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spk01: Good day, and thank you for standing by. Welcome to the Optinose fourth quarter 2021 earnings 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 will need to press star one on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Jonathan Neely, Vice President of Investor Relations. Please go ahead.
spk08: Good morning, and thank you for joining us today as we review OptiNose's fourth quarter 2021 performance and our plans for the remainder of the year. I am joined today by our CEO, Peter Miller, President and Chief Operating Officer, Rami Mahmoud, our Chief Commercial Officer, Vic Covelli, and our CFO, Keith Goldan. During this call, we will refer to the slides that 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 factor section and elsewhere in OptiNose's most recent Form 10-K that is followed with the SEC, 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. 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?
spk03: Thanks, Jonathan, and good morning, everybody. We appreciate you joining us this morning at a very exciting time for our company. First, because we continue to produce strong revenue growth on our current business, and second, because we recently announced positive results from ReOpen1, the first of our two Phase 3B clinical trials evaluating ExHance and the novel indication of treatment for patients with chronic sinusitis. We also continue to expect top-line data from our second pivotal trial in the second quarter of this year. In a moment, I will discuss why we believe potential approval of ExHance as the first-ever drug treatment for this indication could be a game-changer for both the 30 million patients suffering from symptoms of chronic sinusitis and for our company. Starting on slide three, I'd like to begin by reviewing our 2021 full-year results. For the full year of 2021 versus 2020, enhanced net revenues increased 52% to $73.7 million, enhanced total prescriptions increased by 28%, and enhanced new prescriptions increased by 27%. In my view, these are outstanding results, particularly in context of a pandemic environment which has constrained both patient visits to physician offices and the ability of our territory managers to broadly meet in person with our targeted physicians. Our growth in total prescriptions of 28% was against a category that was flat, and new prescription growth of 27% was achieved in a category that increased only 4%. Revenue growth at 52 percent outpaced prescription volume growth in 2021 as a direct and intentional consequence of changes we made in 2021 to our full-pay assistance program. These changes led to a sizable 19 percent year-over-year increase in average net revenue per prescription from $185 for full year 2020 to $219 for full year 2021. In addition, we continue to be disciplined with respect to our expenses. For full year 2021, we had $132 million of operating expense, inclusive of almost $23 million of development costs associated with the chronic sinusitis programs. This is aligned with our last guidance range and represents just a 4% increase compared to full year 2020. Turning to slide four, as I mentioned up front, We believe that if we are successful in the development of Xhance as the first FDA-approved drug treatment for chronic sinusitis, it could be a game-changer for both the 30 million people who suffer with the disease and for our company. Last night, we reviewed the data from the trial and the potential benefit for patients, so I will focus my remarks today on the value for our company. This new indication creates multiple new opportunities for growth. each of which we believe has the potential to be individually larger than the current market opportunity in nasal polyps. Unlike the largely undiagnosed nasal polyp population, for whom Xhance and other therapies compete today, an approval in chronic sinusitis would make Xhance the only marketed treatment in the large, well-diagnosed, and underserved chronic sinusitis population. At a high level, we believe a CS indication would unlock new value by dramatically expanding our target patient audience and would address key insurance and promotional barriers that constrain broad adoption of exams today. First, I'd like to talk about the market expansion opportunity. The CS indication would increase our current target patient audience of adults being actively treated by a physician from approximately one million patients diagnosed with nasal polyps, a current indication, to approximately 10 million by adding those who are diagnosed with chronic sinusitis. On top of that, there are an additional estimated 20 million patients who suffer from symptoms of the disease who are not receiving care. I'd like to break that down a bit further for you. With our