OptiNose (NASDAQ:OPTN), a specialty pharmaceutical company, reported its third-quarter earnings on November 9, 2024, acknowledging a dip in expected revenue but reaffirming the growth potential of its flagship product, XHANCE, for chronic sinusitis treatment. The call, led by VP of Investor Relations Jonathan Neely, CEO Dr. Ramy Mahmoud, new CFO Terry Kohler, and Chief Commercial Officer Paul Spence, centered on strategic plans and market opportunities for XHANCE.
Key Takeaways
- OptiNose reported $20.4 million in net revenue for XHANCE in Q3 2024, a 3% year-over-year increase.
- Full-year 2024 revenue guidance for XHANCE has been adjusted to $75 million to $79 million, down from the previous $85 million to $90 million.
- The company projects that peak annual net revenue for XHANCE could exceed $300 million.
- There has been an increase in targeted healthcare providers (HCPs) and inclusion in Express Scripts' national formularies.
- OptiNose confirmed sufficient funds to sustain operations for at least the next 12 months.
Company Outlook
- OptiNose is optimistic about new prescription growth and plans to improve insurance coverage and fulfillment processes.
- The company is exploring primary care partnerships and expects to tap into a larger patient base.
Bearish Highlights
- The company has seen a lower than expected net revenue for Q3 and has reduced its full-year revenue guidance.
- Approximately 50% of insurance plans covering XHANCE require prior authorizations, complicating patient access.
Bullish Highlights
- Average net revenue per prescription has increased by 36% to $320.
- The company has seen an increase in the number of new prescribers for XHANCE.
- OptiNose has been included in Express Scripts' national formularies, potentially easing access for over 24 million lives.
Misses
- Full-year 2024 revenue projections have been lowered due to the slower initial launch and inventory stocking impacts.
Q&A Highlights
- Analysts inquired about inventory impacts, prescription trends, and healthcare provider perceptions of XHANCE.
- The company acknowledged the need to better communicate the benefits of XHANCE to healthcare providers.
OptiNose's third-quarter earnings call reflected a mix of challenges and opportunities. The company reported a slight increase in net revenue for Q3 2024 but had to revise its full-year revenue guidance downwards. Despite this, there is a strong belief in the long-term potential of XHANCE, highlighted by a significant market opportunity and strategic commercial efforts to enhance healthcare provider targeting and insurance coverage. The company remains committed to optimizing prescription fulfillment and exploring new market partnerships. With a focus on continuous improvement, OptiNose is looking ahead to capitalize on the momentum built around XHANCE and its role in treating chronic sinusitis.
InvestingPro Insights
OptiNose's (OPTN) recent earnings call paints a picture of a company navigating challenges while maintaining optimism about its future prospects. This perspective is further enriched by data from InvestingPro, which offers additional context to the company's financial position and market performance.
Despite the lowered revenue guidance for 2024, OptiNose's gross profit margin stands out as a significant strength. According to InvestingPro data, the company boasts an impressive gross profit margin of 89.92% for the last twelve months as of Q2 2024. This aligns with one of the InvestingPro Tips, which highlights the company's "impressive gross profit margins." This robust margin suggests that OptiNose maintains strong pricing power for XHANCE, which could be crucial as the company works to expand its market presence.
However, the company's financial health presents a mixed picture. An InvestingPro Tip indicates that OptiNose is "quickly burning through cash," which correlates with the company's negative operating income of -$18.83 million for the last twelve months as of Q2 2024. This cash burn rate underscores the importance of the company's statement during the earnings call about having sufficient funds to sustain operations for at least the next 12 months.
The market's reaction to OptiNose's recent performance is reflected in its stock price, which InvestingPro data shows is trading near its 52-week low. This aligns with the company's reduced revenue guidance and the challenges discussed in the earnings call. However, it's worth noting that 2 analysts have revised their earnings upwards for the upcoming period, according to another InvestingPro Tip, suggesting some optimism about the company's near-term prospects.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips and insights beyond those mentioned here. In fact, there are 11 more InvestingPro Tips available for OptiNose, providing a deeper dive into the company's financial health and market position.
Full transcript - OptiNose (OPTN) Q3 2024:
Operator: Good day, and welcome to the OptiNose Third Quarter 2024 Earnings Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] As a reminder, this call may be recorded. I would now like to turn the call over to Jonathan Neely, Vice President, Investor Relations. Please go ahead.
