Edwards looks to a rocky 2014 as Medtronic looms

Edwards Lifesciences' Sapien valve--Courtesy of Edwards Lifesciences

Edwards Lifesciences' ($EW) days of market dominance are numbered, and with Medtronic ($MDT) threatening its U.S. monopoly and Boston Scientific ($BSX) soon to enter the crowded European space, the California devicemaker is less than optimistic about 2014 sales.

The company expects its banner Sapien line of replacement heart valves to bring in between $700 million and $820 million next year, an oddly wide range that comes in well below analysts' estimates of $844.7 million, The Wall Street Journal notes. Medtronic is expected to make U.S. landfall with its CoreValve device next year, while Boston Scientific plans to commercialize the Lotus valve overseas around the same time, but until Edwards knows exact launch dates, it can't get too specific on Sapien sales, CEO Michael Mussallem said.

Edwards' shares have fallen about 9.3% since the announcement, and the company has plummeted almost 45% since the start of the year.

But the leader in transcatheter aortic valve replacement isn't without hope. Edwards expects to win FDA approval for the lower-profile Sapien XT in the first half of next year, and the company is on track to win a CE mark for the next-generation Sapien 3 by the end of 2013. Meanwhile, Edwards' phased Japanese launch of XT is progressing well, the company said, and it expects to get its third-generation valve approved in the U.S. by 2016.

Edwards has long been plagued by analyst downgrades and investor malaise as it repeatedly posts unimpressive sales for its market-leading valve and forecasts weak performances for the near future. The problems began in April when the company slashed its full-year sales projections by about 5%, surprising investors and sending its shares down 20%. Since then, the company has been working to cobble together some confidence on Wall Street, and now the rise of its rivals is doing little to help.

But some analysts still have faith Edwards can weather the storm. The company has now set a "scorched earth" guidance for 2014, Canaccord Genuity's Jason Mills said in a note Tuesday, but it has a good chance of coming out the other side with a stronger than ever market share.

- read Edwards' release
- check out the WSJ story

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