Okay, let's get started. This is David Amsellem from the biopharma team, Piper Sandler, day three of the Piper Sandler Healthcare Conference, sorry, the 36th annual Piper Sandler Healthcare Conference. And our next company is Optinose. We have CEO Ramy Mahmoud here and new CFO Terry Kohler. So thanks, gentlemen, for joining us. And I'll dive right into questions. You had the label expansion for XHANCE in chronic sinusitis. Maybe just talk generally about the impact of that expansion as something that's unique to XHANCE and just give us some background on the treatment landscape prior to this expansion and the absence of any product that was actually labeled for chronic sinusitis without polyps. I think that's an important sort of stage setting here. So I'll turn it over to you, Ramy. Yeah, great. Thanks. I appreciate the question. So the indication that we received this year was for chronic rhinosinusitis without nasal polyps. Now, that's not a term that shows up in ICD-10. It's not usually used in practice. There's no billing or patient coding for that. Most people refer to this as just chronic sinusitis. And that is, as you said, distinct from nasal polyps. It's a much, much larger market than the nasal polyps market. Market research and publications in the peer-reviewed literature suggest about 30 million people are suffering from chronic sinusitis overall. About 20 million of those are not actively seeing a doctor in any given year. We refer to them as dissatisfied dropouts. They know they have symptoms. They usually treat with over-the-counter products. They don't necessarily see a doctor unless they get an acute infection or some other sort of exacerbation. The other 10 million are seeing a doctor. We estimate that about two-thirds of those see a primary care doctor and about one-third see a specialist. Those 10 million are also divided up between polyps and non-polyps speaking back to the new indication. So we estimate that somewhere between 10% and 30% of the overall population have polyps and the remainder do not. But polyps can be underdiagnosed. So if you look at the number of claims in medical claims databases, there's only about 660,000 annual claims for nasal polyp diagnosis at a physician visit. And that compares to between 10 and 12 million for a chronic sinusitis diagnosis. Yeah. So much bigger market. Much bigger market. Yeah. You've talked to around $300 million or so in sales potential for XHANCE with the wider label, so maybe talk to your efforts to get prescription growth to inflect both in terms of promotion and in terms of driving better payer access. Yeah. There are several things that we think are important to facilitate uptake of the product with the new indication. And as I've mentioned before, our efforts internally are focused on the specialty audience, not that primary care audience. But in the specialty audience, we think several of the things that are important include our sales execution efforts. We have to really get the word out on this. This is not the same thing as nasal polyps. There are no other products indicated for chronic sinusitis and never have been in the U.S. or elsewhere, unlike nasal polyps where there were other indicated products, multiple other indicated products. So the sales efforts are very important getting the new data out, the new indication out. That's number one. Number two, the prescription fulfillment efforts. I think you may be aware we adopted a new hub for distribution for prescription fulfillment, which many, but not all, physicians use. And it always takes time for that to get sort of through a shakedown cruise where you kind of get all the kinks worked out of the system. And I can give more examples of exactly the kinds of things we've had to work out. And then the third big thing, as you alluded to, is insurance coverage. You probably saw this summer we improved our insurance coverage through ESI, and we're actively working for improved coverage with other PBMs or insurers. Yeah. I think recently on your third quarter call, you cited some degree of inflection in XHANCE volume. So can you provide more specifics on what you've been seeing regarding the volume trends? Yeah. As you mentioned, in the third quarter call, we showed data showing an inflection in new prescriptions growth. We really started to see that occur sort of towards the tail end of third quarter and on into the first part of fourth quarter, which is the data that we showed, I think, through October 25th. And it's very encouraging. But of course, new prescriptions don't comprise the bulk of our prescriptions. You can't have a refill without a new prescription, but it's a chronic disease product. So our total prescription volume is comprised mostly of refills. And it takes a little time for that to percolate through. Okay. In terms of the growth in volumes, the recent growth in volumes, is it being driven by physicians who are returning to the product or physicians who are new to the product or more frequent prescribing behavior by existing prescribers? I mean, or maybe a mix of all of these. But help us understand the dynamics in terms of physician behavior. Well, so the simplest answer is it is all of those. We do have more total prescribers than we have in the past. So there's been a slow gradual growth. But since we are still in the specialty space, the same as we have been in previous years, the bulk of the potential opportunity here is around growing the number of prescriptions and not just by obtaining completely new prescribers who had never prescribed in the past. So there are many more patients with the new diagnosis, and we would like to see many more prescriptions as a result of treating many more patients, even in doctors who have prescribed but rarely in previous years. Okay. So you mentioned the hub, and you talked about improvements. So maybe talk more specifically about the hub and the mechanics around that and also the greater efficiencies that you've been citing of late. Yeah. I think you're aware about how a hub works. Prescriptions are written into the hub. The hub itself is not a dispensing pharmacy typically. It's a non-dispensing pharmacy. And there's a variety of dispensing pharmacies to whom they