Jonathan Neely: Good morning, and thank you for joining us today as we review OptiNose's third quarter 2024 performance and our plans for the year ahead. I am joined today by our CEO, Dr. Ramy Mahmoud; our new CFO, Terry Kohler; and our Chief Commercial Officer, Paul Spence. 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 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 in OptiNose's most recent Form 10-K and 10-Q that are filed with the SEC and available at their website, sec.gov, and on our website at optinose.com. You're cautioned not to place undue reliance on forward-looking statements. The 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 Ramy.
Ramy Mahmoud: Thank you, Jonathan, and thank you to everyone listening for joining us this morning. We appreciate you joining us for our third quarter 2024 update. Before we get into the call, I want to offer a warm welcome to Terry Kohler, our new Chief Financial Officer. Terry brings significant expertise in leading financial strategy for commercial stage branded pharmaceutical products and is a strong new addition to our leadership team. Welcome, Terry. Starting on Slide 3. We have a lot to unpack on the call today. I'll start with a brief outline of what we'll cover during our call. First, I'll provide a high-level overview and key takeaways from today's call. Second, our Chief Commercial Officer, Paul Spence, will provide a commercial update with a focus on what we've learned during the CS launch, how we've adapted business practices during the third quarter and on recent data that suggests we have now begun to observe an inflection in XHANCE prescription growth. Next (LON:NXT), Terry will walk you through our financial performance and our financial guidance for full-year 2024. Finally, I will return to wrap up the call and take your questions. Turning to Slide 4. I'd like to cover three key topics in today's presentation. First, I'd like to reiterate the significant long-term opportunity in front of us and provide high-level context for our commercialization activities in 2024. We believe peak annual net revenue will exceed $300 million with our specialty-focused efforts, a magnitude of opportunity that we believe has potential to reshape our business for years into the future. Claims data suggests that chronic sinusitis is currently being diagnosed and coded for by health care providers an estimated 10 million or more times per year, which is more than 10x more frequently than nasal polyps. While our revenue in the third quarter was not in line with our expectations, we believe we are now observing a clear inflection in new prescription demand. We believe the recent accelerating trend in new prescription demand reinforces the magnitude of the longer-term opportunity. In addition, we believe that our experience in the initial phases of the launch has improved our understanding of the key drivers of adoption and that this experience will help support achievement of our peak year objective. As a reminder, in 2024, we commercialized XHANCE without any change in the size of our prior sales force infrastructure. Since launch and with evolution in recent months, we have provided enhanced HCP targeting and call frequency plan, sharpened HCP messaging, created and then expanded our suite of chronic sinusitis focused promotional materials, increased the quality of XHANCE payer access and continued enhancements in our specialty pharmacy and hub operations to improve HCP and patient experiences with prescription fulfillment. Our objective was and remains to attain peak year net revenues of at least $300 million with a specialty focused field force calling on ENTs, allergists, pulmonologists and a limited number of call points within primary care. In addition to that, we continue to believe there is a significant incremental revenue opportunity for the new CS indication within the traditional primary care market, which is largely outside of our existing call point, and we are actively exploring ways to enter that market in the coming year. Our focus on growing profitable prescriptions rather than simply overall prescription volume and on building a broader base of prescribers who are new to XHANCE in the context of the launch rather than focusing only on the historical base of high prescribers for nasal polyps are among the factors that have shaped 2024 performance. Eventually, we believe the business we build with attention to profitability and to breadth of prescribing will be more robust. Second, earlier today, we reported $20.4 million of XHANCE net revenue for the third quarter. While this is less than our expectations for the quarter and may reflect a slower than initially anticipated uptake, we believe we are now seeing clear progress towards our peak sales expectations. As context, I'd like to remind you of the strategic direction of our commercial efforts since our launch in April. In order to achieve the full commercial potential of XHANCE, we felt it was necessary to make changes to our call point messaging to emphasize the important new clinical efficacy profile, to modify our prescriber targeting towards those with potential in the new indication and to modify our previous distribution and fulfillment strategy to allow scalability in volume, which involved the implementation of a new hub services platform. The hub platform was also intended to improve patient access and improve prescription fulfillment service levels for both patients and prescribers by standardizing reimbursement and fulfillment processes and increasing visibility