [26][72] Strategic Acquisitions - Boston Scientific announced agreements to acquire Penumbra and Valencia Technologies, expected to close in 2026, enhancing its portfolio in high-growth segments [15][35] - The acquisition of Nalu Medical has been completed, complementing the neuromodulation pain franchise [35]

Industry Overview - The Zacks Medical - Products industry is facing challenges due to tariffs imposed by the U.S. on trading partners, impacting margins for companies like GE HealthCare, Baxter, and Abbott [1] - Medical device makers are experiencing rising commodity and manufacturing costs post-COVID-19, particularly in consumer-facing areas like Nutrition, leading to price hikes that may constrain volume due to increased price sensitivity among consumers [2] - The industry's profitability is under strain from tariff-related expenses and persistent component shortages, which create inefficiencies and constrain output [7] Trends and Innovations - Industry players are mitigating challenges through product innovation and the adoption of AI and digital services, with the rise of GLP-1 medication acting as a tailwind for certain medical device areas [3] - The market for remote patient monitoring platforms is projected to reach $57 billion by 2030, driving margin expansion and shifting profit pools from hardware to data-driven services [9] - The U.S. market is shifting from inpatient hospital settings to Ambulatory Surgery Centers (ASCs) and home-based monitoring, with the ASC market expected to reach $205 billion by 2030 [10] Company Performance - Boston Scientific (BSX) is positioned for strong growth driven by demand across its diversified product portfolio, with a commitment to over 10% growth over the next three years [29] - ResMed is experiencing strong momentum with 11% top-line growth in Q2 fiscal 2026, driven by rising demand for CPAP therapy and the adoption of GLP-1 drugs [35][36] - Phibro Animal Health Corporation (PAHC) is benefiting from the integration of the Zoetis Medicated Feed Additive portfolio, contributing $80.5 million in sales in Q1 fiscal 2026, and expects favorable net price impacts to improve profitability [42] Financial Outlook - The Zacks Consensus Estimate for BioLife Solutions (BLFS) indicates a 16.4% revenue growth for 2026, with earnings expected to grow by 38.1% [27] - Boston Scientific's revenue for 2026 is estimated at $22.32 billion, projecting an 11.3% growth, with EPS expected to improve by 13.5% [32] - ResMed's revenue for fiscal 2026 is pegged at $5.58 billion, indicating an 8.5% growth, with EPS expected to rise by 15% [39] - PAHC's revenue for fiscal 2026 is estimated at $1.47 billion, projecting a 13.1% growth, with EPS expected to improve by 32.1% [46]

Boston Scientific Conference Call Summary Company Overview - **Company**: Boston Scientific - **Analyst**: Robbie Marcus, MedTech Analyst at J.P. Morgan - **Key Executives Present**: Mike Mahoney (CEO), Jon Monson (CFO), Dr. Stein (Chief Medical Officer) Key Industry Insights Market Growth and Product Launches - Boston Scientific is committed to achieving **10%+ growth** over the next three years and **150 basis points of margin improvement** [2] - The company anticipates an increase in the weighted average market growth rate from **8% in 2025 to 9%** over the next three years [2] - The **Pulsed Field Ablation (PFA)** market is projected to grow at a minimum of **15%+** annually, with the overall market growth reaching **20%** in 2025 [4][10] Product Highlights - **Pulsed Field Ablation**: Recognized as a leading product in the medtech market, with significant market share and growth potential [4] - **FARAPOINT**: Recently approved for use in the U.S. and Europe, expected to enhance the portfolio for arrhythmias and expand into non-AF ablations [11][18] - **Watchman**: Holds a **91% market share** in left atrial appendage closure (LAAC), with potential for growth in concomitant procedures [28][30] Competitive Landscape - Boston Scientific's leadership in the PFA market is attributed to strong execution and a comprehensive product pipeline [6] - The company emphasizes the importance of having a complete toolset for electrophysiology (EP) procedures, which includes various catheter types and access solutions [11][19] Financial Performance and Projections Revenue and Market Position - The company is confident in its ability to meet investor day targets and has consistently delivered on commitments [26] - Anticipated growth in the **interventional oncology** and **vascular therapies** divisions, with ongoing trials and product launches expected to drive revenue [40][42] Pricing Strategy - Boston Scientific aims to maintain flat pricing, with expectations of slight declines in certain markets due to competitive pressures [64] - The company has improved its pricing strategy, targeting flat pricing after previously facing headwinds [61] Strategic Initiatives Innovation and R&D - Boston Scientific invests heavily in both internal and external innovation, with a focus on maintaining a strong pipeline and venture portfolio [56][57] - The company is committed to improving operational efficiency, with ongoing initiatives in AI and ERP systems to enhance productivity [62] Market Expansion - The company is optimistic about growth in **China**, projecting sustainable growth in the teens despite market challenges [66] - Boston Scientific is also exploring opportunities in the **ASC (Ambulatory Surgery Center)** market to increase patient volumes and lab capacity [14][15] Additional Insights Clinical Trials and Future Opportunities - The **AVANT GUARD trial** aims to establish catheter ablation as a first-line therapy for persistent atrial fibrillation, with results expected to influence future treatment protocols [21] - The company is exploring the use of its products in various clinical settings, including potential applications for ventricular tachycardia and redo ablations [18][19] Conclusion - Boston Scientific is well-positioned for continued growth with a robust product pipeline, strong market leadership, and a commitment to innovation and operational efficiency. The company is focused on leveraging its competitive advantages in the medtech space to drive future success.