distribute prescriptions after processing them. So there are advantages in terms of more predictable and better controlled customer service for physicians' offices, prescribers' offices, and for patients. Advantages with regard to being able to work directly with the hub to help make sure that patients who have been prescribed a product for X number of months actually get it for that number of months that they were prescribed, so hopefully better refill behavior. And that there will be more sort of appropriate energy devoted to working through any utilization management, so prior authorizations and step edits and those kinds of things. So that's why and volume management. The hub can manage in a much more flexible way different volume. And as we grow the product with a new indication, we needed to be able to have a distribution system that can handle increased volumes. So those are the reasons that we wanted to go to the hub. Now, it takes time to work through the details of how the hub works. And at first, I think there's always a risk with any new hub that physicians will perceive it as increasing the burden, increasing sort of the hassle factor of filling prescriptions. And we've been working through that. As we develop data at the hub, what is actually happening with the different kinds of prescriptions that come in, we've been able to modify business rules in ways that make it less likely that a doctor does a lot of work that ultimately doesn't result in no prescription getting filled for the patient and increase the likelihood that when they are doing the work, it's in a plan and in a context where it's likely to result in the patient being treated, which increases everybody's satisfaction. So that's just an example of how optimizing hub functioning over time can improve the experience for doctors and patients and therefore hopefully produce a positive halo for more prescriptions and not just do something like increase a written-to-dispensed ratio or a refill rate. Can you talk to the sales organization at present in terms of sales force sizing and also how many territories you have in your footprint? Yeah. We currently have nominally 75 sales territories. It's the same number we had last year. It's the same number we plan to have next year. So we're not intending to have a meaningful growth in our sort of commercial footprint as the primary vehicle for the growth we're experiencing now or we're planning for in 2025. Sure. And in terms of number of reps right now, where are you? I think we have filled 74 of our 75 territories. So it's still at that 75 territory footprint. Okay. Got it. And remind us what the breakdown is in terms of your call audience among ENTs, allergists. And I think you've been targeting historically some general practitioners as well. Just talk about those different buckets. The bulk of the people we call on are specialists, mostly ENT and allergy, a small sliver of pulmonary, but mostly ENT and allergy. We have maybe 1,000, 1,500-ish doctors who are primary care designated. We think some of them, maybe many of them, are sort of functioning as allergists in settings where allergy specialists are not available, which is not that rare. Allergy is not a very big specialty. It's smaller even than ENT. ENT is the largest fraction of what we call on. More than half of our called on universe is ENT. Allergy is the next largest. So as you think about XHANCE with this new label, with this wider label, I mean, how is your call audience, your target audience evolving compared to where you were when you just had nasal polyps in the label? So historically, it was the same specialties. But earlier this year, in anticipation of the approval, we did modify our sales targeting. So it did have a disruptive effect on relationships. We had new doctors that were receiving more calls and some doctors, the old doctors, receiving less calls. And that's because we were trying to target doctors who had the greatest potential in chronic sinusitis rather than our historical targeting, which was aimed at nasal polyps specifically. So that has resulted in some disruption. But from a specialty distribution, that hasn't changed. Okay. So general practitioners, obviously a bigger audience with the wider label. So as you think about 25 and even longer term, what's the extent to which you plan to go deeper into the GP audience? And I guess that sort of leans into my other question, which is on a co-promote. This is something that you've talked about for quite some time, something you've been open to, a company that could be a partner that has a significant general practitioner-focused commercial infrastructure. So wanted to get your latest thinking there as well. Yeah. As we discussed earlier, a large portion of the potential patient opportunity with this new indication is in primary care. And we have a limited ability to go after that with a single product. It's difficult to have the right efficiency for the infrastructure necessary in primary care if you only have a single product. So we don't plan to go after that ourselves in primary care in sort of any kind of large way that would access the bulk of that opportunity. So like you said, a primary care partner is the most obvious way to go after that. And we would like to have a primary care partner. It's a serendipitous thing to be able to find the right partner. The right partner is going to be someone who has an existing primary care infrastructure and has a need for an additional product sort of in the bag to go into that primary care space. It needs to be someone who intends to stay in primary care for a meaningful length of time. We have a product that we believe has an extended exclusivity period in front of it. So we'd like to have a partner who is capable of promoting in primary care for years to come. Yeah. And actually, I did want to touch on your exclusivity runway. I mean, it says now is as good a time as any to sort of talk about it. But in terms of the IP protecting the product and other picket fences just in terms of the complexity of formulation, how do you envision your exclusivity runway? And maybe I'll ask an even more blunt question, which is, do you think there could ever be a generic of