NASDAQ:OPTN OptiNose Q1 2024 Earnings Report $9.28 +0.02 (+0.22%) Closing price 04/25/2025 04:00 PM EasternExtended Trading$9.28 0.00 (0.00%) As of 04/25/2025 04:05 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast OptiNose EPS ResultsActual EPS-$1.80Consensus EPS -$1.50Beat/MissMissed by -$0.30One Year Ago EPSN/AOptiNose Revenue ResultsActual Revenue$14.88 millionExpected Revenue$13.95 millionBeat/MissBeat by +$930.00 thousandYoY Revenue GrowthN/AOptiNose Announcement DetailsQuarterQ1 2024Date5/14/2024TimeN/AConference Call DateTuesday, May 14, 2024Conference Call Time10:00AM ETUpcoming EarningsOptiNose's Q1 2025 earnings is scheduled for Tuesday, May 13, 2025, with a conference call scheduled at 10:00 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2025 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by OptiNose Q1 2024 Earnings Call TranscriptProvided by QuartrMay 14, 2024 ShareLink copied to clipboard.There are 7 speakers on the call. Operator00:00:00Please be advised that today's conference is being recorded. Speaker 100:00:03I would Operator00:00:03now like to hand the conference over to your speaker today, Jonathan Neely, VP of Investor Relations. Please go ahead. Speaker 200:00:11Good morning, and thank you for joining us today as we review OptiNose's Q1 2024 performance and our plans for the year ahead. Am joined today by our CEO, Doctor. Rami Mahmoud. 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. Speaker 200:00:31All 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, well as under the Risk Factors section and elsewhere in Optinose's most recent Form 10 ks and 10 Qs that are filed with the SEC and available at their website, sec.gov and on our website atoptinose.com. You're 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. Speaker 200:01:17We 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 Rami. Speaker 300:01:24Thank you, Jonathan, and thank you to everyone listening for joining us this morning. We appreciate you joining us for our Q1 2024 update. Starting on Slide 3, I'll start with a brief outline of what we'll cover during our call today. To start off, I'll review 3 key takeaways from today's call and discuss our initial plans to reach out to our ENT and allergy specialist physician audience with XHANCE's new clinical profile, including communication of data showing strong efficacy in chronic sinusitis, which our market research indicates is a leading driver of prescribing behavior. Next, Jonathan Neely, our VP of Investor Relations and Business Development will review our Q1 2024 performance and our financial guidance for full year 2024. Speaker 300:02:08Finally, I'll return to review information about our peak net revenue estimates for XHANCE and the profitability targets that we described on our XHANCE chronic sinusitis launch call in April. Then we'll wrap up the call and take your questions. Turning to Slide 4. We'll go into more detail in a moment, but I'd like to highlight 3 key takeaways from today's presentation. First, I'd like to reiterate the significance of the opportunity in front of us, which we believe has potential to reshape this business in the last three quarters of 2024 and for years into the future. Speaker 300:02:40Claims data suggest that chronic sinusitis is currently being diagnosed by healthcare providers at least 10 times more frequently than nasal polyps. Following our national launch meeting the week of April 8, we have now fully engaged our sales team in our chronic sinusitis launch with training and a full set of materials. As a reminder, our plan is to launch with our current sales force structure armed with a new suite of chronic sinusitis promotional materials accompanied by digital and non personal promotion efforts based on the new label and with the objective of attaining peak year sales of at least $300,000,000 and producing positive income from operations for full year 2025. 2nd, thanks to the efforts of our team, we have a significantly stronger base to build on than we did at the start of 2023. When I started as CEO, we implemented an initiative to greatly increase our operating efficiency and to stabilize XHANCE revenue while preparing our organization to seize the greatly expanded opportunity in chronic sinusitis. Speaker 300:03:40We successfully met or exceeded the financial expectations we set for the last 5 consecutive quarters of revenue achievement, aggressive operating expense reductions and improvements in our average net revenue per prescription. 3rd, the combination of expanded market opportunity and improved base business fundamentals has set up the opportunity for OptiNose to return to strong growth in 2024. We've now announced our initial guidance for full year 2024 net revenues and total operating expenses. Mindful that the full launch of the CS indication started in mid April, we expect XHANCE net revenues to increase by 20% to 34% for full year 2024 compared to full year 2023. We also believe that XHANCE net revenue growth can be achieved with modest incremental operating expense increases to support promotional efforts while leveraging our existing commercial infrastructure. Speaker 300:04:36Turning to Slide 5. Last week, we announced a $55,000,000 registered direct financing, which was led by Nantaheila and D. E. Shaw and had participation from both new and existing healthcare focused investors. As a result of this funding, OptiNos now has cash and cash equivalents of approximately $100,000,000 Following on top of the recent approval of the chronic sinusitis indication, this financing is transformative for our company because in the context of our base business plan, we now have sufficient cash runway to operate our business while servicing our debt through 2025, which is when we expect to produce income from operations for the full year. Speaker 300:05:16As part of the funding, we also favorably amended the terms of our debt agreement with a waiver of the going concern covenant until the filing of our December 31, 2025 financial statements, which is expected to occur in March of 2026. Additionally, the minimum liquidity covenant will be reduced from $30,000,000 to $20,000,000 following the date of the 1st quarterly payment to principal, which is due on September 30, 2025. We also extinguished $4,700,000 of outstanding amendment and waiver fees, which have now been converted to equity. As a result of this financing and our revised debt agreement, OptiNose is in a greatly strengthened financial position to consider multiple future opportunities for value creation with our initial focus remaining squarely on our XHANCE launch plan. Turning to Slide 7 and our launch plan. Speaker 300:06:07In the Q2 of this year, we are leveraging 4 major tactics to launch XHANCE into this major new market opportunity. These include our sales force, non personal promotion, peer to peer education and presence at medical meetings. Let's begin with our 75 person sales organization. In the Q2, our team plans to reach approximately 7,500 target healthcare providers and make over 35,000 total sales calls. We're also supplying the field with 50% more XHANCE samples to stimulate additional physician and patient trial. Speaker 300:06:41In a highly symptomatic condition like chronic sinusitis, samples can be effective in facilitating new product adoption. It's still very early days for us in the field, but initial feedback has been quite positive, execution has been strong expect the momentum in XHANCE prescribing to build over time with continued sales force engagement. We are supplementing the field force with non personal promotion targeting a total of 22,000 of the highest potential largely specialty prescribers. These tactics include digital media, search engine marketing and social media. In the Q2, we plan to generate 1,500,000 healthcare provider impressions and over 50,000 customer engagements using this approach. Speaker 300:07:25We're also deploying a peer to peer speaker program with approximately 80 specialist prescribers familiar with both the product and the clinical trial data who are available to host educational events for their peers. During the Q2, we plan to reach over 1,000 healthcare providers to highlight the new XHANCE clinical profile and discuss unmet need and diagnostic criteria, which are important considerations for facilitating appropriate patient identification in the clinic. Lastly, we're planning a strong presence at medical meetings during the Q2, including 