The Menlo Park, Calif.-based company posted a net loss of -$4.3 million on sales of $22.3 million for the 3 months ended Sept. 30, for sales growth of 21% compared with the same period last year.
Adjusted to exclude 1-time items, earnings per share were -15¢, five cents ahead of consensus on The Street, where analysts were looking for sales of $21.5 million.
Intersect ENT raised its full-year sales guidance from $91 – $93 million to $94.1 – $94.6 million.
The company’s steroid-releasing implant, Sinuva, is on track for commercialization in the second quarter of 2018, management reported. The FDA is slated to decide whether to approve the therapy or not by Jan. 7.
The Sinuva implant, which was previously called the Resolve implant, is placed during an in-office doctors appointment and is designed to be a treatment option for patients with recurrent ethmoid sinus obstruction. Traditionally, treatment for the condition includes high-dose oral steroids and repeat surgery.
The company also said in its earnings call that it plans to launch a new clinical study of Sinuva in the fourth quarter this year to evaluate the repeated use of the implant. The 50-patient trial will focus on assessing repeat placement of Sinuva in chronic sinusitis patients with nasal polyps.
The FDA has confirmed that the results of this new study are not required for Sinuva’s approval, according to Leerink analysts Danielle Antalffy and Rebecca Wang.
XENT shares were trading at $28.25 apiece today in early-morning trading, down -1.7%.