this product? Well, so that last part, could there ever be? The answer is always going to be yes because could there ever be accounts for a lot of possibilities. We think it'll be a long time before we face especially an AB-rated generic. And there are several challenges to bringing an AB-rated generic into our space. First, of course, is our patent portfolio. We have more than 12 Orange Book-listed patents, the last of which expires, I think, in 2036. And that creates one set of challenges for someone who wanted to do that. It is also a complex product, meaning it's a drug-device combination, which has another set of challenges associated with it. And it's a topically acting product, which means that you can measure blood levels like in a bioequivalent study, but those blood levels don't predict either safety or efficacy. So you have to have other ways to be able to demonstrate that you have a bioequivalent product that are not as simple as just measuring blood levels. Yeah. Okay. So going back to the payer landscape, so I think you mentioned with the recent addition of XHANCE, the ESI national formularies. But beyond that, just talk to where XHANCE stands with the other major PBMs and your contracting efforts there? Yeah, so we have what we think is relatively good overall rates of coverage in the commercially insured space. We have, depending on how you assess it or measure it, between 70% and 80% of commercial lives that have some type of coverage for XHANCE. Commonly, that coverage, though, is subject to utilization management criteria. So that would be like prior authorizations or step edits. And we have roughly similar magnitude coverage in Medicaid. We have less coverage in Medicare, and there tend to be higher out-of-pockets in Medicare for patients even when they are covered. With regard to our strategy and what we're trying to do, of course, like with ESI, we are trying to improve both the quantity and especially the quality of coverage with regard to reducing the hurdles associated with utilization management and make it just a little bit easier for the patients who have a need for the product to be able to get it so that the doctors don't have quite the hassle. I mean, if you're in a doctor's shoes and you're trying to give this to patients twice a quarter, it's maybe not such a hassle for your office. But if you're trying to do it twice a day, it starts to become more burdensome. So we're trying to be sensitive to our customers' needs to manage that. What does utilization management look like? I know it can vary. But what's the extent to which patients are having to step through an intranasal corticosteroid or whether it's a prescription or an OTC product or even something more onerous like a nasal lavage? I mean, so help us understand what that looks like. I'm really glad you asked that question because some of these terms are kind of big umbrellas, and they can encompass a wide range of burden for doctors or patients in the way they define the audience. So in our case, sometimes utilization management is just a step edit, which means that a patient has to have failed on some prior treatment, which can be automatically established if there's a prior prescription in the database or sometimes is established from the doctor's office. In our case, that would be prior treatment with generally it's any nasal steroid. Prior authorization is usually more involved and isn't automated out of the system from prior prescriptions and can, with some products, be quite convoluted and lengthy, picture a multi-page form type of complexity. In our case, it's not generally like that. There is variability, like you said. But in our case, generally, there are three criteria. Need to be an adult because we're not indicated in pediatrics. You need to have a on-label indication, which is good for us because chronic sinusitis has no other indicated treatments and really is the main reason for use. And then it goes back to you have to have previously tried and not achieved successful outcomes with a nasal steroid. Yeah, so then that varies according to plans. Of course. It really does vary according to, overwhelmingly, those three things are pretty much it. It's a very, very short prior authorization. So from our perspective, we don't view the complexity of a form as a challenge in our case. The mere fact that there is one at all is more of an issue than the complexity of the form. Yeah. So I guess the question here is, how big of a priority is it to get those removed? And I mean, there's a cost associated with that. So how do you sort of balance driving ease of access with also driving more profitable prescriptions for the product? Yeah. I mean, there is a balance. So yes, it would be very nice to have that removed. It'd be good for patients and good for patient care. And it would also be good for our business. More people could be effectively treated. But it's not sort of at any cost. And that's why there isn't a negotiation, as you said, with any PBM or payer around sort of what's reasonable. In our case, we have to think about the overall cost to the patient. We have to think about the cost of buying down copays, our copay support programs. We have to think about halo effects, meaning if a product is easier to get, does that mean I'll write more prescriptions in general for this or other insurers? There's multiple considerations that go into our calculus. Yeah. Okay. Looking at net revenue per prescription, I mean, that's a metric that you're pretty transparent on. Can you give us a review regarding what drove the significant year-over-year growth in 3Q for that metric? Terry? Sure. So just as a reminder, the company last year looked to move towards a more profitable model and reduce the amount of unprofitable scripts. So in that, they changed the copay program at the back half of last year. So over the course of this year, we have seen a steady increase in the net revenue per prescription. Specifically to Q3, there also was additional inventory that was put into the channel. And that inventory also caused an increase in Q3 net revenue per prescription. Okay. How should we think about net revenue per RX for XHANCE in 4Q and moving into 2025? Sure, so we gave full-year