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spk00: Hello, and welcome to the OptiKnow's second quarter 2024 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising that your hand has been raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. It is now my pleasure to introduce Vice President of Investor Relations, Jonathan Neely.
spk05: Good morning. Thank you for joining us today as we review OptiNose's second quarter 2024 performance and our plans for the remainder of the year. I'm joined today by our CEO, Dr. Rami Mahmoud, and our Chief Commercial Officer, Paul Spence. 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 in 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 Opti-Nose's most recent Form 10-K and 10-Q that are filed with the SEC and available at their website, sec.gov, and our website at optinose.com. Your caution not to place undue reliance on forward-looking statements. Forward-looking statements during this conference call speak only as of the original date of this call or any earlier date indicated in such statement, and we undertake no obligation to update or revise any of these statements. We will now make prepared remarks, and then we will move to a question and answer session. With that, I will now turn the call over to Rami.
spk02: Thank you, Jonathan, and thank you to everyone listening for joining us this morning. We appreciate you joining us for our second quarter 2024 update. Starting on slide three, We're pleased to report a promising start to our chronic sinusitis launch and good progress in the quarter. I'll start with a brief outline of what we'll cover during our call today. First, I'll review three key takeaways from today's call. Second, our Chief Commercial Officer, Paul Spence, will discuss our early efforts to educate our ENT and allergy specialist physician audience on XANCE's new clinical profile and some encouraging early signals of progress that will enable future uptake. Next, Jonathan Neely, our VP of Investor Relations and Business Development, will review our second quarter 2024 performance and our financial guidance for full year 2024. Finally, we'll return to wrap up the call and take your questions. Turning to slide four, I'd like to highlight three key takeaways from today's presentation. First, I'd like to reiterate the significant long-term potential of the opportunity in front of us, which we believe has potential to reshape our business for years into the future. Claims data suggests that chronic sinusitis is currently being diagnosed by healthcare providers at least 10 times more frequently than nasal polyps. Reshaping our business by launching exams in chronic sinusitis started in the second quarter. In April, we held a national sales meeting to complete training of our sales team, and they are now engaged with a full set of new materials and have been interacting with a universe of both familiar and new prescribers. As a reminder, our plan is to launch with our current Salesforce infrastructure Arming our sales team with a suite of new chronic sinusitis promotional materials accompanied by digital and non personal promotion. And by educational efforts based on the new label with the objective of attaining peak year sales of at least $300 million and producing positive income from operations for full year 2025. Over the course of the prior five quarters since I accepted responsibility for this position, our focus has been on seeking approval for the new first and only chronic sinusitis indication. on greatly increasing our operating efficiency, on stabilizing enhanced revenue, and on preparing our organization for the greatly expanded opportunity in chronic sinusitis. Our success in these areas means that initial launch efforts by our commercial team in the second quarter of this year are building on a significantly stronger base than we had at the start of 2023. From a financial perspective, this includes a stronger balance sheet, lower expenses, and improving average net revenue per prescription. During the first few quarters of launch, we are aiming to sustain our operating efficiency gains while building on the strength and foundation to begin to penetrate the greatly expanded total addressable market resulting from our first and only new CS indication. Over the initial quarters after launch, we expected gradually improving insurance coverage and are pleased that late in second quarter, expense was added to large Express Scripts national formularies. You'll hear more about that in a moment. In the second quarter, we also empowered our sales force to use new and differentiated clinical data and new promotional materials to engage prescribers and begin the educational interactions that should facilitate gradual adoption of exams as a regular part of clinical practice for treating this underserved disease. In addition, as we previously noted earlier this year, we began to transition much of our prescription fulfillment to a central intake pharmacy or hub. And during the first few quarters of launch, we expect to continue work to optimize the effectiveness of that fulfillment channel. Overall, we believe we're making progress on laying the necessary foundation to be able to realize the significant long-term potential of Exance in our new market. Today, we're reporting on the first quarter of our launch and have achieved