OptiNose [OPTN] Conference call transcript for 2022 q2
2022-08-13 15:04:09
Fiscal: 2022 q2
Operator: Good day, and thank you for standing by. Welcome to the OptiNose's Second Quarter 2022 Earnings Call. 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.
Jonathan Neely: Good morning, and thank you for joining us today as we review OptiNose'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, Ramy Mahmoud; and our Chief Commercial Officer, Vic Clavelli. The slides that will be presented on this call 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 the 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 OptiNose'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. 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?
Peter Miller: Thanks, Jonathan, and good morning, everybody. We appreciate you joining us today. Starting on Slide 4. We'll go into more detail in a moment, but I would like to highlight 4 key takeaways from today's presentation. First, we reported top line results from ReOpen2 in the second quarter, and we're pleased with the positive results. We believe the ReOpen program is a landmark in chronic sinusitis, as it is to our knowledge the first Phase III program for nasal treatment and 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 the 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 XHANCE as a treatment for chronic sinusitis. We are very excited by the potential that new indication would create, and I will discuss that briefly on the next slide. Third, we implemented a change to our Co-Pay Assistance Program at the start of 2022 to reduce the co-pay 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 6 months of 2022 when compared to the same period in 2021. Fourth, we revised our guidance for full year 2022 XHANCE net revenues and operating expenses. XHANCE net revenues increased 21% in the first 6 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 that $85 million 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 $6 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 the chronic sinusitis indication. Turning to Slide 5. Our excitement for the ReOpen 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 1 million patients with nasal polyps, the current indication for XHANCE, 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 of 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 opportunity 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 50,000 to 60,000 additional physicians in primary care. This incremental physician audience and patient population represent an additional market opportunity of approximately $7 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 were 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 Ramy to discuss the results of the ReOpen program and next steps. Ramy?
Ramy Mahmoud: Thank you, Peter. Turning to Slide 7. I'd like to start by thanking the clinical research team at OptiNose for their work on the ReOpen program. Without their efforts, particularly through the worst periods of the pandemic, these trials would not have been possible to bring to completion. ReOpen1 and ReOpen2 have produced landmark results in the treatment of patients with chronic sinusitis. On this and the following slides, I'll describe some of the key efficacy findings from the 2 trials. The first co-primary endpoint evaluated in each of the ReOpen trials was the mean change in combined symptom score at week 4. We believe this result is important because symptom relief is a primary objective in treatment of patients suffering from chronic sinusitis and contributes to understanding of the clinical importance of the treatment. In ReOpen1 and ReOpen2, patients started the trial with moderate-to-severe symptoms. In both trials and for both active treatment arms, XHANCE treatment produced statistically significantly more improvement in symptoms than was reported by patients using the placebo comparator. The magnitude of this improvement was consistent with the magnitude of improvement in the prior XHANCE clinical program that supported initial approval of the product by the FDA. Turning to Slide 8. The second co-primary endpoint in each of the ReOpen trials was a measure of the amount of inflammation inside the ethmoid and maxillary sinuses. This was assessed using computer assistance to evaluate the 3-dimensional sinus spaces and objectively quantify the average of changes in the percentage of opacification of the sinus cavities after 24 weeks of treatment. Although changes in imaging are not routinely used as either a treatment objective or as a way of tracking a patient's response to treatment, we view the second endpoint as important because it establishes whether a treatment effect is occurring inside the sinus cavities, as distinct from a treatment effect inside the nasal cavity as we have previously reported with nasal polyps. At the time of entry into ReOpen1 and ReOpen2, all patients were required to have at least a minimum level of sinus opacification in order to prove the disease was present inside the sinus cavities. In both trials and for both active treatment arms, we found statistically significantly more improvement in sinus opacification for patients treated with XHANCE compared to those receiving the placebo comparator. We've previously shared images to show how obvious this amount of mean change is on an ordinary 2-dimensional scan image. But in addition to that, we have now performed analyses that show that this amount of mean change was accompanied by a meaningful improvement in disease as perceived by patients, which we measured using the patient global impression of change. As Peter noted earlier, we believe that these results from the ReOpen program mark the first time ever that a Phase III program testing a nasal therapy for chronic sinusitis has been able to show improvement in both symptoms and inflammation inside the sinuses. Turning to Slide 9. In another noteworthy first, ReOpen is the first Phase III program we are aware of ever to show that nasal therapy can significantly reduce the number of acute exacerbations of chronic sinusitis. As with other respiratory diseases, such as asthma and COPD, acute exacerbations of chronic sinusitis are both common and important. Exacerbations are a major source of disability for CS patients. Data suggest that there are 10 million or more physician office visits for CS annually and that approximately 70% of the patients who visit a doctor for