guidance of approximately $270 for net revenue per prescription. That would imply a step down in Q4. That step down is, again, in Q3, it was a bit artificially high given the stock and with inventory, but also, there tends to be a year-end effect of the product, so at the end of the year, some of the ex-factory units are actually going into the channel but not being pulled through until next year when deductibles are being reset, etc., so there is a bit of a step down in ASP in Q4. Okay, and just in terms of seasonality, as we think about the calendar year, how should we think about that for 2025? In terms of net revenue per prescription? In terms of net revenue, yeah. For instance, 1Q. Yeah. So 1Q will usually be your trough in terms of net revenue per prescription because of the high deductibility step. Also, there tends to be some inventory that comes out in Q1 just based on the way that distributors buy at the end of the fourth quarter. And so that will be your trough. Okay. How should we think about spend in 2025 given the launch? I mean, you haven't expanded the headcount dramatically. It's not like you have a major DTC program or anything like that. So I mean, but that being said, I'm just trying to get a sense of where you're going to land on spend relative to 2024. Sure. So we haven't given any guidance for 2025, but I think it's reasonable to say that we're going to continue to be very cautious around our spend, make sure that we're managing our cash appropriately. That said, you would expect to see an SG&A, moderate SG&A increase next year, just as we assume that volume will also increase. So there's a variable component to our OpEx. Yeah. I didn't ask about nasal polyps, but it still matters. And so I wanted to get your thoughts on that business and where you see that portion of your business going. And there's a sort of second part of the question that I wanted to cover, which is that you have more and more biologics that are being developed for chronic sinusitis with nasal polyps. Obviously, they're at a higher price point, but they're there. So how do you think about that as it relates to that piece of your business, that part of your label? There's probably more than one way to think about this, but I can tell you that I do not think that it's appropriate to think of our business as having sort of a 100% nasal polyps component prior to the new indication and then that sort of a stable base and then everything incremental that is non-nasal polyps. I think prior to the new indication, there was some prescribing for nasal polyps and some prescribing not. And after the new indication, there is some prescribing for nasal polyps and some not. It's very difficult for us to draw those distinctions because I don't feel comfortable that we have accurate by diagnosis data to inform prescribing. I can tell you that our promotional activity, though, now is focused almost exclusively on chronic sinusitis and not really on nasal polyps. Will it be used for nasal polyps? I do think it will continue to be used. It's a great drug for that. And I think it's a great choice for people. But I don't think our competitive set is mostly about working to sort of acquire market share in nasal polyps anymore. We're now working to acquire market share in chronic sinusitis. With regard to the biologics, there are multiple biologics who have indications in nasal polyps. And in a way, I think that's good for us. It's sort of a foil. It's something that's available to patients who need it when our product might not have been successful. It's not a panacea. It won't work for every single patient. It's great that there is something available when that happens. But it's also very expensive, much, much more expensive than we are. I think that can create an incentive for insurers or health plans or even doctors and patients to give a second thought about trying our product before they jump straight to a product that's that much more expensive. And just, this is more of a backward-looking question, but historically, I mean, pre-label expansion, I mean, you did have some plans that were trying to limit usage to patients who had nasal polyps. I'm assuming that that's firmly in the rearview mirror with the label expansion. Is that fair? I think that was very common. That the utilization management criteria we were talking about before were limited to nasal polyps, which was the FDA-approved indication and the only thing we promoted for. Most of those plans that I'm aware of have gradually, and it didn't happen right away. It took a period of months. But most of those plans have now modified their sort of on-label permissiveness to be inclusive of either chronic sinusitis or nasal polyps. Okay. So in the minute or so we have left, I wanted to ask about the capital structure, the cash position, the cash burn, how you're thinking about your timeline of profitability. Just help us better understand how you're thinking about all that given that you're in a promotion-sensitive treatment arena where investment is important and required. Sure. So from a cash position standpoint, we ended the third quarter with $82 million in cash. We said at that time that that was sufficient to get us at least 12 months from the date of our 10-Q filing, assuming that we were able to maintain compliance with our debt covenants or receive a waiver on those debt covenants. So we have a pretty solid cash position at this time. The debt that we do have in place will start to require principal payments at the end of the third quarter of next year. So it is something that we'll want to tackle in 2025. But there's no new news to announce on that at this point. Yeah. So I guess that sort of, I mean, one last question as we run out of time is thinking about the cap structure and where you are, does that sort of lead you to think about being open to overall strategic alternatives? I think I said publicly before, and I'll reinforce it now, that we are open to strategic alternatives. We're looking at all available alternatives to maximize shareholder value right now. And that's definitely in that space. Okay. Well, I'll leave it there. Thank you, Ramy. Thank you, Terry. Thanks, everyone in the audience. Thank you.