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Edwards Lifesciences Corp (NYSE: EW) is a pioneering global entity in the realm of heart valve technology and hemodynamic monitoring. Headquartered in Irvine, California, the company has a robust presence across North America, Europe, Japan, Latin America, and Asia, employing approximately 6,400 individuals worldwide. Edwards Lifesciences specializes in developing medical devices and technologies that address structural heart disease and critical care monitoring, aiming to save and enhance patients' lives.
Originating from a spin-off of Baxter International in 2000, Edwards Lifesciences has cemented its position as a leader in manufacturing and marketing advanced medical equipment. The company's core products include surgical tissue heart valves, transcatheter valve technologies, surgical clips, and catheters. These innovations have positioned Edwards Lifesciences as a key player in the medical field, particularly in the areas of heart valve replacement and repair.
Edwards Lifesciences generates about 55% of its sales from international markets, showcasing its extensive global reach. The company's commitment to innovation is evident in its continuous development of technologies that monitor vital signs in critical care settings, ensuring that patients improve their quality of life.
Recently, Edwards Lifesciences announced a significant transaction with Becton, Dickinson and Company (BD), where BD will acquire Edwards' Critical Care product group for $4.2 billion in cash. This acquisition is expected to unlock new value creation opportunities and enhance BD's portfolio of smart connected care solutions. The Critical Care unit, known for its advanced patient monitoring solutions and AI-driven technologies, will operate as a separate business unit within BD's Medical segment, maintaining its base in Irvine.
The transaction is anticipated to be immediately accretive to all key financial measures, with a strong focus on revenue growth, adjusted gross and operating margins, and adjusted earnings per share. It highlights Edwards Lifesciences' strategic intent to drive innovation and value through partnerships and strategic acquisitions.
Edwards Lifesciences reported Q3 2022 sales of $1.32 billion, a 1% increase, with adjusted EPS rising 13% to $0.61. TAVR sales reached $862 million with 1% growth. The company anticipates 2022 total sales at the low end of its previous range of $5.35 to $5.55 billion. Discontinuation of the HARPOON program led to a $0.07 per share charge. Edwards received FDA and CE Mark approvals for its PASCAL Precision and SAPIEN 3 Ultra valve. Adjusted EPS guidance for 2022 is now $2.40 to $2.50, highlighting strong financial performance amidst ongoing challenges.
Edwards Lifesciences (NYSE: EW) will announce its Q3 2022 operating results on October 27, 2022, after market closure. A conference call is scheduled for 5:00 p.m. ET that same day to discuss the results. This event marks a key opportunity for investors to gain insights into the company’s financial performance and outlook amidst its focus on innovations for structural heart disease and critical care monitoring.
Edwards Lifesciences Corporation (NYSE: EW) announced results from the CLASP IID trial, the first randomized controlled study comparing two transcatheter edge-to-edge repair (TEER) therapies for degenerative mitral regurgitation (DMR). The trial confirmed the PASCAL system's non-inferiority to the MitraClip device in safety, with a major adverse event rate of 3.4% at 30 days. Furthermore, 97.7% of patients achieved mitral regurgitation (MR) ≤2+ at six months. The findings support TEER as a safe and effective treatment for high-risk patients with DMR.
Edwards Lifesciences Corporation (NYSE: EW) announced FDA approval for its PASCAL Precision transcatheter valve repair system, aimed at treating patients with degenerative mitral regurgitation (DMR). This innovative device features independent grasping and atraumatic clasp technology, enhancing treatment safety and efficacy. The approval follows successful outcomes in the CLASP IID pivotal trial, the first to compare contemporary TEER therapies. The PASCAL Precision system is already CE Mark certified for both mitral and tricuspid regurgitation, with plans to enroll U.S. patients in a registry to build real-world evidence.
Edwards Lifesciences (NYSE: EW) has launched the SAPIEN 3 Ultra RESILIA valve, following FDA approval. This valve utilizes RESILIA tissue technology, enhancing calcium blocking properties and offering a dry storage solution. The SAPIEN 3 Ultra RESILIA valve aims to reduce reintervention rates in heart valve replacement. It will be available in limited release in the U.S. in Q4 2022, contributing to 2022 financial expectations.
Edwards Lifesciences Corporation (NYSE: EW) announced its PASCAL Precision transcatheter valve repair system has received CE Mark approval for treating mitral and tricuspid regurgitation (MR and TR). This advancement enhances the company's partnership with physicians addressing valve disease. The PASCAL Precision system features innovative navigation and implant delivery, aiming to improve outcomes for patients. The system includes PASCAL and PASCAL Ace implants, designed for complex anatomies. Edwards remains committed to transforming valve disease treatment through clinical evidence.
Edwards Lifesciences (NYSE: EW) reported Q2 2022 sales of $1.37 billion, flat compared to the previous year, with underlying growth of 5%. TAVR sales were $907 million, up 1% year-over-year. Adjusted EPS was $0.63. The company lowered its second-half sales growth outlook to 10%. Q2 gross profit margin improved to 80.5%. The firm anticipates a full-year sales range of $5.35 to $5.55 billion and adjusted EPS guidance of $2.50 to $2.65. Edwards is optimistic about future growth opportunities driven by its strong pipeline and ongoing investments in TAVR and TMTT technologies.
Edwards Lifesciences will announce its operating results for the quarter ending June 30, 2022, on July 28, 2022, after market close. A conference call to discuss the results is scheduled for 5:00 p.m. ET that day. Interested participants can join by calling (877) 704-2848 or (201) 389-0893. The call will also be available live and archived on the Investor Relations section of the Edwards website.
Edwards Lifesciences is recognized as a leader in patient-focused innovations for structural heart disease and critical care monitoring.
Edwards Lifesciences Corporation (NYSE: EW) announced its participation in the Bernstein 38th Annual Strategic Decisions Conference on June 2, 2022. CEO Michael A. Mussallem will present at 1:30 p.m. ET. The presentation will be accessible via a live webcast on the company's investor relations website, ir.edwards.com, with an archived version available later the same day. Edwards Lifesciences focuses on patient-centric innovations for structural heart disease and critical care monitoring.
Edwards Lifesciences (NYSE: EW) has announced key events at EuroPCR 2022, occurring from May 17 to 20 in Paris. Notable presentations include:
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