to performance metrics to allow a continuous improvement. Since the launch of the CS indication, we also felt it was important to focus on improving the quality of XHANCE insurance coverage, including the inclusion of the new indication and utilization management schemes and other improvements in coverage, such as inclusion of the product in preferred formulary positions as we saw with the addition of XHANCE to large Express Scripts' national formularies in July. In addition, we felt it was important to focus on consistent and repeated communication over time of our new clinical data through our sales force, a cumulative effort that we believe is an important driver of trial and then adoption by physicians. During the first months of launch, we have focused on field performance against core elements of this plan and our prescription fulfillment related efforts, including migration to the new hub. We monitor performance and as we learn from experience, our commercial team has taken actions to improve sales execution and increase efficiency of prescription fulfillment. We believe leading data suggests that these actions are having an effect, and we are beginning to see a corresponding inflection in performance. Paul will provide additional color during his update on how we believe we are now progressing up the launch curve in the chronic sinusitis market as we advance health care provider knowledge and confidence in the efficacy of XHANCE and address the overall prescribing experience. He will also speak to the improvement in XHANCE insurance coverage in the third quarter and how we believe that has contributed to recent positive trends in our business and why we continue to seek to further improve the quality of our coverage heading into 2025. Finally, as Terry will cover in more detail, the delayed inflection of prescription growth trends, although not changing our expectation for at least $300 million in peak revenue, has resulted in a reduction in our guidance for calendar year 2024 XHANCE net revenue. We now expect revenues in a range from $75 million to $79 million compared to prior expectations of $85 million to $90 million. The new range implies 6% to 11% growth compared to full-year 2023 XHANCE net revenue of approximately $71 million. While the road we traveled in the third quarter had some bumps and our trajectory has been a bit delayed as a result, I am pleased with the team's focus on continuous improvement. We believe their efforts have placed us on a growth trajectory in chronic sinusitis. Recent data now indicate growth trends that reinforce our belief in the significant long-term potential of XHANCE as it penetrates a total addressable market of over 30 million patients. I'd now like to turn the call over to Paul Spence, to review initial launch performance and some recent commercial highlights. Paul?
Paul Spence: Thank you, Ramy. Turning to Slide 6. I would like to dive a little further into three aspects of our commercial effort that as Ramy just described, we believe are supporting a recent acceleration of growth. First aspect I will discuss is sales force execution. In the third quarter, appropriate delivery of on-target, efficacy-focused discussions at sufficient frequencies continue to be an area of focus. Balancing the initial excitement of having the first and only FDA-approved drug treatment for chronic sinusitis, gets the need to focus sales calls on XHANCE's differentiated clinical efficacy remains critical because efficacy remains the primary CS therapy choice driver for prescribers. In addition, accelerating the number and quality of efficacy discussions with the segment, potential prescribers that were new to our target universe continue to be an area of focus because new targets represent an important part of our growth in the new indication and are part of our audience necessary to reach the future peak potential sales for XHANCE in our specialty space. We believe we see an improvement in both efficacy messaging and an HCP target reach and frequency, producing improved metrics on call plan attainment. We believe this is an important contributor to the new prescription growth inflection observed in the latter part of the third quarter. We view continued focus on these aspects of sales execution as critical because both external benchmarks and our own launch data demonstrate that with HCPs who are naive to XHANCE. It could require 10 to 12 total calls before they fully understand and believe in the product's clinical information and then identify appropriate patients to trial a new medication and begin to change behavior. On that note, we observed a number of new prescribers of XHANCE increased steadily in the third quarter. We believe this is evidence that we are starting to change behavior and broaden our prescribing audience. Looking slightly forward, we've modified our call plan for our territory managers in the fourth quarter to concentrate on a target audience of the top 75 CS potential HCPs per territory. That's compared to approximately 105 Top CS potential HCPs that we targeted earlier this year. In doing so, we aim to increase the number and frequency of calls on our most important targets and accelerate progress towards product adoption as a standard part of clinical practice. This elevation in focus and frequency is supported by promotional response analysis from the first six months of the XHANCE launch. Prescription fulfillment and particularly hub services and the pharmacy network is the second aspect of commercial performance that I would like to address