Good morning. Welcome, everyone. Thank you for joining us at the H.C. Wainwright 26th Annual Global Investment Conference, taking place on September 9th - 11th, 2024. My name is Douglas MacPherson, and I'm an Equity Research Associate here at H.C. Wainwright. H.C. Wainwright is a full-service investment bank dedicated to providing a variety of financial services to public and private companies across multiple sectors. We have a total of 24 publishing senior analysts with over 630 covered companies. For this conference, please join us for one-on-one meetings, corporate presentations, and panels that will be available both live and streaming, September 9th-11th. With that said, right now we have a very interesting and enjoyable session planned for you now, and I'd like to introduce our presenter for this session. Please welcome Ramy Mahmoud, who is the CEO of Optinose, a company which specializes in developing therapeutics to treat ear, nose, and throat disorders. Welcome, Ramy. Thank you, Doug, and thank you to H.C. Wainwright for inviting us to present this morning. I'm happy to introduce some information about our company, our market, and our product. These are all forward-looking statements, as designated here. First, a quick overview about Optinose and things that are highly relevant to us. The first is we market today one product. That product is called XHANCE. It's a highly differentiated product, as I'll discuss more during this presentation. XHANCE is now, in 2024, the first and only product approved by the FDA for the treatment of chronic sinusitis, which is also called chronic rhinosinusitis without nasal polyps. Market research indicates this product is strongly preferred by physicians when they're exposed to the target product profile in market research, and there's excellent intent to use. But of course, we're at the very beginning of that process, having just been approved this year, and we'll talk more about those things during the presentation. We believe there's a very significant near-term growth opportunity for the company, with this new approval in 2024. XHANCE net revenue in 2023 was $71 million, and that was on the basis of a prior indication in the treatment of nasal polyps. And we'll talk more about how chronic sinusitis is different from nasal polyps. The label expansion was received from FDA in March, and we launched that label expansion in April. And we believe that with this new indication, the number of patients available for treatment on label is expanded by up to 10x, compared to the number that was available to us with the previous indication in nasal polyps. Now, there are some limitations to what you can reach. Obviously, if you're in the specialty space, ENT and allergy, as we said earlier, compared to the overall market opportunity in primary care and in patients who are not yet available for treatment in doctor's offices. So today, we are launching. In 2024, we are launching with our current specialty sales force footprint. That's the 75 sales territories, same as we had last year, and with a very modest phased increase planned for our investment in the launch. So it's an incremental expense compared to prior year pre-launch, but not the kind of incremental expense that was normally associated with a new product launch. Our base forecast for the product anticipates approximately 3 million currently treated patients in the specialty segment to be available to us, ultimately, as we expand our promotional effort in the specialty space. In the long run, however, there's a different opportunity. As I've alluded to already, the total addressable market as we expand, is going to comprise up to 30 million patients, 10 million of whom are already currently diagnosed and seeking care in any given year. We know that from claims data. Another 20 million of whom know they have the diagnosis, report the symptoms that are diagnostic for the disease, but who don't necessarily seek care today. We think most of them are what we would call dissatisfied dropouts, who would like to have treatment, but don't think the medical system has anything to offer them. Getting into those spaces requires efforts that are beyond our current base forecast, including primary care partnership or direct-to-consumer or direct-to-patient type outreach. Lastly, with regard to cash flow, and the durability of this opportunity, we're currently 13 Orange Book-listed patents on this product, last of which expires in 2036. So, we believe there's a long revenue tail potentially, and in part, that's of course, because this is a locally acting product, and cannot have, bioavailability assessed, by blood levels, because blood levels are not predictive of safety or efficacy. With regard to, so financial opportunity, we think that the new CS indication, creates an opportunity for peak net revenue potential of at least $300 million in the specialty audience. Now, that's obviously not going to happen immediately, but over time, we think that's the peak potential available. With regard to efficiency, we are launching, as I said, into this greatly expanded opportunity number of patients with our existing territory sales force coverage and with a base of insurance coverage, which helps us to get started, although we obviously need to improve that over time, and I'll discuss that more in a few minutes. With regard to profitability, we believe that we will be able to reach positive income from operations for full year 2025. Let me start by introducing you to what I'm talking about when I talk about chronic sinusitis. Chronic sinusitis, for which no product has ever been approved before, is a common chronic inflammatory disease. It sounds like it's an infection. It's not an infection, although it does predispose to infection. This chronic inflammatory disease is diagnosed very frequently. I'll talk more about that in a minute, and it may or may not be accompanied by comorbid allergies. It's not the same thing as allergic rhinitis and not the same thing as, allergies. This persistent inflammatory process, deep in the nasal labyrinth, like inflammation in any part of the body, is associated with pain, swelling, and can lead to obstruction in deep nasal passages and the sinus drainage tracts, so the openings to the sinuses or ostia can be blocked, causing problems inside the sinus cavities, which are openings inside the skull. The primary symptoms include congestion or obstruction of the nose, facial pain or pressure, rhinorrhea, which is often purulent drainage, either postnasal drip or anteriorly, and a loss of sense of smell or taste. Those four are considered cardinal symptoms. Usually, at least two of those four are required for a minimum