Core Insights - Boston Scientific (BSX) has a stretched valuation with a Value Score of C, trading at a forward five-year price/earnings (P/E) of 27.77X, which is above its median and the industry average of 20.01X [1] - The company's performance has been mixed over the past year, underperforming key rivals Abbott (ABT) and Medtronic (MDT), but still faring better than the industry and sector [2] Valuation and Market Position - BSX's P/E ratio is higher than the broader Medical sector's P/E of 21.03X, indicating an expensive valuation compared to peers [1] - Key competitors, Abbott and Medtronic, are trading at lower P/E ratios of 22.15X and 20.01X, respectively [1] Business Performance and Growth Drivers - WATCHMAN sales increased by 35% in Q3 2025, supported by growing U.S. concomitant use, while the Electrophysiology (EP) business surged 63% in the same quarter due to FARAPULSE adoption [9][15] - The Urology business is driving strong sales from the global stone management franchise, with expectations of improving growth through 2026 following recent European approvals [10] - Endoscopy is experiencing robust growth in anchor products, and the Intracept procedure for chronic vertebrogenic pain is a significant growth driver in Neuromodulation [11] Strategic Initiatives - Boston Scientific aims to outpace market growth across neuromodulation, urology, and endoscopy, which together serve a global market of $20 billion growing nearly 7% [12] - The planned acquisition of Nalu Medical will expand the portfolio into peripheral nerve pain, presenting additional growth opportunities [12] Future Outlook - Management expects approximately 25% of U.S. WATCHMAN procedures to be performed concomitantly by the end of 2025, with a projected market growth of roughly 20% in the coming years [14] - Analysts remain optimistic about the company's earnings for 2025 and 2026, indicating confidence in its growth trajectory [16] Conclusion - Despite a premium valuation, Boston Scientific's innovative portfolio and strategic execution position it well for long-term growth, particularly through its WATCHMAN and EP products [18]