current commercial infrastructure, we call on a physician universe focused on the ENT and allergy specialists who treat most of the roughly 1 million diagnosed nasal polyp patients. While this is a sizable market that we believe represents a total market opportunity for its hands of approximately $1 billion at our current value per patient, a new chronic sinusitis indication would triple the accessible patient population treated by these targeted physicians to 3 million, with no additional investment in our commercial infrastructure. In addition to the population of 3 million target patients treated by specialists, there are an estimated 7 million more candidate patients currently diagnosed and being treated by roughly 50,000 to 60,000 additional physicians in primary care. As we've said previously, we do not plan to build direct selling infrastructure to optimize reach into this primary care opportunity. Instead, we intend to secure a partner with an existing, leverageable primary care deployment to efficiently broaden adoption to clinicians outside of our call-on universe. We have been assessing this space and are optimistic there are multiple partners with potential to jointly benefit from helping us realize this additional value. In addition to the opportunities to create incremental value that I've already mentioned, tripling the patient population in our current commercial footprint and accessing a large new primary care population with a partner, there is an additional potential value lever. An estimated 20 million patients who report symptoms of chronic sinusitis have basically given up seeking regular care by a physician for their symptoms. Hesitancy to progress to surgery, dissatisfaction with prior treatment options, and a belief that a doctor wouldn't have anything new to offer them are among the reasons why so many patients lapse out of the healthcare system. Direct-to-consumer promotional pilots we conducted in several markets support that many patients could be successfully activated via DTC advertising. The proposition of DTC is further supported by research which reveals that the quality of life burden associated with chronic sinusitis is comparable to other serious chronic diseases such as COPD, asthma, and chronic angina, and that the value of ex-hance, distribution of drug high and deep in the nasal cavity, is intuitive to patients. Partnership with the right primary care partner could open up substantial opportunity to add these estimated 20 million dissatisfied dropout patients to the 10 million diagnosed and actively treated patients I discussed a moment ago. Turning to slide five. While the dramatic expansion of our target patient population with the chronic sinusitis indication is an obvious lever for potential future value creation, it's also important to consider how the indication will impact the insurance and promotional environment for ExHance. As we've previously described, insurance coverage for Xhance is very good, with approximately 80% of commercial lives in a plan that covers Xhance. However, approximately half of those lives are in a plan that constrains prescribing by requiring physicians to attest they are prescribing Xhance for the approved indication, which is currently nasal polyps. This is important because we have found that many physicians who routinely diagnose chronic sinusitis do not often make the diagnosis of nasal polyps. Ultimately, claims data suggests that CS is diagnosed 10 times more often than nasal polyps. Accordingly, another important implication for value creation with the potential chronic sinusitis indication is that in an insurance environment where some payers interrogate the diagnostic decisions of physicians, many HCPs report hesitating before diagnosing nasal polyposis, a condition which is already underdiagnosed. For the more readily diagnosed chronic sinusitis population, a much broader swath of physicians are expected to prescribe the product, to prescribe it for more patients, and to ultimately be successful in overcoming insurance-associated challenges to secure a chance for their patients. Turning to slide six, additionally, Thanks to our CS development program, objective evidence from large, controlled trials of effect on inflammation deep inside the sinuses is available for Xhance for the first time. On this slide, you can see before and after CT images of a patient treated with Xhance from the REOPEN1 trial. This is an example of a coronal image, which you can see is a front-to-back view with the eye spaces visible on each side. These images are from a patient randomized to one spray per nostril, twice daily of his hands, who was calculated to have an absolute 6.4% improvement in APOP. As you can see in this patient, there was an obvious increase in the sinus open