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Edwards (EW) Completes Enrollment for PARTNER 3 Sub-Study
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Edwards Lifesciences Corporation (EW - Free Report) has announced that its computed tomography imaging (within the PARTNER 3 trial of the SAPIEN 3 valve) sub-study has recently completed enrollment.
Notably, this sub-study is evaluating the leaflet mobility of both SAPIEN 3 and surgical heart valves in patients, who are at low risk and experiencing valve replacement for treating severe aortic stenosis. Data from the main PARTNER 3 study will be presented at ACC 2019. Notably, the company expects an FDA approval for the indication late in 2019.
Per management, Edwards Lifesciences is studying the SAPIEN 3 Ultra System (featuring an on-balloon delivery system and next-generation sheath technology) as part of a single-arm multi-center trial of up to 30 intermediate-risk patients.
The company now anticipates the system’s launch in late 2018 across both Europe and the United States. It also announced that the updated timing for the European launch of the system does not change the 2018 sales guidance, pegged at the high end of the projected $3.5-$3.9 billion range.
Market Potential
Per a report by Zion Market Research, the global heart valve devices market is estimated to be worth $10.35 billion by the end of 2022 at a CAGR of around 13% between 2017 and 2022.
A very noteworthy player in this niche is Abbott (ABT - Free Report) .
THV in Focus
Basically, SAPIEN 3 is an artificial valve, which falls under Edwards Lifesciences’ Transcatheter Heart Valves (THV) segment. The THV segment includes technologies designed to treat heart valve diseases using catheter-based approaches, opposed to open surgical techniques. In the fourth quarter of 2017, the company reported 20.2% of THV sales growth over the prior-year quarter’s tally. In the United States, THV increased 22.3% year over year, attributable to an excellent clinical performance by SAPIEN 3 as well as a continued strong therapy implementation across all regions. Outside the United States, the underlying growth rate was 22% with contributions from all regions. The company continues to see a strong TAVR therapy adoption in Japan, driven by SAPIEN 3.
Buoyed by the previous quarter’s strong performance, Edwards Lifesciences now predicts full-year THV sales growth rate at the high end of the 11-15% guided range. Also, per management, THV boasts the highest margin business.
Of late, Edward Lifesciences has witnessed multiple developments in its THV segment. Good news is that the company has recently received a CE Mark for its self-expanding CENTERA.
Also, management released positive patient outcomes on SAPIEN 3 valve including high survival rates and low rates of stroke and paravalvular leak.
Share Price & Estimate Revision Trend
Edwards has been gaining investor confidence on consistently positive results. Over a year’s time, the company’s share price has outperformed the industry. The stock has soared 45.6% compared with the industry’s 22.6% rally.
Headquartered at Irvine, CA, the company’s estimate revision trend for 2018 has been positive. In the past couple of months, 12 analysts moved north with no revision in the opposite direction. Earnings estimates rose around 8.7% to $4.52 per share.
Zacks Rank & Other Key Picks
Edwards Lifesciences carries a Zacks Rank #2 (Buy). Other two top-ranked stocks in the broader medical sector are Bio-Rad Laboratories (BIO - Free Report) and Varian Medical Systems, Inc. .
Varian Medical has a long-term expected earnings growth rate of 8%. The stock carries a Zacks Rank of 2.
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Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
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Edwards (EW) Completes Enrollment for PARTNER 3 Sub-Study
Edwards Lifesciences Corporation (EW - Free Report) has announced that its computed tomography imaging (within the PARTNER 3 trial of the SAPIEN 3 valve) sub-study has recently completed enrollment.
Notably, this sub-study is evaluating the leaflet mobility of both SAPIEN 3 and surgical heart valves in patients, who are at low risk and experiencing valve replacement for treating severe aortic stenosis. Data from the main PARTNER 3 study will be presented at ACC 2019. Notably, the company expects an FDA approval for the indication late in 2019.
Per management, Edwards Lifesciences is studying the SAPIEN 3 Ultra System (featuring an on-balloon delivery system and next-generation sheath technology) as part of a single-arm multi-center trial of up to 30 intermediate-risk patients.
The company now anticipates the system’s launch in late 2018 across both Europe and the United States. It also announced that the updated timing for the European launch of the system does not change the 2018 sales guidance, pegged at the high end of the projected $3.5-$3.9 billion range.
Market Potential
Per a report by Zion Market Research, the global heart valve devices market is estimated to be worth $10.35 billion by the end of 2022 at a CAGR of around 13% between 2017 and 2022.
A very noteworthy player in this niche is Abbott (ABT - Free Report) .
THV in Focus
Basically, SAPIEN 3 is an artificial valve, which falls under Edwards Lifesciences’ Transcatheter Heart Valves (THV) segment. The THV segment includes technologies designed to treat heart valve diseases using catheter-based approaches, opposed to open surgical techniques. In the fourth quarter of 2017, the company reported 20.2% of THV sales growth over the prior-year quarter’s tally. In the United States, THV increased 22.3% year over year, attributable to an excellent clinical performance by SAPIEN 3 as well as a continued strong therapy implementation across all regions. Outside the United States, the underlying growth rate was 22% with contributions from all regions. The company continues to see a strong TAVR therapy adoption in Japan, driven by SAPIEN 3.
Buoyed by the previous quarter’s strong performance, Edwards Lifesciences now predicts full-year THV sales growth rate at the high end of the 11-15% guided range. Also, per management, THV boasts the highest margin business.
Of late, Edward Lifesciences has witnessed multiple developments in its THV segment. Good news is that the company has recently received a CE Mark for its self-expanding CENTERA.
Also, management released positive patient outcomes on SAPIEN 3 valve including high survival rates and low rates of stroke and paravalvular leak.
Share Price & Estimate Revision Trend
Edwards has been gaining investor confidence on consistently positive results. Over a year’s time, the company’s share price has outperformed the industry. The stock has soared 45.6% compared with the industry’s 22.6% rally.
Headquartered at Irvine, CA, the company’s estimate revision trend for 2018 has been positive. In the past couple of months, 12 analysts moved north with no revision in the opposite direction. Earnings estimates rose around 8.7% to $4.52 per share.
Zacks Rank & Other Key Picks
Edwards Lifesciences carries a Zacks Rank #2 (Buy). Other two top-ranked stocks in the broader medical sector are Bio-Rad Laboratories (BIO - Free Report) and Varian Medical Systems, Inc. .
Bio-Rad Laboratories sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. The company has a long-term expected earnings growth rate of 20%.
Varian Medical has a long-term expected earnings growth rate of 8%. The stock carries a Zacks Rank of 2.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
See the pot trades we're targeting>>