10 national and 20 regional events for ENTs and allergists. We have a booth where our team can interface with prescribers and are also planning to host promotional events such as product theaters with speakers. These events are aimed at disseminating our message about the recent approval and new clinical trial data, reinforcing the clinical benefits of XHANCE and reinforcing our leadership and visibility in the chronic sinusitis space. Speaker 300:08:22Taken together, these 4 tactical pillars are essential elements of our launch plan. I'll also remind you that we recently implemented hub services intended to increase the service level for prescribers and patients, while also resulting in overall improvement in the rate of written prescriptions that are ultimately filled and the rate at which insurance coverage and co pay support are correctly applied to each prescription. Our generous co pay support program will continue to facilitate patient starts with many patients being offered $0 co pays in their 1st month. Although many of these new initiations are not captured by IQVIA, they can help patients and providers gain personal experience with the benefits of XHANCE even if insurance coverage is still pending. We're also aware that it can often require 5 to 7 calls on new physicians before initiation of product trials and that successful product trials are a precursor for consistent adoption over time. Speaker 300:09:18We believe our planned efforts will get the ball rolling and result in gradually accelerating product uptake. All these activities in the context of our pre existing payer access, which includes broad commercial coverage and which we expect to typically adapt to include our new indication over the 1st few months following approval are expected to drive an uptick in XHANCE growth this year and ultimately deliver at least $300,000,000 in peak sales in peak year. I would like now to turn the call over to Jonathan Neely to review our financial guidance for full year 2024 and the equity offering we announced on May 9. Jonathan? Speaker 200:09:56Thank you, Rami. Turning to Slide 9. We're encouraged by our Q1 2024 financial results. Regarding revenue, OptiNose recognized $14,900,000 of XHANCE net revenue in the Q1 of 2024, a 26% increase compared to Q1 2023 net revenues of $11,800,000 As discussed on our last earnings call, strength and demand afforded us the opportunity to make gradual changes that we had that have had a positive influence on profitability. In late 2023 and early 2024, we made gradual revisions to our co pay assistance program and implemented new hub services. Speaker 200:10:32These changes have prioritized growth in profitable prescriptions and have reduced both the number and proportion of unprofitable prescriptions. The net result is evident in XHANCE net revenue per prescription. Based on available prescription and inventory data purchased from third parties and on data we received directly from our hub and preferred pharmacy network. The estimated XHANCE average net revenue per prescription for the Q1 of 2024 was $2.27 per prescription. This is a 63% increase compared to $139 of estimated average net revenue per prescription in the Q1 of 2023. Speaker 200:11:07In addition to the changes in co pay assistance and the implementation of hub services, we believe the disruption in services that change healthcare claims processor for our vendor that administers the XHANCE copay support program hindered access to our copay benefit for uncovered patients. Believe this disruption had a favorable effect on Xtant's net revenue per prescription and expect it to be isolated to Q1 2024. Finally, as we reported earlier, OptiNose recognized $21,700,000 of SG and A plus R and D expenses in the Q1 of 2024. This is approximately a $3,000,000 or 11% decrease compared to Q1 2023 expenses of $24,500,000 Last week, we announced our initial financial guidance for full year 2024 ExHANCE net revenue and full year 2024 operating expenses. In addition, given the stronger than expected performance in the Q1 2024, we increased our expectation for full year 2024 Exantas net revenue per prescription. Speaker 200:12:06First, for the full year of 2024, we expect total operating expenses to be between $95,000,000 to $101,000,000 of which approximately $6,000,000 is expected to be stock based compensation. 2nd, we anticipate strong growth for XHANCE net revenues given the expanded market opportunity available in CS. Our expectation for XHANCE net revenue for full year 2024 is between $85,000,000 to $95,000,000 Finally, we now expect Xantzen's net revenues per prescription to exceed $2.30 for the full year of 2024. Previously, we expected Xtantra net revenues per prescription to be approximately $2.20 for the full year of 2024. I will now turn the call back over to Rami for closing remarks. Speaker 200:12:47Rami? Speaker 300:12:48Thank you, Jonathan. Turning to Slide 13. In April, we provided a financial outlook for XHANCE in chronic sinusitis that we believe we can meet or exceed within our base business. It's important to note that in the context of our base business objectives, although we're treating this as a product launch, in the short term, we're not planning significantly increased investments in our commercial infrastructure. For the time being, we plan to engage a largely specialty physician audience with our current 75 territory size sales team, although we may consider a future expansion of our sales organization to further accelerate our launch. Speaker 300:13:23Although the size of our sales team is remaining steady, what will be dramatically different is the message we can convey to doctors as we promote XHANCE for a significantly larger population of approximately 3,000,000 patients cared for in our specialty segment. Importantly, we believe that a much broader range of physicians commonly make the diagnosis of chronic sinusitis than the diagnosis of nasal polyps. This includes prescribers who are not equipped to routinely perform nasal endoscopy in office, a procedure which is often relied on to confirm a diagnosis of nasal polyps. With this in mind, we believe we can realistically achieve peak net revenues of at least $300,000,000 and produce positive income from operations for full year 2025. Turning to Slide 14. Speaker 300:14:07In addition to the potential within our base business, we believe there's meaningful future potential value to unlock outside of our base business plan and I'll focus on that topic to wrap up today's call. The first thing I'll highlight is the potential to expand the size of our sales organization by adding up to 40 additional sales territories. Increasing our sales reach to a larger population of specialty prescribers could push our peak year net revenue potential above our initial guidance of at least $300,000,000 and we will carefully consider if and when this incremental investment is appropriate. Next, we believe our product is well suited to support outreach to a primary care prescribing audience. We could pursue this opportunity either by adopting alternative selling models like digital promotion or through direct selling partnerships to access an additional $7,000,000 actively diagnosed and treated patients with chronic sinusitis. Speaker 300:14:59In future, we could also invest in capital efficient approaches to activating the 20,000,000 additional patients with chronic sinusitis who are symptomatic but not actively seeking care each year. Based on direct to consumer pilot data that we have, we believe the XHANCE product profile is well suited to support strong patient activation. 