space or the black region representing air in the right image at week 24 compared to the left image at baseline. As you can tell, We are very excited about the potential value of a chronic sinusitis indication for our company. We are also feeling very good about the business we are currently building with a nasal polyp indication and would now like to turn to those results. Turning to slide eight. With respect to our Q4 2021 performance, I'd like to highlight four key takeaways from today's presentation. First, Consistent commercial execution drove strong year-over-year growth in fourth quarter 2021. Across the board on revenue, prescriptions, and size of our top physician prescriber segment, ExHANDS delivered strong growth rates. Second, we are providing initial financial guidance for full year 2022. Importantly, please be aware that for 2022, We believe that our territory managers' access to our target position offices will not meaningfully improve from the levels that existed in 2021. We expect a year-over-year growth rate implied by the guidance range for Ex-Hance full-year net revenues to be at least 22 percent, which is strong double-digit growth. Keith will have more on financial guidance later in the presentation. There is an increasing recognition in our target physician audience of the important role ex-hands can play in a medically appropriate and fiscally prudent stepwise care paradigm for treating nasal polyps. Moreover, with our fresh reopen one results, physician adoption in 2022 will have new support from controlled trial evidence for nasal polyp patients treated with ex-hands who also have chronic sinusitis. As I've already discussed, looking beyond this year and assuming positive data from ReOpen2 and FDA approval, we expect greater potential value from Promotion of Exhance as the first drug treatment for patients with chronic sinusitis. And fourth, getting results from both chronic sinusitis trials this year has been a key objective for our organization. As highlighted earlier, we successfully completed that objective for ReOpen1 and remain on track for top line data from ReOpen2 in Q2 2022. Given the positive results of Reopen 1, if Reopen 2 is also positive, we plan to move quickly to file a marketing application with the FDA. Turning to slide 9, we had strong performance in fourth quarter 2021, and I will briefly touch on the year-over-year growth highlights on this slide and the next. In fourth quarter 2021, there were approximately 29,900 new prescriptions for Ex-Hance a 21% increase compared to fourth quarter 2020, while the market increased 14% over the same period. We remain pleased with the relative strength of enhanced prescriptions. It is important to note that in addition to increasing the number of new prescriptions through 2021, we also have durably improved the quality of our new prescriptions due to changes in our copay assistance program. Changes in 2021 increased the proportion of covered versus uncovered patients filling first prescriptions, which has improved average revenue per prescription. Covered patients also tend to have higher reflow rates, a benefit that takes more time for us to realize, but we are seeing improvement there as well. The total number of enhanced prescriptions in the fourth quarter of 2021 was approximately 93,700. This represents 27% growth over the fourth quarter of 2020 in a market environment which increased only 6% over the same period. Turning to slide 10, enhanced market share increased from 5.1 percent in the fourth quarter of 2020 to 6.3 percent in the fourth quarter of 2021. As market volumes potentially grow in the future, we are focused on continuing to grow our market share in the near term, and there remains lots of headroom for continued share growth, especially if we should achieve the new chronic sinusitis label expansion. breadth and depth of physician prescribing as measured by the total number of physicians who have patients filling ex-hance prescriptions and the numbers of prescriptions filled for writing physicians respectively increased from fourth quarter 2020 to fourth quarter 2021 as well. Regarding breadth, in fourth quarter 2021, approximately 7,500 physicians had a patient fill at least one prescription of ex-hance, an increase of 12% compared to fourth quarter 2020. Regarding depth, the number of physicians who had more than 15 enhanced prescriptions filled by their patients in a quarter has grown even faster, with that number increasing by 25% from fourth quarter 2020 to fourth quarter 2021, with nearly 1,600 physicians now in this segment. In a few moments, I'll provide some closing remarks, but first I'll turn the call over to our CFO, Keith Koldan, for comments regarding fourth quarter 2021 results and perspectives regarding our corporate guidance.
