Losses grew 36.4% for Santa Barbara, Calif.-based Sientra, to -$26.5 million, or -91¢ per share, on sales growth of 19.6% to $17.6 million during the three months ended March 31, compared with Q1 2018.
Analysts on Wall Street were looking for losses per share of -78¢ on sales of $17.6 million. Breast implant sales were $9.8 million during the quarter, the company said.
“In the first quarter, we continued to drive robust growth across both of our segments, achieving net sales of $17.6 million, a 20% increase compared to the year-ago period. This quarterly performance represents a solid start towards our 2019 objectives. Our breast products segment grew net sales 14% year over year, strong evidence that we continue to gain market share. I am extremely proud of this accomplishment considering the media headwinds this category experienced in the first quarter. We were pleased with the FDA’s announcement last week confirming that all breast implant options remain safe and effective and will continue to be available in the United States. We are also excited about the FDA’s recent approval of our extra-high profile implants, which we expect to be a key addition to our breast reconstruction portfolio.”
Sientra said it expects to report sales of $79 million to $83 million this year, including breast product sales of $44 million to $46 million.
SIEN shares were off -13.2% to $7.18 apiece today in mid-day trading.
Textured breast implant risks take their toll
In March the federal safety watchdog’s General & Plastic Surgery Devices panel held two days of hearings before reaching its conclusion, over the protests of patient advocates and despite a surge in adverse event reports.
The FDA only in 2011 began reporting on the cancer, known as breast implant-associated anaplastic large cell lymphoma, and its link to implants. In February the federal watchdog said it has received 457 unique reports of the cancer, with 246 new reports logged since 2017. Textured breast implants accounted for less than 10% and macro-textured implants only 5% of the total sold in the U.S. last year, the agency said.
In March the FDA warned Sientra and Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide over failures to conduct appropriate post-approval studies of the devices. Allergan (NYSE:AGN) has already pulled its textured implants from the European market and France and Australia are considering outright bans.
This week Allergan said its breast product sales were off -30.9% to $72.4 million during the first quarter, with sales up 0.8% to $61.2 million in the U.S. but down-74.6% to $11.2 million internationally.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.