today. We always expected that incremental refinements in the efficiency and delivered HCP and patient experience, would be necessary over the first months of initial implementation of our new hub, both for new and refill prescription processes. However, this has required more time and effort to optimize than initially anticipated. An important example is that in September, we decided to add to the network dispensing pharmacies underneath the hub to improve prescription fulfillment and capacity. We also made other changes to optimize hub performance during the third quarter, most especially related to the HCP and patient prescribing fulfillment experience. We're continuing to work closely with our customers, patients and partners to get their feedback and ideas to continually optimize prescription fulfillment processes. Finally, improving the quality of insurance coverage is another focus of our commercialization effort. While approximately 70% of lives are in insurance plans that cover XHANCE, we estimate that approximately 50% of commercial covered lives are subject to prior authorizations. We believe that prior authorizations can create hassles for prescribers and challenges for efficient prescription fulfillment for the patient. On that front, we announced some positive news at the start of the third quarter with the addition of XHANCE to Express Scripts' national formularies, including National Preferred Flex (NASDAQ:FLEX) and Basic formularies, which are among the largest commercial formularies in the U.S. with more than 24 million lives in total. We believe this is an important milestone for patients who suffer from chronic sinusitis and for our business as this improvement will make it easier and more affordable for patients in these plans to get XHANCE, the only FDA-approved medication for the treatment of this disease. From a business perspective, ESI preferred formulary coverage requires only a single step that the patient has previously used standard delivery nasal steroids. Prescribers will not have to complete a prior authorization if the insurer's records support the patient's prior use of such therapy. Being included on Express Scripts' formularies was just a step of this journey. In the third quarter, we began to equip our territory managers with training, messaging and tools that enable them to have discussions with individual prescribers about this improved insurance coverage that was specific to their practices. Using these tools, our representatives were able to start the process of reforming target prescribers with a concentration of patients in these formularies about the new coverage. And we are now starting to see the evidence of the pull-through, which I will discuss further in the next slide. During the third quarter, our sales team increased the total calls with top potential ESI targets by 24% over the first quarter, and we are seeing a significant increase in new prescriptions from these targets through early October. As we move forward, we believe this type of coverage enhancement can facilitate improvement in both prescribing and in fulfillment at the pharmacy. And so we're pursuing opportunities for OptiNose to continue to improve coverage by reducing utilization management burden, for example, removing prior authorizations and step edits. Further streamlining the prescription fulfillment process and improving the quality of our insurance coverage over time, will also help prepare the market for potential future commercial initiatives that we've discussed in the past, such as sales force expansion in specialty offices, the addition of a primary care partnership and direct-to-consumer engagement aimed at expanding our reach to more than 30 million total patients with chronic sinusitis. Turning to Slide 7. We believe new prescription growth is an important measure of CS launch performance. We believe the improvements in sales force execution and hub services and pharmacy network and in insurance coverage have all contributed to a recent inflection in new prescriptions. On this slide, we show the four-week moving average of weekly new prescriptions, starting with the week ended June 28 through the week ended October 25, which is the most recent week available for today's presentation. We're showing a moving average to better illustrate trends over time by reducing the week-to-week noise created by factors such as holiday weeks and the estimation process inherent to the third-party data included in our prescription metrics. As you can see, in July and August, prior to the inflection period during September, this moving average range between approximately 1,760 to 1,960 NRx. During October so far, the moving average has reached approximately 2,300 to 2,500 NRx per week. That equates to a growth of approximately 20% to 40%. As we've discussed previously, new prescriptions drive the refill prescriptions that are a vital component to enhance net revenues and overall growth in future periods. It's noteworthy that new prescriptions for the most recent six weeks ending October 25 include the top 5 ranked weeks for new prescriptions in 2024. In addition, we believe that among other changes made in the third quarter, the enhancement of sales force targeting to focus on the top ESI HCPs and generating a desirable promotional response is contributing meaningfully to the overall inflection that new prescriptions has occurred. I would like to turn the call over now to Terry Kohler to review our third quarter financial performance and the financial guidance for the full-year 2024. Terry?
