Edwards Lifesciences is trading higher after reporting higher than expected adjusted earnings for Q2/19. The company estimates that the FDA will approve its SAPIEN 3 valve and SAPIEN 3 Ultra system in Q3/19.
Structural heart disease and critical care monitoring device and platform firm Edwards Lifesciences Corp. (EW:NYSE)announced second quarter earnings after the market closed yesterday.
The firm reported sales for Q2/19 ending June 30, 2019, were $1.1 billion, up 15% over the prior year, or 14% on an underlying basis. Fully diluted earnings per share (EPS) for the quarter decreased to $1.14, while adjusted EPS grew higher than expected by 11% to $1.38.
For Q2/19, the company reported Transcatheter Aortic Valve Replacement (TAVR) sales increased to $678 million in Q2/19, an increase of 16% over Q2/18, or 18% on an underlying basis. According to the company, those results grew in-line with estimated global procedure growth. Edwards advised that global average selling prices remained stable, and its global competitive position was consistent with both Q1/19 and Q2/18.
Surgical Structural Heart sales for the Q2/19 were $218 million, up 15% compared to Q2/18 and Critical Care sales were $184 million for Q2/19, up 9% over Q2/18 boosted by strong growth of HemoSphere advanced monitoring platform sales in the U.S.
Chairman and CEO of Edwards Lifesciences Michael A. Mussallem stated, "We are pleased to report stronger than expected sales growth in the second quarter, which continued a long-term trend of reaching more patients with innovative therapies and creating value. . .Increased demand for TAVR therapy resulted in underlying total company sales growth of 14 percent, which also reflected strength in all four of our product lines across all regions."
Mr. Mussallem added, "We now estimate that in Q3/19 the FDA will approve the SAPIEN 3 valve and SAPIEN 3 Ultra system for patients with low surgical risk. Over time, we expect the SAPIEN 3 Ultra valve system will replace SAPIEN 3 valve globally."
The company updated its business outlook: "For 2019, the company now expects total sales to be between $4.0 billion and $4.3 billion, with underlying sales growth around the top end of its previous 9 to 12% range. Additionally, the company raised its full year 2019 adjusted earnings per share guidance to $5.20 to $5.40 from $5.10 to $5.35. For the third quarter 2019, the company projects total sales to be between $1.02 billion and $1.06 billion, and adjusted EPS of $1.13 to $1.23."
Based in Irvine, Calif., Edwards Lifesciences identifies itself as the global leader in patient-focused medical innovations for structural heart disease and critical care monitoring and states that its commitment to transformational heart valve technology began in 1960 with the first commercially available heart valve. Product offerings include tissue replacement heart valves and repair products, as well as transcatheter heart valves for those patients considered at intermediate or greater risk for conventional valve replacement.
Edwards also provides technologies that facilitate on-pump cardiac surgery procedures through smaller incisions. Theses minimally invasive valve surgery solutions include soft tissue retractors, venous and arterial cannulae, aortic occlusion, venting and coronary sinus catheters. Edwards additionally provides evidence-based programs such as Enhanced Surgical Recovery Program that support the implementation and compliance to protocolized care pathways in the OR and ICU.
The firm's shares opened 11.63% higher today at $218.16 (+$22.70) over the prior day's $195.46 closing price. Shares have traded today between $211.34-219.71 on higher than average volume setting both an intraday 52-week and 5-year high price. The stock is currently trading at $211.41/share (+15.95, +8.16%).
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