Shares in Intersect ENT (NSDQ:XENT) got a boost yesterday on news that the Centers for Medicare and Medicaid Services (CMS) had assigned the company’s Sinuva corticosteroid-eluting sinus implant a preliminary J-code.
Intersect ENT stock, which had been bumping along just under $30 per share last week, jumped to $33.13 per share at Monday’s market open, then dipped slightly, opening today at $31.96.
Analysts at SVBLeerink expect Sinuva to gain a permanent J-code in January 2020, and believe that should help the device gain private-payer reimbursement over the coming years. They also said expect Sinuva to generate $10 million in revenue this year, and approximately $28 million in 2020.
“We don’t expect much of a tangible SINUVA (revenue) impact in the very near-term (i.e. 2019), and we’d note that mgmt. has previously indicated that its 2019 (revenue) outlook is not contingent upon receiving a J-Code,” they added.
Intersect ENT (Menlo Park, Calif.) is expected to issue new earnings guidance for 2019 in its first-quarter earnings report on Monday, May 6, the analysts wrote. The company declined to comment on the CMS decision.
Sinuva is designed to deliver an anti-inflammatory steroid (mometasone furoate) directly to the site of nasal polyps for up to 90 days. Made of bioabsorbable polymers designed to soften over time, the implant softens and polyps decrease, according to Intersect ENT. The device can be implanted a doctor’s office under local or topical anesthesia and is intended for adults who have had previous sinus surgery.
Intersect ENT won FDA approval for Sinuva in December 2017 and launched in the U.S. in April 2018.