OptiNose, Inc.

Good day, and thank you for standing by. Welcome to Optinose's third quarter 2023 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Jonathan Neely, Vice President, Investor Relations and Business Development. Please go ahead, sir.

Good morning, and thank you for joining us today as we review OptiNose's third quarter 2023 performance and our plans for the remainder of the year. I'm joined today by our CEO, Dr. Rami Mahmood, and our Chief Commercial Officer, Paul Spence. The slides that will be presented on this call can be viewed on our website, OptiNose.com, in the Investor 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 Factor section and elsewhere in Opti-Nose's most recent Form 10-K and 10-Qs that are filed with the SEC and available at their website, sec.gov, and on our website at optinose.com. Your caution 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 Rami.

Thank you, Jonathan, and thank you to everyone listening for joining us this morning. We appreciate you joining us for our third quarter update. Starting on slide three, we're going to more detail in a moment, but I'd like to highlight three key takeaways from today's presentation. First, I'd like to reiterate the significance of the opportunity in front of us, which we believe has potential to reshape our business in the coming months and for years into the future. Claims data suggests that CS is currently being diagnosed by healthcare providers at least 10 times more frequently than nasal polyps. Second, I'd like to remind you that our supplemental new drug application for the new indication for ex-hance is far along in the FDA review window. We submitted our application in February and are rapidly approaching the FDA target action date in December. And last, our results demonstrate that we have continued to successfully execute on our 2023 operating strategy. That strategy has been to greatly increase our operating efficiency and to stabilize revenue in the current comparatively niche indication, while preparing our organization to seize the opportunity created by the potential approval of Exance as the first prescription treatment for one of the most common diseases diagnosed in adult outpatient medicine. We believe the new launch opportunity can enable us to build a profitable ENT and allergy-focused business by accessing greatly expanded net revenue potential through an efficient existing base of commercial capabilities. In addition, as I previously noted, we continue to actively explore commercial partnerships in primary care and other approaches to accessing the incremental value beyond what we can create on our own in the largely specialty segment where we're currently deployed. Turning to slide four, we believe future approval of Xhance as the first and only FDA approved treatment for CS has potential to increase the number of patients for whom the product can be promoted by at least tenfold because medical claims data indicate that an order of magnitude more patients are currently being diagnosed with chronic sinusitis than are being diagnosed with nasal polyps. We believe that nasal polyps is also underdiagnosed relative to the published prevalence, in part because it can be difficult to visualize the part of the nasal labyrinth where polyps emerge in offices that do not have the ability to perform nasal endoscopy. This further accentuates the potential associated with a new indication that is more amenable to office diagnosis by a broad range of physicians. The new indication would create opportunity for strong growth within our existing commercial footprint, promoting largely to specialists who see large numbers of patients with the diagnosis. And the newly expanded universe of patients would also include patients cared for by physicians outside of our current commercial reach. And we are actively exploring commercial partnerships, alternative selling models, and other ways to facilitate future outreach to those physicians and patients. Turning to slide six. Previously, we announced that the FDA accepted our supplemental new drug application in pursuit of an enhanced indication for the treatment of patients with chronic rhinosinusitis. This is a novel indication for which the agency has never previously approved any drug product. Our regulatory and clinical teams have focused on being responsive to the FDA during the review, and they will continue to do so through the remaining weeks of the review process. The FDA action goal date is December 16th of this year. Turning to slide eight. As a reminder, our objective in 2023 has been to stabilize demand trends in our current nasal polyp specialty business with a reduced commercial footprint and materially reduced expense, while both preserving necessary launch capabilities and improving operational efficiency and effectiveness of our commercial resources. This is intended to best set us up for successful launch of XANCE into the new chronic sinusitis space in 2024. With that objective in mind, we are very pleased by Ex-Hance prescription demand results in the third quarter of 2023. As we discussed in our last call, overall prescription demand in the first half of the year for Ex-Hance was stronger than we initially anticipated. This has created the opportunity for us to take thoughtful action to attempt to reduce both the number and proportion of unprofitable prescriptions. We are seeing early evidence in our prescription data that our actions have begun to produce the intended outcome, which is also resulting in an improvement in the average net revenue per prescription. Regarding prescription demand, in the third quarter of 2023, there were approximately 27,400 new prescriptions for expense, a decrease of 4% compared to the third quarter of 2022. In addition, there were approximately 84,100 total prescriptions for expense, in the third quarter of 2023, a decrease of 6% compared to the third quarter of 2022. We measure breadth and depth of physician prescribing by estimation of the total number of physicians who have patients filling various numbers of ex-hance prescriptions. Regarding breadth, in the third quarter of 23, there were approximately 8,400 physicians who had a patient fill at least one prescription of ex-hance, an increase of 5% compared to the third quarter of 2022. Regarding depth, the number of physicians who had more than 15 ex-hance prescriptions filled by their patients in the quarter decreased from 1,485 in the third quarter of 2022 to 1,346 in the third quarter of 2023. I'd like to note that all the data on this slide is estimated based in part on monthly prescription and inventory data from third parties and on data directly reported to us by pharmacies that are part of the ex-hance preferred pharmacy network. I will also note that the third quarter 2022 data we're showing today reflects our current 2023 methodology. For reference, we footnoted our prior estimates based on prior methodology. I'll now turn the call back over to Jonathan to discuss third quarter financial performance.