Earlier this month Sientra put a temporary hold on U.S. sales of implants made by Brazilian contract manufacturer Silimed, after Brazilian regulator Anvisa and the U.K.’s Medicines & Healthcare Products Regulatory Agency had already suspended sales after contamination was detected during an audit of the company’s manufacturing practices.
The problem for Sientra was compounded by an Oct. 22 fire at the Silimed plant, which damaged 1 of 2 buildings where the Sientra implants are made. Zeini remained noncommittal when asked about the timeline for getting things back on track.
“I can always count on you to keep asking the same questions but as I indicated on this call, we’re not going to give guidance, we’re not going to discuss long term guidance, future guidance, and 2016 guidance, as we have done in the past. When the appropriate time arrives, we’re fully transparent and we’ll do so accordingly,” Zeini said, according to the Pacific Coast Business Times.
Sientra has about a year’s worth of inventory on hand that it could sell after getting the go-ahead from the FDA, he said.
Leerink Partners analyst Richard Newitter said Sientra has 2 paths back to market: Reestablishing production in Brazil or using the existing inventory.
A Brazilian reboot “involves either 1) activating a production line at Silimed’s 2nd manufacturing plant (F1, unaffected by the fire), but this would require modifying the lines for SIEN’s breast implant production and receiving regulatory clearance. Regarding the plant that was affected by the fire (F2), it is unclear what the extent of the damage is and whether the equipment used to manufacture Sientra implants is operational as fire officials have not allowed anyone to access the building since the investigation is ongoing,” Newitter wrote.
The 2nd option “would involve using SIEN’s existing inventory following a period of extended testing,” he wrote.
“In this scenario, the company expects to deliver findings to the FDA by the end of calendar 2015 and resume sales following approval. Should this come to fruition, management would resume sales out of existing inventory, which should last for ~12 months – which assumes existing order patterns according to mgmt – before the company would need to replenish inventory,” Newitter wrote in a note to investors.