CS receive an antibiotic, making this a top driver of all ambulatory care antibiotic use in the United States. Frequent antibiotic use has been found to mediate the harm to quality of life suffered by CS patients and poses risks both to individuals and society. The mean frequency of acute exacerbation was a prespecified key secondary endpoint evaluated in pooled data from ReOpen1 and ReOpen2 measured by acute escalations in care during the 24-week treatment period of the trials. Escalation of care most frequently involved prescribing of an antibiotic, but accounts for other interventions as well. We found that compared to placebo treatment, XHANCE produced a statistically significant reduction of 66% in the incidence of exacerbations for patients receiving 2 sprays twice daily -- two sprays per nostril twice daily. In additional exploratory pre-planned analysis, similar reductions, which ranged from 53% to 80% in the number of exacerbations were also found for patients who used 1 spray per nostril twice daily and in subgroups either with or without nasal polyps. We believe this first ever finding of a sizable reduction in acute exacerbations and associated use of antibiotics could be of interest from a regulatory perspective and could also influence future treatment guidelines for standard of care in this disease. The new data specific to patients with nasal polyps is also immediately promotable with improvement of up to 80% observed in the subgroup of chronic sinusitis patients who also had nasal polyps from the ReOpen2 trial. Turning to Slide 10. Our road map for the remainder of 2022 includes a pre-NDA meeting with FDA prior to data submission. That has now been scheduled by FDA for the end of September. Our clinical and regulatory teams have already started work on the sNDA with a plan to submit by the end of 2022 and for XHANCE to ultimately become the first medication ever approved for treatment of this common disease. I'd also like to remind you that we anticipate that the standard FDA review period for this type of application would be 10 months. To learn more details about the ReOpen program, including baseline characteristics and safety information, I invite you to view the replays of the Top Line Results webcast for both ReOpen1 and ReOpen2, which are available in the Investors section of our website and to review our SEC filings. I'll now turn the call back over to Peter to discuss our second quarter commercial performance.
Peter Miller: Thanks, Ramy. Turning to Slide 12. We are pleased with the performance in second quarter 2022. As I review the next 3 slides, there are 2 things that we believe are important to keep in mind as they frame our year-to-date performance and expectations for the full year of 2022. First is that we implemented a change to our Co-Pay Assistance Program in January 2022, intended to prioritize growth in our more profitable customers and to reduce the number and proportion of unprofitable prescriptions. We believe the year-over-year increase in revenue per prescription is evidence that the co-pay program changes are performing as intended and that the growth rate of profitable prescriptions is greater than the overall growth rates. This is desirable and reflected in our increasing average net revenue per prescription. However, as our business mix has intentionally changed, year-over-year comparisons of total prescription numbers will also be more difficult to interpret correctly until we have moved a year past the co-pay program shift. Second is that we experienced a greater than originally expected level of vacancies within our sales territories and softer-than-expected prescription volumes in June and July. We believe the softer volumes may be the impact of these vacancies and what may have been greater than expected summer seasonal volume declines, but collectively, these factors drove our decision to revise our expectations for full year 2022 XHANCE net revenues. We're optimistic that new hires that are already beginning to fill vacant sales territories over the summer, combined with the return of a normal fall seasonal volume increases for the market versus the suppressed fall season experienced in 2021 due to the Delta variant will support volume growth. We're also very excited by the novel finding in our ReOpen program that XHANCE treatment resulted in reduced acute exacerbations in nasal polyp patients. As Ramy alluded to, we plan to start actively reaching out to inform physicians about this new data in September. That said, let me now review the results. In second quarter 2022, there were approximately 29,200 new prescriptions for XHANCE, a 1% increase compared to second quarter of 2021, while the market which includes INS prescriptions written by any physician for any condition, a large component of which are prescriptions for allergic rhinitis, increased 8% over the same period. For the first 6 months of 2022, there were approximately 57,400 new prescriptions, a 5% increase compared to the first 6 months of 2021, while the market increased 11% over the same period. Turning to Slide 13. In second quarter 2022, there were approximately 87,600 total prescriptions for XHANCE, a 6% increase compared to second quarter 2021, while the market increased 4% over the same period. For the first 6 months of 2022, there were approximately 168,000 total prescriptions, an 8% increase compared to the first 6 months of 2021, while the market increased 6% over the same period. Turning to Slide 14. XHANCE market share increased from 5.2% in second quarter of 2021 to 5.6% in second quarter of 2022. We remain excited about the headroom for future growth as more physicians incorporate XHANCE into their practice of medicine. Breadth and depth of physician prescribing is measured by the total number of physicians who have patients filling XHANCE prescriptions continue to increase from second quarter 2021 to second quarter 2022 as well. Regarding breadth, in second quarter 2022, 7,851 physicians had a patient fill at least one prescription of XHANCE, an increase of 9% compared to second quarter 2021. Regarding depth, the number of physicians who had more than 15 XHANCE prescriptions filled by their patients in a quarter grew as well, with that number increasing by 6% from second quarter 2021 to second quarter 2022, with 1,500 physicians now in this segment. I'll now turn the call over to Jonathan to discuss second quarter financial performance.
