Intersect ENT Reports Third Quarter Results

Menlo Park. Calif.-based Intersect ENT Inc. has reported its financial results for its third quarter for 2015 that ended on Sept. 30. The company makes ear, nose and throat treatment technology.

Revenue for the third quarter of 2015 increased 56 percent to $14.2 million, from $9.1 million in the same period of 2014. This increase is attributable to higher unit sales driven largely by the acquisition of new accounts and expanded adoption by existing customers. Gross margin for the third quarter of 2015 was 80 percent, up from 72 percent in the same period of 2014. This increase in gross margin was due primarily to spreading the company’s manufacturing costs over higher production volumes.

Operating expenses for the third quarter of 2015 were $21.2 million, an increase of 71 percent compared to $12.4 million in the same period of 2014. The increase in operating expenses was driven primarily by growth in headcount, notably in sales and clinical staffing, an increase in clinical trial spending, as well as expenses associated with being a public company and stock-based compensation expense. The third quarter of 2015 operating expenses included $1.4 million in stock-based compensation expense compared to $0.4 million in the same period of 2014.
Net loss for the third quarter of 2015 was $9.7 million, compared to $5.9 million for the same period of 2014. Basic and diluted net loss per share for the third quarter of 2015 was $(0.35).
Cash, cash equivalents and short-term investments totaled $131.1 million as of September 30, 2015.

During the quarter, Intersect ENT submitted a premarket approval supplement to the U.S. Food and Drug Administration to seek approval to expand the indication of the Propel mini steroid releasing implant to the treatment of patients following frontal sinus surgery. The company reported preliminary results for the 80 patients in the Propel mini cohort of the Progress study showing that the study met its primary efficacy endpoint, demonstrating a statistically significant 38 percent relative reduction in the need for post-operative interventions such as additional surgical procedures or need for oral steroid prescription compared to surgery alone. The device placement success rate was 100 percent and there were no device-related adverse events.

Initiated enrollment of the second cohort of 80 patients in the Progress study evaluating Nova, an investigational bioabsorbable steroid releasing implant. This study is a prospective, randomized blinded multicenter trial to assess the safety and efficacy of Nova when used following frontal sinus surgery.

Continued enrollment of patients in Resolve II, a 300-patient pivotal Phase III clinical study of the Resolve investigational steroid releasing implant designed to treat patients with recurrent sinus obstruction in the office setting.

Reported positive clinical results from three studies evaluating steroid releasing implants placed in the physician’s office, including long-term results from a study evaluating office-based treatment with Resolve, a study assessing patient-reported and endoscopic outcomes after placement of the Propel steroid releasing implant following sinus surgery during a post-operative office visit, and three-month results from the Exceed study evaluating Nova.

“Our progress this year demonstrates the value we are delivering to chronic sinusitis patients through Propel’s proven ability to improve surgical outcomes,” said Lisa Earnhardt, president and CEO of Intersect ENT. “We also achieved significant advances in our pipeline of potential new products through both our clinical milestones and the recent clinical data presentations.”