3rd, I'd like to note that to date we have not invested significant energy in establishing international partnerships for XHANCE, but we have maintained patents in select major markets. These represent another potential incremental source of value. Lastly, we aim to leverage our existing infrastructure, particularly our commercial infrastructure to generate synergies by working on additional products. Speaker 300:15:43OptiNose is establishing strong infrastructure, experience and competencies in what we consider the comparatively blue ocean ENT and allergy specialty space. As we generate income from operations, which we expect for full year 2025 and continue to strengthen the organization, OptiNose has potential to become the commercialization or development partner of choice for companies in this specialty space. Collectively, we believe there are significant opportunities ahead to create shareholder value and when the time is right, we will carefully consider our options and the potential to return to our successful development routes and build a pipeline of new and innovative treatments to address unmet need in our specialty arena. Turning to Slide 15. Before moving to take any questions, I'd like to reiterate the significance of the opportunity in front of us, which we believe has potential to reshape our business starting in the Q2 of this year and for years into the future. Speaker 300:16:39We're pleased with our success in executing our pre launch operating strategy through 2023 and Q1 of 2024. We achieved greatly increased operating efficiency while stabilizing revenue in the comparatively niche nasal polyp indication, while preserving capital and focusing our organization on preparations to seize the opportunity created by approval of XHANCE as the first prescription treatment for one of the most common diseases diagnosed in adult outpatient medicine. We believe the launch opportunity we are just getting off the ground coupled with our recent financing position us well to build a profitable ENT and allergy focused business by accessing greatly expanded net revenue potential through an efficient existing base of commercial capabilities. In addition, we believe the chronic sinusitis indication will facilitate commercial partnerships or other approaches to accessing incremental value in the primary care space that is in addition to what we can access on our own in the specialty segment. With that, I'd like to thank you for your attention and open up the call for Q and A. Operator00:18:01And our first question comes from Thomas Flaten with Lake Street Capital Markets. Your line is now open. Speaker 400:18:07Good morning. I appreciate you guys taking the questions. I'm just trying to digest the significant upside to the average revenue per prescription, particularly in light of the comment made in the Q about the change health care potentially one time upside. I was just curious if you could help us maybe map out how you expect the average revenue per prescription to what the cadence is going to be over the course of the year. We're used to seeing a huge swing upward in the Q2, but I'm not sure if we should be thinking the same way for this year. Speaker 400:18:36Any help there would be greatly appreciated. Speaker 100:18:39Do you want Speaker 200:18:39to pick up the parts about change healthcare and I'll talk about the cadence? Speaker 300:18:43So we do believe change healthcare had an effect. But as we pointed out in our comments, Tom, it's not the only reason that we had a higher average net revenue per prescription in the Q1 of 2024 than we did in prior years. So, we do think there's still a seasonal trend, if you will, where Q1 will generally be lower than subsequent quarters. However, what we've done is we provided full year guidance for our expected average net revenue per prescription to help give a sense of how we think that will pan out over the remainder of the year. Speaker 200:19:16Yes. And so in terms of thinking about the cadence within the year relative to years prior, I don't think what we're projecting is a really significant increase in revenue per prescription moving from Q1 into the rest of the year. But we do believe that the changes that we put into the business proactively were going to have a positive influence on revenue per prescription on a year over year basis as we move through the year. But we've moved our estimate now up from approximately $2.20 to at least or to exceed $2.30 per prescription. So we still do think that there's going to be improvement within the year. Speaker 400:19:59And then another thing I saw in the Q was that there was a comment that your number of covered lives that have access to XHANCE decreased from 80% to 70%. I was curious if you can comment on that. Speaker 300:20:12Yes. I think that's more a consequence of the way in which we are measuring it, than it is a consequence of any change in coverage. So I apologize if you took away the wrong impression there. The intent has always been or the expectation that we had was always that our number of covered lives wouldn't change materially with the new indication. What we do expect is an improvement in the ease with which coverage can be obtained within those lives because we expect people subject to utilization management like prior authorizations to no longer be required to have only a nasal polyp indication, which is harder to harder, diagnosis to make and less often coded for, and now to be able to also have a chronic sinusitis indication, which is much more broadly coded for in outpatient visits. Speaker 300:21:06I think historically when we talked about percentage Speaker 200:21:11of lives that are covered or in plans that cover XHANCE, I think we've historically focused on commercial only, but I think we've moved to providing a measure that's of all insurance plans, whether it's commercial or government. Speaker 400:21:28Makes sense. And then one final quick one. The samples that you're handing out, is that a full 30 day dose or are there 30 days of doses available now or is there a smaller quantity of drug in the samples? Speaker 300:21:40No, Jen. The samples most of the samples that we are handing out are a specific sample put up, which is not a full 30 days. It's just enough to get you started, and hopefully give you time to be able to receive your prescription from whichever pharmacy, including mail order that you might be accessing. Speaker 400:21:57Understood. Thanks, Mosk. Thanks so much. Operator00:22:00Thank you, Tom. Thank you. One moment for our next question. Our next question comes from David Amsellem with Piper Sandler. Your line is now open. Speaker 500:22:14Hi. This is Skyler on for David. Can you speak anecdotally to what you've been seeing on the payer landscape front since the expanded label? Have there been any roadblocks to getting coverage for patients about nasal polyps? And then for net revenue for Rx in the long term, how do you think that is going to evolve in the context of the wider Speaker 300:22:33label? So, Skyler, thanks for your questions. I'll start with the second one. With regard to average net revenue per prescription, I don't think we view that as something that is a function of the label change. It's been very sensitive to changes we've made in our co pay support program and sort of other sort of business actions, but not really a function of the indication for which the drug is prescribed. Speaker 300:22:59With regard to anecdotes about insurance coverage, all I can share with you is in fact just anecdotes. It's premature for us to have sort of broad patterns established since our launch. There just hasn't been enough elapsed time. And of course there are thousands of different insurance plans out there. I can't speak to all of them. Speaker 300:23:19I can tell you we have gotten specific anecdotal reports of the new indication being added in to prior authorization forms exactly as we've discussed before, which is what we would expect to happen over a number of months following the approval. And I'm not aware of any adverse actions that have occurred as a result of the new indication. We do expect gradually to see the new indication added in to the current prior authorization criteria. Speaker 500:23:49Got it. That's helpful. And then one more on the sales force sizing, you mentioned potential expansions in the future. Can you talk about what factors would inform that? Speaker 300:23:59Yes. I think, we're looking to see, the results of our initial promotional activities. And we're following it closely with fairly intense analytics. And as we get a better sense of the uplift that we're generating and sort of the drivers that are producing the best ROI, then we'll use that information to inform the magnitude and the timing of any changes we make in our promotional activities. Speaker 500:24:28Got it. Helpful. Thank you. Operator00:24:32Thank you. Our next question comes from Glenn Santangelo with Jefferies. Your line is now open. Speaker 100:24:50Yes. Thanks for taking my question. Hey, Rami, I also wanted to follow-up on in terms of what you're seeing in terms of payer coverage. It sounds like you said you're gradually seeing the new indication added. Can you give us a sense for maybe how long that will take? Speaker 100:25:04Because I'm trying to I thought