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David Rolfe Comments on Edwards Lifesciences

- By Holly LaFon

We established a new position in Edwards Lifesciences (EW) in the first quarter. Edwards is a pioneer in heart valve surgery, with nearly 90% of its revenues tied to heart valve replacement, by virtue of its best-in-class portfolio of intellectual property, backed by a relatively lengthy history of clinical data and successful outcomes. Heart disease is the world's leading killer, and the incidence of heart disease grows with age, meaning that the aging of populations across the developed world is directly leading to a rise in the occurrence of heart problems. Over half of the Company's business is tied to the rapidly-growing TAVR, or Transcatheter Aortic Valve Replacement, category. TAVR--as opposed to SAVR, which is Surgical Aortic Valve Replacement, which is generally a type of open-heart surgery--is a fairly recent technological advancement, with the first human procedure occurring in 2002; the first market approval in Europe in 2007; and US approval in 2011. We view TAVR, which replaces a heart valve using a small incision, usually in a patient's leg, as clearly superior to traditional open-heart surgery, with similar clinical results at a comparable price, but without the need to crack open a patient's chest. As the market for TAVR has developed, it was first approved for patients for whom traditional surgery was too risky to be a viable option, followed by patients for whom surgery was considered a high risk. 2016 saw a surge in procedures as TAVR was approved for patients for whom surgery is an intermediate risk, and clinical trials are underway to seek approval for low-risk patients, as well.

EW is the clear market leader in the TAVR segment of the market, and we expect its TAVR solutions to continue to gain significant share industry-wide over time as the procedure spreads into the low-risk patient population, especially as regulatory issues constraining the growth of the procedure ease over time, and as the industry invests in patient and physician education to expand the overall valve-replacement population, well beyond prior expectations. In addition, there are a significant amount of underserved populations among patients not yet showing symptoms and patients who might not have considered treatment previously, when the only option was to have their chests cracked open. We believe, over time, that TAVR's superior, much less invasive treatment option could lead to earlier screening of asymptomatic patients, as well as to patients proactively inquiring about therapy.

On the valuation front, the stock looks attractive in relation to peers and the broader market, having pulled back almost a third from its highs, down to the middle of its historical valuation range, after the past few quarters of earnings results slightly underperformed versus very high expectations. Specifically, there was a temporary issue with France running out of money in its budget for TAVR reimbursement, as the budget had not anticipated the tremendous growth in TAVR procedures for intermediate-risk patients. We view this as a non-issue, longer-term. Further, the sequential growth rate for TAVR revenues slowed in the second half of 2016, despite a continuation of extremely healthy year-over-year growth, which registered nearly 30% globally and nearly 40% in the US in the fourth quarter, for example. We view this as very attractive growth and understand that there will be fits and starts in sequential growth rates around product approval cycles. Longer-term, we view Edwards as an attractive growth opportunity, as aging populations lead to increasing heart disease, and as TAVR takes share within the valve-replacement market. We see opportunities for growth within the established patient population, in addition to current estimates of the patient population that we think are significantly understated, meaning that the market's long-term growth expectations are also understated. We believe the under-appreciated growth opportunities, the secular shift towards less invasive procedures, and the reasonable valuation makes EW an attractive long-term holding.

From David Rolfe (Trades, Portfolio)'s Wedgewood Partners first-quarter 2017 shareholder letter.
This article first appeared on GuruFocus.