Cutera slashes guidance on FDA warning, shares fall

Shares in Cutera have fallen more than 20% today after the company cut its sales guidance for the third quarter and full year.

The Brisbane, Calif.-based company said that it now expects to post sales of approximately $40 million in the third quarter.

Cutera said that in light of the adjustment, it lowered its full year fiscal guidance, now expecting to post between $165 million and $170 million, down from previous guidance of between $178 million and $181 million.

The company said that the reduced sales were due to a number of factors, including a July FDA statement warning about “vaginal rejuvenation” procedures and associated tech, and a reduced sales force.

“A few key factors that negatively impacted our third quarter results are expected to continue into fourth quarter. Given this, we are reducing our 2018 revenue guidance. Among the factors are headwinds faced by Juliet, our distributed women’s health system. We believe there was a clear impact on the overall market following the recent FDA communication to multiple manufacturers. While Cutera did not receive a notification from the agency, we believe our third quarter Juliet sales were negatively affected. Additionally, our hiring goals for US-based capital equipment sales personnel remain unmet. The result is an overburdened sales team, which we also believe will impact the fourth quarter as we hire and train new sales personnel. The newly revised 2018 revenue guidance incorporates these challenges with plans to remediate the latter in preparation for 2019. While the Q3 result did not meet our expectations, it should not overshadow an exceptional launch of our next generation body sculpting offering, truSculpt iD, which delivered a record number of systems in the quarter. We continue to be excited about our prospects in the fast-growing body sculpting segment,” prez & CEO James Reinstein said in an SEC filing.

Shares in Cutera are down 22.8% so far today, at $23 as of 10:33 a.m. EDT.

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