Terry Kohler: Thank you, Paul. Turning to Slide 9. As Ramy mentioned earlier in his remarks, OptiNose recognized $20.4 million of XHANCE net revenue in the third quarter of 2024, a 3% increase compared to third quarter 2023 net revenues of $19.8 million. As we also mentioned in our 10-Q filed this morning, revenue in the quarter reflects an increase in inventory in the channel, driven in part by the addition of new dispensing pharmacies in the hub pharmacy network, as Paul discussed earlier. 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 third quarter of 2024 was $320, a 36% increase compared to $236 of estimated average net revenue per prescription in the third quarter of 2023. The year-over-year increase is driven by favorable business mix resulting from the changes we made to our co-pay support program, which improved our commercial business mix and by the channel inventory build associated in part with the onboarding of new pharmacies in the latter part of the third quarter. I will discuss this in more detail when reviewing our expectations for full-year 2024. Finally, as we've reported earlier, OptiNose recognized $20.4 million of SG&A plus R&D expenses in the third quarter of 2024. This is an increase of approximately $1 million compared to third quarter 2023 expenses of $19.3 million and is attributable to promotional efforts supporting the CS launch. However, compared to our original expectations, there is favorability in operating expenses. This operating expense favorability influences our thinking about financial guidance for full-year 2024 and projected cash balances, which I will discuss shortly. Turning to Slide 10. Similar to our results through the first half of 2024, our third quarter results reflect improvements to net revenue per prescription and the initial investments to support the CS launch. Regarding revenue, OptiNose recognized $55.8 million of XHANCE net revenue year-to-date through September 2024, a 9% increase compared to prior year period XHANCE net revenue of $51.1 million. XHANCE average net revenue per prescription for the nine months ended September 30, 2024 was $285, a 45% increase compared to $197 of estimated average net revenue per prescription for the prior year period. Most of this increase is driven by the changes to our co-pay assistance program, which has resulted in a reduction in the number and proportion of commercial prescriptions that were historically unprofitable. In addition, the increase in inventory in the channel during the third quarter of 2024 that we discussed earlier provided some lift. Finally, as we reported earlier, OptiNose recognized $67.2 million of SG&A plus R&D expenses in year-to-date through September 2024. This is approximately a $2 million increase compared to year-to-date through September 2023 expenses of $64.9 million. As with the third quarter results, the year-to-date increase was expected and is attributable to the promotional efforts supporting the CS launch. Turning to Slide 12. Based on all the factors we have just discussed, we are changing our expectation for full-year 2024 XHANCE net revenue, XHANCE revenue per prescription and operating expenses. Our guidance for XHANCE net revenue for full-year 2024 is between $75 million to $79 million. Previously, we expected XHANCE net revenue for full-year 2024 to be between $85 million and $90 million. The implied fourth quarter revenue guidance is approximately $19 million to $23 million, reflecting uncertainty projecting the shape of the curve and demand growth we will experience in the context of an encouraging recent inflection in new prescriptions, but recognizing that much of our business is comprised of refills that will take time to come into play. As we have discussed previously, we continue to expect average net product revenues per prescription to increase in 2024 compared to 2023, primarily because of revisions that we made to our co-pay assistance program in 2023 and early 2024. The magnitude of the benefit derived from these revisions to our co-pay assistance program was greater than we expected in the first nine months of 2024. As a result, we are increasing our expected average net product revenues per prescription estimate for full-year 2024. Specifically, we now expect XHANCE average net revenues per prescription to be approximately $270 for the full-year of 2024, which represents an increase of approximately 29% compared to $209 for the full-year of 2023. Previously, we expected XHANCE average net revenues per prescription to exceed $250 for the full-year 2024. In addition, the change in loans trajectory has resulted in operating expense favorability. A portion of the favorability is volume related in the form of lower-than-projected variable product expenses. Together with reduced third-party expenses and payroll savings, we expect an overall reduction of at least $5 million. Our full-year 2024 operating expense guidance is now $90 million to $93 million of which approximately $6 million is expected to be stock-based compensation. Previously, we expect the total operating expenses to be between $95 million to $101 million, of which approximately $6 million was expected to be stock-based compensation. Based on these new expectations, we now believe our existing cash and cash equivalents will be sufficient to fund our operations and debt service obligations for at least the next 12 months, if we are able to maintain compliance with or obtain a waiver or modification of the financial and other covenants under our debt agreement. I will now turn the call back over to Ramy for closing remarks. Ramy?