spk02: Thank you, Peter, and thanks to everyone for joining us this morning. Turning to slide 12. As we reported, OptiNose recognized $22.5 million of enhanced net revenue this fourth quarter, an increase of 44% compared to the fourth quarter of 2020. Full year 2021, enhanced net revenue was $73.7 million, aligned with our guidance range of $71 to $75 million, and an increase of 52% compared to full year 2020. Turning to slide 13. Based on available prescription data purchased from third parties and also on data we received directly from our preferred pharmacy network, enhanced average net revenue per prescription for the fourth quarter of 2021 was $240, an increase of 14% compared to $211 of average net revenue per prescription in fourth quarter 2020. Full year 2021 average net revenue per prescription was $219 and reflects an increase of 19 percent compared to $185 for full year 2020. We believe the 19 percent increase in full year 2021 average net revenue per prescription is driven in large part by changes made in 2021 to our co-pay assistance program. The changes to our co-pay assistance program in 2021 are important going forward as they are intended to sustainably increase average net revenue per prescription by reducing the rate of growth in prescription fills by commercially insured patients in plans that do not cover expense while sustaining the rate of growth in covered plans. We believe the change has had the targeted effect, resulting in reduced growth in unprofitable prescriptions and increasing average net revenue per prescription, and we expect the benefits of average net revenue per prescription to continue going forward. Turning to slide 14. Today we announce our initial financial guidance for 2022. First, we expect expense net revenue to be at least $90 million for full year 2022. Second, as part of our expectation for full year 2022, We anticipate that first quarter 2022 ex-hance net revenue will decrease compared to fourth quarter 2021 ex-hance net revenue, which was $22.5 million. This reflects the same pattern of calendar effect on ex-hance revenue as we've reported the last two years. As in prior years, the primary driver for the sequential revenue decrease in first quarter 2022 is our expectation that average net revenue per prescription will be lower in Q1 2022 than it was in Q4 2021. Also, as in prior years, we anticipate that average net revenue per prescription will improve substantially for the remaining three quarters of 2022. This cadence for enhanced net revenue per prescription is driven by two effects that we believe are common for chronic treatments in our industry and that we highlighted last year as well. The first factor relates to patient insurance deductible resets that occur in January. A second factor contributing to this decrease is the delay or loss of refill prescriptions by patients whose insurance coverage changed with the new year. We expect average enhanced net revenue per prescription for 2022, with respect to average net revenue per prescription for 2022, we expect the full year to be at least $210. Moving on to operating expenses, our initial guidance for full year 2022 includes modest increases associated with key commercial and development initiatives, notably including one-time costs associated with the planned filing of an SNDA for chronic sinusitis. Other factors driving the modest 2022 increase are volume-related fees paid to preferred pharmacy network partners and other distribution fees, as well as the completion of conduct of our chronic sinusitis clinical trials. For the full year of 2022, we expect total operating expenses to be in the range from $135 million to $140 million, of which approximately $10 million is stock-based compensation. Total operating expenses excluding stock-based compensation are expected to be in the range from $125 million to $130 million. Turning to slide 15, yesterday we announced positive top-line data from ReOpen1. A replay of the webcast we hosted to discuss those results will be available in the investor section of our company website for the next 60 days. Producing top-line results for ReOpen1 in the first quarter of this year was a key objective for our organization. Looking ahead, with recruitment complete, we remain on track to deliver top-line results from ReOpen2 in the second quarter of 2022. I'll now turn the call back over to Peter for closing remarks. Peter? Thanks, Keith.
spk03: Turning to slide 17, today we've described several reasons why we are so excited about the progress that has been made and the opportunities that lie ahead in 2022. The last two years have certainly created challenges for our people and our business. but I'm so proud of how our team has weathered the storm and put us in the position we are today, poised for great things. In the near term, commercial team continues to focus on driving our business, and if we see a second positive trial by the end of 2Q, we are prepared to race towards filing of an S.N.D.A. for chronic sinusitis as soon as possible. Thank you. Now I'd like to open up the call for Q&A.
spk01: Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the panel key. Please stand by while we compile the Q&A roster. Our first question comes from Brandon Foulkes with Cantor Fitzgerald. Your line is open.
spk06: Hi. Thanks for taking my questions, and congratulations on the very good performance. So maybe just three from me. I guess maybe one high level. How do you see the CS competitive market shaping up? I think we've seen some companies recently talk about studying migraine drugs in CRS. So is this helping a category just yet? There's a bit of excitement for your reps out there. Maybe just on the guidance, net revenue per prescription, I think it's guidance is 210. That's down from 219 in 2021. And look, the I'm looking at this in context, you have exceeded this guidance in the past, but can you just elaborate on the assumptions in that net revenue per script guidance for 2022 compared to 2021? And lastly, if I may, I'm sorry, walking them all up front. Can you just remind us in the follow ups and reopen to just if we look at the enrollment timeline and we try sort of think about when we could get data? any reason just at this stage not to sort of look, not to just push it and say it's going to be three months later, then reopen one just because of when you complete an enrollment.