revenue consistent with our expectations. Our Chief Commercial Officer, Paul Spence, will provide some encouraging updates about initial progress by his team in just a moment. We continue to believe the first few quarters after launch will produce gradual growth while we progressively implement insurance coverage changes and steadily educate target prescribers on clinical data related to the new indication. We continue to believe that consistent commercial plan execution on multiple fronts will lead to future acceleration of the growth trajectory in the much larger market that has now been opened for exams. Lastly, during the first half of this year, we have been more successful than we originally anticipated in our efforts to focus on profitable business and move away from lower profit and unprofitable business. As a result, we are increasing our expectation for enhanced net revenue per prescription for full year 2024 to at least $250, compared to our previous expectation of at least $230, an increase of at least 20% compared to 2023. We're also narrowing our full year 2024 enhanced net revenue guidance range to $85 to $90 million from $85 to $95 million previously. The new range represents revenue growth of 20 to 27% compared to full year 2023 revenues of $71 million. The narrowing of the revenue range reflects removal of revenues associated with lower profit and unprofitable business for which we have intentionally reduced copay support. We believe focusing on growth in profitable lines of business will result in a healthier more sustainable business over the long term. It's important to note that the combined effect of these two changes is directionally offsetting, which leaves our expectations for cash runway and operating income largely unchanged. Finally, with respect to operating expense, we continue to plan for full year 2024 to be modestly incremental to full year 2023 in support of promotional launch efforts as previously communicated. I'd now like to turn the call over to Paul Spence, to review initial launch performance and recent commercial highlights. Paul?
spk04: Thank you, Rami. Turning to slide six. To set the context, we are leveraging four major tactics to launch Xhance into this major new market opportunity. These include in-person promotions by our sales force, non-personal promotion, peer-to-peer education, and presence at medical meetings. The Xhance launch into chronic sinusitis required a significant shift in our commercial model, most especially around the opportunity to expand the number of new advanced prescribers. Some estimate that with new products and indications, they require 10 to 12 calls on new physicians before they fully understand and believe in a product's clinical information, and then identify appropriate patients to trial the new medication and change behavior. In second quarter, we started that climb to the hill. Successful product trials across our new physician targets will be a precursor for consistent adoption and continued growth over time. Our efforts thus far are already getting the ball rolling with both naive enhanced prescribers and those ACPs we believe prescribe very little due to prior restrictions around the nasal polyps only indication. And we expect gradually accelerating product uptake in the second half of this year. Since the CS launch, more than half of the sales calls have been made to ACPs who we categorize as naive to prescribing these hands or as having a history of infrequently prescribing prior to the CS approval. New and total prescription growth with both groups has started out positive and we believe is responding to a combination of sales calls, peer-to-peer education programs, and sampling. Our market research suggests that within this group of HCPs, the allergy and primary care prescribers appear to be having a stronger initial response to our communication about the new CS indication and efficacy of . In addition, market research validates that these HCP targets use efficacy as their number one preference driver in the CS space. And therefore, our primary strategic communication focus is to educate them about Exhance's differentiated efficacy. We expect the adoption of Exhance by this group of high potential HCPs to gradually continue to grow in the second half and that we will advance the number of both new and more frequent prescribers of Exhance. The balance of our direct selling resources are deployed against high CS volume ENT and allergy specialists who have a history of prescribing Exhance. We continue to listen to and work closely with these ACPs and their staff to support their efforts to bring ACANTS to significantly more CF patients via strong clinical evidence, personal experience with the product ACANTS, and streamlined prescribing process. For example, we've deployed new field support resources via the Hub that we expect to help advance HCP staff proficiency within the ACANTS patient support program and to ease the process of working with the hub. We believe this, in combination with important educational efforts on new Xhance clinical information, will begin to translate into this group of prescribers choosing Xhance for treatment of more CS patients over time. In parallel, we are also focused on increasing productivity of our promotional efforts by improving overall commercial coverage and access to