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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 a 15% increase in Q3 sales to $1.3 billion, with TAVR sales also up 15% year-over-year, despite challenges from the Delta variant. The company maintains its full-year sales guidance of $5.2 to $5.4 billion and adjusted EPS guidance at $2.07 to $2.27. TMTT sales totaled $22 million, with expectations for significant market growth in the upcoming years. The company continues to invest in R&D, with expenses growing 22% to $238 million.
Edwards Lifesciences (NYSE: EW) is set to release its operating results for Q3 2021 on October 27, 2021, after market close. A conference call will follow at 5:00 p.m. ET to discuss the results. The company is recognized as a leader in innovations for structural heart disease and critical care monitoring, dedicated to improving patient outcomes.
Edwards Lifesciences reported Q2 2021 sales of $1.4 billion, a 49% increase year-over-year, with TAVR sales up 52% to $902 million. Adjusted EPS reached $0.64. The company raised its full-year sales guidance to $5.2-$5.4 billion from $4.9-$5.3 billion. Continued advancements in five pivotal trials for TMTT were noted, with a market opportunity projected to triple by 2025. Free cash flow was reported at $457 million. Edwards remains optimistic about long-term growth driven by increasing adoption of its innovative therapies.
Edwards Lifesciences (NYSE: EW) announced positive clinical and economic results from the 3M Transcatheter Aortic Valve Replacement (TAVR) Economic Study and the PARTNER 3 Bicuspid Registry at TVT 2021. The 3M-TAVR study indicated reduced hospitalization costs by $10,843 per patient and cumulative savings of $11,305 within 30 days compared to traditional TAVR. The PARTNER 3 study showed similar clinical outcomes for low-risk patients with bicuspid versus tricuspid aortic valves. Both studies support TAVR's efficiency and highlight its potential to save healthcare costs.
Edwards Lifesciences (NYSE: EW) will announce its operating results for Q2 2021 on July 29, 2021, after market close. A conference call is scheduled for 5:00 p.m. ET the same day to discuss these results. Interested participants can join the call at (877) 704-2848 or (201) 389-0893, with an audio replay available for 72 hours. The call will also be streamed live or archived on the Investor Relations section of the Edwards website.
Edwards Lifesciences announced FDA clearance for its Acumen Hypotension Prediction Index (HPI) software, utilizing the noninvasive Acumen IQ finger cuff. This innovative solution, employing machine learning, alerts clinicians about the risk of hypotension in patients not requiring invasive arterial lines. The Acumen IQ cuff will be integrated with the HemoSphere advanced monitoring system, enabling real-time hemodynamic monitoring and promoting better patient outcomes. The launch reflects Edwards' commitment to enhancing patient care with smart monitoring tools.
Edwards Lifesciences (NYSE: EW) announced positive results from a real-world study on patients with bicuspid aortic stenosis treated with SAPIEN 3 and SAPIEN 3 Ultra TAVR. The one-year data showed low rates of death (4.6%) and stroke (2.0%), comparable to tricuspid valve patients. The study incorporated over 6,000 patients, indicating significant quality of life improvements and minimal paravalvular leak rates. These findings enhance physician confidence in recommending TAVR for younger patients, aligning with recent ACC/AHA guidelines emphasizing shared decision-making.
Edwards Lifesciences (NYSE: EW) announced positive clinical outcomes from its transcatheter mitral and tricuspid valve programs presented at EuroPCR 2021. Key findings include:
- TRISCEND study: 30-day results showed device success of 98% and significant TR reduction.
- CLASP study: 2-year survival rate at 80% with an 85% reduction in heart failure hospitalizations.
- CLASP TR study: 6-months data indicated substantial safety and TR reduction.
- TriBAND study: 30-day outcomes revealed a device success rate of 97% with low mortality at 1.6%.
Both the PASCAL and Cardioband systems hold CE Mark in Europe but are not yet approved in the U.S.
Edwards Lifesciences Corporation (NYSE: EW) held its annual meeting on May 5, 2021, where stockholders voted in favor of all board recommendations. Key outcomes included the election of eight directors for one-year terms, approval of executive compensation, and ratification of the independent accounting firm for fiscal 2021. Additionally, the board authorized an extra $1 billion for share repurchases, complementing the remaining $262 million authorization. Changes in board leadership were noted, including Nicholas J. Valeriani's appointment as chair of the compensation committee and William J. Link's retirement.
Edwards Lifesciences is partnering with Providence and local cities to establish two mass COVID-19 vaccination clinics in Orange County, California. The clinics will be located at Edwards' Santa Ana campus and the Orange County Great Park. The Santa Ana site is now operational while the Irvine site opens on April 26, 2021. The initiative, supported by a $500,000 donation from Edwards, aims to vaccinate up to 4,000 residents daily. Providence has already administered over 256,815 doses and is committed to equitable vaccine distribution in vulnerable communities.
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