spk03: Thank you. Thanks very much, Brandon. I'll take the first one and then I'll pass it to Keith and Rami for the next two. I would say, Brandon, I think the interest you're seeing in CS is an indication of how big and how underserved the market is. And, you know, I think you know that the, people for years have been trying to be successful in studies to show that they work in chronic sinusitis because it's a very big market, as we described, and very, very underserved currently, as I described as well. So I'll start off by saying that I view the activity in the market as a sign of this is a big market with high potential. Relative to competitors, the thing I feel really good about, Brandon, is we are out front. I mean, we're a good bit ahead of anybody else. that's behind us, and there are some therapies out there that are going to be more appropriate just in the ENT space, but there are some migraine treatments that are beginning some trials, but we don't really see broad competition in the near term, certainly in the primary care space, but also in the ENT allergy space. I don't know if the team has anything to add on that.
spk07: I would just point out, with regard to the competitors that are running trials, that some of those trials, like you mentioned the one with a migraine product, those are really not the same design, and they're focused, to the best that we're aware, I have no non-public information, of course, but they're focused on facial pain or pressure, as you might expect for a migraine product, and it's not entirely clear sort of what will come from that, but as you pointed out, We're very happy to see this sort of enthusiasm created around this market space by the multiple different products that they're pursuing.
spk03: The last comment I'll make, Brandon, is we're just so excited about our trial results that Rami covered last night. You know, this really could be a landmark. It was a landmark study that we published, first ever evidence of bringing benefit not only on symptoms but also objectively on showing benefit in the sinus cavities. And we just think that is – you saw the images that we showed on screen. We think that could be very compelling.
spk02: So, Brandon, this is Keith. I'll take the second question with respect to average net revenue per prescription. So as we've done in prior years, the guidance that we've given this year, including the guidance for expected net revenue for the year, was setting a floor. So I think in the past two years we've done the same. This year we've set the floor at at least $90 million. So with respect to average net revenue per prescription, I made comments in my prepared remarks with respect to some of the changes that were made last year in our co-pay assistance program that were intended to have sustained benefit. And I think you can see by the results that we put up for 2021, those benefits were surely recognized. We took the same approach to guiding on average net revenue per prescription this year by setting a floor of 210. I'll remind you that 219 is at least 210, the number that we achieved last year, so it's definitely within the range. You know, because we are setting floors in terms of revenue and average net revenue per prescription, we were intending to capture a a variety of outcomes with respect to revenue and total prescriptions, which, of course, are the numerator and denominator in the calculation.
spk07: And, Brandon, your last question was we might expect results, and I think you're on the right track. Based on when we announced completion of enrollment, the knowledge there's a 24-week follow-up, and it takes time, of course, to lock and clean the database and perform statistical analyses before you can produce top-line results. I think it's reasonable to expect that it will be the back half of the quarter before we see results.
spk06: Great. Thank you to all three of you, and congratulations on all the success. Thanks, Brandon. Thanks, Brandon.
spk01: Our next question comes from Dave Sillem with Piper Sandler. Your line is open.
spk04: Okay, just a few questions. So I know this has been asked before, but can you just talk about the mix between nasal polyp patients and non-polyp patients, or at least volumes currently. That's number one. Then number two is, as you think about commercialization, Peter, can you talk about your latest thinking regarding a co-promote or put differently, the extent to which you would expand a sales organization to target some of the GP audience that you would need to address for the expanded indication. And then lastly, just give us a sense of how the payer landscape is evolving. And what I guess I'm getting at here is with the expanded label to the extent you get it, how do you see the payer landscape evolving with a wider label? Thanks.