it was going to be a relatively quick process given the payers familiarity with the product. And I'm trying to put that into context with that with the full year fiscal 'twenty four guidance and maybe the decision to leave the commercial those payer contracts can be amended and when we should start to expect some acceleration on the revenue side? Speaker 300:25:37Well, so Glenn, thank you for the question. This might sound obvious, but we don't directly control the pace at which these changes are made at various insurance plans. And there are there's a small number of major PBMs and insurers, but there are thousands and thousands of insurance plans. And I have concrete examples of cases where the changes have already been made, other examples where it hasn't been made. So we are estimating that it could take in some plans a few weeks, in some plans some months for these changes ultimately to roll out. Speaker 300:26:14And it's one of the things that we just have to keep an eye on ourselves. We have tried to be transparent with insurers so that everyone would be fully aware of the new indication that was coming. And we've done everything we can to facilitate their ability to make those changes. But at the end of the day, it's not something we directly control. And you asked sort of when can we start difference in revenue? Speaker 300:26:40We've tried to give you guidance that I think makes it clear that we're expecting an increase in revenue this quarter. So in Q2, we're expecting revenue to start increasing and we expect it to increase over the remainder of the year, ultimately reaching $85,000,000 to $95,000,000 for calendar 2024, which is meaningfully higher than 2023. Speaker 200:27:02Glenn, you did ask a question about yes, you asked the question about the cadence of amendment of our agreements. And I think it's not so much a cadence of amendment to the agreements. I think it's more of a cadence of the payers and their processes reflecting the contracts that largely contemplate the expanded label. They contemplate rebates whenever the product is reimbursed, for FDA approved indications that are on the label. So it's I don't think it's a contracting discussion. Speaker 200:27:32I think it's more having processes that the insurers reflect the state of the label of the product and having their business processes reflect that. It's not a renegotiation. Speaker 100:27:45All right. Maybe just 2 other quick ones for me and then I'll hop off. The total scripts in this quarter look like they were down a fair amount based on that average rev per script. I was wondering if you can sort of comment on that. And then secondly, on your $300,000,000 peak sales number, could you maybe, Ramy or John, put a little bit more meat behind that number and how you sort of came to that number and how we should think about that from a script and average rev per script perspective? Speaker 100:28:12Thanks. Speaker 200:28:16Sure. So I mean in terms of the prescriptions on a quarterly basis, I think as we described, we've made some we believe has kind of focused us on growing the profitable portion of our business and has reduced the number and proportion of unprofitable prescriptions. So the year over year result, if you look at prescriptions, you're down, I think almost 23% on a year over year basis. But importantly, there are prescriptions leaving the business that on net improve our revenue performance by them no longer being filled. So again, coming back to what we're here for in terms of financial performance, revenues were up 26% on a year over year basis. Speaker 300:29:18And just to add a little bit to that, you might have sort of missed it in the earlier comments, but we are reducing the number unprofitable or even negative revenue prescriptions. We also have we have focused on growth for profitable prescriptions. So in terms of managing the business, what we're trying to do is not grow total prescriptions, but grow profitable prescriptions. The other thing I'll mention, sort of just as a reminder is that the tracking of prescriptions by external third party providers is imperfect. And it's always been imperfect and it varies over time how closely it mirrors our actual numbers. Speaker 300:29:58But one of the things I highlighted in my earlier comments is that new initiations, which disproportionately we're trying to drive with the new launch, new initiations that have a $0 copay may not be captured by 3rd party data providers at all. So it will be invisible to you. Speaker 200:30:16So then I'll comment on the guide for the year and the implications for prescription growth and revenue per prescription growth. Yes, I think given that we've provided a range for revenues and a floor, if you will, for revenue per prescription, I think if you reverse into the math, you can derive that we are expecting both prescriptions to grow on a year over year basis, as well as revenues to grow on a year over year basis and along with the kind of the revenue per prescription. Speaker 100:30:56All right. That's all. Thank you very much. Speaker 300:30:58Glenn, the last thing I'll add is you asked about the $300,000,000 My view is that, the growth to get us from 2024 out to peak year is growth in use of the product. It's not really meaningful incremental growth in the average net revenue per prescription. There were a lot of levers to pull there, sort of in the last, I don't know, say 9 months or so. But in the future, primarily the growth will come from increased uptake of the product. Speaker 100:31:26Perfect. Thanks a lot. Operator00:31:30Thank you. One moment for our next question. Our next question comes from Matthew Caulfield with H. C. Wainwright. Operator00:31:39Your line is now open. Speaker 600:31:42Hey, good morning guys. Thanks for taking our question and congrats on the successful launch so far. So appreciating the specialist focused efforts targeted towards allergists and ENTs, do you plan to share any granularity around the number of prescriptions that could be coming from the primary care segment in the coming quarters? And then maybe how that could inform any future sales efforts? Presumably primary care could be prescribing, just not being kind of the current focus. Speaker 300:32:14Yes. So Matt, we haven't made a decision yet about sort of how we'll report out on the sort of indicators for future growth. But as you said, our efforts right now are focused primarily on a specialty audience. We do have some primary care physicians in our called on university. It was not a huge number. Speaker 300:32:34And we do have a larger audience for our non personal promotional efforts. And we will of course be gathering data about promotional responsiveness and uptake and the sort of the manner in which the product is being used in the different segments, which we'll use to inform our future efforts. But Matt, I don't want to set an expectation that we'll be reporting anything specifically by prescriber specialty in the near future at least. Speaker 600:33:00Okay, fair enough. Very helpful and very excited to see the launch. Congrats guys. Speaker 300:33:04Thanks again, Matt. Operator00:33:06Thank you. I'm showing no further questions at this time. I would now like to turn it back to Rami Mahmud, CEO for closing remarks. Speaker 300:33:14Great. I'd like to thank you all for joining us this morning. Appreciate your attention and help and I hope you share our excitement in what a different place the company is in today compared to a year or more ago. With the new approval and the new financing that we've accomplished in the last few months, we feel like we're in a much better position to really create shareholder value and to help millions of people with the disease that previously had no treatment alternatives. And we look forward to getting back with you again in August to share our Q2 results. Operator00:33:43This concludes today's conference call. Thank you for participating. You may nowRead morePowered by Conference Call Audio Live Call not available Earnings Conference CallOptiNose Q1 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsSlide DeckPress Release(8-K)Quarterly report(10-Q) OptiNose Earnings HeadlinesOptinose Reports 2024 Financial Results, Highlights Prescription Growth and First Operational IncomeMarch 28, 2025 | msn.comOptinose reports Q4 EPS (3c) vs ($1.33) last yearMarch 27, 2025 | markets.businessinsider.comThe Trump Dump is starting; Get out of stocks now?The first 365 days