Jonathan Neely: Thanks, Peter. Turning to Slide 16. As we reported, OptiNose recognized $20.6 million of XHANCE net revenue in the second quarter of 2022, an increase of 12% compared to the second quarter of 2021. Year-to-date, 2022 XHANCE net revenue stands at $35.3 million, an increase of 21% compared to the 6 months ended June 30, 2021. Turning to Slide 17. As we discussed on our first quarter call, we made change to our Co-Pay Assistance Program at the start of 2022 that was intended to increase net revenue and average net revenue per prescription by reducing the number of proportion -- of prescription bills by commercially-insured patients and plans that have a high deductible, while sustaining the growth rate in covered plans where prescriptions are profitable. Patients who are covered, but in a high-deductible plan, can end up costing us substantially more as a group than what we received for providing XHANCE. We see good evidence that this change is reducing unprofitable bills in our average net revenue per prescription results. Based on available prescription data purchased from third parties and also on data we received directly from our preferred pharmacy network, XHANCE average net revenue per prescription for the second quarter of 2022 was $235, an increase of 6% compared to the $221 of revenue per prescription in the second quarter of 2021.Year-to-date, 2022 average net revenue per prescription stands at $210, an increase of 12% compared to $188 for the 6 months ended June 30, 2021. Turning to Slide 18. We have revised our financial guidance for full year 2022 for both net revenues and operating expenses. First, as Peter just discussed, we now expect XHANCE net revenue to be between $85 million to $92 million for the full year 2022. Second, our guidance for XHANCE's average net revenue per prescription is unchanged. We expect to see improvement in the second half of 2022 compared to the first half of 2022 and expect to exceed $220 for the full year of 2022. Third, for the full year of 2022, we now expect operating expenses to be in the range from $129 million to $134 million, of which approximately $9 million is stock-based compensation. Total operating expenses, excluding stock-based compensation, are therefore, expected to be in the range from $120 million to $125 million. Previously, we expected operating expenses to be in the range from $135 million to $140 million and so the improvement of $6 million. Finally, we amended our agreement with Pharmakon to lower the December 31, 2022, trailing 12-month revenue covenant from $90 million to $85 million. We believe this is important to address now, given the change to full year 2022 XHANCE net revenue guidance. I will now turn the call back over to Peter for closing remarks. Peter?
Peter Miller: Thanks, Jonathan. Before moving to Q&A, I'll take a moment to reiterate that overall, we are pleased with the progress we made in second quarter of 2022 and are laser-focused on completing the necessary work to support an sNDA submission by the end of 2022, and continue to grow XHANCE where we aim for the major potential that we look forward to unlocking with the future CS indication. Now I'd like to open the call up for Q&A.
Operator: Your first question comes from the line of Brandon Folkes from Cantor.
Brandon Folkes: Congratulations on the quarter. Let me just -- since your have come out, is there increase in CS uses that you are seeing out there? And maybe I heard the commentary on the guidance, I appreciate that refinement of that range. Just any change in market dynamics you're seeing just in terms of volume in the back half of the year that drove that as well? Anything coming out of the CS? Just any color would be great.
Peter Miller: Maybe Iâll take both of those and to keep paired in because relative to physician reaction to the data â first of all, Brandon, thanks for the questions. Relative to physician reaction to CS, we donât expect to see a lot of reaction, Brandon, for a while. We do plan to publish the data. We think, as we said, this is a landmark trial. So, therefore, we plan to publish the data, that will be at some point later in the fall. That is an opportunity for our sales reps to make the physicians aware of the data, but as of now, itâs -- certainly, our investigators are aware of the data, but broadly, physicians are not aware of the data at this point. Relative to market dynamics, weâre honestly sort of excited about the back half of the year, Brandon, for 2 reasons. Last year, we did not really have a fall allergy season because of the Delta variant suppressing patient visits to offices. And we have this, what we think is very exciting data on acute exacerbations. So that begs the question, hey, why did you guys make a revision of the guidance. As mentioned in the call, we saw some softness we didnât really expect in June, July. But as we also said, we think that is something that as we fill some vacant sales territories, we get a return to a normal season than we can see a real nice volume correction in the back half of the year.