spk03: Yeah, I'll probably take all of them and I'll ask for support from Vic or Rami. You know, what we try to convey relative to the pile of patients currently, David, is number one, it's an underdiagnosed condition, but What we found in the sort of prescribing practices of doctors is we find the majority of doctors are limiting the prescribing to only polypatients. That's in research we've conducted. It's from lots of work that we've done. So the mix as we see it, there are some physicians, a smaller group of physicians that are writing broadly across multiple indications. but the majority of doctors are limiting their prescribing to nasal polyps. It's why we believe that, you know, the CS indication could be an incredible value unlocker because as we talk to physicians, and I encourage you guys to talk to physicians, when we ask them the question, you know, with a CS indication, you know, how much do you see your prescribing changing? And what's reported is substantially more prescribing. So, you know, as I said, we think it's a game changer on that front. Can I just elaborate?
spk07: Yeah, please, Ron. If you look at public data today, we want to caution you against extrapolating from the proportions by diagnosis that you might see from current prescribing to what might be potential for the product in the future, because today's proportions are driven disproportionately by the physicians who prescribe the most, those people that Peter referred to that have adopted broadly. The potential for the product, though, is driven by having an even larger audience of physicians adopt more broadly. So it's not really, it's easy but probably not correct to extrapolate the current proportions in the same, you know, and assume that we're already getting business in CS that would be available should we get the indication.
spk03: On the second question, David, we've been very consistent in terms of our view of how we capture the opportunity broadly in primary care. And I'll repeat what I said in my remarks, that in our current infrastructure, so in our current call on universe, we go from a million diagnosed nasal polyp patients to three million without doing anything to our commercial infrastructure. So I want to emphasize that point. We think there's a very big potential expansion opportunity just in the doctors we're already calling on for the reasons I just talked about a minute ago. Relative to that next group, you know, the six or seven million patients being treated by roughly 50 to 60,000 primary care doctors, we do not, David, intend to build out a big infrastructure to capture that benefit. You know, the work we've done, you know, we think there are multiple partners that already are calling on those doctors and would be interested in a co-promoter or licensing deal in the primary care space. There is potential, by the way, that, you know, we could expand marginally in primary care with our current reps, but we're going to capture, our plan is to capture the majority of the value there via partnering. I think we've been pretty consistent there. The payer landscape, you know, David, this is what excites me, honestly, is that, you know, our partners, The insurance environment that I described, you know, roughly half, we have good insurance coverage, 80% coverage, but half of our coverage has a PA associated with it. And where we do have a PA, it's typically to indication. So the payer says the physician has to attest to a nasal polyp indication. We believe the majority of those contracts are going to be converted. They're going to stay as they are, but with a CS indication, it will be to now indicate not only the nasal polyp indication, but also the CS indication. And it's what we were trying to describe in our remarks that, you know, there are 10 million diagnosed patients in total, 3 million diagnosed patients in the ENT allergy segment. And we think that is good, you know, as patients no longer have to attest to nasal polyps, they have to attest to chronic sinusitis, which is already broadly diagnosed. We think that is sort of the game changer in terms of creating significantly more volume in the ENTology segment alone.
spk04: Okay, great. Helpful. Thank you. Thanks, David.
spk01: Thank you. As a reminder to ask a question at this time, please press star then 1. Our next question comes from Gary Nachman with BMO Capital Markets. Your line is open.
spk05: Hi, guys. Good morning. What's the level of in-person detailing now coming out of the pandemic, and how much do you expect that to accelerate in the coming months? I think you said it wouldn't improve that much. I'm curious why not. And do you expect more of the increased use of exams to come from deeper penetration of existing writers or by bringing in new physician writers at this point? I'll stop there. I have a couple of follow-ups.