of the Trump presidency… Will be the best time to get rich in American history.April 26, 2025 | Paradigm Press (Ad)Optinose Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Operational HighlightsMarch 26, 2025 | markets.businessinsider.comSHAREHOLDER INVESTIGATION: Halper Sadeh LLC Investigates GB, RDFN, PRA, OPTN on Behalf of ShareholdersMarch 25, 2025 | morningstar.comOptinose downgraded to Neutral from Buy at H.C. WainwrightMarch 22, 2025 | markets.businessinsider.comSee More OptiNose Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like OptiNose? Sign up for Earnings360's daily newsletter to receive timely earnings updates on OptiNose and other key companies, straight to your email. Email Address About OptiNoseOptiNose (NASDAQ:OPTN), a specialty pharmaceutical company, focuses on the development and commercialization of products for patients treated by ear, nose, throat, and allergy specialists in the United States. The company offers XHANCE, a therapeutic product utilizing its proprietary exhalation delivery system (EDS) that delivers a topically acting corticosteroid for the treatment of chronic rhinosinusitis with nasal polyps, as well as is in Phase IIIb clinical trial for treatment of chronic sinusitis; and Onzetra Xsail, a powder EDS device. It has a license agreement with Currax Pharmaceuticals LLC for the commercialization of Onzetra Xsail. 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There are 7 speakers on the call. Operator00:00:00Please be advised that today's conference is being recorded. Speaker 100:00:03I would Operator00:00:03now like to hand the conference over to your speaker today, Jonathan Neely, VP of Investor Relations. Please go ahead. Speaker 200:00:11Good morning, and thank you for joining us today as we review OptiNose's Q1 2024 performance and our plans for the year ahead. Am joined today by our CEO, Doctor. Rami Mahmoud. 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. Speaker 200:00:31All 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, well as under the Risk Factors section and elsewhere in Optinose's most recent Form 10 ks and 10 Qs that are filed with the SEC and available at their website, sec.gov and on our website atoptinose.com. You're 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. Speaker 200:01:17We 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 Rami. Speaker 300:01:24Thank you, Jonathan, and thank you to everyone listening for joining us this morning. We appreciate you joining us for our Q1 2024 update. Starting on Slide 3, I'll start with a brief outline of what we'll cover during our call today. To start off, I'll review 3 key takeaways from today's call and discuss our initial plans to reach out to our ENT and allergy specialist physician audience with XHANCE's new clinical profile, including communication of data showing strong efficacy in chronic sinusitis, which our market research indicates is a leading driver of prescribing behavior. Next, Jonathan Neely, our VP of Investor Relations and Business Development will review our Q1 2024 performance and our financial guidance for full year 2024. Speaker 300:02:08Finally, I'll return to review information about our peak net revenue estimates for XHANCE and the profitability targets that we described on our XHANCE chronic sinusitis launch call in April. Then we'll wrap up the call and take your questions. Turning to Slide 4. We'll go into more detail in a moment, but I'd like to highlight 3 key takeaways from today's presentation. First, I'd like to reiterate the significance of the opportunity in front of us, which we believe has potential to reshape this business in the last three quarters of 2024 and for years into the future. Speaker 300:02:40Claims data suggest that chronic sinusitis is currently being diagnosed by healthcare providers at least 10 times more frequently than nasal polyps. Following our national launch meeting the week of April 8, we have now fully engaged our sales team in our chronic sinusitis launch with training and a full set of materials. As a reminder, our plan is to launch with our current sales force structure armed with a new suite of chronic sinusitis promotional materials accompanied by digital and non personal promotion efforts based on the new label and with the objective of attaining peak year sales of at least $300,000,000 and producing positive income from operations for full year 2025. 2nd, thanks to the efforts of our team, we have a significantly stronger base to build on than we did at the start of 2023. When I started as CEO, we implemented an initiative to greatly increase our operating efficiency and to stabilize XHANCE revenue while preparing our organization to seize the greatly expanded opportunity in chronic sinusitis. Speaker 300:03:40We successfully met or exceeded the financial expectations we set for the last 5 consecutive quarters of revenue achievement, aggressive operating expense reductions and improvements in our average net revenue per prescription. 3rd, the combination of expanded market opportunity and improved base business fundamentals has set up the opportunity for OptiNose to return to strong growth in 2024. We've now announced our initial guidance for full year 2024 net revenues and total operating expenses. Mindful that the full launch of the CS indication started in mid April, we expect XHANCE net revenues to increase by 20% to 34% for full year 2024 compared to full year 2023. We also believe that XHANCE net revenue growth can be achieved with modest incremental operating expense increases to support promotional efforts while leveraging our existing commercial infrastructure. Speaker 300:04:36Turning to Slide 5. Last week, we announced a $55,000,000 registered direct financing, which was led by Nantaheila and D. E. Shaw and had participation from both new and existing healthcare focused investors. As a result of this funding, OptiNos now has cash and cash equivalents of approximately $100,000,000 Following on top of the recent approval of the chronic sinusitis indication, this financing is transformative for our company because in the context of our base business plan, we now have sufficient cash runway to operate our business while servicing our debt through 2025, which is when we expect to produce income from operations for the full year. Speaker 300:05:16As part of the funding, we also favorably amended the terms of our debt agreement with a waiver of the going concern covenant until the filing of our December 31, 2025 financial statements, which is expected to occur in March of 2026. Additionally, the minimum liquidity covenant will be reduced from $30,000,000 to $20,000,000 following the date of the 1st quarterly payment to principal, which is due on September 30, 2025. We also extinguished $4,700,000 of outstanding amendment and waiver fees, which have now been converted to equity. As a result of this financing and our revised debt agreement, OptiNose is in a greatly strengthened financial position to consider multiple future opportunities for value creation with our initial focus remaining squarely on our XHANCE launch plan. Turning to Slide 7 and our launch plan. Speaker 300:06:07In the Q2 of this year, we are leveraging 4 major tactics to launch XHANCE into this major new market opportunity. These include our sales force, non personal promotion, peer to peer education and presence at medical meetings. Let's begin with our 75 person sales organization. In the Q2, our team plans to reach approximately 7,500 target healthcare providers and make over 35,000 total sales calls. We're also supplying the field with 50% more XHANCE samples to stimulate additional physician and patient trial. Speaker 300:06:41In a highly symptomatic condition like chronic sinusitis, samples can be effective in facilitating new product adoption. It's still very early days for us in the field, but initial feedback has been quite positive, execution has been strong expect the momentum in XHANCE prescribing to build over time with continued sales force engagement. We are supplementing the field force with non personal promotion targeting a total of 22,000 of the highest potential largely specialty prescribers. These tactics include digital media, search engine marketing and social media. In the Q2, we plan to generate 1,500,000 healthcare provider impressions and over 50,000 customer engagements using this approach. Speaker 300:07:25We're also deploying a peer to peer speaker program with