Ramy Mahmoud: Thanks, Terry, and thank you, Paul. Turning to Slide 14. Before moving to take questions, I'd like to return to a high level view of the opportunity in front of us. High disease prevalence, the high perceived unmet need and symptomatic nature of the disease, and the lack of alternative medications that are proven to work or which are approved by FDA for the condition. We believe the overall future potential of XHANCE with the new chronic sinusitis indication is large and has potential to reshape this business for years into the future. While the initial CS launch, like many product launches, has been a bit slow, recent data suggests that we are starting to see evidence of progress consistent with the expected future potential of XHANCE. XHANCE remains an attractive asset. And in our current specialty audience, we believe peak annual net revenues of at least $300 million are achievable. In addition, we are actively working to engage in a commercial primary care partnership or to adopt other approaches that will allow us to access the large incremental opportunity in the primary care space. With that, I'd like to thank you for your attention and open the call for Q&A.
Operator: Thank you. [Operator Instructions]. Our first question comes from Thomas Flaten with Lake Street Capital Markets. Your line is open.
Thomas Flaten: Good morning. Thanks for taking the questions. Just on the guide, on the low end, if we just do the math, that would imply a sequentially down fourth quarter. Could you maybe fill us in on some of the factors that would prompt you to be that conservative at this point?
Terry Kohler: Sure, Thomas. Good morning. Thank you for the question. So in the third quarter, our revenue was affected as we mentioned in our script with some inventory stocking in the channel. That inventory stocking represented a little under $3 million. And so when you think about Q4, our guide in the context of that adjusted Q3, there's a step up in demand that we're expecting in Q4.
Thomas Flaten: Got it. And then there was a fair bit of conversation about insurance coverage and you mentioned 70% of the patients who had or plans that covered XHANCE, what number -- what proportion of the plans that currently cover XHANCE have updated their policies for the new indication?
Ramy Mahmoud: So Thomas, it's a little hard to be sure about that, because some of the updates aren't sort of fundamental changes in coverage, there changes qualitatively to the content of the prior authorization forms. But we believe that at this point, most plans have updated their coverage to be inclusive of both approved indications.
Thomas Flaten: Got it. And then just one final one. You have talked about full-year profitability in 2025. Any change to that guidance? Or should we or how should we think about that?
Terry Kohler: We are actually -- we're evaluating that, Thomas. We are not going to have give any 2025 guidance on today's call. But we are removing that guidance so that we can take an opportunity to evaluate our performance in the fourth quarter and how that will impact our expectations for 2025 revenue.
Ramy Mahmoud: Just to add to that, as Terry said a few minutes ago, with the recent inflection in demand that we've seen, which is encouraging, it becomes a little bit more difficult to forward project exactly what we're going to see over the course of the entire coming year. And as a consequence of some of that uncertainty associated with our recent positive inflection, we have to be in the position of reevaluating what the next year is going to look like.
Thomas Flaten: Excellent. I appreciate you taking the question. Thank you.
Operator: Thank you. Our next question comes from David Amsellem with Piper Sandler. Your line is open.
David Amsellem: Thanks. Just a quick one on the cost structure. Do you feel like it's rightsized. Can you talk about, I know you've talked about a primary care co-promote, but just talk generally about the cost structure, the sales force and to the extent that there isn't a partner, how are you thinking about managing spend given the trajectory of XHANCE so you can get to profitability eventually? Thank you.
Ramy Mahmoud: Yes. That's a complex and challenging question, David. We have been cautious about our spending. As you can tell from the fact that our operating expenses are actually relatively tightly controlled even in the context of a launch year. So I think the answer is that we have to regularly continuously monitor the rate of our investment in the business based on the responsiveness we're seeing to our investments and the rate of growth that we're seeing. So the recent inflection in growth that we've seen over the last few months here changes our thinking relative to what it might have been as recently as the middle of this summer. And we're going to have to continue to reassess as we go forward. So I can't really give you a concrete answer about that, but I will also add that -- and as we have said before, we believe that there is incremental opportunity even in the specialty space, beyond what we're able to get at with our current level of investment. So when the time is right, we think there's ROI positive opportunity for incremental investment even within our current footprint outside of the primary care space.
Operator: Thank you. Our next question comes from Glen Santangelo with Jefferies. Your line is open.