Core Insights - Atrial fibrillation (AF) affects nearly 38 million people globally, with projections indicating this number could nearly triple by 2030. Boston Scientific (BSX) is a leader in left atrial appendage closure (LAAC) devices and is expanding in the pulsed field ablation (PFA) segment, which is the fastest-growing area in AF treatment. The FARAPULSE technology has become widely used since its U.S. launch in 2024 [1][8]. Company Developments - Over 500,000 patients have been treated with the FARAPULSE system, demonstrating consistent real-world results. The one-year results from the FARADISE trial confirm favorable procedural and safety outcomes across various ablation strategies and AF types [2]. - In Q3 2025, FARAPULSE experienced strong double-digit growth in the U.S., driven by the adoption of the OPAL HDx mapping system. One in three FARAPULSE accounts now utilizes the integrated FARAWAVE NAV and OPAL device. The FDA has also approved expanded labeling for the system to treat drug-refractory, symptomatic, persistent AF, supported by clinical evidence from the ADVANTAGE AF trial [3][4]. - Positive results from the second phase of the ADVANTAGE trial support the FARAPOINT PFA catheter as an adjunct technology for treating atrial flutter in patients with persistent AF, with plans for launch by the end of 2025. The company is investing to exceed the expected 15% market growth through 2028 by enhancing its innovative solutions across AF and non-AF segments [4]. Market Position and Performance - Boston Scientific shares have increased by 2.5% over the past year, contrasting with a 3.3% decline in the industry [7]. - The stock is currently trading at a forward five-year Price-to-Earnings (P/E) ratio of 27.06, which is above its median but lower than the industry average [9]. - Earnings estimates for Boston Scientific are trending upward, with current estimates for the current quarter at $0.78 and for the next year at $3.45 [10][11].

Core Insights - Boston Scientific has experienced significant growth over the past few years and is looking to build on this momentum moving forward [1] - The company aims to highlight its current growth drivers, such as FARAPULSE and WATCHMAN, while also focusing on future opportunities in adjacent markets [2] Company Growth and Strategy - The recent Investor Day was successful in showcasing the excitement around Boston Scientific's current offerings and future potential [2] - The company emphasizes a strong market growth in the procedures it addresses, alongside a commitment to innovation to enhance product value [2]

Financial Data and Key Metrics Changes - The electrophysiology (EP) business has experienced significant growth, with FARAPULSE driving growth at approximately twice the market rate since its introduction in the EU in 2021 [2][4] - The U.S. market penetration for FARAPULSE has quickly surpassed 50%, indicating strong adoption and market presence [4][5] Business Line Data and Key Metrics Changes - The FARAPULSE ecosystem, including FARAWAVE catheter and Opal mapping system, has been pivotal in driving success across global markets [2][3] - The Watchman franchise is projected to be a long-term growth engine for the company, with expectations of over 20% growth depending on the outcomes of OPTION and CHAMPION trials [14][17] Market Data and Key Metrics Changes - The global electrophysiology market is valued at $13 billion, with $9 billion attributed to atrial fibrillation (AF) and $4 billion to other indications [9] - The renal denervation market is being re-evaluated, with hypertension being a common condition affecting one in four adult Americans, presenting a significant opportunity for device-based therapies [38] Company Strategy and Development Direction - The company is focused on expanding its leadership in the electrophysiology market while exploring adjacent markets such as diabetes [9][10] - There is a strategic emphasis on category leadership across various medical technology segments, including interventional cardiology and structural heart [62][63] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the competitive landscape in cardiology, emphasizing the importance of understanding competition and focusing on their ecosystem of products [10][12] - The company is preparing for a shift of inpatient procedures to outpatient settings, aligning with CMS goals to enhance accessibility [47][48] Other Important Information - The company is investing in artificial intelligence to enhance product development and operational efficiency, with applications in imaging and electrophysiology [59][61] - The upcoming CHAMPION trial is expected to significantly expand the eligible patient population for the Watchman device, potentially tripling its total addressable market to $6 billion by 2030 [17][18] Q&A Session Summary Question: What is the growth outlook for the Watchman franchise? - The Watchman franchise is expected to grow over 20% long-term, contingent on positive outcomes from the OPTION and CHAMPION trials [14][17] Question: How does the company view the competitive landscape in electrophysiology? - The company recognizes the competitive nature of the market but believes it has a strong understanding of upcoming competition and is focused on its product ecosystem [10][12] Question: What is the timeline for the Seismic device and clinical data? - The Seismic device is currently enrolling in the Fracture ID study, with completion anticipated in Q1 2026 and a commercial launch expected in the first half of 2027 [30][31] Question: How does the company plan to address the access issues in renal denervation? - The company plans to focus on educating both physicians and patients about the therapy, which is crucial for market development [45][46] Question: What are the expectations for the CRM market? - The CRM market is currently the lowest growth area for the company, but a complete revamp of the CRM portfolio is underway, aiming for at or above market growth [50][52]