Operator: Your next question is from the line of Gary Nachman from BMO Capital Markets.
Gary Nachman: When you file for the expanded indication, what will you be looking for on the label? How broad of an indication? And Peter, if you're in the middle of partnership discussions, would a potential partner want to be part of the filing process or it would strictly be a commercial arrangement for primary care?
Ramy Mahmoud : So Gary, thanks for the question. I'll take the first part of that. Our understanding of the FDA's current stance on this is that there are sort of 2 segments of the total chronic rhinosinusitis space. And with our new filing for the sNDA, we would expect to be indicated for the full range across both of those segments.
Peter Miller: I'll take the second, Gary, and thanks for the question, Gary. I'm not going to comment, Gary, on any discussions we're having with partners. What I can tell you though is that if you look normally, typically, deals of our type are done in between data, all the way up through approval. And therefore, there are instances where a partner would be involved in the label discussions. There are also instances where the partner would not be involved in the partner -- in the labeling discussions. So as I said, I'm not going to comment on where we are in our partnering discussions, but we continue to feel good about getting a partner.
Gary Nachman: Okay. And then maybe just talk a little bit more about the vacancy rates in the sales territories you see now. What do you think caused that? How much turnover there was? How many reps have you lost? And how quickly will you be able to fill them? And then the exacerbation data for nasal polyps, how much of an impact do you think that will have once the reps start promoting that?
Peter Miller: I'll take vacancy, Gary. And I'll first off say that we're not immune to turnover in our sales force. And our turnover in total is really no different than pharmaceutical industry averages. So we don't have a phenomenon here that is unusual. We just happen to experience a little bit more at this point in the year in the second quarter. . But I will say, we've already hired, I think, almost all the territories, right, Vic? So -- and I'm really excited about the new reps we're bringing on. We're attracting a lot of real high-quality talent to the company. So it's something that I just think is normal. It just happened to hit a little bit all at once in 2Q. But as I said, it's already been corrected relative to the hiring. The exacerbation data, Gary, is we will see, but we're really excited about the initial interactions that we're having with physicians. Vic and his team have done a good bit of research to understand potential reaction. And we have to go prove it in the market, but we're very excited. This is big news as Ramy sort of referenced in his discussion. This is an area that the use of antibiotics for this patient population is significant. And our data suggests we have the potential to reduce that use. So as I said, we're excited. We've got to go make it happen, but very, very excited about the data.
Gary Nachman: Okay. And can you just remind us how many reps do you think you need to effectively target the ENT and allergists, and then on the primary care side, just rough ballpark, how big of an effort do you think you would need there in terms of size of the sales force to really tap into it?
Peter Miller: Yes. So Gary, weâre between 90 and 100 is where weâve been in terms of the territories and for the ENT allergy specialty market, and we think thatâs the right size. So as we â some of what we think is so interesting about the CS indication is that to take advantage of that in the ENT allergy opportunity, we donât need any expansion of sales force. Weâve got a terrific sales team, theyâre calling on all the doctors who are high prescribers of nasal polyps, but who will also be the high prescribers of chronic sinusitis. So weâre feeling very good. Relative to primary care, it really depends on the breadth you want to go to, Gary. And I want to be clear, weâre not going to build a primary care sales force. We are going to work to partner with someone who has a sales force in the primary care space. If you want to go all the way to the 7 million patients in primary care being treated by physicians, itâs 50,000 to 60,000 primary care doctors. So thatâs a sales force of, what, Vic? 600 to 800 territory managers. But obviously, there are ways to go after that, that you donât necessarily go to the full breadth, but you go after the top deciles. And we think a lot of volume in primary care can be captured with 300, 400 territory managers.
Operator: Your next question is from the line of David Amsellem from Piper Sandler.
Unidentified Analyst: This is Isaac on for David. Just 2 from us. Trying to get a better handle on what patient attrition or conversely persistence looks like. Do you have a sense of what that is, how it's evolving, if at all? And as we move away from the pandemic, could we see persistence rates improve to the extent that more patients are consistently seeing their doctors in person? And then assuming a label expansion in 2023, how do you guys think about the gross to net spreads for XHANCE and payer contracting overall?