Xhance. We're constantly working to streamline the process for managing prior authorization paperwork and the overall prescription fulfillment process and continuing to offer a patient-friendly co-pay support program to ensure the experience for HCPs and patients is as smooth and accessible as possible. Removing and reducing obstacles to filling and refilling prescriptions for both patients and doctors alike will ensure that more CS patients can receive and stay on enhanced therapy maintaining their symptom control throughout the year. Turning to slide seven. At the end of June, we announced the addition of the CANS to large Express Scripts national formularies. Concluding in this is national preferred, flex, and basic formularies. These are among the largest commercial formularies in the US with more than 24 million lives. This also marks the first time that CANS has held preferred tier two coverage on a national formulary. 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 a CAN, which is the only approved medication for the treatment of this disease. From a business perspective, the new ASI preferred formulary coverage requires only a simple step, that the patient is privileged to use a standard delivery nasal steroids. Prescribers will not have to complete prior authorization paperwork. This is expected to improve prescribing and fulfillment at the pharmacy. 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 Salesforce expansion in specialty offices the addition of a primary care partnership, and further consumer engagement, which can expand our reach to more than 30 million total patients with chronic sinusitis. As mentioned earlier, the Xhance CS launch presents a significant change in our commercial strategy and requires a shift in the Xhance business from a small, dense group of prescribers to now a much larger group of HCPs with big future potential in CS. It takes time to deliver the necessary number of engagements with high potential HCPs, especially including both those new to Xant and those not new, but are new to the chronic sinusitis data, in order to move their interest and prescribing of Xant. We expect this to gradually accelerate over the first few quarters of our launch, and I believe we're seeing early patterns suggesting green shoots of growth that increase my confidence and future potential of Xhance. Finally, you may recall earlier this year, we launched a central intake pharmacy model, or a hub, to prepare for the growth that we expect from Xhance's new indication. During Q2, we transitioned to a significant portion of our business from a historical preferred pharmacy network, now to the hub. In addition to offering the necessary scalability for anticipated growth and providing improved protections for business continuity, we believe the hub has the potential to provide more comprehensive and consistent patient support and prescription fulfillment services. This transition has been slight, has had a slight headwind as we continue to optimize the process at the hub and as ACP offices become familiar with working with this new fulfillment channel. However, We believe this transition will become a tailwind as we begin to realize the efficiencies that the hub can offer. I would like to now turn it over to Jonathan Neely to review our second quarter financial performance and financial guidance for the full 24 year. Jonathan.
spk05: Thank you, Paul. Turning to slide nine. We are encouraged by our second quarter 2024 financial results. Regarding revenue, OptiNose recognized $20.5 million of ExanceNet revenue in the second quarter. A 5% increase compared to the second quarter of 2023 net revenues of $19.5 million. Based on available prescription and inventory data purchased from third parties and on data which we received directly from our hub and preferred pharmacy network, the estimated expense average net revenue per prescription for the second quarter of 2024 was $309, a 44% increase compared to $214 of estimated average net revenue per prescription in the second quarter of 2023. As discussed on our first quarter earnings call, the year-over-year increase is driven by favorable business mix resulting from changes we made to our co-pay support program. I will discuss this in more detail when reviewing our expectations for full year 2024. Finally, as we reported earlier, Opti-Notice recognized $25.1 million of test DNA plus R&D expenses in the second quarter of 2024. This is an increase of approximately $4 million compared to the second quarter 2023 expenses of $21.1 million. Turning to slide 10, our results for first half of 2024 similarly reflect the improvements to net revenue per prescription and the initial investments to support the CS launch. Regarding revenue, OP&NOS recognized $35.4 million of EXAMS net revenue in the first half of 2024, a 13% increase compared to the first half of 2023 net revenues of $31.3 million. Expanse net revenue per prescription for the first half of 2024 was $269, a 51% increase compared to $178 of estimated average net revenue per prescription in the first half of 2023. Finally, as we reported earlier, OptiNose recognized $46.8 million of SG&A plus R&D expenses in the first half of 2024. This is approximately $1 million increase compared to the first half 2023 expenses of $45.6 million. Turning to slide 12, our full-year 2024 operating