OptiNose, Inc.

Good day and thank you for standing by. Welcome to the Opti-Nose second quarter 2022 earnings call. At this time, all participants are in the listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising that your hand is raised. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker for today, Mr. Jonathan Neely, Vice President of Investor Relations. Please go ahead.

Good morning, and thank you for joining us today as we review Optinosa's second quarter 2022 performance and our plans for the remainder of the year. I am joined today by our CEO, Peter Miller, our President and Chief Operating Officer, Rami Mahmood, and our Chief Commercial Officer, Vic Clovelli. 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 Factors section and elsewhere of Opti-Nose'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. Viewer caution not to place undue reliance on forward-looking statements. 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?

Thanks, Jonathan, and good morning, everybody. We appreciate you joining us today. Starting on slide four, we'll go into more detail in a moment, but I'd like to highlight four key takeaways from today's presentation. We reported top line results from re-open two in the second quarter and were pleased with the positive results. We believe the re-open program is a landmark in chronic sinusitis as it is to our knowledge the first phase three program in which a nasal treatment has shown improvement on both symptoms and measure of inflammation inside the sinuses. We view this as an important development for the approximately 30 million adults in the United States who suffer from the symptoms of chronic sinus disease one of the most common chronic diseases of adults in the United States, reported to drive 10 million outpatient visits per year. Second, our clinical and regulatory teams are seizing the opportunity created by the ReOpen program to pursue a supplemental approval for ExHance as a treatment for chronic sinusitis. We are very excited by the potential the new indication would create, and I will discuss that briefly on the next slide. We implemented a change to our copay assistance program at the start of 2022 to reduce the copay assistance we provide for unprofitable prescriptions filled by patients with high deductibles. That change is having the intended effect of reducing the number and proportion of that type of unprofitable prescription, which is driving the 12% increase in average net revenue per prescription for the first six months of 2022 when compared to the same period in 2021. Fourth, We revised our guidance for full-year 2022 enhanced net revenues and operating expenses. Enhanced net revenues increased 21% in the first six months of 2022 compared to the same period a year ago. That is strong growth and within reach of our prior guidance, which was at least for $90 million in net revenues, which implies at least 22% growth for the full year. We're still working to deliver more than $90 million, but for reasons that I will discuss in a moment, we believe the $85 to $92 million is the right guidance to provide for full year 2022 at this time. We've also reduced our full year 2022 operating expense guidance by six million to offset the reduced expectation for net revenues. Overall, we're taking an approach of smart growth with Xhance with its current nasal polyp indication while preparing for the much larger opportunity we see with a chronic sinusitis indication. Turning to slide five. Our excitement for the reopened program centers around the potential that a first ever indication for the treatment of chronic sinusitis has to significantly increase our target patient population. We anticipate increasing our current diagnosed patient population from up to one million patients with nasal polyps, the current indication for example, to a much bigger patient audience of approximately 10 million by adding those who are already diagnosed with chronic sinusitis. With our current commercial infrastructure, We call on a physician universe focused on the ENT and allergy specialists who treat most of the up to 1 million diagnosed nasal polyp patients. While this is a sizable market that we believe represents a total market opportunity for approximately $1 billion at our current value per patient, a new chronic sinusitis indication would triple the promotionally accessible patient population treated by our current target group of physicians to 3 million. increasing the market opportunities to approximately $3 billion, all of which could be accessed without significant incremental investment in our commercial infrastructure. On top of that, there is an opportunity for a potential partner with the primary care infrastructure. In addition to the 3 million patients currently treated in our specialty physician target audience, there are an estimated 7 million additional patients currently diagnosed and treated by roughly 50 to 60,000 additional physicians in primary care. This incremental physician audience and patient population represent an additional market opportunity of approximately seven billion. For a partner in primary care, there are an additional estimated 20 million patients who suffer from symptoms of the disease, many of whom are likely aware of their diagnosis, but who are no longer receiving active care. We believe these patients are not well but have given up on regular physician visits, feeling forced to rely on over-the-counter remedies because they do not believe what their physician has historically been able to offer them for prescription medical treatment, surgery, or repeat surgery will meet their needs. In summary, we believe this dramatic potential expansion of our target audience can be a true game changer for our company in the near term. I'll now turn the call over to Rami to discuss the results of the re-open program and next steps. Rami?