of 12 consecutive weeks, for the diagnosis to be made on symptoms. But there are many other symptoms that frequently accompany this, including sleep loss, persistent fatigue, and recurrent sinus infections, because you are predisposed, by damaging the normal, mucociliary clearance process that protects you from environmental particulates. You're predisposed to both infections and allergies. Those acute exacerbations can be common, sometimes multiple times per year, and they're often the trigger for doctor's visits and the trigger for a great deal of healthcare utilization. Chronic sinusitis is so common that data suggests, claims data for actual coded medical claims, suggests it's actually one of the top three adult physician diagnoses, adult outpatient visit diagnoses in the United States, accounting for about 10 million annual office visits, about 70% of which result in the prescription of an antibiotic. Anyone who's concerned about antibiotic stewardship and reduction in the emergence of resistant organisms to antibiotics should be concerned about trying to control the need for antibiotics in chronic sinusitis. Many of the people who have a diagnosis of chronic sinusitis ultimately will undergo surgery, but surgery is generally not curative. It is helpful, it is effective, on average in reducing symptoms, but it's very common for symptoms to either be incompletely resolved or to recur over time after the surgical procedure. Despite patient dissatisfaction with currently available medical therapy, none of which, by the way, has been demonstrated in controlled trials to be effective. Despite that patient dissatisfaction, today's healthcare providers tend to cycle through standard delivery nasal steroids. That would be products like Flonase, Nasonex, and others of that category, before they escalate treatment or refer for surgery, and that's despite the fact that there are multiple published double-blind, placebo-controlled studies which do not show efficacy with any of these nasal standard delivery nasal steroids, so absent evidence of efficacy, the primary rationale for use is simply that they are safe and that they are inexpensive. They're available over the counter, don't even require a physician visit. Over 80% of patients with chronic sinusitis are frustrated when they receive standard delivery nasal steroids. We have direct patient report information on this. It's not that they're useless, really, it's that they're unsatisfactory or insufficient. And many healthcare providers, not all, but many healthcare providers already believe that the reason for the inefficacy of these standard delivery nasal steroids is related to the fact that the drug being delivered does not reach the site of inflammation, that the sinus ostia, sinus cavities, and sinus drainage tracts, as opposed to because the molecular mechanism of action of the steroid being delivered is inadequate for controlling inflammation. So what is the product itself? The product itself really is a delivery device intended to change the site of delivery of the medication. So this is a photograph of the device. Some of the component parts of the device include a patented sealing and stenting nose piece, a translating mouthpiece, which helps to adapt to varying patient anatomy, an internal valve system, which helps to control the burst and timing of delivery relative to patient breath, so you don't have some of the same challenges as you have with inhalers trying to get the inhaled drug into the lungs, and the drug-filled vial at the bottom. So the reason the device is important is it creates different biomechanics during delivery, and the different biomechanics that occur inside the head during delivery are what produce a different pattern of deposition for the drug. I'll highlight the key parts of the biomechanics that are different. The first is, this is sealed palate delivery. So the palate is closed by the positive pressure created in the oral airway during use of the device. That sealed palate isolates the nasal cavity from the oral cavity and lungs during drug delivery. The second is that the drug is delivered under positive pressure. So with the exhaled breath at physiologic temperature and humidity, the drug is floated with under positive pressure into the nose, which is important because unlike standard nasal sprays, which are sniffed, you don't create Bernoulli's forces, which tend to narrow and collapse narrow spaces in the nasal cavity. Instead, you widen those, which allows drug to penetrate more deeply. And then lastly, you create bidirectional flow. So as you can see in the bottom left there, drug flows in one side, deeply penetrates the nasal cavity, and the air pressure does not build up against the ears like it might be if you were pinching your nose and exhaling. Instead, it's relieved by passing behind the nasal septum and out the opposite nostril. So the air pressure is relieved that direction. As a consequence of these three things, which are different from standard nasal spray, which is typically open palate, forced open, actually, by the sniffing process, negative pressure and unidirectional flow, you get a different pattern of deposition of drug. So radiolabeled drug, delivered with a standard nasal spray is illustrated in the right-hand pair of panels on the left. Standard nasal spray delivers drug primarily to the nasal vestibule, so it's on the nasal valve, the anterior parts of the nasal septum, and on the floor of the nasal cavity, underneath the inferior turbinate bone, passing back towards the throat as you sniff. You can see on the right-hand panel that the pattern of drug deposition produced by an exhalation delivery system is really markedly different. You actually have some less drug on the nasal vestibule and front part of the nasal septum, less drug on the floor of the nasal cavity, underneath the inferior turbinate bone, and more drug in the superior and posterior parts of the nasal cavity, which are the target areas for treatment of sinus disease, where the sinuses and sinus drainage tracts are. As a result of that, we were motivated to do clinical trials in chronic sinusitis, despite the fact that all standard delivery nasal steroids previously studied had failed to show benefit in that condition, and in fact, we ran two trials, which were published earlier this year, which demonstrated significant clinical benefit. I'm just gonna highlight a couple of things from those trials. The first is on the composite symptom score, which was an FDA endpoint for patient subjective symptoms. Combining these three of the four cardinal symptoms, there was significant benefit at both of the tested doses at each tested time point early starting at week four, and importantly, and for the first time ever that we're aware of, we demonstrated a significant reduction in the risk of acute exacerbations of chronic sinusitis. So we think of this as somewhat analogous to the acute exacerbations of asthma that are commonly studied with inhaled drugs for the treatment of asthma. 