approximately 80 specialist prescribers familiar with both the product and the clinical trial data who are available to host educational events for their peers. During the Q2, we plan to reach over 1,000 healthcare providers to highlight the new XHANCE clinical profile and discuss unmet need and diagnostic criteria, which are important considerations for facilitating appropriate patient identification in the clinic. Lastly, we're planning a strong presence at medical meetings during the Q2, including 10 national and 20 regional events for ENTs and allergists. We have a booth where our team can interface with prescribers and are also planning to host promotional events such as product theaters with speakers. These events are aimed at disseminating our message about the recent approval and new clinical trial data, reinforcing the clinical benefits of XHANCE and reinforcing our leadership and visibility in the chronic sinusitis space. Speaker 300:08:22Taken together, these 4 tactical pillars are essential elements of our launch plan. I'll also remind you that we recently implemented hub services intended to increase the service level for prescribers and patients, while also resulting in overall improvement in the rate of written prescriptions that are ultimately filled and the rate at which insurance coverage and co pay support are correctly applied to each prescription. Our generous co pay support program will continue to facilitate patient starts with many patients being offered $0 co pays in their 1st month. Although many of these new initiations are not captured by IQVIA, they can help patients and providers gain personal experience with the benefits of XHANCE even if insurance coverage is still pending. We're also aware that it can often require 5 to 7 calls on new physicians before initiation of product trials and that successful product trials are a precursor for consistent adoption over time. Speaker 300:09:18We believe our planned efforts will get the ball rolling and result in gradually accelerating product uptake. All these activities in the context of our pre existing payer access, which includes broad commercial coverage and which we expect to typically adapt to include our new indication over the 1st few months following approval are expected to drive an uptick in XHANCE growth this year and ultimately deliver at least $300,000,000 in peak sales in peak year. I would like now to turn the call over to Jonathan Neely to review our financial guidance for full year 2024 and the equity offering we announced on May 9. Jonathan? Speaker 200:09:56Thank you, Rami. Turning to Slide 9. We're encouraged by our Q1 2024 financial results. Regarding revenue, OptiNose recognized $14,900,000 of XHANCE net revenue in the Q1 of 2024, a 26% increase compared to Q1 2023 net revenues of $11,800,000 As discussed on our last earnings call, strength and demand afforded us the opportunity to make gradual changes that we had that have had a positive influence on profitability. In late 2023 and early 2024, we made gradual revisions to our co pay assistance program and implemented new hub services. Speaker 200:10:32These changes have prioritized growth in profitable prescriptions and have reduced both the number and proportion of unprofitable prescriptions. The net result is evident in XHANCE net revenue per prescription. Based on available prescription and inventory data purchased from third parties and on data we received directly from our hub and preferred pharmacy network. The estimated XHANCE average net revenue per prescription for the Q1 of 2024 was $2.27 per prescription. This is a 63% increase compared to $139 of estimated average net revenue per prescription in the Q1 of 2023. Speaker 200:11:07In addition to the changes in co pay assistance and the implementation of hub services, we believe the disruption in services that change healthcare claims processor for our vendor that administers the XHANCE copay support program hindered access to our copay benefit for uncovered patients. Believe this disruption had a favorable effect on Xtant's net revenue per prescription and expect it to be isolated to Q1 2024. Finally, as we reported earlier, OptiNose recognized $21,700,000 of SG and A plus R and D expenses in the Q1 of 2024. This is approximately a $3,000,000 or 11% decrease compared to Q1 2023 expenses of $24,500,000 Last week, we announced our initial financial guidance for full year 2024 ExHANCE net revenue and full year 2024 operating expenses. In addition, given the stronger than expected performance in the Q1 2024, we increased our expectation for full year 2024 Exantas net revenue per prescription. Speaker 200:12:06First, for the full year of 2024, we expect total operating expenses to be between $95,000,000 to $101,000,000 of which approximately $6,000,000 is expected to be stock based compensation. 2nd, we anticipate strong growth for XHANCE net revenues given the expanded market opportunity available in CS. Our expectation for XHANCE net revenue for full year 2024 is between $85,000,000 to $95,000,000 Finally, we now expect Xantzen's net revenues per prescription to exceed $2.30 for the full year of 2024. Previously, we expected Xtantra net revenues per prescription to be approximately $2.20 for the full year of 2024. I will now turn the call back over to Rami for closing remarks. Speaker 200:12:47Rami? Speaker 300:12:48Thank you, Jonathan. Turning to Slide 13. In April, we provided a financial outlook for XHANCE in chronic sinusitis that we believe we can meet or exceed within our base business. It's important to note that in the context of our base business objectives, although we're treating this as a product launch, in the short term, we're not planning significantly increased investments in our commercial infrastructure. For the time being, we plan to engage a largely specialty physician audience with our current 75 territory size sales team, although we may consider a future expansion of our sales organization to further accelerate our launch. Speaker 300:13:23Although the size of our sales team is remaining steady, what will be dramatically different is the message we can convey to doctors as we promote XHANCE for a significantly larger population of approximately 3,000,000 patients cared for in our specialty segment. Importantly, we believe that a much broader range of physicians commonly make the diagnosis of chronic sinusitis than the diagnosis of nasal polyps. This includes prescribers who are not equipped to routinely perform nasal endoscopy in office, a procedure which is often relied on to confirm a diagnosis of nasal polyps. With this in mind, we believe we can realistically achieve peak net revenues of at least $300,000,000 and produce positive income from operations for full year 2025. Turning to Slide 14. Speaker 300:14:07In addition to the potential within our base business, we believe there's meaningful future potential value to unlock outside of our base business plan and I'll focus on that topic to wrap up today's call. The first thing I'll highlight is the potential to expand the size of our sales organization by adding up to 40 additional sales territories. Increasing our sales reach to a larger population of specialty prescribers could push our peak year net revenue potential above our initial guidance of at least $300,000,000 and we will carefully consider if and when this incremental investment is appropriate. Next, we believe our product is well suited to support outreach to a primary care prescribing audience. We could pursue this opportunity either by adopting alternative selling models like digital promotion or through direct selling partnerships to access an additional $7,000,000 actively diagnosed and treated patients with chronic sinusitis. Speaker 300:14:59In future, we could also invest in capital efficient approaches to activating the 20,000,000 additional patients with chronic sinusitis who are symptomatic but not actively seeking care each year. Based on direct to consumer pilot data that we have, we believe the XHANCE product profile is well suited to support strong patient activation. 