OptiNose, Inc. (NASDAQ:OPTN) Q3 2022 Earnings Conference Call November 10, 2022 8:00 AM ET

Company Participants

Jonathan Neely - VP, IR and Business Development

Peter Miller - CEO

Ramy Mahmoud - President and COO

Conference Call Participants

Glenn Santangelo - Jefferies

Isaac Somekh - Piper Sandler

Gary Nachman - BMO Capital Markets

Stacy Ku - Cowen

Brandon Folkes - Cantor

Jonathan Neely

[Starts Abruptly]

Third quarter 2022 performance and our plans for the remainder of the year. I'm joined today by our CEO, Peter Miller; our President and Chief Operating Officer, Dr. Ramy Mahmoud; and our Chief Commercial Officer, Victor Clavelli.

The slides that will be presented on this call can be viewed on our website, optinose.com in the Investors section. Before we start, I would like to remind you that our discussions during this conference call will include forward-looking statements. All statements that are not historical facts are hereby identified as forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated by such statements.

Additional information regarding these factors and forward-looking statements is discussed under the cautionary note on forward-looking statements section of the earnings release that we issued today as well as under the Risk Factors section and elsewhere of OptiNose's most recent Form 10-K and Form 10-Q that are filed with the SEC and available at their website, sec.gov, and on our website at optinose.com.

You are cautioned not to place undue reliance on forward-looking statements. The forward-looking statements during this conference call speak only as of the original date of this call or any earlier date indicated in such statement, and we undertake no obligation to update or revise any of these statements.

We will now make prepared remarks, and then we will move to a question-and-answer session. With that, I will now turn the call over to Peter Miller. Peter?

Peter Miller

Thanks, Jonathan, and good morning. We appreciate you joining us today. Starting on Slide 4. We'll go into more detail in a moment, but I'd like to highlight 5 key takeaways from today's presentation. First, consistent with the expectations set in our last call, we met with the FDA in September to discuss our supplemental NDA submission for XHANCE as a treatment for chronic sinusitis. Ramy will cover this further during his prepared remarks in a moment.

In summary, we believe it was a positive meeting. Our second key takeaway for today is that following the discussion with FDA, we now expect to submit our supplemental NDA in early 2023. Third, we remain enthusiastic about the potential addition of an indication to treat chronic sinusitis. CS is diagnosed approximately 10x more frequently than nasal polyps, and in the current health care environment where off-label use is increasingly constrained by payers, we believe the new indication will allow us to access a significantly larger physician and patient audiences to drive growth.