Edwards Lifesciences CorpNYSE
Mon, Nov. 28, 6:53 AM
- Edwards Lifesciences (NYSE:EW) agrees to acquire privately held Valtech Cardio. The Or Yehuda, Israel-based firm markets a portfolio of solutions for mitral and tricuspid valve repair and replacement. Its flagship product is the Cardioband System which combines a reconstruction implant with a transcatheter approach. It was CE Mark'd in 2015.
- Under the terms of the agreement, Edwards will pay $340M in cash and stock at closing and up to $350M in milestones over the next 10 years. In Q1, Valtech intends to spin off its early-stage transseptal mitral valve technology program, which Edwards retains an option to acquire.
- Separately, Edwards' board authorizes a new share buyback program to repurchase up to an additional $1B of the company's common stock. It has $277M remaining of its current $750M repurchase plan. The new authorization will offset the dilution from the Valtech transaction.
- Management will discuss the Valtech deal and release 2017 guidance at its annual investor conference on December 8.
Wed, Nov. 23, 10:13 AM
- Nano cap Neovasc (NVCN +13.7%) perks up on modestly higher volume in response to its announcement that the U.S. District Court in Massachusetts has granted its motion to dismiss the class action lawsuit Grobler v. Neovasc, et al. (Civil Action No. 16-11038-RGS). The court ruled in favor of the company and its officers on all claims and ordered the case closed.
- Various law firms descended on the company after shares plunged when the company lost a patent case against Edwards Lifesciences (EW +1.6%) unit CardiAQ earlier this year related to the Tiara valve replacement device.
- Previously: Neovasc gets thumped in patent case, on the hook for $91M; shares plummet 41% (Nov. 1)
Tue, Nov. 22, 12:12 PM| Tue, Nov. 22, 12:12 PM | 17 Comments
Wed, Oct. 26, 12:45 PM
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Tue, Oct. 25, 5:37 PM
Tue, Oct. 25, 4:56 PM
- Edwards Lifesciences (NYSE:EW) Q3 results ($M): Revenues: 739.4 (+20.1%); Transcatheter Heart Valve Therapy: 410.1 (+38.5%); Surgical Heart Valve Therapy: 190.9 (+1.6%); Critical Care: 138.4 (+5.2%).
- Net Income: 141.4 (+19.7%); Non-GAAP Net Income: 148.2 (+24.9%); EPS: 0.65 (+20.4%); Non-GAAP EPS: 0.68 (+25.9%).
- 2016 Guidance: Revenues: high end of $2.7 - 3.0B (unch); Non-GAAP EPS: 2.82 - 2.92 from 2.78 - 2.88.
- Q4 Guidance: Revenues: $750M - 790M; Non-GAAP EPS: $0.67 - 0.77.
- Revenues were 1.3% below consensus of $749.1. Non-GAAP EPS met consensus.
- Shares are down 17% after hours on robust volume.
Tue, Oct. 25, 4:18 PM
Mon, Oct. 24, 5:35 PM
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Thu, Sep. 29, 9:43 AM
- Edwards Lifesciences Corporation (EW -0.2%) announces that it has received CE Mark clearance for its INSPIRIS RESILIA aortic valve, the first in a new class of resilient heart valves. Incorporating the advanced RESILIA tissue, INSPIRIS leverages features of the PERIMOUNT Magna Ease valve and includes the proprietary VFit technology, which is designed for potential future valve-in-valve procedures.
- RESILIA tissue utilizes Edwards' integrity preservation technology, which preserves the tissue and provides improved anti-calcification properties and sustained hemodynamic performance. In addition, the valve is stored dry and ready to use.
- Targeted commercial release in Europe should commence in Q4 followed by full launch in Q1 2017. The VFit feature is available in sizes 19mm through 25mm. It is not approved for commercial use in the U.S.
Mon, Sep. 19, 9:30 AM
- Edwards Lifesciences (NYSE:EW) receives CE Mark clearance for the uses of its SAPIEN 3 transcatheter heart valve in patients with severe aortic stenosis who are at intermediate risk for an open-heart surgical procedure. The valve was originally approved in Europe in January 2014 for the same patients are at high risk for open heart surgery.
- The FDA approved the new indication last month. It was originally approved in the U.S. for high risk patients in June 2015.
- Previously: FDA OKs expanded use of Edwards' SAPIEN 3 heart valve (Aug. 18)
Thu, Aug. 18, 3:26 PM
- The FDA approves the use of Edwards Lifesciences' (EW +1.9%) SAPIEN 3 transcatheter heart valve in patients with severe symptomatic aortic stenosis who have been determined to be at intermediate risk for open-heart surgery, the first transcatheter aortic replacement (TAVR) therapy so designated in the U.S.
- The data supporting approval was generated in the 2,005-subject PARTNER II study that showed patients implanted with the SAPIEN 3 experienced clinically significant improvements as measured in a composite primary endpoint of mortality, stroke and moderate/severe aortic regurgitation at Year 1 compared to surgery.
- The original approval in 2015 was for patients with severe symptomatic aortic stenosis who are at high-risk for open heart surgery.
Thu, Jul. 28, 12:29 PM
- Hologic (NASDAQ:HOLX) upgraded to Buy from Hold by Evercore ISI. Price target raised to $42 (11% upside) from $38.
- Edwards Lifesciences (NYSE:EW) upgraded to Buy from Neutral by Bank of America.
- UnitedHealth Group (NYSE:UNH) upgraded to Buy from Hold with a $170 (20% upside) price target by Argus Research.
- NeoGenomics (NASDAQ:NEO) downgraded to Hold from Buy by BTIG Research.
- Depomed (NASDAQ:DEPO) downgraded to Neutral from Overweight by Piper Jaffray. Price target lowered to $18 (6% downside risk) from $21.
- HealthStream (NASDAQ:HSTM) downgraded to Equal Weight from Overweight by First Analysis. Price target lowered to $27 (7% upside) from $30.
- Gilead Sciences (NASDAQ:GILD) downgraded to Hold from Buy by Needham.
- Athenahealth (NASDAQ:ATHN) downgraded to Hold from Buy by Deutsche Bank. Price target lowered to $147 (13% upside) from $165.
Wed, Jul. 27, 9:23 AM
Wed, Jul. 27, 9:21 AM
- Edwards Lifesciences (NYSE:EW) Q2 results ($M): Revenues: 759.3 (+23.1%); Transcatheter Heart Valve Therapy: 418.6 (+48.8%); Surgical Heart Valve Therapy: 198.7 (-2.6%); Critical Care: 142.0 (+8.1%).
- Net Income: 126.6 (+12.3%); Non-GAAP Net Income: 164.6 (+30.9%); EPS: 0.58 (+13.7%); Non-GAAP EPS: 0.76 (+33.3%).
- 2016 Guidance: Revenues: high end of $2.7B - 3.0B; Non-GAAP EPS: $2.78 - 2.88.
- Q3 Guidance: Revenues: $720M -760M; Non-GAAP EPS: $0.62 - 0.68.
- Shares are up 8% premarket on increased volume.