3rd, I'd like to note that to date we have not invested significant energy in establishing international partnerships for XHANCE, but we have maintained patents in select major markets. These represent another potential incremental source of value. Lastly, we aim to leverage our existing infrastructure, particularly our commercial infrastructure to generate synergies by working on additional products. Speaker 300:15:43OptiNose is establishing strong infrastructure, experience and competencies in what we consider the comparatively blue ocean ENT and allergy specialty space. As we generate income from operations, which we expect for full year 2025 and continue to strengthen the organization, OptiNose has potential to become the commercialization or development partner of choice for companies in this specialty space. Collectively, we believe there are significant opportunities ahead to create shareholder value and when the time is right, we will carefully consider our options and the potential to return to our successful development routes and build a pipeline of new and innovative treatments to address unmet need in our specialty arena. Turning to Slide 15. Before moving to take any questions, I'd like to reiterate the significance of the opportunity in front of us, which we believe has potential to reshape our business starting in the Q2 of this year and for years into the future. Speaker 300:16:39We're pleased with our success in executing our pre launch operating strategy through 2023 and Q1 of 2024. We achieved greatly increased operating efficiency while stabilizing revenue in the comparatively niche nasal polyp indication, while preserving capital and focusing our organization on preparations to seize the opportunity created by approval of XHANCE as the first prescription treatment for one of the most common diseases diagnosed in adult outpatient medicine. We believe the launch opportunity we are just getting off the ground coupled with our recent financing position us well to build a profitable ENT and allergy focused business by accessing greatly expanded net revenue potential through an efficient existing base of commercial capabilities. In addition, we believe the chronic sinusitis indication will facilitate commercial partnerships or other approaches to accessing incremental value in the primary care space that is in addition to what we can access on our own in the specialty segment. With that, I'd like to thank you for your attention and open up the call for Q and A. Operator00:18:01And our first question comes from Thomas Flaten with Lake Street Capital Markets. Your line is now open. Speaker 400:18:07Good morning. I appreciate you guys taking the questions. I'm just trying to digest the significant upside to the average revenue per prescription, particularly in light of the comment made in the Q about the change health care potentially one time upside. I was just curious if you could help us maybe map out how you expect the average revenue per prescription to what the cadence is going to be over the course of the year. We're used to seeing a huge swing upward in the Q2, but I'm not sure if we should be thinking the same way for this year. Speaker 400:18:36Any help there would be greatly appreciated. Speaker 100:18:39Do you want Speaker 200:18:39to pick up the parts about change healthcare and I'll talk about the cadence? Speaker 300:18:43So we do believe change healthcare had an effect. But as we pointed out in our comments, Tom, it's not the only reason that we had a higher average net revenue per prescription in the Q1 of 2024 than we did in prior years. So, we do think there's still a seasonal trend, if you will, where Q1 will generally be lower than subsequent quarters. However, what we've done is we provided full year guidance for our expected average net revenue per prescription to help give a sense of how we think that will pan out over the remainder of the year. Speaker 200:19:16Yes. And so in terms of thinking about the cadence within the year relative to years prior, I don't think what we're projecting is a really significant increase in revenue per prescription moving from Q1 into the rest of the year. But we do believe that the changes that we put into the business proactively were going to have a positive influence on revenue per prescription on a year over year basis as we move through the year. But we've moved our estimate now up from approximately $2.20 to at least or to exceed $2.30 per prescription. So we still do think that there's going to be improvement within the year. Speaker 400:19:59And then another thing I saw in the Q was that there was a comment that your number of covered lives that have access to XHANCE decreased from 80% to 70%. I was curious if you can comment on that. Speaker 300:20:12Yes. I think that's more a consequence of the way in which we are measuring it, than it is a consequence of any change in coverage. So I apologize if you took away the wrong impression there. The intent has always been or the expectation that we had was always that our number of covered lives wouldn't change materially with the new indication. What we do expect is an improvement in the ease with which coverage can be obtained within those lives because we expect people subject to utilization management like prior authorizations to no longer be required to have only a nasal polyp indication, which is harder to harder, diagnosis to make and less often coded for, and now to be able to also have a chronic sinusitis indication, which is much more broadly coded for in outpatient visits. Speaker 300:21:06I think historically when we talked about percentage Speaker 200:21:11of lives that are covered or in plans that cover XHANCE, I think we've historically focused on commercial only, but I think we've moved to providing a measure that's of all insurance plans, whether it's commercial or government. Speaker 400:21:28Makes sense. And then one final quick one. The samples that you're handing out, is that a full 30 day dose or are there 30 days of doses available now or is there a smaller quantity of drug in the samples? Speaker 300:21:40No, Jen. The samples most of the samples that we are handing out are a specific sample put up, which is not a full 30 days. It's just enough to get you started, and hopefully give you time to be able to receive your prescription from whichever pharmacy, including mail order that you might be accessing. Speaker 400:21:57Understood. Thanks, Mosk. Thanks so much. Operator00:22:00Thank you, Tom. Thank you. One moment for our next question. Our next question comes from David Amsellem with Piper Sandler. Your line is now open. Speaker 500:22:14Hi. This is Skyler on for David. Can you speak anecdotally to what you've been seeing on the payer landscape front since the expanded label? Have there been any roadblocks to getting coverage for patients about nasal polyps? And then for net revenue for Rx in the long term, how do you think that is going to evolve in the context of the wider Speaker 300:22:33label? So, Skyler, thanks for your questions. I'll start with the second one. With regard to average net revenue per prescription, I don't think we view that as something that is a function of the label change. It's been very sensitive to changes we've made in our co pay support program and sort of other sort of business actions, but not really a function of the indication for which the drug is prescribed. Speaker 300:22:59With regard to anecdotes about insurance coverage, all I can share with you is in fact just anecdotes. It's premature for us to have sort of broad patterns established since our launch. There just hasn't been enough elapsed time. And of course there are thousands of different insurance plans out there. I can't speak to all of them. Speaker 300:23:19I can tell you we have gotten specific anecdotal reports of the new indication being added in to prior authorization forms exactly as we've discussed before, which is what we would expect to happen over a number of months following the approval. And I'm not aware of any adverse actions that have occurred as a result of the new indication. We do expect gradually to see the new indication added in to the current prior authorization criteria. Speaker 500:23:49Got it. That's helpful. And then one more on the sales force sizing, you mentioned potential expansions in the future. Can you talk about what factors would inform that? Speaker 300:23:59Yes. I think, we're looking to see, the results of our initial promotional activities. And we're following it closely with fairly intense analytics. And as we get a better sense of the uplift that we're generating and sort of the drivers that are producing the best ROI, then we'll use that information to inform the magnitude and the timing of any changes we make in our promotional