spk03: I'll take the first. I'll lead and Vic can jump in. But it's interesting, Gary, what we found in the pandemic environment, there's obviously two factors that are impacting. One is patient volumes, but you're obviously talking about in-person detailing. And what we found across last year is that as mask mandates either went up or they went down, you know, in cities and different geographies, we did not see a dramatic change in offices, how physicians were sort of reacting to those changes in terms of rep access. And this is anecdotal, Gary, but we're not calling on nearly all the physicians we were calling on pre-pandemic. So I want to be clear about this. Our reps are out there making significant number of calls every day, but the number of doctors we're able to call on in person is is limited because of physicians not allowing reps into the offices. So the assumption we've made for 2022 is that's not going to dramatically change. And it obviously varies by territory and by geography, but, you know, anywhere from 30% to 50% of offices in a territory are not allowing reps to call on the office. So we're doing other things, by the way. It doesn't mean that we just give up. We try virtual. We do telephonic. We do things that we can. But that is what has been limiting on physician detailing. The other thing that's limited, too, is our speaker programs and our lunches and things of that nature that are very impactful promotionally. We just found a lot of physicians across last year not willing to attend speaker programs. So, you know, as we go into this year, we're coming into the year not believing it's going to dramatically change. You know, that's our view on that. Relative to, you know, I'll answer your question on where do we look for expansion in our physician universe. I'll answer it two ways. Gary, one is in the near term and the other is in the longer term. But in both cases, it's both. So we call on roughly 10,000 doctors right now. You saw our believer, dabbler, writer chart. About 8,000 doctors in total are writing, roughly, Vic, right? About 1,600 are in the segment that is writing a good bit more frequently. So I think in the near term, the majority of our growth is moving people from that, what we call dabbler segment, into the believer segment. And we've been very nicely growing that higher prescriber segment year over year. But we also intend, even in the near term, to try to expand our writing universe. Although even in that second group, I think the majority of it's going to come relative to depth of prescribing. Because we're pretty well penetrated. The majority of doctors we're calling on in ENTology are already writing. So in the near term, it's largely going to be on getting people to write more. But I do want to remind you of the longer-term opportunity with CS. You know, that's where we think we'll get a dramatic expansion of the physician universe. So, Dick, I don't know if you have anything to add there.
spk00: I mean, I think that's right, Peter. The only thing I'd add to that is we do see a significant opportunity in doctors who are writing us, but just occasionally and really encouraging them to integrate it as part of their standard of care, and we think the data helps us expand that group, so.
spk03: We are, Gary. I mean, the thing that Vic and his team are working on in the near term is we think we can grow our nasal polyp business, by the way. I mean, I want to be clear that, you know, while we're very excited about the CS opportunity, Vic and the team are working very hard to, across the next 12 to 18 months, continue to expand our business behind nasal polyps.
spk05: Okay, great. And then just following up from yesterday's CS data, if you consider modifying Reopen 2 after fully analyzing Reopen 1, and it sounded like that could be a possibility, could you still have Reopen 2 data in the second quarter regardless, you know, even if you make some changes? And then, Peter, how are the discussions going on a potential PC partner? Is it more likely that would happen after Reopen 2 data? Is it possible it could even happen before? Thanks.
spk07: So, Gary, I think what you're asking is if we were to choose to change the statistical analysis plan in Reopen 2 based on what we learned from Reopen 1, would that delay the results? And I believe the answer is no. I don't envision any changes that would involve changing the timeline for producing the topline report.
spk05: Okay, but I just want to confirm, wait, Peter, before you get to the next one, I just want to confirm that what you said yesterday, when you reevaluate the statistical plan, so it doesn't sound like it would be in terms of number of patients, like adding enrolled patients into the study. It would just be in terms of how you analyze the data statistically. Is that correct? You're comfortable, again, with the N in that study, the number of patients? Yes.
spk07: We have no plan to add additional patients to reopen to. Okay.
spk03: All right, great. Gary, relative to partnering, I'm not going to comment, Gary, on the discussions we're having on the partnering front. I will say what we've said historically is that typically in this kind of situation where it's a licensing deal or a co-promote, deals are typically done after data before filings. that's the time frame that most companies are more interested and candidly you maximize value relative to the deal. Okay.
spk06: Thanks.
spk01: Thank you. And I'm currently showing no further questions at this time. I'd like to turn the call back over to Peter Miller for closing remarks.
spk03: Well, we thank you for joining us both last night and this morning. And as you can tell, we're very, very excited about what lies ahead. So thank you very much.
spk01: This concludes today's conference call. Thank you for participating. You may now disconnect.
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