Edwards Lifesciences Corp Stock Price, News & Analysis

Edwards Lifesciences Corporation (NYSE: EW) presented its long-term growth strategy, technology pipeline updates, and financial guidance during its annual investor conference on December 8, 2022. Key highlights include a projected global market opportunity nearing $20 billion by 2028 and reaffirmation of October 2022 financial guidance. For 2023, sales are expected between $5.6 billion and $6.0 billion, with 9%-12% underlying growth. TAVR sales are projected at $3.6 billion to $4.0 billion. The company also plans to invest 17%-18% of sales in R&D to drive innovations.

Edwards Lifesciences Corporation (NYSE: EW) announced its CEO succession plan due to Michael A. Mussallem's upcoming retirement at the Annual Meeting of Stockholders on May 11, 2023. Bernard Zovighian, currently the vice president and general manager of the Transcatheter Mitral and Tricuspid Therapies (TMTT) business, will become CEO after serving as president starting January 1, 2023. Larry Wood and Daveen Chopra are also assuming expanded roles. The company emphasizes a smooth transition and its commitment to patient-focused innovation in the medical field.

Edwards Lifesciences Corporation (NYSE: EW) reported promising one-year results from the TRISCEND study of its EVOQUE transcatheter tricuspid valve replacement system. The study involved 176 patients with symptomatic tricuspid regurgitation. Key outcomes include a 90.1% survival rate and 88.4% freedom from heart failure hospitalization. Additionally, 97.6% of patients experienced significant TR reduction. The results highlight the EVOQUE system's potential as a vital treatment option for patients with this condition, emphasizing Edwards' commitment to innovative therapies.

Edwards Lifesciences (NYSE: EW) has initiated an accelerated share repurchase (ASR) agreement worth $750 million. This move marks a total of over $1.7 billion in shares repurchased by the company in 2022. The ASR will provide an initial delivery of around 8 million shares, with the final amount contingent on the average share price during the agreement's term. Funding for this ASR comes from existing cash reserves, leaving approximately $900 million available under their share repurchase authorization.

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.