expense guidance remains unchanged. We expect total operating expenses to be between $95 to $101 million, of which approximately $6 million is expected to be stock-based compensation. What is changing is our expectation for both full-year 2024 expense net revenue and full-year 2024 revenue per prescription. As we have discussed previously, we expect average net product revenues per prescription to increase in 2024 compared to 2023, primarily as a result of the revisions that we made to our copay assistance program in 2023 and early 2024, intended to enhance average net revenue per prescription by reducing copay support to, and thus prescriptions filled by, patients and commercial insurance plans that either do not cover exams or are in commercial insurance plans that have high deductibles as these prescriptions have limited or no profitability. The magnitude of the benefit derived from these revisions to our copay assistance program was greater than we expected in the first half of 2024. And as a result, today we are increasing our expected average net product revenues per prescription estimate for the full year 2024, while narrowing our expected range for full year 2024 exams net revenues. Specifically, we now expect XAMPP's net revenues per prescription to exceed $250 for the full year of 2024, which represents an increase of at least 20% compared to $209 for the full year of 2023. Previously, we expected XAMPP's average net revenues per prescription to exceed $230 for the full year of 2024. Finally, our guidance for XAMPP's net revenue for the full year of 2024 is now between 85 to $90 million compared to full year 2023. This is growth of 20 to 20, 20% to 27%. Previously, we expected exams net revenue for the full year 2024 to be between 85 million to $95 million. The narrowing of the guidance range for the full year of 2024 exam notes net revenues is primarily driven by our expectation for less net revenue from prescriptions that have limited or no profitability for which we have intentionally reduced the level of copay support. These revised expectations are offsetting, and as a result, our projections for operating income and cash runway are largely unaffected. We continue to expect that our existing cash and cash equivalents will be sufficient to fund our operations and debt service obligations through 2025, and that we will produce positive income from operations for full year 2025. I will now turn the call back over to Rami for closing remarks. Rami?
spk02: Thanks, Jonathan. Turning to slide 14. Before moving to take questions, I'd like to reiterate the significance of the opportunity in front of us, which we believe has potential to reshape our business for years into the future. We're pleased with the success we had in executing our prelaunch operating strategy. In 2023, we achieved increased operating efficiency while stabilizing revenue in the comparatively niche nasal polyp indication. At the same time, we preserved capital and focused our organization on preparations to seize the much larger opportunity that would be created by approval of exams as the first prescription treatment for one of the most common diseases diagnosed in adult outpatient medicine. We are still in the early innings of our launch, but we've already begun to see the desired improvements in insurance coverage following our new indication and are laying the groundwork necessary to expand our prescriber base for the future. Although we expect it will naturally take some time to realize the benefits of our initial efforts, We continue to believe that the size of this opportunity, coupled with a stronger balance sheet, position us well to build a profitable ENT and allergy-focused business by tapping into the significantly expanded net revenue potential with an efficient base of commercial capabilities. In addition, we believe the chronic sinusitis indication will facilitate commercial partnerships or other approaches to accessing additional value in the primary care space that's incremental to what we can access on our own in the specialty segment. With that, I'd like to thank you very much for your attention and open the call up for Q&A.
spk00: As a reminder, ladies and gentlemen, to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. And our first question comes from the line of David Amsalem with Piper Sandler.
spk01: Hi, thanks. It's a Skyler on for David. So curious, what are your assumptions for your path to profitability? In other words, what level of sales do you think you need to get to in order to reach break even? And what are your overall thoughts on balancing the sales force versus extending cash runway? And then similarly, how do you feel about your revenue covenant in third quarter? Are you concerned at all about not meeting that minimum? Thanks.
spk02: Thanks for the question. I'll take the second of your three questions and I'll ask Jonathan to speak to the first and the third. Your second one was around the Salesforce and I'll just reiterate what we have said before that our plan is to launch with our current Salesforce infrastructure. So at least through third quarter, probably through the remainder of the year and potentially significantly longer. We don't expect to make material changes to our current Salesforce infrastructure. Jonathan, do you want to address the first and third questions?
