Intersect ENT announces prelim Q4 financials at JPM, defining goals for its drug-loaded stents

Intersect CEO Lisa Earnhardt

Sinusitis implant maker Intersect ENT ($XENT) took the stage at the JP Morgan Healthcare Conference in San Francisco this week to announce preliminary financial results from the fourth quarter of 2014, its first full quarter since its July IPO worth $63.3 million.

Intersect, maker of the Propel and Propel Mini steroid-eluting sinus stents for chronic sinusitis, has enjoyed a serious uptick in sales of its devices, CEO Lisa Earnhardt said in a presentation at the conference. With sales more than doubling in 2014 compared to 2013, she reported preliminary revenue in the fourth quarter between $13.2 million and $13.4 million as per current expectations without an official audit. This demonstrates an increase of about 91% over last year's fourth quarter.

The Propel and Propel Mini sinus implants deliver the corticosteroid mometasone furoate when implanted in the ethmoid sinus cavity, eventually dissolving completely over a period of 30 to 45 days, Earnhardt said in her presentation. This is placed after sinus surgery to keep the passage open and reduce post-op complications. She noted that the implant improves upon both intranasal steroids, which only deliver about 2% of the drug to the nasal cavity, and oral steroids, which come with a host of side effects despite their potency.

Most of Earnhardt's presentation focused on the future of Intersect and its goals for 2015 onward. With the company's current lineup of the two implants, Earnhardt and her team are looking to collect new accounts, extolling the benefits of the devices to more physicians performing sinus surgery around the country.

"At this point, really, our focus is all about driving adoption, both in terms of garnering new accounts, as well as working with new physicians and going deeper with our existing accounts," Earnhardt told the San Francisco audience. "So while we've made tremendous progress on the adoption front, we have a lot of headroom for growth."

Intersect is also looking to branch out into expanded indications for Propel Mini in particular with regards to other areas of the sinuses. They are currently enrolling patients in a study designed to test post-op intervention in the frontal sinus, with an anticipated PMA in 2016.

Intersect's Propel sinus implant, the size of a quarter--Courtesy of Intersect ENT

"Propel and Propel Mini are indicated for use in the ethmoid sinus on either side of your nasal passage, and we believe there will (also) be utility for Propel Mini in the frontal sinus which is right above your eyebrows," Earnhardt said. "It's a very narrow channel with close proximity to both the ocular compartment and the brain and so it's one of the more challenging sinuses that the physician operates on. We estimate about 25% of procedures have the frontal sinuses treated, so this will enable us to bring this therapy to additional patients and procedures."

Menlo Park, CA-based Intersect, founded in 2003 with its first funding in 2006, is rising fast. The company was a member of FierceMedicalDevices' 2013 Fierce 15, and Earnhardt herself made this year's report highlighting influential women in the industry.

The company is looking toward 2015 now, forecasting $60 million to $70 million in revenue supported by an almost doubled sales force and with increased gross margins of about 75% to 78%. Earnhardt said Intersect would also forecast operating expenditures of about $74 million to $76 million as it invests not only in its commercial efforts but in its pipeline as well. That pipeline includes its Resolve device for patients with post-op complications and its Nova implant for early disease prevention, featuring an in-office placement procedure.

Overall, Earnhardt said the company is looking to take a bite out of what is estimated to be an $800 million market opportunity, "squarely focused on driving adoption of the Propel and Propel Mini, making it the standard of care for sinus surgery."

- here's the release
- and the presentation from CEO Lisa Earnhardt

Special Reports: Top women in medical devices 2014 - Lisa Earnhardt, Intersect ENT | FierceMedicalDevices' 2013 Fierce 15 - Intersect ENT