Peter Miller: Vic, I'll let you take the second one. But on the first one, we're really encouraged by persistence, Isaac. We have a lot of data that we get, de-identified patient data from our pharmacies. And so we have a very consistent persistency rate. So once a patient gets on the product, we see a very consistent number of fills per year and patients really staying with the product. So that is a key reason why we're building a really nice business here. So I say all the time, the product really works. And so when patients use it, they get better and the data supports that. As more patients get returned to doctors' offices and get care outside of -- as the pandemic sort of continues to wane, that is an opportunity to get continued growth. So Vic, I'll let you take the second question.
Vic Clavelli: Yes. I mean the reason we're excited about a lot of that growth is because it brings new patients in that actually allows us to introduce more patients to XHANCE. And of course, our pharmacy network is particularly good at keeping patients on therapy over time. Your second question is really about the opportunity that chronic sinusitis creates with payers. And we're really enthusiastic about what that's going to mean for the business. In nasal polyps today, there are a number of other products that are indicated for. In chronic sinusitis, there are no other indicated products. And the other advantage in chronic sinusitis is both the patients and the physicians readily diagnose chronic sinusitis. They know what it is and the availability of a treatment is an advantage, not just for those physicians, but also for the payers.
Peter Miller: And by the way, Isaac, the thing Iâll add, Vic, I would agree with everything you said. This acute exacerbation data combined with already a very strong pharmacoeconomic story that we have. And also the cost of our medication relative to other options, we think is very attractive for payers. So weâre very confident weâre going to be able to get good coverage with the new indication for the payer universe.
Operator: Your next question is from Stacy Ku from Cowen.
Stacy Ku: Congratulations on the quarter and the progress. We have a few. First on the chronic sinusitis opportunity. So would you first provide an update following the September meeting with the FDA? That's the first question. And then the second is, for that updated sales force leveraging in September, can you discuss if there are any reimbursement for patients about nasal polyps? Do they require a few more steps to get approval? We ask because the recent chronic sinusitis results, is that something that they're able to socialize or would that cause friction with reimbursement? And then the third question is on XHANCE. Thanks for all the details on the metrics for Q2. But can you discuss in more detail what you're seeing in Q3 so far? Specifically, are we still expecting some growth quarter-over-quarter?
Peter Miller: Stacy, thanks very much for the questions. I think it's probably unlikely we're going to provide an update following the FDA meeting. We'll talk about it, I would imagine as part of our normal call in 3Q, in the November time frame. Jonathan, I don't know if you have anything to add there?
Jonathan Neely: Yes. I mean, so the timing of our Q3 call would be typically first or second week of November. I'm not certain that the meeting minutes will come back in time for us to provide an update then. But then certainly, there will be opportunities to update investors subsequent to that.
Peter Miller: And Stacy, I want to make sure I understand your second question about the information that we're taking out in the marketplace. I don't think it will really affect reimbursement in any way, if that was your question, because we have a nasal polyp indication right now that is, as we've talked about historically, that we do have prior authorizations with some of our prescriptions. Those prescriptions typically require the physician to attest that there's a nasal polyp diagnosis. I don't think the -- any of the new data we have is necessarily going to change that environment. So Vic, I think you probably agree with that, right?
Vic Clavelli: Yes, I do agree with it. So the exacerbations is relevant in the nasal polyp population. And so they're very used to thinking about exacerbations in asthma or in COPD and the fact that now there'll be an opportunity to talk about the chance to improve the rate of exacerbations in chronic sinusitis with nasal polyps as a big advantage for us, so...
Peter Miller: Yes. And I think you're clear on this, Stacy. The data we have is from our ReOpen1 program, but the data is specific to nasal polyp patients. So it's within our promotional labeling. It just is another good reason to tell us to give the physician for patients they believe are appropriate for our product. It's another good reason to prescribe the product. And finally, on Q3, Jonathan, I don't know if you want to comment on that?
Jonathan Neely: Yes. I mean, I think we really don't have much in terms of complete data for Q3. We're sitting here in August. We have a little bit of information about July. I think what we acknowledge is that the softness in volumes that we saw that drove us to shift the net revenue range to $85 million to $92 million was based on some softness in the June and July time frame, but there's really not too much to the data set for Q3 today.
Operator: There are no further questions at this time. I would now like to turn the conference back to our presenters for the closing.
Peter Miller: Well, I just like to thank everybody for joining. As I said in my remarks, we're very excited about the back half of the year, continuing to grow the XHANCE business with our current indication, but most importantly, doing all the work necessary to get the product filed by the end of the year with an indication, we think really would be very, very important to patients and also a game-changer for our company. So thanks for joining.
Operator: This concludes today's conference call. Thank you all for attending. You may now disconnect.