spk05: Sure. Might ask you to remind me of the third one by the time we get there. But in terms of the pathway to profitability, I think what we've highlighted for everybody is that for this year, we're expecting revenue growth of somewhere between 20% to 27%. And that over the long term, we think that the peak revenue potential for this product inside of our current commercial infrastructure is approximately $300 million. And so that's going to, you know, apply kind of multiple years of strong growth ahead of us. And so, you know, we think that if you were to look at a product with 90%, you know, approximately 90% gross margins and the types of operating, you know, expense structure, you know, that, you know, we have today that, you know, there's a clear pathway to profitability, you know, for the full year of 2025. In terms of The third question, can you remind me of the third question? I was taking some notes on the first one.
spk01: Yeah, no, just if you're confident on the revenue covenant in the third quarter.
spk05: Oh, yeah. I mean, I think, you know, this third quarter revenue covenant, I think, you know, we're probably already on a trailing 12-month basis, you know, I think, ahead of that. And so, you know, again, I think we're expecting growth for this year. And so, I think we're on a pathway to maintain compliance as a reminder. I think that number is $72.5 million for the third quarter, and for the fourth quarter, the target is trailing 12 months of sales of $75 million.
spk01: Great. Helpful. Thank you.
spk00: Thank you. One moment, please, for our next question. Our next question comes from the line of Thomas Flatton with Lake Street Capital Markets.
spk03: Good morning. I appreciate you taking the questions. Uh, Jonathan, on the average net revenue per prescription, you know, for the first half, you're already at 269 and, and that number tends to stay similar across the third and fourth quarter. So 250 seems a bit conservative. Should I read it that way? Or do you think there's upside to that number? And I know you said it would exceed 250, but it seems like 250 is a very conservative number.
spk05: Um, Thanks, Thomas, for the question. Yeah, so I mean, again, I think what we're trying to build in to our expectation for average net revenue per prescription is some flexibility for the lower profit or not profitable kind of volumes to rebound in conjunction with the launch. Clearly, I think through the first half, we haven't seen that volume kind of come back into the business. And it also, I think, allows us, you know, some operational flexibility, you know, related to co-pay assistance and other programs that could be used to, you know, stimulate additional demand, you know, as we move through the second half. I think our, you know, so yes, we're at 269, you know, on a year-to-date basis, and there is some room up against the 250, but it allows us some flexibility.
spk02: You know, Tom, I'll just, this is Rami, I'll just remind you that, you know, In first half, we also had the sort of strange one-time event of the change healthcare disruption in the switch. And as a consequence of that, we saw sort of an artificial one-off suppression of unprofitable volumes with an emphasis on profitable volumes that we might not otherwise have seen. So we're trying to think carefully about the effect of that sort of one-time event also.
spk03: Great. And then maybe for Paul, I'm just curious, in the dialogue you've had with payers to expand the coverage to the new indication, qualitatively, what have those engagements been like? Has there been any pushback? Is it more of just a paper processing issue?
spk04: Yeah. Thanks for the question, Thomas. What I'd say is that payers are seeing the increased demand in prescribing as a result of the new indication in our efforts. And as a result, more and more are approaching us about that indication and the opportunity for improved access and improved coverage across the board. Other than that, we continue to work with our own processes and HCPs around paperwork and supporting their staff and the HCPs and the patients in doing it. But overall, payers are noticing the demand increasing as a result of the indication and our efforts.
spk03: Excellent. Thanks so much. Thank you.
spk00: Thank you. I'll now hand the call back over to CEO Rami Mahmoud for any closing remarks.
spk02: Great. Thank you very much. So I'll just close by reiterating that we're in a formative phase of our business right now. We've made a major transition from preparing ourselves and sort of laying the groundwork to be able to seize the opportunity associated with our new indication to beginning the execution process on the gradual ramp up over time with the new indication. And we believe we're making progress on those foundational activities in the initial couple of months here. We look forward to getting back with you again in a few months to tell you a little bit more about our progress during the second quarter of launch. Thank you again for joining today.
spk00: Ladies and gentlemen, thank you for participating. This does conclude today's program, and you may now disconnect.
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