56% and 66% reduction in the risk of acute exacerbations. Just diving a little bit deeper in some of my earlier comments about the potential market, because we are today fundamentally at the very beginning, sort of a ground floor, of entry into a space where there's never been an effective previous medication treatment. There's a large number of patients suffering from this disease. It's not the same disease as allergic rhinitis, and it's not as common as allergic rhinitis, but it's still extremely common. So we think up to 30 million patients, I'm suggesting an approximately $30 billion TAM overall, suffer from the disease. Two-thirds of them, we think, are promotionally, potentially responsive to DTC or DTP promotion, but are not currently seeing a doctor. Those are the dissatisfied dropouts I talked about before, and about 1/3, about $10 billion TAM, are currently seeing a doctor, and going in on sort of at least once-a-year basis. Of those who are seeing a doctor, we think roughly 30% are seeing a specialist and roughly 70% are not seeing a specialist, and the part that are seeing a specialist who are currently diagnosed are the segment that today that we're currently addressing with our current commercial efforts. As I said earlier, we had our launch meeting in April to begin commercialization of the product. We're building on a commercial foundation, so this is a launch that's not a new introduction to the market. We have an existing supply chain, good manufacturing with capability to support launch volumes now and into the future, and we have some existing insurance coverage with the previous nasal polyp's indication. We had a sales force in place, as I said earlier, 75 sales territories, which we have not increased, which had some existing relationships that could be leveraged to try to get access to ENT and allergy specialty offices. Earlier this year, we initiated hub services through Asembia, their Aspen Pharmacy hub, in an effort to improve patient and provider service levels, and hopefully also increase the likelihood that written prescriptions could actually be filled with appropriate application of co-pay support programs, and support for refills as intended by prescribers. And we have a really strong clinical science data package, excellent publications, and strong data to support adoption, although low levels of familiarity as of yet, for that data. We have market research, as I alluded to, that when exposed to the target product profile with this new data, there's a very high degree of interest in prescribing the product. So more than 87% of healthcare providers indicate they are likely to prescribe the product for chronic sinusitis patients once they are exposed to the product profile. So if you think about the kind of product you would like to have to take into the marketplace, we have a lot of the characteristics of a desirable product. There's an extremely large market available for the future. There's a high degree of unmet need and patient dissatisfaction today with currently available interventions. We have a product that we believe is promotionally responsive. When exposed to the product, we believe physicians greatly increase their desire to prescribe, and we have a product which is highly differentiated. It's highly effective and is the only product approved for the treatment of this disease. With regard to the launch, we reported that through second quarter, our sales force made 35,000 calls, approximately, about 60% of which were to naive and low-frequency prescribers, where we're just getting off the ground on getting them to start prescribing. We also have non-personal promotion, congress presences, and peer-to-peer education to start the process of getting clinical education about the data. Focus areas in the second half, including continuing to build our prescriber audience. We need to go to doctors who are not as familiar with the product, and those who are familiar need to be educated about what's new, something that's different, where they don't necessarily believe any product is effective. So there's a lot of mind-changing that needs to happen. We need to apply best practices and learn as we go. First few months are sort of practice, where we need to learn and see what's working and what's not working, and we intend to do that, and as I said earlier, through our brand-new hub services, we need to increase both the efficiency of first fill and efficiency of refills, and that's sort of work in progress. We also very much need to improve insurance coverage. As you may have seen earlier, we made a press release at the end of June. Starting in July, XHANCE was added to Express Scripts preferred national formularies. It's the first time the product has ever been on national formularies in a preferred position, and these are among the largest commercial formularies, with more than 24 million lives. It's an excellent start, and we want to do more of that to improve insurance coverage. We believe improving insurance coverage is a strong prerequisite for future success of the product. With regard to future growth opportunities, we believe there's space to expand in the specialty market. We're not saturating that. As I alluded to earlier, we believe it's important and potentially the biggest part of the future potential of the product to begin to penetrate the other 7 million patients who are not seeing a specialist and the other 20 million patients who may not be seeking active care today because they think there's nothing effective for them if they were to go and see a doctor. We also think there's potential outside the U.S. We've actually maintained patents in select major markets, including China and Europe, and those are opportunities not accounted for, of course, in our base case forecasts. And lastly, I'll mention we do have some capacity, of course, in the ENT allergy space where we promote today. We are promoting a single product, and there's space for us to be able to promote another product. So we're looking at opportunities that could allow us to leverage our infrastructure. So with that, I'll conclude my comments. Thank you very much for coming and listening today. Outstanding. Thank you, Ramy, so much for your presentation. We're so grateful for your presence at our conference this year and thank you again to everyone from the H.C. Wainwright team.