Edwards Lifesciences has predicted its business will achieve underlying growth of 9% to 12% in 2019, potentially moving global sales past the $4 billion mark.
The forecast, which is up slightly on Edwards' outlook for 2018, is based on expectations that the critical transcatheter aortic valve replacement (TAVR) business will continue to grow at a double-digit rate.
Edwards' growth strategy is predicated on a series of clinical trials it thinks will help to grow the global TAVR opportunity to $7 billion by 2024, and ensure it retains a sizable slice of the market.
Edwards went into 2018 predicting that 11% to 15% growth at its TAVR business, then known as the transcatheter heart valve therapy unit, would ensure near-double-digit global sales for the company as a whole. With 2018 sales on track to hit their targets, Edwards has revealed a very similar set of forecasts for the coming year.
Looking ahead to 2019, Edwards expects 11% to 15% growth in TAVR sales to help the overall global business to grow by between 9% and 12%. The upper end of the target growth range for the business as a whole is up two percentage points on the previous forecast, but other than that the predictions map perfectly onto last year's outlook.
The quick, steady growth reflects Edwards' belief that the TAVR opportunity is still growing and that it has the products to capture the growing market. Edwards now expects the global TAVR market to hit $7 billion by 2024 on the back of its efforts to expand use of the approach.
Those efforts will go up a notch in 2019, although Edwards will only start realizing the benefits in the back half of the year and beyond. With the Sapien 3 Ultra system expected to win FDA approval soon, Edwards looks set to start the new year with a new delivery system as it seeks to hold off competition from Boston Scientific and Medtronic.
A bigger moment will come in March when Edwards presents TAVR data in low-risk surgical patients. Talking to investors in October, Edwards CEO Michael Mussallem predicted the trial will show "TAVR is substantially equivalent to surgery for all patients" and make anatomy, not risk, the factor with the most influence over treatment choice. Edwards expects to get FDA clearance in low-risk patients late next year and complete enrollment in a study of the pre-symptomatic population in 2020.
Edwards sees the TAVR market growing quickly through to 2024 and beyond, and it is also laying the groundwork for a push to claim a piece of another transcatheter market. Edwards expects the market for transcatheter mitral and tricuspid therapies (TMTT) to grow to $3 billion by 2024 and has several products targeting the sector in development.
The repair technologies are set to come to market in Europe and enter U.S. pivotal trials next year. One of the technologies, the mitral regurgitation version of Cardioband, is already in a pivotal trial but Edwards has paused enrollment while it evaluates the trial design. The pause follows the release of impressive data on Abbott's MitraClip in patients with secondary mitral regurgitation.
TMTT is currently a tiny part of Edwards' business and no meaningful growth is forecast for next year. The unit has better mid-term growth prospects than Edwards' more established surgical structural heart and critical care businesses, though. Of those two units, critical care is predicted to grow fastest, in part because of the rollout of the now-FDA-cleared HemoSphere hemodynamic monitoring platform.
Shares in Edwards closed down 4% following the investor conference.