Glen Santangelo: Yes, good morning. Thanks for taking my question. Hey, Terry, I missed in your prepared remarks, you gave the net revenue for prescription this quarter. Did you say $320. And can you remind us what that was in 2Q?
Terry Kohler: Sure, Glen. In 2Q, it was $309. And yes, that's correct, $320 in Q3.
Glen Santangelo: Okay. And so maybe just back to that previous question on the implied 4Q guidance, because it looks like your scripts are almost trending up almost 30% on a sequential basis. And with the improved sort of reimbursement, it would seem like even accounting for the inventory, the inventory gain in 3Q is just sort of like the low end of that guidance somewhat not consume with the uptick in the scripts that you're seeing. So I just want to make sure I'm not misstating else.
Terry Kohler: So year-to-date, net revenue per prescription is about $285 million. So you're correct. There is an implied step down in Q4. As a reminder, the year-to-date figure includes the impact of the changed health care outage in Q2, which we believe benefited our net revenue per prescription and as you mentioned that the inventory stocking in the third quarter benefited the third quarter number. So full-year guidance is at 270-foot per prescription.
Ramy Mahmoud: Glen, can I just add a couple of thoughts to what Terry just said, it might help address your question. The first is that the average net revenue per prescription in the fourth quarter, historically, if you look over all the years we've been on the market tends to be lower than it has been in some of the prior quarters. So take a look at our overall expectation for the year and not just our third quarter results as you're thinking about projecting the fourth quarter. The other thing I want to kind of remind you about and we mentioned this earlier, is that we showed you the NRx trends, the new prescription trend. But we have a chronic disease treatment. And historically, and I would expect in the future, a large fraction of our total prescriptions are actually refilled and not just new prescriptions. So new prescriptions are a leading indicator, and it takes some time for all the refills to stack up subsequent to the new prescriptions and drive total prescriptions up correspondingly.
Glen Santangelo: Okay. Thanks very much.
Operator: Thank you. Our next question comes from Matthew Caufield with H.C. Wainwright. Your line is open.
Matthew Caufield: Hi, thanks. Good morning guys. For the specialty space, how is the uptake differ at all between polyp or non-polyp patients? And is that distinction even being made by prescribers based on the broad labeling?
Ramy Mahmoud: So Matt, I appreciate your question. I think I understand where you're coming from. But I'll just reiterate something that I think we've said before, which is that we have difficulty distinguishing the parts of our business that are coming from nasal polyps and chronic sinusitis. I don't know that we can have confidence in the specificity with which that is reported in prescribing practice or the specificity with which it's reported in sort of third-party purchased claims data. So I think it's our overall business we have to look at, and we just don't want to pay too much attention to the buy diagnosis fractions of that business, it's just not clear we can rely on that.
Matthew Caufield: Got it. Okay. That's helpful. And then just one other follow-up. I was curious is the greatest kind of high level pushback from prescribers based on not distinguishing that XHANCE is not just a familiar steroid therapy. Is that kind of their biggest version or pushback to getting on board?
Ramy Mahmoud: I think -- and I'm kind of paraphrasing something that Paul articulated earlier. I think our view is that we have to get the word out. We can't assume that prescribers will understand the benefit of our product, especially in the new indication, where their prior experience suggests that the products they've tried before in the nasal steroid category have not been very helpful would limited data of benefit and personal experience supporting that. So it's incumbent on us to get the word out about the clinical data that we have and the real benefit that they can bring to patients. And it's taking us time, and we have to learn from experience as we go and how we can be effective in getting the word out. So it's not so much push back. It's about people won't adopt until they appreciate the real benefits that can be offered. And it's taking us -- it's a real effort to get that out in people's hands.
Matthew Caufield: Okay. Very helpful. I appreciate that.
Operator: Thank you. I'm showing no further questions at this time. I'd like to turn the call back over to Ramy Mahmoud for closing remarks.
Ramy Mahmoud: All right. So thank you very much for joining this morning. I appreciate you hanging with us as we went through a little bit more content than usual to describe sort of a complex quarter and unpack all the different things that have happened. We're looking forward to some of the positive trends that we have described being projected forward into the fourth quarter, and we look forward to coming back and telling you about it in our next quarterly update call. Thank you again.
Operator: Thank you for your participation. This does conclude the program, and you may now disconnect. Everyone, have a great day.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.