TAVR performance trends
In the second quarter, Edwards Lifesciences (EW) has guided for TAVR (Transcatheter Aortic Valve Replacement) sales of $2.5 billion to $2.7 billion in fiscal 2019. The company had previously estimated fiscal 2019 TAVR sales at $2.4 billion to $2.7 billion.
In the second quarter, Edwards Lifesciences estimates its TAVR procedure growth in line with the global procedure growth. The company, however, maintained stable pricing across the world. Physicians are expected to switch from SAPIEN 3 to the more advanced SAPIEN 3 Ultra system.
According to the second-quarter earnings call, the company reported high-teen TAVR sales growth in the US market. Robust results from the PARTNER 3 trial led to a significant improvement in the overall confidence for TAVR therapy.
The Partner 3 demonstrated superiority of the SAPIEN 3 TAVR over surgery, in ssAS (severe symptomatic aortic stenosis) patients with low surgical risk. TAVR has also demonstrated a 1% risk of death or stroke at one year, which compares favorably with the 2.9% risk reported for the surgical option. Notably, Edwards Lifesciences is expecting FDA approval for SAPIEN 3 and SAPIEN 3 Ultra in ssAS patients with low surgical risk in the third quarter.
International market performance
Edwards Lifesciences expects international markets to be a key sales driver for its TAVR offerings. The company has estimated a mid-teen YoY rise of TAVR procedures in these markets. This growth is in line with the company’s performance.
Edwards Lifesciences is focused on launching Sapien Ultra 3 in Europe. The company expects this product to account for most of TAVR sales in Europe by the end of fiscal 2019. An increasing number of centers and robust adoption of SAPIEN 3 are driving the company’s penetration in Japan. To know more about key competitor Medtronic’s position in the TAVR space, please read Here’s What Could Boost Medtronic’s Growth in Fiscal 2019.
TMTT performance trends
Edwards Lifesciences has guided for fiscal 2019 TMTT (Transcatheter Mitral and Tricuspid Therapies) revenues of $40 million. The company has estimated the global TMTT market opportunity to be worth $3.0 billion by 2024.
In the second quarter, the company reported TMTT revenues of $7.0 million. The commercial launch of PASCAL Transcatheter valve repair system in MR (mitral regurgitation) indication has contributed significantly to TMTT sales. The company is also focused on driving the use of the Cardioband Mitral Reconstruction system to reduce MR.
Edwards Lifesciences has reported favorable six-month data from CLASP study for its PASCAL system in MR indication. According to the second-quarter earnings call, the company plans to begin enrollment in CLASP IIF pivotal trial in late 2019. In this trial, the company will compare PASCAL with Abbott Laboratories’ MitraClip device in symptomatic heart failure patients with moderate-to-severe or severe FMR (functional mitral regurgitation). Besides, the company is also enrolling patients in a pivotal CLASP IID trial. Here, the company aims to study the PASCAL system in mitral valve disease.
According to the second-quarter earnings call, Edwards Lifesciences will also be enrolling patients in a pivotal trial for SAPIEN M3 transseptal therapy in mitral valve replacement. The company plans to position PASCAL and Cardioband as prominent treatment options for tricuspid regurgitation. The company, however, has decided to discontinue the FORMA program in tricuspid indication.
Surgical structural heart trends
Edwards Lifesciences has reaffirmed its fiscal 2019 underlying sales growth guidance for the Surgical Structural Heart segment of 1% to 3%. This segment reported revenues of $218 million in the second quarter, a YoY rise of 2%. This increasing adoption of innovative surgical treatment options is mainly fueling this growth. The segment is also benefiting from demand in international markets. However, increasing adoption of TAVR has resulted in a drop in surgical procedures in the US.
In late 2019, Edwards Lifesciences plans to launch HARPOON system in Europe. According to the second-quarter earnings call, this is an echo guided mitral valve repair therapy.
Critical care trends
Edwards Lifesciences has increased fiscal 2019 guidance for underlying sales growth of the Critical Care segment from 5%-7% to 8%-10%. In the second quarter, the segment reported revenues of $184 million, a YoY rise of 9%. The successful commercial launch of all-in-one monitoring platform HemoSphere has helped boost Critical Care sales.