activities. Speaker 500:24:28Got it. Helpful. Thank you. Operator00:24:32Thank you. Our next question comes from Glenn Santangelo with Jefferies. Your line is now open. Speaker 100:24:50Yes. Thanks for taking my question. Hey, Rami, I also wanted to follow-up on in terms of what you're seeing in terms of payer coverage. It sounds like you said you're gradually seeing the new indication added. Can you give us a sense for maybe how long that will take? Speaker 100:25:04Because I'm trying to I thought it was going to be a relatively quick process given the payers familiarity with the product. And I'm trying to put that into context with that with the full year fiscal 'twenty four guidance and maybe the decision to leave the commercial those payer contracts can be amended and when we should start to expect some acceleration on the revenue side? Speaker 300:25:37Well, so Glenn, thank you for the question. This might sound obvious, but we don't directly control the pace at which these changes are made at various insurance plans. And there are there's a small number of major PBMs and insurers, but there are thousands and thousands of insurance plans. And I have concrete examples of cases where the changes have already been made, other examples where it hasn't been made. So we are estimating that it could take in some plans a few weeks, in some plans some months for these changes ultimately to roll out. Speaker 300:26:14And it's one of the things that we just have to keep an eye on ourselves. We have tried to be transparent with insurers so that everyone would be fully aware of the new indication that was coming. And we've done everything we can to facilitate their ability to make those changes. But at the end of the day, it's not something we directly control. And you asked sort of when can we start difference in revenue? Speaker 300:26:40We've tried to give you guidance that I think makes it clear that we're expecting an increase in revenue this quarter. So in Q2, we're expecting revenue to start increasing and we expect it to increase over the remainder of the year, ultimately reaching $85,000,000 to $95,000,000 for calendar 2024, which is meaningfully higher than 2023. Speaker 200:27:02Glenn, you did ask a question about yes, you asked the question about the cadence of amendment of our agreements. And I think it's not so much a cadence of amendment to the agreements. I think it's more of a cadence of the payers and their processes reflecting the contracts that largely contemplate the expanded label. They contemplate rebates whenever the product is reimbursed, for FDA approved indications that are on the label. So it's I don't think it's a contracting discussion. Speaker 200:27:32I think it's more having processes that the insurers reflect the state of the label of the product and having their business processes reflect that. It's not a renegotiation. Speaker 100:27:45All right. Maybe just 2 other quick ones for me and then I'll hop off. The total scripts in this quarter look like they were down a fair amount based on that average rev per script. I was wondering if you can sort of comment on that. And then secondly, on your $300,000,000 peak sales number, could you maybe, Ramy or John, put a little bit more meat behind that number and how you sort of came to that number and how we should think about that from a script and average rev per script perspective? Speaker 100:28:12Thanks. Speaker 200:28:16Sure. So I mean in terms of the prescriptions on a quarterly basis, I think as we described, we've made some we believe has kind of focused us on growing the profitable portion of our business and has reduced the number and proportion of unprofitable prescriptions. So the year over year result, if you look at prescriptions, you're down, I think almost 23% on a year over year basis. But importantly, there are prescriptions leaving the business that on net improve our revenue performance by them no longer being filled. So again, coming back to what we're here for in terms of financial performance, revenues were up 26% on a year over year basis. Speaker 300:29:18And just to add a little bit to that, you might have sort of missed it in the earlier comments, but we are reducing the number unprofitable or even negative revenue prescriptions. We also have we have focused on growth for profitable prescriptions. So in terms of managing the business, what we're trying to do is not grow total prescriptions, but grow profitable prescriptions. The other thing I'll mention, sort of just as a reminder is that the tracking of prescriptions by external third party providers is imperfect. And it's always been imperfect and it varies over time how closely it mirrors our actual numbers. Speaker 300:29:58But one of the things I highlighted in my earlier comments is that new initiations, which disproportionately we're trying to drive with the new launch, new initiations that have a $0 copay may not be captured by 3rd party data providers at all. So it will be invisible to you. Speaker 200:30:16So then I'll comment on the guide for the year and the implications for prescription growth and revenue per prescription growth. Yes, I think given that we've provided a range for revenues and a floor, if you will, for revenue per prescription, I think if you reverse into the math, you can derive that we are expecting both prescriptions to grow on a year over year basis, as well as revenues to grow on a year over year basis and along with the kind of the revenue per prescription. Speaker 100:30:56All right. That's all. Thank you very much. Speaker 300:30:58Glenn, the last thing I'll add is you asked about the $300,000,000 My view is that, the growth to get us from 2024 out to peak year is growth in use of the product. It's not really meaningful incremental growth in the average net revenue per prescription. There were a lot of levers to pull there, sort of in the last, I don't know, say 9 months or so. But in the future, primarily the growth will come from increased uptake of the product. Speaker 100:31:26Perfect. Thanks a lot. Operator00:31:30Thank you. One moment for our next question. Our next question comes from Matthew Caulfield with H. C. Wainwright. Operator00:31:39Your line is now open. Speaker 600:31:42Hey, good morning guys. Thanks for taking our question and congrats on the successful launch so far. So appreciating the specialist focused efforts targeted towards allergists and ENTs, do you plan to share any granularity around the number of prescriptions that could be coming from the primary care segment in the coming quarters? And then maybe how that could inform any future sales efforts? Presumably primary care could be prescribing, just not being kind of the current focus. Speaker 300:32:14Yes. So Matt, we haven't made a decision yet about sort of how we'll report out on the sort of indicators for future growth. But as you said, our efforts right now are focused primarily on a specialty audience. We do have some primary care physicians in our called on university. It was not a huge number. Speaker 300:32:34And we do have a larger audience for our non personal promotional efforts. And we will of course be gathering data about promotional responsiveness and uptake and the sort of the manner in which the product is being used in the different segments, which we'll use to inform our future efforts. But Matt, I don't want to set an expectation that we'll be reporting anything specifically by prescriber specialty in the near future at least. Speaker 600:33:00Okay, fair enough. Very helpful and very excited to see the launch. Congrats guys. Speaker 300:33:04Thanks again, Matt. Operator00:33:06Thank you. I'm showing no further questions at this time. I would now like to turn it back to Rami Mahmud, CEO for closing remarks. Speaker 300:33:14Great. I'd like to thank you all for joining us this morning. Appreciate your attention and help and I hope you share our excitement in what a different place the company is in today compared to a year or more ago. With the new approval and the new financing that we've accomplished in the last few months, we feel like we're in a much better position to really create shareholder value and to help millions of people with the disease that previously had no treatment alternatives. And we look forward to getting back with you again in August to share our Q2 results. Operator00:33:43This concludes today's conference call. Thank you for participating. You may nowRead morePowered by